EU proposes Union-wide ban on PFHxA in cosmetics to address environmental and health risks

Ingredients: UNDECAFLUOROHEXANOIC ACID (PFHxA), its salts, and related substances

Date of publication: 19/06/2023

On June 19, 2023, the European Commission notified WTO of a draft regulation amending the Annex XVII to Regulation (EC) No 1907/2006 (REACH). This draft proposes to prohibit the use of Undecafluorohexanoic Acid (PFHxA), its salts, and related substances in various applications, including cosmetics.

BACKGROUND

Undecafluorohexanoic Acid (PFHxA), its salts, and related substances are persistent in the environment and have hazardous properties, which can lead to their accumulation in the environment and increased exposure for both the environment and humans.

WHAT’S NEW?

On June 19, 2023, the European Commission notified WTO of a draft regulation aiming at amending the Annex XVII to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

This draft proposes to prohibit the use of Undecafluorohexanoic Acid (PFHxA), its salts, and related substances in various applications, including cosmetics, and is currently open for comments until August 18, 2023.

To address the environmental and health risks, the draft proposes that PFHxA, its salts and related substances shall not be used in cosmetics in a concentration equal to or greater than 25 ppb for the sum of PFHxA and its salts, or 1000 ppb for the sum of PFHxA-related substances, measured in homogeneous material.

WHAT NOW?

A non-exhaustive list of substances belonging to the scope of the restriction proposal is available here.

Proposed date of adoption: Fourth quarter of 2023.

Proposed date of entry into force: 20 days from publication in the Official Journal of the EU.

The restriction for cosmetic products will enter into force 24 months after the entry into force of this amending Regulation.

References:

WTO – Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances

other REGULATORY UPDATES

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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.

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.

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.

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.

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.