CHEMICALS ACT("Off. Herald of RS", Nos. 36/2009, 88/2010, 92/2011, 93/2012 and 25/2015) |
Article 1
This Act regulates integrated management of chemicals; classification, packaging and labeling of chemicals, the integral registry of chemicals and the registry of chemicals placed on the market, restrictions and ban on production, placing on the market and use of chemicals, import and export of certain hazardous chemicals, permits for trade and permits for use of particularly hazardous chemicals, placing detergents on the market, systematic supervision of chemicals, availability of data, monitoring, and other issues relevant for managing chemicals.
Article 2
The Act is based on the principle of precaution and the principle that the manufacturer, importer and downstream user produce, place on the market and use chemicals in such a manner that there is no adverse effect upon human health and environment.
Article 3
Certain terms in this Act have the following meaning:
1) Downstream user is a legal person or sole trader with headquarters on the territory of the Republic of Serbia, other than the manufacturer of the substance or the importer of the chemical, who uses the substance or the substance contained in a mixture for industrial or professional purposes, including also the person who manufacturers the mixture. The distributor and consumer are not considered to be the downstream user;
2) Detergent is a substance or mixture which contains soaps, i.e. other surfactants, which is used for washing and cleaning purposes. Detergents include also supplementary mixtures intended for washing purposes (prewashing, rinsing or bleaching of clothes), fabric softeners, mixtures for other cleaning purposes and similar products;
3) Distributor is a legal person or sole trader with headquarters on the territory of the Republic of Serbia, who stores chemicals or places them on the market:
4) Good laboratory practice is a laboratory practice which is carried out in compliance with the principles (guidelines) stipulated by legislation which regulates medicines and medical devices;
5) Scientific research and development is a scientific experimentation, analysis or research of chemicals conducted under controlled conditions;
5a) Recall is an activity or measure aimed at achieving the return of a product or chemical that has already been delivered by a manufacturer i.e. distributor, or which has already been available to consumers i.e. downstream users;
5b) Withdrawal is an activity or measure aimed at preventing further distribution or making available of a chemical or product that has been put into circulation;
6) Complete aerobic biodegradability is such level of biodegradability in which the surfactant with the aid of microorganisms in the presence of oxygen is completely degraded to carbon dioxide, water and mineral salts (mineralization);
7) Washing is washing of laundry, dishes and hard surfaces;
8) Primary biodegradability is a structural change (transformation) of the surfactant under the influence of microorganisms, causing loss of its capability of surface activity due to the degrading of its structure;
9) Product is an object which during production is given a special shape or design which determine its function more than its chemical composition;
10) Production is a production or extraction of substances in their natural state;
11) Manufacturer is a legal person or sole trader which produces a substance;
12) Handling is production, processing, packing, storing, trading, transportation and use of chemicals or any other activity related to chemicals;
13) Mixture is a mixture or solution of two or more substances;
14) Supplier is a legal person or sole trader who is the manufacturer, importer, distributor or downstream user, who places the chemicals on the market;
15) Placing on the market is supplying or making chemicals accessible to third parties in the territory of the Republic of Serbia, either for a compensation or without compensation, whereas the import is also considered to be placing on the market;
16) Substance is a chemical element and its compounds in natural shape or obtained by a production process, including additives necessary to preserve its stability and impurities arising from the applied production process, excluding any solvent which can be separated in a manner that will not affect the stability of the substance or change its composition;
17) Surfactant is an organic substance i.e. mixture which has surface-active properties, and which contains one or more hydrophilic and hydrophobic groups which are capable of reducing surface tension of water by forming a spread or adsorbing monolayer at the water-air interface and creating an emulsion i.e. micro-emulsion, i.e. micelles, as well as to be adsorbed at water-solid interface;
18) Exposure scenario is a set of conditions and measures, including conditions at the workplace, by which risk is managed and which describe how the substance is manufactured or used during its life-cycle, how the manufacturer or importer can control it, which give recommendations to the downstream user how to control the substance when humans and the environment are exposed to it, whereas the recommendation can relate to one specific process or manner of use, or to several processes or ways in which the substance is used;
19) Chemical name according to IUPAC nomenclature is the name of the chemical identified in the nomenclature of the International Union of Pure and Applied Chemistry - IUPAC;
20) Chemical is a substance and mixture;
20a) Chemical and product intended for general use is an item of general use in terms of the legislation governing health safety of items of general use;
21) Cleaning equals the definition of this term as contained in the standard SRPS ISO 862.
2. Exceptions from Application
Article 4
Provisions of this Act do not apply to:
1. Radioactive chemicals;
2. Chemicals in transit;
3. Transportation of hazardous chemicals.
Provisions of this Act do not apply to chemicals which are:
1. Considered to be waste pursuant to provisions of the legislation that regulates waste management;
2. Under customs supervision within the customs warehouse or free zones for reasons of re-exporting or transit if the chemicals are not processed or treated on the spot.
Provisions of this Act which relate to the registration of chemicals with the Registry of Chemicals and the registration of substances which cause concern into the Registry of chemicals do not apply to chemicals which in their final form are placed on the market as:
1. Biocide products;
2. Plant protection products;
3. Medications and medical devices for use in human and veterinary medicine;
4. Cosmetic products;
5. Food, alimentary additives and aromas;
6. Animal food and additives thereto.
Provisions of this Act related to classification, packaging and labeling of chemicals do not apply to chemicals:
1. Which are used for scientific research and development and are not placed on the market, and are used under controlled conditions in which exposure is reduced,
2. Which in their final form are placed on the market as:
- Medicines and medical devices used in human or veterinary medicine;
- Cosmetic products;
- Food, alimentary additives and aromas;
- Animal nutrition and additives thereto.
Provisions of this Act set forth in Chapter VIII which relate to the import and export of certain hazardous chemicals do not apply to:
1. Chemical weapons and precursors for chemical weapons;
2. Precursors for narcotics and psychotropic substances;
3. Food and alimentary additives;
4. Animal food and additives thereto;
5. Medicines used in human and veterinary medicine;
6. Chemicals which are used for purposes of scientific research and development in quantities which do not affect human health and the environment, and do not exceed 10kg for each chemical per each import;
II COMPETENCES OF THE MINISTRY COMPETENT FOR ENVIRONMENTAL PROTECTION
Article 5
The ministry competent for environmental protection provides the conditions for quality, efficient and safe management of chemicals and biocidal products.
Article 6
The ministry competent for environmental protection is in charge of:
1. Adoption of secondary legislation for implementation of the Chemicals Act and the Biocide Products Act;
2. Establishing the List of Classified Substances;
3. Passing of decisions on registration of chemicals with the Registry of Chemicals and keeping this Registry;
4. Keeping the Integral Registry of Chemicals;
5. Declaring the List of Substances which Cause Concern;
6. Implementing the procedure of prior notification and the procedure of getting consent on the basis of prior notification for export and import of certain hazardous chemicals;
7. Issuing permits for conducting trade of particularly hazardous chemicals;
8. Issuing approvals for the use of surfactants in the detergent;
9. Drafting and implementing the projects which monitor whether the chemicals are placed on the market and used in such a way as not to have adverse effects upon human health, the environment and property;
10. Declaring the lists of active substances in a biocide product;
11. Passing decisions on the registration of a biocide product with the Provisional List for the Submission of the Technical Dossier;
12. Issuing approvals for placing a biocide product on the market;
13. Taking care of the assessment of the technical dossier of a biocide product;
14. Preparing annual declarations on the production, processing and use of chemicals from lists stipulated by a legislation which regulates the ban on development, production, stockpiling and use of chemical weapons and destruction thereof, as well as annual declarations on the production of discrete organic substances and performing other activities pursuant to this legislation;
15. Performing expert and administrative and technical activities for the needs of the Common Body for Integrated Chemicals Management;
16. Providing information and expert instructions to economic entities, units of local self-government and inspectors for implementation of legislation in the field of chemicals and biocide products management, as well as to provide professional assessment of the properties and intended use of certain chemicals;
17. Establishing cooperation with the European Chemicals Agency, agencies of other countries and secretariats of international conventions which regulate the management of chemicals and other international organizations which deal with different aspects of chemicals management;
18. Carrying out activities whereby the public is informed about the impact of chemicals upon human health and the environment, measures for risk reduction and safe use of chemicals;
19. Performing other activities established by this Act, legislation which regulates biocide products, and other legislation.
III INTEGRATED MANAGEMENT OF CHEMICALS
Article 7
In order to achieve principles of strategic approach to chemicals management, and to ensure adequate chemicals management in all phases of chemicals’ life-cycle from production, i.e. import, to disposal, as well as in order to contribute to sustainable development of the Republic of Serbia, the minister competent for the environment (hereinafter: Minister), pursuant to rules which regulate the state administration, establish by his decision the Common Body for Integrated Chemicals Management (hereinafter: Common Body).
The Common Body is made of representatives of relevant government bodies in the field of chemical management, industry, scientific research organizations, and non- governmental organizations.
The ministry competent for environmental protection performs expert and administrative-technical activities for the needs of the Common Body.
The task of the Common Body is to prepare the Integrated Chemicals Management Program and action plans for implementation thereof, as well as to follow the realization of the program and action plans and to coordinate activities which are related to safe chemicals management.
The Integrated Chemicals Management Program is adopted by the Government.
Article 8
A legal and natural person who handles the chemicals should undertake necessary measures in order to deter or avoid adverse effect of chemicals upon human health, the environment and property.
The manufacturer, importer or downstream user who places a chemical on the market assesses the dangerous properties of that chemical prior to its placement on the market and notifies thereof other legal and natural persons so that they could handle the chemical safely.
The manufacturer, importer and others who handle the hazardous chemical should replace it by a safer alternative whenever this is possible, i.e. when socio-economic reasons and technical possibilities allow this.
IV CLASSIFICATION, PACKAGING, LABELING AND STORING OF CHEMICALS
1. General Provisions on Classification, Packaging and Labeling
Article 9
The manufacturer, importer and downstream user who place chemicals and certain products on the market must categorize them, and the supplier of chemicals must label them and pack them pursuant to this Act and subsequent bylaws.
The exporter must pack and label the chemical for export pursuant to this Act and subsequent bylaws, unless it is necessary to pack and label the chemical in another way, pursuant to international standards, and the importing country requires it to be done.
Article 10
Classification of a chemical and a certain product is made on the basis of an assessment of their physical and chemical properties, properties which affect human life and health, properties which affect the environment, as well as criteria established for their classification into certain hazardous categories.
A hazardous chemical is a chemical which can be classified into at least one of the hazardous categories.
Within the hazardous categories the chemical can be further categorized in different ways depending on the path of exposure of people and environment to this chemical or on the basis of the nature of its effects.
The ministry competent for environmental protection defines in more detail the method by which a chemical or a certain product is classified.
Article 11
A substance is classified pursuant to the classification of the substance with the identical chemical composition from the List of Classified Substances.
If a substance is not listed in the List of Classified Substances or is not classified within this List in all hazardous categories and varieties within these categories, its classification is made on the basis of already existing data on the properties of that substance, i.e. on the basis of results of new researches of its properties and by comparing these data, i.e. results, with criteria established for the classification of the chemical.
The ministry competent for environmental protection adopts the List of Classified Substances.
Article 12
Mixtures are classified by estimating their hazard on the basis of data related to the properties of substances contained in the mixture, on the basis of analysis of existing data related to the hazard of the mixture, i.e. on the basis of direct experimental research of the properties of the mixture, and by comparing these data, i.e. results, with established criteria for classification of the chemical.
Article 13
For the classification of chemicals use can be made of data contained in epidemiological studies, statistical data on professional diseases, i.e. data on the effect of the chemical upon people when exposed in the case of chemical accidents, as well as data acquired by other internationally recognized methods for identifying chemicals' properties.
Evidence of a chemical's hazardous effect that is collected in research on animals are used for classification, regardless of the lack of findings on the effects upon humans in the studies referred to in paragraph 1 of this Article.
For classification purposes the properties of a chemical are identified in regard to the form, i.e. physical condition in which the chemical is placed on the market, and in special cases for the form, i.e. physical condition, in which the chemical is used.
Article 14
New research of a chemical for the purpose of classification should be conducted in such a manner as to avoid, whenever possible, experiments which include vertebrate animals.
It is prohibited to conduct research on primates in order to classify a chemical.
Article 15
New research of a chemical for the purpose of its classification is carried out pursuant to prescribed methods.
Toxicological and eco-toxicological research is conducted in laboratories whose work is harmonized with the principles of good laboratory practice.
The ministry competent for environmental protection prescribes the methods for the examination of hazardous properties of substances.
4. Packaging, Labeling, Advertising and Recording of Data
Article 16
The packaging for a hazardous chemical and a certain product must correspond to the properties, purpose and manner of use of a chemical or a product and must be labeled in a prescribed way.
The packaging for a hazardous chemical, a certain product and a certain mixture which is not hazardous but contains at least one substance which has been classified as hazardous, must be labeled in such a way as to contain particularly the trade mark of the chemical, the names of certain hazardous substances contained in the mixture, the name and address of the supplier of the chemical, the quantity of the chemical in the packaging, as well as graphic symbols, labels and text which indicate the hazardous properties of the chemical.
The packaging for a chemical and a certain product must be labeled in the Serbian language too.
A certain hazardous chemical must be labeled in such a manner as to enable handicapped persons to identify the hazard, and the package of a given hazardous chemical must have a safety cup which makes it difficult for children to open it.
The way of labeling and packaging of a hazardous chemical depends on whether this chemical is packed in both the internal and external packaging, i.e. whether or not the chemical is in a single package which serves also for placing on the market and transportation.
The ministry competent for environmental protection defines in more detail the way in which a chemical and a certain product are packed and labeled.
Article 17
The supplier of a hazardous chemical and a certain mixture which is not hazardous but does contain at least one substance which is classified as hazardous, must point out in the advertising message its hazardous properties and to advertise it in such a manner that users thereof are not mislead in regard to the chemical’s hazardous properties.
The ministry competent for environmental protection prescribes in more detail the way to advertise the chemical.
Article 18
The ministry competent for environmental protection issues the regulation in accordance with EU rules on the manner of classification, packing, labeling and advertising of a chemical and a certain product set forth in Article 10 paragraph 4, Article 16 paragraph 6, and Article 17 paragraph 2 of this Act.
Apart from rules mentioned in paragraph 1 of this Article the ministry competent for environmental protection adopts also the rules which regulate the method of classification, packing, labeling and advertising of a chemical and certain product in accordance with the UN Globally Harmonized System of Classification and Labeling.
A chemical and a certain product can be classified, packaged, labeled and advertised in accordance with the rule contained in paragraph 1 of this Article or paragraph 2 of this Article.
Article 19
The supplier must keep records on chemicals that contain in particular the data on the identity of the chemical, distributors, i.e. downstream users, and quantities of chemicals which were delivered to them, as well as on aggregate quantities of chemicals which were sold to consumers in a calendar year.
The supplier must collect all data on chemicals which relate to the classification and labeling, as well as other data which he needs for the purpose of implementing this Act.
The supplier must maintain the records mentioned in paragraph 1 of this Article and the data mentioned in paragraph 2 of this Article for not less than 10 years after the last manufacturing, placing on the market and use of the chemical and to deliver them to the ministry competent for environmental protection upon its request.
If the supplier cedes its business or part of its business to a third party, the obligation to protect data is transferred to that person, and if it goes out of business the responsible person of the supplier is obligated to deliver these data immediately upon termination of operation to the ministry competent for environmental protection.
The ministry competent for environmental protections defines the ways in which the records on chemicals are kept.
Article 20
The supplier must submit the safety data sheet when placing a hazardous chemical on the market, a chemical which contains substances identified as persistent - bio-accumulative - toxic (hereinafter: PBT) or very persistent - very bio-accumulative (hereinafter vPvB) and other chemicals with properties set forth in Article 43, paragraph 3, of this Act to any other distributor or downstream user in the supply chain without compensation, in Serbian language, in printed or electronic form.
The exporter of the chemical set forth in paragraph 1 of this Article must submit the safety data sheet to the importer, and if possible the safety data sheet should be in the language of the country of import.
The safety data sheet contains in particular the identification of the chemical, data on the properties of the chemical, the way in which it is used, preventive measures, measures for risk reduction and data on the supplier of the chemical.
If the report on the safety of a chemical and the exposure scenario have been made, the information mentioned in the safety data sheet must correspond with the information contained in the report on the safety of the chemical, and the exposure scenario must be mentioned in the annex to the safety data sheet.
The ministry competent for environmental protection defines the criteria for identification of the substance as PBT or vPvB and the more detailed contents of the safety data sheet.
Article 21
The supplier is obliged to submit the safety data sheet to any other distributor or downstream user in the chain of supply upon their request when they purchase a mixture which is not classified as hazardous but does contain:
1) At least one hazardous substance, according to the hazard which this substance represents for human health and the environment, in a quantity of at least 1% of the mass of the mixture which is not in gaseous form, i.e. at least 0,2% of the volume of the mixture in gaseous form;
2) At least one substance, in a quantity of not less than 0.1% of the mass of the mixture which fulfils criteria to be identified as PBT or vPvB or other substances with properties set forth in Article 43, paragraph 3 of this Act;
3) Substance for which maximum allowed concentrations at the workplace are prescribed.
Article 22
The supplier is not obliged to submit the safety data sheet for a hazardous chemical intended for public use if for this chemical sufficient information regarding security, protection of human health and the environment has been submitted, unless required by the downstream user or distributor.
Article 23
The supplier referred to in Article 20, paragraph 1 of this Act is obliged to make amendments and supplements to the contents of the safety data sheet in accordance with new knowledge on the chemical, and particularly in the case of knowledge which can influence both measures for risk reduction and risk control, i.e. the chemical's hazard, as well as the restrictions or ban on production, placing on the market and use of the chemical.
The supplier referred to in paragraph 1 of this Article is obliged to submit the amended and supplemented safety data sheet to any other distributor or downstream user in the chain of supply to whom the chemical has been delivered in the last 12 months.
The amended and supplemented Safety Data Sheet must contain the note "Revised" and the date on which the amendments i.e. supplements were introduced.
6. Report on the Safety of the Chemical
Article 24
The report on a chemical's safety is a document containing the assessment of a chemical’s safety with measures for risk reduction and risk control in regard to a substance.
Article 25
The safety of a chemical is assessed in two phases.
In the first phase it is assessed how hazardous the substance is and whether the substance fulfils the criteria to be identified as a PBT or vPvB substance.
In the second phase the assessment is made on the exposure of humans and of the environment to this substance and characterization of the risk for the substance which in the first phase was assessed to have fulfilled the criteria to be classified as hazardous, i.e. to have fulfilled criteria to be identified as a PBT or vPvB substance.
The assessment of exposure and characterization of risk is established for all identified ways in which the substance is used.
Article 26
On the basis of assessment the chemical’s safety measures are established for reducing and control of the risk presented by the substance.
The ministry competent for environmental protection prescribes the way in which the safety of the chemical is assessed and the contents of the report on the chemical's safety.
The chemical safety report is submitted in Serbian language to the ministry competent for environmental protection, and may also be submitted in English language as one of the languages in official use in the EU.
7. Other Information on the Chemical
Article 27
The manufacturer, importer or distributor of the product containing a substance which has characteristics of the substance referred to in Article 43, paragraphs 2 and 3 of this Act with a concentration greater than 0.1%, i.e. a substance candidate for the List of Substances which Cause Concern is obliged to provide each distributor or downstream user in the supply chain information sufficient for the safe use of that product, and at least the name of that substance.
The manufacturer, importer or distributor of the product set forth in paragraph 1 of this Article is obliged to submit information on the substance set forth in paragraph 1 of this Article, without payment upon request of a consumer.
The ministry publishes the List of Substances referred to in paragraph 1 of this Article in the "Official Herald of the Republic of Serbia".
Article 28
Persons using hazardous material are obliged to handle them in a safe manner in accordance with the instructions on proper use, safety and protection of health during the use, the instruction on handling the residues of unused hazardous chemicals and empty packaging, first aid measures and measures for environmental protection contained in the safety data sheet, as well as in accordance with other available information.
Article 29
The manufacturer, importer, distributor and downstream user (all in the chain of supply) must share new knowledge on hazardous properties of a chemical as well as other information related to data contained in the safety data sheet which refer to certain ways in which this chemical is used.
8. Alternative Chemical Name of Substance
Article 30
In the safety data sheet, or when labeling the packaging the presence of a hazardous substance contained in the mixture, the alternative chemical name for this substance can be used in a manner which identifies the most important chemical functional groups or another alternative designation should be used.
The manufacturer, importer or downstream user of the hazardous substance contained in the mixture submits a request to use the alternative chemical name to the ministry competent for environmental protection.
The alternative chemical name can be used if the use of the chemical name of the substance can result in violating a business secret or intellectual property right, and if the alternative chemical name provides sufficient information for undertaking measures aimed at safety and health at the workplace and risk control when handling the mixture.
The alternative chemical name can be used for a substance that has specific properties.
The manufacturer, importer or downstream user pays a fee for expert assessment of justifiability of use of the alternative chemical name.
The ministry competent for environmental protection prescribes the properties of a substance which may be used with an alternative chemical name, as well as the content of the request for use of an alternative chemical name.
Article 31
The ministry competent for environmental protection can, within 45 days after the day of submission of the request set forth in Article 30 paragraph 2, ask the applicant to submit additional data necessary for making the decision on the use of the alternative chemical name.
If conditions mentioned in Article 30 paras. 3 and 4 of this Act are met, the ministry competent for environmental protection issues the approval for the use of the alternative chemical name.
The applicant can start using the alternative chemical name 45 days after the day of submission of request if the ministry competent for environmental protection did not ask for additional data, i.e. 45 days upon submitting additional data.
The ministry competent for environmental protection can decide to withdraw the approval for the use of the alternative chemical name if upon new information it establishes that the alternative chemical name does not provide sufficient information for undertaking measures aimed at security and health at the workplace and risk control when handling the mixture.
In the case mentioned in paragraph 4 of this Article the ministry competent for environmental protection can approve some other alternative chemical name for this substance.
The decision set forth in paragraphs 2, 4 and 5 of this Article can be appealed to the Government.
The decision on appeal set forth in paragraph 6 of this Article is final and it can be challenged in administrative dispute.
9. Storing, Disposal and Retail
Article 32
The manufacturer, importer, distributor and downstream user are obliged to store the hazardous chemicals in such a manner so as not to endanger human health and the environment.
The person stipulated in paragraph 1 of this Article must collect, store and safely dispose of residual hazardous chemicals and empty packages pursuant to rules which regulate waste management.
Article 33
A certain hazardous chemical which is being placed on the market as a product intended for general usage can be sold in stores specialized for chemicals, and in other stores it must be kept separately from other goods so that it does not come into contact with other goods, that it is out of reach of children and that it does not mislead the consumer as to its purpose.
The ministry competent for environmental protection defines in more detail the conditions under which hazardous chemicals are to be kept in the store and the way in which that place in the store has to be marked.
Article 34
The supplier of hazardous chemicals must provide a person who takes care of proper management of these chemicals (hereinafter: chemical counselor).
Notwithstanding paragraph 1 of this Article, specific suppliers of hazardous chemicals are not obliged to provide a chemical counselor.
The ministry competent for environmental protection prescribes the type, sector and area of activity of the supplier referred to paragraph 2 of this Article.
Article 35
The chemical counselor must have adequate professional education and passed exam for the chemical counselor.
The knowledge of the chemical counselor is tested every six years.
The ministry competent for environmental protection prescribes the professional degree, the training program and methods by which the knowledge of the chemical counselor is tested.
Article 36
Training and testing of knowledge of the chemical counselor in accordance with a prescribed program is performed by a legal person or sole trader which meets the conditions regarding expert staff, premises and technical equipment to perform the training.
The ministry competent for environmental protection issues the approval to the legal person or sole trader which fulfilled the conditions mentioned in paragraph 1 of this Article.
The ministry competent for environmental protection defines in more detail the conditions which a legal person or sole trader who train and test the knowledge of the chemical counselor must fulfill.
Article 37
In order to manage the hazardous chemicals in a manner which leads to risk reduction and the minimization of harmful effect of these chemicals upon human health and the environment, and to ensure the implementation of preventive measures, the chemical counselor controls whether this Act and subsequent bylaws are properly implemented.
VI INTEGRAL REGISTRY OF CHEMICALS
Article 38
The integral registry of chemicals placed on the market of the Republic of Serbia consists of the Registry of Chemicals and the Registry of Biocide Products, as well as of data on plant protection products.
Data on plant protection products mentioned in paragraph 1 of this Article encompass particularly those related to the plant protection product's trade name, the name and properties of active substances, allowed ways of use, the person who places them on the market and on quantities which have been placed on the market, which have been obtained by the plant protection authority in the registration procedure on the basis of a legislation which regulates plant protection products.
The authority competent for plant protection submits to the ministry competent for environmental protection the data mentioned in paragraph 2 of this Article once a year, not later than 31 March of the current year for plant protection products which have been placed on the market in the previous year.
The ministry competent for environmental protection keeps the integral registry of chemicals also as an electronic database with the aim to share data and to manage chemicals in an integrated manner.
Article 39
The chemicals which are manufactured in or imported to the market of the Republic of Serbia are recorded in the Registry of Chemicals.
Notwithstanding paragraph 1 of this Article, the chemicals which have certain properties or are used for certain purposes, and are placed on the market in quantities which are lower than the prescribed lowest threshold on an annual level, as well as other specific chemicals, are not recorded in the Registry of Chemicals.
The ministry competent for environmental protection prescribes that certain chemicals are not entered into the Registry of Chemicals as well as the lowest threshold for the quantity of a chemical with certain properties and ways of usage, below which this chemical is not recorded in the Registry of Chemicals.
Article 40
The manufacturer, importer or downstream user (hereinafter: person who registers the chemicals) is obliged to file with the ministry competent for environmental protection an application to enter the chemical into the Registry of Chemicals until 31 March of the current year for the chemicals which he produced, i.e. imported, in the previous year.
A foreign manufacturer can submit confidential information required for registration of chemicals in the Registry of Chemicals to the ministry competent for environmental protection directly or through an agent who is required to attach the power of attorney.
The application mentioned in paragraph 1 of this Article contains: name and address, taxpayer's identification number, type of activity, name of the responsible person in the firm, and when it is mandatory to have a chemical counselor also the name of that person.
Together with the application set forth in paragraph 1 of this Article a dossier on each chemical is also submitted, and for the chemical for which it is prescribed that it must have the safety data sheet also this sheet.
The dossier on a chemical contains particularly:
1) Trade name of the chemical and other identification of the chemical;
2) Data on the quantity of the chemical placed on the market;
3) Data on each way in which the chemical can be used that is known to the person which registers the chemical;
4) Data on chemical composition.
The ministry competent for environmental protection defines in more detail the contents of the dossier on chemicals.
Article 41
Within six months upon receipt of the application the ministry competent for environmental protection verifies from the dossier the completeness of the data on chemicals.
The ministry competent for environmental protection issues the decision on the entry of the chemical into the Registry of Chemicals for the chemicals whose dossier is complete and for which the safety data sheet has been submitted pursuant to this Act.
In the decision on the registering the entry of the chemical into the Registry of Chemicals the ministry competent for environmental protection records the registry number for each chemical referred to in Article 2 of this Article.
The manufacturer, importer or downstream user pays the republic administrative fee for entry of chemicals into the Registry of Chemicals.
The decision referred to in paragraph 2 of this Article may be appealed to the Government.
The decision upon the appeal referred to in paragraph 5 of this Article is final and an administrative dispute may be initiated against it.
Article 42
A person who registered the chemicals into the Registry of chemicals is obliged to submit each subsequent year within the time limit stipulated in Article 40, paragraph 1 of this Act for these chemicals the data on quantities placed on the market and other changes regarding data in the submitted dossiers on chemicals.
The ministry competent for environmental protection prescribes in more detail which data on each chemical are kept in the Registry of Chemicals.
2. Entry of Substances which Cause Concern into the Registry of Chemicals
Article 43
In order to enable risk control and secure replacement of a certain substance with an adequate safer alternative substance the ministry competent for environmental protection declares the List of Substances which Cause Concern.
The List of Substances which Cause Concern is made of substances which fulfill the criteria to be classified as carcinogenic categories 1 and 2, mutagenic categories 1 and 2, toxic in regard to reproduction 1 and 2, as well as substances identified as PBT or vPvB substances.
The List of Substances which Cause Concern is also made of substances which lead to disturbances in the functioning of the endocrine system or have PBT or vPvB properties, but do not fulfill the criteria to be identified as PBT or vPvB, and it has been scientifically established that they provoke significant consequences for human health and the environment.
The List of Substances which Cause Concern is published in the "Official Herald of the Republic of Serbia".
Article 44
The List of Substances which Cause Concern contains the following data:
1) Identity of the substance;
2) Classification of the substance, i.e. whether it is identified as PBT or vPvB or is fulfilling other conditions stipulated in Article 43, paragraph 3 of this Act;
3) Ways of use for which it is not necessary to prescribe the additional measures for risk reduction.
Article 45
Downstream user who uses the substance which causes concern, i.e. mixture which contains this substance, is obliged to submit to the ministry competent for environmental protection the application set forth in Article 40, paragraph 1 of this Act with the dossier on the chemical for the purpose of recording the chemical in the Registry of Chemicals.
Article 46
The dossier on the chemical for the substance which causes concern, i.e. the mixture which contains this substance, apart from data set forth in Article 40 of this Act, also contains a more detailed description of the way in which this substance, or the mixture which contains it, is used, the description of measures for risk reduction regarding this method of use as well as the suggestion regarding the way in which the use should be systematically monitored.
The dossier on the chemical set forth in paragraph 1 of this Article also contains, if available, the data on possible alternative substances, dangers i.e. risk which these alternative substances can represent for human health and the environment, as well as technical and socio-economic data on how feasible it is to replace these substances with alternative ones.
The ministry competent for environmental protection makes an expert assessment of submitted data, measures for risk reduction and the proposal for way in which the use of the substance which causes concern from the dossier on chemicals should be systematically monitored.
If the ministry competent for environmental protection deems that measures for risk reduction i.e. way for systematic monitoring of the use of the substance which causes concern are not adequate it issues a decision by which it orders amendments and supplements to proposed measures for risk reduction, i.e. the way for systematic monitoring of the use of the substance which causes concern, and sets a time limit for the implementation of ordered measures.
The decision set forth in Article 4 of this Article can be appealed to the Government.
The decision on appeal set forth in paragraph 5 of this Article is final.
Article 47
In case of a substance which causes concern, i.e. the mixture which contains this substance, the decision to enter the chemical into the Registry of Chemicals can include measures for risk reduction and the way in which the use is systematically monitored.
The manufacturer, importer or downstream user is obliged to obey measures for risk reduction and the way in which the use is systematically monitored set forth in the decision referred to in paragraph 1 of this Article.
Article 47a
The manufacturer, importer or downstream user pays a fee for placing on the market of substances which cause concern.
Article 48
(Deleted)
VII RESTRICTIONS AND BANS ON PRODUCTION, PLACING ON THE MARKET AND USE OF CHEMICALS
Article 49
For chemicals which represent an unacceptable risk for human health and the environment the ministry competent for environmental protection issues a regulation to prescribes restrictions, i.e. bans regarding their production, placing on the market and use (hereinafter: restrictions and bans).
The regulation set forth in paragraph 1 of this Article contains prohibited i.e. allowed ways of use, as well as other conditions relating to the production, placing on the market and use of the substance, mixture or product.
In case that due to technical, social and economic reasons it is not possible to promptly implement the restrictions and bans for a certain substance, mixture or product, the ministry competent for environmental protection by the very same regulation defines the time limits within which it is mandatory to implement the restrictions and bans.
Article 50
The manufacturer, importer, distributor and downstream user of the substance, mixture and product must comply with the restrictions and bans prescribed by this Act and regulations adopted on the basis of this Act.
VIII IMPORT AND EXPORT OF CERTAIN HAZARDOUS CHEMICALS
Article 51
With the aim to enhance sharing of responsibility and cooperation in international trade in hazardous chemicals pursuant to the Rotterdam Convention on the procedure of giving consent based on prior notification for certain hazardous chemicals and pesticides in international trade (hereinafter: Rotterdam Convention) a procedure of prior notification, i.e. procedure for giving consent on the basis of prior notification is implemented (hereinafter: PIC procedure) for the import and export of a certain substance, as well as for certain mixtures and products which contain this substance, for whose production, placing on the market and use the restrictions and bans have been established.
Restrictions and bans set forth in paragraph 1 of this Article relate to restrictions and bans set forth in Article 49 of this Act or these restrictions and bans are established on the basis of a regulation which permits placing on the market of a chemical pursuant to a legislation which regulates plant protection products, i.e. legislation which regulates biocide products.
The procedure of prior notification is applied to chemicals from the List of Chemicals for the procedure of prior notification, and the PIC procedure is applied to chemicals from the List of Chemicals for PIC procedure.
The List of Chemicals for prior notification procedure particularly contains the name of the chemical, the numbers by which the chemical is identified, the tariff number and the chemical's subcategory.
The List of Chemicals for PIC procedure particularly contains the name of the chemical, the numbers by which the chemical is identified, the tariff number and the category of the chemical.
The List of Chemicals for the procedure of prior notification contains also certain chemicals from the List of Chemicals for PIC procedure.
The List of Chemicals for PIC procedure contains also chemicals from the list of the Rotterdam Convention.
Article 52
Categories of chemicals for which the PIC procedure is implemented are industrial chemicals and pesticides.
Subcategories of industrial chemicals to which the procedure of prior notification is implemented are:
1) Subcategory of chemicals for general use;
2) Subcategory of chemicals for professional use.
Subcategories of pesticides to which the procedure of prior notification is implemented are:
1) Subcategory plant protection products;
2) Subcategory of other pesticides which encompasses biocide products and other chemicals which have effects like pesticides.
1. Procedure of Prior Notification
Article 53
The procedure of prior notification for export is implemented by the ministry competent for environmental protection which submits to the competent authority of the importing country a notification on the export of a chemical from the List of Chemicals which fall under prior notification procedure, i.e. chemical which contains the substance from this List in such a concentration that pursuant to this Act it is labeled as hazardous, as well as the notification on the export of the product which contains the chemical from the List of Chemicals for PIC procedure.
The exporter of the chemical and product set forth in paragraph 1 of this Article is obliged to submit to the ministry competent for environmental protection before the export the request for the implementation of the procedure of prior notification and to submit with the request the information that contains particularly the identity of the chemical, data on himself and the importer of the chemical or the product, as well as data on this chemical's properties and risk reduction measures.
On the basis of information set forth in paragraph 2 of this Article the ministry competent for environmental protection prepares the notification for the importing country and implement the procedure of prior notification.
The ministry competent for environmental protection issues to the exporter set forth in paragraph 2 of this Article the certificate that the procedure of prior notification has been implemented.
The ministry competent for environmental protection adopts a regulation whereby it prescribes the procedure and deadlines within which the procedure of prior notification is implemented, cases in which it is not necessary to further implement the procedure of prior notification, the contents of the notification on the export, as well as documents which are submitted for the implementation of that procedure.
The integral part of the regulation set forth in paragraph 5 of this Article is also the List of Chemicals for the procedure of prior notification.
Article 54
The procedure of prior notification for import is implemented for chemicals whose production, placing on the market and use is prohibited i.e. restricted pursuant to rules of the exporting country, is such a manner that the ministry competent for environmental protection, after acquiring information on the export from the relevant authority of the exporting country, inform that authority that it has received this information.
Article 55
PIC procedure is implemented to the import i.e. export of a chemical which is on the List of Chemicals for PIC procedure i.e. to a chemical which contains a substance from this list in such concentration that pursuant to this Act is labeled as hazardous.
The ministry competent for environmental protection is obliged to submit to the Secretariat of the Rotterdam Convention the answer regarding the import of each chemical from the list of the Rotterdam Convention.
The ministry competent for environmental protection is obliged to submit the answer on the import of the chemical which is not on the list of the Rotterdam Convention to the competent authority of the exporting country if this country requests prior consent pursuant to PIC procedure.
The answer referred to in paras. 2 and 3 of this Article may be the consent, consent under certain conditions, i.e. no consent, and is prepared on the basis of established restrictions and bans set forth in Article 49 of this Act or on the basis of rules which allow for a chemical to be placed on the market pursuant to a legislation which regulates the plant protection products, i.e. biocide products.
The answer referred to in paras. 2 and 3 of this Article for plant protection products is prepared by the ministry competent for environmental protection in cooperation with the authority competent for plant protection, and for chemicals with a pesticide effect with the authority competent for such chemicals.
Article 56
The exporter is obliged to submit to the ministry competent for environmental protection the request for the implementation of the PIC procedure for a chemical which is on the List of Chemicals for PIC procedure, i.e. for a chemical which contains the substance from this list in such concentration that pursuant to this Act it is labeled as hazardous.
Notwithstanding paragraph 1 of this Article an exporter has no obligation to file a request for the implementation of PIC procedure for a chemical from the list of the Rotterdam Convention if the country which is party to the Rotterdam Convention submitted the answer for that chemical to the Secretariat of that convention.
Upon request set forth in paragraph 1 of this Article the ministry competent for environmental protection requests the competent authority of the importing country to give a prior consent pursuant to PIC procedure.
The ministry competent for environmental protection issues to the exporter who submitted the request for the implementation of PIC procedure a certificate that the PIC procedure has been done and notes in this certificate the answer set forth in Article 55, paragraph 4, of this Act.
The exporter referred to in paragraph 4 of this Article is obliged to act in accordance with the answer of the competent authority of the importing country.
Article 57
The ministry competent for environmental protection defines in more detail the procedure and deadlines within which the PIC procedure is implemented as well as the contents of the request for the implementation of the PIC procedure.
The integral part of the rules set forth in paragraph 1 of this Article is the List of Chemicals for PIC procedure.
3. Other Provisions Relating to the Import and Export of Chemicals
Article 58
An exporter of a chemical from the List of Chemicals, for the purpose of the procedure of prior notification i.e. a chemical which contains a substance from that list, as well as a chemical from the List of chemicals for PIC procedure i.e. chemicals and products which contain a substance from this list, is obliged to submit until 31 March of the current year for the previous year to the ministry competent for environmental protection information on exported quantities, the country to which the chemicals i.e. products were exported, and general data on the importer.
An importer of a chemical from the List of chemicals, for the purpose of the procedure for prior notification, i.e. a chemical which contains a substance from that list, as well as a chemical from the List of chemicals for PIC procedure, i.e. a chemical which contains a substance from that list, is obliged to submit to the ministry competent for environmental protection apart from data set forth in Article 42, paragraph 1 of this Act and not later than 31 March of the current year for the previous year, also the information on the exporting country and general data on the exporter.
An importer of a product which contains a chemical from the List of Chemicals for PIC procedure is obliged to submit to the ministry competent for environmental protection not later than 31 March of the current year the information for the previous year regarding imported quantities, the exporting country and general data on the exporter.
On the basis of data set forth in paragraphs 1, 2, and 3 of this Article the ministry competent for environmental protection maintains the Records of imported and exported chemicals i.e. products along the procedure for prior notification and PIC procedure in the form of an electronic database.
Article 59
An importer is obliged to submit to the ministry competent for environmental protection information requested by the competent authority of the signatory country to the Rotterdam Convention related to the transit over its territory of a chemical on the list of the Rotterdam Convention not later than 30 days prior to the day of the first transit, or eight days prior to each subsequent transit.
The ministry competent for environmental protection submits to the competent authority of the signatory country to the Rotterdam Convention referred to in paragraph 1of this Article information on the transit of the chemical not later than 15 days prior to the first transit or before each subsequent transit.
The ministry competent for environmental protection defines the list of signatory countries to the Rotterdam Convention which request information on the transit of chemicals and the contents of that information.
Article 60
Certain hazardous chemicals and products whose use is banned must not be exported.
Apart from chemicals set forth in paragraph 1 of this Article banned for export are also the chemicals, and particularly pesticides, whose purity is not in compliance with the prescribed one, as well as chemicals whose expiry date is six months after export.
The list of hazardous chemicals and products whose export is prohibited contain particularly the name of the hazardous chemical, i.e. product, numbers which identify the chemical, i.e. product, and tariff number of the hazardous chemical, i.e. product.
The ministry competent for environmental protection defines the List of Hazardous Chemicals and products whose export is prohibited.
Article 60a
An exporter pays a fee for assessment of the data it submits for the purpose of carrying out procedure of prior notice and the PIC procedure.
Article 61
(Deleted)
Article 62
The customs organ verifies whether the procedure of prior notification, i.e. the PIC procedure has been carried out.
IX PERMITS FOR CONDUCTING TRADE AND PERMITS FOR USE OF PARTICULARLY HAZARDOUS CHEMICALS
Article 63
Certain hazardous chemicals (hereinafter: particularly hazardous chemicals) can be placed on the market only by legal persons or sole traders who have the permit to conduct trade in these chemicals.
The permit for conducting trade in particularly hazardous chemicals is issued to a legal person or sole trader who ensured such storing and keeping of particularly hazardous chemicals that they cannot be accessible to persons who could use them for prohibited purposes and who defined preventive measures for safe keeping and storing of particularly hazardous chemicals.
The ministry competent for environmental protection prescribes particularly hazardous chemicals for which a permit is issued, as well as particularly hazardous chemicals for which no permit is needed.
Article 64
Natural persons who use particularly hazardous chemicals are obliged to have a permit to use these chemicals.
The permit for using particularly hazardous chemicals is issued to a natural person who uses them for artistic, scientific and other specific purposes, if no other alternative chemicals can be used as replacement, if he is using them and keeping in a safe way, as well as if he had not been convicted to a non-suspended imprisonment for a period longer than six months.
Article 65
The request for issuance of the permit set forth in Article 63, paragraph 1 and Article 64, paragraph 1 of this Act particularly contains the name and address of the applicant, data on particularly hazardous chemicals and the purpose for which the permit is requested.
The evidence that an adequate storehouse is provided for and that preventive measures for safe keeping and storing of particularly hazardous chemicals have been established are attached to the request for issuing of the permit for conducting trade in particularly hazardous chemicals.
The explanation for the way of use of the particularly hazardous chemical, way of keeping these chemicals, as well as evidence that the natural person had not been convicted to a non-suspended imprisonment for a period longer than six months are attached to the request for issuing of the permit for usage of particularly hazardous chemicals.
Preventive measures set forth in paragraph 2 of this Article relate particularly to safe keeping i.e. storing of particularly hazardous chemicals, safety procedures, as well as to the manner of carrying out internal control of safety procedures and handling of particularly hazardous chemicals.
The ministry competent for environmental protection prescribes:
1) The form of the request and the form of the permit for conducting trade, i.e. permit for using particularly hazardous chemicals;
2) Instructions on establishing preventive measures for safe keeping, storing i.e. using particularly hazardous chemicals.
Article 66
Within the procedure for issuing the permit for conducting trade in particularly hazardous chemicals an assessment is made on whether it is necessary to write down in the permit also the conditions for safe keeping and storing of these chemicals.
Within the procedure for issuing the permit to use particularly hazardous chemicals an assessment is made on whether it is necessary to write down in the permit also the conditions for safe keeping and using of these chemicals.
Within the procedure for permit issuing set forth in paragraph 1 and 2 of this Article a time limit is also set for the validity period of the permit which cannot exceed five years.
Article 67
A permit for conducting trade in particularly hazardous chemicals is issued by the ministry competent for environmental protection to the importer, manufacturer i.e. downstream user.
A permit for conducting trade in particularly hazardous chemicals to a distributor who is not the importer, manufacturer i.e. downstream user, as well as a permit for using particularly hazardous chemicals are issued by the competent authority of the self-government unit.
The name of the holder of the permit, the purpose for which the permit is issued, the validity period of the permit, as well as conditions for safe keeping and storing i.e. safe keeping and using established within the procedure in which the permit has been issued are particularly written down into the permit set forth in Article 63, paragraph 1 and Article 64, paragraph 1 of this Act.
A competent authority of a self-government unit submits once a year a report on issued permits referred to in paragraph 2 of this Article to the ministry competent for environmental protection, and not later than 31 March of the current year for the previous year.
The decision set forth in paras. 1, 2 and 3 of this Article can be appealed to the Government.
The decision on appeal set forth in paragraph 5 of this Article is final and it can be challenged in administrative dispute proceedings.
An importer, manufacturer, i.e. downstream user or distributor who is not the importer, manufacturer, i.e. downstream user pays a fee for issuance of the permit for conducting trade in particularly hazardous chemicals, while a natural person pays a fee for issuance of the permit for using particularly hazardous chemicals.
Article 68
The validity period of the permit set forth in Article 66, paragraph 3, of this Act can be extended upon permit holder’s request.
The ministry competent for environmental protection or the organ of the unit of self- government conducts the assessment of the request for extension of the permit and extends the permit if conditions for its issuance are still fulfilled.
The decision set forth in paragraph 2 of this Article can be appealed to the Government.
The decision on appeal referred to paragraph 3 of this Article is final and can be challenged in administrative dispute proceedings.
An importer, manufacturer, i.e. downstream user or distributor who is not an importer, manufacturer, i.e. downstream user pays a fee for extension of the permit for conducting trade in particularly hazardous chemicals, while a natural person pays a fee for extension of the permit for using particularly hazardous chemicals.
Article 69
A holder of the permit is obliged to observe preventive measures set forth in Article 63, paragraph 2 of this Act and conditions for safe keeping and storing, i.e. conditions for safe keeping and use of a particularly hazardous chemical referred to in Article 67, paragraph 3 of this Act as well as to submit immediately upon acquiring relevant knowledge all changes in data which he submitted in the procedure for issuance of the permit.
Article 70
The ministry competent for environmental protection, i.e. the organ of the self-government unit shall revoke the permit set forth in Article 63, paragraph 1, and Article 64, paragraph 1 of this Act if during the permit issuing procedure incorrect data have been submitted and if the conditions from the permit are no longer fulfilled.
The decision set forth in paragraph 1 of this Article can be appealed to the Government.
The decision set forth in paragraph 2 of this Article is final and can be challenged in administrative dispute proceedings.
Article 71
Scientific and research organizations, persons who take part in culture activities, state administration organs, public agencies and organs of self-government units which need the particularly hazardous chemicals for performing their jobs, as well as legal and natural persons who have the permit for production i.e. trade in medicines pursuant to the legislation which regulates medicines, do not need a permit to conduct trade in particularly hazardous chemicals.
Article 72
A holder of the permit for conducting trade in particularly hazardous chemicals can conduct trade in particularly hazardous chemicals with legal persons, i.e. sole traders who use them for industrial or professional purposes, as well as other holders of permits for conducting trade or permits for using particularly hazardous chemicals.
A holder of the permit for conducting trade in particularly hazardous chemicals is obliged to, apart from the records set forth in Article 19 of this Act, keep also the records on customers to whom the particularly hazardous chemical was sold or given without compensation.
The ministry competent for environmental protection prescribes the way in which records on the trade in particularly hazardous chemical is kept.
Article 73
A detergent manufacturer places the detergent on the market if the surfactant contained in that detergent fulfils the criteria on full aerobic biodegradability and if chemicals and surfactants contained in the detergent fulfill other conditions stipulated by this Act.
The manufacturer of the detergent referred to in paragraph 1 of this Article is a legal person or sole trader who places the detergent or surfactant on the market, and who produces or imports them, or changes the detergent’s characteristics and packs i.e. changes the labels of the detergent.
Notwithstanding paragraph 1 of this Article, a detergent containing the surfactant which does not meet the criteria of complete aerobic biodegradability can be placed on the market if the ministry competent for environmental protection issued an approval for usage of that surfactant in the detergent (hereinafter: approval) or a legislation has been adopted which approves the use of the surfactant in a detergent in the EU.
The manufacturer of the detergent referred to in paragraph 3 of this Article is obliged to submit to the ministry competent for environmental protection a certified copy of the legislation which allows for the use of the surfactant in a detergent in the EU.
The ministry competent for environmental protection prescribes the criteria and methods for testing the biodegradability of the surfactant.
Article 74
A manufacturer of the detergent referred to in Article 73 paragraph 3 of this Act submits a request to the ministry competent for environmental protection to acquire approval prior to placing the detergent with this surfactant on the market.
Together with the request set out in paragraph 1 of this Article a technical dossier on the surfactant is also submitted which particularly contains the identity of the surfactant, results of testing of surfactant’s biodegradability, information on the surfactant and metabolites of biodegradability, data on the quantity of the surfactant in the detergent which is placed on the market, envisaged way of usage of the detergent, as well as a proposal for assessing risks which the surfactant represents.
The technical dossier referred to in paragraph 2 of this Article is submitted in Serbian language, but may also be submitted in English language as one of the official languages of the EU.
The ministry competent for environmental protection prescribes in more detail the contents of the technical dossier on the surfactant.
Article 75
If needed for the purpose of assessing the risk which the surfactant represents, the ministry competent for environmental protection can within 90 days after the day of submission of the request referred to in paragraph 1 of Article 74 of this Act demand supply of additional information.
If the applicant does not act in accordance with the request set out in paragraph 1 of this Article, the ministry competent for environmental protection can issue a conclusion whereby rejecting the request as incomplete.
Against the conclusion referred to in paragraph 2 of this Article an appeal can be filed with the Government.
The decision upon the appeal referred to in paragraph 3 of this Article is final and it can be challenged in administrative dispute proceedings.
Article 76
On the basis of the technical dossier referred to in Article 74 paragraph 2 of this Act the ministry competent for environmental protection establishes whether:
1) The surfactant contained in the detergent meets the criteria of primary biodegradability;
2) The detergent with this surfactant is used for industrial or professional purposes;
3) The detergent is used in such a way that the surfactant is released to the environment in small quantities;
4) The risk which this surfactant represents for human health and the environment is small having in mind the quantity of the surfactant in the detergent which is placed on the market and the way in which this detergent is used, and comparing this risk with socio-economic benefit when using that detergent and having in mind the benefit of its usage for the safety of food and maintaining hygiene.
The manufacturer of the detergent pays a fee for assessment of the technical dossier on the surfactant.
Article 77
The ministry competent for environmental protection issues the approval within 12 months from the day of submission of the complete technical dossier on the surfactant, if the conditions referred to in Article 76 of this Act are met.
The ministry competent for environmental protection can establish in the approval the conditions under which the surfactant can be placed on the market and used as a component of a detergent.
The holder of the approval is obliged to comply with the conditions for placing on the market and the use of the surfactant as a component of a detergent.
Against the decision referred to in paras. 1 and 2 of this Article an appeal can be filed to the Government.
The decision upon appeal referred to in paragraph 4 of this Article is final and it can be challenged in administrative dispute proceedings.
Article 78
Upon request of the ministry competent for environmental protection, the holder of the approval is obliged to submit the technical dossier on the surfactant updated with new information regarding the quantity of the surfactant in the detergent which is placed on the market, i.e. regarding the new way in which this detergent is used.
If on the basis of information from paragraph 1 of this Article the ministry competent for environmental protection assesses that the surfactant does not meet the conditions referred to in Article 76 of this Act it can issue:
1) A new approval which defines the conditions for using that surfactant;
2) A decision on the termination of validity of the approval and in this decision to establish the time limit in which this surfactant i.e. detergent which contains it must be withdrawn from the market.
Against the decisions referred to in paragraph 2 of this Article an appeal can be filed to the Government.
The decision upon the appeal referred to in paragraph 3 of this Article is final and it can be challenged in administrative dispute proceedings.
Article 79
The List of Surfactants for which an approval has been issued or a legislation was passed which allows for the use of the surfactant in a detergent in the EU, as well as the List of Surfactants for which the request for approval was refused, and surfactants which are prohibited in the EU are published in the "Official Herald of the Republic of Serbia".
Article 80
The laboratory which establishes biodegradability of the surfactant must be accredited for the relevant testing method or its work must be harmonized with principles of good laboratory practice.
Article 81
A manufacturer of the detergent is obliged to keep the testing results which confirm that the criterion on complete aerobic biodegradability of the surfactant has been met and submit them to the ministry competent for environmental protection upon its request.
In addition to obligations set forth in the provisions of this Act which refer to the classification, packaging and labeling, a manufacturer of the detergent is obliged to label the detergent pursuant to a legislation regulating detergent labeling which has been adopted on the basis of this Act.
The manufacturer of the detergent intended for general use is obliged to make a List presenting the detergent’s composition and must keep it for five years, as well as make certain data contained in this List available to the public on its web-site.
The ministry competent for environmental protection prescribes the specific way in which detergents are labeled, the contents of the List presenting the detergent’s composition, as well as the data from that List which should be made available to the public.
Article 81a
The amount of fee, fee payers, as well as the method of payment of the fee referred to in Article 30, paragraph 5, Article 47a, Article 60a, Article 67, paragraph 7, Article 68, paragraph 5 and Article 76, paragraph 2 of this Act is established by the Government upon proposal of the ministry competent for environmental protection.
Revenue from the fees prescribed by this Act belongs to the budget of the Republic of Serbia.
XI SYSTEMATIC MONITORING OF CHEMICALS
Article 82
The ministry competent for environmental protection drafts and carries out projects for monitoring of how the chemicals are placed on the market, monitoring of their metabolites and the route of chemicals in the environment and living organisms with the aim of monitoring the risks which the chemicals represent for human health and the environment i.e. controlling the way in which the substances which cause concern are used and how the restrictions and bans in regard to the production, placing on the market and the use of chemicals are implemented.
The ministry competent for environmental protection can hire scientific and research organizations for the purpose of implementing the projects referred to in paragraph 1 of this Article.
Article 83
The Poisoning Control Center submits to the ministry competent for environmental protection data collected pursuant to a legislation that regulates healthcare.
The ministry competent for environmental protection can use data referred to in paragraph 1 of this Article only for control of risk which certain chemicals present for human health and the environment.
The ministry competent for environmental protection submits to the Poison Control Center information on chemicals and the properties of chemicals that it has at its disposal and which are necessary for the Centre’s work.
The information referred to in paragraph 3 of this Article can be obtained by the Poisoning Control Centre in emergency cases also from the person which places the chemicals on the market.
The Poisoning Control Centre and other medical workers, i.e. medical collaborators, can use obtained information for medical purposes only, i.e. for preventive and curing measures, particularly in emergency cases and may not be used for other purposes.
Article 84
Data submitted to the ministry competent for environmental protection within the procedure for entering the chemical into the Registry of Chemicals are available to the public, as well as other data at the disposal of the ministry competent for environmental protection, in particular:
1) The chemical name pursuant to IUPAC nomenclature of the hazardous substance contained in the chemical;
2) The trade name of the chemical;
3) The classification and labeling of the chemical;
4) The data on physical and chemical properties of the chemical;
5) The data on the route of the substance and its fate in the environment;
6) The results of toxicological and eco-toxicological testing of the chemical;
7) The effect threshold;
8) The instructions for safe handling;
9) The analytical methods for the identification of the hazardous substance in the case when it has been released into the environment, and for determining direct human exposure.
In addition to data referred to in paragraph 1 of this Article, the data from notifications referred to in Article 53 of this Act are also available to the public.
The ministry competent for environmental protection shall consider the following as confidential and shall not make it available to the public:
1) The information on the full contents of the mixture;
2) The precise purpose and method of application of the substance;
3) The relationship between the producers, importers and downstream users in the supply chain;
4) The precise amount of chemicals produced or placed on the market.
In case of an emergency, when necessary for the safety and protection of human health and the environment, the ministry competent for environmental protection may also make available the information specified in paragraph 3 of this Article.
Article 85
A person who in accordance with provisions of this Act submits to the ministry competent for environmental protection data relevant to the procedures for the entry of chemicals into the Registry of Chemicals, data relevant to the procedure for issuing the permit for conducting trade and the permit for using particularly hazardous chemicals and other procedures, or submits to the ministry competent for environmental protection upon its request data which are not set forth in Article 84 paras. 1 and 2 of this Act can mark certain data as confidential.
Anybody can file a request for accessing data which are at the disposal of the ministry competent for environmental protection.
The ministry competent for environmental protection shall not allow the applicant referred to in paragraph 2 of this Article access to data which are marked as confidential if it assesses that access to these data has to be restricted pursuant to this Act and legislation which regulates free access to information of public importance and issues a decision to this effect.
Before issuing the decision referred to in Article 3 of this Article the ministry competent for environmental protection is obliged to consult the person who marked these data as confidential.
Employees in the ministry competent for environmental protection, in the Center for Poisoning Control, medical workers, as well as other persons who while performing their jobs had access to confidential data, are obliged to keep them even after termination of these jobs.
Against the decision referred to in paragraph 3 of this Article an appeal can be filed to the Government.
The decision upon appeal referred to in paragraph 6 of this Article is final and can be challenged in administrative dispute proceedings.
Article 86
The implementation of this Act and regulations adopted on the basis of this Act is monitored by the ministry competent for environmental protection.
Inspection supervision is performed by the ministry competent for environmental protection through the inspector for environmental protection, by the ministry competent for health affairs through health inspectors and the ministry competent for trade affairs through market inspectors.
The inspector for environmental protection performs inspection supervision over classification, packaging, labelling, and advertising chemicals, contents and delivery of the safety data sheet, providing advisor for chemicals, entering chemicals into the Registry of Chemicals, placing on the market of particularly hazardous chemicals and detergents, import and export of certain hazardous chemicals, as well as over the implementation of the provisions of this Act for which a sanitary, i.e. market inspector has no jurisdiction over.
The sanitary inspector performs inspection supervision over the implementation of restrictions and bans on manufacturing, placing on the market and using of chemicals and products intended for general use.
The market inspector performs inspection supervision over fulfilment of the requirements for keeping hazardous chemicals in the sales area and the way of marking such area.
Inspections referred to in paragraph 2 of this Article mutually cooperate, i.e. inform each other on undertaken measures, share information, provide immediate assistance and undertake joint measures and activities relevant to the carrying out of supervision.
A unit of self-government performs inspection supervision over duties assigned to it by this Act.
Article 87
(Deleted)
Article 88
The ministries referred to in Article 86, paragraph 2 of this Act, by means of an agreement, form, in accordance with the regulations governing state administration, a joint body for the purpose of: planning, monitoring, harmonizing and undertaking joint measures and activities for implementation of this Act, mutual cooperation, including inspection supervision and training of the competent inspections staff, in accordance with this Act.
The agreement referred to in paragraph 1 of this Article also governs the issues of planning and programming of measures and activities in conducting supervision over implementation of this Act.
Article 89
Inspectors for environmental protection and sanitary inspectors (hereinafter: inspectors) may take samples and conduct preliminary control of the content of a chemical and a product aiming at establishing whether the conditions are fulfilled for placing on the market i.e. for using the chemical and the product.
When taking samples, a legal or natural person or a sole trader is obliged to provide to the competent inspector the needed quantities of samples free of charge which are required for testing.
The costs of sampling and testing of a chemical and a product are borne by the legal or natural person or sole trader from which the sample has been taken, if the finalized procedure establishes that it does not conform to the prescribed properties. If the sample conforms to the prescribed properties the costs of sampling and testing of the chemical and the product are borne by the funds provided by the budget of the Republic of Serbia.
Article 90
When performing inspection supervision, an inspector has the right and the duty to establish:
1) Whether a chemical and a certain product which are placed at the market are classified, labeled and packaged in accordance with this Act and regulations adopted on the basis of this Act:
2) Whether a hazardous chemical and a certain mixture which is not hazardous but does contain at least one substance which is classified as hazardous pursuant are advertised in accordance with this Act;
3) Whether the prescribed records are kept and the prescribed data on chemicals are collected, as well as whether these records and data are kept within the prescribed time limit;
4) Whether the planned duties related to the contents, updating and submission of the safety data sheet are accomplished;
5) In case of a product which contains a substance of prescribed properties and concentration, whether information which is sufficient for the safe use of that product is submitted, and particularly the name of that substance;
6) Whether the approval has been issued which allows for the use of the alternative chemical name of the substance and whether that name is used in accordance with the approval;
7) Whether hazardous chemicals are stored in such a way as not to endanger human life and health and the environment, i.e. whether the residual chemicals and the empty packaging are treated with in accordance with a regulation governing waste management;
8) Whether hazardous chemical are kept in the sales area under the prescribed conditions and whether such area is marked in the prescribed way;
9) Whether the supplier provided a chemical counselor and whether that counselor has the prescribed professional degree and the proof on the passed exam;
10) Whether the application for a chemical which must be registered in the Registry of Chemicals was filed in the prescribed time limit, i.e. whether in each subsequent year the prescribed data have been submitted in the established time limit and whether the submitted data were accurate;
11) Whether measures written down in the decision on the entry of the chemical into the Registry of Chemicals have been applied in regard to the substance which causes concern;
12) Whether restrictions and bans are observed;
13) Whether the information prescribed for the procedure of prior notification have been submitted prior to export and whether this information have been submitted within the prescribed time limit;
14) Whether the request for the implementation of the PIC procedure has been submitted;
15) Whether the placing on the market or usage of particularly hazardous chemicals has been carried out by a person who has the permit for that;
16) Whether a person who holds the permit for conducting trade or the permit for using particularly hazardous chemicals ensured an adequate storehouse, and also whether such a person complies with prescribed preventive measures and conditions;
17) Whether the prescribed obligations regarding a detergent have been observed;
18) Whether other measures and conditions prescribed by this Act are being implemented.
Article 91
In performing the tasks set forth in Article 90 of this Act the inspector is authorized and obliged to:
1) Order that the chemical and certain product which are placed on the market are classified, labeled and packaged in accordance with this Act and subsequent secondary legislation passed on the basis of this Act;
2) Prohibit placement on the market of the chemical and certain product which are classified, labeled and packaged contrary to provisions of this Act and subsequent secondary legislation passed on the basis of this Act;
2a) Order or arrange the withdrawal from the market of a chemical and specific product which has been classified, labeled and packaged in contravention of the provisions of this Act and the subsequent secondary legislation passed on the basis of this Act, and order or arrange to warn the consumers and downstream users of the hazards posed by the chemical and the specific product;
3) Order that the advertising of a dangerous chemical and a certain mixture which is not hazardous but does contain at least one substance which is classified as hazardous is performed in accordance with this Act and subsequent secondary legislation passed on the basis of this Act;
4) Prohibit advertising that is carried out contrary to provisions of this Act and subsequent secondary legislation passed on the basis of this Act of the hazardous chemical and a certain mixture which is not hazardous but does contain at least one substance which is classified as hazardous;
5) Order the keeping of prescribed records and collection of prescribed data on the chemical, as well as to keep these records and data within the prescribed time limit;
6) Order the fulfillment of the prescribed duties in relation to the contents, updating and submitting of the safety data sheet;
7) Prohibit the placing on the market of a hazardous chemical, a chemical which contains a substance identified as PBT or vPvB, as well as some other chemical with properties set out in Article 43 paragraph 3 of this Act if the prescribed obligations related to the contents, updating and submitting of the safety data sheet have not been fulfilled;
8) Order the submission of information that are sufficient for a safe use a product which contains a substance with prescribed properties and concentrations, and particularly the name of that substance;
9) Prohibit the use of the alternative chemical name of a substance if no approval has been issued or order that such a name is used in accordance with the approval;
10) Order that dangerous chemicals are stored in such a manner so as not to endanger human life and health and the environment, i.e. order that the residual chemicals and the empty packages are handled in accordance with a legislation which regulates waste management;
11) Prohibit that hazardous chemicals are stored in a manner which endangers human life and health and the environment, namely to prohibit that the residual chemicals and the empty packages are handled in an unsafe manner contrary to a legislation which regulates waste management;
12) Order that a certain hazardous chemical which is placed on the market as a product intended for general use is sold in accordance with prescribed conditions;
13) Prohibit the selling of a certain hazardous chemical which is placed on the market as a product intended for general usage contrary to prescribed conditions;
14) Order the supplier to provide a chemical counselor who has the prescribed professional degree and the proof on the passed exam;
15) Prohibit the supplier to conduct business until the supplier provides a chemical counselor with the prescribed professional degree and the proof on the passed exam;
16) Order that an application of a chemical which must be registered in the Registry of Chemicals is filed with the registry within a specified period of time, i.e. that prescribed data are submitted every subsequent year within the prescribed time limit;
17) Order the substances which cause concern are subjected to the measures written down in the decision on the entry of the chemical into the Registry of Chemicals;
18) Prohibit the usage of a substance which causes concern until measures written down in the decision on the entry of the chemical into the Registry of Chemicals are implemented;
19) Order the observing of restrictions and bans;
20) Prohibit production, placing on the market and usage of a substance, mixture and a product if they are handled contrary to the restrictions and bans;
21) Order the withdrawal from the market of a substance, mixture and product if restrictions and bans have not been observed;
21a) Order, coordinate or, where necessary, arrange with the manufacturers, importers, distributors and competent authorities the recall of a substance, mixture and product in case of failure to comply with the restrictions and bans, including the compulsory enforcement of the measure of recall of a substance, mixture and product, as well as their destruction in an appropriate manner by and at the expense of the manufacturer, importer i.e. distributor;
22) Order that the substance, mixture and product which were not handled in accordance with restrictions and bans are returned to the country of origin or to treat them in accordance with the regulation which governs waste management;
23) Order the submission of prescribed information for the procedure of prior notification before the export and that such information must be submitted within the prescribed time limit;
24) Order the submission of a request for the implementation of PIC procedure;
24a) Order the supplier to obtain the permit from the competent authority for carrying out activities of trade in or use of particularly hazardous chemicals;
25) Prohibit the usage or placing of particularly hazardous chemicals on the market by a person who has no permit for that;
26) Order that for particularly hazardous chemicals an adequate storehouse is ensured and that prescribed preventive measures and conditions are implemented;
27) Order that actions taken are in accordance with prescribed obligations regarding a detergent;
28) Prohibit placing on the market of a detergent if action is not taken in accordance with prescribed obligations regarding the detergent;
29) Order the execution of other prescribed obligations within a specified time limit, in accordance with law.
Article 92
The inspector issues a decision to order measures during inspection.
In the case of undertaking particularly emergent measures with the aim to remove immediate danger for human life and health and the environment the inspector can issue the decision referred to in Article 91 of this Act also orally and order that it must be executed without delay.
The inspector is obliged to issue the oral decision referred to in paragraph 2 of this Article also in writing at the latest within the time limit of eight days from the day when the oral decision was declared.
Article 93
Against the decision of the inspector for environmental protection an appeal can be filed to the minister.
Against the decision of the sanitary inspector an appeal can be filed to the minister competent for health affairs.
Against the decision of the market inspector an appeal can be filed to the minister competent for trade affairs.
The appeal referred to in paragraphs 1-3 of this Article is filed within 15 days from the day of receipt of the decision.
The appeal against the inspector’s decision does not delay its enforcement.
The decision upon appeal referred to in paras. 1, 2 and 3 of this Article is final and it can be challenged in administrative dispute proceedings.
Article 94
Any legal or natural person or sole trader is obliged to enable the inspector to perform the inspection supervision, to make available without delay the necessary documentation and other evidence and to give a statement on facts significant for the inspection.
Article 95
If during supervision the inspector finds that other laws and regulations have been violated whose breach can have impact upon human life and health, the environment and safety at the workplace, he is obliged to promptly inform the competent authority about that and together with it conduct supervision and undertake appropriate measures
Article 96
The inspector has an official identification card, badge and adequate equipment.
Article 97
Against a legal person a fine shall be imposed for an economic offense in the range from 1,500,000 to 3,000,000 dinars if:
1) A chemical and a certain product which it places on the market are not classified, i.e. labeled and packaged pursuant to this Act and secondary legislation adopted on the basis of this Act (Article 9, paragraph1);
2) For the purpose of classification it conducts experiments on primates (Article 14, paragraph 2);
3) It places on the market a hazardous chemical and a certain mixture which is not hazardous but does contain at least one substance which is classified as hazardous, and does not point out its hazardous properties in an advertising message and advertises it in such a way that its users are misled in regard to the hazardous properties of the chemical (Article 17, paragraph 1);
4) It places a hazardous chemical on the market, as well as a chemical which contains substances defined as PBT or vPvB and other chemicals which have properties set out in Article 43 paragraph 3 of this Act and fails to submit without charge, in printed or electronic form, the safety data sheet in the Serbian language to any other distributor or downstream user in the chain of supply (Article 20, paragraph 1);
5) If fails to submit the safety data sheet to the importer (Article 20, paragraph 2);
6) The safety data sheet does not contain data set out in Article 20 paragraph 3 of this Act;
7) The information set out in the safety data sheet does not correspond to information contained in the report on the chemical’s safety, and the exposure scenario is not mentioned in the annex to the safety data sheet, whereas the report on the chemical’s safety and the exposure scenario have been made (Article 20, paragraph 4);
8) It fails to make amendments and supplements of the contents of the safety data sheet in accordance with new knowledge on the chemical, and particularly knowledge which can affect the measures related to reduction and control of the risk i.e. hazard of the chemical, as well as on restrictions and bans regarding production, placing on the market or usage of the chemical (Article 23, paragraph 1);
9) It failed to submit the amended and supplemented safety data sheet to every other distributor or downstream user in the chain of supply to whom the chemical was delivered within the previous 12 months (Article 23, paragraph 2);
10) It failed to submit to every other distributor or downstream user in the chain of supply the information sufficient for safe usage of the product which contains a substance that has the prescribed properties and concentrations (Article 27, paragraph 1);
11) Without approval of the ministry competent for environmental protection, it uses the alternative chemical name for a hazardous substance in the safety data sheet or when labeling a package of that substance contained in a mixture, or fails to does so in accordance with the approval (Article 30, paragraph 1 and Article 31 paras. 2 and 5);
12) It fails to store the hazardous chemicals in such a way so as not to jeopardize human life and health and the environment (Article 32, paragraph 1);
13) If fails to collect, store and safely dispose of residuals of hazardous chemicals and the empty packaging in accordance with regulations governing waste management (Article 32, paragraph 2);
14) If fails to provide a chemical counselor and if that counselor does not have the prescribed professional degree and the proof that he passed the exam (Article 34, paragraph 1, and Article 35, paragraph 1);
15) It fails to submit within the defined time limit the application to enter the chemical into the Registry of Chemicals, in case of a chemical for which it is mandatory to be entered into this registry, or provides false data in the application to enter the chemical into this registry (Article 40, paragraph 1);
16) For a chemical which is entered into the Registry on Chemicals it fails to submit within the set time limit the data on quantities placed on the market and other changes regarding data contained in the submitted dossiers on chemicals or submits false data (Article 42, paragraph 1);
17) For a substance which causes concern i.e. the mixture which contains this substance it fails to file with the ministry competent for environmental protection the application and dossier on the chemical with the aim to register it in the Registry of Chemicals (Article 45);
18) It fails to comply with risk reduction measures and the method for systematic monitoring of the use of the substance which causes concern as set forth in the decision on the registering of the chemical into the Registry of Chemicals (Article 47, paragraph 2);
19) It does not comply with restrictions and bans prescribed by this Act and regulations adopted on the basis of this Act (Article 50);
20) It exports certain hazardous chemicals and products whose usage is prohibited (Article 60, paragraph 1);
21) It places on the market particularly hazardous chemicals without having the permit for conducting trade in particularly hazardous chemicals (Article 63, paragraph 1);
22) It fails to comply with preventive measures set forth in Article 63 paragraph 2 of this Act and conditions for safe keeping and storing, as well as if it fails to submit all changes in data which have been submitted in the procedure of permit issuance, immediately after getting the knowledge thereof (Article 69);
23) It enters into trade in particularly hazardous chemicals with legal persons i.e. sole traders who do not use them for industrial or professional purposes, as well as with other persons who do not have the permit for conducting trade or the permit to use particularly hazardous chemicals (Article 72, paragraph 1);
24) It places on the market a detergent which contains a surfactant which does not comply with the criteria of complete aerobic biodegradability, and has no permit for usage of this surfactant in a detergent issued by the ministry competent for environmental protection, i.e. has no document whereby the surfactant is allowed to be used in a detergent in the EU (Article 73, paragraph 3);
25) It fails to comply with the conditions contained in the permit for placing on the market and usage of the surfactant as a component of a detergent (Article 77, paragraph 3);
26) It fails to withdraw from the market a surfactant i.e. a detergent which contains it within the time limit set out in the decision of the ministry competent for environmental protection (Article 78, paragraph 2).
For the economic offence set forth in paragraph 1 of this Article a fine may be imposed proportionate to the amount of inflicted damage, defaulted obligation, or the value of the goods or other object that is the subject of the economic offense, but not more than twenty times the amount of the inflicted damage, defaulted obligation, or the value of the goods or other object that is the subject of the economic offense.
For the economic offense referred to in paragraph 1 of this Article the responsible person in the legal entity shall also be imposed with a fine in the range from 100,000 to 200,000 dinars.
For the economic offense referred to in paragraph 1 of this Article a protective measure constituting a ban on conducting certain business activity for up to 10 years may be imposed against the legal person in addition to the imposed fine.
For the economic offense referred to in paragraph 1 of this Article a protective measure constituting a ban on conducting certain activities for up to 10 years may be imposed against the responsible person in the legal person in addition to the imposed fine.
Article 98
Against the legal person a fine shall be imposed for misdemeanor in the range from 500,000 to 1,000,000 dinars if:
1) It fails to keep the records and collect data pursuant to Article 19 paras. 1 and 2 of this Act and fails to keep these data for at least 10 years after the last production, placing on the market and use of chemicals or fails to submit them to the ministry competent for environmental protection upon its request (Article 19);
2) It fails to submit the safety data sheet to every other distributor or downstream user in the chain of supply at their request if they obtain the mixture referred to in Article 21 of this Act;
3) It failed to submit the safety data sheet relating to a hazardous chemical intended for general use upon the request of the downstream user or distributor (Article 22);
4) The amended and supplemented safety data sheet does not contain the note "Revised" and the date when the amendments i.e. supplements were made (Article 23, paragraph 3);
5) It fails to submit, upon request of a consumer, without charge, the information on the substance set out in Article 27 paragraph 1 of this Act (Article 27, paragraph 2);
6) It fails to share with producers, importers, distributors and downstream users the new knowledge on hazardous properties of a chemical, as well as other information which are linked to data contained in the safety data sheet, and relate to certain ways in which that chemical is used (Article 29);
7) It fails to keep a certain hazardous chemical separately from other goods so as to prevent contact with other goods and be out of reach of children, as well as if it misleads a consumer in regard to its intended use (Article 33, paragraph 1);
8) Prior to the export of the chemical and product referred to in Article 53 paragraph 1 of this Act it fails to file a request with the ministry competent for environmental protection for instituting the procedure of prior notification, or if, together with the request, it has not submitted information containing the prescribed data (Article 53, paragraph 2);
9) It fails to file with the ministry competent for environmental protection a request for implementing the PIC procedure for prescribed chemicals or fails to act in accordance with the answer of the importing country (Article 56, paras. 1 and 5);
10) It fails to submit information on the exported quantities, the country importing the chemical i.e. products and general data on the importer to the ministry competent for environmental protection for the prescribed chemicals and products within the prescribed time limit (Article 58, paragraph 1);
11) It fails to submit to the ministry competent for environmental protection, apart from data referred to in Article 42, paragraph 1 of this Act also the information on the exporting country and general data on the exporter for the prescribed chemicals within the prescribe time limit (Article 58, paragraph 2);
12) It fails to submit, within the prescribed time limit, to the ministry competent for environmental protection the information on imported quantities of the product containing a chemical from the List of Chemicals for PIC Procedure, the exporting country and general data on the exporter (Article 58, paragraph 3);
13) It fails to submit to the ministry competent for environmental protection within the prescribed time limit the information requested by a competent authority of a country signatory to the Rotterdam Convention on the transit of a chemical over its territory (Article 59, paragraph 1);
14) Apart from the records referred to in Article 19 of this Act, it fails to keep the records on consumers to whom the particularly hazardous chemical was sold i.e. given without compensation (Article 72, paragraph 2);
15) It fails to keep the testing results which confirm that the criterion on complete aerobic biodegradability of a surfactant has been met, or it fails to submit them to the ministry competent for environmental protection upon its request (Article 81, paragraph 1);
16) It fails to label a detergent in accordance with provisions of this Act and in accordance with a regulation on detergent labeling passed on the basis of this Act (Article 81, paragraph 2);
17) It fails to make a List of Detergent’s Composition or fails to keep this list for five years, or fails to make available to the public on its web-site certain data contained in that list (Article 81, paragraph 3);
18) Fails to act upon the inspector’s decision, i.e. fails to enable the inspector to perform the inspection supervision (Arts. 91 and 94).
A fine may be imposed for the misdemeanors referred to in paragraph 1 of this Article in proportion to the amount of the inflicted damage or defaulted obligation, value of the merchandise or other object which is the subject of the misdemeanor, not exceeding twenty times these values.
In addition to the imposed fine for the misdemeanor referred to in paragraph 1 of this Article a legal person can be also imposed with a protective measure of a ban on conducting a certain activity for up to three years.
A responsible person in the legal person shall be fined for the misdemeanor referred to in paragraph 1 of this Article in the range of 25,000 to 50,000 dinars.
In addition to the imposed fine for the misdemeanor referred to in paragraph 1 of this Article the responsible person in a legal person can be imposed with a protective measure constituting a ban on conducting certain tasks for up to one year.
A sole trader can also be fined for the misdemeanor referred to in paragraph 1 of this Article in the range from 50,000 to 500,000 dinars.
In addition to the imposed fine for the misdemeanor referred to in paragraph 1 of this Article a sole trader can be also imposed with a protection measure constituting a ban on conducting a certain activity for up to three years.
Article 99
A responsible person within the ministry competent for environmental protection shall be fined for misdemeanor in the range from 10,000 to 50,000 dinars if:
1) Within the prior notification procedure he/she does not submit to the competent authority of the importing country a notification on the export of a chemical from the List of Chemicals for the procedure of prior notification, i.e. a chemical which contains a substance from this List in such a concentration that pursuant to this Act it must be labelled as hazardous, as well as a notification on the export of a product which contains a chemical from the List of Chemicals for PIC Procedure (Article 53, paragraph 1);
2) After receiving a notification on the export from the competent organ of the exporting country he/she does not inform that authority that the notification was received (Article 54);
3) He/she does not submit to the Secretariat of the Rotterdam Convention the answer regarding import of each chemical from the list of the Rotterdam Convention (Article 55, paragraph 2);
4) He/she does not submit to the competent authority of the exporting country the answer on the import of a chemical which is not on the list of the Rotterdam Convention, and for which that country does not request prior consent pursuant to the PIC procedure (Article 55, paragraph 3);
5) Upon request of the competent authority of a country signatory to the Rotterdam Convention over whose territory the chemical which is on the list of the Rotterdam Convention is transiting he/she does not submit requested information not later than 15 days prior to the day of the first transit, i.e. prior to any future transit (Article 59, paragraph 2);
6) He/she does not issue approval for use of a surfactant in a detergent within 12 months from the day of submission of the complete technical dossier on the surfactant, if the conditions set forth in Article 76 of this Act were met (Article 77, paragraph 1);
7) He/she does not make available to the public data on chemicals referred to in Article 84, paras. 1 and 2 of this Act;
8) He/she makes available to the public data on chemicals which are considered to be business secret referred to in Article 84, paragraph 3 of this Act except in emergency cases when this is necessary for reasons of safety and protection of human health and the environment (Article 84, paragraph 4).
For the misdemeanor referred to in paragraph 1 of this Article, and in addition to the imposed fine, the responsible person in the ministry competent for environmental protection may also be imposed with a protective measure constituting a ban on performing certain activities for the duration of one year.
Article 100
A sole trader shall be imposed with a fine ranging from 50,000 to 500,000 dinars for a misdemeanor if he/she performs any of the actions referred to in Article 97, paragraph 1 of this Act.
Article 101
A natural person shall be fined for a misdemeanor in the range from 10,000 to 50,000 dinars if:
1) He/she uses particularly hazardous chemicals without permit (Article 64, paragraph 1);
2) He/she does not observe purposes for which the permit relating to particularly hazardous chemicals was issued (Article 64, paragraph 2);
3) He/she does not comply with conditions for safe keeping and use of particularly hazardous chemicals referred to in Article 67 paragraph 3 of this Act or does not submit immediately after finding out about all changes of data which he/she submitted in the permit issuing procedure (Article 69);
4) He/she does not keep confidential data referred to in Article 84 paragraph 3 and Article 85 of this Act upon termination of activities within which they became accessible to him/her (Article 85, paragraph 5);
For misdemeanors referred to in paragraph 1 of the Article a fine can be imposed that is proportionate to the amount of the inflicted damage or defaulted obligations, the value of merchandise or other object that is the subject of the misdemeanor, but not exceeding twenty times the amount of these values.
XV TRANSITIONAL AND FINAL PROVISIONS
Article 102
The supplier is obliged to classify, label, package and advertise the chemicals and certain products pursuant to the regulation set forth in Article 18, paragraph 1 of this Act or in accordance with the regulation referred to in Article 18, paragraph 2 of this Act within one year from the day on which these regulations enter into force, whereas the regulation set forth in Article 18, paragraph 1 of this Act is applied until the deadline set out in the regulation referred to in Article 18, paragraph 2 of this Act.
The supplier is obliged to provide a chemical counselor within two years from the day of entering into force of the regulations set out in Article 34 paragraph 3, Article 35 paragraph 2 and Article 36 paragraph 3 of this Act.
A legal person and a sole trader who conduct trade in particularly hazardous chemicals and a natural person who uses particularly hazardous chemicals, are obliged to submit a request for obtaining the permit for trading in or the permit for using of particularly hazardous chemicals, pursuant to provisions of this Act, within one year from the day on which the regulations referred to in Article 63 paragraph 3, Article 65 paragraph 5 and Article 72 paragraph 3 of this Act enter into force, and the ministry competent for environment protection, i.e. unit of local self-government decides on this request within one year from the day on which the request was submitted.
If a detergent containing a surfactant which does not meet the conditions of complete aerobic biodegradability is on the market on the day when this Act enters into force, this detergent can remain further on the market if the manufacturer of the detergent files a request for issuance of the approval within one year from the day of entry into force of the regulations referred to in Article 73 paragraph 5, Article 74 paragraph 3 and Article 81 paragraph 4 of this Act.
If the ministry in charge of the environment protection issues a decision by which it refuses the request for issuance of the approval referred to in paragraph 4 of this Article, this decision sets the time limit for withdrawing the detergent from the market, which cannot exceed two years from the day on which the decision was passed.
Article 103
Proceedings which were instituted under the regulations which were in force until the day of entry into force of this Act shall be brought to the end in accordance with those regulations.
Article 104
Secondary legislation for the implementation of this Act shall be adopted within two years of the day of entry into force of this Act.
Article 105
Until adoption of secondary legislation on the basis of authorization from this Act the following regulations are applied: the Decision on Labeling Poisons on the Market ("Official Gazette of FRY", No. 38/97) and the Rules on Criteria for Categorizing Poisons into Groups and on Methods by which the Level of Toxicity of certain Poisons is Established ("Official Herald of SFRY", No. 79/91).
On the day of entry into force of this Act the following regulations are repealed: the Decision on Conditions which Legal Persons and Sole Traders who Produce, Place on the Market and Control Poisons must fulfil ("Official Gazette of FRY", No. 30/96), the Decision on Conditions to be met by a Legal Person that Conducts Activities of Poison Control Center ("Official Gazette of FRY", No. 30/96), the Rules on Conditions which have to be Met by Organizations which Issue Toxicological Assessments of Poisons and Organizations which issue the Assessment on Efficiency of Poisons ("Official Gazette of SFRY", No 22/92) and the Rules on Methods to Destroy Unused Poisons and Packaging used for Packing Poisons and on Methods of Withdrawal of Poisons from the Market ("Official Gazette of SFRY", No. 7/83).
Article 106
On the day of entry into force of this Act provisions of Article 51 of the Act on Transport of Hazardous Material ("Official Gazette of SFRY", Nos. 27/90 and 45/90 and "Official Gazette of FRY", No. 24/94 - other law, 28/96 -other law and 68/02) which relate to approval for transportation of poisons across the state border (import, export and transit) are repealed.
Article 107
On the day of entry into force of this Act the Act on Production and Trade in Poisonous Materials ("Official Gazette of FRY", Nos. 15/95, 28/96 - other law and 37/02 and "Official Herald of RS", No. 101/05 - other law) is repealed, except for provisions on categorizing and testing of poisons which shall be applied only to plant protection products, by the authority competent for plant protection, until the day of entry into force of a legislation that regulates plant protection products.
Article 108
This Act enters into force on the eighth day after the day of its publication in the "Official Herald of the Republic of Serbia".
Independent Articles of the Act Amending the Chemicals Act
("Off. Herald of RS", No. 93/2012)
Article 17
The rights and obligations of the Agency for Chemicals, established by the Decision on the Establishment of the Agency for Chemicals ("Official Herald of RS", No. 78/09), as well as employees, objects, equipment, work gear, archives and registration material whose storage has not expired, are taken over by the Ministry of Energy, Development and the Environment Protection for the purpose of exercise of authority in the field of chemicals and biocide products management, in the state they were in on the day this Act entered into force.
Article 18
The Agency for Chemicals ceases operation as of the day this Act enters into force.
Article 19
This Act enters into force on the following day after the day of its publication in the "Official Herald of the Republic of Serbia".
Independent Articles of the Act Amending and Supplementing the Chemicals Act
("Off. Herald of RS", No. 25/2015)
Article 21
The secondary legislation adopted on the basis of this Act shall be adopted within three months as of the day of entry into force of this Act.
Article 22
This Act enters into force on the day following the day of its publication in the "Official Herald of the Republic of Serbia".
PUBLISHER'S NOTE
Since Article 16, paragraph 1 of the Act Amending the Chemicals Act ("Off. Herald of RS", No. 93/2012 - hereinafter: the Act) has established that in the specific provisions of the Chemicals Act ("Off. Herald of RS" , Nos. 36/2009, 88/2010 and 92/2011), the word "Agency" in a certain case is replaced by the words: "the ministry competent for environmental protection", in the appropriate case, and bearing in mind that in this way a comprehensive revised text of that legislation has been amended with the exception of Article 31 paragraph 4, the Editorial Board has carried out this amendment in this Article of the consolidated text also, even though that was not explicitly established by the Act.