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

More documents

Recommendations

Info

L 342/62ENOfficial Journal of the European Union 22.12.2009(39) Council Directive 86/609/EEC of 24 November 1986 onthe approximation of laws, regulations and administrativeprovisions of the Member States regarding the protectionof animals used for experimental and other scientific purposes( 1 ) established common rules for the use of animalsfor experimental purposes within the Community and laiddown the conditions under which such experiments mustbe carried out in the territory of the Member States. In particular,Article 7 of that Directive requires that animalexperiments be replaced by alternative methods, wheresuch methods exist and are scientifically satisfactory.(40) The safety of cosmetic products and their ingredients maybe ensured through the use of alternative methods whichare not necessarily applicable to all uses of chemical ingredients.Therefore, the use of such methods by the wholecosmetic industry should be promoted and their adoptionat Community level ensured, where such methods offer anequivalent level of protection to consumers.(41) The safety of finished cosmetic products can already beensured on the basis of knowledge of the safety of theingredients that they contain. Provisions prohibiting animaltesting of finished cosmetic products should thereforebe laid down. The application, in particular by small andmedium-sized enterprises, of both test methods and assessmentprocedures for relevant available data, including theuse of read-across and weight-of-evidence approaches,which do not involve the use of animals for assessing thesafety of finished cosmetic products could be facilitated byCommission guidelines.(42) It will gradually become possible to ensure the safety ofingredients used in cosmetic products by using non-animalalternative methods validated at Community level, orapproved as being scientifically validated, by the EuropeanCentre for the Validation of Alternative Methods (ECVAM)and with due regard to the development of validationwithin the Organisation for Economic Cooperation andDevelopment (OECD). After consulting the SCCS asregards the applicability of the validated alternative methodsto the field of cosmetic products, the Commissionshould immediately publish the validated or approvedmethods recognised as being applicable to such ingredients.In order to achieve the highest possible degree of animalprotection, a deadline should be set for theintroduction of a definitive prohibition.(43) The Commission established timetables of deadlines upto 11 March 2009 for prohibiting the marketing of cosmeticproducts, the final formulation, ingredients or combinationsof ingredients which have been tested onanimals, and for prohibiting each test currently carried outusing animals. In view, however, of tests concerningrepeated-dose toxicity, reproductive toxicity and toxicokinetics,it is appropriate for the final deadline for prohibitingthe marketing of cosmetic products for which those( 1 ) OJ L 358, 18.12.1986, p. 1.tests are used to be 11 March 2013. On the basis of annualreports, the Commission should be authorised to adapt thetimetables within the abovementioned maximum timelimit.(44) Better coordination of resources at Community level willcontribute to increasing the scientific knowledge indispensablefor the development of alternative methods. It isessential, for this purpose, that the Community continueand increase its efforts and take the measures necessary forthe promotion of research and the development of newnon-animal alternative methods, in particular within itsFramework Programmes for research.(45) The recognition by third countries of alternative methodsdeveloped in the Community should be encouraged. Inorder to achieve this objective, the Commission and theMember States should take all appropriate steps to facilitateacceptance of such methods by the OECD. The Commissionshould also endeavour, within the framework ofEuropean Community cooperation agreements, to obtainrecognition of the results of safety tests carried out in theCommunity using alternative methods so as to ensure thatthe export of cosmetic products for which such methodshave been used is not hindered and to prevent or avoidthird countries requiring the repetition of such tests usinganimals.(46) Transparency is needed regarding the ingredients used incosmetic products. Such transparency should be achievedby indication of the ingredients used in a cosmetic producton its packaging. Where for practical reasons it isimpossible to indicate the ingredients on the packaging,such information should be enclosed so that the consumerhas access to this information.(47) A glossary of common ingredient names should be compiledby the Commission to ensure uniform labelling andto facilitate identification of cosmetics ingredients. Thisglossary should not be intended to constitute a limitativelist of substances used in cosmetic products.(48) In order to inform consumers, cosmetic products shouldbear precise and easily understandable indications concerningtheir durability for use. Given that consumersshould be informed of the date until which the cosmeticproduct will continue to fulfil its initial function andremain safe, it is important to know the date of minimumdurability, i.e. the date by which it is best to use the product.Where the minimum durability is more than 30months, the consumer should be informed of the period oftime after opening that the cosmetic product may be usedwithout any harm to the consumer. However, this requirementshould not apply where the concept of the durabilityafter opening is not relevant, that is to say for single-useproducts, products not at risk of deterioration or productswhich do not open.
22.12.2009ENOfficial Journal of the European Union L 342/63(49) A number of substances have been identified by the SCCSas likely to cause allergic reactions and it will be necessaryto restrict their use and/or impose certain conditions concerningthem. In order to ensure that consumers areadequately informed, the presence of these substancesshould be mentioned in the list of ingredients and consumers’attention should be drawn to the presence of theseingredients. This information should improve the diagnosisof contact allergies among consumers and shouldenable them to avoid the use of cosmetic products whichthey do not tolerate. For substances which are likely tocause allergy to a significant part of the population, otherrestrictive measures such as a ban or a restriction of concentrationshould be considered.containing substances which have raised serious doubts interms of safety.(55) This Regulation is without prejudice to the possibility forMember States to regulate, in compliance with Communitylaw, the notification by health professionals or consumersof serious undesirable effects to the competent authoritiesof Member States.(56) This Regulation is without prejudice to the possibility forMember States to regulate, in compliance with Communitylaw, the establishment of economic operators in the areaof cosmetic products.(50) In the safety assessment of a cosmetic product it should bepossible to take into account results of risk assessmentsthat have been carried out in other relevant areas. The useof such data should be duly substantiated and justified.(57) In case of non-compliance with this Regulation, a clear andefficient procedure for the withdrawal and recall of productsmay be necessary. This procedure should, where possible,build upon existing Community rules for unsafegoods.(51) The consumer should be protected from misleading claimsconcerning efficacy and other characteristics of cosmeticproducts. In particular Directive 2005/29/EC of the EuropeanParliament and of the Council of 11 May 2005 concerningunfair business-to-consumer commercial practicesin the internal market ( 1 ) is applicable. Furthermore, theCommission, in cooperation with Member States, shoulddefine common criteria in relation to specific claims forcosmetic products.(58) In order to address cosmetic products which, despite complyingwith the provisions of this Regulation, might endangerhuman health, a safeguard procedure should beintroduced.(59) The Commission should provide indications for the uniforminterpretation and application of the concept of seriousrisks in order to facilitate the consistentimplementation of this Regulation.(52) It should be possible to claim on a cosmetic product thatno animal testing was carried out in relation to its development.The Commission, in consultation with the MemberStates, has developed guidelines to ensure thatcommon criteria are applied in the use of claims and thatan aligned understanding of the claims is reached, and inparticular that such claims do not mislead the consumer.In developing such guidelines, the Commission has alsotaken into account the views of the many small andmedium-sized enterprises which make up the majority ofthe ‘non-animal testing’ producers, relevant nongovernmentalorganisations, and the need for consumersto be able to make practical distinctions between productson the basis of animal testing criteria.(53) In addition to the labelled information, consumers shouldbe given the possibility to request certain product-relatedinformation from the responsible person in order to makeinformed product choices.(54) Effective market surveillance is necessary in order to ensurethat the provisions of this Regulation are respected. To thisend, serious undesirable effects should be notified andcompetent authorities should have a possibility to requestfrom the responsible person a list of cosmetic products( 1 ) OJ L 149, 11.6.2005, p. 22.(60) In order to comply with principles of good administrativepractices, any decision by a competent authority in theframework of market surveillance should be dulysubstantiated.(61) In order to ensure effective in-market control, a highdegree of administrative cooperation amongst the competentauthorities is necessary. This concerns in particularmutual assistance in the verification of product informationfiles located in another Member State.(62) The Commission should be assisted by the SCCS, an independentrisk assessment body.(63) The measures necessary for the implementation of thisRegulation should be adopted in accordance with CouncilDecision 1999/468/EC of 28 June 1999 laying down theprocedures for the exercise of implementing powers conferredon the Commission ( 2 ).(64) In particular, power should be conferred on the Commissionto adapt the Annexes to this Regulation to technicalprogress. Since those measures are of general scope and aredesigned to amend non-essential elements of this Regulationthey must be adopted in accordance with the regulatoryprocedure with scrutiny provided for in Article 5a ofDecision 1999/468/EC.( 2 ) OJ L 184, 17.7.1999, p. 23.
Page 1 and 2: 22.12.2009ENOfficial Journal of the
Page 3: 22.12.2009ENOfficial Journal of the
Page 23 and 24: 22.12.2009 EN Official Journal of t
Page 55 and 56:
22.12.2009ENOfficial Journal of the
Page 57 and 58:
Page 59 and 60:
Page 61 and 62:
Page 63 and 64:
Page 65 and 66:
Page 67 and 68:
Page 69 and 70:
Page 71 and 72:
ReferencenumberaChemical name/INNbN
Page 73 and 74:
Page 75 and 76:
ReferencenumberaChemical name/INN12
Page 77 and 78:
Page 79 and 80:
Page 81 and 82:
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
Page 89 and 90:
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
Page 101 and 102:
Page 103 and 104:
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
Page 113 and 114:
Page 115 and 116:
Page 117 and 118:
Page 119 and 120:
ReferencenumberChemicalNameSubstanc
Page 121 and 122:
Page 123 and 124:
Page 125 and 126:
Page 127 and 128:
Page 129 and 130:
Page 131 and 132:
Page 133 and 134:
Page 135 and 136:
ReferencenumberChemicalname/INNSubs
Page 137 and 138:
Page 139 and 140:
Page 141 and 142:
Page 143 and 144:
ANNEX VILIST OF UV FILTERS ALLOWED
Page 145 and 146:
22.12.2009 EN Official Journal of t
Page 147 and 148:
Page 149 and 150:
Page 151:
show all

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

Create successful ePaper yourself

Delete template?

Save as template?