CMRs
CMR, which is an abbreviation for “Carcinogenic, Mutagenic or Toxic to Reproduction”, means carcinogenic, mutagenic and toxic substances for reproduction.
CMR substances are classified as categories 1A, 1B and 2 in Annex VI Part 3 of the CLP regulation no. 1272/2008.
CLP Regulation
The European Parliament and Council decision no. EC/1272/2008 on the classification, labeling and packaging of substances and mixtures was published on 30 December 2008 and entered into force on 20 January 2009.
The categories mentioned below are arranged by taking into account the hazards of the substances called CMR.
Category 1A: Largely based on human evidence,
Category 1B: Largely based on animal studies,
Category 2: Although there are data obtained from animal and human studies, they are not as convincing as categories 1A and 1B.
Cosmetics Regulation and CMR Substances
Article 15 of the Cosmetics Regulation No. 1223/2009 prohibits the use of substances listed in Annex 2 of the Regulation on Substances Prohibited for Use in Cosmetic Products and substances classified as CMR according to the CLP Regulation for cosmetic products.
The approach of the cosmetics regulation No. 1223/2009 regarding CMR substances and the situations that can be considered as exceptions for the use of these substances are explained in “Article 15”.
According to the CLP Regulation, in order for substances included in Category 2 to be used, they must be evaluated by the SCCS and approved as safe for use. Substances included in Category 1A and Category 1B classes are strictly prohibited unless there are exceptions depending on certain conditions.
Endocrine Disruptors
Endocrine disruptors (EDs) are a group of environmental and food pollutants that can interfere with endocrine balance, especially reproductive hormones (androgens and estrogens) and thyroid hormones. They are substances or mixtures that can cause adverse health effects in the body and in multiple generations by altering the functions of the endocrine system, both in the body and through gene transfer, and can be found naturally in nature or in various synthetic and industrial products.
Exposure to endocrine disruptors has many negative effects on human health, such as thyroid disorders, types of cancer, and asthma.
Scientific concerns about the endocrine disrupting properties of substances used in cosmetic products are addressed in the SCCS’s risk assessment, as are other substances that concern human health.
As a result of the relevant studies, the list of 28 endocrine disrupting substances is divided into the following 2 groups.
Endocrine Disruptors
Group A consists of high priority substances for which concerns have been confirmed after a Substance Evaluation (SEV) under REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) for endocrine disruptor concerns.
Group B refers to substances that have more environmental than human health effects.
To prioritize the substances, they were split into the 2 following groups.
Group A
Benzophenone-3, Kojic acid, 4-Methylbenzylidene Camphor (4-MBC), Propylparaben, Triclosan, Resorcinol, Octocrylene, Triclocarban, BHT/Butylated hydroxytoluene, Benzophenone, Homosalate, Benzyl Salicylate, Genistein and Daidzein.
14 substances to be treated with higher priority for assessment as they were undergoing substance evaluation (SEV) under REACH for ED concerns or the SEV had already confirmed ED concerns at the time of publication of the priority list.
Group B
Butylparaben, BHA / Butylated hydroxyanisole / tert-Butylhydroxyanisole, Ethylhexyl Methoxycinnamate (EHMC) / Octylmethoxycinnamate (OMC) / Octinoxate, benzophenone-1 (BP-1), Benzophenone-2 (BP-2), Benzophenone-4 (BP-4), Benzophenone-5 (BP-5), Methylparaben, Cyclopentasiloxane / Decamethylcyclopentasiloxane / D5, Cyclomethicone, Salicylic acid, Butylphenyl methylpropianol / BMHCA, Triphenyl phosphate and Deltamethrin.
14 substances where either no SEV had been initiated or the outcome of the SEV was an environmental ED concern and not a human health one at the time of publication of the priority list.
Group B also contained substances that had been recently evaluated by the SCCS and found safe, and/or substances that had been recently classified as CMRs under the CLP, where corresponding risk assessment/management measures were already in place to prohibit/restrict their use in cosmetic products.
To ensure your cosmetic products are safe and do not contain any ingredients of concern, feel free to check out our Cosmetic Product Safety Assessment services.
