M Paz Pellús

Kojic acid and its new regulation

Pharmacist specialising in cosmetics and regulatory affairs
16 of April of 2024
Save

The new Regulation (EU) 2024/996 has not only brought news for Retinol. This text also deals with ingredients that are widely used in the cosmetics industry, such as kojic acid.

Kojic acid is one of the most widely used active ingredients for the removal of hyperpigmentation. This cosmetic active ingredient has several mechanisms by which it can be used as a depigmenting agent, the main one being the inhibition of the enzyme tyrosinase, which is involved in the formation of melanin in the skin.

Thanks to this activity, it can be found in the cosmetics industry as part of products designed to eliminate skin hyperpigmentation.  Until now, the recommended dosage was between 1-4%, to achieve effective results in reducing hyperpigmentation and uneven skin tone (taking into account individual tolerance and skin response, of course).

But in the new Commission Regulation (EU) 2024/996, the "Restrictions" section has been added to Annex III of the Cosmetics Regulation 1223/2009.

According to this new regulation, which was published on 4 April 2024, kojic acid may be used up to a maximum of 1% in facial and hand depigmenting products.

What are the deadlines?

This new Regulation indicates two different dates:

  • No products that do not comply with the restriction will be placed on the market from 1 February 2025.
  • Products that do not comply with the restriction shall not be placed on the market after 1 November 2025.
About the author
M Paz Pellús

Mª Paz Pellús García

Pharmacist specialising in cosmetics and regulatory affairs

Graduate in Pharmacy from the UAH and Master's in Cosmetics and Dermopharmacy, Pharmaceutical Care in Dermatology, Pharmaceutical Marketing, and Digital Marketing. Expert in the evaluation of the safety of cosmetic products. Thanks to her expertise in galenic development, regulatory affairs, and skin care, and her knowledge of the market, she has a 360º vision within the cosmetics industry. In addition, she also creates content for social networks and media related to the sector. https://dermofarmablog.com/
See all author's articles