This article was originally published in Food Naviigator.
Could new novel food rules open up the European market to a wave of exotic foods and ingredients? Katia Merten-Lentz, partner at international law firm Keller and Heckman, believes a streamlined process offers potential to increase innovation around ‘traditional’ food.
Unlike its predecessor, under which all novel foods were subjected to the same rules, the new Novel Food Regulation (2015/2283) introduces the notion of ‘traditional foods from a third country’. By laying down specific rules for food that fall into this category, the regulation aims to facilitate their entry onto the EU market.
What is a ‘traditional food from a third country’?
A traditional food from a third country is defined as a “novel food which is derived from primary production (…) with a history of safe food use in a third country”.
According to this definition, a traditional food is, first and foremost, a novel food. This term refers to food that was not consumed within EU before 1997.
It must also fall into one of the categories explicitly mentioned in the Regulation. Notably, traditional foods can be categorised as food consisting of, isolated from or produced from: microorganisms, fungi or algae; plants of their parts; animals and their parts or cell culture of tissue culture derived from animals, plants, micro-organisms, fungi or algae.
The other six categories of novel foods mentioned by the Regulation, mainly refer to technological progress and therefore cannot be considered as traditional food.
A traditional food from a third country should be derived from primary production, articulated in General Food Law Regulation 178/2002: “The production, rearing or growing of primary products including harvesting, milking and farmed animal production priori to slaughter, hunting, fishing and the harvesting of wild products”.
Lastly, a traditional food must have a history of safe food use in at least one non-EU country. In other words, its safety must be confirmed with compositional data and experience of continued used in the customary diet of a significant number of people in at least one third country for at least 25 years.
Simplified authorisation procedure
Like every other novel food, a traditional food from a third country needs a pre-market authorisation to be able to be sold or used in the EU.
However, articles 14 to 20 of Regulation 2015/2283 completed by Commission Implementing Regulation 2017/2468 that specify administrative and scientific requirements concerning traditional foods from third countries, introduce a special procedure for their safety assessment.
Instead, instead of following the normal procedure for authorizing a novel food, a food business operator may opt to submit to the Commission a simple notification of his intention to place on the EU market a traditional food from a third country. The Commission will then forward this notification to all the Member States and EFSA. These parties can then submit duly reasoned safety objections within four months.
In case of any safety objection, the applicant may convert the notification into a formal application for which a safety evaluation will be requested from EFSA. Otherwise, the traditional food will be directly authorised by the European Commission.
The total time length of these two simplified procedures should be four to fifteen months. The classical procedure took take nearly twice as much time. Also, the content of the dossier, even when converted in a genuine application, has been reduced.
First test: fonio and haskap berries
Since the new Novel Food Regulation entered into force in January, two notifications have been submitted to the European Commission: one for fonio (decorticated grains of a small seeded cereal, historically used in West-Africa as a substitute for rice) and one for haskap berries (consumed at least in Japan over past 25 years according to the applicant).
The way these notifications will be handled will be a first real test. It is likely to foreshadow the practice that will be developed by the authorities. We will see if fonio and haskap berries can be legally marketed in the EU in the coming months.