BRB 3CvAd 20.qxp_Layout 1 09/09/2021 11:54 Page 1 REGULATION 17
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has been classified as an inhalation carcinogen in certain forms
Commission Regulation (EU) 2021/850 also amends the entry in Annex III (Entry 98) for salicylic acid in order to align its use with the original SCCS opinion.1
For uses other than a
preservative, salicylic acid can be used in body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant at up to 0.5%. This aligns its use for these products with the maximum permitted concentration when used as a preservative. Commission Regulation (EU) 2021/1099
prohibits the use of tetrahydropyranyloxy phenol and adds it to the list of prohibited substances (Annex II, Entry 1657). The SCCS reviewed the safety of this substance in 2015 and concluded that it is not safe to use in face creams because hydroquinone will be formed during the ‘life-cycle of the product (e.g. storage conditions and stability under in-use conditions)’ at levels that are a safety concern.2 The Regulation also restricts the use of
dihydroxyacetone to 6.25% in non-oxidative hair dye products and 10% in self-tanning products by adding it to Annex III, Entry 321 of Regulation 1223/2009. From 26 January 2022, only hair dye and self-tanning products, which comply with this regulation may be placed on the EU market. From 22 April 2022, all such products not complying with these restrictions are banned.
WTO notifications On 22 January 2021, the EC notified the WTO of its intention to prohibit the use of 23 substances in cosmetic products. According to the EC, the measure is due to the requirement to enact the prohibition from use of substances which were classified as CMR according to Regulation 2020/1182. Of the 23 substances, zinc pyrithione, butylphenyl methylpropional and sodium hydroxymethylglycinate are permitted in cosmetic products with restrictions. Zinc pyrithione is permitted as a preservative
in rinse-off hair products at up to 1% and other rinse - off products at up to 0.5% but is not permitted to be used in oral care products under Annex V, Entry 9 of Regulation 1223/2009. It is permitted to be used in leave–on hair products at a maximum concentration of 0.1% under Annex III, Entry 101, provided that its use is not to inhibit the development of micro-organisms.
www.personalcaremagazine.com On 14 September 2018, ECHA’s Risk
Assessment Committee adopted an opinion to classify zinc pyrithione as a CMR 1B substance under Regulation (EC) No 1272/2008 (CLP).3 Under Article 15 of Regulation 1223/2009 substances which are classified as CMR, 1A, or 1B shall be prohibited unless four criteria are all met: ■ They comply with the food safety requirements as defined in Regulation (EC) No. 178/2002 ■ There is no suitable alternative ■ An application is made for a particular use with a known exposure ■ They have been evaluated as safe to use in cosmetic products by the SCCS In March 2020, the SCCS concluded that
zinc pyrithione was safe to use as an anti- dandruff in rinse-off hair products at up to a maximum concentration of 1%.4
On 19 May
2020, Commission Delegated Regulation (EU) 2020/1182 classified it as CMR 1B (H360D) and added it to Annex VI of Regulation 1272/2008. This applies from 1 March 2022. The EC’s notification to the WTO noted the SCCS’s conclusion but still proposed to ban zinc pyrithione as “it has not been established that there are no suitable alternative substances available”.5 Sodium hydroxymethylglycinate is a
preservative listed in Annex V of Regulation 1223/2009 and is permitted to be used up to a maximum concentration of 0.5%. It was classified as mutagenic category 2 and carcinogenic category 1B by Regulation 2020/1182. It will be banned from 1 March 2022 as the use of this preservative was not defended by the cosmetics industry. Butylphenyl methylpropional is one of the
fragrance allergens that has to be included in the ingredients list if present in concentrations greater than 0.01% in rinse-off products or 0.001% in leave-on products. It was classified as reprotoxic category 1B by Regulation 2020/1182 and is thus also to be banned in the EU. Methyl-N-methylanthranilate is a fragrance
ingredient which is not prohibited or restricted for use by Regulation 1223/2009. The SCCS concluded that it is phototoxic6
and that this is
the toxicological endpoint of concern. In 2020, the committee confirmed that it “should not be used in sunscreen products and products
November 2021 PERSONAL CARE
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