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: 16 May 2019 - 15 October 2019

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 14 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 SCCS, interested parties are invited to submit any 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 A (see ‘background’ below). These include the following

INCI Name Chemical Name CAS No. Benzophenone-3 2-Hydroxy-4-methoxybenzophenone 131-57-7 Kojic acid 5-Hydroxy-2-hydroxymethyl-4-pyrone 501-30-4 4-Methylbenzylidene camphor (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one 36861-47-9 Propylparaben Propyl 4-hydroxybenzoate 94-13-3 Triclosan 5-Chloro-2-(2,4-dichlorophenoxy)phenol 3380-34-5 Resorcinol 1,3-benzenediol 108-46-3 Octocrylene 2-Cyano-3,3-Diphenyl Acrylic Acid 2-Ethylhexyl Ester 6197-30-4 Triclocarban 1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl)urea 101-20-2 BHT (butylated hydroxytoluene) 2,6-Di-tert-butyl-p-cresol 128-37-0 Benzophenone Benzophenone 119-61-9 Homosalate 2-hydroxybenzoic acid (3,3,5-trimethylcyclohexyl) ester or Benzoic Acid, 2-Hydroxy-, 3,3,5-Trimethylcyclohexyl Ester 118-56-9 Benzyl salicylate Benzyl salicylate 118-58-1 Genistein 5,7-dihydroxy-3-(4-hydroxyphenyl)-4-benzopyrone 446-72-0 Daidzein 4',7-Dihydroxyisoflavone or 7-hydroxy-3-(4-hydroxyphenyl)chromen-4-one or 7-Hydroxy-3-(4-hydroxyphenyl)-4H-1-benzopyran-4-one” 486-66-8

Interested parties are requested to provide their input together with

a) the attached template (template for submitting input – checklists)

b) a table of contents

c) numbered references

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

How to submit your contribution

Any information should be delivered with the reference: ‘Endocrine disruptors’ by post or e-mail by 15 October 2019 at the latest to

European Commission

Directorate General Internal Market, Industry, Entrepreneurship and SMEs

Unit D/4, Health Technology and Cosmetics

Avenue d’Auderghem 45, BREY 12/10

1040 Brussels

Belgium

Email: grow-cosmetics-and-medical-devices@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 report 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 overall conclusion at this stage is that the cosmetic regulation provides the adequate tools to regulate the use of cosmetic substances that present a potential risk for human health.

In the report, the Commission also commits to establishing a priority list of potential endocrine disruptors not already covered by the bans in the cosmetics regulation by the end of March 2019 for risk assessment. The starting point for this priority list was the result of the screening study that was conducted to support the impact assessment in the field of plant protection products and biocides. The screening study identified 6 substances (benzophenone-3, kojic acid, 4-methylbenzylidene camphor, propylparaben, triclosan and resorcinol) used in cosmetic products as potentially having endocrine-disrupting properties that were not covered by an existing or ongoing prohibition.

The Commission presented the preliminary list of 6 substances to the members of the working group on cosmetic products in a meeting in December 2018. Working group members were invited to comment on the list and submit other substances of concern considered as potential endocrine disruptors along with argumentation for this consideration by the end of February 2019 (extended to 8 March 2019 upon request).

Following working group members’ input, a final list of 28 substances was consolidated. To prioritise the substances on this list, internal discussions were carried out to determine if any of these 28 substances were being assessed under REACH for endocrine disruptor (ED) concerns. Additionally, an informal consultation with the SCCS helped to prioritise the substances based on scientific evidence/literature. As a result of these discussions, the list of 28 substances was split into the 2 following groups:

Group A

Group A consists of 14 substances that should be treated with higher priority for assessment as they are undergoing substance evaluation (SEV) under REACH for ED concerns or the SEV has already confirmed ED concerns.

Group B

Group B consists of 14 substances where either no SEV has been initiated or the outcome of the SEV is of an environmental ED concern and not a human health one. These substances are: butylparaben, tert-butylhydroxyanisole/Butylated hydroxyanisole/BHA, 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.

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

This first call for data relates to the 14 substances found in Group A. 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.

A second call for data related to the 14 substances found in Group B will take place in the future, taking into consideration any relevant developments.