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.

On November 11, 2022, the European Commission published the Regulation (EU) 2022/2195, amending Annexes III (list of restricted ingredients) and VI (list of authorised UV filters) to EU Cosmetics Regulation No. 1223/2009.

Based on the latest scientific opinions published by the Scientific Committee on Consumer Safety (SCCS), the amendments provide for new conditions of use of the following ingredients:

BHT (Butylated Hydroxytoluene; CAS No. 128-37-0)

– Mouthwash products, up to 0.001%

– Toothpastes, up to 0.1%

– Other leave-on and rinse-off products, up to 0.8%.

Entry into force from 1 July 2023 for products placed on the market and 1 January 2024 for products made available on the market (off-shelves).

Acid Yellow 3 (CAS No. 38615-46-2)

– Limited to non-oxidative hair dye products at a maximum concentration of 0.5%. Any other use not explicitly regulated will not be allowed.

Entry into force from 1 July 2023 for products placed on the market and 1 January 2024 for products made available on the market (off-shelves).

Homosalate (CAS number: 118-56-9)

– Face products, except propellant sprays, up to a maximum concentration of 7.34%.

Entry into force from 1 January 2025 for products placed on the market and 1 July 2025 for products made available on the market (off-shelves).

HAA299 (Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine; CAS No. 919803-06-8)

– New UV filter added to Annex VI, safe up to a maximum concentration of 10%. In the case of the combined use of Piperazine and Piperazine (nano), the sum shall not exceed 10%.

– HAA299 in nano form must meet some additional requirements: Purity ≥ 97%; Median particle size D50 ≥ 50 nm of number size distribution; It cannot be used in applications that may lead to exposure of user’s lungs by inhalation.

Entry into force on 1 December 2022.

Resorcinol (CAS number: 108-46-3)

Correction in Annex III to Regulation (EC) No 1223/2009, in the row for entry 22, column i, point (a), the last sentence is replaced by the following: “Do not use to dye eyelashes.”

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References:

1. Commission Regulation (EU) 2022/2195 of 10 November 2022 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Butylated Hydroxytoluene, Acid Yellow 3, Homosalate and HAA299 in cosmetic products and correcting that Regulation as regards the use of Resorcinol in cosmetic products.

other REGULATORY UPDATES

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.

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.

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.

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.

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.

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.