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

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.

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) 2022/692 – 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.

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.

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.

French Anti-Waste Law – Impact in Cosmetics Packaging and Labelling

PACKAGING WASTE MANAGEMENT

Date of application: 01/01/2023, with a transition period until 09/03/2023 for packaging produced or imported before 09/09/2022.

The Loi relative à la lute contre le gaspillage et a l’économie circulaire (Anti-Waste for a circular economy) has come officially into force in France in 2020. From January 2023 the requirements of the law became mandatory, including specific symbols on the packaging or labelling of cosmetic products.

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