Information Letter 063 – July 2019

Subject: Publication of the ‘Omnibus Regulation 2019’ (Caution: Salicylic Acid)

Dear All,

Soon after the publication of the ‘Omnibus Regulation 2018’ (see IL-061), the European Commission started a public consultation with regard to the next version ‘Omnibus Regulation 2019’. From now on, such an amendment to the European Cosmetics Regulation, prohibiting batches of substances classified CMR, will be published every year.

As you may know, Article 15 of the European Cosmetics Regulation regulates the use of CMR substances in cosmetic products. In principle, the use of CMR substances is prohibited in the EU although exemptions remain possible under specific conditions. The regulatory procedure implies the publication of an amendment to Annex II (prohibited substances) before a ban takes effect. Annex III (restricted substances) and Annex V (preservatives) may also have to be adapted if an exemption is granted.

The draft ‘Omnibus Regulation 2019’ is now under consultation at the World Trade Organization level and until August 11th, 2019. The new regulation is expected to be published by the end of the year and without further modifications. The content of this regulation is reported below. Despite a long list of ingredients, only a few ones are relevant to the cosmetic industry:

Cosmetic ingredients prohibited (addition to Annex II):

Cosmetic ingredients further restricted (modification of Annex III and Annex V):

While the ban of the three first ingredients is expected to have a very little impact (if any), we ask you to pay the greatest attention to the new restrictions affecting Salicylic acid and its salts.

Salicylic acid and its salts (see annex) have been recently classified as substances toxic for reproduction. However, the Scientific Committee on Consumer Safety released a positive Scientific Opinion on December 21st, 2018 (with corrigendum on June 21st, 2019), which supports the safe use of Salicylic acid under specific conditions. The SCCS conclusions have been transposed in the current draft legislation:

Products that may lead to exposure of the end-user’s lungs by inhalation: These terms typically translate to specific product categories, including aerosols, some types of spray and loose powders (if size of particles/droplets exceed 10 micrometers).

According to the plan of the European Commission, this regulation should be enforced by the end of this year. A short transition period will be granted and the legal changes reported above will start to apply on May 1st, 2020.

We hope that this letter will be of help and stay at your disposal for any questions related to this topic. Should you have any questions, please, feel free to contact your dedicated Account Manager.

Best regards,
Dr. Fred Lebreux

Annex: Salicylic acid and its salts