REGULATIONS 11
Regulatory update for the European Union
n Dr Martin Perry – Advanced Development and Safety Laboratories Limited, UK
This article looks at the amendments that have been made to the European cosmetic Regulation (EC) No 1223/2009 in 2019. It also looks at the final opinions of the Scientific Committee on Consumer Safety (SCCS) for 2019 and for the first quarter of 2020.
Commission Regulation (EU) 2019/1857 Commission Regulation (EU) 2019/1857 amends entry 27a for titanium dioxide (nano) in annex VI. It adopts the opinion of the Scientific Committee on Consumer Safety and permits the use of titanium dioxide (nano) sunscreens coated with a combination of silica up to 16% and cetyl phosphate up to 6%; alumina up to 7% and manganese dioxide up to 0.7%; alumina up to 3% and triethoxycaprylylsilane up to 9%.1 The regulation does not permit titanium dioxide (nano) sunscreens with these coatings to be used in products that may be inhaled in to the consumer’s lungs. Titanium dioxide (nano) coated with alumina and manganese dioxide must not be used in lip products due to the harmful effects of ingesting manganese dioxide. For face products containing titanium dioxide (nano) coated with the combination of alumina and manganese dioxide the warning “Not to be used on the lips” must be used.
Commission Regulation (EU) 2019/1858 Commission Regulation (EU) 2019/1858 adopts the Scientific Committee on Consumer Safety’s opinions of 7 April 2017 and 5 March 2019 that hydroxyethoxyphenyl butanone (HEPB) should be permitted to be used as a preservative in rinse-off, oral care and leave- on cosmetic products up to a maximum concentration of 0.7%. In the 7 April 2017 opinion the Scientific Committee on Consumer Safety concluded that hydroxyethoxyphenyl butanone could be used as a preservative in rinse-off, oral care and leave-on cosmetic products but more information was required to assess
June 2020
hydroxyethoxyphenyl butanone for eye irritation.2
In the 5 March 2019 opinion
the Scientific Committee on Consumer Safety concluded that the use of hydroxyethoxyphenyl butanone as a preservative in rinse-off, oral care and leave- on cosmetic products at a maximum concentration of 0.7% is safe with regards to eye irritation. Commission Regulation (EU) 2019/1858 adds hydroxyethoxyphenyl butanone to annex V (entry 60) of Regulation (EC) No 1223/2009 and permits its use as a preservative.
Commission Regulation (EU) 2019/1966 Commission Regulation (EU) 2019/1966 amends annexes II (prohibited substances), III (restricted substances) and V (positive list of preservatives) of Regulation (EC) No 1223/2009 for substances classified as carcinogenic, mutagenic and toxic for reproduction (CMR). This regulation
includes substances classified as CMR substances by Commission Regulation (EU) 2018/1480 which will apply from 1 May 2020 and also 19 substances or groups of substances classified as CMR substances by Commission Regulation (EU) 2016/1179 which became applicable on 1 March 2018. Commission Regulation (EU) 2019/1966 also prohibits the use of 30 substances or groups of substances and adds them to annex II entries 1612 to 1641. Substances include potassium permanganate, benzyl dimethylamino morpholinophenyl butanone, tetramethrin and 1-vinyl imidazole. It also adds disodium octaborate anhydrous to the prohibited borate substances listed in entry 1396 in annex II. Salicylic acid has been classified as CMR
category 2. Article 15 of Regulation (EC) No 1223/2009 requires that substances classified as CMR category 2 are assessed for safety by the Scientific Committee on Consumer Safety and found to be safe if
PERSONAL CARE EUROPE
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