Article 3 item 4 of the Austrian Food Safety and Consumer Protection Act (LMSVG), Federal Law Gazett I No. 13/2006, as amended, defines the term “food supplement” as:

"Foodstuffs the purpose of which are to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small-unit quantities."

Main Properties of Food Supplements

Food supplements are foods. Any misleading and disease-related claims made to market supplements are prohibited.

They supplement the normal diet. Food supplements are not intended as a substitute to general nutrition. As a result, they cannot replace a balanced diet and cannot compensate nutritional deficiencies caused by unhealthy and one-sided nutrition. The labelling and packaging of food supplements and their marketing must not claim or give an impression that a varied and balanced diet is not enough to supply the body with sufficient quantities of nutrients. Statements such as “the adequate supply of minerals to the human body is basically impossible as a result of our nutrient-depleted soil” are prohibited when launching food supplements. Furthermore, supplements must not carry a recommendation for “cosmetic use” (application to the skin).

Food supplements are concentrates. Thus, highly diluted products manufactured in a similar way as homeopathic products (e.g. Schuessler Salts, Bach Flowers) are not supplements.

Food supplements have a nutritional or physiological effect. Unlike medication, supplements are not intended to heal, alleviate or prevent human diseases.

Food supplements are marketed in doses. Stating a clear recommended dose is obligatory for supplements. Furthermore, when food supplements are marketed they must carry the information that the recommended daily dose must not be exceeded.

Food supplements are designed to be ingested in small, measured doses. Goods intended for ingestion in large quantities (e.g. one litre per day) are not considered food supplements.

Food Supplement Regulation

The essential cornerstones of the Food Supplement Regulation BGBl. II Nr. 88/2004, as amended, are:

Food supplements must only be distributed to the end-consumer as packaged goods. It is not permitted to use other substances than those vitamins and minerals listed in Appendix 1 in any other forms than those listed in Appendix 2 for the manufacturing of food supplements. The statutory term “Nahrungsergänzungsmittel“ (food supplement) must be used for food supplements in accordance with the Lebensmittelinformationsverordnung (LMIV – Food Information Regulation).

Labels of food supplements must contain the following information under all circumstances, in addition to the information in accordance with the Food Labelling Regulation (LMKV):

Nutritional Category and Recommended Doses

Category names of nutrients or other substances that are typical for the product or information on the properties of the nutrients or other substances, as well as the recommended daily dose in the units typical for the product in question.

Warnings

A warning not to exceed the recommended daily dose and a note that food supplements must not be used as replacements for a balanced diet. A third note should state that the product must be kept out of the reach of children.

Labelling

Labels and the visual appearance of food supplements and their advertising must not contain any hints claiming or giving the impression that the adequate supply of nutrients is impossible with a balanced diet.

Quantity

The amount of nutrients or other substances with nutritional or physiological effects contained in the product must be indicated on the label in numbers.
The indication of nutrient quantities or those of other substances must be shown on the label as a recommended daily dose.

Appendix 1 Units

The units provided in Appendix 1 must be used for vitamins and minerals.

One key problem in food law is the differentiation between foods and pharmaceuticals. Food supplements differ from “traditional” foods for the consumer on the basis of their presentation (capsules, tablets, etc.) and dosage alone. The purpose of all foods, including food supplements, is Nutrition.

The Austrian Federal Ministry of Health (BMG) has published Recommendations of the Codex Sub-Committee Food Supplements with regards to the maximum amounts of vitamins/minerals in food supplements, analysis tolerances in food supplements and plant parts used in food supplements.

Definition of Pharmaceuticals

When used in the human body or in animals, pharmaceuticals are substances or preparations of substances that, in accordance with the generally accepted standard or type and form of marketing, are intended to:

help recognise the condition or functions of the body or psychological conditions

replace active substances or body fluids produced by the human or animal body

fend off, eliminate or make pathogens, parasites and foreign substances harmless

heal, alleviate, prevent or identify diseases, ailments, damage to the body or pathological symptoms 

influence the nature, condition and function of the body and mind.

Abgrenzungsbeirat (Advisory Board on Classification)

The Advisory Board on Classification (Abgrenzungsbeirat) is a commission set up by the Austrian Federal Ministry of Health (BMG) (§ 49a AMG) to prepare expert reports in connection with questions concerning the legal differentiation between medicinal products and other goods. This commission acts solely on the behalf of the BMG or the Federal Office for Safety in Health Care (BASG). Individuals intending to place a product on the Austrian market can apply for an expert statement from the Advisory Board on Classification at the Federal Office for Safety in Health Care (BASG). This submission is subject to a fee pursuant to the agency’s fee regulation (Appendix VII.4 determination procedures according to Art.1 para. 3b AMG 1,000 EUROS).
However, note Art. 3 para. 1 of the procedures of the Advisory Board on Classification (Federal Law Gazette II No. 354/2006):

“The Advisory Board of Classification (Abgrenzungsbeirat) is obliged to prepare expert reports on behalf the Federal Minister of Health and Women or the Federal Office for Safety in Health Care on questions concerning the legal differentiation between medicinal products and other products, in particular in determination procedures pursuant to Art. 1 para. 3b Medicines Law and to advise them in questions concerning the legal differentiation between medicinal products and other products.”

Beyond that there are no comments on whether the good that is the subject of the expert report of the Advisory Board on Classification may be placed on the market according to its intended purpose in accordance with legislation. Testing products for their marketability (e.g. compliance with legal nutritional provisions) is not part of the expert report issued by the Advisory Board on Classification.

The expert reports of the Advisory Board of Classification and the reasons for its decision must be published on the BASG homepage, according to the “Regulation by the Federal Minister of Health and Women, which constitutes the procedures of the Abgrenzungsbeirat”, Federal Law Gazette II 354/2006. Further information on the Advisory Board on Classification (Abgrenzungsbeirat) can be found on the homepage of the BMG and BASG.