Endocrine Disruptors in Europe

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):

NamePrevious entry
Methenamine 3-Chloroallylochloride (INCI: Quaternium 15)V, 31
2-Chloracetamide (INCI: Chloroacetamide)V, 41
DichloromethaneIII, 7
Formaldehyde, Paraformaldehyde and Methylene GlycolIII, 13 and V, 5
Perboric Acid and Sodium PerborateIII, 1a and III, 12
Borates, Tetraborates and Octaborates and other Boric Acid Salts or EstersIII, 1a and III, 1b

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

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?


  • Frédéric Lebreux

    Dr. Frédéric Lebreux is Biorius's Chief Executive Officer and has worked in the cosmetic industry for more than 13 years. He is regularly invited as a speaker or Professor to cosmetic events.

    View all posts