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Regulation & Compliance

EU Omnibus VI halves CMR phase-out to six months; nanomaterial rule stays

EU lawmakers agree to compress CMR substance phase-outs to six and twelve months and reinstate nanomaterial pre-market notifications, drawing a measured welcome from Cosmetics Europe and six partner trade bodies.

By Rebecca Stone · · 4 min read · 801 words

Composition

  1. EU Council and Parliament reached a provisional Omnibus VI agreement on 18 June 2026, halving the Commission's 12/24-month CMR phase-out to 6/12 months.
  2. Companies will have 12 months to file a derogation request after a substance's new CMR classification; derogations denied on safety grounds trigger 3- and 9-month halts, while those denied on alternative availability trigger 24- and 36-month halts.
  3. Pre-market nanomaterial notification was reinstated but with a shortened waiting window versus the original six months.
  4. The seven-organisation industry statement puts the European fragrance, cosmetics and personal care sector at €180 billion in value, €30 billion in exports and 3.5 million jobs.
  5. The text enters force 20 days after EU Official Journal publication; the Commission must publish alternative-analysis guidance within 12 months.

EU co-legislators have agreed to halve the exit window for cosmetics containing newly banned CMR substances, cutting it to six months for market placement and twelve months for sell-through once a prohibition takes effect.

The provisional agreement on the Omnibus VI package, struck this week between the European Council and European Parliament, halves the 12- and 24-month phase-out the European Commission had originally proposed. Both timelines run longer than current law, which sets no staggered transition at all.

The deal also restores pre-market notification for nanomaterials, keeps a ban trigger open even when a CMR classification rests on oral or inhalation data rather than skin contact, and obliges the Commission to publish guidance on alternative-substance analysis one year after entry into force.

What timelines did lawmakers set?

The text, which still needs formal endorsement by both Parliament and Council, lays out four clock paths that compliance teams can now programme against:

  • Six months to cease placing an affected product on the market; twelve months before the product can no longer be made available, where a company does not defend continued use of the banned substance.
  • Twelve months from a substance's new CMR classification to file a derogation request.
  • Three-month placement halt and nine-month availability halt if the derogation is refused on safety grounds.
  • Twenty-four and thirty-six months respectively if the refusal rests on the availability of safer, more suitable alternatives.

The "phase-out clock" only begins when a derogation appeal is decided. The Commission will publish its alternative-analysis guidance twelve months after the regulation enters force.

The text also reverses a Commission proposal that would have spared substances whose CMR classification derived only from oral or inhalation exposure. In the agreed wording, oral- or inhalation-based CMR classifications can still trigger a cosmetics ban or derogation process, regardless of exposure route.

What changes for formulators and compliance teams?

The compressed phase-out tightens the runway between a substance hitting the prohibited list and stockpile turning into write-off. Brand owners running inventory forecasts must now plan around 12- to 36-month horizons, not the 24-month baseline the Commission offered.

The narrower derogation window — twelve months from classification — raises the bar on dossier readiness. Safety assessors will need standing workflows for hazard reclassification monitoring, exposure data, and alternative-substance justification before any clock starts.

Dimitris Tsiodras (EPP, Greece), rapporteur for the Environment, Climate, and Food Safety Committee, framed the political choice: "With this agreement, we have demonstrated that simplification and a high level of protection can go hand in hand. We have reduced unnecessary burdens for businesses, strengthened the visibility of safety information for consumers, and delivered greater legal certainty for industry, while fully preserving Europe's high standards for health and environmental protection."

Why does the nanomaterial rule still matter?

Co-legislators reinstated the requirement for cosmetics containing nanomaterials — including specific UV filters, colorants, and functional ingredients — to be notified to the Commission before market placement. The Commission had wanted to drop the rule, citing redundancy with REACH and other notification regimes.

The agreement keeps the requirement but shortens the waiting period. The exact implementation window is still to be confirmed in implementing acts. For formulators working with nano-grade titanium dioxide, zinc oxide, carbon black, and certain silicates, pre-launch lead times will still sit ahead of the production calendar, even at a reduced window. Procurement should expect longer R&D-to-shelf intervals in affected categories.

How did industry respond?

Cosmetics Europe and six partner associations issued a joint statement welcoming the compromise. Co-signatories: the European Federation for Cosmetic Ingredients, European Federation of Essential Oils, International Federation of Essential Oils and Aroma Trades, the International Fragrance Association (IFRA), International Natural and Organic Cosmetics Association, and SMEunited.

The statement framed the result in commercial terms: "The agreement demonstrates that consumer safety, innovation, and competitiveness can go hand in hand with science-based policymaking."

The same note put weight behind the sector: Europe's fragrance, cosmetics, and personal care industry is valued at €180 billion (US$206 billion), generates €30 billion (US$34 billion) in export revenue, and supports 3.5 million jobs.

John Chave, director general of Cosmetics Europe, tied the package to competitive positioning: "The Omnibus VI gives our industry more predictability with clearer and enforceable rules the sector needs to keep innovating and competing globally, with science at the heart of every decision."

What happens next?

Council and Parliament now face a formal endorsement vote. Once approved, the regulation enters force twenty days after publication in the EU Official Journal. The Commission must deliver its alternative-analysis guidance within twelve months of that entry into force — the first compliance milestone to track, alongside the implementing acts that will specify the shortened nanomaterial notification window.

via personalcareinsights.com (Original)

Filed under

  • eu-omnibus-vi
  • cmr-substances
  • nanomaterial-regulation
  • cosmetics-regulation
  • cosmetics-europe

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Rebecca Stone

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Staff writer covering industry trends and analytics at INCI File.

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