Ministry of Science and Environmental Protection of Republic of Serbia

Directorate for Environmental Protection

DRAFT LAW ON CHEMICALS

-working paper -

Belgrade, April 2005.

GENERAL PROVISIONS

Article 1.

This act regulates conditions of production, use and placing on the market of chemicals, and especially: classification, packaging and labelling of chemicals; Good Laboratory Practice; Inventory of chemicals; Register of chemicals; notification of new chemical substances; existing chemical substances; risk assessment of chemical substances; bans; permits for use of chemicals; export and import; register of persons and inspection surveillance in order to ensure protection of human life and health and environment.

Article 2.

Expressions used in this article are defined as follows:

  1. chemical is chemical substance and chemical preparation;
  1. chemical substance is chemical element or compounds thereof in the natural state or obtained in any production process, including any additives required to maintain their stability, and impurities whose presence cannot be avoided owing to the production procedure used. This term shall also apply to polymeric substances, and solutions of substances from which the removal of the solvent would cause a chemical change in the substance or would affect its existence (hereinafter: substance);
  1. polymeric substances are substances composed of molecules which typically consist of a sequence of one or more types of monomer units, the vast majority of which contain at least three monomer units covalently bonded among themselves or to one or more different monomers or other reactants, and the majority of which have the same molecular mass. The molecular masses of polymeric substances may be distributed inside such a region that differences between them may be principally attributed to differences in the number of monomer units present. In this sense the term “monomer unit” shall mean a monomer in reacted form within a polymer;
  1. chemical preparations are mixtures and solutions composed of two or more substances (hereinafter: preparations);
  1. explosive chemicals are chemicals in solid, liquid, pasty or gelatinous form that can react exothermically, even in the absence of atmospheric oxygen, thereby quickly evolving gases that under specific conditions detonate, burn rapidly or owing to heating or increasing pressure explode if they are confined spatially.
  1. oxidizing chemicals are chemicals that cause strongly exothermic reactions when in contact with other substances, and particularly flammable materials;
  1. extremely flammable chemicals are liquid chemicals with an extremely low flash point and low boiling point, and gaseous chemicals that are flammable in contact with air at ambient temperature and pressure;
  1. highly flammable chemicals are:

- chemicals that in contact with air can heat up and catch fire of their own accord at ambient temperature and pressure without external supply of energy;

- solid chemicals that can rapidly catch fire after brief contact with a source of ignition and then burn on and consume themselves following the removal of such a source;

- liquid chemicals having a very low flash point;

- chemicals that in contact with water or damp air can evolve dangerous quantities of flammable gases;

  1. flammable chemicals are chemicals having a low flash point;
  1. very toxic chemicals are chemicals that when ingested, inhaled or absorbed via the skin in minute quantities cause death or acute or chronic damage to health;
  1. toxic chemicals are chemicals that when ingested, inhaled or absorbed via the skin in small quantities cause death or acute or chronic damage to health;
  1. harmful chemicals are chemicals that when ingested, inhaled or absorbed via the skin can cause death or acute or chronic damage to health;
  1. corrosive chemicals are chemicals that in contact with living tissue can damage or destroy it;
  1. irritant chemicals are chemicals that are not corrosive which through immediate, prolonged or repeated contact with the skin or mucous membranes may cause inflammation;
  1. sensitising chemicals are chemicals that when ingested, inhaled or absorbed via the skin can cause a sensitising reaction in such a way that further exposure causes the onset of distinctive negative effects;
  1. carcinogenic chemicals are chemicals that when ingested, inhaled or if they penetrate the skin can cause cancer or increase its incidence;
  1. mutagenic chemicals are chemicals that when ingested, inhaled or if they penetrate the skin can cause genetic mutation or increase its incidence;
  1. chemicals which are toxic for reproduction are chemicals which, if they are ingested or inhaled or if they penetrate the skin can cause or increase the incidence of, non-heritable adverse effects in the progeny and/or adverse effects in male or female reproductive functions or capacity;
  1. chemicals dangerous for the environment are chemicals which, were they enter the environment, would cause or may cause an immediate or delayed danger for one or more components of the environment;

20. CASnumber is the characteristic number of a substance already invented according to the Chemical Abstracts Service list;

  1. production of chemicals is acquisition, manufacture and final processing, treatment, processing, packaging, pouring over and mixing of chemicals to form intermediate or final products via chemical, physical or biological processes and procedures, and their transport within a production plant (hereinafter: production);
  1. professional use of a chemical is any use of a chemical for the purpose of engaging in business activity;
  1. dangerous substances with harmonized classification and labelling in EU are substances included in Annex I of Directive 67/548/EEC;
  1. scientific research and development means scientific experimentation, analysis or chemical research carried out under controlled conditions; it includes the determination of intrinsic properties, performance and efficacy as well as scientific investigation related to product development;
  1. process-orientated research and development means the further development of a substance in the course of which pilot facilities or production trials are used to test the fields of application of the substance;
  1. placing on the market means supplying or making available to third persons, either in return for payment or free of charge;
  1. chemical name according to IUPAC nomenclature is name of chemical as identified in nomenclature of International Union of Pure and Applied Chemistry;
  1. EINESC list is European Inventory of Existing Commercial Substances which contains substances which are placed on the market of EU between 1. January 1971. and 18. September 1981;
  1. ELINCS list is European List of Notified Commercial Substances which is managed by European Commission and which contains new substances produced by certain producer and notified to competent authority of member country;
  1. Substances in procedure for inclusion in ELINCS list are substances which are notified to competent authority of member country, but still not included into ELINCS list.

Article 3.

The provisions of this act shall not apply to:

  1. following chemicals as final products:

-remedies for human and veterinary use;

-food and products and substances which come into contact with food;

-cosmetic products;

-illicit drugs and other means that cause addiction;

-fodder;

-ammunitions and explosives;

-plant protection products;

-mineral fertilisers;

-biocides.

  1. transport of dangerous chemicals;
  1. radioactive materials.

Notwithstanding the point 1. paragraph 1. of this article, to all chemicals shall apply provisions of this act regulating:

-good laboratory practice, the use of data acquired by testing on vertebral animals, the collecting, arranging and forwarding of data on poisonings and effects of chemicals and temporary measures.

Notwithstanding the point 1. paragraph 1. of this article, to plant protection products and biocides shall apply provisions of this act regulating:

-classification, labelling and packaging as well as prior informed consent procedure for export and import.

The provisions of this Act on classification and labelling shall apply to waste.

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Article 4.

The provisions of this Act shall apply to:

-production and trade of chemical weapons and precursors for chemical weapons in so far as they are not covered by a separate act;

-production and trade of precursors for drugs and psychotropic substances in so far as they are not covered by a separate act.

CLASSIFICATION, PACKING AND LABELLING

Article 5.

According to assessment of dangers affecting human life and health or environment, shall be made a classification of chemicals depending on their physical and chemical characteristics which affect human life and health, and according to characteristics which affect environment.

Depending on physical and chemical characteristics, chemicals are classified in following categories:

1)explosive;

2)oxidizing;

3)extremely flammable;

4)highly flammable;

5)flammable.

Depending on characteristics which affect human life and health, chemicals are classified into following categories:

1)very toxic;

2)toxic;

3)harmful;

4)corrosive;

5)irritant;

6)sensitizing;

7)carcinogenic;

8)mutagenic;

9)toxic for reproduction.

Depending on characteristics affecting environment, chemicals are classified in the following category:

1)dangerous for environment.

Chemicals classified at least in one of categories from paragraph 2-4. of this article are dangerous substances and preparations.

Article 6.

Before placing it on the market, a producer or an importer of a substance or a preparation is obliged to classify it.

The classification of a substance shall be done in accordance with classification of substancewith same chemical composition from List of classified substances.

If a substance is not on the list from paragraph 2. of this article, the classification shall be carried out on the basis of:

1)results gained through a substance characteristics testing;

2)the analysis of existing data.

The classification of preparations shall be carried out as follows:

1)through calculating methods;

2)through direct experimental establishment of characteristics affecting human life and health, in accordance with regulation actions and measures;

3)checking through existing information about characteristics of the substances within a preparation.

Toxicological and ecotoxicological studies and tests on basis of which is carried out classification should be performed in accordance with principles of Good Laboratory Practice.

Testing of substances and preparation shall be carried out in accordance with rules concerning tests on vertebrate animals set up in articles 45.-47. of this Law.

A producer or an importer is obliged to submit data used for classification of the chemicals if asked so by competent authority, as well as to keep them all the time while the chemicals are on the market and three years after the last placing thereof.

The minister prescribes the methods of research and the way of classification of chemicals.

Article 7.

Chemicals classified as dangerous ones may be advertised only if that advertising does draw attention to their dangerous characteristics, and in a such a manner that does not make confusion about dangerous properties of chemical.

Packing and labelling

Article 8.

A producer or an importer is obliged to pack and label the chemical which is being placed on the market in accordance with provisions of this Law and regulations made on its basis.

Producer or and importer is obliged to, when place on the market, label, in accordance with this Act and regulations on its base, certain products which contains dangerous chemicals.

Minister shall prescribe list of products which have to be labelled in accordance with provision of paragraph 2. of this article.

Exceptionally to paragraph 1. of this article the exporter is obliged to pack and label the chemical that is being exported in accordance with regulations of a country which is the importer, if those regulations are opposite to the provisions on packing and labelling of this Law and regulations made on its basis.

Article 9.

The package must be appropriate to dangerous properties of the chemical as well as to its purpose and way of use.

The label on the package of dangerous chemicals must particularly contain the trade name of the chemical, names of certain dangerous substances within the preparation, the name and address of the producer or the importer, the mark of danger, mark of warning (R phrase), mark of information (S phrase), quantity of chemical, information about the procedures of handling with packaging waste and leftovers of the chemical.

Producer, importer or person which place dangerous chemical on the market as product for general use, is obliged to provide to consumer, instructions for proper use, safety and health at work, measures of first aid, as well as instructions for handling with leftovers of dangerous chemicals and empty packaging of dangerous chemicals.

The packages with dangerous chemicals must be labelled in Serbian language.

Certain chemicals must be in packages with child-resistant fastening and tactile warning to people with special needs.

Containers, tanks and storages where dangerous chemicals are kept as well as pipelines for dangerous chemicals must be labelled in accordance with provisions of this Act and regulations on its base.

The minister prescribes the way of packing, labelling and advertisement of chemicals depending on their classification.

Article 10.

A producer or an importer is obliged, when placing dangerous chemicals on the market, to supply safety data sheet in Serbian language.

Safety data sheet particularly contains summarized data about the producer or the importer, data about the danger of a substance or a preparation; measures for protection of human life and health, safety measures at work, measures for environmental protection as well as date of issuing of SDS.

The minister prescribes the contents of the safety data sheet.

Article 11.

The producer, the importer or the distributor is obliged to supply safety data sheet to:

  1. every professional user when providing dangerous chemicals for the first time;
  1. at a request of any professional user:

1)when providing a chemical for the first time, provided that the chemical is not classified as dangerous one but contains a dangerous substanceat least 1% of weight for solid or liquid preparations, i.e. at least 0,2% of volume of gaseous preparation;

2)when providing a chemical for the first time, provided that the chemical is not classified as dangerous one but contains a chemicals for which regulations about limit quantities for exposure at work place have been prescribedat least 1% of weight for solid or liquid preparations, i.e. at least 0,2% of volume of gaseous preparation.

The producer, the importer or the distributor is obliged to supply safety data sheet free of charge.

Article 12.

The producer or importer from the Article 10 of this Law is obliged to make changes and supplements to the safety data sheet in accordance with new acknowledgements about the chemical.

Produce, importer of distributor is obliged, when changes and supplements to SDS are made, to submit it to every professional user to whom chemical is been delivered in previous 12 months.

The person from paragraph 1. of this article or importer is obliged to supply safety data sheet to the authority in charge of chemicals management before first placement on the market or when the changes in the safety data sheet have been made.

Article 13.

Persons which use dangerous chemicals are obliged to follow instructions for proper use, safety and health at work, measures of first aid, instructions for handling with leftovers of dangerous chemicals and empty packaging of dangerous chemicals, as well as measures for protection of environment from SDS.

Article 14.

The Minister in charge of chemicals management authorizes laboratories which can control whether the packaging of chemicals is appropriate for its dangerous properties, in accordance with the provisions of this Law and with regulations made on its basis (hereinafter: “authorized laboratories”).

The authorized laboratories from paragraph 1. of this article can also perform analysis of the samples taken by the inspector during inspection supervision.

The authorized laboratories must be independent and must fulfil the requirements regarding the equipment, competence and quality system.

Further requirements which must be fulfilled by the authorized laboratories as well as the way of gaining the authorization are prescribed by the minister.

GOOD LABORATORY PRACTICE

Article 15.

Non–clinical testing of a chemicals, whose results facilitate evaluation of their potential dangers for human life and health or environment and which are used in procedures for placing them on the market or use them, in registration procedures, in notification procedures, in licensing procedures, is carried out in accordance with the principles of good laboratory practice (hereinafter “GLP”).

Competent authority for chemicals management issues a certificate on compliance with the principles with GLP (hereinafter “GLP certificate”).

The minister prescribes the regulations on the principles of GLP and GLP certificate form.

Article 16.

The compliance of work of laboratory with GLP principles is verified in the process of inspection.

The inspection from paragraph 1. of this article is carried out by evaluators.

The GLP evaluators must fulfil the conditions regarding their competence, work experience and other prescribed requirements and they must have an authorization of the minister in charge of chemicals management.

The minister prescribes further conditions that must be fulfilled by GLP evaluators.

Article 17.

The laboratory submits a request for the inspection to the competent authority for chemicals management.

The request contains the name and address of the legal person, name and address of the laboratory, name and address of the responsible person in the laboratory, as well as all categories of chemicals which are going to be tested and types of testing in the laboratory.

Article 18.

Verification of compliance with the principles of GLP conveys the following types of inspection:

  1. basic inspection – done in order to issue a GLP certificate;
  2. periodical inspection – done every second year in order to check the compliance with the principles of GLP;
  3. special inspection – done if required so by competent authority which requires a GLP certificate for the registration or notification procedure or issuing of licence for placing on the market of chemical;
  4. extra inspection.

Inspection from paragraph 1. of this article comprises the inspection of a laboratory or the control of already done studies whose results facilitate the assessment of danger chemicals for people and environment (hereinafter “the studies”) and current studies.

The minister prescribes the procedure and the contents of the inspection.

Article 19.

During the inspection of laboratories the GLP evaluator is obliged to present the authorization of the minister in charge of chemicals management to the responsible person in the laboratory.