It remains unclear how key parts of the EU’s revised classification and labelling regime should be implemented by the supply chain, industry experts told attendees at a Chemical Watch Events & Training conference in Brussels last week.
The warning comes with the earliest compliance deadlines now just months away.
For some products, companies will have to apply criteria for the new hazard classes, which include endocrine disruption, from 1 May 2025.
However, it is not yet clear exactly how this should be done, said André Schlichting, regulatory affairs manager at Colgate Palmolive. "We have to face the fact that we are not fully aware of the assessment procedure," he said.
Endocrine disruption is already part of hazard assessment under EU pesticides and biocides regulations. But the assessment procedure under these is "much clearer" than it is under CLP, Dr Schlichting said. He added that ECHA guidance is sorely needed.
ECHA is expected to update its CLP guidance for the new hazard classes by the end of this month. However, Elisabetta Di Caprio from industry association Concawe, which represents oil and petrochemicals producers, implied this may not give companies enough time to conduct the assessments needed to comply with the 1 May deadline, which applies for products that are new to the market.
"We will have only a few months to assess hundreds of substances," she said.
Di Caprio also said that the relative lack of data on endocrine disruption would be a problem, given that REACH does not yet contain information requirements for that endpoint.
Open questions
CLP is being revised in two parts. In addition to the annex changes adopted by the European Commission last year by delegated act, the EU is on the cusp of signing off an update to the main text via the ordinary legislative process.
Together the two parts encompass a broad range of changes to the legislation, covering:
- more than one constituent substances (MOCS);
- the obligation to notify ECHA with classifications;
- harmonised classification and labelling (CLH) proposals by ECHA or the European Food Safety Authority (EFSA);
- harmonised classifications for groups of substances;
- labelling (including formats, digital labels, fold out labels);
- advertising; and
- poison centre notifications.
Dr Schlichting said there remained "many open questions" over implementation.
In addition to how substances should be assessed against the criteria for the new hazard classes, it is not clear what impact on marketability the resulting classifications would have, he said.
For example, it is expected that category 1 endocrine disruptors will be handled similarly to carcinogenic, mutagenic and reprotoxic (CMR) substances under sector specific legislation that uses CLP for regulatory triggers. How category 2 endocrine disruptors are handled remains unknown, however, said Dr Schlichting.
There is also uncertainty over what the new labelling requirements should entail in practice. For example, the incoming legislation requires labelling to have a line separation of 120%, which can be interpreted multiple ways, he said.
And companies must use black colour on a white background for the text. A strict interpretation here might exclude recycled packaging, which more commonly has a grey or brown hue, with unintended impacts on sustainability.
Act now
Updates to the ECHA guidance to account for the ordinary legislative process are expected next year, with the agency starting the task of publishing the final legislation.
In the meantime, companies can take action to prepare, Dr Schlichting said. For the new hazard classes, they should take steps to ensure relevant data is up to date and start talking to raw material suppliers about the "huge communication upgrade" that will be needed.
Also, companies should explore now how they will handle labelling changes, particularly if new packaging concepts are also required, he said.
Torsten Funk from the Association of the European Adhesive & Sealant Industry said guidance would be key to successful implementation of the CLP revision.