Approaching deadlines for EU Cosmetic Regulatory changes

Topic: REGULATORY UPDATES

Date of publication: 01/02/2025

Several Cosmetic Regulations related to nanomaterials, vitamin A, and other ingredients will come into force from 1st February 2025, with product withdrawal deadlines later in the year.

What’s new?

The European Union has adopted several regulations impacting the cosmetic industry, with important deadlines approaching in early 2025:

Regulation (EU) 2024/858: Nanomaterials

For comprehensive information on this regulation, see our previous article on nanomaterials in cosmetics.

Affected nanomaterials include:

Styrene/Acrylates Copolymer (nano)
Copper (nano) and Colloidal Copper (nano)
Colloidal Silver (nano)
Gold (nano) and Colloidal Gold (nano)
Thioethylamino Hyaluronic Acid Gold (nano)
Platinum (nano) and Colloidal Platinum (nano)

Hydroxyapatite (nano) is restricted with specific allowances:

Maximum 10% in toothpaste and 0.465% in mouthwash
Must not allow inhalation exposure
Particles must be rod-shaped with a controlled aspect ratio
Must not be coated or modified

Regulation (EU) 2024/996: Vitamin A and other substances

As detailed in our previous analysis of Regulation 2024/996, these changes represent significant shifts in EU cosmetic ingredient policy.

Key restrictions include:

Genistein: Maximum 0.007% in ready-to-use products
Daidzein: Maximum 0.02% in ready-to-use products
Kojic Acid: Allowed up to 1% in facial and hand products
Alpha-Arbutin: Up to 2% in facial creams and 0.5% in body lotions
Arbutin: Up to 7% in facial creams
Vitamin A (retinol): Has specific restrictions with later implementation dates

Regulation (EU) 2022/2195: Homosalate

For the full SCCS opinion and initial regulatory response regarding Homosalate, refer to our earlier publication on UV filter regulations.

New restrictions:

Homosalate is now allowed only in face products (non-spray and pump spray products) up to a maximum concentration of 7.34%

What now?

Key deadlines for nanomaterials (Regulation 2024/858):

From 1st February 2025: Products containing the specified nanomaterials must not be placed on the EU market
From 1st November 2025: Such products must not be available on the EU market

Key deadlines for Vitamin A and other substances (Regulation 2024/996):

From 1st February 2025: Products containing Genistein, Daidzein, Kojic Acid, Alpha-Arbutin, and Arbutin that do not comply with the new restrictions cannot be placed on the EU market
From 1st November 2025: Non-compliant products must not be available on the EU market
For Vitamin A (retinol): Non-compliant products cannot be placed on the market from 1st November 2025 and must not be available on the market from 1st May 2027

Key deadlines for Homosalate (Regulation 2022/2195):

From 1st January 2025: Products containing Homosalate that do not comply with the new restrictions cannot be placed on the EU market
From 1st July 2025: Non-compliant products must not be available on the EU market

References:

other REGULATORY UPDATES

Regulation (EU) 2022/2195 – Updates to cosmetic ingredients use requirements

Ingredients: BHT, ACID YELLOW 3, HOMOSALATE, HAA299 and RESORCINOL

Date of publication: 11/11/2022

Date of application: 01/07/2023

Commission Regulation (EU) 2022/2195 of November 2022 amends Regulation (EC) No 1223/2009, restricting the use of BHT, Acid Yellow 3, Homosalate, HAA299 and Resorcinol, in cosmetic products.

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.

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.

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.

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.

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.