Bans on substances under EU cosmetics law


New substance bans make cosmetic products in the EU safer and require manufacturers and distributors to act.

When new bans on ingredients for use in cosmetics come into force, the question arises as to which duties are incumbent on responsible persons, which generally means manufacturers or importers, and on distributors.

We highlight the possible consequences of such substance bans, which has come into effect on 1 March 2022, taking the ban on the commonly used fragrance chemical Lilial as an example.

Current bans on CMR substances

At regular intervals, the European Commission extends the list of "CMR substances" prohibited for use in cosmetics, meaning substances that are classified as carcinogenic, mutagenic or toxic for reproduction. The most recent amendment was made by Commission Regulation (EU) 2021/1902 of 29 October 2021 amending Annexes II, III and V to Regulation (EC) No 1223/2009, also known as the 4th European CMR ("Omnibus IV") Regulation. This Regulation, which applies from 1 March 2022, adds 23 ingredients to the annexes of Regulation (EC) No 1223/2009 on cosmetic products. The associated classifications entail several restrictions.

In practice, the most relevant new inclusion in Annex II of the EU Regulation on cosmetic products is that of the ingredient Lilial (also: 2-(4-tert-butylbenzyl) propionaldehyde, or butylphenyl methylpropional). As a result, Lilial can no longer be used in cosmetics as of March 2022 (Article 14 (1) b) EU Regulation on cosmetic products).

Cosmetic products containing the ingredient Lilial can no longer be made available on the EU market

What exactly this reclassification of Lilial means for responsible persons and distributors, however, raises a number of practical questions.

One thing appears certain: cosmetics containing the ingredient can no longer be made available on the EU market from March 2022. Responsible persons are therefore banned from supplying products containing Lilial to their distribution partners. Distributors are no longer allowed to supply such products for distribution, consumption or use, whether in return for payment or free of charge. These consequences depend on the respective amending regulation, which may, for example, provide for a longer conversion period or a time lag between the ban on placing the product on the market and the ban on making it available.

Market participants may be subject to further duties

What is less obvious, however, is what duties the responsible person and distributors have beyond this.

On the one hand, distributors – if they have reason to believe that a cosmetic product does not comply with the requirements of the EU Regulation on cosmetic products – must take the necessary measures themselves. If an ingredient is banned, the product is in conflict with the EU Regulation on cosmetic products and does not meet its requirements. In addition to the duty to cease supplying products containing Lilial from 1 March 2022, other duties may apply, for example when there are concerns that products were supplied despite the ban.

On the other hand, the comprehensive responsibility of the responsible person for the cosmetic product during its entire life cycle would suggest that this person remains responsible for the safety of the product even after it has been placed on the market. Primarily, this could mean duties to provide information to distributors and the withdrawal of products.

Requirements of cosmetics law alone are the relevant standard

It is important to keep in mind the correct standard when reviewing duties under legislation governing cosmetic products: tempting though it may be to include sale of goods law considerations in this assessment, only the standards of cosmetics law can in fact be applied.

Issues such as the existence of a defect, whether and when the risk passed or what contractual agreements were made inter partes between responsible person and distributor are irrelevant to duties under cosmetics laws. This is because the latter are precautionary duties under public law.

Whether inter partes contractual claims exist between the responsible person and the distributor is another matter.