GLOBAL REGULATIONS
lungs by inhalation. There will be a nine-month implementation period for placing products on the EU market that do not comply with this amendment to regulation (EC) 1223/2009 and 18 months for them to be off the EU market.
Commission Delegated Regulation (EU) 2022/692 (18th ATP to CLP) In May 2022 the European Commission published Commission Delegated Regulation (EU) 2022/692 which is commonly referred to as the 18th ATP to CLP. A number of chemicals were classified as carcinogenic category 1B including Benzophenone which has UV properties but was not listed in Annex VI, Theophylline an impurity in Caffeine, Pentetic Acid and Pentasodium Pentetate which have chelating properties and 2-Ethylhexanoic acid and its salts. 2-Ethylhexanoic acid and 2-ethylhexanoic acid nickel salt have already been prohibited from use in cosmetic products and are listed in Annex II (entries 1024 and 1460 respectively). 2-Ethylhexanoic Acid Zinc salt, which has the INCI name Zinc Ethylhexanoate, is expected to be added to Annex II and will be prohibited from use in cosmetic products when the sixth omnibus regulation is published and comes into force on 1 December 2023. Commission Delegated Regulation (EU) 2022/692 also classified Margosa (Azadirachta Indica) Extract, Melamine and Trimethylolpropane Triacrylate as carcinogenic category 2. As none of these ingredients were defended by the cosmetic industry, all will be prohibited from use in the European Union.
United Kingdom since Brexit Until 31 December 2020 the UK followed the European cosmetic regulation (EC) 1223/2009. After the end of the Brexit transition period the UK adopted the European regulation through schedule 34 of the Product Safety and Metrology Statutory Instrument.11 Products sold in Northern Ireland have to
comply with the EU cosmetic regulation (EC) 1223/2009 as part of the Northern Ireland protocol. This has led to the UK regulation starting to diverge from the EU regulation. The Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS) has been created by the Office for Product Safety and Standards (OPSS) to advise it on changes to the UK regulation. The UK cosmetic regulation has been amended by Statutory Instrument to prohibit the use of 4-[(tetrahydro-2H-pyran-2-yl)oxy]phenol in cosmetic products.12
2-yl)oxy]phenol has been added to Annex II (entry 1645). The statutory instrument also prohibits
the use of the fragrance allergen (2-(4-tert- Butylbenzyl)propionaldehyde and Zinc Pyrithione and adds them to Annex II (entries 1666 and 1669 respectively). The entry in Annex III for (2-(4-tert-Butylbenzyl)propionaldehyde has been omitted. The entry in Annex III for water soluble zinc salts (Annex III entry 24) excludes the use of Zinc Pyrithione and the entry for Zinc Pyrithione in Annex V (entry 8) has also been omitted. The statutory instrument also prohibits the use of 35 other substances (Annex II entries 1646 to 1665, 1667, 1668 and 1670 to 1679).
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The use of Sodium Hydroxymethylamino
Acetate, which is a formaldehyde-releasing preservative listed in Annex V (entry 51), has been further restricted so that it can only be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the product placed on the market is less than 0.1% w/w.
The entry in Annex III for Salicylic Acid
(entry 98) has been amended. The statutory instrument amends the entry to include its use in body lotion, eye shadow, mascara, eyeliner, lipstick and roll on deodorant at up to 0.5%. All the changes made to the Cosmetic Products Regulation UK No 1223/2009 by statutory instrument 2022 No. 659 have been implemented as the transition period has passed. On 28 May 2023 the UK Department for
4-[(Tetrahydro-2H-pyran-
Business and Trade notified the World Trade Organisation of its intention to restrict the use of the fragrance ingredient Methyl-N- Methylanthranilate to 0.1% in leave-on products and 0.2% in rinse-off products. Its use in leave- on products is prohibited in sunscreen products and products marketed for exposure to natural or artificial UV light. It is not to be used with nitrosating agents and must not have a nitrosamine content exceeding 50 µg/kg. It must be kept in nitrite- free containers. Products not complying with this amendment to the UK cosmetics regulation need to be placed on the market before 6 July 2024 and can stay on the market until 6 July 2026. The UK Department for Business and Trade has also notified the World Trade Organisation of its intention to permit the use of the UV filters Bis-(Diethylaminohydroxybenzoyl) Piperazine and Bis-(Diethylaminohydroxybenzoyl) Piperazine (nano).
Conclusion The article has looked at recent amendments to the EU and UK cosmetic regulations, it has considered future changes that are likely to occur to these regulations. For the exact wording used please refer to the relevant regulation, statutory instrument or opinion.
PC
References 1. European Commission Scientific Committee on Consumer Safety. SCCS/1625/20
2. European Commission Scientific Committee on Consumer Safety. SCCS/1627/21
3. European Commission Scientific Committee on Consumer Safety. SCCS/1632/21
4. European Commission Scientific Committee on Consumer Safety. SCCS/1636/21
5. European Commission Scientific Committee on Consumer Safety. SCCS/1631/21
6. European Commission Scientific Committee on Consumer Safety. SCCS/1622/20
7. European Commission Scientific Committee on Consumer Safety. SCCS/1638/21
8. European Commission Scientific Committee on Consumer Safety. SCCS/1533/14
9. European Commission Scientific Committee on Consumer Safety. SCCS/1634/21
10. European Commission Scientific Committee on Consumer Safety. SCCS/1648/22
11. UK government. Schedule 34 of the Product Safety and Metrology Statutory Instrument consolidated legal text UK Retained Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance)
12. UK government. Statutory Instrument 2022 No. 659 Consumer protection The Toys and Cosmetic Products (Restriction of Chemical Substances) Regulations 2022
July 2023 PERSONAL CARE
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