Summary of EU Biotech Act impact on novel foods
- EU Biotech Act introduces more EFSA pre-submission consultations for applicants
- EFSA aims to reduce delays by offering detailed technical guidance early
- Approval process remains lengthy and costly, discouraging investment in areas such as cultivated meat
- Novel foods excluded from EU regulatory sandboxes due to cultural and ethical concerns
- Next phase of Biotech Act expected to focus more heavily on food innovation
The first part of the EU’s Biotech Act has been published. The act, which is mainly focused on health, also touches on food innovation and the regulation around novel foods.
Overall, it’s a mixed bag. On the one hand, the act increases novel food pre-submission interactions between the European Food Safety Authority (EFSA) and the applicant. On the other, novel foods are explicitly cut out of planned regulatory sandboxes for new biotech products.
Win: Novel foods will receive more presubmission consultations
The EU’s novel food approval process is known for two things: first, the stringency and high quality of its assessments, and secondly, the fact they can take a long, long time.
While this first aspect is enough to make EFSA’s approval a desirable accreditation for any start-up, it also means approval is a costly and time-consuming process. Because EFSA takes so long to approve novel foods, investors have been reluctant to embrace areas that rely heavily on these approvals, such as cultivated meat.
Now, the EU is planning to increase the frequency of pre-submission meetings between EFSA and the applicant prior to submission.
Too few pre-submission meetings, explained EFSA’s new executive director Nikolaus Kriz recently, is one of the main factors holding approvals back. A lack of clarity for the regulator leads to numerous “stop the clock” incidents, where the whole approval process is put on hold while it asks for information and clarification from the applicant.
The Biotech Act has pledged that EFSA will provide very specific advice to applicants, especially SME’s who are often inexperienced in applications. As Kriz says, without advice this inexperience can slow down the application process.
EFSA will be provided with additional resources to help it with providing this advice. If it does not get these resources, the act points out, further delays may be created, making the whole exercise pointless.
“We welcome changes that would enable EFSA to engage with applicants earlier in the process in a more detailed and technical manner, similar to the model used by the European Medicines Agency. This would help ensure we receive more complete applications and reduce delays due to missing data as is often the case for novel food applications,” says a spokesperson from EFSA.
Lose: Novel foods cut out of regulatory sandboxes
Regulatory sandboxes are a tool that are often used to speed up regulatory risk assessments. Essentially, they are a controlled environment where companies can test out their ideas without being regulated, inside a market where they otherwise would be.
In the UK, cultivated meat has been provided with such a sandbox. The sandbox collects key cultivated meat players from around the world, who are working together on streamlining the application process.
It is already, according to those involved, delivering on its promises. In particular, the teamwork and communication have been praised. The sandbox is even attracting applicants, such as Mosa Meat, to the UK market.
However, whatever advantages a sandbox may have, the EU is not interested. Due to the fact that some novel foods “trigger ethical or cultural concerns among various consumer segments,” novel foods are excluded from the regulatory sandboxes proposed by the regulation.
Instead of being allowed to access sandboxes, the act says, novel foods should be regulated by the existing framework.
Indeed, many consumers are reluctant to eat novel foods such as cultivated meat or precision fermentation-derived products, although some demographics, such as the young, are more open to these foods than the population at large.
Part two of the Biotech Act will be released next year, and is expected to have a greater focus on food. Right now, those making novel foods have a lot to be hopeful for, and a lot to be disappointed by.
