The Commission has organised another experts’ meeting on 7 April on criteria for identifying biocide products that act as endocrine disruptors. Although no vote is planned, the Commission is hoping to make progress on the chemical products deliberately devised to disrupt the endocrine system (so-called “growth regulators”).
In the middle of last year, the Commission proposed maintaining three criteria for identifying (and ultimately banning) chemical substances that have a hazardous impact on the hormonal system (see EUROPE 11573). Its proposals are based around two texts: a draft regulation on pesticides and a delegated act on biocides.
So far, five meetings have been organised and it appears that an agreement is not so far off: during an indicative vote on 28 February, 11 member states supported the proposal on pesticides, 8 abstained (7 of them because the criteria and derogations were not voted on in a single block, and one of them because it opposed the provisions on growth regulators), 8 opposed the proposal (5 also calling for a vote on a single block and 3 believing that the requirements for proof were too high) and one member state was absent.
The Commission took advantage of this opportunity to clarify certain provisions (particularly on procedures) and justify the choices it had made (particularly with regard to growth regulators). On this last point, the Commission re-iterated that these criteria are cut-off criteria based only on hazard assessment. “A full risk assessment for human health and for the environment is always foreseen, even if a substance is not identified as an endocrine disruptor. In other words, in any case an active substance can only be approved if there are no adverse effects demonstrated for humans and no unacceptable effects for non-target organisms”, it states.
The discussions on 7 April will focus on a slightly amended text “on the form and not the substance”, the Commission stated. The new version says that the derogation for growth regulators will not apply to vertebrates. It also says that it will only apply to pesticides and biocides, even though the criteria have been extended to other European texts. In February, the Commission also introduced a 6-month transition clause and a 7-year revision clause (which two member states opposed because they believed the duration should be reduced).
Positions highlighted
The minutes from the Standing Committee on Plants, Animals, Food and Feed on pesticides, as well as from the experts’ group on biocides, provide a good insight into the different positions expressed. In them, we therefore learn that: - nine national experts from the biocide experts’ group did not agree with including a provision to clarify the scope for growth regulators; - two member states wanted this to be included and one member state highlighted the fact that without this provision, no horizontal criteria between biocides and pesticides could be obtained; - and one member state, subsequently supported by the others would like active substances with an intended endocrine disruptive effect to be labelled as endocrine disruptors. Another example is that two member states expressed concerns about the fact that the co-formulants are covered by criteria, and one member state repeated its concern regarding the requirement for evidence, which it believes is too high.
Procedure clarified
During the February meeting, the Commission largely insisted, at the request of the member states, on the adoption procedure. The two legislative proposals both relate to the previous committee procedures. The regulation on pesticides is subject to regulatory procedure with controls: this requires a vote at qualified majority voting at the Standing Committee on Plants, Animals, Food and Feed on pesticides before the Commission can officially submit the proposal to the Parliament and Council – which will have three months to oppose it and therefore compel the Commission to revise its proposal or put forward a new text.
The delegated regulation on biocide products only has to be discussed at the experts’ group before the Commission decides on whether to adopt it. The text is considered adopted if neither the Parliament nor the Council oppose it. These two institutions, however, have two months (or four if they wish) to force the Commission to review its text.
EFSA, ECHA and the JRC are gradually developing guidance for implementing these new criteria. According to the Commission, this guidance should be published in the middle of this year for consultation. The proposal on biocides of 7 April and the report of 28 April can be consulted on: http://bit.ly/2ohRUri (Original version in French by Sophie Petitjean)