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“Omnibus act” 2017 – Prohibition of CMR substances in cosmetic products



Substances which are classified as CMR (CMR = “carcinogenic”, “mutagenic” and “reprotoxic“) of Category 2 according to the criteria laid down in the CLP (= Regulation 1272/2008 on Classification, Labelling and Packaging of substances and mixtures) are usually automatically prohibited for cosmetic products in accordance with Article 15 of the European Cosmetics Regulation. Exceptions are applicable for substances that have been evaluated as safe for cosmetic products by the European Scientific Committee on Consumer Products (SCCS). For substances classified as the more severe categories 1A and 1B, beside from the SCCS approval several other criteria must be fulfilled for the use in cosmetic products.

The general source for information on substances which are banned for cosmetics is Annex II of the Cosmetic Regulation 1223/2009, however, many CMR substances have not been included there notwithstanding their prohibition. It has been recently agreed by the European Commission (EC) after years of discussion that the prohibition of CMR classified substances according to Article 15 shall only take effect when these are implemented in Annex II. The subsequent procedure, named as “Omnibus act”, is highly appreciated by the industry since it creates more transparency and allows easier handling in terms of prohibited substances. With the current act, about 200 substances that have been newly classified as CMR after 2010 and not fall under legal derogations for cosmetics will be added to Annex II.
The Omnibus act will be expected for publication until the end of 2017. The proposed transition period for manufacturers to comply with the new requirements will be probably 12-15 months. As an exception, those substances which have not been listed in the CosIng database (and typically not used for cosmetics) will be immediately added to Annex II after publication without transition period.

There will be similar acts in the future on a yearly basis for the purpose of continuous synchronization of the CLP and Cosmetics Regulation and to implement a clear process for the handling of CMR classified substances.

If you have any questions, please contact us under cosmetics@mdss.com.


Draft regulation: Amendments following Article 15 of the cosmetic Regulation 1223/2009