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

More documents

Recommendations

Info

L 342/60ENOfficial Journal of the European Union 22.12.2009(10) The presentation of a cosmetic product and in particular itsform, odour, colour, appearance, packaging, labelling, volumeor size should not endanger health and safety of consumersdue to confusion with foodstuffs, in accordancewith Council Directive 87/357/EEC of 25 June 1987 onthe approximation of the laws of the Member States concerningproducts which, appearing to be other than theyare, endanger the health or safety of consumers ( 1 ).(11) In order to establish clear responsibilities, each cosmeticproduct should be linked to a responsible person establishedwithin the Community.(12) Ensuring traceability of a cosmetic product throughout thewhole supply chain helps to make market surveillance simplerand more efficient. An efficient traceability systemfacilitates market surveillance authorities’ task of tracingeconomic operators.(13) It is necessary to determine under which conditions a distributoris to be considered as the responsible person.(14) All legal or natural persons in the wholesale trade as wellas retailers selling directly to the consumer are covered byreference to the distributor. The obligations of the distributorshould therefore be adapted to the respective role andpart of the activity of each of these operators.(17) For the purpose of effective market surveillance, a productinformation file should be made readily accessible, at onesingle address within the Community, to the competentauthority of the Member State where the file is located.(18) In order to be comparable and of high quality, the resultsof the non-clinical safety studies carried out for the purposesof assessing the safety of a cosmetic product shouldcomply with the relevant Community legislation.(19) It should be made clear which information is to be madeavailable to the competent authorities. That informationshould include all the necessary particulars relating to identity,quality, safety for human health and the effects claimedfor the cosmetic product. In particular, this product informationshould include a cosmetic product safety reportdocumenting that a safety assessment has been conducted.(20) To ensure the uniform application and control of therestrictions for substances, sampling and analysis shouldbe carried out in a reproducible and standardised manner.(21) The term ‘mixture’ as defined in this Regulation shouldhave the same meaning as the term ‘preparation’ previouslyused in Community legislation.(22) For reasons of effective market surveillance, the competentauthorities should be notified of certain information aboutthe cosmetic product placed on the market.(15) The European cosmetics sector is one of the industrialactivities affected by counterfeiting, which may increaserisks to human health. Member States should pay particularattention to the implementation of horizontal Communitylegislation and measures regarding counterfeitproducts in the field of cosmetic products, for exampleCouncil Regulation (EC) No 1383/2003 of 22 July 2003concerning customs action against goods suspected ofinfringing certain intellectual property rights and the measuresto be taken against goods found to have infringedsuch rights ( 2 ) and Directive 2004/48/EC of the Europeanparliament and of the Council of 29 April 2004 on theenforcement of intellectual property rights ( 3 ). In-marketcontrols represent a powerful means of identifying productsthat do not comply with the requirements of thisRegulation.(16) To ensure their safety, cosmetic products placed on themarket should be produced according to good manufacturingpractice.( 1 ) OJ L 192, 11.7.1987, p. 49.( 2 ) OJ L 196, 2.8.2003, p. 7.( 3 ) OJ L 157, 30.4.2004, p. 45.(23) In order to allow for rapid and appropriate medical treatmentin the event of difficulties, the necessary informationabout the product formulation should be submitted to poisoncontrol centres and assimilated entities, where suchcentres have been established by Member States to thatend.(24) In order to keep administrative burdens to a minimum, thenotified information for competent authorities, poisoncontrol centres and assimilated entities should be submittedcentrally for the Community by way of an electronicinterface.(25) In order to ensure a smooth transition to the new electronicinterface, economic operators should be allowed tonotify the information required in accordance with thisRegulation before its date of application.(26) The general principle of the responsibility of the manufactureror importer for the safety of the product should besupported by restrictions of some substances in Annexes IIand III. Moreover, substances which are intended to beused as colorants, preservatives and UV-filters should belisted in the Annexes IV, V and VI respectively in order tobe allowed for these uses.
22.12.2009ENOfficial Journal of the European Union L 342/61(27) To avoid ambiguities, it should be clarified that the list ofallowed colorants contained in Annex IV includes onlysubstances which colour through absorption and reflectionand not substances which colour through photoluminescence,interference, or chemical reaction.(28) To address safety concerns raised, Annex IV, which is currentlyrestricted to skin colorants, should also include haircolorants once the risk assessment of these substances bythe Scientific Committee for Consumer Safety (SCCS) setup by Commission Decision 2008/721/EC of 5 September2008 setting up an advisory structure of ScientificCommittees and experts in the field of consumer safety,public health and the environment ( 1 ) has been finalised.To this end, the Commission should have the possibility toinclude hair colorants in the scope of that Annex by thecomitology procedure.(29) The use of nanomaterials in cosmetic products mayincrease with the further development of technology. Inorder to ensure a high level of consumer protection, freemovement of goods and legal certainty for manufacturers,it is necessary to develop a uniform definition for nanomaterialsat international level. The Community shouldendeavour to reach an agreement on a definition in appropriateinternational fora. Should such an agreement bereached, the definition of nanomaterials in this Regulationshould be adapted accordingly.(30) At present, there is inadequate information on the risksassociated with nanomaterials. In order to better assesstheir safety the SCCS should provide guidance in cooperationwith relevant bodies on test methodologies which takeinto account specific characteristics of nanomaterials.(31) The Commission should regularly review the provisions onnanomaterials in the light of scientific progress.as CMR 1A or 1B substances, there should be a possibility,in the exceptional case that these substances comply withfood safety requirements, inter alia as a result of their naturallyoccurring in food, and that no suitable alternativesubstances exist, to use such substances in cosmetic productson the condition that such use has been found safe bythe SCCS. Where such conditions are met, the Commissionshould amend the relevant Annexes to this Regulationwithin 15 months of classification of substances as CMR1A or 1B substances under Regulation (EC) No 1272/2008.Such substances should be continuously reviewed by theSCCS.(33) A safety assessment of substances, particularly those classifiedas CMR 1A or 1B substances, should consider theoverall exposure to such substances stemming from allsources. At the same time, for those involved in producingsafety assessments, it is essential that there be a harmonisedapproach to the development and use of such overallexposure estimates. In consequence, the Commission, inclose cooperation with the SCCS, the European ChemicalsAgency (ECHA), the European Food Safety Authority(EFSA) and other relevant stakeholders, should, as a matterof urgency, carry out a review and develop guidanceregarding the production and use of overall exposure estimatesfor these substances.(34) The assessment by the SCCS of the use of substances classifiedas CMR 1A and 1B in cosmetic products should alsotake into account the exposure to those substances of vulnerablepopulation groups, such as children under threeyears of age, elderly people, pregnant and breast-feedingwomen and persons with compromised immuneresponses.(35) The SCCS should give opinions where appropriate on thesafety of use of nanomaterials in cosmetic products. Theseopinions should be based on full information being madeavailable by the responsible person.(32) Given the hazardous properties of substances classified ascarcinogenic, mutagenic or toxic for reproduction (CMR),category 1A, 1B and 2, pursuant to Regulation (EC)No 1272/2008 of the European Parliament and of theCouncil of 16 December 2008 on classification, labellingand packaging of substances and mixtures ( 2 ), their use incosmetic products should be prohibited. However, as ahazardous property of a substance does not necessarilyalways entail a risk, there should be a possibility to allowthe use of substances classified as CMR 2 substances where,in view of exposure and concentration, they have beenfound safe for use in cosmetic products by the SCCS andare regulated by the Commission in the Annexes to thisRegulation. With regard to substances which are classified( 1 ) OJ L 241, 10.9.2008, p. 21.( 2 ) OJ L 353, 31.12.2008, p. 1.(36) Action by the Commission and Member States relating tothe protection of human health should be based on theprecautionary principle.(37) In order to ensure product safety, prohibited substancesshould be acceptable at trace levels only if they are technologicallyinevitable with correct manufacturing processesand provided that the product is safe.(38) The Protocol on protection and welfare of animals annexedto the Treaty provides that the Community and the MemberStates are to pay full regard to the welfare requirementsof animals in the implementation of Community policies,in particular with regard to the internal market.
Page 1: 22.12.2009ENOfficial Journal of the
Page 5: 22.12.2009ENOfficial Journal of the
Page 9 and 10: 22.12.2009ENOfficial Journal of the
Page 23 and 24: 22.12.2009 EN Official Journal of t
Page 53 and 54:
22.12.2009ENOfficial Journal of the
Page 55 and 56:
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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?