Scientific Committee on Consumer Safety (SCCS) Opinions

李锦聪3个月前 (06-19)法规

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.

· New coating for Titanium Dioxide (nano form)

SCCS/1667/24 - 20 May 2024

Deadline for comments: 22 July 2024


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.

· Citral (CAS No. 5392-40-5, EC No. 226-394-6) sensitisation endpoint

SCCS/1666/24 - 27 March 2024


· Triphenyl phosphate (CAS No. 204-112-2, EC No. 115-86-6)

SCCS/1664/24 - 27 March 2024


· Inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil – AVO (CAS No 84082-84-8, EC No 282-031-1) in sprayable cosmetic products - Submission IV

SCCS/1663/24 - 28 February 2024


Final Opinions

Colorant

· Safety of Silver (CAS/EC No. 7440-22-4/231-131-3) used in cosmetic products

SCCS/1665/24 - 20 June 2024

Fragrance

· Hexyl Salicylate (CAS/EC No. 6259-76-3/228-408-6)

SCCS/1658/23 - 28 February 2024


· Benzyl salicylate (CAS No. 118-58-1, EC No. 204-262-9)

SCCS/1656/23 - 26 October 2023


· Scientific Advice – children exposure on Methyl salicylate (methyl 2-hydroxybenzoate)

SCCS/1654/23 - 14 September 2023

Hair dyes

· Hydroxypropyl p-phenylenediamine and its dihydrochloride salt (A165) (CAS/EC No. 73793-79-0/827-723-1 and 1928659-47-5/-)

SCCS/1659/23 - 28 February 2024


· 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

· Fullerenes, Hydroxylated Fullerenes and hydrated forms of Hydroxylated Fullerenes (nano)

SCCS/1649/23 - 26 October 2023


· Hydroxyapatite (nano)

· SCCS/1648/22 - 21-22 March 2023

Preservatives

· Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0)

SCCS/1650/23 - 21 December 2023


· Methylparaben (CAS No. 99-76-3, EC No. 202-785-7)

SCCS/1652/23 - 14 December 2023

A corrigendum clarifying SCCS conclusion under question 1 was adopted by written procedure on 28 February 2024.


· Butylparaben (CAS No. 94-26-8, EC No. 202-318-7)

SCCS/1651/23 - 26 October 2023


· Safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products

SCCS/1643/22 - 24-25 October 2022

UV Filters

· Scientific Advice on Titanium dioxide (TiO2) (CAS/EC numbers 13463-67-7/236-675-5, 1317-70-0/215-280- 1, 1317-80-2/215-282-2)

SCCS/1661/23 - 13 May 2024


· Benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2)

SCCS/1660/23 - 27 March 2024


· 4-Methylbenzylidene camphor (4-MBC)

SCCS/1639/21 - 29 April 2022

Other

· Safety of aluminium in cosmetic products - Submission IV

SCCS/1662/23 - 27 March 2024


· Water-soluble zinc salts used in oral hygiene products - Submission II

· SCCS/1657/23 - 26 October 2023


· 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

The corrigendum 1 on Table 3A page 27 (footnote added under deo non-spray) was adopted on 26 October 2023 and the corrigendum 2 on Tables 3A and 3B was adopted on 21 December 2023


· Checklists for Applicants submitting dossiers on Cosmetic Ingredients to be evaluated by the SCCS

· SCCS/1588/17 - 7 March 2017 - revised on 16 May 2018

Previous committee

Opinions SCCS (April 2016 - December 2021)


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