Service details
Regulatory evaluation of the native ingredient before processing (plant, animal product, other source, etc) in EU Member States that specifically qualify it (positive/negative lists, potential doctrines, etc.).
Why do I need to submit a novel foods application?
Foods that were not consumed ‘to a significant degree’ in the EU before 15 May 1997 require an application for use. These foods must be safe for human consumption, and not mislead the customer in relation to nutritional value if there is the intention that this food will replace another.
The application requires:
– A complete description of the manufacturing process, safety protocols, and certifications
– A full analysis of the ingredient
– A calculation of human exposure (mean and 95th percentile exposure)
– Genotoxicity testing (a minimum of 2 studies)
– A 90-day sub-chronic toxicity study
– An evaluation of the potential allergenicity (if the ingredient contains proteins)
Unfortunately, the novel foods application process is very technical and requires expertise and time that’s not often available within an organization. Relying on our team of experts to assist with this process allows your team to focus on other objectives. Our knowledge of—and experience in—novel food applications ensures your application will meet all the regulatory requirements that EFSA and the European Commission need to approve your submission.
At FoodChain ID we work with you to select the right service for your product, from regulatory analysis to a consultation process and any submissions or follow-ups with EFSA. This removes the strain from your business, and at 50% of the typical cost, it allows budget to be made available for other projects.
From start to finish, using an expert to support your novel food application means you benefit from the knowledge we have gained from our years of experience.
Procedure Selection
- Consultation process according to Regulation (EU) 2018/456
- Traditional food from third countries process according to Regulation (EU) 2015/2283
- Complete procedure according to Regulation (EU) 2015/2283
Scientific Gap Analysis of Data in Accordance with Regulatory Admissibility Criteria
- Characterization data for the food/ingredients
- History of consumption for the food/ingredients
- Pharmacokinetic data for the food/ingredients
- Allergenicity data for the food/ingredients
- Safety/toxicological data for the food/ingredients
Expert Recommendations
- Strengths and weaknesses of the substantiation
- Complementary elements to provide including additional toxicology and/or quality studies
File Preparation & Submission
- Preparation of the file
- EC submission
Communications with Authorities (EFSA & European Commission)
- Novel Foods in Europe: How to Determine Status and Achieve Market Authorization
- EU News on Food Supplement Regulations
- The novel food evaluation process delays access to food innovation in the European Union
- The Key Point of the New EFSA Novel Food Guidance
- Novel foods in Europe: Opportunities, challenges and new demands from The EFSA
- Quality of food supplements – Europe
In the European Union, a Novel Food (NF) is defined as any food that was not consumed to a significant degree by humans within the Union before May 15, 1997. The regulation of NFs, primarily under Regulation (EU) 2015/2283, aims to ensure the safety of new food products before they enter the market. This framework is crucial for integrating innovative food items into existing food systems, particularly as society seeks more sustainable, functional, and health-promoting options.
The average duration for a Novel Food application from initial submission to the publication of the European Food Safety Authority (EFSA) opinion is approximately 2.56 ± 1.19 years, or about 31 months. The process involves several key stages:
– EC Verification (A): The European Commission verifies the application’s receivability, averaging 114 ± 181 days.
– EFSA Suitability Check (B): EFSA checks the application’s suitability and completeness, averaging 185 ± 122 days.
– EC Validation Phase (AB): The total time from submission to the start of scientific evaluation, averaging 299 ± 218 days.
– EFSA Scientific Evaluation (C): EFSA’s risk assessment, averaging 629 ± 338 days (about 20.7 months).
– Time to Publication (D): The period from opinion adoption to publication, averaging 48 ± 16 days.
– The overall process (W), from submission to publication, averages 937 ± 436 days.
Significant delays in the Novel Food authorization process are often attributed to:
Suitability Checks and EC Validation: Administrative steps like EFSA’s suitability check and European Commission (EC) validation can take nearly a year, with high variability due to inconsistent dossier quality and procedural inefficiencies.
Additional Data Requests (ADRs): EFSA frequently issues ADRs to applicants, which significantly extend timelines. These requests, averaging 2.7 per application, often pertain to production processes, compositional data, and toxicological assessments. Applicants take an average of 130 days to respond to each ADR, with the cumulative response time accounting for nearly half (47 ± 25%) of the total scientific evaluation period.
Transparency Regulation (EU) 2019/1381: Implemented in 2021, this regulation introduced additional obligations, such as mandatory notification of studies, leading to application rejections (30 applications were rejected due to non-compliance) and increased complexity.
Updated Scientific Guidance: While intended to provide clarity, the 2021 and 2024 updates to EFSA’s scientific guidance have also introduced more stringent requirements, potentially adding to the burden on applicants.
The current EU Novel Food regulatory framework significantly delays market access for innovative food products, potentially hindering innovation across the food sector. The lengthy and sometimes inconsistent evaluation procedures can discourage applicants, particularly small and medium-sized enterprises, from engaging with the regulatory process. These delays can lead to the failure of food businesses by extending market access timelines beyond what is sustainable. Moreover, it limits consumer choice and access to beneficial food products, which is problematic when global challenges like sustainability, economic competitiveness, and evolving dietary needs require prompt solutions. The process is perceived as a disincentive for investment and entrepreneurial experimentation.
Despite the procedural challenges and lengthy timelines, the European Food Safety Authority (EFSA) has a high rate of positive opinions for Novel Food applications. Among the 93 applications that reached the published or publishing stage, EFSA confirmed the safety of the novel food in 79 cases, resulting in a positive opinion rate of 86.81%. The main reasons for rejection were safety concerns (8 cases), inability to identify the source of the novel food (1 case), and poor application quality or lack of pertinent responses from the applicant (3 cases).
The EU’s regulatory landscape for Novel Foods is recognized as one of the most rigorous globally. However, this rigor, combined with the lengthy authorization timelines, means that sustainable alternatives like plant-based proteins, fungal biomasses, and cellular meat—which are already approved in other regions—remain largely inaccessible in the EU due to pending regulatory approvals. This regulatory lag poses a risk to the competitiveness of the European food industry and its ability to adapt to evolving societal demands for sustainable food systems, such as those promoted by the Farm to Fork Strategy. The delay in authorizing new food ingredients, even those derived from valorized agri-food waste, can impede the rapid adoption of eco-friendly practices.
The Transparency Regulation (EU) 2019/1381, implemented in 2021, has notably impacted the Novel Food authorization process. It imposes additional regulatory obligations on food business operators, most significantly the mandatory notification of studies prior to submitting an application. Failure to comply with these requirements can lead to the outright rejection of applications by authorities. This adds a layer of complexity and risk to an already rigorous process. For instance, 30 applications were rejected specifically due to non-compliance with Article 32b of this regulation, with the average time to rejection for such cases being 297 ± 121 days.
To improve the efficiency of the EU’s Novel Food evaluation process while maintaining high safety standards, several recommendations are put forth:
– Improved Guidelines and Pre-submission Support: Providing clearer guidance and enhanced pre-submission dialogue for applicants could streamline the process and improve dossier quality, reducing the need for Additional Data Requests (ADRs).
– Streamlined Risk Assessments: Implementing more robust upstream risk assessments could reduce the number of dossiers systematically referred to EFSA by the European Commission, allowing EFSA to focus on more complex or truly novel evaluations.
– Balancing Rigor and Efficiency: Policymakers need to critically reassess the procedural design to balance scientific rigor with regulatory efficiency.
– Addressing Bottlenecks: Identifying and addressing administrative bottlenecks, particularly in the suitability check and validation phases, is crucial to reduce the overall duration of the process.-
