Risk management recommendation on market authorisation of one traditional food notification January 2026
The Food Standards Agency (FSA) risk management recommendations on one traditional food from a third country notification.
Subject and purpose
On this page we publish the Food Standards Agency (FSA) risk management recommendations on one traditional food from a third country notification.
The FSA and Food Standards Scotland (FSS) risk assessors deliver the science behind our advice. They are responsible for identifying and characterising hazards and risks to health and assessing exposure levels. For this traditional food, The Advisory Committee on Novel Foods and Processes (ACNFP) reviewed the notification and issued their output. The FSA’s response to their output can be found in the following Annex.
The FSA will be making a formal submission to ministers in England and Wales on the final terms of authorisation and will consider stakeholders' views received from this consultation. FSS will write to their minister with the terms of authorisation recommendations which will have considered stakeholders’ views as a result of this consultation.
List of Annexes
Annex A: RP2272, Bambara groundnut (seeds and seed flour of Vigna subterranea (L.) Verdc.) (new) (Traditional Food)
Annex A
FSA risk management recommendations
RP2272 Bambara groundnut (seeds and seed flour of Vigna subterranea (L.) Verdc.) (new) (Traditional Food)
Introduction
A notification for the traditional food, Bambara groundnut (seeds and seed flour of Vigna subterranea (L.) Verdc) was submitted to the FSA for authorisation in Great Britain (GB) in October 2024 by WhatIF F&I Pte Ltd.
For a traditional food from a third country to be placed on the market in GB, a notification shall be submitted in accordance with assimilated Regulation (EU) 2015/2283 (“the Novel Food Regulations”).
Under Article 14 of the Regulation, traditional foods which have a history of safe use in a third country, as defined by Article 3.2(b) of the Novel Food Regulations, can be authorised by ministers. These authorised traditional foods will have been safely consumed outside of the United Kingdom and the European Union for at least 25 continuous years before the notification is made.
Scientific output summary and protective measures
The Advisory Committee on Novel Foods and Processes (ACNFP) has reviewed the notification and issued their output:
The FSA has thoroughly considered this output and has concluded that the hazards outlined by ACNFP can be controlled by applying protective conditions of use, ensuring the safety of consumers. The FSA has also concluded that, in addition to the controls under the Novel Foods Regulations, existing regulatory frameworks provide further protections to consumer safety including the provisions of General Food Law (assimilated Regulation (EC) 178/2002), and General Food Hygiene Regulations (assimilated Regulation (EC) 852/2004); the FSA therefore has no reasoned safety objections to the placing on the market of the traditional food in GB.
The FSA recognises the following key elements from the ACNFP’s output which require further appropriate risk mitigation to ensure continued consumer safety:
- allergenicity from cross-reactivity for other legume allergens, for example, peanuts
- presence of phytotoxins and antinutrients in the raw traditional food
- presence of mycotoxins in the traditional food
- effective controls to minimise microbial growth
The FSA therefore proposes the following conditions for the authorisation of the traditional food to protect consumers from these hazards:
- To mitigate the risk of exposure of legume allergic consumers to the traditional food, the FSA proposes that foods containing the traditional food are clearly labelled that ‘the seeds and seed flour of Vigna subterranea may cause allergic reactions to consumers with allergies to peanuts and soybeans’.
- Similarly to other raw legumes (e.g. kidney beans, chickpeas, lentils) which contain phytotoxins and antinutrients, levels can be significantly reduced through simple preparation techniques such as soaking and boiling. The FSA therefore proposes additional labelling that the product must be soaked and boiled before consumption to reduce the presence of phytotoxins and antinutrients to safe levels.
- To reduce the exposure of consumers to mycotoxins from the traditional food, the FSA proposes to apply maximum levels for mycotoxins to ensure consumer safety; proposals are in line with established protective maximum levels for similar products as set in assimilated Regulation (EC) No. 1881/2006, and are set as low as reasonably achievable.
- The FSA proposes the reduction of the limits for ‘yeast and mould count’ and ‘total plate count’ requested by the applicant to match established standards and measures which protect consumer safety and ensure high standards in the production of the traditional food.
The proposals are reflected in the following terms of authorisation.
Relevant legislation
- Assimilated Regulation (EU) 2015/2283 (“the Novel Food Regulations”)
- Assimilated Regulation (EU) 1169/2011 on the provision of food information to consumers
Terms of authorisation
Authorised Novel Food |
Conditions under which the novel food may be used |
Additional specific labelling requirements |
Other requirements |
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Seeds and seed flour of Vigna subterranea (L.) Verdc. (Traditional food from a third country) |
Specified food category |
Maximum levels |
1. The designation of the novel food on the labelling of the food containing it must be ‘Bambara (Vigna subterranea) seeds/nut/bean/groundnut’ or ‘Bambara (Vigna subterranea) seed/nut/bean/groundnut flour’ depending on the form used. 2. The labelling of the food containing the traditional food must bear a statement that the seeds and the seed flour of Vigna subterranea may cause allergic reactions to consumers with known allergies to peanuts and soybeans. This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredients, in close proximity to the name of the food. 3. When the seeds are sold uncooked, the labelling must bear a statement that they should be soaked and boiled before consumption. 4. The food information must be presented in accordance with the provisions of assimilated Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers (EUR 2011/1169) which apply to mandatory food information. |
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Not specified |
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Specification
The proposed terms of authorisation are set out in the following table:
Authorised Novel food |
Specification |
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Seeds and seed flour of Vigna subterranea (L.) Verdc. (traditional food from a third country)
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Description/Definition:The traditional food consists of de-shelled whole dried seeds of Vigna subterranea (L.) Verdc. [Family: Fabaceae (alt. Leguminosae)] or the flour obtained by several steps, including heat treatment and milling of the seeds. Synonyms: Cryptolobus subterraneus (L.) Spreng., Glycine subterranea L., Tetrodea subterranea (L.) Raf., Voandzeia subterranea (L.) Thouars. Common names: Bambara groundnut, Bambara nut, Bambara bean, Bambara pea, Nyimo bean. Dried seeds:Typical composition range:Moisture: 7-11 % Protein: > 15 % Carbohydrates: 32 - 65 % Sugar: < 6.0 % Fat: 4-7 % Fiber: 7-31 % Heavy metals:Arsenic: < 0.05 mg/kg Cadmium: < 0.02 mg/kg Lead: < 0.05 mg/kg Mercury: < 0.01 mg/kg Mycotoxins: Sum of Aflatoxins (B1+B2+G1+G2): < 4 μg/kg Aflatoxin B1: < 2 μg/kg Sum of Fumonisin (B1+B2+B3): < 60 μg/kg Deoxynivalenol: < 0.1 mg/kg Ochratoxin A: < 0.5 μg/kg Zearalenone: < 0.1 mg/kg Other contaminants or anti-nutrient factors:Hydrocyanic acid (including hydrocyanic acid bound in cyanogenic glycosides): < 15 mg/kg Microbiological Criteria:Aerobic mesophilic spores: < 1 Spore/g Alicyclobacillus: Not detected in 10 g Presumptive Bacillus cereus: < 10 cfu/g Coliforms: < 10 cfu/g Escherichia coli: < 10 cfu/g Salmonella: Not detected in 25 g Staphylococcus aureus: < 10 cfu/g Total Plate Count: < 5 000 cfu/g Yeast & Moulds: < 100 cfu/g Dried seed flourTypical composition range:Moisture: 4-7 % Protein : > 15 % Carbohydrates: 55-75 % Sugar: < 20 % Fat: 4-9 % Fiber: 10-30 % Heavy metals:Arsenic: < 0.05 mg/kg Cadmium: < 0.02 mg/kg Lead: < 0.05 mg/kg Mercury: < 0.01 mg/kg Mycotoxins:Sum of Aflatoxins (B1+B2+G1+G2): < 4 μg/kg Aflatoxin B1: < 2 μg/kg Sum of Fumonisin (B1+B2+B3): < 60 μg/kg Deoxynivalenol: < 0.1 mg/kg Ochratoxin A: < 0.5 μg/kg Zearalenone: < 0.1 mg/kg Other contaminants or anti-nutrient factors:Hydrocyanic acid (including hydrocyanic acid bound in cyanogenic glycosides): < 10 mg/kg Phytic acid: < 0.01 g/100 g Microbiological Criteria:Aerobic mesophilic spores: < 1 Spore/g Alicyclobacillus: Not detected in 10 g Presumptive Bacillus cereus: < 10 cfu/g Coliforms: < 10 cfu/g Escherichia coli : < 10 cfu/g Salmonella: Not detected in 25 g Staphylococcus aureus: < 10 cfu/g Total Plate Count: < 1 000 cfu/g Yeast & Moulds: < 100 cfu/g cfu: colony forming units |
Proposed uses
Per the terms of the traditional food notification process, the authorised uses may only be those covered by traditional use evidenced in the notification. As evidence was demonstrated for the continuous safe use of the traditional food in the form of whole seeds and seed flours in a third country for 25 years, the food’s uses are restricted to seeds (cooked or uncooked) and seed flours.
Supplementary information
N/A
Labelling
Article 9(3)(b) of assimilated Regulation (EU) 2015/2283 provides that an authorisation of a novel food should include additional specific labelling requirements.
- The designation of the novel food on the labelling of the food containing it must be ‘Bambara (Vigna subterranea) seeds/nut/bean/groundnut’ or ‘Bambara (Vigna subterranea) seed/nut/bean/groundnut flour’ depending on the form used.
- The labelling of the food containing the traditional food must bear a statement that ‘the seeds and the seed flour of Vigna subterranea may cause allergic reactions to consumers with known allergies to peanuts and soybeans’. This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredients, in close proximity to the name of the food.
- When the seeds are sold uncooked, the labelling shall bear a statement that they should be soaked and boiled before consumption.
The food information must be presented in accordance with the provisions of Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers (EUR 2011/1169) which apply to mandatory food information.
Transitional requirements/ provisions
N/A
Further explanation/ rationale
N/A
Post market monitoring
N/A
Definitions
N/A
Other legitimate factors
N/A
Impacts
As part of the risk analysis process, FSA has assessed the potential impacts that would result from the authorisation of this traditional food. No significant impacts were identified. The impacts considered included those most frequently identified as potential impacts when introducing or amending food and feed law (i.e. environmental, trade, and consumer interests).
The authorisation of this product should generally result in greater market competition, supporting growth and innovation in the sector.
Trade
Food exported from the UK to other countries/blocs will need to continue to meet the rules of those countries/blocs.
EU
Bambara groundnut (seeds and seed flour of Vigna subterranea (L.) Verdc.) is already approved for use in the EU.
Northern Ireland
This product is already authorised for use in Northern Ireland. The authorisation of this product in GB would create alignment with Northern Ireland.
Risk management recommendation
The FSA risk management recommendation concludes Bambara groundnut (seeds and seed flour of Vigna subterranea (L.) Verdc.) as described in this notification, is safe and is not liable to have an adverse effect on the target population, environmental safety and human health at the intended concentrations of use.