Brussels, 13/06/2016 (Agence Europe) - The European Commission has been walking on eggshells in the sensitive dossier on endocrine disruptors. On Wednesday 15 June, it is expected to propose that it draw on the WHO/IPCS criteria to define - and ultimately prohibit - substances that alter the endocrine system. This approach does, therefore, not take into account the potency of an agent (the link between the dose and the effect) as supported by the industry or the "potential" disruptors that endocrinologists would have liked.
Substances that have an active effect on the endocrine system are chemical substances that interfere with normal hormonal activity. They are found, for example, in environmental pollutants or medicines. They are considered as "endocrine interrupters" when they have a harmful effect on human health such as diabetes and obesity, sterility and some kinds of cancer. Given the potential dangers, regulations on biocide (EU 528/2012) and phytosanitary products (EU 1107/2009) the European Commission was called on to elaborate, before the end of 2013, Community criteria to help identify substances that effectively and dangerously alter the endocrine system. The Commission, however, continually extended this deadline due to the economic implications of these criteria. EU rules stipulate that substances that are recognised as endocrine interrupters are quite simply withdrawn from the market.
Avoiding another "glyphosate" scenario. It is therefore only after two and a half years of delay, a decision made against it by the General Court of European Union and numerous and extremely urgent resolutions from the European Parliament that the Commission is now ready to present its famous definition criteria on 15 June. This decision is largely influenced by the extremely difficult glyphosate dossier. It should be pointed out that the Commission had originally intended to reauthorise this herbicide until 2031 but was forced to revise its draft by the member states, bolstered by the diverging results from the investigations made by the World Health Organisation (WHO) (that glyphosate is probably carcinogenic to human beings) and the European Food Safety Agency (EFSA) (that glyphosate is probably not carcinogenic to human beings). The member states are unable to even agree on extending the current glyphosate licence until the end of 2017, the date the European Chemical Agency (ECHA) is expected to provide its conclusions on the carcinogenic nature of this substance and its impact on the endocrine system.
The choice: option 2. In the wider dossier on endocrine interrupters, the Commission therefore appears to have decided to go along with the WHO in an effort to proceed appropriately in the event of an authorisation or ban on an active substance. On 15 June, it is expected to present a restrictive definition that leaves no room for uncertainty. In other words, if a substance is an endocrine disruptor it should be banned and replaced, if possible, by an alternative substance. If this is not the case, it should be authorised. The Commission rejects all the different sources of uncertainty, such as the idea of the scenario 3 roadmap (June 2014) for adding different categories on the basis of the degree of proof (active substances, suspected or confirmed endocrine disruptors). Or the idea of scenario 4, taking into account the quantity of the substance needed to produce a certain effect (the criteria of potency). The latter was largely supported by the industry but was rejected in the middle of the last April by participants at the experts' conference organised in Berlin by the German Institute for Risk Assessment (BfR).
The criteria retained are based on the definition provided by the International Programme on Chemical Safety (IPCS) and the World Health Organisation (WHO) based on hazard identification. According to the WHO/IPCS, "an endocrine disruptor is a substance known or presumed to have caused undesirable effects on the endocrine system in human beings or animals species in the environment or has been the subject of experimental study trials (in vivo)”, which can potentially be backed up by other information that can lead to a strong presumption being made in this connection. This implies that it is not because a substance interacts with the endocrine system that it has necessarily had a harmful effect on health or the environment.
Consequences. In practice, the Commission is expected to propose two legislative proposals on 15 June: an amendment to the regulation on biocide products and an amendment to the regulation on phytosanitary products. It is not, however, expected to amend other legislation, such as the directive on cosmetic products or the one on water. The two legislative documents accompany a cost and social economic benefits study in 4 different scenarios and analysis of around 700 substances (400 pesticides, 100 biocides and 200 miscellaneous), carried out by the Joint Research Centre (JRC). The documents will immediately be sent to the European Parliament and Council for their approval and will apply as from the date of their publication in the EU Official Journal.
At the present time, it is still too early to know what substances will be banned or authorised. According to our information, it will be up to the ECHA and EFSA to proceed to a meticulous analysis. The WHO/IPCS definition will contain an identification procedure that is divided into well-defined stages: firstly, an analysis of the scientific data available and a quality assessment, reliability, data reproduction capacity and stability. The EU agencies will then ensure that the disruption is indeed due to a specific endocrine-mediated mode of action and not to a non-specific secondary consequences of other toxic effects. The process will be concluded with a final toxicological assessment that indicates, if possible, whether side-effects relate to human health and the environment and what are the basis and mechanisms involved (oestrogen, androgen, thyroid and/steroidogenic based). As we go to press, the Commission documents were still being consulted by the inter-services and could subsequently still be subject to further amendments. (Original Sophie Petitjean)