GLOBAL REGULATIONS
cosmetic products if the requirements of article 15 (CMR) of Regulation (EC) 1223/2009 cannot be met.
Homosalate The SCCS was asked to consider whether homosalate when used as a UV filter at up to a maximum concentration of 10% is safe in cosmetic products.15
They concluded that it was not safe
when used as a UV filter at concentrations up to 10%. In the SCCS’s opinion the use of homosalate
is safe up to a maximum concentration of 0.5%. The SCCS commented that the current evidence for homosalate being an endocrine disruptor is inconclusive. Although there are indications from some studies that suggest that it may have endocrine effects, the evidence is not sufficient to derive a specific endocrine related toxicological point of departure for use in safety assessment. The SCCS stated that using it at a lower maximum concentration may have a bearing on its ability to give sufficient sun protection but it was outside of its remit to assess the effectiveness of homosalate when used as a UV filter at lower concentrations. Subsequently to this opinion, the SCCS was
asked to consider whether they considered homosalate as safe when used as a UV filter at up to 7.34% in face cream and pump spray. They confirmed that it is considered safe at up to 7.34% in face cream and pump spray.16
Benzyl salicylate The Commission asked the SCCS to assess whether benzyl salicylate is safe to use at 4% in hydroalcoholic-based fragrances (spray and non-spray), 0.5% in rinse-off skin & hair products (except rinse-off body products), 1.3% in rinse-off body products, 0.5% in leave-on skin & hair products (non-spray/non-aerosol) (except body lotion), 0.5% in leave-on hair products (spray/aerosol), 0.7% in leave-on body products (non-spray/spray/aerosol), 0.2% in face make-up products and make-up remover, 0.004% in oral care, 0.91% in deodorant products (spray/aerosol).17 The SCCS has until November 2022 to reach a decision on the safety of benzyl salicylate.
Genistein and daidzein The SCCS was asked to consider if genistein and daidzein are safe to use in cosmetic products at up to 0.007% for genistein and 0.02% for daidzein.18 The SCCS concluded that genistein was safe
to use in cosmetic products up to a maximum concentration of 0.007% but they were unable to assess the safety of daidzein as the genotoxicity data was not sufficient to rule out genotoxic effects.
Conclusion This article has looked at recent amendments to Regulation (EC) 1223/2009 and future changes to the regulation as notified to the World Trade Organisation by the European Commission. It has also looked at the SCCS opinions for endocrine disruptors. For the exact wording used please refer to the relevant regulation or opinion.
www.personalcaremagazine.com
References 1. Commission Delegated Regulation (EU) 2022/692
2. 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. Brussels. 7.11.2018 COM(0) 739 final
3. European Commission. Call for data on ingredients with potential endocrine- disrupting properties used in cosmetic products. 15 February 2021.
https://ec.europa. eu/newsroom/growth/items/702447/en
4. Regulation (EC) No 1223/2009 Annex VI entry 4 5. SCCS. Opinion on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5). SCCS/1625/20 Final Opinion
6. SCCS. Opinion on Kojic Acid. SCCS/1637/21 7. Regulation (EC) No 1223/2009 entry 18 8. SCCS. Opinion on 4-Methylbenzylidene Camphor (4-MBC). SCCS/1640/21
9. SCCS. Opinion on 4-Methylbenzylidene Camphor (4-MBC). SCCP/1184/08
10. SCCS. Opinion on Propylparaben (PP). SCCS/1623/20 Final Opinion
11. SCCS. Scientific Advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products
12. SCCS. Opinion on Resorcinol. SCCS/1619/20 Final Opinion
13. SCCS. Opinion on Octocrylene. SCCS/1627/21 Final Opinion
14. SCCS. Opinion on Butylated Hydroxytoluene (BHT). SCCS/1636/21
15. SCCS. Opinion on Homosalate. SCCS/1622/20 Final Opinion
16. Scientific advice on the safety of Homosalate (CAS No 118-56-9, EC No 204-260-8) as a UV- filter in cosmetic products. SCCS/1638/21
17. SCCS. Request for a scientific opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9)
18. SCCS. Opinion on Genistein and Daidzein. SCCS/1641/22
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PC July 2022 PERSONAL CARE
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