By Rebecca Pickering, Senior Regulatory Specialist, Supply Chain team, UL Solutions
On Mar. 31 2023 the European Commission published a new Delegated Regulation amending the CLP regulation which introduced four new hazard classes along with new label elements, EUH phrases and the generic concentration limits for mixtures.
The new hazards classes are:
- Endocrine disruption for health hazard (ED HH)
- Category 1 and 2
- Endocrine disruption for the environment (ED ENV)
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- Category 1 and 2
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- Persistent, Bioaccumulative and Toxic (PBT) / Very Persistent, Very Bioaccumulative (vPvB)
- Persistent, Mobile and Toxic (PMT) / Very Persistent, Very Mobile (vPvM)
Application dates
The new Delegated Regulation came into force on Apr. 20 2023, and from this date EU Member States can make proposals for harmonised classification and labelling (CLH) with the new hazard classes. There are transitional periods during which suppliers are not yet required to classify their substances and mixtures with the new hazard classes, however these can always be applied on a voluntary basis.
Date of application for all new hazard classifications | |
Substances placed on the market prior to May 1 2025 | November 1 2026 |
Substances placed on the market after May 1 2025 | May 1 2025 |
Mixture placed on the market prior to May 1 2026 | May 1 2028 |
Mixtures placed on the market after May 1 2026 | May 1 2026 |
Hazard communication
The new hazard classes come with new label elements including eight new EUH statements. They are identified with an EUH code because they are unique to the EU, however they should be treated the same as the other GHS hazard statements and not the supplemental EUH-statements found in CLP Annex II Part 1 and 2. There are currently no new hazard pictograms associated with the new hazard classes, any new pictograms will be introduced via the Globally Harmonised System (GHS).
The reclassification of products with the new hazard classes will also trigger updates to Safety Data Sheets (SDS). This will reinforce the Commission Regulation (EU) 2020/878 amendment to REACH Annex II which saw the requirement to provide information on endocrine disruptors and PBT/vPvB properties in Section 2, 11 and 12 of the SDS.
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Next steps
Controversially these new hazard classes have not been adopted into GHS and therefore the EU has deviated significantly from the rest of the world including the UK. The new classes have been brought up for consideration in the UN’s 2023-2024 biennium by the EU and the sub-committee will need to reach a consensus for the new classes to enter the GHS. If the new hazard classes are accepted, they will then have to be implemented into local legislation.
The publication of Commission Delegated Regulation (EU) 2023/707 is expected to trigger several amendments to other EU regulations including CLP, BPR and REACH. Therefore, industry will need to be proactively monitoring the various proposals and updates to stay on top of potential changes that can impact their business.
Companies need to review their portfolio and start to identify raw materials that may be affected by these changes. Substances need to be checked to whether they meet the new classification requirements and a good place to start is by looking at the Candidate list of SVHCs, formal PBT and vPvB assessments for >10 tpa REACH registered substances and EU/UN/international screening lists. Substances with new classifications will require updates to labels/SDSs, C&L notifications and REACH registrations. Mixtures that contain identified substances will need to be reclassified and, if applicable, updates to their labels/SDS and poison centre notifications.
References
Commission Delegated Regulation (EU) 2023/707: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0707
Commission Regulation (EU) 2020/878: eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0878&from=EN
Working documents for the 43rd session of Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals: https://unece.org/info/Transport/events/368936
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