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cmr substances

What are the new rules in Europe for CMR?

Article 15 of the Cosmetics Regulation 1223/2009 contains provisions on the use of CMR in cosmetic products.

The general principle laid down in Article 15 is that substances classified as CMR substances of category 1A, 1B or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 are banned for use in cosmetic products. Exceptions to this general rule are possible only subject to the conditions laid down in Article 15 of the Cosmetics Regulation.

Article 15 of the Cosmetics Regulation applies from 1 December 2010, as well as Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15. Article 4b of the Cosmetics Directive 76/768/EEC on the use of CMR substances in cosmetic products is repealed with effect from the same date.

As from 1 December 2010 a substance classified as a CMR substance of category 1A, 1B or 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 is, as from the date of application of its classification, automatically prohibited for use in cosmetic products.

The Commission does not adopt anymore implementing measures to list it in Annex II to the Cosmetics Regulation so as to make the ban effective.

The Commission only adopts implementing measures in order to authorize in cosmetic products those CMR substances of category 1A, 1B or 2 that fulfil the conditions laid down in Article 15 of the Cosmetics Regulation for the derogation to the general prohibition principle.

Article 15 of the Cosmetics Regulation Provisions:

CMR 2 substances

"[…] a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products. To these ends the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation."

CMR substances of category 1A or 1B

"[…] such substances may be used in cosmetic products by way of exception where, subsequent to their classification as CMR substances of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008, all of the following conditions are fulfilled:
(a) they comply with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
(b) there are no suitable alternative substances available, as documented in an analysis of alternatives;
(c) the application is made for a particular use of the product category with a known exposure; and
(d) they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population groups.

Specific labelling in order to avoid misuse of the cosmetic product shall be provided in accordance with Article 3 of this Regulation, taking into account possible risks linked to the presence of hazardous substances and the routes of exposure.

In order to implement this paragraph, the Commission shall amend the Annexes to this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation within 15 months of the inclusion of the substances concerned in Part 3 of Annex VI to Regulation (EC) No 1272/2008."

When applies the new regime on CMR substances?

This new regime in relation to CMR substances applies at the date of repeal of the corresponding provisions of the Cosmetics Directive and of entry into force of the related provisions of the Cosmetics Regulation, i.e. from 1 December 2010. Consequently, it concerns only the classifications under Part 3 of Annex VI to Regulation (EC) No 1272/2008 which are applicable as from 1 December 2010, that is the classifications introduced by Commission Regulation (EC) No 790/2009 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 and all the harmonised classifications that will be introduced in the future through adaptations to technical and scientific progress of that Regulation.

This regime does not concern those substances for which the classification is accompanied by specific concentration limits.

The CMR substances already regulated in the Annexes to the Cosmetics Directive/Regulation in accordance with Article 4b of the Cosmetics Directive will continue to be listed in those Annexes.

Which are the CMR substances concerned?

Some of the substances classified as CMR substances under Commission Regulation (EC) No 790/2009 had already been regulated in Annex II to the Cosmetics Regulation through previous adaptations to technical progress of the Annexes to the Cosmetics Directive (which had been taken over by the Cosmetics Regulation). They continue therefore to be listed in this Annex and to be banned for use in cosmetics. In addition, some substances classified as CMR substances under Commission Regulation (EC) No 790/2009 are considered to be covered by existing entries in Annex II to the Cosmetics Regulation.

For ease of reference you may consult the list of substances banned for use in cosmetic products as from 1 December 2010 due to their classification as CMR substances of category 1A, 1B or 2 under Commission Regulation (EC) No 790/2009. This list does not contain those substances classified under Commission Regulation (EC) No 790/2009, but which had been already listed in Annex II to the Cosmetics Regulation before 1 December 2010 (due to previous adaptations to technical progress of the Annexes to the Cosmetics Directive) or which are considered to be covered by existing entries in Annex II to the Cosmetics Regulation. 

More information on CMR

For more information on the status of a specific substance, you may also consult the CosIng database.

You may also find below relevant links towards the webpages of the European Chemicals Agency that allow stakeholders to follow the discussions on harmonised classification and labelling of substances (follow the intentions of the Member States, participate in the public consultations and follow progress):

Registry of intentions

Dossiers submitted

Ongoing public consultations

Closed public consultations