June 19, 2023 by Olivia Tran

New CLP classes_Olivia blog imagee

The EU has recently finalised new hazard classes under the Classification, Labelling and Packaging (CLP) Regulation. The new hazard classes are:

  • Endocrine disruption for human health, Category 1 and 2
  • Endocrine disruption for the environment, Category 1 and 2
  • PBT (persistent, bioaccumulative and toxic) and vPvB (very persistent and very bioaccumulative)
  • PMT (persistent, mobile and toxic) and vPvM (very persistent and very mobile)

The new hazard classification rules came into force on 20 April 2023. Companies will need to update their substance and mixture classification and labelling before the following deadlines:

  • 1 May 2025 for new substances on the EU market
  • 1 May 2026 for new mixtures on the EU market
  • 1 November 2026 for existing substances on the EU market
  • 1 May 2028 for existing mixtures on the EU market

ECHA is planning to publish updated classification guidance in mid-2024.

For substances registered under REACH, some of the REACH data requirements provide information to classify under the new hazard classes:

  • PBT/vPvB: This assessment is already required for substances registered at Annex VIII and above. The data requirements at Annex VII provide screening information that may be sufficient to conclude on PBT/vPvB.
  • PMT/vPvM: Assessment of persistence and toxicity will be the same as that in PBT/vPvB assessment. The assessment of mobility is based on the organic carbon-water partition coefficient (log Koc), which is a data requirement at Annex VIII and above. An estimate of log Koc can also be obtained with Annex VII data requirements (octanol-water partition coefficient (Kow) and water solubility).
  • Endocrine disruption (ED): There are currently no specific ED data requirements under REACH, but new ED data requirements for human health and the environment are proposed under the REACH revision (expected to be published soon at the time of writing). The current chronic mammalian toxicity and ecotoxicity data requirements at Annex IX and X can provide some information on endocrine effects. However, there are currently no data requirements providing mechanistic information on endocrine activity, which is a crucial aspect of the EU’s definition of an endocrine disruptor. The REACH revision plans to introduce mechanistic data requirements starting at Annex VII and additional bioassays at Annex VIII or IX (depending on the policy option selected) and above for information on adverse effects. An assessment of the new testing requirements for ED under REACH has been conducted by wca based on the initial policy options proposals and these were presented at the 33rd annual meeting of the Society of Environmental Toxicology and Chemistry (SETAC) which was held in Dublin in May 2023 (download pdf).

For mixtures and substances exempt from REACH, companies can classify based on existing information; new testing is not required. Companies with mixtures will need to track any changes in the classification of their mixture components. Updated ECHA guidance on mixture classification rules for the new hazard classes will be crucial in order to assess whether any new hazard classifications for the mixture components will affect the classification of the whole mixture.

wca have extensive experience in classifying substances and mixtures under the CLP Regulation. With regards to the new hazard classes, wca have conducted many ED assessments for plant protection products and biocides, and PBT/vPvB assessments under REACH. We are also experts in assessing mobility as part of exposure assessments. We always consider non-testing approaches first in our assessments and we do this by searching for existing information in literature, using prediction models where appropriate, considering read-across from similar substances and developing a weight of evidence if possible. If testing is necessary, we have experts in environmental fate and human health and environmental endocrine disruption to assist with suitable test designs and study monitoring. Please get in touch if you would like more information.