On 9^th November 2016, the European Commission (EC) issued a new version of the two sets of their long overdue scientific criteria for the identification of Endocrine Disrupting Chemicals (EDCs). The new set of criteria was meant to be an improvement on the widely criticised version of the criteria issued on 15^th June 2016. One of the remaining stumbling blocks is issue of the burden of proof. 

The new wording requiring chemicals to “show” adverse effects could still be construed as being as restrictive as the June 2016 version that referred to chemicals “known to have” an adverse effect.  In effect, few chemicals would end up being regulated as EDCs.

HCWH Europe has been very active in highlighting the damaging knock-on effects of such a narrow definition of EDCs on the soon to be formally adopted Medical Devices Regulation. On 11^th October 2016, we addressed a letter to Commissioner Bieńkowska (DG MARKT) and Commissioner Andriukaitis (DG SANTE) to share our deep concern regarding the on-going discussions on the elaboration of the EDC criteria.

Following the publication of the new set of criteria on 9^th November, we wrote letters to all the EU Member States representatives sitting on the Biocides Committee - the competent authority that is part of the approval process of the new set of criteria. A similar letter was also sent to all EU Member State’s Health Ministers as well as to all the members of the ENVI Committee of the European Parliament.

Read our letter to the Biocides Committee here.

In these letters we reiterated our deep concern regarding the on-going discussion on the elaboration of the EDC criteria, focusing specifically on how inappropriate criteria could undermine the Medical Devices Regulation. The letter we sent to the Biocides Committee was uploaded on the public part of the CIRCABC (Communication and Information Resource Centre for Administrations, Businesses and Citizens). This means that our letter will be shared with Member States and other stakeholders actively involved in the discussions on this topic.

In terms of timing, we know that the more recent versions of the criteria were discussed by the respective Member States Competent Authorities on 18^th November. During these meetings, the European Commission did not put its draft criteria to a vote but instead asked Member States to provide further input to rework their new version, which is still seen as falling short. The next discussions are not expected before January 2017.

Background

On 9^th November, the European Commission issued a new version of the two sets of their long overdue scientific criteria for the identification of EDCs. One set was an obligation under the Pesticides Regulation (EC) No 1107/2009 and the other – of more relevance to us as the criteria will apply to the new Medical Devices Regulation – was mandated by the EU’s Biocides Regulation (EU) No 52812012.  These sets of criteria are now close to three years overdue and have formed the subject of a condemnation of the European Commission by the General Court of the European Union in December 2015.