Worrying findings in animal feeding trials, flawed safety tests, and incomplete analyses mean public health may be at risk from LegH Prep consumption

The European Food Safety Authority’s (EFSA)’s favourable opinions on a GMO yeast-derived “fake meat” ingredient are full of data gaps and errors and put public health at risk, according to a new analysis by Claire Robinson of GMWatch and Prof Michael Antoniou.

EFSA’s food additives (FAF) and GMO Panels said they had no safety concerns about Impossible Foods’ application for EU market approval of its soy leghemoglobin product (LegH Prep), which is derived from a genetically modified version of the yeast K. phaffii. LegH Prep is intended to give the company’s meat substitute products, such as the Impossible Burger, a “bleeding” appearance and a meaty flavour.

However, neither K. phaffii – GM or not – or soy leghemoglobin have ever formed part of the human diet and therefore have no history of safe use. It’s now up to EU Member States and the Commission as to whether it is approved for human consumption in the bloc.

As part of EFSA’s public consultation on the product, which ends on 16 December, Claire Robinson of GMWatch and Prof Michael Antoniou have submitted comments on its panels’ opinions. They’re published here.

Robinson and Antoniou are calling upon EFSA to withdraw and revise their opinions on the grounds that they contain major gaps and errors that put public health at risk.

The GMO Panel’s opinion relies heavily on the FAF Panel’s earlier opinion, so Robinson and Antoniou comment on both publications. They found that the EFSA panels
* Ignored or dismissed important findings in Impossible Foods-commissioned animal feeding trials with LegH Prep, including signs of anemia, reduced blood clotting ability, and kidney function problems, based on unscientific arguments.
* Accepted safety data on LegH Prep derived from an irrelevant GM yeast strain, rather than just the “optimised” one that the company intends to use for commercial production for the EU. This is in spite of the FAF Panel’s statement that any authorisation should only apply to the relevant commercial strain and that any other production strain would require its own separate safety assessment.
* Accepted incomplete data from the company based on partial and flawed analyses, leaving major unanswered questions over the potential toxicity and allergenicity of LegH Prep.
* Failed to adequately address the issue that LegH Prep is only 65% soy leghemoglobin, with the remaining 35% consisting of contaminant proteins and potentially metabolites. This high level of contaminants – effectively the ‘dark matter’ of LegH Prep – includes an unknown number of proteins that remain unidentified and unanalysed for safety. Potential contaminating metabolites have not been analysed at all.
* The 35% contaminants are especially concerning in light of a tragic episode in the 1980s, in which over 1500 people were sickened and some died after consuming a GM bacteria-produced version of the food supplement L-tryptophan. The toxicity turned out to be due to unexpected contaminants resulting from unpredictably disturbed biochemistry of the GM bacteria. Even though the L-tryptophan purification process used by the manufacturer was of a high standard, the company was unaware of these contaminating toxins. Therefore, the purification process proved to be inadequate. The bacterial strain had been progressively optimised for higher L-tryptophan production, with an increasing number of transgene insertions. Impossible Foods has similarly optimised its LegH Prep production strain of GM yeast, resulting in a what appears to be a strain containing a minimum of 25 transgenes. Yet some of the safety data that the company provided to EFSA are on LegH Prep made with a different, less “optimised” strain of GM yeast from the one that the company wants to use for soy leghemoglobin production for the EU. Given that the two strains are markedly genetically and therefore biochemically different, they will have different risk profiles.

Prof Michael Antoniou commented: “It is a basic principle of food safety testing and risk assessment that you test and evaluate the substance that is actually going to be consumed by the public. The fact that EFSA has used safety data from LegH Prep produced from a commercially irrelevant strain of yeast is incomprehensible and imposes an unacceptable risk on the public. In particular, the possibility that this product could contain novel toxins or allergens cannot be ruled out.

“To see if the signs of toxicity found in the 90-day animal feeding trials resolve themselves or escalate into serious harm, the studies should be extended to a long-term period (12-24 months).”

Claire Robinson commented: “We were shocked to find so many gaps in the manufacturer’s and EFSA’s knowledge about this novel product. It seems that many of those gaps could be filled just by doing a few more tests and analyses. EFSA should demand that the company do their homework. There is no excuse to cut corners when it comes to food safety.

“It is especially alarming that risks are being taken to smooth the path to market for a product that is not going to feed the world or save the planet, but is simply intended to give a highly processed, GMO-derived meat substitute product a ‘bleeding’ appearance.”
    
Robinson and Antoniou conclude their analysis by calling upon EFSA to require the company to re-submit its application with complete data drawn only from tests on the LegH Prep derived from commercially relevant strain of yeast. They add that EFSA must also publish and objectively address the worrying findings from the animal feeding studies with LegH Prep. They recommend that EFSA should withdraw its published opinions and revise them based on its obligation to respect the precautionary principle and protect public health.

Impossible Foods’ LegH Prep is the first GMO submitted for EU approval that is intended for direct human consumption. While many other GMOs are approved for import into the EU, they are almost all used in animal feed or biofuels, where consumers do not see the GM label.