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.

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.

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 consultation on opinion about Salicylic Acid

Ingredients: SALICYLIC ACID

Date of publication: 15/12/2022

On December 15, 2022, the EU Scientific Committee on Consumer Safety (SCCS) released the preliminary opinion on Salicylic Acid (CAS No. 69-72-7). This opinion is open for comments until February 17, 2023.

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 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.