Manufacturers and distributors: who pays for the withdrawal from the market of lilial, the prohibited substance?

From March 1, 2022, cosmetic products containing the Lilial substance cannot be marketed.

This causes controversy between the manufacturers and distributors of the cosmetic products that contain it, regarding who is responsible for withdrawing them from the market and for bearing the economic costs of it, since, up to that date, it has been possible sell normally, in accordance with current legislation.

At the European level, cosmetics are regulated in Regulation (EC) 1223/2009 of the European Parliament and of the Council, of November 30, 2009, on cosmetic products and, at the national level, this Regulation has its counterpart in the Royal Decree 85/2018, of February 23, which regulates cosmetic products.

Both regulations are applicable to cosmetics and to natural or legal persons who manufacture, import, place on the market, market, distribute, sell or professionally use cosmetic products. The objective is that the cosmetic products that are marketed are safe for health when used under normal or reasonably foreseeable conditions of use.

Due to this, the Regulation establishes some restrictions for certain substances in the composition of cosmetics, such as prohibited substances, substances subject to restriction, colorants, preservatives or ultraviolet filters. Within the prohibitions, in what now matters, the Regulation includes the prohibition of the use in cosmetics of substances classified as CMR (carcinogenic, mutagenic and reprotoxic) of category 2. These lists can be adapted according to the progress and technical evolution of the substances and products.

On March 1, 2022, the Delegated Regulation (EU) 2020/1182 of the Commission of May 19, 2020, published almost two years ago in the Official Journal of the European Union, entered into force. This Regulation modified list IV of Regulation (EU) No. 1272/2008 of the European Parliament and of the Council, of December 16, 2008, on classification, labeling and packaging of substances and mixtures, and included the substance butylphenyl methylpropional or 2-(4 -tert-Butylbenzyl) Propionaldehyde CAS No. 80-54-6, commonly known as Lilial, as CMR substance.

The controversy arises because in the cosmetic sector there is the figure of the responsible person, who will be the person who guarantees compliance with the requirements established in the applicable regulations.

The legislative change regarding the Lilial raises different issues. Should it be understood that products containing the substance Lilial must be withdrawn from the market by the manufacturer? And, if so, should you bear its cost? Or, on the contrary, is it up to the distributor, who acquired the Lilial products and did not market them within the long transition period, to withdraw them from the market and bear their cost?

In this sense, it should be remembered that in Spain the general principle of non-retroactivity of the regulations governs, so that any introduction on the market of the cosmetic product with Lilial before the aforementioned day of March 1, 2022, does not contravene the regulations applicable to cosmetic products. cosmetics. From there, a peaceful solution cannot be offered, because during a two-year transition period, relations between manufacturer and distributor can have many variants.

Given that the casuistry can be extensive, it will be advisable to analyze each specific case and, in particular, by way of example, but not limitation, the terms of the contractual relationship between the manufacturer and the distributor, the time of manufacture of the product, the date and content of communications from the manufacturer to its distribution chain regarding the new qualification of the substance Lilial and the date of purchase from the distributor. In this way, responsibility can be defined and, where appropriate, avoiding the use of the legislative amendment so that manufacturers suffer the consequences of an irresponsible purchase of this type of product.

In short, and given the impossibility of avoiding legislative changes that affect products already marketed, as a result of technical advances, it is necessary to appeal to transparent communication between market participants and contractual good faith, in order to avoid abuses and that the sector continues to enjoy a high reputation not only on the Community market, but also on the international market.