Unified EU chemical assessments could narrow cosmetics’ regulatory flexibility

The European Commission (EC) has proposed a “one substance, one assessment” (OSOA) approach to assessing chemicals across the EU. The proposal aims to prevent EU bodies from reaching different safety conclusions about the same chemical used in multiple industries. 

If the proposal is implemented, cosmetics brands could face earlier regulatory pressure to reformulate ingredients that are flagged as hazardous in other sectors — moving EU legislation closer to a hazard-based system. However, some members of the cosmetics industry have openly expressed their opposition to a hazard-based system, since the reformulations it may require risk disrupting supply chains.

The OSOA proposal aims to rectify situations where the same ingredient has different scientific conclusions depending on which regulatory agency assessed it.

“Such fragmentation increases the likelihood of inconsistency between various assessments of the same chemical required by various union acts,” the proposal reads.

As part of the proposal, chemical assessments would be handled more centrally by EU agencies, rather than being carried out by different committees or commission services.

In this scenario, the European Chemicals Agency (ECHA) will assume additional responsibility for evaluating chemical hazards and providing scientific opinions. This could reduce duplication and speed up regulatory decisions.

Another measure of the proposal suggests creating a new common EU data platform for chemicals to centralize their data. This includes hazard data, exposure data, environmental monitoring, and scientific studies, which EU authorities will be able to reuse across different sectors.

The platform would be managed by ECHA and shared with other EU agencies and member states.

The two parts of the proposal aim to form one legislative package. The EC views the move as a solution to the long-standing inconsistencies in EU chemicals regulation.

Transparency tightens controls

Cosmetics would be directly affected if the proposal were to be accepted, even though the Cosmetics Regulation itself remains unchanged. With the shared data platform, regulators will focus on substances rather than product formulas.

“Information related to cosmetic products … should not be included in the common data platform. However, chemicals data and information on individual chemical ingredients of cosmetic products should be included,” the proposal reads.

For cosmetics companies, the shared platform would increase regulatory exposure of shared ingredients. If an ingredient shows hazardous effects in agriculture, industrial use, or causes environmental harm, that evidence will also be visible and usable in cosmetic safety assessments.

The commission‘s “one substance, one assessment” approach aims to rectify situations where the same ingredient has different scientific conclusions.The increased transparency in cross-industry chemical assessments could make it increasingly difficult for regulators to accept contradictory scientific conclusions. If a substance is classified as “hazardous” in other industries, it may be more difficult for companies to seek an exemption for its use in cosmetics.

The shared data would not necessarily mean that a substance banned in one sector will be automatically banned in cosmetics. Instead, risk assessments will still consider exposure and use, which are usually determined based on the intended product format.

However, once a substance is classified as hazardous at the EU level, cosmetic restrictions are more likely to follow and may occur more rapidly.

Risk vs hazard

The OSOA package follows an earlier debate over proposed changes to the EU’s Classification, Labelling and Packaging (CLP) regulation. In June, the CLP proposal aimed to permit certain ingredients to remain in cosmetic products based on their risk.

It would be permitted, for example, for a company to use a carcinogen in a product, provided it can demonstrate that its exposure would be low enough.

In this regard, the OSOA package would give the cosmetics industry less scope to argue over whether or not an ingredient is hazardous, while the June proposal would give regulators more flexibility in deciding how it can be used. 

Many stakeholders in the personal care industry have opposed the EU’s move toward a hazard-based system. One core concern is that the process for seeking an exemption to use an ingredient classified as hazardous is overly complex. Industry coalitions have warned that overly strict hazard classifications risk disrupting supply chains, unnecessarily wasting resources.

“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,” Charles de Lusignan, global communication director at International Fragrance Association, previously told Personal Care Insights.