Setting the course
for innovation in novel food
The concept of "novel food" is now part of the everyday vocabulary of any food business operator. However, food business operators still face a number of challenges, particularly the very first task of ascertaining the novelty of an ingredient. On top of this assessment, obtaining the final approval for their new ingredient will vary depending on the region of the world.
One significant obstacle that should not be overlooked is the absence of a general “culture of innovation," which presents a considerable challenge.
State of the art/Analogs
Each legal system establishes its own distinct regulations with respect to novel food assessment.
The European novel foods procedure is generally considered to be stricter than procedures in other jurisdictions. The current authorisation process, implemented by Regulation (EU) 2015/2283, is considerably more efficient than its predecessor. However, obtaining authorisation remains a lengthy process extending over several years. In addition, the procedure generates substantial costs due to the extensive studies and data required.
In the United States, the novel food status of a new ingredient can be rapidly confirmed as 'generally recognised as safe' (GRAS) within the space of a few months thanks to the assessment of a group of independent experts, independent from the authorities. After being assessed by a panel, Food and Drug Administration (FDA) is generally consulted. If the FDA determines that there are no safety or regulatory concerns, it will issue a "no questions asked" letter, thus finalising the process in less than a year.
While regulations provide a necessary framework for guaranteeing consumer safety, it is, in reality, the cultivation of an innovation-driven culture that will drive the novel food landscape forward.
Aim – Fill in the gap
In this regard, the novel food landscape is undergoing a gradual fragmentation of the novel food landscape.
Over the past decade, the European Union (EU) has witnessed the emergence of several innovative foods in the market, including insects, high-protein powders, and various forms of algae. However, when it comes to current trending topics like cannabidiol or cellular meat, Europe is notably falling behind. This gap is also evident at the national level, as several EU Member States have taken positions against this kind of novel food.
In March 2023, the Italian government introduced a draft law (1) to ban food or feed "from cell cultures or tissues derived from vertebrate animals" from being produced and commercialised in Italy, in a bid to protect its food heritage. On the 19th July the draft Italian law was approved by the Senate under the new title “Provisions on the prohibition of the production and placing on the market of food and feed consisting of, isolated from or produced from cell cultures or tissues derived from vertebrate animals as well as the prohibition of the name 'meat' for processed products containing plant proteins”. The draft still has to go to the Chamber.
Just a few weeks later, the French Senate released a report regarding cellular food, expressing its reservation and advocating for a strengthening of the novel food authorisation procedure.
Meanwhile the UK, which, since Brexit is still modelled on the European system, is now resolute in its quest for greater innovation.
Last February, the UK Food Standards Agency (FSA) asked a private consultancy to evaluate the current novel food landscape. The trigger for this initiative appears to be the flood of applications for marketing authorisation for cannabidiol, which has clogged up the novel food authorisation process and shed light on the weakness of the existing system. The report suggests potential reforms “to keep pace with innovation” and make the novel food process “better tailored to meet the needs of the UK” (2). The idea is that FSA takes a “collaborative” approach wherein novel food could be authorized based on approvals obtained in other jurisdictions. Such an approach would represent a significant advancement in the realm of novel food approvals such as cell meat or precision fermentation.
As evidenced by this FSA’s recent Strategic Assessment on Food System (3), the UK’s food system is currently undergoing a comprehensive reassessment, from a reconsideration of novel food system, to the impact of Brexit and the conflict in Ukraine on global trade, together with a focus on enhancing healthy diets and food sustainability. However, the practical implications of these efforts will need to be assessed.
Other jurisdictions in the world have consistently advocated for an innovative approach to novel food.
In 2020, Singapore became the first country to approve the commercialisation of cultivated meat when it approved EAT JUST cultivated chicken. While Singapore has been the world’s only producer of cellular meat for three years, the United States has just caught up. Just last month, the USDA also approved by giving its grant of inspection, the sale of cultivated EAT JUST chicken as well as Upside Foods. This follows the “no questions letter” received earlier from the FDA.
The question of the future of novel foods seems now to be more a matter of political will than a strict legal or scientific matter. Consequently, depending on the region of the world, the willingness of food business operators to innovate could - unfortunately - receive a different echo.
References and notes
- Proposta legge cibo sintetico_28.3.2023
- Novel Foods Regulatory Framework Review: Executive Summary
- Strategic Food System Assessment, FSA March 2023