Starting from February 15, 2021, the European Commission launched a call for any interested parties to submit scientific information related to some cosmetic ingredients that may have potential endocrine-disrupting properties. Once the consultation period will be over, the European Commission will request an opinion to the EU Scientific Committee on Consumer Safety (SCCS) on this topic.
This initiative is part of the Fitness Check program on endocrine disruptors published by the European Commission on October 14, 2020, in the context of chemical strategy for sustainability towards a toxic-free environment. Some substances were identified as endocrine disruptors and divided in two groups: Group A for the very high-risk ingredients and Group B for the remaining ones.
The call for Group A substances took place in 2019 and, currently, the SCCS is in charge of carrying out the related risk assessments, while the new call concerns Group B endocrine disruptors. The SCCS risk evaluation can have an impact on the Cosmetics Regulation and, in particular, on its Annexes, in case any of these substances should be considered risky for the consumers’ health. In fact, as a result, further restrictions and bans will be needed.
What is an endocrine disruptor? And which are the EU regulatory approaches on the topic?
An endocrine disruptor is defined as “an exogenous substance or mixture that alters functions of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations” (World Health Organization, 2002).
At the moment, the Cosmetics Regulation does not include any specific provision concerning endocrine disruptors; therefore, substances considered as potential endocrine disruptors are banned only if they are also classified as CMR. In all other cases, to amend the Annexes to the Cosmetics Regulation is necessary to follow the procedure stated in article 31 – which includes asking for SCCS’s opinion.
This approach applies also to the food sector, while in the areas of biocides and plant protection products, the EU law expressly states that endocrine disruptors are not permitted, unless by way of derogation. Lastly, the MDR provides that the use of endocrine disruptors in invasive medical devices is justified so that the benefit of their use is higher than the potential risk related to them. One of the objectives pursued by the fitness check above-mentioned is to verify if all these different approaches are effective in minimizing the risks related to endocrine-disruptors.
The call for data
The call announced on February 2, 2021 concerns the substances included in Group B, which are: Butylparaben, Methylparaben, Ethylhexyl Methoxycinnamate (EHMC)/Octylmethoxycinnamate (OMC)/Octinoxate, Benzophenone-1 (BP-1), Benzophenone-2 (BP-2), Benzophenone-4 (BP-4), Benzophenone-5 (BP-5), BHA/Butylated hydroxyanisole/tert-butyl-4-hydroxyanisole, Triphenyl Phosphate and Salicylic Acid. The other 4 substance of Group B, D5, Cyclomethicone, BMHCA and Deltamethrin are excluded from the call for data due to other discussions going on around them which might lead to no need for further data.
The consultation started on February 15, 2021 and it will last until November 15, 2021 (July 15, 2021 only for Butylparaben) and research institutes, national competent authorities, cosmetic’s manufacturers, and producers of these substances are invited to submit the data in their possession.
The urgency of acquiring data on Butylparaben is justified by the fact that this substance has been recently classified as of very high concern for human health and included in the REACH list in June 2020.
Once data will be collected , the European Commission will mandate the SCCS to evaluate the substances and then, if needed, it will take action and prohibit or restrict the use of these substances in cosmetics.
It needs to be considered that SCCS takes around 9 months to issue an opinion as such only in 2022 we will have the final output.
Meanwhile, SCCS was mandated to issue opinions on remaining substances from Group A substances included in this category in 2018 due to the very high concern about their endocrine disrupting effect on human beings – 4-MBC, BHT, Kojic acid, Genistein and Daidzein
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- European Commission. (2021). Call for data on ingredients with potential endocrine-disrupting properties used in cosmetic products. Retrieved on 21/04/2021 from https://ec.europa.eu/growth/content/call-data-ingredients-potential-endocrine-disrupting-properties-used-cosmetic-products-0_en
- European Commission. (2020). Commission Staff Working Document Executive Summary of the Fitness Check on endocrine disruptor of the Communication from the Commission to the European Parliament, the Council, the European Economics and Social Committee and the Committee of the Regions. Retrieved on 23/04/2021 from https://ec.europa.eu/environment/pdf/chemicals/2020/10/Executive_summary_FC_EDC.pdf
- European Commission. (2018). Report from the Commission to the European Parliament and the Council. Review of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products with regard to substances with endocrine-disrupting properties. Retrieved on 21/04/2021 from https://ec.europa.eu/transparency/regdoc/rep/1/2018/EN/COM-2018-739-F1-EN-MAIN-PART-1.PDF
- World Health Organization. (2002). Global Assessment of the State-of-the-Science of Endocrine Disruptors. Retrieved on 28/04/2021 from https://www.who.int/ipcs/publications/en/ch1.pdf?ua=1