CMR & dangerous substances

Hazardous and CMR substances

are concerned by both CLP Regulation and Cosmetics Regulation.

Hazardous/CMR substances and CLP:

CLP Regulation No 1272/2008 is the European Regulation on Classification, Labelling and Packaging of chemical substances and mixtures.

This Regulation, entered into force on 20 January 2009, aligns the EU classification system to the UN Globally Harmonised System (Globally Harmonised System of Classification and Labelling of Chemicals) ensuring that the same hazards are described and labelled in the same way all around the world.

The CLP Regulation - which is directly coming into force in all EU Members States and is legally binding - will gradually replace the Dangerous Substances Directive 67/548/EEC (DSD) and the Dangerous Preparations Directive 1999/45/EC (DPD) after a transitional period, i.e. on 1 December 2010 for substances and 1 June 2015 for mixtures.

It aims to protect workers, consumers and the environment by means of labelling which reflect hazards of chemicals.

In hazardous chemical substances legislation (CLP), a CMR substance is a substance classified in Part 3 of Annex VI to CLP Regulation as carcinogenic, mutagenic or toxic for reproduction. Annex VI which lists the hazardous substances for which harmonized classification and labelling has been adopted at the Community level, has been yet updated by two Commission’s Adaptations to Technical Progress, the Commission Regulation No 790/2009 that entered into force on 25 September 2009 and the Commission Regulation No 286/2011 that entered into force on 19 April 2011.

CLP defines new CMR categories:

CATEGORY 1 A (formerly 1): Classification is based on human evidence (epidemiological data),
CATEGORY 1 B (formerly 2): Classification is based on animal evidence,
CATEGORY 2 (formerly 3): Classification based on the evidence obtained from human and/or animal studies, but which is not sufficiently convincing to place the substance in Category 1A or 1B.

With CLP, a mixture is classified as carcinogenic, mutagenic or toxic to reproduction of category 1A, 1B or 2 if it contains a component classified as CMR at a concentration equal or upper to concentration limits defined in Annex 1 to CLP.

CMR & Cosmetics Regulation

Regulation No 1223/2009, the new European regulatory framework for cosmetics entered into force on 11 January 2010. Streamlining terminology and simplifying the process of placing a cosmetic product on the EU market, it is a recast of Council Directive 76/768/EEC which will be repealed progressively.

While most of its provisions will be enacted on 11 July 2013, Article 15 provides for the use of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) and applies since 1 December 2010.

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 the CLP Regulation 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:

1) Substances classified as CMR substances of category 1A or 1B

A CMR substance of category 1A or 1B is automatically prohibited for use in cosmetic products. By way of exception, the Commission may adopt measures for the authorization of these categories of substances provided that all the following conditions listed in article 15, paragraph 2 are fulfilled:

Food safety requirements pursuant to Regulation No 178/2002 must be met,

No suitable alternative substances are available,

The application is made for a particular use of the product category with a known exposure,

Assessment by the Scientific Committee for Consumer Safety (SCCS) of the European Commission concluding to the safety for use in cosmetic products.

2) Substances classified as CMR substances of category 2

At the date of application of their classification under Part 3 of Annex VI to Regulation No 1272/2008, CMR substances of category 2 are automatically prohibited for use in cosmetics and they will not be any more listed in Annex II to the Cosmetics Regulation. However, where a CMR 2 substance is defended for use in cosmetic products and where, following the appropriate evaluation, it is found safe by the SCCS, the Commission will adopt measures amending the Annexes of the Cosmetics Regulation in order to authorize the use of that substance in cosmetic products.

Within this regulatory context, UNITIS has conducted with European Experts a large study on the possible presence of hazardous and/or CMR substances in living botanicals and its ingredients. This work which focuses on 569 plants/parts of plants provides related information regarding the nature of the extracts.

This study is solely reserved to UNITIS Members.

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