In a new report from Biosolutions Forum+, companies including Novonesis, Arla Foods Ingredients, Spora, Bactolife and Unibio describe how unclear requirements, extensive documentation and approval processes can take several years to make it  from the laboratory to the European market.

“Europe cannot afford to become a place where only great ideas are born, but scaled and produced elsewhere. High food-safety standards for the consumers are absolutely key. But the path to the EU market needs to be much clearer, more predictable and faster for the solutions that can maintain European food security and resilience” says Anne Lerche, Managing Director of the Alliance for Biosolutions.

Promising opportunities are being rejected

The EU’s special rules on novel foods generally apply to products that were not consumed to a significant extent in the EU before 15 May 1997. This includes a range of new proteins and ingredients produced using microorganisms, fermentation and other novel production methods.

On paper, the EU’s processing of an application can take up to 18 months. However, the clock stops when the authorities request additional information from the company. The companies interviewed for the report therefore often find that it takes two to three years or longer to obtain approval for a product.

This uncertainty is already affecting which opportunities companies choose to pursue. Novonesis, for example, maintains 150,000 different microorganisms that could potentially be used to develop new foods and ingredients, among other things. However, according to the company, the prospect of an extensive EU approval process means that only a limited number are worth pursuing further.

For startups and smaller companies, the lengthy processes can also mean that their funding runs out before the product reaches the market.

Companies and authorities need to engage earlier

Alliance for Biosolutions and the public-private platform Biosolutions Forum+ are therefore proposing a new testing environment for innovative foods and ingredients - also known as a the regulatory sandboxes

Within this framework, companies, authorities and researchers should be able to clarify early in the development process which rules apply to a product, which studies are necessary, and how the company can best document that the product is safe. This should reduce the risk of companies spending time and money on studies that later turn out not to meet the authorities’ requirements.

The testing environment should also allow for controlled taste tests and consumer studies, enabling companies to assess interest in a product before investing in a full application.

“We must not have to choose between innovation and safety. A regulatory sandbox is precisely intended to make us better at achieving both. When authorities, companies and researchers can work together on specific issues early in the process and under controlled conditions, we gain a stronger knowledge base, more predictable processes and practices that are more conducive to innovation and keep pace with technological developments,” says Linda Nielsen, Professor of Law at the University of Copenhagen and Chair of Biosolutions Forum+ under The Danish Chamber of Commerce.

The report recommends five elements for the testing environment:

1. Companies should receive clear information about regulations and documentation requirements at an earlier stage.
2. New products should be eligible for testing in controlled taste tests and consumer studies.
3. Approval requirements and processing times should to a greater extent reflect the specific risk posed by the product.
4. Experiences from companies’ approval processes should be used to improve regulations and guidance from the authorities.
5. Startups and smaller companies in particular should have better access to advice, testing facilities and financing.

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Find the report here.

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