Food supplements follow the same rules as foods. It is always the responsibility of the producer or importer and seller of foods that the products are safe for the consumer. See articles 14 and 17 in Regulation (EC) No 178/2002 concerning general principles and requirements of food law. In addition to the general food legislation, food supplements must be in compliance with the rules in Directive 2002/46/EC. The Directive is implemented into Swedish legislation without national amendments.
There is no registration or notification procedure for food supplements at the National Food Agency. However, all producers or importers and sellers of food products, including food supplements, have to be registered at or approved by the municipality where the company is located.
Sometimes, it is difficult to determine whether a product should be classified as a drug or food. The Medical Product Agency make this decision and more information about classification of drugs can be found on their website. One important rule is that food supplements are not intended to prevent, treat or cure human disease. If this is claimed on the package or in the marketing of a product it will be classified as a drug.
Vitamins and minerals
There are no Swedish national amendments to the lists of vitamins and minerals or the chemical forms of vitamins and minerals that may be used in the manufacture of food supplements, see annex I and II respectively in Directive 2002/46/EC. The lists in annex I and II has been amended by Regulation (EC) no 1170/2009 to include additional substances. There are no maximum levels for vitamins and minerals in food supplements. It is the responsibility of the producer or importer and seller of food supplements that the products are safe.
Directive 2002/46/EC does not contain any "positive lists" of other ingredients, including herbs. However, there is a list of plants "unsuitable" in foods, VOLM. The list is based on toxicological evaluations carried out by the National Food Agency after receiving questions about various plants. The list is not exhaustive and is no legal document but serves as guidelines for food operators and food inspectors.
The European Food Safety Authority (EFSA) has developed a toolkit, consisting of two documents, for safety assessment of botanicals. The first is a guidance document on safety assessment of botanicals and the second a compendium of botanicals that have been reported to contain toxic, addictive or other substances of concern. The compendium is not exhaustive and will be updated continuously. The two documents are intended to guide food operators in their safety assessments and to support food inspectors in their control.
Ingredients that have not been consumed to a significant degree by humans in the EU prior to 1997 are considered as Novel foods. Such ingredients must be authorised by the EU-commission before they can be used in food supplements.
The labelling of food supplements sold in Sweden has to be in Swedish and comply with the rules in Directive 2002/46/EC as well as with the Community legislation on the labelling of foodstuffs.
Health and nutrition claims that may be used for food products are regulated according to Regulation (EC) 1924/2006 on nutrition and health claims made on foods. More information is found on the website of the European commission.