European Mancozeb Task Force
EU MTF
The EU Mancozeb Task Force is a joint activity of UPL Europe Ltd and Indofil Industries Ltd as notifiers of the active substance Mancozeb.
ID: 728319515523-50
Lobbying Activity
Response to Criteria to identify endocrine disruptors for plant protection products
27 Jul 2016
The EU Mancozeb Task Force (TF) has reviewed the draft European Commission Regulation setting out scientific criteria for the determination of endocrine disrupting properties on Plant Protection Products (PPPs) and biocides as well as the European Commission Communication and Impact Assessment and would like to provide the following comments:
1/ European Commission Draft Regulation
• The TF considers the proposal for the criteria for PPPs to be difficult to work in its current form and calls on the European Commission and Member States to amend it. The European Commission must adopt robust, proportionate and science based criteria for endocrine disrupting properties. These criteria have to maintain the existing high levels of protection for human health and the environment, while ensuring EU farmers have access to the essential crop protection products they need.
• While the TF supports the use of the WHO/IPCS definition, we believe that the lack of inclusion of potency and other relevant aspects of hazard characterisation is a major omission. These aspects of hazard characterisation are critical to distinguish between substances which pose a real danger to health and the environment and those that do not. This significant omission will have major unintended consequences with many substances being identified as endocrine disruptors when they pose no risk in normal use.
• The TF believes that further socio economic considerations, including a risk-benefit analysis (Option C of policy options in the roadmap) should be taken forward when defining the criteria. It would be counter-productive to ban substances that provide valuable benefits to farmers if that does not bring any positive contribution to human health and environmental safety. For example, socioeconomic analyses commissioned by the TF, demonstrate how the loss of mancozeb to farmers would cause large decreases in crop yields and increased problems due to pest resistance with no increased benefit to health.
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2/ Impact Assessment
• The European Commission’s Impact Assessment concludes that Options 2, 3, and 4 “offer the same high level of protection for human health”. However, Option 2 and 3 were assessed as having “the highest impact on sectorial competitiveness, agriculture, and trade”. We do not understand why the Commission has proposed Option 2.
• The European Commission does not support Option 4 (WHO definition with potency), while the Impact Assessment concluded that it offers the best regulatory option when all factors are taken into account. It justifies not following its own impact assessment based on the statement from the German Risk Institute (BfR). However, the BfR statement further goes on to highlight the importance of potency as well as risk assessment in the regulation of endocrine disruptors.
• The TF strongly believes that endocrine disruptors must be regulated like other substances of potential concern and be subject to risk assessment which considers both hazard and exposure. As EFSA, the BfR consensus noted, risk assessment can be applied to endocrine disruptors just as it is applied to other substances.
Mancozeb was screened as part of the Screening published in July 2016. Although the process is described in detail, the data summaries on individual substances entered into the spreadsheets are not provided. It is difficult therefore to know exactly on what data the conclusions were drawn. The EU Mancozeb Task Force has conducted new studies and new weight of evidence analyses in support of the renewal of the approval of mancozeb under Regulation (EC) 1107/2009. The EU Mancozeb Task Force wants to note that as a result of these, it considers that mancozeb does not have an adverse effect relevant for human or environmental health and therefore it is not an endocrine disruptor.
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