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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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.

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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.

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Any REGULATORY QUESTION?

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.

Read More »