ECPA welcomes EFSA’s scientific input but sees it as late and fears ED rules will crush innovation in farm inputs
Today the European Food Safety Authority’s (EFSA) Scientific Committee published its opinion on identifying endocrine disrupting chemicals (EDs). ECPA welcomed the EFSA opinion but is concerned how late the input has been requested in a process that has been rushed to meet political deadlines. The process to create new EU rules to identify and regulate EDs, threatens to take action based on theoretical rather than proven risks, to the detriment of European industry competitiveness and the broader public good.
“ECPA appreciates EFSA’s scientific input but sees its contribution as unfortunately late when the ED criteria are all but finalised. It is even more perplexing why the Commission’s own scientific committees have been absent from the development of the ED criteria”, said Friedhelm Schmider, Director General of the European Crop Protection Association (ECPA). “Endocrine disruption is a complex scientific issue and the Commission’s own scientific committees could have made an invaluable contribution in providing clear expert advice to European regulators and politicians."
Ignoring established scientific principles and rushing the development of the ED criteria risks dealing a crushing blow to European industrial innovation. The criteria as recently drafted would deny EU farmers access to essential and innovative plant protection products which they safely use today. This will deprive EU farmers of important tools at a time when productivity must rise to meet increasing demand for food.
ECPA is clear that protecting human and environmental safety should not be compromised. Satisfying this goal and retaining industry competiveness can co-exist if the ED criteria focus on actual rather than perceived risks. The EFSA opinion raises several important technical considerations which ECPA welcomed and which demand further consideration in this respect:
- risk assessment – EDs can be treated like most other substances and risk assessment is a suitable method to evaluate the level of concern posed by EDs, i.e. consideration of actual or predicted exposure and not only hazard;
- potency and severity – are important and relevant indicators of potential concern, and should be considered; and
- establishing safe dose/concentrations, above which adverse effects occur, is possible.
Further input of EFSA’s Scientific Committee on the many complex topics around endocrine disruption is essential. As the scientific debate continues on these topics, robust and independent scientific advice is important to ensure European regulation addresses substantiated concerns rather than fear. A broader return to risk assessment over hazard assessment would meaningfully contribute towards this goal.
- ECPA (European Crop Protection Association) represents the European R&D based manufacturers of plant protection products (pesticides). Plant protection products are essential tools to help EU farmers protect their crops from pests and diseases.
- Under the new pesticides regulation, Regulation 1107/2009, substances considered to have “endocrine disrupting properties” in humans or non-target species will not be approved. The inclusion of this hazard based criteria is a departure from the established tool of risk assessment for evaluating the safety of substances, where both the hazard and exposure to a substance is considered. No criteria are included to define what are considered to be endocrine disrupting properties, however, the European Commission must come forward with a proposal for these criteria for pesticides by 13 December 2013.
- Within the Commission, the responsibility for preparing the scientific criteria has been delegated to DG Environment, who has been tasked with developing criteria for the identification of endocrine disruptors which will be applied to general chemicals (REACH), biocides (Regulation 528/2012) as well as to pesticides (Regulation 1107/2009), and possibly also to cosmetics (Regulation 1223/2009).
- In February 2013, DG Environment released a revised proposal for the criteria for the identification of endocrine disruptors, “Revised version of possible elements for criteria for identification of endocrine disrupters”. The final horizontal criteria are expected to be published in May 2013 after which they will be transposed into the different pieces of sectorial legislation, including Regulation 1107/2009 for pesticides.
- In September 2012, DG Sanco requested a scientific opinion from the EFSA Scientific Committee (European Food Safety Authority) as part of the input into the process for the development of the endocrine disruption criteria.
- The European Commission has three non-food related Scientific Committees, these include: Scientific Committee on Consumer Safety (SCCS), Scientific Committee on Health and Environmental Risks (SCHER), Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). Although these committees have the relevant expertise none have been formally consulted during the process for the development of the criteria for the identification of endocrine disruptors.
- Experts from industry, including ECPA, have contributed significant scientific expertise to the issue of endocrine disruption. Through ECETOC (European Centre for Ecotoxicology and Toxicology of Chemicals, industry experts developed a regulatory proposal for managing endocrine disruptors (Bars, R., I. Fegert, M. Gross, D. Lewis, L. Weltje, A. Weyers, J.R. Wheeler, Galay-Burgos, M. 2012. Risk assessment of endocrine active chemicals: identifying chemicals of regulatory concern. Regul Toxicol Pharmacol. 64(1):143-154). The publication was recently awarded the title of “Best Published Paper Advancing the Science of Risk Assessment” by the Society of Toxicology.