22 GLOBAL REGULATIONS


or substance evaluation had already confirmed endocrine disruptor concerns. The 14 substances are: benzophenone-3,


kojic acid, 4-methylbenzylidene camphor, propylparaben, triclosan, triclocarban, resorcinol, octocrylene, butylated hydroxytoluene (BHT), benzophenone, homosalate, benzyl salicylate, genistein and daidzein. The Commission has looked at the safety of all of these substances except benzophenone. The 14 substances which are not on the priority


list are: butylparaben, tert-butylhydroxyanisole (BHA), ethylhexyl methoxycinnamate, benzophenone-1, benzophenone-2, benzophenone-4, benzophenone-5, methylparaben, cyclopentasiloxane, cyclomethicone, salicylic acid, butylphenyl methylpropianol, triphenyl phosphate and deltamethrin. Of these, the Commission has asked for


relevant scientific data on ten of these substances. The 4 substances that have been excluded are: cyclopentasiloxane, cyclomethicone, butylphenyl methylpropianol and deltamethrin.3


Benzophenone-3 Benzophenone-3 is permitted to be used as a UV filter up to a maximum concentration of 6%.4


The SCCS was asked to consider if


it considered benzophenone-3 to be safe when used as a UV filter up to a maximum concentration of 6% and 0.5% when used to protect the product formulation.5 The SCCS concluded that benzophenone-3


is not safe as a UV filter when used at up to 6% in sunscreen products used in the form of body cream, sunscreen propellant spray or pump spray. The use of benzophenone-3 as a UV filter at a maximum concentration of 6% in face cream, hand cream and lipstick is safe for the consumer. The use of benzophenone-3 at up to 0.5%


to protect the cosmetic product is safe. The SCCS was of the opinion that benzophenone-3 could be used up to a maximum concentration of 2.2% in body creams, propellant sprays and pump sprays provided that there is no additional use of benzophenone-3 for protecting the product.


Kojic acid SCCS has been asked to review the safety of kojic acid and consider whether kojic acid is safe when used in cosmetic products up to a maximum concentration of 1%.6


The SCCS concluded that


kojic acid is not safe at a maximum concentration of 1% but is safe up to 0.7% when used as a skin lightening agent in cosmetic products. Kojic acid derivatives such as kojic acid


dipalmitate, kojic acid isopalmitate and chloro- kojic acid had not been included in their opinion as no data had been submitted for them to consider.


4-Methylbenzylidene camphor 4-Methylbenzylidene camphor is permitted to be used at up to 4% as a UV filter.7


The


SCCS has been asked to review the safety of 4-methylbenzylidene camphor and consider whether it is safe when used as a UV filter at a maximum concentration of 4%.8


PERSONAL CARE July 2022 The SCCS concluded that they were unable


to evaluate its safety as there is insufficient information to evaluate the potential genotoxicity. The SCCS went on to say that there is sufficient evidence that it may act as an endocrine disruptor and has an effect on the thyroid and endocrine system. Even if the genotoxicity was excluded, they


concluded that it would not be safe if used at 4% due to a higher exposure level than in their previous opinion.9


Propylparaben The SCCS was asked to consider whether propylparaben was still safe to use as a preservative at a maximum concentration of 0.14% (measured as the equivalent acid) in light of the fact that it has been identified as a potential endocrine disruptor.10 The SCCS concluded that although


propylparaben provided some evidence of endocrine effects there was not sufficient evidence to conclusively regard it as an endocrine disrupting substance or to derive a specific endocrine related toxicological point of departure for use in safety assessment. The SCCS confirmed that it was safe to use


at up to 0.14% (calculated as the equivalent acid) in cosmetic products.


Triclosan and triclocarban According to Regulation (EC) 1223/2009 (Annex V, entry 25) triclosan is safe to use at up to 0.3% in toothpastes, hand soaps, body soaps/shower gels, deodorants (non-spray), face powders and blemish concealers, nail products for cleaning the fingernails and toenails before the application of artificial nail systems and up to 0.2% in mouthwash. The SCCS was asked to consider the safety


of triclosan and concluded that it was safe at up to 0.03% in shower gel and hand soap, 0.2% in mouthwash, 0.3% in toothpaste, deodorant stick, face powder and blemish concealer and 0.03% in body lotion when used individually or in combination.11 For triclocarban, the EU cosmetic Regulation


(EC) 1223/2009 permits its use at up to 0.2% as a preservative and up to 1.5% in rinse-off


products where its function is not to inhibit the development of micro-organisms. The SCCS in their opinion concluded that it is safe at the levels stated in the regulation.11


Resorcinol In light of resorcinol being identified as a potential endocrine disruptor the SCCS was asked to consider if it safe when used as an oxidative hair dye in products intended for hair and eyelashes up to a maximum concentration of 1.25% and up to 0.5% in hair lotions and shampoos. The SCCS concluded that resorcinol is safe at these concentrations.12


Octocrylene Octocrylene has been identified as potentially having endocrine disrupting properties. The SCCS was asked to consider if octocrylene is safe when used as a UV filter at up to 10% in cosmetic products.13


They concluded that it is safe at


concentrations up to 10% in cosmetic products when used individually. The SCCS also considered it safe at up to


10% when used in combination with sunscreen cream/lotion, sunscreen pump spray, face cream, hand cream and lipstick but not sunscreen propellant spray. They considered it as safe when used at a maximum concentration of 9% when used together with face cream, hand cream, and lipstick containing 10% octocrylene.


Butylated hydroxytoluene (BHT) The SCCS looked at the safety of butylated hydroxytoluene and concluded that it was safe at up to 0.001% in mouthwash, 0.1% in toothpaste and 0.8% in other leave–on and rinse-off products.14 Butylated hydroxytoluene is also considered


safe for a combined use of 0.001% in mouthwash, 0.1% in toothpaste and 0.8% in other leave–on and rinse-off products.


Benzophenone Commission Delegated Regulation (EU) 2022/692 has classified benzophenone as carcinogenic category 1B (Carc. 1B) and applies from 23 November 2023. Benzophenone may be banned from use in


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