Key Changes in Cosmetic Legislation (EU, UK & US)
This monthly note highlights regulatory changes and guidance from the EU, UK (GB), US, and Canada that landed in August 2025 and may affect your portfolios, labels, safety files, and QA systems. For each item we summarise What is it?, Why it matters, and Application / Impacted products so RA, R&D and QA can align actions quickly. A practical “Immediate actions” checklist follows, and an ADSL services section is included at the end for rapid support with reformulating, testing, documentation and notifications.
CTPA Microbial Quality Management (MQM) guidance update (19 Aug)
What is it? Practical guidance spanning development → manufacture, water systems, and sampling.
Why it matters: Strong GB benchmark for due diligence; supports safety substantiation and PMS narratives.
Application / Impacted products: All categories; revisit preservation strategies, bioburden specs, cleaning validation and sampling plans.
Ingredient deadlines highlighted in August
Methyl salicylate (Annex III update — GB):
- Placing on market: 30 Sept 2025
Making available (sell-through end): 31 March 2026
Benzophenone-3 (UV Filter — GB):
- Placing on market: 21 January 2026
Making available (sell-through end): 21 July 2026
Why it matters: Reformulation, label updates, and de-stock planning are time-critical.
Application / Impacted products: Sun care, fragranced products, and leave-ons where these substances occur.
TPO ban: scope clarified (effective 1 Sept 2025)
What is it? Trimethylbenzoyl Diphenylphosphine Oxide (TPO) is banned via Annex II; Commission Q&A reiterates no sell-through and applies to professional supply.
Why it matters: You must stop placing and stop supplying any TPO-containing cosmetic from 1 Sept 2025.
Application / Impacted products: UV-cured nail systems (gels, builders, top coats) and any UV-cured cosmetics using TPO as a photoinitiator.
Borderline Manual v5.5 (20 Aug)
What is it? Updated Commission guidance on whether products are cosmetics vs other frameworks.
Why it matters: Affects claims, presentation, and device/consumable bundles.
Application / Impacted products: Multi-benefit leave-ons, quasi-medicinal claims, devices with consumables.
Spain: draft accessible labelling (notified 1 Aug; consultation to 23 Sept)
What is it? Proposed Spanish Decree requiring accessible elements (e.g., Braille/QR/tactile locator) and information in Spanish.
Why it matters: May add Spain-specific pack requirements.
Application / Impacted products: All cosmetics marketed in Spain; plan pack variants and QR content if adopted.
MoCRA: keep your house in order (no new rule in August; GMP final due Dec 2025)
What is it? Ongoing obligations for facility registration, product listing, serious adverse event reporting, safety substantiation, and label contact details; FDA cosmetic GMP final rule expected 29 Dec 2025.
Why it matters: Expect audits aligned to ISO-22716-like controls; closing gaps late will be costly.
Application / Impacted products: All cosmetics for the U.S.; higher scrutiny for eye-area, aerosols, talc.
Hotlist: Cannabis/hemp entries amended (6 Aug)
What is it? Health Canada adjusted Hotlist entries to align with Cannabis regulations—terminology/scope clarifications.
Why it matters: Reduces ambiguity when screening hemp-derived materials.
Application / Impacted products: Any cosmetics using Cannabis spp. derivatives (e.g., seed oils, proteins).
Immediate actions (August → September)
- EU (TPO): Stop EU supply of TPO-containing SKUs; switch photoinitiators; update PIF/CPSR/CPNP and artwork by 1 Sept 2025.
- GB: Lock methyl salicylate formulas/labels by 30 Sept 2025; complete sell-through by 31 Mar 2026; check BP-3 portfolios.
- US: Verify MoCRA registrations/listings; run a GMP gap-assessment; refresh SAER SOPs and safety files.
- Canada: Re-screen hemp/Cannabis ingredients against the amended Hotlist; update PIFs accordingly.
How ADSL Can Help
- Regulatory strategy & screening — Portfolio audits for restricted/ban-listed ingredients (e.g., TPO, methyl salicylate, BP-3), cross-market deltas (EU/GB/US/Canada), and risk-ranked remediation plans (timelines & stock-down).
- Reformulation support — Photoinitiator swaps and alternatives; preservation strategy refresh (incl. water activity & water systems); compatibility, stability, scale-up, and change-control documentation.
- Testing & substantiation — Stability & pack-compat, microbiology, PET/challenge tests; claims studies (performance/consumer), label checks, and substantiation summaries.
- Safety & documentation — CPSR updates, exposure recalcs, tox addenda, PIF maintenance; notifications & listings (CPNP/SCPN) and U.S. MoCRA facility/product listings.
- Quality & GMP — ISO 22716/MQM health-checks, SOPs, water system & cleaning validation, sampling plans; PMS & SAER readiness (workflows, forms, training).
Market-specific support —
US (MoCRA): label contact compliance, safety substantiation files, GMP gap-assessments.
Canada: Hotlist screening & PIF updates.
Spain: accessible-labelling roadmap (artwork, Braille/QR, Spanish content).
📩 Need help interpreting or applying these changes?
Contact your ADSL project lead or email us at [email protected]
ADSL – Advanced Development & Safety Laboratories
Technical Team | Paignton, UK
