European Commission publishes Omnibus Act VI

On 20 July 2023, the European Commission published the CMR Omnibus VI Regulation (EU) 2023/1490. This regulation prohibits the substances classified as Carcinogenic, Mutagenic and Toxic to Reproduction (CMR) 1A, 1B, or 2 by the 18th Adaptation to Technical Progress (ATP) to the EU Classification Labelling and Packaging (CLP) Regulation. The regulation enters into force on the 1st of December 2023.

On July 20, 2023, the European Commission published Commission Regulation (EU) 2023/1490 (Omnibus Act VI).

This regulation prohibits the use of the CMR (Carcinogenic, Mutagenic or Toxic for Reproduction) substances classified as such in 2022, adding 30 new entries to Annex II to the EU Cosmetics Regulation No. 1223/2009.

WHAT NOW?

Among the 30 new entries, ingredients used in cosmetics which are now classified as CMR (prohibited) are the following:

Benzophenone (CAS 119-61-9)
Teophylline (CAS 58-55-9)
Pentetic Acid (CAS 67-43-6)
Pentasodium Pentetate (CAS 140-01-2)
Salts of 2-ethylhexanoic acid (Zinc Ethylhexanoate) (CAS 149-57-5)
Melamine (CAS 108-78-1)
Azadirachta Indica Seed Extract (CAS 84696-25-3)
Azadirachta Indica Bark/Seed Extract (CAS 84696-25-3)
Trimethylolpropane Triacrylate (CAS 15625-89-5)

The Commission Regulation will apply from 1 December 2023.

Therefore, beauty brands have few months to ensure compliance with the new requirements and to sell the existing stocks. As of December 1, 2023, non-compliant products must be sold or, otherwise, recalled from the EU market.

References:

Commission Regulation (EU) 2023/1490 of 19 July 2023 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction

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.

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.

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.

Italy and France – Environmental Labelling of Cosmetic Products

PACKAGING WASTE MANAGEMENT

Date of application:01/01/2023

Although the European Cosmetics Regulation is applicable to every cosmetic product made available in the European Union market, some national legislations may also apply. Environmental regulations in Italy and France specify mandatory labelling requirements applicable to packaged products marketed in these countries.