GLOBAL REGULATIONS
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European Union cosmetics regulation – 2022 update
Martin Perry - Advanced Development and Safety Laboratories
In the November 2021 edition of Personal Care Global, I reviewed recent amendments to the European Cosmetics Regulation (EC) No 1223/2009, notifications by the European Commission to the World Trade Organisation (WTO) and Scientific Committee on Consumer Safety (SCCS) opinions for nanomaterials. This article follows on from that article and
looks at more recent amendments to Regulation (EC) 1223/2009 and further notifications to the World Trade Organisation. It also looks at the SCCS opinions on endocrine disruptors.
Commission Regulation (EU) 2021/1902 On 22 January 2021, the Commission notified the World Trade Organisation of its intention to prohibit the use of 23 substances as they had been classified as carcinogenic, mutagenic and toxic to reproduction by Delegated Regulation (EU) 2020/1182 (15th ATP to CLP). Three of the substances already had entries in Regulation (EC) 1223/2009. Zinc pyrithione was permitted to be used as a preservative (Annex V, entry 8) and in leave–on hair products (Annex III, entry 101). Butylphenyl methylpropional is a fragrance allergen (Annex III, entry 83). Sodium hydroxymethylglycinate is a formaldehyde releasing preservative (Annex V, entry 51). Commission Regulation (EU) 2021/1902 has amended the Cosmetics Regulation (EC) 1223/2009 and prohibits the use of zinc pyrithione and butylphenyl methylpropional by adding them to Annex II. Sodium hydroxymethylglycinate is
permitted to be used as a preservative at up to 0.5% providing the maximum theoretical concentration of releasable formaldehyde from all sources combined does not exceed 0.1% w/w. The changes to the cosmetic regulation (EC) 1223/2009 apply from 1 March 2022.
Commission Regulation (EU) 2022/135 Methyl-N-methylanthranilate is a fragrance ingredient. Commission Regulation (EU) 2022/135 adds methyl-N-methylanthranilate to Annex III (entry 323) of Regulation (EC) 1223/2009 and permits it to be used at up to 0.2% in rinse-off products and 0.1% in leave-on products except for sunscreen products and products marketed for exposure to natural or artificial UV light. As methyl-N-methylanthranilate is a
secondary amine, it should not be used with
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nitrosating agents, the maximum nitrosamine content should not exceed 50 µg/kg and it should be stored in nitrite-free containers.
WTO notifications The European Union on 11 February 2022 notified the World Trade Organisation of its intention to prohibit the use of the following nanomaterials in cosmetic products: styrene/ acrylates copolymer, sodium styrene/ acrylates copolymer, copper, colloidal copper, hydroxyapatite, gold, colloidal gold, gold thioethylamino hyaluronic acid, acetyl heptapeptide-9 colloidal gold, platinum, colloidal platinum, acetyl tetrapeptide-17 colloidal platinum. In March 2022, the Commission asked the
SCCS for a scientific opinion on the safety of hydroxyapatite (nano). This was due to industry submitting additional information to support its safe use in oral products and addressing its potential genotoxicity. Having notified the World Trade
Organisation in August 2021 of its intention to introduce new and revised entries for the harmonised classification and labelling of 56 substances, the EU published the 18th adaptation to technical and scientific progress (ATP-18) to Regulation (EC) 1272/2008 (CLP).1 The following cosmetic ingredients have been classified as carcinogenic, mutagenic and
toxic to reproduction: benzophenone (Carc. 1B), theophylline (Repr.1B), melamine (Carc. 2), pentetic acid (Repr. 1B), pentasodium pentetate (Repr. 1B), margosa (azadirachta indica) extract (Repr. 2) and trimethylolpropane triacrylate (Carc. 2). The classifications will apply from 23
November 2023. If these ingredients are to be used in cosmetic products, they will need to comply with the requirements of Article 15 (CMR) of Regulation (EC) 1223/2009.
Endocrine disruptors Endocrine-disrupting chemicals are chemicals that mimic, block, or interfere with hormones in the body’s endocrine system. On 7 November 2018, the European
Commission adopted a review of the Cosmetic Regulation (EC) No 1223/2019 that concluded that the regulation was adequate to regulate the use of endocrine disruptors in cosmetic products.2 In the review, the Commission committed
to establish a priority list of potential endocrine disruptors not already restricted or prohibited for use in cosmetic products. Following consultation with the working group on cosmetic products, 28 substances were identified as potential endocrine disruptors in March 2019. Of the 28 substances, 14 were identified as
a priority as they were undergoing substance evaluation under REACH for endocrine concerns
July 2022 PERSONAL CARE
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