John Chave
Director General, Cosmetics Europe, Brussels

The European cosmetics and personal care industry is a dynamic, innovative and export-oriented sector. While many multinational companies are household names, it is less well known that there is a huge and diverse constituency of small and medium-size enterprises (SMEs), more than 9600, in Europe, contributing significantly to the sector’s dynamism and export success – our industry had a trade surplus of nearly 21 million in 2024 (1).

However, Europe, once the largest market for cosmetics and personal care products, has fallen second behind the US in recent years. During this time an increase in the number of regulations impacting our industry initiated by the EU has created challenges for our companies. The challenge of burdensome regulation and its impact on Europe’s competitiveness in general was recently highlighted by former Italian Prime Minister and head of the European Central Bank, Mario Draghi, in his report on European competitiveness (2).

In particular, we have witnessed increased regulatory focus on ingredients used in cosmetics. For instance, the EU’s flagship Green Deal project, launched in 2020, which aimed to introduce a more precautionary approach to chemicals in general, including the introduction of new, restrictive criteria (3).

While the industry does not of course oppose regulation, and does not compromise on safety, disproportionate regulation (that is regulation that goes beyond what is necessary to achieve safety) may have negative implications for competitiveness, by for example imposing unnecessary costs, diverting resources from innovation, or reducing product functionality. This impact is felt disproportionality by SMEs, which the EU itself recognises are an important engine for growth (4).

Rising concerns relating to the relative decline of the European economy, as highlighted in the Draghi report, as well as the evolving geopolitical context, led to a commitment by the European Commission president, Ms Von der Leyen, to prioritise competitiveness in her second term, which began in November 2024.

In January 2025, she launched a Competitiveness Compass highlighting eight areas of EU policy action which address competitiveness related issues (5). One area – ‘simplification’ explicitly aims to tackle what Ms Von Der Leyen refers to as ‘red tape ’or excessive regularity burden, while remaining committed to sustainability goals.

Simplification addresses specific regulatory burdens across a number of sectoral and horizontal (applying to many sectors) regulations. The vehicles for Simplification are Omnibus measures, so called because they address multiple EU Directives or Regulations in a single statutory instrument. One such Omnibus, Omnibus VI, published in July 2025 addresses chemical legislation (6).

A major concern of the European cosmetics industry has been the interplay between Classification, Labelling and Packaging (CLP) Regulation and the Cosmetics Products Regulation (CPR).

Under the CLP, chemicals can be classified as hazardous within a range of specified hazard classes. One such hazard class is carcinogenic, mutagenic and reprotoxic (CMR). Classification as hazardous does not in itself constitute a ban on the use of such substances.

However, responding to concerns about the possible risk to consumers of such ingredients, the CPR provides that unless a derogation is granted in accordance with strict criteria, then under Article 15 of the CPR, a classified CMR category 1 is automatically banned for use in cosmetics. It is to be noted here that classification under CLP is on a hazard basis – that is, irrespective of consumer exposure, while for chemicals falling outside the CLP framework, the CPR provides for assessment on a risk/exposure basis, overseen by the EU’s Scientific Committee on Consumer Safety (SCCS).

Such bans have significant consequences for the industry and for consumers, including loss of valued ingredients, unnecessary reformulations, and removal of safe products from the market.

The issue has become more acute in recent years, due to a significant increase in CMR classifications or intentions to classify cosmetic ingredients. Recent examples include P-Cymene, heliotropin, Sodium Fluoride and Ethanol. This development has created a significant degree of concern within the cosmetics industry, because while the industry is confident in the safety of such substances in cosmetic uses, the regulatory framework under Article 15, in particular the unclear derogation criteria and the lack of a clear definition of what constitutes a suitable alternative, constrain the industry’s scope for successfully demonstrating that use in cosmetic should continue to be permitted. In the worst case, this threatens perfectly safe ingredients with removal from the market. In the past 12 years, only two substances* were considered for a derogation, and both requests were denied despite the SCCS concluding that they could be safely used in certain types of cosmetics (7, 8, 9, 10). This then would seem to be a case where ‘simplification ‘might be relevant, by facilitating the application of derogations, provided of course that safety is in no way compromised.

The Omnibus VI on chemicals addresses this question, by among other things refining the derogation criteria and introducing clearer deadlines for the submission of evidence that a derogation is appropriate.