CHEMICALS ACT("Off. Herald of RS", Nos. 36/2009, 88/2010, 92/2011, 93/2011 and 25/2015) |
Article 1
This Act shall regulate 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, licenses for trade and licenses to use 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 shall be 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 shall have the following meaning:
1) Downstream user shall mean the legal person or sole trader registered within 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 shall not be considered as downstream users;
2) Detergent shall mean any substance or mixture which contains soaps, or other surfactants, which is used for washing and cleaning purposes. Detergents shall also include supplementary mixtures intended for washing purposes (prewashing, rinsing or bleaching), fabric softeners, mixtures for other cleaning purposes and similar products;
3) Distributor shall mean any legal person or sole trader registered within the Republic of Serbia, who stores chemicals or places them on the market;
4) Good laboratory practice shall be 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 shall mean scientific experimentation, analysis or research of chemicals conducted under controlled conditions;
5a) Recall shall mean any activity or measure aimed at achieving the return of a chemical or a product that has already been delivered by a manufacturer or distributor, or which has already been made available to consumers, i.e. end users;
5b) Withdrawal shall mean any 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 shall mean such level of biodegradability in which the surfactant, with the help of microorganisms in the presence of oxygen is completely degraded to carbon dioxide, water and mineral salts (mineralization);
7) Washing shall mean washing of laundry, dishes and hard surfaces;
8) Primary biodegradability shall mean structural change (transformation) of the surfactant because of the effect of microorganisms, causing loss of its capability of surface activity due to the degrading of its structure;
9) Product shall mean the object which during production is given a special shape or design which determine its function to a greater degree than does its chemical composition;
10) Production shall mean the production or extraction of substances in their natural state;
11) Manufacturer shall mean any legal person or sole trader which produces the substance;
12) Handling shall mean production, processing, packing, storing, trading, transportation and use of chemicals or any other activity related to chemicals;
13) Mixture shall mean the mixture or solution of two or more substances;
14) Supplier shall mean any legal person or sole trader who is the manufacturer, importer, distributor or downstream user, and who places the chemicals on the market;
15) Placing on the market shall mean 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 shall also be considered as placing on the market;
16) Substance shall mean a chemical element or its compounds in natural shape or obtained by a production process, including additives necessary to preserve its stability and impurity arising from a production process, excluding a solvent which can be separated in a manner which shall not affect the stability of the substance or change its composition;
17) Surfactant shall mean any 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 adsorb themselves at interface between water and solid surface;
18) Exposure scenario shall mean the 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 usage, or to several processes or ways in which the substance is used;
19) Chemical name according to IUPAC nomenclature shall mean the name of the chemical identified in the nomenclature of the International Union of Pure and Applied Chemistry - IUPAC;
20) Chemical shall mean the substance and mixture;
20a) Chemical and product intended for general use shall mean item of general use in terms of the Act governing health safety of items of general use;
21) Cleaning shall mean the definition of this notion as contained in the standard SRPS ISO 862.
2. Exceptions from Application
Article 4
Provisions of this Act shall not apply to:
1) Radioactive chemicals;
2) Chemicals in transit;
3). Transportation of hazardous chemicals.
Provisions of this Act shall not apply to chemicals which:
1). Are considered to be waste pursuant to provisions of the act which regulates waste management;
2) Are under customs supervision within the customs warehouse or in free zones for reasons of re-exporting or transit if the chemicals are not processed or additionally 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 shall not apply to chemicals which are placed on the market in their final form as:
1) Biocidal products;
2) Plant protection products;
3) Medication and medical devices for human and veterinary use;
4) Cosmetic products;
5) Food, alimentary additives and aromas;
6) Animal food and additives for that food.
Provisions of this Act related to classification, packaging and labeling of chemicals shall not apply to the following chemicals:
1) Those that 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) Those that in their final form are placed on the market as:
- Medicines and medical devices for human or veterinary use;
- Cosmetic products;
- Food, alimentary additives and aromas;
- Animal food and additives for that food.
Provisions of this Act set forth in Chapter VIII which relate to the import and export of certain hazardous chemicals shall 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 for that food;
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 effect human health and the environment, and do not exceed 10 kg for each chemical for each import.
II COMPETENCES OF THE MINISTRY RESPONSIBLE FOR ENVIRONMENTAL PROTECTION
Article 5
The ministry competent for environmental protection shall ensure conditions for quality, efficient and safe management of chemicals and biocidal products.
Article 6
The competences of the ministry responsible for environmental protection shall be to:
1. Adopt secondary legislation relevant to the implementation the Chemicals Act and Biocidal Products Act;
2. Establish the List of Classified Substances;
3. Adopt decisions on registration of chemicals with the Registry of Chemicals and to keep this Registry;
4. Keep the Integral Registry of Chemicals;
5. Publish the List of Substances which Cause Concern;
6. Implement the procedure of prior notification and the procedure of gaining consent on the base of prior notification for the import and export of certain hazardous chemicals;
7. Issue licenses for conducting trade of particularly hazardous chemicals;
8. Issue approvals for the use of surfactants in detergents;
9. Draft and implement projects which control 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. Publish lists of active substances in a biocidal product;
11. Adopt decisions on the registration of a biocidal product in the Provisional List for the submission of the technical dossier;
12. Issue approvals for placing a biocidal product on the market;
13. Take care of the assessment of a technical dossier of a biocidal product;
14. Prepare annual declarations on the production, processing and use of chemicals from lists stipulated by the act which regulates the ban on development, production, storing and usage of chemical weapons and their destruction, as well as annual declarations on the production of discrete organic substances and performs other activities pursuant to that act;
15. Perform expert and administrative and technical activities for the needs of the Common Body for Integrated Chemicals Management;
16. Provide information and expert instructions to economic subjects, units of local self-government and inspectors for enforcement of acts in the field of chemicals and biocid products management, as well as to provide professional assessment of the properties and intended use of certain chemicals;
17. Establish 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 take part in different aspects of chemicals management;
18. Carry out activities to inform the public on the effect of chemicals upon human health and the environment, measures for risk reduction and safe use of chemicals;
19. Perform other activities established by this Act, act that regulates biocidal products and other acts.
III INTEGRATED MANAGEMENT OF CHEMICALS
Article 7
In order to achieve the principles of strategic approach to chemicals management, to ensure adequate chemicals management in all phases of chemicals’ life-cycle from production, i.e. import to disposing, as well as in order to contribute to sustainable development of the Republic of Serbia, the minister competent for the environment (hereinafter: the Minister), pursuant to rules which regulate the state administration, shall establish by his decision the Common Body for Integrated Chemicals Management (hereinafter: Common Body).
The Common Body shall comprise representatives of relevant government bodies in the field of chemical management, industry, scientific and research organizations and non-governmental organizations.
The ministry competent for environmental protection shall perform expert and administrative and technical activities for the needs of the Common Body.
The task of the Common Body shall be 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 shall be adopted by the Government.
Article 8
A legal and natural person who handles the chemicals shall undertake necessary measures to deter or avoid hazardous effect of chemicals upon human health, the environment and property.
The manufacturer, importer or downstream user who places a chemical on the market shall assess dangerous properties of that chemical prior to its placement on the market and shall notify on that matter other legal and natural persons how to handle a chemical safely.
The manufacturer, importer and others who handle the hazardous chemical shall replace it by a safer alternative whenever this is possible, i.e. when socio-economic reasons and technical possibilities make this possible.
IV CLASSIFICATION, PACKAGING, LABELING AND STORING OF CHEMICALS
1. General Provisions on Classification, Packaging and Labeling
Article 9
A manufacturer, importer and downstream user who place chemicals and certain products on the market shall classify them, and the supplier of chemicals shall label them and package them pursuant to this Act and legislation adopted pursuant to this Act.
The exporter shall package and label the chemical for export pursuant to this Act and legislation adopted pursuant to this Act, unless it is necessary to label and package the chemical in another way, pursuant to international standards, and the importing country requires it to be done.
Article 10
Classification of chemicals and certain products shall be based on the assessment of their physical and chemical properties, properties which effect human life and health, properties which effect the environment, as well as criteria established for their classification into certain hazard classes.
A hazardous chemical shall be a chemical that can be classified into at least one of the hazard classes.
Within a hazard class the chemical can be further classified in different ways depending on the path of exposure of humans or the environment to this chemical or on the basis of the nature of its effect.
The ministry competent for environmental protection shall define in more detail the method by which a chemical or certain product shall be classified.
Article 11
A substance shall be classified pursuant to the classification of the substance with identical chemical composition from the List of Classified Substances.
If a substance is not listed in the List of Classified Substances or is within this List not classified into all hazard classes and varieties within these classes, its classification shall be made on the basis of existing data on the properties of that substance, i.e. on the basis of results of new research regarding its properties and by comparing these data, i.e. results with criteria established for the classification of chemicals.
The ministry competent for environmental protection shall enact the List of Classified Substances.
Article 12
A mixture shall be classified by assessing its 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 that mixture represents, i.e. by 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
While classifying a chemical, 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 humans when they exposed to the chemical in case of an accident, as well as data acquired by other internationally recognized methods for identifying chemicals' properties.
Evidence of a chemical's hazardous effect gained through research on animals shall be 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 shall be 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 on the chemical for the purpose of classification shall be conducted in such a manner as to avoid, whenever possible, using the vertebrates.
It shall be prohibited to conduct research aimed at classifying chemicals by using primates.
Article 15
New research of a chemical for the purpose of its classification shall be carried out pursuant to prescribed methods.
Toxicological and eco-toxicological research shall be conducted in laboratories whose work is harmonized with principles of good laboratory practices.
The ministry competent for environmental protection shall prescribe methods for the examination of hazardous properties of chemicals.
4. Packaging, Labeling, Advertising and Data Recording
Article 16
A package for a hazardous chemical and a certain product shall correspond to the properties, purpose and manner of use of a chemical or product and shall be labeled in a proper way.
The package for a hazardous chemical, a given product and a given 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 name 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 package, as well as graphic symbols, labels and text which indicate the hazardous properties of the chemical.
The package of a chemical and a certain product shall contain the label also in the Serbian language.
A given hazardous chemical shall be labeled in such a manner as to enable handicapped persons to identify the hazard, and the package of a given hazardous chemical shall have a safety cap which makes it difficult for children to open it.
The way of labeling and packaging of a hazardous chemical shall depend on whether this chemical is packaged in both the internal and external package, i.e. whether or not the hazardous chemical is in a single package which serves also for placing on the market and for transportation.
The ministry competent for environmental protection shall define in more detail the way in which a chemical and a given product is packaged and labeled.
Article 17
The supplier of a hazardous chemical and a given mixture which is not hazardous but does contain at least one substance which is classified as hazardous, shall 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 shall prescribe in more detail the way to advertise the chemical.
Article 18
The ministry competent for environmental protection shall issue the regulation on the manner of classification, packaging, 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 pursuant to EU rules.
Apart from the regulation mentioned in paragraph 1 of this Article the ministry competent for environmental protection shall also adopt the rule which regulates the method of classification, packaging, labeling and advertising of a chemical and certain product pursuant to the UN Globally Harmonized System of Classification and Labeling of Chemicals.
A chemical and a certain product may be classified, packaged, labeled and advertised in accordance with the regulation contained in paragraph 1 of this Article or paragraph 2 of this Article.
Article 19
The supplier shall keep records on chemicals which contain in particular 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 shall 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 shall keep the records mentioned in paragraph 1 of this Article and data stipulated 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 terminates operation the responsible officer of the supplier shall deliver these data immediately upon termination of operation to the ministry competent for environmental protection.
The ministry competent for environmental protection shall define the ways in which records on chemicals are kept.
Article 20
The supplier shall submit the safety data sheet when placing a hazardous chemical on the market, a chemical which contains substances identified as persistent – bioaccumulative - toxic (hereinafter: PBT) or very persistent-very bioaccumulative (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, printed or in electronic form.
The exporter of the chemical set forth in paragraph 1 of this Article shall 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 shall contain particularly 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 safety report for a chemical and the exposure scenario have been made, 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 shall define criteria for the identification of the substance as PBT or vPvB and the more detailed contents of the safety data sheet.
Article 21
The supplier shall 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 presents 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. A substance for which maximum allowed concentrations at the workplace are prescribed.
Article 22
The supplier shall not 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 was submitted, unless required so by the downstream user or distributor.
Article 23
The supplier referred to in Article 20, paragraph 1 of this Act shall amend and supplement 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 the measures for risk reduction and control, i.e. the chemical's hazard, as well as about 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 shall 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 past 12 months.
The amended and supplemented safety data sheet shall contain the note "Revised" and the date on which the amendments i.e. supplements have been introduced.
6. Report on the Safety of the Chemical
Article 24
The report on safety of a chemical shall mean a document containing the assessment of a chemical’s safety with measures for reduction and control of substance’s risk.
Article 25
The assessment of the safety of a chemical shall be done in two phases.
In the first phase it shall be 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 assessment shall be made about the exposure of humans and of the environment to this substance and characterization of the risk that a substance which in the first phase was assessed to have fulfilled the criteria to be classified as hazardous, i.e. to fulfill the criteria to be identified as a PBT or vPvB substance.
The assessment of exposure and characterization of risks shall be made for all identified ways in which the substance is used.
Article 26
On the basis of assessment the chemical’s safety, measures shall be established to reduce and control the risk presented by the substance.
The ministry competent for environmental protection shall prescribe the way in which the safety of a chemical shall be assessed and the contents of the report on the chemical's safety.
The chemical safety report shall be submitted to the ministry competent for environmental protection in the Serbian language, and can be submitted in the 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 shall provide each distributor or downstream user in the supply chain with information sufficient for the safe use of such 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 shall without compensation, upon request of the consumer, submit information on the substance set forth in paragraph 1 of this Article.
The ministry shall publish 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 chemicals shall handle them in a safe manner in accordance with the instructions on proper use, safety and protection of health during usage, the instructions on handling the residues of unused hazardous chemicals and empty packages, 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) shall share new knowledge on hazardous properties of chemicals, 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 on the package the hazardous substance contained in the mixture, the alternative chemical name for that substance can be used in the way that a name is used which identifies the most important chemical functional groups or another alternative designation.
The manufacturer, importer or downstream user of the hazardous substance contained in the mixture shall submit the 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 certain properties.
The manufacturer, importer or downstream user shall pay a fee for expert assessment of justifiability of use of the alternative chemical name.
The ministry competent for environmental protection shall prescribe the properties of a substance for which an alternative chemical name can be used, 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, paragraph 3 and 4 of this Act are met, the ministry competent for environmental protection shall issue 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 cancel 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 shall be final and it can be challenged in administrative dispute proceedings.
9. Storing, Disposal and Retail
Article 32
The manufacturer, importer, distributor and downstream user shall 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 shall collect, store and safely dispose residues of hazardous chemicals and empty packages pursuant to regulations which govern waste management.
Article 33
A given 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 shall define in more detail the conditions under which hazardous chemicals are to be kept in the store and the way in which the place where they are sold has to be marked.
Article 34
The supplier of hazardous chemicals shall provide a person which takes care of proper management of these chemicals (hereinafter: chemical counselor).
Notwithstanding paragraph 1 of this Article, specific suppliers of hazardous chemicals shall not be obligated to provide a chemical counselor.
The ministry competent for environmental protection shall prescribe the type, sector and area of activity of the supplier referred to paragraph 2 of this Article.
Article 35
A chemical counselor shall have adequate professional education and passed chemical counselor exam.
The knowledge of the chemical counselor shall be tested every six years.
The ministry competent for environmental protection shall prescribe the professional degree, the training program and method by which the knowledge of the chemical counselor shall be tested.
Article 36
Training and testing of knowledge of the chemical counselor in accordance with the prescribed program shall be performed by a legal person or sole trader who meets the conditions regarding expert staff, premises and technical equipment to perform the training.
The ministry competent for environmental protection shall issue the approval to the legal person or sole trader who fulfilled conditions mentioned in paragraph 1 of this Article.
The ministry competent for environmental protection shall define in more detail the conditions which a legal person or sole trader must fulfill in order to train chemical counselors and test their knowledge.
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, a chemical counselor shall control whether this Act and subsequent regulations adopted on the basis of this Act are properly implemented.
VI INTEGRAL REGISTRY OF CHEMICALS
Article 38
The integral registry of chemicals which are in the market of the Republic of Serbia shall consist of the Registry of Chemicals and the Registry of Biocidal Products, as well as of data on plant protection products.
Data on plant protection products mentioned in paragraph 1 of this Article encompass particularly the data on trade name of the plant protection product, 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; the plant protection authority obtains these data within the registration procedure on the basis of the act which regulates plant protection products.
The authority competent for plant protection shall submit to the ministry competent for environmental protection 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 were placed on the market in the previous year.
The ministry competent for environmental protection shall maintain the integral registry of chemicals also as an electronic database with the aim to share data and integrate the management of chemicals.
Article 39
The chemicals which are manufactured or imported to the market of the Republic of Serbia shall be registered with 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 below the regulated annual threshold, as well as other specific chemicals shall not be registered with the Registry of Chemicals.
The ministry competent for environmental protection shall prescribe certain chemicals which shall not be registered with the Registry of Chemicals as well as the threshold for the quantity of chemicals with certain properties and ways in which they are used, below which such chemical shall not be registered with the Registry of Chemicals.
Article 40
The manufacturer, importer or downstream user (hereinafter: person who registers the chemicals) shall 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 with the Registry of Chemicals directly to the ministry competent for environmental protection or through an agent who shall attach the power of attorney.
The application mentioned in paragraph 1 of this Article shall contain: name and address, taxpayer's identification number, type of business, name of the responsible officer in the company, 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 submitted shall be also the dossier on each chemical, and for the chemical for which it is prescribed that it must have the safety data sheet also that sheet.
The dossier on chemicals shall contain particularly:
1. Trade name of the chemical and other identification of the chemical;
2. Data on the quantity of 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 shall define 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 shall verify from the dossier the completeness of the data on chemicals.
The ministry competent for environmental protection shall issue 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 sheet data was 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 shall record the registry number for each chemical referred to in Article 2 of this Article.
The manufacturer, importer or downstream user shall pay 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 shall be final and an administrative dispute may be initiated against it.
Article 42
The person who registered the chemicals with the Registry of Chemicals shall each subsequent year within the time limit stipulated in Article 40, paragraph 1 of this Act for those chemicals submit data on quantities placed on the market and other changes regarding data in the submitted dossiers on chemicals.
The ministry competent for environmental protection shall prescribe in more detail which data on each chemical shall be kept with 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 given substance with an adequate safer alternative substance the ministry competent for environmental protection shall publish the List of Substances which Cause Concern.
The List of Substances which Cause Concern shall be formed by the substances that fulfill 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 shall also contain substances which lead to disturbances in the functioning of the endocrine system or have PBT or vPvB properties, but do not fulfill 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 shall be published in the "Official Herald of the Republic of Serbia”.
Article 44
The List of Substances which Cause Concern shall contain 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 define additional measures for risk reduction.
Article 45
Downstream user who uses the substance which causes concern, i.e. mixture which contains this substance, shall 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 with the Registry of Chemicals.
Article 46
The Dossier on a chemical for a substance which causes concern, i.e. the mixture which contains this substance, shall include apart from data set forth in Article 40 of this Act also a more detailed description of the way in which this substance or the mixture which contains it shall be 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 a chemical set forth in paragraph 1 of this Article shall contain, if available, also 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 shall make an expert assessment of submitted data, measures for risk reduction and the proposal for the manner of systematic monitoring of the use of the substance which causes concern from the dossier on the chemical.
If the ministry competent for environmental protection should assess that measures for risk reduction i.e. manner of systematic monitoring of the use of the substance which causes concern are not adequate, it shall issue a decision to order amendments and supplements to proposed measures for risk reduction, i.e. manner of systematic monitoring of the use of the substance which causes concern, and shall set a time limit for the execution 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 shall be final.
Article 47
In case of a substance which causes concern, i.e. the mixture which contains this substance, the decision on registration of the chemical with the Registry of Chemicals can include measures for risk reduction and the manner in which the use shall be systematically monitored.
The manufacturer, importer or downstream user shall obey the measures included in the decision referred to in paragraph 1 of this Article for risk reduction and the manner in which the use is systematically monitored.
Article 47a
The manufacturer, importer or downstream user shall pay 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 shall prescribe 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 shall contain 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 immediately implement the limitations and bans for a given substance, mixture or product, the ministry competent for environmental protection shall by the very same regulation define time limits upon expiration of which the limitations and bans shall become applicable.
Article 50
The manufacturer, importer, distributor and downstream user of the substance, mixture and product shall comply with limitations and bans prescribed by this Act and regulations enacted 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 consent procedure based on prior information for given hazardous chemicals and pesticides in international trade (hereinafter: Rotterdam Convention), a procedure of prior notification, i.e. procedure for giving consent upon prior notification (hereinafter: PIC procedure) shall be executed for the import and export of a certain substance for whose production, placing on the market and use limitation and ban were established, as well as for certain mixtures and products which contain this substance.
Limitations and bans set forth in paragraph 1 of this Article shall relate to limitations and bans set forth in Article 49 of this Act or these limitations and bans shall be established on the basis of an act which allows for placing on the market of a chemical pursuant to the act which regulates plant protection products, i.e. the act which regulates biocidal products.
The procedure of prior notification shall be applied to chemicals from the List of Chemicals for the procedure of prior notification, and the PIC procedure shall be applied to chemicals from the List of Chemicals for PIC procedure.
The List of Chemicals for prior notification procedure shall particularly contain 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 shall particularly contain 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 shall contain also certain chemicals from the List of Chemicals for PIC procedure.
The List of Chemicals for PIC procedure shall contain also chemicals from the List of the Rotterdam Convention.
Article 52
Categories of chemicals for which the PIC procedure is implemented shall be industrial chemicals and pesticides.
Subcategories of industrial chemicals to which the procedure of prior notification is applied shall be:
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 applied shall be:
1) Subcategory of plant protection products;
2) Subcategory of other pesticides which encompasses biocidal products and other chemicals which have pesticidal effects.
1. Procedure of Prior Notification
Article 53
The procedure of prior notification shall be implemented for exports by having the ministry competent for environmental protection submit 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, i.e. chemical which contains a substance from this list in such a concentration that pursuant to this Act it is labeled as hazardous, as well as the information on the export of the product which contains the chemical from the List of Chemicals for PIC procedure.
The exporter of the chemical and products set forth in paragraph 1 of this Article shall 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 containing particularly the identity of the chemical, data on himself and the importer of the chemical or the product, as well as data on that 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 shall prepare the notification for the importing country and shall implement the procedure of prior notification.
The ministry competent for environmental protection shall issue to the exporter set forth in paragraph 2 of this Article the certificate that the procedure of prior notification was implemented.
The ministry competent for environmental protection shall prescribe the procedure and time limits within which the procedure of prior notification shall be 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 shall be submitted for the implementation of that procedure.
The integral part of the regulation set forth in paragraph 5 of this Article shall also be the List of Chemicals for the procedure of prior notification.
Article 54
For chemicals whose production, placing on the market and use is prohibited i.e. limited pursuant to rules of the exporting country, the procedure of prior notification for import shall be implemented by having the ministry competent for environmental protection, after acquiring notification on the export from the relevant authority of the exporting country, inform that authority that it had received the notification.
Article 55
PIC procedure shall be implemented to the import i.e. export of a chemical that is on the List of Chemicals for PIC procedure i.e. a chemical which contains a substance from this list in such concentration that pursuant to this Act it is labeled as hazardous.
The ministry competent for environmental protection shall 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 shall 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 paragraphs 2 and 3 of this Article can be consent, consent under certain conditions, i.e. denial, and shall be prepared on the basis of established restrictions and bans set forth in Article 49 of this Act or on the basis of the act which allows the chemical to be placed on the market pursuant to acts which regulate plant protection products, i.e. biocidal products.
Regarding plant protection products, the ministry competent for environmental protection shall prepare the answer referred to in paragraphs 2 and 3 of this Article in cooperation with the authority competent for plant protection, and for chemicals that have pesticidal effect with the authority competent for such chemicals.
Article 56
In case of a chemical which is on the List of Chemicals for PIC procedure, i.e. a chemical which contains a substance from this list in such a concentration that pursuant to this Act it is labeled as hazardous, the exporter shall submit to the ministry competent for environmental protection the request for the implementation of the PIC procedure.
Notwithstanding paragraph 1 of this Article, the exporter shall have no obligation to file a request for the implementation of PIC procedure in the case of a chemical from the list of the Rotterdam Convention if the country which is party to the Rotterdam Convention has submitted the answer for this chemical to the Secretariat of that convention.
Upon request set forth in paragraph 1 of this Article the ministry competent for environmental protection shall request prior consent pursuant to PIC procedure from the competent authority of the importing country.
The ministry competent for environmental protection shall issue to the exporter who submitted the request for the implementation of PIC procedure the certificate that the PIC procedure has been implemented and enters therein the answer set forth in Article 55, paragraph 4 of this Act.
The exporter referred to in paragraph 4 of this Article shall act in accordance with the answer of the competent authority of the importing country.
Article 57
The ministry competent for environmental protection shall define in more detail the procedure and time limits within which the PIC procedure shall be implemented, as well as the content of the request for the implementation of the PIC procedure.
The integral part of the regulation referred to in paragraph 1 of this Article shall be the List of Chemicals for PIC procedure.
3. Other Provisions Relating to the Export and Import of Chemicals
Article 58
The exporter of the chemical from the List of Chemicals, in case of the procedure of prior notification i.e. chemical which contains a substance from this 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, shall 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.
The importer of the chemical from the List of chemical, in case of the procedure for prior notification, i.e. the chemical which contains a substance from this list, as well as chemicals from the List of chemicals for PIC procedure, i.e. chemicals which contain a substance from this list, shall 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.
The importer of the product which contains the chemical from the List of Chemicals for PIC procedure shall submit to the ministry competent for environmental protection not later than 31 March of the current year for the previous year the information 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 shall maintain the Records of imported and exported chemicals i.e. products under the procedure of prior notification and PIC procedure in a form of an electronic database.
Article 59
The exporter shall submit to the ministry competent for environmental protection information requested by the competent authority of the country that is party to the Rotterdam Convention related to the transit over its territory of a chemical from the list of the Rotterdam Convention not later than 30 days prior to the first transit, or eight days prior to each subsequent transit.
The ministry competent for environmental protection shall submit to the competent authority of the country that is party to the Rotterdam Convention referred to in paragraph 1 of this Article information on the transit of chemical not later than 15 days prior to the first transit or prior to each subsequent transit.
The ministry competent for environmental protection shall define the list of countries that are parties 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 shall not be exported.
Apart from chemicals set forth in paragraph 1 of this Article, the chemicals, particularly pesticides whose purity is not in compliance with the prescribed one, as well as chemicals whose expiration date is six months after export, shall not be exported.
The list of hazardous chemicals and products whose export is prohibited shall 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 shall define the List of Hazardous Chemicals and products whose export is prohibited.
Article 60a
The exporter shall pay a fee for assessment of the data submitted for the purpose of carrying out procedure of prior notification and the PIC procedure.
Article 61
(Deleted)
Article 62
The customs authority shall verify the implementation of prior notification procedure, i.e. the PIC procedure.
IX LICENSES FOR TRADE AND LICENSES FOR USE OF PARTICULARLY HAZARDOUS CHEMICALS
Article 63
A certain hazardous chemicals (hereinafter: particularly hazardous chemicals) can be placed on the market only by legal persons or sole traders who have the license to trade in these chemicals.
The license for trading in particularly hazardous chemicals shall be issued to the legal person or sole trader who both 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 shall prescribe particularly hazardous chemicals for which licenses shall be issued as well as particularly hazardous chemicals for which no license shall be needed.
Article 64
Natural persons who use particularly hazardous chemicals shall have the license to use these chemicals.
The license for using particularly hazardous chemicals shall be issued to the natural person which uses them for artistic, scientific and other specific purposes, if no other alternative chemicals can be used as replacement, if he is using and keeping them in a safe way, as well as if he was not convicted to non-suspended imprisonment for a period longer than six months.
Article 65
The request for issuance of the license set forth in Article 63, paragraph 1 and Article 64, paragraph 1 of this Act shall particularly contain the name and address of the applicant, data on particularly hazardous chemicals and the purpose for which the license is requested.
With the request for issuing the license for trade in particularly hazardous chemicals submitted shall also be the evidence that an adequate storehouse has been provided and that preventive measures for safe keeping and storing of particularly hazardous chemicals have been established.
With the request for issuing the license to use particularly hazardous chemicals submitted shall also be 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 has not been convicted to non-suspended imprisonment for a period longer than six months.
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 the manner of executing the internal control of safety procedures and handling of particularly hazardous chemicals.
The ministry competent for environmental protection shall prescribe:
1) Form of the request and form of the license for trading, i.e. license for using particularly hazardous chemicals;
2) Instructions on establishing preventive measures for safe keeping, storing i.e. using particularly hazardous chemicals.
Article 66
The procedure for issuing the license for trading in particularly hazardous chemicals shall include an assessment on whether it is necessary to write down in the license also the conditions for safe keeping and storing of these chemicals.
Within the procedure for issuing the license to use particularly hazardous chemicals an assessment shall be made on whether the license should also contain conditions for safe storing and using of these chemicals.
The time limit for the validity period of the license which cannot exceed five years shall also be set in the procedure for license issuing set forth in paragraphs 1 and 2 of this Article.
Article 67
The license for trading in particularly hazardous chemicals to the importer, manufacturer i.e. downstream user shall be issued by the ministry competent for environmental protection.
The license for trading in particularly hazardous chemicals to a distributor other than the importer, manufacturer i.e. downstream user, and the license for using particularly hazardous chemicals, shall be issued by the competent authority of the self-government unit.
Into the license set forth in Article 63, paragraph 1 and Article 64, paragraph 1 of this Act shall in particular contain the name of the holder of the license, the purpose for which the license is issued, the validity period of the license, as well as conditions for safe keeping and storing i.e. safe keeping and using established within the procedure in which the license has been issued.
The competent authority of the self-government unit shall submit once a year the report on issued licenses 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 paragraphs 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 shall be final and it can be challenged in administrative dispute.
The importer, manufacturer, i.e. downstream user or distributor who is not an importer, manufacturer, i.e. downstream user shall pay a fee for issuance of the license for trading in particularly hazardous chemicals, and a natural person shall pay a fee for issuance of the license for using particularly hazardous chemicals.
Article 68
The validity period of the license set forth in Article 66, paragraph 3, of this Act can be extended upon its holder’s request.
The ministry competent for environmental protection or the body of the unit of self-government shall assess the request for extension of the license and shall extend the license if conditions for issuing it 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 shall be final and can be challenged in administrative dispute proceedings.
The importer, manufacturer, i.e. downstream user or distributor who is not the importer, manufacturer, i.e. downstream user shall pay a fee for extension of the license to conduct trade in particularly hazardous chemicals, and the natural person shall pay a fee for extension of the license for using particularly hazardous chemicals.
Article 69
The holder of the license shall 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 particularly hazardous chemicals referred to in Article 67, paragraph 3 of this Act, as well as to submit all changes regarding data which he submitted in the procedure for issuing of the license, immediately after he finds out about such changes.
Article 70
The ministry competent for environmental protection, i.e. a body of a self-government unit, shall revoke the license referred to in Article 63, paragraph 1, and Article 64, paragraph 1 of this Act if during the license issuing procedure incorrect data were submitted and if the conditions set forth in the license are no longer fulfilled.
The decision referred to in paragraph 1 of this Article can be appealed to the Government.
The decision upon appeal referred to in paragraph 2 of this Article shall be final and can be challenged in administrative dispute proceedings.
Article 71
Scientific and research organizations, persons who are active in the field of culture, state administration bodies, public agencies and bodies of self-government units which need the particularly hazardous chemicals for performing their jobs, as well as legal and natural persons who have the license for production i.e. trade in medicines pursuant to the Act which regulates medicines, shall not need a license to trade in particularly hazardous chemicals.
Article 72
The holder of the license for trading in particularly hazardous chemicals can trade the particularly hazardous chemicals with legal persons, i.e. sole traders who use them for industrial or professional purposes, as well as with other holders of licenses for trade or licenses for use of particularly hazardous chemicals.
The holder of the license for trading in particularly hazardous chemicals shall, apart from the records set forth in Article 19 of this Act, keep also the records of customers to whom the particularly hazardous chemical was sold or given without payment.
The ministry competent for environmental protection shall prescribe the way in which records on the trade in particularly hazardous chemical are kept.
Article 73
A manufacturer of a detergent shall place the detergent on the market if the surfactant contained in this 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 shall be a legal person or sole trader who places the detergent or surfactant on the market, and who produces them, imports them or changes the detergent’s characteristics and who packages i.e. changes the labeling of the detergent.
Notwithstanding paragraph 1 of this Article, the detergent containing the surfactant which does not meet the criteria of complete aerobic biodegradability may be placed on the market if the ministry competent for environmental protection issued the approval to use that surfactant in the detergent (hereinafter: approval) or an act was passed by which it was approved to use the surfactant in detergents in the EU.
The manufacturer of the detergent referred to in paragraph 3 of this Article shall submit to the ministry competent for environmental protection a certified copy of the act which allows for the use of the surfactant in the detergent in EU.
The ministry competent for environmental protection shall prescribe criteria and methods for research of the biodegradability of the surfactant.
Article 74
The manufacturer of the detergent referred to in Article 73 paragraph 3 of this Act shall submit the request to the ministry competent for environmental protection for approval prior to placing the detergent with that surfactant on the market.
Together with the request set out in paragraph 1 of this Article submitted shall also be the technical dossier on the surfactant which particularly contains the identity of the surfactant, results of research on biodegradability of the surfactant, information on the surfactant and the metabolites of biodegradability, data on the quantity of the surfactant in the detergent which is placed on the market, the way in which it is envisaged that the detergent shall be used, as well as a proposal for assessing risks which this surfactant represents.
The technical dossier referred to in paragraph 2 of this Article shall be submitted in Serbian language, and can also be submitted in English language as one of the languages in official use in the EU.
The ministry competent for environmental protection shall prescribe 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 demand additional information within 90 days after the submission of the request referred to in Article 74 paragraph 1 of this Act.
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 shall issue a conclusion whereby it shall rejects 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 shall be 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 shall establish 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 of the use of this detergent in view of the benefit of its usage for the safety of food and maintaining hygiene.
The manufacturer of the detergent shall pay a fee for assessment of the technical dossier on the surfactant.
Article 77
The ministry competent for environmental protection shall give the approval within 12 months after the complete technical dossier on the surfactant was submitted, if the conditions referred to in Article 76 of this Act are met.
In the approval the ministry competent for environmental protection can determine conditions under which the surfactant can be placed on the market and used as the component of the detergent.
The holder of the license shall comply with the conditions for placing on the market and the use of the surfactant as the component of the detergent.
Against the decision referred to in paragraph 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 shall be final and it can be challenged in administrative dispute proceedings.
Article 78
The holder of the approval shall upon request of the ministry competent for environmental protection 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. the new way in which that detergent shall be used.
If on the basis of 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 to revoke the approval and in this decision establish the time limit in which this surfactant i.e. detergent which contains it must be withdrawn from the market.
Against the decision referred to in paragraph 2 of this Article an appeal can be filed to the Government.
The decision of the Government upon the appeal referred to in paragraph 3 of this Article shall be final and it can be challenged in administrative dispute proceedings.
Article 79
The List of Surfactants for which the approval has been issued or an act was passed which allows for the use of this surfactant in the detergent in the EU, as well as the List of Surfactants for which the request was rejected, and surfactants which are prohibited in the EU shall be published in the "Official Herald of the Republic of Serbia”.
Article 80
The laboratory which establishes biodegradability of the surfactant shall be accredited for the relevant research method or its work shall be harmonized with principles of good laboratory practice.
Article 81
The manufacturer of the detergent shall store the research results which confirm that the criterion on complete aerobic biodegradability of the surfactant is met and submit them to the ministry competent for environmental protection upon its request.
Apart from obligations in accordance with the provision of this Act which refer to the classification, packaging and labeling, the manufacturer of the detergent shall label the detergent pursuant to the rule on detergent labeling which was adopted on the basis of this Act.
The manufacturer of the detergent intended for general use shall make a Folio presenting the detergent’s composition and store it for five years, as well as make certain data contained in that List available to the public on its web-site.
The ministry competent for environmental protection shall prescribe the specific way in which detergents are labeled, the contents of the Folio on the detergent’s composition, as well as 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 shall be established by the Government upon proposal of the ministry competent for environmental protection.
Revenue from the fees prescribed by this Act shall belong to the budget of the Republic of Serbia.
XI SYSTEMATIC MONITORING OF CHEMICALS
Article 82
The ministry competent for environmental protection shall design and carry out projects in order to monitor how the chemicals are placed on the market and used, to monitor their metabolites and the routes of chemical in the environment and living organisms with the aim to monitor the risk which the chemicals represent for human health and the environment i.e. to control 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.
For implementing projects referred to in paragraph 1of this Article the ministry competent for environmental protection can hire scientific and research organizations.
Article 83
The Poisoning Control Centre shall submit to the ministry competent for environmental protection data collected pursuant to the act which 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 shall submit to the Poison Control Centre information on chemicals and the properties of chemicals that it has at its disposal and which are necessary for the Centre’s work.
Information referred to in paragraph 3 of this Article the Poisoning Control Centre can obtain in emergency cases also from the person which places the chemical 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 cannot 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 shall be available to the public, as well as other data at the disposal of the ministry competent for environmental protection, in particular:
1) Chemical name pursuant to IUPAC nomenclature of the hazardous substance contained in the chemical;
2) Trade name of the chemical;
3) Classification and labeling of the chemical;
4) Data on physical and chemical properties of the chemical;
5) Data on the route of the substance and its fate in the environment;
6) Results of toxicological and ecotoxicological research of the chemical;
7) Threshold of the effect;
8) Instruction for safe handling;
9) Analytical methods for the identification of the hazardous substance in the case of its release 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 hereof shall also be available to the public.
The ministry competent for environmental protection shall consider the following a trade secret and shall not make it publicly available:
1) Information on the full composition of the mixture;
2) Precise purpose and method of application of the substance;
3) Relationship between producers, importers and further users in the supply chain;
4) Precise amount of chemicals produced or placed on the market.
In emergency cases, when necessary for the safety and protection of human health and the environment, the ministry competent for environmental protection may make available the information specified in paragraph 3 of this Article too.
Article 85
A person who in accordance with provisions of this Act submits to the ministry competent for environmental protection data in the procedure for the entry of chemicals into the Registry of Chemicals, in the procedure for issuing the license for trade and the license for using particularly hazardous chemicals and other procedures, as well as the data which it submits to the ministry competent for environmental protection upon its request and which are not stated in Article 84 paragraphs 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 needs to be restricted pursuant to this Act and legislation which regulates free access to information of public importance and shall issue a decision to this effect.
Before issuing the decision referred to in Article 3 of this Article, the ministry competent for environmental protection shall consult the person which marked these data as confidential.
Employees of the ministry competent for environmental protection, those of the Centre for Control of Poisoning, medical workers, as well as other persons who while performing their jobs had access to confidential data, shall keep them also 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 shall be final and can be challenged in administrative dispute proceedings.
Article 86
The implementation of this Act and regulations adopted thereunder shall be monitored by the ministry competent for environmental protection.
Inspection shall be performed by the ministry competent for environmental protection through the inspector for environmental protection, ministry competent for health affairs through health inspectors and ministry competent for trade affairs through market inspectors.
The inspector for environmental protection shall monitor the classification, packaging, labelling, and advertising of chemicals, contents and delivery of the safety data sheet, provision of counselor for chemicals, entering of 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 the implementation of the provisions of this Act for which sanitary, i.e. market inspector has no jurisdiction.
The sanitary inspector shall monitor the implementation of limitations and bans on production, trading in and using of the chemicals and products intended for general use.
The market inspector shall monitor the fulfilment of the requirements for keeping hazardous chemicals in the sales area and the way of labelling such area.
Inspections referred to in paragraph 2 of this Article shall cooperate and inform each other on measures undertaken, share information, provide immediate assistance and undertake joint measures and activities relevant to the implementation of monitoring.
The unit of self-government shall monitor the affairs assigned to it by this Act.
Article 87
(Deleted)
Article 88
The ministries referred to in Article 86, paragraph 2 of this Act shall, by means of an agreement, form, in accordance with the regulations governing state administration, a joint body for the purpose of: planning, monitoring, harmonising and undertaking joint measures and activities for implementation of this Act, mutual cooperation, including inspection and training of the competent inspection staff, in accordance with this Act.
The agreement referred to in paragraph 1 of this Article shall also govern the issues of planning and programming of measures and activities in supervision of implementation of this Act.
Article 89
Inspectors for environmental protection and sanitary inspectors (hereinafter: inspectors) can take samples and preliminary control of the content of a chemical and 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 shall put at the disposal of the inspector in charge the quantities of free samples required for analysis.
The costs of sampling and analysis of the chemical and product shall be borne by the legal or natural person or sole trader from which the sample was taken, if determined in a final procedure that it does not conform to the prescribed properties. If the sample conforms to the prescribed properties, the costs of sampling and analysis of the chemical and product shall be paid from the funds provided by the budget of the Republic of Serbia.
Article 90
When performing the inspection the inspector shall have the right and the duty to establish:
1) Whether a chemical and a given 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 the advertising of a hazardous chemical and a given mixture which is not hazardous but does contain at least one substance which is classified as hazardous is in accordance with this Act;
3) Whether the prescribed records are kept and prescribed data on chemicals 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 with the prescribed characteristics and concentrations, whether the information is submitted which is sufficient for the safe use of that product, and particularly the name of that substance;
6) Whether the approval was issued for the use of an alternative chemical name of a substance and whether this name is used in accordance with the approval;
7) Whether the hazardous chemicals are stored in such a way as not to endanger human life and health and the environment, i.e. whether the residues of such chemicals and the empty packages are handled in accordance with the regulation which governs waste management;
8) Whether hazardous chemical are kept in the sales area under the prescribed conditions and if such area is labeled 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 chemical with statutory obligation to be registered with the Registry of Chemicals was filed for registration in the prescribed time limit, i.e. whether in each subsequent year in the given time limit the prescribed data were submitted and whether the submitted data were accurate;
11) Whether the measures written down in the decision on the entry of the chemical into the Registry of Chemicals are implemented in regard to the substance which causes concern;
12) Whether actions are taken in accordance with bans and limitations;
13) Whether prior to export the information prescribed for the procedure of prior notification are being submitted and whether this information is being submitted within the prescribed time limit;
14) Whether the request for the implementation of the PIC procedure is being submitted;
15) Whether the placing on the market or using of particularly hazardous chemicals was performed by the person who has the license to do so;
16) Whether the person who holds the license for trade or the license 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 detergents are complied with;
18) Whether other measures and conditions prescribed by this Act are implemented.
Article 91
In performing duties set forth in Article 90 of this Act the inspector shall be authorized and obliged to:
1) Order that the chemical and given product which are placed on the market are classified, labeled and packaged in accordance with this Act and regulations adopted on the basis of this Act;
2) Prohibit placement on the market of the chemical and given product which are classified, labeled and packaged contrary to provisions of this Act and regulations adopted 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 regulations adopted on the basis of this Act, and order or arrange that the consumers and end users are warned about the hazards posed by the chemical and specific product;
3) Order that the advertising of a dangerous chemical and a given 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 regulations adopted on the basis of this Act;
4) Prohibit advertising of the hazardous chemical and a given mixture which is not hazardous but does contain at least one substance which is classified as hazardous which is contrary to provisions of this Act and regulations adopted on the basis of this Act;
5) Order that the prescribed records must be kept and the prescribed data on the chemical to be collected, as well as that the records and data are stored during the prescribed time limit;
6) Order the fulfillment of prescribed obligations in relation to the contents, updating and submitting of the safety data sheet;
7) Prohibit the placement on the market of a hazardous chemical, a chemical which contains a substance identified as PBT or vPvB, as well as 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 were not fulfilled;
8) Order that for the product which contains the substance with prescribed properties and concentrations information shall be submitted which shall be sufficient for a safe use of that product, and particularly the name of that substance;
9) Prohibit the use of the alternative chemical name of the substance if the approval has not 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 residues of these chemicals and the empty packages are handled in accordance with the regulation which governs waste management;
11) Prohibit that hazardous chemicals are stored in a manner which endangers human life and health and the environment, i.e. that the residues of such chemicals and the empty packages are handled in an unsafe manner contrary to the regulation which governs waste management;
12) Order that a given 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 given hazardous chemical which is placed on the market as a product intended for general usage, contrary to prescribed conditions;
14) Order the supplier to ensure 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 ensures a chemical counselor with the prescribed professional degree and proof on the passed exam;
16) Order that the chemical for which the obligation of registration with the Registry of Chemicals has been prescribed, is filed for registration within a specified time limit, i.e. that prescribed data are submitted every subsequent year within the prescribed time limit;
17) Order the implementation of measures written down in the decision on the registration of the chemical with the Registry of Chemicals in the case of substances which cause concern;
18) Prohibit the usage of the substance which causes concern until measures written down in the decision on the registration of the chemical with the Registry of Chemicals are implemented;
19) Order that the limitations and bans are complied with;
20) Prohibit production, placing on the market and usage of the substance, mixture and product if they are handled contrary to limitations and bans;
21) Order the withdraw from the market of a substance, mixture and product if the limitations and bans are not complied with;
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 limitations and bans, including the compulsory execution of the measure ordering recall of the 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 prohibitions are returned to the country of origin or to treat them in accordance with the regulation which governs waste management;
23) Order the submission prescribed information for the procedure of prior notification prior to the export and the submission of such information within the prescribed time limit;
24) Order the submission of a request for the PIC procedure;
24a) Order the supplier to obtain the license from the competent authority for carrying out activities of trade in or use of particularly hazardous chemicals;
25) Prohibit that particularly hazardous chemicals are placed on the market or used by a person which has no license in this regard;
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 the detergent;
28) Prohibit placing on the market of the detergent if actions are 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 the law.
Article 92
For measures ordered during inspection the inspector shall issue a decision.
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 may issue the decision referred to in Article 91 of the present Act also orally and order its execution without delay.
The decision declared orally and referred to in paragraph 2 of this shall also be issued in writing by the inspector within 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 market inspectors an appeal can be filed with the minister competent for trade.
The appeal referred to in paragraphs 1-3 of this Article shall be filed within the time limit of 15 days as of the day of receipt of the decision.
The appeal against the inspector’s decision shall not delay its enforcement.
The decision upon appeal referred to paragraph 1, 2 and 3 of this Article shall be final and it can be challenged in administrative dispute proceedings.
Article 94
Any legal or natural person or sole trader shall enable the inspector to perform the inspection, 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 inspection the inspector finds that other acts and regulations are violated whose violation can have impact upon human life and health, the environment and safety at the workplace, he shall immediately inform the competent authority and together with it he shall conduct monitoring and undertake appropriate measures.
Article 96
The inspector shall have an official identification card, badge and adequate equipment.
Article 97
Against a legal person a fine shall be imposed in the range from 1,500,000 to 3,000,000 dinars if:
1) The chemical and the given product which it places on the market are not classified, i.e. labeled and packaged pursuant to this Act and relevant regulations adopted on the basis of this Acts (Article 9, paragraph 1);
2) For the purpose of classification of a chemical it experiments on primates (Article 14, paragraph 2);
3) It places on the market a hazardous chemical and a given mixture which itself is not hazardous but does contain at least one substance which is classified as hazardous, and fails to point out its hazardous properties in the 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 on the market a hazardous chemical, 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 deliver without compensation, 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 deliver 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) 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 were made (Article 20, paragraph 4);
8) If fails to make amendments and supplements to the contents of the safety data sheet in accordance with new knowledge on the chemical, and particularly knowledge which can affect the measures for reduction and control of the risk i.e. chemical’s hazard, as well as on restrictions and prohibitions regarding production, placing on the market or usage of the chemical (Article 23, paragraph 1);
9) It failed to deliver 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) If fails to deliver to every other distributor or downstream user in the chain of supply information sufficient for safe usage of the product which contains the substance which has prescribed properties and concentrations (Article 27, paragraph 1);
11) It uses the alternative chemical name for the hazardous substance contained in the mixture without the approval of the ministry competent for environmental protection in the safety data sheet or when labeling the packaging, or does that contrary to the contents of the approval (Article 30, paragraph 1 and Article 31 paragraphs 2 and 5);
12) If 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 residues of hazardous chemicals and the empty packaging in accordance with the regulations governing the 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) If fails to submit within the defined time limit the request for registration of chemicals with the Registry of Chemicals for a chemical for which it is mandatory to be entered into this Registry or provides inaccurate data in the request for registration with that Registry (Article 40, paragraph 1);
16) For a chemical which is entered into the Registry on Chemicals it fails to submit within the prescribed time limit the data on quantities placed on the market and other changes regarding data contained in the submitted dossiers on chemicals or submits inaccurate data (Article 42, paragraph 1);
17) For a substance which causes concern i.e. a mixture which contains that substance it fails to file with the ministry competent for environmental protection the request and dossier on the chemical for the purpose of registration 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 with the Registry of Chemicals (Article 47, paragraph 2);
19) It fails to comply with restrictions and prohibitions stipulated by this Act and regulations adopted on the basis of it (Article 50);
20) It exports certain hazardous chemicals and products whose use is prohibited (Article 60, paragraph 1);
21) It places on the market particularly hazardous chemicals without having the license for 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 immediately after getting knowledge thereof all changes regarding data which it submitted in the procedure of license issuance (Article 69);
23) It conducts 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 license to conduct trade or license to use particularly hazardous chemicals (Article 72, paragraph 1);
24) It places on the market the detergent which contains the surfactant which does not comply with criteria of complete aerobic biodegradability, and has no approval issued by the ministry competent for environmental protection to use this surfactant in the detergent, i.e. has no legal instrument which allows the use of the surfactant in detergents in the EU (Article 73, paragraph 3);
25) It fails to comply with conditions contained in the approval for placing on the market and use of the surfactant as the component of the detergent (Article 77, paragraph 3);
26) It fails to withdraw from the market the surfactant i.e. detergent which contains this surfactant 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 can be imposed proportionate to the amount of inflicted damage, unfulfilled obligation or value of goods or other item which constitutes the subject matter of the economic offense, but not exceeding twenty times the value of the inflicted damage, unfilled obligation or value of goods, or other item which constitutes the subject matter of the economic offense.
For the economic offense referred to in paragraph 1 of this Article a responsible officer of the legal person shall be fined in the range from 100,000 to 200,000 dinars.
In addition to the imposed fine for the economic offense referred to in paragraph 1 of this Article against the legal person a protective measure may be imposed constituting a ban on conducting certain business activity for up to 10 years.
In addition to the imposed fine for the economic offense referred to in paragraph 1 of this Article against the responsible officer of the legal entity a protective measure may be imposed constituting a ban on conducting certain jobs for up to 10 years.
Article 98
Against a 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 to collect data pursuant to Article 19 paragraphs 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 the 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 procure the mixture referred to in Article 21 of this Act;
3) Upon request of the downstream user or distributor it failed to submit the safety data sheet relating to the hazardous chemical intended for general use (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 inserted (Article 23, paragraph 3);
5) Upon request of consumers it fails to submit without compensation 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 the chemical, as well as other information connected to data contained in the safety data sheet, related to certain ways in which that chemical is used (Article 29);
7) It fails to store a given hazardous chemical separately from other merchandise so as to prevent contact with other goods and to be out of reach of children, as well as if it misleads the consumer in regard to its purpose (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 procedure of prior notification, or if together with the request it did not submit the 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, paragraphs 1 and 5);
10) Regarding prescribed chemicals and products, it fails to submit to the ministry competent for environmental protection within the prescribed time limit the information on the exported quantities, the country importing the chemicals i.e. products and general data on the importer (Article 58, paragraph 1);
11) Regarding the prescribed chemicals, and apart from data referred to in Article 42, paragraph 1 of this Act, it fails to submit to the ministry competent for environmental protection within the prescribed time limit also the information on the country from which it imported, and general data on the exporter (Article 58, paragraph 2);
12) Regarding the product containing the chemical from the List of Chemicals for PIC Procedure, it fails to submit to the ministry competent for environmental protection within the prescribed time limit the information on imported quantities, the country from which it imported, 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 information requested by the competent authority of the country that is party to the Rotterdam Convention on the transit of the chemical over the territory of that country (Article 59, paragraph 1);
14) Besides the records referred to in Article 19 of this Act, it fails to also keep the records on consumers to whom the particularly hazardous chemical was sold i.e. given away (Article 72, paragraph 2);
15) It fails to store the research results which confirm that the criterion on complete aerobic biodegradability of the surfactant was 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 the detergent in accordance with provisions of this Act and in accordance with the regulation governing detergent labeling that was adopted on the basis of this Act (Article 81, paragraph 2);
17) If fails to make the Folio on the detergent’s composition or it fails to store that folio for five years, or it fails to make available to the public on its web-site certain data contained in this folio (Article 81, paragraph 3);
18) It fails to act in accordance with the inspector’s decision, i.e. it fails to let the inspector to perform the inspection (Articles 91 and 94).
A fine for misdemeanors referred to in paragraph 1 of this Article may be imposed in proportion to the value of the inflicted damage or unfulfilled obligation, or the value of the merchandise or other item which constitutes the subject matter 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 protective measure - ban on conducting certain business activity for up to three years may also be imposed on a legal person.
A responsible officer of the legal person shall also be fined in the range of 25,000 to 50,000 dinars for the misdemeanor referred to in paragraph 1 of this Article.
In addition to the imposed fine, a protective measure - ban on doing certain jobs for up to one year may also be imposed on the responsible officer of the legal person, for the misdemeanor referred to in paragraph 1 of this Article.
For misdemeanor referred to in paragraph 1 of this Article a sole trader shall also be fined 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 protective measure - ban on conducting certain business activity for up to three years may also be imposed on the sole trader.
Article 99
A responsible officer 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 information on the export of the chemical from the List of Chemicals for the prior notification procedure, i.e. a chemical which contains a substance from this list in such a concentration that pursuant to this Act it must be labeled as hazardous, as well as notification on the export of the product which contains a chemical from the List of Chemicals for PIC Procedure (Article 53, paragraph 1);
2) After receiving notification on the export from the competent authority of the exporting country he/she does not inform that authority that the information was received (Article 54);
3) He/she does not submit to the Secretariat of the Rotterdam Convention the answer regarding import of every 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 about the import of a chemical which is not on the list of the Rotterdam Convention, but for which that country requests prior consent pursuant to the PIC procedure (Article 55, paragraph 3);
5) Upon request of the competent authority of the country that is party to the Rotterdam Convention over whose territory the chemical which is on the list of the Rotterdam Convention is transiting he/she fails to submit the requested information at the latest 15 days prior to the first day of transit, i.e. prior to any future transit (Article 59, paragraph 2);
6) He/she does not issue the approval for usage of the surfactant in the detergent within 12 months from the day on which the complete technical dossier on the surfactant was submitted, 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, paragraphs 1 and 2 of this Act;
8) He/she makes available to the public data on chemicals which are considered to represent business secret referred to in Article 84, paragraph 3 of this Act except in emergency cases when this is necessary for reasons of security and protection of human health and the environment (Article 84, paragraph 4).
For misdemeanor referred to in paragraph 1 of this Article, and in addition to the imposed fine, the responsible officer within the ministry competent for environmental protection may also be imposed with a ban on conducting certain jobs, as a protective measure lasting one year.
Article 100
A sole trader shall be imposed with a fine ranging from 50,000 to 500,000 dinars for misdemeanor if he/she commits any of the acts referred to in Article 97, paragraph 1 of this Act.
Article 101
A natural person shall be fined for misdemeanor in the range from 10,000 to 50,000 dinars if:
1) He/she uses particularly hazardous chemicals without license (Article 64, paragraph 1);
2) He/she does not observe purposes for which the license 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 promptly after getting knowledge thereof all changes regarding data which he/she submitted in the license 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 after termination of jobs in which such data 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 value of inflicted damage or unfulfilled obligation, the value of merchandise or other item which constitutes the subject matter of the misdemeanor, but not exceeding twenty times the amount of these values.
XV TRANSITIONAL AND FINAL PROVISIONS
Article 102
The supplier shall classify, label, package and advertise the chemicals and certain products pursuant to the regulation referred to 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 referred to in Article 18, paragraph 1 of this Act shall be applied until the deadline set out in the regulation referred to in Article 18, paragraph 2 of this Act.
The supplier shall provide a chemical counselor within two years from the day of entering into force of the regulation referred to in Article 34 paragraph 3, Article 35 paragraph 2 and Article 36 paragraph 3 of this Act.
The legal person and the sole trader who trade in particularly hazardous chemicals and the natural person who uses particularly hazardous chemicals, shall submit the request for obtaining the license for trading or the license for using 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 entered into force, and the ministry in charge of environmental protection i.e. unit of local self-government shall decide on this request within one year from the day on which the request was submitted.
If the detergent containing the surfactant which does not fulfill the conditions of complete aerobic biodegradability is on the market on the day of entering into force of this Act, that detergent can remain further on the market if the manufacturer of the detergent files the request for issuing of the approval within one year from the day of entering 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 environmental protection issues a decision by which it rejects to issue the approval referred to in paragraph 4 of this Article, it shall set the time limit in this decision for withdrawing the detergent from the market, which cannot exceed two years from the day of issuance of the decision.
Article 103
Proceedings which were instituted along with regulations which were applicable 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 the secondary legislation on the basis of authorization from this Act, the Decision on Labeling Poisons on the Market ("Official Herald of FRY", No. 38/97) and the Rules on Criteria for Categorizing Poisons into Groups and on Methods for Determining the Level of Poison in certain Poisons ("Official Herald of SFRY", No. 79/91) shall apply.
On the day of entry into force of this Act, the Decision on Conditions which Legal Persons and Sole Traders who Produce, Place on the Market and Control poisons must Fulfill ("Official Herald of SRY", No. 30/96), the Decision on Conditions to be met by a Legal Person Conducting Activities of the Poison Control Centre ("Official Herald of SRY", 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 Herald of SFRY", No 22/92) and the Rules on how to Destroy Unused Poisons and Packaging used for Poisons and on Manner of Withdrawing Poisons from the Market ("Official Herald of SFRY", No. 7/83) shall be repealed.
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 Herald of SFRY", Nos. 27/90 and 45/90 and "Official Herald of SRY", No. 24/94-other Act, 28/96-other Act and 68/02) which relate to approval for transportation of poisons across the state border (import, export and transit) shall be repealed.
Article 107
On the day of entry into force of this Act, the Act on Production and Trade in Poisonous Materials ("Official herald of SRY", Nos. 15/95, 28/96-other act and 37/02 and "Official Herald of RS", No. 101/05-other act) shall be repealed, except for provisions on categorization and analysis of poisons which shall be applied only to plant protection products by the authority competent for plant protection, until coming into force of the act which regulates plant protection products.
Article 108
This Act shall enter into force on the eighth day after 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, items, equipment, means of production, archives and registration material whose period of storage has not expired, shall be taken over by the Ministry of Energy, Development and Environment Protection for the exercise of authority in the field of chemicals and biocides management, with the state they were in at the moment this Act entered into force.
Article 18
The Agency for Chemicals shall cease operation as of the day this Act enters into force.
Article 19
This Act shall enter 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 to be 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 shall enter into force on the day following the day of its publication in the "Official Herald of the Republic of Serbia".