As a result of the introduction of new EU classifications, the classifications PBT (persistent, bioaccumulative and toxic) and vPvB (very persistent and very bioaccumulative) are currently defined in both the REACH Regulation and the CLP Regulation. But how do these definitions differ and how do the new classifications relate to the two regulations?

How did the double definition come about?

PBT and vPvB are among the properties that classify substances as substances of very high concern. These properties are already described in the original 2006 REACH Regulation [1] and are part of the chemical safety assessment required for the registration of substances.

In the CLP Regulation, however, the PBT and vPvB classifications were supplemented together with other EU-specific classifications as an innovation in Delegated Regulation (EU) 2023/707 [2].

How do the definitions of PBT and vPvB differ?

This question arose when I read the classification conditions in the CLP Regulation. The definitions can be found in Annex XIII of the REACH Regulation and as part of the environmental hazards in Annex I, Part 4 of the CLP Regulation.

The definitions for persistent (P), very persistent (vP), bioaccumulative (B) and very bioaccumulative (vB) are identical. However, there is an addition to toxic (T) in the CLP Regulation that is not included in the REACH Regulation: substances that are endocrine disruptors (endocrine disruption, category 1, human health and/or environment) fulfill the condition (T) according to the CLP Regulation. The CLP Regulation refers to two further classifications that were added in the same amending regulation [2].

What happens next?

The description of the classifications in the CLP Regulation is more up-to-date and in principle contains a further classification criterion. I therefore consider it likely that this definition will become the new standard definition for both regulations – both for PBT classification and as an SVHC criterion and in the chemical safety report.

The new PBT classification in the CLP Regulation is still in a transitional period and can already be used voluntarily. The EU is also making efforts to integrate this classification at GHS level. The next few years will therefore show whether, for example, the entry in the REACH Regulation will be dropped and a direct reference to the CLP Regulation will follow, or whether the new classification criterion for (T) will also be adopted in the REACH Regulation.

Sources:

[1] REACH Regulation, original legal act

[2] Amending Regulation to CLP (EU) 2023/707