News

The European Council and Parliament have reached a provisional agreement on the new regulatory framework for New Genomic Techniques (NGTs), supporting food security, innovation, and reduced dependence on external inputs.

Key Points of the Agreement:

1. Confirms that NGT-1 plants (those equivalent to conventional plants) will follow a simplified procedure, with:

• Verification only at first generation
• No mandatory labelling for food/feed products
• Labelling only for seeds and reproductive material

2. Defines an exclusion list of traits not allowed in NGT-1 (e.g., herbicide tolerance).

Image courtesy of our Member Cesare Varallo.

3. NGT-2 plants (with more complex changes) remain under full GMO legislation, including:

• Authorisation
• Labelling
• Traceability
• Monitoring
• Member State opt-out options.

4. Includes provisions to improve transparency on patents and licensing, including a public database and an expert group on patenting.

5. The European Commission will publish a study on patent impacts one year after entry into force.

Next steps

The provisional agreement will now have to be endorsed by the Council and the Parliament before it can be formally adopted.

Read full European Council press release. 

One approach to verifying that undeclared GMOs in raw materials are compliant with legal thresholds is to test for GMOs in the manufactured product and then extrapolate the GMO content in the ingredient using the pro-rata recipe proportions.  This is an attractive approach for enforcement testing which does not always have access to the raw materials.

The authors of this paper (purchase required) investigated the inherent bias in this approach.  They prepared in-house model processed foods (heat-treated soybeans) containing GM events and then tested them using a GMO quantification method incorporating taxon-specific real-time PCR with longer amplicons They observed that the extrapolated GMO content increased with the length of the amplicon used in the taxon-specific PCR assay. When a longer amplicon was deliberately employed, the GMO content calculated for the processed food always exceeded that expected by pro-rata calculation from the raw material.

They conclude that this finding can be used to advantage. The use of longer amplicons in taxon-specific PCR can lead to an overestimation of GMO content at the raw material stage based on the measurements from processed foods. If the overestimated value remains below the labelling threshold, the appropriateness of GMO labelling can still be confirmed. The proposed method offers a simplified and practical screening approach for use in routine inspections.

Unauthorized GM (UGM) refers to those GM crops or products that have not received approval in a particular country..

DNA-based methods are preferred for testing of raw or partially processed food products.  More heavily processed food can be more of an analytical challenge; DNA methods are still applicable provided the quality of DNA enables amplification despite being hampered by the processing procedures or presence of inhibitors or due to complexity in composition in terms of ingredients.

This review (purchase required) focused on possible approaches for adhering to the regulatory requirements while verifying UGM in processed food products. Technical challenges and approaches for extracting purified DNA and necessary quality checks are described. The article covers amplification as well as sequencing-based methods which can be applied to check for presence of UGM ingredients amongst a complex mix of other ingredients. The authors discuss the comparative assessment of these methods in the context of regulatory testing requirements and availability of information of transgenic DNA.

Photo by Kseniya Nekrasova on Unsplash

In March 2023, Dr Malcolm Burns, Head of the GMO Analytical Unit at the National Measurement Laboratory at LGC presented presented at the International Conference on GMO and New Genomic Techniques on 'Analytical strategies for detection of GMO's and NGT products- status and challenges'. The presentation explored some of the opportunities and challenges for the development of methods for the detection of NGT products.

You can now view Malcolm's presentation here.         
Note: all information given in the presentation was correct at the time of the presentation in March 2023.