On 2 March 2023, the European Union notified the World Trade Organization (WTO) of a draft Regulation consisting on the 19th Adaptation to Technical and Scientific Progress (ATP) of the Regulation (EC) 1272/2008 (CLP – Classification, Labelling and Packaging of Substances). This new regulation impacts a total of 16 substances that can be used in cosmetics, including two with new CMR classificatios, which ultimately threatens their use in cosmetic products.
Based on the opinions of the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) issued in 2021, the purpose of this draft is to amend Table 3 of Part 3 of Annex VI to the CLP Regulation, by introducing new and revised entries for the harmonised classification and labelling of several substances or substance groups.
What is the impact on cosmetic products?
The draft regulation concerns a total of 16 substances that may be used in cosmetic products and that were classified as hazardous:
- Dimethyltolylamine (CAS 99-97-8): Carc. 1B, Acute Tox. 4, Acute Tox. 3, STOT RE 2, Aquatic Chronic 3
- Trimethylbenzoyl Diphenylphosphine Oxide (CAS 75980-60-8): Repr. 1B, Skin Sens. 1B
- Basic Red, CI 45160 (CAS 989-38-8): Acute Tox. 3, Eye Dam. 1, Skin Sens. 1, Aquatic Acute 1, Aquatic Chronic 1
- Disperse Red 17 (CAS 3179-89-3): Skin Sens. 1
- Cinnamal (CAS 104-55-2): Skin Sens. 1A
- 1,4-Butanediol dimethacrylate (CAS 2082-81-7): Skin Sens. 1B
- Di-HEMA Trimethylhexyl Dicarbamate (CAS 41137-60-4 / 72869-86-4): Skin Sens. 1B
- Triethylene glycol dimethacrylate (CAS 109-16-0): Skin Sens. 1B
- Potassium Chlorate (CAS 3811-04-9): Ox. Sol. 1, Acute Tox. 3
- Sodium Chlorate (CAS 7775-09-9): Ox. Sol. 1, Acute Tox. 3
- Benzyl Alcohol (CAS 100-51-6): Acute Tox. 4, Eye Irrit. 2, Skin Sens. 1B
- Resorcinol (CAS 108-46-3): Acute Tox. 4, STOT SE 1, Skin Irrit. 2, Eye Irrit. 2, Skin Sens. 1B, Aquatic Acute 1
- Ethyl Acrylate (CAS 140-88-5): Flam. Liq. 2, Acute Tox. 3, Acute Tox. 4 (H312), Acute Tox. 4 (H302), STOT SE 3, Skin Irrit. 2, Eye Irrit. 2, Skin Sens. 1
- Allyl Methacrylate (CAS 96-05-9): Flam. Liq. 3, Acute Tox. 2, Acute Tox. 3, Acute Tox. 4, Aquatic Acute 1
- Triethylamine (CAS 121-44-8): Flam. Liq. 2, Acute Tox. 3 (H331), Acute Tox. 3 (H311), Acute Tox. 3 (H301), Skin Corr. 1A, Eye Dam. 1
- Benzisothiazolinone (CAS 2634-33-5): Acute Tox. 2, Acute Tox. 4, Skin Irrit. 2, Eye Dam. 1, Skin Sens. 1A, Aquatic Acute 1, Aquatic Chronic 1
In accordance with article 15 of the EU Cosmetics Regulation (EC) 1223/2009, the use in cosmetic products of substances classified as CMR substances of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 is prohibited, unless the substances fulfill certain strict conditions.
Proposed date of adoption: 2nd quarter 2023
Proposed date of entry into force: 20 days from publication in the Official Journal of the EU (about 2 months after adoption).
References:
World Trade Organization (WTO) – Committee on Technical Barriers to Trade, G/TBT/N/EU/957
