On 17 May, the European Commission may well indeed put its proposal on endocrine disruptors to a vote. The compromise to be presented to national experts that day authorised intended disruptors but withdraws the idea of a derogation for active substances that present a negligible risk.
It should be pointed out that in the middle of last year, the Commission proposed retaining three criteria for identifying (and ultimately banning) chemical substances that dangerously interfere with the hormonal system (see EUROPE 11573). Its proposals come three years later than the initially proposed calendar, however. They are based around two texts subject to different adoption procedures: a draft regulation on pesticides and a delegated act on biocides. Both of them are divided into a part involving specific criteria and another on derogations.
The Commission strategy is very clear: ensuring support by a qualified majority of national experts on the part on “pesticides” before putting the text to a vote and adopting the part on biocides. This approach will be taken because the draft regulation on pesticides has to be adopted by the member states, whilst for the one on biocides, the Parliament and Council can only oppose it after the adoption by the Commission (see EUROPE 11758).
After six meetings staggered throughout the year, everything appears to be appropriate for the European Commission taking action.
What could future criteria look like?
The compromise that will appear on the table of the standing Committee on Plants, Animals, Food and Feed (PAFF) on 17 May is proposing:
- that 3 criteria are retained for identifying active substances: 1) the appearance of unwanted side-effects; 2) the endocrine mode of action (which helps to explain the effect at cellular and molecular level); 3) a correlation between the two previous criteria (see EUROPE 11573). Compared to previous versions, the new compromise emphasises, in its clauses, that this correlation must be based on a principle of “biological plausibility” underpinned by current scientific knowledge and guidelines agreed at international level. It also explains that, “The determination of endocrine disrupting properties should be based on human and/or animal evidence”.
- the authorisation, in certain conditions, of active substances whose intended plant protection mode of action is to control target organisms other than vertebrates (intended disruptors) but only if this follows a risk assessment and regulation 283/2013 establishing the requirements on criteria for active substances. During the meeting on 7 April, eight countries (Belgium, the Netherlands, Austria, Sweden, Norway, France, Spain and Finland) supported a compromise amendment submitted by Denmark, calling for intended disruptors to be labelled as such.
- to maintain the current derogations authorising certain pesticides or biocides that disrupt the endocrine system. According to this approach, the active substances identified as endocrine disruptors and which present negligible exposure in cases involving phytopharmaceutical products or a negligible risk after exposure (in cases involving biocides) will be approved, contrary to the general principle that called for a ban on endocrine destructors.
In response, the PAN-Europe NGO has already said that it regretted that the requirements for evidence is still so high when it comes to identifying pesticides that disrupt the endocrine system. This NGO is involved in combating pesticides and points out that the EU is only currently applying one criteria for identifying carcinogens (side-effects), although the Commission proposed three criteria in this regard (side-effect, mode of action and correlation). It is particularly concerned that assessments could be based on scientific data from “alternative prediction systems”. It also claims that the systems are largely supported by the industry insofar as they are based on suppositions and ultimately discredit the results from studies carried out on animals. The text for the proposal can be seen at:
http://ec.europa.eu/health/endocrine_disruptors/next_steps_en (Original version in French by Sophie Petitjean)