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Almost all soya is provided by South and North American countries, where GM technology adoption is over 90%. In total, the EU imports approximately 35 million tonnes (MT) per year or over 60 kg of soya bean products per citizen (including crushed soya meal). Soya beans primarily feed our cows, pigs and chickens, helping EU livestock farms prosper which drives EU exports, jobs and growth.

This paper details the weight of evidence (WOE) and stepwise approaches used to assess the food and feed safety of newly expressed proteins (NEPs) in genetically modified (GM) plants, based on previously reported principles. The WOE approach is critical, as in a vast majority of cases no single assay or biochemical characteristic can identify a protein as a hazard. A stepwise approach is recommended to evaluate the safety of NEPs taking the totality of information into account. Potential triggers for the need for supplementary toxicology studies are discussed, and an alternative in vitro method for the acute toxicology study is proposed.

Additional safety assessment of a stacked trait product produced by conventional breeding should not be required unless there is a plausible and testable hypothesis for interaction of the traits. However, the different approaches employed for the regulation of stacked trait products between countries results in asynchronous approvals, increasing the potential for trade flow disruptions, and adds to the regulatory burden for product developers.

A set of core studies including molecular characterization, expression and characterization of the newly expressed proteins (or other expression product), and safety assessment of the introduced protein, are appropriate to characterize the product and assess safety. Using data from core studies and employing a “problem formulation” approach, the need for supplementary hypothesis-driven or case-by-case studies can be determined. Employing this approach for the evaluation of GM plants will remove regulatory data requirements that do not provide value to the safety assessment, and provide a consistent framework for global regulation.

Risk assessment of genetically modified (GM) crops includes an evaluation of hazard and exposure to newly expressed crop constituents, exempli- fied herein by newly expressed proteins (NEPs). Guidance directing dietary exposure assessments (DEAs) is limited and/or globally inconsistent. Best practices for conducting DEAs are presented and include a preliminary problem formulation step to determine if a formal DEA is necessary to support the risk assessment. If a formal DEA is deemed necessary, the type of exposure (acute or chronic) and the availability of food con- sumption data relevant to the targeted population should be identified.

An investigation of the potential aller- genicity of newly expressed proteins in genetically modified (GM) crops comprises part of the assessment of GM crop safety. However, allergenicity is not completely predictable from a definitive assay result or set of protein characteristics, and scientific opinions regarding the data that should be used to assess allergenicity are continuously evolving.

The goals of this paper are to: 1) define the process for identifying potential pathways to harm based on robust problem formulation; 2) provide an overview of data that inform the science-based ERA for cultivation approval; 3) provide examples of data that are routinely or occasionally required but do not inform the ERA; and 4) make recommendations for harmonization of global ERA data requirements. Refinement and harmonization of data requirements across global regulatory authorities will add transparency and predictability to the ERA of GM crops globally, while ensuring that each country’s protection goals are respected.

Genetically modified (GM) plants used for food and feed have an established history of safe use over more than 25 years of their commercialization. Developers and regulatory authorities have accumulated extensive experience in evaluating their safety over time. The studies required for the safety assessment of GM plants used for food and feed should now be re-defined to leverage this experience and increased scientific knowledge. This paper, a companion paper for Waters et al. also published in this issue, presents a systematic approach for the safety assessment of newly expressed proteins (NEPs) in GM plants by evaluating the two components of risk: hazard and exposure.