On this page find out what is deemed a novel food, how to properly market novel or novel traditional foods, and the steps involved in authorisation.
Novel foods
Foods may usually be placed on the market without authorisation. Novel foods and ingredients (novel foods) are an exception as there is a lack of empirical evidence on safety and tolerability.
They include:
- newly-developed and innovative products, such as krill oil and plant sterols,
- foods produced using new technologies and processes, such as UV-treated mushrooms and products made from cultured cells,
- foods that are traditionally consumed in third countries but not in Europe or Switzerland – such as cañihua and baru nut.
You’ll find answers to frequently-asked questions on novel foods here:
What is a novel food?
What is a novel traditional food?
What are not novel foods?
What about genetically modified foods?
When do foods fall under the novel food regulations due to the method of production?
Distinction between therapeutic products and foods
Novel food is defined as food that had not been consumed to a significant degree by humans in Switzerland or the EU before 15 May 1997, and is broken down into one of the categories set out in Art. 15 para. 1 FUAO Novel foods: Definition.
The legal framework comprises Section 2 FUAO Novel foods FUAO and the FDHA Ordinance on Novel Foods.
A novel food must belong to one of these ten categories:
- Foods with a new or intentionally modified molecular structure.
- Foods consisting of, isolated from or produced from microorganisms, fungi or algae.
- Foods consisting of, isolated from or produced from material of mineral origin.
- Food consisting of, isolated from or produced from plants or their parts,
except when the product has a history of safe use in Switzerland or the EU and is consisting of, isolated from or produced from a plant or a variety of the same species:- traditional propagating practices that were used for food production before 15 May 1997, or
- non-traditional propagating practices that were not used for food production before 15 May 1997, where those practices do not cause changes to its nutritional value, how it is metabolised, or level of undesirable substances.
- Food consisting of, isolated from or produced from animals or their parts.
- Foods consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, microorganisms, fungi or algae.
- Foods resulting from a production process that was not used for food production before 15 May 1997 and that changes the nutritional value, metabolisation or level of undesirable substances.
- Foods consisting of engineered nanomaterials.
- Vitamins, minerals and other substances that fall underKategorie 7, consisting of or containing nanomaterials.
- Foods used exclusively in food supplements before 15 May 1997 and are now intended to be used in other foods.
Novel traditional foods are foods that meet all the following conditions:
- They do not originate from Switzerland or the EU.
- They are deemed novel in Switzerland or in the EU and fall under categories 2,4,5 or 6 (see ‘What is a novel food’).
- They are derived from primary production.
- They have at least a 25-year history of safe use as foods in a third country (not CH/EU).
Examples: cañihua (Bolivia), baru nut (Brazil), lily bulbs (China), kakdu plums (Australia).
The following, among others, are not novel foods: genetically modified foodstuffs, food enzymes, additives, flavourings and extraction solvents.
Genetically modified foods are classified differently in Switzerland and in the EU:
- Products of fermentation: In Switzerland, foods produced from genetically modified organisms are deemed genetically modified foods. In the EU, however, they are considered novel foods. Cf. Art. 30 FUAO Genetically modified organisms: Definition
- Marketability: Products that are authorised as novel foods in the EU (for example vitamins) but that are deemed GMOs in Switzerland, may be placed on the market in Switzerland without any additional authorisation. Cf. [Link] Annex 3 part B VGVL Other GMO products.
- Exception enzymes: Food enzymes made from genetically modified microorganisms are not novel foods. [Link] Annex 3 part A VGVL Enzymes lists all enzymes that are deemed GMO in Switzerland and may be placed on the market without authorisation from the FSVO.
More:
Authorisation of genetically modified organisms (GMOs)
Labelling of genetically modified organisms (GMOs)
Foods are deemed novel foods if they meet all the following conditions:
- They were not consumed to a significant degree by humans in Switzerland or the EU before 15 May 1997.
- They result from a production process that was not used for food production before 15 May 1997.
- The process causes significant changes to the nutritional value, metabolisation or level of undesirable substances.
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Products must be classified correctly to ensure that they are in fact foodstuffs and not therapeutic products. Medicinal products and medical devices are not classed as foods and can therefore not be placed on the market as novel foods.
Swissmedic, the FOPH and the FSVO have jointly compiled a report to clarify the distinction between therapeutic products and foods. It takes account of the Swiss and European legal framework and shows which authority is responsible for which measures.
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How to place a novel food on the market
Only novel foods require authorisation from the EU Commission or the FSVO. The crucial factor is therefore determining whether a food falls under the definition of novel food (Evaluation of novel food status).
Food companies must ensure that their products meet the legal requirements. They are required to review and document the novel food status as part of their self-supervision.
More: Art. 26 FoodA Obligations for Companies: Self-supervision
Step 1: Evaluation of novel food status
Companies first check whether their product is classed as a novel food. Information and guidance documents are provided for this purpose. More information can be found in the section ‘Evaluation of novel food status as part of self-supervision’.
Step 2: Authorisation procedure
The authorisation procedure is structured in two parts.
- Assessment of novel food status: If a foodstuff is classed as a novel food, an application must be submitted to the FSVO. The FSVO examines and decides on the status (subject to a fee).
- Assessment of food safety: For the actual authorisation a technical dossier is required. The FSVO assess the safety of the food and issues an order (subject to a fee).
You’ll find further information in the section ‘Authorisation procedure for novel food’.
Responsibilities EU and Switzerland
In the EU and in Switzerland novel foods require authorisation to be placed on the market as they are lacking adequate consumption history. In the EU the risk assessment is carried out by the European Food Safety Authority EFSA, and in Switzerland by the FSVO. The responsible body for authorisation in the EU is the European Commission and in Switzerland the FSVO.
Below you’ll find the answers to some frequently-asked questions about placing novel foods on the market.
Why do novel foods need to be authorised?
What needs to be authorised?
Novel foods require authorisation to:
- Guarantee food safety: As novel foods are new on the market, there is often only a small amount of data on their long-term health impact. The authorisation ensures that they are comprehensively checked before they are placed on the market.
- Protect consumers: Novel foods may pose risks – such as allergic reactions, toxicity or undesirable interactions with other foods or drugs. The authorisation identifies and evaluates such risks.
- Create transparency: The process ensures that consumers are informed about the type and origin of novel food and can make sound decisions about their nutrition.
The authorisation requirement applies to individual substances (for example protein extract derived from insects) or primary products (for example cañihua as a novel traditional food) and not for a composite product that contains a novel food as an ingredient (e.g. cereal bars enriched with protein extract derived from insects). No authorisations are issued for composite foods.
Authorisation requests should be prepared accordingly.
Evaluation of novel food status as part of self-supervision
Determining novel food status is crucial in order to decide whether or not a food requires authorisation to be placed on the market. If there is no information available about novel food status, companies themselves must establish whether the food was consumed in Switzerland and/or the EU to a significant degree before 15 May 1997.
Below you will find answers to frequently-asked questions on the evaluation of novel food status as part of self-supervision.
Who has to determine the novel food status and when?
How can novel food status be determined?
How to determine whether my food is a novel traditional food?
What should be done if there is no information available on the novel food status?
Can a novel food status from one food be transferred to another?
Can the novel food status of a raw material be transferred to derived products (for example extracts)?
How should the research concerning the novel food status be documented?
The distributor must review the novel food status itself as part of self-supervision. This involves establishing whether the food was consumed by humans in Switzerland and/or the EU to a significant degree before 15 May 1997. The assessments must be properly and transparently documented and presented to the cantonal enforcement authorities during inspections.
More: Art. 26 FoodA Obligations for Companies: Self-supervision
The distributor draws on guidance documents and existing information. Sections A, B and C of information meet 1 help them carry out the assessments in a systematic and transparent way.
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Novel traditional foods are foods that have been eaten safely for at least 25 years in a third country (not in Switzerland or the EU).
To this end, evidence must be provided that:
- They are deemed novel in Switzerland or in the EU and fall under categories 2,4,5 or 6 (see ‘What is a novel food’), and
- they have at least a 25-year history of safe use as foods in a third country (not CH/EU).
Section D of information sheet 1 helps distributors carry out the assessments in a systematic and transparent way.
If information is not available, the distributor must establish and document the status itself. Section D of information sheet 1 can be used as a guide.
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No. The status must be determined for every substance or every product individually.
Example: If the leaves of a plant have a proven history of safe consumption before 15 May 1997, this does not automatically apply to the roots of the same plant.
No. The status of a raw material does not automatically apply to derived products.
Example: A plant with a proven history of consumption before 15 May 1997 is not automatically deemed safe for derived extracts – even if they are obtained using traditional methods. The same applies if the history of consumption is only proven for certain food categories or production methods.
There are no formal requirements. However, the documentation must be compiled in a way that is clear and comprehensible for the cantonal enforcement authority. The Annex to the application form and the information sheet 2 can be used as an aid to help structure the documentation.
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Authorisation procedure for novel food
[Paragraph] If the self-supervision process reveals that the food is a novel food or a novel traditional food, authorisation must be requested from the FSVO before it can be placed on the market.
The procedure involves two steps:
- Assessment of novel food status
- Assessment of food safety
1. Assessment of novel food status
For this, all the documents compiled as part of the self-supervision to evaluate novel food status must be submitted. The FSVO reviews them and decides on novel food status. If information is missing, the FSVO requests additional documents.
2. Assessment of food safety
After the status is confirmed, the FSVO reviews the safety of the food. This requires the submission of a technical dossier. The FSVO checks completeness and safety and decides on whether to grant authorisation.
Scope and costs
- Novel food authorised by the FSVO may only be marketed in Switzerland.
- Novel foods authorised in the EU are licensed in the EU and in Switzerland.
- The procedure is subject to a fee (see ‘How much does the authorisation procedure for novel foods cost?’)
Below you’ll find the answers to some frequently-asked questions about the authorisation procedure for novel foods.
What has to be submitted if you wish to have a novel food authorised?
What documents need to be submitted for the assessment of novel food status?
What documents need to be submitted for the assessment of food safety for novel foods?
What documents need to be submitted for the assessment of food safety for novel traditional foods?
How should the documents be submitted?
How much does the authorisation procedure cost for novel foods?
Can an application be withdrawn at any time?
How long does the authorisation process take?
What does the FSVO do during the authorisation procedure?
How does communication with the FSVO work?
Are authorisations from the FSVO also valid in the EU?
For whom does an authorisation for novel foods apply?
For whom does an authorisation for novel traditional foods apply?
If your self-supervision process concludes that the food is novel or is a novel traditional food, you need to submit the following for the authorisation procedure:
- Completed application form to assess novel food status
- Technical dossier to assess food safety
Documents
Contact
You can contact the FSVO before submission to clarify any unanswered questions on the procedure or the scientific requirements. This will help you prepare a complete and correct file.
Email: lme@blv.admin.ch
For the assessment, the completed annex to the application form must be submitted – including all evidence from the documented self-supervision process to determine novel food status. The FSVO examines these documents and decides on the status (subject to a fee).
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Novel foods must undergo a comprehensive safety assessment before they are approved in Switzerland or in the EU. This requires detailed scientific evidence showing that the food is safe under the relevant conditions. This usually includes:
- Description of the food (identity, composition, production process)
- Data on absorption, distribution, metabolism and excretion (ADME).
- Toxicological studies on potentially harmful effects
- Nutritional information, particularly if the novel food is designed to replace another food
- Assessment of allergenic potential
- Proposed conditions of use and consumption quantities
You’ll find more detailed instructions in the information sheet:
Please note: The supporting documents must be submitted at the latest by when the FSVO confirms the novel food status, or the food is classed as ‘novel’ as part of the self-supervision process.
Novel traditional foods are a sub-category of novel foods. They have been safely consumed by many people in a third country for at least 25 years (see ‘Novel foods’). The authorisation procedure is therefore simplified.
The focus is on proving a tradition of safe use:
- Composition of the food
- Evidence of long-standing and safe use in a third country’s diet (e.g. consumption data, nutritional studies)
- Proposed conditions of use in Switzerland or in the EU
As there is a history of safe consumption, fewer toxicological studies are usually required than for completely new substances. Nevertheless, the composition of five independent and representative batches must be checked (including for the presence of undesirable substances such as heavy metal residues and toxins). If there are specific concerns, further tests may be necessary (for example on antinutrients or undesirable substances).
More detailed instructions can be found in the information sheet:
Please note: The supporting documents must be submitted at the latest by when the FSVO confirms the novel traditional food status, or the food is classed as ‘novel traditional’ as part of the self-supervision process.
All documents (application forms, attachments, technical dossier) can be emailed to the FSVO. For large files, the FSVO can provide a file transfer link on request.
Email: lme@blv.admin.ch
Alternatively, they can be submitted by post:
Federal Food Safety and Veterinary Office FSVO
Food and Nutrition – Market Access
Schwarzenburgstrasse 155
3003 Bern
The processing of an application for authorisation (including consultation process) is subject to a fee. The fees are based on the individual effort involved and are between CHF 200 and CHF 50,000.
The following are guide values:
- Assessment of novel food status: CHF 500 to CHF 3,000.
- Assessment of food safety and order on novel traditional foods: CHF 1,000 to CHF 3,000.
- Assessment of food safety and order on novel foods: CHF 5,000 to CHF 30,000.
More on fees:
Art. 108-109 FLIO Fees charged by federal authorities
Annex 4 FLIO Fees charged by federal authorities
Ordinance on the Implementation of Foodstuffs Legislation FLIO
Art. 17 FUAO Authorisation
Yes. After every step, the FSVO informs the applicant, who can decide at any time whether they wish to pursue or withdraw the application.
The duration depends on the completeness and quality of the documents and on the complexity of the product. It is not possible to say exactly how long it will take. As a guide, it takes around 12 months to process a complete dossier.
The Food and Nutrition division checks the completeness of the documents on novel food status and food safety. The Knowledge Foundations Division then conducts the substantive examination and risk assessment and compiles a report on it. The FSVO then makes a decision on authorisation on this basis.
When submitting the application, a contact person is designated at the FSVO. They are available to answer questions and will provide information on the status of the application after each intermediate step. The applicant can also get in touch with the contact person at any time if they have questions.
No. FSVO authorisations are only valid in Switzerland. Conversely, EU authorisations are also valid in Switzerland.
An authorisation for novel foods is issued in the form of an individual order. It is valid for five years with no extension option. If the requirements regarding food safety and prohibition of deception continue to be met, the FSVO will, after a further examination, record the novel food in the Annex to the FDHA Ordinance on Novel Foods.
An authorisation for novel traditional foods is issued in the form of a general order. It is valid for all interested parties. The authorised products are published on a periodic basis in the Annex to the FDHA Ordinance on Novel Foods.
More information
In detail
Novel Food Status
Contact
Applications including attachments can be submitted digitally by email: lme@blv.admin.ch
Alternatively, they can be submitted by post:
Federal Food Safety and Veterinary Office FSVO
Food and Nutrition – Market Access
Schwarzenburgstrasse 155
3003 Bern
Last modification 11.05.2026
