Inclusion of Over a Hundred Endocrine Disruptors and PBT/vPvB Substances in EU CLP Regulation Delayed, But Still Moving Forward

The revised CLP Regulation (Article 37(7)) establishes a mechanism for transferring into the list of substances with harmonised classification and labelling (CLH) substances that have already been identified as endocrine disruptors (EDs) or as PBT/vPvB substances under other EU regulatory frameworks, including the REACH Candidate List and, more importantly, the Plant Protection Products Regulation (PPPR) and the Biocidal Products Regulation (BPR).

The Commission was required to complete this transfer by 11 June 2026. Although this deadline has been missed, the process remains ongoing. The Commission indicated at the July CARACAL meeting that it intends to adopt the transfer regulation as soon as possible, without a further round of discussions in the autumn. 

A key concern is that some companies may have disagreed with the original ED, PBT, or vPvB determinations, particularly under the BPR and PPPR, where the criteria and assessment methodologies have been subject to significant criticism. As a result, some companies may not have aligned their classification and labelling practices with those determinations. Moreover, additional scientific data may have become available since those assessments were completed, potentially supporting the conclusion that certain substances do not meet the ED, PBT, or vPvB criteria.

The Commission has confirmed that the transfer regulation will be subject to a public consultation. The public consultation will be the unique opportunity for companies to challenge the classification and voice their concerns. 

Once the transfer regulation enters into force, however, the resulting harmonised classifications will become legally binding under CLP, including for substances for which evidence may now exist that they should not be classified as ED, PBT, or vPvB.

The consequences may be significant. At a minimum, the harmonised classification will trigger mandatory CLP labelling and update to Safety Data Sheets. It would also lead to increased regulatory scrutiny and further risk management measures, including potential REACH restriction or authorisation initiatives.

In addition, a CLH as ED can trigger substance-specific restrictions under various product regulations, including toys and medical devices. The number of regulatory regimes scrutinizing these CLHs is expected to increase further in the coming years (incl. cosmetics, food-contact materials, etc.). Furthermore, CLH for ED, PBT, and vPvB properties generally result in a substance being regarded as a "substance of concern" under a growing number of EU legislative instruments, including the Ecodesign for Sustainable Products Regulation (ESPR) and the Packaging and Packaging Waste Regulation (PPWR).

With respect to the transition period, the Commission indicated that 18 months remains the starting point under consideration. 

Conclusion
Companies should review their portfolios to identify substances falling within the scope of Article 37(7) CLP. Companies should then assess both the regulatory consequences and the options available for challenging classifications that may no longer be scientifically justified. 

For assistance with this exercise, or if you have any questions about Article 37(7), please contact Ales Bartl, Ph.D. (bartl@khlaw.com or +32 (0) 2 645 5085), or your existing contact at Keller and Heckman LLP.