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EC是什么意思
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EC是什么意思 EC在线翻译 EC什么意思 EC的意思 EC的翻译 EC的解释 EC的发音 EC的同义词 EC的反义词 EC的例句 EC的相关词组 EC意思是什么
EC[,i'si]　EC 基本解释EC的解释abbr.Electronic Commerce 电子商务; European Community 欧共体EC 网络解释1. 乙基纤维素：河北志诚化工集团山东分公司河北志诚化工集团山东分公司供应甲基纤维素(MC) 羟丙基甲基纤维素(HPMC) 羟乙基纤维素(HEC) 乙基纤维素(EC) 羧甲基纤维素(CMC) 高取代羟丙基纤维素(H-HPC) 阿维菌素原药 百奥植物抗病有机发酵肥 百奥生物肥 等优质产品,2. 厄瓜多尔：连入NSFNET的国家:南极洲(AQ)、喀麦隆(CM)、塞浦路斯(CY)、厄瓜多尔(EC)、爱沙尼亚(EE)、科威特(KW)、拉脱维亚(LV)、卢森堡(LU)、马来西亚(MY)、斯洛伐克(SK)、斯洛文尼亚(SI)、泰国(TH)、委内瑞拉(VE).3. \u\u006E\u\u002E\u\u\u\u002E\uF\u006D3. 乳油：顾地丰公司是一家自主多品牌运营的高科技新型农用化学品企业,集产品策划、研发、生产、推广和销售于一体,下辖广州市顾地丰农药有限公司和清远顾地丰生物科技有限公司. 现拥有微乳剂(ME)、乳油(EC)、悬浮剂(SC)、可湿性粉剂(WP)和可分散粒剂(WDG)等不同剂型的杀虫剂、杀螨剂、杀菌剂和除草剂产品一百余个.4. \u\u\u8BE2\u00B7\u82F1\u8BED\u5355\u8BCD4. ec：ent 企业文化5. 5. ec： 电子商务6. EC什么意思6. ec： 内皮细胞7. ec： 食管癌EC 双语例句1. We would be grateful if you could please sign the original document and return it to us to confirm that you have read and understood our general Terms of Engagement.&&&&在我们最初的会谈中你已经非常具体地向我们指出你的长期目标就是要可能在EC下获取新西兰居留，那麼我们也讨论过像你这种情况的申请人申请LTBV所需的费用。2. The final individual caffeine, the caffeine analysis by the HPLC instrumental, which indicated that EGC of caffeine, EGCG were more than EC, ECG, obviously has no significant difference compared the tea type caffeine content by the fermentation market green tea with other tea type.&&&&同时探讨用煮制的佳叶龙茶进行动物试验，以评估佳叶龙茶之护肝及其他之生理功效。佳叶龙茶之GABA含量显著高於其他茶类。总儿茶素及总多元酚含量，以市售绿茶表现最佳。3. In most cases, our rules will be the same as those in other EC/EEA countries although there may be some differences.&&&&在大多数情况下，我们的规则将相同欧共体其他/欧洲国家虽然可能会有一些分歧。4. The relationship between temperature and development of Spodoptera litura was simulated by the sine model V=A+B sin(C 0+C 1e C 3T +C 2e -C 3T), and the threshold temperature and thermal requirment for its development at different stages were estimated by the direct optimum method.&&&&用正弦模型V=A+Bsin(C0+C1eC3T+C2e-C3T)拟合了斜纹夜蛾发育与温度的关系，并用直接最优法估算了斜纹夜蛾不同发育阶段的温度阈值和所需热量。5. 5. Ethylcellulose（ec, 100cps）was used to adjust the releasing rate. the content of the major drug was determined by uv spectrophotometry at 295 nm. the drug release in vitro was determined according to the method of chinese pharmacopoeia（2000）and a survey of its stability was conducted.&&&&用紫外分光光度法在295 nm测定吸收度a来测主药含量，根据中国药典2000年版释放度测定法测定其体外释放度，并对其稳定性作了初步考察。6. Ampicillin sodium was embeded in ethylcellulose nanospheres made of low-molecular-weight EC.&&&&低分子量的乙基纤维素包覆氨苄青霉素钠，采用纳米沉淀法制备氨苄青霉素钠-乙基纤维素纳米微球。7. 7. Ethylcellulose Low-molecular-weight EC Nanospheres Control release Ampicillin sodium&&&&乙基纤维素；低分子量EC ；纳米球；控制释放；氨苄青霉素钠8. EC 32. Lead oxide in seal frit used for making window assemblies for Argon and Krypton laser tubes.&&&&用于氩和氪激光管防护窗组合件的封装玻璃料里的铅的氧化物。9. Tyrosinase(EC 1.14.18.1), a ubiquitously expressed enzyme in organisms, plays a pivotal role in the melanin biosynthesis.&&&&酪氨酸酶(EC 1.14.18.1)是生物体合成黑色素的关键酶。10. 10. Objective To study the inhibitory effect of tannins on human esophageal carcinoma cells EC9706 in vitro.&&&&目的探讨鞣酸对体外培养的人食管癌细胞EC9706的生长抑制作用。11. For example, if the interval is 5 seconds to 10 exposures, then cuniform test is an e-commerce function similarly to facilitate.&&&&&&例如，如果举行隔断为5秒钟的10不主曝平尝试，那么楔形尝试条比EC用不躺下更便当一些。12. \u\u\u8BE2\u00B7\u82F1\u8BED\u5355\u8BCD12. Commonly used with EC test and cuniform test, which control will work better, you can increase or decrease exposure time as you want.&&&&&&常用的有EC尝试条和楔形尝试条，后者把持成果更好，可以力不从心不天补充曝平工夫。13. If you want to do some flexible exposures, we recommend using cuniform test, because we can increase the exposure time, unlike the EC so restricted.&&&&&&如果给举行一些板滞的曝平尝试，我们保举搁置楔形尝试条，因为我们可以辛不从心不天补充曝平工夫，不像EC那样受到不拘。14. 14. Methods 22 cases of superior sagittal sinus rupture were repaired with muscular fasciae and gelatin sponge or muscular sheet smeared with EC glue.&&&&&&方法用涂有EC耳脑胶的明胶海绵肌筋膜或肌片修补22例上矢状窦破裂出血的静脉窦口。15. In response, EC officials have maintained that the Community's policy is incontestably the most liberal''and that it is compatible with GATE rules.&&&&&&对此，欧盟官员坚持认为，共同体的政策是无可争议的最自由''，这是符合门的规则。16. In this study we investigated the use of ultrasound indetecting neuraxial structures during insertion and placementof EC in children.&&&&&&在这项研究中，作者研究了超声在儿童硬膜外导管置入和安放中探查神经轴索结构的作用。17. EC是什么意思17. Fulfill the requirements of /EC, paragraphs 6.5, 6.6, 6.8 and 6.9 of Annex I.&&&&&&满足/EC的要求，附录I的第6.5段，第6.6段，第6.8段和第6.9段。18. EC18. This is a prelimiary study on the toxicity of chromium to the Nitzshia sp. and Cryptophto by means of batch culture. Experimental results indicate that their growth rates are inhibited when the concentration of Cr is larger than 16μg/dm3 and their EC50 values for 72 hours are 260μg/dm3 and 230 μg/dm3 respectively.&&&&&&本工作使用一次培养法初步研究了Cr对菱形硅藻和隐藻的毒性，实验结果表明，当Cr浓度大于16ppb时，则对其生长率产生抑制作用，其72小时EC_(50)值分别为260ppb和230ppb。19. 19. Besides EU Directive 96/9/EC could we use unfair competition to solve the protection issue?&&&&&&除欧体指令之立法模式外，得否以不正竞争法制加以解决？20. This study focuses on the changes of Spanish immigration policy after Spain becomes the member of EC, and analyses the development of European Union`s immigration policy with intergovernmentalism.&&&&&&本文研究系以西班牙加入欧体后，在迈向共同移民政策的架构下如何去调整该国的政策为主轴，并以政府间主义分析欧盟移民政策的发展。EC 单语例句1. The nomination threshold requires a candidate to have no less than 150 nominations and each EC member can only nominate one candidate.2. The EC project includes retrofitting each of the four larger generating units with three types of emissions control equipment reducing certain emissions substantially.3. It is also the first China policy paper released by the current EC, headed by President Jose Manuel Barroso.4. If the EC decides to seek the dissolution, it will pass on the case to the Office of the Attorney General.5. Britons'confidence in the EC is the lowest among all EU members.6. The latest results echoed those released by the EC late Sunday night, with 92 percent of votes counted seven hours after the voting closed.7. The EC's department for competition is looking into complaints about the way soccer's governing body FIFA is selling tickets and is in contact with FIFA.8. China also produces light helicopter EC 120 in cooperation with Europe and Singapore, and has sold 400 such helicopters worldwide.9. The three organic laws need amendments in line with the amended constitution, so that the EC can effectively hold the election.10. I will explain my belief and values to the 800 members of the EC and to the 7 million people of Hong Kong.EC的近义词EC是什么意思,EC在线翻译,EC什么意思,EC的意思,EC的翻译,EC的解释,EC的发音,EC的同义词,EC的反义词,EC的例句,EC的相关词组,EC意思是什么,EC怎么翻译,单词EC是什么意思常用英语教材考试英语单词大全 (7本教材)
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中文翻译停止操作指令无操作&&&&no. ＝number. &&&&Op ＝ op art, optical art 〔口语 ...&&&&无操作指令&&&&O.P.＝observation post 【军事】观测所。 Op ＝operator. op ＝out of print (书刊等)已售完；已绝版。 Op ...&&&&前缀 〔用于 p 前〕＝ob-. &&&&协同合作法&&&&频道操作员&&&&〔口语〕 ＝ co-operative store [society]. &&&&自动洗衣店; 自助洗衣店&&&&雷新桂先生&&&&间宫光学&&&&曼弗雷德交响曲&&&&微指令&&&&电动机拖动的&&&&空操作指令; 无操作指令&&&&空操作指令&&&&运算放大器&&&&运算放大器; 组混音滤波运放&&&&奥普艺术; 欧普艺术&&&&运算码&&&&奥普公司&&&&乐观型帆船女子组&&&&op磁铁&&&&铁钴氧化物烧结磁铁&&&&组洛老式淬火法
例句与用法If there is no instruction cache , this subroutine may be a no - op如果在你的目标机上，没有指令缓存，则可能不做任何操作。 No - op instruction无作业指令The easiest way a no - op is to simply have the insurer implement the wsdl document describing the getquote interface themselves最简单的方法（无为法）是仅仅让保险公司他们自己实现描述getquote接口的wsdl文档！ While these methods may not take a lot of time to execute , every second in an xml parsing applicat unfortunately , these no - op methods waste valuable time虽然执行这些方法不会花费很多时间，但xml解析应用程序中的每一秒都很关键；遗憾的是，这些不执行任何操作的方法浪费了宝贵的时间。 &&
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OJ L 342, 22.12.2009, p. 59-209
中文标题：
欧洲议会和理事会条例(EC) No ，关于化妆品
原文标题：
Regulation (EC) No
of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Text with EEA relevance)
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of document: 30/11/2009
of effect: 11/01/2010; Entry into force Date pub. + 20 See Art 40.1
of effect: 11/07/2013; Implementation See Art 40.2
of effect: 01/12/2010; Partial implementation See Art 40.2
of effect: 11/01/2013; Partial implementation See Art 40.2
end of validity: 99/99/9999
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Subject matter:
Approximation of laws, Technical barriers
Miscellaneous information
European Parliament, Council
Regulation
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Legislative history:
Opinion Economic and Social C OJ C 2009/27 P 0034
Opinion European P given on 24/03/2009
Decision C given on 20/11/2009
Proposal C Com
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Regulation (EC) No
of the European Parliament and of the Council
of 30 November 2009
on cosmetic products
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee [1],
Acting in accordance with the procedure laid down in Article 251 of the Treaty [2],
(1) Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products [3] has been significantly amended on several occasions. Since further amendments are to be made, in this particular case it should be recast as one single text in the interests of clarity.
(2) A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for diverging transposition by Member States. Moreover, a Regulation ensures that legal requirements are implemented at the same time throughout the Community.
(3) This Regulation aims at simplifying procedures and streamlining terminology, thereby reducing administrative burden and ambiguities. Moreover, it strengthens certain elements of the regulatory framework for cosmetics, such as in-market control, with a view to ensuring a high level of protection of human health.
(4) This Regulation comprehensively harmonises the rules in the Community in order to achieve an internal market for cosmetic products while ensuring a high level of protection of human health.
(5) The environmental concerns that substances used in cosmetic products may raise are considered through the application of Regulation (EC) No
of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency [4], which enables the assessment of environmental safety in a cross-sectoral manner.
(6) This Regulation relates only to cosmetic products and not to medicinal products, medical devices or biocidal products. The delimitation follows in particular from the detailed definition of cosmetic products, which refers both to their areas of application and to the purposes of their use.
(7) The assessment of whether a product is a cosmetic product has to be made on the basis of a case-by-case assessment, taking into account all characteristics of the product. Cosmetic products may include creams, emulsions, lotions, gels and oils for the skin, face masks, tinted bases (liquids, pastes, powders), make-up powders, after-bath powders, hygienic powders, toilet soaps, deodorant soaps, perfumes, toilet waters and eau de Cologne, bath and shower preparations (salts, foams, oils, gels), depilatories, deodorants and anti-perspirants, hair colorants, products for waving, straightening and fixing hair, hair-setting products, hair-cleansing products (lotions, powders, shampoos), hair-conditioning products (lotions, creams, oils), hairdressing products (lotions, lacquers, brilliantines), shaving products (creams, foams, lotions), make-up and products removing make-up, products intended for application to the lips, products for care of the teeth and the mouth, products for nail care and make-up, products for external intimate hygiene, sunbathing products, products for tanning without sun, skin-whitening products and anti-wrinkle products.
(8) The Commission should define the categories of cosmetic products which are relevant for the application of this Regulation.
(9) Cosmetic products should be safe under normal or reasonably foreseeable conditions of use. In particular, a risk-benefit reasoning should not justify a risk to human health.
(10) The presentation of a cosmetic product and in particular its form, odour, colour, appearance, packaging, labelling, volume or size should not endanger health and safety of consumers due to confusion with foodstuffs, in accordance with Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers [5].
(11) In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community.
(12) Ensuring traceability of a cosmetic product throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities
task of tracing economic operators.
(13) It is necessary to determine under which conditions a distributor is to be considered as the responsible person.
(14) All legal or natural persons in the wholesale trade as well as retailers selling directly to the consumer are covered by reference to the distributor. The obligations of the distributor should therefore be adapted to the respective role and part of the activity of each of these operators.
(15) The European cosmetics sector is one of the industrial activities affected by counterfeiting, which may increase risks to human health. Member States should pay particular attention to the implementation of horizontal Community legislation and measures regarding counterfeit products in the field of cosmetic products, for example Council Regulation (EC) No
of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights [6] and Directive 2004/48/EC of the European parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights [7]. In-market controls represent a powerful means of identifying products that do not comply with the requirements of this Regulation.
(16) To ensure their safety, cosmetic products placed on the market should be produced according to good manufacturing practice.
(17) For the purpose of effective market surveillance, a product information file should be made readily accessible, at one single address within the Community, to the competent authority of the Member State where the file is located.
(18) In order to be comparable and of high quality, the results of the non-clinical safety studies carried out for the purposes of assessing the safety of a cosmetic product should comply with the relevant Community legislation.
(19) It should be made clear which information is to be made available to the competent authorities. That information should include all the necessary particulars relating to identity, quality, safety for human health and the effects claimed for the cosmetic product. In particular, this product information should include a cosmetic product safety report documenting that a safety assessment has been conducted.
(20) To ensure the uniform application and control of the restrictions for substances, sampling and analysis should be carried out in a reproducible and standardised manner.
(21) The term &mixture& as defined in this Regulation should have the same meaning as the term &preparation& previously used in Community legislation.
(22) For reasons of effective market surveillance, the competent authorities should be notified of certain information about the cosmetic product placed on the market.
(23) In order to allow for rapid and appropriate medical treatment in the event of difficulties, the necessary information about the product formulation should be submitted to poison control centres and assimilated entities, where such centres have been established by Member States to that end.
(24) In order to keep administrative burdens to a minimum, the notified information for competent authorities, poison control centres and assimilated entities should be submitted centrally for the Community by way of an electronic interface.
(25) In order to ensure a smooth transition to the new electronic interface, economic operators should be allowed to notify the information required in accordance with this Regulation before its date of application.
(26) The general principle of the responsibility of the manufacturer or importer for the safety of the product should be supported by restrictions of some substances in Annexes II and III. Moreover, substances which are intended to be used as colorants, preservatives and UV-filters should be listed in the Annexes IV, V and VI respectively in order to be allowed for these uses.
(27) To avoid ambiguities, it should be clarified that the list of allowed colorants contained in Annex IV includes only substances which colour through absorption and reflection and not substances which colour through photoluminescence, interference, or chemical reaction.
(28) To address safety concerns raised, Annex IV, which is currently restricted to skin colorants, should also include hair colorants once the risk assessment of these substances by the Scientific Committee for Consumer Safety (SCCS) set up by Commission Decision /EC of 5 September 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment [8] has been finalised. To this end, the Commission should have the possibility to include hair colorants in the scope of that Annex by the comitology procedure.
(29) The use of nanomaterials in cosmetic products may increase with the further development of technology. In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at international level. The Community should endeavour to reach an agreement on a definition in appropriate international fora. Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly.
(30) At present, there is inadequate information on the risks associated with nanomaterials. In order to better assess their safety the SCCS should provide guidance in cooperation with relevant bodies on test methodologies which take into account specific characteristics of nanomaterials.
(31) The Commission should regularly review the provisions on nanomaterials in the light of scientific progress.
(32) Given the hazardous properties of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A, 1B and 2, pursuant to Regulation (EC) No
of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures [9], their use in cosmetic products should be prohibited. However, as a hazardous property of a substance does not necessarily always entail a risk, there should be a possibility to allow the use of substances classified as CMR 2 substances where, in view of exposure and concentration, they have been found safe for use in cosmetic products by the SCCS and are regulated by the Commission in the Annexes to this Regulation. With regard to substances which are classified as CMR 1A or 1B substances, there should be a possibility, in the exceptional case that these substances comply with food safety requirements, inter alia as a result of their naturally occurring in food, and that no suitable alternative substances exist, to use such substances in cosmetic products on the condition that such use has been found safe by the SCCS. Where such conditions are met, the Commission should amend the relevant Annexes to this Regulation within 15 months of classification of substances as CMR 1A or 1B substances under Regulation (EC) No . Such substances should be continuously reviewed by the SCCS.
(33) A safety assessment of substances, particularly those classified as CMR 1A or 1B substances, should consider the overall exposure to such substances stemming from all sources. At the same time, for those involved in producing safety assessments, it is essential that there be a harmonised approach to the development and use of such overall exposure estimates. In consequence, the Commission, in close cooperation with the SCCS, the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA) and other relevant stakeholders, should, as a matter of urgency, carry out a review and develop guidance regarding the production and use of overall exposure estimates for these substances.
(34) The assessment by the SCCS of the use of substances classified as CMR 1A and 1B in cosmetic products should also take into account the exposure to those substances of vulnerable population groups, such as children under three years of age, elderly people, pregnant and breast-feeding women and persons with compromised immune responses.
(35) The SCCS should give opinions where appropriate on the safety of use of nanomaterials in cosmetic products. These opinions should be based on full information being made available by the responsible person.
(36) Action by the Commission and Member States relating to the protection of human health should be based on the precautionary principle.
(37) In order to ensure product safety, prohibited substances should be acceptable at trace levels only if they are technologically inevitable with correct manufacturing processes and provided that the product is safe.
(38) The Protocol on protection and welfare of animals annexed to the Treaty provides that the Community and the Member States are to pay full regard to the welfare requirements of animals in the implementation of Community policies, in particular with regard to the internal market.
(39) Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes [10] established common rules for the use of animals for experimental purposes within the Community and laid down the conditions under which such experiments must be carried out in the territory of the Member States. In particular, Article 7 of that Directive requires that animal experiments be replaced by alternative methods, where such methods exist and are scientifically satisfactory.
(40) The safety of cosmetic products and their ingredients may be ensured through the use of alternative methods which are not necessarily applicable to all uses of chemical ingredients. Therefore, the use of such methods by the whole cosmetic industry should be promoted and their adoption at Community level ensured, where such methods offer an equivalent level of protection to consumers.
(41) The safety of finished cosmetic products can already be ensured on the basis of knowledge of the safety of the ingredients that they contain. Provisions prohibiting animal testing of finished cosmetic products should therefore be laid down. The application, in particular by small and medium-sized enterprises, of both test methods and assessment procedures for relevant available data, including the use of read-across and weight-of-evidence approaches, which do not involve the use of animals for assessing the safety of finished cosmetic products could be facilitated by Commission guidelines.
(42) It will gradually become possible to ensure the safety of ingredients used in cosmetic products by using non-animal alternative methods validated at Community level, or approved as being scientifically validated, by the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the Organisation for Economic Cooperation and Development (OECD). After consulting the SCCS as regards the applicability of the validated alternative methods to the field of cosmetic products, the Commission should immediately publish the validated or approved methods recognised as being applicable to such ingredients. In order to achieve the highest possible degree of animal protection, a deadline should be set for the introduction of a definitive prohibition.
(43) The Commission established timetables of deadlines up to 11 March 2009 for prohibiting the marketing of cosmetic products, the final formulation, ingredients or combinations of ingredients which have been tested on animals, and for prohibiting each test currently carried out using animals. In view, however, of tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, it is appropriate for the final deadline for prohibiting the marketing of cosmetic products for which those tests are used to be 11 March 2013. On the basis of annual reports, the Commission should be authorised to adapt the timetables within the abovementioned maximum time limit.
(44) Better coordination of resources at Community level will contribute to increasing the scientific knowledge indispensable for the development of alternative methods. It is essential, for this purpose, that the Community continue and increase its efforts and take the measures necessary for the promotion of research and the development of new non-animal alternative methods, in particular within its Framework Programmes for research.
(45) The recognition by third countries of alternative methods developed in the Community should be encouraged. In order to achieve this objective, the Commission and the Member States should take all appropriate steps to facilitate acceptance of such methods by the OECD. The Commission should also endeavour, within the framework of European Community cooperation agreements, to obtain recognition of the results of safety tests carried out in the Community using alternative methods so as to ensure that the export of cosmetic products for which such methods have been used is not hindered and to prevent or avoid third countries requiring the repetition of such tests using animals.
(46) Transparency is needed regarding the ingredients used in cosmetic products. Such transparency should be achieved by indication of the ingredients used in a cosmetic product on its packaging. Where for practical reasons it is impossible to indicate the ingredients on the packaging, such information should be enclosed so that the consumer has access to this information.
(47) A glossary of common ingredient names should be compiled by the Commission to ensure uniform labelling and to facilitate identification of cosmetics ingredients. This glossary should not be intended to constitute a limitative list of substances used in cosmetic products.
(48) In order to inform consumers, cosmetic products should bear precise and easily understandable indications concerning their durability for use. Given that consumers should be informed of the date until which the cosmetic product will continue to fulfil its initial function and remain safe, it is important to know the date of minimum durability, i.e. the date by which it is best to use the product. Where the minimum durability is more than 30 months, the consumer should be informed of the period of time after opening that the cosmetic product may be used without any harm to the consumer. However, this requirement should not apply where the concept of the durability after opening is not relevant, that is to say for single-use products, products not at risk of deterioration or products which do not open.
(49) A number of substances have been identified by the SCCS as likely to cause allergic reactions and it will be necessary to restrict their use and/or impose certain conditions concerning them. In order to ensure that consumers are adequately informed, the presence of these substances should be mentioned in the list of ingredients and consumers
attention should be drawn to the presence of these ingredients. This information should improve the diagnosis of contact allergies among consumers and should enable them to avoid the use of cosmetic products which they do not tolerate. For substances which are likely to cause allergy to a significant part of the population, other restrictive measures such as a ban or a restriction of concentration should be considered.
(50) In the safety assessment of a cosmetic product it should be possible to take into account results of risk assessments that have been carried out in other relevant areas. The use of such data should be duly substantiated and justified.
(51) The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products. In particular Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market [11] is applicable. Furthermore, the Commission, in cooperation with Member States, should define common criteria in relation to specific claims for cosmetic products.
(52) It should be possible to claim on a cosmetic product that no animal testing was carried out in relation to its development. The Commission, in consultation with the Member States, has developed guidelines to ensure that common criteria are applied in the use of claims and that an aligned understanding of the claims is reached, and in particular that such claims do not mislead the consumer. In developing such guidelines, the Commission has also taken into account the views of the many small and medium-sized enterprises which make up the majority of the &non-animal testing& producers, relevant non-governmental organisations, and the need for consumers to be able to make practical distinctions between products on the basis of animal testing criteria.
(53) In addition to the labelled information, consumers should be given the possibility to request certain product-related information from the responsible person in order to make informed product choices.
(54) Effective market surveillance is necessary in order to ensure that the provisions of this Regulation are respected. To this end, serious undesirable effects should be notified and competent authorities should have a possibility to request from the responsible person a list of cosmetic products containing substances which have raised serious doubts in terms of safety.
(55) This Regulation is without prejudice to the possibility for Member States to regulate, in compliance with Community law, the notification by health professionals or consumers of serious undesirable effects to the competent authorities of Member States.
(56) This Regulation is without prejudice to the possibility for Member States to regulate, in compliance with Community law, the establishment of economic operators in the area of cosmetic products.
(57) In case of non-compliance with this Regulation, a clear and efficient procedure for the withdrawal and recall of products may be necessary. This procedure should, where possible, build upon existing Community rules for unsafe goods.
(58) In order to address cosmetic products which, despite complying with the provisions of this Regulation, might endanger human health, a safeguard procedure should be introduced.
(59) The Commission should provide indications for the uniform interpretation and application of the concept of serious risks in order to facilitate the consistent implementation of this Regulation.
(60) In order to comply with principles of good administrative practices, any decision by a competent authority in the framework of market surveillance should be duly substantiated.
(61) In order to ensure effective in-market control, a high degree of administrative cooperation amongst the competent authorities is necessary. This concerns in particular mutual assistance in the verification of product information files located in another Member State.
(62) The Commission should be assisted by the SCCS, an independent risk assessment body.
(63) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision /EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [12].
(64) In particular, power should be conferred on the Commission to adapt the Annexes to this Regulation to technical progress. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision /EC.
(65) When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision /EC for the adoption of certain measures relating to CMRs, nanomaterials and potential risks to human health.
(66) Member States should lay down provisions on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.
(67) Economic operators as well as Member States and the Commission need sufficient time to adapt to the changes introduced by this Regulation. Therefore it is appropriate to provide for a sufficient transitional period for that adaptation. However, in order to ensure a smooth transition, economic operators should be allowed to place on the market cosmetic products which comply with this Regulation before the expiry of that transitional period.
(68) In order to enhance the safety of cosmetic products and strengthen the market surveillance, cosmetic products placed on the market after the date of application of this Regulation should comply with its obligations regarding safety assessment, the product information file and notification, even if similar obligations have already been fulfilled under Directive 76/768/EEC.
(69) Directive 76/768/EEC should be repealed. However, in order to ensure appropriate medical treatment in the event of difficulties and to ensure market surveillance, the information received pursuant to Article 7(3) and Article 7a(4) of Directive 76/768/EEC concerning cosmetic products should be kept by the competent authorities for a certain period of time and the information kept by the responsible person should remain available for the same period of time.
(70) This Regulation should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex IX.
(71) Since the objective of this Regulation, namely the achievement of the internal market and a high level of protection of human health through the compliance of cosmetic products with the requirements laid down in this Regulation, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,
HAVE ADOPTED THIS REGULATION:
SCOPE, DEFINITIONS
Scope and objective
This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health.
Definitions
1. For the purposes of this Regulation, the following definitions shall apply:
(a) &cosmetic product& means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or co
(b) &substance& means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or chan
(c) &mixture& means a mixture or solution composed of tw
(d) &manufacturer& means any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under h
(e) &distributor& means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the C
(f) &end user& means either a consumer or professional using
(g) &making available on the market& means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payme
(h) &placing on the market& means the first making available of a cosmetic product on the C
(i) &importer& means any natural or legal person established within the Community, who places a cosmetic product from a third country on the C
(j) &harmonised standard& means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services [13] on the basis of a request made by the Commission in accordance with Article 6 of that D
(k) &nanomaterial& means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100
(l) &preservatives& means substances which are exclusively or mainly intended to inhibit the development of micro-organisms in
(m) &colorants& means substances which are exclusively or mainly intended to colour the cosmetic product, the body as a whole or certain parts thereof, by absorption or reflect in addition, precursors of oxidative hair colorants shall
(n) &UV-filters& means substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV
(o) &undesirable effect& means an adverse reaction for human health attributable to the normal or reasonably foreseeable use o
(p) &serious undesirable effect& means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate
(q) &withdrawal& means any measure aimed at preventing the making available on the market of a cosmetic product
(r) &recall& means any measure aimed at achieving the return of a cosmetic product that has already been made avail
(s) &frame formulation& means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation. The Commission shall provide indications for the establishment of the frame formulation and adapt them regularly to technical and scientific progress.
2. For the purposes of point (a) of paragraph 1, a substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered to be a cosmetic product.
3. In view of the various definitions of nanomaterials published by different bodies and the constant technical and scientific developments in the field of nanotechnologies, the Commission shall adjust and adapt point (k) of paragraph 1 to technical and scientific progress and to definitions subsequently agreed at international level. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
CHAPTER II
SAFETY, RESPONSIBILITY, FREE MOVEMENT
A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account, in particular, of the following:
(a) presentation including conformity with Directive 87/357/EEC;
(c) instructions
(d) any other indication or information provided by the responsible person defined in Article 4.
The provision of warnings shall not exempt persons defined in Articles 2 and 4 from compliance with the other requirements laid down in this Regulation.
Responsible person
1. Only cosmetic products for which a legal or natural person is designated within the Community as &responsible person& shall be placed on the market.
2. For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation.
3. For a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer established within the Community shall be the responsible person.
The manufacturer may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.
4. Where, for a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer is established outside the Community, he shall designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.
5. For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market.
The importer may, by written mandate, designate a person established within the Community as the responsible person who shall accept in writing.
6. The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.
The translation of information relating to a cosmetic product already placed on the market shall not be considered as a modification of that product of such a nature that compliance with the applicable requirements of this Regulation may be affected.
Obligations of responsible persons
1. Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2) and (5), as well as Articles 20, 21, 23 and 24.
2. Responsible persons who consider or have reason to believe that a cosmetic product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate.
Furthermore, where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the competent national authorities of the Member States in which they made the product available and of the Member State in which the product information file is readily accessible, giving details, in particular, of the non-compliance and of the corrective measures taken.
3. Responsible persons shall cooperate with these authorities, at the request of the latter, on any action to eliminate the risks posed by cosmetic products which they have made available on the market. In particular, responsible persons shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of specific aspects of the product, in a language which can be easily understood by that authority.
Obligations of distributors
1. In the context of their activities, when making a cosmetic product available on the market, distributors shall act with due care in relation to applicable requirements.
2. Before making a cosmetic product available on the market distributors shall verify that:
- the labelling information provided for in Article 19(1)(a), (e) and (g) and Article 19(3) and (4) is present,
- the language requirements provided for in Article 19(5) are fulfilled,
- the date of minimum durability specified, where applicable under Article 19(1), has not passed.
3. Where distributors consider or have reason to believe that:
- a cosmetic product is not in conformity with the requirements laid down in this Regulation, they shall not make the product available on the market until it has been brought into conformity with the applicable requirements,
- a cosmetic product which they have made available on the market is not in conformity with this Regulation, they shall make sure that the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate, are taken.
Furthermore, where the cosmetic product presents a risk to human health, distributors shall immediately inform the responsible person and the competent national authorities of the Member States in which they made the product available, giving details, in particular, of the non-compliance and of the corrective measures taken.
4. Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in this Regulation.
5. Distributors shall cooperate with competent authorities, at the request of the latter, on any action to eliminate the risks posed by products which they have made available on the market. In particular, distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product with the requirements listed under paragraph 2, in a language which can be easily understood by that authority.
Identification within the supply chain
At the request of a competent authority:
- responsible persons shall identify the distributors to whom they supply the cosmetic product,
- the distributor shall identify the distributor or the responsible person from whom, and the distributors to whom, the cosmetic product was supplied.
This obligation shall apply for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor.
Good manufacturing practice
1. The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article 1.
2. Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.
Free movement
Member States shall not, for reasons related to the requirements laid down in this Regulation, refuse, prohibit or restrict the making available on the market of cosmetic products which comply with the requirements of this Regulation.
CHAPTER III
SAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION
Article 10
Safety assessment
1. In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.
The responsible person shall ensure that:
(a) the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in t
(b) an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from
(c) the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.
The first subparagraph shall also apply to cosmetic products that have been notified under Directive 76/768/EEC.
The Commission, in close cooperation with all stakeholders, shall adopt appropriate guidelines to enable undertakings, in particular small and medium-sized enterprises, to comply with the requirements laid down in Annex I. Those guidelines shall be adopted in accordance with the regulatory procedure referred to in Article 32(2).
2. The cosmetic product safety assessment, as set out in Part B of Annex I shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.
3. Non-clinical safety studies referred to in the safety assessment according to paragraph 1 and carried out after 30 June 1988 for the purpose of assessing the safety of a cosmetic product shall comply with Community legislation on the principles of good laboratory practice, as applicable at the time of performance of the study, or with other international standards recognised as being equivalent by the Commission or the ECHA.
Article 11
Product information file
1. When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.
2. The product information file shall contain the following information and data which shall be updated as necessary:
(a) a description of the cosmetic product which enables the product information file to be clearly attributed to
(b) the cosmetic product safety report referred to in Article 10(1);
(c) a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8;
(d) where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for
(e) data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.
3. The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept.
The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State.
4. The requirements provided in paragraphs 1 to 3 of this Article shall also apply to cosmetic products that have been notified under Directive 76/768/EEC.
Article 12
Sampling and analysis
1. Sampling and analysis of cosmetic products shall be performed in a reliable and reproducible manner.
2. In the absence of any applicable Community legislation, reliability and reproducibility shall be presumed if the method used is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.
Article 13
Notification
1. Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission:
(a) the category of cosmetic product and its name or names, enabling its spe
(b) the name and address of the responsible person where the product information file is mad
(c) the country of origin i
(d) the Member State in which the cosmetic product is to be
(e) the contact details of a physical person to contact in t
(f) the presence of substances in the form of nanomaterials and:
(i) their identification including the chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI to this R
(ii) the reasonably foreseeable
(g) the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI to Regulation (EC) No ;
(h) the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties.
The first subparagraph shall also apply to cosmetic products notified under Directive 76/768/EEC.
2. When the cosmetic product is placed on the market, the responsible person shall notify to the Commission the original labelling, and, where reasonably legible, a photograph of the corresponding packaging.
3. As from 11 July 2013, a distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law, shall submit, by electronic means, the following information to the Commission:
(a) the category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its spe
(b) the Member State in which the cosmetic produ
(d) the name and address of the responsible person where the product information file is made readily accessible..
4. Where a cosmetic product has been placed on the market before 11 July 2013 but is no longer placed on the market as from that date, and a distributor introduces that product in a Member State after that date, that distributor shall communicate the following to the responsible person:
(a) the category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its spe
(b) the Member State in which the cosmetic produ
(c) his name and address.
On the basis of that communication, the responsible person shall submit to the Commission, by electronic means, the information referred to in paragraph 1 of this Article, where notifications according to Article 7(3) and Article 7a (4) of Directive 76/768/EEC have not been carried out in the Member State in which the cosmetic product is made available.
5. The Commission shall, without delay, make the information referred to in points (a) to (g) of paragraph 1, and in paragraphs 2 and 3 available electronically to all competent authorities.
That information may be used by competent authorities only for the purposes of market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.
6. The Commission shall, without delay, make the information referred to in paragraphs 1, 2 and 3 available electronically to poison centres or similar bodies, where such centres or bodies have been established by Member States.
That information may be used by those bodies only for the purposes of medical treatment.
7. Where any of the information set out in paragraphs 1, 3 and 4 changes, the responsible person or the distributor shall provide an update without delay.
8. The Commission may, taking into account technical and scientific 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 this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
CHAPTER IV
RESTRICTIONS FOR CERTAIN SUBSTANCES
Article 14
Restrictions for substances listed in the Annexes
1. Without prejudice to Article 3, cosmetic products shall not contain any of the following:
(a) prohibited substances
- prohibited substances listed in Annex II;
(b) restricted substances
- restricted substances which are not used in accordance with the restrictions laid down in Annex III;
(c) colorants
(i) colorants other than those listed in Annex IV and colorants which are listed there but not used in accordance with the conditions laid down in that Annex, except for hair colouring products referred to in paragraph 2;
(ii) without prejudice to points (b), (d)(i) and (e)(i), substances which are listed in Annex IV but which are not intended to be used as colorants, and which are not used in accordance with the conditions laid down in that A
(d) preservatives
(i) preservatives other than those listed in Annex V and preservatives which are listed there but not used in accordance with the conditions laid down in that A
(ii) without prejudice to points (b), (c)(i) and (e)(i), substances listed in Annex V but which are not intended to be used as preservatives, and which are not used in accordance with the conditions laid down in that A
(e) UV-filters
(i) UV-filters other than those listed in Annex VI and UV-filters which are listed there but not used in accordance with the conditions laid down in that A
(ii) without prejudice to points (b), (c)(i) and (d)(i), substances listed in Annex VI but which are not intended to be used as UV-filters and which are not used in accordance with the conditions laid down in that Annex.
2. Subject to a decision of the Commission to extend the scope of Annex IV to hair colouring products, such products shall not contain colorants intended to colour the hair, other than those listed in Annex IV and colorants intended to colour the hair which are listed there but not used in accordance with the conditions laid 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 procedure with scrutiny referred to in Article 32(3).
Article 15
Substances classified as CMR substances
1. The use in cosmetic products of substances classified as CMR substances, of category 2, under Part 3 of Annex VI to Regulation (EC) No
shall be prohibited. However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products. To these ends the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation.
2. The use in cosmetic products of substances classified as CMR substances, of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No
shall be prohibited.
However, such substances may be used in cosmetic products by way of exception where, subsequent to their classification as CMR substances of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No , all of the following conditions are fulfilled:
(a) they comply with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [14];
(b) there are no suitable alternative substances available, as documented in an anal
(c) the application is made for a particular use of the product category w and
(d) they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population groups.
Specific labelling in order to avoid misuse of the cosmetic product shall be provided in accordance with Article 3 of this Regulation, taking into account possible risks linked to the presence of hazardous substances and the routes of exposure.
In order to implement this paragraph, the Commission shall amend the Annexes to this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation within 15 months of the inclusion of the substances concerned in Part 3 of Annex VI to Regulation (EC) No .
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 32(4) of this Regulation.
The Commission shall mandate the SCCS to re-evaluate those substances as soon as safety concerns arise, and at the latest five years after their inclusion in Annexes III to VI to this Regulation, and at least every subsequent five years.
3. By 11 January 2012, the Commission shall ensure that appropriate guidance is developed with the aim of enabling a harmonised approach to the development and use of overall exposure estimates in assessing the safe use of CMR substances. This guidance shall be developed in consultation with the SCCS, the ECHA, the EFSA and other relevant stakeholders, drawing, as appropriate, on relevant best practice.
4. When Community or internationally agreed criteria for identifying substances with endocrine-disru