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

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L 342/74ENOfficial Journal <strong>of</strong> <strong>the</strong> <strong>European</strong> Union 22.12.<strong>2009</strong>4. For cosmetic products that are not pre-packaged, are packagedat <strong>the</strong> point <strong>of</strong> sale at <strong>the</strong> purchaser’s request, or are prepackagedfor immediate sale, Member States shall adopt detailedrules for indication <strong>of</strong> <strong>the</strong> information referred to in paragraph 1.5. The language <strong>of</strong> <strong>the</strong> information mentioned in points (b),(c), (d) and (f) <strong>of</strong> paragraph 1 and in paragraphs (2), (3) and (4)shall be determined by <strong>the</strong> law <strong>of</strong> <strong>the</strong> Member States in which <strong>the</strong>product is made available to <strong>the</strong> end user.6. The information mentioned in point (g) <strong>of</strong> paragraph 1 shallbe expressed by using <strong>the</strong> common ingredient name set out in <strong>the</strong>glossary provided for in Article 33. In <strong>the</strong> absence <strong>of</strong> a commoningredient name, a term as contained in a generally acceptednomenclature shall be used.Article 21Access to information for <strong>the</strong> publicWithout prejudice to <strong>the</strong> protection, in particular, <strong>of</strong> commercialsecrecy and <strong>of</strong> intellectual property rights, <strong>the</strong> responsible personshall ensure that <strong>the</strong> qualitative and quantitative composition <strong>of</strong><strong>the</strong> cosmetic product and, in <strong>the</strong> case <strong>of</strong> perfume and aromaticcompositions, <strong>the</strong> name and code number <strong>of</strong> <strong>the</strong> compositionand <strong>the</strong> identity <strong>of</strong> <strong>the</strong> supplier, as well as existing data on undesirableeffects and serious undesirable effects resulting from use <strong>of</strong><strong>the</strong> cosmetic product are made easily accessible to <strong>the</strong> public byany appropriate means.The quantitative information regarding composition <strong>of</strong> <strong>the</strong> cosmeticproduct required to be made publicly accessible shall belimited to hazardous substances in accordance with Article 3 <strong>of</strong><strong>Regulation</strong> (<strong>EC</strong>) <strong>No</strong> 1272/2008.Article 20Product claims1. In <strong>the</strong> labelling, making available on <strong>the</strong> market and advertising<strong>of</strong> cosmetic products, text, names, trade marks, pictures andfigurative or o<strong>the</strong>r signs shall not be used to imply that <strong>the</strong>seproducts have characteristics or functions which <strong>the</strong>y do not have.2. The Commission shall, in cooperation with Member States,establish an action plan regarding claims used and fix prioritiesfor determining common criteria justifying <strong>the</strong> use <strong>of</strong> a claim.CHAPTER VIIMARKET SURVEILLANCEArticle 22In-market controlMember States shall monitor compliance with this <strong>Regulation</strong> viain-market controls <strong>of</strong> <strong>the</strong> cosmetic products made available on<strong>the</strong> market. They shall perform appropriate checks <strong>of</strong> cosmeticproducts and checks on <strong>the</strong> economic operators on an adequatescale, through <strong>the</strong> product information file and, where appropriate,physical and laboratory checks on <strong>the</strong> basis <strong>of</strong> adequatesamples.After consulting <strong>the</strong> SCCS or o<strong>the</strong>r relevant authorities, <strong>the</strong> Commissionshall adopt a list <strong>of</strong> common criteria for claims whichmay be used in respect <strong>of</strong> cosmetic products, in accordance with<strong>the</strong> regulatory procedure with scrutiny referred to in Article 32(3)<strong>of</strong> this <strong>Regulation</strong>, taking into account <strong>the</strong> provisions <strong>of</strong> Directive2005/29/<strong>EC</strong>.By 11 July 2016, <strong>the</strong> Commission shall submit to <strong>the</strong> <strong>European</strong>Parliament and <strong>the</strong> Council a report regarding <strong>the</strong> use <strong>of</strong> claimson <strong>the</strong> basis <strong>of</strong> <strong>the</strong> common criteria adopted under <strong>the</strong> secondsubparagraph. If <strong>the</strong> report concludes that claims used in respect<strong>of</strong> cosmetic products are not in conformity with <strong>the</strong> common criteria,<strong>the</strong> Commission shall take appropriate measures to ensurecompliance in cooperation with <strong>the</strong> Member States.3. The responsible person may refer, on <strong>the</strong> product packagingor in any document, notice, label, ring or collar accompanyingor referring to <strong>the</strong> cosmetic product, to <strong>the</strong> fact that no animaltests have been carried out only if <strong>the</strong> manufacturer and his suppliershave not carried out or commissioned any animal tests on<strong>the</strong> finished cosmetic product, or its prototype, or any <strong>of</strong> <strong>the</strong>ingredients contained in it, or used any ingredients that have beentested on animals by o<strong>the</strong>rs for <strong>the</strong> purpose <strong>of</strong> developing newcosmetic products.Member States shall also monitor compliance with <strong>the</strong> principles<strong>of</strong> good manufacturing practices.Member States shall entrust to market surveillance authorities <strong>the</strong>necessary powers, resources and knowledge in order for thoseauthorities to properly perform <strong>the</strong>ir tasks.Member States shall periodically review and assess <strong>the</strong> functioning<strong>of</strong> <strong>the</strong>ir surveillance activities. Such reviews and assessmentsshall be carried out at least every four years and <strong>the</strong> results <strong>the</strong>re<strong>of</strong>shall be communicated to <strong>the</strong> o<strong>the</strong>r Member States and <strong>the</strong> Commissionand be made available to <strong>the</strong> public, by way <strong>of</strong> electroniccommunication and, where appropriate, by o<strong>the</strong>r means.Article 23Communication <strong>of</strong> serious undesirable effects1. In <strong>the</strong> event <strong>of</strong> serious undesirable effects, <strong>the</strong> responsibleperson and distributors shall without delay notify <strong>the</strong> following to<strong>the</strong> competent authority <strong>of</strong> <strong>the</strong> Member State where <strong>the</strong> seriousundesirable effect occurred:(a)all serious undesirable effects which are known to him orwhich may reasonably be expected to be known to him;

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