Omnibus Regulation 2019

CMRs: An important piece of legislation will be published soon

Article 15 of the EU Cosmetics Regulation regulates the use of CMRs1 in cosmetic products. By default, the use of CMR substances is prohibited in the EU, although exemptions remain possible under specific conditions. Silent until recently, the regulatory procedure now implies the publication of an amendment to Annex II (prohibited substances) before a ban takes effect.
Annex III (restricted substances) also needs to be amended in case an exemption is granted.

On July 3rd, 2017, the Standing Committee on Cosmetic Products voted a Regulatory Proposal prohibiting or restricting officially the use of 9 cosmetic ingredients (or group of cosmetic ingredients), recently classified as CMR substances. This piece of legislation is expected to be published in the next few months and its enforcement will be immediate. In other words, no transition periods will be offered to the Industry and the regulation will start applying 20 days after its publication.

Substances to be prohibited by this upcoming regulation (addition to Annex II):

Name Previous entry
Methenamine 3-Chloroallylochloride (INCI: Quaternium 15) V, 31
2-Chloracetamide (INCI: Chloroacetamide) V, 41
Dichloromethane III, 7
Formaldehyde, Paraformaldehyde and Methylene Glycol III, 13 and V, 5
Perboric Acid and Sodium Perborate III, 1a and III, 12
Borates, Tetraborates and Octaborates and other Boric Acid Salts or Esters III, 1a and III, 1b

Substances to be restricted by this upcoming regulation (addition to Annex III):

Name Conditions
2-Furaldehyde (Furfural) Maximum 10 ppm (0.001 %)
Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
(INCI: Trimethylbenzoyl diphenylphosphine oxide)
Maximum 5.0 % in nail modelling products for professionals (no other permitted use)
Polyhexamethylene biguanide hydrochloride (INCI:
Polyaminopropyl Biguanide), PHMB
Maximum 0.1% in all product categories
except spray able formulations

Any questions?

Author

  • Christophe Brault-Chevalier is the Scientific & Regulatory Affairs Director at Biorius, bringing over 20 years of experience in the cosmetics industry. He has previously held positions at International Flavors & Fragrances Inc. (IFF) and LVMH, further enhancing his expertise in the field.

    View all posts Scientific & Regulatory Affairs Director @ BIORIUS