Crop Biotech Update

EFSA Publishes Criteria for Risk Assessment of Plants Produced by Targeted Mutagenesis, Cisgenesis, and Intragenesis

January 25, 2023

The European Food Safety Authority (EFSA) has published the criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis, and intragenesis. The statement is published in the EFSA Journal.

On April 28, 2022, the European Commission requested EFSA, in accordance with Article 31 of Regulation (EC) No 178/2002, to develop a statement on possible criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis, and intragenesis. The statement was requested as advice for consideration by the European Commission to support the ongoing policy initiative on plants produced by targeted mutagenesis and cisgenesis. To develop the statement, EFSA considered previously published EFSA Opinions on targeted mutagenesis, cisgenesis, and intragenesis and those assessment aspects discussed by the GMO Panel in the EFSA Opinions on plants developed through synthetic biology which are relevant for the risk assessment of plants developed through targeted mutagenesis, cisgenesis, and intragenesis.

In the Statement, EFSA identified the following criteria:

  • Criterion 1: is any exogenous DNA sequence(s) present? This criterion aims to evaluate whether the GM plant contains any exogenous DNA sequence.
  • Criterion 2: is the DNA sequence(s) from the breeders' gene pool? In Criterion 2, the GM plant which contains exogenous DNA sequence(s) will be evaluated, which assesses whether the source of the DNA sequence(s) is from the breeders' gene pool.
  • Criterion 3: what is the type of integration? Criterion 3 applies only to cisgenic and intragenic plants and defines how the sequence can be introduced.
  • Criterion 4: is there an unintended interruption of an endogenous gene? Criterion 4 applies only to cisgenic or intragenic plants for which the type of insertion was random or for SDN-3 approaches for which GSH has not been demonstrated. 
  • Criterion 5: history of use. The history of use includes the history of safe use (HoSU) for consumers and/or animals and familiarity with the environment which are key elements in the assessment of plants produced by targeted mutagenesis, cisgenesis, and intragenesis.
  • Criterion 6: function and structure associated with the new allele. This criterion states that when the HoSU and/or familiarity cannot be sufficiently demonstrated, the risk assessment should focus on the function and the structure associated with the new allele and consider the probability for such an allele to be obtained by conventional breeding.

For more details, download the Statement from the EFSA Journal.

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