When and for what is an authorisation required? Which foods need to be authorised? These questions are answered on this page.
Since the complete revision of Swiss food law with effect from 1 May 2017, the provision stating that products may be placed on the market only if they have been described in an Ordinance or authorised by the FSVO no longer applies. With the exception of a few reservations (e.g. novel foods), non-described foods without an authorisation may now also be placed on the market, provided they meet all of the requirements of food law.
Novel foods
Novel foods are generally divided into two categories:
- Novel traditional foods
- Novel foods
Novel traditional foods are foods that are traditionally consumed outside Switzerland and the EU (e.g. cañihua). They benefit from a simplified authorisation procedure.
Novel foods, on the other hand, such as protein extracts derived from insects, require a more complex authorisation procedure in order to guarantee food safety. The legal definition of novel foods can be found in Article 15 para. 1 of the Ordinance on Foodstuffs and Utility Articles (FUAO) (in French).
Novel foods listed in the Annex to the FDHA Ordinance on Novel Foods (in French) do not require an authorisation. In addition to three insect species, these are all novel foods that are authorised in the EU (see EU Union list) or can be placed on the market on the basis of notifications (see “More information”). The provisions set out in the individual implementing decisions and notifications must be complied with. The person named in the implementing decision or notification and to whom the decision or notification is addressed is deemed to be the authorisation holder. The stated product may be placed on the market only by that person, or by other persons having their consent.
Important:
- Authorisations are generally not issued for composite foods. The authorisation requirement always relates to a particular substance (e.g. protein extract derived from insects as a novel food) or a particular primary product (e.g. cañihua as a traditional novel food), rather than to a composite product containing a novel food as an ingredient (e.g. cereal bars enriched with protein extract derived from insects). Applications for authorisations must be prepared accordingly.
- All novel foods that are marketable in the EU according to the Union List may be placed on the market in Switzerland without authorisation, insofar as they comply with all regulations in accordance with individual implementing decisions and notifications. However, the reverse situation does not apply. Foods that are not novel foods in Switzerland or have been authorised as such in Switzerland and are classified as a novel food in the EU require an authorisation from the European Commission for market placement in the EU.
Authorisation procedure for novel foods
The processing of applications for authorisation is generally subject to a fee (see Art. 108–109 of the Ordinance on the Implementation of Foodstuffs Legislation (FLIO) (in French).
Establishing novel food status
Novel food status unknown
Novel food status known
The distributor must first establish the novel food status of the food in question using the EU Novel food catalogue, the “Consultation process on novel food status” list and the FSVO “Novel food status” list (see “More information”). The distributor must establish whether the food was used for human consumption to a significant degree in Switzerland and/or the EU before 15 May 1997.
Important:
- If a plant or fungus in foodstuffs or food supplements is classified as non-novel, this classification does not apply in principle to the derived extracts. For example, if constituents are isolated or purified by means of extraction processes for production of a foodstuff, the composition of the resulting products is no longer the natural composition.
- If parts of plants or fungi or derived preparations have a documented history of use as a safe foodstuff to a significant degree in the EU before 15 May 1997, this classification does not apply automatically to all parts or other parts of those plants or fungi or other derived preparations. Different parts of plants and fungi and their preparations can differ widely in terms of their composition.
- If individual parts of plants and fungi, their preparations or individual substances have a documented history of use as a safe foodstuff to a significant degree before 15 May 1997 but solely for specific food categories, this documentation does not apply automatically to all food categories and production methods.
In this case, the novel food status of the foodstuff must be assessed.
In Switzerland, in contrast to the EU, products produced by genetically modified microorganisms ("fermenter products") fall under the definition of genetically modified organisms (GMO). However, as of the 1st July 2020, they shall be subject to the Novel Food Authorisation Procedure. Consequently, products (e.g. vitamins) produced by genetically modified micro-organisms and authorised as a novel food in the EU are also marketable in Switzerland without additional authorisation. This does not include food enzymes that, according to Art. 15 para. 2 FUAO, are not covered by the Novel Food provisions, and therefore continue to be subject to the GMO authorisation requirement (see “Authorisation of genetically modified organisms (GMOs”) (in french).
If the food is neither listed in the EU Novel Food Catalogue nor in the Union list of the EU nor in the List "Consultation process on novel food status", nor classified in the FSVO “Novel food status” list (see “More information”), then the novel food status must be independently established and documented by the distributor as part of its self-regulation. For this the “document checklist for classification of Novel Food status” may be helpful (cf. “More information”). This checklist is based essentially on the provisions of the “Commission Implementing Regulation (EU) 2018/456 of 19. March 2018 on the procedural steps of the consultation process for determination of novel food status“. The check list (CL) has been matched to the provisions of Switzerland. Section 5 of this CL includes additional questions to establish the consumption history as a foodstuff in analogy to the EU document “Human Consumption to a Significant Degree”. The “Substance lists for plants and fungi (in french)” may also be helpful when classifying plants or fungi; extracts of plants and fungi in particular must always be classified on a case-by-case basis (see “Establishing novel food status”).
Only when the relevant documentation has been compiled in full can the distributor submit an application to the FSVO. As a minimum requirement must be completed, the relevant application form and the entry clarification (Part A) in accordance with the “Check list for documents for the classification of the novel food status”, together with the complete documentation.
The FSVO checks whether the documents and information submitted are sufficient to determine the novel food status of the food. If so, it classifies the food accordingly (see “More information”).
If a food has been assessed, and has been classified as a novel food or a novel traditional food, all documents and evidence for the substantive evaluation of the application (Part B of the application form) must be submitted.
Novel foods must undergo a uniform safety assessment before they can be placed on the market. This includes extensive toxicological studies (chapter 2.10 of the instructions for submitting an application for novel foods) that can demonstrate the safety of the food.
Before submission, the distributor must ensure that the application has been compiled and structured in the form of a complete and detailed technical dossier, in accordance with the guidance on preparing applications for authorisation of novel foods or novel traditional foods.
A separate application must be submitted for each food and each application type (see “More information”).
The relevant completed and signed authorisation form must be submitted by post. The annexes listed in the form may also be submitted electronically (see contact details under “More information”). The application must be submitted either in an official language of the Swiss Confederation or in English.
Authorisation of novel foods
If a novel food is classified as such and authorised, this is done in the form of an individual order. The authorisation is granted for a period of five years with no option of extension. If the conditions relating to food safety and prohibition of deception are still fulfilled after the authorisation has expired, the novel food is included in the Annex to the FDHA Ordinance on Novel Foods (in French) after re-examination by the FSVO.
On the other hand, if a novel traditional food is authorised, this is done in the form of a general order. Authorised novel traditional foods are periodically included in the Annex to the FDHA Ordinance on Novel Foods (in French).
Distinction between therapeutic products and foods
Representatives of Swissmedic and the FSVO have produced a report clarifying the distinction between therapeutic products and foods. The Swiss and European legal bases were taken into account. The report makes it easier to determine which authority is responsible for which measure (see under “More information”).
More information
In detail
Novel Food Status
Authorisation of novel foods
Authorisation of novel traditional foods
Novel Food Status
Links
Contact
Applications must be submitted by post to the following address:
Federal Food Safety and Veterinary Office FSVO
Food and Nutrition
Market Access
Schwarzenburgstrasse 155
3003 Bern, Switzerland
Annexes may also be submitted by email to lme@blv.admin.ch.
Last modification 14.11.2024
