Information Letter 062 – June 2019

Subject: Further Regulation of Climbazole

Dear All,

Climbazole (CAS 38083-17-9) is a preservative regulated by the European Cosmetics Regulation (EC
No 1223/2009) and reported at Entry 32 of Annex V. Until now, this substance could only be used as a preservative at a maximum concentration of 0.5%.

Climbazole also exhibits interesting anti-dandruff properties and the industry submitted a safety dossier to the SCCS to have this function added to the Cosmetics Regulation. The SCCS released a Scientific Opinion, which was followed by the European Commission and the EU Member States.

Regulation EU No 2019/698 has been published and confirms the use of Climbazole as an antidandruff ingredient in rinse-off shampoos at maximum 2 %. When used as an anti-dandruff ingredient, the purpose has to be apparent from the presentation of the product (e.g. “Antidandruff
ingredient: climbazole” added to the product label or “Climbazole (anti-dandruff)” in the list of ingredients).

Furthermore, the use of Climbazole in all product types at maximum 0.5 % was reconsidered in the light of new safety data and the restriction has been modified as follows:

  • Hair lotions: maximum 0.2%
  • Face creams: maximum 0.2%
  • Foot care products: maximum 0.2%
  • Rinse-off shampoo: maximum 0.5%
  • Other uses: prohibited

Transition periods have been granted by the European Commission for the technical adaptation of products not complying with the new restrictions related to the use of Climbazole as a preservative:

  • From November 27th, 2019, products containing Climbazole and not complying with the new requirements listed above shall not be placed on the Union market.
  • From February 27th, 2020, products containing Climbazole and not complying with the new requirements listed above shall not be made available on the Union market.

Within the context of cosmetics not manufactured in the EU, “placed on the market” means “imported” and notified on CPNP. Products that are duly notified on CPNP and have entered the EU territory before the deadline of November 27th, 2019 can be sold until February 27th, 2020.

However, products that have not cleared the EU customs by November 27th, 2019 could not be sold anymore.

We hope that this letter will be of help and stay at your disposal for any questions related to this topic.

Best regards,
Dr. Fred Lebreux