In Switzerland, Novel Food status (“new type of food”) is particularly important before placing a new ingredient on the market in a food supplement.

1. When is an ingredient considered a Novel Food?

A food or ingredient is generally considered a Novel Food when its human consumption in Switzerland or the EU was negligible before 15 May 1997 and when it falls within a category covered by Swiss regulations, including new substances, microorganisms, fungi, algae, innovative processes, or foods derived from new technologies.

⚠️ Key point for food supplements:
Novel Food status must be assessed on an ingredient-by-ingredient basis and cannot automatically be transferred from :
– a plant to its extract;
– leaves to roots;
– a raw material to a concentrated extract;
– one manufacturing process to another.

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2. Steps to be considered in Switzerland

Step 1 — Conduct an Internal Novel Food Status Assessment

The company responsible for placing the product on the market must carry out this assessment as part of its self-monitoring procedures. The following elements should be investigated in particular:

• the exact identity of the ingredient;
• its origin;
• its composition;
• the manufacturing process;
• the form in which it is used;
• its human consumption history;
• evidence of significant consumption prior to 15 May 1997 in Switzerland or the European Union.

This assessment must be documented and made available to the cantonal enforcement authorities. The documentation should include:

• conditions of use;
• proposed daily intake;
• ADME data;
• toxicological data;
• nutritional data;
• allergenicity assessment;
• available scientific and clinical studies.

The FSVO (Federal Food Safety and Veterinary Office) subsequently assesses the safety of the product before issuing its decision.

Step 2 — Check Available Databases and Lists

For a high-quality assessment, the following sources can be reviewed, for example:

– the FSVO Novel Food Catalogue;
– existing Swiss authorisations;
– lists of Novel Foods authorised in the European Union;
– specific conditions of use;
– any dosage restrictions or restrictions relating to product categories;
– scientific literature demonstrating a history of food consumption prior to 1997.

The FSVO indicates that Novel Foods authorised at EU level may, as a general rule, also be marketed in Switzerland. Provided that the applicable Swiss requirements and the specifications set out in the relevant authorisation are complied with.

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3. If Novel Food Status is Confirmed

If your assessment concludes that the ingredient is a Novel Food, an authorisation must be obtained before it can be placed on the market.

The Swiss procedure involves two main phases:

Phase A — Confirmation of Novel Food Status by the FSVO based on:

• the application form;
• your status assessment;
• documentary evidence;
• evidence demonstrating the absence or existence of a history of consumption.

The FSVO then officially assesses the status of the ingredient.

Phase B — Scientific Safety Assessment

If the ingredient is confirmed as a Novel Food, a technical dossier must be submitted. This may include, in particular:

• identification and characterisation of the ingredient;
• composition and specifications;
• manufacturing process;
• contaminant analyses;
• stability data;
• conditions of use;
• proposed daily intake;
• ADME data;
• toxicological data;
• nutritional data;
• allergenicity assessment;
• available scientific and clinical studies.

The FSVO then evaluates the safety of the ingredient before issuing its decision.

4. Special Case: Traditional Novel Food

An ingredient may fall under the status of a traditional Novel Food when it:

• originates from a third country;
• is novel in Switzerland and the EU;
• has a history of safe food use for at least 25 years in the third country;
• meets the applicable regulatory requirements.

In this case, the procedure may be simplified. However, it is necessary, in particular, to demonstrate the history of safe consumption and provide analytical data representative of the product.

The assessment of a complete dossier may take approximately 12 months, depending on the complexity of the product and the quality of the submitted dossier.

CONCLUSION :

The regulations applicable to food products are constantly evolving.

From product development through to commercialization, a wide range of regulations must be taken into account. These may relate, for example, to recyclability, environmental sustainability, or the sourcing of ingredients and components. It is essential to have a thorough understanding of these requirements in order to ensure full compliance with the applicable regulatory framework.

Looking to bring your beauty and wellness products to the Swiss market? Surround yourself with regulatory experts who understand the Swiss market and its specific requirements.

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