EU Updates Cosmetics Regulation in Regard to CMR Substances
SAFEGUARDS | Cosmetics, Personal Care and Household NO. 093/19
The European Commission published Regulation (EU) 2019/831 on May 22, 2019 to amend Annexes II, III and V to Regulation (EC) No. 1223/2009 in regard to substances classified as carcinogenic, mutagenic and reprotoxic (CMR) of categories 1A, 1B or 2 under Regulation (EC) No. 1272/2008 as at December 1, 2018. In this update, over 200 entries are added to Annex II of prohibited substances.
According to Article 15 of Regulation (EC) No. 1223/2009, a substance classified as a CMR of category 2 may be used in cosmetic products where the substance has been evaluated by the Scientific Committee on Consumer Safety (SCCS) and found safe for use in cosmetic products. Substances classified as a CMR of category 1A or 1B shall be prohibited in cosmetic products, unless such substances meet a number of conditions laid down in paragraph 2 of Article 15(2) by way of exemption.
Some of the updates are highlighted as below. For details, please refer to the official publication. The regulation will come into force on June 12, 2019.
| Changes | Annex | Substance identification | Restrictions | Remarks | ||
|---|---|---|---|---|---|---|
| Chemical name/INN/ INCI Name |
CAS number | EC number |
||||
| Add | II | Quaternium-15 | 51229-78-8 | 426-020-3 |
Prohibited (and removed from Annex V) |
CMR substance of category 2 |
| Add | II | Chloracetamide | 79-07-2 | 201-174-2 |
Prohibited (and removed from Annex V) |
CMR substance of category 2 |
| Add | II | Dichloromethane | 75-09-2 | 200-838-9 |
Prohibited (and removed from Annex III) |
CMR substance of category 2 |
| Add | II | Formaldehyde | 50-00-0 | 200-001-8 |
Prohibited (and removed from Annexes III and V) |
CMR substance of category 1B |
| Add | II | Perboric acid and Sodium perborate compounds | / | / |
Prohibited (and removed from Annexes III) |
CMR substance of category 1B |
| Add | II |
Boron compounds (originally listed in entries 1a and 1b of Annex III) |
/ | / |
Prohibited (and remove from Annex III) |
CMR substance of category 1B (for some boron compounds) |
| Add | II | Dibutyltin hydrogen borate | 75113-27-0 | 401-040-5 | Prohibited | CMR substance of category 1B |
| Add | II | Paraformaldehyde | 30525-89-4 | 608-494-5 | Prohibited (and remove from Annex V) |
/ |
| Add | II | Methylene Glycol | 463-57-0 | 207-339-5 | Prohibited | / |
| Add | III | Trimethylbenzoyl diphenylphosphine oxide (TPO) | 75980-60-8 | 278-355-8 | Allowed for professional use in artificial nail systems with a maximum concentration of 5% | CMR substance of category 2 |
| Add | III | Furfural | 98-01-1 | 202-627-7 | Allowed for use with a maximum concentration of 0.001% | CMR substance of category 2 |
| Amend | V | Polyaminopropyl Biguanide | 32289-58-9, 27083-27-8, 28757-47-3, 133029-32-0 | 608-723-9, 608-042-7 | Allowed for use as a preservative with a maximum concentration of 0.1%, except in applications that may lead to exposure of the end-user’s lungs by inhalation | CMR substance of category 2 |
Next step:
A lot of chemicals classified as CMR substance of categories 1A, 1B or 2 are now restricted or prohibited in Cosmetics Regulation. Apart from the substances listed above, the industry shall also be aware that substances like D4, Diisobutyl phthalate, Dihexyl phthalate, Petroletum..etc, are also involved in this update.
Source of Information:
For enquiries, please contact:
Queenie TSE
Assistant Technical Service Manager
t: +852 2765 3672
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