Answer given by Mr Breton on behalf of the European Commission
16.4.2021
According to the relevant provisions of the Cosmetics Regulation[1], ultraviolet (UV) filters used in sunscreens are subject to authorisation prior to their placing on the EU market. Currently, octocrylene is an approved UV filter for use in cosmetics, in a maximum concentration of 10%, while the use of benzophenone as such is not explicitly authorised as a UV-filter.
As part of the Commission’s review[2] of endocrine disruptors in cosmetics, the Commission drafted in 2019 a priority list of potential endocrine disruptors. Both octocrylene and benzophenone were included amongst the substances to be analysed as a matter of priority.
Octocrylene is currently under risk assessment[3] by the EU Scientific Committee on Consumer Safety (SCCS) consisting of independent scientists. The SCCS is aware of the CNRS[4] study and will take it under consideration during its assessment. The final SCCS opinion will be shared with Member States after its publication expected in late spring 2021. Once the SCCS has adopted its final opinion, the Commission will consider regulatory measures. This may include a restriction or a prohibition of octocrylene in cosmetics.
Regarding benzophenone, a RAC[5] opinion of 11 June 2020[6] proposes a harmonised classification as carcinogenic Cat. 1B. As soon as a harmonised classification under Regulation 1272/2008[7] is in place, and based on Article 15 of the Cosmetics Regulation, in principle the use of such carcinogenic, mutagenic or toxic substances in cosmetic products shall be prohibited, except if a derogation is granted.
When substances are restricted or prohibited in cosmetics, manufacturers have to adapt their products and comply with any new legal requirements.
- [1] Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products — OJ L 342, 22.12.2009, p. 59
- [2] https://ec.europa.eu/transparency/regdoc/rep/1/2018/EN/COM-2018-739-F1-EN-MAIN-PART-1.PDF
- [3] https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_249.pdf
- [4] France’s national scientific research centre
- [5] The Committee for Risk Assessment (RAC) prepares the opinions of ECHA related to the hazards and risks of substances to human health and the environment in REACH and CLP processes
- [6] https://echa.europa.eu/documents/10162/63078b71-7c88-afa0-241c-ffef8fbdd3bd
- [7] Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures — OJ L 353, 31.12.2008, p. 1