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HomeThe SCCS notes of guidance for the testing of cosmetic ingredients and their safety evaluation
10th revision
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Since July 2013, Regulation (EC) No 1223/2009 applies for cosmetic products. Their safety-in-use is, as was also the case for Directive 76/768/EEC, established by controlling the safety of the ingredients. For those ingredients for which some concern exists with respect to human health (e.g. colourants, preservatives, UV-filters, hair dyes), safety evaluation is done at the Commission level by the Scientific Committee on Consumer Safety (SCCS). These substances are addressed in the Annexes of Regulation (EC) No 1223/2009. For the safety evaluation of cosmetic ingredients, all available scientific data are considered, taking into account the testing and marketing bans in force under Regulation (EC) No 1223/2009. This includes the physical and chemical properties of the compounds under investigation, in silico data such as results obtained from (Q)SAR {(Quantitative) Structure Activity Relationship} modelling, chemical categories, grouping, read-across, Physiologically-Based PharmacoKinetics (PBPK) / ToxicoKinetics (PBTK) modelling, in vitro and ex vivo experimental results and data obtained from animal studies (in vivo) that have been carried out for the purpose of cosmetics before the testing and marketing bans. The animal testing ban on finished cosmetic products applies since 11 September 2004; the testing ban on ingredients or combination of ingredients applies since 11 March 2009. The marketing ban applies since 11 March 2009 for all human health effects with the exception of repeated-dose toxicity, reproductive toxicity, and toxicokinetics. For these specific health effects, the marketing ban applies since 11 March 2013, irrespective of the availability of alternative non-animal methods. In addition, clinical data, epidemiological studies, information derived from accidents, data from Post-Marketing Surveillance (PMS) or other human data are also taken into consideration. In the present update, the state-of-the-art with respect to the validated methods of the 3Rs (Refinement, Reduction and Replacement) strategy of Russell et al. (1959), is incorporated with emphasis on New Approach Methodologies (NAMs). In view of the testing and marketing bans in the cosmetic regulation, the SCCS gives special attention to those alternative methods that are suitable for the safety testing of cosmetic substances. Although the "Notes of Guidance" are concerned with the testing and safety evaluation of the cosmetic substances listed in the Annexes of Regulation (EC) No 1223/2009 and those for which safety concerns have been expressed, they could be also of interest for all substances intended to be incorporated in a cosmetic product. Even though the "Notes of Guidance" have not been written for the latter purpose, they can indeed be of practical use in making a Product Information File (PIF) for a finished cosmetic product as currently required by Regulation (EC) No 1223/2009. The “Notes of Guidance” should not be seen as a prescriptive procedure, but rather as an approach that may need to be adapted on a case-by-case basis when evaluating the safety of the Annex substances. However, when major deviations from standardised protocols/procedures in the safety evaluation process have been adopted, it is essential that Applicants provide scientific justification. The "Notes of Guidance" will be revised as scientifically required on the basis of scientific advances in toxicology and validated alternative methods or legislative changes.
- Közzétéve:
- Témák: Orvosi és biológiai kutatás , Gyógyszer- és kozmetikai ipar , A fogyasztók egészsége
- Témakör: a vegyi anyagokra vonatkozó szabályozás , allergia , bőrbetegség , egészségügyi jogszabályok , egészségügyi politika , fogyasztóvédelem , kozmetikai termék , kémiai vegyület , közegészség , rendelet (EU) , rákkeltő anyag , toxikus anyag
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| ISSN 1831-4767 | ISBN 978-92-76-00245-1 | DOI 10.2875/77673 | Katalógusszám EW-AQ-19-012-EN-N |
- Released on EU publications website:
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