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

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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.
22.12.2009ENOfficial Journal of the European Union L 342/67Article 7Identification within the supply chain(b) an appropriate weight-of-evidence approach is used in thesafety assessment for reviewing data from all existing sources;At the request of a competent authority:— responsible persons shall identify the distributors to whomthey supply the cosmetic product,(c)the cosmetic product safety report is kept up to date in viewof additional relevant information generated subsequent toplacing the product on the market.— the distributor shall identify the distributor or the responsibleperson from whom, and the distributors to whom, the cosmeticproduct was supplied.This obligation shall apply for a period of three years followingthe date on which the batch of the cosmetic product was madeavailable to the distributor.Article 8Good manufacturing practice1. The manufacture of cosmetic products shall comply withgood manufacturing practice with a view to ensuring the objectivesof Article 1.2. Compliance with good manufacturing practice shall be presumedwhere the manufacture is in accordance with the relevantharmonised standards, the references of which have been publishedin the Official Journal of the European Union.Article 9Free movementMember States shall not, for reasons related to the requirementslaid down in this Regulation, refuse, prohibit or restrict the makingavailable on the market of cosmetic products which complywith the requirements of this Regulation.The first subparagraph shall also apply to cosmetic products thathave been notified under Directive 76/768/EEC.The Commission, in close cooperation with all stakeholders, shalladopt appropriate guidelines to enable undertakings, in particularsmall and medium-sized enterprises, to comply with therequirements laid down in Annex I. Those guidelines shall beadopted in accordance with the regulatory procedure referred toin Article 32(2).2. The cosmetic product safety assessment, as set out in Part Bof Annex I shall be carried out by a person in possession of adiploma or other evidence of formal qualifications awarded oncompletion of a university course of theoretical and practicalstudy in pharmacy, toxicology, medicine or a similar discipline, ora course recognised as equivalent by a Member State.3. Non-clinical safety studies referred to in the safety assessmentaccording to paragraph 1 and carried out after 30 June1988 for the purpose of assessing the safety of a cosmetic productshall comply with Community legislation on the principles ofgood laboratory practice, as applicable at the time of performanceof the study, or with other international standards recognised asbeing equivalent by the Commission or the ECHA.Article 11Product information fileCHAPTER IIISAFETY ASSESSMENT, PRODUCT INFORMATION FILE,NOTIFICATIONArticle 10Safety assessment1. In order to demonstrate that a cosmetic product complieswith Article 3, the responsible person shall, prior to placing a cosmeticproduct on the market, ensure that the cosmetic producthas undergone a safety assessment on the basis of the relevantinformation and that a cosmetic product safety report is set up inaccordance with Annex I.The responsible person shall ensure that:1. When a cosmetic product is placed on the market, theresponsible person shall keep a product information file for it.The product information file shall be kept for a period of ten yearsfollowing the date on which the last batch of the cosmetic productwas placed on the market.2. The product information file shall contain the followinginformation and data which shall be updated as necessary:(a)a description of the cosmetic product which enables theproduct information file to be clearly attributed to the cosmeticproduct;(b) the cosmetic product safety report referred to in Article 10(1);(a)the intended use of the cosmetic product and the anticipatedsystemic exposure to individual ingredients in a final formulationare taken into account in the safety assessment;(c)a description of the method of manufacturing and a statementon compliance with good manufacturing practicereferred to in Article 8;
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