Preliminary Opinions open for comments
The preliminary Opinions in this section have been developed by the SCCS on the basis of specific sets of data (dossiers) submitted by specific Applicants (e.g. Industry, Member State authorities, etc.) in order to satisfy specific regulatory requirements.
These preliminary Opinions have been recently approved and are now open for clarification/comment for a minimum period of 4 weeks (if possible, for a period of eight weeks). The exact timeline is given for each Opinion.
This publication intends to enable Applicants, but also other interested parties, to provide clarification/comment, if any, about the evaluation, interpretation, and incorporation of the submitted set of data in the SCCS preliminary Opinion.
Please note that this is NOT a public consultation process whereby new evidence or comments on the scientific basis of the preliminary Opinion are submitted for consideration in order to finalise the Opinion, nor is it an opportunity for the Applicant concerned to submit a totally new set of data that would lead to a new submission and mandate.
Clarifications/comments should preferably be numbered, clearly referring to specific sections of the Preliminary Opinion (to be indicated) and sent to the following mailbox only: SANTE-SCCS@ec.europa.eu
The clarifications/comments received during the commenting period will be forwarded to the SCCS for consideration.
Opinions being finalised
The commenting period for the Opinions in this section has expired. Comments received during this period have been submitted to SCCS and will be discussed in the forthcoming working groups and plenary meetings with the view to finalising the Opinions.
- Water-soluble zinc salts used in oral hygiene products - Submission II
SCCS/1657/23 - 3 July 2023
- Benzyl salicylate (CAS No. 118-58-1, EC No. 204-262-9)
SCCS/1656/23 - 6-7 June 2023
- Methylparaben (CAS No. 99-76-3, EC No. 202-785-7)
SCCS/1652/23 - 6-7 June 2023
- Butylparaben (CAS No. 94-26-8, EC No. 202-318-7)
SCCS/1651/23 - 6-7 June 2023
- Fullerenes, Hydroxylated Fullerenes and hydrated forms of Hydroxylated Fullerenes (nano)
SCCS/1649/23 - 21-22 March 2023
- Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0)
SCCS/1650/23 - 21-22 March 2023
Final Opinions
Fragrance
- Scientific Advice – children exposure on Methyl salicylate (methyl 2-hydroxybenzoate)
SCCS/1654/23 - 14 September 2023
Hair dyes
- Scientific Advice on HC Blue 18 (Colipa No. B122) - Submission II
SCCS/1653/23 - 27 April 2023
- Sodium bromothymol blue (C186) (CAS No. 34722-90-2, EC No. 252-169-7)
SCCS/1645/22 - 21-22 March 2023
Nanomaterial in cosmetic ingredients
- Hydroxyapatite (nano)
SCCS/1648/22 - 21-22 March 2023
Preservatives
- Safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products
SCCS/1643/22 - 24-25 October 2022
UV Filters
- 4-Methylbenzylidene camphor (4-MBC)
SCCS/1639/21 - 29 April 2022
Other
- Salicylic acid (CAS No. 69-72-7, EC No. 200-712-3)
SCCS/1646/22 - 6-7 June 2023
- Safety of aluminium in cosmetic products - Submission III
SCCS/1644/22 - 1 February 2023
A corrigendum has been adopted on 21 March 2023 adding a note explaining that “AP” means “antiperspirant” under Table 6 of the Applicant.
- Safety of alpha-arbutin and beta-arbutin in cosmetic products
SCCS/1642/22 - 31 January 2023
- Revision of the scientific Opinion (SCCS/1576/16) on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate)
SCCS/1639/21 - 24-25 October 2022
- Genistein and Daidzein
SCCS/1641/22 - 16 September 2022
A corrigendum to correct the bioavailability oral route for daidzein has been adopted on 11 October 2022.
- Kojic acid
SCCS/1637/21 - 15-16 March 2022
The Corrigendum includes changes in the abstract, in sections 3.2.4 calculation of SED/LED - 3.4 safety evaluation - 3.5 discussion and relevant conclusions 1 and 2. Adoption 10 June 2022.
- Prostaglandins and prostaglandin-analogues used in cosmetic products
SCCS/1635/21 - 3 February 2022
Statements
- SCCS Guidance on the safety assessment of nanomaterials in cosmetics - 2nd revision
SCCS/1655/23 - 6 June 2023
- SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation - 12th revision
SCCS/1647/22 - 15 May 2023