In a press release published on July 4, 2017, the European Commission (EC) informed that on the same day the representatives of the European Member States (MS) voted in favor of the latest revision of the EC’s proposal on criteria to identify endocrine disrupting chemicals (EDCs) among plant protection products (PPPs) (FPF reported). The vote took place during the meeting of the Standing Committee on Plants, Animals, Food and Feed (SC-PAFF) in Brussels (FPF reported). From the 28 MS, 21 voted in favor of the proposal, with three (Czech Republic, Denmark, Sweden) voting against it, and four (Hungary, Latvia, Poland, UK) having abstained from the vote. In the near future, the EC also “intends to adopt [similar] criteria for biocides” (here, a separate vote by the MS is not required).
Vytenis Andriukaitis, European Commissioner for Health and Food Safety, called the criteria adoption a “great success” and emphasized that the European Union (EU) is “advancing in the direction of the first regulatory system in the world with legally binding criteria to define what an endocrine disruptor is.”
The endorsed criteria for plant protection products, identifying both known and presumed endocrine disruptors, are based on the World Health Organisation (WHO) definition. The criteria further “specify that the identification of an endocrine disruptor should be carried out by taking into account all relevant scientific evidence including animal, in-vitro and in-silico studies, and using weight of evidence-based approach.” Further details can be found in the Frequently Asked Questions about endocrine disruptors, published by the EC on July 4, 2017, and the decision-making process for EU endocrine disruptor criteria is documented on the dedicated website.
The endorsed text of EDC criteria for PPPs will now be sent to the Council of Ministers and the European Parliament (EP), who will have three months to examine it before final adoption by the EC. The regulation will enter into force 20 days after its final publication, and will apply after a transitional period of six months. A guidance document for implementation of the EDC criteria, currently being jointly prepared by the European Chemicals Agency (ECHA) and European Food Safety Authority (EFSA), is also expected to be finalized during this period. The outline of this document was published in December 2016 (FPF reported), and a public consultation on the draft document will be held this autumn.
For both pesticides and biocides, the EC plans to “already apply the criteria to substances for which assessment or re-evaluation is undergoing or for which confirmatory data concerning endocrine properties have been requested.” The EC further noted that the adopted criteria will form a basis for an expanded strategy to regulate endocrine disruptors in the field of toys, cosmetics, and food packaging.
In her article published on July 4, 2017 by Chemical Watch, editor Vanessa Zainzinger pointed out that representatives of both the industry and non-governmental organizations (NGOs) “expressed regret at the vote,” describing the adopted criteria proposal as “fundamentally flawed,” albeit for contrasting reasons.
The European Crop Protection Association (ECPA), represented by the public affairs director Graeme Taylor, said that the criteria in their adopted form “do not allow authorities to clearly separate those substances that have the real potential to cause harm from those that do not,” and thus will “only serve to have a disproportionate and discriminatory impact on European farmers.”
Several NGOs were also “fiercely critical” and explicitly called on the EP to veto the proposal. Director general of the European Consumer Organisation (BEUC), Monique Goyens, said that the EC’s approach “contradicts the precautionary principle, namely that protective action should prevail in the face of scientific uncertainty,” while “business interests seem to prevail over taking sensible measures which would prevent possible harm from happening in the future.” Alice Bernard, lawyer at ClientEarth, similarly noted that “[these] criteria let industry ‘de-identify’ a chemical as endocrine disruptor.”
The EDC-Free Europe coalition, an umbrella organization with over 70 members, published a press release on July 4, 2017, where they also emphasized that the criteria “require a very high burden of proof, which makes the identification of substances as EDCs very difficult and is likely to result in long delays,” and reiterated concerns over a planned derogation for substances with an intended endocrine mode of action in target organisms, such as growth regulators. Similar views were expressed by Ninja Reineke, senior policy advisor at the NGO CHEM Trust (also a member of EDC-Free Europe), in her detailed article published on the same day.
EC (July 4, 2017). “Endocrine disruptors: Major step towards protecting citizens and environment.”
EC (July 4, 2017). “Endocrine disruptors – Frequently asked questions.”
Vanessa Zainzinger (July 4, 2017). “Member States adopt EDC criteria.” Chemical Watch
Ninja Reineke (July 4, 2017). “Identifying EDCs: EU Government experts adopt flawed criteria.” CHEMTrust
Anna Lennquist (July 5, 2017). “Analysis: What will this week’s EDC criteria vote mean in practice?” ChemSec
Frederic Simon (July 5, 2017). “EU experts agree on criteria for endocrine disrupting chemicals in pesticides.” Euractiv