European Regulatory Developments on Endocrine Disruptors

The WHO defines an endocrine disruptor as ‘an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations’. This definition has been retained by the European Union, which started a number of developments to better regulate these substances in the future.

A first important initiative is a ‘Fitness Check’ performed by the European Commission. Endocrine disruptors are regulated by several pieces of legislation and the goal is to analyze the coherence of these different approaches, identify possible gaps and synergies and assess their collective impact on human health and the environment. A public consultation ended in March 2020 and a regulatory proposal will be developed on this basis. This initiative may lead to deep legal changes in the long term.

In parallel, the toxicological assessment of several specific substances suspected to have endocrine disruption properties has been launched by the European Commission. Among these ongoing initiatives, the SCCS (Scientific Committee on Consumer Safety) started to evaluate the safety of several suspected cosmetic ingredients:

  • 5 very high priority materials are currently under review (SCCS mandated in February 2020 to deliver a scientific opinion within 9 months):
    • Benzophenone-3/Oxybenzone (CAS 131-57-7)
    • Propylparaben (CAS 94-13-3)
    • Resorcinol (CAS 108-46-3)
    • Octocrylene (CAS 6197-30-4)
    • Homosalate (CAS 118-56-9)
  • 9 high priority materials will be reviewed in 2021:
    • Kojic acid (CAS 501-30-4)*
    • 4-Methylbenzylidene camphor/4-MBC (CAS 36861-47-9)*
    • Triclosan (CAS 3380-34-5)*
    • Triclocarban/TCC (CAS 101-20-2)*
    • Butylated Hydroxytoluene/BHT (CAS 128-37-0)
    • Benzophenone (CAS 119-61-9)
    • Benzyl salicylate (CAS 118-58-1)
    • Genistein (CAS 446-72-0)*
    • Daidzein (CAS 486-66-8)*
  • 14 low priority materials (only raise environmental concerns and will be reviewed by the European Chemicals Agency or have been already found safe by the SCCS):
    • Butylparaben (CAS 94-26-8)**
    • Butylated Hydroxyanisole/BHA (CAS 25013-16-5)
    • Ethylhexyl methoxycinnamate(EHMC)/Octinoxate (CAS 83834-59-7)
    • Benzophenone-1 (CAS 131-56-6)
    • Benzophenone-2 (CAS 131-55-5)
    • Benzophenone-4 (CAS 4065-45-6)
    • Benzophenone-5 (CAS 6628-37-1)*
    • Methylparaben (CAS 99-76-3)
    • Cyclopentasiloxane/D5 (CAS 541-02-6)**
    • Cyclomethicone (CAS 69430-24-6/556-67-2/541-02-6/540-97-6)**
    • Salicylic acid (CAS 69-72-7)
    • Butylphenyl methylpropional/BMHCA (CAS 80-54-6)**
    • Triphenyl phosphate (CAS 115-86-6)
    • Deltamethrin (CAS 52918-63-5)*

* These ingredients are not (or barely) used in cosmetic products nowadays.

** These ingredients will probably be prohibited or severely restricted before this evaluation takes place (Butylparaben, Butylphenyl methylpropional, Cyclopentasiloxane).

Based on these scientific opinions, regulatory proposals aiming to prohibit or restrict the use of these ingredients in cosmetic products may be developed. The five first scientific opinions should be finalized by January 2021 if the exceptional circumstances of Covid-19 allow (the industry has already been informed that the deadline to submit safety data on the 9 next ingredients has been postponed to January 15th, 2021). At this stage, the possible outcome of this scientific review by the SCCS (and the transition periods to be granted by the European Commission in case some ingredients are not deemed safe) cannot be estimated.

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