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

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L 342/68ENOfficial Journal of the European Union 22.12.2009(d) where justified by the nature or the effect of the cosmeticproduct, proof of the effect claimed for the cosmetic product;(f)the presence of substances in the form of nanomaterials and:(e)data on any animal testing performed by the manufacturer,his agents or suppliers, relating to the development or safetyassessment of the cosmetic product or its ingredients, includingany animal testing performed to meet the legislative orregulatory requirements of third countries.(i)their identification including the chemical name (IUPAC)and other descriptors as specified in point 2 of the Preambleto Annexes II to VI to this Regulation;(ii) the reasonably foreseeable exposure conditions;3. The responsible person shall make the product informationfile readily accessible in electronic or other format at his addressindicated on the label to the competent authority of the MemberState in which the file is kept.(g) the name and the Chemicals Abstracts Service (CAS) or ECnumber of substances classified as carcinogenic, mutagenicor toxic for reproduction (CMR), of category 1A or 1B, underPart 3 of Annex VI to Regulation (EC) No 1272/2008;The information contained in the product information file shallbe available in a language which can be easily understood by thecompetent authorities of the Member State.4. The requirements provided in paragraphs 1 to 3 of thisArticle shall also apply to cosmetic products that have been notifiedunder Directive 76/768/EEC.Article 12Sampling and analysis1. Sampling and analysis of cosmetic products shall be performedin a reliable and reproducible manner.2. In the absence of any applicable Community legislation,reliability and reproducibility shall be presumed if the methodused is in accordance with the relevant harmonised standards, thereferences of which have been published in the Official Journal ofthe European Union.Article 13Notification(h) the frame formulation allowing for prompt and appropriatemedical treatment in the event of difficulties.The first subparagraph shall also apply to cosmetic products notifiedunder Directive 76/768/EEC.2. When the cosmetic product is placed on the market, theresponsible person shall notify to the Commission the originallabelling, and, where reasonably legible, a photograph of the correspondingpackaging.3. As from 11 July 2013, a distributor who makes available ina Member State a cosmetic product already placed on the marketin another Member State and translates, on his own initiative, anyelement of the labelling of that product in order to comply withnational law, shall submit, by electronic means, the followinginformation to the Commission:(a)the category of cosmetic product, its name in the MemberState of dispatch and its name in the Member State in whichit is made available, enabling its specific identification;(b) the Member State in which the cosmetic product is madeavailable;1. Prior to placing the cosmetic product on the market theresponsible person shall submit, by electronic means, the followinginformation to the Commission:(a)the category of cosmetic product and its name or names,enabling its specific identification;(b) the name and address of the responsible person where theproduct information file is made readily accessible;(c)the country of origin in the case of import;(d) the Member State in which the cosmetic product is to beplaced on the market;(c)his name and address;(d) the name and address of the responsible person where theproduct information file is made readily accessible..4. Where a cosmetic product has been placed on the marketbefore 11 July 2013 but is no longer placed on the market asfrom that date, and a distributor introduces that product in aMember State after that date, that distributor shall communicatethe following to the responsible person:(a)the category of cosmetic product, its name in the MemberState of dispatch and its name in the Member State in whichit is made available, enabling its specific identification;(e)the contact details of a physical person to contact in the caseof necessity;(b) the Member State in which the cosmetic product is madeavailable;
22.12.2009ENOfficial Journal of the European Union L 342/69(c)his name and address.(c)colorantsOn the basis of that communication, the responsible person shallsubmit to the Commission, by electronic means, the informationreferred to in paragraph 1 of this Article, where notificationsaccording to Article 7(3) and Article 7a (4) of Directive76/768/EEC have not been carried out in the Member State inwhich the cosmetic product is made available.5. The Commission shall, without delay, make the informationreferred to in points (a) to (g) of paragraph 1, and in paragraphs 2and 3 available electronically to all competent authorities.That information may be used by competent authorities only forthe purposes of market surveillance, market analysis, evaluationand consumer information in the context of Articles 25, 26and 27.6. The Commission shall, without delay, make the informationreferred to in paragraphs 1, 2 and 3 available electronically to poisoncentres or similar bodies, where such centres or bodies havebeen established by Member States.That information may be used by those bodies only for the purposesof medical treatment.(i)colorants other than those listed in Annex IV and colorantswhich are listed there but not used in accordancewith the conditions laid down in that Annex, except forhair colouring products referred to in paragraph 2;(ii) without prejudice to points (b), (d)(i) and (e)(i), substanceswhich are listed in Annex IV but which are notintended to be used as colorants, and which are not usedin accordance with the conditions laid down in thatAnnex;(d) preservatives(e)(i)preservatives other than those listed in Annex V and preservativeswhich are listed there but not used in accordancewith the conditions laid down in that Annex;(ii) without prejudice to points (b), (c)(i) and (e)(i), substanceslisted in Annex V but which are not intended tobe used as preservatives, and which are not used inaccordance with the conditions laid down in that Annex;UV-filters7. Where any of the information set out in paragraphs 1, 3and 4 changes, the responsible person or the distributor shall providean update without delay.(i)UV-filters other than those listed in Annex VI andUV-filters which are listed there but not used in accordancewith the conditions laid down in that Annex;8. The Commission may, taking into account technical andscientific progress and specific needs related to market surveillance,amend paragraphs 1 to 7 by adding requirements.Those measures, designed to amend non-essential elements of thisRegulation, shall be adopted in accordance with the regulatoryprocedure with scrutiny referred to in Article 32(3).CHAPTER IVRESTRICTIONS FOR CERTAIN SUBSTANCESArticle 14Restrictions for substances listed in the Annexes(ii) without prejudice to points (b), (c)(i) and (d)(i), substanceslisted in Annex VI but which are not intended tobe used as UV-filters and which are not used in accordancewith the conditions laid down in that Annex.2. Subject to a decision of the Commission to extend the scopeof Annex IV to hair colouring products, such products shall notcontain colorants intended to colour the hair, other than thoselisted in Annex IV and colorants intended to colour the hair whichare listed there but not used in accordance with the conditionslaid down in that Annex.The decision of the Commission referred to in the first subparagraph,designed to amend non-essential elements of this Regulation,shall be adopted in accordance with the regulatory procedurewith scrutiny referred to in Article 32(3).1. Without prejudice to Article 3, cosmetic products shall notcontain any of the following:(a)prohibited substances— prohibited substances listed in Annex II;(b) restricted substances— restricted substances which are not used in accordancewith the restrictions laid down in Annex III;Article 15Substances classified as CMR substances1. The use in cosmetic products of substances classified asCMR substances, of category 2, under Part 3 of Annex VI to Regulation(EC) No 1272/2008 shall be prohibited. However, a substanceclassified in category 2 may be used in cosmetic productswhere the substance has been evaluated by the SCCS and foundsafe for use in cosmetic products. To these ends the Commissionshall adopt the necessary measures in accordance with the regulatoryprocedure with scrutiny referred to in Article 32(3) of thisRegulation.
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