Looking at the ProFuture microalgae value chain, one action is on ‘regulation and compliance’ – a key step as it defines if we can actually consume the different microalgae species by assessing food security, food safety and sustainable development. The aim: Protecting the consumer from danger and misleading information, while boosting the alternative protein market.

ProFuture partner Food and Agriculture Requirements (FARE) from Italy provides the regulatory and technical advice that is needed to legitimately place microalgae in the European market.

We talked to Dario Dongo, who founded FARE in 2012, after 20 years of work as an international food lawyer and regulatory expert, with a Ph.D. in agro-food systems and an MBA and a master in governance and strategy. Read the interview here:

Can you introduce the team at FARE working for ProFuture?

In the FARE research team, I work together with Giulia Torre, PhD candidate in agri-food systems at the University of Piacenza and Cremona, Andrea Adelmo Della Penna, food technologist and Marta Strinati, journalist in the food and consumers sectors. While having different backgrounds, our common objective is to contribute to the development of sustainable food supply chains, by means of promising ingredients such as microalgae!

Can you tell us more about your role in the project?

Our activity starts from the Novel Foods Regulation application assessment, on basis of species and products characterization. Some species and/or single strains must undergo an authorization procedure - we support the concerned partners in all activities that are needed to draft a technical dossier and the application. This starts with scientific reviews and study design, but also includes Good Manufacturing Practices (GMPs) and Hazard Analysis and Critical Control Points (HACCP) manuals revision, analysis and evaluation. In all cases, both traditional and novel microalgae, we also provide advice on B2B and consumers’ information, nutrition & health claims applicable, and the studies needed in order to apply for new health claims authorizations. Last but not least, we are responsible for the data management policy which is very important as it is the basis for knowledge-sharing in a wider context, also in view of the Sustainable Development Goals (SDGs) 2030.

What are the findings so far for microalgae?

Over the last 5 years, the appetite for alternative sources of proteins and functional ingredients has soured. Microalgae seem to be in a very good position, because of decades of experience in cultivating them for different purposes (food, feed, energy) and their high-potential in food security and nutritional safety perspectives. Also, at global level, there is a good consumer acceptance.

A good part of the microalgae which are considered by the ProFuture project are not novel, for example Spirulina and Chlorella, are already authorized as Novel Foods. The innovation provided will then have an immediate impact on the market, in terms of production sustainability and costs. Other species authorizations are ongoing, some others still need the procedure to be started. The new Transparency Regulation, applicable since 27 March 2021, provides a substantial help because of the much wider set of data on precedent dossiers that the European Commission and the European Food Safety Authority (EFSA) must provide under request.

What are the steps to take with ‘Novel Foods’?

From a regulatory perspective, we first have to assess if the Novel Foods Regulation (EU) No 2015/2283 needs to be applied. But how are novel foods defined? They are foods with no proven track of safe consumption to a significant degree in the EU before 15 May 1997. As a second step, the food business who wants to introduce a Novel Food in the EU must apply for its preventive authorization at EU level. The application must include a technical dossier providing scientific evidence of the food safety for human consumption, and its intended uses. Toxicology studies may not be required, depending for example on the experience of consumption in third countries.

The European Commission verifies its completeness of the application and forwards it to EFSA for a scientific assessment. Novel foods are then authorized by the EC, with the support of Member States representatives, taking into account (but not being tied to) EFSA’s opinion.

What are the challenges in your work?

The Novel Food discipline has always been uncertain because of the space left to Member States interpretation and enforcement. This means that the food business operators often have difficulties understanding the European Commission’s position on foods and/or substances that are considered novel or not, from one country to another. This can be a major obstacle for innovative start-ups and SMEs wishing to innovate, since investors dislike uncertainty and authorization procedures can be burdensome and expensive.

How does the risk assessment work?

EFSA has published guidelines and has done workshops on the general principles that need to be followed to provide evidence of novel food safety. Obviously, there cannot be a ‘one-size-fits-all’ guidance for the enormous variety of products that may fall within the scope of the Novel Food Regulation. Nonetheless, scientific literature and precedent dossiers evaluations by EFSA offer a valuable benchmark on the priorities and the specific criteria to be followed. Teamwork is also very important, in order to share the approach and to update it during the process, taking advantage of different perspectives and backgrounds.

What do food businesses and research centers need to know when introducing microalgae to the market?

Food business operators are responsible to guarantee the safety of all food they place in the EU market. The first issue, in case of microalgae, is to properly identify its species and strains, which is not always an easy task. Once the microalgae is identified and tested, its status can be checked by searching it in the EU novel food catalogue, which is a non-binding and non-exhaustive list managed by the European Commission. In case of uncertainty, further research must be performed either at EU or national level. Research centres can also interact with EFSA, which has implemented several initiatives to support the comprehension of all phases of the procedure (i.e. pre-submission phase, preparation and submission of the application, suitability check, risk assessment and adoption of EFSA’s scientific opinion, post-adoption phase).

To learn more about the safety and regulatory challenges of alternative proteins, join our webinar on 13 December 2021, 10:00 – 11:00!

The webinar is organized by the sister projects – a collaboration between 4 EU projects working on alternative proteins for food and feed.

Speakers from the projects SUSINCHAIN and NEXTGEN Proteins will talk about chemical safety of insects and regulatory challenges of alternative proteins.

Register here: https://bit.ly/3lAay9G

Agenda:

• 10:00 – 10:10 | Introduction - Birgir Örn Smárason (NextGenProteins)

• 10:10 – 10:30 | Regulatory challenges of alternative proteins - Prof. Sveinn Agnarsson (NextGenProteins)

• 10:30 – 10:50 | Chemical safety of insects - Prof. Ine van der Fels-Klerx (SUSINCHAIN)

• 10:50 – 11:00 | Q&A - Discussion around prioritised questions posed by the audience