EU Commission: political statements instead of scientific evidence

14 April 2022 / In a letter written in April 2022, the EU Commission states that CRISPR/Cas applications do not create any new or specific risks due to unintended effects. This letter came in response to a joint letter sent by the German Union of Peasant Farmers (AbL) and Testbiotech. In their letter, Testbiotech and the AbL argued that the statement made by the Commission is not based on scientific facts and is largely driven by trade interests, such as those included in the CETA free trade agreement (The Comprehensive Economic and Trade Agreement) between the EU and Canada.

A recently published report drawn up by Testbiotech and the Canadian Biotechnology Action Network (CBAN) presents robust evidence showing that specific risks are, in fact, associated with the technical potential of the CRISPR/Cas gene scissors - which are now the most important tool in new genetic engineering (New GE). Genetic engineers can use the nucleases to, e.g. override natural genome organisation by altering whole gene families, block the restoration of gene functions and separate genes which are naturally inherited together.

Consequently, the genotypes and phenotypes developed by the scientists are frequently far beyond anything that could be achieved with conventional breeding, as this is based solely on mutations which could also occur naturally. These findings are relevant to both the intended and unintended effects, all of which can significantly raise the level and quality of risks to health and the environment. For example, plants developed in this way might produce new compounds, show unique changes in their composition, unintentionally inherit transgenic elements or disrupt whole ecosystems.

The EU Commission, however, continues to ignore the scientific findings in regard to new and specific risks. For example, the Commission report published in April 2021 equated the risks of the CRISPR/Cas applications in plants to those of conventional breeding. They have continued to repeat this position in the recent letter which states: “(…) unintended modifications do not entail new and specific hazards compared to mutations that occur in conventional breeding or by physical and chemical mutagenesis.”

The EU Commission statement echoes statements made by Health Canada, the Canadian regulatory department. For example, in a January 2022 letter to CBAN, Health Canada they state: “Gene editing technologies do not create any unique risks to food safety compared to any other method of plant breeding.”

Both the Canadian regulator and the EU Commission refer to a limited selection of scientific publications, all of which ignore more recent findings that conclude on specific risks. This kind of cherry-picking in science is common on both sides of the Atlantic and is not just coincidental. As the summaries of CETA meetings between Canadian and EU officials show, the Canadian government is pressuring EU institutions to speed up market approvals of genetically engineered plants and to deregulate New GE.

Christoph Then of Testbiotech comments: “When it comes to the risks of genetically engineered organisms, politics should follow the science and not trade agreements. It is our responsibility to avoid harm for future generations. Therefore, the precautionary principle needs to be applied.”

Article 25 of the Canada-European Union trade agreement CETA, specifies that “regulatory cooperation to minimize adverse trade impacts of regulatory practices related to biotechnology products” and has established a “Dialogue on Biotech Market Access Issues” between the Government of Canada and the EU Commission, including for the purpose “to exchange information on policy, regulatory and technical issues of common interest related to biotechnology products, and, in particular, information on their respective systems and processes for risk assessments for decision-making on the use of genetically modified organisms.”

The 21 October 2020 Dialogue meeting, for example, states that "Canada encouraged the Commission to consider a pragmatic approach to [compliance enforcement and verification for products of new breeding techniques], in recognition that many products of gene editing are not distinguishable from their conventional counterparts".

The underlying framework of CETA is also likely to have influenced recent EU Commission statements on transgenic chicken derived from CRISPR/Cas processes. In its letter from April, the Commission simply repeat the claims made by a company that there would be no unintended effects and the eggs could be marketed in the same way as conventionally produced eggs. This statement again highlights an intention to deregulate New GE under the terms and framework of CETA, and thus simply ignores legal provisions for the risk assessment and labelling required in EU law. As a recent opinion poll in Germany shows, consumers would overwhelmingly reject these GE eggs, especially if they were to be marketed without labelling.