Deadline for label warning about formaldehyde releasers

Topic: DEADLINE FOR LABEL WARNING ABOUT FORMALDEHYDE RELEASERS

Date of publication: 31/07/2024

Since 31 July 2024, the warning "releases formaldehyde" is mandatory for products placed on the market, where the total concentration of formaldehyde released in the finished product exceeds 0,001 % (10 ppm).

Background

Formaldehyde is classified as a carcinogen (category 1B) and a skin sensitizer (Category 1), according to CLP Regulation (Regulation (EC) No. 1272/2008). According to the European Cosmetics Regulation (Regulation (EC) No 1223/2009), the use of formaldehyde is prohibited in cosmetic products, and it is included in Annex II (List of Substances Prohibited in Cosmetic Products, entry 1577).

Some preservatives (allowed in cosmetics and listed in Annex V of the Cosmetics Regulation) can gradually release Formaldehyde in order to fulfil a preserving function in the final cosmetic product and are called ‘formaldehyde releasers’.

In May 2021, the European Commission’s Scientific Committee on Consumer Safety (SCCS) published a scientific advice on the threshold for the warning ‘releases formaldehyde’ in Annex V (preamble point 2 for formaldehyde-releasing substances).

According to the preamble of Annex V (List of Preservatives Allowed in Cosmetic Products) of the Regulation, “All finished products containing substances which are listed in this Annex and which release formaldehyde shall be labelled with the warning “releases formaldehyde” where the total concentration of formaldehyde released in the finished product exceeds 0,001 % (10 ppm), irrespective of whether the finished product contains one or more substances releasing formaldehyde.”.

What’s new?

As previously announced in our previous articles (New Formaldehyde Threshold in Cosmetic Products ; Regulatory updates to cosmetic product regul that come into force in 2024), Point 2 of the preamble of Annex V to Regulation was replaced by the following:

“However, all finished products containing substances referred to in the first subparagraph which comply with Regulation (EC) No 1223/2009 as applicable on 30 July 2022 may be placed on the Union market until 31 July 2024 and be made available on the Union market until 31 July 2026.”

This means that, when the stated threshold is exceed, the warning “releases formaldehyde” is now mandatory for products placed on the market and will be mandatory for products made available on the market after 31 July 2026.

References:

Commission Regulation (EU) 2022/1181 amending the preamble of Annex V to Regulation (EC) No 1223/2009

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.

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 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.

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 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.