Regulation (EC) No 1223/2009 of the European ... - Mattilsynet

L 342/66ENOfficial Journal of the European Union 22.12.2009The manufacturer may designate, by written mandate, a personestablished within the Community as the responsible person whoshall accept in writing.with all the information and documentation necessary to demonstratethe conformity of specific aspects of the product, in a languagewhich can be easily understood by that authority.4. Where, for a cosmetic product manufactured within theCommunity, and not subsequently exported and imported backinto the Community, the manufacturer is established outside theCommunity, he shall designate, by written mandate, a personestablished within the Community as the responsible person whoshall accept in writing.5. For an imported cosmetic product, each importer shall bethe responsible person for the specific cosmetic product he placeson the market.The importer may, by written mandate, designate a person establishedwithin the Community as the responsible person who shallaccept in writing.Article 6Obligations of distributors1. In the context of their activities, when making a cosmeticproduct available on the market, distributors shall act with duecare in relation to applicable requirements.2. Before making a cosmetic product available on the marketdistributors shall verify that:— the labelling information provided for in Article 19(1)(a), (e)and (g) and Article 19(3) and (4) is present,6. The distributor shall be the responsible person where heplaces a cosmetic product on the market under his name or trademarkor modifies a product already placed on the market in sucha way that compliance with the applicable requirements may beaffected.The translation of information relating to a cosmetic productalready placed on the market shall not be considered as a modificationof that product of such a nature that compliance with theapplicable requirements of this Regulation may be affected.Article 5Obligations of responsible persons1. Responsible persons shall ensure compliance withArticles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24.— the language requirements provided for in Article 19(5) arefulfilled,— the date of minimum durability specified, where applicableunder Article 19(1), has not passed.3. Where distributors consider or have reason to believe that:— a cosmetic product is not in conformity with the requirementslaid down in this Regulation, they shall not make theproduct available on the market until it has been broughtinto conformity with the applicable requirements,— a cosmetic product which they have made available on themarket is not in conformity with this Regulation, they shallmake sure that the corrective measures necessary to bringthat product into conformity, withdraw it or recall it, asappropriate, are taken.2. Responsible persons who consider or have reason to believethat a cosmetic product which they have placed on the market isnot in conformity with this Regulation shall immediately take thecorrective measures necessary to bring that product into conformity,withdraw it or recall it, as appropriate.Furthermore, where the cosmetic product presents a risk tohuman health, responsible persons shall immediately inform thecompetent national authorities of the Member States in whichthey made the product available and of the Member State in whichthe product information file is readily accessible, giving details, inparticular, of the non-compliance and of the corrective measurestaken.3. Responsible persons shall cooperate with these authorities,at the request of the latter, on any action to eliminate the risksposed by cosmetic products which they have made available onthe market. In particular, responsible persons shall, further to areasoned request from a competent national authority, provide itFurthermore, where the cosmetic product presents a risk tohuman health, distributors shall immediately inform the responsibleperson and the competent national authorities of the MemberStates in which they made the product available, giving details,in particular, of the non-compliance and of the corrective measurestaken.4. Distributors shall ensure that, while a product is under theirresponsibility, storage or transport conditions do not jeopardiseits compliance with the requirements set out in this Regulation.5. Distributors shall cooperate with competent authorities, atthe request of the latter, on any action to eliminate the risks posedby products which they have made available on the market. Inparticular, distributors shall, further to a reasoned request from acompetent national authority, provide it with all the informationand documentation necessary to demonstrate the conformity ofthe product with the requirements listed under paragraph 2, in alanguage which can be easily understood by that authority.