CMR substances prohibited by Omnibus Act VII
Ingredients: DIMETHYLTOLYLAMINE, TRIMETHYLBENZOYL DIPHENYLPHOSPHINE OXIDE

Date of publication: 24/06/2024

On June 24, 2024, the European Commission (EC) notified to the World Trade Organization (WTO) the “Omnibus VII” regulation. The adoption is expected to take place after the September 1st, 2025.

Background

On June 24, 2024, the European Commission (EC) notified to the World Trade Organization (WTO) the “Omnibus VII” regulation. The adoption is expected to take place after the September 1st, 2025.

This regulation incorporates substances categorized as CMR (Carcinogenic, Mutagenic, or Toxic for Reproduction) according to regulation EC 2024/197, also known as 21st Adaptation to Technical Progress (ATP) to the EU Classification, Labelling and Packaging (CLP) Regulation, into the European Cosmetic Regulation 1223/2009. Since none of these substances have been defended by the industry, they will be added to Annex II (prohibited substances) of the Cosmetics Regulation.

What’s new?

Among the newly classified CMR substances, two ingredients are used in cosmetic products:

  • Dimethyltolylamine, carcinogenic 1B – used as a nail conditioning agent
  • Trimethylbenzoyl diphenylphosphine oxide (TPO), reprotoxic 1B – used as a skin conditioning agent

What now?

Starting September 1st, 2025, products containing either of these ingredients will be banned. This means no product containing them can be available on the EU market after this date.

References

European Commission notification to the World Trade Organization (WTO). Omnibus Act VII

other REGULATORY UPDATES

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.

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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.

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Any REGULATORY QUESTION?

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.

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