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Monday, November 12, 2018Regulation

Safety assessment: 10th revision of the SCCS' Notes of Guidance

10e révision des NOG du CSSC

At its plenary meeting on October 24 and 25, 2018, the SCCS adopted the final version of the 10th revision of its Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation. Compared to the previous version, changes have been made both in the structure of the text and in its content.

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In its introduction, the text states that 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) No1223/2009 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) No1223/2009.
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 …

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