Novel food authorisation barriers

Part I. Findings

The Council records three conditions affecting how Regulation (EU) 2015/2283 on novel foods applies to small EU producers. Each is supported by sources cited at the foot of this Position.

Finding 1. EU novel food authorisation takes, on average, more than two and a half years.

Peer-reviewed analysis published in 2025 in npj Science of Food records that the average duration of a novel food application, from initial submission to publication of the EFSA scientific opinion, is 2.56 years (approximately 31 months), with a standard deviation of 1.19 years^[4],[5]. The validation phase alone averages ten months, with the scientific evaluation taking between six months and four and a half years depending on dossier quality and follow-up data requests^[4]. After the EFSA opinion is published, the Commission then takes up to a further seven months to present a draft authorising regulation for publication in the Official Journal^[2].

Finding 2. The procedural design of the regulation creates a structural barrier for small producers and start-ups.

Peer-reviewed analysis records that lengthy and inconsistent evaluation procedures discourage applicants, particularly small and medium-sized enterprises, from engaging with the regulatory process at all^[4]. The same analysis records that approximately 47 per cent of total evaluation time is taken up by applicants responding to additional data requests from EFSA, with an average single-request response time of 130 days, a burden that scales unfavourably for producers without dedicated regulatory affairs capacity^[4]. The Wageningen University analysis of firm-level outcomes records a measurable effect of the novel food regime on innovation activity by smaller firms^[6].

Finding 3. The simplified pathway for traditional foods from third countries is welcome but conditional on a 25-year evidence threshold.

Article 14 of Regulation (EU) 2015/2283 provides a notification procedure for traditional foods from third countries, under which a traditional food may be placed on the EU market within approximately four months if no safety concerns are raised by any Member State or EFSA^[7]. The condition is that the applicant demonstrate the food has been used continuously for at least 25 years in the customary diet of a significant number of people in at least one third country^[1],[8]. The European Commission acknowledged in July 2025 that overall novel food timelines remain a barrier to EU competitiveness and signalled an intent to boost market access^[9].

Part II. Position

On the basis of these Findings the Council holds that:

1. Food safety in the assessment of novel foods is non-negotiable. The Council does not advocate for shortcuts, weakened safety thresholds, or reduced evidence requirements in the underlying scientific assessment.
2. The Council holds that the procedural and time burden of novel food authorisation falls disproportionately on small producers, who cannot sustain market entry timelines averaging 31 months and who lack dedicated regulatory affairs capacity to respond efficiently to EFSA additional data requests. This is a procedural problem, not a science problem.
3. The Council welcomes Article 14’s simplified pathway for traditional foods from third countries and the Commission’s July 2025 intent to broaden market access, while noting that the 25-year evidence threshold is a significant barrier for traditional ingredients with strong regional but undocumented historical use.

Part III. Commitments

The Council will:

1. Track Commission and EFSA action on novel food authorisation timelines, particularly any procedural reform addressing the ADR response burden.
2. Submit comment in consultations on novel food regulation where the impact on small producers and traditional ingredients is material.
3. Where members consent, document the practical barriers encountered in attempting to bring a traditional or novel ingredient to the EU market, so that the Council’s consultation submissions are grounded in producer-level evidence.

Revision

This Position will be reviewed annually, or sooner if Regulation (EU) 2015/2283 is materially amended, if the Commission publishes procedural reform of the novel food authorisation timeline, or if Article 14’s traditional food threshold is revised.

Sources

1. [1]Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 and repealing Regulation (EC) No 258/97. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015R2283
2. [2]European Food Safety Authority, Novel food application procedure (procedural guidance). https://www.efsa.europa.eu/en/applications/novel-food
3. [3]European Commission, Novel food authorisations (Food Safety Directorate-General). https://food.ec.europa.eu/food-safety/novel-food/authorisations_en
4. [4]The novel food evaluation process delays access to food innovation in the European Union, npj Science of Food (Nature Portfolio), 2025. https://www.nature.com/articles/s41538-025-00492-x
5. [5]PMC mirror of the above peer-reviewed analysis, PMC12219162. https://pmc.ncbi.nlm.nih.gov/articles/PMC12219162/
6. [6]Wageningen University and Research, The effect of the EU's novel food regulations on firm-level innovation outcomes. https://edepot.wur.nl/684557
7. [7]Article 14 of Regulation (EU) 2015/2283 — notification of a traditional food from a third country (simplified procedure). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015R2283
8. [8]European Commission, Novel food legislation (overview of authorisation pathways including traditional food from third countries). https://food.ec.europa.eu/food-safety/novel-food/legislation_en
9. [9]FoodNavigator, EU to boost market access for novel foods (record of July 2025 Commission policy direction acknowledging timeline issues). https://www.foodnavigator.com/Article/2025/07/03/eu-novel-foods-to-be-boosted/

Issued under Council authority. European Heat Council, 2026-06-25.