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Biocides EDC criteria to apply from June

The European Commission has published its delegated Regulation setting out the criteria for identifying endocrine disrupting chemicals (EDCs) under the biocidal products Regulation (BPR) in the EU Official Journal. The criteria will apply from 7 June 2018.

Unlike the proposal for EDC criteria for plant protection products, the European Parliament and Council did not block the BPR proposal from entry into force. The PPP proposal was vetoed in October, sending the European Commission back to the drawing board to come up with an amended measure.

This means the BPR regime will be the first to apply the criteria. Eventually, they are expected to become applicable across sectors of EU law, such as cosmetics, toys and food contact materials.

The biocides authorities are currently finalising work on guidance papers for their implementation.

Two papers, laying down how the criteria should affect active substances and biocidal products, have been on the agenda for last week's meeting of the biocides competent authorities (CA), and several meetings before.

The European Commission said it hopes to finalise and adopt the papers early next year. The next CA meeting will be held on 10-12 January.

Implementation concerns

Both papers have been subject to heated discussion. Industry has voiced concerns over the Commission's plans to apply the criteria to both biocidal actives and non-active substances (co-formulants) in pending product authorisation applications.

Law firm Steptoe and Johnson flagged up potential legal issues with the proposal too, calling it an "overreach" that goes beyond the BPR's remit.

And Echa has said that information on co-formulants is limited and that will create problems in the assessment, for example, data ownership disputes with substance suppliers.

The agency has also expressed concern that active substance evaluations will face delays from the criteria's implementation. It said gathering additional data needed to assess substances for ED properties could add months, or years, to an assessment.

It asked the CAs last week to clarify when the criteria would affect active substances that have already been assessed by Echa's Biocidal Products Committee (BPC). The agency wants to avoid BPC Opinions being sent back to the committee to be checked for ED properties retrospectively.

Echa says it will reject a substance evaluation by an evaluating CA, if it does not contain an assessment for ED properties, from the date the criteria apply.

The Commission asked Echa to discuss these situations with the relevant CAs directly.

Guidance expected

Meanwhile, Echa and the European Food Safety Authority (Efsa) have confirmed they intend to publish draft guidance on the EDC criteria in early December.

The team with responsibility for the guidance gave a status update to last week's meeting of the Competent Authorities for REACH and CLP (Caracal).

It is processing more than 1,800 comments received during the second consultation on the matter, which involved member state competent authorities, industry and "public interest stakeholder organisations".

Echa told the CAs last week that it expects to revise the paper by March 2018, and publish the final guidance in May 2018.

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