March 18, 2022 – Are you a cosmetic manufacturer aiming to sell your products in the EU market?
Do you have difficulties keeping track of the latest news regarding the regulatory framework on substances with potential endocrine-disrupting properties?
Find below a helpful update on the SCCS preliminary opinion on Kojic Acid, namely its potential endocrine-disrupting properties.
What is Kojic Acid?
Kojic Acid is a secondary metabolite, usually produced by several ‘filamentous fungi’ species (e.g. Aspergillus and Penicillium).
Due to its properties (for example, its inhibitory effect on tyrosinase activity and melanogenesis) it is commonly utilized in cosmetics with the main functions of:
- Skin lightening agent;
- Skin whitening agent;
- Depigmenting agent.
The ingredient Kojic Acid (chemical name: ‘5-Hydroxy-2-(hydroxymethyl)-4H pyrane-4-one’, CAS 501-30-4) is included in the European database for information on cosmetic substances and ingredients (CosIng) with a reported function of both ‘bleaching’ and ‘antioxidant’.
How is Kojic Acid regulated in the EU?
Currently, Kojic Acid is not regulated under the Cosmetic Regulation (EC) No. 1223/2009.
In 2008 and 2012, the Scientific Committee on Consumer Safety (SCCS) has subjected the substance to many safety evaluations.
Specifically, the SCCS 2012 Opinion (SCCP/1481/12) concluded that: “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 [Kojic Acid] is safe for the consumers”.
Suspects of Kojic Acid Endocrine-disruptor properties
What is an Endocrine-disruptor?
An Endocrine disruptor (ED) can be defined as: “An exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations” (IPCS, 2002).
Hence, an ED is an Endocrine active substance that can lead to potential health damages in humans.
Substances containing Endocrine disruptors can be present in several products, including pesticides and cosmetics. Their impact may cause side effects, such as prostate and breast cancer, Infertility, obesity, and many others. Although the impact of EDs is higher during the earlier stages of life, the relevant side effects can become manifest even after decades.
Kojic Acid interferences
Recently, Kojic Acid has been reported to interfere with crucial thyroid functions, particularly iodine organification and iodine uptake. Following the reports, the European Commission called for the recollection of scientific data by the SCCS, and Kojic Acid has been included in the priority list (Group A) for safety assessment, considering the concerns of its potential ED properties.
SCCS Preliminary Opinion
Following the assessment results, the SCCS released a new preliminary opinion during the plenary meeting held on October 26/27, 2021. Considering the evidence provided and the upper mentioned concerns, the Committee clarified that a concentration of 1% Kojic Acid is not safe for the intended use in cosmetic products. Due to the lack of specific data provided by the industry on the number of different cosmetics containing the substance, the SCCS could not advise on its safe concentration in individual products. Nonetheless, as an example, the SCCS clarified that: ”for the combined twice a day use of face cream and hand cream, the maximum concentration of Kojic Acid should not exceed 0.04%”.
At the moment, the SCCS opinion remains preliminary, hence open to further comments. Despite this, we recommend replacing Kojic Acid in the light of a possible ban in the near future.
Update from 18/03/2022
SCCS Final Opinion
At its plenary meeting held on March 15/16, 2022, the SCCS adopted a new opinion on Kojic acid, clarifying the safe concentration of the substance in relation to its potential endocrine disrupting properties.
The Committee reassessed the safe use of the substance in light of newly provided clinical data.
Upon the review of a new set of data the SCCS concluded that: “Kojic Acid is not safe when used as a skin lightening agent in cosmetic products at concentrations of up to 1%” (SCCS, 2022). The Committee clarified that for the substance to be considered safe in a cosmetic, its maximum concentration must not exceed 0.7% in the final product formula.
In addition, the SCCS expressed further concerns regarding the use of Kojic Acid in cosmetic products. As the substance has sometimes been added to peeling agents, a weakened skin barrier after using a peeling in some users may lead to greater dermal absorption, this may lead to further concerns.
Furthermore, it is of the utmost importance to clarify that the SCCS evaluated only the topical use of Kojic Acid in cosmetics. In contrast, it did not consider other uses of the substance.
Moreover, derivatives of Kojic Acid such as:
- Kojic Acid dipalmitate;
- Kojic Acid isopalmitate;
- Chloro-Kojic acid.
Have not been included in the newly released Opinion, as no new scientific evidence has been submitted to the SCCS in this regard.
Was this article of aid?
To get more information regarding the current status of substances containing Endocrine-disruptors, follow the link below:
- SCCS. (2022). Scientific opinion on Kojic acid. Retrieved on 18/03/2022 from https://ec.europa.eu/health/latest-updates/sccs-final-opinion-kojic-acid-2022-03-17_en
- COSlaw. (2021). Endocrine disruptors: keep up with cosmetics news! – COSlaw.eu – Guiding through EU Cosmetics Regulations. Retrieved on 16/11/2021 from https://www.coslaw.eu/endocrine-disruptors-keep-up-with-cosmetics-news/
- SCCS. (2021). Scientific Committee on Consumer Safety SCCS OPINION ON Kojic Acid. Retrieved on 19/11/2021 from https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_098.pdf
- COSMETICOBS. (2021). Kojic Acid: the SCCS preliminary Opinion. Retrieved on 19/11/2021 from https://cosmeticobs.com/en/articles/regulation-57/kojic-acid-the-sccs-preliminary-opinion-6104
- WHO, IPCS. (2002). Global Assessment of the State-of-the-science of Endocrine Disruptors.Retrieved on 13/09/2021 from https://www.who.int/ipcs/publications/en/toc.pdf?ua=1