EU Regulatory Update: Provisions for CMRs

September 14, 2010 | Contact Author | By: Annelie Struessmann, PhD, CONUSBAT
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The first application deadline for Regulation (EC) No. 1223/2009, the recast of the Cosmetics Directive, is approaching. As of Dec. 1, 2010, the new provisions [Article 15(1&2)] on use of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) will apply and Article 4b of the Cosmetics Directive 76/768/EEC will be repealed.

Article 15(1) of the new regulation prohibits the use of substances in cosmetic products classified as CMR Category 2; however, these substances may be used when they have been evaluated by the Scientific Committee for Consumer Safety (SCCS) and found to be safe for this use. The use of CMR substances categorized as 1A or 1B also is prohibited, according to Article 15(2), but an exception can be made if all of the following four criteria apply:

1. The CMR substance complies with the EU food safety requirements (Regulation (EC) No. 178/2002).
2. Suitable alternative substances are not available.
3. The exposure to the cosmetic product in which the CMR substance is formulated is known. The EU Commission will conduct a review and develop guidance regarding the exposure to CMR substances by Jan. 11, 2012 (Article 15(3)). Recital 34 of the preamble mentions that the review especially should consider the exposure for vulnerable population groups such as children, elderly individuals, etc.
4. The substance was found safe by the SCCS.

CAS or EC numbers of CMR substances must be disclosed during notification of the cosmetic products prior to marketing [Article 13(1)g]. The notification provisions apply beginning on Jan. 11, 2012. In comparison, the old EU framework for the Cosmetics Directive prohibited the use of Category 1, 2 and 3 CMRs, with the only exception being the use of Category 3 CMRs if the substance had been evaluated by the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP), the predecessor of SCCS, and found acceptable for use in cosmetic products (Article 4b of the Cosmetics Directive). Therefore, a new provision of Regulation (EC) No. 1223/2009 is that the ban of CMR substances now includes exceptional revocation of the law (derogation) for Categories 1A and 1B.

Category 1, 2 and 3 CMR substances were identified according to Directive 67/548/EEC (Dangerous Substances Directive (DSD)) and listed in Annex I (DSD) as well as in Annex II of the Cosmetics Directive (List of Substances which must not form part of the Composition of a Cosmetic Product). Since Jan. 20, 2009, DSD and its Annex I has been replaced by Regulation (EC) No. 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) and its Annex VI (CLP). The deadline for reclassification of substances is Nov. 30, 2010, and the provisions for CMR substances for Regulation (EC) No. 1223/2009 will apply as of the following day.

Table 3.1 of Annex VI (CLP) provides classification and labeling entries according to the criteria of CLP, whereas the entries in Table 3.2 are according to the DSD criteria. The former CLP categories 1 and 2 are now 1A and 1B CMR categories, and the former category 3 has been changed to category 2. The criteria for CMR classification is equivalent, and the number of classified substances will stay the same as under the former EU legislation.

There will be no further impact on cosmetics products from the CLP deadline of Nov. 30, 2010, because Regulation (EC) No. 1223/2009 defines its own labeling rules and cosmetic products are excluded from the scope of CLP in this regard. In Article 15 of Regulation (EC) No. 1223/2009, the EU Commission, in order to implement the provisions of the paragraph, will amend the Annexes of the regulation within 15 months. For now, all amendments to the annexes are still made in the Cosmetics Directive 76/768/EEC.