Annex II, which lists the substances forbidden in cosmetics, now includes several carcinogenic, mutagenic, and reprotoxic (CMR) chemicals. According to Article 15 of the Cosmetics Regulation, CMR chemicals are absolutely forbidden.
CMR chemicals are subdivided into Categories 1A, 1B, and 2. According to Article 15, Section, 2, CMR chemicals in Category 1A or 1B may be used only when:
- They comply with the food safety requirements as defined in Regulation (EC) No. 178/2002.
- There are no suitable alternative substances available.
- The application is made for a particular use of the product category with a known exposure.
- They have been evaluated and found safe by the SCCS.
According to Article 15, Section 1, a CMR substance of Category 2 may be used in cosmetics when it has been evaluated by the SCCS and found safe for use in cosmetics.
Annex III, the list of substances that are permitted for limited use in cosmetics, was also modified, as was Annex V, the list of preservatives permitted in cosmetics.
In May 2019, the EU Commission included 226 CMR chemicals in Annex II of the Cosmetics Regulation.
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