EFSA has updated its novel food guidance, clarifying the use of genetically modified microorganisms used to produce precision fermentation-derived ingredients, protein quality studies, and cell-cultured meat origin and identity.
On 30 September, the European Food Safety Authority (EFSA) published updated guidance on how to prepare and submit novel foods applications. The European food safety assessor said the updates were needed to reflect recent advances in food research and innovation.
“The novel food industry is evolving quickly, and it’s important that our safety assessment processes keep up,” wrote Ermolaos Ververis, scientific officer in EFSA’s Nutrition and Food innovation Unit, in a press release.
The other reason for the update was to address grey areas and gaps that have become apparent in the last eight years.
“We’ve also learned a lot from assessing novel food applications since the 2018 novel food regulation came into effect. This experience helped us clarify definitions and data requirements, so applicants can submit higher-quality applications, which in turn should lead to a more efficient risk assessment process,” said Ververis.
Overall, the guidance provides a “really good update”, Dr Hannah Lester, CEO of Atova Consulting, told this publication.
“The updates have helped to clarify some of the grey areas and EFSA responded positively to much of the feedback that it received from the industry during the public consultation,” she said.
However, she expressed concern that EFSA has “overstepped the mark” with regard to the classification of genetically modified microorganisms (GMMs).
2011 guidance defines four categories of GMMs for risk assessment purposes:
Category 1: purified substances that are produced with a GMM
Category 2: complex products in which there are no viable cells
Category 3: products derived from GMMs where there are no viable cells but the recombinant DNA is still present in the finished product
Category 4: GMMs are still present in the finished product.
Lester said the updated guidance states that only category 1 and 2 GMMs fall within the scope of novel foods regulation, which means categories 3 and 4 have to be regulated as GM foods.
She takes issue with this on two levels. Firstly, that EFSA is assuming the role of regulator, and secondly, that a substance’s classification as a GMO/novel hinges on the presence or absence of recombinant DNA.
“This statement is not in the legislation and EFSA is overstepping the mark by providing its own interpretation of the definitions contained within the regulation. That is the Commission’s role, not EFSA’s. It is not up to EFSA to define what is and what isn’t GM food,” she said.
She continued: “The regulatory criteria for classification of a product as a GM or novel food should be based on the presence of viable cells, not trace amounts of host strain DNA. The problem is that in cases where GMMs are being used as processing aids, the presence of the host strain is tipping products into genetically modified territory, even though trace amounts of the host strain DNA are not a safety concern at all.”
Lester said the latest guidance would appear to remove the scope for any host strain DNA whatsoever to be present in the final product. Therefore, if applicants are to avoid the same fate as Impossible Foods, which had to submit a GMO dossier for its soy leghemoglobin product because of the presence of host strain DNA, they will need to implement expensive purification technology.
“What the updated guidance implies is that unless they can prove the absolute purity of their product, producers of precision fermentation-derived products will not get anywhere with EU novel foods approval.”
Whilst Lester finds this part of the guidance unsatisfactory, she admits the update has helped clarify other aspects of the novel foods application framework.
“There is quite a lot of useful guidance for producers of cell cultures and cultivated meat, particularly on the origin, identity, and genetic stability of the cells and cell line. Previously there were no provisions for cultivated meat so that in itself is good, as it means that they are recognised as falling within the novel foods framework,” she said.
Another noteworthy revision is a new section on protein quality. Protein quality studies are now required for new proteins that have the potential to make a significant contribution to the diet, and EFSA has said it will consider in vitro models as an alternative to animal studies on a case-by-case basis (as they are not validated).
EFSA has also clarified what it wants to see from genotoxicity studies with a microorganism: the supernatant from three production runs that is pooled and one batch of lysate.
“We know from experience that they were asking companies for this but it wasn’t in the guidance,” said Lester. “It is helpful that it is now included because genotoxicity studies require a huge investment and so if companies get them wrong and have to repeat them, that costs them a lot.”
The updated guidance comes into force on 1 February 2025.
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