Innovation in the food sector can take the form of the development of new matrices – e.g., microalgae, microorganisms – but also with the rediscovery of traditional foods from third countries, which are subject to a notification procedure under Reg. EU 2015/2283(Novel Foods).
Traditional foods from third countries, reg. EU 2015/2283(Novel Foods)
1.1) Definition.
Reg. EU 2015/2283 (Novel Foods) defines traditional foods from third countries as those not used ‘to asignificant degree for human consumption‘ in the EU before 15.5.97 that belong to one of the following categories:
(1) foods consisting of, isolated from, or produced by microorganisms, fungi, or algae,
(2) foods consisting of, isolated from, or produced from plants or parts thereof, with the exception of foods that have a history of safe use as food in the Union and are consisting of, isolated from, or produced from a plant or variety of the same species obtained by:
– Traditional breeding practices used for food production in the EU before 15.5.97, or
– non-traditional breeding practices, not used for food production in the EU before 15.5.97, if they do not involve significant changes in the composition or structure of the food such as to affect its nutritive value, metabolism or content of undesirable substances,
(3) food consisting of, isolated from, or obtained from animals or parts thereof, with the exception of animals obtained by traditional breeding practices used for food production in the EU before 15.5.97, where such food obtained from such animals has a history of safe use as food in the Union,
(4) foods consisting of, isolated from, or produced from cell or tissue cultures derived from animals, plants, microorganisms, fungi or algae. (1)
1.2) Notification of traditional foods from third countries as Novel Foods
As an alternative to the ordinary Novel Foods authorization procedure, which is not without its complexities in demonstrating the safety of the product for human consumption, traditional foods from third countries may come under a notification procedure to the European Commission. Which must always and in any case precede their release into the domestic market (EU Reg. 2015/2283, Article 14).
The notification procedure postulates the demonstration of ‘history of safe use as food in a third country’. That is, the production of from the data on the composition of the food and ‘experience of continued use, over a period of at least 25 years, in the usual diet of a significant number of people in at least one third country‘ (EU reg. 2015/2283, Article 3.2.b).
1.3) Initiation of the procedure
The notification to be submitted to Brussels through the
Food Chain Platform
– in addition to including the applicant’s details, as well as the name, description and detailed composition of the traditional food, its country (or countries) of origin – must attach an application that contains:
– documentation showing the history of safe use of the traditional food (see supra, Section 1.2),
– A proposal for intended conditions of use and specific labeling requirements designed not to mislead consumers. That is, an explanation of why these elements are not necessary (see below, Section 3.1).
1.4) Commission preliminary review, forwarding to member states and EFSA.
The European Commission verifies ‘without delay‘ whether the food falls within the scope of the Novel Foods Regulation and compliance with the requirements prescribed in reg. EU 2017/2468 (Articles 3,5,6. See footnote 2), reg. EC 178/2002 (Art. 32b). With authority to consult with member states and EFSA(European Food Safety Authority), as well as to request additional information from the applicant.
Within one month of the preliminary examination, if the outcome is favorable, the Commission forwards the notification to the Member States and EFSA. Which, within the following four months, may submit scientifically substantiated objections to the food safety of the product (EU Reg. 2015/2283, Article 15. See also EU Reg. 2017/2468, Article 9).
1.5) Consultation outcome member states and EFSA.
As a result of the consultation of member states and EFSA, two alternative scenarios emerge:
(a) if there are no objections, the Commission shall, within the following four months, authorize the release of the traditional food into the EU and update the Novel Food list. Specifying the nature of traditional food from third country, conditions of use, specific labeling requirements, and if applicable, post-market monitoring criteria.
(b) in case of objections, the Commission shall inform the applicant and shall not allow the food to be placed on the Union market or update the EU list. In such a case, the applicant may, if necessary, submit an application for authorization, which must include, in addition to the information already provided, data and documents in response to the objections raised (EU Reg. 2015/2283, Article 16).
1.6) Authorization procedure (if any).
In the event of reasoned safety objections, which are followed by Brussels’ negative response to its notification (see case ‘b’ above), the applicant can then propose an application for authorization of the traditional food from third countries. And EFSA adopts an opinion on its safety, assessing whether:
– history of safe use as food in a third country is attested by reliable data,
– the composition of the food and the conditions of use do not present a safety risk to human health, taking into account vulnerable population groups (e.g., the YOPI, Young Old Pregnant Immunosuppressed, people with food allergies and intolerances),
– where the food is intended to replace another food, if it does not differ from it in such a way as to make its normal consumption nutritionally disadvantageous for the consumer (EU reg. 2015/2283, Article 17).
2) Traditional foods from third countries included in the Novel Foods register.
Some examples of traditional foods from third countries notified to the European Commission and included in the list of Approved Novel foods follow:
– Coffea arabica L. and Coffea canephora Pierre, dried berry pulp and its infusion, as of 13.1.22 (applicants Luigi Lavazza SpA and Société de Produits Nestlé SA. See footnote 3),
– Wolffia arrhiza and Wolffia globosa (water lentil), fresh plants, from 10.12.21 (applicant GreenOnyx Ltd. V. notes 4,5),
– Theobroma cacao L. (‘cocoa pulp’), pulp, pulp juice and pulp juice concentrate of the fruit, from 14.2.20 (applicants Nestec York Ltd Cabosse Naturals NV)
– Sorghum bicolor (L.) Moench, syrup, from 18.12.18 (requesting Sorghum Zrt)
– Lonicera caerulea L. (‘haskap‘), berries, from 13.12.18 (applicant Soloberry Ltd).
3) Novel Foods, scientific approach
The relative simplification of procedures established for the notification and eventual authorization of traditional foods from third countries offers an interesting prospect for shortening the time to market in the proposal of novel foods that are also potentially useful and appreciated in the Old Continent.
The scientific approach in the presentation of the application accompanying the notification is always and always necessary. In fact, the regulation of Novel Foods is in each case based on a thorough assessment of food safety requirements and the suitability of the food to be consumed by the various consumer groups.
3.1) File structure
The file to be attached to the notification of traditional foods from third countries referred to in paragraph 1.3 above must come structured in several sections where to characterize, among other things, the identity of the traditional food (genetic variety, characteristics), production process, composition, specifications (including chemical-physical and microbiological parameters to ensure safety), conditions of use referring to the various categories of consumers. With appropriate considerations in the margin of each section to support the safety of traditional food under the proposed conditions of use.
3.2) Scientific evaluation
The dossier must also address any uncertainties, taking into account the scholarly bibliography and the so-calledgrey literature (grey literature, i.e., materials and research produced by organizations outside the traditional commercial or academic channels of publication and distribution. E.g., reports and, working papers from various sources, government documents, theses, etc.). With a critical evaluation that also considers potentially unfavorable data.
Analyses must be performed at competent facilities and accredited laboratories that can certify the data. Information on the accreditation of the facilities involved, certificates of analysis, the quality of the systems in place to control production processes and their compliance with applicable guidelines as well as with official national and/or international quality systems must also be documented and found to comply with the request.
Our team is available to contribute to research and development projects aimed at approval of novel foods in EU, UK and other regulatory contexts.
Dario Dongo and Giulia Torre
Cover image from Graham Wise, Demetrio Santander. Novel Food Notification for Authorisation of a Traditional Food From a Third Country Under Regulation (EU) 2015/2283 Dried Leaves of Guayusa (Ilex guayusa Loes.). doi: 10.13140/RG.2.2.18400.53762
Notes
(1) Reg. EU 2015/2283 on novel foods, Article 3(2). Combined arrangement of letter ‘a’ points ii,iv,v,vi and letter ‘c’
(2) Reg. EU 2017/2468, laying down administrative and scientific requirements concerning traditional foods from third countries under Regulation (EU) 2015/2283 on novel foods. Consolidated text as of 3/27/21 on Europa Lex, https://bit.ly/35RD29M
(3) Dario Dongo. Dried coffee berry pulp for infusions and drinks, green light in EU. GIFT(Great Italian Food Trade). 20.1.22, https://www.greatitalianfoodtrade.it/innovazione/polpa-essiccata-di-bacche-di-caffè-per-infusi-e-bevande-via-libera-in-ue
(4) Marta Strinati. Water lentil, a superfood to be discovered. GIFT (Great Italian Food Trade). 3.11.19, https://www.greatitalianfoodtrade.it/mercati/lenticchia-d-acqua-un-superfood-da-scoprire
(5) Dario Dongo, Andrea Adelmo Della Penna. Novel food, EFSA approves turmeric extracts and rejects Tongkat Ali. Water lentil in the center. GIFT (Great Italian Food Trade). 12/30/21, https://www.greatitalianfoodtrade.it/progresso/novel-food-efsa-approva-gli-estratti-di-curcuma-e-boccia-il-tongkat-ali-lenticchia-d-acqua-al-centro
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
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