The European Commission has brought only marginal changes to its proposals on endocrine disruptors, according to documents seen by EUROPE. Health organisations and the industry are disappointed.
In mid-June, the Commission set out a series of criteria to identify (and, ultimately, ban) chemicals that have a harmful effect on the hormonal system (the so-called endocrine disruptors) (see EUROPE 11573). In its proposals on pesticides and biocides, it used the following three cumulative criteria (1) adverse effects; (2) the endocrine mode of action (which makes it possible to explain the effect at cellular or molecular level); (3) correlation between the two previous criteria.
To address the criticism from some member states which have formed a blocking minority, the Commission began this week to circulate amended proposals. The main change consists of identifying agents which “show” adverse effects rather than those “known” to cause harmful effects. In itself, this amounts to no change.
Nothing more than cosmetic changes, rage health organisation. Despite the criticism, the Commission is sticking with its proposal that chemical agents presenting “negligible risk” may exceptionally be authorised. This is a departure from current rules on pesticides (Annex II of Regulation 1107/2009), which restrict such derogations to substances presenting “negligible exposure”. “We made this change because, in our view, exposure is impossible to measure and monitor. I do not think that this offers any less protection”, said a Commission official. Endocrinologist Jean-Pierre Bourguignon does not share this opinion: “This change presents a dual problem: firstly, the risk assessment includes exposure and the dose-response relationship, which re-introduces the strength criterion rejected by endocrinologists and supported by industry. Secondly, this is an exception that cannot be defined by conditions. Consequently, a company manufacturing a molecule will seek to come within the exception”, he said, adding: “The Commission does not even define what is meant by negligible. Thus we have criteria with no criteria!” he railed.
PAN-Europe, an organisation opposed to pesticides, and the EDC-Free Europe coalition adopt the same line. Both organisations regret that the new proposals have still not adopted the idea of categories (active substances, suspected disruptors and proven disruptors). They argue that the level of proof required to demonstrate that a chemical agent does, indeed, disrupt the hormonal system is far too high. It will be much more difficult to ban a cancer-causing agent (a carcinogen) than one that disrupts the endocrine system, PAN-Europe says. The ECD-Free Europe coalition and the SomOfUs movement have so far gathered 217,661 signatures against the Commission proposals.
The European Crop Protection Association (ECPA), which represents the industry, also criticised the latest draft of the proposals. The Commission has “missed yet another opportunity to demonstrate their commitment to regulate endocrine disruptors in line with the relevant scientific evidence”, said Graeme Taylor, ECPA Director of Public Affairs, referring principally to there being no strength criterion (linking dosage and effect) backed by the industry.
“Lowest common denominator”. The Commission has defended itself: “Health organisations and the industry present diametrically opposed points of view. There is a point where science differs, but this is the point way up the scale. The two sides of science agree on that point and agree that from there it is not possible to find any higher denominator which would make sense for regulatory purpose”, an official told us. The Commission may even face a complaint before the World Trade Organisation as may be seen from the discussion of WTO members on 27 and 28 October (see EUROPE 11660). More than 20 countries expressed concern at the criteria established by the Commission, which they felt were overly based on danger and not enough on risk. In response to our question, our Commission source said: “Europe is not safe from action at the WTO. There is as much as a 50% chance that a complaint will be lodged against it. I don’t think, however, that there is much of a prospect of its losing”. (Original version in French by Sophie Petitjean)