EU legislation on novel foods is based on an essential rule: they cannot be placed on the market without prior authorisation in accordance with Regulation (EU) 2015/2283. Where a safety assessment is required, this is carried out by EFSA. The system guarantees a high level of health protection, although some sectors question its complexity, duration and degree of regulatory predictability.
Now, the Opinion adopted by the European Parliament’s Committee on the Environment, Climate and Food Safety (ENVI) on the future European Biotech Act introduces a proposal that deserves particular attention: allowing novel foods to participate in regulatory sandboxes, something that the European Commission’s original proposal expressly excluded.
The issue is relevant because it may anticipate how the European Commission will manage the next generation of food innovations, from precision fermentation to new proteins obtained through biotechnology.
The current framework: prior authorisation and safety assessment
Regulation (EU) 2015/2283 on novel foods currently establishes a system based on prior authorisation before placing on the market. In general terms, any food that had not been consumed to a significant degree in the Union before 15 May 1997 must undergo a specific procedure that includes:
- submission of a scientific dossier;
- safety assessment by EFSA;
- authorisation decision by the European Commission;
- inclusion in the Union list of authorised novel foods.
It is a robust and well-established system whose main objective is to ensure that novel foods do not pose risks to consumers’ health before they are placed on the market.
However, this model was designed at a time when many of today’s food technologies did not even exist. The emergence of precision fermentation, proteins obtained through microorganisms, cellular agriculture and certain functional ingredients generated through biotechnological techniques has highlighted the need for more flexible regulatory tools that make it possible to learn as innovation develops.
What is a regulatory sandbox?
A regulatory sandbox could be defined as a controlled and supervised environment where companies, researchers and authorities can test innovative technologies under specific conditions and for a limited period, generating data and regulatory experience before the full application of the legal framework.
The idea has already been used in sectors such as digital finance, artificial intelligence and health technologies. Until now, however, its application in the European food sector had been very limited.
The Commission’s proposal: excluding novel foods
The initial European Biotech Act proposal opted to exclude novel foods from regulatory sandboxes. The Commission considered that certain products could raise ethical, cultural or social acceptance issues that should continue to be addressed exclusively through the formal procedure laid down in Regulation (EU) 2015/2283.
In other words, the message was clear: food innovation could benefit from certain regulatory flexibilities, but novel foods could not.
Parliament changes the rules of the debate
The European Parliament’s Committee on the Environment, Climate and Food Safety (ENVI) proposes removing this automatic exclusion. If this change is adopted during the legislative process, removing that exclusion would represent a significant political and regulatory shift.
The parliamentary opinion considers that sandboxes can play a useful role in:
- generate scientific evidence;
- test study designs;
- validate innovative production processes;
- develop assessment methodologies;
- reduce regulatory uncertainties;
- improve the quality of future authorisation dossiers.
However, Parliament introduces a fundamental limitation: ENVI’s position incorporates a fundamental limitation: the participation of a novel food in a sandbox would not replace, anticipate or prejudge the authorisation required under Regulation (EU) 2015/2283.
The safety assessment would remain the responsibility of EFSA and authorisation would continue to be carried out through the legal procedure currently in force.
A change in approach: from exclusively ex ante control to regulatory learning
I consider that, at this point, the main novelty is not legal but conceptual. The Novel Food Regulation is essentially based on a prior control model: first, all the necessary scientific evidence is generated and then authorisation is requested.
ENVI’s proposal introduces an additional dimension: the possibility of developing regulatory learning spaces before the formal submission of the dossier. This could be particularly useful for emerging technologies where methodological uncertainties still exist, for example:
- precision fermentation;
- microbial biomass;
- alternative proteins;
- new sources of functional ingredients;
- innovative food production systems based on biotechnology.
In these cases, the value of the sandbox would not lie in authorising products, but in helping to better understand what data are needed to assess them.
EFSA takes on a more prominent role
ENVI’s position provides that EFSA could, where appropriate, take on a scientific guidance role within these regulatory environments. The Authority could participate, where appropriate, by providing scientific guidance on:
- study design;
- data generation;
- quality of scientific evidence;
- assessment methodologies;
- proportionate risk mitigation measures.
In addition, it is envisaged that EFSA could recommend to the Commission the creation of regulatory sandboxes at European level. This point is particularly interesting because it opens the door to avoiding excessive fragmentation between Member States and favours a more harmonised approach within the internal market.
This is not deregulation
It is important to emphasise what this proposal actually entails and, above all, what it does not entail. It does not lower safety requirements, eliminate prior authorisation or open a fast track for placing novel foods on the market. The approach is more cautious: to create a regulatory learning environment subject to clear safeguards, requiring the express consent of the Member State concerned and the informed consent of participating consumers, together with specific labelling and traceability conditions. A prior risk assessment should also be guaranteed, accompanied by the necessary mitigation measures, supervision by the competent authorities and transparency through the publication of the results obtained.
Therefore, this is neither deregulation nor a relaxation of the applicable framework. The sandbox should be understood as a regulatory support tool: a controlled space for generating knowledge, reducing uncertainties and improving the preparation of future dossiers, without replacing the safeguards provided for in Regulation (EU) 2015/2283.
What could it mean for the food sector?
It is still too early to know what the final wording of the European Biotech Act will be. The legislative process is continuing, and both Parliament and the Council will have to establish their final positions.
However, the political signal sent by ENVI is clear. The EU appears to be beginning to recognise that certain food innovation processes need more than authorisation procedures. They also need spaces where authorities, scientists and companies can learn together how to assess increasingly complex technologies.
If this vision progresses, regulatory sandboxes could become a complementary element of Regulation (EU) 2015/2283: not to replace scientific safety assessment, but to make it more predictable, more efficient and better adapted to the food innovations of the future.
Ultimately, the European Parliament is not proposing to lower the requirements applicable to novel foods. What it appears to be proposing is something different: incorporating a prior regulatory learning phase that would make it possible to generate better science, reduce uncertainties and facilitate innovation reaching the market without compromising the high level of protection that characterises the EU food safety model.
