Ban on substances under EU cosmetics legislation

The new bans on substances make cosmetic products in the EU safer and require the intervention of manufacturers and distributors.

When new bans on ingredients for use in cosmetics come into effect, the question arises of what duties are incumbent on responsible persons, which generally mean manufacturers or importers, and on distributors.

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

Current bans on CMR substances

At regular intervals, the European Commission expands the list of “CMR substances” banned for use in cosmetics, ie substances classified as carcinogenic, mutagenic or toxic for reproduction. The last modification was made by Commission Regulation (EU) 2021/1902 of 29 October 2021, which amends Annexes II, III and V of Regulation (EC) no. 1223/2009, also known as 4th European CMR Regulation (“Omnibus IV”). 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 carry 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 butylphenylmethylpropionate). As a result, Lilial can no longer be used in cosmetics as of March 2022 (Article 14 (1) b) EU Cosmetics Regulation).

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

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

One thing seems certain: cosmetics containing the ingredient will no longer be made available on the EU market from March 2022. Managers are therefore prohibited from supplying products containing Lilial to their distribution partners. Distributors are no longer authorized to supply such products for distribution, consumption or use, whether for consideration 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 additional obligations

What is less obvious, however, are the tasks that the responsible person and the 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 conflicts with the EU Cosmetics Regulation and does not meet its requirements. In addition to the obligation to stop supplying products containing Lilial from March 1, 2022, other duties may apply, for example when there is concern that the products have been supplied despite the ban.

On the other hand, the overall responsibility of the cosmetic product manager throughout 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. First, this could mean obligations to inform distributors and take back products.

The only requirements of the Cosmetics Act are the relevant standard

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

Issues such as the existence of a defect, if and when the risk has passed or what contractual arrangements have been made between the responsible person and the distributor are irrelevant to the obligations under the cosmetic laws. This is because the latter are precautionary obligations under public law.

Another question is whether there are inter partes contractual claims between the responsible person and the distributor.

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