European Union notifies WTO of the draft 22nd ATP to CLP Regulation – Impact in cosmetics

Topic: Draft 22nd ATP to CLP Regulation

Date of publication: 18/01/2024

On January 18, 2024, the European Commission (EC) notified the World Trade Organization's (WTO) Technical Barriers to Trade (TBT) Committee about the 22nd Adaptation to Technical and Scientific Progress (ATP) to Regulation (EC) 1272/2008, also known as CLP Regulation. This update amends 42 substances or substance groups and deletes one entry.

BACKGROUND

The objectives of Regulation (EC) No 1272/2008 (CLP) are to ensure the protection of human health and the environment while facilitating the free movement of substances, mixtures, and articles. These objectives are achieved by establishing a harmonized list of substances with their classifications and labeling elements at the European Union (EU) level.

Article 37(5) of Regulation (EC) No 1272/2008 grants the European Commission the authority to include substances in Table 3 of Part 3 of Annex VI if it considers harmonization of classification and labeling appropriate. The CLP Regulation is updated through an “Adaptation to Technical Progress (ATP)” which is issued yearly by the European Commission.

Based on opinions from the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA), along with feedback from EU Member States and industry stakeholders, it was deemed necessary to introduce or update harmonized classification and labeling for specific substances and amend Table 3 of Part 3 of Annex VI to CLP Regulation, accordingly.

WHAT’S NEW?

On January 18, 2024, the European Commission (EC) notified the World Trade Organization’s (WTO) Technical Barriers to Trade (TBT) Committee about its intention to publish the 22nd Adaptation to Technical and Scientific Progress (ATP) to Regulation CLP.

The purpose of the draft text of what will become the 22nd ATP is to amend Table 3 of Part 3 of Annex VI to the CLP Regulation, by introducing 27 new harmonised classifications, modifying 16 preexisting entries and deleting one harmonised classification.

Some cosmetic ingredients will be affected due to their hazardous harmonized classification as CMR (Carcinogenic, Mutagenic or Toxic for Reproduction).

CMR substances of category 1, under Part 3 of Annex VI to Regulation (EC) No 1272/2008, shall be tipically directly prohibited in cosmetics.

CMR substances of category 2, shall be either directly prohibited or may be allowed where the substance has been evaluated by the Scientific Committee on Consumer Safety (SCCS) and found safe for use in cosmetic products.

Amongst the substances listed, 17 might be used in cosmetics. From these, the following substances have been assigned a CMR classification, which triggers the need for a positive opinion from the SCCS to secure the continuation of use in cosmetics:

Hexyl Salicylate (CAS No. 6259-76-3) – Repr. 2, Skin Sens. 1
O-Phenylphenol (CAS No. 90-43-7) – Carc. 2, Skin Corr. 1, Eye Dam. 1, Skin Sens. 1B
N,N’-Methylenebisacrylamide (CAS No. 110-26-9) – Muta. 1B
Silver powder [particle diameter > 100 nm < 1 mm] (CAS No. 7440-22-4) – Repr. 2
Silver nano [particle diameter > 1 nm ≤ 100 nm] (CAS No. 7440-22-4) – Repr. 2

WHAT NOW?

The updates shall enter into force on the twentieth day following its publication in the Official Journal of the European Union (expected in the second quarter of 2024). It shall apply following 18 months after the date of entry into force.

Note: the 22nd ATP will only apply in the EU and the UK has not yet adopted the changes in the 18th, 19th, 20th or 21st ATPs to GB CLP. Some of the substances have been notified to the WTO and an update to the GB CLP mandatory list of classifications is expected later in 2024.

References:

World Trade Organization (WTO) – Committee on Technical Barriers to Trade, G/TBT/N/EU/1042

other REGULATORY UPDATES

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) 2022/1531 – 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.

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.

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.

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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