Permitted under conditionsAnx. IIIRef. III/373

GENISTEIN

SKIN CONDITIONING - MISCELLANEOUS

CAS
446-72-0
EC
207-174-9
IUPAC
—
Max conc.
0,007 %

Last CosIng update

4 April 2024

Description

Genistein is an isoflavone, as follows from its chemical name 4',5,7-Trihydroxyisoflavone. In the cosmetic field, it is declared with the technical function SKIN CONDITIONING - MISCELLANEOUS. Ingredients classified within the skin conditioner category are those incorporated into formulations with the general purpose of contributing to maintaining the condition of the skin in terms of appearance and texture. In the official listings it also appears under the name GENISTEIN.

Under Regulation (EC) No 1223/2009 on cosmetic products, this substance is included in Annex III, reference 373, corresponding to the substances subject to restrictions that may only be used within the limits and conditions established. The maximum authorized concentration in the finished product is "0,007 %". The additional conditions set state that "From 1 February 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market." The substance has no CMR classification, and no additional mandatory labelling warnings or specific restrictions by type of cosmetic product are recorded in the regulatory record.

As a specific cosmetic restriction, what is indicated in III/373 applies. The information presented is for technical reference only and does not constitute a recommendation for use or an efficacy claim.

Detailed EU regulation

%

Maximum permitted concentration

0,007 %

§

Regulatory framework

Regulation (EC) No 1223/2009 — Annex III, ref. 373

Last update reflected in the database: 4 April 2024

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Conditions of use

From 1 February 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.

Recent analyses mentioning this ingredient

  • SeguimientoOpinión científica SCCS (versión final con corrigendum) · 23 de septiembre de 2022
    Genistein and Daidzein

    El SCCS concluye, en la opinión SCCS/1641/22 (versión final adoptada el 16 de septiembre de 2022, con corrigendum del 11 de octubre de 2022), que la genisteína es segura en productos cosméticos hasta una concentración máxima de 0,007 % y que la daidzeína es segura hasta 0,02 %. La evaluación se basa en las formas aglicona de ambas isoflavonas y considera sus posibles propiedades de disrupción endocrina. El corrigendum corrige la biodisponibilidad por vía oral de la daidzeína a 25 % en el cálculo del margen de seguridad. Las preguntas 2 y 3 del mandato (concentración máxima alternativa y otras preocupaciones científicas) no reciben una respuesta adicional.

Data source: Official CosIng from the European Commission, updated on 4 April 2024. Learn more →