Use of CMR Substances in Cosmetic Products

CMR stands for substances that are carcinogenic, mutagenic or toxic to reproduction; they are generally referred to as a group due to similarities in classification and legal approaches. It is used as an abbreviation for "Carcinogenic, Mutagenic or Toxic to Reproduction". CMR substances are primarily classified in Annex VI Part 3 of Regulation (EC) No 1272/2008 (CLP Regulation) as categories 1A, 1B and 2.

CLP Regulation and Classification Principles

The CLP Regulation is a regulation prepared to ensure compliance with the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria regarding the classification, labelling and packaging of substances and mixtures. CMR substance categories within the CLP Regulation are organized based on hazard levels. The classification of CMR substances is based on the strength of evidence demonstrating that hazards to human health arise from one of the CMR types. Carcinogenicity - A carcinogenic substance or mixture of substances that triggers cancer or increases the frequency of its occurrence. Mutagenicity - A mutation is a permanent change in the amount or structure of genetic material in a cell. Reproductive toxicity - Reproductive system toxicity includes adverse effects on sexual function and reproduction in adult males and females and developmental toxicity in offspring.

CMR Substances & EU Cosmetics Regulation

Article 15 of Regulation (EC) No 1223/2009 on Cosmetics prohibits the use in cosmetic products of substances listed in Annex II of the Regulation, 'List of Substances Prohibited in Cosmetic Products', as well as substances classified as CMR under the CLP Regulation. The approach of Regulation (EC) No 1223/2009 on cosmetics regarding carcinogenic, mutagenic and reproductive toxic substances (CMR) and the exceptional circumstances for their use are explained in Article 15. Substances classified as Category 2 according to the CLP Regulation may be used only after evaluation by the SCCS and approval of safe use, whereas substances classified as Category 1A and 1B are completely prohibited unless there are exceptional circumstances subject to specific conditions.

CMR Substances & Turkish Cosmetics Regulation

With a provision added to the Cosmetics Regulation on 15 July 2015, the use of carcinogenic, mutagenic, reproductive toxic (CMR) substances was prohibited. (1) Substances classified as carcinogenic, mutagenic and reproductive toxic within categories 2, 1A and 1B as specified in the Third Section of Annex 6 of the Regulation on the Classification, Labelling and Packaging of Substances and Mixtures published in the Official Gazette dated 11/12/2013 and numbered 28848 are prohibited for use in cosmetic products. The Regulation on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) regulates the administrative and technical procedures and principles relating to the classification, labelling and packaging of substances and mixtures placed on the market.

Evaluation of CMR Substances in Cosmetic Products

• A declaration regarding CMR substance content must be present in the cosmetic product's product information file. • Information on CMR substances must be provided under the toxicology section of the cosmetic product's safety data sheet (SDS-MSDS). • If the cosmetic product contains CMR substance(s); the presence of these substances must be indicated when submitting the product notification. Since the use of CMR substances in cosmetic products is prohibited for the domestic market, statements must be made regarding the absence of CMR substances in the aforementioned matters, whereas for products manufactured for the EU market and intended solely for export, it must also be documented that the substances used have been approved by the SCCS.   Ebru Bal Chemist Project Manager Pimgrup Education and Consulting