Katia Merten-Lentz of international law firm Keller and Heckman looks at how the EU’s regulation of traditional foods from third countries is proving to be a challenge for companies to successfully navigate.
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Since 1997, any food that was not consumed to a significant degree within European Union is generally speaking considered to be legally novel, and as such, deemed unsafe. To access the EU market, novel foods must undergo a safety assessment by the European Food Safety Authority and be authorized by the European Commission However, some of those novel foods are now considered ‘less new’ than others derived from new technologies, as they are widely consumed in other parts of the world. The new Novel Food Regulation (EU) 2015/2283, adopted in 2015, aimed to ease the marketing of those traditional foods from third countries within EU, thanks to a faster and a simplified procedure.
Traditional foods from third countries are, first and foremost, novel foods, which is to say foods that were not consumed to a significant degree within EU before 15 May 1997 and that fall into at least one of the ten categories of foods listed by the Regulation. More precisely among those ten categories, foods can only be considered as traditional if they are consisting of, isolated from, or produced from:
- microorganisms, fungi or algae;
- plants or their parts;
- animals and their parts; or
- cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae.
In addition, they must be derived from primary production, legally defined as the production, rearing or growing of primary products. Finally, and more importantly, their safety must have been “confirmed with compositional data from experience of continued [food] use for at least twenty-five years in the customary diet of a significant number of people in at least one third country”.
As any other novel food, traditional foods must have been authorized and included in the Union list of novel foods to be placed on the EU market, as such, or used in foods, in accordance with all conditions of use and specific labelling requirements specified therein.
However, instead of following the common procedure of authorization, the food business operator who intends to market a traditional food from a third country may opt to submit a notification of that intention to the Commission. That notification must contain, among others, documented data demonstrating the history of safe use in a third country. On receipt of a such notification, the Commission must verify the validity of the notification, and if necessary, may request additional information. Valid notifications are forwarded to the Member States and to EFSA, without delay and no later than one month after having verified its validity. Then, Member States and EFSA have four months to submit duly reasoned safety objections to the placing on the EU market of the traditional food concerned.
Even though it is not required by law, at this step, EFSA systematically carries out a hazard identification and, if necessary, a risk assessment, in order to detect potentially harmful substances that could be contained in the traditional food.
In case of duly reasoned safety objections from EFSA and/or any Member State, the Commission cannot authorize the traditional food. In this case, the applicant may convert his notification into a “normal” application – once again, following specified simplified rules – by including, in addition to the information already provided, documented data related to the objections.
To date, just over two years after these new rules entered into application, only four traditional foods from third countries have been authorized:
- haskap (Lonicera caerulea) berries;
- decorticated fonio (Digitaria exilis) grains;
- Sorghum (Sorghum bicolor) syrup; and
- cocoa (Theobroma cacao L) pulp, pulp juice and concentrated pulp juice.
A fifth one, herbal infusion from coffee leaves (Coffea arabica L and/or Coffea canephora Pierre ex A. Froehner), is soon to be listed in the Union list, as no safety objections have been raised. But those five represent less than 10% of all the notifications actually submitted to the European Commission.
In practice, the first step (validity check) seems to be the most difficult one, as only nine notifications moved to the second step and were sent to the Member States and EFSA. During the assessment of the first two submitted traditional foods (fonio and haskap berries), some Member States raised objections to their marketing, because of a lack of information provided by the applicants, but they had not been considered duly reasoned by the Commission.
General feedback on dossiers submitted points out that most of them are of poor quality and do not contain all adequate data.
Indeed, duly reasoned safety objection must be supported by “a scientific statement indicating why the traditional food from a third country may pose a safety risk to human health”. To avoid any future similar situation and since EFSA and Member States cannot request additional information once the validity check of the notification is completed, they are now consulted by the Commission during the verification process. This also results in a stricter control on the validity of the dossiers after their submission, which often leads to requests from additional data and delays in the treatment of the notifications.
At the beginning of 2020, three traditional foods have been subject to safety objections from EFSA:
- leaf powder of Moringa stenopetala (because of a lack of information regarding the quality and quantity of undesirable substances potentially present in the traditional food and the absence of an exposure assessment) ;
- powder and juice concentrate of berries of Aristotelia chilensis (because of the absence of quantitative information on the presence of alkaloids); and
- roasted sacha inchi seeds from Plukenetia volubilis L. (because of a lack of information on the type and quantity of alkaloids).
For now, none of them seems to have been turned into application, so there is still no feedback on the complete procedure applicable to traditional foods.
However, almost 70% of the submitted notifications since the 1st January 2018 are still stuck in the validity check phase and the request for additional information from the applicants. General feedback on dossiers submitted points out that most of them are of poor quality and do not contain all adequate data. Differences between the form of food that is used traditionally and the form in which it is intended to be placed on the EU market have also been observed. But even if data about the history of use are not so easy to find, applicants must keep in mind that it is a key element of notifications for traditional foods. When dossiers are sufficiently documented, experience has also shown that this notification remains more effective, efficient and faster (less than 1 year on average) than a full authorization.