August monthly roundup

EU

TPO ban clarity after confusion

The European Commission has now officially banned TPO (Triphenyl Phosphine Oxide) in cosmetics, effective 1 September 2025, through Regulation (EU) 2025/877. This follows its classification as a CMR 1B substance (toxic for reproduction) under the 21st ATP of the CLP Regulation.

A five-year timeline

• Aug 2020: Sweden proposed a harmonised classification of TPO as Rep. 1B (H360Fd).
• Sept 2021: RAC confirmed classification. The industry had the chance to defend itself, but did not.
• Jan 2024: Delegated Regulation (EU) 2024/197 formalised the classification.
• May 2025: Regulation (EU) 2025/877 amended the Cosmetics Regulation to include TPO in Annex II (prohibited substances).

From that moment, the ban became inevitable. Despite the long lead-up, confusion remained in the market, with many operators appearing surprised by the short three-month transition window.

Clarifications from regulators

• The French DGCCRF (4 July 2025) published a communiqué explaining the consequences and urging companies to take action.
• European Commission (7 August 2025): issued an FAQ after receiving numerous queries from national authorities, trade associations, and companies.

The key points:

• Scope: Ban applies to placing on the market (manufacturing, imports, first distribution) and making available on the market (wholesale, retail, B2B, salons).
• Professional use: Nail technicians are not permitted to use TPO gels in salons, even if they were purchased previously. Consumers who already own such products may continue to use them privately, although strongly discouraged.
• No sell-through period: Stocks must be removed from sale and professional use by 1 September 2025. Unlike microplastics (banned under REACH with long transition periods), the Cosmetics Regulation prioritises  immediate health protection.
• Polymerised gels: Even though fully cured gels may not pose exposure risks, the ban applies regardless. Only a new SCCS evaluation could exempt TPO, but none was submitted.
• Industry impact: SMEs and nail salons are most affected, with sudden withdrawal and no stock use-up. The Commission acknowledges the rigidity but states that until the Cosmetics Regulation revision is approved, there is no flexibility.

Takeaway: This is not unexpected news—companies had ample time since 2020—but it is now a hard stop: from 1 September 2025, TPO is banned in all forms of cosmetic use in EU. It is likely that TPO will be banned in UK early 2027.

Ukraine-Draft Resolution to align with EU Cosmetics Regulation

Ukraine continues its path toward EU regulatory harmonisation, updating its Technical Regulation on Cosmetic Products to align with Regulation (EC) 1223/2009.

Main changes

1. Labelling
   • INCI names no longer need to be translated into Ukrainian.
   • Packaging rules clarified:
     • If only primary packaging is used, all required labeling elements must appear on it.
     • If secondary packaging is present, → INCI list is only required on secondary packaging.
2. Annexes update
   • Amendments to Annexes 2–6 to reflect the latest EU safety standards, including CMR prohibitions, restrictions, preservatives, UV filters, and colourants.
   • Transitional provisions were introduced for substances newly regulated.
3. Consultation process
   • Draft open for public comment until 28 September 2025.
   • Adoption date still pending.

Implications: For companies exporting to Ukraine, this represents a significant step towards regulatory convergence with the EU, simplifying compliance for brands already aligned with Regulation 1223/2009.

UK

HSE Opinions on Tea Tree Oil, HEMA, and HPMA

The UK’s Health and Safety Executive (HSE) continues its alignment with EU classification work, albeit with nuances, by publishing new opinions on three key cosmetic-related substances.

HEMA (2-Hydroxyethyl Methacrylate)

• Function: nail sculpting (CosIng).
• Proposed classification:
  • STOT SE 3 (respiratory irritation ≥10%).
  • Skin Irrit. 2 – Causes skin irritation.
  • Eye Irrit. 2 – Causes eye irritation.
  • Skin Sens. 1 – May cause an allergic reaction.
  • Note D – must be labelled as “non-stabilised” if sold unstabilised.
• Aligned with ECHA RAC’s Dec 2023 Opinion.
• Industry implications: highlights the need for stronger hazard communication in nail salons and stricter handling procedures for nail technicians.

HPMA (Hydroxypropyl Methacrylate)

• Function: film forming.
• Similar classification to HEMA: respiratory irritant, eye irritant, sensitiser.
• Note D requirement also applies.
• Implications: Increased safety requirements for use in coatings, adhesives, and nail gels.

Tea Tree Oil (Melaleuca alternifolia)

• Widely used for fragrance, antioxidant, and antimicrobial claims.
• HSE proposed classification includes:
  • Flammable liquid.
  • Harmful if swallowed or inhaled.
  • Skin irritant, sensitiser.
  • Aspiration hazard.
  • Aquatic toxicant (acute and chronic).
• Notably, HSE diverges from RAC: RAC proposed adding reproductive toxicity (H360F, H360d), but HSE is withholding classification pending new studies and clarification of exposure routes.
• Implications: Tea tree oil remains a controversial ingredient. If further data confirms reproductive risks, restrictions or bans may follow.

Takeaway: Nail-related methacrylates face reinforced hazard recognition, while Tea Tree Oil remains under scientific debate, with future restrictions possible.

USA/CANADA

Triphenyl Phosphate (TPhP) under scrutiny

The California Department of Toxic Substances Control (DTSC) is moving to regulate nail products containing Triphenyl Phosphate (TPhP) at concentrations >250 ppm.

Proposal

• Nail polishes, coatings, and artificial nails with TPhP would be listed as Priority Products under California’s Safer Consumer Products (SCP) programme.
• Manufacturers selling into California would be required to:
  • Conduct Alternatives Analysis to determine if TPhP is necessary.
  • Identify safer substitutes to reduce worker/consumer exposure.

Why?

• TPhP is used as a plasticiser but is linked to endocrine disruption and potential reproductive toxicity.
• Nail salon workers face heightened exposure, raising occupational health concerns.

Next steps

• Public consultation open until 22 September 2025.
• If adopted, this will drive a shift in the market towards green chemistry alternatives.

Implications: With both the EU and California moving against TPhP, global manufacturers must prepare to phase it out of nail products.

Amendments to the Cosmetic Ingredient Hotlist – Cannabis derivatives

Health Canada has revised the Cosmetic Ingredient Hotlist, further clarifying the scope of cannabis-related prohibitions and restrictions.

What is prohibited?

• All forms of Cannabis plant material and phytocannabinoids, including:
  • THC (delta-9-tetrahydrocannabinol).
  • CBD (Cannabidiol).
  • CBN (Cannabinol).
  • Cannabis sativa flower, leaf, and stem extracts.

What is restricted?

• Certain derivatives exempt under the Cannabis Act remain permitted under conditions:
  • Cannabis sativa seed oil.
  • Hemp seed oil.
  • Hydrolyzed hemp seed protein.
• Condition: products must not contain isolated or concentrated phytocannabinoids or synthetic versions.

Definition of Cannabis under Canadian law

• Broad: covers any part of the plant and any phytocannabinoid, regardless of extraction method.
• Exemptions: non-viable seeds, mature stalks without leaves/seeds/branches, fibres, roots.

Industry impact: CBD-based cosmetics remain strictly prohibited; only hemp seed derivatives are acceptable, provided they are free from cannabinoids. The enforcement focus will be on labeling and claims to ensure compliance.