Policy fields

Internal market and industry, public health

Target

Any interested parties, including academic and other research institutes, EU countries’ authorities, manufacturers of cosmetic products, producers of the substances concerned and consumers associations.

Period of consultation

From 15 February to 15 November 2021 on all substances except for Butylparaben.

Period of consultation for Butylparaben

From 15 February to 15 July 2021.

Request

The Commission would like to invite any interested parties, including academic and other research institutes, EU countries’ authorities, manufacturers of cosmetic products, producers of the 10 substances mentioned below and consumers associations, to submit any scientific information relevant to safety assessment.

Action proposed by the Commission

To prepare requests for scientific opinions to the EU Scientific Committee on Consumer Safety (SCCS), interested parties are invited may submit relevant scientific information including data regarding all physicochemical properties, toxicokinetics and toxicological end-points, assessment of exposure through consumer products and/or an indication of the suggested safe concentration limits for the substances listed in Group B (see ‘background’ below). These include those listed in the following table.

How to submit your contribution

Interested parties are requested to provide their input together with

1. the attached template (template for submitting input – checklists)
2. a table of contents
3. numbered references

Data submitted should be in line with the SCCS notes of guidance for the testing of cosmetic ingredients and their safety evaluation (10^th revision).

Email all information with the reference ‘Endocrine disruptors’ to: GROW-COSMETICS-CALLS-FOR-DATA@ec.europa.eu

Background

Regulation (EC) No 1223/2009 on cosmetic products (Cosmetics Regulation) provides a regulatory framework to ensure a high level of protection of human health.

To address potential risks for human health, the cosmetics regulation lays down a system of restrictions and bans on the use of certain substances in cosmetics based on a scientific risk assessment carried out by the Scientific Committee on Consumer Safety (SCCS).

Scientific concerns about the endocrine-disrupting properties of substances used in cosmetic products are, like other substances of concern for human health, addressed in the risk assessment of the SCCS. Conclusions are made on whether endocrine/hormonal activities are linked to the critical endpoint for assessing the safety of these substances for consumers, including vulnerable groups such as children when applicable.

As per Article (15)(4) of the Cosmetics Regulation, the Commission will review the regulation on substances with endocrine-disrupting properties.

On 7 November 2018, the Commission adopted the review of Regulation (EC) No 1223/2009 on cosmetic products regarding substances with endocrine-disrupting properties. The document is factual and takes stock of how substances considered as potential endocrine disruptors were tackled under the cosmetics regulation – namely, banned or restricted on a case-by-case basis following their safety assessment by the SCCS. The review concluded that the cosmetics regulation provides the adequate tools to regulate the use of cosmetic substances that present a potential risk for human health.

In the review, the Commission also commits to establishing a priority list of potential endocrine disruptors not already covered by the bans in the cosmetics regulation for their subsequent assessment. A priority list of 28 potential EDs in cosmetic products was consolidated in early 2019 based on input provided through a stakeholder consultation.

To prioritise the substances, they were split into the 2 following groups.

Group A

Benzophenone-3, Kojic acid, 4-Methylbenzylidene Camphor (4-MBC), Propylparaben, Triclosan, Resorcinol, Octocrylene, Triclocarban, BHT/Butylated hydroxytoluene, Benzophenone, Homosalate, Benzyl Salicylate, Genistein and Daidzein.

14 substances to be treated with higher priority for assessment as they were undergoing substance evaluation (SEV) under REACH for ED concerns or the SEV had already confirmed ED concerns at the time of publication of the priority list.

Group B

Butylparaben, BHA / Butylated hydroxyanisole / tert-Butylhydroxyanisole, Ethylhexyl Methoxycinnamate (EHMC) / Octylmethoxycinnamate (OMC) / Octinoxate, benzophenone-1 (BP-1), Benzophenone-2 (BP-2), Benzophenone-4 (BP-4), Benzophenone-5 (BP-5), Methylparaben, Cyclopentasiloxane / Decamethylcyclopentasiloxane / D5, Cyclomethicone, Salicylic acid, Butylphenyl methylpropianol / BMHCA, Triphenyl phosphate and Deltamethrin.

14 substances where either no SEV had been initiated or the outcome of the SEV was an environmental ED concern and not a human health one at the time of publication of the priority list.

Group B also contained substances that had been recently been evaluated by the SCCS and found safe, and/or substances that had been recently classified as CMRs under the CLP, where corresponding risk assessment/management measures were already in place to prohibit/restrict their use in cosmetic products.

Further background

A public call for data on the 14 Group A substances was organised in 2019 to enable the preparation of the safety assessment of these substances. Based on data received in 2019, and in February 2020, the Commission mandated the SCCS to carry out the risk assessments for five substances, including one hair dye (Resorcinol), one preservative (Propylparaben) and three UV-filters (Octocrylene, Homosalate and Benzophenone-3). Currently, based on further data received in 2020, the Commission is in the process of mandating the SCCS to carry out further risk assessments on 4-Methylbenzylidene Camphor (4-MBC), Butylated Hydroxytoluene (BHT), Kojic Acid, Genistein and Daidzein during the course of 2021. 

In parallel, this second public call for data relates to 10 of the Group B substances. In view of the identification of Butylparaben as a substance of very high concern (SVHC) due to ED properties with effects on human health and its subsequent inclusion in the REACH candidate list of SVHCs in June 2020, the deadline to submit data is shorter. As regards Cyclopentasiloxane / Decamethylcyclopentasiloxane / D5, Cyclomethicone, Butylphenyl Methylpropianol / BMHCA and Deltamethrin, they are excluded in this call for data due to other pending regulatory measures or discussions which could prejudge the need for further action.

Upon receipt of sufficient data, the Commission will mandate the SCCS to evaluate the substances as soon as possible. If needed, the Commission will then take appropriate action to prohibit or restrict the use of the different substances in cosmetics.

More information

• Template for submission input – Checklist for call data
• Privacy statement