Omnibus VI vote grants cosmetic companies grace periods for CMR withdrawals

The European Parliament has approved revised rules under the Omnibus VI chemicals package, giving cosmetic manufacturers in the EU more time to withdraw products containing carcinogenic, mutagenic, or reprotoxic (CMR) substances. 

The changes give beauty brands more room to plan reformulations and run down existing inventory, while keeping the ban on CMR ingredients in place. However, consumer safety advocates warn that longer withdrawal periods could leave potentially harmful products on shelves for longer. 

The vote formalizes a provisional agreement reached by parliament and the EU council on June 17.

Members of the European Parliament adopted the legislation on October 22, with 477 votes in favor, 59 against, and 41 abstentions. The text amends Article 15 of the Cosmetic Products Regulation, which governs CMR substances. Under current rules, when an ingredient is added to the CMR list, companies must go through an exemption process to keep using it.

Omnibus VI is one of a series of EU packages aimed at reducing administrative burdens for businesses. However, the industry previously criticized it for adding more red tape. The final text scales back several elements of the commission’s original proposal. 

Industry backs the reform

The cosmetics sector now backs the Omnibus VI, after previous concerns on the complexities of reformulation and exemptions. The final rules give manufacturers grace periods to sell through existing stock after a CMR ban takes effect, rather than requiring immediate withdrawal, and set a three-month window to apply for an exemption. 

In a joint statement, organizations including Cosmetics Europe and the International Fragrance Association (IFRA) said the proposal “does not relax any safeguards.”

After the June agreement, Cosmetics Europe and other European cosmetics, fragrance, and essential oils associations welcomed the deal.The EU gives cosmetics makers more time to pull CMR products. 

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

“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.”

New withdrawal deadlines

Currently, products containing a newly classified CMR must be withdrawn immediately once the ban takes effect. Instead, the new rules introduce a risk-based grace period after that date, with the deadline depending on what scientific assessments find about the safety of the substance. 

Companies applying for an exemption must do so within three months of the new CMR classification taking effect. If an exemption is refused on safety grounds, companies will have three months to stop placing products on the market and nine months before they can no longer be sold. Products considered safe but for which alternatives exist can stay on the market for two years, with three years to clear them from shelves.

Manufacturers that do not seek an exemption will have six months to stop placing affected products on the market and 12 months to sell through existing stock. This is half of the 12 and 24 months the commission originally proposed.

During negotiations, lawmakers also dropped a proposal to assess CMRs by how consumers are exposed to them, which could have allowed a carcinogenic substance in skin-applied products even if it was banned in products that are swallowed or inhaled.

Consumer groups remain critical 

The European Consumer Organization (BEUC) has stated that the final deadlines are shorter than the commission proposed, but still longer than the current rules. The consumer group has warned that the plan would give the beauty industry more time to keep harmful chemicals in cosmetics and open new routes for exempting certain carcinogenic substances from the existing ban.

“Sadly, this deal means that toothpastes, deodorants, or lipstick containing toxic ingredients will stay longer in consumers’ homes. This is bad news, knowing that more than four in five EU consumers worry about the impact of harmful chemicals on their health and the environment,” said Agustín Reyna, director general of BEUC, after the June agreement.

“The silver lining is that EU institutions have managed to avoid the worst, since the final deal drops the original proposal’s most problematic points.” The new rules set risk-based deadlines for hazardous ingredients.

Divided path to agreement

Earlier in the negotiations, the cosmetics industry clashed with the EU council over its stricter approach. 

An EU spokesperson told Personal Care Insights at the time that the council aimed to balance simplification against the Cosmetic Products Regulation’s core goal of protecting human health and the environment.

Trade associations, including IFRA, Cosmetics Europe, the European Federation for Cosmetic Ingredients, and SMEunited, criticized that position. “The council’s position reinstates unnecessary red tape,” said Chave. “We regret this lost opportunity to better ensure safe ingredients and products stay on the market.”

IFRA warned that around half a million cosmetic products on the EU market could face reformulation if the derogation procedure remained unworkable.

The final agreement has eased many of those concerns by simplifying the exemption process and adding grace periods for existing stock. Personal care groups, including Cosmetics Europe, have since welcomed the deal, citing greater predictability and clearer rules.

The council must now formally adopt the text before it is published in the Official Journal of the EU and enters into force.