EFSA agrifood pre-dossier & compliance with food standards

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 101036838. D1.6 – EFSA agrifood pre-dossier & compliance with food standards July 2025 Authors: Sofía Martínez López (CTNC) Ref. Ares(2025)6161147 - 29/07/2025 A2C – Deliverable D1.6v2.0 Page 2 І24 Technical references Project Acronym Agro2Circular Project Title TERRITORIAL CIRCULAR SYSTEMIC SOLUTION FOR THE UPCYCLING OF RESIDUES FROM THE AGRIFOOD SECTOR Project Coordinator Fuensanta Monzó CETEC [email protected] Project Duration October 2021 – March 2025 (42 months) Deliverable No. D6 Dissemination level* PU Work Package WP 1 – A2C Specifications, Residues Management and Data Integration System Task T1.2 – A2C Methodologies Lead beneficiary Partner number (partner short name) Contributing beneficiary/ies 13 (CTNC) Due date of deliverable 31 September 2024 Actual submission date 09 October 2024 * PU = Public PP = Restricted to other programme participants (including the Commission Services) RE = Restricted to a group specified by the consortium (including the Commission Services) CO = Confidential, only for members of the consortium (including the Commission Services) A2C – Deliverable D1.6v2.0 Page 3 І24 Document history V Date Comments v0.1 02.10.2024 First draft of document v0.2 03.10.2024 Revised version based on the comments of Name Reviewer(s) - Organisation v1.0 09/10/2024 First final version, approved by the WP leader and the project coordinator, (will be) submitted to EC. v2.0 29/07/2025 Second final version, approved by the WP leader and the project coordinator, (will be) submitted to EC. Document Distribution Log Versio n Date Distributed to v0.1 02/10/2024 Peer reviewers and coordinator v1.0 09/10/2024 Coordinator and WP leader V2.0 29/07/2025 Coordinator and WP leader Verification and approval Name Date Verification Final Draft by WP leader Jaime Ortíz-CETEC 29/07/2025 Approval Final Deliverable by coordinator Fuensanta Monzó-CETEC 29/07/2025 A2C – Deliverable D1.6v2.0 Page 4 І24 Disclaimer and acknowledgement This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101036838 Disclaimer This document reflects only the views of the author(s) the European Research Executive Agency (REA) is not responsible for any use that may be made of the information it contains. Whilst efforts have been made to ensure the accuracy and completeness of this document, the A2C consortium shall not be liable for any errors or omissions, however caused. A2C – Deliverable D1.6v2.0 Page 5 І24 Table of contents 1 List of abbreviations 7 2 Executive summary <abstract> ................................................... 8 3 Introduction ................................................................................ 10 4 Requirements ............................................................................ 12 4.1 Identity of the NF ............................................................................................... 12 4.2 Production process ........................................................................................... 13 4.3 Compositional data ........................................................................................... 15 4.3.1 Stability ......................................................................................................... 18 4.3.1.1 Stability of the bulk material .................................................................. 18 4.3.1.2 Stability when added to food formulations ............................................. 19 4.4 Specifications .................................................................................................... 19 4.5 Other aspects to be included ........................................................................... 20 5 Conclusions ............................................................................... 21 6 Evaluation of the results ............................................................ 22 7 Bibliography ............................................................................... 23 8 ANNEX I - EFSA Novel Food Pre-Dossier Template ................ 24 List of Tables Table 1. Analysis of phenolic and fibre extracts obtained from lemon waste, on average. 15 Table 2. Analysis of phenolic and fibre extracts obtained from artichoke waste, on average. 16 Table 3. Analysis of phenolic and fibre extracts obtained from broccoli waste, on average. 16 Table 4. Analysis of phenolic extracts obtained from grape waste, on average. 17 A2C – Deliverable D1.6v2.0 Page 6 І24 Table 5. Analysis of fibre extracts obtained from apple waste, on average. 17 Table 6. Analysis of other compounds of interest in phenolic extracts. 18 Table 7. Analysis of other compounds of interest in phenolic extracts. 18 Table 8. Specification of the NF 19 Table 9. Structure and Content of the EFSA Novel Food Pre-Dossier Template 24 List of Figures Figure 1. Diagram for obtaining NF from agri-food waste ................................................. 13 A2C – Deliverable D1.6v2.0 Page 7 І24 1 List of abbreviations ADME → Absorption, Distribution, Metabolism and Excretion AOAC → Association of Official Agricultural Chemists EC → European Commission EFSA → European Food Safety Authority EU → European Union HPLC → High-Performance Liquid Chromatography HPLC-MS/MS → High-Performance Liquid Chromatography–Tandem Mass Spectrometry ΙCP-MS → Inductively Coupled Plasma Mass Spectrometry ISO → International Organization for Standardization NDA → Novel Foods and Food Allergens NF → Novel Food RH → Relative humidity WP → Work Package A2C – Deliverable D1.6v2.0 Page 8 І24 2 Executive summary <abstract> This document provides guidance to applicants preparing applications for a new authorisation of novel foods in the European Union within the scope of Article 10 of Regulation (EU) 2015/2283 and Commission Implementing Regulation (EU) 2017/2469. The present pre-dossier includes the information to be provided for an application submitted for the authorisation of a novel food, considering extracts obtained from agri-food waste used for the development of new food formulations (WP2 at laboratory scale and further scaling up in WP4) as novel foods, in terms of risks assessment. In developing this document, consideration has been given to the "Administrative guidance for the preparation of applications on novel foods pursuant to Article 10 of Regulation (EU) 2015/2283" 1 as a general reference guide, as well as “Safety of bovine milk osteopontin as a Novel food pursuant to Regulation (EU) 2015/2283” 2 and “Safety of water lentil protein concentrate from a mixture of Lemna gibba and Lemna minor as a novel food pursuant to Regulation (EU) 2015/2283” 3 as practical examples, among others. The above Administrative guidance applies to all applications submitted to the European Commission from 27 March 2021 and should be used for the preparation of applications to be submitted from that date. According to the guidance, the life-cycle of an application encompasses various steps and activities: ▪ Pre-submission phase: this covers the preparation of the application and all presubmission activities; ▪ Submission phase and suitability check: consists of the application to the European Commission, and EFSA checks that the application is complete and suitable; ▪ Risk assessment phase: following the validation of the application, EFSA performs the risk assessment leading to the adoption of EFSA’s scientific opinion by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA); 1 https://doi.org/10.2903/sp.efsa.2021.EN-6488 2 https://doi.org/10.2903/j.efsa.2022.7137 3 https://doi.org/10.2903/j.efsa.2023.7903 A2C – Deliverable D1.6v2.0 Page 9 І24 ▪ Post-adoption phase: EFSA’s scientific opinion is published in the EFSA Journal and the EC prepares, where appropriate, a draft implementing act authorising the placing on the EU market of the novel food. The present pre-dosser will improve the understanding of the application requirements after the application preparation and submission stage (pre-submission phase and submission phase), namely once the application has been validated and the documentation for the risk assessment phase has to be prepared. A2C – Deliverable D1.6v2.0 Page 16 І24 Table 2. Analysis of phenolic and fibre extracts obtained from artichoke waste, on average. Parameter (%) Phenolic extract Fibre extract Method of analysis Moisture 4.2 6.3 Gravimetry Carbohydrates (including sugars) 43.3 1.9 Calculation Dietary fibre 33.4 75.1 Gravimetry Proteins 15.8 10.7 Kjeldahl Gunning-Arnold (KGA) Fat 0.3 1.9 Liquid-liquid extraction - Gravimetry Ash 3.0 4.1 Gravimetry Total sugar 13.2 0.8 Ion exchange HPLC Table 3. Analysis of phenolic and fibre extracts obtained from broccoli waste, on average. Parameter (%) Phenolic extract Fibre extract Method of analysis Moisture 4.8 5.4 Gravimetry Carbohydrates (including sugars) 45.5 3.5 Calculation Dietary fibre 6.1 70.1 Gravimetry Proteins 18.9 10.8 Kjeldahl Gunning-Arnold (KGA) Fat 1.2 0.4 Liquid-liquid extraction - Gravimetry Ash 23.5 9.8 Gravimetry Total sugar 38.7 <0,1 Ion exchange HPLC A2C – Deliverable D1.6v2.0 Page 17 І24 Table 4. Analysis of phenolic extracts obtained from grape waste, on average. Parameter (%) Phenolic extract Method of analysis Moisture 8.9 Gravimetry Carbohydrates (including sugars) 86.1 Calculation Dietary fibre 0.6 Gravimetry Proteins 1.3 Kjeldahl Gunning-Arnold (KGA) Fat 0.1 Liquid-liquid extraction - Gravimetry Ash 3.0 Gravimetry Total sugar 55.2 Ion exchange HPLC Table 5. Analysis of fibre extracts obtained from apple waste, on average. Parameter (%) Fibre extract Method of analysis Moisture 2.2 Gravimetry Carbohydrates (including sugars) 9.9 Calculation Dietary fibre 69.8 Gravimetry Proteins 5.6 Kjeldahl Gunning-Arnold (KGA) Fat 11.6 Liquid-liquid extraction - Gravimetry Ash 0.9 Gravimetry Total sugar 7.0 Ion exchange HPLC Heavy metal content (ICP-MS method of analysis), pesticides (HPLC-MS/MS), and pathogenic microorganisms (Mesophilic aerobes (ISO 4833-2:2014), Salmonella (ISO 65791:2017), L. monocytogenes (ISO 11290-1:2017), moulds and yeasts (ISO 21527‐2:2008) and E. coli ß-Glucuronidase positive (ISO 16649-2:2001) have also been evaluated. A2C – Deliverable D1.6v2.0 Page 18 І24 Salmonella and L. monocytogenes were not detected in any of the extracts analysed. Aerobic counts, mould and yeast counts and E. coli counts were <10 cfu/g in all extracts analysed (considering cfu as colony forming units). As for other compounds of interest, total polyphenols, among other compounds, have been analysed in phenolic extracts. Table 6. Analysis of other compounds of interest in phenolic extracts. Parameter (mg/kg dry matter) Lemon phenolic extract Grape phenolic extract Method of analysis Total polyphenols 124,400 208,900 Folin–Ciocalteu Hesperidin 52,796 - HPLC Limonin 10,763 - HPLC Vitamin C 641.1 HPLC Table 7. Analysis of other compounds of interest in phenolic extracts. Parameter (mg/kg dry matter) Artichoke phenolic extract Broccoli phenolic extract Method of analysis Total polyphenols 202.438 15,830 Folin–Ciocalteu Chlorogenic acid 113,827 80.2 HPLC 4.3.1 Stability 4.3.1.1 Stability of the bulk material The applicant performed stability testing with four independently produced batches of the NF under standard storage conditions. The tests were carried out at 25°C in dark sealed packages at 40–60% RH for a period of 6 months. The batches were analysed for microbiological stability and lipid oxidation over this period. Antioxidant capacity was also assessed over time. These studies showed no significant changes in any of the microbiological parameters tested after 1, 1.5 and 6 months. A2C – Deliverable D1.6v2.0 Page 19 І24 4.3.1.2 Stability when added to food formulations Food formulations have been developed with the NFs described above: ▪ Juices with 1.5% fibre (from the various fibre extracts). ▪ Vegan burger with 1 to 2% fibre (from the different fibre extracts). ▪ Vegetable desserts with 0.3% fibre (from the different fibre extracts). ▪ Jams with 1% fibre (from the different fibre extracts) ▪ Juices with 0.5% phenolic compounds (from the different phenolic extracts) ▪ Compote with 0.5% phenolic compounds (from the different phenolic extracts). Stability studies on food formulations are being carried out comparatively between samples including NF and control samples (without NF). Samples with NF and control without NF will be stored at room temperature (25°C) and 60% relative humidity, and under accelerated conditions (40°C and 75% relative humidity) for a maximum of 180 days. During the study, a complete nutritional analysis of the formulations and microbiological quality shall be evaluated at 30-day intervals. * The stability study is in its early stages, so there is no complete information available on the stability of the formulations compared to the control. 4.4 Specifications The specifications of the NF are indicated in Table 8: Table 8. Specification of the NF Parameter (unit) Fibre/Phenolic extract Fibre (%) 1 70-80 Total polyphenols (%) 2 > 7 Moisture (%) <9.0 Heavy metals (mg/kg) Arsenic Cadmium Lead <0.1 <0.05 <0.05 A2C – Deliverable D1.6v2.0 Page 20 І24 Mercury <0.05 Pesticides (mg/kg) <0,01 Microbiological contaminants Mould/ yeast (cfu/g) Salmonella L. monocytogenes E. coli (cfu/g) <10 Absent/ 25 g Absent/ 25 g <10 1 Applicable to fibre extracts 2 Applicable to phenolic extracts 4.5 Other aspects to be included Other aspects to be included in the safety assessment application are the history of use of the NF and/or its source. It is also important to include a section on the proposed uses of NF and use levels and anticipated intake. This section should include the target population (e.g. in this case the general population, as NF is used as a food ingredient in several food categories). The target population is limited to adults only for the intake of NF as a food supplement. The use levels will be specified per food category. For anticipated intake, daily intake data for the food categories shall be considered, calculating the intake of the NF based on the uses proposed by the applicant and the proposed maximum use levels. It is also important to provide information on absorption, distribution, metabolism and excretion (ADME). The applicant shall provide data on digestion and bioavailability of NF, among others. This part could be based on previous studies already published about similar extracts. Finally, toxicological information will be included, considering genotoxicity, subchronic toxicity or allergenicity, among others. A2C – Deliverable D1.6v2.0 Page 21 І24 5 Conclusions The preparation of this pre-dossier in the context of the safety assessment of NF (fibre extracts and phenolic extracts) is a strategic step that aims, in the first place, to highlight the quality of the products obtained in this project. It is imperative to ensure that the extracts obtained, which are expected to be used in food (as well as in other sectors that are not of concern to us in this case, such as cosmetics), meet the necessary quality and safety standards. This pre-dossier also plays a crucial role in understanding the process of requesting approval for a novel food. By outlining the specific requirements set out in Article 10 of Regulation (EU) 2015/2283, the document acts as a guide that facilitates navigation through the complexities of the regulatory framework, helping future applicants to understand EFSA's expectations. The information available so far on A2C extracts allows the safety of these extracts to be assured, taking into account that relevant toxicological studies need to be carried out to complete the risk assessment. A2C – Deliverable D1.6v2.0 Page 22 І24 6 Evaluation of the results In light of one of the key objectives of the project, incorporating the extracted compounds into food formulations and pursuing future commercialization, it is essential to thoroughly understand the current regulations in the European Union that the developed products must comply with. It is important to note that the preparation of a pre-dossier for EFSA contributes to strengthening consumer confidence in novel foods. This is essential considering the source of the NF in question: agri-food waste. By demonstrating the developers' commitment to safety and quality, an environment of transparency is fostered that can be beneficial for the acceptance of these products on the market, thereby promoting the circular economy. Although conducting an EFSA novel food acceptance process may seem challenging due to the long timelines and the amount of information and analysis required, approval of a novel food is essential to market the product in the European Union and given the size and influence of the European market, obtaining approval can open significant doors for the marketing and distribution of the food. A2C – Deliverable D1.6v2.0 Page 23 І24 7 Bibliography EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck, D., Castenmiller, J., De Henauw, S., Hirsch‐Ernst, K. I., Kearney, J., ... & Knutsen, H. K. (2022). Safety of bovine milk osteopontin as a Novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 20(5), e07137. https://doi.org/10.2903/j.efsa.2022.7137 EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck, D., Bohn, T., Castenmiller, J., De Henauw, S., Hirsch‐Ernst, K. I., ... & Knutsen, H. K. (2023). Safety of water lentil protein concentrate from a mixture of Lemna gibba and Lemna minor as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 21(4), e07903. https://doi.org/10.2903/j.efsa.2023.7903 European Food Safety Authority (EFSA). (2021). Administrative guidance for the preparation of applications on novel foods pursuant to Article 10 of Regulation (EU) 2015/2283 (Vol. 18, No. 3, p. 6488E). https://doi.org/10.2903/sp.efsa.2021.EN-6488 Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods. Official Journal of the European Union, L 327/1, of 11 December 2015. https://eur-lex.europa.eu/eli/reg/2015/2283/oj A2C – Deliverable D1.6v2.0 Page 24 І24 8 ANNEX I - EFSA Novel Food Pre-Dossier Template This annex provides a structured template summarising all required sections for preparing a novel food pre-dossier in line with Article 10 of Regulation (EU) 2015/2283 and Commission Implementing Regulation (EU) 2017/2469. Table 9. Structure and Content of the EFSA Novel Food Pre-Dossier Template Section title Content to include 1. Identity of the Novel Food Source, botanical origin, physical form, intended use, processing level. 2. Production Process Description of processing steps, control points, and standard operating procedures. 3. Compositional Data Analytical composition (macro and micronutrients, contaminants), batch analysis, method of analysis. 4. Specifications Chemical and microbiological limits; ranges and tolerances. 5. History of Use Prior use of the food or its source in the EU or third countries. 6. Proposed Uses, Use Levels & Anticipated Intake Target population, food categories, estimated daily intakes. 7. ADME (Absorption, Distribution, Metabolism and Excretion) Data on digestion, metabolism, and bioavailability. 8. Nutritional Information Impact on nutritional quality of diet. 9. Toxicological Information Genotoxicity, subchronic toxicity, allergenicity, human studies. 10. Allergenicity Potential allergenic reactions, comparison with known allergens. 11. Overall Risk Assessment Summary of safety conclusions, uncertainties, and data gaps.