Regulatory Status for Use in Dietary Supplements
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Regulatory Status for Use in Dietary Supplements
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Tomato Liquid Concentrate
Switzerland
This section provides a regulatory assessment for the use of Tomato Liquid Concentrate in Food Supplements in Switzerland.
1. Regulatory Background on Food Supplements in Switzerland
In Switzerland, a food supplement does not require official authorization nor a notification before being placed on the Swiss market. It is the responsibility of the food business operator (FBO) to comply with the following criteria:
A. The food supplement must be safe:
Figure 1. Article 8 of Swiss Food Ordinance 817.02 [1]English translation:
- "When assessing the safety of a food, consideration should be given to:
- the probable effects of this food on health, whether immediate, short-term, or long-term, not only for the person who consumes it but also for his offspring;
- probable cumulative toxic effects;
- particular health sensitivities of a specific category of consumers when the foodstuff is intended for them.
- When assessing the edibility of a foodstuff, consideration should be given to whether, taking into account the intended use, this foodstuff might not be suitable for human consumption due to the presence of foreign substances or contamination from another source, or due to putrefaction, deterioration or decomposition.
- During the assessments referred to in paragraphs 1 and 2, elements mentioned in article. 7 para 3 LDA1 should also be taken into account."
B. "Food" i.e. including food supplements and their ingredients must not fall under the scope of therapeutic products legislation as described in Art. 2, al. 4 of Swiss Food Law 817.0 [2]. In particular, substances that likely present a toxicological risk or have a pharmacological effect can only be used in medicinal products.
Figure 2. Excerpt from Article 2 al. 4 of Swiss Food Law 817.0 [2]
English translation:
Art, 2 Scope
"(…) It does not apply to:
- primary production of food for personal domestic use;
- the import of foodstuffs or everyday objects intended for personal domestic use;
- the domestic manufacturing, processing, and storage of foodstuffs or everyday objects intended for personal domestic use;
- substances and products subject to the legislation on therapeutic products."
C. The food supplement must fall under the definition of food as well as a food supplement:
Figure 3a. Excerpt from Article 4 of Swiss Food Law 817.0
English translation:
"Food means “all processed, partially processed or unprocessed substances or products which are intended to be ingested or which can reasonably be expected to be ingested by humans.”
Figure 3b. Excerpt from Article 1 of Swiss Ordinance
on Dietary Supplement 817.022.14 [3]
English translation:
"Dietary supplements are foodstuffs whose purpose is to supplement the normal diet. They constitute a concentrated source of vitamins, minerals or other substances having a nutritional or physiological effect alone or in combination, marketed in the form of doses."
To support the food business operator (FBO) with compliance with these requirements, the Swiss Federal Food Safety and Veterinary Office (FSVO) has issued a Question and Answer on food supplements for professionals [4] and a Letter of Information for the use of plants in food supplements [5].
The Q&A includes principles on the use of regulated substances and other substances not specifically regulated which may be added to food supplements:
Figure 4. Excerpt from Swiss authority FSVO Q&A on Food supplement
English translation:
"1. Which substances can be used in food supplements?
Art. 2 para. 3, of the Ordinance of the DFI on food supplements (OCAl; RS 817.022.14) [3] regulates the substances admitted in the food supplement. These may contain:
- vitamins and minerals listed in Annex 1, Part A, OCAl, conditions indicated therein;
- other substances, subject to the restrictions set out in Annex 1, Part B, OCAl;
- novel food admitted for the food supplement or authorized by the FSVO;
- other foodstuffs; the let. a to c are reserved.
In the context of self-monitoring, other substances than those listed in Annex 1, Part B, OCAl can in principle be found in the food supplement provided that all the requirements of the food legislation are complied with. […]"
Specific to botanicals, FSVO recommends the FBO uses the German list of authorized plants added to food [6] as a guideline when evaluating the safety of plants (see Figure 5).
Figure 5. Excerpt from Chapter 5 of FSVO Letter of Information for the use of plants in food supplements
English translation:
"The FSVO takes current developments into account and recommends using the German lists as a guide when assessing "substances" as foodstuffs or their ingredients. These lists do not claim to be exhaustive nor do they relieve the person responsible for placing it on the market of its responsibility to ensure that each product is safe and can legally be placed on the market as food.
It is possible that some classifications in Switzerland differ from those indicated in the above lists. In all cases, the relevant Swiss provisions prevail, whether it concerns the classification into specific categories (e.g. novel food), the requirements relating to each category of foodstuffs (e.g. infusions, food supplements, edible mushrooms), the list of prohibited plants, parts of plants and plant-based preparations or the delimitation in relation to medicinal products. The use of extracts of different “substances” for the purposes of flavoring is governed by the provisions of the Ordinance on flavorings."
In addition, FSVO and Swissmedic (Swiss Agency for Therapeutic Products) have published a guide of criteria for the delimitation between therapeutic products, foodstuffs, and utility articles [7], The latter indicates that therapeutically effective dosage of botanical is not permitted in food (including in food supplement), otherwise, the products fall under the scope of therapeutic products legislation.
Figure 6. Excerpt from Chapter 1, 1b of Swissmedic Guidelines on Criteria for distinguishing therapeutic products from foodstuffs with reference to orally administered products [7]
2. Permitted Use of Tomato Liquid Concentrate as an Active Ingredient in Food Supplements
As per the legal definition of “food supplement”, it must contain one or more characteristic ingredients such as vitamins, minerals, or other substances that have nutritional or physiological effects (see Figure 3b above). As a result, to be an active ingredient in food supplements, the tomato liquid concentrate must have such effects, otherwise, it can be used in food supplements as a ‘normal ingredient’ (for taste, coloring…) in association with active ingredients.
Tomato liquid concentrate is not listed in the Swiss List of Prohibited Plants and Preparation Thereof or the Swiss List of Prohibited Substances.
Furthermore, the German list of authorized plants added to food does not provide restrictions for tomato and their preparation (including tomato liquid concentrate).
Figure 7. Excerpt from German List of Botanical substances on Solanum lycopersicum
However, when formulating a supplement, manufacturers to take into consideration the fact that EFSA has set an acceptable daily intake (ADI) of 0.5 mg/kg body weight (bw) per day for lycopene from all sources [8].
For information, lycopene from tomatoes is authorized as a novel food in the EU (and Switzerland) with a maximal daily level in food supplements of 15 mg/day.
Figure 8. Entry for Lycopene from tomatoes in Regulation (EU) 2017/2470 [9]
Conclusion
In Switzerland, tomato liquid concentrate is permitted to be used as an active ingredient in food supplements. While there is no legal maximum limit, EFSA has set an ADI of 0.5 mg/kg body weight (bw) per day for lycopene from all sources.
3. References
1. Swiss Ordinance on Food 817.02
https://www.fedlex.admin.ch/eli/cc/2017/63/fr
2. Swiss Food Law 817.0
https://www.fedlex.admin.ch/eli/cc/2017/62/fr
3. Swiss Ordinance on Dietary Supplements 817.022.14
https://www.fedlex.admin.ch/eli/cc/2017/155/fr
4. FSVO Question and Answer on Food supplement for professionals
5. FSVO Letter of Information 2021/4 on Use of substance from plants, fungi, lichens, algae and preparations made therefrom as foodstuffs or their ingredients
6. German list of plant authorized added in food “Stoffliste des Bundes und der Bundesländer, Kategorie « Pflanzen und Pflanzen-teile » “
7. FSVO and Swissmedic - Criteria for the delimitation between medicaments, food-stuffs and utility articles
8. EFSA assessment on the safety of lycopene in foods
https://www.efsa.europa.eu/en/news/efsa-assesses-safety-lycopene-foods
9. Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R2470-20230412
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