Croplife Europe signs the Code of Conduct for responsible food business and marketing practicesDownload
CropLife Europe input for SCOPAFF meeting 5-6 July 2021
• Guidance Documents
• Improving the efficiency of the process of a.s. approval / renewal
• Safeners and Synergists
• Use of the IUCLID new data format and upcoming renewal dossiers
- 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.
- 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.
- 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.
- 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.
- 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.
- We support the biodegradability criteria as proposed by ECHA.
Christopher Dobe,*† Sébastien Bonifay,‡ Joachim D Krass,§ Claire McMillan,|| Adrian Terry,|| and Matthias Wormuth†
†Syngenta Crop Protection AG, Basel, Switzerland
‡Corteva Agriscience, Production Agriscience Belgium BVBA, Brussels, Belgium §BASF SE, Ludwigshafen, Germany
||Cambridge Environmental Assessments, Cambridge, United Kingdom
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)
Christopher Dobe,1,∗ Sebastien Bonifay,2 Ralph Fliege,3 Joachim Krass,4 Volker Mostert,5 Renate Vosswinkel,3 and Matthias Wormuth1
This article reviews the interactions between the REACH (Registration, Evaluation, Autho- rization and restriction of Chemicals) regulation and the plant protection product regulation for substances used as coformulants in the European Union, and describes generic exposure scenarios developed for their exposure and risk assessment. The REACH exposure scenarios describe the operational conditions and risk management measures used in the risk assess- ment of a coformulant, and as such these translate as the boundaries of safe use. The generic exposure scenarios are designed to be simple, and closely integrate with REACH use de- scriptors and customized exposure models. Clustering of application methods and exposure determinants resulted in four generic exposure scenarios, each covering professional work- ers or consumers, and application of products in liquid, granular form, or applied on seeds. When used in conjunction with appropriate exposure models, the generic exposure scenar- ios support efficient first-tier risk assessment of coformulants by utilizing a higher level of abstraction and conservatism than typically used in plant protection product assessments.
ECPA Position Paper on the proposed Regulation 1107/2009 Annex III impurity limit in PPPs
The 0.01% limit for unintentional impurities contained in the draft Reg 1107/2009 Annex III proposal is a more problematic element of the text than currently seems to be generally recognised, and it needs to be reconsidered. The proposed limit is 10x lower than the comparable limit for impurities established and implemented through REACH and CLP Regulations, no justification for the approach has so far been provided, and it is expected to cause significant and unjustified implementation difficulties together with high compliance costs.
Whether for food, medicines or chemicals, the EU’s risk assessment agencies improve the lives of citizens across the EU by enabling access to innovative biotechnology products whilst ensuring the highest level of consumer safety.
Benefits for patients, farmers and consumers range from life-saving medicines to high yielding GM crops that can improve food security, environmental sustainability and nutrition. But only efficient assessment can yield such benefits.