What differences between Swiss and EU rules?

Which texts govern supplements in Switzerland and the EU?

The Swiss framework: FSA, FSUAO and OAVMS

Three texts structure Swiss legislation applicable to food supplements. The Federal Act on Foodstuffs and Utility Articles (FSA, SR 817.0)^[1] and its implementing ordinance, the Foodstuffs Ordinance, form the base of general food legislation. The text specific to supplements is the FSUAO (SR 817.022.14)^[2], enacted by the Federal Department of Home Affairs on 16 December 2016^[2]. The FSUAO sets, in its Article 2, the legal definition of supplements^[2]: concentrated sources of nutrients or other substances with a nutritional or physiological effect, packaged in doses, intended to supplement the normal diet and not to replace it. Its Annex 1 lists the admitted ingredients — vitamins, mineral salts and other active substances — with their maximum daily quantities^[2]. The OAVMS (SR 817.022.32) completes this framework by listing in its Annex 4 the substances banned in supplements (lactulose, melatonin, Monascus purpureus)^[2], which are subject to a separate therapeutic regime.

The European framework: Directive 2002/46/EC

The EU harmonised the definition and labelling of supplements through Directive 2002/46/EC of 10 June 2002^[3], transposed into each national legislation. The directive sets a harmonised positive list of admitted vitamins and mineral salts (Annex I) and the usable formulations (Annex II)^[3], with a mandatory nutrition declaration. By contrast, it does not set harmonised maximum quantities^[3]: each Member State applies its own thresholds, which explains the marked divergences in dosages and admitted ingredients. EFSA evaluates the risks, but the final authorisation rests with the European Commission. The directive does not cover plant-based substances: their framework remains partially national, and a phytomedicine may fall under a different therapeutic regime depending on the Member State.

On which substances and dosages do the rules diverge?

Substances banned in Switzerland but admitted in certain EU countries

Several substances authorised in certain EU countries as supplements are classified as medicines in Switzerland and inaccessible without a prescription. Melatonin is the most telling example: in Germany, it is sold freely in chemist shops up to 1 mg per tablet^[4]; in France, preparations under 2 mg per dose are available without prescription. In Switzerland, it appears in Annex 4 of the OAVMS as a substance banned in supplements^[2]: only Circadin® 2 mg and Melatonin-Mepha 2 mg, authorised by Swissmedic^[4] for primary insomnia from age 55, are available, on prescription. Red yeast rice (monacolin K) follows the same logic: strictly regulated in Switzerland^[2], it remains sold in the EU under certain dosage limits. The boundary between foodstuff and medicine accounts for most of the practical divergences between the two systems.

Maximum dosages: Swiss ceilings, European heterogeneity

The FSUAO sets, in its Annex 1, maximum quantities per recommended daily dose for each admitted vitamin and mineral salt^[2]. The maximum-quantity model revised in July 2020^[5] rests on the tolerable upper intake level (UL) defined by EFSA, reduced by the estimated baseline nutritional intake from the usual diet^[5]. Switzerland sets, for example, the vitamin D ceiling at 70 µg per daily dose^[2], whereas the EFSA UL for adults reaches 100 µg per day^[5]. The EU had planned to harmonise the maximum contents under Directive 2002/46/EC^[3], but this exercise never came to fruition. Consequence: a vitamin supplement compliant in a Member State may exceed the Swiss thresholds, which creates practical import and export gaps. For substances classified as novel foods (negligible consumption before 15 May 1997), prior authorisation is required in both systems — by the European Commission for the EU, by the FSVO for Switzerland — and a novel food authorised by the EU is not automatically admitted in Switzerland^[12].

How do Cassis-de-Dijon and the FSVO procedure work?

An explicit exception for foodstuffs

The Cassis-de-Dijon principle, transposed into Swiss law in Art. 16a-16e of the Federal Act on Technical Barriers to Trade (FATTB, SR 946.51)^[6], in principle allows products originating in the EU or EEA and legally marketed there to access the Swiss market without prior control. A specific exception targets foodstuffs: under Art. 16c FATTB, a food product that does not meet Swiss technical requirements requires prior authorisation from the FSVO before its first placing on the market^[7]. Supplements are part of foodstuffs under Art. 1 of the FSUAO^[2]; they therefore fall within this exception^[8]. The Confederation has justified this legal regime by the particular sensitivity of the food sector in matters of public health and protection against deception^[7].

The FSVO decision of general scope

The FSVO issues the authorisation in the form of a decision of general scope, valid for all comparable products^[7]. Once published, the decision automatically applies to all foodstuffs of the same nature marketed on Swiss territory, and not only to the applicant’s product^[8]. The importing business must prove two elements: that the supplement is legally sold in an EU or EEA Member State, and that it meets the technical requirements of that State (Art. 4 to 11 of the OPTFMR^[9]). The office then assesses health safety and compliance with consumer information rules^[8]. Only two grounds justify a refusal: risk to health or risk of deception (Art. 16d para. 1 FATTB^[6]). According to the Fédération romande des consommateurs, the FSVO has published 41 decisions of general scope concerning foodstuffs since 2010^[10]. The official list is available at cassis.admin.ch.

Private importation: a separate regime

Art. 2 para. 4 let. b of the FSA exempts foodstuffs intended for private domestic use^[1]. A private individual may order online from a European site or bring back from France, Germany or Italy a supplement that does not comply with the FSUAO for personal consumption, under their own responsibility. The exception does not cover resale, free distribution to third parties or commercial importation by a professional, which remain subject to the FSVO regime^[8]. This private regime also does not cover products reclassified as medicines by Swissmedic: melatonin, DHEA and growth hormones imported privately are seized by the Federal Office for Customs and Border Security (FOCBS)^[4], as are certain phytomedicines subject to prescription. The SECO negative list of products excluded from Cassis-de-Dijon is regularly updated^[11].

Which grounds block an authorisation and what mistakes should be avoided?

Three EU-Switzerland gaps most often cause a refusal

Exceeding the thresholds, novel-food status and non-compliant labelling dominate the grounds for rejection. The Swiss thresholds for vitamins and mineral salts (Annex 1 of the FSUAO^[2]) are often lower than those applied in Member States such as Germany or the Netherlands. A European supplement dosed at 100 µg of vitamin D cannot be distributed as is in Switzerland^[2], even when authorised in France. Ingredients qualified as novel foods by the FSVO require a separate procedure, independent of Cassis-de-Dijon^[12]. The labelling must meet the conditions of Art. 36 of the Foodstuffs Ordinance before the dossier is filed, including nutritional information and the mention of authorised claims (Annex 14 of the FIO). Health protection takes precedence: no Cassis-de-Dijon derogation can justify exceeding a national health threshold^[7].

The most frequent importer mistakes

Confusing EU compliance with access to the Swiss market remains the most costly mistake. A product compliant with Directive 2002/46/EC^[3] and legally sold throughout the EEA is not automatically authorised in Switzerland: commercial resale requires an FSVO decision^[8]. Second common mistake: translating the label after the dossier is filed, whereas Art. 36 of the Foodstuffs Ordinance requires labelling in German, French or Italian as soon as the product is placed on the market. Third mistake: ignoring the Swissmedic dimension. A plant-based supplement may be reclassified as a medicine if its pharmacological effect is established, which shifts the authorisation outside the FSVO’s scope^[4]. The cantonal enforcement authorities order the compliance measures (Art. 34 FSA^[1]); the product may be confiscated, rendered harmless or disposed of at the business’s expense. Infringements are forwarded to the criminal prosecution authority (Art. 64 FSA^[1]). The FOCBS controls compliance at the border, and the importer remains responsible even when buying the product already labelled from a European supplier.

Frequently asked questions