September 13, 2021 – You want to place your cosmetic products on the EU market, but you are not sure if a certain ingredient will soon be restricted?
Have you ever wondered how to stay up to date on the topics currently under discussion in the EU bubble?
Find below the summary of what is going on in relation to substances with possible endocrine-disrupting properties and catch a glimpse on what to expect in the future!
What are endocrine disruptors?
Endocrine active substances are chemicals that interact with the endocrine system without posing any concerns for human health if absorbed in normal foreseeable amounts. Conversely, whenever an endocrine active substance leads to potential damages to people health, it is classified as an endocrine disruptor (ED). Hence, “an endocrine disruptor is 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” (IPCS, 2002). Infertility, breast and prostate cancer, obesity, diabetes, memory and cardiovascular diseases are some of the side effects linked to ED action. The impact of endocrine disruptors is higher during the fetal stage, childhood, and puberty, and the effects may become manifest even after decades.
Substances with endocrine-disrupting properties can be synthetic or of natural origin, and they may be present in several products such as pesticides, biocides and cosmetics.
Endocrine disruptors in the EU Cosmetics regulatory framework
In the EU Cosmetics Regulation, there are no specific provisions addressing endocrine disruptors, but the fitness check conducted in 2019 by the European Commission has shown that the tools foreseen in the Regulation are suitable to deal with the potential health hazards connected to ED. Therefore, when a substance is identified as a potential endocrine disruptor, the Scientific Committee on Consumer Safety (SCCS) is requested to perform a safety assessment and, based on its results, the European Commission may eventually ban or restrict the use of that raw material in cosmetic products.
On December 16, 2014, the SCCS adopted a memorandum in which it is explained the approach adopted in the safety assessment of a potential endocrine disruptor. In particular, to determine whether a potential ED is an actual ED it is necessary to prove a causal relationship between the endocrine activity induced by the substance and the adverse effect detected in the organism. The evaluation takes the form of a risk assessment based on the following main criteria: critical effect, severity, irreversibility, and potency.
Lastly, the document highlights the importance of data from animal studies to substantiate the above-mentioned causal relationship. Therefore, “Due to the ban on animal testing for cosmetic ingredients effective since 2013, it will be extremely difficult in the future to differentiate between a potential ED and an ED, if the substance is registered solely for use in cosmetic products” (SCCS, 2014).
What is next?
In 2019, the European Commission released a list of 28 substances suspected to be endocrine disruptors and mandated the Scientific Committee on Consumer Safety to assess whether their use in cosmetic formulations is safe for human health. When all the opinions will be issued, the European Commission might ban or restrict some ingredients due to their endocrine-disrupting properties, by adding them to Annexes II or III to the EU Cosmetics Regulation. The SCCS’s safety assessments will be based on the data provided by the cosmetic industry: thus, the European Commission has invited the interested parties to submit any relevant information.
The substances were divided into two groups based on priority as follow:
- Group A – High priority: the data was collected between May and October 2019 and the SCCS is currently performing the safety assessments [Table 1];
- Group B – Low priority: the call for data is open. [Table 2] The substances included in this list are considered of low priority, because they did not undergo the substance evaluation under REACH, or its outcome resulted in a concern related to the environment and not to human health.
|Group A - SCCS Safety Assessment ongoing|
|#||INCI Name||CAS Nr.||SCCS Opinion||Date|
|1||Benzophenone-3||131-57-7||Final Opinion 1625/20||30-31/03/2021|
|2||Kojic Acid||207-922-4||Final Opinion 1637/21||15-16/03/2022|
|3||4-Methylbenzylidene Camphor||36861-47-9||Preliminary Opinion 1640/21||22/12/2021|
|4||Propylparaben||94-13-3||Final Opinion 1623/20||30-31/03/2021|
|5||Triclosan||3380-34-5||Scientific Advice 1643/22||15-16/03/2022|
|6||Resorcinol||108-46-3||Final Opinion 1619/20||30-31/03/2021|
|7||Octocrylene||6197-30-4||Final Opinion 1627/21||30-31/03/2021|
|8||Triclocarban||101-20-2||Scientific Advice 1643/22||15-16/03/2022|
|9||BHT||128-37-0||Final Opinion 1636/21||02/12/2021|
|10||Benzophenone||119-61-9||To be treated via Omnibus Act on CMR|
|11||Homosalate||118-56-9||Final Opinion 1622/20||24-25/06/2021|
|Scientific Advice 1638/21||02/12/2021|
|12||Benzyl salicylate||118-58-1||Request for a Scientific Opinion||03/02/2022|
|13||Genistein||446-72-0||Preliminary Opinion 1641/22||12/01/2022|
|14||Daidzein||486-66-8||Preliminary Opinion 1641/22||12/01/2022|
Benzophenone-3 (BP-3) is currently included in Annex VI to the EU Cosmetics Regulation as a UV-filter allowed to be used in cosmetic formulations at a maximum concentration of 6% in a finished product and up to 0.5% when used to protect product formulation.
In March 2021, the SCCS concluded that the data currently available on BP-3 is not enough to assess whether this ingredient is an endocrine disruptor and, therefore, further studies are needed.
However, based on the present information, the SCCS noted that:
- The use of BP-3 is safe for the consumer up to 0.5% to protect the cosmetic formulation and up to a maximum concentration of 6% as a UV-filter in face cream, hand cream and lipstick;
- The use of BP-3 up to a maximum concentration of 6% in finished products is not safe in sunscreen products. According to the SCCS, the use of BP-3 in sunscreen products (body cream, propellent or pump spray) is safe:
- Up to 2.2% when no additional BP-3 is used for protecting the cosmetic formulation;
- Up to 1.7% when BP-3 is also used at 0.5% for protecting the cosmetic formulation.
In light of the above, it is expected that the European Commission will amend the EU Cosmetics Regulation to align with this opinion.
In its opinion 1623/20 of March 2021, the SCCS confirmed that the use of Propylparaben (PP) as a preservative up to a maximum concentration of 0.14% in a finished product – as stated in Annex V to the EU Cosmetics Regulation – is safe.
Moreover, the suspected endocrine-disrupting properties of PP cannot be unequivocally confirmed on the basis of the data collected, therefore, PP must be considered as a potential endocrine disruptor.
According to the SCCS’ final opinion 1619/20 published in March 2021, the use of Resorcinol as an oxidative hair dye is safe in products intended for hair and eyelashes up to 1.25% and up to 0.5% in hair lotions and shampoos. These parameters are already established in Annex III to the EU Cosmetics Regulation, entry 22.
Octocrylene is listed in Annex VI to the EU Cosmetics Regulation as a UV-filter allowed to be used in formulations up to a concentration of 10% as an acid. However, in the opinion 1627/21 of March 2021, the SCCS concluded that “the use of Octocrylene in sunscreen propellant spray is considered safe when its concentration does not exceed 9% when used together with face cream, hand cream, and lipstick containing 10% Octocrylene” (SCCS, 2021).
The European Commission may include the above condition in Annex VI as an additional requirement on the use of Octocrylene in cosmetic products.
Lastly, for Octocrylene, the evidence available at the moment is not sufficient to confirm its suspected endocrine-disrupting properties either.
Benzophenone has been classified as CMR substance of category 2 due to its carcinogenic effects, therefore, the EU Commission is planning to ban its use in cosmetic products via a new CMR Omnibus Act. Considering this, Benzophenone potential endocrine-disrupting properties do not need to be further investigated.
At present, the use of Homosalate as UV-filter is allowed in cosmetics up to a maximum concentration of 10% in a finished product (Annex VI, entry 3). The SCCS does not consider it safe for human health. According to its Opinion finalized in June 2021, the limits should be 0.5%.
Considering the above, the European Commission asked the SCCS to provide its opinion on the safety of Homosalate used as a UV-filter in face products. In the Scientific Advice 1638/21, dated December 2, 2021, the Scientific Committee concluded that the UV-filter Homosalate is safe up to a maximum concentration of 7,34% in face cream and pump-spray.
The European Commission will likely discuss the modification of Annex VI to the EU Cosmetics Regulation in view of the above-mentioned opinions.
|Group B - Call for data ongoing|
|#||INCI Name||CAS Nr.||Deadline|
|3||Ethylhexyl Methoxycinnamate / Octyl methoxycinnamate / Octinoxate||5466-77-3||15/11/2021|
|8||BHA / Butylated Hydroxyanisole||25013-16-5||15/11/2021|
- Cosmetics & Toiletries. (2021). European Regulatory Update: Greenwashing, Endocrine Disruptors and PFAS. Retrieved on 10/09/2021 from https://cosmeticsandtoiletries.texterity.com/cosmeticsandtoiletries/september_2021/MobilePagedArticle.action?articleId=1719165#articleId1719165
- SCCS. (2021). Opinion on Benzophenone-3. Retrieved on 10/09/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_247.pdf
- SCCS. (2021). Opinion on Propylparaben (PP). Retrieved on 10/09/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_243.pdf
- SCCS. (2021). Opinion on Resorcinol. Retrieved on 10/09/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_241.pdf
- SCCS. (2021). Opinion on Octocrylene. Retrieved on 10/09/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_249.pdf
- SCCS. (2021). Opinion on Homosalate. Retrieved on 10/09/2021 from https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_244.pdf
- EC. (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 10/09/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52018DC0739&rid=2
- SCCS. (2014). Memorandum on Endocrine Disruptors. Retrieved on 10/09/2021 from https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_009.pdf
- WHO, IPCS. (2002). Global Assessment of the State-of-the-science of Endocrine Disruptors. Retrieved on 13/09/2021 from https://www.who.int/ipcs/publications/en/toc.pdf?ua=1
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