FantasticSearch

REFERENCE PROVISIONS FOR COMMUNITY HARMONISATION LEGISLATION FOR PRODUCTS Chapter R1 Definitions

Article R1 Definitions For the purposes of this ... [act] the following definitions shall apply: 1. ‘making available on the market’ shall mean any supply of a product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge; 2. ‘placing on the market’ shall mean the first making available of a product on the Community market; 3. ‘manufacturer’ shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark; 4. ‘authorised representative’ shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks; 5. ‘importer’ shall mean any natural or legal person established within the Community who places a product from a third country on the Community market; 6. ‘distributor’ shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market; 7. ‘economic operators’ shall mean the manufacturer, the authorised representative, the importer and the distributor; 8. ‘technical specification’ shall mean a document that prescribes technical requirements to be fulfilled by a product, process or service; 9. ‘harmonised standard’ shall mean a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC on the basis of a request made by the Commission in accordance with Article 6 of that Directive; 10. ‘accreditation’ shall have the meaning assigned to it by Regulation (EC) No 765/2008; 11. ‘national accreditation body’ shall have the meaning assigned to it by Regulation (EC) No 765/2008; 12. ‘conformity assessment’ shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled; 13. ‘conformity assessment body’ shall mean a body that performs conformity assessment activities including calibration, testing, certification and inspection; 14. ‘recall’ shall mean any measure aimed at achieving the return of a product that has already been made available to the end user; 15. ‘withdrawal’ shall mean any measure aimed at preventing a product in the supply chain from being made available on the market; 16. ‘CE marking’ shall mean a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing; 17. ‘Community harmonisation legislation’ shall mean any Community legislation harmonising the conditions for the marketing of products.

2. Before placing a product on the market importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the product bears the required conformity marking or markings and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article [R2(5) and (6)]. Where an importer considers or has reason to believe that a product is not in conformity with … [reference to the relevant part of the legislation], he shall not place the product on the market until it has been brought into conformity. Furthermore, where the product presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect 3. Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product

4. Importers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned 5. Importers shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in … [reference to the relevant part of the legislation] 6. When deemed appropriate with regard to the risks presented by a product, importers shall, to protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of such monitoring

7. Importers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the Community harmonisation legislation applicable shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken 8. Importers shall, for ... [period to be specified in proportion to the lifecycle of the product and the level of risk], keep a copy of the EC declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request

9. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market. Article R5 Obligations of distributors 1. When making a product available on the market distributors shall act with due care in relation to the requirements applicable

2. Before making a product available on the market distributors shall verify that the product bears the required conformity marking or markings, that it is accompanied by the required documents and by instructions and safety information in a language which can be easily understood by consumers and other end-users in the Member State in which the product is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Article [R2(5) and (6)] and Article [R4(3)]. Where a distributor considers or has reason to believe that a product is not in conformity with … [reference to the relevant part of the legislation], he shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities 3. Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in ... [reference to the relevant part of the legislation]

4. Distributors who consider or have reason to believe that a product which they have made available on the market is not in conformity with the Community harmonisation legislation applicable shall make sure that the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the product presents a risk, distributors shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken 5. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have made available on the market.

Article R6 Cases in which obligations of manufacturers apply to importers and distributors An importer or distributor shall be considered a manufacturer for the purposes of this ... [act] and he shall be subject to the obligations of the manufacturer under Article [R2], where he places a product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected. Article R7 Identification of economic operators Economic operators shall, on request, identify the following to the market surveillance authorities, for ... [period to be specified in proportion to the lifecycle of the product and the level of risk]:

(a) any economic operator who has supplied them with a product;

(b) any economic operator to whom they have supplied a product. Chapter R3 Conformity of the product

Article R8 Presumption of conformity Products which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the requirements covered by those standards or parts thereof, set out in … [reference to the relevant part of the legislation].