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

22.12.2009ENOfficial Journal of the European Union L 342/71The responsible person may designate another legal or naturalperson by written mandate for the notification of nanomaterialsand shall inform the Commission thereof.The Commission shall provide a reference number for the submissionof the toxicological profile, which may substitute theinformation to be notified under point (d).4. In the event that the Commission has concerns regardingthe safety of a nanomaterial, the Commission shall, without delay,request the SCCS to give its opinion on the safety of such nanomaterialfor use in the relevant categories of cosmetic productsand on the reasonably foreseeable exposure conditions. The Commissionshall make this information public. The SCCS shall deliverits opinion within six months of the Commission’s request. Wherethe SCCS finds that any necessary data is lacking, the Commissionshall request the responsible person to provide such datawithin an explicitly stated reasonable time, which shall not beextended. The SCCS shall deliver its final opinion within sixmonths of submission of additional data. The opinion of the SCCSshall be made publicly available.5. The Commission may, at any time, invoke the procedure inparagraph 4 where it has any safety concerns, for example due tonew information supplied by a third party.6. Taking into account the opinion of the SCCS, and wherethere is a potential risk to human health, including when there isinsufficient data, the Commission may amend Annexes II and III.7. The Commission may, taking into account technical andscientific progress, amend paragraph 3 by adding requirements.8. The measures, referred to in paragraphs 6 and 7, designedto amend non-essential elements of this Regulation, shall beadopted in accordance with the regulatory procedure with scrutinyreferred to in Article 32(3).cosmetic products within the Community, including thoseused as colorants, UV-filters and preservatives in a separatesection. The first report shall be presented by 11 July 2014The report update shall summarise, in particular, the newnanomaterials in new categories of cosmetic products, thenumber of notifications, the progress made in developingnano-specific assessment methods and safety assessmentguides, and information on international cooperationprogrammes.11. The Commission shall regularly review the provisions ofthis Regulation concerning nanomaterials in the light of scientificprogress and shall, where necessary, propose suitable amendmentsto those provisions.The first review shall be undertaken by 11 July 2018.Article 17Traces of prohibited substancesThe non-intended presence of a small quantity of a prohibitedsubstance, stemming from impurities of natural or syntheticingredients, the manufacturing process, storage, migration frompackaging, which is technically unavoidable in good manufacturingpractice, shall be permitted provided that such presence is inconformity with Article 3.CHAPTER VANIMAL TESTINGArticle 18Animal testing1. Without prejudice to the general obligations deriving fromArticle 3, the following shall be prohibited:9. On imperative grounds of urgency the Commission mayuse the procedure referred to in Article 32(4).10. The following information shall be made available by theCommission:(a)the placing on the market of cosmetic products where thefinal formulation, in order to meet the requirements of thisRegulation, has been the subject of animal testing using amethod other than an alternative method after such alternativemethod has been validated and adopted at Communitylevel with due regard to the development of validation withinthe OECD;(a)By 11 January 2014, the Commission shall make available acatalogue of all nanomaterials used in cosmetic productsplaced on the market, including those used as colorants,UV-filters and preservatives in a separate section, indicatingthe categories of cosmetic products and the reasonably foreseeableexposure conditions. This catalogue shall be regularlyupdated thereafter and be made publicly available.(b) the placing on the market of cosmetic products containingingredients or combinations of ingredients which, in order tomeet the requirements of this Regulation, have been the subjectof animal testing using a method other than an alternativemethod after such alternative method has been validatedand adopted at Community level with due regard to thedevelopment of validation within the OECD;(b) The Commission shall submit to the European Parliamentand the Council an annual status report, which will giveinformation on developments in the use of nanomaterials in(c)the performance within the Community of animal testing offinished cosmetic products in order to meet the requirementsof this Regulation;