November monthly roundup

EU

Thiomersal & Phenylmercuric salts – SCCS preliminary Opinion on mercury-based preservatives

Regulatory context

Mercury and its compounds are generally prohibited in cosmetics under Annex II (entry 221) of Regulation (EC) No 1223/2009. Two exceptions still exist in Annex V (preservatives list):

• Thiomersal (entry 16)
• Phenylmercuric salts (including borate) (entry 17)

Due to the severe health risks associated with mercury, the European Commission asked the SCCS to reassess the safety of cosmetic eye products.

Key scientific conclusions (preliminary)

• The SCCS assessed renal toxicity as the most sensitive endpoint.
• The Margin of Safety (MoS) is below 100, indicating an unacceptable safety margin at the currently permitted concentrations.
• Genotoxicity data remain unclear, further adding to concerns.
• Result: Thiomersal and Phenylmercuric salts are not considered safe at the current authorised levels in cosmetic eye products.
• The potential risk is aggravated by additional mercury exposure from non-cosmetic sources.

Timeline & next steps

• Opinion status: Preliminary.
• Comment period open until 21 January 2026.
• Post-comment, a final SCCS Opinion is expected, potentially leading to the restriction or removal of these exceptions in Annex V.

Impact for brands

• Eye products using these preservatives are under severe regulatory pressure.
• Early reformulation planning away from mercury-based systems is strongly advisable.

Cannabidiol (CBD) – SCCS preliminary Opinion sets first EU safety limits

Regulatory context

Cannabidiol (CBD) (CAS 3956-29-1) is a cannabinoid widely used in cosmetics, listed in CosIng as skin conditioning, skin protecting, antioxidant, anti-sebum, etc.

Given limited safety data, the SCCS launched a call for data (Jun 2023–Sep 2024) and has now issued a preliminary Opinion.

Key safety conclusions

• CBD is considered safe up to 0.19% in dermal and oral cosmetic products (used alone or together).
• THC impurities are considered safe up to 0.00025% in dermal and oral cosmetics.
• The Opinion does not cover inhalation exposure (no assessment of sprays/aerosols that could lead to lung exposure).

Timeline

• Opinion status: Preliminary.
• Comment period open until 21 January 2026.

Impact for brands

• Provides a clear reference concentration (0.19%) for CBD in EU-compliant formulations.
• Brands must verify:
• CBD level in finished products, and
• THC content in CBD raw material remains ≤ 0.00025%.
• Inhalable formats still sit in a regulatory grey area.

BHA (Butylated Hydroxyanisole) – SCCS preliminary Scientific Advice on suspected endocrine disruptor

Regulatory context

BHA (INCI: Butylated Hydroxyanisole, CAS 25013-16-5) is used as an antioxidant and fragrance ingredient, and is not currently regulated under Regulation (EC) No 1223/2009.

Because of suspected endocrine-disrupting properties, the Commission mandated that the SCCS evaluate its safety, in parallel with the previous assessment of BHT.

Key conclusions (preliminary Advice)

• The SCCS considers BHA safe at concentrations up to 0.07% in leave-on and rinse-off dermal cosmetic products.
• The assessment covers dermal exposure only. It does not apply to:
• Oral care products, or
• Products that may expose the lungs via inhalation (sprays, mists, aerosols).
• Environmental aspects are outside the mandate and were not assessed.

Timeline

• Status: Preliminary Scientific Advice.
• Comment period open until 19 January 2026.

Impact for brands

• If your current formulas use BHA above 0.07%, downward adjustment or substitution should be considered.
• Expect future regulatory alignment (e.g., Annex III/Annex V style restrictions) based on the final SCCS position.

UK

4. Hexyl Salicylate – GB SAG-CS and EU SCCS converge on safe-use levels

Regulatory context in GB

Hexyl Salicylate (CAS 6259-76-3) is a fragrance ingredient classified as CMR Category 2 under the GB CLP Regulation and included in the GB Mandatory Classification and Labelling (MCL).

Industry requested an exemption from a full cosmetics ban, prompting an assessment by the Scientific Advisory Group on Chemical Safety (SAG-CS).

GB SAG-CS conclusions

Hexyl Salicylate is considered acceptable for use at the following maximum concentrations:

• Adults & children ≥ 3 years:

• Hydroalcoholic-based fragrances (spray & non-spray): 2%
• All rinse-off products: 0.5%
• All leave-on products: 0.3%
• All oral care products: 0.001%

• Children 0–3 years:

• 0.1% in: shower gel, hand soap, shampoo, hair conditioner, body lotion, face cream, hand cream, lipstick/lip balm, fragrance products
• 0.001% in toothpaste

The SAG-CS notes that data for children ≥3 years remain limited and recommends a more detailed risk assessment once better data and methodology are available.

EU SCCS & Omnibus 8 alignment

The SCCS issued a similar Opinion, and the Commission has included Hexyl Salicylate in the draft 8th CMR Omnibus Regulation, applicable from 1 May 2026, with essentially the same limits but more detailed product categories (including mouthwash at 0.0001%) and explicit conditions for children under 3.

Impact for brands (GB & EU)

• Hexyl Salicylate can remain in use but is now under tight concentration limits, especially for children’s products and oral care.
• Harmonised limits between GB and EU will require coherent reformulation and labelling strategies for brands selling in both markets.

Great Britain – Draft measure on 4-MBC, 16 CMRs, and formaldehyde releasers

Regulatory context

On 31 October 2025, Great Britain notified a draft regulation that will amend how the EU Cosmetics Regulation 1223/2009, as retained in GB law, applies in England, Wales, and Scotland.

Key measures

Full ban on UV filter 4-MBC (Enzacamene)

• INCI: 4-Methylbenzylidene Camphor
• Included in Annex II (prohibited substances), entry 1744.
• GB timings:
• Applicable to products placed on the market from 15 July 2026
• Applicable to products made available on the market from 15 January 2027
• EU comparison: Regulation (EU) 2024/996 already bans 4-MBC from 1 May 2025 (placed) and 1 May 2026 (made available).

Addition of 16 CMR substances to Annex II

• Only one substance has an INCI name:
• Trimethylbenzoyl Diphenylphosphine Oxide (TPO).

• GB timings for the CMR with INCI (TPO):
• Ban on products placed on the market from 15 August 2026
• Ban on products made available on the market from 15 February 2027
• EU comparison: TPO is already prohibited by Regulation (EU) 2025/877 as of 1 September 2025.

Lowering the labelling trigger for formaldehyde releasers

• The preamble to Annex V (preservatives) will be amended to require the warning “releases formaldehyde”on finished products containing Annex V preservatives that release formaldehyde when the free formaldehyde level exceeds 0.001% in the finished product.

• GB timings:
• Applies to products placed on the market from 15 July 2026
• Applies to products made available on the market from 15 January 2027
• EU comparison: The equivalent rule under Regulation (EU) 2022/1181 has applied since 31 July 2024(placed) and will apply from 31 July 2026 (made available).

Impact for brands

• Brands operating in both the EU and GB must manage slightly different yet converging timelines, with the EU generally leading earlier.
• Action points:
• Confirm removal of 4-MBC from UK-specific formulas by mid-2026.
• Screen all ingredients against the new CMR Annex II list, particularly TPO.
• Ensure formaldehyde content from releasers is measured and appropriately labelled at the new 0.001% threshold.

Canada

Proposed updates to the Cosmetic Ingredient Hotlist (public consultation)

Regulatory context

Health Canada has opened a 60-day public consultation on a new set of proposed amendments to the Cosmetic Ingredient Hotlist, following a notice to stakeholders issued in May 2025.

The Hotlist serves as Canada’s key risk management tool for substances that are prohibited or restricted in cosmetics.

Key proposed additions

Basic Violet 4

• Not permitted in leave-on hair products.
• Allowed at:
• 0.4% in hair dye products
• 0.2% in rinse-off hair care products

Basic Blue 7

• Not permitted in leave-on hair products.
• Allowed at:
• 0.4% in hair dye products
• 0.2% in rinse-off hair care products
• 0.8% in nail products
• 2% in bath products

Polyaminopropyl Biguanide (PAPB)

• Not permitted in spray or aerosol formulations.
• Allowed at up to 0.2% in other cosmetics.

Key proposed revisions

Symphytum spp. (comfrey)

• Due to new data on echimidine, a hepatotoxic alkaloid, Health Canada proposes removing the exception for Symphytum officinale.
• As a result, all Symphytum species and derivatives would be prohibited.

Brucine and its salts

• Because of neurotoxic properties, Health Canada proposes to entirely prohibit brucine and potentially extend the ban to its salts (e.g., brucine sulfate).

Imperatorin

• The standalone entry would be deleted, and the substance would be included under the broader furocoumarins entry.

Furocoumarins

• Proposed change: Furocoumarins would not be allowed as intentionally added ingredients.
• They would be permitted only at trace levels when naturally occurring in plant extracts, with limits such as:
• 0.0001% (1 ppm) in leave-on products when naturally present
• Rinse-off products are allowed only for naturally occurring trace levels (no intentional addition).

Impact & next steps for brands

• This consultation is a critical opportunity to provide scientific and technical feedback, especially for brands using:
• Cationic colourants in hair, nail, or bath products,
• PAPB as a preservative,
• Plant extracts that may contain furocoumarins or comfrey derivatives.

• Companies should:
• Map potentially impacted SKUs in the Canadian market,
• Prepare data or justification where necessary,
• Begin scenario planning for reformulation or portfolio adjustment, depending on the final Hotlist wording.

Previously announced regulatory changes to keep an eye on:

Siloxanes – Cyclopentasiloxane (D5) & Cyclohexasiloxane (D6)

The upcoming restriction will limit D5and D6 to max. 0.1% in all cosmetic products.

• Off-shelf deadline (sell-through): 6.6.2027
  Brands still using volatile silicones should begin phase-out planning now — but there is still sufficient time to reformulate ahead of the 2027 off-shelf date.

Retinoids – Retinol, Retinyl Acetate, Retinyl Palmitate

EU restrictions and new labelling requirements will apply under the Annex III update.

• Placing on the market: 1 November 2025
• Off-shelf / made available: 1 May 2027
  Given the long transition period, brands still have time to adjust concentrations, update labels, and manage artwork pipelines before products must fully comply.