What’s Next for the EU Criteria to Identify Endocrine Disruptors: A Legal Map of the Adoption Process


Since June 2016, the EU has discussed several draft proposals for scientific criteria to identify endocrine disruptors (EDCs). On July 4th, representatives of Member States agreed upon the criteria for pesticides. These criteria are far from what would be needed to actually identify, and eventually get rid of, all EDCs, but nothing is set in stone (yet).

So what does this mean?

There is an internationally agreed definition of endocrine disruptors from 2002 from the World Health Organisation’s International Program on Chemical Safety: Global assessment of the state of the science of endocrine disruptors. This definition, however, required further refinement to be applied to EU regulations.

Despite the mandate to develop harmonized hazard-based criteria to identify EDCs, the EU Commission has been focusing its efforts on specifically designing EDC identification criteria in the limited context of only two legal acts: the ‘pesticides regulation’ (plant protection product regulation n°1107/2009) and the ‘biocides regulation’ (biocidal product regulation n°528/2012).

The pesticides and biocides regulations contain a similar provision requiring EDC identification criteria, but the adoption procedure is slightly different in each, requiring two different expert committees and different timing, which impacts the final adoption procedure for the criteria.

What happens to the EDC criteria now under the pesticide regulation?

Under the pesticides regulation, the Commission had to present a proposal to a committee of EU member states – the Standing Committee on the Food Chain and Animal Health (SC-PAFF). Since June 2016, the Commission presented and amended the draft five times, until it was finally agreed upon by SC-PAFF on July 4th.

The adoption procedure under the pesticides regulation, referred to as the regulatory procedure with scrutiny, involves the EU Parliament and Council. The Commission has to submit the text of the criteria to the two institutions. Then, both the Parliament and Council can oppose the criteria if:

  • The Commission exceeds the implementing powers provided in the pesticides regulation,
  • The criteria are not compatible with the aim or the content of the pesticides regulation, or
  • The criteria do not respect the principles of subsidiarity or proportionality.

Both institutions have three months to adopt a decision to oppose the criteria, via a simple majority for the Parliament and qualified majority for the Council (that is 55% of member states, representing at least 65% of total EU population).

If three months expire without action from the Parliament or Council, the criteria are considered adopted and shall be published in the Official Journal of the EU.

There are two reasonable grounds upon which Parliament and the Council should oppose the criteria agreed upon on July 4th:

  1. the criteria contain an exception for substances specifically intended to control target organisms via their endocrine systems, and
  2. the very high burden of proof to identify a substance as an EDC.

Opposition from either of these institutions would effectively block final adoption of the criteria. In case of opposition, the Commission may submit amended draft criteria to the SC-PAFF.

The criteria will enter into force twenty days after their publication in the Official Journal of the EU, and –as specifically indicated in the current draft- application will begin six months after its entry into force. 

The EDC criteria in the biocides regulation

Under the biocides regulation, the Commission still has a pending obligation to adopt the criteria through a delegated act after consultation of the Member States Competent Authorities for Biocidal Products. The deadline for adoption expired in 2013, and in 2015, the European Court of Justice condemned the Commission for its delay.

After the adoption of the delegated act, the Commission notifies the Parliament and Council of the criteria, both of which will then have two months to object, extendable by other two months.

The Parliament decision is adopted via a majority vote, while the Council requires a qualified majority. In this case, the institutions are not bound by specific grounds of opposition.

Other EU regulations – beyond biocides and pesticides

The EU 7th Environmental Action Programme and the EU Better Regulation Agenda mandated that the Commission develop horizontal criteria applicable across EU regulations, to account for the presence of endocrine disrupting chemicals in products other than pesticides and biocides. However, the nearly adopted criteria are narrowly designed for application within the biocides and pesticides regulations to the exclusion of all other areas where EDCs exist.

While the medical devices regulation directly refers to the criteria under the biocides regulation, other areas of EU law remain in a regulatory void. As a result of the flawed, narrow, sectoral approach chosen by the Commission and validated by the member states, endocrine disruptors are not only escaping identification in pesticides, biocides, and medical devices in contact with the most vulnerable, but also remain unregulated in entire product markets such as cosmetics, toys, and food contact material.