CLP is updated by Regulation (EU) 2024/2865

CLP is updated by Regulation (EU) 2024/2865

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Posted By: Trace One

Regulation (EU) 2024/2865

On 20 November 2024, Regulation (EU) 2024/2865 of the European Parliament and of the Council was published, amending Regulation 1272/2008 (CLP) on classification, labelling and packaging of substances and mixtures. In particular, it introduces new instructions for the classification of complex substances (‘substances containing more than one constituent’ or ‘MOCS’) and adds Chapter 3 to Title III of the CLP, updating the labelling formats.

Regulation (EU) 2024/2865: new classification approach

Regulation (EU) 2024/2865 introduces a new classification approach for substances containing more than one constituent (MOCS) in relation to the hazard classes in Annex I of the CLP:

  • Germ cell mutagenicity (section 3.5)
  • Carcinogenicity (section 3.6)
  • Reproductive toxicity (section 3.7)
  • Endocrine disruption for human health (section 3.11)
  • Endocrine disruption for the environment (section 4.2)
  • Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative properties (section 4.3)
  • Persistent, Mobile and Toxic or Very Persistent, Very Mobile properties (section 4.4)

The assessment of MOCS is based on available information on these known constituents and on the substance itself. However, available information on the substance itself may only be considered if:

  1. the information clearly demonstrates the presence of the hazardous properties listed above (mutagenicity, carcinogenicity, etc.).
  2. the information supports the conclusions obtained from the information on the individual constituents.

Finally, the information available on the MOCS itself, which demonstrates the absence of these or less severe properties, does not override the information available on the constituents of the substance.

Regulation (EU) 2024/2865: labelling

Regulation (EU) 2024/2865 introduces new labelling requirements.

Therefore, in addition to the physical label, label elements may be provided in digital form (‘digital label’). However, the digital label remains voluntary and complementary to the physical label.

In addition, the criteria for formatting the label are updated by amending Table 1.3 of Annex I of the CLP, which specifies the minimum font size.

The text establishes the size of each pictogram, label and font used for labelling information (in millimetres) as a function of packaging capacity. Additional rules are also defined with regard to the minimum spacing between lines (‘120% of the font’), the font type (no serifs) and further provisions with regard to folding labels.

Traceone has planned a regulatory analysis on this and will keep you updated.

Click on this link to consult Regulation (EU) 2024/2865