SCCS Preliminary Opinion on Kojic Acid
In 2019, the European Commission set out two lists of ingredients suspected of having endocrine disrupting properties. Kojic Acid was included in group A (higher priority) and the European Commission asked the SCCS to carry out a safety assessment on this ingredient. The SCCS has published its preliminary opinion on Kojic Acid and the deadline for comments was set at 14 January 2022.
Picture of Marta Pinto

Marta Pinto

Regulatory Affairs Associate

KOJIC ACID SAFETY ASSESSMENTS

Kojic Acid is a heterocyclic compound and is a secondary metabolite commonly produced by many species of filamentous fungi (like Aspergillus and Penicillium). In cosmetics and personal care products, Kojic Acid is used as an antioxidant and bleaching agent. Due to its inhibitory effect on tyrosinase activity and melanogenesis, Kojic acid has been widely used as a skin lightening/whitening or depigmenting agent in cosmetics. Kojic Acid is not currently included in the annexes of the European Cosmetics Regulation (No. 1223/2009), which means its use is not restricted in cosmetic products.

In 2010, the Cosmetic Ingredient Review (CIR) Expert Panel has assessed the safety of Kojic Acid and concluded that it was safe for use in cosmetic products, up to a maximum concentration of 1%. The Panel considered that the two endpoints of concern (dermal sensitization and skin lightening) would not be seen at use concentrations below 1%.

The Scientific Committee on Consumer Products (SCCP) issued its first opinion on the safety of Kojic Acid in 2008. The Committee concluded that, based on the information provided and the calculation of margins of safety (MoS), the use of Kojic Acid at a maximum concentration of 1.0% in skin care formulations poses a risk to the health of consumers and that Kojic Acid had the potential to induce skin sensitization. SCCP asked for the submission of relevant data on kinetics of the ingredient (after dermal application) in order to refine the MoS approach.

A new dermal penetration study and the industry response was presented and in 2012 the European Commission’s Scientific Committee on Consumer Safety (SSCS) issued a second opinion on Kojic Acid. The SCCS stated that “re-examination of the available data for Kojic Acid, used as a skin whitening agent at a concentration of 1.0% in leave-on creams, which are generally applied to the face and/or hands leads to the conclusion that it is safe for the consumers”. No conclusion was drawn on the derivatives of Kojic Acid (e.g., esters of Kojic Acid, Kojic Acid dipalmitate, Kojic Acid isopalmitate and chloro-Kojic Acid), as no data was submitted on these. Moreover, the Committee considered that a concern on the use of Kojic Acid arises when the human skin barrier is weakened (e.g., after peeling) or when the ingredient is applied on larger skin surfaces.

NEW SCCS PRELIMINARY OPINION

In early 2019, a priority list of 28 potential endocrine disruptors (not already covered by the bans of cosmetic regulation) was established by the Commission. From these 28 substances, 14 were considered as higher priority (Group A) and the other 14 were included in the low priority group (Group B). The public call for data for the considered higher priority substances was carried out in 2019. Kojic Acid was included in Group A. (see previous post)

During the call for data, stakeholders submitted scientific evidence to demonstrate the safety of Kojic Acid in cosmetic products. The European Commission asked the SCCS to carry out a safety assessment on Kojic Acid considering the data submitted.

At its plenary meeting in October, the SCCS issued a preliminary opinion on Kojic Acid. Considering the concerns related to potential endocrine disrupting properties of Kojic Acid, the SCCS is of the opinion that “the concentration of 1% Kojic acid is not safe for the intended use in cosmetic products”. Moreover, the SCCS was unable to advice on the safe concentration of Kojic Acid in individual cosmetic products. For example, Kojic Acid should not exceed 0.04% if a face cream and hand cream are combined on a twice a day use.

Kojic Acid is sometimes added to peeling agents and a weakened skin barrier may be of additional concern due to increased dermal penetration.

The SCCS preliminary opinion is open for comments until 14 January 2022.

If you wish to get more information on the safety of cosmetic ingredients, feel free to contact us at info@criticalcatalyst.com.

References:

  1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
  2. Scientific Committee on Consumer Safety (SCCS). Opinion on Kojic Acid. SCCP/1182/08. 2008
  3. Scientific Committee on Consumer Safety (SCCS). Opinion on Kojic Acid. SCCS/1481/12. 2012
  4. Scientific Committee on Consumer Safety (SCCS). Opinion on Kojic Acid. SCCS/1637/21. Preliminary version. 2021

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