Regulatory news: European Union

Packaging and Packaging Waste Regulation applies: cosmetic packaging in scope

In the EU, Regulation (EU) 2025/40 on packaging and packaging waste (PPWR) applies from 12 August 2026, bringing cosmetic packaging within a harmonised framework covering packaging minimisation and eco-design, recyclability requirements, recycled-content targets, restrictions on substances of concern in packaging including PFAS, harmonised labelling, and extended producer responsibility obligations, with a prohibition on certain single-use hotel miniature formats following from 2030. Compliance sits with the packaging rather than the formulation, so it runs alongside, not within, the cosmetic Product Information File; brands should review pack formats, material choices and supplier declarations against the new requirements.

Source: Regulation (EU) 2025/40, EUR-Lex

Expanded fragrance allergen labelling now mandatory for new EU products

In the EU, from 31 July 2026 cosmetic products placed on the market must individually label the expanded list of fragrance allergens established by Regulation (EU) 2023/1545, which raises the number of substances requiring declaration from 24 to more than 80, including natural extracts, where they exceed 0.001% in leave-on or 0.01% in rinse-off products. Products placed on the market before that date may continue to be made available until 31 July 2028. Ingredient lists and artwork for EU products should already reflect the expanded list; where a fragrance compound’s allergen declaration has not been re-obtained from the supplier since 2023, it is now the gating document.

Source: Regulation (EU) 2023/1545, EUR-Lex

Draft EU amendment notified: Omnibus Ingredients III and Omnibus CMR IX combined

The European Commission has notified the WTO of a draft Regulation amending Regulation (EC) No 1223/2009, combining recent SCCS opinions (Omnibus Ingredients III) with the next round of CMR-related prohibitions (Omnibus CMR IX). The draft would prohibit Benzophenone-1, Benzophenone-2, Basic Brown 16, Basic Blue 99, prostaglandins and their analogues, and the mercury-containing preservatives Thimerosal and phenylmercuric salts, and would introduce new restrictions for CBD and BHA alongside updated conditions for Hydroxyapatite (nano), Propylparaben and Butylparaben. Adoption is currently expected in Q4 2026, with the CMR-related prohibitions applying from 1 February 2027. Brands with affected ingredients should begin reformulation planning now rather than waiting for adoption: the direction of travel is settled even where the final text is not.

Provisional agreement reached on faster CMR phase-outs in the EU Cosmetics Regulation

In the EU, the Council and Parliament reached a provisional political agreement on 17 June 2026 on the Omnibus VI simplification package, which amends Regulation (EC) No 1223/2009 alongside the CLP and Fertilising Products Regulations. For cosmetics, the agreement sets faster phase-out timelines for products containing newly classified CMR substances than the Commission had proposed: where a substance is not defended by a derogation request, companies have six months to stop placing affected products on the market and twelve months in total before they may no longer be made available, with defined windows for requesting derogations for essential uses. The agreement also reintroduces nanomaterial notification with a shortened waiting period. The text still requires formal adoption and publication in the Official Journal, but the direction is settled: CMR reclassifications will bite faster, and reformulation planning should assume the compressed clocks.

Source: Council of the EU press release, 17 June 2026

Regulation (EU) 2026/909 in force: four annexes amended on SCCS opinions

In the EU, Commission Regulation (EU) 2026/909, published on 28 April 2026, has taken effect, amending the prohibited, restricted, preservative and UV filter annexes of Regulation (EC) No 1223/2009. Notable changes include a prohibition on Triphenyl Phosphate affecting nail products, new product-specific concentration limits for aluminium compounds across antiperspirants, toothpaste, make-up and hair products, and a 10 ppm impurity limit for DnHexP in the UV filter DHHB. For most affected substances, products placed on the market must comply from 1 January 2027, and non-compliant products must be off the market by 1 July 2028. Formulations containing the affected ingredients should be checked against the new limits and the PIF updated to record the assessment.

Source: Regulation (EU) 2026/909, EUR-Lex

Omnibus VIII applies: silver regulated by particle size, Hexyl Salicylate restricted

In the EU, Commission Regulation (EU) 2026/78 (Omnibus VIII), published on 13 January 2026, applies from 1 May 2026, aligning the Cosmetics Regulation with the CMR classifications of the 22nd ATP to CLP. Silver is now regulated by particle size: nano silver and bulk silver are prohibited, while micrometre-range silver powder remains permitted within strict limits, 0.05% in toothpaste and mouthwash and 0.2% as a colorant in lip products and eye shadow. Hexyl Salicylate, reclassified as CMR Category 2, moves to Annex III with defined concentration limits following SCCS/1668/24. Children’s products are particularly affected, and there is no explicit sell-through provision, so stock in the supply chain needs review, not just new production.

Source: Regulation (EU) 2026/78, EUR-Lex