Assessment of eight GMOs applications submitted in accordance with Retained Regulation (EC) No 1829/2003

Background

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) have undertaken an assessment to quality assure risk assessments conducted by the European Food Safety Authority (EFSA), of eight GMOs applications (two renewal and six new applications) as outlined in the linked assessments. FSA/FSS risk assessors have reviewed the EFSA opinions for the applications listed in the context of intended GB use and have concluded that the intended uses are safe. 

Summary

Eight applications have been submitted for authorisation in each nation of Great Britain (GB), where the decision on authorisation is made by the respective Ministers in England, Scotland and Wales.

In respect to Northern Ireland, EU legislation on GMOs continues to apply under the current terms of the Protocol on Ireland/Northern Ireland (NIP). This means the eight applications require authorisation under the EU’s authorisation procedures, before being placed on the market in Northern Ireland. 

Whilst it was a Member State of the EU, the UK accepted the assessments of EFSA in support of authorisations for regulated food and feed products. Since the end of the transition period, FSA/FSS has adopted equivalent technical guidance and quality assurance processes to make independent GB risk assessments. Where EFSA, prior to the end of the transition period, evaluated an application for a product for which an application is now made to GB, FSA and FSS has decided to make use of the EFSA risk assessment, where this is appropriate, in forming the GB safety assessment. 

The EFSA risk assessment has been reviewed to ensure it is appropriate for GB risk analysis. The result of the assessment is that the EFSA scientific opinion is adequate also for GB considerations. FSA and FSS risk assessors have reviewed the EFSA opinions for the applications below in the context of intended GB use and have concluded that the intended uses are safe. 

The FSA/FSS assessment for each application is published within a separate report at the links below. These represent the opinions of the FSA and FSS in relation to these dossiers.

Key uncertainties

The uncertainties for each of the opinions is explored in the individual assessments. 

Next steps

The opinions have informed the risk proposal for risk management that is subject to public consultation. Following this process they will be supporting evidence to be considered by Ministers to inform decision making on whether to authorise the individual applications for use in England, Scotland and Wales. 

Risk assessments

• Assessment of application EFSA-GMO-NL-2016-132 for authorisation of genetically modified, insect-resistant and herbicide-tolerant soybean DAS–81419–2 x DAS–44406–6 for food and feed uses, import and processing submitted in accordance with Regulation (EC)
• Assessment of an application by Dow AgroSciences (EFSA-GMO-NL-2013-116) for placing on the market of genetically modified insect-resistant soybean DAS-81419-2 for food and feed uses, import and processing under Regulation (EC) No 1829/2003
• Assessment of genetically modified soybean SYHT0H2 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003
• Assessment of genetically modified maize MON 88017 x MON 810 for renewal authorisation under Regulation (EC) No 1829/2003
• Assessment of genetically modified maize MON 87427 x MON 87460 x MON 89034 x 1507 x MON 87411 x 59122 for food and feed uses
• Assessment of genetically modified maize 1507 x MIR162 x MON810 x NK603 for food and feed uses
• Assessment of genetically modified cotton GHB614 x T304-40 x GHB119 for food and feed uses, import and processing
• Assessment of genetically modified oilseed rape GT73 for renewal authorisation