EDs criteria still controversial for EU chemicals regulation

In February 2015 DG SANTE published its responses to the public consultation launched in December 2014 as part of the roadmap for identifying criteria on endocrine disruptors (EDs) in the context of the implementation of the Plant Protection Products Regulation 1107/2009 (PPPR) and Biocidal Products Regulation 528/2012 (BPR). A summary report of the industries' replies is also expected in the upcoming weeks.

By way of background, the Commission stated earlier last year, that although provisions on EDs are in force in some sectorial EU legislation, no formal criteria have been established internationally or at EU level for identifying EDs. The BPR and the PPPR provide that substances having endocrine disrupting properties which may cause adverse effects can only be approved for the respective use if they comply with strict conditions. In this regard, both regulations empower the Commission to establish scientific criteria to identify substances with endocrine disrupting properties.

It should be noted that, although the roadmap is primarily aimed at the BPR and the PPPR, the objective of the Commission is to establish horizontal hazard-based criteria to identify EDs, which would also be applicable to other sectors, e.g. REACH, cosmetics, and medical devices.

In addition to the EDs criteria consultation, in December 2014 the Commission's Scientific Committee on Consumer Safety (SCCS) published a memorandum on the topic supporting the World Health Organization (WHO) definition of ED, which reads as follows:

''An endocrine disruptor is an exogenous substance or mixture that alerts function (s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub) populations.''

Moreover, the memorandum also endorses the criteria proposed by the WHO, which suggests that an ED should be defined by the presence of: 1) an adverse effect in an intact organism or a (sub) population; 2) an endocrine activity; and 3) a plausible causal link between the two.

The whole ''saga'' surrounding the EDs criteria stems from two main issues brought up by EU biocides and pesticides stakeholders - namely, the delay of the process for setting up the criteria on the part of the Commission, and the proposed hazard-based approach as opposed to a risk assessment.

The first clash concerns biocides, whereby last year, Sweden lodged a complaint before the General Court (case T-521/14) arguing that by failing to adopt delegated acts to specify scientific criteria for EDs by the deadline of 31 December 2013, the European Commission has infringed Article 5(3) of the BPR. It has been recently announced that the Council of Ministers and Denmark will also join the court case. A formal decision of the European Parliament to join is still pending.

The issue with EU EDs criteria has been equally controversial for the pesticides industry in Europe. In particular, in an interview published by EurActiv, Jean-Charles Bocquet - the Director General of the European Crop Protection Association (ECPA) - expressed two main concerns regarding the impact of the delayed ED criteria. First, the delay on the part of the Commission has created uncertainty for the various parties - i.e. Member States, the European Food Safety Authority (EFSA), risk managers, and companies.

Second, the ECPA is not in favour of the proposed hazard-based criteria, which if used would lead to every technology, including natural products, being caught under the ''hazard'' label. In that regard, the European Association shares, its US counterpart's, CropLife, position that the American risk-based system (used so far also in the EU) is the better regulatory model for Europe which will not compromise food safety or environmental protection. In their view, the precautionary principle envisaged by Brussels decision-makers is overly cautious, unrealistic, and would also have a negative impact on agricultural innovation and trade, with the latter being very important in the current Transatlantic Trade and Investment Partnership (TTIP) agreement negotiations.

Clearly, the debate on setting up an EDs criteria for biocides, agrochemicals, and other chemicals horizontally, has proved to be quite problematic and more is expected in view of the summary report of the public consultation's replies, and more importantly in view of the fact that the Commission, Council and Parliament are not expected to finalize this dossier before the end of 2016.