EDC criteria update

On 8th February 2017, the European Commission issued its fourth draft of Endocrine Disrupting Chemicals (EDC) criteria required under Biocidal Products Regulation (528/2012), and Article 80 (7) of the Pesticides Regulation (1107/2009): (click through for the latest versions of the Biocides EDC Criteria and Pesticides EDC criteria). This most recent draft will be on the agenda of the Standing Committee on Plants, Animals, Food, and Feed Committee (PAFF) and Biocides Committee due to meet on the 28th February.

Ahead of this meeting, as part of EDC-free Europe, HCWH Europe co-signed a letter addressed to European Commission First Vice-President Mr Frans Timmermans. In addition, we sent a letter to all the EU Health Ministers as well as to those national experts sitting on the Biocides Committee.

Since June 2016, we have repeatedly written to EU Health Ministers, various Member States’ Permanent Representations, experts on the Biocides Committee, the European Commission, and even the ENVI Committee of the European Parliament. Each time we have shared our deep concern at the on-going discussion about the elaboration of the EDC criteria (as currently defined by the draft delegated act under the Biocidal Product Regulation (EU) No 528/2012).

Specifically, we alerted them to the potentially damaging knock-on effects of the BP EDC criteria on the Medical Devices Regulation (soon to be formally adopted). Sadly, the revised EDC criteria proposal that was issued on 8th February remains a source of concern, in particular the high burden of proof required to identify EDCs.


The European Commission was under a legal obligation to provide scientific criteria for EDCs by December 2013 so as to regulate these harmful chemicals more effectively. The legal obligations came from two sources, two different Regulations: Article 5 (3) of the Biocidal Products Regulation (528/2012), and Article 80 (7) of the Pesticides Regulation (1107/2009).

As part of our broad mission, HCWH Europe has been active in tackling the health issues linked to endocrine disrupting chemicals (EDCs), specifically focussing on medical devices. We continue to support EDC criteria that are aligned with Option 3, as defined by the 2014 Commission Roadmap. Option 3 uses the WHO/IPCS definition combined with three categories based on the different strength of evidence. This option is the one that is supported by most independent scientists, the European Parliament, and the EDC-Free Europe coalition.

More information

To learn more about EDCs, their current use in healthcare, and the availability of safer alternatives - visit our infographic: