January 2023: we’ve updated the infographics on the new hazard classes (tentative, as the rules may still change)
PBT_vPvB Infographic V3Download the PDF for PBT/vPvB
Infographic-ENV V3Download the PDF for PMT/vPvM
Infographic - Human health V3Download the PDF for Human Health Endocrine Disruptors
Infographic-ENV V3Download the PDF for Environmental Endocrine Disruptors
December 2022: a new set of proposals has been issued by the EU, you can find them here:
The updated proposals are here: https://environment.ec.europa.eu/publications/proposal-clp-revision_en
and the actual draft regulation and ATP are available here: https://environment.ec.europa.eu/publications/clp-delegated-act_en
September 2022: We’ve made a couple of videos going through the draft proposal from the EU on new hazard classes.
You can find the EC proposals here:
and
Video 1 covers PBT/vPvB and PMT, vPvM
Transcript Proposed new EU hazard classes PBT and PMT 2022-09-21
Download the transcript (PDF)
TLDR:
- PBT/vPvB comes from REACH; PMT/vPvM comes from plant protection products/ biocidal products regulation
- these are called EUH statements but are being proposed to be brought into CLP in the same sections as H statements
- at the same time as bringing them into EU-CLP, the EU have taken these new hazard statements (also including endocrine disruptors) to the UNECE GHS committee and are trying to get them adopted as GHS hazards
- the classification methods are relatively straightforward
- bridging principles are absent, which is a bit anomalous
- the new classifications bring in signal words and P statements, but not new pictograms
- the absence of pictograms may be to avoid interfering with Transport of Dangerous Goods classifications
Video 2 covers Endocrine Disruptors
Transcript Proposed new EU hazard classes endocrine disruptors 2022-09-21
Download the transcript (PDF)
TLDR:
- Endocrine disruptors classification for substances is are not as clear-cut in as the new PBT and PMT classifications discussed in the first video
- these are also called EUH statements but are being proposed to be brought into CLP in the same sections as H statements
- bridging principles are present for mixtures
- the new Endocrine Disruptor classifications bring in signal words and P statements, but not new pictograms
- to be classified as ED, 3 tests must be passed, (a) Endocrine activity and (b) An adverse effect and (c) A biologically plausible link between (a) and (b).
- the “biologically plausible link” definition includes correlation, leaving it open to interpretation by toxicologists
- there is a lot of overlap between existing STOT classifications and proposed ED classifications
- extra testing may be required to differentiate between STOT and ED, but is there appetite for more animal testing?
- remember this is all at proposal level, so feed back concerns to ECHA
- do not take any classification actions or decisions until the regulation is actually published, as there may be alterations to the draft –
- even if these are brought into the EU, there are very long implementation times
- and they may not be brought into the UK at all, or if they are it is likely to be “downstream” of, and therefore later than in the EU