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

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L 342/74ENOfficial Journal of the European Union 22.12.20094. For cosmetic products that are not pre-packaged, are packagedat the point of sale at the purchaser’s request, or are prepackagedfor immediate sale, Member States shall adopt detailedrules for indication of the information referred to in paragraph 1.5. The language of the information mentioned in points (b),(c), (d) and (f) of paragraph 1 and in paragraphs (2), (3) and (4)shall be determined by the law of the Member States in which theproduct is made available to the end user.6. The information mentioned in point (g) of paragraph 1 shallbe expressed by using the common ingredient name set out in theglossary provided for in Article 33. In the absence of a commoningredient name, a term as contained in a generally acceptednomenclature shall be used.Article 21Access to information for the publicWithout prejudice to the protection, in particular, of commercialsecrecy and of intellectual property rights, the responsible personshall ensure that the qualitative and quantitative composition ofthe cosmetic product and, in the case of perfume and aromaticcompositions, the name and code number of the compositionand the identity of the supplier, as well as existing data on undesirableeffects and serious undesirable effects resulting from use ofthe cosmetic product are made easily accessible to the public byany appropriate means.The quantitative information regarding composition of the cosmeticproduct required to be made publicly accessible shall belimited to hazardous substances in accordance with Article 3 ofRegulation (EC) No 1272/2008.Article 20Product claims1. In the labelling, making available on the market and advertisingof cosmetic products, text, names, trade marks, pictures andfigurative or other signs shall not be used to imply that theseproducts have characteristics or functions which they 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 the use of a claim.CHAPTER VIIMARKET SURVEILLANCEArticle 22In-market controlMember States shall monitor compliance with this Regulation viain-market controls of the cosmetic products made available onthe market. They shall perform appropriate checks of cosmeticproducts and checks on the economic operators on an adequatescale, through the product information file and, where appropriate,physical and laboratory checks on the basis of adequatesamples.After consulting the SCCS or other relevant authorities, the Commissionshall adopt a list of common criteria for claims whichmay be used in respect of cosmetic products, in accordance withthe regulatory procedure with scrutiny referred to in Article 32(3)of this Regulation, taking into account the provisions of Directive2005/29/EC.By 11 July 2016, the Commission shall submit to the EuropeanParliament and the Council a report regarding the use of claimson the basis of the common criteria adopted under the secondsubparagraph. If the report concludes that claims used in respectof cosmetic products are not in conformity with the common criteria,the Commission shall take appropriate measures to ensurecompliance in cooperation with the Member States.3. The responsible person may refer, on the product packagingor in any document, notice, label, ring or collar accompanyingor referring to the cosmetic product, to the fact that no animaltests have been carried out only if the manufacturer and his suppliershave not carried out or commissioned any animal tests onthe finished cosmetic product, or its prototype, or any of theingredients contained in it, or used any ingredients that have beentested on animals by others for the purpose of developing newcosmetic products.Member States shall also monitor compliance with the principlesof good manufacturing practices.Member States shall entrust to market surveillance authorities thenecessary powers, resources and knowledge in order for thoseauthorities to properly perform their tasks.Member States shall periodically review and assess the functioningof their surveillance activities. Such reviews and assessmentsshall be carried out at least every four years and the results thereofshall be communicated to the other Member States and the Commissionand be made available to the public, by way of electroniccommunication and, where appropriate, by other means.Article 23Communication of serious undesirable effects1. In the event of serious undesirable effects, the responsibleperson and distributors shall without delay notify the following tothe competent authority of the Member State where the seriousundesirable effect occurred:(a)all serious undesirable effects which are known to him orwhich may reasonably be expected to be known to him;
22.12.2009ENOfficial Journal of the European Union L 342/75(b) the name of the cosmetic product concerned, enabling itsspecific identification;(c)the corrective measures taken by him, if any.2. Where the responsible person reports serious undesirableeffects to the competent authority of the Member State where theeffect occurred, that competent authority shall immediately transmitthe information referred to in paragraph 1 to the competentauthorities of the other Member States.3. Where distributors report serious undesirable effects to thecompetent authority of the Member State where the effectoccurred, that competent authority shall immediately transmit theinformation referred to in paragraph 1 to the competent authoritiesof the other Member States and to the responsible person.4. Where end users or health professionals report seriousundesirable effects to the competent authority of the MemberState where the effect occurred, that competent authority shallimmediately transmit the information on the cosmetic productconcerned to the competent authorities of the other MemberStates and to the responsible person.5. Competent authorities may use the information referred toin this Article for the purposes of in-market surveillance, marketanalysis, evaluation and consumer information in the context ofArticles 25, 26 and 27.Article 24Information on substancesIn the event of serious doubt regarding the safety of any substancecontained in cosmetic products, the competent authority of aMember State in which a product containing such a substance ismade available on the market may by reasoned request require theresponsible person to submit a list of all cosmetic products forwhich he is responsible and which contain this substance. The listshall indicate the concentration of this substance in the cosmeticproducts.Competent authorities may use the information referred to in thisArticle for the purposes of in-market surveillance, market analysis,evaluation and consumer information in the context ofArticles 25, 26 and 27.CHAPTER VIIINON-COMPLIANCE, SAFEGUARD CLAUSEArticle 25Non-compliance by the responsible person1. Without prejudice to paragraph 4, competent authoritiesshall require the responsible person to take all appropriate measures,including corrective actions bringing the cosmetic productinto conformity, the withdrawal of the product from the marketor its recall, within an expressly mentioned time limit, commensuratewith the nature of the risk, where there is non-compliancewith any of the following:(a) the good manufacturing practice referred to in Article 8;(b) the safety assessment referred to in Article 10;(c)the requirements for the product information file referred toin Article 11;(d) the provisions on sampling and analysis referred to inArticle 12;(e) the notification requirements referred to in Articles 13and 16;(f) the restrictions for substances referred to in Articles 14, 15and 17;(g) the animal testing requirements referred to in Article 18;(h) the labelling requirements referred to in Article 19(1), (2), (5)and (6);(i)(j)the requirements related to product claims set out inArticle 20;the access to information for the public referred to inArticle 21;(k) the communication of serious undesirable effects referred toin Article 23;(l)the information requirements on substances referred to inArticle 24.2. Where applicable, a competent authority shall inform thecompetent authority of the Member State in which the responsibleperson is established of the measures which it has requiredthe responsible person to take.3. The responsible person shall ensure that the measuresreferred to in paragraph 1 are taken in respect of all the productsconcerned which are made available on the market throughoutthe Community.4. In the case of serious risks to human health, where the competentauthority considers that the non-compliance is not limitedto the territory of the Member State in which the cosmetic productis made available on the market, it shall inform the Commissionand the competent authorities of the other Member States ofthe measures which it has required the responsible person to take.5. The competent authority shall take all appropriate measuresto prohibit or restrict the making available on the market of thecosmetic product or to withdraw the product from the market orto recall it in the following cases:(a)where an immediate action is necessary in the event of seriousrisk to human health; or
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