EU reaches landmark Omnibus VI deal: Industry welcomes streamlined substance statutes

The European Council and European Parliament have reached a provisional interinstitutional agreement on the Omnibus VI package, a legal overhaul of cosmetic regulations in Europe presented by the European Commission (EC). The Council and Parliament are pushing to eliminate cosmetics containing carcinogenic, mutagenic, and reprotoxic substances (CMR) more quickly than the EC had proposed.

The agreement was met with positive response from personal care industry players, with Cosmetics Europe releasing a joint statement with six other European organizations within the cosmetics, fragrance, and essential oils sectors.

“This agreement shows that Europe can streamline the regulatory framework and reduce administrative burden while maintaining the highest consumer safety standards. 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,” says John Chave, director general at Cosmetics Europe.

Terms of the deal

The European Council and European Parliament have concurred that companies will have six months to stop placing affected products on the market and 12 months before they can no longer be made available, once a ban on a substance takes effect, should it not be defended for continued use.

This timeline contrasts with the EC’s proposal of 12 and 24 months, respectively. Both timelines — the co-legislators’ and the EC’s — are longer than the current rules, which set no staggered transition.

In the case that a company wishes to continue using a substance, it will have up to 12 months from the substance’s new classification to request a derogation. The “phase-out clock” starts once the appeal is decided.

If the derogation is declined on the grounds of safety, the company will subsequently have three months to cease product placement in the market and nine months before the products can no longer be made available.

In the event that the derogation is refused due to the availability of safer and more suitable alternative ingredients, the company will have 24 and 36 months to fulfill the respective guidelines.

The EC had previously suggested that, in certain cases, CMR substances should not automatically trigger a cosmetics ban if their CMR classification was based on oral or inhalation exposure, and not based on skin exposure. The co-legislators decided against this exemption, stating that even if the CMR classification of a substance is oral or inhalation dependent, it can still trigger a cosmetics ban or derogation process, regardless of the route of exposure.

Additionally, the co-legislators have reintroduced the requirement for cosmetic products containing nanomaterials — as used in certain UV filters, colorants, or functional ingredients — to be notified to the EC prior to being placed on the market.

The present guidelines stipulate that nanomaterials must be notified to the EC six months before market placement. The EC had previously proposed to remove this requirement, citing duplicated notification and unnecessary administrative burden as the reasoning. The new agreement maintains the notification requirement, but shortens the six-month wait.

“With this agreement, we have demonstrated that simplification and a high level of protection can go hand in hand,” says Dimitris Tsiodras (EPP, Greece), rapporteur for the Environment, Climate, and Food Safety Committee.

“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.”

According to the European Parliament, to accelerate the replacement of hazardous substances in cosmetic products, the EC will develop guidance specifying the analysis of alternatives one year after entry into force of this legislation.

The informal agreement must now be endorsed by both Parliament and Council. It will then enter into force 20 days after it has been published in the EU Official Journal.

Warm industry response

After the agreement by the co-legislators and the EC, the following organizations released a joint statement to the press: Cosmetics Europe, European Federation for Cosmetic Ingredients, European Federation of Essential Oils, International Federation of Essential Oils and Aroma Trades, International Fragrance Association, International Natural and Organic Cosmetics Association, and SMEunited.

The statement reads that the organizations welcome the political agreement on Omnibus VI. They maintain that it reaches a compromise between “Europe’s high standards of consumer protection, while improving the clarity, predictability, and workability of the regulatory framework for cosmetics and fragrances.”

“The agreement demonstrates that consumer safety, innovation, and competitiveness can go hand in hand with science-based policymaking.”

The statement highlights the importance of reaching an agreement that balances the interests of industry and consumer safety. It underscores that the European fragrance, cosmetics, and personal care industry is valued at €180 billion (US$206 billion), amounts to €30 billion (US$34 billion) in export revenue for the European economy, and bolsters 3.5 million jobs.

“Consumer safety is the priority for the cosmetics, fragrance, essential oils, and cosmetic ingredients industries. It remains fully upheld, while the objective to reduce administrative burdens and boost competitiveness is achieved through science-based and proportionate regulation,” the joint statement reads.