The legislative package known as “Omnibus VI” was adopted by a large majority in the European Parliament on Wednesday, April 29 (540 votes in favour, 60 against, and 45 abstentions). The compromise reached two weeks earlier by the Environment and Internal Market Committees was approved without changes, with all amendments rejected. The text will now move to interinstitutional negotiations (“trilogue”) before a final adoption by the co-legislators — the Parliament and the Council.
What is the current situation?
Substances classified as CMR — carcinogenic, mutagenic, or toxic to reproduction — are prohibited in cosmetic products placed on the European Union market.
These substances are grouped into three categories: 1A (known effects), 1B (presumed effects), and 2 (suspected effects). The list is regularly updated: the European Chemicals Agency (ECHA) assesses substances to determine whether they should be classified as CMR by the European Commission.
Following a new CMR classification, cosmetic manufacturers have 18 months to reformulate their products. After that deadline, cosmetics containing the substance can no longer be marketed. However, exemptions may apply, depending on the substance’s hazard level.
What are the main elements of the proposal?
The plan to ease certain aspects of chemicals regulation is part of a broader set of “simplification” measures adopted by the European Union in recent months.
Industry stakeholders had raised concerns about the possible classification as CMR of substances such as paracymene or acetophenone — used in particular in perfumery. They also pointed to the difficulties involved in obtaining exemptions.
The text — revised in committee in mid-April — extends the timelines, giving companies around two and a half years to withdraw products containing CMR substances from the market where no exemption request is submitted. In some cases, additional time may be granted on a case-by-case basis, extending the deadline to more than six years.
Another provision would have allowed the use of substances classified as carcinogenic via oral or inhalation exposure when used exclusively in products intended for topical application. This measure was ultimately dropped following opposition from MEPs.
The industry’s perspective
John Chave, Managing Director of Cosmetics Europe, believes the proposal "marks progress in the right direction, which is reducing administrative burden, while maintaining the highest safety standards."
For its part, the French Federation of Beauty Companies (FEBEA) described the compromise adopted on Wednesday as “perfectly balanced.” The Omnibus VI proposal “provides greater predictability,” FEBEA scientific director Brice Leclerc told AFP. According to him, it enables manufacturers “to reformulate effectively and on a scientific basis, and to assess alternatives more robustly,” while also facilitating exemption requests.
“A substance may be hazardous, but depending on its conditions of use and consumer exposure, it does not necessarily pose a health risk,” he also stated, citing ethanol as an example, which presents “no risk to consumer health” when used “in hand sanitizers or in perfumery.” He further added that the additional time granted “is necessary given the realities of the industry.”
What do advocates of stricter regulation argue?
French NGO Générations Futures considers the extended deadlines for the continued marketing of products containing newly classified CMR substances “totally unacceptable,” stressing that the EU process for classifying substances as CMR already takes several years.
The Health and Environment Alliance (HEAL), an NGO representing approximately 70 health and environmental organisations, welcomed the rejection of an exemption concerning substances classified as carcinogenic by inhalation or ingestion. However, it said that forthcoming negotiations between the Council, Parliament, and the European Commission must lead to stronger consumer protection. “We call on all parties (…) to prioritise health protection,” said Sandra Jen, Programme Lead for Health and Chemicals at HEAL.
