Cosmetic products

Background: 

Endocrine disruptors (ED) are substances that have an unwanted impact on the endocrine systems of human and animals and as such may exert a negative influence on human and animal health. Such effects have also been observed with naturally occurring compounds, such as the isoflavones daidzein and genistein or the fungal metabolite kojic acid. The use of 4-methylbenzylidene camphor (4-MBC), genistein, daidzein, kojic acid, triclosan and triclocarban in cosmetics has now been restricted or prohibited by Commission Regulation (EU) 2024/996 amending Regulation (EC) No. 1223/2009 on cosmetic products.

Strategic evaluation

Endocrine disruption, i.e. unwanted, negative interference with hormonal control circuits in humans or animals, has long been the subject of discussions among regulatory toxicologists. In 2018, the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) published a joint paper on scientific assessment criteria for ED. Based on this, the Scientific Committee on Consumer Safety (SCCS) has now evaluated the first 14 of 28 substances that are classified as priority substances for use in cosmetic products. These are benzophenone-3, kojic acid, 4-methylbenzylidene camphor, propylparaben, triclosan, resorcinol, octocrylene, triclocarban, butylhydroxytoluene, benzophenone, homosalate and benzyl salicylate, along with the isoflavones genistein and daidzein. In April 2024, the European Commission imposed a ban on the use of 4-methylbenzylidene camphor and defined conditions of use for kojic acid, daidzein and genistein in cosmetic products with Commission Regulation (EU) 2024/996.

Challenges facing our customers

Frequently referred to as “phytoestrogens”, genistein and daidzein are often found in natural cosmetic products as constituents of soya or red clover extracts, for example. Products containing these substances may only be placed on the market from 1 February 2025 onwards, and may only be made available on the Union market from 1 November 2025 if they contain less than the maximum levels specified in Annex III of the Regulation on cosmetic products (see table).

Table 1: Restrictions according to Annex III of Regulation (EC) No 1223/2009

PhytoLab’s service for you

Apart from many years of experience, PhytoLab also has established methods at its disposal for determination of daidzein, genistein and other isoflavones, e.g. in soya, pueraria or red clover preparations, as well as other substances prioritised by the SCCS, such as methylparaben or salicylic acid. PhytoLab’s Medical Affairs team can offer you expert support in the preparation of safety assessments for your ingredients and finished products.

Your contacts at PhytoLab:

Analysis:

DR. KLAUS REIF
Phone +49 9163 88-337
klaus.reif@phytolab.de

Sales:

ELKE LENZER
Phone+49 9163 88-597
sales@phytolab.de