- Endocrine disruption for human health (ED HH Category 1 and ED HH Category 2)
- Endocrine disruption for the environment (ED ENV Category 1 or ED ENV Category 2)
- Persistent, Bioaccumulative and Toxic or Very Persistent, Very Bioaccumulative properties (PBT and vPvB)
- Persistent, Mobile and Toxic and Very Persistent, Very Mobile properties (PMT and vPvM)
EU CLP regulation | New rules to classify endocrine disruptors and persistent chemicals enter into force
May 15, 2023
The Delegated Regulation adds four new hazard classes to Regulation (EC) No 1272/2008:
Manufacturers, importers, downstream users and distributors placing their products on the EU market must classify their substances or mixtures according to the new hazard classes by the relevant deadline (see the table below). Companies can of course voluntarily apply the new hazard classes before then.
Compliance deadlines for updating the classification and labelling for substances / mixtures:
| 1 May 2025 | 1 November 2026 | 1 May 2026 | 1 May 2028 |
|---|---|---|---|
| New substances on the EU market | Substances already on the EU market | New mixtures on the EU market | Mixtures already on the EU market |
Organizations should not under-estimate the importance of a robust approach or the effort involved in evaluating the impact of the new hazard classes on their product portfolios. According to Sue Bullock, Head of Chemical Compliance, Stewardship & Sustainability at Sagentia Regulatory. ‘These new hazard classes will certainly give rise to questions relating to data, approach and outcomes. An early approach will allow companies time to gauge, consider and respond thoughtfully to any issues thrown up by this new process. This should also give companies adequate time to identify substances that may be affected by the changes and make informed decisions about the use of these substances, providing opportunities for companies to enhance the sustainability and safety of their products, with benefits all round.’
Our team of scientific and regulatory experts is available to assist you in assessing the impact of the evolving regulations on your product portfolios. To learn more about our services, please contact us at [email protected], and we will schedule a call to discuss your requirements.
In a previous advisory – European Commission presents proposal for revised CLP regulation – our experts noted that while existing EU regulations already mandate evaluation of these chemical properties in certain circumstances, creating hazard classes under the CLP regulation will require their assessment for a much vaster set of chemicals. These assessments will often require expert judgements and assessment techniques to make sense of complex data sets, studies and related evidence. Better data may be needed to support conclusions and many more chemicals may be identified as of potential concern warranting more detailed assessment and/or risk management measures as a result. The forthcoming update to the REACH registration information requirements will clarify expectations on the data underpinning these hazard classes.
