Summary of SCCS Opinions from January to June 2022

Scientific Committee on Consumer Safety (SCCS) Opinion on Genistein and Daidzein

Publication date: a preliminary version on 12 January 2022

Deadline for public consultation: 14 March 2022

Content: On 13 January 2022, SCCS issued a final opinion SCCS/1641/22 on Genistein and Daidzein. The conclusions are as follows:

For Genistein (CAS No.446-72-0, EC No.207-174-9), the maximum safe amount in cosmetics should not exceed 0.007%. For Daidzein (CAS No.486-66-8), the existing data are not enough to complete the risk assessment on its use in cosmetics, so the limit of safe application of Daidzein in cosmetics cannot be given.

Purpose of Use: skin conditioning

Links: https://ec.europa.eu/health/publications/genistein-and-daidzein_en

SCCS Issued an Opinion on Prostaglandins and Prostaglandin-analogues Used in Cosmetic Products

Publication date: preliminary version on 27 September 2021 and the final version on 3 February 2022

Content: On 3 February 2022, SCCS issued an opinion SCCS/1635/21 on Prostaglandins and Prostaglandin-analogues used in cosmetic products. The conclusions are as follows:

• As there is limited data available in literature and research materials, it is not possible for SCCS to conclude on the safety of isopropyl cloprostenate (CAS No.157283-66-4) when used up to the intended use concentrations (0.007%).
• As there is limited data available in literature and research materials, it is not possible for SCCS to conclude on the safety of Ethyl Tafluprostamide (DDDE, CAS No.1185851-52-8) when used up to the intended use concentrations (0.018%).
• Prostaglandin-analogues (PGA) are registered drugs for the treatment of glaucoma. They can also be used as active ingredients in eyelash growth promoting cosmetics. A review of the open literature indicates that PGA is a very potent pharmacologically active substance, with serious side effects reported after being used in the proximity of the eyes.
• Taking physicochemical, toxicological, and exposure considerations into account, SCCS has concerns that the use of PGA in cosmetics might pose health risks to consumers.
• Considering the lack of relevant data on pharmacological activity and safety, SCCS is currently unable to provide recommendations on the safe concentration of PGA used in cosmetics and needs to collect more evidence for evaluation.

Purpose of Use: Hair conditioning

Links: https://ec.europa.eu/health/publications/prostaglandins-and-prostaglandin-analogues-used-cosmetic-products_en

SCCS Issued a Final Opinion on Kojic Acid and a New Maximum Safe Concentration

Publication date: a preliminary version on 26-27 October 2021, the final version on 15-16 March 2022, and corrigendum on 10 June 2022

Content: On 17 March 2022, SCCS issued a final assessment draft SCCS/1637/21 on Kojic acid, a whitening ingredient in cosmetics. It concluded that Kojic acid has potential endocrine-disrupting properties and a maximum concentration of 1% allowed for use in cosmetics in the European Union is no longer considered safe. At the same time, SCCS gave a maximum safe concentration of 0.7% for kojic acid when it is used as a cosmetic whitening agent.

Purpose of Use: whitening agent

Links: https://ec.europa.eu/health/publications/kojic-acid_en

SCCS Issued an Expert Opinion on the Safety of Triclocarban and Triclosan as Substances with Potential Endocrine Disrupting Properties in Cosmetic Products

Publication date: a preliminary version on 15-16 March 2022

Deadline for public solicitation: 27 May 2022

Content: On 25 March 2022, SCCS issued a preliminary opinion draft SCCS/1643/22. The conclusions are as follows:

• The use of Triclocarban as a preservative in cosmetic products is safe up to a maximum concentration of 0.2%.
• In addition to the preservative function, the use of Triclocarban is also safe up to a maximum concentration of 1.5% in rinse-off products when used individually or in combination.
• The use of Triclosan is safe as a preservative up to a maximum concentration of 0.03% in shower gel and hand soap, 0.2% in mouthwash, and 0.3% in toothpaste, deodorant stick, face powder and blemish concealer when used individually or in combination.
• The use of Triclosan is not considered safe as a preservative up to a maximum concentration of 0.3% in body lotion when used individually or in combination. The use of Triclosan in body lotion is considered safe when its concentration does not exceed 0.03% when used individually or combined with the above-mentioned products.

Purpose of Use: anticorrosive

Links: https://ec.europa.eu/health/publications/safety-triclocarban-and-triclosan-substances-potential-endocrine-disrupting-properties-cosmetic_en#description

SCCS Issued an Expert Opinion on the Safety of Alpha-arbutin and Beta-arbutin in Cosmetic Products

Publication date: a preliminary version on 15-16 March 2022

Deadline for public solicitation: 27 May 2022

Content: On 25 March 2022, SCCS issued a draft opinion on the safety of Alpha-Arbutin and Beta-Arbutin, in which it concludes that without data on Hydroquinone release and its ultimate destination, it is not possible to determine the safe concentration of any Arbutin in cosmetics.

Purpose of Use: whitening agent

Links: https://ec.europa.eu/health/publications/safety-alpha-arbutin-and-beta-arbutin-cosmetic-products_en

SCCS Issued a Final Opinion on 4-Methylbenzylidene camphor (4-MBC)

Publication date: a preliminary version on 22 December, the final version on 29 April 2022

Content: On 10 May 2022, SCCS issued an opinion SCCS/1640/21 on the safety of 4-Methylbenzylidene camphor (4-MBC). The conclusions are as follows:

• The SCCS cannot conclude on the safety of 4-MBC, because the information provided is insufficient to fully evaluate potential genotoxicity.
• Moreover, there is sufficient evidence that 4-MBC may act as an endocrine disruptor and has effects on both the thyroid and estrogen systems. Effects on the androgen system are not so evident, as only in vitro evidence is available.
• Even if the genotoxic potential was excluded, the current re-evaluation of 4-MBC established a higher exposure level than in the previous Opinion. This would result in a lower MoS value, indicating that the use of 4-MBC at the maximum concentration of 4% in cosmetic ingredients would not be safe.
• It is not possible to derive a maximum concentration for safe use of 4-MBC, because a genotoxicity potential cannot be excluded.
• The SCCS mandate does not address environmental aspects. Therefore, this assessment did not cover the safety of 4-MBC for the environment.

Purpose of Use: Sunscreen

Links: https://ec.europa.eu/health/publications/4-methylbenzylidene-camphor-4-mbc_en

SCCS Issued an Opinion on the Safety of Aluminum in Cosmetic Products

Publication date: a preliminary version on 6 May 2022

Deadline for public solicitation: 25 July 2022

Content: On May 30, 2022, the Scientific Committee for Consumer Safety of the European Union (SCCS) issued an opinion draft SCCS/1644/22 on the Aluminium. It is concluded that the SCCS considers that Aluminium compounds are safe when used in the following conditions:

• In non-sprayable product categories at the maximum levels indicated in Table 4;
• In sprayable antiperspirant products, provided that the maximum percentage of particles with 10 μm diameter does not exceed 20% of the total aerosolized particles.
• The SCCS could not assess the safety of Aluminium compounds in sprayable applications other than antiperspirants. Therefore, these applications (including Eau de toilette, Eau de parfum, and hair spray) are therefore excluded from this Opinion.

Purpose of Use: Colorant

Links: https://ec.europa.eu/health/publications/sccs-safety-aluminium-cosmetic-products-submission-iii_en

Further Information

SCCS Issued an Opinion on the Safety of Aluminum in Cosmetic Products

SCCS Released A Draft Opinions on the Safety of Alpha-Arbutin and Beta-Arbutin in the Cosmetic Products

The Scientific Committee for Consumer Safety of the European Union (SCCS) Issued A Preliminary Assessment of Cosmetics Whitening Ingredients of Kojic Acid, the Use Concentration of 1% is no Longer Considered Safe