Details
- Status
- Open
- Opening date
- Deadline
Target audience
The Commission would like to invite any interested parties, including
- academic and other research institutes
- EU countries’ authorities
- cosmetic products manufacturers
- raw material producers and suppliers
- consumer associations
to submit data, scientific evidence and relevant information about aggregate exposure to salicylic acid from the use of salicylic esters in cosmetic products, as identified in Tier 1.
Policy fields
Internal market and industry, public health.
Objective of this call for data
On 25 June and 27 October 2021, the Scientific Committee on Consumer Safety (SCCS) adopted its final opinions on homosalate and methyl salicylate respectively. In these opinions, the SCCS raised concerns over the potential overexposure of consumers to salicylic acid from various salicylates used in cosmetic products.
Following these SCCS opinions, a number of EU countries expressed their concerns over possible overexposure to salicylic acid and a potential risk to human health. The Commission therefore intends to request 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 for the SCCS, interested parties are invited to submit, in accordance with the requirements described below, any relevant information and data in order to proceed with assessing the aggregate exposure to salicylic acid from the salicylic esters used in cosmetic products.
Consultation period
Data on aggregate exposure to salicylic acid must be based on the salicylates identified in Tier 1. It must be submitted from 1 July 2024 to 1 July 2025.
Requirements
Please use our applicants' checklist when preparing your submission. Your input should include the following elements
- table of contents
- numbered references
Submitted data should also be in line with the SCCS ‘Notes of Guidance’ for testing cosmetic ingredients and evaluating their safety (12th revision).
How to submit your contribution
Please email your submission to GROW-COSMETICS-CALLS-FOR-DATA
ec [dot] europa [dot] eu (GROW-COSMETICS-CALLS-FOR-DATA[at]ec[dot]europa[dot]eu) by 1 July 2025. It should contain the reference ‘Call for data – Salicylic esters: Tier 2’.
If you have any queries about data protection, please read our privacy statement.
Why we are consulting
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 with the provisions laid out in Article 15 of the CPR.
This 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 countries expressed their concerns over the possible overexposure to salicylic acid and a potential risk to human health. The Commission therefore intends 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, for Tier 1, the Commission services requested data relevant to the identification of salicylic esters used in cosmetic products, as well as info on their physicochemical properties, kinetics, metabolism and skin penetration.
Whereas in Tier 2, the Commission services seeks to gather information on the aggregate exposure to salicylic acid via the identified salicylic esters from Tier 1, which would allow the SCCS to perform a safety assessment.
Moreover, to allow for the submission of adequate data, information and evidence, Tier 2 will run for a year. It is important to note that this approach has been followed to accommodate the particularities of this exercise and to meet its specific aims.
Upon receipt of sufficient and appropriate data, the Commission will assess the respective information and proceed in mandating the SCCS for Tier 2 of this exercise.
If needed, the Commission may take appropriate action to prohibit or restrict the use of specific substances in cosmetics.