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

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L 342/72ENOfficial Journal of the European Union 22.12.2009(d) the performance within the Community of animal testing ofingredients or combinations of ingredients in order to meetthe requirements of this Regulation, after the date on whichsuch tests are required to be replaced by one or more validatedalternative methods listed in Commission Regulation(EC) No 440/2008 of 30 May 2008 laying down test methodspursuant to Regulation (EC) No 1907/2006 of the EuropeanParliament and of the Council on the Registration,Evaluation, Authorisation and Restriction of Chemicals(REACH) ( 1 ) or in Annex VIII to this Regulation.2. The Commission, after consulting the SCCS and the EuropeanCentre for the Validation of Alternative Methods (ECVAM)and with due regard to the development of validation within theOECD, has established timetables for the implementation of theprovisions under points (a), (b) and (d) of paragraph 1, includingdeadlines for the phasing-out of the various tests. The timetableswere made available to the public on 1 October 2004 and sent tothe European Parliament and the Council. The period for implementationwas limited to 11 March 2009 in relation to points (a),(b) and (d) of paragraph 1.In relation to the tests concerning repeated-dose toxicity, reproductivetoxicity and toxicokinetics, for which there are no alternativesyet under consideration, the period for implementation ofparagraph 1(a) and (b) shall be limited to 11 March 2013.The Commission shall study possible technical difficulties in complyingwith the ban in relation to tests, in particular those concerningrepeated-dose toxicity, reproductive toxicity andtoxicokinetics, for which there are no alternatives yet under consideration.Information about the provisional and final results ofthese studies forms part of the yearly reports presented pursuantto Article 35.paragraph 1. The request shall contain an evaluation of the situationand indicate the measures necessary. On this basis, theCommission may, after consulting the SCCS and by means of areasoned decision, authorise the derogation. That authorisationshall lay down the conditions associated with this derogation interms of specific objectives, duration and reporting of the results.A derogation shall be granted only where:(a)the ingredient is in wide use and cannot be replaced byanother ingredient capable of performing a similar function;(b) the specific human health problem is substantiated and theneed to conduct animal tests is justified and is supported bya detailed research protocol proposed as the basis for theevaluation.The decision on the authorisation, the conditions associated withit and the final result achieved shall be part of the annual reportpresented by the Commission in accordance with Article 35.The measures referred to in the sixth subparagraph, designed toamend non-essential elements of this Regulation, shall be adoptedin accordance with the regulatory procedure with scrutinyreferred to in Article 32(3).3. For the purposes of this Article and Article 20:(a)‘finished cosmetic product’ means the cosmetic product in itsfinal formulation, as placed on the market and made availableto the end user, or its prototype;On the basis of these annual reports, the timetables established asreferred to in the first subparagraph, could be adapted upto 11 March 2009 in relation to the first subparagraph and maybe adapted up to 11 March 2013 in relation to the second subparagraphand after consultation of the entities referred to in thefirst subparagraph.The Commission shall study progress and compliance with thedeadlines as well as possible technical difficulties in complyingwith the ban. Information about the provisional and final resultsof the Commission studies forms part of the yearly reports presentedpursuant to Article 35. If these studies conclude, at the latesttwo years prior to the end of the maximum period referred toin the second subparagraph, that for technical reasons one ormore tests referred to in that subparagraph will not be developedand validated before the expiry of the period referred to therein itshall inform the European Parliament and the Council and shallput forward a legislative proposal in accordance with Article 251of the Treaty.In exceptional circumstances, where serious concerns arise asregards the safety of an existing cosmetic ingredient, a MemberState may request the Commission to grant a derogation from( 1 ) OJ L 142, 31.5.2008, p. 1.(b) ‘prototype’ means a first model or design that has not beenproduced in batches, and from which the finished cosmeticproduct is copied or finally developed.CHAPTER VICONSUMER INFORMATIONArticle 19Labelling1. Without prejudice to other provisions in this Article, cosmeticproducts shall be made available on the market only wherethe container and packaging of cosmetic products bear the followinginformation in indelible, easily legible and visible lettering:(a)the name or registered name and the address of the responsibleperson. Such information may be abbreviated in so faras the abbreviation makes it possible to identify that personand his address. If several addresses are indicated, the onewhere the responsible person makes readily available theproduct information file shall be highlighted. The country oforigin shall be specified for imported cosmetic products;
22.12.2009ENOfficial Journal of the European Union L 342/73(b) the nominal content at the time of packaging, given byweight or by volume, except in the case of packaging containingless than five grams or five millilitres, free samplesand single-application packs; for pre-packages normally soldas a number of items, for which details of weight or volumeare not significant, the content need not be given providedthe number of items appears on the packaging. This informationneed not be given if the number of items is easy tosee from the outside or if the product is normally only soldindividually;For the purpose of this Article, an ingredient means any substanceor mixture intentionally used in the cosmetic productduring the process of manufacturing. The following shall not,however, be regarded as ingredients:(i)impurities in the raw materials used;(ii) subsidiary technical materials used in the mixture butnot present in the final product.(c)the date until which the cosmetic product, stored underappropriate conditions, will continue to fulfil its initial functionand, in particular, will remain in conformity withArticle 3 (‘date of minimum durability’).The date itself or details of where it appears on the packagingshall be preceded by the symbol shown in point 3 ofAnnex VII or the words: ‘best used before the end of’.The date of minimum durability shall be clearly expressedand shall consist of either the month and year or the day,month and year, in that order. If necessary, this informationshall be supplemented by an indication of the conditionswhich must be satisfied to guarantee the stated durability.Perfume and aromatic compositions and their raw materialsshall be referred to by the terms ‘parfum’ or ‘aroma’. Moreover,the presence of substances, the mention of which isrequired under the column ‘Other’ in Annex III, shall be indicatedin the list of ingredients in addition to the terms parfumor aroma.The list of ingredients shall be established in descending orderof weight of the ingredients at the time they are added to thecosmetic product. Ingredients in concentrations of less than1 % may be listed in any order after those in concentrationsof more than 1 %.All ingredients present in the form of nanomaterials shall beclearly indicated in the list of ingredients. The names of suchingredients shall be followed by the word ‘nano’ in brackets.Indication of the date of minimum durability shall not bemandatory for cosmetic products with a minimum durabilityof more than 30 months. For such products, there shallbe an indication of the period of time after opening for whichthe product is safe and can be used without any harm to theconsumer. This information shall be indicated, except wherethe concept of durability after opening is not relevant, by thesymbol shown in point 2 of Annex VII followed by the period(in months and/or years);(d) particular precautions to be observed in use, and at leastthose listed in Annexes III to VI and any special precautionaryinformation on cosmetic products for professional use;(e)(f)the batch number of manufacture or the reference for identifyingthe cosmetic product. Where this is impossible forpractical reasons because the cosmetic products are toosmall, such information need appear only on the packaging;the function of the cosmetic product, unless it is clear fromits presentation;(g) a list of ingredients. This information may be indicated on thepackaging alone. The list shall be preceded by the term‘ingredients’.Colorants other than colorants intended to colour the hairmay be listed in any order after the other cosmetic ingredients.For decorative cosmetic products marketed in severalcolour shades, all colorants other than colorants intended tocolour the hair used in the range may be listed, provided thatthe words ‘may contain’ or the symbol ‘+/-’ are added. The CI(Colour Index) nomenclature shall be used, where applicable.2. Where it is impossible for practical reasons to label theinformation mentioned in points (d) and (g) of paragraph 1 asprovided, the following applies:— the information shall be mentioned on an enclosed orattached leaflet, label, tape, tag or card;— unless impracticable, this information shall be referred to byabbreviated information or the symbol given in point 1 ofAnnex VII, which must appear on the container or packagingfor the information referred in point (d) of paragraph 1and on packaging for the information referred in point (g) ofparagraph 1.3. In the case of soap, bath balls and other small productswhere it is impossible for practical reasons for the informationreferred to in point (g) of paragraph 1 to appear on a label, tag,tape or card or in an enclosed leaflet, this information shall appearon a notice in immediate proximity to the container in which thecosmetic product is exposed for sale.
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