EU
Regulation (EU) 2026/909: New Restrictions for 12 Cosmetic Ingredients
The European Commission has adopted Regulation (EU) 2026/909, updating the EU Cosmetics Regulation in line with new classifications under the CLP Regulation.
This Omnibus update introduces simultaneous changes across Annex II, III, IV, V and VI, impacting key ingredient categories: UV filters, fragrances, preservatives and colourants.
What to do now
- Audit formulations against updated Annexes
- Update PIFs and CPSRs
- Review labelling requirements (Annex III)
- Confirm transition timelines per ingredient
This update requires a full portfolio review, not isolated checks.
4-MBC, Silver and Hexyl Salicylate: Full Enforcement from 1 May 2026
A critical regulatory milestone is approaching under Regulation (EU) 2026/78, with full enforcement on 1 May 2026 and no sell-through period in the EU.
The most immediate impact concerns 4-Methylbenzylidene Camphor (4-MBC), a UV filter that has already been banned but now reaches its final compliance stage. From May 2026, any remaining products containing 4-MBC must be completely withdrawn from the EU market, with no exceptions. This represents a strict enforcement scenario where non-compliant stock cannot remain in distribution channels.
Silver introduces a more technically complex situation. The regulation establishes a particle-size-based framework, fundamentally changing how this ingredient is assessed. Both nano silver (1–100 nm) and massive silver (≥1 mm) are now prohibited. However, micron-sized silver (100 nm–1 mm) remains permitted under strict conditions: up to 0.05% in oral care products and up to 0.2% when used as a colourant (CI 77820) in lip and eye products.
The key compliance challenge here is not only concentration, but physical characterisation. Without precise particle size documentation included in the PIF, it is impossible to demonstrate whether the ingredient falls under a permitted or prohibited category. This makes supplier data and analytical verification critical regulatory tools.
For Hexyl Salicylate, the regulation introduces a structured restriction under Annex III, with a maximum concentration of 2% in hydroalcoholic fragrance products, alongside additional limits depending on product category. Particular attention is required for products intended for children under 3 years, where stricter conditions apply.
From an operational standpoint, companies must act immediately to:
- Remove non-compliant products from the EU market
- Reformulate products exceeding new thresholds
- Update safety documentation and labelling
- Communicate changes across distribution channels
Micron-Sized Silver: SCCS Reverses Its Position
In April 2026, the Scientific Committee on Consumer Safety published its final opinion (SCCS/1687/25), marking a significant shift in the regulatory landscape for silver.
Contrary to its 2024 conclusion, the SCCS now considers micron-sized silver safe at concentrations up to 0.2% in rinse-off products and 0.3% in leave-on products, based on new evidence demonstrating no dermal penetration through intact human skin.
This revision has direct regulatory implications, as it underpins the permissions granted under Annex III and IV in Regulation (EU) 2026/78. However, the opinion explicitly excludes spray and aerosol formats, where inhalation exposure remains unassessed. As a result, silver in inhalable formats currently has no safety basis in the EU.
Cannabidiol (CBD): Clear Safety Thresholds Established
The SCCS has also finalised its opinion on Cannabidiol (SCCS/1685/25), establishing for the first time clear and harmonised safety limits for its use in cosmetics.
CBD is considered safe at 0.19% in both dermal and oral cosmetic products, with a strict impurity limit for delta-9-THC set at 0.00025% (2.5 ppm). This dual requirement introduces a new level of scrutiny for suppliers, who must now provide robust certificates of analysis confirming THC compliance.
Importantly, the opinion excludes all inhalable formats, meaning sprays, aerosols, and powders fall outside the scope of safe use. Until further assessment is conducted, CBD should not be used in such formats within the EU.
BHA: Safety Confirmed at Lower Concentrations
The SCCS has confirmed that Butylated Hydroxyanisole (BHA) is safe at a maximum concentration of 0.07% in dermally applied cosmetic products, both leave-on and rinse-off.
This conclusion addresses previous concerns regarding potential endocrine-disrupting properties, which were not considered relevant at this concentration level. However, the opinion does not cover oral care or inhalation exposure, leaving regulatory uncertainty for those applications.
For formulators, this represents a significant reduction compared to historical usage levels, requiring careful reformulation and validation to ensure that antioxidant performance is maintained at lower concentrations.
Methylparaben: Under Strategic Review
Methylparaben remains authorised under current limits (0.4% single, 0.8% mixture), but its inclusion in the CoRAP evaluation under REACH signals increased scrutiny.
The evaluation focuses on endocrine disruption and cumulative exposure, considering not only cosmetics but also pharmaceuticals and food sources. While no immediate changes are required, the outcome could lead to future classification or restriction, making it essential for companies to begin exploring alternative preservation strategies.
Canada: Fragrance Allergen Labelling Now in Force
Canada has officially implemented Phase 1 of its fragrance allergen disclosure requirements as of 12 April 2026, aligning closely with the EU framework.
Cosmetic products must now declare 24 specific fragrance allergens individually when present above:
- 0.01% in rinse-off products
- 0.001% in leave-on products
The use of generic terms such as “fragrance” or “parfum” is no longer sufficient.
Looking ahead, Phase 2 will expand the list to 81 allergens from 1 August 2026 for new products, with a final compliance deadline of August 2028 for existing products.
Health Canada has adopted a progressive enforcement approach, focusing on compliance support until April 2027, after which risk-based enforcement will apply.
