ChemRegs Newsletter – November 2024
Updated guidance on new EU CLP criteria
The European Chemicals Agency (ECHA) has updated and issued new guidance on the application of the classification, labelling and packaging (CLP) regulation in Europe. Note – this does not apply to Great Britain.
It covers advice on the new hazard criteria for endocrine disruptors (ED) for human health or the environment;
persistent, bioaccumulative and toxic (PBT); very persistent and very bioaccumulative (vPvB) substances; and
persistent, mobile and toxic (PMT); very persistent and very mobile (vPvM) substances.
The introduction of guidance on the new hazard classes (part 3.11: Endocrine disruption HH, part 4.2 Endocrine disruption env, and part 4.3: PBT/vPvB and PMT/vPvM) in parts 3 and 4 of the CLP guidance, respectively, required that the guidance be split into its various parts to make them easier to use. Therefore, the guidance on the application of the CLP criteria is now presented in five separate documents.
• Application of the CLP criteria guidance series overview [PDF]
• Part 1: General Principles for Classification and Labelling [PDF]
(Including Annex I: Collection of Internet links for the users of the Guidance)
• Part 2: Physical Hazards [PDF]
(Including Annex I: Relation between Transport and CLP classification regarding Physical Hazards)
• Part 3: Health Hazards [PDF]
(Including Annex I: Background document to the guidance for setting specific concentration limits for substances classified for reproductive toxicity)
• Part 4: Environmental Hazards and Part 5: Additional Hazards [PDF]
(Including Annexes:
I. Aquatic Toxicity
II. Rapid Degradation
III. Bioacumulation
IV. Metals and Inorganic Metal Compounds)
Although split into separate parts, these guidance series documents together constitute a single Guidance on the Application of the CLP Criteria. As such, users of the CLP Guidance series are advised to carefully consult ‘Part 1: General Principles for Classification and Labelling’ before progressing to any of the subsequent parts.
For more information on the new hazard classes in EU CLP go to the ECHA “Understanding CLP” webpage.
Publication of GB mandatory classification and labelling list (MCL) technical reports
The next batch of GB MCL technical reports for substances classified according to the GB CLP Regulation is now available for download at the end of the GB MCL publication table (.xlsx).
A GB MCL technical report is an independent scientific evaluation of the information submitted under the stand-alone GB mandatory classification and labelling (GB MCL) process or as part of the EU harmonised classification and labelling process (EU CLH).
It sets out whether there is adequate scientific evidence to support a new or revised GB MCL of a substance and what that GB MCL should be. If evidence comes to the attention of HSE that may lead to new or revised GB MCL, then HSE has the scientific and regulatory expertise to prepare a GB MCL proposal.
HSE continues to monitor international forums such as the ECHA Committee for Risk Assessment (RAC) for information that may lead to proposals for new or revised GB MCL. When a RAC opinion is published, HSE as the GB CLP Agency must reach an opinion of its own on whether to align with RAC under the Article 37 procedure in the GB CLP Regulation.
GB is free to determine its own GB MCLs where it is justified by supporting scientific data and wider policy considerations. This may result in GB having a different MCL to the for the same substance.
The new GB MCL technical reports include copper substances and follows on from the GB MCL proposal produced by the Agency in 2024.
The remaining GB MCL technical reports relate to 19 substances for which the Committee for Risk Assessment (RAC) published a RAC Opinion under Article 37(4) of EU CLP during 2024, based on information submitted under the EU CLP Regulation. This includes sodium bromide, calcium bromide, potassium bromide, and various inorganic borate compounds.
At the time of publication, the classification and labelling proposed in these technical reports has not been agreed and/or adopted in GB.
HSE expect to publish the next batch of technical reports in March 2025.
For information on the next steps in the process, please see the HSE webpage on the GB MCL system.
ADR 2025
ADR 2025 in both hard copy (2 volumes) and as an editable pdf can now be purchased from distributors of United Nations Publications or from the UN Publications Sales Office. The free non-editable electronic files will be uploaded to the UN ECE website from January 2025.
A corrigendum has also been issued for a couple of corrections to the published versions of ADR 2025.
For more information on anything in this Newsletter, please contact us at info@chemregs.co.uk