EU Lays Groundwork for Regulating Endocrine Disruptors

16.06.2016 -

In the form of an Impact Assessment Report and two draft legal acts – a Plant Protection Products Regulation and a Biocidal Products Regulation – the European Commission (EC) on Jun. 15 presented its long awaited proposals designed to lay the groundwork for identifying endocrine disruptors and for future legislation.

At present, there are no overarching rules governing endocrine disruptors anywhere in the world. For the EU, the Commission was due to define test criteria by December 2013 but failed to do so, sparking criticism from environmental authorities in some member states – in particular Sweden, which sued the EU governing body.

France, which has spearheaded regulation of endocrine disruptors such as bisphenol A, the chemical used as a starting material for polycarbonate and epoxy resin-based can liners, also has been highly critical of Brussels’ slow approach. The EU has not yet formally discussed the country’s proposal to reclassify BPA as a category 1B substance toxic for reproduction.

While, some EU authorities, in particular the European Food Safety Authority (EFSA) have, looked at specific substances, such as bisphenol A, results so far have been inconclusive. Several studies are still in progress.

Days before the Jun. 15 presentation, the European Parliament on Jun. 8 criticized the EU’s legislative body for foot dragging on endocrine disruptors and adopted a resolution demanding immediate action.

The Commission said its just-presented proposals are based on scientific data defined by the World Health Organization (WHO), which classify a substance as an endocrine disruptor if it has an adverse effect on human health, an endocrine mode of action or if there is a causal link between the adverse effect and the mode of action.

WHO also specifies how the identification of an endocrine disruptor should be carried out, namely by “making use of all relevant scientific evidence, using “a weight of an evidence-based approach and applying a robust systematic review.”

Apart from defining criteria, the EC said it plans to step up its efforts to minimize exposure to endocrine disruptors, in the short term through research and international cooperation, in the mid-term through developing test methods and in the long term through regulation.

To kick-start the process, the Commission said it would ask EFSA and the European Chemicals Agency (ECHA), the body that administrates the REACH chemicals legislation, to begin looking at whether approved individual substances can be identified as endocrine disruptors. This, it said, would help to ensure that the two agencies are “ready to apply the criteria” as soon as the rules enter into force.

Of the EU’s two draft legal acts, the Plant Protection Products Regulation will be voted on by the member states, while the latter will be discussed by an expert panel of member states prior to adaption by the Commission. Both acts will then be presented simultaneously to the European Parliament and the Council for their approval.

The Commission also hinted at – unspecified – changes it said could be made under the plant protection legislation to reflect “the latest scientific knowledge.” However, it said the hazard-based approach of the existing Pesticides Regulation will be maintained, in which substances can be banned without regard to exposure levels, a nod to France, which favors this approach.

As could be expected, the chemical industry were critical of some of the EC proposals. European Crop Protection, the trade body representing the agrochemicals industry, said its members were “extremely disappointed” that after six years of hard work with input from EFSA, scientific experts and various stakeholders, the criteria were no more than the WHO/IPCS definition, developed over a decade ago.

Also with an eye to agrochemicals, the German chemical industry association Verband der Chemischen Industrie called on the Commission to “limit the regime for endocrine disruptors to substances that trigger a harmful effect in humans or in the environment already in low quantities or doses.

“The decision as to whether a substance is in need of regulation should take into account the severity of harmful effects, the reversibility of a negative effect and the informative value of scientific data,” VCI added.