REPUBLIC OF BULGARIA

MINISTRY OF ENVIRONMENT AND WATER

1000 Sofia, 67 W. Gladstone St., Bulgaria

National Profile to Assess

the National Infrastructure for Management of Chemicals

Silvia Raikova

National Co-ordinator

december, 1997

 Table of Contents

Introduction in the National Profile. Summary

Chapter 1: General Information on Republic of Bulgaria

Chapter 2: Chemical Production, Import, Export and Use

Chapter 3: Priority Concerns Related to Chemical Production, Import, Export and Use

Chapter 4: Legal Instruments and Non - regulatory Mechanisms for Managing Chemicals

Chapter 5: Ministries, Agencies and Other Institutions Managing Chemicals

Chapter 6: Relevant Activities of Industry, Public Interest Groups and Research Sector

Chapter 7: Inter - ministerial Commissions and Co-ordinating Mechanisms

Chapter 8: Data Access and Use

Chapter 9: Technical Infrastructure

Chapter 10: International Linkages

Chapter 11: Awareness/Understanding of Workers and the Public

Chapter 12: Resources Available and Needed for Chemicals Management

Annexes

INTRODUCTION

UNO’s Conference on the Environment Protection and Sustainable Development (hold in Rio de Janeiro in 1992) specified the international political frame for activities in the field of chemicals’ management. Representatives of all participating countries approved the idea for environmentally friendly management of chemicals, including prevention of illegal international traffic of toxic and dangerous products till year 2000. The participants in the International Conference on Chemicals’ safety (hold in Stockholm in 1994) further developed this idea.

Contribution of international legal instruments, connected with specific aspects of chemicals’ management and accepted in eighty’s is very significant.

Preparation of a National profile for evaluating the national infrastructure for chemicals’ management in Bulgaria and in other countries is a result of efforts made by UNITAR/IOMC.

Contemporary management of chemicals and chemical products in Republic of Bulgaria by the Government is imposed by some important reasons:

• to meet the international agreements connected with a) harmonisation of Bulgarian’s legislation with the legislation of the European Community, and b) admission of Republic of Bulgaria to membership of the World Trade Organization;
• to ensure the safety necessary for chemicals’ production, use, transport and storage;
• to decrease the environmental and health risk, as well as the consequences of eventual accidents;
• to meet the requirements for European Community membership;

Big enterprises for producing organic and inorganic chemical products are available in Bulgaria. In spite of the problem's characteristic for all industrial sectors during the transitional period, chemical industry remains one of the most attractive and dynamic branches of Bulgarian’s industry. It realizes more than 30 per cent of country’s export and main import of chemical substances and products, and forms about 1/3 of the total national income. That’s why, increased interest in privatization of many chemical enterprises is shown, and the biggest transactions of cash privatization are in this sector of industry.

Elaboration of National profile for evaluating the national infrastructure for chemicals’ management is based on an agreement between UNO’s Institute for Training and Research (UNITAR) and Ministry of Environment and Water (MEW) – Bulgaria. Directorate GENERAL XI, Environment, Nuclear Safety and Civil Protection of the European Commission grant the project. Information and consulting aid submitted by UNITAR was decisive for project’s realization.

Recommendations suggested, structure and contents given in the Guide issued by the UNITAR were followed, when the National profile was elaborated. According to the Guide’s requirements, many meetings were conducted with representatives of organizations and institutions interested in the profile’s preparation (such as Government institutions and non-governmental organizations: Bulgarian Industrial Association, Center for Clean Industry, Branch Chamber of Trade Companies of Chemicals’ Producers, Union of Chemists in Bulgaria, firms producing chemicals, and municipal administration.

Main aims of the joint work are:

• Collecting reliable information for chemicals’ production and use;
• Representation of the present state and problems (from legal, institutional, administrative and technical point of view) in chemicals’ management;
• Co-ordination between different institutions and organizations aimed at ensuring contemporary and correct management of chemicals;
• Preventing environmental and health problems arising at different stages of chemicals’ (including use of pesticides) life cycle in industry, agriculture and everyday life.
• Achieving sustainable agricultural and industrial development and high level of environment and human health protection.

First National meeting on profiles’ elaboration (with 31 participants, in November 1996, at Ministry of Environment and Water) was hold after necessary preliminary preparation being done by the Ministry of Environment and Water, including translation of UNITAR’s Guide in Bulgarian. Experience of different government and non-governmental organizations and institutions towards chemicals’ management was specified at the meeting. Agreement about the National co-ordinator was reached and initial tasks in the common work were considered. National co-ordinating team was formed. The team made working groups, which have to discuss (in close collaboration) specific aspects in profiles’ elaboration. The working groups are connected with activities in the following fields: environment protection, industry, trade, finances, health protection, transport, risk assessment and risk management, emergency prevention, scientific-research and scientific-educational sectors. It was decided that the working groups created would collect and process the information available while co-ordinating their activities. Goals and scope of the further activity of working groups and joint work at national level were outlined.

The National co-ordinating team has been sanctioned by a decree of the Minister for the environment and water. This act showed a) the acceptance of necessity to create the National profile, and b) recognition of the benefit of Profile’s elaboration.

Tasks connected with National profile’s elaboration were distributed among all team participants. External consultants (continuously increasing number) have been included in the profile’s preparation, because of tasks’ complication and multiformity.

The National coordinating team has considered a report entitled "Nomenclature of chemical products, produced by chemical and petrochemical industry in Republic of Bulgaria", at its working meeting hold on 11-th of May 1997. This report has served as a basis for elaborating the final report.

Most important meetings for defining the scope of work to be done, are the following:

01.07.1997 – working meeting aimed at up-to-dating and making more precise whole information concerning the country. Chapter 1 of the "National profile for chemicals’ management" was discussed. Eleven participants from Ministry of Environment and Water, Bulgarian Industrial Association, National Statistical Institute, Branch Chamber of Chemists, "Clean Industry Centre" and non-governmental organisations took part.

03.07.1997 – working meeting on methods for collecting, analysing and representing the information on chemicals’ production, import and export. Classes of chemical substances, which would be considered in the National profile, were determined. Thirteen participants from Ministry of Industry, National Statistical Institute, Ministry of Environment and Water, Ministry of Trade and Tourism, Ministry of Agriculture, etc. took part.

04.07.1997 – working meeting aimed at making clear the priorities connected with life cycle of chemical substances. Fifteen persons from Ministry of Environment and Water, Ministry of Health, Ministry of Agriculture and Forestry, Ministry of Labour and Social Politics, Branch Chambers, Unions of Chemists, non-governmental organisations, etc. participated in the meeting.

07.07.1997 – working meeting for discussing legal instruments and mechanisms for chemicals’ management. Thirteen representatives of Ministry of Industry, Ministry of Environment and Water, Ministry of Health, Ministry of Labour and Social Politics, non-governmental organisations, Civil Protection, etc. took part.

09.07.1997 – working meeting for considering the list of ministries, agencies and other institutions taking part in chemicals’ management and their role in the process. Representatives (eleven persons) of all institutions interested in participated in the meeting.

10.07.1997 – working meeting for discussing the participation of non-governmental organisations in industrial and non-industrial sectors. Nine persons took part, seven of them were representatives of non-governmental organisations in industrial and non-industrial sectors.

14.07.1997 – intermediate meeting for considering drafts of chapters 1, 2, 3, 4, 5 and 6 of the ‘National profile for chemicals’ management". Draft variants, reported by the corresponding heads of working groups, were discussed. Twelve representatives of institutions and non-governmental organisations took part.

16.07.1997 – working meeting for discussing and determining inter-ministry commissions and mechanisms for their co-ordinating, as well as international relations in the field of chemicals’ management. Nine representatives of different institutions participated in.

18.07. 1997 – working meeting for discussing a) access to information, connected with chemicals, and b) acquaintance of workers and public with mechanisms existing for chemicals’ management and with the risk connected with chemicals. Fourteen representatives of Ministry of Environment and Water, Ministry of Labor and Social Politics, Central Institute for Scientific and Technical Information, Civil Protection, Committee of Standardization, Ministry of Health, non-governmental organizations, etc., attended the meeting.

22.07.1997 – working meeting for considering the technical infrastructure and availability of resources for chemicals’ management. Eleven representatives from different organisations and institutions took part.

28. 07.1997 – intermediate meeting for discussing drafts of chapters 7, 8, 9, 10, 11 and 12 of the "National profile for chemicals’ management". Draft variants, reported by the corresponding leaders of working groups were considered. Fourteen representatives of some institutions and non-governmental organisations attended the appointment.

The National co-ordinating team discussed the final version of the "National profile for chemicals’ management" at its final working meeting, hold in December 1997. Decisions about a) eventual necessary supplements, b) making more precise the content to be submitted to UNITAR, c) content and possibility for circulation of the Working Summary (of the document) among all institutions, branch chambers, non-governmental and other organizations interested in, and participating in different activities connected with the life cycle of chemicals in republic of Bulgaria.

In this aspect, present report is a synthesized product of the efforts made by many specialists of different organizations. Undoubtedly it will contribute to improvement of already existing system for chemicals’ management in Republic of Bulgaria.

National Coordinator – Ministry of the Environment and Water 

National Co-ordinating Team

National Co-ordinator - Ministry of Environment and Water, Silvia Raikova, Dr. Eng.

Ministry of Environment and Water	Silvia Raikova, Dr.Eng. Dimitar Vergiev, Dipl.Eng. Ekaterina Kulisheva, Dipl.Eng.
Ministry of Health	Ivanka Dumanova, Dr. Ivan Ivanov, Dr.
Ministry of Forests and Agriculture	Margarita Tzenova
Ministry of Labour and Social Politic	Bojidar Dimov, Dr. Eng.
Ministry of Trade and Tourism	Vladislav Tozev Hristo Atanassov, Economist
Ministry of Industry	Anna Popova, Dipl. Eng. Reneta Kopandanova, Dipl. Eng.
Ministry of Transport	Bogomil Tzenev, Dipl. Eng.
Ministry of Justice and European Integration	Silvi Gavrilov, Lawyer
MD - Civil Protection	Svetoslav Andonov, Dipl.Eng.
National Statistical Institute	Stefan Tzonev Svetlana Ganeva Rayko Bachvarov
Committee of Standardisation and Metrology	Irina Stanimirova, Dipl.Eng.
National Centre of Hygiene Medical Ecology and Nutrition	Ada Bajnova, Prof. Dr. Maria Tasheva, Assoc. Prof. Dr. Todor Popov, Prof. Dr. Anna Mihajlova, Assoc. Prof.Dr
Ecotech Consult - Ltd	Ekaterina Todorova, Dr.Eng. Petia Ivanova, Lawyer
Balkan Science and Education Centre on Ecology and Environment	Ivan Dombalov, Prof.Dr.Eng.
Union of Chemists in Bulgaria	Nayden Naydenov, Dipl. Eng.

 

Summary

UNO’s Conference on the Environment Protection and Sustainable Development (hold in Rio de Janeiro in 1992) specified the international political frame for activities in the field of chemicals’ management. Representatives of all participating countries approved the idea for environmentally friendly management of chemicals, including prevention of illegal international traffic of toxic and dangerous products till year 2000. The participants in the International Conference on Chemicals’ safety (hold in Stockholm in 1994) further developed this idea.

Contribution of international legal instruments, connected with specific aspects of chemicals’ management and accepted in eighty’s is very significant.

Preparation of a National profile for evaluating the national infrastructure for chemicals’ management in Bulgaria and in other countries is a result of efforts made by UNITAR/IOMC.

Contemporary management of chemicals and chemical products in Republic of Bulgaria by the Government is imposed by some important reasons:

• to meet the international agreements connected with a) harmonisation of Bulgarian’s legislation with the legislation of the European Community, and b) admission of Republic of Bulgaria to membership of the World Trade Organization;
• to ensure the safety necessary for chemicals’ production, use, transport and storage;
• to decrease the environmental and health risk, as well as the consequences of eventual accidents;
• to meet the requirements for European Community membership;

Big enterprises for producing organic and inorganic chemical products are available in Bulgaria. In spite of the problem's characteristic for all industrial sectors during the transitional period, chemical industry remains one of the most attractive and dynamic branches of Bulgarian’s industry. It realizes more than 30 per cent of country’s export and main import of chemical substances and products, and forms about 1/3 of the total national income. That’s why, increased interest in privatization of many chemical enterprises is shown, and the biggest transactions of cash privatization are in this sector of industry.

Elaboration of National profile for evaluating the national infrastructure for chemicals’ management is based on an agreement between UNO’s Institute for Training and Research (UNITAR) and Ministry of Environment and Water (MEW) – Bulgaria. Directorate GENERAL XI, Environment, Nuclear Safety and Civil Protection of the European Commission grant the project. Information and consulting aid submitted by UNITAR was decisive for project’s realization.

Recommendations suggested, structure and contents given in the Guide issued by the UNITAR were followed, when the National profile was elaborated. According to the Guide’s requirements, many meetings were conducted with representatives of organizations and institutions interested in the profile’s preparation (such as Government institutions and non-governmental organizations: Bulgarian Industrial Association, Center for Clean Industry, Branch Chamber of Trade Companies of Chemicals’ Producers, Union of Chemists in Bulgaria, firms producing chemicals, and municipal administration.

Main aims of the joint work are:

• Collecting reliable information for chemicals’ production and use;
• Representation of the present state and problems (from legal, institutional, administrative and technical point of view) in chemicals’ management;
• Co-ordination between different institutions and organizations aimed at ensuring contemporary and correct management of chemicals;
• Preventing environmental and health problems arising at different stages of chemicals’ (including use of pesticides) life cycle in industry, agriculture and everyday life.
• Achieving sustainable agricultural and industrial development and high level of environment and human health protection.

Stagnation of industry in a period of transition from 1989 till 1994 gives real positive influence with change for the better environment. All emission of dangerous substances in the air decreases with 24% compare with 1990, consumption of raw materials decreases with 25% and wastes in the rivers decrease with 6.5%. Sudden drop in economic period of 1989-1994 were followed with change of industrial production quality. The changes to displacements close the plants which pollute water to the plants which pollute mainly air. There in a low tendencies to generation of less contaminators per unit production of some indices ( industrial waste waters and undangerous solid industrial wastes).There is real almost twice reduction of emissions in the most of "hot points" and statistical visible improvement in the quality of surface water in big part of probe points. Nitrates TLV’s is low than European Community requirements. At the same time sizeable grow up part of pollute industry branches in all industrial production (chemistry, metallurgy, power production, coal output) from 26.7% in 1990 to 46.3% in 1995. These branches take 60% from industrial waste water and over 90% from undangerous solid wastes. Expected macroeconomical stabilisation after 1996 is followed in short term with unproportional grow of environment pollution, but only when there are active compensation measures. Discard or exchange of old installations and change in power consumption will put down emissions per unit production. There is expectation of drop of plumb aerosols because of measures to low down the contamination from lead-zinc plants and growing up use of leaded gasoline. Decrease of contamination of water goes down because of going down water use (the prises of water goes higher 10 way). Better management and higher prises of raw materials, energy, water and sanction of contamination environment will stimulate industrial managers to more ecological production.

The complete analysis of the legal instruments for managing chemicals indicates that the existing legislation is fragmented into a great number of legal documents, most of them regulations (legal instruments which have less legislative force than laws) and bylaws and therefore rather inconsistent.

The responsibilities of different ministries, institutions or their representative authorities quite often overlap (the Ministry of Environment and Water, the Ministry of Health, the Ministry of Trade). There is no system for co-ordination between them. This leads to decreasing the efficiency of exercising control over activities related to managing chemicals and also impedes the realisation of those activities.

A better coherence between the different parts of the existing legislation and its approximation with the legal documents of the European Union is desirable. There is a need for a unified law concerning management and control of chemicals and preparations. A group of experts from different governmental and non- governmental bodies has been already established.

A number of legal documents are enforced in the country, determining the obligations and rights of different institutions and their control authorities. A co-ordination of the implemented legal base is necessary for the period of transition to market economy and integration with the European Legislation and the involvement of non-governmental institutions and employer services in its development.

Essential disadvantages are the complicated and long procedure in issuing permission and the absence of uniform national criteria for that.

Considering the government officials’ engagement and providing active participation of the public, it is necessary to involve specialised non-governmental institutions in the development of the new legal base for chemicals management. In order to achieve effectiveness in the activities, and to shorten the procedure for the permissible regime and observe the European legislation, it is necessary to create a National Register existing of Chemical Substances. In the "White Book" an engagement is undertaken to harmonise the legal instruments with the European Union’s Directives, concerning the chemical substances.

Regulations for classification, packaging and labelling of the dangerous chemical substances and preparations has to be designed in compliance with Directive issued 67/548/EEC of the EU.

The Law of Chemical Substances is already in a process of development is, which will regulate the management and control of chemical substances, aiming at preserving the life and health of the population and environment.

A progress has been achieved in the development of the computer base, particularly for the government register introduction, most of the institutions need financial aid, because in the Currency Board conditions the budget can not provide financial resources for this purpose.

On the basis of data mentioned above and their commentary following conclusions and recommendations might be given:

• The activity of specialising secondary schools, colleges and higher schools is directly connected to the problems of management of chemical substances and waste products. Training of management staff on the levels of secondary schools, colleges or higher schools has to be regulated by corresponding documents in the training programmes. Introduction of specialised courses, lectures and exercises concerning is necessary. It is necessary also to introduce specialities dealing with the problems of management of chemical substances and waste products, toxicology, chemical safety risk assessment.
• Institutes, Universities, Academies and correlated to them units (like Research Sectors, authorised laboratories, research laboratories, computer centres, etc.) took part in chemicals management.
• Research institutes and their units in state-owned and in private sectors can participate quite effectively in development of new chemical substances; characterisation, choice and control of imported and exported chemicals; production, processing, transport, storage and control of waste products; resolving the problems concerning energy- and raw materials deficit, etc.

The existing mechanisms for co-ordinating activities among ministries and other relevant governmental and non - governmental bodies do not work effectively at all times.

The state of the Normative Acts and decrees cleaning with the management of chemicals and chemical products is indicative of unsatisfactory inter - ministerial co-ordination.

The existing inter - ministerial commissions are not linked with each other and they work separately.

We consider it expedient the realisation the following solutions:

• the establishment of an on-line system connecting the governmental bodies charged in chemicals management;
• the establishment of regular newsletter;
• the education and retraining of specialists dealing with the chemicals management.

The major problem for their realisation is the lack of financial resources.

A major weakness of the information base dealing with national chemical's management is the hope adjusted exchange of data and documentation on one hand between the bodies at the national level and those on the local level, and on the other hand, between the different institutions at one at the same level. This is a result of the lack of an integrated system of chemical's management in the country.

If an analogous Profile is developed at regional level, it may improve the mechanisms of collecting and disseminating of the information.

The development of the National Profile accordingly to the Guidance Document has led to an initiative to improve the collecting and disseminating of the information dealing with chemical's management. Entire technical infrastructure of Republic of Bulgaria is not adequate with respect to the management of chemicals.

Laboratory Infrastructure

Bulgarian accredited laboratories are illegitimate for the European Community. Moreover, the following shortcomings can be specified:

• Principal requirement (of European standards) for independence and impartiality of our accredited laboratories can be seriously call in question.
• Certificates for conformity with European standards are received by laboratories incompatible in respect to their capabilities and competence.
• Claims to competency of accredited laboratories, as far as European Directives, related standards and global approach modules are concerned, are not formulated clearly and equally.
• Doubts can appear as to the necessity of so many accredited laboratories with doubling activity.

Problems above mentioned can be almost solved by accepting Directives of the European Community as legal instruments of the country.

Government Information System / Computer Capabilities

It is necessary a united national computer network for chemicals' management to be built on the territory of Republic of Bulgaria. The national computer network has to include all Government departments - ministries, committees and institutes, which deal (directly or indirectly) with data on chemicals' movement. The system has to follow life cycle of the chemicals.

Technical insurance of chemicals' information system requires (when enough personal computers are available at creators and users of information on chemicals). All institutions interested in chemicals' information to be connected with INTERNET or to use the Bulgarian variant of e-mail (provided by BULPAK telecommunication company) till all institutions are included in INTERNET.

In this case, programming the e-mail pages to be spread and determining organisations (experts) - recipients represent a very important problem. Consequently, it has to be very precisely defined: i) what is open information; ii) concepts and parameters used. Necessary software preparation for these INTERNET tables has to be done.

Overview of Technical Training and Education Programmes

Technical education programs developed at Bulgarian universities provide technical expertise required to implement Government policies and programmes related to chemicals' management and environment protection. It is recommendable post-diploma specialisation and short term training and education courses (aimed at increasing competency of officials working in chemicals' management system) to be developed.

The developed projects allow to speed up the process of modernisation of the legal documents in the country, in correspondence with the requirements of United Nations’ conventions and with the European Union’s directives, orders and regulations. Besides all, our country definitely needs greater financial, scientific and technical support for elaboration of new legal instrumentation in the field of the chemical substances. In the country has no law of chemical substances’ management to determine the main requirements for the producers, consumers and control authorities of the government. The legal acts in force now, are many in number, and often are not clear for the consumers. There is no national register for chemical substances and it is hard to be created in the near future without external support. The legislative base for classification, packaging and labelling of the substances does not meet the requirements of the European and United Nations’ directives. In the conditions of currency board and reduction of government administration, neither the finances nor the stuff would help to solve the chemicals management problem soon. Only by means of effective external support and using the experience of other countries, the period of harmonisation of the legal documents and their implementation would be fulfilled in short terms. The existing Interdepartmental Council (National Co-ordinating team) and the gained experience in developing the present National Profile would help in speeding up the process.

The Government goals consist of contemporary transition of society. In this transition period the opinion of the civil organisations and of every citizen will become of more importance for the institutions. Some persons and groups will define and follow up their awareness, competently without the Civil Authorities. The tendencies of increasing information and environmental education in the society present some of the phenomenon in this period, that leads to decrease of the importance of the pyramidal hierarchy structure. The developed societies will be characteristic with horizontal network for management accomplished by non government, local associations of citizens, living near a metallurgy plant or Thermal Power Plant. These organisations will be interested in decrease the risk for the region. They will introduce their requirements in the municipality. Thus, a "joint management approach" will be achieved. The tasks and the responsibilities of the Government administration in the transition period are: To create legal instruments as well as technical, economic and tax instruments, necessary for the reconstruction of the industry, including the chemical industry, which will create a clean production. That means providing of safe and healthy working conditions and significant reduction of the environment pollution. In all transition stages to give a thorough information to the public about the risk factors in the company and perform public discussion concerning the measures necessary for their prevention. To introduce an adequate control and inspection measures, corresponding to the legislation in force, which will guarantee the safety and healthy working conditions and environment protection. To make amendments in the legislation in order to improve the interference of non governmental organisations and reduce the risk problems of working conditions and the ecological problems.

The data for the available and needed professional and financial resources from the government institutions show that the number of specialists in chemicals management is defined to a certain degree, and do not need extend in this field.

At present, financing the government administration activities is in the framework of the government budget. It is necessary to look for other financial sources in a manner to stimulate the available human resources in chemicals management. It is important to create independent, financially provided and equipped laboratories, providing control on the chemical substances.

Different non government organizations can aid the Government efforts in chemicals management, regarding to the possibilities for examination, which includes:

• possibilities for data acquirement, processing and preservation;
• testing of different chemicals;
• evaluation of the risk;
• decrease of the risk;
• providing training programs for chemicals management;
• possibilities for analyses of the government politics in this field;
• investigation activities for finding ecological substitutes;
• monitoring and distribution of important information to the key employment sections and to the public;
• raising the public awareness for team work for the resolution of the regional problems due to environmental pollution.

The non-government institutions have adequate possibilities for co-operation between them and with the Government institutions in the realizations of plans and tasks in the routine chemicals management.

Providing additional financial resources is necessary for:

• preparation of special software for the National Profile for chemical management for input of the data base;
• preparation of the needed software to switch on the data base "Economics" in the NSI on special page for chemicals management in Bulgaria and its distribution; building up a connection between the Government institutions and MEW /or other institution/ where the data base input is accomplished for the National Profile for chemical management; training of the profile specialists in correct and simple usage of the statistic information, groups and combinations, defined by the national and international classifications and nomenclatures by the NSI.
• Assumption of relevant information of the European legislation and the practice of its implementation in the field of chemicals management.

To accomplish the tasks of chemicals management for the needed human resources and the listed above definite tasks, some further activities have to be financed:

• amendment of the legislation, concerning the full "life-cycle" of the chemical substances;
• training in chemicals management;
• risk assessment, risk management and risk communication in the human health and environment posed by chemicals;
• strengthening of the import control;
• investigation activities on trying to find healthy and ecological substitutes;
• laboratory control maintenance.

More effective engaging of non-governmental and governmental organisations in solution of different problems, including the process of chemical management and waste can be achieved by implementation of following actions:

• revising of existing legislation concerning chemicals management;
• development of new normative acts, norms and standards for management of chemical substances and waste products;
• co-ordination and effective work with the environmental non-governmental organisations;
• harmonisation of national and European legislation for management of chemical substances and waste products;
• confirmation the legislation documents in a Law for chemical management
• implementation and enforcement of laws and regulations in practice to juridical and physical persons concerned directly or indirectly with chemical substances and waste products.

As a final it should be stated that the National Profile developed was the first attempt in Bulgaria under the umbrella of the Ministry of Environment and Waters to established an large group of experts from NGO’s and authorities to assess the National Infrastructure for Management of Chemicals. The UNITAR GUIDELINES had a crucial role in the process. There is a common understanding concerning the need to update the profile after one or two years and the development of some regional profiles.

Acknowledgements

 Elaboration of the first Bulgarian National Profile for evaluating the national infrastructure for chemical’s management is based on an agreement between UNO’s Institute for Training and Research (UNITAR) and Ministry of Environment and Water (MEW) of Bulgaria. Recommendations suggested and Guidelines provided by the UNITAR were of high importance for the successful development of the project.

Behalf of the Ministry of Environment and Water and working team we would like to express our thanks to Directorate GENERAL XI, Environment, Nuclear Safety and Civil Protection of the European Commission for financial support of the project.

Working team will be happy to get any comments or advises from other parties and readers.

Chapter 1 : General Information on Republic of Bulgaria

The Republic of Bulgaria is situated on the Balkan Peninsula in the South - Eastern part of Europe. It is bound on the North by r. Danube and Romania, on the East by Black Sea, on the South by Turkey and Greece, on the borders are 2245 km, including 1181 km terrestrial frontiers.

1.1 Physical and Demographic Aspect

Table 1 - General data about the country

Description	Measure	Quantity
Official Language		Bulgarian
Form of government		republic
Area of the country	km2	110994
Total population	number	8340936
Density of the population	persons on km2	75,5
Urban Population	number	5636632
	%	67,84
Rural Population	number	2706334
	%	32,16
Average Age of the Population	years	38,8
Population of Working Age	number	4 749 223
Live Birth Rates	per 1000 persons	8,6
Death Rates	per 1000 persons	minus 5,0
Infant mortality rates	per 1000 born alive	14,8
Net Coefficient of Reproduction		0,586
Expectation of life at birth - total	years	70,58
Expectation of life at birth - Males	years	67,11
Expectation of life at birth - Females	years	74,62
Population literacy level	%	98,1
Average Educational level of the Population	years	9,5
Unemployed People Registration the Labour Offices	number	479000
Unemployment Rate	%	12,5
Percentage of Women Employed Outside the Home	%	No Data

The presented data on the population literacy level are calculated for the population aged over 7 years according to the 1992 census.

The data on Average Educational Level constitutes the average number of educational years for inhabitants aged 25 years and over according to the 1992 census.

The other dates on Table 1 are based on the current demographic statistics and present the population of the country as of 31.12.1996.

The distribution of inhabitants to Urban and to Rural is performed by means of prescribed criteria.

The population of Working Age includes women aged from 15 to 55 years and men aged from 15 to 60 in accordance with the personable age.

The presented physical and demographic data are being collected and brought up to date by the National Statistical Institute (NSI). The NSI is the state statistical office that organises statistical surveys on the economy, on the social and on the demographic processes in the country both at the national and at the regional levels.

The methods that the NSI uses in their surveys are in accordance with the methods of the observance and the treatment of information based, as a rule, on the internationally recognised definitions, indicators and methods. National classifications are being created compatible with the European classifications. The applied methods of treatment and forming of analytic statistical characteristics are in conformity with the well-defined methods and mean.

1.2 Political and Geographic Structure of the Country

According to geographic and economical factors the territory of the country is divided into 7 districts: Sofia-city, North-western, North-central, North-eastern, South-western, South-central and South-Eastern.

The main administrative territorial unit of the country is the region. There are municipalities (and districts for the big towns) as territorial differentiated structures.

The regions are managed by state authorities appointed by the Council of Ministers, The municipalities have local self-government and they are managed by elected authorities.

Figure 1.1 presents a map of the country that indicates the regions. It is an Annexe to the Profile.

• Administrative authorities at regional level:

  • Regional Governor;

  • Regional Administration.

• Authorities of local self-government at municipal level:

  • Mayor - elected;

  • Municipal Council - elected;

  • Municipal Administration.

There are 9 regions. Every one of them is divided to municipalities.

Fig.1. - Map of Bulgaria and the main administrative territorial unit

Number of municipalities

Region of Sofia-city	24
Region of Bourgas	26
Region of Varna	30
Region of Lovech	38
Region of Montana	38
Region of Plovdiv	38
Region of Rouse	37
Region of Sofia	53
Region of Haskovo	38

Relation between geographical and administrative structure of the country:

1.3 Industrial and Agricultural Sectors

This section comprises characteristics of the industrial and agricultural sectors in the economy, made in accordance with the accepted terminology in Bulgaria.

The data that is presented below are the maximally available possible, vis-เ-vis the suggested contents of the tables, comprised with the Guidance Document for Preparing the Profile.

The tables by activities or by sectors are composed in concordance with the International Standard Industrial Classification of all Economic Actives: ISIC Rev.2.

The only country sours of the required information is the National Statistical Institute. The NSI uses National Classification created on the basis of the European classification: NASE Rev.1. Corresponding code tables are nigh the link to International Standard Industrial Classification of all economic activities, Rev.3 (ISIC, Rev.3) elaborated by United Nations. These tables are used also in the statistical registrar. So, there is a possibility to have information by groupings ISIC Rev.3 and NACE Rev.1.

Translation of statistical data to groupings of ISIC, Rev.2, because of the way of elaboration of ISIC, Rev.3 in comparison with the ISIC Rev.2, gives unaccurate data. They can be used with reporting the level of conventionality (in the future using).

We consider it is more useful in the future to collect data for the Profile in accordance with the classifications NASE Rev.1, respectfully ISIC Rev.3, so they are adopted in all European Countries.

Table 1.A - Overview of the Industrial and Agricultural Sectors, Data for 1995

Sector	Gross Domestic Product		Share in the Gross Domestic Product (%)	Number of Employees
.	(m lv)	(m $)	.	.
Industrial Sector	292397	4353	33,7%	1109566
Agricultural Sector	120584	1796	13,9%	782918
Services	454710	6769	52,4%	1389699
Total	867691	12918	100,0%	3282183

The Industrial Sector includes mining and extraction activities, manufacturing and construction. Information regarding the Gross Domestic Product, by regions, for the present, does not exist.

Table 1. B Structure of the Industrial and Agricultural Sectors.

This table provides data dealing with the number of the economy subjects arranged in groups according to the number of employees.

The NSI maintains the state register of economy subjects: Register "BULSTAT". This register includes all economic units, registered in accordance with trade and other national lows, legitmated business subjects realizing financial transactions in the national economy of the country. Register "BULSTAT" is basic administrative business register of the country. It is used for the statistical purposes as a basis for statistical register.

The Register "BULSTAT" contains units of the agricultural, industrial and the services sectors, if the units are registered under the following legislative acts: Trade Low, Political Parties Act, Co-operative organisation Act, Obligations and Contractic Act, Persons and Family Act. These part of agricultural units, that consists of proprietorships of land owners, are filed in a separate register, which is currently being elaborating.

During the last two years NSI has been refining the national register in the direction of creating unity with the usage of European Union methodology (and EDI-fact). In connection with this the units in the register are arranging by number of employees. According to the requirement of the EEC Concil regulation No2186/93 concerning the coordination of EU dealing with the creation of bussiness registers for statistical perposes, the size of units in the groups must be in accordance with the number of employees as follows: 1; 2; 3-4; 5-9; 10-19; 20-49; 50-99; 100-149; 150-199; 200-249; 250-499; 500-999; 1000 and over. Presently, these units are being arranging accordingly, using the statistical information of 1996.

For the present, information regardined the Table 1.B does not exist. In the near future NSI expected to have at disposal reliabble data, required by this table, dealing with the industrial and serrices sectors.

Table 1.C - Breakdown of Agricultural Production by Regions

Region	Major Crops	Total Value of the Crops (m lv)	Quantity of Crops (thous.t.)	Total Number of Employees (nos)	Size of Productive Areas (ha)
Region of Sofia-city		188	28.9	1627	8959
	Wheat	102	18.5		5687
	Barley	29	6.4		2486
	Tomatoes	57	4		383
	Cabbage	0			403
Region of Bourgas		10134	1319.9	17204	402489
	Wheat	2890	526.1		173980
	Barley	1484	330.3		101499
	Sunflower	1187	128		88717
	Tomatoes	1806	126.4		5937
	Green Peper	473	30.6		2679
	Wine Grapes	2088	133.7		25277
	Onion	205	44.8		4400
Region of Varna		11032	1766.4	15034	552188
	Wheat	5165	940.1		267878
	Corn	3403	482.5		121708
	Sunflower	1907	205.6		129326
	Onion	94	20.5		2408
	Clover	208	102.9		29110
	Sweet Grapes	255	14.8		1758
Region of Lovech		4369	630.1	21491	142881
	Wheat	941	171.2		55909
	Corn	2127	301.5		72404
	Sugar Beet	794	77.4		4164
	Onion	138	30.3		3596
	Apples	229	26.7		1032
	Plums	141	23		5776
Region of Montana		2744	360.2	8730	165612
	Corn	1706	241.9		78235
	Sunflower	791	85.3		84189
	Water Melons and Melons	246	33		3188
Region of Plovdiv		6487	432.2	12627	42388
	Green Peper	1147	74.2		3884
	Cabbage	334	24.2		1013
	Potatoes	3211	203.1		13257
	Apples	324	37.8		7595
	Wine Grapes	1251	80.1		14570
	Sweet Grapes	220	12.8		2069
Region of Rousse		12878	1764.6	16219	476708
	Wheat	3261	593.6		170777
	Corn	3357	475.9		130350
	Sunflower	1401	151.1		112223
	Sugar Beet	317	30.9		1710
	Tomatoes	1734	121.4		5065
	Water - Melons and Melons	1067	143		10514
	Clover	326	160.9		34406
	Wine Grapes	951	60.9		9388
	Sweet Grapes	463	26.9		2275
Region of Sofia		3662	473.1	6077	66108
	Wheat	651	118.5		50235
	Potatoes	2487	157.3		13734
	Hay	324	173.9
	Apples	201	23.4		2139
Region of Haskovo		3749	383.7	11234	89172
	Barley	879	195.7		70661
	Oriental Tobacco	779	6.7		4783
	Tomatoes	867	60.7		4093
	Green Peper	626	40.5		2861
	Water - Melons and Melons	597	80.1		6774

Table 1.D - Industrial Production by Regions

Region	Code	Number of Industrial Enterprises	Tatal Value of Production (m lv)	Number of Employees
Region of Sofia - city	01	293	120808	121531
Region of Bourgas	02	262	134181	109629
Region of Varna	03	250	75024	96973
Region of Lovech	04	486	97247	135518
Region of Montana	05	261	42647	48285
Region of Plovdiv	06	376	104752	132916
Region of Rousse	07	268	50329	68952
Region of Sofia	08	408	85279	98453
Region Haskovo	09	284	75289	109727
Total for the country		2888	785556	921984

The data provided in Tables 1D, 1D.1 and 1D.2 cover the enterprises observed by BIA for the period of 1995

Table 1.D-1- Number of Enterprises by Banches and by Regions

Discription of the activities	Sofia-city	Bougas	Varna	Lovech	Montana	Plovdiv	Rousse	Sofia	Haskovo
INDUSTRY - TOTAL	505	340	297	590	313	620	344	496	390
Production of electrocity and of heat energy	14	9	7	16	8	10	12	10	11
Coal industry	0	8	0	1	0	0	0	18	11
Oil and gas industry	0	0	0	2	0	0	0	0	0
Black metallurgy	10	2	2	2	2	19	2	9	9
Colour metallurgy	7	1	1	2	1	18	1	6	9
Machine building and metal manufacturing industry	103	64	62	153	66	113	81	85	83
Production of electric machines and appliances and of electronic devices	85	26	30	43	19	62	27	47	27
Chemical and oil processing industry	46	19	17	23	13	29	19	24	8
Industry for building materials	18	17	19	37	28	18	19	28	15
Lumbering and wood-processing industry	16	44	32	75	38	72	33	81	36
Production of cellulose and paper	3	1	4	7	6	10	2	12	3
Glass, china and faience industry	1	2	6	6	1	1	5	1	1
Textile industry	22	28	9	34	15	30	15	28	26
Clothing industry	23	22	19	22	16	38	20	32	32
Leather, fur and shoe industry	7	4	5	12	3	10	5	18	8
Printing and publishing industry	19	6	3	7	3	6	5	8	7
Food, wine and tobacco industries	45	66	59	107	64	91	76	68	70
Other branches of industry	86	21	22	41	30	93	22	21	34

Table 1.D-2 - Products by Regions

1.4 Industrial Employment by Major Economic Sectors.

The data in table 1.E are grouped according to the major activity of the enterprises and should be accepted conditionally, given that the ISIC Rev.3 classification is not adequately compatible with the ISIC Rev.2 classification, as explained in the previous section. The "Mining and Extraction", "Electric generation", and "Other Sectors of Manufacturing" include the enterprises that are performing coresponding to the headings activity. Every one of these headings covers several industrial sectors of ISIC Rev.2. The heading "Dry Ceaning" includes enterprises that perform this activity (sector’s code 9500 by ISIC Rev.3) as well as includes enterprises from other sectors that also perform dry cleaning.

The emissions are shown according to CORINAR and the calculations have been made by the National Statistical Institute and the Ministry of the Environment and Water.

Table 1.E - Industrial Employment by Major Economic Sectors

				Major Emissons (ths. t)
ISIC Code	Number of Enterprises (nos)	Total Employment (average per year) (nos)	Output Value (per year) (m lv)	SOx	NOx	Non - metane Volatile Compounds	CH4	NH3	CO
Food Industry	431	144580	135070	10	1	4	0	0	0
Textiles / Chothing and Leather Goods	302	23964	77928	1	0	0	0	0	0
Wood and Wood Products	101	3378	7274	0	0	1	0	0	0
Paper and Paper Products	98	19368	22786	4	1	0	0	0	0
Chemical / Coal / Petrol / Plastic Products	682	292445	279002	102	58	29	318	24	9
Non - metalic Mineral Products	67	15845	24217	4	7	0	0	0	1
Basic Metals Industry	39	3153	7363	0	0	0	0	0	1
Fabrication of Machinery and Equipment	762	181700	272394	13	9	5	2	0	146
Other Manifacturing Industries	12	3432	6658	0	0	0	0	0	0
Mining and Extraction (Coal / Oil / Natural Gas / Minerals / Metals)	63	23519	21939	1	0	0	3	0	0
Electric Generation	63	60591	38271	1224	69	1	1	0	4
Dry Cleaning	17	1078	2015	0	0	1	0	0	0
Other Sectors of Manifacturing	251	12501	27067	8	1	2	1	0	0
Total	2888	785556	921984	1367	146	43	325	24	161

Chapter 2: Chemical Production, Import, Export and Use

2.1 Production, Import and Export of Chemicals.

Macroeconomics conditions in the country from the beginning of reform 1990/1991 to the end of 1995 are characterised with dynamic processes, connected with considerable decay in production, restrictive money policy, several times shocking devaluation of leva and high inflation. The negative results of the Bulgarian economic are due mainly to the slow down of structural reforms (privatisation) and the specific foreign conditions – the embargo and trade restrictions imposed of ex. Jougoslawia and Iraq by ON, considerable payments’ of the foreign debt, noncorrespondent to the current export abilities, etc. The economical reforms are still on the stage of financial and macroeconomics stabilisation in acceleration of the privatisation and structural reforms. After solving these problems, it could be accepted, that the country will enter the next stage of the economical transition more and more closely national economy commitment to the economics of the EU Member States (for example Hungary, Slovene, Poland).

Industrial production – (for the country) is decreased in half towards 1989 in period 1989 – 1995. The biggest is decrease of the production in electromechanical and electronic industry – 76 % compared to industry in 1989, in machine building and metalworking industry – with 64 %, in wood-working and black-metallurgy.

Decrease is more limited in the production of electro- and thermal-energy, coal industry, dressmaking industry, black-metallurgy, chemical and petroleum-working industry. Contribution of separately branches in the pointed industrial growth is exceptionally irregular. By the moment are identified branches, which have reached the "bottom". These branches keep already reached capacity of production, in some cases it can expect certain increase.

Organisational structure of Bulgarian industry management includes that levels as follow: branch (for example industrial section), divisions, class, economical unit (enterprise, which is possible to be Trade Company or State enterprise).

There is information by the firms, producers and consumers of chemical substances for the produced, imported and exported quantity chemical substances, collected in the period of preparation of the National profile.

Data collected of the industrial units are by National Nomenclature of Industrial Production, built up by National Statistical Institute on the basis of PRODCOM list with close connection with the Combined Nomenclature-positions (CN-positions). National Statistical Institute is going to implement this Nomenclature from beginning of 1998. Collected by the units' data are useful for future maintenance of the "National profile".

In the Table 2A there are statistical data as a result of the regular statistical surveys in 1996. Production data are collected by previous national nomenclature not well connected with the custom tariff (based on Harmonised System (HS)). It is a prerequisition for a conventionality of the shown data.

Import-export data are based on the custom declarations. As a rule these data are influenced by the differences in the level of custom tariff.

Table 2.A - Chemical Production and Trade

Chemical Type	Production (ton)	Production (thous.lv.)	Import (ton)	Export (ton)
Pesticides (agricultural, public health & consumer Use)	11333	3599046	33654	9041
Fertilisers	2038602	60249312	0	243102
Petroleum Products	9637789	206889889	580115	288361
Industrial (used in manufacturing/processing facilities)	4647926	67505358	1325077	243750
Organic chemicals	1274619	91935009	1271861	243750
Inorganic chemicals	4327681	32288797	53216	0
Consumer Chemicals	64413.351	30375781	46419	86112
Other chemicals (unknown/mixed use)	15923	1508265	17448	0
TOTAL	17370360.35	426846099	2002713	870366

Data are a result of a summing of the production, import and export data by products, if they are measured in kilogram (or ton). Value data are for all produced products.

Information in the Table 2A can help us in case of building up and maintenance of the normative basis for chemical management in the country.

The number of respective chemicals on customs tariff defines groups, as customs tariff is harmonised European society. The group of pesticides includes chemicals' part 38 of customs tariff and they include the whole part 3808. The group of Fertilisers consists chemicals from part 31; more exactly 3102, as well as 2834.

The group of petroleum products includes part 27; from 2710 to 2715. Organic industrial substances include the following parts; from 2701 to 2709, from 2901 to 2936, from 3901 to 3926, from 4001 to 4017, from 3201 to 3205, from 3208 to 3211, from 3801 to 3807, as substances aren't included in the pharmaceutical products.

Inorganic industrial substances include part 28, as well as from 3206 to 3207, from 3212 to 3213. Consumer chemicals include parts 33 and 34 on Customs tariff.

Chemicals from parts 36 and 37 on Customs tariff are included in the group of other chemicals.

Pesticides import

The crisis in agricultural production has reflected negatively on the local production, but pesticides import has had high position during the last 3 years. Pesticides’ market and new normative basis has reflected positively on management and application of the pesticides. High price has limited their over consumption, and in the other hand the import and local production are limited in type, according to European directives and practicable experience in countries of European union. There is an urgent need to harmonise Bulgarian legislation with the Directives 67, 88,91,93/??? and regulations related, which mince development of new umbrella law and several new regulations, connected to the management of chemicals as all. The same time the last developments in European legislation in this area must be followed up, especially concerning pesticides. There are differences in the dynamic of different pesticides groups.

Fig.2.1- Pesticides import by groups for period 1994 –1996

Firms with licences and newly entering in force normative acts in 1997, it might affirm, that management of pesticides is existing in the European countries (including also Bulgaria).

Dates are with relative precision about 10 %, as they are taken by import-licences, which in some cases do not reflect the real import correctly.

Fig.2.2- Data about import of Pesticides in 1994, 1995, 1996 years.

National statistical institute has adopted National activity classification, National product classification by activity and National nomenclature of industrial production, based and compatible with the corresponding NACE Rev.1, CPA, PRODCOM list for general implementation in national economical practice. Custom tariff of Republic of Bulgaria also is in accordance with the Custom tariff of the European Communities - Combined nomenclature. On this basis data for 1998 could be completely corresponding with the European standards.

Creating and Maintenance of the computer data-base for the indicators, included in table 2A, require to establish well defined and working set of institutional links, so the statistical data for production, import and export chemicals to be available regularly for the management chemicals' purposes.

To provide regular receiving of this information there is a necessity of assigning if a set of contracts between MEW and government and non- government institutions for the conditions and terms for data-exchange with data groupings by the national classifications and nomenclatures, compatible with the European ones. As a rule in those contracts could be causes as the follows:

• Operating and insurance of the specific for the profile data to be included in regular activity of the institution or to be provided finance for the especially initial receiving of necessary starting data.
• To specify exactly the terms in the year, so to be clear how and when every one institution could provide the information for the Profile regularly.
• To specify the procedure for control and adjustment of the received from different institutions data.
• To specify the persons, responsible for the receiving of information and the way of data presentation.

Table 2A-1- Type and quantity of the approved by the MEW substances, imported for the last 1996 year

Product	Measure	Quantity
1,2 di-chlorine ethane	pcs	12
acetic acid	ton	706.7
acetic anhydride GR (granules)	pcs	120
acrylic acid	ton	5
aluminium chloride	ton	553.55
ammonium bromide extra pure	kg	1
benzoic peroxide 75%	ton	10
benzol	ton	7 100
butyl acetate	ton	250
butyl acetate for synthesis	pcs	6
by-arsenic trioxide	ton	14
catalyst "C" (tertiary butyl per benzoate)	ton	50
chloroform	ton	19.8
chloroform, technical	ton	3.08
chromium sulphate	ton	18
Congo red indicator	kg	6
copper sulphate	ton	200
curita f-5110	ton	9
curizete 611 B	ton	25
cyanic chloride	ton	2
cyclohexane	pcs	1
diethyl aluminium chloride	ton	120
diethylene triamine	ton	5,040
dimethyl amine 60 %	ton	270
dimethyl disulphide	ton	20
dimethyl flour amide	ton	332
durferrite carboneutral	ton	8
durferrite GS 670	ton	4
epichlorhydrine	ton	50
ethyl acetate	ton	40
ethyl alcohol 95.7%	ton	50
ethyl aluminium sescichloride	ton	45
ethyl glycol	ton	51
ethyl glycol acetate	ton	20
ethyl liquid	ton	450
ethyl silicate 40	ton	40
formaldehyde solution	pcs	8
formic acid	ton	22,2
formic acid - technical	ton	15,840
freon 13	ton	3,831
freon 134 A	ton	19,655
freon 22	ton	28,43
freon 23	kg	95.4
fuchsine cyanide	kg	8
fur cleaning detergent	ton	4
ground-glue	ton	1.6
ground-glue 1019	ton	13,920
haemozyle 211 haemizyle 220	ton	0.622
heizlebel lacquer 751/24, concentration 51%, thermal-sticking lacquer	ton	7,100
hydrazine	ton	37
hydrazine hydrate	ton	12.4
hydrofluoric acid	ton	83.68
hydrogen peroxide 60%	ton	80
hydroxinone	ton	10
ink and solvent	l	380
isocyanides	ton	0.752
isopropyl alcohol	ton	60
izobutane	ton	15 000
levoxyne	ton	25,400
liquid chlorine	ton	27,000
mercury	ton	2,549
mercury 99.99%	ton	0.600
methyl acrylate	ton	2,390
methyl alcohol	ton	10,760
methyl chloride	ton	20
methyl ethyl ketone	ton	3.5
mineral turpentine (white spirits)	ton	50
monohydroperoxide of the di-isopropyl benzol	ton	12
monomethyl ether of the hydroxyonine	ton	1,50
monopropyl glycol	ton	20
N-butanol	ton	125
N-hexane extra pure	pcs	600
N-hexane GR (GRANULES)	pcs	100
N-pentane	ton	160
nitro-bicizobe-thylonitril	ton	4.2
nitro-bicizobe-thyronitril	ton	2.4
nitrogen	ton	210
normal hexane	ton	19,600
oleine acid	ton	460
orthophosphoric acid	pcs	12
orthoxylol	ton	1,000
oxalic acid	ton	20
oxygen hydrate (hydrogen peroxide)	ton	100
per chlorine ethylene	ton	20
per chlorine ethylene	kg	20,43
phenol GR (GRANULES)	kg	2
phosphoric acid	ton	120
polycrene A 496 B	ton	2
polyurethane	ton	1,587
potassium bisulphate	kg	2
potassium carbonate	ton	20
potassium chlorate (Bertholete salt)	ton	21
potassium hydroxide	ton	347
potassium hypo chloride (chlorine lime)	ton	600
potassium nitrate	ton	43
potassium nitrate	ton	42
potassium permanganate	ton	274.6
red phosphorus	ton	32
refrigerant CYBA 134 A	ton	6,069
refrigerant CYBA HP 62	ton	0.392
refrigerant CYBA HP 80	ton	0.702
refrigerant CYBA MP 39	ton	0.804
rubber glue "Altene Primar P19"	ton	5
selenium, pure 99.999% and pure selenium, subsidised with 120, 140 and 200 ppm chlorine	ton	2
selenium, pure 99.999% and pure selenium, subsidised with 7.6% tellurium and 55 ppm chlorine	ton	4
selenium, pure 99.999% and pure selenium, subsidised with 7.6% tellurium and 65 ppm chlorine	ton	1
ship chemicals "Air Cooler Clender"	l	2 200
ship chemicals "Alkalinity"	l	400
ship chemicals "Carlon Remover"	l	200
ship chemicals "Descaling Liquid"	l	800
ship chemicals "Diesel fuel"	ton	0.300
ship chemicals "Liquitreat"	l	400
ship chemicals "Metal Bright"	l	1 400
ship chemicals "Oxygen Control"	l	150
sodium chlorate	ton	32
sodium cyanide	ton	71.55
sodium dithyonote	ton	60
sodium peroxydisulfate GR (GRANULES)	kg	4
sodium sulphate anhydrite GR (GRANULES)	kg	6
sodium sulphide	ton	91
sulphuric acid	ton	4
tertiary dodecile mercaptane	ton	80
tetra-chlorine methane	l	160
tetra-chlorine methane	ton	5,250
thermoform sulphur	ton	30
trichlorine ethylene	ton	20
vinyl chloride monomer	ton	6610
Vulcan paste packaged with solvent	ton	4.927
vynilite VYHD and VNCC	ton	0.240
xylene mixture	ton	2 325
xylenole orange tetrasoduim	ton	0.200
zinc powder, particle size 63	kg	6

The insurance of the current supporting Profile with data from different institutions demands constant work in this aspect, connected with current proceeding data and their treatment.

The maintenance of the "National Profile to Assess the National Infrastructure for Management of Chemicals" requires permanent work, connected with regular operating and receiving data by different institutions.

2.2 Chemical use by categories.

At this time in Bulgaria the chemical data collected is different from the data required in Table 2.B In the table is given information for some group of substances, classified, according to the National Statistics.

The table 2.B-1 represents the pesticides used in Bulgaria for the last 3 years.

Table 2B-1. Pesticides use in kg

Year	Herbicides	Insecticides	Fungicides
1994	2 893 611	1 159 245	2 534 919
1995	3 191 216	1 067 100	2 743 993
1996	3 465 199	702 820	2 599 733

On Fig.2.3 Are given comparative data about herbicides, insecticides and fungicides use in a period 1994 – 1996 in dependency on correlation pesticide gram product/decare.

Fig. 2.3 -Comparative graphic arts for pesticides used during the last 3 years

The main agrochemistry task is keeping and maintenance of the soil fertility. Stopping the subsidies for producers, continuously increasing the prices of mineral manure’s and slowing-down of land reform are main disadvantages for the soil fertility insurance. Therefore we have not information about the condition of farming lands degree of supply with the main macro- and microelements, pH and humus contents. The negative tendencies in the nutrition of agricultural cultures continue in this year, also.

 In 1989 are used 16,399 kg NPK per decarable land, in 1994 – 4,695 kg, in 1995 – 2,964 kg and in 1996 – 3,407 kg. That defines the level of the received yields as a result of the agriculture.

There are many reasons for the cut fall in use of mineral fertilisers, but the most important are the continuously increasing prices and the noncorrespondent agricultural products prices.

Until 1990 are finished 5 cycles of agrochemical farming production control. Agrochemical analyses are made only when the producer wishes (from 1991) as he pays expenses for analyses and recommendations for fertilisation. There is decreased number of analysed tests – in 1995 are analysed 2021, while in 1996 they were 1564.

That is result of missing the co-ordination in the system of MFA, where by PHARE-PROGRAMME are made free of charge analyses. There is no defined methodology of taking tests, of methods, of analysis and of fertilisers use recommendation.

Limited number of taken and analysed tests do not allow to make general conclusions on national scale, but it clear there are permanent negative tendencies.

Very important is the question for the reduction of humus content and number of absorber phosphorus in the soil.

When we have such extensive agriculture the reduction of the soil fertility will intensify in the next year. This fact is anxiously, so it is well-known, that for increasing of humus content in the soil with only 1% there is a necessity of a period long about 50 years.

In the NOFPQAC-system are analysed 24624 tests for nitrates in the plants production.

The efforts of NOFPQAC in this and the next years should be in direction to extend the number of services in agrochemical laboratories by adding new analyses. In present economical situation it is unthinkable to grant means from budget for agrochemical control on the farming lands.

The one way to find a decision of the problem is to be elaborated and adopted in short terms a legislation of fertilisers use.

 2.3 Danger Wastes.

The problems on waste management is one of leading priorities in our ecological politics.

Many of problems, connected the activity of waste management, have their decisions with the adoption of The Law for harmful influence limit of waste on environment in September 1997.

Table 2.C - Danger Waste Formation and Trading

Code	Name of the Waste Product	Formation t/year	Export, t/year
1.	Waste Products, Obtained by the Chemical Processing and Syntheses	Total	Total
11	Oxides, hydroxides, salts	54446.1	-
12	Acids, hydroxides and their concentrated solutions	6117.8	-
13	Waste products of pesticides, preservatives of wood and pharmaceutical products	3536.1	-
14	Waste products of mineral oils and coal processing	16945.1	200
15	Organic solvents, paints, lacquers, glues, pastes and polymers	1833.5	400
16	Rubber and plastics products	988.5	-
17	Textile waste products	374.5	-
18	Other waste products of the chemical processing and syntheses	22680.5	-
2.	Waste Products of Mineral Origin and of Processing Products	Total	Total
21.	Waste products of mineral origin (excluding the metal waste products) and packages, polluted by them	1556343.5	472.7
22.	Metal containing waste products and packages, polluted by these	10620324.0	-
23.	Other waste products with mineral origin	3,270.0	-
3.	Waste Products of Plant and Animal Origin, and the Products of their Processing	Total	Total
31.	Foodstuffs waste products	22.8	-
32.	Waste Products of the Production of Plant Oil and Animal Fat Products	1 097.0	-
33.	Waste products of stock breeding and meat production	94.0	-
34.	Leather and fur waste products	14,540.4	-
35.	Wood waste products	53.8	-
36.	Cellulose, paper and cartoon waste products	6.9	-
4.	Waste Products of Purification Equipment, Danger Hospital and Everyday use Waste Products	Total	Total
41	Waste products of the water purification, other purification waste products and waters preservation	396772.0	-
42	Liquid waste products from waste product processing and purification equipment	2 500.-	-
43	Dangerous hospital waste products	1 393.2	-
	Total:	12703339.7	1 072.7

Bulgaria is member of Basel convention for control of transfrontier movement dangerous waste and their purification since 1996.

Data about dangerous waste are collected yearly by producing firms using questionnaires, in which have to be shown the name, the quantity, characteristics, movement, keeping and purification of the waste.

Now it is in elaboration a programme product for information system for industrial and dangerous waste management. In the information system as a basis will be the parameters defined from European offices for waste management. There will be also the formulas, defined by Law for harmful influence limit of waste on environment and Governmental Decree No 153 from 6.8.1993 for collection, transport, keeping and purification dangerous waste.

In the last there year is fixed that 50% of all dangerous wastes are generated from cleaning installations and the biotic wastes a very small quantity.

The advanced data for the quantity dangerous waste in the country and exported quantity for 1996 are in Table 2C. The final data for 1996 will be published in Year Bulletin for the Condition Environment in Bulgaria.

Code of dangerous waste is in accordance with the categories, included in the Dangerous waste catalogue by Governmental Decree 153/93.

The main source of almost 90% from dangerous wastes are 50 enterprises in Bulgaria. There are 30 enterprises, which produce 45% from all wastes.

The formed dangerous wastes in 1996 are about 12,7 million tons, from them 11-million tons are generated only in some mining-ore-dressing plants in areas of Sofia and of Smolian.

The biggest part –about 80 % of formed waste from cleaning equipment belongs to REI Burgas.

There are not imported dangerous waste in 1996, total quantity of exported waste in other countries is 1072,7 t.

Main way to make render harmless dangerous wastes in Bulgaria is depoting. There are a few depot at moment, which servicing its own plants. In the most cases, they not response to the requirements of dangerous waste depots.

Ecological politic in Bulgaria is connected with wastes is:

• prevent and out down waste production;
• recycling and second use;
• making ecological render harmless accordingly to technical norms;
• reducing risk of historical pollutes.

Chapter 3: Priority Concerns Related to Chemicals Production, Import, Export And Use

Republic of Bulgaria is a country with developed chemical, oilprocessing, cement and extraction industries, as well as metallurgy and energetic. Industries' functioning requires use of different raw materials - home and imported. Capacity of the industrial branches mentioned above entirely meets the demands of our country, and a considerable part of the production is exported. Producing enterprises are concentrated in some regions and towns. This is the reason for creating a potential risk for the local pollution due to the exposure to chemicals. Activities connected with production, use and storage of chemical substances, as well as chemicals' release as by-products, residuals and tails create potential risk for air, water and soil pollution.

3. 1 Priority Concerns Related to Chemicals Production and Use

Agriculture, developed in all regions of Bulgaria, requires use of pesticides and fertilisers. Their impact on the environment is connected both with their production and their storage and accumulation.

Air pollution

Air pollution (by gas emissions and suspended particles) is a problem, localised mainly in differentiated industrial centres for: chemicals' and fertilisers' production, oilprocessing, as well as in areas where cement industry and ferrous and non-ferrous metallurgy are developed. Main air pollutants (created by industry) are the following: NOx (emitted by chemical, oilprocessing industry and by motor transport), SOx (emitted by Thermo-Electric Power Stations (TEPSs), chemical and oilprocessing industry), COx (emitted by TEPSs and motor transport), ammonia (emitted by chemical and food industry - local pollution), organic chemical substances - mainly phenol (emitted by metallurgy and oilprocessing industry), aerosols of heavy metals (emitted by the motor transport and non-ferro metallurgy), and total suspended particles (result of residential and municipal activities).

Industrial accidents contribute to the local pollution of air. Fires in oil-processing industry are rather dangerous. Chemical's use in the agriculture also creates potential risk for air pollution.

Atmospheric movement creates possibilities for transregional and transborder pollution.

Ministry of the Environment and National Statistical Institute make inventory of: a) harmful substances emitted in the air (according to the EC - CORINAIR - 90 Protocol), and b) greenhouse gases (using IPCC Protocol, in compliance with requirements of UNO's Convention for climate's changes).

National network for air quality control consists of 110 stations. A tendency to air quality deterioration is not observed for the country as a whole.

Pollution of Inland Waterways

The negative influence on inland waterways and their quality change is caused by anthropogenic activity manifested itself as changes in water flow and as discharge of sewage and industrial waste water. Air pollution, polluted precipitates and river sediments (eventually secondary source of pollution) can be pointed out as indirect cause for inland waterways' deterioration. Following items are among the main tasks of the National System for Environmental Monitoring: to monitor the quality of surface waters (physical-chemical parameters), to analyse and evaluate water quality before and after passing by big pollution sources, and to estimate their influence. Industry is the main cause for pollution of surface water - rivers, lakes and dam-lakes - which (for some regions) are sources of drinking water. Main river pollutants are heavy metals, organic substances and products of oilprocessing industry. Rivers, polluted by flowing through industrial regions, can contaminate areas remote from industrial centres.

Use and storage of pesticides, fertilisers and other chemicals, applied in agriculture, represent a potential danger for inland water. When soil and crops are incorrectly treated, chemicals mentioned above easily enter inland waterways, leading to a danger of large regions' pollution. Surface water pollutants can easily enter ground water.

Ground Water Pollution

Ore and coal mining activities and chemicals' deposition represent a potential danger for ground water pollution in Republic of Bulgaria. Agricultural activity and industrial accidents are cause for local deterioration of ground water. Overflow of highly toxic water (when fires in chemical and oilprocessing plants are extinguished) create prerequisites for surface and ground water pollution. Ground water quality is evaluated on the basis of data (collected by 16 Regional Environmental Inspectorates - REI) on its physical-chemical and microbiological organoleptic parameters.

Drinking Water Contamination

The drinking water contamination is due to polluted surface and ground water and polluted ambient air. The Regional Hygiene Epidemiological Inspectorates currently monitor the drinking water sources around big industrial areas and big towns. They are responsible for the quality control of the drinking water supplied to the consumers. The drinking water is in compliance with the Bulgarian State Standard 2823-83 "Drinking water". Immediately before its distribution in water-supply network, the drinking water is additionally purified and mineralised.

Soil Contamination

The ferrous- and non-ferrous metallurgy, the irrigation with polluted water and the incorrect use of pesticides are the main sources of soil pollution. A network, having 220 stations for soil pollution control, has been established in the country. Concentrations of lead, zinc, copper, nickel, cadmium, arsenic, etc., in soil are monitored by the Central Laboratory on Soil Quality and by Chemical Laboratory at National Centre for Environment Protection and Sustainable Development. Similar investigations are carried out in accredited laboratories, mentioned in Chapter 9, as well as by laboratories at enterprises, research institutes and universities and HEI.

The quantity of polluted soil is not the main reason of concern (although a part of the contaminated soil is situated in intensive agricultural regions). Their persistent pollution and long time period needed for soil recultivation are of major concern, specially in the areas with geologic-chemical anomalies that are not liable to recultivation.

Pesticides' Residues in Food

Pesticides are widely used in agricultural products. The problem is of national scale, because agriculture is developed in all regions of Bulgaria. A network for monitoring pesticide residues in food exists in the country. An authorisation regime for pesticides' import is available. Only pesticides with a permit to enter the country are imported. Measures, preventing pesticide overuse are included in their control. The regional Hygiene Epidemiological Inspectorates have laboratories for chemical monitoring and control of pesticide residues in food.

Heavy Metals in Food

The heavy metal contamination in food is a consequence of soil and water pollution. Potential danger for heavy metal pollution of agricultural products exists mainly in regions where ferrous- and non-ferrous metallurgy is developed. A system of regional centres for monitoring of heavy metals in food has been built. Treatment of industrial air emissions, waste water is carried out in order to avoid pollution of soil and water (surface and ground) with heavy metals. Also, agricultural activity is being restricted in regions where an increased risk of pollution with heavy metals exists.

Import of Unknown Chemicals

In general, there is a suitable control of the import of chemicals. There are problems with the smuggled introduction of dangerous chemicals and preparations without analytical certificates. Similar difficulties might be found in the European Union countries for quality control of the chemicals.

Chemical Accidents: Industry and Transport

An eventual risk for chemical accidents depends on: quantities and concentrations of dangerous substances, design of technological processes, climate's characteristics, physical parameters of the medium, and measures taken to present and restrict the adverse consequences. The economic crisis influences negatively possibilities for accident prevention in chemical industry. Its adverse effect is spread mainly on emergency prevention in chemical industry. The chemical accidents are related to gaps in the good manufacturing practice, the lack of suitable process alarm system and block equipment in small and middle size enterprises. The emergency presentation program are not a Bulgarian practice. The procedure of chemical safety audit is not introduced for the facilities which have had chemical accidents. This is a practice strongly support by EU and USEPA.

Adverse effects caused by industrial and transport accidents are significant. Considerable part of accidents with chemicals is due to: a) incorrect decisions about enterprises' location with respect to towns and villages, transport junctions and raw material sources, and b) lack of necessary standards and legal instruments for emergency prevention.

In order to prevent accidents with chemicals, it is necessary to ensure a good co-ordination between all Government institutions (such as MH, MEW, SS, MAF, MI MD, MIA, MLSP, PCAP, etc.) dealing with chemical safety.

An Automatised information system and emergency response that can help in case of accidents with chemicals has been introduced. Data base, containing Material Safety Data Sheets (MSDS) describing handling and use of 200 hazardous chemicals, is available at PCAP and MH. MSDS for safe use of pesticides are available in MFA. The Environmental Management Training Centre (EMTC) has some integrated US EPA's information systems ( IRIS and CAMEO system).

Table 3.A - Description of Problem Areas

Nature of Problem	City/Region	Brief Description of Problem	Chemical(s)/Pollutant(s)
Pollution of air, water, soil and food	Plovdiv region	Non-ferrous metallurgy	Pb, Co, Mn, Cu, Zn, SO2, SO3, other heavy metals
Pollution of air, water, soil and food	Pirdop region Chelopech Village	Non-ferrous metallurgy	As, Cd, Cu, Zn, U, other heavy metals, salts, SO2
Pollution of air, water, soil and food	Burgas region	Oil-processing industry	CO, SO2, NOx, Pb, toxic organic substances, oil products
Pollution of air, water, soil and food	Vratsa region	Chemical industry (Carbide), Cement industry	SOx, NOx, ammonia, suspended particles (from cement industry)
Pollution of air, water, soil and food	Stara Zagora region Dimitrovgrad town	TEPSs, Coal mining, Chemical industry, Fertilisers production	ammonia, NOx
Pollution of air, water and soil	Sofia region Pernic Region Buhovo and Novy Han towns	Ferrous- and Non-ferrous mining and processing, Uranium mining and processing, Deposition of radioactive waste	Pb, Cd, Cu, CO, SO2, NOx, Cl2, radionuclides
Pollution of air, water and soil	Kozloduy, Svishtov towns	Atomic Power Station, Chemical industry	radionuclides, organic chemical substances
Pollution of air, water and soil	Pleven town, Zlatna Panega village	Oil-processing industry, Cement industry	NOx, SOx, organic substances, oil products
Pollution of air, water and soil	Varna region/ Devnja town	Chemical industry, Cement industry, TEPS, Fertilisers production	NOx, SOx, Cl2, CO, heavy metals, organic substances
Pollution of air, water and soil	Kardzali region	Non-ferrous metallurgy	Pb, Cd, Zn, SO2, NOx, other heavy metals

Table 3. B - Priority Concerns Related to Chemicals

Nature of Problem	Scale of Problem1	Level of Concern2	Ability to Control Problem2	Availability of Statistical Data*	Specific Chemicals Creating Concerns	Priority Ranking3
Air Pollution	N	H	M	MEW, MH, Air emissions monitoring	SO2, NOx, metal aerosols	2
Pollution of Inland Waterways	N	H	M	insufficient, W&C, MEW, BAS	organic substances, nitrates, phosphates, metals	1
Marine Pollution	R			MEW, BAS, MH	oil products, H2S industrial waste water	2
Groundwater Pollution	N	H	M	insufficient, W&S, MEW, MH(HEI)	metals, metal salts, S-containing compounds, nitrates	1
Soil Contamination	N	H	M	insufficient, MH(HEI), BAS, NHC MAF	heavy metals, pesticides, nitrates, biodegradable co-polymers bearing heavy metals	1
Chemical residues in Food	N	H	M	MH(HEI), NHC	pesticides, metals, micro-organisms, parasites	2
Drinking Water Contamination and Regime of Use	N	H	M	MH(HEI), W&S, NHC	metals, nitrates, micro-organisms, regime of use	1
Hazardous Waste Treat-ment/Disposal	N	H	L	MEW(REI), MAF, MI	heavy metals, oil products, pesticides, radionuclides	1
Occupational Health: Agriculture	N	H	L	MH, MAF	pesticides, fertilisers, agro-chemicals	3
Occupational health: Industrial	N	H	M	MH, MHC, MLSP	heavy metals, organic compounds, suspended particles	2
Public Health	N	H	L	MH, HEI- regional centres	heavy metals, suspended particles, asbestos	1
Chemical Accidents: Industrial	N	H	L	MH, MEW, MI, SS	organic substances, oil products, toxic gases, ammonia, Cl2, inorganic acids	2
Chemical Accidents: Transport	N	H	M	MEW,MLSP SS, MIA	pesticides, organic substances oil products, toxic gases, inorganic acids	2
Unknown Chemical Imports	N	H	M	MEW, MH, MAF, SS, MTT, CPUAE	industrial, agriculture, household, radioactive	2
Storage/ Disposal of Obsolete Chemicals	N	H	L	Municipal Boards, MEW, MH, SS, MAF, CPUAE	pesticides, industrial chemicals, oil products, radioactive waste, tailings' ponds, biodegradable co-polymers bearing heavy metals	1
Chemical Poisoning/ Suicides	N	M	M	MH	drugs, pesticides, household chemicals	3
Persistent Organic Pollutants	N	H	L	MH, MEW, MAF	pesticides, industrial organic substances	2

Note: W&C - Water and Cascades; W&S - Water and Sewerage;

1 - L-local, R - regional, N - national; 2 - L - low, M - medium, H - high; 3 - Relative ranking from 1 to 5 of the problems being faced by the country (1=most severe problem(s), 2=second most severe problem(s), etc.)

3.2 Comments/Analysis

Stagnation of industry in a period of transition from 1989 till 1994 gives real positive influence with change for the better environment. All emission of dangerous substances in the air decreases with 24% compare with 1990, consumption of raw materials decreases with 25% and wastes in the rivers decrease with 6.5%. Sudden drop in economic period of 1989-1994 were followed with change of industrial production quality. The changes to displacements close the plants which pollute water to the plants which pollute mainly air.There in a low tendencion to generation of less contaminatiors per unit production of some indices ( industrial waste waters and undangerous solid industrial wastes).There is real almost twice reduction of emissions in the most of "hot points" and statistical visible improvement in the quality of surface water in big part of probe points. Nitrates TLV’s is low than European Community requirements.At the same time sizeable grow up part of pollute industry branches in all industrial production (chemistry, metallurgy, power production, coal output) from 26.7% in 1990 to 46.3% in 1995. These branches take 60% from industrial waste water and over 90% from undangerous solid wastes.Expected macroeconomical stabilisation after 1996 is followed in short term with unproportional grow of environment pollution, but only when there are active compensation measures. Discard or exchange of old installations and change in power consumption will put down emissions per unit production. There is expectation of drop of plumb aerosols because of measures to low down the contamination from lead-zinc plants and growing up use of leaded gasoline. Decrease of contamination of water goes down because of going down water use (the prises of water goes higher 10 way). Better management and higher prises of raw materials, energy, water and sanction of contamination environment will stimulate industrial managers to more ecological production.

CHAPTER 4
LEGAL INSTRUMENTS AND NON-REGULATORY MECHANISMS FOR MANAGING CHEMICALS

Chapter 4 considers existing legal and other mechanisms for chemical management. It contains basic data about all the legal instruments in this field. In section 4.3 these instruments are classified according to the category of chemicals under control and according to the different stages of their lives and the activities related to treatment of chemicals. A short characterization of the basic legal documents and a description of the existing legal instruments and non-regulatory mechanisms for chemical control are given.

4.1 Overview of National Legal Instruments Which Address the Management of Chemicals

Section 4.1 contains some basic information about the legal documents regulating the management of chemicals arranged in groups as follows: agricultural, industrial, consumer product chemicals, chemicals emitted in the air, soil and water, and chemical waste.

As a result of the large amount of information the further listed legal instruments are not presented in Table 4.A, but are spread out throughout the presentation. The data has a numeration corresponding to the columns in the table. As far as allocated resources are concerned (Column 6, Table 4.A) it should be indicated that for the implementation of all legal instruments at present, budgetary or other funds are not being granted. The organization of and the control over the implementation is realized by the employees in the corresponding ministries and other institutions within the framework of their official jurisdiction.

I. 1. Environmental Protection Act, published in The State Gazette, issue 86/91, last amendment in issue 13/97 (translated in English)

• The Ministry of Environment, Regional Environmental Inspectorates, Municipal Authorities

• all chemicals polluting the environment

• issues related to risk assessment and risk management for human health and the environment

• all provisions, Appendixes 1, 2

II. 1. Free Air Preservation Act, published in The State Gazette, issue 45/96, amended in issue 49/96

• The Ministry of Environment, the Ministry of Health, the Ministry of Internal Affairs, the Ministry of Transport, Regional Environmental Inspectorates, Municipal Authorities

• chemicals emitted into the atmosphere

• protecting the health of people and their progeny, of animals and plants, of human societies and habitats, of natural and cultural values from harmful impacts, as well as to prevent dangers and damages due to quality changes of ambient air as a result of various activities

• all provisions

III. 1. Water and Soil Protection Act, published in The State Gazette, issue 84/63, last amendment in issue 45/96 (translated in English)

• The Ministry of Environment, the Ministry of Health, the Ministry of Agriculture and Food Processing Industry

• emissions of harmful substances into water and soil

• protection of water and soil from pollution

• Articles 3, 10, 11, 12, 16, 20 etc.

IV. 1. Agricultural Lands Protection Act, published in The State Gazette, issue 35/96

• the Ministry of Agriculture and Food Processing Industry, Agricultural Lands Committee

• chemicals used in agriculture

• protection from eventual damages; restoration and improvement of the fertility of agricultural lands, which are a national treasure

• Articles 1, 3 - 6 etc.

V. 1. Public Health Act, published in The State Gazette, issue 88/73, last amendment in issue 12/97 and Public Health Act Implementation Regulations, published in The State Gazette, issue 31/74, last amendment in issue 54/96 (translated in English)

• The Ministry of Health, the Ministry of Internal Affairs, the Ministry of Agriculture and Food Processing Industry, the Ministry of Environment, state sanitary control authorities.

• all kinds of substances related to the life style and health of the population, including toxic substances and highly active substances, nuclear materials and other sources of ionizing radiation

• stimulating favorable conditions for harmonious physical and spiritual development and higher life expectancy, as well as for protection of the population’s reproduction

• Articles 15, 19 - 21 of the Public Health Act; Articles 12a, 12d, 16 - 26 of the Public Health Act Implementation Regulations

VI. 1. Act Concerning Control over Foreign Trade Activities Connected with Weapons, and Goods and Technologies with a Possible Double Usage, published in The State Gazette, issue 102/95 and Control over Foreign Trade Activities Connected with Weapons, and Goods and Technologies with Possible Double Use Act Implementation Regulations, published in The State Gazette, issue 21/96, amended in issue 35/96

• Interdepartmental Council on the Issues of the Military Industrial Complex and the Mobilization Readiness of the Country; Committee of Control and Permission of Foreign Trade transactions with Weapons, and Goods and Technologies with Possible Double Usage under the Ministry of Trade and Foreign Economic Cooperation

• initial chemical compounds and elements with possible application in the field of chemical, biological and nuclear weapons

• control over foreign trade activities concerning weapons, and goods and technologies with possible double usage in order to protect national security and the foreign-political interests of the country, consolidation of international trust and stability, and fulfillment of the international obligations of the Republic of Bulgaria

• Articles 1 - 4, Chapter 9 from the Act and Chapter 2 from the Regulation

VI*.1. Act for limitation of the hazardous influence of waters on the environment, published in the State Gazette, issue 86/97

• Ministry of Environment, Ministry of Health, Municipal Authorities

• communal waters, industrial waters, hazardous water

• protection of human health and environmental components

• Article 1.2-68

VII. 1. Criminal Code of the Republic of Bulgaria, published in The State Gazette, issue 26/68, last amendment in issue 107/96 (translated in English)

• jurisdiction authorities of the Republic of Bulgaria - courts, prosecutor’s office

• all chemicals polluting the environment and in particular petroleum products and their derivatives

• protecting the personality from criminal violations; protecting the rights, health and life of the citizens and the legal order established in the country

• Article 352, Article 352a, Article 353

VIII. 1. Regulations (Bylaw) Concerning the Organization and the Activities of the National Service for Plant Protection, Quarantine and Agricultural Chemistry, published in The State Gazette, issue 65/93, last amendment in issue 67/96

• National Service for Plant Protection, Quarantine and Agricultural Chemistry; the Ministry of Agriculture and Food Processing Industry

• chemicals used in agriculture

• regulates the organization structure of the National Service for Plant Protection, Quarantine and Agricultural Chemistry as an authority responsible for state policy with respect to organization, management and control of plant protection, plant quarantine, mineral and organic fertilizing in the Republic of Bulgaria

• Article 4, Points 4, 5, 6, 7; Article 5

IX. 1. Governmental Decree 153 Concerning the Collection, Transportation, Storage and Safe Disposal of Hazardous Waste, published in The State Gazette, issue 70/93, last amendment in issue 4/96

• The Ministry of Environment, the Ministry of Health, the Ministry of Internal Affairs, the Ministry of Trade, Public Protection Department, municipal councils

• all kinds of hazardous waste except for the ones in provision 2 from the Additional Provisions of the Decree (see Section 4.2, part II, Point 1)

• contains the basic requirements for the realization of the activities related to hazardous waste treatment

• all provisions

X. 1. Governmental Decree 266 Concerning Export and Import Regime, published in The State Gazette, issue 2/96, last amendment in issue 18/97 (translated in English)

• The Ministry of Trade and Foreign Economic Cooperation, the Ministry of Finance

• imported and exported goods, including a number of chemical substances, which are imported in and exported from the country

• regulates import and export regime of goods from and on the territory of the Republic of Bulgaria, realized by juridical persons and sole traders, by introducing bans, quotas, customs restrictions etc.

• all provisions, Appendix 1 under Article 2

XI. 1. Governmental Decree 268 Concerning Import and Transit Transportation of Waste and Dangerous Substances, published in The State Gazette, issue 94/96, amended in issue 3/97

• The Ministry of Environment, Customs Department of the Ministry of Finance, the Standardization and Metrology Committee, municipal councils

• dangerous substances and waste

• regulates import and transit transportation of waste and dangerous substances; with the Decree is passed a Regulation Concerning Conditions and Procedures for Permitting Import and Transit Transportation of Waste and Dangerous Substances.

• all provisions, Appendixes 1, 2, 3, 4

XII. 1. Governmental Decree 38 Concerning Export and Import of Chemicals Under Control, Used for the Production of Anesthetics and Psychotropic Drugs, as well as the Conditions and Procedures for Trade, Production and Consumption, published in The State Gazette, issue 15/97

• The Ministry of Trade and Foreign Economic Cooperation, the Ministry of Finance, the Ministry of Health, the Ministry of Industry

• chemicals used for the production of anesthetics and psychotropic drugs

• regulates the regime of import and export of chemicals under control used for the production of anesthetics and psychotropic drugs from and on the territory of the Republic of Bulgaria, as well as the conditions and procedures for their trade, production and consumption in correspondence with the obligations assumed by the Republic of Bulgaria under the UN Convention Concerning Measures against Illegal Traffic with Anesthetics and Psychotropic Drugs

• all provisions

XIII. 1. Regulation Concerning Conditions and Procedures for Coordinating and Permitting Export and Import of Chemicals under Control /CUC/, passed with Governmental Decree 38, published in The State Gazette, issue 15/97.

• The Ministry of Trade and Foreign Economic Cooperation, Customs Department

• chemicals, used for the production of anesthetics and psychotropic drugs

• regulates the conditions and the procedures for permission of export and import of chemicals under control according to appendix 1 under article 1, paragraph 2 from Governmental Decree 38

• all provisions

XIV. 1. Regulation Concerning Conditions and Procedures for Registration of Persons Engaged in Trade, Production and Consumption of Chemicals under Control in the Republic of Bulgaria , Used for the Production of Anesthetics and Psychotropic Drugs, Keeping Record of Required Documentation and Labeling, passed with Governmental Decree 38, published in The State Gazette, issue 15/97.

• The Ministry of Trade and Foreign Economic Cooperation

• chemicals, used for production of anesthetic and psychotropic drugs

• regulates the conditions and the procedures for registration of persons, engaged in trade, production and consumption of chemicals under control according to appendix 1, article 1, paragraph 2 from Governmental Decree 38.

• all provisions

XV. 1. Regulation Concerning Conditions and Procedures for Permission of Import and Transit Transportation of Waste and Dangerous Substances, passed with Governmental Decree 268, published in The State Gazette, issue 94/96.

• The Ministry of Environment, Regional Environmental Inspectorates

• waste and dangerous substances

• regulates conditions and procedures for permission of the import and transit transportation of waste and dangerous substances

• all provisions

XVI. 1. Regulation Concerning Penal Procedures in Cases of Damaging or Polluting the Environment above Admissible Levels, passed with Governmental Decree 24, published in The State Gazette issue 15/93, amendment in issue 101/95

• The Ministry of Environment, Regional Environmental Inspectorates

• all kinds of chemicals, polluting the environment

• regulates measures undertaken against juridical persons and sole traders in cases of damaging or polluting the environment

• all provisions and appendixes to them

XVII. 1. Regulation 1 Concerning the Environmental Impact Assessment, issued by the Minister of the Environment, the Minister of Town Development and Construction, the Minister of Health and the Minister of Agriculture and Food Processing Industry, published in The State Gazette, issue 73/95 /translated in English/.

• The Ministry of Environment, Regional Environmental Inspectorates
• all chemicals, polluting the environment
• regulates the scope and the content of the Environmental Impact Assessment reports in connection with the sites concerned, as well as EIA and EAudit procedures, with a view to organizing effective control over the projects, sites and the activities, related to the environment
• all provisions

XVIII. 1. Regulation 2 Concerning Emergencies in Activities Connected with Dangerous Chemicals, issued by the Quality Committee and the Ministry of Transport, published in The State Gazette, issue 100/90

• The Ministry of Health

• dangerous chemicals

• to guarantee the protection of people, material values and the environment in cases of emergencies connected with dangerous chemicals

• articles 1,2,5-15

XIX. 1. Regulation 2 Concerning Plant Products Control, Phytopharmaceuticals and Chemical Fertilizers, issued by the Minister of Agriculture and Food Processing Industry, published in The State Gazette, issue 109/96

• The Ministry of Agriculture and Food Processing Industry, the National Service for Plant Protection, Quarantine and Agricultural Chemistry

• phytopharmaceuticals for plant protection, chemical fertilizers and food media

• defines the procedure for exercising interdepartmental control within the system of the Ministry of Agriculture and Food Processing Industry in connection with the above mentioned substances and detergents

• articles 1,6,7,19,25

XX. 1. Regulation 2 Concerning Safe Sanitary Zones around Water Springs and Water-Supply Utilities for Drinking and Household Needs, issued by the Town Planning Committee, published in The State Gazette , issue 68/89

• The Ministry of Town Development and Construction

• industrial, agricultural and consumer chemicals and waste

• defines the conditions and the procedure for researching, designing , establishing, exploiting and controlling the safe sanitary zones around the water springs and the water-supply utilities for drinking and household needs

• article 3, Appendix 01 to article 7

XXI. 1. Regulation 14 Concerning Threshold Limit Values (TLV’s) of Harmful Substances in the Ambient Air of the Settlements, issued by the Ministry of Public Health, published in The State Gazette, issue 88/97.

• The Ministry of the Environment, the Ministry of Town Development and Construction, the Ministry of Internal Affairs

• harmful substances emissions in the ambient air

• defining the TLV’s of harmful substances in the ambient air of the settlements

• articles 1,2,3, appendix 1 to article 2 and appendix 2 to article 3, paragraph 1

XXII.1. Regulation 3 Concerning the Threshold Limit Values (TLV’s) of Harmful Substances in the Soil issued by the Environmental Protection Committee Chairman, published in The State Gazette, issue 36/79, amendment in issue 5/96.

• The Ministry of the Environment

• industrial and agricultural chemicals

• defining the threshold limit levels of harmful substances in the soil

• all provisions, appendixes

XXIII. 1. Regulation 3 Concerning the Threshold Limit Values (TLV’s) of Chemicals, Emitted from Polymer Construction Materials in Buildings, issued by the Ministry of Public Health, published in The State Gazette, issue 17/84

• authorities, responsible for state sanitary control

• chemicals, used in construction and household

• defines the TLV’s of chemicals, emitted from polymer materials in the indoor environment

• articles 1,2,3 and appendixes

XXIV. 1. Regulation 3 Concerning Biological Testing and Licensing of Plant Protection Chemicals, Growth Regulators and Micro Fertilizers, issued by the Minister of Agriculture and Food Processing Industry, published in The State Gazette, issue 16/96

• The Ministry of Agriculture and Food Processing Industry, National Service for Plant Protection, Quarantine and Agricultural Chemistry

• chemicals, used in agriculture

• defines the conditions and the procedure for biological testing and licensing of plant protection chemicals, growth regulators and micro fertilizers, imported or produced in the country

• all provisions

XXV. 1. Regulation 5 Concerning Sanitary Norms for Maximum Admissible Levels for Chemicals or Biological Polluting Agents in Food Products, issued by the Ministry of Public Health, published in The State Gazette, issue 39/84, last amendment in issue 66/92

• state sanitary control authorities

• chemicals, natural or synthetic introduced during production, processing, or storage of food products

• establishes procedures for setting sanitary norms for the maximum admissible levels of chemical and biological polluting agents

• articles 1-6

XXVI. 1. Regulation 8 Concerning Conditions and Procedures for Coordinating Export and Import of Medicines, issued by the Minister of Health, published in The State Gazette, issue 32/95

• National Institute of Medicines, the Ministry of Health

• chemicals under control

• coordinating export and import of medicines

• art.3, point 4;art. 4, p.2; art. 6; art. 7, p.2, p.6; art. 8

XXVII. 1. Regulation 10 Concerning Sanitary Requirements for Using Pesticides in the National Economy and Private Farming, issued by the Minister of Public Health and National Agrarian and Industrial Association, published in The State Gazette, issue 88/85

• The Ministry of Health, state sanitary control authorities

• pesticides

• defines the sanitary requirements for import, production, trade, storage, transport and use of pesticides in the economy and private farming

• all provisions

XXVIII. 1. Regulation 11 Concerning Sanitary Requirements about the Structure and Operation of Agricultural Pharmacy Drug Stores, issued by the Minister of Health and the Minister of Agriculture and Food Processing Industry, published in The State Gazette, issue 37/95

• National Service for Plant Protection, Quarantine and Agricultural Chemistry, state sanitary control authorities

• pesticides

• defines the sanitary requirements for structuring and operation of agricultural pharmacy drug stores for ensurement of adequate storage and sale of pesticides

• all provisions

XXIX.1. Regulation 12 Concerning Sanitary Requirements for Import, Production and Use of Asbestos and Materials or Products Containing Asbestos, issued by the Ministry of Health, published in the State Gazette, issue 98/93

• state sanitary control authorities

• asbestos and asbestos containing materials and products
• establishment of sanitary requirements for import, production and use of asbestos and asbestos containing materials and products for the purpose of protection of workers’ and people’s health form the dangerous influence of asbestos
• all provisions

XXX. 1. Regulation 13 Concerning Threshold Limit Values (TLV’s) of Harmful Substances in the Air and Working Environment, issued by the Ministry of Health, published in The State Gazette, issue 81/92, last amendment in issue 57/94

• The Ministry of Health, state sanitary control authorities

• emissions of harmful chemicals in the air of working environment

• defines the TLV’s of harmful substances in the air and working environment

• articles 1-8, Appendixes 1,2,3,4,5

XXXI. 1. Regulation 27 Concerning Import of Goods Related to Public Health, issued by the Minister of Health, published in The State Gazette, issue 75/95 /translated in English/

• The Ministry of Health, state sanitary control authorities

• chemicals, used in industry, agriculture, private farming and household

• defines the list of imported goods, related to public health and the conditions and procedures for issuing import sanitary permit, registration, as well as sanitary conclusion for placement of goods

• all provisions, Appendixes 1,2,3,4

XXXII. 1. Regulation 34 Concerning Sanitary Requirements in Cosmetics, issued by the Minister of Health, published in The State Gazette, issue 82, 83/95

• The Ministry of Health, state sanitary control authorities

• chemicals, used in the production of cosmetics

• regulates the sanitary requirements for chemicals used in cosmetics, issuing sanitary permits and the procedure for sanitary control

• article 4, appendix 2 to article 4

XXXIII.1. Regulation 35 Concerning Sanitary Requirements for Consumer Detergents, issued by the Minister of Health, published in the State Gazette, issue 83/95.

• The Ministry of Health, state sanitary control authorities

• chemicals used in washing and cleaning products

• regulates washing and cleaning chemicals, imported or produced in the country, issuing of sanitary permits and the procedures for sanitary control

• article 4, appendix 2 to article 4

XXXIV. 1. Regulation 45 Concerning Sanitary Norms and Requirements for Additives to Food Products, issued by the Minister of Health, published in the State Gazette, issue 110/95

• The Ministry of Health, state sanitary control authorities

• chemicals used in the food processing industry

• defines sanitary norms and requirements for food additives

• article 2, article 7, article 9, article 12 and appendixes to them

XXXV. The Republic of Bulgaria joined the following international conventions, addressing chemicals:

• UN Convention Concerning Measures against Illegal Traffic of Anesthetics and Psychotropic Drugs, ratified with an Act, passed by the National Assembly, published in the State Gazette, issue 89/93.

• Basel Convention Concerning Transborder Movement Control and Safe Disposal of Dangerous Waste, ratified with Act passed by the National Assembly, published in the State Gazette, issue 1/97.

• Convention Concerning Psychotropic Drugs, published in the State Gazette, issue 40/95, amendment in issue 83/96.

• United Convention Concerning Anesthetics, 1961, amended with the Protocol in 1972, published in the State Gazette, issue 87/96.

 Note: Changes in the names of different ministries have not been reflected in the legal instruments. It should be taken into consideration that the present name of:

• the Ministry of Agriculture and Food Processing Industry is the Ministry of Agriculture, Forestry and Agrarian Reform;

• the Ministry of Trade and Foreign Economic Cooperation is the Ministry of Trade and Tourism;

• The Ministry of Environment is the Ministry of Environment and Water.

Note 1: The analysis includes legislation up to March 1997. Amendments made after this date are not taken into consideration

4.2 Summary Description of Key Legal Instruments Relating Chemicals

The key legal instruments with reference to the management of chemicals could be considered within the following groups:

• Laws;

• Governmental Decrees;

• Regulations issued by the Council of Ministers, by different ministries or other state institutions.

All legal instruments in the Republic of Bulgaria are made public through the State Gazette and this is a prerequisite for their enforcement.

I. LAWS

Of major importance are the following laws: The Environmental Protection Act, the newly passed Free Air Preservation Act and the Agricultural Land Protection Act, The Water and Soil Protection Act, The Public Health Act and The Act Concerning Control of Foreign Trade Activities Connected with Weapons and Goods and Technologies with a Possible Double Usage.

1. Environmental Protection Act is the key legal instrument in the field of ecology. This law does not regulate activities concerning concrete chemicals but at the same time it encompasses such activities as long as its subject is protection of the environment and in particular: gathering and providing information concerning the current ecological state, exertion of control over the state of the environment, working out of Environmental Impact Assessment /EIA/, and finally the rights and obligations of state and municipal authorities as well as those of juridical and physical persons with respect to environmental protection.

The Environmental Protection Act imposes an explicit ban on import into the country of wastes and dangerous substances:

• with indefinite chemical composition as well as for which there are no available methods for analyses in the Republic of Bulgaria
• for the purpose of storing, disposal, destroying or recycling
• for the purpose of putting such substances into production in the case when the decision of the EIA authorities is negative.

With a view of exerting control over the state of the environment, article 11, par.2 from the Act obliges the juridical and physical persons, producers of goods and performers of services to provide the respective authorities, i.e. The Ministry of Environment, the Ministry of Health, the Ministry of Agriculture and Food Processing Industry, the National Statistical Institute and the municipal authorities, with data concerning activities which result in or might lead to polluting or damaging the environment or its components, as well as information about activities undertaken with respect to environmental protection and restoration. Article 16 obliges the above mentioned authorities to constantly supervise the qualities of the environmental elements and to register any changes and the sources of such changes applying methods approved by the Minister of Environment.

In addition the Act requires from the producers of and dealers in goods and services to provide the buyers or the consumers with written information and only in some less important cases with oral information about any harmful components consistent in the goods or services as well as about any possible negative effects and this information should be promptly supplied at the time of the sale/purchase or of performing the service respectively.

Another mechanism introduced by the Act referring to environmental protection is working out of EIA for activities of physical and juridical persons, of state or municipal authorities. Article 20 provides for obligatory EIA with reference to:

• projects and sites quoted in Appendixes 1 and 2 from the Act,

• national and regional programs for development, area and urban planning projects and their modifications

• reconstruction and development projects in connection with the above mentioned projects and sites.

EIA is prepared regularly for sites in operation and for highly polluting sources/sites at least once in every five years.

In addition, in the cases when there is a decision by the competent authorities or an offer by persons concerned, addressed to the respective authorities, such EIA could include projects, sites or activities outside the list.

Regulations concerning the carrying out of assessments as well as procedures concerning their consideration are envisaged in a separate Regulation 1/7 August 1995 for EIA, issued by the Ministry of Environment, the Ministry of Town Development and Construction, the Ministry of Health and the Ministry of Agriculture and Food Processing Industry. Appendixes 1, 2 and 3 of the Regulation provide for the scope and the content of the EIA and E Audit reports in connection with the sites and projects for which they are worked out. The EIA procedure is also defined in connection with the sites and projects considered and this procedure should include:

• drawing up of EIA or E Audit report

• public discussion of the report

• making the decisions on EIA or E Audit report by the competent authorities.

EIA and EAudit reports are drawn up by disinterested experts whose competence is in compliance with the requirements of Regulation 2/1995 concerning certification of professional competence of experts performing the EIA or EAudit, issued by the Ministry of Environment. The Regulation defines the conditions on which licences are issued for the preparation of performing EIA and EAudit reports and for presenting professional statements on the basis of certified professional qualification.

Chapter 5 of the Environmental Protection Act regulates in detail the obligations of the Minister of Environment, of the Regional Environmental Inspectorates and of the municipal authorities responsible for the environmental protection issues.

One of the main obligations of the Minister of Environment is that he in cooperation with the Minister of Health, the Minister of Agriculture and Food Processing Industry, the Minister of Town Development and Construction and the state authorities should approve:

• emission and threshold limit concentration norms for harmful substances in connection with regions, environmental components and types of polluting agents;

• instructions concerning labelling of goods;

• instructions concerning transportation, storing, use and disposal of dangerous substances etc.

The municipal authorities are obliged:

• to control the disposal of waste and dangerous substances on their territory;

• to build and exploit City Waste Water Treatment Stations;

• to organize and control safe collection and disposal of household waste; etc.

The Regional Environmental Inspectorates are founded by the Minister of Environment and belong to the Ministry of Environment. They serve the municipalities where there is a lack of the necessary equipment or trained staff /article 25/.

In the cases of failure to observe the obligations regulated by the Environmental Protection Act administrative penalties - fines are imposed, if the deed cannot be considered as a crime according to the Criminal Code of the Republic of Bulgaria. In addition the law provides that the person or persons who have caused harm to others by polluting or damaging the environment should undertake all responsibility for compensations.

2. Ambient Air Preservation Act /AAPA/ regulates defining of indexes and norms for the quality of free air; setting emission limits; rights and obligations of state and municipal authorities, of physical and juridical persons responsible for the control, management and preservation of the quality of free air.

The quality of free air is assessed on the basis of the following indexes - concentration of:

a. particles /aerosols, fogs, smoke, dust/;

b. sulfur dioxide;

c. nitrogen dioxide;

d. lead /aerosol/,

e ozone

and for certain areas also concentrations of hydrogen sulfide, phenol, ammonium, cadmium, etc.

With the view of preserving the quality of the ambient air according to the established standard, the following norms have been set:

a/ norms concerning the content of lead, sulfur and other ecologically harmful substances in fuels, established by the Minister of Environment together with the Minister of Health and concerted with the authorities concerned, banning import of fuels containing the above mentioned substances in concentrations above the norms;

b/ norms for admissible concentrations of harmful substances, emitted in the atmosphere from immobile sources, established by the Minister of Environment in cooperation with the respective authorities concerned;

c/ norms concerning the emissions of harmful substances in exhaust gases from motor vehicles, established by the Minister of Transport together with the Minister of Environment and the Minister of Health.

The quality of ambient air is monitored by means of a National System for supervision of, control over and information about the environmental state, which system is established at the Ministry of Environment.

Health and environmental risk related to the quality of the ambient air is assessed by the Ministry of Health and the Ministry of Environment.

In Chapter 4 from the Act are laid out the special requirements concerning the designing, building and exploitation of sites with emission sources. A permit which sets special conditions of exploitation and with a validity of 1 to 5 years is issued for the sites and equipment which are potential emission sources and about which there has been a positive EIA or E Audit decision /in the cases when such a procedure is required on the basis of the Environmental Protection Act/. The conditions and procedures concerning the issuing of such permits should be defined by a regulation from the Minister of Environment that is about to be issued. According to article 18 from the Act the physical and juridical persons involved in activities with emission sources are obliged to regularly monitor the emissions, to make checks and to prepare and follow a program for technical maintenance of the purification systems with a view of strict observance of the emission norms defined in the permit.

The immediate control over the state and exploitation of sites with emission sources, over the operation of the purification systems and over the emissions of the different sources, is exerted by the Minister of Environment, the Regional Environmental Inspectorates and the municipal authorities and as far as the motor vehicles are concerned, the control is exerted by the Ministry of Internal Affairs and the Ministry of Transport. In the cases of registered infringements, the authorities responsible for the exertion of control decide the measures to be undertaken and their carrying out is obligatory. In the cases of failure in carrying out the required measures as well as in the cases when the type and level of ambient air pollution present a higher risk for human health and the environment the respective authorities could set restrictions upon or even terminate production or other activities.

For infringements of the other obligations established by the Ambient Air Preservation Act the law makes provisions for taking administrative measures such as differentiated fines.

3. Water and Soil Protection Act /WSPA/.

After passing the considerably more efficient as a legal base Environmental Protection Act and Ambient Air Preservation Act, the importance of WSPA significantly decreased.

WSPA does not refer to particular chemicals but to all polluting agents having impact on water and soil.

The Act makes provisions for the division of responsibilities of the Ministry of Environment and the Ministry of Health in connection with protecting the waters and soils from pollution and furthermore, for the norms established by the Minister of Agriculture and Food Processing Industry. Article 3 provides that the Minister of Environment should exercise control in connection with preserving the waters and soils from pollution and the Minister of Health should exercise sanitary control over the state of water and soil. Both ministers are responsible for defining norms and regulations which are obligatory for all institutions, organizations and bodies. The Minister of Agriculture and Food Processing Industry establishes obligatory norms and regulations in connection with animal and agricultural plants protection.

The Act imposes a ban on exploitation of industrial enterprises, thermal electric power stations, stock-breeding farms, if they are not equipped with purification systems.

The industrial enterprises, thermal electric power stations, stock-breeding farms, households, institutions, offices, restaurants, bars, etc. are obliged to have equipment for waste collection and for safe disposal of sewer waters, harmful substances and other waste which could pollute the soil /article 16/.

The law requires preliminary permit in writing issued by the Ministry of Environment for disposal of household and industrial waste water into surface water basins, fish farms or littoral sea waters.

For non-compliance with the obligations as per the Act, fines are imposed but the amounts have not yet been updated and are liable to changes.

4. Agricultural Land Protection Act /ALPA/

The objective of this Act is agricultural land protection.

Article 3 from the Act establishes an obligation for the owners or users of agricultural land to protect it from erosion, pollution, accumulation of salts and acids, forming of marshes and other kinds of damage and to maintain and increase the land’s fertility.

In order to fulfill this essential obligation the owners are not allowed to:

• use pesticides, mineral, leaf feeding and micro fertilizers, also biologically active substances which were not granted biological and toxicological registration by the specialized committees to the Ministry of Agriculture and Food Processing Industry, the Ministry of Health and the Ministry of Environment;

• introduce organic residues from industrial or other waters or household waste into the agricultural lands without license from the responsible authorities to the Ministry of Agriculture and Food Processing Industry.

• use water containing harmful substances or waste above the admissible norms for irrigation

-etc.

Article 5, paragraph 5 regulates tax and credit preferences for owners and users of agricultural land who:

• comply with the imposed restrictions when cultivating the agricultural land;

• apply the systems of natural agriculture and systems of reduced usage of herbicides, pesticides and artificial fertilizers;

-etc.

With a view of rendering support to the owners and users of agricultural land to fulfill the above mentioned obligations, the Ministry of Agriculture and Food Processing Industry is obliged to provide official information about the quality of agricultural land; the restrictions concerning agricultural land usage; about pesticides, fertilizers, industrial or household waste; biologically active or other substances which have been registered and approved for usage; about sanitary norms and their implementation; substances banned for usage, etc. The Ministry of Agriculture and Food Processing Industry maintains information system concerning the monitoring of agricultural soil resources and also it has a special registrar for agricultural lands which are:

• polluted with heavy metals and metalloids, radionucleids, petroleum products and other organic polluting agents, industrial, construction and household waste;

• endangered by erosion, pollution, accumulation of salts and acids or forming of marshes.

Persons participating in activities leading to damaging agricultural land are fined with amounts established in chapter nine of the Act.

5. Public Health Act /PHA/ and Public Health Act Implementation Regulations /PHAIR/

These two legal instruments address toxic and highly active substances, nuclear materials and other sources of ionizing radiation as well as all goods and substances relating to public health.

According to article 15 of PHA and article 12 of PHAIR the Ministry of Health together with other state authorities with competence established by law are responsible for permitting and supervising import, production, usage, storage, transportation and safe disposal of the toxic and highly active substances, nuclear materials or other sources of ionizing radiation.

The Minister of Health sets obligatory sanitary norms, rules and requirements with respect to sanitary issues, chemical and radiation safety and epidemiology.

The Ministry of Health exercises sanitary control through the following authorities: Preventive Medicine and State Sanitary Control Department, part of the Ministry of Health, National Center of Hygiene, Medical Ecology and Nutrition, National Center of Radiology and Radiation Safety and 28 Hygiene Epidemiological Inspectorates /regional authorities of the state sanitary control/.

Import, production, storage, transportation of and trade in all goods relevant to public health should undergo state sanitary control. The Minister of Health makes the list of goods relevant to public health and the producers and distributors of such goods are required to have a permit issued by the state sanitary control authorities. The conditions and procedures for issuing of permits are defined in a separate regulation by the Minister of Health.

The state sanitary control authorities have to approve any new chemical, biological or radioactive substances, technologies for food production, growth regulators and stock-breeding agents, chemical and biological formulations for plant protection, synthetic and bio-synthetic materials and other chemical or biological products. It is within the sanitary authority's competence to ban production, transportation and usage of chemicals which are harmful or dangerous for public health and to demand that they are destroyed or processed and used for other purposes.

The state sanitary officials are obliged to maintain confidentiality with respect to proprietary information and facts which they come across during fulfillment of their duties.

Chapter thirteen of PHA makes provisions for administrative measures undertaken in the cases of non-compliance with the obligations as per the Act.

6. Act Concerning Control over Foreign Trade Activities Connected with Weapons and Goods and Technologies with a Possible Double Usage and the Act Control over Foreign Trade Activities concerning Weapons and Goods and Technologies with a Possible Double Usage Implementation Regulations

The Act addresses the conditions and procedures for engaging in foreign trade activities concerning weapons and goods and technologies with a possible double usage and the state control exerted over these activities.

According to article 4 of the Act the state can impose restrictions and bans on foreign trade activities concerning weapons and goods and technologies with a possible double usage in the cases when:

• any such activity presents a threat to the national security and the foreign policy interests of the country;

• the goods or technologies could be used for creating weapons of mass destruction;

• the Republic of Bulgaria has undertaken obligations to this respect by being part in international conventions or on the basis of membership in international organizations.

Goods and technologies under restrictions or ban for foreign trade activities are made known to the public by publishing them in the State Gazette.

Foreign trade activities concerning goods and technologies under restriction are carried out on the basis of separate permit for every transaction, issued by the Committee for Control over and Permission of Foreign Trade Transactions with Weapons and with Goods and Technologies with a Possible Double Usage at the Ministry of Trade and Foreign Economic Cooperation. Any person applying for permit is obliged to submit all documentation pointed out in Chapter 2, Section III of the Implementation Regulations. The required documentation defers depending on the type of transaction for which a permit is requested.

For some foreign trade transactions under restriction a license is required. Granting of such license is an obligatory condition for issuing a permit in order to have the particular transaction realized. The license is granted for a 1 year period by the Interdepartmental Council on Issues concerning the Military Industrial Complex and Mobilization Readiness of the Country after submission of the documents required in Chapter 2, Section II of the Implementation Regulations. Goods and technologies for which a license is required in order to have transactions carried out include nuclear materials and in particular: initial chemical compounds, equipment and technologies with a possibility for application in chemical weapons production, goods and technologies with a possible application in missile production and in particular chemical, biological and nuclear missiles, etc.

The authorities responsible for granting the licences exert control over fulfillment of the obligations and the conditions provided in the licence or permit. In the cases of registered violation the authorities should approach the Prosecutor’s Office.

The authorities exercising the control are obliged to maintain confidentiality with respect to business, production or trade secrets of the bodies under control.

According to article 14 of the Act, persons engaged in foreign trade activities with goods and technologies under control are obliged to keep record about conducted transactions and to keep commercial and transportation documentation and all information related to conclusion of the transaction for a period of time not less than 5 years.

Property fines for infringement of the regulated obligations by the Act are provided in Chapter 6.

II. Decrees by the Council of Ministers /Governmental Decrees/

1. Governmental Decree Number 153 Concerning Collection, Transportation, Storage, Disposal of Hazardous Waste, published in the State Gazette issue 70/93, last amendment in issue 4/96

The objective of the Governmental Decree 153 encompasses activities concerning treatment of hazardous waste. According to Provision ง1 from the Additional Provisions of the decree, "waste" is substance, object or part of object for which there is no stipulated immediate application or from which the owner wishes to or is obliged to dispose of and "hazardous waste" is the waste which composition, quantity or properties present risk for human health and for the environment. Provision ง2 from the Additional Provisions regulates that the decree does not apply to special nuclear materials, exhaust nuclear fuel, radioactive waste, waste from mine extraction industry, ashes and cinders from thermal electric power stations using solid fuel, phosphorus plaster and residues, pointed out in the appendixes. The present legal instrument does not address the waste which is made use of by physical or juridical persons. Provision ง4 introduces the presumption that in the cases when certain waste is suspected to possess dangerous properties but it could not be established whether these properties are within the set criteria for danger, the waste is presumed hazardous until proved otherwise.

The decree provides the conditions for the permission of such activities as collection, transportation, storage and safe disposal of hazardous waste as well as any intermediate operations. Any physical or juridical person involved in any of the above mentioned activities is obliged to have the respective permit. The application for such a permit has to be enclosed with all documentation as per article 8, paragraph 2. The permits are with validity of not more than 3 years.

The decree also makes provision for additional requirements concerning treatment of hazardous waste.

The transportation means used for hazardous waste should meet the requirements as per article 19, paragraph 2 and with routes agreed on in advance and approved by the competent authorities as per article 20, paragraph 3.

The collection and temporary storage of any hazardous waste are done on the premises of the body responsible for the discharge or is stored at special collection places where the waste is delivered, safely disposed of or treated in any other way in compliance with the requirements of the decree.

The collection places and the places for recycling are obliged to keep a record of all waste delivered and about the forms of disposal and this record should be kept for unlimited period of time (article 25, paragraph 2).

The physical and juridical persons are obliged to keep record of, to declare and give account of hazardous waste according to the provisions of this Governmental Decree.

Bodies responsible for the discharge of hazardous waste are obliged to declare such discharges every year in advance, by submitting the so called Informational Declaration Paper for Registering Dangerous Waste until 31 January the latest. The information submitted is supervised by the Regional Environmental Inspectorate. A copy of the Informational Declaration should be submitted to the Laboratory and Information Center at the Ministry of Environment (article 10, paragraph 1, 2).

31 March is the deadline for the bodies responsible for the discharge of hazardous waste to submit to Regional Environmental Inspectorates the so called Informational Paper - Account of Dangerous Waste with respect to types and quantities of dangerous waste discharged in the previous year. A copy has to be submitted to the Laboratory and Information Center at the Ministry of Environment (article 11).

The Laboratory and Information Center at the Ministry of Environment establishes a system for monitoring, control and information with respect to hazardous waste, aiming at safe disposal (provision 5 of the Preceding and Concluding provisions).

All physical and juridical persons engaged in activities connected with collection, transportation, storage, recycling or safe disposal of hazardous waste prepare the so called Emergency Plan for the current year, coordinated with the Regional Environmental Inspectorates, the Public Safety Department at the municipal councils, the regional Fire Protection offices, the regional departments of the Ministry of Internal Affairs and the Sanitary Epidemiological Inspectorate (article 29, paragraph 1).

The responsibility for monitoring the compliance with the governmental decree is undertaken by the Ministry of Environment and its inspection authorities, the Ministry of Health and its inspection authorities, the Ministry of Internal Affairs and its regional departments, the Public Safety Department, the Ministry of Transport and its inspection authorities and the municipal councils.

The Minister of Environment can ban or stop activities connected with treatment of hazardous waste which lead to polluting or damaging the environment.

Infringements of this governmental decree are fined according the Administrative Non-Compliance and Penalties Act /ANCPA/. ANCPA regulates procedures such as registering infringements, issuing, appealing and implementation of penal decrees.

Physical persons who have given incorrect data in the Informational Paper - Account of Dangerous Waste are under penal prosecution proceedings according to article 313 of the Criminal Code.

Juridical persons who have caused damage or pollution to land while being involved in unregulated disposal of dangerous waste are liable to sanctions according to the Regulation Concerning Procedures for Defining and Imposing of Sanctions in Cases of Damaging or Polluting the Environment above Admissible Levels.

Despite the imposed penal proceedings for damage caused to environment as a result of treatment of dangerous waste, the persons responsible are under obligation to make compensations with amounts relevant to expenditure on restoration (article 37).

2. Governmental Decree 38 Concerning Export and Import of Chemicals under Control, Used in Production of Anesthetics or in Psychotropic Drugs and Trade, Production and Consumption Conditions and Procedures, published in the State Gazette, issue 15/97

This decree is in compliance with the obligations undertaken by the Republic of Bulgaria under the UN Convention concerning measures against illegal traffic of anesthetics and psychotropic drugs:

• the procedures connected with export and import of chemicals under control/CUC/, used for the production of anesthetics and psychotropic drugs, hence referred to as CUC.

• conditions and terms of trade, production and consumption of CUC.

The main criterion for addressing a certain chemical in the provisions of the Governmental Decree is the possibility that the particular chemical might be used in the production of anesthetics and psychotropic drugs.

Appendix 1 in conformity with article 1, paragraph 2 gives the CUC list under permit regime. For every transaction concerning import or export of CUC, included in the appendix is required a permit issued by the Ministry of Trade and Foreign Economic Cooperation. With the Governmental Decree is passed Regulation Concerning the Conditions and Procedures for Coordinating and Permitting Export and Import of CUC. The applicant for import or export permit is obliged to submit a standard declaration form addressed to the Ministry of Trade and Foreign Economic Cooperation. Article 6, paragraph 2 of the regulation points out the required documentation from the bodies having received import or export permits. In the cases considered in article 3, paragraph 3 it is required that the transaction should be coordinated with the Ministry of Health and the Ministry of Industry.

The Governmental Decree makes provision that all persons engaged in import, export, trade, production and consumption of CUC, listed in appendix 1 in correspondence with article 1, paragraph 2 should be registered. Activities related to CUC should be carried out by sole traders or juridical persons, registered as per Regulation concerning Conditions and Procedures for Registering Persons Engaged in Trade, Production and Consumption in the Republic of Bulgaria of CUC, Used for the Production of Anesthetics and Psychotropic Drugs, Keeping Record of Required Documentation and Labeling (also passed with the Decree under consideration), except in the cases when the above mentioned persons have permit for production, issued after the procedure of chapter II of the Medicines and Pharmacies Act. The registration of the dealers in CUC is done by the Ministry of Trade and Foreign Economic Cooperation at submission of documentation according to article 4 of the Regulation. The registration of the producers and consumers of CUC is done by the Ministry of Industry at submission of documentation according to article 7 of the Regulation. The Regulation establishes an obligation for the persons involved in trade, production of consumption of CUC to keep record of every activity connected with export, import, transit transportation, trade, production or consumption within the country, by including data according to article 9, paragraph 1, point 1. The record is kept for a period of time of 10 years.

The Governmental Decree under consideration requires that export, import and transit transportation of CUC should be carried out only through the border customs offices pointed out in appendix 2 (article 3, paragraph 1). Export, import and transit transportation of CUC through duty free zones are forbidden. The transit transportation of CUC through the territory of the Republic of Bulgaria is regulated by the Ministry of Finance.

The responsibility for the implementation of the Governmental Decree and the Regulations passed with it is undertaken by the Foreign Trade Proceedings Department at the Ministry of Trade and Foreign Economic Cooperation, Customs Department at the Ministry of Finance, the control over drugs authorities at the Ministry of Health and the International Integration Department at the Ministry of Industry. The above mentioned departments and authorities have the responsibility to:

• require information connected with export, import, trade, production and consumption of CUC from all bodies, dealers and organizations concerned; to audit documentation and to confiscate documentation if necessary in order to carry out the audits,

• visit the bodies under control;

• consult the Central Department Against Organized Crime at the Ministry of Internal Affairs.

The persons responsible for infringements of the Governmental Decree or the Regulations according to article 5 and 6, in the cases when they are under no liability for higher penal proceedings, are addressed according to article 32 of the Administrative Non-Compliance and Penalties Act. The statements about registered infringements are drawn up by official representatives of the inspection authorities, and the penal decrees by the respective minister.

Non-compliance with the provisions of the governmental decree and the regulations passed with it can lead to canceling the registration of the dealer, producer or consumer of CUC respectively.

The Governmental Decree sets the requirement that the persons engaged in trade, production or consumption of CUC should make an account of CUC movement in writing by filling in a special form according to Appendix 6 in conformity provision ง3, paragraph 2 and submit it to the ministry concerned.

3. Governmental Decree 268 concerning Import and Transit Transportation of Waste or Dangerous Substances

This Governmental Decree regulates import and transit transportation of waste and dangerous substances on and through the territory of the Republic of Bulgaria and to this purpose is passed Regulation concerning Conditions and Procedures for Permission of Import and Transit Transportation of Waste and Dangerous Substances.

Waste and dangerous substances, permitted for import are listed in Appendixes 1 and 2 of the Governmental Decree respectively the substances permitted for transit transportation are listed in Appendixes 3 and 4 of the Governmental Decree.

Import and transit transportation of waste and dangerous substances on and through the territory of the Republic of Bulgaria should be carried out by juridical persons or sole traders who have obtained the required permit, issued by the Ministry of Environment. In order to obtain the permit the applicants are required to submit to the Ministry of Environment a special form for import/transit transportation and to enclose all documentation as per article 2, section 2 of the Regulation. In the permit the Ministry of Environment and the Regional Environmental Inspectorates state the conditions for importing and transit transportation of waste and dangerous substances. The Ministry of Health issues the sanitary permits for the import of dangerous substances.

III. Regulations

1. Regulation Concerning Procedures for Defining and Imposing of Sanctions in Cases of Damaging or Polluting the Environment above Admissible Levels, passed with Governmental Decree, published in the State Gazette, issue 15/93, amended in issue 101/95

The Regulation considers penal procedures for damaging or polluting the environment above admissible levels. Such procedures refer to juridical persons or sole traders who have caused damage or pollution to the environment above admissible levels. All measures taken in this respect are defined in an Order by the Minister of Environment or persons authorized by him. The amounts from the fines are transferred on the accounts of the National Environmental Fund and the Municipal Environmental Funds.

In order to carry out their duties provided for in the Governmental Decree the inspection authorities from the Ministry of Environment take samples and make quantitative analyses to determine the pollution above admissible levels or damage caused on environmental components. These proceedings are carried out in front of a representative of the site which is a source of pollution or damage. The sampling and the performance of making the analyses should be carried out in compliance with the Bulgarian State Standard and in the cases when it is not applicable, in compliance with methods defined by the Minister of Environment. Persons who are under imposed sanctions have the right to appeal according to the Administrative Non-compliance and Penalties Act. Unpaid amounts on fines are collected according to State Receipts Collection Act. In the cases when the persons under sanctions have put an end to or have reduced the pollution or damaging the environment, they have the right to submit a claim in writing to the inspection authorities of the Ministry of Environment and appeal for suspension or relief of the sanctions.

Chapter 2 of the Governmental Decree regulates methods for defining the extent of the sanctions in cases of pollution and damage in relation to the environmental component polluted or damaged.

Section I to Chapter 2 regulates sanctions imposed in cases of pollution of surface water basins. The sanctions imposed are defined on the basis of single fine amount for each polluting substance or index, quantity of substances polluting above admissible levels, waste water debit and duration of discharge. The polluting substances and indexes, the single fine for each of them and the formulae used to calculate the fines for every particular case are stated in points 1 and 2 of Appendix 1 of the Governmental Decree. Single fine for polluting substances not mentioned in point 1 of the Appendix 1 is defined in relation to iron or ammonium nitrogen depending on the type of polluting substance according to point 3 of the same Appendix.

Section II, Chapter 2, regulates measures taken against pollution of ambient air. The sanctions are defined on the basis of single fine for each polluting substance, quantity of polluting substances and duration of discharge. The polluting substances, the amount of single fine for each of them and the formulae for calculating the amount of the fine in every particular case are stated in points 1 and 2 of Appendix 2. The amount of single fine for polluting substances not mentioned in point 1 of Appendix 2 is defined in relation to sulfur dioxide or copper depending on the type of polluting substance according to point 3 of the same Appendix.

In a similar way are defined sanctions in the cases of damaging or polluting the surface of the earth. /See section III and appendix 3, points 1 and 2 from the Regulation/

It is within the Minister of Environment’s competence to change the concrete amount of the fine, defined in the present Regulation, in the cases of availability of information and data about worsening of the environmental state in the region or endangering human health.

In the cases when there are no admissible norms or requirements established for certain types of damaging or polluting substances the Regulation is implemented after passing a legal instrument by the authorities concerned.

2. Regulation 2 Concerning Threshold Limit Values (TLV's) of Harmful Substances in the Ambient Air of Settled Areas, issued by the Ministry of Health, published in the State Gazette issue 88/97

The Regulation has been issued on the basis of provision 2 and in relation to article 20 of the Public Health Act and has been coordinated with the Ministry of Environment, the Ministry of Construction and Settlements and the Ministry of Internal Affairs. The TLV's of harmful substances in the ambient air of settled areas are defined in terms of the maximum one-time concentration, the average daily concentration and the average annual concentration according to Appendix 1. When making assessment of the ambient air pollution with harmful substances being simultaneously identified, it is accepted that the overall impact is measured according to Appendix 2. In these cases not only is the isolated impact of each substance taken into account but the combined additive impact of interaction as well.

Appendix 1 gives a list of polluting substances in alphabetical order.

3. Regulation 13 Concerning Threshold Limit Values (TLV's) of Harmful Substances in the Working Environment, Issued by the Ministry of Health, published in the State Gazette published in issue 81/92, last amendment in issue 57/94

The Regulation establishes the TLV's for harmful substances in the air of the working environment, stated in Appendixes 1 and 2 which have to be taken into account in drawing up projects, construction activities, import of technologies, machine and equipment design, introducing new facilities, reconstructing of enterprises, exploitation of existing facilities or working places. The TLV's of a harmful agent in the air or in the working environment is the maximum concentration which does not present a danger for the workers in the respective environment established according to contemporary methods of health examination, during their working exposure, throughout their whole lives and the lives of their progeny.

In relation to the duration of the occupational exposure the TLV's, classified as follows: time - weighted average, maximal short - term exposure, and exposition threshold limit concentration. In the cases when there is no TLV's set for any particular substance, the temporary standards can be considered as such, called "safety impact levels" /Appendixes 4 and 5/. During simultaneous identification of several harmful substances with additive combined effect in the working environment, the sum of the relations between the factual concentration of each of them in the working environment air deluded to the respective TLV's of the substance should not exceed 1 /article 5/. During simultaneous identification of several harmful substances with different biological effect in the working environment air, the TLV's are the same as those considered during isolated exposure.

The Regulation includes the TLV's for industrial dust in the working environment (Appendix 2)

Persons under 18 are not allowed access to working places where the concentration of harmful substances is above the levels stated in Appendix 3 neither to work nor with educational purposes.

4. Regulation 3 concerning Threshold Limit Values (TLV's) of Harmful Substances in Soil, issued by the Chairman of the Environmental Protection Committee, published in the State Gazette, issue 36/79., amended in issue 5/96

The Regulation has been issued on the basis of the Air, Water and Soil Protection Act and is obligatory for all economic organizations and their branches. The responsibility for monitoring its implementation is undertaken by the Environmental Protection Committee and the Regulation has been coordinated with the Ministry of Health and the Ministry of Agriculture and Food Processing Industry.

The TLV's of harmful substances in the soil are stated in the Appendix. Taking soil samples and analyzing them should be in compliance with the Bulgarian State Standard. Harmful substances for which there are no established standards are analyzed by methods approved by the Chairman of the Environmental Protection Committee.

In the Appendix are stated admissible content levels of the following substances given in groups:

First group - lead, copper, zinc.

Second group - arsenic.

Third group - pesticides with TLV's for herbicides, insecticides and fungicides.

NB: The present name of the Environmental Protection Committee is the Ministry of Environment and Water.

5. Regulation 27 Concerning Import of Goods Related to Public Health, issued by the Minister of Health, published in the State Gazette, issue 75/95

The Regulation defines the goods related to public health /Appendix 1/ and regulates the import of such goods which are allowed into the country after obtaining a sanitary permit. Conditions and procedures for giving sanitary permit for import and sanitary conclusion concerning placement of goods are also considered in this Regulation. Goods containing banned chemicals and with expired dates are not allowed for import. Every imported commodity should be labelled both on the marketing and on the transportation package with instructions for usage in Bulgarian.

In order to get a sanitary permit and to obtain license for the goods the importer has to submit to the Ministry of Health an application form including the requirements indicated in article 4, paragraph 1 and to enclose the documents required according to paragraph 2, the same article. The import sanitary permit is issued by the Chief Sanitary State Inspector or by persons authorized by him according to appendix 3 from the regulation. All necessary documents accompanying the imported batch as well as the indexes and rate of frequency of laboratory control (article 5, paragraph 3) are listed in the permit. The sanitary import permit is issued for an indefinite period of time. A single sanitary permit for a particular batch of goods can be issued on the basis of a sanitary conclusion on laboratory results of a given tested sample. The tests are carried out by the specialized authorities of the State Sanitary Control which is a part of the Ministry of Health. A new sanitary permit is issued when there is a change in the name, brand, composition, formula, technology, package, labelling, structure or sanitary control indexes of a particular commodity

The imported goods are registered on the basis of issued sanitary permits.

The importer is allowed distribution or marketing of the goods only after a sanitary conclusion for each imported batch has been obtained from the respective Regional Hygiene Epidemiological Inspectorate In order to obtain a sanitary conclusion the importer is obliged to present to the inspectorate a customs declaration to be legalized, the sanitary import permit and an application, according to appendix 4; hi is also obliged to provide access to goods for taking samples for laboratory control; to take the necessary measures for safe storing of the goods in warehouses, approved by the respective regional Sanitary Epidemiological Institute. Persons, trading in placement of imported goods are able to sell them only if they have a copy from the sanitary conclusion for every batch.

The procedure for issuing sanitary permits according to this Regulation does not apply to import of asbestos and materials and products, containing asbestos.

The Regulation is issued on the basis of provision 3 from the concluding provisions of the Public Health Act in connection with article 25 from the Public Health Act Implementation Regulations.

This Regulation refers to import of chemicals listed in appendix 1 to article 1 paragraph 1, positions 19-29, 34-36. Appendix 2 indicates the required data for issuing of import sanitary permit, depending on types of goods allowed for import only with permit.

The following goods are included:

• industrial chemicals and products;

• plant protection chemicals and products;

• disinfectants, disinsecting and deratization products.

6. Regulation 3 Concerning Biological Testing and Registration/Licensing of Plant Protection Chemicals, Growth Regulators and Micro Fertilizers, issued by the Minister of Agriculture and Food Processing Industry, published in the State Gazette, issue 16/96

The regulation defines the conditions and the procedure for biological testing and licensing of plant protection chemicals /PPC/, growth regulators /GR/ and micro fertilizers /M/, produced in the country or imported, and these activities are within the competence of the Ministry of Agriculture and Food Processing Industry and The National Service for Plant Protection, Quarantine and Agrarian Chemistry /NSPPQAC/ which is part of the above ministry. The Minister of Agriculture and Food Processing Industry approves a list on an annual basis of PPC, GR and M, permitted to be produced, imported or used. The list is coordinated with the Ministry of Health.

In article 4 are listed the chemicals and products which undergo biological testing and registration according to the procedures provided in this regulation:

• insecticides, fungicides, herbicides, defoliants, desiccants and other plant protection chemicals;

• growth regulators, micro fertilizers and others.

• disinfectants for disinfecting stores, transport equipment and others, used in storing and transportation of agricultural production

• attractants and repellents;

• biological products and formulations

• stimulants, anti-vaporizers, formulations active substances used for improvement of plant protection detergents

The producers /importers who need biological licensing of PPC submit a written application to NSPPQAC until the 10th of January the latest of the current year. The application is considered if the information pointed out in article 5, points 1-16 is available. On the basis of the applications submitted, the NSPPQAC works out a program for testing, legalized by the Minister of Agriculture and Food Processing Industry. Data from the biological tests are sent to NSPPQAC in writing and after the biological registration/licensing is done, the data are available only to the companies-applicants. The testing period is at least one year -for pesticides on a known active basis, and at least two years- for pesticides on an unknown active basis.

The biological licensing is carried out by a professional committee, appointed by an order, issued by the Minister of Agriculture and Food Processing Industry. The committee includes representatives from the Ministry of Agriculture and Food Processing Industry, NSPPQAC, the Ministry of Health, the Ministry of Environment, the Ministry of Internal Affairs, as well as eminent scientists in the field of plant protection and agrarian chemistry from the Agricultural Academy. On the basis of a decision made by the professional committee, NSPPQAC prepares an official list including the approved plant protection chemicals, growth regulators and micro fertilizers, for which a control certificate is issued. The licensing is valid for a period of 7 years. Renewal of licenses of PPC, GR, and M is carried out on the basis of data concerning their use in the country and on the basis of experiments for biological efficiency according to the procedures of article 15.

The PPC, GR and M import and usage are possible after the issuing of control certificate by the Minister of Agriculture and Food Processing Industry and a sanitary permit by the Minister of Health. For the import of PPC, GR and M is a label in Bulgarian, is required according to the indication in article 21, points 1-22, legalized by NSPPQAC.

Advertising unlicensed PPC, GR and M is forbidden. Advertising of licensed PPC, GR and M has to give information about data from the biological tests and registration.

7. Regulation 10 Concerning Sanitary Requirements for Using Pesticides in National Economy and Private Farming, issued by the Minister of Public Health, the National Agrarian Industrial Association, published in the State Gazette, issue 88/85

The Regulation defines the sanitary requirements concerning import, production, trade, storing, transportation and use of pesticides in the national economy and private farming /article 1/. According to the extent of toxic effect pesticides are classified in four groups in compliance with the criteria pointed out in appendix 1. For all activities under article 1 from the Regulation is required a respective sanitary permit , issued by Department’ Preventive Medicine and State Sanitary Control’ /DPMSSC/ to Ministry of Health.

The Ministry of Health /MH/, the National Agrarian Industrial Association /NAIA/, the Ministry of Internal Affairs /MIA/ and the Environmental Protection Committee /EPC/ annually publish a list of licensed pesticides. Retail trade in pesticides from the third and the fourth group is licensed by MH and MIA.

Section 2 from the Regulation provides sanitary requirements for using pesticides. The enterprise-producer, the company-importer and the trade organization-seller are obliged to use special packaging for pesticides according to the provisions of the Bulgarian State Standard 12717-84, which should meet the requirements under article 7. Areas treated with pesticides have to be marked with signs, which ban trespassing or working until the safety restrictions are lifted, according to appendix 2. For pesticides, which are not listed in the appendix the ban is valid for at least 5 days.

Pesticides are sprayed with special equipment, airplanes or by other means, in compliance with the requirements, stated in article 11. Special rules are provided in the cases of use of pesticides by fumigation-article 12 from the Regulation, or in the cases of preparing toxic baits with rodenticides /articles 13,14/ and for disinfecting of seeds /articles 16,17,18/. Article 20 provides the obligatory requirements for using pesticides in agricultural aviation.

Appendixes 3 and 4 to the Regulation give instructions for keeping detailed record of registering disinfected seeds and used pesticides, registering crops treated with pesticides, as well as registering animals and birds, treated with pesticides.

The implementation of Regulation control is assigned to Department ‘Preventive Medicine and State Sanitary Control of the Ministry of Health and to Department ‘Plant Protection and Fertilizing’ of the National Agrarian Industrial Association.

Note: Changes in the names of different ministries are not reflected in legal instruments. It should be taken into consideration the present name of :

• The Ministry of Agriculture and Food Processing Industry is the Ministry of Agriculture, Forestry and Agrarian Reform;

• The Ministry of Trade and Foreign Economical Cooperation is the Ministry of Trade and Tourism;

• The Ministry of the Environment is the Ministry of Environment and Water.

4.3 Existing Legislation by Use Category Addressing Various Stages of Chemicals from Production/Import through Disposal

In the beginning of this section the legal instruments referring to activities connected with treatment of all type of chemicals are listed. Legislation by the use category addressing various stages of chemicals’ life cycle as presented in table 4 B immediately follows the enumeration of general legal instruments. The symbol "X" used in the table reads adequately regulated stage. In the cases when there is no legislation or the existing is inapplicable, the column is left empty.

LEGAL INSTRUMENTS Addressing All Chemicals:

1. Environmental Protection Act (EPA)

The Act addresses all chemicals which at certain stage of their life cycle could act as polluting agents to the environment. Hence this Act applies to all stages of chemicals, from import to disposal.

2. Public Health Act and Public Health Act Implementation Regulations

The Act and the Regulations address all chemicals relevant to public health and human life, including toxic and highly active substances as well as nuclear materials. As is the situation with the Environmental Protection Act, these two legal instruments also apply to all stages of chemicals from import to disposal.

3. Ambient Air Protection Act /point II from 4.1, see also Section 4.2/

4. Water and Soil Protection Act /point III from 4.1, see also Section 4.2/

5. Criminal Code

Article 352 and following from the Criminal Code of the Republic of Bulgaria provides for measures and proceeding against environmental pollution with chemicals and in this way indirectly addresses all activities connected with treatment of chemicals. It includes a text especially addressed to measures and proceeding against sea pollution with petroleum products.

6.Regulation Concerning Penal Procedures and Measures against Damaging or Polluting the Environment above Admissible Levels, passed with Governmental Decree 24 / point XVI from Section 4.1, also see Section 4.2/

7.Regulation 1 Concerning Environmental Impact Assessment, issued by the Minister of Environment, the Minister of Town Development and Construction, the Minister of Health, the Minister of Agriculture and Food Processing Industry /point XVII from Section 4.1/

8.Regulation 2 Concerning Emergency Protection in Activities Connected with Dangerous Chemicals, issued by the Quality Committee and the Ministry of Transport,/point XVIII from Section 4.1/;

Legal Instruments Which Regulate Separate Stages of the Life cycle of Different Categories of Chemicals as Given in Table 4 B:

I. PESTICIDES /used in agriculture, medicine and private farming/

1. Import - Regulations (Bylaw) Concerning the Organization and Activities of the National Service for Plant Protection, Quarantine and Agrarian Chemistry /point VIII from Section 4.1/

Governmental Decree 268 Concerning Import and Transit Transportation of Waste and Dangerous Substances /point XI from Section 4.1/

Regulation 2 Concerning Plant Products Control, Phytopharmaceuticals and Mineral Fertilizers, issued by the Minister of Agriculture and Food Processing Industry /point XIX from Section 4.1/

Regulation 3 Concerning Biological Testing and Registration/Licensing of Plant Protection Chemicals, Growth Regulators and Micro Fertilizers, issued by the Minister of Agriculture and Food Processing Industry /point XXIV from Section 4.1/;

Regulation 10 Concerning Sanitary Requirements for Using Pesticides in National Economy and Private Farming, issued by the Minister of Health and the National Agrarian and Industrial Association /point XXVII from Section 4.1/

Regulation 27 Concerning Import of Goods Related to Public Health, issued by the Minister of Health /XXIX from Section 4.1/;

2. Production - Regulations Concerning the Organization and Activities of the National Service for Plant Protection, Quarantine and Agrarian Chemistry /point VIII from Section 4.1/

Regulation 2 Concerning Plant Products Control, Phytopharmaceuticals and Mineral Fertilizers, issued by the Minister of Agriculture and Food Processing Industry /point XIX from Section 4.1/

Regulation 3 Concerning Biological Testing and Registration/Licensing of Plant Protection Chemicals, Growth Regulators and Micro Fertilizers, issued by the Minister of Agriculture and Food Processing Industry /point XXIV from Section 4.1/;

Regulation 10 Concerning Sanitary Requirements for Using Pesticides in National Economy and Private Farming, issued by the Minister of Health and the National Agrarian and Industrial Association /point XXVII from Section 4.1/

3. Storage - Regulations Concerning the Organization and Activities of the National Service for Plant Protection, Quarantine and Agrarian Chemistry /point VIII from Section 4.1/

Regulation 2 Concerning Safe Sanitary Zones around Water Springs and Water Supply Utilities for Drinking and Household Needs issued by the Town Planning Committee /point XX from Section 4.1/

Regulation 10 Concerning Sanitary Requirements for Using Pesticides in National Economy and Private Farming, issued by the Minister of Health and the National Agrarian and Industrial Association /point XXVII from Section 4.1/

4. Transportation - Governmental Decree 268 Concerning Import and Transit Transportation of Waste and Dangerous Substances /point XI from Section 4.1/

Regulation 10 Concerning Sanitary Requirements for Using Pesticides in the National Economy and Private Farming, issued by the Minister of Health and the National Agrarian and Industrial Association /point XXVII from Section 4.1/

5. Distribution/Marketing - Regulations Concerning the Organization and Activities of the National Service for Plant Protection, Quarantine and Agrarian Chemistry /point VIII from Section 4.1/

Regulation 2 Concerning Plant Products Control, Phytopharmaceuticals and Mineral Fertilizers, issued by the Minister of Agriculture and Food Processing Industry /point XIX from Section 4.1/

6. Use/Handling - Agricultural Land Protection Act /point IV from Section 4.1/

Regulations Concerning the Organization and Activities of the National Service for Plant Protection, Quarantine and Agrarian Chemistry /point VIII from Section 4.1/

Regulation Concerning Penal Procedures and Measures against Damaging or Polluting the Environment above Admissible Levels, passed with Governmental Decree 24 / point XVI from Section 4.1/

Regulation 2 Concerning Plant Products Control, Phytopharmaceuticals and Mineral Fertilizers, issued by the Minister of Agriculture and Food Processing Industry /point XIX from Section 4.1/

Regulation 2 Concerning Safe Sanitary Zones around Water Springs and Water Supply Utilities for Drinking and Household Needs issued by the Town Planning Committee /point XX from Section 4.1/

Regulation 3 Concerning TLV’s of Harmful Substances in the Soil, issued by the Chairman of the Environmental Protection Committee /point XXII from Section 4.1/;

Regulation 3 Concerning Biological Testing and Registration/Licensing of Plant Protection Chemicals, Growth Regulators and Micro Fertilizers, issued by the Minister of Agriculture and Food Processing Industry /point XXIV from Section 4.1/;

Regulation 5 Concerning Sanitary Norms for Maximal Admissible Levels for Chemical or Biological Polluting Agents in Food Products, issued by the Minister of Health /point XXV from Section 4.1/

Regulation 10 Concerning Sanitary Requirements for Using Pesticides in the National Economy and Private Farming, issued by the Minister of Health and the National Agrarian and Industrial Association /point XXVII from Section 4.1/

Regulation 34 Concerning Sanitary Requirements in Cosmetics, issued by the Minister of Health /point XXX from Section 4.1/

7. Disposal - no legislation

II. FERTILIZERS

1. Import - Regulations Concerning the Organization and Activities of the National Service for Plant Protection, Quarantine and Agrarian Chemistry /point VIII from Section 4.1/

Governmental Decree 266 Concerning Export and Import Regime /point X from Section 4.1/

Governmental Decree 268 Concerning Import and Transit Transportation of Waste and Dangerous Substances /point XI from Section 4.1/

Regulation 2 Concerning Plant Products Control, Phytopharmaceuticals and Mineral Fertilizers, issued by the Minister of Agriculture and Food Processing Industry /point XIX from Section 4.1/

Regulation 3 Concerning Biological Testing and Registration/Licensing of Plant Protection Chemicals, Growth Regulators and Micro Fertilizers, issued by the Minister of Agriculture and Food Processing Industry /point XXIV from Section 4.1/;

2. Production - Regulations Concerning the Organization and Activities of the National Service for Plant Protection, Quarantine and Agrarian Chemistry /point VIII from Section 4.1/

Regulation 2 Concerning Plant Products Control, Phytopharmaceuticals and Mineral Fertilizers, issued by the Minister of Agriculture and Food Processing Industry /point XIX from Section 4.1/

Regulation 3 Concerning Biological Testing and Registration/Licensing of Plant Protection Chemicals, Growth Regulators and Micro Fertilizers, issued by the Minister of Agriculture and Food Processing Industry /point XXIV from Section 4.1/;

3. Storage - Regulations Concerning the Organization and Activities of the National Service for Plant Protection, Quarantine and Agrarian Chemistry /point VIII from Section 4.1/

Regulation 2 Concerning Safe Sanitary Zones around Water Springs and Water Supply Utilities for Drinking and Household Needs issued by the Town Planning Committee /point XX from Section 4.1/

4. Distribution - Regulations Concerning the Organization and Activities of the National Service for Plant Protection, Quarantine and Agrarian Chemistry /point VIII from Section 4.1/

5. Usage - Agricultural Land Protection Act /point IV from Section 4.1/

Regulations Concerning the Organization and Activities of the National Service for Plant Protection, Quarantine and Agrarian Chemistry /point VIII from Section 4.1/

Regulation Concerning Penal Procedures and Measures against Damaging or Polluting the Environment above Admissible Levels, passed with Governmental Decree 24 / point XVI from Section 4.1/

Regulation 2 Concerning Plant Products Control, Phytopharmaceuticals and Mineral Fertilizers, issued by the Minister of Agriculture and Food Processing Industry /point XIX from Section 4.1/

Regulation 2 Concerning Safe Sanitary Zones around Water Springs and Water Supply Utilities for Drinking and Household Needs issued by the Town Planning Committee /point XX from Section 4.1/

Regulation 3 Concerning Biological Testing and Registration/Licensing of Plant Protection Chemicals, Growth Regulators and Micro Fertilizers, issued by the Minister of Agriculture and Food Processing Industry /point XXIV from Section 4.1/;

7. Disposal - no legislation

III. INDUSTRIAL CHEMICALS /used in manufacturing/processing facilities/

1. Import - Act Concerning Control over Foreign Trade Activities Connected with Weapons, and Goods and Technologies with a Possible Double Usage and Implementation Regulations to the Act /point VI from Section 4.1/

Governmental Decree 266 Concerning Export and Import Regime /point X from Section 4.1/

Governmental Decree 268 Concerning Import and Transit Transportation of Waste and Dangerous Substances /point XI from Section 4.1/

Governmental Decree 38 Concerning Export and Import of Chemicals Under Control, Used for the Production of Anesthetics or Psychotropic Drugs, and Conditions and Procedures for Trade, Production and Consumption /point XII from Section 4.1/;

Regulation Concerning Conditions and Procedures for Coordinating and Permitting Export and Import of Chemicals under Control, passed by Governmental Decree 38 /point XIII from Section 4.1/

Regulation Concerning Conditions and Procedures for Registering Persons Engaged in Trade, Production and Consumption in the Republic of Bulgaria of Chemicals under Control, Used in the Production of Anesthetics and Psychotropic Drugs; Keeping of Required Documentation and Labeling, passed with Governmental Decree 38 /point XIV from Section 4.1/;

Regulation 8 Concerning Conditions and Procedures for Coordinating Export and Import of Medicines, issued by the Minister of Health /point XXIX, Section 4.1/

Regulation 27 Concerning Import of Goods Related to Public Health, issued by the Minister of Health /point XXIX, Section 4.1/

2. Production - Governmental Decree 38 Concerning Export and Import of Chemicals Under Control, Used for the Production of Anesthetics or Psychotropic Drugs, and Conditions and Procedures for Trade, Production and Consumption /point XII from Section 4.1/;

Regulation Concerning Conditions and Procedures for Registering Persons Engaged in Trade, Production and Consumption in the Republic of Bulgaria of Chemicals under Control, Used in the Production of Anesthetics and Psychotropic Drugs; Keeping of Required Documentation and Labeling, passed with Governmental Decree 38 /point XIV from Section 4.1/;

Regulation 2 Concerning Safe Sanitary Zones around Water Springs and Water Supply Utilities for Drinking and Household Needs issued by the Town Planning Committee /point XX from Section 4.1/

3. Storage - Governmental Decree 38 Concerning Export and Import of Chemicals Under Control, Used for the Production of Anesthetics or Psychotropic Drugs, and Conditions and Procedures for Trade, Production and Consumption /point XII from Section 4.1/;

Regulation 2 Concerning Safe Sanitary Zones around Water Springs and Water Supply Utilities for Drinking and Household Needs issued by the Town Planning Committee /point XX from Section 4.1/

4. Transportation - no legislation

5. Distribution/Marketing - Governmental Decree 38 Concerning Export and Import of Chemicals Under Control, Used for the Production of Anesthetics or Psychotropic Drugs, and Conditions and Procedures for Trade, Production and Consumption /point XII from Section 4.1/;

Regulation 27 Concerning Import of Goods Related to Public Health, issued by the Minister of Health /point XXIX, Section 4.1/

6. Usage - Governmental Decree 38 Concerning Export and Import of Chemicals Under Control, Used for the Production of Anesthetics or Psychotropic Drugs, and Conditions and Procedures for Trade, Production and Consumption /point XII from Section 4.1/;

Regulation Concerning Conditions and Procedures for Registering Persons Engaged in Trade, Production and Consumption in the Republic of Bulgaria of Chemicals under Control, Used in the Production of Anesthetics and Psychotropic Drugs; Keeping of Required Documentation and Labeling, passed with Governmental Decree 38 /point XIV from Section 4.1/;

7. Disposal - no legislation

IV. PETROLEUM PRODUCTS

1. Import - Governmental Decree 266 Concerning Export and Import Regime /point X from Section 4.1/

Governmental Decree 268 Concerning Import and Transit Transportation of Waste and Dangerous Substances /point XI from Section 4.1/

2. Production - Regulation Concerning the Organization of Production Enterprises and Storage Places for Explosives, Weapons and Munitions and Exertion of Control over Related Activities

3. Storage - Regulation Concerning the Organization of Production Enterprises and Storage Places for Explosives, Weapons and Munitions and Exertion of Control over Related Activities

Regulation 1 Concerning Collection, Storage and Usage of Exhausted Oil

4. Transportation - Regulation 4 Concerning Development and Implementation of Transportation Technologies for Freights to be Processed for Mechanical Treatment

Governmental Decree 38 Concerning Protection of Main Oil Pipelines, Petroleum Products Pipelines, Gas Pipelines and their Branch Pipelines and Lineal Equipment on the Territory of the Republic of Bulgaria.

5. Distribution/Marketing - no legislation

6. Usage - Agricultural Land Protection Act /point IV from Section 4.1/

7. Disposal - no legislation

V.CONSUMER CHEMICALS

1. Import - Governmental Decree 266 Concerning Export and Import Regime /point X from Section 4.1/

Regulation 27 Concerning Import of Goods Related to Public Health, issued by the Minister of Health /point XXIX, Section 4.1/

Regulation 34 Concerning Sanitary Requirements in Cosmetics, issued by the Minister of Health /point XXX from Section 4.1/

Regulation 35 Concerning Sanitary Requirements for Consumer Chemical Detergents, issued by the Minister of Health /point XXXI from Section 4.1/

2. Production - Regulation 34 Concerning Sanitary Requirements in Cosmetics, issued by the Minister of Health /point XXX from Section 4.1/

Regulation 35 Concerning Sanitary Requirements for Consumer Chemical Detergents, issued by the Minister of Health /point XXXI from Section 4.1/

Regulation 45 Concerning Sanitary Norms and Requirements for Additives to Food Products, issued by the Minister of Health /point XXXII from Section 4.1/;

3. Storage - Regulation 35 Concerning Sanitary Requirements for Consumer Chemical Detergents, issued by the Minister of Health /point XXXI from Section 4.1/

4. Transportation - no legislation

5. Distribution/Marketing - no legislation

6. Usage - Regulation 27 Concerning Import of Goods Related to Public Health, issued by the Minister of Health /point XXIX, Section 4.1/

Regulation 34 Concerning Sanitary Requirements in Cosmetics, issued by the Minister of Health /point XXX from Section 4.1/

Regulation 45 Concerning Sanitary Norms and Requirements for Additives to Food Products, issued by the Minister of Health /point XXXII from Section 4.1/;

7. Disposal - no legislation

 Table 4B - Overview of Legal Instruments to Manage Chemicals by Use Category

 VI. CHEMICAL WASTES

1. Import - Governmental Decree 268 Concerning Import and Transit Transportation of Waste and Dangerous Substances /point XI from Section 4.1/

Regulation Concerning the Conditions and Procedures for Licensing the Import and Transit Transportation of Waste and Dangerous Substances /point XV, Section 4.1/

2. Production - Governmental Decree 153 Concerning Collection, Storage and Safe Disposal of Dangerous Waste /point IX, Section 4.1/;

3. Storage - Governmental Decree 153 Concerning Collection, Storage and Safe Disposal of Dangerous Waste /point IX, Section 4.1/;

4. Transportation - Governmental Decree 153 Concerning Collection, Storage and Safe Disposal of Dangerous Waste /point IX, Section 4.1/;

5. Distribution/Marketing- no legislation

6. Usage - no legislation

7. Disposal - Governmental Decree 153 Concerning Collection, Storage and Safe Disposal of Dangerous Waste /point IX, Section 4.1/;

Note: Changes in the names of different ministries are not reflected in legal instruments. It should be taken into consideration that the present name of :

• The Ministry of Agriculture and Food Processing Industry is the Ministry of Agriculture, Forestry and Agrarian Reform;

• The Ministry of Trade and Foreign Economical Cooperation is the Ministry of Trade and Tourism;

• The Ministry of the Environment is the Ministry of Environment and Water.

4.4 Summary Description of Key Approaches and Procedures for Control of Chemicals

The Key Approaches and Procedures for Control of Chemicals and the authorities responsible for exercising the control are considered according to categories of chemicals ordered as given in Table 4B.

I. PESTICIDES AND FERTILIZERS

The following mechanisms with respect to exercising permanent control over import, production, use and storage of pesticides and fertilizers are established in the legislation:

1. Establishing the sanitary norms related to usage of pesticides and fertilizers and providing official information with respect to these sanitary norms to proprietors and users of agricultural lands is the responsibility of the Ministry of Agriculture and Food Processing Industry, according to article 4, article 1, point 4 from the Agricultural Land Protection Act.

2. Establishing the norms for admissible quantities of pesticides residues and other chemicals in the soil is the responsibility of the Ministry of Environment, regulated by Regulation 3 Concerning Admissible Quantities for Dangerous Substances in the soil.

3. Establishing the norms for highest admissible quantities of pesticides residues in food products is the responsibility of the Ministry of Health and the relevant legal instrument is Regulation 5 Concerning Sanitary Norms for Admissible Quantities of Chemical and Biological Polluting Agents in Food Products.

4. Registration of pesticides and artificial fertilizers: it is done on the request of the producer (importer) after the necessary efficacy trials, by an expert committee, including representatives from the Ministry of Agriculture and Food Processing Industry, the National Service for Plant Protection, Quarantine and Agrochemistry, the Ministry of Health, the Ministry of Environment, the Ministry of Internal Affairs, as well as, eminent scientists in the field of plant protection and agrochemistry from the Academy of Agriculture.

The registration of pesticides and fertilizers is carried out according to Regulation 3 Concerning Biological Testing and Registration/Licensing of Plant Protection Products, Growth Regulators and Micro Fertilizers.

5. Licensing - Permitting regime concerning activities with reference to production, import, usage and trade of phytopharmaceuticals; mineral, micro and macro fertilizers, liquid fertilizers for leaves, etc.

The licensing permits for import, production and trade are issued by the Ministry of Agriculture and Food Processing Industry or by an authorized body for a period of three years according to the stipulations of Regulation 2 Concerning Control over Plant Products, Phytopharmaceuticals and Mineral Fertilizers.

A permit for single import is issued for every imported batch as per the above mentioned procedures and with a validity of three months after issuing.

6. Permanent check-ups for the strict observance of the stipulations in the permits and of the other requirements provided by law is a responsibility of the Ministry of Agriculture and Food Processing Industry and is exerted by the respective controlling authorities on a national and regional scale, and namely, the National Service of Plant Protection, Quarantine and Agrochemistry and its regional representatives according to the provisions of Regulation 2 Concerning Control over Plant Products, Phytopharmaceuticals and Mineral Fertilizers.

7. Sanctions in the cases of non-compliance with the requirements provided by the law:- fines according to Regulation 2 Concerning Control over Plant Products, Phytopharmaceuticals and Mineral Fertilizers and the Regulation Concerning Defining and Imposing of Sanctions in Cases of Damaging and Polluting the Environment above Admissible Levels, passed with Governmental Decree 24/93.

- suspension of permits concerning import and production of and trade with pesticides and fertilizers: on a negative statement submitted by the bodies responsible for the exertion of control, it is within the competence of the judiciary authorities to suspend licenses and immediately ban a particular activity. / Regulation 2 Concerning Control over Plant Products, Phytopharmaceuticals and Mineral Fertilizers/.

II. INDUSTRIAL CHEMICALS /used in manufacturing/processing facilities/:

Mechanisms of control over industrial chemicals are defined in relation to whether they are dangerous chemicals, restricted chemicals, chemicals used for the production of anesthetics or psychotropic drugs (hence referred to as chemicals under control or CUC), chemicals related to public health, etc.

The following mechanisms of control have been established:

1. Permission regime concerning:

• import and transit transportation of dangerous substances; the permits are issued by the Ministry of Environment according to the Regulation Concerning Conditions and Procedures for Licensing of Import and Transit Transportation of Waste, passed with Governmental Decree 268/96.

• import and export of CUC; the permits are granted by the Ministry of Trade and Foreign Trade Cooperation after notifying and consulting the Ministry of Health and the Ministry of Industry according to the Regulation Concerning Conditions and Procedures for Coordinating and Permitting Import and Export of Chemicals under Control, passed with Governmental Decree 38/1997.

• import of industrial chemicals and detergents related to public health listed in Appendix 1 to article 1, paragraph 1, of Regulation 27 Concerning Import of Goods Related to Public Health issued by the Ministry of Health. This Regulation stipulates that permits are granted by the state sanitary control authorities.

• import and export of goods and technologies with a possible double usage, listed in article 26, paragraph 1 of the Act Concerning Control over Foreign Trade Activities Connected with Weapons and Goods and Technologies with a Possible Double Usage Implementation Regulations. For conducting any transaction concerning import or export of such goods a permit has to be granted by the Committee of Monitoring and Licensing Foreign Trade Transactions with Weapons and Goods and Technologies with a Possible Double Usage, which is part of the Ministry of Trade and Foreign Economic Cooperation to persons licensed to conduct such transactions as per the provisions made in the Act Concerning Control over Foreign Trade Activities Connected Weapons and Goods and Technologies with a Possible Double Usage and the Implementation Regulations related to the Act.

All other industrial chemicals, liable to permitting regime for import or export activities in compliance with the Bulgarian legislation or the responsibilities undertaken by the Republic of Bulgaria as part of international agreements, are regulated by the permitting procedures according to Governmental Decree 266 Concerning Import and Export Regime and Regulation 27 concerning import of goods related to public health.

2. Registration of persons involved in trade, production and consumption of chemicals under control, listed in Appendix 1, article 1, paragraph 2 of Governmental Decree 38/97 Concerning Import and Export of Chemicals under Control /CUC/, Used for the Production of Anesthetics and Psychotropic Drugs and Conditions and Procedures for Trade, Production and Consumption, is the responsibility of the Ministry of Trade and Foreign Economic Cooperation according to the Regulation Concerning Conditions and Procedures for Registration of Persons Engaged in Trade, Production and Consumption of Chemicals under Control in the Republic of Bulgaria , Used for the Production of Anesthetics and Psychotropic Drugs, Keeping Record of Required Documentation and Labeling, passed with Governmental Decree 38/97.

3. Licensing of persons, engaged in foreign trade activities connected with goods and technologies with a possible double usage under restriction according to article 4, paragraph 2 of the Act Concerning Control over Foreign Trade Activities Connected with Weapons and Goods and Technologies with Double Usage. The licensing is the responsibility of the Interdepartmental Council on the Issues of the Military Industrial Complex and the Mobilization Readiness of the Country in compliance with the requirements of the Act and the Implementation Regulations related to the Act.

4. Establishing norms for threshold limit values (TLV’s) of harmful chemicals in the ambient air of settlements and in working environment. The norms are set by the Ministry of Health and respectively with Regulation 14/97 Concerning TLV’s of Harmful Substances in the Ambient Air of Settlements and with Regulation 13/92 Concerning TLV’s of Harmful Substances in the Working Environment.

5. Sanctions imposed in cases of non-compliance with the stipulations in the permits and licenses, in cases of violations of the TLV’s or of other requirements provided by law:

• suspension of permits and licenses;

• imposing a ban on the respective activities;

• fines.

III. PETROLEUM PRODUCTS

With respect to petroleum products the following mechanisms for exertion of control are applied:

1. Permission regime concerning import and transit transportation: it is regulated by Governmental Decree 268/96 Concerning Import and Transit Transportation of Waste and Dangerous Substances for the listed petroleum products in the appendixes under the Governmental Decree. Permits and licenses are issued by the Ministry of Environment according the provisions made in the Regulation Concerning Conditions and Procedures for Permission of Import and Transit Transportation of Waste and Dangerous Substances, passed with the Governmental Decree under consideration.

2. Registration of transactions concerning import and export of petroleum products, listed in appendix 1 under article 2 from Governmental Decree 266 Concerning Import and Export Regime.

3. Establishing the levels of TLV’s of petroleum products in the ambient air of settlements is the responsibility of the Ministry of Health and is considered in Regulation 14/97 Concerning Highest Admissible Concentrations of Harmful Substances in the Ambient Air of Settlements, appendix 1 under article 2, paragraph 1, positions 22 and 23.

4. Sanctions imposed in the cases of infringement on requirements provided by the law:

• fines

• suspension of permits/licenses

• imprisonment from 1 to 5 years and fines up to 1 million leva for a physical person who has polluted or admitted petroleum or petroleum derivatives pollution to sea waters or sea water zones defined by an international agreement of which the Republic of Bulgaria is a part /article 352a from the Criminal Code/.

IV. CONSUMER CHEMICALS

The following control mechanisms are regulated:

1. Registration and permission regime for import and distribution of consumer chemicals related to public health according to Regulation 27 Concerning Import of Goods Related to Public Health, issued by the Ministry of Heath. The registration and the issuing of sanitary permits is within the competence of the Ministry of Health and in particular of the state sanitary control authorities. The sanitary conclusions, which are obligatory for distributing or marketing the goods, are issued by the regional HEI.

2. Licensing/permission regime concerning import, production, storage and distribution of cosmetics and consumer chemical detergents, according to Regulation 34 by the Ministry of Health Concerning Sanitary Requirements in Cosmetics and Regulation 35 by the Ministry of Health Concerning Sanitary Requirements for Consumer Chemical Detergents.

3. Permanent sanitary control over cosmetics and consumer chemical detergents for meeting sanitary requirements, established in the above mentioned Regulations under point 2, is the responsibility by the sanitary control authorities.

V. WASTE

Control mechanisms with respect to waste are introduced with Regulation Concerning the Conditions and Procedures for Permitting/Licensing the Import and Transit Transportation of Waste, passed with Governmental Decree 268/96 and Governmental Decree 153/93 Concerning Collection, Transportation, Storage and Safe Disposal of Hazardous Waste and are as follows:

1. Permission regime concerning import and transit transportation of waste and all activities related to treatment of hazardous waste.

The permits for import or transit transportation of waste are issued by the Ministry of Environment;

The permits for collection, transportation, storage and safe disposal of hazardous waste are issued by the Regional HEI (for activities of 750 kg per hour productivity, carried out only in the respective region) and by the Ministry of Environment (in all other cases).

2. With respect to controlling dangerous waste there is the requirement for regular provision of information concerning the expected and the actually discharged dangerous waste on an annual basis. The body responsible for the discharge of waste is under obligation to provide this information. The information is given on special informational cards and a copy has to be submitted to the Laboratory and Information Complex which is part of the Ministry of Environment.

3. Sanctions imposed in cases of non-compliance with the requirements provided by law are as follows:

• fines;

• suspension of permits;

• terminating activities which lead to polluting or damaging the environment;

• full compensations for the damage caused to the environment.

On the basis of the information given in section 4.4 the following categories BANNED OR SEVERELY RESTRICTED CHEMICALS can be summarized:

 BANNED CHEMICALS:

1. Banned for use in the Republic of Bulgaria are the following substances listed in Appendix 1 under article 2, point 2 from Regulation 2 Concerning Emergencies in Activities Connected with Dangerous Chemicals, issued by the Quality Committee and the Ministry of Transport, published in The State Gazette, issue 109/96 and Law for plant protection

Azinfos-methyl, Aldicarb, Aldrin, Amitrol, DDT, Dieldrin, Endrin, Toxafen, Captafol, Lindan, Methyl-paration, Nitrofen, Paraquat, Parathion, Heksachlorciclohexan, Heptachlor, Clordan, Chlordimeform, Cyhexatin, Metamidofos, Crimidin, Metamidofos, Crimidin, Metidation, Hg fungicides, Sn organic fungicides.

2. Banned for import are all kinds of waste except for the listed in Appendix 1 under article 2, point 1 from Governmental Decree 268 Concerning Import and Transit Transportation of Waste and Dangerous Substances, published in the State Gazette, issue 94/96.

3. Banned for import are dangerous substances listed in Appendix 2 under article 2, point 2 from Governmental Decree 268.

SEVERELY RESTRICTED CHEMICALS

• Types of dangerous waste listed in Appendix 3 under articles 3 and 4 from Governmental Decree 268.

• Types of dangerous waste, listed in Appendix 4 under article 3 from Governmental Decree 268

• Goods and technologies with a possible double usage, examples listed in article 26 from the Act Concerning Control over Foreign Trade Activities Connected with Weapons and Goods and Technologies with a Possible Double Usage Implementation Regulations, published in the State Gazette, issue 21/96.

• Chemicals under control listed in Appendix 1 under article 1, paragraph 2 from Governmental Decree 38 Concerning Export and Import of Chemicals under Control, Used in the Production of Anesthetics and Psychotropic Drugs, and Conditions and Procedures for Trade, Production and Consumption, published in the State Gazette, issues 14 and 15/97.

• Chemicals under permission regime, listed in Appendix 2 under article 3, point 2 from Governmental Decree 266 Concerning Export and Import Regime, published in the State Gazette issue 2/96.

4.5 Non-Regulatory Mechanisms for Managing Chemicals

In general risk management of chemicals in Bulgaria is regulated by legal instruments and a significant part of them comprise regulations (legal instruments which have less legislative force than laws) and bylaws. The non-regulatory mechanisms primarily concern the production of chemicals. Every manufacturer of chemical products manages their activities according to documents called "Technological Requirements"- including the technical specification. There are different Technological Requirements for the different types of products. Non-regulatory mechanisms related to production include also technological instructions for exploitation of installations, instructions for safe and healthy work, instructions for emergency prevention. Non-regulatory mechanisms also include the Bulgarian State Standards, which set the parameters for produced chemicals and their testing.

Expert Councils on Standardization are created at the Ministry of Health which check documentation and give permissions for import production and use of chemicals and preparations.There is no information about volunteer programs or system of economic incentives or other initiatives related to managing chemicals.

4.6 Comments and Analyses

The complete analysis of the legal instruments for managing chemicals indicates that the existing legislation is fragmented into a great number of legal documents, most of them regulations (legal instruments which have less legislative force than laws) and bylaws and therefore rather inconsistent. Approximately 22% of the legal instruments have been translated into English.

The responsibilities of different ministries, institutions or their representative authorities overlap (the Ministry of Environment and Water, the Ministry of Health, the Ministry of Trade). There is no system for coordination between them. This leads to decreasing the efficiency of exercising control over activities related to managing chemicals and also impedes the realization of those activities.

There is neither legal, nor material basis for introduction in Bulgaria of the ELINCS registration according to Directive N 67/548/EEC.

A better coherence between the different parts of the existing legislation and its approximation with the legal documents of the European Union is desirable. There is a need for a unified law concerning management and control of chemicals and preparations and it is already under way, being prepared by a group of experts from different governmental and non- governmental bodies.

Chapter 5: Ministries, Agencies and Other Institutions Managing Chemicals

5.1 Responsibilities of different Government Ministries, Agencies and Other Institutions.

The chemicals management is related with many institutions and organizations with adequate competence, under the terms of the committed rights and obligations in correspondence with the country’s legislation in force. Table 5A provides a general overview of the main areas of competence.

Government Decrees determine the responsibilities of the separate Government Ministries by means of defining the functions, obligations and rights of the different ministers and ministries.

Table 5.A - Responsibilities of the Government Ministries, Agencies and Other Institutions

Note * I-Importation; P-production; S-storage; T-transport; E-exportation; U-use/handling; D-disposal; L-liquidation

The main responsibilities for licensing the producer plants, approving technical projects and employing boards of managers for the companies with government participation are determined by the Ministry of Industry.

Ministry of Environment and Waters exercise control functions on new projects and periodic control of the existing facilities by the procedures for Environmental Impact Assessment and Environmental Audit. The responsibility of the Ministry of Environment and Waters includes the control of dangerous substances, liable to permission regime, according to the legislation enforce. At the same time the Ministry of Health has the responsibility to permit the productions import and usage of chemical substances - industrial, agricultural and consumer products, medicines, and other substances relevant to the people’s health. The permission of usage and control on agricultural chemicals management is an obligation of the Ministry of Agriculture and Forests. The Ministry of Internal Affairs has the responsibilities for substances with military usage. Special legal instruments define the responsibilities of the CUAEPP for exercising control on the exploitation of the sources and transport of radioactive substances, products and nuclear fuel. The Ministries of Transport, Finances and Trade have the responsibility for import, export and transport of dangerous chemical substances, related with the country’s permissible regime for import and export. The Permanent Governmental Commission for protection of population in case of Distress and Accidents, headed by the deputy prime minister in the Government, has the power of attorney and responsibilities to perform the activities for the emergency response..

 Table 5A-1 - Responsibilities of the Government Ministries, Agencies and Other Institutions - with regard to the pesticides

Note: *I-Importation; P-production; S-storage; T-transport; Ds-distribution; U-use/handling; D- disposal

5.2 Description of Ministerial Authorities and Mandates

The chemicals management in the country is carried out by the institutions listed in Table 5a, which have the obligations and rights, consigned by the enforced laws and regulation instruments.

Ministry of Environment and Waters-gathers and provides information for the state of environment, controls the state of environment, performs environmental impact assessment and environmental audit, controls the dangerous substances, under the permissible regime, in compliance with the legal documents.

Ministry of Environment and Water control the waste export.

Ministry of Health-According to the Law of Public Health controls the import, production, trade, storage, usage, transport and decontamination of dangerous chemical substances, issues permission for new chemicals management for industry, agriculture and consumer needs. It bans or restricts the usage and transport of goods, including chemical substances, which could be harmful for the health of the population.

Ministry of Agriculture and Forests-accomplishes biological registration and controls the proper management of the plant protection preparations, bioregulators and chemical fertilizers. Import, export and transport of dangerous chemical substances are regulated by the Ministries of Transport, Finances and Trade. In particular, the Customs Department of the Ministry of Finance exercises control on all goods, imported and exported from the country in compliance with the Customs Act.

The Ministry of Trade and Tourism-registers and permits import and export of goods for juridical persons and sole traders. A preliminary co-ordination with the Ministry of Health is necessary in the cases of import for Anesthetics or Psychotropic Drugs as well as the goods and chemicals, connected with the population health, under control for their production.

Ministry of Labor and Social Politics-According to the Labor Code exercise thorough control on following the labor legislation, including the obligations for providing safety and healthy working conditions. It issues permissions and exercises control on the safety usage of explosive substances.

Ministry of External Affairs-coordinates the activities regarded to the observation of the ratified Convention for Chemical Weapons Ban. A law of Chemical Weapons Ban is designed and is under discussion now.

A Standing Government Board for Protection of the Public in Case of Disasters and Accidents of the Council of Ministries has been founded in the country. Chairman is the deputy prime minister. Members of the Board are representatives from all concerned ministries, committees and the academic community.

According to the Council of Ministry Decree issued 45/88 and the Regulation for implementation of the rescue and urgent emergency and restoration activities in case of disasters and accidents, the Civil Protection Department studies the state of the emergency prevention, elaborates plans for reduction of material damages and maintains rescue procedures in case of accidents. The Civil Protection Department organizes the liquidation of the consequences from the accidents and protection of the public and the environment.

According to the Criminal Code the illegal acquiring and management of strong active toxic substances, and the infringement of the established rules and requirements are considered as criminal acts and are imposed with fines and imprisonment.

Ministry of Environment and Waters, fulfilling its responsibilities, cooperates with 16 regional Inspections on Environment covering Bulgarian territory. Respectively, MH, MIA, MAF dispose of their own services in the different towns. MF has at its disposal its own offices- customs on the border checkpoints and on the free trade zones. MLSP and the Ministry of territorial development and construction have their own structure covering all populated areas. The MSC disposes regional and special structures. In compliance with their responsibilities very specialized and restricted in their jurisdiction are the MT, the Committee on the Use of Atomic Energy for Peaceful Purposes, Government Board for Protection of the Public in Case of Disasters and Accidents and the non-governmental organizations like the Branch Camera for chemical substances producers, the Union of Chemists, etc. In conformity with their legal jurisdiction the MH and MLSP have priority responsibilities in the area of controlling the quality of working environment, workers health and the risk management of chemical substances. The Ministry of Environment and Water is responsible to control the quality of the natural environment and permissible regime. Priorities for the pesticides and fertilizers have the MA, with legal jurisdiction to regulate the production, import, export and usage of agricultural chemicals. The Ministry of Environment and Water and MH have the greatest jurisdiction for applying sanctions and terminating the production in cases of non-compliance with the regulations enforced. Qualified specialists work in the different government institutions, and they will be able to realize the chemicals management in the presence of contemporary legal base. The resources for chemical management after the introduction of the Currency Board are strongly reduced and limited. The professional staff available could manage with difficulties with the vary present responsibilities, but could not design and enforce new legal base in short terms.

5.3 Comments/Analyses

A number of legal documents are enforced in the country, determining the obligations and rights of different institutions and their control authorities. A co-ordination of the implemented legal base is necessary for the period of transition to market economy and integration with the European Legislation and the involvement of non-governmental institutions and employer services in its development.

Other essential disadvantages are the complicated and long procedure in issuing permission and the absence of uniform national criteria for that.

Considering the government officials’ pressure of work and providing active participation of the public, it is necessary to involve specialized non-governmental institutions in the development of the new legal base for chemicals management. In order to achieve effectiveness in the activities, and to shorten the procedure for the permissible regime and observe the European legislation, it is necessary to create a National Register of Chemical Substances. In the "White Book" an engagement is undertaken to harmonize the legal instruments with the European Union’s Directives, concerning the chemical substances.

A project for Regulation of classification, package and labelling of the dangerous chemical substances and preparations has been designed in compliance with Directive issued 67/548/EEC of the EU.

In a process of development is the Law of Chemical Substances, which will regulate the management and control of chemical substances, aiming at preserving the life and health of the population and environment.

Although a progress has been achieved in the development of the computer base, particularly for the government register introduction, most of the institutions need financial aid, because in the Currency Board conditions the budget can not provide financial resources for this purpose.

Chapter 6 : Relevant Activities of Industry, Public Interest Groups and the Research Sector

The necessity of harmonisation, co-ordination, binding and agreement of activities represents certain interest at the time when national economy is passing from centralised management to new forms of organisation and management, when the ownership is changing from public to private one and private sector is consolidating. Similar necessity is also indispensable under conditions of market economy and privatisation, under conditions of rapid development of small and medium size business at the expanse of large-scale business and monopoly and under conditions of intensive and extensive development of different production activities.

The gained experience in the world as well the experience of Bulgaria suggests that non-governmental bodies can play and should play important part in the ppolicy maiking process of each country, because of specificity structures, their method for financing, their forms of existence and manner of work. Main subject of their activity is the environmental problems, especially those related to chemical risk management.

We could classify non-governmental bodies in Bulgaria, having in mind aforementioned subject of activities as well as their great variety in our country, as follows:

• Industrial organisations, unions, branch associations and chambers, economic groups, holdings, companies, trade associations, R & D departments etc.;
• Universities, higher institutes, research institutes, colleges, technical schools, specialised private schools, specialised national and international qualification courses, research sectors, associations, foundations, private laboratories, libraries etc.
• Other non-governmental bodies as entirely stationed joint-stock companies, ltd companies, joint-stock companies, private tradesmen, private companies, centres, societies, clubs, movements etc.

The method for registration of existing non-governmental bodies determines quite similar subject of activities for them irrespective of their variety. This allows versatile activities - production, import and export, use of chemical substances, development and application of new chemical substances, training courses, etc.

Monitoring, control, evaluation, storage, deactivating and reprocessing of wastes (especially of solid wastes and hazardous preparations) are also subject of activities for a number of non-governmental structures.

The lack of uniform system for management of chemical substances, including hazardous wastes, has an adverse effect on the state and non-governmental bodies. All aforesaid determines the necessity of creating national system for chemicals management and elaborating international standards in this field. The new legislation is urgently needed as a basis for the responsibilities and rights of authorities and other parties of the society.

6.1 Description of Organizations

INDUSTRIAL ORGANIZATIONS AND UNIONS

Non-governmental organizations in Bulgaria, which deal or have some relationship to the production, sales/marketing (including import and export), transport, storage or disposal of chemical substances are mainly branch chambers, unions and associations. All of them are members of Bulgarian Industrial Association. Besides similar non-governmental organizations, a lot of Bulgarian private companies and representative offices of big European, American and Japanese companies dealing with chemicals production and trade exist in Bulgaria. These companies and representative offices, however, are not incorporated in bigger organizations and unions, their activities are not co-ordinated, so similar bodies are not included in the present National Profile.

The Bulgarian Branch Chamber of Trade Companies of Chemicals’ Producers (BCTCCP) in fact is a basic non- governmental organization dealing with all aspects of chemicals management. It is founded in 1994 and is officially registered in 1995. There are 52 Bulgarian chemical firms and companies as members of the Chamber for the time being. The address of Branch Chamber of Trade Companies of Chemicals’ Producers is as follows : SOFIA 1309, 205 Al.Stamboliyski Blvd; Chairman: Mr D.Doganov; Executive Secretary - Mrs D.Bogdantsalieva. Contact phone: 03592-9200573. Basic objectives of BCTCCP are: to contribute to the restructuring and privatisation of Bulgarian Chemical Industry, to take an active part in modernisation of existing chemical plants by implementation of up-to-date equipment and technologies. BCTCCP elaborates and takes part in discussions of concepts for future development of Bulgarian chemical industry; provides protection of chemical companies interests at Government, regional authorities and trade unions during elaboration and discussion of projects for preferential taxes, tariffs, etc., concerning chemicals, takes an active part in negotiations between Government, workforce and trade unions for establishment of labour agreements and safety directives for Bulgarian chemical industry.

BCTCCP signed a contract with CEFIC in August 1997 for co-operation in the project focused on the assessment of the influence of the White Paper on the approximation of chemical legislation in Bulgaria with this in EU countries. The project is elaborating according to the corresponding PHARE Programme focused on the assistance to the Central and Eastern Europe countries for their integration in the European Union. The aforementioned contract represents a first stage of the following developments, connected with elaboration and passing the Bills in Bulgarian Parliament considering management of chemical substances, which have to be in compliance with the European legislation. The development of new legislation acts and the time schedule are very strongly related to the available external financial and experts help.

BCTCCP is in a direct and very close contact with Bulgarian Ministry of Industry during its activities. Recently contacts have been realised by BCTCCP and Ministry of Environment and Waters mainly for informing the public about risks connected with production, application and transport of chemicals.

Many other non-governmental bodies and organizations in Bulgaria which activities are concerning mainly with application and end-use of chemicals participate more or less in risk management. Similar non-governmental organizations are included in other programmes for management of chemicals and preparations:

• Branch Union of Machine-Building for Food Industry and Biotechnologies - elaborates and implements technologies and equipment for food industry and biotechologies. Chairman: E.Enchev - HRANINVEST -Stara Zagora. Phone 035942-25216; fax - 035942-43163.
• Branch Union of Leather, Fur, Shoemaker’s and Haberdashery Industries - purchases, conveys and uses different chemical products - artificial leather, polymers, dyestuffs, glues, special chemicals (lubricants, equalisers, etc).Chairman: P.Papadopulov - Sofia 1303, 125-2 Al.Stamboliyski Blvd. Phone/fax:03592- 220124.
• Branch Chamber of Woodworking and Furniture Industries - purchases, transports and uses many chemical products - polymer films, glues (C-200, urea-formaldehyde,etc.), dyestuffs and varnishes. Chairman: Gr.Gradev - BULES - Burgas. Phone 035956-26146.
• Branch Union of Wool and Silk Industries - purchases, transports and applies different chemical products - man-made fibres, dyestuffs, special chemicals (lubricants, textile fenishes, bleachers, antistatics, equilizers, etc.). Chairman: G.Topchiev- INTURG-Sliven. Phone 035944-26769; fax: 035944-86300.
• Branch Chamber of Glass and China-Faience Industries - purchases transports and basically uses chemical products-inorganic raw materials (limestone, kaolin, soda ash, sand), dyestuffs, varnishes, enamels, etc. Chairman: D.DIMITROV- Sofia 1113, 14 G.M.Dimitrov Blvd. Phone 03592-700470; fax 03592-9712472.
• Branch Union of Cellulose-Paper Industry - applies mainly chemical products - caustic soda, chlorine and chlorine compounds, cellulose, etc. Chairman - D.ISKILIEV - RODINA -Plovdiv; Phone: 032-553964; fax 032 - 552280;
• Branch Chamber of Cotton, Flax and Hemp Industries - purchases, transports and applies chemical products - man-made fibres, caustic soda, bleaching agents, dyestuffs, speciality chemicals (lubricants, antistatics, optical brighteners, equilizers, textile finishing agents, etc.). Chairman: P.Tsakov - PAMUKOTEX ENGINEERING - Sofia 1517, 56 Misia Str. Phone: 03592-451172; fax: 03592- 470153
• Bulgarian Branch Union of Knitwear Industry - purchases, transports and uses chemical products - man-made fibres, dyestuffs, special chemicals (lubricants, antistatics, equilizers, textile finishes, etc.). Chairman: St.Kolev - RUEN - Sofia 1000, 8 Pozitano Str. Phone: 03592- 9803267; fax: 03592-9805286.
• Bulgarian Branch Chamber of Medical Industry - applies mainly chemical products - pharmaceuticals, antibiotics, sanitary dressings, disposable medical goods, disinfectants, prostheses, etc. Chairman: D.Georgiev - Sofia 1404, 20-A Bademova gora Str. Phone: 03592- 203272; fax: 03592-591149;
• Union of Edible-Oil Producers in Bulgaria - applies chemical products, like acids, alkalises, etc.; also produces chemical products - organic acids, soaps, oils, etc. Chairman: prof.M.Gardev, Sofia1000, 50 Samuil Str. Phone/fax: 03592- 802614.

Aforesaid organizations are the main non-governmental organizations more or less connected to the management of chemical substances in Bulgaria. All other Branch Chambers and Unions existing now in Bulgaria are included to some extent in this process, because one hardly can found a branch of industry or of real life where chemicals are not applied.

UNIVERSITIES, HIGHER INSTITUTES, COLLEGES, AND MANAGEMENT OF CHEMICAL SUBSTANCES

The management of chemical substances, as it was already mentioned, is not as an end in itself, but is a necessity which has to be implemented immediately in the everyday practice.

Having in mind that in the management of chemical substances a large number of activities, such as: production, application, import/export, storage and transport, improvement and modernisation of applied technologies and equipment, recycling of waste products or making them innocuous and introduction of low-pollution technologies is involved, a special attention has to be directed to the management.

Specialists for production, application, import/export of chemical substances, called further "personnel for management of chemical substances" are trained at different levels in different schools. Generally such schools may be classified, as follows:

-colleges;

-specialised courses and training schools for qualification and re-qualification of specialists with secondary education;

-higher schools, institutes, universities, academies;

-postgraduate specialised courses and training schools for qualification and re-qualification.

Technical schools for chemical industry

Technical schools exist mainly as two different types: "General profile" and "Specialised by branch profile" - silicate industry, textile industry, rubber and plastics, etc.

Technical schools for chemical industry in Dimitrovgrad, Varna, Sofia, Stara Zagora, Vidin and Ruse during many years have gained a lot of experience and tradition. Executive specialists for almost all branches of Bulgarian chemical industry have been and are still trained in these technical schools. They work successfully in the chemical departments, as operators, laboratory assistants, chiefs of laboratories, quality inspectors.

The specialists are concerned with production, use, transport and storage of chemicals and the requirements to provide such conditions that guarantee enforcement of national and international norms, legislation and standards.

A conclusion can be made that students in chemical technical schools have to be acquainted with the problems concerning management of chemical substances either by studying suitable subject, or by series of special lectures.

Colleges

Since the beginning of 1997 the existing so called "semi-higher schools" is transformed into colleges. Their objective is to educate specialists for chemical industry of higher level: monitors of shifts, heads of departments, production managers, chiefs of laboratories, heads of divisions, managers of plants, etc. Similar specialists can work successfully in project and design organizations, Regional Environmental Inspectorates, specialised laboratories, import and export firms for chemical substances.

All these colleges are independent, but at the same time are structural sections of appropriate higher institutes. There are 44 colleges in Bulgaria. Special attention should be directed to the colleges for chemical industry in Sofia, Varna and Razgrad. These colleges are closely linked with higher chemical institutes in Sofia and Burgas.

Universities and Higher Institutes

There are 41 universities in Bulgaria, from which two are specialised to train in the field of chemical industry: a) University of Chemical Technology and Metallurgy (UCTM) - Sofia; b) University of Chemical Technology "Prof. Dr.Assen Zlatarov"- Burgas.

Chemical engineers for almost all branches of chemical industry (inorganic chemicals technology; silicate industry; rubber industry; plastics industry; printing and publishing industry; leather industry; electrochemical industry; organic synthesis; fuels; biotechnological industry; engineering chemistry; engineering ecology, etc.) are trained and graduated in both Universities.

Specialists trained for higher chemical engineering education are graduated at UCTM - Sofia jointly with Universities from Germany and France. Since 1988 higher education courses in Sofia University are converted to courses earning the degrees of Bachelor (B.Sc.) and Master (M.Sc.).

Strong research sectors exist in the two Universities. With experience in the theory and practice of chemical technologies. Possessing an up-to-date material and technical foundation as well a lot of effective contacts with the chemical enterprises.

Having in mind the aims of the National Profile for assessment of the national infrastructure for chemicals management, it is advisable to:

a) include the chemical Universities in the preparation of the legislation for chemicals management;

b) introduce specialised educational courses for earning the Degrees of B.Sc. and M.Sc.;

c) convert problems connected with chemicals management to a subject of specialised postgraduate courses and Ph.D. and D.Sc. theses;

d) engage the research sectors of universities in an appropriate way for managing of chemical substances;

e) organise the participation of licensed laboratories at the Universities in the chemicals management (see Table 9A, No1 and No4).

Along with UCTM-Sofia and University "Prof. Dr Assen Zlatarov"-Burgas, several other Bulgarian Universities, Institutes and High Schools have to be included in the number of non-governmental organizations working in the management of chemical substances: UCTM-Sofia -Chemical Department; Plovdiv University "P.Hilendarsky"; Shumen University "Bishop Konstantin Preslavsky"; High Institute for Food, Wine and Tobacco industries-Plovdiv; University for National and World Economy - Sofia; High Agricultural Institute - Plovdiv; Higher Military School "P.Volov"- V.Tarnovo.

Research Institutes

Research Institutes in the field of chemistry and chemical technologies contribute to the development of new chemical substances, to their structure-mechanical, physical, chemical characterisations, to their modification and to their practicable implementation. They should participate in the National Profile for assessment of the national infrastructure for chemicals management. Such Institutions are following:

• Chemical Institutes of Bulgarian Academy of Sciences (BAS) - Institute for General and Inorganic Chemistry; Institute for Organic Chemistry; Institute for Catalysis; Central Laboratory for Electrochemical researches (CLEHIT); Institute for Physical Chemistry; Institute for Engineering Chemistry; Institute for Polymers;
• National Centre of Environment and Sustainable Development (NCESD) at the MEW has laboratories and technical basis for evaluation of environmental pollutants in the air, water and soil; mobile equipment for expert analyses and a data - base for the pollutants in the environmental medicine. The Centre has a well-supplied library related to the management of the lifecycle of chemicals. It issues in Republic Bulgaria which contain systemic reused and summarised ecological information.
• National Centre of Hygiene, Medical Ecology and Nutrition (NCHMEN) at the MH performs the postgraduation training in hygiene, toxicology, medical physics, sanitary chemistry and nutrition. It has a well-supplied library, introduced international information system (IRIS, IRPTC, HAZOP, CAMEO) for environmental and health protection, physical and chemical laboratories and contacts with USEPA, OECD, International Chemical Safety Program of WHO, the Environmental Departments of EBRD and World Bank. The Centre is involved in the risk assessment, risk management and risk communication of the chemical hazards in the ambient and working environment. It performs quantitative espouse assessment and epidemiological studies and participates in the chemical emergency prevention.
• National Service for Plant Protection, Quarantine and Agrochemistry (NSPPQA) at the MFA creates the necessary conditions for proper plant protection, manages the import and the application of pesticides and artificial fertilisers in Bulgaria. It is responsible for the phytosanitary control, the biological testing of agricultural products, the control of the pesticide residues, nitrates, heavy metals, etc., in the agricultural products. The National Service analyses soils and underground waters, controls the proper use of fertilisers and performs the pesticide and fertiliser registration.
• National Statistical Institute (NSI) is characterized with methodology in compliance with the requirements for harmonization of the National statistic system the European Union. According to the rules the requirements are defined by the European Statistic Office of the European Union- EUROSTAT; putting into practice the national classifications and nomenclatures, developed on the base of the European ones, providing direct and simple connection with the United Nations’ classifications and nomenclatures; coordination of the statistic investigations between them, for providing information of the national accounts.
• Specialised Institutes: Institute for Chemical Industry - Sofia; Institute for Rubber and Plastics Industries - Sofia; Institute for Cellulose and Paper Industries - Sofia; Institute for Special Chemicals - Dimitrovgrad; Research Institute for Chemicopharmaceuticals (NIHFI) - Sofia; Institute for Glass and Fine Pottery - Sofia; Institute for Building Materials - Sofia; Institute for Ferrous Metallurgy -Sofia; Institute for Nuclear Physics - Sofia, etc.
• Institutes (research bases, centres, departments) in Bulgarian chemical plants: "Himko"-Vratsa; "Agrobiochim"-Stara Zagora; "Agropolychim" Devnya; "Neftochim"-Burgas; "Yambolen"-Yambol; "Farmacia"-Dupnitsa; Institute for Non-ferrous Metallurgy-Plovdiv, etc.

Foundations, Associations, Libraries

The libraries possessing national and international information chemicals management are recognised as useful bodies for elaboration and resolution of arise problems. Libraries can participate either in work out of National Profile for assessment of the national infrastructure for chemicals management or using their possibilities to bring elaborated Profile to the knowledge of juridical and physical persons concerned.

The libraries engagement and participation will be useful specially nowadays when the access to foreign sources and publications is quite difficult for the majority of juridical and physical persons. It is possible to use the inter-library exchange, the international book-stock funds, INTERNET,etc.

Foundations and Associations also can find their place in the management of chemical substances, having in mind their organisational activities, highly qualified specialists, data-banks for national and international projects, as well as approved contacts in the country and abroad.

OTHER NON - GOVERNMENTAL ORGANIZATIONS

Non-governmental bodies in Bulgaria, like the world practice, are organized as societies, clubs, centres, groups, consulting firms, etc.

The activities of similar organizations are quite versatile. Majority of the non-governmental bodies in Bulgaria is occupied with consultation, research, production (production of chemicals), resolving ecological problems, information activities, trade, etc.

Concerning the problems of present National Profile for assessment of the national infrastructure for chemicals management, it is necessary to underline that the number of non-governmental bodies directly engaged in the lifecycle of chemical substances is quite limited. At the same time non-governmental organizations working on ecological problems and on protection of environment are more than 140. The organizations were founded only about 5 years ago, but their activities deserve admiration and much appraisal. Such activities approve similar bodies as necessary and prospective structures for settlement of the problems connected with the development of the society.

It is difficult sustainable to analyse the aims and objectives of all non-governmental organizations in Bulgaria. Only some of them will be mentioned here below - bodies which can claim on participation in the National Profile for assessment of the national infrastructure for chemicals management working out considering their participation in resolving of problems connected with production, use, control, transport, improvement and management of chemical substances.

POVVIK - JSC - a non-governmental organization with head-office in Sofia-1138; 30 B.Rangelov Str. Main projects worked out by "Povvik" during last two years directly or indirectly concern the management of chemical substances are, as follows:

• Investigation of pollution sources for depositories-for Vidima-Ideal-Sevlievo;
• Investigations of industrial galvanic waste waters precipitation - for Varna Shipbuilding Company (shipyard);
• General characteristics of accumulated pesticides in Bulgaria - for RWE - Entsorgung - Germany;
• Environment impact assessment - for "Agrobiochim"-Stara Zagora.

Centre "Clean Industry" - a non-governmental organization with head-office in Sofia 1000; 16-20 Alabin Str. Basic priorities of Centre "Clean Industry" are the following:

• Information of Bulgarian industrial plants for challenges resulting from implementation of the new standards concerning management of environment;
• Organization of lecturer’s training and creation of networks of auditors, consultants and specialists;
• Co-ordination and assessment of industrial plant’s programmes for management of Environment;
• Popularisation of a display projects;
• Assistance in the dialogue between Government and financial institutions domestic and foreign sponsors, and companies wishing for application of systems for management of Environment;
• Creation of data-base for clean and energy-saving technologies, diminution of waste products, etc.;

Balkan Scientific-Educational Centre on Ecology and ENVIRONMENT (BSECEE) - Non-governmental organisation with head-office in Sofia 1756, 10 Kl.Ohridsky Blvd.

Main activities of the Centre are following: General education; Research; Consultations; Investigations and appraisals by experts; Information; Design and project. Basic development and projects of BSSECEE are, as follows:

• Basic barriers towards investments for ecology and Environment protection - joint project with Centre "Clean Industry";
• Management of air quality in Stara Zagora - joint project with USEPA;
• Foundation of monitoring and control centre for heavy metals environment pollution - joint project with OTI-Athens- financed by PHARE-Programme;
• Ecological impact assessment of Copper-Smelting Plant - Pirdop on the soils in Zlatitsa-Pirdop area;
• Environment impact assessment for the objects: "Antibiotic"-Razgrad; "Non-Ferrous Producing Plant" - Sofia; "Syntermat"-Novi Iskar; "Eterna"- Pleven; Limestone quarry - Maritsa-Iztok, etc.

Environmental Management Training CENTRE (EMTC)-Non-governmental organisation with head office: Sofia 1000, 4 P. Parchevich Str. Established and sponsored by the USEPA with the following main activities:

• Training in environmental and health management: elaboration, adaptation and delivery of short postgraduate courses, training materials, information’s systems and "training of trainers" according to USEPA&EBRD programs (risk assessment of chemicals, chemical safety auditing, hazardous waste management, chemical emergency prevention, EIA and EAuditing) and PHARE program (industrial medicine services). Data-base of environmental experts and trainers in Bulgaria;
• Consult and expert support in the field of environmental risk assessment, environment and health legislation, decision-making for health promotion and for emergency prevention in chemical industry (Projects: "Environmental Risk Assessment in the Kurdjali Region" with the Institute of World Resources, USA; "Lead exposure in Bulgaria" with the World Bank)
• EIA and E Audit for the EBRD: "Serdika-Danon"-Sofia; "Wholesale Markets" in Bulgaria; "Vitalakt-Delta IceCream"- Varna; "Jambolen" - Jambol, "Storko"- Pleven; "Milky Way"-St. Zagora and "Aroma-Astera" - Sofia.

FIRMS

"Ecotech Consult" Ltd - Registered by Trade Low with head-office in Sofia 1113; complex "Javorov" bl.68. The basic activities of "Ecotech Consult" Ltd are research developments, performance of Environment Impact Assessments and Environmental Audit Projects, and investigations directly concerned with management of chemical substances, as follows:

• Production of water-insoluble synthetic pine flotation oil (SINOL I) and investigation of possibilities for implementation and production of water-soluble synthetic pine flotation oil (SINOL II) - financed by "Crystal"-JSC- Velingrad for needs of flotation plants;
• Development of technology for extraction of gold from ores and concentrates from "BIMAK"-JSC and "CHELOPECH"-Ltd;
• Environment Impact Assessment and E Audit for: "Di-flubenzuron production plant" in "Neochim" - Dimitrovgrad; "Liquid sulphur dioxide production plant" in "Neochim"-Dimitrovgrad;
• "Analysis of production - technologies, pollution sources for environment. Area of Chelopech" -Part of the project "Ecological impact assessment of Copper-Smelting Plant-Pirdop on the soils in Zlatitsa-Pirdop area - contract with BSECEE, financed by PHARE-MEW.
• Project "National Profile to Assess the National Infrastructure for Management of Chemicals" for Bulgaria and financed by UNITAR.

"Interlex"-Ltd - a consulting society with head-office in Sofia 1000, 6 Parchevich Str. "Interlex" priorities are: analyses in fields of Environment, legislation and intellectual property. The basic activities of "Interlex" concerning directly or indirectly management of chemical substances and waste products are, as follows :

• Environment Impact Assessment :improvement of decision-making process by presenting an environment information - organisation of seminars with participation of Regional Environmental Inspectorates, municipalities and partnership of Centre for International Ecological Legalisation -Washington -sponsored by US Agency for International Development (USAID);
• Comparison of legal Regulations for Environment Impact Assessment in Bulgaria, USA, Czech Republic, Slovakian, European Union, the World Bank and European Bank for Research and Development (EBRD) - preparation and distribution of Reference-book, sponsored by USAID.
• Application of effective programme for licences and control of domestic and regional level - organisation of seminars with Regional Environmental Inspectorates, municipalities and partnership of Institute for Sustainable Communities - Vermont, USA, financed by USAID;
• Gasification project for Stara Zagora;
• Project for management of Sofia waters according to the Agreement signed between Capital General Municipality - Sofia and French company SOR;
• Project "Control Functions of REI in protected areas".

6.2 Summary of available professional opportunities in the non-governmental sector

Non-governmental sector has at its disposal enough potential to fulfil definite functions on chemicals management, in connection with their "lifecycle". As it was already mentioned, non-governmental organisations dealing with ecology and environment protection are about 140. They are registered in the book of the Regional Environmental Centre (REC). The REC for Central and Eastern Europe - Bulgaria issued in 1996 a notebook with short information about non-governmental organisations. Results of these organisations activities remain often "closed" in the Contracting Partners and can not be multiplied and distributed on Departmental, Branch, or National levels. The information systems like "Different Libraries", "Scientific and Patent Literature", "Archives", etc. are closed for the results of work and activities of non-governmental organisations and during the time they are left without practicable implementation.

Table 6.A - Summary of available professional opportunities in a non-governmental sector

Note: JSCo = Joint-Stock Company

6.3 Analysis, Assessment and Recommendations

- The activity of specialising secondary schools, colleges and higher schools is directly connected to the problems of management of chemical substances and waste products. Training of management staff on the levels of secondary schools, colleges or higher schools has to be regulated by corresponding documents in the training programmes. Introduction of specialised courses, lectures and exercises concerning is necessary. It is necessary also to introduce specialities dealing with the problems of management of chemical substances and waste products, toxicology, chemical safety risk assessment.

- Institutes, Universities, Academies and correlated to them units (like Research Sectors, authorised laboratories, research laboratories, computer centres, etc.) took part in chemicals management.

- Research institutes and their units in state-owned and in private sectors can participate quite effectively in development of new chemical substances; characterisation, choice and control of imported and exported chemicals; production, processing, transport, storage and control of waste products; resolving the problems concerning energy- and raw materials deficit, etc.

More effective engaging of non-governmental organisations in solution of different problems, including the process of chemical management and waste can be achieved by implementation of following actions:

• revising of existing legislation concerning chemicals management;
• development of new normative acts, norms and standards for management of chemical substances and waste products;
• co-ordination and effective work with the environmental non-governmental organisations;
• harmonisation of national and European legislation for management of chemical substances and waste products;
• confirmation the legislation documents in a Law for chemical management
• implementation and enforcement of laws and regulations in practice to juridical and physical persons concerned directly or indirectly with chemical substances and waste products.

CHAPTER 7: INTER-MINISTERIAL COMMISSIONS AND CO-ORDINATING MECHANISMS

7.1 Inter-ministerial Commissions and Co-ordinating.

The situation in Bulgaria, following the changes in eastern Europe during 1989, is a result of the changing the political system and the slow transfer from centralized into market economy. This situation is marked by a considerable disorganization of the economical activities and by an unstable state government poorly adjusted toward regulating the processes within the economy.

Chemical's management in the country deals with the utilization of chemicals in the manufacture of industrial, agriculture and consumer goods, as well as the trading (including export/import) of chemicals.

Most of the major industrial enterprises lost their foreign markets, resulting in considerable decreased production. Other enterprises got into debt and have gone bankrupt. While, a third group of enterprises changed their major activity. The slow running process of privatization causes additional difficulties in the normal running of the enterprises. Many small and medium-sized enterprises, using chemicals in their activity, established during the past few years, are excepting governmental management sphere. (For example: In the state register BULSTAT, more than 121 thousand enterprises are registered, but national Statistical Institute maintains statistical information of 1996 for 2888 of them).

The quality control, required by Bulgarian Quality Standardization, over the production of chemical products has been reduced. In the mean time, the production of chemicals products which lack quality control standardization has been on the increase. There is a lack, as well, of Normative Acts that require the application of international quality standards. The chemical products manufacturers and the chemical users/customers determine the quality of the products on the basis of their own technical requirements.

At this juncture, on the governmental level the following problems relevant to the chemical's management are being worked on:

• the creation and the issuance of decrees dealing with the control of chemicals and chemical products;
• the creation and the issuance of decrees dealing with the obligations which proceed from the signed and ratified international conventions;
• the preparation for Bulgarian participation in other international agreements;
• the assessment of environmental influence for everyone of the industrial enterprises that are on the market for privatization;
• the control and the assessment of industrial enterprises, the establishment of new productions or new technology with a view toward health and environmental safety;
• the licensing of industrial enterprises according to ISO 9000 and ISO 14000;
• the education and retraining of specialists dealing with the chemical management.

 7.2 Description of Inter-ministerial Commissions and Co-ordinating Mechanisms.

The frequency of the Inter-ministerial Commissions’ meetings is determined by their needs. The decisions-making procedures are set by the Government.

Table 7.A - Overview of Inter-ministerial Commissions and Coordinating Mechanisms

Name of Mechanism	Institutions Included	Nature of the Commission	Delegated Powers	Information Provided in Secion 7.2
1	2	3	4	5
Higher Council of Experts in Ecology	MEW, MI, MH, MFA, BIA	Permanent	Taking decisions on the assessments of the environmental influence	Yes
Inter-departmental Council for the Narcotics	MTT, MH, MF, NCHMEN	Permanent	Control	No
Inter-departmental Council for the Making Destruction of Pesticides	MFA, MEW, MTT, MH	Temporary	Taking decisions and organizing their accomplishment	No
Commission for Authorising Experts to Assess the Influence on the Environment	MEW, MH, MFA,	Permanent	Licensing	No
Commission for the Defence of the Population in Cases of Natural Calamities or Industrial Accidents	MFAff, MIA, MI, MH, MLSH, MEW, MFA and etc. (total 22 institutions)	Permanent	Taking decisions and organizing their accomplishment	No
Commission for the Registration of Opiates and their raw materials	MH, MF	Permanent	Registration	No
National Labour Council	MH, MLSH, syndicates, workers	Permanent	Control	No
Commission for the Registration of the Imported Pesticides	MFA, MH, MIA, MEW, Agriculture Academy	Permanent	Registration	No

 One of the coordinating mechanisms is the Higher Council of Experts in Ecology (HCEE), and it attached to the Ministry of the Environment and Water. It’s activities and duties are regulated by the Environmental Minister.

The HCEE has the following functions:

• decision-taking dealing with environmental assessment reports;
• decision-making on the accomplishment of projects and reports dealing with the environment;
• examines environmental reports and proposes projects for ministerial decision-making;
• explores competitive project themes on the basis of ministerial priorities for the given time period;
• approves the competitive project programs on the basis of set criterion;
• assesses the implementation of the projects and programs dealing with the environment;
• Assess the projects and programs, which are related to the ecological policy, by order of Environmental Minister.

The Council of Experts in Ecology structure is made up of: co-presidents which are Deputy Ministers of the Environment and Water, a secretary, permanent members and additional members.

The permanent members are made up from: the Department Heads of the same Ministry, the Head of the National Environmental Center, representatives of MEW, MFA, MH, MTSH and other related ministries and institutions.

The additional (augmented) membership comes from: the Bulgarian Academy of Science representatives, the university representatives, and the representatives of Research Departments from other ministries. On an as-needed basis, representatives from environmental non-governmental organizations are also included.

The additional members join in the commission’s meetings on a case - by- case basis and provide written position paper and vote in decision - taking.

The Council of Experts in Ecology functions divided into two sectors:

• decision - making dealing with the environmental and water protection;

• assessment of environmental projects, including those stemming from the PHARE program. It can also deal with other environmental issues.

 7.3 Description of Mechanisms for Obtaining Input from Non-Governmental Bodies.

The number of Bulgarian non-governmental organizations dealing with chemical's management are relatively few.

They are follows: The Branch Chamber of Trade Companies of Chemicals’ Producers, which unites industrial enterprises with related activities; Union of Chemists; research centres and laboratories; a number of private companies that deal with the assessment of environmental influence; and environmental groups.

The non-governmental organization obtain local information about improper use of chemicals, pollutant release, hazardous emissions and waste. Their reports help on governmental decision - making raise control of Inspecting Institutions and invoke sanctions.

For the present non - governmental bodies do not participate directly in planning, in decision - making and in implementation of national chemicals management programs and policies.

7.4 Comments and Analysis

The existing mechanisms for coordinating activities among ministries and other relevant governmental and non - governmental bodies do not work effectively at all times.

The state of the Normative Acts and decrees cleaning with the management of chemicals and chemical products is indicative of unsatisfactory inter - ministerial co-ordination.

The existings inter - ministerial commissions are not linked with each other and they work separately.

We consider it expedient the realization the following solutions:

• the establishment of an on-line system connecting the governmental bodies charged with chemicals management;
• the establishment of regular newsletter;
• the education and retraining of specialists dealing with the chemicals management.

The major problem for their realization is the lack of financial resources.

We would like to think, that UNITAR will be able to propose through IOMC programs and financial resources for purposes of the chemical's management in the country.

Chapter 8: Data Access and Use

8.1 Availability of Data for National Chemicals Management

There is no integrated system of chemical's management on the national level in the country. The chemical's management is accomplished separately, accordingly to the type of chemicals, and by the relevant governmental body.

The Table 8.A provides data about the available information related to chemical's management, as well as the institutional maintenance of the information for some of the chemicals.

Table 8.A - Quality and Quantity of Available Information

Data Needed for:	Pesticides (agricultural, public health and consumer use)	Industrial Chemicals	Consumer Chemicals	Hazardous Chemical Wastes
Priority Setting	X MFA MEW	X MI	X	X
Assess Chemicals Impact under Local Conditions	X MEW MH MEA PGCPPDA	X MEW MH MEA PGCPPDA	X MEW MH MEA PGCPPDA	X MEW
Risk Assessment (environment/health)	X MEW MH MEA PGCPPDA	X MEW MH MEA PGCPPDA	X MEW MH MEA PGCPPDA	X MEW MH MEA PGCPPDA
Classification /Labelling	X	X	X	X
Registration	X	X	X	X
Licensing	X	X	X	X
Permitting	X MFA	X MEW	X MH, MEW	X MEW
Risk Reduction Decisions	X MEW MH MEA PGCPPDA	X	X	X MEW MH MEA PGCPPDA
Accident Preparedness /Response	X MLSH MIA	X MLSH MIA	X MLSH MIA	X MLSH MIA
Poisoning Control	X MEW MH ME CP	X MEW MH ME CP	X MEW MH ME CP	X MEW MH MEA CP
Emissions Inventories	X MH MEW	X NSI	X	X MH MEW
Inspections &Audits (Environment/health)	X MFA MH MEW	X MFA MH MEW	X MFA MH MEW	X MFA MH MEW
Information to workers	X	X	X	X
Information to the public	X	X	X	X

8.2 Location of National Data

The Table 8.B indicates the location of national data, the source of the data, who has access to the data, the restrictions on access and the form in which the data is maintained.

Table 8.B - Location of National Data

Type of data	Locations	Data Source	Who has access?	How to gain access	Format
Production Statistics	NSI	each statistical unit	everybody	restriction for data on individuals	paper; disc
Import Statistics	NSI MTT Customs	customs	nobody	confidential business information	paper; disc
Export Statistics	Customs MTT	customs	nobody	confidential business information	paper; disc
Chemical Use Statistics	NSI MTT	manufacturers merchants	everybody	without restrictions	paper; disc
Industrial Accident Reports	CP MEW municipality	enterprises	CP relevant ministry and municipality	pending juducial inquiry	fax
Transport Accident Reports	CP MT MEW	police	CP relevant ministry and municipality	pending juducial inquiry	paper
Occupational Health Data (agricultural)	NCESD	HEI	everybody	without restrictions	paper
Occupational Health Data (industrial)	NCESD	enterprises	everybody	without restrictions	paper
Poisoning Statistics	MH NCESD	clinics and hospitals	everybody	without restrictions	paper
Pollutant Release and Transfer Register	MEW NCESD	RIE NCESD	everybody	without restrictions	paper; disc
Hazardous Waste Data	MEW NCESD	REI CP	everybody	without restrictions	paper; disc
Register of Pesticides	MFA	MFA	employees	without restrictions	paper; disc
Register of Toxic Chemicals	MH MEW MT	RIE HEI	employees	without restrictions	paper; disc
Inventory of Existing Chemicals	No	No	No	No	No
Register of Imports	Customs MEW MTT MH MF	customs	employees	without restrictions	paper; disc
Register of Producers	NSI	enterprises	everybody	without restrictions	paper; disc
PIC Decisions	No	No	No	No	No

It should be mentioned, that the National Statistical Institute ensures an open access to the summarised national data, but it does not provide information for a particular statistical unit. This same restriction is on a national data, when it is collected from only one statistical unit which is a monopolist in the country.

The data related to the Import Statistics of commodities with health effects contain information on the type of imported chemicals, the importer, and written instructions for harmless usage.

The import of waste and hazardous chemicals is made only by permission of Ministry of the Environment and the Water.

The information about the data on the Pollutant Release is provided in the Table 8.B, but it should be noted that a Transfer Registrar has not been created in the country yet.

8.3 Procedures for collecting and Disseminating National /Local Data

The National Law requires for the governmental authorities to be provided with the type and quantity of produced and imported chemicals, quality certificates, and the destination of the chemicals (manufacturing / trading). The data span the life cycle of the chemical, including the pollutant release during the manufacturing.

The data are being collected by National Statistical Institute, Ministry of Envirounment and the Water Resources, MFA, MH, CP, MIA, MLSH, MI accordingly to the type of chemicals and the established duties and responsibilities for each of the governmental bodies.

The Environmental Protection Act lays down the procedures for assessment of environmental influence is obligatory on developing programmes, town plans, investment projects, and on manufacturing activities. The reports on the assessment of environmental influence are being approved by the Higher Council of Experts in Ecology who is attached to the Ministry of the Environment and Water. On the local level the reports on the assessment are approved by the RIE.

The data on the environment are collected by the Ministry of the Environment and the Water on the national level and by RIE on the local level.

The Ministry of Environment and the Water publishes an annual newsletter on the state of the environment which provides a systematised ecological information. The newsletter is created jointly with NCESD by using their own information as well as the information collected from National Statistical Institute, the HEI and other bodies.

Fig. 8.1. - Dissemination of data dealing with industrial accident at the local and national level.

The data on the health effects of chemicals are being collected by the MH at the national level and by the HEI and clinics and hospitals at the local level.

The Statistical Act has set down the definition of the confidential business information and the procedures for the given protection.

The data which access is not restricted, are provided by governmental bodies’ Information Bureau.

Figure 8.1 indicates the dissemination of data dealing with industrial accident. The access to this information could be restricted as long as the data is used in a pending judicial inquiry.

8.4 Availability of International Literature

The available international literature and databases are maintained by governmental bodies accordingly to established duties and responsibilities of each of them, as well as by non - governmental institutions accordingly to their activities. The duties and responsibilities of each governmental body are indicated in Chapter 5.

Table 8.C - Availability of International Literature

Literature	Locations	Who has access?	How to gain access
Environmental Health Criteria Documents (WHO)	MEW MH	everybody	without restrictions
Health and Safety Guides (WHO)	MH	everybody	without restrictions
International Chemicals Safety Data Cards (IPCS/EC)	MEW MH	enterprise employees	with permission of these Ministries
Decision Guidance Documents for PIC Chemicals (FAO/UNEP)	MEW MFA MH	employees of these ministries	without restrictions
FAO/WHO Pesticides Safety Data Sheets	MH MFA	employees of these ministries	without restrictions
Documents from FAO/WHO Joint Meeting on Pesticide Residues	MH MFA	employees of these ministries	without restrictions
Material Safety Data Sheets (industry)	MEW MLSH MH	enterprise employees	without restrictions
OECD Guidelines for the Testing of Chemicals	CSM MH
Good Laboratory Practice Principles	CSM MH	everybody	without restrictions
Good Manufacturing Practice Principles	CSM	everybody	without restrictions
WHO/UNEP Global Env. Library Network	MEW

The libraries of the Universities, the Academies, the Research Institutes and other bodies, maintain technical, juridical and economic literature dealing with chemicals. Each one these bodies regulate the access to their literature. The governmental institutions could use this literature without restrictions.

This year, the European Union has provided the Ministry of the Environment and the Water Resources with the Registrar of Chemicals and the current White Book.

The European Integration Centre in Sofia maintains information regarding the Normative Base of Chemicals management and everyone may to gain access to the data without any restriction.

The Bulgarian Normative Acts relative to the chemical's management, that have been translated into English, is indicated in Chapter 4.

8.5 Availability of International Databases

The used international databases on the chemical's management are indicated into Table 8.D.

Table 8.D - Availability of International Databases

Database	Locations	Who has access?	How to gain access
IRPTC	MEW MH	specialists and employees	with permission by the Ministry
ILO CIS	MLSH	specialists and employees	with permission by the Ministry
IPCS INTOX	MH	specialists and employees	with permission by the Ministry
Chemical Abstract Services Database	CP MEW	specialists and employees	with permission by the Ministry
Global Information Network of Chemicals (GINC)		everybody	by Internet
STN Database	No	No	No
Relevant Databases from Other Countries	Canada - The Transport Centre	everybody	without restrictions
IRIS	MH EMTC	everybody	with permission by the Ministry
CAMEO	EMTC	everybody	with permission by the Ministry

8.6 National Information Exchange Systems

A National Information Exchange System related to the chemical management has not been created. Chapter 2 of the National Profile provides the information items that have already been collected by all the governmental and non - governmental bodies.

Chapter 9 and Chapter 12 indicate what could be done so that the collected information is continuously up - dated and disseminated to the users with different levels of an access.

8.7 Comments / Analysis

A major weakness of the information base dealing with national chemical's management is the poorly adjusted exchange of data and documentation on one hand between the bodies at the national level and those on the local level, and on the other hand, between the different institutions at one at the same level. This is a result of the lack of an integrated system of chemical's management in the country, as was indicated in the section 8.1. If an analogous Profile is developed at regional level, it may improve the mechanisms of collecting and disseminating of the information.The development of the National Profile accordingly to the Guidance Document has led to an initiative to improve the collecting and disseminating of the information dealing with chemical's management. As was said in the previous section, these efforts are indicated in Chapter 9 and Chapter 12.

Chapter 9: Technical Infrastructure

9. 1 Overview of Laboratory Infrastructure

Many laboratories that can be included in the management of chemicals (at different stages of their "life cycle") are available in Republic of Bulgaria. These are laboratories with analytical chemistry capabilities that can ensure determination of chemicals' quality, identify unknown substances, monitor and describe possible adverse effects, etc. These laboratories can be licensed under legislation operating now in Bulgaria.

9. 1. 1. Aim of Accreditation

Aim of a laboratory accreditation is to ensure that results obtained by tests, made in the laboratory, are accepted with confidence. In order not to endanger validity of test results, it is necessary to make more clearly the meaning of term "accreditation". Also, requirements and documents on which the accreditation procedure will be based are to be precisely defined.

9. 1. 2. Legal Instruments for Accreditation

Management of quality of products can be carried out in accordance with ISO standards (9000 series) or Manual 25 of ISO/IEC.

Most used way to guarantee products' quality is their certification according to ISO standards (9000 series).

Large number of organisations, which are certifying products in conformity with ISO standards (9000 series) and particularly with ISO 9002, guarantee validity of results from tests at a level equivalent to the accreditation in accordance with Manual 25 of ISO/IEC. However, essential differences exist between Manual 25 and ISO 9002. ISO standard- 9000 series propose a determined system for managing the quality of a certain organisation, independently on its functions.

Essence of Manual 25 guarantees validity of test results ensuring technical competency, while proficiency competency and technical reliability are not treated by ISO 9002.

Laboratories' audit aimed at their accreditation as well as the audits of an organisation evaluating the quality system, have many comparable elements and require similar capabilities of all persons, responsible for this activity accomplishment.

Bodies on accreditation, unlike Bodies on certification of quality systems, additionally elaborate documentation, in compliance with Manual 25. It contains many detailed technical descriptions in the corresponding field.

The necessity of supervision of laboratories' development means of inter-laboratory comparisons which is an element in the procedure for laboratories' accreditation, is not discussed in quality system.

Organisations can be certified for conformity with one standard of a quality system for a very large number of industrial enterprises or products.

Bodies on accreditation support laboratories when later refer (in their protocols) to the Body. Then Bodies’ publicly state that test results are obtained by an licensed laboratory, competent to carry out unbiased tests.

ISO standards (9000 series) are not created to meet this goal. They consider organisation's capabilities from the viewpoint of systems for quality management, but not taking into consideration its specific technical potentialities. The sign of Bodies certifying quality systems should not be used by the organisation as a certification mark showing products' conformity with a defined specification.

Assessment (aimed at laboratories' authorisation) of a quality management system according to ISO standards - 9000 series does not meet user's needs of correct test results, because standards for quality systems do not evaluate technical competency of staff engaged in test performance.

Users of test results are interested both in laboratory's capability to evaluate the quality (quality system) and in its technical competence (ability to realise technical result). The best way to achieve both goals mentioned above is to seek help from Bodies which: i) accredit laboratories according to the requirements of the Best International Practice (Manual 58 of ISO/IEC or Standards EN 45002 and EN 45003), ii) demand tests to be conducted (by authorised laboratories) according to the Best Laboratory Practice (Manual 25 or EN 45001 are to be followed), and iii) engage experts in some interesting for the client tests.

Because of the reasons above mentioned, laboratories' accreditation on national or international level has to be based on application of Manual 25. In this way, necessary confidence in validity of test results obtained by certain laboratory can be guaranteed.

9. 1. 3. Legal Instruments of a System for Environmental Management

ISO 14000 series standards, determining rules for an environmental management system are in close relation with ISO 9000 series standards. ISO 14000 series standards are of the same importance for the environment just like ISO 9000 series standards for the quality. ISO environmental standards are very important, because environment protection has become a main item of policy of every government all over the world.

European level discussions on the relationship between both series of standards have come to the following formulations:

• A system for environmental management can function in an enterprise, only if it is based on ISO 9001 standard.

• The system for environmental management in the enterprise can not be entirely built in compliance with ISO 9001.

When both systems (a Quality System - according to ISO 9000 series standards, and an Environmental Management System - according to ISO 14000 series) are implemented, the corresponding documentation has to be structured so that terms "quality" and "environment protection" to be considered in unity. Their further development is to be based on this unification.

More detailed matrix, where requirements of ISO 9001 and ISO 14001 are approximated, is created by constructing an integrated management system (based on both series of standards).

A quality system, existing in an enterprise and certified according to ISO 9000 series, can serve as a basis for building an environmental management system. Common part of the united system is constructed by its adjustment to each of both included systems. So, the quality system is supplemented with a text representing the most important moments of the environmental management. Rules and information, not corresponding to the general part of the text, are included in additional chapters. Large part of procedures important for the environmental management system, has to be created and introduced at the stage of building of the quality system. Lacking procedures and rules, as well as responsibilities for environment protection have to be additionally defined and to be integrated with procedures and rules already available in the quality system.

ISO 14000 series standards are applicable both for producing enterprises and for organisations in the field of community utilities; for public and private sector. These standards indicate the measures to be taken by an organisation in order to be able to administer the influence of its own activity on the environment, but the standards do not give instructions how this control should be done.

When ISO 14000 series standards are implemented, it is expected that a law frame would be created for all concerned fields by means of : i) submission of international methods for assessment of the environment protection, ii) supplying information about products' origin and recycling, and iii) availability of information able to prevent any obstacles during the trade.

9. 1. 4. Instructions for Good Manufacturing Practice (GMP)

Instructions for Good Manufacturing Practice (GMP) are typical example of a quality system.

Good Manufacturing Practice (GMP) represents a system of rules for production and quality control of pharmaceutical goods. It is aimed to assure their effectiveness, harmless and quality. Requirements of GMP are created in compliance with internationally approved ISO - 9000 series standards.

Implementation of GMP in pharmaceutical production in Bulgaria is connected with contemporary requirements in medicines' trade. International organisations dealing with medicines frequently require a preliminary check-up of producer. They control implementation and observance of GMP requirements.

Bulgarian version of Instructions for Good Manufacturing Practice in pharmaceutical production is elaborated on the basis of: i) Manual (its new version) on Good Manufacturing Practice of the World Health Organisation, ii) documents of the European Community, and iii) the Convention for mutual recognition of inspections with respect to the pharmaceutical production.

Instructions for GMP are co-ordinated with Bulgarian legislation for pharmaceutical production, but they have not a law force and do not interpret laws concerning pharmacy.

GMP instructions are principals, serving as a basis for adapting to specific conditions of production and control of different medicines. Pharmaceutical goods have to be produced by licensed producers. Producers have to guarantee (by means of following the GMP instructions) production of effective and harmless medicines, conforming with the specification declared at their registration.

GMP is a part of the whole quality system. It is aimed at ensuring production and control of pharmaceutical goods, in accordance with approved quality standards and with requirements raised at their registration. Alternative approaches for quality ensure can be applied, if their validity and equivalence (with GMP instructions) are proved.

9. 1. 5. Rules of Good Laboratory Practice (GLP)

Mutual recognition of laboratory tests, which is a basis for mutual acknowledgement of quality and represents a powerful instrument for international trade enhancement, is an important aspect of laboratories' organising activity.

Risk assessment of chemical substances' usage is a task of particular importance in laboratories' activity. In order to solve this problem, Rules for Good Laboratory Practice (GLP) have been developed and accepted by a special Expert group at the Organisation for Economic Co-operation and Development (OECD). GLP rules regulate the organisation process and conditions of: planning, carrying out, controlling, documenting and reporting laboratory tests.

Comparing fundamental principles of ISO 9003 and GLP rules, it can be seen that both documents place analogical tasks before the management. In both cases the management is obliged to make a program ensuring quality and to guarantee program's realisation by providing necessary staff and resources. GLP rules are more detailed than ISO 9003 due to their specific subject - to regulate protocols for performing physical - chemical and toxicological analyses of specified chemical substances.

GLP rules can be applied for all chemical substances and chemical products, independently of the spread pharmaceutist' opinion that GLP concerns only laboratories investigating medicines. Similar problem's hindering should not be tolerated, especially in light of the new approach for a high quality life. The GLP is required for the classification packaging and labelling of dangerous chemicals (Directive 67/548/EEC)

Laboratory's adaptation to GLP rules requires overhead expenditure - in the range of 15 - 39 % (of usual working expenses). Main part of the additional money needed is for providing up-to-dated laboratory equipment, its testing and maintenance, as well as for improving the organisation of work.

Requirements to the system for laboratories' accreditation will be increased by establishment of GLP rules. In this way, a correct assessment of laboratories' potentialities will be made and laboratories will be given licences authorising them to carry out specific analyses.

At present, laboratories' accreditation according to the GLP is not being realised in Republic of Bulgaria.

9. 1. 6. Differences in Requirements and Mechanisms for Laboratories' Accreditation Between Republic of Bulgaria and Internationally Accepted Procedures

All European countries have accepted (with corresponding specific peculiarities and negligible differences) the following levels of a National Accreditation and Certification System:

• National Council on Accreditation and Certification

• National Association on Accreditation and Certification

• Agency on Accreditation

• Agency on Certification

• Supervision Agencies

• Accredited testing laboratories

• Standards.

Present state of levels of the system on accreditation and certification in Republic of Bulgaria is as it follows:

National Council on Accreditation and Certification is not available. The Committee on Standardisation and Metrology (CSM) undertakes some of functions of an eventual National Council, particularly in their part concerning contacts with European institutions.

At present, the CSM is the central institution for accreditation and certification.

Agencies on Accreditation and Certification in the sense of requirements of European standards (EN 45003 - "General Criteria for Agencies on Accreditation of Testing Laboratories", EN 45011 - "General Criteria for Agencies on Products' Certification", and EN 45012 - "General Criteria for Agencies Certifying Quality Systems") are not available for the time being. Functions of Agencies on Accreditation and Certification are executed by the "Accreditation" department in Central Administration of CSM and by the "Certification" department of the Bulgarian Institute on Standardisation (BIS).

9. 1. 7. Accredited Laboratories

Republic of Bulgaria is close to the European requirements for laboratories' accreditation.

Certificates on compliance with requirements of EN 45001 "General Criteria for the Activity of Testing Laboratories", and of EN 45002 "General Criteria for Assessment of Testing Laboratories " are issued by the "Accreditation" department of CSM.

Most important critical note with respect to laboratories' accreditation is that protocols written out by laboratories are not legitimate on the European market, because our country has not a National Accreditation and Certification System, recognised by the European Community (EC). Furthermore, many of laboratories accredited double their activity.

Main laboratories capable to carry out chemical analyses of different substances are situated in producing enterprises, firms and institutes. For example accredited laboratory at University of Chemical Technology and Metallurgy (UCTM) in Sofia is specialised in analyses of mineral salts and in environment and working place assessment. Laboratory at "Asen Zlatarov" University in Bourgas is specialised in analyses of polymers, organic substances and fuels. Accredited laboratories, conducting tests in the field of industry, are situated mainly at big enterprises and are specialised in corresponding production testing.

9. 2 Overview of Government Information Systems / Computer Capabilities

National Statistical Institute (NSI) is the main Government institution that collects and processes information on chemical' movement in Republic of Bulgaria. Information available in NSI is incomplete and is mainly related to products, produced by different branches of the national industry.

Data base on the import and export of chemical substances is available in the Ministry of Trade and Tourism. Other Government institutions have their own systems for collecting and storing data related to their main activity, for example: sanitation, environment protection, agriculture, energetic, transport, defence, etc.

Systems for information collecting, processing and storing, available at different Government institutions are independently built. Data base is stored mainly in computers. A joint computer network connecting different institutions has not been built. Computers are used for many purposes, not specially for chemicals' management.

Table 9.A - Overview of Laboratory Infrastructure for Regulatory Chemical Analysis

No.	Name/ Description of Laboratory	Location	Equipment/ Analytical Capabilities Available	Purpose
1.	Testing laboratory on analy sis and assess ment of work ing place and environment	University of Chemical Technology and Metallur gy, Sofia, "Kl. Ohridski"bul,8		Qualitative and quantitative analysis of chemicals
2.	"Analysis+"testing laboratory	Ruse	CORY I spectrophotome ter, "Spectra A-10-plus" atomic absorption spectro photometer (AAS), "Vari an-Star" gas chromatograph	air, water, soil, detergents, fertilisers
3.	"Analytical chemistry and microbiology" testing laboratory	"Bulgarian Rose" Joint Stock Company -Plovdiv	"Spekol-11" spectrophotometer, "Kreis DR-286" half-shade polarimeter	raw materials and cosmetics
4.	"Mineral salts" testing laboratory	UCTM - Sofia		qualitative and quantitative analysis of salts
5,	Laboratory for rubber articles testing and textile fibres	"Chimateh" Sole Proprietor Limited (SPLtd.)	"Spekol-11" spectrophotometer, UR-20-Infrared spectrophotometer, "Spekord" UV-VIS spectrophotometer, ozone chamber, Machine for wear testing according to Shoper-Sholbah	rubber and rubber articles, raw materials, charged rubber, vulcanizates
6.	Laboratory for polymers testing	"Asen Zlatarov" University- Bourgas		polyethylene, polypropylene, polystyrene co-polymers, polyvinylchloride, bulex1502
7.	Laboratory for organic products' testing	"Asen Zlatarov" university-Bourgas	"Abbe" refractometer, gas chromatograph with flame-ionised detector	acrylonitrile, acetone, benzene, methanol, butanol, phenol, toluene, organic products
8.	Testing laboratory	"Bulgarian Rose" JSC - Karlovo	"Philips" PV-4550 gas chromatograph, Pye-Unicam gas chromatograph	perfumery and cosmetic goods, raw materials needed, organic and inorganic products
9.	"Fertilisers" testing laboratory	Agropolychim-SPLtd. Devnja	"Philips" PW 9416 ion selective analyser, "Tecator"FIA Star -5020 spectrophotometer, "Perkin Elmer"AAS	fertilisers, organic and inorganic products
10.	Central testing laboratory	"Polymers" SPLtd. -Devnja	"Shimadsu" UV 102-02 spectrophotometer; KPhK-2 photocolourimeter; "Spekol 11" spectrophotometer; VEGA 600, MEGA 5320 and MEGA 5340 gas chromatograps; "Ubelode", "Bruckfield" and "Phord" viscosimeters; "Perkin Elmer" 2100 AAS	polymers, inorganic substances
11.	Testing laboratory	"Devnja-invest" SPLtd.	KPhK-2 photometer, "Perkin Elmer" 2380 AAS	organic and inorganic substances
12.	Testing laboratory	"Agria"JSC - Plovdiv	Gas chromatograph, spectrophotometer	Pesticides
13.	"Pneumatic tires" testing laboratory	"Vidachim" JSC - Vidin	Stands for tires' testing	pneumatic tires
14	Testing laboratory	"Chimateh" STLtd., Iskarsko shose - Sofia	GBS 903 AAS, "Spekol 11" and "Spekord 759 R" spectrophotometers, "Pye-Unicam 304" gas chromatograph	organic and inorganic products
15.	Central testing laboratory	"Lakprom" SPLtd. Svetovrachene, district of Sofia	Device for testing hardness of different paints, "Abbe" refractometer	different paints and raw materials for their preparation
16.	Central testing laboratory	"Sodi" SPLtd. - Devnja	"Spekol 11" spectrophotometer, KPhK-2 photocolourimeter	organic and inorganic substances
17.	Testing laboratory for analyses of fresh and scavenge oil and of asphaltum oil	"Nomat" SPTld. Bourgas	ANALIZ device for determining stability of foaming, devices for determining freezing temperature and flow temperature AAS 1N atomic absorption spectrophotometer	petroleum derivatives and products
18.	Central Scientific Department GSMP	Sofia	"Spekord 75 IR" and "Spekord" UV - VIS spectrophotometers, "Abbe" refractometer	liquid fuels, lubricating oil, lubricants, antifreeze, braking liquid
19.	"Ecology of Black Sea and Danube" testing laboratory	Institute of Water Transport - Varna	"Philips" SP3-200 A infrared spectrophotometer, "Karl Zeiss" UV - VIS spectrophotometer	water, fuels, engine oil
20.	Laboratory for testing petroleum and petroleum products	"Petrol" JSC	UIT-65 device for clear octane determining, "Oxford" AB X3000 X-ray fluorescent spectrophotometer	engine, gaseous, diesel, jet-engine and solid fuel; lubricating oil, lubricants, braking liquid
21.	Complex laboratory for fuel' testing	"Asen Zlatarov" Chemical Technical University Bourgas	Device for determining the fractional composition according to Engler OV-502	Fuels
22.	Testing laboratory	"Trojapharm" JSC	"Abbe" refractometer, "Spekord JR 71" infrared spectrophotometer, "Perkin Elmer" -Sigma 4B gas chromatograph	raw materials for toothpaste, shampoos
23.	Testing laboratory	"Inpako" SPLtd.	"Spekol 11" spectrophotometer, "Abbe" refractometer	washing and cleaning consumer product
24.	Testing laboratory	"Lavena" JSC, Shumen	Gas chromatograph	raw materials for toothpaste, shampoos, essential oil, soaps
25.	"Pleven" petroleum testing complex	"Plama"JSC - Pleven	Infrared spectrophotometer, "Spekord" spectrophotometer	petrol; engine, diesel and boiler oil; motor, bearing, gearing and lubricating oil; oil for aircraft; cutting oil, breaking liquid, antifreeze
26.	"Analytical chemistry and microbiology" testing laboratory	"Alen mak" JSC - Plovdiv	"Spekol 21" spectrophotometer, gas chromatograph with mass detection	raw material for cosmetic and perfumery industry
27.	Testing laboratory	245-tz Unit - Sofia	Device for determining the ignition temperature, devices for determining sulphur content and tar, devices for determining fractional composition according to Engler	petrol, diesel and burning oil, lubricating oil, lubricants, braking liquid, turpentine
28.	"Analytical chemistry" testing laboratory	"Biovet" - Peshtera	"Spekol 11" spectrophotometer, MPM 3000 universal photometer	Water

Note 1: All laboratories shown in Table 9.A are accredited by Body on Accreditation at CSM, according to the Bulgarian State Standards EN 45001 and EN 45002.

Note 2: There are not available (in the Republic of Bulgaria) laboratories, classified according to the Rules for Good Laboratory Practice

9.3 Overview of Technical Training and Education Programmes

Education programmes, aimed at providing the technical expertise required to assess risks in production, import, export, use and deposition of chemicals have been developed at some universities, such as: University of Chemical Technology and Metallurgy - Sofia, "Asen Zlatarov" University - Bourgas, Chemical Faculty of "St. Clement Ohridski" University - Sofia and Medical Universities.

Furthermore, courses on "Environment Protection and Ecology", aimed at increasing specialists' competence to conduct Government programs on environment protection, are delivered at many universities, such as: University of Chemical Technology and Metallurgy - Sofia, "St. Ivan Rilski" University of Mining and Geology - Sofia, "St. Clement Ohridski" Sofia University, University of Forestry - Sofia, Thracian University - Stara Zagora, Technical University - Sofia, Technical University - Varna, "Neophyte Rilski" South - western University - Blagoevgrad, University of Plovdiv, etc.

Postgraduate courses on risk assessment and risk management of dangerous chemicals and hazardous waters according to the USEPA programs are available at the Environmental Management Trining Center - Sofia.

9. 4 Comments / Analyses, Conclusions, Recommendations

Entire technical infrastructure of Republic of Bulgaria is not adequate with respect to the management of chemicals.

9. 4. 1. Laboratory Infrastructure

Bulgarian accredited laboratories are illegitimate for the European Community, as it has been pointed out in 9.1.6. Moreover, the following shortcomings can be specified:

• Principal requirement (of European standards) for independence and impartiality of our accredited laboratories can be seriously questioned.

• Certificates for conformity with European standards are received by laboratories incompatible in respect to their capabilities and competence.

• Claims to competency of accredited laboratories, as far as European Directives, related standards and global approach modules are concerned, are not formulated clearly and equally.

• Doubts can appear as to the necessity of so many accredited laboratories with doubling activity.

Problems above mentioned can be partially solved by accepting Directives of the European Community as legal instruments of our country.

9. 4. 2. Government Information System / Computer Capabilities

It is necessary a united national computer network for chemicals' management to be built on the territory of Republic of Bulgaria. The national computer network has to include all Government departments - ministries, committees and institutes, which deal (directly or indirectly) with data on chemicals' movement. The system has to follow chemicals' movement (debit - production and import; expenditure - use on destination, export, losses, and destruction) and disposal as well as to be able to supply data on current available quantity of chemicals and on possibilities for their management.

Technical insurance of chemicals' information system requires (when enough personal computers are available at creators and users of information on chemicals):

• All institutions interested in chemicals' information system would to be connected with INTERNET. In our opinion, in this way connection between different institutions and their access to open data can be realised with minimum money. Consequently, some computers have to be supplied with an INTERNET modem.
• It is possible to use the Bulgarian variant of e-mail (provided by BULPAK telecommunication company) till all institutions are included in INTERNET.

In this case, programming the e-mail pages to be spread and determining organisations (experts) - recipients represent a very important problem. Consequently, it has to be very precisely defined: i) what is open information; ii) concepts and parameters used. Necessary software preparation for these INTERNET tables has to be done.

9. 4. 3. Overview of Technical Training and Education Programmes

Technical education programs developed at Bulgarian universities provide technical expertise required to implement Government policies and programmes related to chemicals' management and environment protection. It is recommendable post-diploma specialisation and short term training and education courses (aimed at increasing competency of officials working in chemicals' management system) to be developed.

Chapter 10: International Linkages

10.1 Co-operation and Involvement with International Organizations, Bodies and Agreements

During the years of transition, the Republic of Bulgaria maintains a consistent policy for integration to the Europe Union. In correspondence with it, the priorities for active participation in the process "The Outer Environment for Europe" have been established. A sign of this consistence has been the organization of the Third Ministry Pan-European Conference in October 1995 in Sofia. During this period a definite progress has been achieved in the co-operation with the UN and many of its institutions, with the World Bank, Global Ecological Fund, OECD, etc.

Table 10.A - Membership in International Organizations, Programs and Bodies

International organization/ Body/Activity	National Focal Point	Other Ministries /Agencies Involved	Related National Activities
Intergovernmental Forum on Chemical Safety (IFCS)	Ministry of Industry, National Centre of Hygiene, Medical Ecology and Nutrition	Ministry of Environment and Water, Ministry of Agriculture and Forests, Ministry of Health	Development of priority projects for deposited chemical wastes and unused pesticides
UNEP	Ministry of Environment and Water	Ministry of Health, National Statistical Institute, Ministry of Agriculture and Forests	Keep country engagements under UN conventions
IRPTC	Ministry of Environment and Water	Ministry of Industry, Ministry of Health	Fulfillment of a contract on chemical substances management
IE/PAC	Bulgarian Industrial Association, Center for Clean Industry	Ministry of Industry, Ministry of Environment and Water	Implementation of ISO 9000 and 14000 standards
WHO	Ministry of Health	Ministry of Environment and Water	National program - environment and health
FAO	Ministry of Agriculture and Forests	Ministry of Environment and Water, Ministry of Health
UNIDO	Ministry of Environment and Water, Ministry of Industry	National Center on Environment and Sustainable Development	Implementation of initiatives with reduction of air contamination
WTO	Ministry of Trade and Tourism	Ministry of Finances, Ministry of Internal Affairs	Bulgaria was admitted to membership less than one year ago, but negotiations for co-operation are held
IAEA	Committee on the Use of Atomic Energy for Peaceful Purposes	Ministry of Health, Ministry of Environment and Water	Development of projects related to contamination reduction
Regional Economic Commissions	Ministry of Environment and Water	National Center on Environment and Sustainable Development	National program on unleaded gasoline
GEF	Ministry of Environment and Water	Ministry of Industry, Ministry of Finances	National program on discontinuing of cessation the usage of ozone-depleting substances
CEFTA	Ministry of Trade and Tourism	Ministry of Industry	Under negotiations
OECD	Ministry of Internal Affairs	Ministry of Industry, Ministry of Environment and Water	National policy on enhancement of environmental quality
EBRD	Ministry of Finances	Ministry of Industry, C	Projects financing
World Bank	Ministry of Finances	Ministry of Industry, Ministry of Environment and Water	National program on unleaded gasoline and reorganization of productions

Table 10.B - Participation in International Agreements/Procedures Related to Chemical Substances Management

International Agreements	Primary Responsible Agency	Relevant National Activities to be Implemented (Carried out)
Agenda 21 for sustainable development	Interdepartmental council for sustainable development	Several items of the national programme are developed related with the environment and health protection
Montreal Protocol	Ministry of Environment and Water	Inventory is made, a national programme is under implementation
UN recommendations for transportation of chemical substances /London Convention/	Ministry of Environment and Water, Ministry of Health, Ministry of Agriculture	By a Decree of the Council of Ministers dangerous chemical substances are controlled by the responsible offices through permission regime /under preparation for ratifying/
Basel Convention	Ministry of Environment and Water	Law on waste management is passed - September 1997
GATT/WTO - agreements related to chemicals trade	Ministry of Economical Development, Trade and Tourism, Ministry of Industry	Under the signed agreement for accepting Bulgaria in the WTO realization of the taken obligations is forthcoming
Regional contract on economical cooperation of the countries from the Black sea zone	Ministry of Internal Affairs, Ministry of Environment and Water	A plan for region development with accent on environment protection is under preparation
Bilateral contracts with the Republic of Romania, Republic of Greece, Slovak Republic, Poland	Ministry of Environment and Water	Clauses concerning control and permission regime of trade with chemical substances are included

10.2 Participation in Relevant Technical Assistance Projects

The basic strategic materials, developed till now, involving the problems of chemical management in the country are:

• Environment Protection Strategy, elaborated with the assistance of the World Bank and USA in 1992 and modernized in 1994
• National Plan for Environment and Health, which is still in process of development
• Investigation of the State and the Activities on Environment Protection, carried out by OECD in 1996
• Exploration the Hazardous Waste Management in Bulgaria, worked out in 1996 on the base of collaboration with the USEPA, with determined priority projects for realization
• National Program for Decreased Use of Ozone Depleting Substances, on the base of grant assistance in the Global Ecological Fund. Investment projects are in process of development till 1998, complying with the requirements of the Viennese convention
• Strategy of Bulgaria to harmonize the legal instrumentation with those of the European Union.

With the assistance of UNEP a Seminar on the chemicals management has been held with the participation of the government officials from the Ministry of environment and waters. It advanced the introduction of permissible regime for chemicals in the country. At present a contract between The Branch Chamber of Trade Companies of Chemicals’ Producers and the European Association of Chemical Industry is carried out, concerning evaluation of "White Book" influence in the area of chemicals management.

10.3 Analyses and Comments

The developed projects allow to speed up the process of modernization of the legal documents in the country, in correspondence with the requirements of United Nations’ conventions and with the European Union’s directives, orders and regulations. Besides all, our country definitely needs greater financial, scientific and technical support for elaboration of new legal instrumentation in the field of the chemical substances. In the country has no law of chemical substances’ management to determine the main requirements for the producers, consumers and control authorities of the government. The legal acts in force now, are many in number, and often are not clear for the consumers. There is no national register for chemical substances and it is hard to be created in the near future without external support. The legislative base for classification, packaging and labelling of the substances does not meet the requirements of the European and United Nations’ directives. In the conditions of currency board and reduction of government administration, neither the finances nor the stuff would help to solve the chemicals management problem soon. Only by means of effective external support and using the experience of other countries, the period of harmonization of the legal documents and their implementation would be fulfilled in short terms. The existing Interdepartmental Council and the gained experience in developing the present National Profile would help in speeding up the process.

Chapter 11: Awareness/Understanding of Workers and the Public

The sociologist, while examining labor market and social relations noted that in 90-ties a loosening in the heirarchy’s hold has been established, although each country has built up its own structure, dealing with all life important problems of the society. Such problems are the mechanisns providing information for workers and the public about the working conditions, and especially the potential risks related to the production, import, export, handling, use and disposal of chemical subsances. By means of the Labor Code /LC/, the Government garantees health and safety working conditions and obligates the employers to create them.

The working conditions are considered safety if allow to carry out the working process in a way, preserving the physical and psychological human integrity. The working conditions are considered healthy when ensure the normal functions of the human organism. These two requirements are mutually related, act simultaneous, and pursue the same aim - to preserve the life, health, labor efficiency of workers and officers /A 275, Labor Code/.

Specific rules for safety and healthy working conditions are in force in the chemical industry, presented by internal regulations with legal significance. It is necessary to aware the personal with the regulations. This is carried out from one side by means of initial, periodic, extraordinary instructions, and from the other by list of instructions put on a place where available to read for everyone. The employer is obliged to sign particular rules, concerning both the specific working conditions in the company and the safety exploitation of the control and complex installations and devices/A267, LC/. The instructions and training activities of the personal are employer’s responsibilities, too/A281, LC/ who is controlled by the Government /Chief Labor Inspection, Chapter IX, LC/. The procedure of instruction and teaching of workers is determined by Regulation No3 on instructions issued by the Ministry of Labor and Social Cares and published in State Gazette issue 44/96. The instructions involve: INITIAL instruction performed on entrance into the company work, the first working day in the chemical industry; PERIODIC instruction - on every three months for the chemical industry; DAILY instruction - every day for work with very dangerous substances; EMERGENCY instruction - after a fatal accident. The worker or the official in the chemical industry has to pass an examination for safety work and fire protection before admitted to individual work. A special licence No2 is issued for the worker, which is kept in his personal record. The examination takes place periodically, and involves all of the workers and officials, including the secondary and high school graduates.

The relevant contemporary regulations in force are:

1. Regulation No1 concerning working condition passports from the Central Council of Bulgarian Professional Unions /CCBPU/, Ministry of Public Health /MPH/, Labor Committee, published in State Gazette (SG) 32/87, supplemented SG 63/93. The regulation requires determination of: the hazardous sources, exposure assessment, measures for elimination of the harmful and dangerous effects. Collective labor contract determines the continuation of the workday, the annual vacation, the free of charge food, working and special clothes and personal protection equipment.

2. Regulation, concerning complex work assessment, from Ministry of Labor and Social Cares /MLSC/, published in Labor Bulletin, including 10 elements’ assessment in point system. Each point provides at least 0.05% from the minimal salary, even in plants, which are going to be closed.

3. Regulation concerning providing free of charge working and uniform clothes, adopted by Council of Ministers Decree 72 and CCBPU published in SG 8/87, supplemented SG 38/90. The clothes are considered as company inventory. Rules for giving them to workers exit. A compensation of money instead of clothes is not allowed.

4. Regulation No11, concerning providing of special working clothes and personal protective equipment from issued by MLSC and MH, published in SG 66/93.

5. Regulation No286 from Ministry of Public Health and Social Cares, CCBPU, concerning development and approval of new models personal protective equipment, working clothes, shoes, published in SG 18/68, supplemented SG 66/93.

6. Regulation No8 concerning providing of free food for the workers involved in harmful for health processes issued by MH, Labor Committee, CCBPU, published in SG 43/87, SG 58/93).

7. Regulation No3 concerning compulsory preliminary and periodic medical examinations of workers and officials issued by MH, published in SG 16/87, supplemented SG 65/91.

8. Regulation No4 concerning working activities banned for 15-18 years old persons (Labor Committee, MH, CCBPU, published in SG 44/87, amended 44/93). Hard, harmful and dangerous activities mentioned in the enclosed list, headed from mine and chemical industries, are banned for 15-18 years old persons.

9. Regulation No7 concerning harmful and hard activities, banned for women (MLSC, MH, published SG 58/93).

10. Regulation No6 concerning common requirements and obligations providing safety working activities (MLSC, published SG 75/96).

11. Environment Protection Act (Ministry of Environment, published SG 86/91, amended SG 90/91, supplemented SG 100/92, SG 31/95, SG 63/95).

12. Public Health Act (published SG 88/73, amended SG 92/73, SG 63/78, SG 28/83, SG 66/95, SG 27/96, SG 89/88, SG 87/89, SG 99/89, SG 15/91, SG 24/91,

SG 64/93, SG 31/94, SG 36/96).

13. Regulation No1 on Environmental Impact Assessment issued by Ministry of Environment, published in SG 73/95.

14. Council of Ministries Decree 153/06.08.1993 on collection, transport, storage and decontamination of hazardous wastes (published in SG 70/1993).

15. Regulation No41 for joint rules for insurance of healthy work, MH, published SG 100/95.

16. Regulation No14 on Threshold Limit Values (TLV’s) of Harmful Substances in the Ambient Air of the Settlements, issued by MH, published SG 88/97.

17 Limits for the allowable emissions released in the atmosphere, issued by Ministry of Environment, published SG 81/1991, SG 87/1991).

18. Regulation No3 on the TLV’s of dangerous substances in soil, Ministry of Environment, published SG 36/1979, SG 5/96.

19. Regulation No2 on emergency prevention issued by Ministry of Labor, Committee of Quality, published SG 100/1990.

20. Regulation No7 on harmful and hard labor, banned for women (Ministry of Labor and Social Cares and MH, published SG 58/1993).

The chemical industry administrations have developed department regulations on work safety based on the listed above regulations, with detail reviewed in some specific technologies and requirements for operators, technologists and repair teams. At present 21 Regulations on Safety Work /RSW/ are in force:

1. B 01 04 01 RSW on production of ammonium nitrate

2. B 01 04 06 RSW on production of carbamide.

3. B 01 04 16 RSW on production of mineral fertilizers.

4. B 06 00" RSW on production , storage and transport of phosphorus salts.

5. B 01 04 02 RSW on production of plant protective chemicals. There is a new regulation, concerning plant protection chemicals from 1993.

6. B 01 04 03 RSW on production of ammonia.

7. B 01 04 19 RSW on production, storage and transport of hydrogen sulfide.

8. D 01 016 Regulation No. 2 on work safety in production, and working activities with chlorine. A regulation is developed.

9. B 01 04 04 RSW on production of diluted nitric acid.

10. B 01 04 05 RSW on production of sulfuric acid.

11. F06 003 RSW on production, storage and transport of phosphoric acid.

12. B 01 04 08 RSW on production of carbide.

13. B 01 04 08 RSW on production of lead glaze and minium.

14. B 01 04 09 RSW on production of sodium hydroxide.

15. B 01 04 10 RSW on production of fused-soda ash in ammonia method.

16. B 01 04 12 RSW on production of paints and lacquers.

17. B 01 04 13 RSW on plastic processing.

18. B 01 04 14 RSW in oil-refining and petrochemical plants.

19. B 01 04 15 RSW in rubber processing industry.

20. B 01 04 17 RSW in pharmaceutical, microbiological, essential oil and cosmetics industry.

21. B 01 04 18 RSW on production of artificial fibbers.

Till now, the employer has not been in force to consult personnel about his decisions and activities in improving the working conditions. These requirements of the European legislation are elaborated in the law project for working conditions, which is still discussed in the Council of Ministers. These requirements are regulated by the Council of Ministers Decree from 12.03.1997. and have the force of legal document. Two patterns of organization are created. The first is the National Union on Working Conditions, relevant to commercial companies and plants and organizations with personnel over 50 workers and officials. The Union involves workers and employers’ representatives, and employer is the chairman. Experts, control authorities and representatives of non government organizations can take part in these unions. The second pattern is presented by the three members' groups, which refer to smaller companies. The group is represented by the employer, the responsible person on Work Safety and a worker. The unions and groups, established in this manner, discuss the working conditions every month and communicate the problems and the decisions, concerning the evaluation of the risk and the technology changes planned forward. This modern form for providing first hand information for the workers about the working conditions in the company gives the possibility to make relations with non-government and ecology organizations.

The ecology movements and organizations performed great activity in 1990-1991. Their actionshave resulted in strict prescriptions for environment pollution decrease and technology change in the Dimitrovgrad Plant for sulfuric acid production, in the Lead-Zinc Plant near Plovdiv, and in Lead-Zinc Complex in Kaurjali.

The Non-Ferrous Metals Plants investment in ecology and working conditions has achieved decrease in risk and in social tension in the regions. The ecological movements, the local and central press supervised the introduction of pollutant reduction equipment mentioned above. The measurements of the HEI have shown good results and have been published as well. This information has been reported on conferences and seminars. The 170 IOL convention on safety management chemical substances in the production is going to be ratified. A significant number of requirements correspond with the Bulgarian legislation will be enforced. At present the pharmaceutical plants that have received the GMP licenses before three-four years, have working conditions in the plants relevant to the Convention requirements.

The Government goals consist of contemporary transition of society. In this transition period the opinion of the civil organizations and of every citizen will become of more importance for the institutions. Some persons and groups will define and follow up their awareness, competently without the Civil Authorities. The tendencies of increasing information and environmental education in the society present some of the phenomenon in this period, that leads to decrease of the importance of the pyramidal hierarchy structure. The developed societies will be characteristic with horizontal network for management accomplished by non government, local associations of citizens, living near a metallurgy plant or Thermal Power Plant. These organizations will be interested in decrease the risk for the region. They will introduce their requirements in the municipality. Thus, a "joint management approach" will be achieved.

The tasks and the responsibilities of the Government administration in the transition period are:

• To introduce an adequate control and inspection measures, corresponding to the legislation in force, which will guarantee the safety and healthy working conditions and environment protection.
• To create legal instruments as well as technical, economic and tax instruments, necessary for the reconstruction of the industry, including the chemical industry, which will create a clean production. That means providing of safe and healthy working conditions and significant reduction of the environment pollution.
• In all transition stages to give a thorough information to the public about the risk factors in the company and perform public discussion concerning the measures necessary for their prevention.
• To make amendments in the legislation in order to improve the interference of non governmental organizations and reduce the risk problems of working conditions and the ecological problems.

Chapter 12: Resources Available and Needed for Chemicals Management

12.1 Resources Available in Government Ministries/Institutions

Professional staff: The data for the available stuff of professionals, are related to the chemicals management specialists from the following ministries and government institutions: MEW-Ministry of Environment and Waters, National Center of Environment and Sustainable Development (NCESD), MAF- Ministry of Agriculture and Forests, MH (National Center of Hygiene, Medical Ecology and Nutrition - NCHMEN) MLSP- Ministry of Labor and Social Politics, MT- Ministry of Trade and Tourism, MD- Ministry of Defense, MI- Ministry of Industry, MT- Ministry of Transport, CSM- Committee of Standardization and Metrology, NSI- National Statistic Institute. The number of specialists on chemical substances management is presented in:

• units - MEW, MLSP
• departments - MTT
• sections - CSM, NSI
• fields- MD - Civil Protection

The study does not involve the personnel working in the field of the "life-cycle" investigation of chemical substances- production, import, export, storage, transport, distribution, consumption and deposits. The Professional stuff, related with chemicals management in the quoted institutions is presented by high school graduates- doctors of medicine, toxicologists, pharmaceutists, economists, mathematicians, chemists, physicists, biologists, machine engineers, chemical engineers, metal engineers, agricultural chemists. Most of them are qualified, with theoretical and practical experience and have:

• specific knowledge in the field of their activity;
• knowledge in the national and international legislation in the corresponding field of activity;
• knowledge in the international and national practice, in the corresponding field of activity, involving information processing;
• knowledge in foreign languages and computers.

The data of the available number of specialists on chemical substances are regarded to 30.06.1997. The number will probably change in the course of the forthcoming structural reform.

Financial Resources: The available financial resources are calculated on the base of the average year salary for the corresponding institution and the available computer technique used for chemicals management (average price 1000$ per computer). These data are quite relative, especially in the absence of data base for chemicals management in the country. In order to determine more accurately the available financial resources, the whole budget of a certain administration must be divided in the number of the officials. Thus, besides the average year salary some other expanses such as rent, building maintenance, expense for materials, etc. will be involved in the resources. The financial resources are calculated on the base of 1700 leva for 1 $ /30.06.1997/.

Table12.A- Resources available in Government Ministries/Institutions

Ministry /Government Institution	Number of Professional Stuff Involved	Type of Specialists Available	Financial Resources Available, million leva per year
1	2	3	4
MEW Central Department National Center on Environment and Sustainable Development Regional Environment Inspectorates	2   - 16	Experts     Chief specialists	18
MH Department "Health Prophylactics and State Sanitary Control" Regional HEI NCHMEN Department "Toxicology" Department "Labour Protection" Department "Sanitary Chemistry" Department "Nutrition Hygiene" Department "Sanitary Technical Expertise"	4 28 30	Experts Chief specialists Experts and Chief specialists	700
MAF National Service for Plant Protection, Quarantine and Agricultural Chemistry /NSPPQAC/ Central Department Central Control Laboratory for Analyses of Pesticides, Heavy Metals and Nitrates Agrochemical laboratories	2         40   28	Experts Chief specialists	1 150
MLSP Chief Labor Inspectorates Regional Labor Inspectorates	5   31	Inspectors	135
MTT Department "International Control Trade" Department "Register and License of External Government Deal"	5     2	Experts	17
MD- Civil Protection Burgass Varna Lovetch Montana Plovdiv Russe Sofia-city Sofia- region Haskovo	31 88 31 25 88 31 88 10 31	Experts	1 228,8
MI	10	Experts	25
MT	4	Experts	8
CSM Standardization Accreditation Custom Control	6 1 1	Experts Chief specialists	13,5
NSI	10	Experts Chief specialists	23

 12.2 Resources Needed by the Ministries and Government Institutions

Professional stuff: According to the obtained information, in general for activities related to the chemicals management, the government institutions do not need more stuff. Some of them need supplementary personnel, for instance: MTT needs specialist for the section "Chemicals", MEW needs specialists in the Central Department and NCESD, CSM needs specialist in accreditation and custom control. The type and number of needed specialists for NSI to maintain the National Profile for evaluation of the natural infrastructure and chemical managing is the same as quoted in Table12.A-1.

Financial Resources: The data for the financial resources need are within the framework of determined budget for the Government institutions. It involves the average annual salary /on the base of the present salary/, computer and laboratory technique needed, finances for official trips.

The financial resources needed for the NSI are:

• ten man-month power, which means ten average budget salaries
• resources for preparation of special software for the profile and to ensure outputs necessary for the profile- 2 man-month power.
• resources for the preparation of the needed software to input "Economics" data base on a special page for chemicals management in Bulgarian Republic and its distribution on INTERNET /including the currents/.
• resources for hardware to provide connection between the NSI and MEW(or other institution, where the data base for National Profile to Assess the National Infrastructure for Management of Chemicals for evaluation of the national infrastructure for chemicals management is available).

Table12A-1- Data for the NSI

Number of Professional Stuff Involved	Type of the Available Knowledge and Experience	Financial Resources Available per year
10 persons from the sections: - Environment Statistics; - Industry Statistics; - Agriculture, Forest and Fish Industry Statistics; - National Material Balances; - Classifications and Nomenclatures; - Information Services; - National Statistic Archives.	-education- as a rule- high graduates in Economics specific knowledge in the corresponding field of statistics; knowledge in the national and international standards, classifications and nomenclatures in the field of statistics; knowledge in statistic practice; knowledge in the international statistic practice: methodology and directions in linkages’ development and co-ordination of the statistic examinations in different aspects of economy and knowledge	if the tasks of the National Profile for chemical management are involved in the NSI program, approved by the Parliament: need of co-ordination between the institutions and financing from the government budget if the tasks are not provided for the profile, then financing of the following directions: 10 man-month powers need for technical devices for connection with INTERNET and building up a connection with MEW or another agency, maintaining the profile; initially resources for software -for the needed supplementary processing of the statistic information

For specialists, maintaining the National Profile to Assess the National Infrastructure for Management of Chemicals, we offer training in the future from the NSI in order to provide correct and simple management of the statistic information, groups and combinations defined by the national and international classification and nomenclatures.

It is necessary to undertake measures to keep the qualified personnel such as increase in salary, good motivation.

The resources for providing the needed statistic information for the National Profile for Evaluation of the National Infrastructure for chemical management can be arranged in the following groups:

• Obtaining information from the existing statistic examinations of the profile: concerning the general data of the country and the chemical product demand.

• Comparing the information of the different sections, providing range and statistic meters, corresponding to those presented in the tables. Evaluation of the range according to the national and international classifications and nomenclatures.

• Preparing outputs appropriate to the profile needs.

For specialists maintaining the National Profile, the Department "Toxicology" offers training in Risk Assessment, Risk Management and Risk Communication.

Table12.B - Resources Needed in Government Institutions

Ministry /Government Institution	Professional Stuff Needed in number	Financial Resources Needed in million leva per year
MEW	20	25
MH	20	25
MAF	38	47.5
MLSP	36	152.5
MTT	8	21
MD-Civil Protection	15	20
MI	10	30
MT	4	13
CSM	10	17.5
NSI	10

Table 12.B-1- Requirements for Training

Ministry	Requirements for training
MEW	Harmonization of the existing legal base with the European Acts International register of potentially dangerous chemical substances Risk Assessment, Risk Management and Risk Communication Laboratory control
MH	Harmonization of the existing legal base with the European Acts International register of potentially dangerous chemical substances Risk Assessment, Risk Management, Risk Communication Chemical Emergency Prevention Laboratory control
MAF	Biology and Toxicology Tests for Pesticides: Risk Assessment and Risk Management Plant protection Agricultural Chemistry
MLSP	Law of Working Conditions /project/ European Union’s directives for health promotion and safety at work IOL convention
MTT	Courses in marketing and foreign economical activities
MD-Civil Protection	Special training for work with chemical substances including chemical emergency prevention and chemical emergency response
MI	Improvement of the professional, computer and language qualification Acquirement of the advanced countries’ experience
CSM	Seminars on control of the movement of chemical substances
NSI	Studding the indexes, by which information for National Profile to Assess the National Infrastructure for Management of Chemicals chemicals management is provided: Risk Assessment and Risk Management Definition of the common features and the peculiarities between our practice and the international practice in the field of statistic examinations

12.3 Analyses

The data for the available and needed professional and financial resources from the government institutions show that the number of specialists in chemicals management is defined to a certain degree, and do not need extend in this field. The creation of National Profile to Assess the National Infrastructure for Management of Chemicals for Evaluation of the National Infrastructure for Chemical Management will find whether the ascertained resources in the field are adequate /sufficient and appropriate/.

At present, financing the government administration activities is in the framework of the government budget. It is necessary to look for other financial sources in a manner to stimulate the available human resources in chemicals management. Such model is the augmentation in the general financial politics in order to use the possibilities of the internal financing. It is important to create independent, financially provided and equipped laboratories, providing control on the chemical substances.

Different non government organizations can aid the Government efforts in chemicals management, regarding to the possibilities for examination, which includes:

• possibilities for data acquirement, processing and preservation;
• testing of different chemicals;
• evaluation of the risk;
• decrease of the risk;
• providing training programs for chemicals management;
• possibilities for analyses of the government politics in this field;
• investigation activities for finding ecological substitutes;
• monitoring and distribution of important information to the key employment sections and to the public;
• raising the public awareness for team work for the resolution of the regional problems due to environmental pollution.

The non-government institutions have adequate possibilities for co-operation between them and with the Government institutions in the realizations of plans and tasks in the routine chemicals management.

Providing additional financial resources is necessary for:

• preparation of special software for the National Profile to Assess the National Infrastructure for Management of Chemicals for Evaluation of the National Infrastructure for Chemical Management for input of the data base;
• preparation of the needed software to switch on the data base "Economics" in the NSI on special page for chemicals management in Bulgaria and its distribution in INTERNET, including the currents; building up a connection between the Government institutions and MEW /or other institution/ where the data base input is accomplished for the , National Profile to Assess the National Infrastructure for Management of Chemicals for Evaluation of the National Infrastructure for Chemical Management training of the profile specialists in correct and simple usage of the statistic information, groups and combinations, defined by the national and international classifications and nomenclatures by the NSI.
• Assumption of relevant information of the European legislation and the practice of its implementation in the field of chemicals management.

To accomplish the tasks of chemicals management for the needed human resources and the listed above definite tasks, some further activities have to be financed:

• amendment of the legislation, concerning the full "life-cycle" of the chemical substances;
• training in chemicals management;
• risk assessment, risk management and risk communication in the health and ecology problems posed by chemicals;
• strengthening of the import control;
• investigation activities on trying to find healthy and ecological substitutes;
• laboratory control maintenance.

ANNEXES

Annex I - Glossary