EU amends CLP Regulation for harmonized classification and labeling of substances – Impact in cosmetics

Ingredients: Dimethyltolyamine, Trimethylbenzoyl Diphenylphosphine Oxide - TPO

Date of publication: 05/01/2024

On 5 January 2024, the EU amended the CLP Regulation for harmonized classification and labeling of substances.

WHAT’S NEW?

The Delegated Regulation (EU) 2024/197 of 19 October 2023 has been published in the Official Journal of the European Union on 5 January 2024. It is the 21st ATP (Adaptation to Technical and Scientific Progress) of the European CLP Regulation No. 1272/2008 (Classification, Labelling and Packaging of substances).

This amendment to CLP Regulation includes 28 new additions and 24 amendments. From the substances listed, 16 ingredients are reported to be used in cosmetics and are not yet included in Annex II (list of substances not allowed in cosmetics).

From these 16 ingredients, 2 were classified as CMR (Carconogenic, Mutagenic or Toxic for reproduction):

Dimethyltolyamine (CAS No:99-97-8) – carcinogenic 1B, functions as nail conditioning, not currently listed in annexes to the EU Cosmetics Regulation.
Trimethylbenzoyl Diphenylphosphine Oxide – TPO (CAS No:75980-60-8) – reprotoxic 1B, functions as skin conditioning, currently listed in Annex III entry 311 of the EU Cosmetics Regulation.

According to Article 15 of the EU Cosmetic Regulation, the use in cosmetic products of substances classified as CMR substances, of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) 1272 2008 shall be prohibited.

WHAT NOW?

Delegated Regulation (EU) 2024/197 applies from 1st September 2025.

The cosmetic ingredients were not defended by industry and will therefore be included in Annex II (list of prohibited substances) of the EU Cosmetics Regulation (EC) No. 1223/2009 via the 7th CMR Omnibus Regulation.

The making available (off-shelf) deadline for products containing these substances will be 18 months after publication of the 21st ATP to CLP on the EU Official Journal, that is, 5 June 2025.

Note: this new legislation will not automatically be included within the Great Britain (GB) CLP Regulation. So currently, the announced bans will apply only in the EU market.

References:

Commission Delegated Regulation (EU) 2024/197 of 19 October 2023, amending Regulation (EC) No 1272/2008 as regards the harmonised classification and labelling of certain substances.

other REGULATORY UPDATES

Regulation (EU) 2022/692 – OMNIBUS ACT VI – New and Updated Classification of Cosmetic Ingredients

Ingredients: BENZOPHENONE, TEOPHYLLINE, MELAMINE, AZADIRACHTA EXTRACTS, TRIMETHYLOLPROPANE TRIACRYLATE, PENTETIC ACID, PENTASODIUM PENTETATE

Date of publication: 03/05/2022

Date of application: 01/12/2023

The Commission Delegated Regulation (EU) 2022/692 includes new or updated classification for 12 chemicals that may be used as cosmetic ingredients. Seven out of these 12 are now classified as carcinogenic, mutagenic or toxic to reproduction (CMR) and are banned from cosmetic products marketed in the EU.

Update on the classification and labelling of Titanium Dioxide in powder form

Ingredients: TITANIUM DIOXIDE

Date of publication: 23/11/2022

The EU General Court annuls the Commission Delegated Regulation of 2019 in so far as it concerns the harmonised classification and labelling of Titanium Dioxide as a carcinogenic substance by inhalation in certain powder forms.

French labelling requirement for leave-on products containing Phenoxyethanol repealed

Ingredients: PHENOXYETHANOL

The EU Court of Justice repealed the French requirement for the labelling of the precautionary measurement “Not to be used on the nappy-skin area of children under 3 years of age” on leave-on cosmetic products containing Phenoxyethanol. Therefore, the labelling restriction related to Phenoxyethanol is officially not mandatory for products imported into France.

SCCS Final Opinion on the Safety of Triclocarban and Triclosan

Ingredients: TRICLOCARBAN and TRICLOSAN

Date of publication: 25/10/2022

During the plenary meeting on 24-25 October 2022, the Scientific Committee on Consumer Safety (SCCS) presented its final opinion on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products.

SCCS Revision of the Scientific Opinion on Vitamin A

Ingredients: RETINOL, RETINYL PALMITATE, RETINYL ACETATE, RETINYL LINOLEATE, RETINAL

Date of publication: 25/10/2022

The Scientific Committee on Consumer Safety has issued a final version of the Scientific Opinion on Vitamin A, concluding that exposure to Vitamin A derived from cosmetics can be a concern for higher exposure consumers, and since cosmetics alone do not exceed the upper limit the SCCS cannot suggest maximum concentration limits that take into account contributions from other sources.

SCCS Preliminary Opinion on Sodium Bromothymol Blue (C186) as hair dyeing

Ingredients: SODIUM BROMOTHYMOL BLUE (C186)

Date of publication: 28/10/2022

Following the request from the EU Commission for a scientific opinion on the hair dye Sodium Bromothymol Blue (C186), on October 2022 the Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion. In light of the data provided, when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5%, the SCCS is of the opinion that the complete safety of Sodium Bromothymol Blue could not be assessed.