May regulatory roundup

EU NEWS

EU Notifies the 8th CMR Regulation – Enforcement from May 2026

On 22 May 2026, the European Commission notified the draft for the 8th annual update of the CMR Regulation, aligned with the 22nd ATP of the CLP (EU 2024/2564). This regulation will apply from 1 May 2026 and includes:

  • 16 new substances were added to Annex II (Prohibited list), such as N, N’-Methylenebisacrylamide.
  • Silver: Prohibited in massive and nano forms; permitted in powder form at 0.05% (toothpaste & mouthwashes) and 0.2% (lip/eye products).
  • Hexyl Salicylate: Added to Annex III with strict concentration limits depending on product type and age group.
  • Sodium o-Phenylphenate: Now authorized as a preservative in Annex V, with max limits aligned with o-Phenylphenol.
  • Perborates: Merged and redefined for clarity.
  • It applies fully across all EU Member States as of 1 May 2026.

EU Publishes the 7th CMR Regulation – Effective September 2025

The 7th CMR Regulation (EU) 2025/877 has been officially published and will apply from 1 September 2025.

Key takeaways:

  • Twenty-one substances newly classified as CMRs are added to Annex II (the Prohibited List).
  • Includes Trimethylbenzoyl Diphenylphosphine Oxide and Dimethyltolylamine, which are now banned despite previously being authorized.
  • No defense dossiers were submitted for the relevant substances.

This marks another clear move by the EU toward stricter safety control on CMR-classified ingredients.

SCCS Final Advice: Methyl Salicylate in Children’s Products

After revising exposure estimates for children, the SCCS has issued final guidance on Methyl Salicylate (Wintergreen oil).

Final limits for children 0–3 years:

  • 0.4% in toothpaste
  • 0.02% in all other cosmetic products

SCCS reinforces the importance of careful aggregate exposure evaluation in early-age formulations.

SCCS Final Opinions: Butylparaben & Salicylic Acid in Kids

In response to industry data on endocrine disruption concerns, the SCCS has published updated conclusions:

Butylparaben (preservative)

  • Not safe at 0.14% in combined uses for children 0.5–10 years.
  • Safe if reduced to:
  • 0.002% in leave-on
  • 0.092% in oral care
  • 0.14% in rinse-off (standalone use)

Salicylic Acid

  • Not safe at current allowed levels in multiple product categories.
  • Safe if reduced to:
  • 0.5% rinse-off
  • 0.15% leave-on
  • 0.1% oral care

Note: These opinions only apply to children aged 3 years and above and exclude spray formats.

CANADA NEWS

Canada’s Hotlist: Major Changes on the Horizon

Health Canada has announced upcoming amendments to the Cosmetic Ingredient Hotlist, providing the industry with time to prepare before the official 60-day consultation period.

New additions include:

  • Basic Violet 4 & Basic Blue 7: Restricted due to carcinogenic concerns.
  • Polyaminopropyl Biguanide: Limited use with inhalation bans due to sensitization risks.

Revised entries:

  • Symphytum spp.: The current exception for Symphytum officinale will be removed.
  • Brucine: To be entirely banned due to toxicity.
  • Imperatorin: To be added as a furocoumarin.
  • Furocoumarins: Restrictions expanded to all leave-on products.

Under assessment: 12 substance groups like parabens, alcohols, and boric acid.

Regulatory foresight: Companies should now review formulations that are likely to be affected.

UK NEWS

4. GB Notifies Restrictions on Benzophenone-3

Great Britain has opened a 60-day consultation on its plan to restrict Benzophenone-3 based on the SAG-CS scientific opinion.

Proposed limits:

  • 6% for face/lip/hand products (non-sprays)
  • 2.2% for body products (including sprays)
  • 0.5% for other uses (preservative purpose only)

Enforcement schedule:

  • In force: 21 January 2026
  • Sell-through allowed until 31 July 2026

These align with EU restrictions introduced by Regulation (EU) 2022/1176.