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EU issued guidance on agronomic/phenotypic characterization of GM crops
Jul. 8, 2015
EU issued new guidance for the agronomic and phenotypic characterisation of GM plants, and is designed to assist applicants in the generation, analysis and interpretation of the agronomic and phenotypic dataset submitted as part of their GM plant applications under Directive 2001/18/EC or Regulation (EC) No 1829/2003. It supplements general recommendations on the agronomic and phenotypic characterisation of GM plants outlined in previous EFSA GMO Panel guidelines and Implementing Regulation (EU) No 503/2013.
The risk assessment of GM plants starts with hazard identification, during which any characteristic of the GM plant potentially having adverse effects (hazards) on human and animal health and the environment is identified. A comparative approach, based on data derived from the molecular, compositional and agronomic/phenotypic characterisation of GM plants, is typically followed internationally to identify differences between the GM plant and its conventional counterpart. This approach enables an evaluation of the relevance of potential risks posed by a GM plant and derived food and feed products, by assessing whether intended and unintended differences alter the level of risk or give rise to additional risks.
The guidance clarifies the EFSA GMO Panel’s view on how agronomic and phenotypic data support the risk assessment of GM plants. The agronomic and phenotypic characterisation aims (1) to detect and measure agronomic and phenotypic differences between the GM plant and its conventional counterpart; (2) to assess to what extent the environmental and agricultural conditions under which the GM plant can be grown affect these differences; (3) to confirm that good agricultural practices have been followed for the generation of the compositional data and to identify possible factors that might bias the outcomes of the comparative analysis; and (4) to support the risk characterisation of GM plants.
Source: EFSA
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