Endocrine Disruption: What’s coming and how you can prepare
2022 is the year we’re expecting to see the most significant updates to Endocrine Disruption assessments for REACH and BPR in over 5 years. Here we’ll talk about what’s coming and the steps you can take to make sure you’re prepared for these changes.
Over the coming year three major changes are expected:
- Full implementation of the ED assessment under the BPR
- Publication of the ED CLP criteria
- Revision of REACH requirements for ED assessment
1. New BPR Information Requirements Applicable from April 2022
The scientific criteria for identifying endocrine disruptors (EDs) for both biocides and plant protection products have applied since June 2018. To support the ED criteria, joint guidance on how to identify endocrine disrupting substances, including recommended studies, was published in 2018.
The BPR active substance information requirements have now been updated to include ED specific studies as core data requirements for assessing the impact on human health and non-target organisms. If conclusions on ED properties can’t be reached on the basis of the mammalian data, then ED studies on fish and amphibian studies need to be considered, along with a systematic review of literature data.
How you can prepare
If you are applying for active substance approval or renewal you need to:
- Perform literature searches, and evaluate all available data to navigate the best path through the potential testing options listed in the new data requirements
- The results of your literature review may require the commissioning of new studies
Undertaking ED testing is time consuming and should not be underestimated, with high demand for these studies at contract laboratories, advanced planning is critical.
2. CLP: New Endocrine Disruption Hazard Classes and Criteria
The Classification, Labelling and Packaging (CLP) regulation is due to be amended, as part of the EU Chemicals Strategy for Sustainability. This will involve new hazard classes for human health and the environment. The wording for the new ED hazard classes is due to be finalised this year. This will clarify the difference between:
Category 1: known or presumed endocrine disruptors, and
Category 2: suspected endocrine disruptors.
At the time of writing, the aim is to have the new hazard classes adopted by the end of this year. The impact assessment for the CLP revisions is due to be completed this spring, with the proposed CLP revision due to be available in the second half of 2022.
How you can prepare
This amendment is undoubtedly going to result in a change of classification for many substances
- Have a strategy in place to handle the change in classification. Who, When, How
- Register for updates from ECHA, and the EC site for the CLP revision initiative to stay up-to-date with the latest developments.
3. REACH Revision: Information Requirements for Endocrine Disruption
The draft revised information requirements for REACH are also due to be published this year. There will be more information required for critical hazard properties, including carcinogenicity and endocrine disruption, and a mixture assessment factor will be introduced.
The requirements addressing ED are expected to be based on those in the 2018 EFSA/ECHA guidance, with the level of detail or specific study types depending on the tonnage band. The planned updates to REACH include classifying endocrine disrupting substances as SoVHC (Substances of Very High Concern), along with persistent, mobile and toxic (PMT), and very persistent, very mobile (vPvM) substances.
The public consultation for these revisions is open now, until the 15th April 2022, with the commission due to present the proposal for REACH revisions by the end of 2022.
How you can prepare
- Register for updates from ECHA, and the EC site for the revision initiative
- Have your say and offer your feedback on the proposals