
Recent regulatory buzz around cosmetics in Europe and the UK is broad-ranging. Activities include the addition of 64 substances (8 INCIs) to the UK CMR list, kojic acid's listing in the UK's Annex III, and the World Trade Organization's (WTO's) notification of an amendment to the UK Cosmetics Regulation to include restrictions on methyl salicylate use levels. There are also updates on PFAS, the ruling restricting PFHXA in cosmetics, and a German chemical association's pushback against the European Commission president's proposal to simplify REACH, among others. Following is brief overview, including comments from the CTPA's Director-General Emma Meredith, Ph.D., and Mojgan Moddaresi, Ph.D., Pharm.D., technical manager of the Personal Care Regulatory consultancy.
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Recent regulatory buzz around cosmetics in Europe and the UK is broad-ranging. Activities include the addition of 64 substances (8 INCIs) to the UK CMR list, kojic acid's listing in the UK's Annex III, and the World Trade Organization's (WTO's) notification of an amendment to the UK Cosmetics Regulation to include restrictions on methyl salicylate use levels. There are also updates on PFAS, the ruling restricting PFHXA in cosmetics, and a German chemical association's pushback against the European Commission president's proposal to simplify REACH, among others. Following is brief overview, including comments from the CTPA's Director-General Emma Meredith, Ph.D., and Mojgan Moddaresi, Ph.D., Pharm.D., technical manager of the Personal Care Regulatory consultancy.
8 INCIs Named CMRs, Kojic Acid Added to Annex III
Per the Cosmetic, Toiletry and Perfumery Association (CTPA), in December 2024, the Office for Product Safety and Standards (OPSS) published its Statutory Instrument (SI), "‘The Cosmetic Products (Restriction of Chemical Substances) (No. 2) Regulations 2024." This instrument added 64 substances to the mandatory classification of carcinogen, mutagen and reprotoxic (CMR) — under the GB Classification, Labelling and Packaging (CLP) Regulation — to Annex II of the UK Cosmetics Regulation (UKCR). The SI will come into force on Jan. 31, 2025, and includes the following 8 INCI names.
- Methylene di-t-butylcresol (CMR 1B) – Annex entry 1681
- Methyl isobutyl ketone (MIBK) – Annex entry 1691
- Benzophenone – Annex entry 1704
- Theophylline – Annex entry 1706
- Trimethylolpropane triacrylate – Annex entry 1712
- Margosa (Azadirachta indica) extract (from the kernels of Azadirachta indica extracted with water and further processed with organic solvents) – Annex entry 1722
- Melamine – Annex entry 1730
- Dimethyltolylamine – Annex entry 1740
For ingredients 1-7, the "placing on the market" deadline is April 20, 2025, and the "making available" deadline (off shelf) is Oct. 20, 2025. For ingredient 8, the "placing on the market" deadline is Sept. 2, 2025, and the "making available" deadline (off shelf) is March 2, 2026.
Kojic acid, previously restricted in face and hand products for skin brightening up to 1%, also was added to Annex III of the UKCR. The "placing on the market" deadline is June 20, 2025, and the "making available" deadline (off shelf) is Nov. 1, 2025.
CTPA Clarifies, Provides Context on CMR, Kojic Acid Moves
Emma Meredith, Ph.D., director general of the CTPA, provided some clarity and context on these moves:
The UK Statutory Instrument, ‘The Cosmetic Products (Restriction of Chemical Substances) (No. 2) Regulations 2024,’ is a piece of UK legislation that has followed action being taken under the GB Classification, Labelling and Packaging (CLP) Regulation and an independent review of kojic acid by the UK’s scientific committee, SAG-CS (Scientific Advisory Group on Chemical Safety of Non-food and Non-medicinal Consumer Products).
The action follows similar reviews and actions taken in the EU under the EU CLP Regulation and a review of kojic acid by the EU Commission’s independent scientific committee, the SCCS (Scientific Committee on Consumer Safety). We therefore were expecting this action in the UK, as while the UK has its own procedure for ingredient review both under CLP and general ingredient safety, we have seen that in the initial period post-Brexit the UK has looked at the same chemicals that have recently been under review at an EU level.
CTPA works with both the regulators and the industry when any ingredients are under review in the UK in order that any submissions to support the use of ingredients meet the authorities’ needs.
The substances being banned, by being added to Annex II of the UK Cosmetics Regulation, under this SI have also been banned at an EU level. The UK and EU Cosmetics Regulations contain a direct link to the GB and EU CLP Regulations. If a cosmetic ingredient receives a CMR classification under CLP, the cosmetics industry must prepare a safety dossier for review by the authorities to permit the ingredient’s continued safe use in cosmetics. In many cases, including for the ingredients added to Annex II by this new SI, there is not sufficient interest in the continued use of these ingredients to warrant the industry preparing the legally required dossier. As I am sure you are aware, the CMR classification process under the CLP Regulation is solely based on the hazardous properties a substance might have under a "worst case" situation.
... [And] although 64 substances have been classified as CMR substances in the recent action, the eight that we highlight are the only ones that have an INCI (International Nomenclature of Cosmetic Ingredients), and have not been supported by industry, therefore banned in the UK (and EU) by being added to Annex II of the respective Cosmetics Regulations. The other substances are chemicals that would not be used in cosmetics.
For kojic acid, the EU SCCS and UK SAG-CS opinions on kojic acid both conclude it to be safe to use at 1% in face and hand products. Kojic acid has already been added to Annex III of the EU Cosmetic Products Regulation for these uses, and the UK SI now adds kojic acid to Annex III of the UK Cosmetics Regulation.
Kojic Acid: Not Banned but Restricted, Deadlines Differ and Derivatives Not Included
Mojgan Moddaresi, Ph.D., Pharm.D., of the Personal Care Regulatory consultancy, underscored that kojic acid is not banned but will be restricted in both the EU and UK based on different deadlines.
[The updates on] kojic acid is especially hot news. Since many of our brands use it, after we shared the news, they came back with more questions. In the UK, kojic acid was added to Annex III (as an ingredient to be used with restrictions) but not banned. The ‘placing on the market’ deadline is June 20, 2025; the ‘making available’ deadline (off shelf) is Nov. 1, 2025.
However, in the EU, it is restricted to the same level but with different deadlines: From Feb. 1, 2025, cosmetic products containing the substance and not complying ... shall not be placed on the European Union market. From Nov. 1, 2025, cosmetic products containing the substance and not complying with the conditions shall not be made available on the European Union market.
It is important to bear in mind that only the topical use of kojic acid in cosmetics has been considered in the Opinion. As far as the derivatives of kojic acid are concerned, e.g., esters of kojic acid such as kojic acid dipalmitate and kojic acid isopalmitate, and derivatives such as chloro-kojic acid, these have not been included in the Opinion, as no data has been submitted.
Both scientific committees (the SAG-CS in the UK and SCCS in Europe) did not consider kojic acid to be an endocrine disrupter at up to 1% for face and hand cream applications.
WTO Notified of Methyl Salicylate Restrictions
The CTPA also reported, on Jan. 20, 2025, the OPSS notified the WTO of an amendment to the UKCR updating Annex III to include the new restriction to methyl salicylate. According to the source, the Annex III entry for methyl salicylate is proposed as follows:
- For rinse-off skin and hair products (except hand wash products), limits of 0.02% for products intended for children 0.5-1 years and 0.06% for products intended for children above one year and adults;
- In hand wash products, limits of 0.02% in products for children 0.5-1 years and 0.6% in products intended for children above one year and adults;
- For leave-on skin products (except face make-up, spray/aerosol body lotion, spray/aerosol deodorant and hydroalcoholic-based fragrances) and hair products (non-aerosol), limits of 0.02% for products intended for children 0.5-1 years and 0.06% for children above one year and adults;
- In lipsticks and lip balm, limits of 0.02% for products intended for children 0.5-1 years and 0.03% for children above one year and adults;
- For face make-up products, a limit of 0.05%;
- In eye make-up products and make-up removers, a limit of 0.002%;
- For toothpaste, 2.5%;
- In mouthwash, limits of 0.1% for products intended for children six to 10 years and 0.4% in products for children above 10 years and adults;
- For mouth sprays, 0.65%;
- For hydroalcoholic-based fragrances, 0.6%;
- In deodorant spray/aerosol products, a 0.003% limit;
- In hair products (spray/aerosol), 0.009%; and
- For body lotion spray, 0.04%.
The proposed "placing on the market" deadline is Sept. 30, 2025, and "making available on the market (off-shelf)," March 31, 2026. The draft legislation is reportedly open for comments for 60 days from the date of notification.
PFAS Update — Proposed Ban, PFHXA Restriction
Reuters recently highlighted the EU's proposed ban on PFAS (aka forever chemicals) in consumer products. The source emphasized the broad array of applications and industries that use PFAS, which in and of itself is a family of thousands of materials. Reuters added that work by the European Chemicals Agency (ECHA) to assess the scope of the proposed ban has drawn thousands of comments; more than 5,600, according to a collective progress update on the PFAS restriction process.
As of ECHA's December 2024 update, discussions took place and provisional conclusions were drawn for the "consumer mixtures, cosmetics and ski wax" sector in March and June of 2024 but no final conclusions have been announced. The anticipated schedule outlines gathering the opinion of committees and making a decision that would enter into force in 2025, with imposed restrictions in effect by 2026-2027; follow along as we watch for these updates.
In the meantime, in September 2024, in its latest PFAS-related move, the European Commission restricted undecafluorohexanoic acid (PFHxA) and related substances under the REACH regulation, which affects consumer textiles, food packaging, cosmetics and certain firefighting foams.
Chemical Industry Challenges EC's Proposal to Simplify REACH
Finally, in November 2024, the German chemical association VCI (Verband der Chemischen Industrie e.V. Wir gestalten Zukunft) issued a statement responding to political guidelines proposed in September 2024 by Ursula von der Leyen, president of the European Commission, to simplify REACH, among other measures, to create a more circular and resilient economy. “We will put forward a new chemicals industry package, aiming to simplify REACH and provide clarity on 'forever chemicals, or PFAS," she stated.
Per VCI, von der Leyen and her political guidelines additionally state:
- “We need to make business easier and faster in Europe;”
- “I will make speed, coherence and simplification key political priorities in everything we do;” and
- “Each Commissioner will be tasked with focusing on reducing administrative burdens and simplifying implementation: less red tape and reporting, more trust, better enforcement, faster permitting.”
The association urged the new commission to make no quick decisions on a REACH revision, and to fundamentally question the concepts originally proposed under its chemical strategy, such as the generic risk approach, mixture assessment factor and the proposed blanket ban on PFAS. "The REACH regulation is well-functioning and sets the highest safety standards worldwide," VCI wrote, adding that quality must take precedence over speed, with "thorough involvement of the industry concerned as well as wide impact assessments and the new SME competitiveness check."
The association furthered that generalized and blanket approaches are not simplifications for companies. "Quite the contrary, they undermine scientific risk assessment and are at the expense of chemical diversity, innovation, competitiveness and planning security and could unduly reduce the participation of companies, e.g., in restriction procedures. This is especially true for the Generic Approach to Risk Management (GRA), the Mixture Assessment Factor (MAF) or the proposed blanket ban on PFAS."