The European Commission has published the new Biotech Act, which aims to boost the EU’s global competitiveness in biotechnology. The Act is mainly focused on the health sector, but also includes measures that could help commercialise the findings of European researchers working on techniques such as precision fermentation.
Nonprofit think tank GFI Europe has welcomed parts of the Act, including plans to expand the advice regulators provide to innovators bringing new foods to market. Companies applying to sell foods made with precision fermentation in the EU must apply to the European Food Standards Agency (EFSA), which then carries out an assessment of their safety and nutritional value.
The Act will allow startups to request advice from regulators on the technical and scientific information their applications need to include before making submissions. It also provides details about additional EFSA staff to ensure that this advice function is properly resourced. The measure, which could make the application process clearer and prevent authorisation delays, has been celebrated by industry alliance Food Fermentation Europe.
“Food Fermentation Europe welcomes the overall ambition to strengthen
the framework for biotech, in particular the focus on funding,
infrastructure and scale-up,” said the organisation. “We also welcome a concrete win for novel foods: the extension of enhanced scientific pre-submission interactions with EFSA.”
Novel foods excluded from sandboxes
However, the European Commission has also excluded novel foods from a proposal to create regulatory sandboxes. The decision has been made on the grounds that these foods may “trigger ethical or cultural concerns among various consumer segments regarding their acceptability”.
“The Commission’s decision to block novel foods from the sandbox rollout is a disappointing move that marks a missed opportunity to drive forward evidence-based regulation while providing a forum for open dialogue that can give consumers more confidence in new products,” said GFI Europe.
The think tank has called for sandboxes —- controlled and time-limited environments that enable experts to design standards for new products — to be introduced across all regulatory food and feed categories. Food Fermentation Europe has also expressed concern about the exclusion of novel foods.
“Properly designed sandboxes would not weaken safety standards; they
would allow limited, tightly controlled testing and tastings in a more
supervised, transparent and evidence-based way, keeping innovation,
investment and jobs in Europe,” says the organisation.
New financing for food biotechnologies
GFI Europe has urged the Commission to bring in ambitious new financing for food biotechnologies in the Biotech Act Part II, which is expected to be published late next year. This would build on plans to establish a pilot investment facility supporting the scale-up of health biotechnology industries. It could help startups that are struggling to bring fermentation products to market because Europe lacks the large-scale facilities needed to ramp up production.
“By expanding the regulatory guidance available to food innovators, the
Biotech Act will play an important role in bringing new products to market in a way that meets the EU’s world-beating safety standards, helping to drive green growth, reduce our reliance on imports and boost competitiveness,” said Seth Roberts, senior policy manager at GFI Europe.
