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