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• New Genomic Techniques (NGTs) can contribute to the Green Deal objectives by enabling and accelerating the development of resilient plant varieties for sustainable food production.
• In the EU, the regulatory framework for NGT products is not fit for purpose. The current rules hinder the development and availability of NGT products for European farmers, and negatively impact EU innovation and competitiveness.
• CropLife Europe calls on the European Commission and EU policymakers to drive forward an enabling and science-based regulatory framework for plants developed through NGTs by establishing a process to determine their regulatory status on a case-by-case basis.

• Sustained imports of protein-rich GM crops are central for the EU feed value chain. Delays in the authorisation process may result in trade disruptions and uncertainty for value chain operators.
• GM crops have a long history of safe use. To be authorised on the EU market they undergo strict assessment by EFSA on any possible risks posed to human and animal health, as well as to the environment.
• CropLife Europe calls for an efficient and timely authorisation process for the import of GM crops into the EU, respecting legally foreseen deadlines.

1. The EU regulatory framework needs to be predictable: Political considerations should be informed by independent expert risk assessment and respect particularly the role of scientific evidence in decision making. Trust in the rigor and independence of the EU system needs to be enhanced.
2. EU farmers need access to crop protection tools and EU trade partners need confidence in our system: Blocking the setting of such trade standards, when no concerns have been identified by the risk assessors, limits the access of EU farmers to crop protection tools and erodes trade partner confidence in the objectivity and predictability of the EU risk assessment system.
3. MRLs are trading standards and are required to avoid trade disruptions: The impacts on European consumers, farmers and the food industry that arise from blocking certain MRLs or ITs can be significant. Trade disruption is not in the interest of EU citizens, businesses, or our trade partners. Such disruptions can have long-lasting negative consequences for food availability and development.

1. CropLife Europe (CLE) advocates for a transition period of 11 years for crop protection products, seed treatments and coatings. This is to allow sufficient time for the supply chain to formulate new material and have them approved under the EU regulatory system.
2. We support a size limit that does not go below 0.1 μm (= 100 nm) as proposed by the European Chemicals Agency (ECHA) to ensure compliance and enforceability.
3. We support the biodegradability criteria as proposed by ECHA.

The European Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation requires that quantitative environmental risk assessment is carried out for hazardous substances used as coformulants in plant protection products (PPPs), if registered above 10t/y. The European Crop Protection Association (ECPA) has developed generic exposure scenarios and specific environmental release categories (SpERCs) to support these risk assessments. The SpERCs offer refinements to the default release factors defined in environmental release categories (ERCs) and are intended to be used with nested multimedia mass balance models as part of the assessment of regional predicted environmental con- centrations. Based on the application method of PPPs, 2 scenarios were defined for which SpERCs were developed: 1) spraying of PPPs and 2) direct application of granular products or treated seeds to soil. The SpERC for spray applications includes release factors to air and soil that depend on the vapor pressure of the coformulant. Calculations are presented to support the subSpERCs describing the transition from nonvolatile to volatile behavior. The most recent version of the spray application SpERC defines a release factor for surface water and more conservative release factors to soil compared with previous versions. Use of the ECPA SpERCs allows the coformulant emissions from PPPs to be fully accounted for in the regional‐scale environmental risk assessment for a given substance, along with all other sources of emissions. Qualitative and quantitative justification for the ECPA‐derived SpERCs is presented and serves as the background documentation to the online European Chemicals Agency (ECHA) SpERC factsheets. The approach developed here whereby regional‐scale SpERCs are used in combination with a customized local‐scale exposure model is potentially applicable for other sectors that are required to conduct exposure assessments outside the scope of the standard environmental REACH models. Integr Environ Assess Manag 2020;16:472–480. © 2020 Syngenta Crop Protection AG. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC)