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

L 342/70ENOfficial Journal of the European Union 22.12.20092. The use in cosmetic products of substances classified asCMR substances, of category 1A or 1B under Part 3 of Annex VIto Regulation (EC) No 1272/2008 shall be prohibited.However, such substances may be used in cosmetic products byway of exception where, subsequent to their classification as CMRsubstances of category 1A or 1B under Part 3 of Annex VI toRegulation (EC) No 1272/2008, all of the following conditionsare fulfilled:ECHA, the EFSA and other relevant stakeholders, drawing, asappropriate, on relevant best practice.4. When Community or internationally agreed criteria foridentifying substances with endocrine-disrupting properties areavailable, or at the latest on 11 January 2015, the Commissionshall review this Regulation with regard to substances withendocrine-disrupting properties.(a)they comply with the food safety requirements as defined inRegulation (EC) No 178/2002 of the European Parliamentand of the Council of 28 January 2002 laying down the generalprinciples and requirements of food law, establishing theEuropean Food Safety Authority and laying down proceduresin matters of food safety ( 1 );Article 16Nanomaterials1. For every cosmetic product that contains nanomaterials, ahigh level of protection of human health shall be ensured.(b) there are no suitable alternative substances available, as documentedin an analysis of alternatives;2. The provisions of this Article do not apply to nanomaterialsused as colorants, UV-filters or preservatives regulated underArticle 14, unless expressly specified.(c)the application is made for a particular use of the productcategory with a known exposure; and(d) they have been evaluated and found safe by the SCCS for usein cosmetic products, in particular in view of exposure tothese products and taking into consideration the overallexposure from other sources, taking particular account ofvulnerable population groups.Specific labelling in order to avoid misuse of the cosmetic productshall be provided in accordance with Article 3 of this Regulation,taking into account possible risks linked to the presence ofhazardous substances and the routes of exposure.In order to implement this paragraph, the Commission shallamend the Annexes to this Regulation in accordance with theregulatory procedure with scrutiny referred to in Article 32(3) ofthis Regulation within 15 months of the inclusion of the substancesconcerned in Part 3 of Annex VI to Regulation (EC)No 1272/2008.On imperative grounds of urgency, the Commission may use theurgency procedure referred to in Article 32(4) of this Regulation.The Commission shall mandate the SCCS to re-evaluate thosesubstances as soon as safety concerns arise, and at the latest fiveyears after their inclusion in Annexes III to VI to this Regulation,and at least every subsequent five years.3. In addition to the notification under Article 13, cosmeticproducts containing nanomaterials shall be notified to the Commissionby the responsible person by electronic means six monthsprior to being placed on the market, except where they havealready been placed on the market by the same responsible personbefore 11 January 2013.In the latter case, cosmetic products containing nanomaterialsplaced on the market shall be notified to the Commission by theresponsible person between 11 January 2013 and 11 July 2013by electronic means, in addition to the notification in Article 13.The first and the second subparagraphs shall not apply to cosmeticproducts containing nanomaterials that are in conformitywith the requirements set out in Annex III.The information notified to the Commission shall contain at leastthe following:(a)the identification of the nanomaterial including its chemicalname (IUPAC) and other descriptors as specified in point 2of the Preamble to Annexes II to VI;(b) the specification of the nanomaterial including size of particles,physical and chemical properties;(c)an estimate of the quantity of nanomaterial contained in cosmeticproducts intended to be placed on the market per year;3. By 11 January 2012, the Commission shall ensure thatappropriate guidance is developed with the aim of enabling a harmonisedapproach to the development and use of overall exposureestimates in assessing the safe use of CMR substances. Thisguidance shall be developed in consultation with the SCCS, the(d) the toxicological profile of the nanomaterial;(e)the safety data of the nanomaterial relating to the category ofcosmetic product, as used in such products;( 1 ) OJ L 31, 1.2.2002, p. 1.(f)the reasonably foreseeable exposure conditions.