October monthly roundup

Omnibus VI – Parliament adopts new withdrawal rules for CMR substances

On 22 October 2026, the European Parliament approved the cosmetics section of the Omnibus VI chemicals package, introducing a significant update to Article 15 of Regulation (EC) No 1223/2009, which regulates CMR substances in cosmetics. This amendment directly impacts how regulatory departments and brands must manage reformulation and stock sell-through when an ingredient is newly classified as CMR. The new rules clarify the timeframe companies have to adapt, making it essential to monitor ingredient classifications and prepare compliance strategies in advance.

The prohibition on CMR substances remains unchanged, but the key update concerns the timeline for compliance when a substance receives a new CMR classification. Currently, products containing such ingredients must be withdrawn from the market immediately once the ban is enforced. With the new rules, the withdrawal deadline will vary depending on the company’s chosen regulatory pathway and the outcome of scientific assessments. This change introduces more flexibility but also requires careful planning and prompt action from regulatory teams.

Scenario	Stop placing on the market	Stop making available (sell-through)
No exemption requested	6 months	12 months
Exemption refused on safety grounds	3 months	9 months
Considered safe, but alternatives exist	2 years	3 years

If a company wishes to seek an exemption for a newly classified CMR ingredient, it is now mandatory to submit the exemption request within three months from the date the new classification becomes effective. This short window highlights the importance of proactive ingredient monitoring and having all necessary toxicological and usage data readily available.

What happens next: the Council must formally adopt the text, after which it will be published in the Official Journal and enter into force. Until then, the current rules apply.

What we recommend: keep a watch list of ingredients with pending CLH proposals (for example, those under RAC review). The three-month exemption window is short. Having toxicological data and use information ready in advance will decide whether an exemption request is realistic.

SCCS sets safe limits for acetophenone and heliotropin

Two fragrance ingredients facing classification as Reproductive Toxicity Category 1B now have SCCS final opinions that define safe conditions of use. Without these opinions, both would fall under the automatic ban in Article 15.

Ingredient	SCCS opinion	Safe level	Scope of the conclusion
Acetophenone (CAS 98-86-2)	SCCS/1689/26, final 14 October 2026	100 ppm (0.01%) in the finished product	Only as a trace constituent of natural complex substances (essential oils, absolutes, resinoids); adults and children from 3 years
Heliotropin / piperonal (CAS 120-57-0)	SCCS/1688/26, final 12 October 2026	1.8%	Fine fragrances for adults only

Two points deserve attention. For acetophenone, the SCCS did not assess intentional addition, and it did not evaluate the natural materials themselves, only their acetophenone content. For heliotropin, other product types (including products for children) were not endorsed and would need a new Commission mandate.

These opinions are not yet law. They are expected to feed into the next Omnibus Act on CMR substances.

What we recommend: check formulas against both limits now, especially heliotropin in any product other than fine fragrance. For acetophenone, confirm with suppliers whether it is present via an NCS and at what concentration in the finished product. Our full analysis is available in our post SCCS publishes final opinions on Acetophenone and Heliotropin.

EU upcoming: Omnibus Act IX – new bans expected from 1 February 2027

The draft Omnibus Act IX, notified to the WTO in July 2026, is expected to be adopted in Q4 2026. The CMR-related bans will apply from 1 February 2027, the same date as the underlying classifications in Delegated Regulation (EU) 2025/1222 (23rd ATP to CLP). For the other changes, transitional periods are expected.

New Annex II prohibitions include:

• 11 substances newly classified as CMR under Regulation (EU) 2025/1222. For cosmetics, the most relevant is tetrahydrofurfuryl methacrylate, a monomer used in UV gel nail systems; most of the others (such as ozone or fluoroethylene) are not typical cosmetic ingredients
• Basic Brown 16 and Basic Blue 99 (hair dyes), and prostaglandins and their analogues, found in some eyelash serums (all judged not safe by the SCCS)
• Benzophenone-1 and Benzophenone-2 (potential endocrine-disrupting properties)

Annex III and V changes:

Ingredient	Proposed change
BHA (Butylated Hydroxyanisole)	Max. 0.07% in leave-on and rinse-off products
Cannabidiol (CBD)	Max. 0.19%, with THC ≤ 0.00025% (2.5 ppm) in the finished product
Hydroxyapatite (nano)	Toothpaste 10% → 29.5%; mouthwash 0.465% → 10%
Butylparaben	Separate entry (12b); max. 0.14% retained; no longer allowed in sprayable products
Thiomersal and phenylmercuric salts	Deleted from Annex V; mercury preservative exception removed

What we recommend: screen your portfolio now for Benzophenone-1/-2, BHA above 0.07%, CBD above 0.19%, and butylparaben in sprays. For CMR-linked bans, the 1 February 2027 date leaves very little time for reformulation and relabelling.

 

Sweden signals a new classification process for silver and three silver compounds

On 21 October 2026, ECHA announced Sweden’s intention to start a new harmonised classification and labelling (CLH) process for silver and three of its compounds. At this stage it is only an intention: no proposal has been published and no classification applies.

The context matters for silver users. Massive silver was added to Annex II under Omnibus Act VIII (Regulation (EU) 2026/78, applicable since 1 May 2026). In September, a Commission draft proposed broader permitted uses for porous, sintered silver powder (100 nm–1 mm). Separately, Sweden’s CLH proposal for silver chloride, a preservative allowed at max. 0.004% in Annex V, is already at the opinion-development stage, with Muta. 2 and Repr. 1B among the classifications proposed.

What we recommend: if your products contain silver or silver salts, document the exact form, particle specification and function of each ingredient. A future Repr. 1B classification would trigger Article 15, and with the new Omnibus VI rules, the clock for exemption requests will be short. We will follow the ECHA registry and report when the proposal and its consultation are published.

EU: Regulation 2026/909, D5/D6 restriction and EUDR – key dates

Regulation (EU) 2026/909 – citral now has a concentration limit. From 1 January 2027, non-compliant products can no longer be placed on the EU market (making available ends in mid-2028). The most practical change is for citral, geranial and neral (Annex III, entry 70): limits now range from 0.063% to 1.2% depending on the product category, with 0.15% relevant to many skin care products. Until now, citral was only a labelling allergen. The limit applies to total citral in the finished product, including citral from lemon, lime or lemongrass oils. The same regulation bans triphenyl phosphate in nail products, revises benzyl salicylate limits (0.004%–4%), and sets a 10 ppm limit for the impurity DnHexP in DHHB (Annex VI, entry 28).

D5 and D6 – 6 June 2027. Under Regulation (EU) 2024/1328 (REACH Annex XVII, entry 70), D5 and D6 will be limited to below 0.1% in all cosmetics, including leave-on products. The rinse-off restriction for D6 has applied since 6 June 2026. In practice, this means a phase-out of cyclic silicones in foundations, primers, hair serums and antiperspirants.

EUDR – 30 December 2026. The EU Deforestation Regulation starts to apply to large and medium operators (30 June 2027 for most micro and small operators). Palm-derived ingredients do not automatically bring a finished cosmetic into scope, but supplier traceability information will be requested along the chain.

What we recommend: run a citral calculation on every formula with citrus or lemongrass essential oils, using supplier composition data. Production planned for 2027 should already be compliant.

Sunscreen monograph, MoCRA rulemaking and Washington State

Sunscreen monograph M020 keeps moving. On 10 September 2026, the FDA issued a final order (OTC000008-1) removing PABA (aminobenzoic acid) and trolamine salicylate from the list of permitted sunscreen active ingredients, concluding that their risks outweigh their benefits. This follows the June 2026 order (OTC000039) that added bemotrizinol at up to 6%. The remaining provisions of the 2021 proposed order, including maximum SPF labelling and permitted dosage forms, are still pending and will be the next compliance checkpoint.

MoCRA: what is still open

Facility registration, product listing and serious adverse event reporting (15 business days) are fully in force, and facilities registered in 2024 are now entering the biennial renewal cycle. The fragrance allergen labelling rule required by MoCRA has not been issued; the FDA regulatory agenda lists a proposed rule for November 2026. There is still no date for mandatory GMP rules.

Washington State: formaldehyde releasers from 1 January 2027.

Chapter 173-339 WAC restricts cosmetics containing intentionally added formaldehyde-releasing agents (the proposed rule identified 28 substances) made, sold or distributed in Washington. In-state retailers have until 31 December 2027 to sell existing stock.

What we recommend: for US sunscreens, check formulas and labels for PABA and trolamine salicylate. For brands selling in Washington, screen preservative systems for DMDM hydantoin, imidazolidinyl urea, quaternium-15 and other releasers now, since reformulation and stability testing take months.

USA: MoCRA – FDA finalises guidance on mandatory recalls

On 22 October 2026, the FDA issued the final guidance Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry. It explains how the FDA will use the mandatory recall authority that MoCRA added under section 611 of the FD&C Act. It covers when the FDA may order a recall, the procedure it will follow, and what it expects from companies that receive a recall order. The text is unchanged in substance from the draft published on 18 December 2025. The FDA still expects companies to recall violative products voluntarily first; a mandatory order is the tool for when they do not.

What we recommend: a recall can now be ordered, not only requested, so recall readiness matters more than before. Batch traceability, distribution records and a written recall procedure should be in place before a problem arises, not after an FDA order.

Consultation on high-risk aesthetic procedures.

 The UK Government has proposed banning certain high-risk cosmetic procedures for under-18s and restricting procedures such as liquid BBLs to qualified healthcare professionals. These measures target services, not cosmetic products, but brands supplying the aesthetics sector should follow them.

What we recommend: brands exporting to Indonesia should use the extra time to map ingredient origins and confirm whether existing foreign halal certificates can be recognised by BPJPH. Oral care brands in China should review product codes and efficacy claims against the new catalog before May 2027.