A recent Council Decision which is part of the new CE framework triad gives some insight on the latest expectations for distributors.
CE Framework Triad = Council Decision 768/2008/EC and regulations 764&765/2008/EC Some excerpts..... Recital 23 The distributor makes a product available on the market after it has been placed on the market by the manufacturer or the importer and must act with due care to ensure that its handling of the product does not adversely affect the compliance of the product. Both importers and distributors are expected to act with due care in relation to the requirements applicable when placing or making products available on the market. Recital 27 Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by national authorities, and should be prepared to participate actively, providing the competent authorities with all necessary information relating to the product concerned. ‘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; ===================== Annex I contains model language for future harmonized product legislation ====================== >From Article R2 "manufacturer obligations" When deemed appropriate with regard to the risks presented by a product, manufacturers 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 any such monitoring. 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. Regards, Lauren Crane Applied Materials america - europe - asia Corporate Product EHS www.amat.com lauren crane (mr.) product regulatory analyst (t) +1.512.272.6540 lauren_cr...@amat.com - external use - Save paper and trees! Please consider the environment before printing this e-mail.