12 REGULATIONS


they are going to be continued to be used. On 21 December 2018 the Scientific Committee on Consumer Safety issued an opinion that salicylic acid is safe for the consumer when used as a preservative at concentrations up to 0.5% except for oral products, and spray products that may result in the product being inhaled in to the lungs. The Scientific Committee on Consumer Safety also concluded that salicylic acid is safe when used for purposes other than preservation at concentrations up to 3.0% for rinse-off hair products, and up to 2.0% for other products except for body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant. Again the opinion is not applicable for oral products and spray products that may result in the product being inhaled in to the lungs. Finally the Scientific Committee on Consumer Safety concluded that salicylic acid is an eye irritant. The European Commission has decided that the conditions of use and warnings for salicylic acid should be amended. The European Commission has


amended entry 98 in annex III so that salicylic acid can be used at a maximum concentration of 3.0% in rinse–off hair products and up to 2.0% in other products except body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant. Salicylic acid should not be used in preparations for children under the age of 3 years. It is not to be used in applications which might lead to exposure of the consumer’s lungs by inhalation, or in oral products. For products containing salicylic acid which might be used for children under the age of 3 years the following warning must appear on labelling “Not to be used for children under 3 years of age”.4 The European Commission has also


amended the entry in annex V (entry 3) for salicylic acid and its salts when used as preservatives. Salicylic acid and its salts are still permitted to be used as preservatives up to a maximum concentration of 0.5% (as acid). Salicylic acid is not permitted to be used in products for children under the age of 3 years, and it is not permitted to be used in oral products and in products which might lead to exposure of the consumer’s lungs by inhalation. For products containing salicylic acid which might be used for children under the age of 3 years the following warning must appear on labelling “Not to be used for children under 3 years of age”.4


Salicylic acid is no longer


permitted to be used in shampoo for children under the age of 3 years. Salicylic acid salts such as calcium


salicylate, magnesium salicylate, MEA- salicylate, sodium salicylate, potassium salicylate, and TEA salicylate must not be used in products for children under the age of 3 years except for shampoo. For


PERSONAL CARE EUROPE


products which might be used for children under 3 years of age and which might remain in prolonged contact with the skin the following warning must appear on labelling “Not to be used for children under 3 years of age”.4 Oxyquinoline and oxyquinoline sulphate


were both included in annex II entry 395 (prohibited substances) of Regulation (EC) No 1223/2009 when it was amended by regulation (EU) 2019/831. Oxyquinoline has been classified as CMR category 1B but the classification does not apply to oxyquinoline sulphate.5


As the CMR


category 1B classification only applies to oxyquinoline and not oxyquinoline sulphate the European Commission has decided that only oxyquinoline should have been included in annex II and that oxyquinoline should have remained in annex III. Therefore oxyquinoline sulphate has been removed from annex II and re-instated in annex III (entry 51).


SCCS Opinions 2019 – March 2020 SCCS/1591/17 Butylphenyl methylpropional Butylphenyl methylpropional is a fragrance allergen listed in annex III (entry 83) of Regulation (EC) No 1223/2009. Regulation 1223/2009 requires it to be labelled in the ingredients list when it is present at a concentration above 0.001% (10 ppm) for leave–on products and above 0.01% (100 ppm) for rinse–off products. The Scientific Committee on Consumer


Safety was asked to consider if the fragrance ingredient butylphenyl methylpropional was safe to use in leave– on and rinse-off cosmetic products at the concentration limits set by the International Fragrance Association (IFRA). The Scientific Committee on Consumer Safety concluded that butylphenyl methylpropional containing 200 ppm of alpha-tocopherol can be considered safe as a fragrance ingredient in rinse–off and leave–on products on an individual product basis but when aggregate exposure arising from the


use of different product types together was considered butylphenyl methylpropional cannot be considered to be safe at the proposed concentrations. The opinion is not applicable to sprayable products containing butylphenyl methylpropional which may lead to exposure to the consumer through inhalation.


SCCS/1605/19 Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate In June 2016 the European cosmetics trade body Cosmetics Europe made a submission for methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate to be used as a UV filter in cosmetic products at a maximum concentration of 5%.6


The Scientific


Committee on Consumer Safety reviewed the safety of methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate as a UV filter and adopted an opinion that based on the data provided that genotoxic potential of methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate cannot be excluded. They also concluded that skin and eye irritation potential cannot be excluded and dermal penetration data for 5% methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate should also be provided. In response to SCCS/1587/17 Cosmetics


Europe submitted a second submission in July 2018 for methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate to be used as a UV filter in cosmetic products at a maximum concentration of 3%. Based on the data provided by Cosmetics Europe the Scientific Committee on Consumer Safety reviewed the safety of methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate and concluded that it is safe to use as a UV filter at concentrations up to a maximum of 3%. As no data was provided for inhalation toxicity the Scientific Committee on Consumer Safety concluded that the opinion does not


June 2020


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