Guidance on the scientific requirements for a notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283

Abstract

The European Commission requested EFSA to update the scientific guidance for the preparation of notifications for authorisation of traditional foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. This guidance document provides advice on the scientific information needed to be submitted by applicants when submitting traditional food notifications pursuant to Article 14 and traditional food applications pursuant to Article 16 of Regulation (EU) 2015/2283. The safety of a traditional food should be substantiated by data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. The applicant should integrate the information on the composition and the experience of continued use and provide a concise overall consideration on how this substantiates the history of safe use of the traditional food and how this relates to the proposed conditions of use for the EU. Potential health hazards identified on the basis of compositional data and/or data from the experience of continued use should be discussed. On the basis of the information provided, EFSA will assess the safety related to the consumption of the traditional food under the proposed conditions of use.

BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION IN 2015

On 25 November 2015, the European Parliament and the Council adopted the Regulation on novel foods. ¹

The Regulation requires that all applications for the authorisation of novel foods shall be submitted to the Commission who may then request a risk assessment from the European Food Safety Authority (EFSA). In assessing the safety of novel foods, EFSA shall, where appropriate, consider the following:

1. whether the food does not, on the basis of the scientific evidence available, pose a safety risk to human health;

2. a novel food, which is intended to replace another food, does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.

The Regulation also introduces a special procedure for safety assessment for traditional foods from third countries, based on a history of safe food use. In this case, a notification for the placing on the market of a traditional food from a third country is sent to the Commission who forwards the valid notification to all the Member States and EFSA. A Member State or EFSA may submit duly reasoned safety objections on the placing on the market of the notified food. In this latter case, the Commission will not authorise the placing on the market of the traditional food concerned. However, the applicant may submit an application following the requirements of Article 16 of the Regulation on novel foods, for which a safety evaluation will be requested from EFSA. In assessing the safety of novel foods, EFSA shall, where appropriate, consider the following:

• –whether the history of safe food use in a third country is substantiated by reliable data submitted by the applicant;
• –whether the composition of the food and the conditions of its use do not pose a safety risk to human health in the Union;
• –where the traditional food from the third country is intended to replace another food, whether it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.

The Commission also adopted implementing rules on administrative and scientific requirements for the preparation and the presentation of the applications for novel foods, as well as for the notifications and applications for traditional foods from third countries for the scientific assessment, respectively, in accordance with Article 13 and Article 20 of the Regulation. These implementing measures need to be complemented with scientific and technical guidance regarding the information that needs to be submitted by the applicants. In this context, the current Commission Recommendation 97/618/EC, ² which is in place for the additional safety assessment of the novel food applications under the current rules (Regulation (EC) No 258/973 ³ ), should serve as the basis for updating the guidance on preparation and presentation of applications for novel foods.

TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION IN 2015

In accordance with Article 29 of Regulation (EC) No 178/2002, the European Commission asks EFSA to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of novel foods, and to develop scientific and technical guidance for notifications and applications for authorisation of traditional foods from third countries.

BACKGROUND AND TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION IN 2020

The European Commission asked EFSA to update the ‘Guidance on the preparation and submission of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283’ ⁴ in order to align it to Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain ⁵ (hereinafter ‘Transparency Regulation’), which applies as of 27 March 2021.

The revision concerned only the administrative part concerning certain obligation on the part of the applicant and did not involve a request for an update on the scientific content.

BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION IN 2023

Following the adoption of Regulation (EU) 2015/2283 on novel foods, the Commission asked EFSA to develop scientific and technical guidance for notifications and applications for authorisation of traditional foods from third countries. EFSA adopted its guidance document on the preparation and presentation of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283 on 22 September 2016.

The EFSA guidance document identified the essential safety elements that need to be part of traditional food notifications and applications pursuant to Articles 14 and 16, respectively, of Regulation (EU) 2015/2283 to support their safety, and served as the basis for the implementation of Commission Implementing Regulation (EU) 2017/2468. ⁶ As this Regulation came into effect after the EFSA guidance was developed and implemented, there is a need to ensure full consistency between Regulation (EU) 2015/2283 and Implementing Regulation (EU) 2017/2468 to better assist and support applicants in the preparation of notifications/applications of traditional foods from third countries.

In addition, since the start of its implementation on 1 January 2018 when Regulation (EU) 2015/2283 came into effect considerable experience has been gained by EFSA in assessing traditional foods from third countries. Given the above, there is a need to update the EFSA guidance document on traditional foods from third countries to the state of the regulatory and scientific part so it can better serve its intended purpose to assist applicants in the preparation of notifications/applications of traditional foods from third countries, and the Member States and EFSA to evaluate and conclude on their safety.

TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION IN 2023

In accordance with Article 31 of Regulation (EC) No 178/2002, the European Commission asks the European Food Safety Authority to update the guidance document for notifications and applications for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283.

OBJECTIVES

This guidance is intended to explain the type and quality of scientific information EFSA needs to conclude whether or not the traditional food is safe under the proposed conditions of use. The scientific requirements for an application for a novel food are dealt with by a separate guidance document by the EFSA NDA Panel (EFSA NDA Panel, 2024).

The guidance will be kept under review and it will be further updated as appropriate in the light of experience gained from the evaluation of traditional foods from third countries or under any legal revision.

SCOPE

The guidance presented in this document is to assist applicants with the scientific requirements in preparing notifications for authorisation of traditional foods from third countries which fall under Article 14 of Regulation (EU) 2015/2283. This guidance is also applicable to applications for the authorisation of traditional foods from third countries under Article 16 of Regulation (EU) 2015/2283 concerning the data on the history of safe use in a third country. Where Article 16 applications under Regulation (EU) 2015/2283 concern data other than the history of safe food use in a third country, applicants are referred to the guidance on the scientific requirements for an application for authorisation of a novel food (EFSA NDA Panel, 2024).

Procedural aspects linked to the submission of a notification/application for authorisation of a traditional food in the context of Regulation (EU) 2015/2283 are not in the scope of this guidance document. Instead, applicants are advised to consult the EFSA Administrative guidance for the preparation of notifications and applications on traditional foods from third country in the context of Regulation (EU) 2015/2283 (EFSA, 2024), the EFSA Administrative guidance for the processing of applications for regulated products (EFSA, 2021a), and the EFSA Catalogue of support initiatives during the life‐cycle of applications for regulated products (EFSA, 2021c).

The present guidance, as well as the guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283, applies as of 1 February 2025.

DEFINITIONS

As per Article 3, paragraph 2 of Regulation (EU) 2015/2283 the following definitions apply:

1. ‘Novel food’ means any food that was not used for human consumption to a significant degree within the Union before 15 May 1997 irrespective of the dates of accession of Member States to the Union. In the context of a traditional food from a third country, the following novel foods categories may apply:

   • ii
     food consisting of, isolated from or produced from microorganisms, fungi or algae;
   • iv
     food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the Union and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by:

     • –
       traditional propagating practices which have been used for food production within the Union before 15 May 1997; or
     • –
       non‐traditional propagating practices which have not been used for food production within the Union before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances;
   • v
     food consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices which have been used for food production within the Union before 15 May 1997 and the food from those animals has a history of safe food use within the Union;
   • vi
     food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, microorganisms, fungi or algae;

2. ‘History of safe food use in a third country’ means that the safety of the food in question has been confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a significant number of people in at least one third country, prior to a notification referred to in Article 14;

3. ‘Traditional food from a third country’ means novel food as defined in point (a) of this paragraph, other than novel food as referred to in points (a) (i), (iii), (vii), (viii), (ix) and (x) thereof which is derived from primary production as defined in point 17 of Article 3 of Regulation (EC) No 178/2002 with a history of safe food use in a third country.

GENERAL PRINCIPLES

1. For information on the traditional food notifications procedure, applicants should consult the EFSA Administrative guidance for the preparation of notifications and applications on traditional foods from third country in the context of Regulation (EU) 2015/2283 (EFSA, 2024). The administrative guidance provides also a full description of the requirements introduced by the Transparency Regulation such as the notification of studies obligations [Article 32b of Regulation (EC) No 178/2022 (hereinafter General Food Law ⁷ )], the possibility to request General Pre‐submission advice (Article 32a of the General Food Law) and the provision of transparency and confidentiality (Articles 38 and 39 of the General Food Law).

2. Several EFSA scientific guidance documents may also be of relevance for the preparation of traditional food notifications and applications, especially those of the EFSA Scientific Committee. ⁸ Some of them are listed throughout the present document. Some EFSA guidance documents may be applicable only in specific cases. Over time, new guidance documents may be developed which may be of relevance for traditional food notifications and applications. Applicants are therefore advised to consult the EFSA webpage and consider the most up‐to‐date versions of the available and applicable guidance documents.

3. The term ‘notification’ is defined in Article 2 of Commission Implementing Regulation (EU) 2017/2468 as a stand‐alone dossier containing the information and the scientific data submitted under Article 14 of Regulation (EU) 2015/2283. It includes information on the history of safe use in a third country submitted for the safety assessment of the traditional food from third countries. The term ‘application’ is defined in Article 2 of Commission Implementing Regulation (EU) 2017/2468 as a stand‐alone dossier containing the information and the scientific data submitted under Article 16 of Regulation (EU) 2015/2283. It contains data submitted in the notification for the safety assessment of the traditional food from third countries (article 14 of Regulation (EU) 2015/2283), including the applicant's response to duly reasoned safety objections which were raised by EFSA and/or Member States during the evaluation of the notification submitted under Article 14 of Regulation (EU) 2015/2283. Hereafter, the term ‘dossier’ is used to denote notifications and applications.

4. As outlined in Regulation (EU) 2015/2283, the safety of a traditional food should be substantiated by reliable data on its composition and its experience of continued use for a period of at least 25 years in the customary diet of a significant number of people in at least one third country (i.e. ‘history of safe food use in a third country’), and its proposed conditions of use. Besides, its normal consumption should not be nutritionally disadvantageous. According to the Regulation, also the specifications of the traditional food and conditions of use must be provided. The structure of the dossier should follow the sections presented in this guidance.

5. Data pertinent to the safety of the traditional food must be identified and documented to demonstrate that the notification covers the complete information package available on the traditional food. Information on the search strategy, including the sources used to retrieve pertinent data (databases, other sources), the terms and limits used (e.g. publication dates, publication types, languages, population, default tags) should be provided. Where applicable, the published literature is to be reviewed taking into account systematic review principles (EFSA, 2010). Full study reports should be provided if available.

6. The applicant should provide their considerations at the end of individual sections on how the information supports the safety of the traditional food under the proposed conditions of use. Uncertainties must be addressed, and a critical appraisal of data both in favour and not in favour, of the safety of the traditional food is to be provided.

7. Deviations from the requirements specified in the respective sections of this guidance document must be justified.

8. Analyses/tests characterising the traditional food should be performed in a facility qualified for this purpose. Quality systems in place for control/documentation have to be indicated. Information on the accreditation of involved facilities and certificates of analyses should be provided. Whenever official guidelines (e.g. Organisation for Economic Co‐operation and Development (OECD), European Medicines Agency (EMA) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)and quality systems (e.g. good laboratory practice (GLP), good manufacturing practice (GMP), good clinical practice (GCP) and applicable International Organization for Standardization (ISO) systems) were followed, the applicant should indicate compliance.

1. IDENTITY OF THE TRADITIONAL FOOD

Information on the identity of the traditional food must be provided considering the requirements outlined in the subsections listed below. There may be cases where two or more subsections could be of relevance to a traditional food. In those circumstances, the respective information for all relevant subsections should be provided. The subsections below are to be distinguished from the categories outlined in Article 3 of Regulation (EU) 2015/2283, to which the applicant must assign their traditional food upon submission of the dossier.

The name of the traditional food in the notification submitted has to reflect its characteristic elements, e.g. its source, the main part(s) of organisms used, its form(s) (e.g. dried, frozen, powder), specific elements of the production process. Scientific names according to the most recent taxonomy or scientific nomenclature are to be included; commercial names, including trademarks, are to be avoided.

1.1. Chemical substances

This section concerns traditional foods which fall under one of the categories covered by Sections 1.2–1.5, and are derived from primary production and not from chemical synthesis. The requirements in this section apply to the traditional food which has been processed to consist of or to contain (a) substance(s) of higher purity or of particular interest. The requirements to be addressed in this section relate to those specific pure substance(s) in the traditional food.

The following information must be provided for traditional foods that are single chemical substances, and for each component when the traditional food is a simple mixture, i.e. a chemical mixture whose constituents can be fully characterised; in these cases, chemical composition and identity must be reported for each component as indicated below and in Section 3.2. Such information, in line with Section 3.3, is to be provided for complex mixtures and whole foods (where not all constituents can be fully chemically characterised and/or identified) for the containing chemical substances which are relevant for the identity and/or the safety of the traditional food.

• Chemical name, when appropriate, according to IUPAC nomenclature rules;

• CAS number, European Community (EC) Number – European Chemicals Agency (ECHA) and other relevant identification numbers (e.g. PubChem, E numbers, ChEBI, ChEMBL, Flavis, HMDB/FooDB, Lipidmaps, ChemSpider, IUBMB number), when available;

• Synonyms or common names, trade names, abbreviations;

• Molecular and structural formulae with stereochemistry;

• Molar mass (g/mol) / Molecular mass (Da);

• InChI (International Chemical Identifier) and InChIkey (digital representation of the InChI);

• Canonical SMILES and isomeric SMILES;

• Identity tests of the relevant constituents should be performed with the most relevant analytical techniques (e.g. chromatography, nuclear magnetic resonance, mass spectrometry, Fourier transform infrared spectroscopy(FT‐IR), ultraviolet spectroscopy (UV), optical rotation in the case of chiral compounds, X‐ray diffraction (XRD) data and/or melting point for solids and crystals);

• Particle size, shape and distribution if particles are present in the final product; ⁹

• Comparison with chemical standards, certified reference materials, authentic biological specimens, naturally occurring compounds or other relevant materials, when available.

1.2. Foods consisting of, isolated from or produced with microorganisms

The scientific requirements for the taxonomic and hazard identification of microorganisms intentionally used in the food chain (including bacteria, yeasts, filamentous fungi and microalgae/protists) depend on the particular role of the microorganism and the qualified presumption of safety (QPS) status.

In the context of traditional foods and for the purpose of this guidance, microorganisms can have different roles:

• traditional foods consisting of non‐genetically modified microorganism(s) (non‐GMMs) capable of multiplication are defined as ‘active agent(s)’.

• Traditional foods made from non‐GMMs in which the inactivated cells, not capable of multiplication and/or their genetic material may still be detected are defined as ‘biomass(es)’.

• Traditional foods produced with non‐GMMs in which these microorganism(s) are used in the manufacturing of the traditional food and defined as ‘production strain(s)’.

The EFSA QPS provides a safety pre‐assessment of microbial strains belonging to QPS taxonomic units (TUs). The lowest TU for which the QPS status is granted is the species level for bacteria, yeasts and microalgae/protists. Only unambiguously identified microbial strains belonging to QPS TUs can benefit from the risk assessment approach based on QPS. Safety concerns related to a QPS TU are reflected, when possible, as ‘qualifications’, which should be tested at strain and/or product level (EFSA BIOHAZ Panel, 2023).

Overall scientific requirements for the taxonomic and hazard identification of microorganisms as traditional foods (active agents and biomasses) or used in the production of traditional foods (production strains) are listed below (detailed description in Appendix A), including references to relevant EFSA guidance documents for additional information:

• Unambiguous taxonomic identification at species level and certificate of deposition (including accession number) of the microbial strain under assessment in an internationally recognised culture collection having acquired the status of International Depositary Authority following the Budapest Treaty (EFSA, 2021b; EFSA FEEDAP Panel, 2018);

• Characterisation of genes of potential concern, i.e. acquired antimicrobial resistance (AMR) genes of clinical relevance, toxigenicity and pathogenicity traits (EFSA, 2021b; EFSA BIOHAZ Panel, 2023; EFSA FEEDAP Panel, 2018);

• Assessment of the capacity of the microbial strain to produce antimicrobials of clinical relevance, unless a QPS TU or a TU known not to produce those antimicrobials (EFSA FEEDAP Panel, 2018);

• Whole genome sequence (WGS) data according to the most up‐to‐date versions of the available and applicable EFSA scientific outputs (e.g. EFSA, 2021b).

Additionally, the presence of viable cells in the traditional food has to be analysed for (i) biomasses and non‐QPS TUs as traditional foods, (ii) QPS TUs with the qualification ‘for production purposes only’, and (iii) non‐QPS production strains (additional requirements in Section 3.1 of EFSA FEEDAP Panel, 2018).

The presence of DNA from the production strain in the traditional food has to be analysed for production strains carrying acquired AMR genes of clinical relevance (additional requirements in Section 3.2 of EFSA FEEDAP Panel, 2018).

1.3. Food consisting of, isolated from or produced from plants, macroscopic fungi and macroalgae or their parts

The following information must be provided in the case of traditional foods consisting of, isolated from or produced from plants, ¹⁰ macroscopic fungi and macroalgae (i.e. seaweed) or their parts. In case of a mixture of source organisms, the information is to be reported for each source and the mass percentages of each source in the mixture must be specified.

• Scientific (Latin) name and taxonomy (family, genus, species and if applicable subspecies, variety with author's name, chemotype, strain) according to the international codes of nomenclature for plants ¹¹ and for macroscopic fungi and macroalgae; ¹²

• Accepted synonyms;

• Trivial or common names used to identify the traditional food intended to be marketed;

• For plants, experimental verification of the identity of the plant (e.g. authentic plant specimen deposit in a recognised herbarium, macroscopic/microscopic verification with comparison to an authentic standard, chemical fingerprint compared to standard, DNA‐based authentication);

• For macroscopic fungi and macroalgae, verification of the identity according to internationally recognised databases and methodology and, if available, deposition in an internationally recognised culture collection with access number;

• Part(s) used (e.g. flower, seed, root);

• Growing region(s) of the source organism (continent, country, region) and, when relevant, season of harvesting;

• Growing conditions to produce the source organism (i.e. cultivated or from the wild, conditions of cultivation);

• Non‐GMO ¹³ statement from the applicant accompanied by information on the source material.

1.4. Food consisting of, isolated from or produced from animals or their parts

The following information is to be provided for traditional foods isolated from or produced from animals or their parts:

• Scientific (Latin) name (family, genus, species, subspecies, breed, if applicable);

• Accepted synonyms;

• Trivial or common names used to identify the traditional food intended to be marketed;

• Verification of the identity (e.g. certification, DNA‐based authentication);

• Suitability of the animal sources for human consumption according to Commission Regulation (EU) No 2015/1162; ¹⁴

• Compliance with Regulation (EU) 2017/625 ¹⁵ on official controls and other official activities and, where applicable, with Regulation (EC) No 853/2004 ¹⁶ on specific hygiene rules for food of animal origin;

• Health status of the source animal, age, access to herd/lot health certification;

• Part(s) used (e.g. organ(s) or tissue(s));

• Geographical origin (continent, country, region), farming and husbandry conditions;

• Origin of the initial livestock (e.g. national repository). In case the source of the traditional food is provided by external vendors, supporting documents should be provided;

• Non‐GMO statement from the applicant accompanied by information on the source material.

1.5. Food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, macroscopic fungi or macroalgae

This section concerns cell/tissue cultures derived from multicellular origin (animals, plants including macroscopic fungi and macroalgae). For foods consisting of, isolated from or produced from cell cultures derived from microorganisms (including bacteria, yeasts, filamentous fungi and microalgae/protists) reference is made to the scientific requirements laid down in Section 1.2. The traditional foods defined under this category can be the harvested cells, the biomass or the further processed biomass obtained from cell or tissue culture.

1.5.1. Foods consisting of, isolated from or produced from cell culture or tissue culture derived from animals

• Identity of the source organism as per the relevant requirements in Section 1.4, including Information to attest that the primary cells and tissues used for the preparation of the traditional food comply with inspection requirements laid down in that section;

• When using established cell lines: genetic and phenotypic identity and stability of cells;

• When using primary cells: biopsy location or source material, cell type(s) isolated, genetic and phenotypic identity of cells;

• Information to attest the absence of any risks of infectivity from viruses or other zoonotic agents e.g. testing for viruses (species‐specific viruses), testing for prions in the case of limited health information on source animals.

1.5.2. Foods consisting of, isolated from or produced from cell culture or tissue culture derived from plants, macroscopic fungi or macroalgae

• Identity of the source organism as per the relevant requirements in Section 1.3;

• Laboratory or culture collection sourced;

• Identity of the cells or cell lines: part(s) of the organism sourced, cell type isolated, genetic and phenotypic identity, genetic and phenotypic stability of the cell lines.

2. PRODUCTION PROCESS

The process(es) employed to produce the traditional food should be comprehensively described. The description of the production process must be detailed enough to ensure understanding of the critical parameters and steps involved, enabling the identification of all potential food safety hazards. This information will form the basis for evaluating the composition, specifications, nutritional value and safety of the traditional food.

The applicant should describe how the traditional food was or is being traditionally produced in the third country (i.e. steps and conditions applied). The applicant should document with published and/or unpublished information the traditional production process(es).

Since the assessment of traditional food as intended to be marketed in the EU gives substantial weight to the ‘history of consumption’ of the traditional food, the production process(es) used to produce the traditional food should be essentially the same as the traditional production process(es) used in the concerned third country(ies). EFSA acknowledges that the production process(es) of the traditional food as intended to be placed on the EU market might differ from the traditional way of production. Where deviations from the traditional manufacturing occur, the applicant should identify such changes and describe the process(es) actually to be applied to produce the traditional food (e.g. cultivation, harvesting, roasting, extraction, fermentation or isolation from a natural source, etc.) following the requirements outlined below. In such cases, the applicant should assess whether and document how these changes may impact the composition, nutritional value and safety of the traditional food.

2.1. General provisions

Information on all input materials used in the manufacturing process of the traditional food should be presented in a tabulated format, including their functional role and their regulatory status in the EU (Appendix B). Additionally, information on the specification and quality of the input/raw materials and fermentation aids has to be provided. ¹⁷ Moreover, for every material in contact with food during the production process (e.g. plastic containers), a declaration of compliance as laid down by Regulation (EC) No 1935/2004 ¹⁸ and any other relevant EU provisions should be provided. Considering all steps during the production process, the production yield, i.e. the resulting amount of a traditional food from its raw materials, should be calculated, providing also the ‘processing factors’, ¹⁹ when applicable. Regarding safety, the description must include information on potential by‐products, impurities or contaminants. Formation of processing contaminants should be also considered based on the processes applied and a description of the parameters that may lead to the formation of a given processing contaminant should be included.

The implementation of food safety management systems in place to produce the traditional food should cover procedures based on the hazard analysis critical control point (HACCP) principles in line with Regulation (EC) No 852/2004 on the hygiene of foodstuffs. ²⁰ Operational limits and key parameters of the production process should be given. Measures implemented for production control and quality and safety assurance should be described (e.g. HACCP, GMP, ISO). These procedures should be detailed, including critical control points, operational prerequisite programmes, monitored parameters, corrective actions, verification procedures, frequency of analysis, analytical methods, etc. A production flow chart should be provided, including quality and safety control checks. Standardisation criteria (e.g. markers for the traditional food) should be provided.

If the description on the production process contains information for which a confidentiality request has been submitted, pursuant to Articles 39 to 39e of Regulation (EC) No 178/2002 and EFSA's Practical Arrangements concerning transparency and confidentiality (EFSA, 2021c), a non‐confidential summary of the production process should also be provided, including all steps of the process with a general description of the operational conditions and safety‐related parameters.

2.2. Considerations for specific production process steps

Information must also be provided on the handling of the sources, for example, the propagation, growth and harvesting conditions for plants and fungi (e.g. wild or cultivated, type of cultivation and cultivation practices, composition of fertilisers used, time of harvest in relation to both season and stage of the plant growth); the cultivation conditions for aquacultures (e.g. measures in place to ensure water quality, temperature, length of growth in the water, composition of fertilisers used); the breeding, rearing, feeding and farming conditions along with the description of feed and certificates of feed compliance with EU Regulations for farmed animals or the hunting, catching or collecting and killing of wild living animals; the culture conditions for microorganisms and algae, and cell culture or tissue culture from plants and animals. The parts of the organism used as a raw material must be specified and information on other starting substances or materials should be provided. The description of the cultivation of plants, fungi, macroalgae and microorganisms and the rearing of animals should also include information on the use of pesticides, hormones, veterinary drugs, antimicrobials and antiparasitic agents or feed additives. Biological agents (e.g. parasites, bacteria, endophytes, viruses, prions) that can infect organisms or tissue cultures used to produce the traditional food or be hosted by these organisms (animals, plants, fungi, macroalgae and microorganisms) should be considered in the assessment. Information and measures in place to mitigate the respective risks should be provided and the impact of these agents on human health should be discussed.

Post‐harvest handling, e.g. transport, drying techniques and storage conditions (duration, light, moisture and temperature) of unprocessed foods and the raw materials for further processing should be described.

When food enzymes are used as processing aids for the production of the traditional food, the presence or absence of the enzymes in the traditional food has to be demonstrated experimentally in at least three representative batches of the traditional food that have been independently produced (preferably with independent batches of raw materials). If the enzyme is present in the traditional food, the enzymatic activity and potential residual activity should be reported in at least three representative batches of the traditional food that have been independently produced (EFSA CEP Panel, 2021). If the enzyme has been inactivated or removed, the processes and operational conditions in place for the inactivation/removal are to be provided. Removal or inactivation of the enzyme should be demonstrated in case of safety concerns. The safety of the food enzyme(s) used in the manufacture of the traditional food is subject to the provisions of Regulation (EC) No 1332/2008 ²¹ and therefore, it is outside the scope of this guidance, which concerns the assessment of the safety of the traditional food according to the provisions of Regulation (EU) 2015/2283. Therefore, the applicant is requested to provide information about the status of the enzyme(s) according to Regulation (EC) No 1332/2008. Food enzymes used in the production of traditional food should preferably have been already assessed with a positive outcome by the EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel, 2021). In case the food enzymes have not been assessed or the risk assessment is still in progress, additional data could be requested to establish the safety of the traditional food (EFSA CEP Panel, 2021). For enzymes of microbial origin, the requested data will be in line with the scientific criteria outlined in relevant EFSA guidance documents (EFSA, 2021b; EFSA CEP Panel, 2021; EFSA FEEDAP Panel, 2018). The assessment of the traditional food will be without prejudice to the safety assessment of the food enzyme per se.

With regard to the use of food additives in the production of a traditional food, it should be noted that such additives must be authorised and listed with conditions of use in the EU's positive list based on Regulation (EC) No 1333/2008. ²² Any unauthorised additives cannot be used.

2.3. Considerations for specific traditional food categories

Regarding production processes employing microorganisms, the techniques used to remove/inactivate microbial cells during downstream processing should be described in detail, with full provision of operational conditions (e.g. time, temperature, kinetics, etc.). In case of a traditional food consisting of viable cells, information on the techniques/methods and operational conditions used to ensure microbial viability must also be reported. The applicant should investigate, and report whether the specific production conditions of the traditional food (e.g. due to processing aids or component of the media) may trigger the formation of toxic compounds by microorganisms.

For traditional foods consisting of, isolated from or produced from plants, macroscopic fungi, macroalgae or animals, a detailed description of the process(es) by which the raw material is converted into an ingredient or a food product, must be provided. Examples may include e.g. heat treatment, extraction, distillation, fractionation, purification, concentration, fermentation or other procedure(s). Information on substances used in the manufacturing process, e.g. identity and purity of the extraction solvents, ratio of extraction solvent to the material, reagents, additives, residues remaining in the final product and any special precautions (e.g. protection from light and controlled temperature) should be provided.

For foods consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, macroscopic fungi or macroalgae, information is to be provided on the type of cells used as source (e.g. primary cells or established cell lines). In case primary cells are used, information on the source, purification steps, cell isolation, cell selection, cell subculture, absence of pathogens and microbial contaminants is to be provided. If cells from established cell lines are used, information must be provided on the source, the cell line preparation, the cell banking process, as well as the passage number of aliquot of cells used. Description of any changes made to the cells used (e.g. selection, differentiation, immortalisation, adaptations, reprogramming), and the link of such changes with the production of substances of possible concern must be included. All processes applied for the treatment, extraction, screening and selection of cell lines or tissues must be provided in detail including all chemicals and biological materials used, and including the impurities that may result from their use. The genetic stability of the cells throughout the production process should be investigated by comparison of the starting material (i.e. initially selected cells from biopsy/cell line) and the cells at different steps of the production process (e.g. propagation step). Also changes of the morphology, markers of differentiation and other phenotypic features of the cells at the start and at the end of the production process should be investigated and described. Information on the compliance with Good Cell Culture Practices ²³ should be provided, as well as on the compliance with applicable relevant standards, such as those outlined in the EMA Guidance document on the derivation and characterisation of cell substrates used for production of biotechnological/biological products. ²⁴ The safety of growth factors of microbial origin (e.g. vitamins, amino acids) used in the production of, e.g. traditional foods consisting of, isolated from or produced from cell culture or tissue culture will be assessed to establish the safety of the traditional food, taking into consideration the scientific requirements for the taxonomic and hazard identification of microorganisms intentionally used in the food chain, as listed in Section 1.2 and Appendix A according to relevant EFSA guidance documents (EFSA, 2021b; EFSA FEEDAP Panel, 2018).

2.4. Additional considerations

In case the traditional food dossier contains analytical data on traditional food batches manufactured by different producers (e.g. the application is submitted by a consortium of producers) or by processes involving steps that can be different (e.g. drying the raw material using various methods), such differences shall be described, equivalency substantiated and consistency in production methods among different producers/processes demonstrated. Food safety management systems (e.g. HACCP plan) should be provided from all producers/processes covering the entire production process. The variability of the supplying starting materials is to be investigated and be covered by the analytical data provided. Any changes to the production process during the risk assessment must be notified to EFSA by the applicant.

3. COMPOSITIONAL DATA

Compositional data serve as a tool to characterise the traditional food and its constituents, encompassing both qualitative and quantitative information on the chemical, physicochemical, microbiological and nutritional attributes of the traditional food. They should facilitate an in‐depth exploration of the compositional characteristics of the traditional food, linked to its source and employed production process. Variability of compositional data between different batches should be analysed and discussed, towards investigating the ability of the food business operator to produce the traditional food in a consistent and reproducible manner, while being the basis for hazard identification and establishment of the specification parameters. Section 3.1 outlines the general data requirements applicable to all traditional foods, while Sections 3.2 and 3.3 set specific requirements, depending on whether the traditional food is a single substance or a simple mixture, a complex mixture or a whole food. ²⁵

The applicant should also provide compositional data from publications on the variability of the traditional food, when available. The applicant should provide, in a tabulated format, including the references of the publications, the range of the values of the parameters analysed in the batches of the traditional food, and those reported in the retrieved publications (Appendix C). If there are significant differences in the composition of the analysed batches of the traditional food as compared to the data retrieved in the literature, the applicant should describe and discuss these differences.

In case changes have been introduced in the process employed to produce the traditional food intended to be placed on the EU market as compared to the traditional production process, the applicant should compare the compositional profile (including new substances potentially resulting from the modification of the production process) of the traditional food produced with the applied production process versus the traditional process. The applicant should discuss how the changes in the compositional profile may impact the nutritional value and/or the safety of the traditional food.

3.1. General requirements

3.1.1. Analytical methods

Validated methods, preferably nationally or internationally recognised (e.g. Association of Official Analytical Chemists, European Pharmacopoeia, International Organization for Standardization, European Committee for Standardization) should be used for the analyses. The respective methods of analysis should be described alongside their references. The limits of detection (LOD) and quantification (LOQ) should be mentioned. Certificates of analyses and information on the matrix accreditation ²⁶ and the scope of accreditation of the laboratories should be provided. If in‐house methods are employed, the analytical protocols implemented should be fully described and the results of the respective method validation procedures should be provided. If an analytical method is used for a food matrix beyond the scope ²⁷ of accreditation/standardisation, it should be treated as in‐house method (the same applies in cases that standard methods are modified). If the analyses are not performed in accredited laboratories, a justification should be provided. A table with all the analytical methods employed and the corresponding analytes should be provided. The table should include the name of the method, the reference, the main analytical technique(s) employed, as well as the respective LOD and LOQ.

3.1.2. Addressing compositional variability

Compositional data and their variability should support the setting of specifications of the traditional food ²⁸ (Section 4). The analytical information should be provided on at least five representative batches of the traditional food that have been independently produced (preferably with independent batches of raw materials), ²⁹ unless a different number of batches is explicitly requested in this guidance. The analyses should preferably be performed on the same group of batches, to obtain a comprehensive picture of their composition. It is expected that the analysed batches are produced either at an industrial production scale or at one representative of it. Representativeness shall be justified. The examined batches should be sampled in a manner adequate to address potential compositional variations (e.g. seasonal) of the raw materials. Additional batches of the traditional food may also be needed to explore the variability of potentially hazardous substances present in the traditional food or its source. When several production processes are proposed, such data should be provided for each process. Moreover, compositional data should also cover the whole variability spectrum of the production process parameters (e.g. highest and lowest amount of solvents used, range of temperatures applied). The compositional variability should be discussed, highlighting the reasons for the variation in results. If the notification pertains to various forms of the traditional food (e.g. dried, frozen, powder), all analyses must be conducted on at least five representative batches of each form, produced independently. Any deviations from this requirement must be justified.

Analytical data from publications can also be used if the publications provide sufficient information on the laboratory where analyses have been carried out, the methods utilised and if the studies were performed with representative samples of the traditional food. Available published data can also contribute to providing information on the variability of the composition of the traditional food.

3.1.3. Sampling practices

Principles of representative sampling should be considered (e.g. sample size, containers, conditions), and the rationale on why the employed sampling plan is considered representative should be provided. Information on any relevant existing legally defined or standard sampling protocols should be considered and provided. On each certificate of analysis, the name as well as the dates of production and analysis of the batch must be stated.

3.1.4. Compositional analytes

Information on the identity and the quantity of impurities or by‐products, residues and chemical and microbiological contaminants should be provided (e.g. heavy metals, mycotoxins, PCBs/dioxins, pesticides, microbial indicators and pathogens). The potential target analytes should be selected considering the sources and the production process, regulatory levels as well as the information available in the scientific literature. For example, for substances obtained by chemical synthesis, residual starting materials and by‐products anticipated from side‐reactions should be analysed; for substances produced by microbial fermentation, the presence of metabolites of safety concern should be investigated; for substances isolated by extraction, data on residual solvents should be provided.

If the publications retrieved by the applicant indicate the potential presence of substances of toxicological concern (e.g. toxins, pathogens, antinutrients, contaminants) in the traditional food or its source, the applicant should provide quantitative data on those substances in the batches of the traditional food, obtained using internationally recognised/validated analytical methods.

Considering their nature and in order to avoid unnecessary testing, some categories of traditional foods do not require a priori nano‐specific risk assessment, e.g. (i) microorganisms (e.g. bacteria, yeasts, fungi, microalgae), (ii) unmodified proteins (including enzymes) and amino acids, (iii) whole foods (e.g. seeds, fruits, insects). Therefore, if the manufacturing process does not include any step that may lead to the presence of small particles, and if it can be demonstrated that a traditional food falls under one of the above or similar categories, the traditional food may qualify for exemption from the characterisation and/or demonstration of the absence of small particles (as defined in EFSA Scientific Committee (2021b)).

3.2. Single substances and simple mixtures thereof

Simple mixtures are mixtures whose components can be fully chemically characterised. For simple mixtures of defined substances, information on the identities and the relative ratios of all components should be provided. This should allow the elaboration of a mass balance. For single substances and substances in simple mixtures, the identity‐relevant analytical data outlined in Section 1.1 should be provided.

3.3. Complex mixtures and whole foods

Complex mixtures (e.g. extracts, protein hydrolysates, active agents, biomasses) and whole foods (e.g. milk, meat, fruits, seeds, insects) are defined as those traditional foods where not all constituents can be fully characterised and/or identified.

A qualitative and quantitative characterisation of the main constituents is to be performed, at least via sum parameters. For whole foods, this should include proximate analyses (i.e. ash, moisture, protein, fat, carbohydrates). On the basis of these data, a mass balance should be calculated. The amount of unidentified components should be indicated and should be as low as possible.

For the classes of naturally or chemically derived components which characterise the traditional food (e.g. amino acids, peptides, phospholipids, carotenoids, phenolics, sterols), comprehensive qualitative and quantitative data should be provided.

Qualitative and quantitative data on nutritionally relevant inherent constituents such as micronutrients, antinutrients ³⁰ and dietary fibre ³¹ should be provided.

Information on the occurrence and occurrence levels of inherent substances of possible concern to human health (e.g. toxic, allergenic) should be provided. The impact of processing on the compositional profile of the traditional food (e.g. occurrence of heat‐induced processing contaminants) should also be considered.

When constituents (e.g. micronutrients, antinutrients or substances of toxicological concern) may impact on safety or be potentially nutritionally disadvantageous, the applicant should compare the content of those constituents in the traditional food with their contents in comparable food(s) currently consumed in the EU. In such cases, exposure estimates may be needed for the concerned substance(s) coming from the traditional food and the comparator(s). The applicant should justify the selection of the comparator(s). Ideally but not necessarily, a comparator should be a food that can reasonably reflect the anticipated consumption pattern of the traditional food. If the applicant considers that no appropriate comparator is available, this should be justified.

In addition to the batch‐to‐batch analysis, a comprehensive literature search should be performed according to the methodology developed by (EFSA, 2010) to retrieve published compositional data (chemical, physicochemical and microbiological) for the source and the part(s) used in/as traditional food, as well as for compositional aspects linked to the production process. Information on the used keywords and applied inclusion/exclusion criteria for the literature search should be provided. Considering the retrieved information, the applicant should provide a rationale on the compositional analysis strategy followed.

Any substances of concern (e.g. toxins, heavy metals) potentially present in the starting materials should be analysed in the traditional food. Particular attention should be given to the possible presence of genotoxic and/or carcinogenic substances.

For plants, levels at which the constituents are present in the respective part of the botanical or botanical preparation should be given where available. It is recommended that chemical fingerprinting of the botanical material is undertaken for this purpose.

The following non‐exhaustive list of tools can help identifying the possible substances of concern in a botanical material:

• The EFSA Compendium of Botanicals, ^{32 , 33} which provides information on naturally occurring substances that may be of concern for human health (EFSA, 2012),

• The EFSA Chemical Hazard Database (OpenFoodTox). ³⁴

The EFSA Scientific Committee has identified potential hazards related to the use of farmed insects as food (EFSA Scientific Committee, 2015). These should be considered in notifications for traditional foods which consist of, are isolated from, or are produced from farmed insects, considering the species and substrates to be used, as well as methods for farming and processing.

For active agents and biomasses, the respective concentration of viable cells and non‐viable cells in the traditional food should be reported.

3.4. Stability testing

3.4.1. Stability of the traditional food

The stability of the traditional food has to be evaluated to ensure both the compositional integrity and the safety of the traditional food. Hazards that might arise during storage and transport must be identified and the nature of degradation products should be characterised.

Stability tests should consider compositional qualifiers, as well as constituents and parameters of the traditional food which may be susceptible to changes during storage and which may affect its safety and/or its identity or serve as indicators for alterations that could have an impact on the safety and/or the integrity of the traditional food. The rationale for the parameters selected to be monitored during the stability testing, as well as for those parameters disregarded as not relevant, should be provided.

Depending on the nature, production process and composition of the traditional food, the testing is to address the chemical, physicochemical and microbiological stability of the traditional food under the intended conditions of storage, taking into account the effect of packaging and the storage environmental parameters (temperature, light exposure, oxygen, moisture, relative humidity). Information on the intended storage conditions, including the proposed shelf‐life, of the traditional food must be provided as well as on the conditions under which the stability testing was performed. The stability testing has to be provided on at least five representative batches of the traditional food that have been independently produced (preferably with independent batches of raw materials). When the notification pertains to various forms of the traditional food (e.g. dried, frozen, powder), such data should be provided for each form. Any deviations from this requirement must be justified. Testing of a lower number of batches should be justified by scientific arguments. The traditional food batches selected to be monitored at the beginning of the stability testing have to be those monitored for the whole duration of the stability testing. The stability testing results can be taken into consideration when establishing the limits of relevant specification parameters. On the other hand, compliance of the traditional food with the specification parameters throughout the proposed shelf‐life should be demonstrated.

The monitoring period of the stability test has to cover at least the end of the proposed shelf‐life. Intermediate intervals of testing must be considered, depending on the nature of the traditional food, its composition, as well as the intended shelf‐life. Although it is advisable to submit stability testing studies under intended conditions of storage, accelerated conditions may be used as an alternative. Such approaches, usually conducted at higher temperature, could be applicable only in cases where chemical parameters are monitored. In cases where results from accelerated conditions are extrapolated to predict results under the intended storage conditions, scientific evidence must be provided to justify the validity of this extrapolation. Information on ingredients added to the traditional food to improve its stability has to be provided.

3.4.2. Impact of processing on the traditional food in the proposed‐for‐use matrices

If the traditional food is used as an ingredient added to other foods the manufacture of which requires further processing (e.g. heating), the impact on the traditional food of this processing is to be investigated. Also alterations in the processed foods due to the presence of the traditional food should be investigated in foods or in relevant model systems (mimicking the food matrix and the respective processing conditions), taking also into consideration at least the extremes of the possible processing conditions (e.g. highest temperature to which the traditional food will be exposed when used as a food ingredient, lowest and highest pH) as resulting from the proposed uses (Section 6.2). More specifically, it should be investigated what happens to relevant components of the traditional food, when it is used as a food ingredient. Interactions with other constituents in the processed foods and the formation of processing contaminants should be investigated. The use of proper controls (e.g. the product manufactured with the same process/recipe without containing the traditional food as ingredient) is necessary.

Moreover, when the traditional food is subject to further processing that differs from the conventionally applied processing methods, any hazards potentially arising are to be identified and characterised.

4. SPECIFICATIONS

Specifications comprise chemical, physicochemical, nutritional and microbiological parameters that characterise and substantiate the identity and safety of the traditional food, including the respective numerical ranges or limits.

Specifications serve as a tool for risk managers, i.e. the European Commission and Member States, who decide which of the proposed specification parameters and respective limits will be considered for inclusion and updating of the Union list of novel foods ³⁵ in accordance with Article 9 of Regulation (EU) 2015/2283, when a traditional food is granted marketing authorisation. Given that risk managers may consider not only compositional aspects, applicants should propose also a brief but comprehensive description of the traditional food, incorporating identity parameters such as the name of the source or relevant parts thereof, and the microbial strain used as traditional food or in the production of traditional foods. It is also advisable to provide key descriptors related to the production process.

Applicants must provide a comprehensive set of compositional specification parameters in a tabulated format. Depending on the identity and composition of the traditional food, the table should include the following:

• proximate analytes (protein, lipids, carbohydrates, ash and moisture),

• the major groups of constituents within the food,

• more characteristic components (e.g. carotenoids, polyphenols, terpenes, alkenyl benzenes, lignin, saponins, chitin, micronutrients, number of viable/non‐viable microorganisms),

• parameters relevant for the safety of the traditional food at the proposed uses and use levels, (e.g. toxins, alkaloids, phytic acid and other antinutrients, heavy metals, pathogens, impurities or degradation products from the production process),

• parameters related to the quality and/or stability that may have an impact on the safety of the traditional food (e.g. markers of lipid oxidation, microbial hygiene indicators or water activity).

The rationale for each proposed specification parameter and respective limits has to be provided.

The table must include minimum and/or maximum specification limits for each selected parameter. The specifications, including their limits, should be supported by the available information on the chemical, physicochemical and microbiological composition of the traditional food including the results from the available batch‐to‐batch analysis and the stability testing. They should be verifiable by means of the analytical techniques as indicated in Section 3. Information on the employed analytical techniques and their sensitivity (LOD/LOQ) should be provided.

In general, the proposed maximum specification limits for undesirable substances should be as low as possible. Existing health‐based guidance values (HBGV) for substances of potential toxicological concern, but also dietary reference values (DRV) including tolerable upper intake levels (UL) for micronutrients and exposure estimates to such compounds, should be considered when proposing the maximum specification limits. Minimum specification limits for nutrients may be necessary to ensure that a minimum level is present in the traditional food, especially when a traditional food represents a potential alternative or is intended to replace an existing food on the market, which provides a relevant contribution to the intake of certain nutrients. If EU regulatory limits are applicable for the traditional food, then they do not necessarily have to be listed in the specifications.

5. DATA FROM EXPERIENCE OF CONTINUED USE OF THE TRADITIONAL FOOD IN THIRD COUNTRIES

This section should provide all available data from the experience of continued use which are pertinent to the safety assessment of the traditional food.

The supporting documentation on the experience of the continued food use should provide a description of the extent of use of the traditional food, the population group for which the traditional food has been a part of their diet, information on its preparation and handling, its role in the diet and the precautions consumers apply. A comprehensive literature review of human studies and reports related to the consumption of the traditional food should be performed. Information on the search strategy, including the sources used to retrieve pertinent data (databases, other sources), the terms and limits used (e.g. publication dates, publication types, languages, population, default tags) should be reported. The published literature should be reviewed by considering systematic review principles indicated by EFSA (2010). When searching for ‘grey literature’, EFSA's principles (2010) should also be adhered to. Full study reports of human studies should be provided if available.

The type of references could include scientific publications, scientific expert opinions, monographs, information from international or national organisations, governmental documentation, figures on cultivation/harvesting and sales and trade. Additional information may be provided from cookbooks, recipes and anecdotal data.

The documentation provided should relate to the traditional food as it is intended to be placed on the EU market.

The applicant should present the data supporting the experience of continued use of the traditional food in third countries in a tabulated format (Appendix D).

5.1. Extent of use

The applicant should characterise the extent of use of the traditional food by documenting:

• the place of production and volume of the traditional food produced per year in the third country or countries;

• the geographical areas (e.g. region, country, continent) where it has been or is being consumed;

• If available, the quantity of consumption, information on the serving size(s), average, high and if available maximum intake levels per person should be provided. If available, intake estimates based on food consumption surveys or other estimates should be provided;

• for botanicals, clear distinction should be made between the intakes of a part of a botanical as such and preparations made of it (e.g. a herbal tea prepared from the traditional food, an essential oil prepared from the traditional food);

• the duration and continuity of its use over time.

5.2. Characteristics of the population group(s) of consumers

Documentation should be provided on whether the traditional food has been consumed by the general population or whether its consumption was rather or entirely limited to specific subpopulations defined by, for example, their age, sex, ethnicity, physiological and/or disease conditions. Information on the size of the population or population groups which have consumed the traditional food should be provided.

5.3. Role in the diet

Documentation should be provided on the consumption pattern, including the frequency, the context of the consumption (e.g. for specific purposes, ceremonies, combined consumption with other foods), the type of dish or meal for which the traditional food is used (e.g. as a snack, main dish, ingredient or spice for specified foods or meals). Information on the contribution of the traditional food to the overall macro‐ and micronutrient intake of the population should be provided.

5.4. Information on the handling and preparation of the traditional food

This section should provide documentation concerning the handling, including storage and the preparation of the traditional food prior to its consumption, e.g. breakup or milling, peeling, removing or making use of only specific parts of the food, any kind of heat treatment (cooking method) or any other type of treatment.

5.5. Precautions for the preparation and restrictions of use of the traditional food

The applicant should provide information on any precautions that have been traditionally applied during the preparation of the traditional food, any kind of treatment or methods that may be deemed to reduce levels of toxic, allergenic or antinutritional substances or to improve digestibility, as well as information on reported limitations and restrictions for sensitive/specific population groups. Information on prohibitions or restrictions of use imposed to the traditional food in the third countries should be provided, if applicable.

5.6. Human data

The applicant should provide a comprehensive literature search to retrieve human data related to the safety of the traditional food (e.g. absorption, nutritional, microbiological and allergenic aspects, tolerability, interaction with medicines). Human data could include human intervention and observational studies, case reports and information from surveillance reports.

The applicant should not only consider and limit their literature search to the traditional food itself, but should also consider searching for studies with specific and typical components of the traditional food and for studies with similar foods from the same or other closely related sources (e.g. other varieties or subspecies or related species of the same genus or the same family).

5.7. Other information

If toxicological studies (e.g. in vitro studies, genotoxicity studies, 90‐day repeated dose studies) relevant for the safety assessment of the traditional food and/or for the safety assessment of constituents in the traditional food are available in the literature, they should be provided. Publications on studies which could indicate allergenic potential of the traditional food (e.g. in silico, in vitro, in vivo, human studies including case reports, cross‐reactivity studies) should be provided. Publications on non‐food uses should also be provided if relevant (e.g. cosmetic, feed studies).

6. PROPOSED CONDITIONS OF USE FOR THE EU MARKET

A rationale for the target population, proposed uses and use levels, precautions and restrictions of use of the traditional food as intended to be placed on the EU market should be provided with cross‐referencing to the relevant data on the ‘history of safe food use’ of the traditional food in a third country.

6.1. Target population

The applicant should unambiguously specify the intended target population. Where it cannot be excluded that a traditional food intended for a particular group of the population would be also consumed by other groups of the population (e.g. a traditional food added as ingredient to foods or to be consumed as a whole food), the safety data provided shall also cover those groups in accordance with Article 5(6) of Commission Implementing Regulation (EU) 2017/2469.

6.2. Proposed uses and use levels

The applicant should specify the intended uses of the traditional food (e.g. as a whole food, ingredient).

If the traditional food is intended to be added as an ingredient to foods, the applicant should provide the following information in a tabulated format:

1. the food categories in which the traditional food is proposed to be added. Food categories can be specified according to the EFSA Food Additive Intake Model (FAIM) tool ³⁶ or the Dietary Exposure (DietEx) tool. ³⁷ All intended uses should be expressed with the use of a unique classification system (i.e. either FAIM tool categories or DietEx tool categories). Codes and names of the proposed food categories should be provided (see examples in Tables 1 and 2);

2. when selecting the FAIM tool categories, please refer to the instructions available on the web site ³⁸ particularly in relation to the unspecified food categories displayed in the FAIM tool;

3. when using DietEx tool, the applicant is advised to use broad food categories instead of overly specific ones (e.g. yoghurts in general rather than certain types of yoghurts; biscuits in general rather than certain types of biscuits).;

4. the proposed maximum use levels (i.e. maximum amounts/concentrations) of the traditional food in each food categories as consumed (e.g. expressed as mg/kg or mg/100 g or mg/100 mL);

5. if the traditional food is proposed in different forms (e.g. dried, frozen, powder), the food categories and maximum use levels should be proposed for each form of the traditional food as requested in the points above. It should be specified whether the different forms of the traditional food are meant to be utilised singularly and/or in combination in a specific food category.

TABLE 1.

Proposed uses and use levels according to the FAIM tool.

FAIM tool code	FAIM tool category	Maximum level
01.7.2	Ripened cheese	100 mg/kg

TABLE 2.

Proposed uses and use levels according to the DietEx tool.

FoodEx code	FoodEx category	Maximum level
A00EY	Cereal bars	10 mg/100 g

Tables 1 and 2 display examples of how the applicant should present the information on the proposed uses and use levels as described in the points above.

When the traditional food is intended to be used as a whole food, the applicant has to indicate food(s) already consumed in the EU (using either a category in the FAIM or in the DietEx tool) which can reasonably reflect the anticipated consumption pattern of the traditional food. Applicants should provide their considerations and explanations as to why it is reasonable to expect that the traditional food corresponds to specific food(s) consumed in the EU.

6.3. Anticipated intake of the traditional food

On the basis of the information provided in Sections 6.1 and 6.2, the applicant should estimate the chronic daily intake of the traditional food. This estimate should include both the amount of traditional food consumed per kilogram of body weight and the total absolute amount of traditional food consumed per day. If estimates are not provided on total absolute intake, the applicant should use the mean default body weights as reported in the EFSA guidance on selected default values to be used in the absence of actual measured data (EFSA Scientific Committee, 2012). The applicant should provide estimates of the mean and high (95th percentile) anticipated daily intakes of the traditional food for each target population group, including specific population groups such as pregnant and lactating women if available.

The FAIM tool and the DietEx tool are available to applicants to perform the chronic intake estimate of the traditional food when added to foods. When estimating the intake, the applicant should consider all food categories to which the traditional food is intended to be added for a conservative scenario. Both FAIM and DietEx tools use individual consumption data from the EFSA Comprehensive Food Consumption Database to generate estimates (mean and 95th percentile) for population groups (infants, young and other children, adolescents, adults) throughout several EU countries. It is noted that the DietEx tool provides more refined food categories as compared to the FAIM tool which uses broader food categories. Thus, DietEx allows a more refined selection of food categories and intake estimates of the traditional food.

If the available toxicological data, human data, data on chemical composition or literature review raise concerns regarding an acute effect, the applicant should also consider acute intake estimates of the traditional food.

When a traditional food is reasonably expected to be used as an alternative to another food already consumed in EU (e.g. when the traditional food is a whole food – Section 6.2), the applicant should use the consumption data of food(s) already consumed in EU to estimate the anticipated intake of the traditional food.

Based on the intended uses of the traditional food (e.g. whole food, ingredient), the applicant should provide the combined intake scenarios resulting from the different uses of the traditional food, considering the highest 95th percentile of anticipated intakes of the traditional food for each group of the target population (as indicated in Section 6.1).

6.4. Intended role in the diet

Where a traditional food is intended or likely to be used as an alternative to another food, the applicant should demonstrate that it does not differ from that food in a way that it would be nutritionally disadvantageous for the consumer.

6.5. Precautions and restrictions of use

When proposing precautions (including directions for its preparation and/or use) and restrictions of use, all available information on safety should be taken into consideration.

The applicant should indicate any restrictions of use and precautions related to the handling, preparation and consumption of the traditional food.

7. CONCLUDING REMARKS

The applicant should integrate the information on the composition and the experience of use and provide a concise overall consideration on how this substantiates the history of safe use of the traditional food and how this relates to the proposed conditions of use for the EU market. Where potential health hazards have been identified on the basis of the composition and/or data from the experience of use, they should be discussed.

8. ‘DULY REASONED SAFETY OBJECTIONS’ (APPLICABLE ONLY FOR ARTICLE 16 TRADITIONAL FOODS APPLICATIONS)

When an application for a traditional food under Article 16 of Regulation (EU) 2015/2283 is submitted, the applicant should provide all safety objections raised either by Member State(s) and/or by EFSA during evaluation of the Article 14 traditional food notification.

9. ‘APPLICANT'S RESPONSE TO DULY REASONED SAFETY OBJECTIONS’ (APPLICABLE ONLY FOR ARTICLE 16 TRADITIONAL FOODS APPLICATIONS)

When an applicant submits an application for a traditional food under Article 16 of Regulation (EU) 2015/2283, the applicant should provide the response(s) to the safety objections raised during the evaluation of the Article 14 traditional food notification. Where Article 16 traditional food applications concern data other than the history of safe food use in a third country, applicants are referred to the guidance on the preparation and presentation of an application for authorisation of a novel food (EFSA NDA Panel, 2024).

STEPS TAKEN BY EFSA

1. On 16 June 2023 EFSA received a mandate from the European Commission with the request to update the guidance document on the preparation and submission of an application for authorisation of a traditional foods from third countries in the context of Regulation (EU) 2015/2283. [Ref. Ares (2023)4194318].

2. During its meeting on 31 January 2024, the NDA Panel endorsed the draft guidance document for public consultation.

3. The public consultation was open from 15 February 2024 to 14 April 2024.

4. The draft guidance document has been amended in view of the comments received during the public consultation. All comments have been addressed by the NDA Panel and are available alongside the respective replies in Annex A of this guidance document.

5. During its meeting on 27 June 2024, the NDA Panel adopted the guidance on the scientific requirements for an application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283.

GLOSSARY

Antimicrobial

An active substance of synthetic or natural origin which destroys microorganisms, supressing their growth or their ability to reproduce in animals or humans, excluding antivirals and antiparasitic agents. For the purpose of the assessment of antimicrobial susceptibility and production in this guidance, the antimicrobial substances considered are those of clinical relevance (EUCAST, 2024).

Antinutrients

Antinutrients are naturally occurring or synthetic compounds that can interfere with the absorption of essential nutrients.

Dietary reference values (DRV)

A set of nutrient reference values that includes the average requirement, the population reference intake, the adequate intake and the reference intake range for macronutrients (EFSA, 2017).

Health‐base guidance value (HBGV)

Umbrella term for values that are established as the result of the risk assessment of chemical substances and provides guidance on safe consumption of substances, taking into account current safety data, uncertainties in these data and the likely duration of consumption. Depending on their nature and applications, a HBGV for oral exposure may be termed tolerable upper intake level (UL) (nutrients), acceptable daily intake (ADI) (food additives, pesticides), tolerable daily intake (TDI) (contaminants) or acute reference dose (ARfD) (EFSA Scientific Committee, 2021a).

Taxonomic units (TUs)

The lowest taxonomic level for which the QPS status is granted ‐ the species level for bacteria, yeasts and protists/algae, and the family level for viruses.

Tolerable upper intake levels (UL)

The maximum level of total chronic daily intake of a nutrient (from all sources) which is not expected to pose a risk of adverse health effects to humans (EFSA NDA Panel, 2022).

ABBREVIATIONS

ADI

acceptable daily intake

AMR

antimicrobial resistance

ARfD

acute reference dose

BIOHAZ

Panel on Biological Hazards

CAS

Chemical Abstracts Service

CEP

Panel on Food Contact Materials, Enzymes and Processing Aids

ChEBI

Chemical Entities of Biological Interest database

ChEMBL

database of bioactive molecules with drug‐like properties. It is maintained by the European Bioinformatics Institute (EBI), of the European Molecular Biology Laboratory (EMBL)

DietEx

Dietary Exposure tool

DRV

dietary reference value

ECHA

European Chemicals Agency

EMA

European Medicines Agency

EUCAST

European Committee on Antimicrobial Susceptibility Testing

FAIM

Food Additives Intake Model

FEEDAP

Panel on Additives and Products or Substances used in Animal Feed

FooDB

database of the macro and micronutrients of a wide range of non‐processed foods

FoodEx

EFSA Food Classification System

FT‐IR

Fourier transform infrared spectroscopy

GCP

good clinical practice

GLP

good laboratory practice

GMM

genetically modified microorganism

GMO

genetically modified organism

GMP

good manufacturing practice

GRIN

Germplasm Resources Information Network

HACCP

hazard analysis critical control point

HBGV

health‐based guidance values

HMDB

Human Metabolome Database

ICH

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

InChI

International Chemical Identifier

IPNI

International Plant Names Index

ITIS

Integrated Taxonomic Information System

ISO

International Organization for Standardization

IUBMB

International Union of Biochemistry and Molecular Biology

IUPAC

International Union of Applied and Pure Chemistry

LOD

limit of detection

LOQ

limit of quantification

NDA

EFSA Panel on nutrition, novel foods and food allergens

OECD

Organisation for Economic Co‐operation and Development

QPS

qualified presumption of safety

SCF

Scientific Committee on Food

SMILES

simplified molecular input line entry system

TDI

tolerable daily intake

TU

taxonomic unit

UL

tolerable upper intake level

UV

ultraviolet spectroscopy

USDA‐ARS

United States Department of Agriculture – Agricultural Research Service

WGS

whole genome sequence

XRD

X‐ray diffraction

CONFLICT OF INTEREST

If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu.

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2023‐00444

COPYRIGHT FOR NON‐EFSA CONTENT

EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source.

PANEL MEMBERS

Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan de Henauw, Karen‐Ildico Hirsch‐Ernst, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri and Marco Vinceti.

Supporting information

Outcome of the Public Consultation

APPENDIX A.  

A.1.

TABLE A.1 Requirements for the taxonomic and hazard identification of microorganisms as traditional foods (active agents and biomasses) or used in the production of traditional foods (production strains).

Requirements	Microorganisms as traditional foods (active agents and biomasses)	Microorganisms used in the production of traditional foods (production strain)
Unambiguous taxonomic identification at species level (EFSA, 2021c; EFSA FEEDAP Panel, 2018) Certificate of deposition (including accession number) of the microbial strain under assessment in an internationally recognised culture collection having acquired the status of International Depositary Authority under the Budapest Treaty (EFSA FEEDAP Panel, 2018)	Mandatory	Mandatory
Acquired antimicrobial resistance (AMR) genes of clinical relevance (EFSA, 2021b; EFSA BIOHAZ Panel, 2023; EFSA FEEDAP Panel, 2018)	Mandatory for bacteria (regardless of QPS status)	Mandatory for bacteria (regardless of QPS status)
Assessment of the capacity of the microbial strain to produce antimicrobial of clinical relevance (EFSA FEEDAP Panel, 2018)	Applicable to TUs: known to produce antimicrobials of clinical relevance not qualifying for the QPS approach included in the QPS list but for which a qualification exists regarding the production of antimicrobials of clinical relevance	Applicable to TUs: known to produce antimicrobials of clinical relevance not qualifying for the QPS approach included in the QPS list but for which a qualification exists regarding the production of antimicrobials of clinical relevance
Toxigenicity and pathogenicity trains (EFSA, 2021b; EFSA FEEDAP Panel, 2018)	Applicable to TUs: not qualifying for the QPS approach included in the QPS list but for which a qualification regarding toxigenic activity exists	Applicable to TUs: not qualifying for the QPS approach included in the QPS list but for which a qualification regarding toxigenic activity exists
Whole genome sequence (WGS) data	According to the most up‐to‐date versions of the available and applicable EFSA scientific outputs (e.g. EFSA, 2021b)	According to the most up‐to‐date versions of the available and applicable EFSA scientific outputs (e.g. EFSA, 2021b)
Presence of viable cells in the traditional food to be analysed (EFSA FEEDAP Panel, 2018)	Applicable to: Biomasses Non‐QPS TUs QPS TUs with the qualification ‘for production purposes only’	Applicable to: QPS TUs with the qualification ‘for production purposes only’ Non‐QPS TUs
Presence of DNA in the traditional food to be analysed (EFSA FEEDAP Panel, 2018)	Not applicable	Applicable to: production strains carrying acquired AMR genes of clinical relevance

APPENDIX B.  

B.1.

TABLE B.1 Table with the input materials used in the production process of the traditional food.

Input material	Production process step(s) used	Chemical identifier (CAS, EC number etc.)	Specifications and/or certificates of analysis	Functional role	Regulatory status in EU (if applicable)
			Name of the CoA document in the dossier

APPENDIX C.  

C.1.

TABLE C.1 Table on the compositional data from the analyses of the traditional food and data retrieved from publications.

Compound/group	Compositional data from the analyses of the traditional food			Compositional data retrieved in the literature
	Concentration as measured in the batches (range) of the traditional food	Units	Analytical technique	Concentration (range)	Units	Analytical technique	Reference
Caffeic acid	5–10	mg/kg	HPLC–UV	2–20	mg/kg	HPLC–UV	XXXX et al. year
Saponins	1–2	mg/kg expressed as XXX equivalents	Spectrophotometric method	0.1–1	mg/kg expressed as XXX equivalents	Spectrophotometric method	XXX et al. year

Abbreviation: HPLC‐UV, high‐performance liquid chromatography with ultraviolet detection.

APPENDIX D.  

D.1.

TABLE D.1 Table on the information on the experience of continued use of the traditional food in third countries.

Reference	Years of consumption (duration)	Country	Traditional food consumed, handling and preparation	Extent of use	Role in the diet	Population of consumers
Example: Author, year, journal name	Years when the consumption of the traditional food occurred	Name of the country where the traditional food was consumed	Describe how the traditional food was prepared and consumed. Indicate whether there are deviations from the traditional food which is intended to be put on the market, and discuss how these deviations may impact the safety profile of the traditional food intended to be put on the EU market	Indicate the quantity of traditional food consumed per person; volume of traditional food produced per year	Indicate whether the traditional food was consumed as a side dish, a snack, consumed only on special occasions	General population or specific population groups

ANNEX A.  

A.1.

The outcome of the public consultation which was open from 15 February 2024 until 14 April 2024 is presented in Annex A. Annex A is available under the Supporting Information section on the online version of the scientific output.

EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens) , Turck, D. , Bohn, T. , Castenmiller, J. , De Henauw, S. , Engel, K.‐h. , Hirsch‐Ernst, K. I. , Kearney, J. , Knutsen, H. K. , Maciuk, A. , Mangelsdorf, I. , McArdle, H. J. , Naska, A. , Pentieva, K. , Siani, A. , Thies, F. , Tsabouri, S. , Vinceti, M. , Peláez, C. , … Turla, E. (2024). Guidance on the scientific requirements for a notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283. EFSA Journal, 22(9), e8966. 10.2903/j.efsa.2024.8966