The following listed laws and regulations regarding industrial law are only available in the three official national Swiss languages: German, French, and Italian.
Swiss legislation
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455 |
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631 |
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812.121 |
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813.1 |
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814.01 |
Bundesgesetz vom 7. Oktober 1983 über den Umweltschutz (Umweltschutzgesetz, USG) |
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814.5 |
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916.40 |
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944 |
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941.20 |
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946.51 |
Bundesgesetz vom 6. Oktober 1995 über die technischen Handelshemmnisse (THG) |
The following listed laws and regulations regarding drug law are only available in the three official national Swiss languages: German, French, and Italian.
Swiss legislation
The last revisions of Swiss Food law took place to adapt the law to the European provisions concerning the foodstuffs sector. The partial revision of the THG (see „Cassis de Dijon “- principle) enables Swiss producers to invoke European law.
The following listed laws and regulations regarding food law are only available in the three official national Swiss languages: German, French, and Italian.
Swiss legislation
Gesetzgebung Europa
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BAG |
Übersicht über die geltenden europäischen Richtlinien und Verordnungen |
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EU |
The following links enable a direct access to the most important laws in the area of food law and drug law. Using the menu "Links" you will find further useful links in the area of intellectual property.
Food that is not circumscribed in article 4 (1) of the Swiss Regulation on food and commodities or by the Federal Department of Home Affairs, needs a grant from the Federal Office of Public Health. The registration of a new product is regulated by article 5 and 6 of the Swiss Regulation on food and commodities. This can be either a new or novel food for normal consumption or a new special food. The Federal Office of Public Health examines the composition, the intended purpose and the declaration, it determines the name under which the product is sold and assigns a grant number to be indicated on the packing or label. The grants can only be given to persons or societies with a domicile or place of business in Switzerland. Foreign applicants must appoint a representative in Switzerland, who must take responsibility for adherence to the regulations.
Admission of Food Manufacturing Businesses in Switzerland
Business operators who manufacture, process, treat, transport, deliver, import or export food must notify the responsible cantonal executive authority of their activity. Important modifications within businesses and cessation of business must also be notified (article 12 of the Swiss regulation on food and commodities). Enterprises that manufacture, process, treat, store, or deliver food of animal origin require an authorisation by the responsible cantonal enforcement authority (article 13 of the Swiss regulation on food and commodities). The Federal Office of Public Health has specified those enterprises that fall under the special arrangement of the grant obligation in its instruction No 7 of 26 January 2006 for the implementation of the two articles 12 and 13 of the Swiss regulation on food and commodities. It has also published, together with the federation of cantonal chemists, an information letter for enterprises on the obligation of notification and authorisation.
Article 31 (3) of the regulations on food and commodities (LGV) prohibits "references of any kind of illness-curative, -relieving or -preventing effects of food or commodities". The Swiss Federal Court has already judged several cases on this regulation. The Federal Court does not interpret the term of illness within advertisements and in connection with advertising messages in a restrictive sense. Advertising referring to health, as far as it is based on justifiable facts and does not mislead the public, is not forbidden by the aforementioned regulation. Thus, it may be pointed out in an advertisement that a regular consumption of milk is good for the health, because thereby the body will be naturally supplied with calcium, which appears to be favourable for the building of bones. On the other hand, the indication that the calcium in the milk helps to prevent "reduction of bone density in old age, so-called Osteoporosis" is unacceptable ("cow Lovely advertisement" in BGE 127 II 91/101).
The sense and purpose of the principal prohibition of medicinal effects are to prevent fundamental errors of the public and thus an at best unfit self-medication due to the stated illness-referred effects of food and commodities. Indications of preventing, treating or curing effects shall be scientifically confirmed and in principle developed in a drug-legal procedure. The manufacturer is required to place its product on the market as medication whereby the endangered public interests are then protected in the context of drug legislation. However, illness-specific advertising and thus health-endangering pseudo-science regarding products, which did not successfully pass the drug law procedure, shall be banned.
The drug law serves the protection of public health in particular by high requirements on the duty of care concerning the handling of medicaments and medicinal products by the pharmaceutical industry, pharmacists and physicians. This concerns above all the production, placing on the market, control, prescription, information and delivery of medicaments. The Swiss Federal law on medicaments and medicinal products (Federal drug act, HMG) is in force since 1 January 2002.
Legal questions in particular concern the way and the protection of a medicament from research to authorisation. In addition, the conditions for its placing on the national, European, and international market at a later date must be fulfilled. Whether a medicine is pharmacy only medicine, prescription only medicine or over the counter medicine, depends on many different criteria.
The Swiss Federal Court did not accept the following statements on cosmetic products:
According to art. 3 lit. c VKos the address of the person responsible for the product must be labelled. The indication of a domestic address (person responsible for placing on the Swiss market) is not required any more. In case of complaints however it must be guaranteed that the documents regarding the objected product can be consulted at the labelled address.
In Switzerland cosmetic product unlike foods still (!) are not ruled by a general prohibition of deception. Delicate information on cosmetic products concern health claims, including statements on the prevention of diseases. To that extent typically medical expressions have to be avoided as well as references to body or organ-specific effects.
Since May 1st, 2009 the Swiss definition of cosmetics in article 35 al 1 LGV is in accordance with the European definition. The former legal requirement that cosmetics may not „unfold any internal effect“ does not exist any more. However, cosmetics are commodities and thus „articles, which may not be advertised as drugs.“
The ingredients and compositions authorized in cosmetics result from a positive list in the appendices of the Swiss regulation on cosmetic products (VKos). In 2010 cosmetics will fall under the “Cassis de Dijon”-principle, which means that European law will be applicable as well.
Rentsch Partner Ltd. supports its clients with the classification, labelling and presentation of cosmetic products according to Swiss and European law.
The Swiss Food Act and thus food control in Switzerland covers beside food also the commodities (see Federal Act on Food and Commodities).
Articles of daily use and consumption (commodities) are products, which fall under one of the following product categories:
Commodities may not be advertised as drugs. They may not endanger the health of the human being within their intended or usually expected use.
The legal requirements on commodities result from the Ordinance on Food and Commodities (LGV), the Ordinance on Food Contact Material, the Ordinance on Cosmetics, as well as the Ordinance on articles for human contact.
Since July 2010, commodities fall under the “Cassis de Dijon” principle of the THG. Swiss producer will have the possibility to manufacture their export and national products according to the EC regulations or in the case of missing or incomplete harmonization according to the regulations of any EC/EEC-Member State. To that extent the European law will become applicable to Swiss consumer products.
Rentsch Partner Ltd. advise you comprehensively on questions in Swiss Commodities Law as well as in European Commodities Law
Serving guests in a restaurant implies a considerable risk of liability for the restaurant operator.
The contractual relation between guests and gastronomes comprises different contractual types relating to performances, in particular purchasing, work, services, supply of materials, order and rent. If the operator does not fulfil any of these contractual duties, a guest may demand cancellation or termination of contract, subsequent improvement, reduction of the price or compensation for damages.
An increased liability risk comes from the fact that running a restaurant implies special duties of care. Business operators, which work with foodstuffs and commodities and deliver these directly to the consumer, in particular those who produce, process, treat or store food, namely shops, restaurants, large-scale catering, canteen kitchen, (and by reference to European Law) casinos, nursing homes, hospitals, and kindergartens (definition, Art. 2 LGV) are responsible for the safe production of food according to Swiss Food Law. If the guest suffers a damage, the gastronome needs to prove that he has complied with the legal regulations and due diligence. Furthermore, the meals and drinks offered are subject to product liability of the business operator.
Restaurant operators and other retailers are well advised to take preventive steps to reduce the liability risk. This includes besides a public liability insurance the systematic organisation of the operating procedures according to the respective food laws and regulations with well trained personnel, sufficient documentation of the self-monitoring as well as adequate contractual agreements with the suppliers supporting the safety requirements.
If food law is violated and if there is a danger to health or in misleading of the consumer, the question of possible sanctions and liability for the responsible food businesses arises. Depending on the type of offence, the responsible person is subject to objections, orders or charges. In civil law, the question of product liability arises.
In public law, the principle of proportionality applies. A first goal is the re-establishment of legal status. An objection serves to resolve the offence by taking suitable corrective measures in an amicable way within the framework of an agreement between the authority and the food enterprise.
If this procedure is not sufficient, the authorities can make orders. Apart from concretely ordered measures, these can also contain sales bans, name prohibitions or prohibitions on advertisements and brochures.
If the violation constitutes a criminal offence (see articles 47 Federal Food Act), criminal proceedings will necessarily follow. Only in particularly minor cases may the authority issue a caution without a charge being laid (article 48 (3) Federal Food Act). At any rate, a complaint will be recorded in the case of endangerment of health (prison or penalty), of grave misleading (prison or penalty up to 20.000, - Swiss francs) and in the case of recurrence. In the area of advertising, a criminal procedure is also possible against media, publishing houses or the administration of advertisements through aiding and abetting (article 48 (2) Federal Food Law).
With the adjustment of the Swiss food law to the law of the European Union, the term "risk-based inspection" has been officially introduced into the activity of official food control. Thus, in the whole of Switzerland, inspection takes place based on risk evaluation.
The enterprises to be inspected are divided into 4 risk categories. This division results from the inspection results regarding self-regulation, food quality, hygienic processes and activities, as well as spatial-operational conditions. Considering further parameters such as production volume, consumers and the type of food produced, the enterprises are graded into risk categories, which serve as a basis for the order of the inspection. Food control more frequently concerns risky enterprises. In principle, detailed complaints over deficiencies and/or notifications of suspicion of food poisonings are given priority.
If hygiene control uncovers a shortcoming, the enterprises are usually obligated to clarify the causes of the shortcoming and to implement appropriate measures using the concept of self regulation in a meaningful way and to enforce them immediately. If the situation does not improve, there could be in-process inspections with costs.
According to the present Swiss definition of food tobacco is considered a luxury food and is regulated by the food law. Luxury foods may not endanger health in a direct or in an unexpected way within their usual use and benefit. Production, marking, advertisement and delivery of tobacco products and smoke goods with tobacco substitutes are regulated in the Ordinance on tobacco (TabV, SR 817,06).
Manufacturers and importers of tobacco products, must submit certain data concerning their tobacco products to the Federal Office for Public Health (BAG). These data are accessible for the public.
Packings of tobacco products must contain special information for consumers. Each packing of tobacco products, which is intended for smoking, must carry a general and a complementary warning. The complementary warning must be combined with selected photos in colour or other illustrations, which represent and explain the consequences of smoking for health. The references must be attached partially in all official languages, at a certain place and in a certain way and size.
Rentsch Partner Ltd. supports you with the marketing of tobacco products and products with tobacco substitutes.
The obligation for self-control is one of the most important principles of the Swiss Food Act (see article 23 Swiss Food Act). It applies to all business operators who manufacture, process, treat, distribute, import or export food, food additives or commodities.
The obligation for self-control has been incorporated in the Swiss Food Act since 1995. It was incorporated in the food law of the EU in 2002. The responsible person ensures within the businesses under their control that all stages of production, processing, and distribution of foods and commodities satisfy the legal requirements, in particular regarding to health protection, the protection against fraud, and the hygienic handling of food and commodities.
Self-control comprises the securing of good manufacturing procedures (article 52, 53 LGV), the application of quality management systems according to the HACCP concept (article 51 LGV), traceability (article 50 LGV) and the obligation of withdrawal and recall of unsafe food (article 54 LGV).
The required information and form of food labelling depend on the kind of food and on the position of the food business operator in the food chain. The Federal Swiss Food Act requires information on the country of production and the composition of the food (article 20 Swiss Food Act).
The Ordinance on food labelling and advertising (LKV) regulates in detail, which information shall be provided on food labels, how this information shall be presented, and how food may be advertised. The revision of the THG will facilitate product information in general (“Cassis de Dijon”). The valid strict regulations concerning the indication of the country of production and the raw materials on food will remain.
According to the Swiss food law food supplements are special foods, which contribute to obtain a certain nutritional-physiological effect (article 2 al 1, 22 Ordinance on Special Foods). If food supplements fulfil the special and general legal requirements, they are marketable without a special authorization.
The demarcation between food supplements and drugs often is problematic. To determine whether a product can be classified as a food supplement primarily the product composition (objective purpose) and in second place the presentation from the view of the manufacturer (subjective purpose) are decisive. A classification of plant materials results from a list of the FOPH.
Contrary to the European Union Switzerland has a positive list of the allowed health related allegations on food. New food supplements or food supplements with new health-claims require an authorization.
Rentsch Partner Ltd. attorneys-at-law and patent attorneys support you with the marketing of Food supplements and other functional foods according to the Swiss and the European legal requirements.
The Swiss Food Act and the regulations that are based on it require a clear distinction between food and drugs. In accordance with article 3 of the Food Act, food serves the development and maintenance of the human body and is not advertised as a cure. Cures are, according to articles 2 and 4 of the Swiss Drug Act, medications and medicinal products intended to detect, prevent and treat diseases, injuries or handicaps. This distinction serves to protect against fraud for the consumer and in the avoidance of risks to health if diseases are treated by unsuitable means.
In article 10 (2 c) of the Swiss Regulation on Food and Commodities, this prohibition against misleading the consumer with food is specified. Swiss law does not allow any references that attribute food characteristics to the prevention, treatment or healing of a human illness. However, "health promotions" that are not intended to deceive are legally permissible, such as notices on the nature and function of essential materials. Products with therapeutic indications are medications and require permission from the Swiss Agency for therapeutic goods (Swissmedic).
In principle, foodstuffs that are authorised in Switzerland are described by product-specific regulations. Products which are not specified in these regulations need authorisation from the Federal Office of Public Health (FOPH) (article 5 (1) Swiss Regulation on Food and Commodities).
Food business operators who produce, process, treat, store, transport, distribute, import or export food have to be registered (article 12 Swiss Regulation on Food and Commodities). Enterprises that produce, process, treat or deliver food of animal origin require authorisation, in principle. Exceptions to this requirement are possible (article 13 Swiss Regulation on Food and Commodities).
The principle of self-regulation applies to food business operators, i.e. they must ensure within the businesses under their control that legal requirements relevant to their activity are met. The criteria for how this control concerning food is to be accomplished is given in the "Swiss food book", as well as instructions, information letters, and manuals from the FOPH. In the case of the distribution of unsafe food or commodities, business operators must inform the relevant authorities.
The Swiss Food Act, the Regulation on Food and Commodities, and other pertinent regulations, form the basis for the execution and implementation of food law. The Federation is responsible for food control at the border. The Cantons execute the food act and provide for food control within Switzerland as far as the federation is not responsible. Administrative controls take place regularly, with appropriate frequency, and usually without advance notice. Administrative control does not replace the tasks and obligations that are to be fulfilled in the context of the personal responsibility of business operators.