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LAW OF THE REPUBLIC OF MOLDOVA

of November 29, 2018 No. 277

About chemicals

This law partially shifts: article 191 of the Agreement on functioning of the European Union of the March 25, 1957 published in the Official magazine of the European Union by C 326 of October 26, 2012 (the consolidated version); Articles 1, 2, 4-6, 8, 35, 43, 46, 47, 49 Regulations (EU) No. 1272/2008 of the European Parliament and Council of December 16, 2008 about classification, marking and packaging of substances and mixes, change and cancellation of Directives 67/548/EEC and 1999/45/EU, and also change of Regulations (EU) No. 1907/2006 (the text concerns EEP) published in the Official magazine of the European Union by L 353 of December 31, 2008; Article 1-3, 5-7, 14, 31, 32, 34, 35, 56, 60-62, 68, 118, 119, 121, 123, 125, 126, Appendix IV and Item 18a (Mercury) from Appendix XVII of Regulations (EU) No. 1907/2006 of the European Parliament and Council of December 18, 2006 about registration, assessment, authorization and restriction of chemicals (REACH), organization of the European agency on chemicals, change of the Directive 1999/45/EU and cancellation of Regulations (EEC) No. 793/93 of Council and the Regulations (EU) No. 1488/94 of the Commission, and also the Directive 76/769/EEC of the Council and Directives 91/155/EES, 93/67/EES, 93/105/ES and 2000/21/EU of the Commission (the text concerns EEP) published in the Official magazine of the European Union by L 396 of December 30, 2006; Article 1-4, 18, 28 Regulations (EU) No. 649/2012 of the European Parliament and Council of the July 4, 2012 about export and import of dangerous chemicals (in the new edition) (the text concerns EEP) published in the Official magazine of the European Union by L 201 of July 27, 2012; Articles 1, 2, 4-6, 10 of Regulations (EU) No. 648/2004 of the European Parliament and Council of the March 31, 2004 about detergents (the text concerns EEP) published in the Official magazine of the European Union by L 104 of April 8, 2004; Article 1-3, 28, 29, 31, 33, 40, 44 Regulations (EU) No. 1107/2009 of the European Parliament and Council of October 21, 2009 about implementation on the market of remedies of plants and cancellation of Directives 79/117/EEC and 91/414/EEC of the Council published in the Official magazine of the European Union by L 309 of November 24, 2009; Articles 1, 3, 17, 19, 20, 22, 25, 48 and Appendix V of Regulations (EU) No. 528/2012 of the European Parliament and Council of May 22, 2012 about ensuring the availability in the market and use of biocidal products (the text concerns EEP) published in the Official magazine of the European Union by L 167 of June 27, 2012; Articles 1, 3, 8 Regulations (EU) No. 850/2004 of the European Parliament and Council of the April 29, 2004 about resistant organic pollutants and change of the Directive 79/117/EEC published in the Official magazine of the European Union by L 158 of April 30, 2004; Article 1 of the Directive 2004/9/EU of the European Parliament and Council of February 11, 2004 about inspection and control of compliance to the principles of the proper laboratory practice (PLP) (the codified version) (the text concerns EEP) published in the Official magazine of the European Union by L 50 of February 20, 2004; Article 1 and determination "Proper laboratory practice" from Item 2. 1, the Section I of Appendix 1 of the Directive 2004/10/EU of the European Parliament and Council of February 11, 2004 about harmonization of the legal acts and administrative acts concerning use of the principles of the proper laboratory practice and supervision of their application when conducting testings of chemicals (the codified version) (the text concerns EEP) published in the Official magazine of the European Union by L 50 of February 20, 2004; Article 1 of the Directive 2006/66/EU of the European Parliament and Council of September 6, 2006 about batteries and accumulators and waste of batteries and accumulators and cancellation of the Directive 91/157/EEC (the text concerns EEP) published in the Official magazine of the European Union by L 266 of September 26, 2006; Article 1 of the Directive 2011/65/EU of the European Parliament and Council of June 8, 2011 about restriction of use of certain dangerous substances in the electric and electronic equipment (the text concerns EEP) published in the Official magazine of the European Union by L 174 of July 1, 2011; Article 11 of the Directive 94/62/EU of the European Parliament and Council of December 20, 1994 about packaging and waste of the packaging published in the Official magazine of the European Union by L 365 of December 31, 1994.

In view of need of ensuring compatibility of national legal acts with the European Union law by implementation of procedures of harmonization, elimination of contradictions and creation of the legislation obligatory for promotion of complex of the precepts of law harmonized with the legislation of Community based on Item r) parts (3) article 72 of the Constitution of the Republic of Moldova

The parliament adopts this organic law.

Chapter I General provisions

Article 1. Subject of the law

(1) This law regulates obligations of physical persons and legal entities which make or place in the market chemicals or mixes, prohibitions and restrictions for production, placement in the market, import, export and use of dangerous chemicals or mixes, conditions of classification, marking and packaging of chemicals and mixes, creation and maintaining the register of chemical goods, the procedure of the reporting under chemical goods, the procedure of authorization of dangerous chemical goods, obligations according to the reporting, the control and other aspects connected with chemicals and mixes.

(2) Provisions of this law are applied to microorganisms and to viruses, such as active agents as a part of remedies of plants and biocidal products.

Article 2. Law purpose

(1) the Purpose of this law is protection of life and health of the person, the environment and property from harmful effects of chemicals and mixes.

(2) For goal achievement, the provided part (1):

a) the legal and institutional base in the field of chemicals and mixes becomes stronger;

b) the body of the public power in the field of chemicals is created, its powers, the rights and obligations are established.

Article 3. Law scopes

(1) Provisions of this law extend to producers, importers, exporters, sellers and users of chemicals as such, in mixes or in products.

(Provisions of this law and measures taken according to it shall not mention 2):

a) the legislation on the environment, including in the part concerning prevention of pollution and complex control of pollution, regulation of industrial emissions in the environment, effective management, protection and use of surface and underground water;

b) legislation on health protection and labor safety.

(3) Substances, mixes or products in sense of article 4 of this law are not considered as waste according to determination of the Law on waste No. 209/2016.

(4) Provisions of this law are not applied to:

a) to the radioactive materials regulated by the Law on safe implementation of nuclear and radiological activities No. 132/2012;

b) to substances as such, in mixes or in products, subject to customs supervision and being in warehouses of temporary storage, in free zone or in free warehouse for the purpose of re-export or transit provided that they are not exposed to any processing or transformation;

c) to not emitted intermediate substances representing substances which in the course of synthesis intentionally are not removed from the equipment in which there is synthesis (except for sampling). This equipment includes reservoir for carrying out reaction, the service equipment and any other equipment through which substance passes / substances pass during continuous or periodic process, and also pipelines on which substance arrives / substances arrive from one reservoir in another for passing of the following stage of reaction, excepting any reservoir in which substance is stored / substances after production are stored;

d) to transportation of dangerous goods by air, sea, road, railway track, by mail or inland waterways which is regulated by the special legislation.

(5) the Provisions of this law concerning registration, authorization and assessment of substances, intermediate substances and technical files, the subsequent users, and also information in supply chain are not applied if substance is used:

1) in medicines for the person and medicines of veterinary appointment;

2) in foodstuff or in sterns for animals including if they are used:

a) as nutritional supplement as a part of foodstuff;

b) as fragrance as a part of foodstuff;

c) as additive to sterns for animals;

d) as a part of forages for animals.

(6) the Provisions of this law concerning information in supply chain are not applied to the following mixes in final structure intended for the end user:

1) drugs for the person and medicines of veterinary appointment;

2) cosmetic products;

3) medical products, invasive or used in direct physical contact with body of the person, in that measure in what classification and marking of dangerous substances and mixes corresponds to the Regulations on classification, marking and packaging of substances and mixes approved by the Government;

4) foodstuff or stern for animals including if they are used:

a) as nutritional supplement as a part of foodstuff;

b) as fragrance as a part of foodstuff;

c) as additive to sterns for animals;

d) as a part of forages for animals.

(7) the Provisions of this law concerning registration and assessment are not applied to the substances specified in appendix 6.

(8) Article Provisions 18, concerning export and import of dangerous chemical goods, are not applied to:

a) to the radioactive materials specified in Item a) parts (4) this Article;

b) to foodstuff and nutritional supplements;

c) to narcotic and psychotropic substances;

d) to waste;

e) to fodder;

f) to genetically modified organisms;

g) to chemical weapon;

h) to the patented medicines, drugs for the person and to medicines of veterinary appointment, except for specified in the subitem c) of Item 14) of Article 4.

(9) the Provisions of this law concerning classification and marking of chemicals and mixes are not applied to:

1) to the substances and mixes specified in part (4);

2) to the substances and mixes which are subject to research and development which is not placed in the market if they are used in controlled conditions according to provisions of the legislation concerning workplace and the environment;

3) to the substances and mixes in final structure intended for the end user in the following type:

a) drugs for the person;

b) medicines of veterinary appointment;

c) cosmetic products;

d) medical products, invasive or used in direct physical contact with body of the person;

e) the foodstuff and forages including used as additives and fragrances in foodstuff, additives to fodder, sterns for animals.

Article 4. Basic concepts

For the purposes of this law the following basic concepts are used:

1) mix - mix or the solution consisting of two or more substances (components);

2) packaging - one or more recipients and any other components or materials necessary for implementation by recipients of function of safety or other functions of safety;

3) product - object which in the course of production acquires form, surface or special type that determines its function more than its chemical composition;

4) authorization for dangerous chemical goods - the allowing document which body of the public power in the field of chemicals or other body authorized by this law resolves placement in the market and use of separately taken dangerous chemical product, with potentially serious consequences for the health and the environment specified in part (1) Articles 23, with indication of the name of chemical or the constituting substances of chemical mix according to nomenclature system of International Union of Pure and Applied Chemistry (IUPAC) and registration number CAS;

5) prior reasonable consent to import - the allowing document for import of dangerous chemical product which is issued by the national authority of the importing country appointed to the Rotterdam convention as a result of consideration of the notification on export of the dangerous chemical product which arrived from the national authority of the exporting country appointed to the Rotterdam convention;

6) detergent - any substance or mix containing the soaps and/or other surfactants intended for processes of sink and cleaning, made in different forms (liquid, powder, paste, whetstone, the block, the cast product, the packed-up product, etc.) realized for use in life, in the departmental or industrial purposes. Other products which are considered as detergents are:

a) the auxiliary washing mix intended for soaking (before washing), rinsings or bleachings of clothes, house linen, etc.;

b) the balm for fabric intended for mitigation of tactile feelings of fabric at the final stage of washing;

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