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Risk assessment

Safety Assessment RP188 Genetically Modified Soybean A5547-127

This section summarises the safety assessment of genetically modified soybean A5547-127 for renewal authorisation under assimilated Regulation (EC) No. 1829/2003.


Following the submission of application RP188 to the Food Standards Agency (FSA) under assimilated Regulation (EC) No. 1829/2003 from BASF Plc (United Kingdom), FSA/FSS (Food Standards Scotland) have undertaken a safety assessment on genetically modified soybean A5547-127. To support the safety assessment by FSA/FSS, the Advisory Committee on Novel Foods and Processes (ACNFP) provided advice to FSA/FSS on the data submitted for the renewal of authorisation for the genetically modified soybean A5547-127, as outlined in this document. The advice of the ACNFP has been taken into account in this safety assessment which represents the opinion of FSA/FSS on the safety of genetically modified soybean A5547-127.

Soybean A5547-127 is modified to express the PAT (phosphinothricin acetyltransferase) protein from the soil bacteria Streptomyces viridochromogenes to confer resistance to glufosinate ammonium herbicide. The PAT protein prevents glufosinate ammonium herbicide from inhibiting the glutamate synthase enzyme, which is essential for nitrogen metabolism in plants.
Soybean A5547-127 has previously been authorised for food and feed uses and is most commonly used as a source of protein in animal feed. The scope of this application is for the renewal of the authorisation for placing on the market of products containing, consisting of, or produced from genetically modified soybean A5547-127. This includes food, feed, and products other than food or feed. The application does not cover cultivation and therefore no soybean A5547-127 will be grown in the UK.

In providing its advice on the safety of soybean A5547-127 for food and feed, the ACNFP considered data provided as part of application RP188 (post-market environmental monitoring reports, evaluation of systematic literature searches, additional studies performed by or on behalf of the applicant, and updated bioinformatics analyses), additional information provided by the applicant, and analyses and reports from outside contractors. The ACNFP assessed these data for possible new hazards, modified exposures, or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application (EFSA GMO Panel 2011).

FSA/FSS concludes, based on ACNFP advice, that there is no evidence in the renewal application RP188 of new hazards, modified exposures, or new scientific uncertainties that would change the conclusions of the original risk assessment of genetically modified soybean A5547-127 (EFSA GMO Panel 2011).

Safety assessment