European Commission presents proposal for revised CLP regulation
The European Commission recently published a draft act proposing significant changes to the European Union’s (EU) Classification, Labelling and Packaging (CLP) regulation as part of the EU Chemicals Strategy for Sustainability. Organizations should assess how this notable change to the classification rules will affect their products, markets and operations within and beyond the European Economic Area (EEA).
New hazard classes
The revision would create new hazard classes under the CLP regulation with important implications for those placing substances and mixtures on the market. The proposed new hazard classes are:
- Endocrine disruption for human health (ED HH1 or ED HH2)
- Endocrine disruption for the environment (ED ENV 1 or ED ENV 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)
Update to REACH requirements will help clarify expectations
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 as a matter of course 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.
Pre-emptively evaluate the impact on product portfolios
“Organizations will benefit from pre-emptively evaluating the impact of these proposals on their product portfolios,” says Sue Bullock, Head of Chemical Compliance, Stewardship & Sustainability at TSG Consulting. “It’s important to consider where and how classification may change and what to do when a substance is classified for any of these properties.”
Comments from more than 150 companies and trade organizations to the public consultation on the proposal show concern about timeframes for compliance, definitions and criteria, labelling, global trade and coherence with the revision of other relevant legislation amongst other things.
The CLP regulation is the EU’s implementation of the United Nations Globally Harmonised System (UN-GHS). This revision will see an introduction of new hazard classes in EU CLP before their adoption in the UN-GHS. It will be interesting to see if the UN-GHS is updated to implement the same or similar hazards.
Chemicals Strategy for Sustainability
In addition to introducing new hazard classes, the CLP regulation is undergoing further revision to help meet the objectives outlined in the EU’s Chemicals Strategy for Sustainability (CSS). The proposed changes include modification of existing, as well as the introduction of new requirements.
The Commission has asked for feedback on the proposals to the revision of the CLP regulation and interested stakeholders can respond here. As of the time of writing, the feedback period is open to 28 March 2023.
If you need support in considering the impact of the changing regulations on your product portfolios, or in providing feedback to the European Commission, our scientific and regulatory experts are on hand to help. Please get in touch at [email protected] and we’ll reach out to schedule a call.