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

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L 342/78 EN Official Journal of the European Union 22.12.2009(2) progress made by the Commission in its efforts to obtainacceptance by the OECD of alternative methods validated atCommunity level and recognition by third countries of theresults of the safety tests carried out in the Community usingalternative methods, in particular within the framework ofcooperation agreements between the Community and thesecountries;(3) the manner in which the specific needs of small and mediumsizedenterprises have been taken into account.Article 36Formal objection against harmonised standards1. When a Member State or the Commission considers that aharmonised standard does not entirely satisfy the requirements setout in the relevant provisions of this Regulation, the Commissionor the Member State concerned shall bring the matter before theCommittee set up by Article 5 of Directive 98/34/EC, giving itsarguments. The Committee shall deliver its opinion without delay.2. In the light of the Committee’s opinion, the Commissionshall decide to publish, not to publish, to publish with restriction,to maintain, to maintain with restriction or to withdraw the referencesto the harmonised standard concerned in the Official Journalof the European Union.3. The Commission shall inform the Member States and theEuropean standardisation body concerned. It shall, if necessary,request the revision of the harmonised standards concerned.Article 37PenaltiesMember States shall lay down the provisions on penalties applicablefor infringement of the provisions of this Regulation andshall take all measures necessary to ensure that they are implemented.The penalties provided for must be effective, proportionateand dissuasive. The Member States shall notify thoseprovisions to the Commission by 11 July 2013 and shall notify itwithout delay of any subsequent amendment affecting them.Article 38RepealDirective 76/768/EEC is repealed with effect from 11 July 2013,with the exception of Article 4b which is repealed with effectfrom 1 December 2010.References to the repealed Directive shall be understood as referencesto this Regulation.This Regulation shall be without prejudice to the obligations ofthe Member States relating to the time-limits for transpositioninto national law of the Directives set out in Part B of Annex IX.However, the competent authorities shall continue to keep availablethe information received pursuant to Article 7(3) andArticle 7a(4) of Directive 76/768/EEC and responsible personsshall continue to keep readily accessible the information collectedpursuant to Article 7a of that Directive until 11 July 2020.Article 39Transitional provisionsBy way of derogation from Directive 76/768/EEC, cosmetic productswhich comply with this Regulation may be placed on themarket before 11 July 2013.As from 11 January 2012, by way of derogation from Directive76/768/EEC, notification carried out in accordance withArticle 13 of this Regulation shall be considered to comply withArticle 7(3) and Article 7a(4) of that Directive.Article 40Entry into force and date of application1. This Regulation shall enter into force on the [twentieth dayafter its publication in the Official Journal of the European Union2. It shall apply from 11 July 2013, with the exception of:— Article 15(1) and (2) which shall apply from 1 December2010, as well as Articles 14, 31 and 32 to the extent thatthey are necessary to apply Article 15(1) and (2); and— Article 16(3) second subparagraph, which shall apply from11 January 2013.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 30 November 2009.For the European ParliamentThe PresidentJ. BUZEKFor the CouncilThe PresidentB. ASK
22.12.2009ENOfficial Journal of the European Union L 342/79ANNEX ICOSMETIC PRODUCT SAFETY REPORTThe cosmetic product safety report shall, as a minimum, contain the following:PART A – Cosmetic product safety information1. Quantitative and qualitative composition of the cosmetic productThe qualitative and quantitative composition of the cosmetic product, including chemical identity of the substances(incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible) and their intended function. In the case of perfumeand aromatic compositions, description of the name and code number of the composition and the identity of thesupplier.2. Physical/chemical characteristics and stability of the cosmetic productThe physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product.The stability of the cosmetics product under reasonably foreseeable storage conditions.3. Microbiological qualityThe microbiological specifications of the substance or mixture and the cosmetic product. Particular attention shall bepaid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under threeyears of age, on elderly people and persons showing compromised immune responses.Results of preservation challenge test.4. Impurities, traces, information about the packaging materialThe purity of the substances and mixtures.In the case of traces of prohibited substances, evidence for their technical unavoidability.The relevant characteristics of packaging material, in particular purity and stability.5. Normal and reasonably foreseeable useThe normal and reasonably foreseeable use of the product. The reasoning shall be justified in particular in the light ofwarnings and other explanations in the product labelling.6. Exposure to the cosmetic productData on the exposure to cosmetic product taking into consideration the findings under Section 5 in relation to1) The site(s) of application;2) The surface area(s) of application;3) The amount of product applied;4) The duration and frequency of use;5) The normal and reasonably foreseeable exposure route(s);6) The targeted (or exposed) population(s). Potential exposure of a specific population shall also be taken intoaccount.
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