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Concerning Modification And Completion Of The Law No. 420-Xvi Of 22 December 2006 On Technical Regulation Activity

Original Language Title: pentru modificarea şi completarea Legii nr. 420-XVI din 22 decembrie 2006 privind activitatea de reglementare tehnică

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    The Parliament adopts this organic law.
Art. I.-Law nr. 420-XVI of 22 December 2006 on technical regulation activity (Official Gazette of the Republic of Moldova, 2007, no. 36-38, art. 141), as amended, is modified and completed as follows: 1. Article 1 shall read as follows: "Article 1. Scope of application (1) the present law establishes general requirements concerning the content and mode of development, approval and implementation of technical regulations in the field of trade, as well as the duties of the regulatory authorities of the regulatory process to ensure transparency and the free movement of products aimed at defending public interests on the domestic market.
(2) the technical regulation constitutes a prerogative of the State being exercised by the regulatory authorities.
(3) this law shall not apply to products: (a)) subject to law. 78-XV of 18 March 2004 concerning foodstuffs;
b) plant protection products and fertilizer;
c) plants, feed and live animals;
d products of human origin) and the products of plant and animal origin that are directly related to their future reproduction;
e) substances, psychotropic drugs and precursors;
f) medicinal products for human and veterinary use;
g) aircraft and equipment in the field of aviation;
h) products are made available on the market as antiques or Museum purposes;
I) products in category of armaments and military equipment, special equipment, involving national defense and safety;
j) services;
k) sanitary and phytosanitary regulations, norms and veterinary requirements whose legal framework is established by law. "
2. The Act is supplemented by article 11 reads: "Article 11. The purpose of the law this law aims at ensuring the free movement of products, creation of conditions for the harmonization of national technical legislation with European Union laws, requirements, and conditions for placing on the market of Republic of Moldova to secure and compliant products that foster a competitive marketplace and to eliminate technical barriers to trade. "
3. Article 2: Basics "trader", "other requirements", "quality", "minimum requirements", "prescribed requirement", "control (inspection) of the State", "State inspector", "placing on the market of products," "prescription", "forgery" (counterfeit), "business standard" and "market surveillance" shall be excluded;
the term "activity" technical regulation shall read as follows: "technical regulation activity-overview of activities relating to the establishment of requirements towards products in terms of their security, the conditions for the marketing and use of them, also determining the rules of market surveillance and conformity assessment;"
the term "regulatory authority" shall read as follows: "regulatory authority-the central body of the public administration specialist responsible, within the limits of its competence, elaboration of technical regulations;" the term "technical barriers to trade", the phrase "national standards" shall be replaced with the phrase "standards";
the notions of "essential requirements", "technical documentation" and "covered" will read as follows: "essential requirements-requirements stipulated in national technical regulations transposing the EC legislation on the harmonisation of the European Union and ensuring national security and the safety of products for life and health of humans, for the animal and the plant, environmental and material possessions in order to protect the interests of the consumer, including practices in order to prevent misleading the consumer as regards the composition of the , destination, origin, quality and safety of products; "" technical documentation-documentation drawn up by the manufacturer, which allows conformity assessment of the product and is intended to provide information on the design, manufacture and operation of the product;
area covered-overview of economic activities and associated products for which specific technical regulations are issued on the conditions for placing on the market and/or make available on the market; "
the term "interested party", the words "or a" Stan "are mutually exclusive;
the term "conformity assessment procedure", the words "prescribed requirements" shall be replaced with the word "requirements";
the notions "product", "technical regulation", "technical specification" and "european harmonised standard" shall read as follows: "product-any good material, including a provision of services intended for distribution, consumption or use on the market in the context of commercial activities, in return for payment or free of charge;"
"technical regulation-regulatory action which provides, directly and/or by reference to certain standards, technical requirements for a product relating to its security, including the relevant administrative provisions compliance with which is mandatory in the case of introductions or available on the market of this product;
technical specification-document that lays down the technical requirements which must be fulfilled by a product; technical specification may be a standard part of a standard or a standard independent document; "
"the harmonized european standard-standard, adopted following a request from the European Commission for the implementation of the harmonisation of the laws of the European Union and that transforms the essential requirements of such legislation in the technical specifications for the products scope;".
4. The title of chapter II shall read as follows: "Chapter IICERINŢE RELATING REGLEMENTAREACOMERCIALIZĂRII PRODUCTS '.


5. Article 3 shall read as follows: "Article 3. General requirements concerning technical regulations (1) in order to ensure the safety of products for life and health of humans, for the animal Kingdom, at environmental and, in order to protect the interests of consumers, including for the prevention of practices liable to mislead them, and for other public order considerations, regulatory authorities shall prepare technical regulations under this law.
(2) For the matters covered in that there is legislation on the harmonisation of the European Union, national technical regulations transposing this legislation. The list of areas covered is given in the annex. 3 the law nr. 235 of 1 December concerning the activities of accreditation and conformity assessment.
(3) For areas where there is legislation on the harmonisation of the European Union, regulators may issue technical regulations for the marketing of national products.
(4) the placing on the market and use of certain products in areas where there is no harmonization of the legislation of the European Union, shall be permitted only if these products are marketed lawfully in another Member State of the European Union and if they offer a degree of protection of consumers ' interests equivalent to that required by the rules applicable in the Republic of Moldova.
(5) National Technical Regulations for the areas in which there is legislation on the harmonisation of the European Union may have direct or indirect effects as a prohibition on placing on the market of a product or type of product, or withdrawal from the market of that product or type of product, or change the times seeking additional product testing/or that type of product.
(6) technical regulations shall be approved by law or by regulatory acts of the Government and complies with the principles laid down by this law. "
6. Article 4: the title of the article, the words "against" shall be replaced with the word "concerning";
under paragraph (2), subparagraph (d)) shall be repealed;
paragraph 3 shall be repealed;
paragraph 4: the letter d) shall read as follows: "(d)) the essential requirements for the groups of products in the scope in which there is legislation on the harmonisation of the European Union: the essential requirements shall be established which shall ensure a high level of safety of the product, taking into account the specific hazards associated with it, or requirements that relate to its performance. The essential requirements constitute a fundamental part of the technical regulation and allow the application of harmonised standards adopted as standards, to remain voluntary. In the absence of harmonised standards or where the manufacturer decide not to resort to such standards, the essential requirements shall allow direct compliance assessment product; "
paragraph is completed with the following letter d1) reads: "d1) requirements for product groups from the domain in which there is legislation on the harmonisation of the European Union: shall establish requirements for products to be identified and placed on the market. Requirements constitute a fundamental part of the technical regulation, and the standards to which reference should make presumes conformity with these requirements products; "

the letter g), the words "national mark of conformity SM" shall be replaced with the text "bookmark";
the letter i) shall read as follows: "i) requirements for accredited bodies for conformity assessment which are recognized and notified for activity in that area, in accordance with the legislation in force, including the specific requirements laid down by the regulatory authority;" after the letter i) introduce the letters j, k)) l) and m) with the following content: "j) the obligations of the manufacturer, the authorised representative, the importer and the Distributor;
k) corrective measures, prohibitions, or withdrawals from the market for consumer recalls of nonconforming product;
l) traceability requirements: product identification elements (type, batch, serial number, etc.) and of the manufacturer/importer (name, trade name or registered trade mark, mailing address etc.);
m) authorities in charge with supervising the market. "the text" the regulators will determine the structure and content of the technical regulation for each case separately. "is excluded;
article is completed (41) and (42) with the following contents: "(43) regulatory authorities will determine the structure and content of the technical regulation for each case separately.
(42) the essential requirements of national technical regulations transposing the harmonisation of legislation of the European Union to be removed even from the point of view of technical content, structure and numbering. "(5): first sentence shall read as follows:" The technical regulations in the areas for which there is no harmonization of the legislation of the European Union, the regulatory authorities shall determine supplementary: ";
the letter a), the word "designated" shall be replaced with the word "recognized";
paragraph (6) shall read as follows: "(6) the list of areas covered by the regulatory authorities and market surveillance authorities is approved and, if necessary, updated by the Government."
7. Article 5: in paragraph 1, the words ' shall be published in the Official Gazette of the Republic of Moldova "shall be replaced by the wording" placed on the official web page of the authority ";
under paragraph (2): introductory part shall read as follows: "to ensure the transparency of the regulatory process (Amendment) regulations technical regulatory authority, through notification and Information Centre of the World Trade Organization:";
under paragraph (2) (b)), ' international or regional "shall be replaced with the words" international and European ";
paragraphs (3) and (4) shall read as follows: "(3) The drafting (Amendment) a technical regulation which may considerably influence the conditions of the import or export of the products, the regulatory authority shall, at the request of States parties justifies the need for technical regulation concerned and transmit those States supporting note through notification and Information Centre of the World Trade Organization as set forth in the agreements. When drawing up a regulation (modification) in accordance with the technical requirements of the relevant international and European standards, it conveys only information concerning the conformity of the technical regulation being developed with relevant international or european standard.
4. Regulatory authorities shall take into account the time limit of 6 months time limit set for the submission of objections on the draft technical regulation by States parties and interested parties of the Republic of Moldova. These objections should be examined together with their authors and other interested parties and the results of the examination shall be taken into account in the finalisation of the project. "in paragraph 5, the words" in this Act "shall be excluded;
paragraph (6) shall read as follows: "(6) technical regulations shall be published in the Official Gazette of the Republic of Moldova in the manner established by law. Between the date of adoption and the date of implementation of the technical rules, if necessary, will be provided for a period of at least 3 months, be determined by the regulatory authority in the field, for the implementation of measures of transition from the old procedures, requirements and standards to the new provisions and requirements laid down in the technical regulations and standards. "paragraph 8 shall read as follows : "(8) the elaboration, coordination and the adoption of technical regulations shall be established in accordance with the legislation in force."
8. In article 6 (2), (3) and (4) shall be repealed.
9. Article 7 shall read as follows: "Article 7. References to standards in technical regulations (1) technical regulations transposing the harmonisation of legislation of the European Union refer to the Moldovan standards by adopting at the national level, the harmonised standards whose references have been published in the official journal of the European Union. They confer a presumption of conformity with the essential requirements laid down in the respective technical regulations.
(2) the Moldovan standards titles and Phrases by which it adopted the harmonized standards shall be published in the Official Gazette of the Republic of Moldova, and the standards are made available by the national standardization body according to law nr. 20 of March 4, 2016 with respect to national standardization.
(3) where there are Moldovan standards by adopting, at national, European and international standards, or conforming to the objectives of elaboration of technical regulations for groups of products in areas for which there is legislation on the harmonisation of European Union regulatory authorities, while respecting the copyright of the national body for Standardization, use these standards in the elaboration of appropriate technical regulations by inserting : a direct reference to standards) in the text of technical regulations to show that the only way to satisfy some conditions of technical regulation is to be in accordance with the standards to which reference is made;
b indirect references to standards) in the text of technical regulations to show that one of the means to satisfy some conditions of technical regulation is to be in accordance with the standards to which reference is made.
(4) compliance with the provisions of the standard to which reference is made in the regulation presumes conformity with technical requirements laid down in the respective technical regulation.
(5) the specialized central body of public administration in charge of the quality infrastructure provides the necessary budgetary funding for international and European standards, as Moldovan standards, including standards concerning test methods and sampling methods, applicable to conformity assessment procedures required for the implementation of appropriate technical regulations and for monitoring the market. "
10. Article 8: (a) the words ", approved by the Government" is excluded;
in paragraph 2, the words "containing technical regulations conformity assessment procedures shall be adopted by the Government" is excluded;
paragraph 21 shall be repealed;
(3) ' before placing on the market of products or services "shall be replaced with the text" before placing on the market of products "and" product or service "-" of the products concerned ";
in paragraph (4) (a)), the words "General safety requirement" shall be replaced with the word "requirements";
paragraph (5) shall read as follows: "(5) the conformity assessment Procedures must not be excessive in relation to the objectives of the technical regulation, referred to in art. "". (1) where a technical regulation shall be drawn up on the basis of the harmonization of the laws of the European Union, the regulatory authority shall be obliged, in the process of elaboration, to establish procedures for assessing the conformity which shall not be more restrictive than those laid down in Community law. "in paragraphs (6) and (61) is repealed;
paragraph 7 shall read as follows: "(7) in the absence of standards, the regulatory authorities shall lay down in detail the requirements for the placing on the market and/or making available products on the market, including test methods and sampling methods, necessary for the implementation of technical regulations in the areas for which there is no harmonization of the legislation of the European Union and for the conformity assessment."
11. Article 9: paragraph (1), the phrase "national standards" shall be replaced with the phrase "standards";
in paragraph 2, the words "including international trade, it" shall be replaced with the word "authority";
paragraph 3 shall be repealed;
article is completed (4), (5), (6) and (7) with the following contents: "(4) If a product falls within the scope of several technical regulations, placing and making available on the market thereof shall take place only if the product complies with all technical regulations applicable to it.

(5) General technical regulations apply to products not limited itself to an exhaustive list thereof and shall, as a rule, requirements relating to the prevention of one or more risks characteristic of all products to which the rules in question apply to them.
(6) specific technical Regulations establish requirements for products or groups of products, the provisions of the General technical regulation concretizînd if it exists. The technical specific rulemaking will ensure compliance with the General safety requirement.
(7) where a product or group of products are applicable to them both general technical regulations, as well as specific technical regulations apply to specific technical regulations. "
12. Article 10: paragraph (1) letter b), the words "in an appropriate manner and in the same volume" shall be replaced by the wording "in the same way";
in paragraph 4, the words ' in respect of goods "shall be replaced with the words ' in the case of import", and the phrase "national standards" with the words "standards".
13. Article 11: the title shall read as follows: "Article 11. Notification and information centre of the World Trade Organization ";
(1) the introductory part shall read as follows: "in the Republic of Moldova information source in the field of technical barriers to trade is the notification and Information Centre of the World Trade Organization (hereinafter referred to as the Centre). The Centre carries out its activities in accordance with the agreements and procedures adopted in the framework of the World Trade Organization and its regulation approved by the Government, and, on request, provide interested parties with information regarding: "the letter d), the words ' of this law" is excluded;
in paragraph 2, the words "Information Center referred to in paragraph 1. (1) of this article "shall be replaced with the word" Centre ";
in paragraph 3, the words "Information Centre" shall be replaced with the word "Centre".
14. Article 12 shall be repealed.
15. Chapter IV shall read as follows: "IVATRIBUŢIILE Chapter 13 REGULATORS. Powers of the regulatory authorities for the development and enforcement of technical regulations, regulatory authorities shall have the following powers: (a) international standards) used European and Moldovan in the elaboration of technical regulations by inserting references into the article. 7;
b) co-ordinates technical regulations developed with the specialized central body of public administration in charge of the quality infrastructure;
(c)) shall, subject to approval and updates the list of Moldovan standards by adopting harmonized standards for technical regulations transposing the harmonisation of legislation of the European Union;
d) presented for endorsement to the national body for standardization list of Moldovan standards by adopting harmonized standards;
e) requires national standardization body drafting the official version in the national language Moldovan standards by which international standards have been adopted, or in original version and intend to make reference in technical regulations;
f) published in the Official Gazette of the Republic of Moldova Moldovan standards list which presumes conformity with requirements of technical regulations;
g) participates as an observer in the process of accreditation of conformity assessment bodies to be or are recognized;
h) recognize, for the purpose of notification, the conformity assessment bodies accredited to operate in the area covered;
I respond to the request) by any State member of the World Trade Organization on the need for the adoption of a technical regulation which do not comply with the provisions of international or European standards, in the form of notifications through the Centre, in one of the working languages of the World Trade Organization (English, French or Spanish).
Article 14. Cooperation between regulatory authorities in the elaboration of technical regulations, regulatory authorities shall cooperate as follows: (a)) requires information Center technical regulations, conformity assessment procedures and standards relating to membership of international organizations participating in the times or the European standards, and on bilateral and multilateral agreements in the field of standardisation and conformity assessment;
b) participate in the elaboration of technical regulations initiated by other regulatory authorities;
c) calls to each other information on technical regulations and conformity assessment procedures developed. "
16. Article 15, chapter V and chapter VI is repealed.
17. Throughout the text of the law, "goods" and "products or services" shall be replaced with the word "products".
Art. II.-this law shall enter into force three months after its publication, with the exception of paragraph 1: (a)), in the part which refers to article 1 (1) of the law on technical regulation activity;
3, point b) in the part which refers to article 2, the notions of "control (inspection) of the State", "State" inspector, "prescription" and "market surveillance" of the law on technical regulation activity;
c) point 16 in part that refers to chapters V and VI of the law on technical regulation activity, which will be implemented from the date of entry into force of law No. 7 of 26 February 2016 concerning market surveillance regarding non-food products.
Art. III.-Government: a) within 12 months from the date of entry into force of the present law, will put its normative acts in compliance with this law;
b) will ensure that republication of law No. 420-XVI of 22 December 2006 on technical regulation activity in the Official Gazette of the Republic of Moldova.