Chemicals that are carcinogenic, mutagenic, or toxic for reproduction are called CMR substances and are divided into three categories based on the type of evidence of their hazardous properties:
- Category 1A – substances classified as CMR according to human studies;
- Category 1B – the evidence of their CMR properties is based on animal studies; hence, the negative effects on humans are only presumed;
- Category 2 – chemicals suspected to be CMR according to limited studies on animals and/or humans.
In December 2008, the European Commission published Regulation (EC) No 1272/2008 on the classification, labelling, and packaging of substances and mixtures (CLP Regulation). All CMR substances are listed in Part 3 of Annex VI. This list is updated annually through the so-called Adaptation to Technical Progress Acts (ATP).
The primary purpose of the CLP Regulation is to protect human health from dangerous chemicals by requiring chemical manufacturers and importers to classify, label and package hazardous substances appropriately.
Chemicals are an essential part of several industries – including the cosmetics one. Therefore, the inclusion of a substance in Part 3 of Annex VI to the CLP Regulation has some implications for the cosmetic regulatory framework as well.
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