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Call for data on ingredients used in cosmetic products

This is a call for data in order to identify the various salicylic esters used in cosmetic products that are metabolised to Salicylic Acid in the framework of the Cosmetic Product Regulation (EC) 1223/2009.

Dettagli

Stato
Aperto
Data di apertura
Scadenza

Destinatari

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

Policy fields

Internal market and industry, public health.

Period of consultation

Identification and information on salicylic esters used in cosmetic products that are metabolised to Salicylic Acid: From 5 April 2022 to 6 January 2023

Request

The Commission would like to invite any interested parties, including academic and other research institutes, EU countries’ authorities, manufacturers of cosmetic products, raw material producers and suppliers, and consumers associations, to submit data, scientific evidence and information relevant to the identification of salicylic esters in cosmetic products that are metabolised to Salicylic Acid, including but not limited to, data on physchem, metabolism, kinetics, skin penetration, etc.

Action proposed by the Commission

On 25 June and 27 October 2021, the Scientific Committee on Consumer Safety (SCCS) adopted their final Opinion on Homosalate and Methyl Salicylate, respectively, whereby the committee raised concerns over the potential overexposure of consumers to Salicylic Acid from various salicylates used in cosmetic products.

Following the SCCS Opinions, a number of EU Member States expressed their concerns over the possible overexposure to Salicylic Acid and a potential risk to human health. The Commission intends, therefore, to request from the SCCS to perform a safety assessment, specifically on the aggregate exposure to Salicylic Acid from salicylic esters used in cosmetic products.

In order to prepare a mandate to the SCCS, interested parties are invited to submit, in accordance with the requirements described below, any relevant information and data in order to identify the various salicylic esters used in cosmetic products that are metabolised to Salicylic Acid, in order to proceed with an assessment of the aggregate exposure to Salicylic Acid from cosmetic products.

Requirements

Interested parties are invited to submit relevant information and evidence on the identification and of use of salicylic esters in cosmetic products, including but not limited to data/information regarding their physicochemical properties and toxicokinetics, an indication of the concentration limits for the salicylates identified, kinetics and metabolism data, as well as skin penetration data.

Please provide your input including the following elements included

a)  template-checklists

b)  table of contents

c)  numbered references

Data submitted should be in line with the SCCS ‘Notes of Guidance’ (testing of cosmetic ingredients and their safety evaluation - 11th revision).

How to submit your contribution

Any information should be delivered with the reference: ‘Call for data – Salicylic esters: Tier 1’ by e-mail to GROW-COSMETICS-CALLS-FOR-DATA@ec.europa.eu by 6 January 2023.

Background

Regulation (EC) No 1223/2009 on cosmetic products (CPR) provides a regulatory framework to ensure a high level of protection of human health, while ensuring the functioning of the internal market. Environmental concerns from substances used in cosmetic products are considered through the application of Regulation (EC) No 1907/2006 (‘REACH Regulation’).

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

Salicylic Acid (CAS No. 69-72-7, EC No. 200-712-3) with the chemical name ‘benzoic acid, 2-hydroxy’ is used in cosmetic products with reported functions as a denaturant, hair and skin conditioning agent, exfoliant/keratolytic, anti-sebum agent, anti-dandruff/anti-seborrheic agent and a product preservative. Salicylic Acid has been subject to a safety evaluation by SCCNFP in 2002 and SCCS in 2018. In particular, the latest SCCS assessment was performed in view the classification of Salicylic Acid as a CMR2 (Repr.2) substance by the Regulation on classification, labelling and packaging of substances and mixtures (‘CLP Regulation’) and in accordance to the provisions laid out in Article 15 of the CPR. It is currently regulated under Annex III (entry 98) and Annex V (entry 3), with specific maximum concentrations and conditions of use. Salicylic Acid was listed in Group B of substances used in cosmetics with potential endocrine effects, as part of the initiative to assess their safety in cosmetics. The SCCS is currently re-assessing the safety of Salicylic Acid based on the information/data submitted vie the call for data that run from 15 February to 15 November 2021.

On 25 June and 27 October 2021, the SCCS adopted their final Opinion on Homosalate and Methyl Salicylate, respectively, whereby the committee raised concerns over the potential overexposure of consumers to Salicylic Acid from various salicylates used in cosmetic products. Furthermore, the committee is currently assessing the safety of Benzyl Salicylate, which is another common salicylate in cosmetic products and which may also contribute to the aggregate exposure.

Following the SCCS conclusions, a number of EU Member States expressed their concerns over the possible overexposure to Salicylic Acid and a potential risk to human health. The Commission intends, therefore, to request from the SCCS to perform a safety assessment, specifically on the aggregate exposure to Salicylic Acid from salicylic esters used in cosmetic products.

In order to proceed with an appropriate assessment it is necessary to identify the various salicylic esters that are used in cosmetics and that are specifically metabolised to Salicylic Acid, as well to collect information and data on the aggregate exposure to Salicylic Acid from such products.

In light of the complexity of this exercise, including the extensive number of salicylic esters potentially used in cosmetic products and the possible need for a probabilistic aggregate exposure assessment based on real life habits and practices, the Commission services have decided to follow a tiered approach. In particular, in Tier 1 the Commission services are requesting data relevant to the identification of salicylic esters used in cosmetic products, as well as info on their physchem properties, kinetics, metabolism and skin penetration, whereas in Tier 2 the Commission services will seek to gather information on the aggregate exposure to Salicylic Acid via the identified salicylic esters from Tier 1. In order to allow the submission of adequate data, information and evidence, the two calls will run for longer periods than usual. It is important to note that this approach has been followed to accommodate the particularities of this exercise and in order to meet its specific aims.

Upon receipt of sufficient data, the Commission will assess the respective information and proceed in mandating the SCCS for each Tier of the exercise. If needed, the Commission may take appropriate action to prohibit or restrict the use of specific substances in cosmetics.

More information