European Union notifies WTO of the draft 19th ATP to CLP Regulation

Ingredients: DIMETHYLTOLYLAMINE, TRIMETHYLBENZOYL DIPHENYLPHOSPHINE OXIDE

Date of draft publication: 02/03/2023

On 2 March 2023, the EU notified the WTO of the 19th ATP to CLP Regulation, potentially impacting a total of 16 substances that can be used in cosmetics, including 2 with new CMR classifications, which ultimately threatens their use in cosmetic products.

On 2 March 2023, the European Union notified the World Trade Organization (WTO) of a draft Regulation consisting on the 19th Adaptation to Technical and Scientific Progress (ATP) of the Regulation (EC) 1272/2008 (CLP – Classification, Labelling and Packaging of Substances). This new regulation impacts a total of 16 substances that can be used in cosmetics, including two with new CMR classificatios, which ultimately threatens their use in cosmetic products.

Based on the opinions of the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) issued in 2021, the purpose of this draft is to amend Table 3 of Part 3 of Annex VI to the CLP Regulation, by introducing new and revised entries for the harmonised classification and labelling of several substances or substance groups.

What is the impact on cosmetic products?

The draft regulation concerns a total of 16 substances that may be used in cosmetic products and that were classified as hazardous:

Dimethyltolylamine (CAS 99-97-8): Carc. 1B, Acute Tox. 4, Acute Tox. 3, STOT RE 2, Aquatic Chronic 3
Trimethylbenzoyl Diphenylphosphine Oxide (CAS 75980-60-8): Repr. 1B, Skin Sens. 1B
Basic Red, CI 45160 (CAS 989-38-8): Acute Tox. 3, Eye Dam. 1, Skin Sens. 1, Aquatic Acute 1, Aquatic Chronic 1
Disperse Red 17 (CAS 3179-89-3): Skin Sens. 1
Cinnamal (CAS 104-55-2): Skin Sens. 1A
1,4-Butanediol dimethacrylate (CAS 2082-81-7): Skin Sens. 1B
Di-HEMA Trimethylhexyl Dicarbamate (CAS 41137-60-4 / 72869-86-4): Skin Sens. 1B
Triethylene glycol dimethacrylate (CAS 109-16-0): Skin Sens. 1B
Potassium Chlorate (CAS 3811-04-9): Ox. Sol. 1, Acute Tox. 3
Sodium Chlorate (CAS 7775-09-9): Ox. Sol. 1, Acute Tox. 3
Benzyl Alcohol (CAS 100-51-6): Acute Tox. 4, Eye Irrit. 2, Skin Sens. 1B
Resorcinol (CAS 108-46-3): Acute Tox. 4, STOT SE 1, Skin Irrit. 2, Eye Irrit. 2, Skin Sens. 1B, Aquatic Acute 1
Ethyl Acrylate (CAS 140-88-5): Flam. Liq. 2, Acute Tox. 3, Acute Tox. 4 (H312), Acute Tox. 4 (H302), STOT SE 3, Skin Irrit. 2, Eye Irrit. 2, Skin Sens. 1
Allyl Methacrylate (CAS 96-05-9): Flam. Liq. 3, Acute Tox. 2, Acute Tox. 3, Acute Tox. 4, Aquatic Acute 1
Triethylamine (CAS 121-44-8): Flam. Liq. 2, Acute Tox. 3 (H331), Acute Tox. 3 (H311), Acute Tox. 3 (H301), Skin Corr. 1A, Eye Dam. 1
Benzisothiazolinone (CAS 2634-33-5): Acute Tox. 2, Acute Tox. 4, Skin Irrit. 2, Eye Dam. 1, Skin Sens. 1A, Aquatic Acute 1, Aquatic Chronic 1

In accordance with article 15 of the EU Cosmetics Regulation (EC) 1223/2009, 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) No 1272/2008 is prohibited, unless the substances fulfill certain strict conditions.

Proposed date of adoption: 2^nd quarter 2023

Proposed date of entry into force: 20 days from publication in the Official Journal of the EU (about 2 months after adoption).

References:

World Trade Organization (WTO) – Committee on Technical Barriers to Trade, G/TBT/N/EU/957

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.

Regulation (EU) 2022/1531 – OMNIBUS ACT V – applicable as of 17 December 2022

Ingredients: METHYL SALICYLATE, SODIUM HYDROXYMETHYLGLYCINATE, DBMC, MIBK

Date of publication: 15/09/2022

Date of application: 17/12/2022

The European Commission has published the Commission Regulation (EU) 2022/1531, which amends the Regulation (EC) No 1223/2009 as regards the use in cosmetic products of certain substances classified as CMR, by adding new entries to Annex II and Annex III and revising an entry in Annex V.

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.

UK Responsible Person Labelling Deadline Extension

RESPONSIBLE PERSON

Date of application: 31/12/2025

The UK Office for Product Safety and Standards (OPSS) have reviewed the requirement to label the product with the UK Responsible Person and have decided to extend this transitional provision for a total period of five years, until 31 December 2025.

Butylphenyl Methylpropional (Lilial) ban in cosmetics comes into force in Great Britain

Ingredients: BUTYLPHENYL METHYLPROPIONAL

Date of application: 15/12/2022

Due to its classification as toxic to reproduction, Butylphenyl Methylpropional is prohibited in cosmetic products placed in the Great Britain market as of December 15, 2022.

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.