THE CROATIAN PARLIAMENT

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1 THE CROATIAN PARLIAMENT 1783 Pursuant to Article 88 of the Constitution of the Republic of Croatia, I hereby issue the DECISION PROMULGATING THE ACT ON AMENDMENTS TO THE CHEMICALS ACT I hereby promulgate the Act on Amendments to the Chemicals Act, passed by the Croatian Parliament at its session on 25 April 2008 Class: /08-01/28 Reg. No.: / Zagreb, 30 April 2008 The President of the Republic of Croatia Stjepan Mesić, m.p. ACT ON AMENDMENTS TO THE CHEMICALS ACT Article 1 Article 1 of the Chemicals Act (Official Gazette 150/05) is amended to read: In order to protect human life and health and the environment from harmful effects of dangerous chemicals, this Act stipulates the requirements for classification, packaging and labelling of chemicals dangerous for human health and the environment; exchange of information on chemicals; bans and limitations on placing of dangerous chemicals on the market and on their use; conditions for the manufacture, marketing and use of dangerous chemicals, and conditions for the performance of import and export of dangerous chemicals. Article 2 In Article 2, item 2 is amended to read: Substances means chemical elements or their compounds in their natural state or obtained by a manufacturing procedure, including any additive necessary to preserve their stability, or any impurity occurring due to the applied manufacturing procedure, but excluding solvents that can be isolated without any impact on stability of the substance or without causing any changes to its composition. Item 4 is amended to read: Polymer substances means substances consisting of molecules characterized by the sequence of one or more types of monomer units. Molecular weights of these molecules should be distributed within the range in which differences between them can be primarily attributed to

2 differences in the number of monomer units. Polymer contains: (a) more than 50% of mass fraction of molecules with at least three monomer units that are covalently bound with at least one other monomer unit or other reactant; (b) less than 50 % of mass fraction of molecules of the same molecular weight. In this context, a monomer unit means the reacted form of a monomer in a polymer. Items 5 and 6 are deleted. In item 17, the word transit, and the sentence: Transit means any carriage of a dangerous chemical across the territory of the Republic of Croatia under customs supervision. are deleted. Items 19a, 19b, 19c and 19d are added after item 19 which read: 19a Further user means any legal or natural person, other than the manufacturer or the importer, who uses individual substances or preparations thereof within the registered activity. Distributor and consumer shall not be considered as further users. 19b Distributor means any legal or natural person who exclusively stores and places on the market individual substances or preparations thereof for third parties or who is involved in retail sale of chemicals. 19c The recipient of the substance or the preparation means any further user or distributor to whom the substance or the preparation is delivered. 19d Prior Informed Consent (PIC) means the procedure under which chemicals, which are either banned or restricted in the exporting country, may be imported only subject to the prior notification sent to the importing country. Chemicals given in the PIC list may be exported only subject to approval by the importing country. If the importing country does not agree to import, it shall also comply with this decision on its territory. Items 22 and 23 are deleted. Article 3 In Article 3, paragraph 1, subparagraph 2, the word which is replaced by the word when. Subparagraphs 7, 8 and 9 are added after subparagraph 6 which read: ammunition and explosives governed by special regulations, mineral fertilizers governed by special regulations and foodstuffs governed by special regulations. Paragraph 4 is amended to read: The provisions of this Act shall not apply to the chemicals covered by the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction, except for notifying procedures, timelines for delivery, contents of data, and methods for collection and use of data referred to in Articles 30, 31 and 33 of this Act. Article 4 Title II NOTIFICATION AND PLACING OF A NEW SUBSTANCE ON THE MARKET and Articles 6, 7, 8, 9, 10 and 11, as well as Title III ASSESSMENT OF NEW SUBSTANCES and Articles 12 and 13, are deleted. Article 5 In Article 26, paragraph 2 is amended to read: The classification of a dangerous substance shall be made on the basis of a valid EINECS list of dangerous substances if a substance is listed accordingly. Paragraph 8 is deleted.

3 Article 6 Article 29 is amended to read: The manufacturer, importer, further user or distributor of a dangerous chemical and plant protection product, who places on the market individual dangerous chemical or preparations thereof or preparations, shall supply the recipient of either that chemical or preparation with a safety data sheet compiled in accordance with the provisions of this Act, and submit it to the Croatian National Institute of Toxicology if: (a) the substance or the preparation meets the criteria under which substances and preparations are classified as dangerous in line with the provisions of this Act and the ensuing subordinate legislation; or (b) the substance is stable, bioaccumulative and toxic or very stable and very bioaccumulative in accordance with the criteria laid down by the ordinance on classification, labelling and packaging of dangerous chemicals; or (c) the substance is included in the appropriate list established in the European Union due to reasons other than those referred to in items (a) and (b) of this paragraph. The manufacturer and/or importer and/or further user shall make an assessment of chemical safety of the substances. Therefore, the data provided in the safety data sheet shall be harmonised with the data from the appropriate assessment. If the safety data sheet is compiled for the preparation for which the manufacturer and/or importer and/or further user made the assessment of chemical safety, it is sufficient for the data in the safety data sheet to comply with the report on chemical safety of the preparation, instead of the report on chemical safety of each of its individual substances. The manufacturer and/or importer and/or further user shall, upon request, supply the recipient with the safety data sheet compiled in accordance with the provisions of this Act and the ordinance on compilation of safety data sheets even if the preparation does not meet the criteria under which the preparations are classified as dangerous preparations pursuant to Article 2 of this Act, but it contains: (a) in individual concentration 1 % of mass fraction in the case of non-gaseous preparations and 0.2 % of volume fraction in the case of gaseous preparations, at least one substance dangerous for human health or the environment, or (b) in individual concentration 0.1 % of mass fraction in the case of non-gaseous preparations, at least one substance that is stable, bioaccumulative and toxic or very stable and very bioaccumulative in accordance with the criteria for determination of stable, bioaccumulative and toxic or very stable and very bioaccumulative substances, or it has been included in the relevant list established on the level of the European Union due to reasons other than those given in item (a) of this paragraph (c) the substance for which occupational exposure limits have been stipulated in the Republic of Croatia. The safety data sheet does not have to be supplied where dangerous substances or preparations offered or sold to the general public are furnished with sufficient information to enable users to take the necessary measures to protect human health, safety and the environment, unless required by the further user or the distributor. The safety data sheet shall be compiled in Croatian language and Latin script. An exception to paragraph 5 of this Article, the safety data sheet can be compiled in a foreign language in case of substances for industrial and laboratory use the annual quantities of which are below 100 kg and under the following conditions: the safety data sheet compiled in a foreign language shall be drafted in accordance with the provisions of this Article and the ordinance on compilation of safety data sheets, the instructions for safe use in the Croatian language and the Latin script shall be enclosed

4 with the safety data sheet, and must contain all important information from the safety data sheet. The instructions must enable the persons using a dangerous substance or a preparation to become aware of the risks posed by the substance or the preparation, measures to prevent intoxication or other incidents, and emergency measures to be taken in the event of intoxication or incidents. The safety data sheet shall be dated and contain the following sections: 1. identification of the substance/preparation and of the legal/natural person, 2. hazards identification, 3. composition/information on ingredients, 4. first-aid measures, 5. fire-fighting measures, 6. accidental release measures, 7. handling and storage, 8. exposure controls/personal protection, 9. physical and chemical properties, 10. stability and reactivity, 11. toxicological information 12. ecological information, 13. disposal considerations, 14. transport information, 15. regulatory information, 16. other information. In annex to the safety data sheet, the manufacturer and/or importer and/or further user, who is obliged to draft the report on chemical safety in accordance with the provisions of this Act, must indicate the risks of exposure for certain uses (including, as appropriate, types of use and exposure) and any special requirements relating to testing of the substance depending on exposure, adjusted to individual substances. In compilation of the safety data sheet, the further user shall take account of exposure risks given in the submitted safety data sheet for particular uses, and he/she may also use any other appropriate data from the concerned safety data sheet. In compilation of the safety data sheet for those uses for which the distributor forwarded information about the use of individual substances or the preparation thereof to the further user, the distributor shall also indicate the exposure risks given in the safety data sheet, and he/she may also use any other appropriate data from the safety data sheet. In accordance with the provisions of this Act, the safety data sheet shall be delivered free of charge, either in hard copy or in an electronic form. The manufacturer and/or importer and/or distributor shall forthwith amend the safety data sheet in the following cases: (a) as soon as any new knowledge that may impact risk management measures or any new knowledge of risks become available, (b) after a marketing authorisation has been granted or refused, (c) once the restriction on placing of the material on the market is introduced. Legal and natural persons referred to in paragraphs 8, 9, 10 and 12 of this Article shall supply free of charge all former recipients, to whom they delivered the substance or the preparation over the last 12 months, with the new dated version, identified as Revision: (date), either in hard copy or electronic form. The registration number shall be given for each amendment to the safety data sheet after registration in the European Union. The ordinance on the compilation of safety data sheets shall be issued by the minister, subject to approval by the minister competent for the economy.

5 Article 7 Article 30 is deleted. Article 8 Article 32 is amended to read: On the international level, the Ministry shall exchange data on dangerous chemicals in accordance with its international obligations. Every five years the Ministry shall submit the report on the implementation of this Act and the ensuing ordinances on the territory of the Republic of Croatia to the European Commission. The report from paragraph 2 of this Article shall include the results of competent inspections, the conducted inspection, the stipulated penalties and other measures taken on the basis of this Act and special regulations. In Article 34, number 30, is deleted. In Article 35 is deleted. The second paragraph of Article 38 is deleted. Article 9 Article 10 Article 11 Article 12 In Article 39, paragraph 1, item 1, words: provided that the competent authority has issued its consent for the use of these rooms or buildings after it had been established that the place, manner of construction and the quality of wall and floor finishes, lighting, ventilation, temperature and air humidity in working and ancillary rooms comply with sanitary-technical and hygienic requirements for a particular purpose«are deleted. Item 4, words in a number defined by the ordinance are replaced by the words in accordance with the ordinance. Article 13 In Article 42, paragraph 1, item 1, words with the place, construction and quality of walls, lighting, ventilation, temperature and humidity complying with technical and sanitaryhygienic conditions based on the finding of the competent authority are deleted. In item 2, words: in a number laid down by the ordinance shall be replaced by the words in accordance with the ordinance. New paragraphs 3 and 4 are added after paragraph 2 and read: Legal or natural persons from paragraph 2 of this Article shall notify the ministry about the beginning of the provision of services or performance of intermediary activities within 30 days of the date of beginning of these activities. Detailed conditions for the performance of activities from paragraph 2 of this Article shall be

6 laid down in an ordinance issued by the minister. Former paragraph 3 becomes paragraph 5. Article 14 In Article 47, paragraph 2, words plant protection products or are deleted. Article 15 In Article 55, paragraph 2 is deleted. In former paragraph 3, which becomes paragraph 2, words to be notified to the ministry are added after the word toxicology. Article 16 Title VII.a and Articles 55a, 55b and 55c are added after Article 55 and read: VII.a IMPORT AND EXPORT OF DANGEROUS CHEMICALS Article 55a Import and export of dangerous chemicals shall comply with the provisions of international agreements to which the Republic of Croatia is a party, the provisions of this Act and the ensuing regulations, and special provisions defining goods imported and exported on the basis of licences. Article 55b Import and export of dangerous chemicals can be carried out by legal and natural persons having the adequate licence. The licence from paragraph 1 of this Article shall be given or refused by a decision of the minister. An appeal cannot be lodged, but administrative proceedings can be instituted against such a decision. Article 55c Dangerous chemicals can be imported and exported by legal and natural persons who meet the conditions for the wholesale of dangerous chemicals, while legal and natural persons who meet the conditions for the production or use of dangerous chemicals can import dangerous chemicals for their own needs. Prior to customs clearance, the importer shall lodge an application with a border sanitary inspector of the Ministry for the sanitary inspection of the dangerous chemical from Article 2, item 9, sub-items f), g), h), i), l), m) and n) of this Act that is being imported. The customs cannot perform customs clearance of dangerous chemicals if the procedure from paragraph 2 of this Article has not been carried out. The provisions of paragraphs 1 to 3 of this Article shall also apply to dangerous chemicals imported to free zones or free warehouses in the Republic of Croatia. The ordinance on import and export of dangerous chemicals shall be issued by the minister. Article 17

7 Articles 56 and 57 are deleted. Article 18 The heading of Title IX is amended to read: IX NATIONAL STRATEGY FOR CHEMICAL SAFETY. Article 59 is amended to read: Upon the proposal of the Government of the Republic of Croatia, the Croatian Parliament shall adopt the National Strategy for Chemical Safety for the purpose of the efficient and harmonised implementation of the national policy in the field of chemical safety. In Article 60, items b) and e) are deleted. In Article 61, paragraph 1, item e) is deleted. In paragraph 2, item b) is deleted. In Article 63, paragraph 2 is deleted. In Article 64, paragraph 2 is deleted. Former items 3 and 4 become items 2 and 3. Article 19 Article 20 Article 21 Article 22 Article 23 In Article 66, paragraph 1, items 1 to 6 are deleted. Item 14 is amended to read: does not provide or amend the safety data sheet in accordance with Article 29 of this Act. Item 15 is deleted. Items 18a and 18b are added after item 18 and read: 18a performs activities referred to in Article 38, paragraph 1 of this Act, and does not procure the approval from the competent authority referred to in Article 43 of this Act, 18b does not notify the Ministry about the beginning of provision of services-intermediary activities referred to in Article 42, paragraph 2 of this Act within defined timelines.«item 32 is amended to read: imports or exports of a dangerous chemical contrary to the provisions of Article 55b and 55c of this Act. Paragraphs 5 and 6 are added after paragraph 4 and read: Sanitary inspector shall fine the responsible person in the legal person or the natural person performing the registered activity of production, marketing or use of dangerous chemicals with HRK 1, for non-compliance with the provisions of this Act and the ensuing subordinate legislation at the place of commission of this misdemeanour. If the person fined for misdemeanour referred to in paragraph 5 of this Article recommits the

8 misdemeanour, he/she shall be fined with HRK 3, at the place of the commission of misdemeanour. Article 24 On the date of accession of the Republic of Croatia to the European Union, the inspection activities relating to the import of dangerous chemicals from Member States of the European Union shall be transferred to internal traffic, which shall be inspected by the sanitary inspection of the ministry and the sanitary inspection in the state administration offices in counties and the Zagreb City Office competent for healthcare activities. Article 25 On the date of accession of the Republic of Croatia to the European Union, the application for the performance of production, marketing and use of dangerous chemicals on the territory of the Republic of Croatia may be filed by a legal or natural person seated in any Member State of the European Union. Article 26 On the date of accession of the Republic of Croatia to the European Union, production, marketing and use of dangerous chemicals and services-agency activities relating to dangerous chemicals on the territory of the Republic of Croatia may be performed by legal and natural persons seated in any Member State of the European Union provided that they meet the conditions laid down by this Act and the ensuing regulations. Article 27 On the date of accession of the Republic of Croatia to the European Union, the certificates or other documents (i.e. certifications, etc.) issued by the competent authorities of Member States of the European Union or by other legal persons involved in the performance of activities on the basis of public authorities shall be recognized as equivalent in terms of professional qualifications, work experience and acquired knowledge (certificates of professional qualifications and competencies) to legal and natural person seated in any Member state of the European Union and filing an application for the performance of production, marketing and use of dangerous chemicals. At the date of the accession of the Republic of Croatia to the European Union, the certificates or other documents (i.e. certifications, etc.) issued by the competent authorities of the Member States of the European Union or by other legal persons involved in the performance of activities on the basis of public authorities shall be recognized as equivalent in terms of the acquired knowledge (certificates of professional qualifications and competencies) to legal and natural person seated in any Member State of the European Union and providing servicesperforming intermediary activities referred to in Article 42, paragraph 2, of the Chemicals Act on the territory of the Republic of Croatia. The evidence referred to in paragraphs 1 and 2 of this Article shall be filed in the original drafted in any of the official languages of the European Union and in an authenticated translation into the Croatian language. Article 28

9 The National Strategy for Chemical Safety shall be adopted by the Croatian Parliament upon the proposal of the Government of the Republic of Croatia. The Government of the Republic of Croatia shall propose the National Strategy for Chemical Safety within one year from the date of the entry into force of this Act. Article 29 The minister shall issue ordinances as authorized by this Act within six months from the date of the entry into force of this Act. Article 30 Until the date of issuance of ordinances from Article 6, paragraph 14 of this Act, the Ordinance on the compilation of safety data sheets (Official Gazette 111/06) shall remain valid. Article 31 The Ordinance on new substances (Official Gazette 71/06) shall cease to have effect as of 1 June Article 32 This Act shall enter into force on the eighth day after the day of its publication in the Official Gazette, with the exception of the provisions of Article 2, paragraphs 1, 2, 3, and 5, Article 4, Article 5, paragraph 1, Article 6, Article 7 and Article 10 thereof, that shall enter into force on 1 June 2008, and the provisions of Article 8, paragraphs 2 and 3 thereof that shall enter into force on the date of the accession of the Republic of Croatia to the European Union. Class: /08-01/02 Zagreb, 25 April 2008 The Croatian Parliament The President of the Croatian Parliament Luka Bebić, m.p.

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