Industry associations push back against “unworkable” EU Council Omnibus position

The EU Council has set its position on the Omnibus VI legislative package, backing stricter rules for hazardous substances and shorter transition periods for reformulating non-compliant cosmetics. The Omnibus VI package is a proposal to simplify the regulation of cosmetics and chemicals in the EU.

EU ministers describe the position as a step toward reducing administrative burdens and strengthening competitiveness. However, industry groups say the council has missed a chance to simplify and now risks reintroducing “unnecessary red tape.”

The draft legislation modifies two key EU cosmetics laws: the Classification, Labelling and Packaging (CLP) Regulation and the 2009 Cosmetics Products Regulation (CPR). The draft legislation’s modifications aim to streamline labelling and packaging requirements while maintaining rigid safety standards.

“The council’s position has been guided by striking the right balance between simplifying and maintaining the core objective of the CPR, which is to ensure a high level of protection for human health and the environment,” an EU spokesperson tells Personal Care Insights. 

However, in a joint statement, seven major trade associations — including the International Fragrance Association (IFRA), Cosmetics Europe, the European Federation for Cosmetic Ingredients, and SMEunited — criticized the council’s position.

In the statement, John Chave, director general of Cosmetics Europe, says: “The council’s position reinstates unnecessary red tape. There is a lack of coherence between the EU’s ambitions to increase competitiveness and the council’s hesitance to support effective simplification. We regret this lost opportunity to better ensure safe ingredients and products stay on the market.”

The coalition warns that some modifications risk disrupting supply chains, discouraging investment in Europe, and limiting consumer access to trusted products. Under the derogation procedure, hazard-based risk assessments may require reformulations.

“We have identified half a million individual cosmetic products on the EU market that could face reformulation if the derogation procedure remains as unworkable as it currently is,” Charles de Lusignan, global communication director at IFRA, tells Personal Care Insights.

The EU Council’s mandate will serve as the basis for upcoming negotiations with the European Parliament. Both institutions will need to agree on a final text before it becomes law.

Simplification standoff

A core concern for the cosmetics industry is the complex process for seeking an exemption to use ingredients that are classified as hazardous. 

The EU is applying the precautionary principle, which requires authorities to act cautiously in the face of scientific uncertainty. Ingredients are restricted or banned based on their hazardous properties, even when real-world exposure risks are low or not fully established.

The Omnibus VI package will only take effect once the European Parliament agrees on the final text.“Europe is verging perilously close toward becoming a ‘hazard-based’ regulatory regime, whereby merely the presence of an ingredient with hazardous properties, per se, is enough to see it banned regardless of actual exposure, absent a derogation,” de Lusignan says.

When a substance is classified based on certain hazardous properties, the industry must submit a dossier that complies with a list of criteria to continue using the ingredient in cosmetics. This relates to Article 15 of the CPR. 

“The commission had in mind to clarify this Article 15 process given that, so far, not a single ingredient has benefited from this derogation process over the past 15 years,” de Lusignan adds.

To clarify the procedure, the commission outlined what constitutes a suitable alternative. According to de Lusignan, the set definition of what constitutes a suitable alternative is so broad that it would make it “very, very difficult (or impossible)” for the industry to demonstrate that there are no suitable alternatives.

“Since these derogations never happen because of the unworkability of the process, Europe is risking the competitiveness of its currently world-leading fragrance and cosmetics value chains, both in the short term (reformulation costs today) and in the long term (squeezed product innovation pipeline),” he says.

The EU spokesperson holds firm that the precautionary principle is a core principle across all EU legislation. They note that recitals 16, 17, 19, and 24 are unchanged, and that the amended recitals aim to offer “clearer explanation” to the public, and not to complicate the rules any further.

De Lusignan counters: “The bulk of the world’s leading fragrance and cosmetics houses are based in Europe. However, some companies in the fragrance value chain report that they are spending up to 80% of their R&D budgets on reformulations linked to the classification of key ingredients. This is an investment being diverted from product and sustainability innovation.”

The cosmetics industry coalition counts on members of the European Parliament to fix this derogation process.

“Safety is at the core of the system and will continue to be, but we also must manage the regulatory burden in such a way that competitiveness and safety go hand in hand,” says de Lusignan.

Industry groups warn that the Council’s “hazard-based” approach could force widespread reformulations and divert R&D investment away from innovation.Countdown pressure

The coalition of associations disapproves of the EU’s modifications to transition timelines. They argue that the reformulation deadlines for non-compliant products are too short. They warn that rapid adaptation would cause waste or product destruction.

“For small and medium enterprises, the consequences will be particularly severe, as they are less likely to have the capacity to reformulate their product ranges,” de Lusignan says.

The EU spokesperson argues that the deadlines are fair, pointing out that today’s chemical industry is more than capable of managing its own by-products efficiently.

“The transition periods set in the council’s position strike a balance between giving industry sufficient time to adapt and ensuring that harmful products are removed from the market without delay… Today’s chemical industry has a serious capacity to dispose of ‘waste’ without causing pollution, turning it into energy, for example. There are innovative technologies in use for that.”

“Of course, there will be trilogues with the European Parliament next year, and we cannot prejudge any outcome,” the EU spokesperson concludes.