- What are food supplements?
- Regulations on food supplements
- Registration, approval and notification of food supplements
- What substances may be included in food supplements?
- Novel food
- Maximum levels for certain contaminants
- How should food supplements be labelled?
- Nutrition and health claims
- Import of food supplements
- This is not food supplements
Food supplements supplement a normal diet by providing concentrated sources of nutrients or other substances. These substances should have nutritional or physiological effects. Food supplements may for example contain vitamins and minerals or various types of plant extracts, amino acids, fatty acids or fibres.
The form of supplements can vary as they can be taken as pills, capsules etc but also in liquid form, to be taken with for example a teaspoon or tablespoon. Some supplements, such as effervescent tablets or powders, may need to be dissolved in liquid before ingestion. Common to all supplements is that they should be taken in measured small unit quantities.
Food supplements are regulated as foodstuffs in accordance with European food law, as well as the Swedish Food Agency’s Regulations on food supplements (LIVSFS 2003:9) (Föreskrifter om kosttillskott) which serves to implement Directive 2002/46/EC on food supplements.
In Sweden, general matters relating to food law are governed by the Food Act (SFS 2006:804) (Livsmedelslagen) and the Food decree (SFS 2006:813) (Livsmedelsförordningen).
Food business operators are responsible for ensuring that their products are safe and comply with the requirements of food law before they are placed on the market.
The Swedish Food Agency provides guidance on the regulations of food supplements (kosttillskott) to facilitate correct application. This guidance is in Swedish.
There is no notification procedure in place for placing food supplements on the Swedish market. However, all food business operators (for example manufacturers, wholesalers or retailers of food products) have to be registered or approved.
Only safe food may be placed on the market. It is the responsibility of the food business operator to ensure compliance with this requirement according to general EU food law (regulation (EC) no 178/2002).
Vitamins and minerals
The use of vitamins and minerals in food supplements is harmonized within the EU by Directive 2002/46/EC. Only those vitamins and minerals listed in Annex I, in the forms listed in Annex II, may be used in the manufacture of food supplements. It is possible for food business operators to apply for approval from the European Commission for new chemical compounds, in which case, the lists may be updated. The European Commission's website contains instructions regarding the application.
On behalf of the government, the Swedish Food Agency has reviewed the need for national maximum levels and this has led to a proposal of new national regulations introducing maximum values for 23 vitamins and minerals in food supplements.
Only safe food may be placed on the market. This is important to keep in mind, as there are currently no maximum values in the EU for vitamins and minerals in food supplements. To ensure food safety, producers or retailers should instead rely on levels scientifically proven to be safe. The European Food Safety Authority (EFSA) has established what are known as “UL values” for various vitamins and minerals. UL stands for tolerable upper level and corresponds to the highest daily amount of a vitamin or mineral that is unlikely to pose a health risk to humans. These values refer to the intake of the respective nutrients from all sources (i.e. not just from food supplements), and can be used by food business operators when developing new products. The website of the European Food Safety Authority's (EFSA) includes an overview table of all UL values.
Vitamins and minerals can be used for purposes other than enriching food, for example as additives to have a technical effect on the product. Regardless of whether vitamins and minerals are used as additives or nutrients, they must meet certain requirements, such as purity requirements, which limit the content of heavy metals.
Unlike vitamins and minerals, there are no regulatory lists of other substances with nutritional or physiological effect. The European Commission is also not expected to propose such lists. On the other hand, Annex III to Regulation (EC) No 1925/2006 contains a short list of substances that are prohibited, restricted, or under Community scrutiny.
Plants or parts of plants
Food supplements often contain extracts of plants or parts of plants and there is often inadequate knowledge about their mode of action and which levels can be tolerated by humans.
The European Food Safety Authority (EFSA) has gathered information about plant or plant parts which have been reported to contain toxic, addictive or other hazardous substances. The resulting database is not exhaustive, but is meant to be a toolkit intended to guide food business operators in their safety assessments and support food inspectors in their official control.
Regulation (EC) No 1333/2008 on food additives regulates which additives may be used in food supplements. Annex II of the Regulation sets out the additives that are allowed in food supplements and the conditions under which they may be used.
Novel food are foods or food ingredients that have not been consumed within the EU to any significant degree prior to 15 May 1997, the date when the regulation on novel food came into force. Novel food have to be authorised by the European Commission before they can be placed on the market. The European Commission has set up a database on food and food ingredients that are subject to this regulation. The database is not exhaustive, but it can serve as a tool for determining whether an authorisation is required before the food can be placed on the market.
Some substances are considered novel in “ordinary” food but not in food supplements.
There are some maximum levels harmonized within the EU. Among others, the maximum levels for lead, cadmium, mercury, PCB, dioxin and polycyclic aromatic hydrocarbon (PAH) are relevant for food supplements. See Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs.
Mandatory food labelling is within the EU is harmonized by Regulation (EU) No 1169/2011 on the provision of food information to consumers. See also the Swedish Food Agency’s Regulations LIVSFS 2014:4 on food information that requires mandatory information to be in Swedish. LIVSFS 2003:9 on food supplements implements Directive 2002/46/EC on food supplements.
Note that food supplements do not need to be labelled with a nutrition declaration. Instead the quantity of the nutrients and other substances with a nutritional or physiological effect must be indicated.
The Swedish Food Agency recommends referring to herbals by their Swedish name. For herbals with no name in Swedish, the scientific name should be used, including both genus and species.
In addition to the general labelling rules the labelling of food supplements should include
- the word “food supplement”
- the names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances
- the daily dose
- a warning not to exceed the recommended daily dose
- a statement that it should not be used as a substitute for a varied diet
- a statement that the products should be stored out of reach for young children
- the amount of the nutrients and other substances with a nutritional or physiological effect.
The Swedish Food Agency’s Kontrollwiki website contains specific requirements for food supplements, as well as general advice and examples of compliant labels.
It may be of interest to producers and marketers of food supplements to make nutrition or health claims in the labelling of their products. This labelling is voluntary.
Nutrition and health claims that may be used in the labelling and marketing of foodstuffs are governed by Regulation (EC) No 1924/2006. According to the Regulation, only authorised nutrition and health claims are allowed. These are listed in a single EU register.
When importing food of animal origin from a non-EU-country into the EU, the goods must be inspected at the EU border. Products shall originate from an EU-approved country and establishment.
Most of the products of non-animal origin imported to Sweden from countries outside the EU do not require border control. But there are some exceptions as you will find when reading the information on the links below.
The labelling requirements for online, distance-selling and selling in a store are largely the same, according to Regulation (EU) No 1169/2011. But there are some additional rules for online sales.
The name ‘food supplement’ may be used for products that comply with the Directive 2002/46/EC and the Regulations LIVSFS 2003:9.
Food supplements must not be readily confused with medicines or food for special medical purposes.
Sometimes, it is difficult to determine whether a product should be classified as a drug or food. The Swedish Medical Products Agency is responsible for the classification. 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 such a claim is made on the package of a product or in marketing, the product is likely to be classified as a drug.
Products containing cannabidiol (CBD) are in some cases medicinal products. The Swedish Medical Products Agency has decided to ban the marketing of a number of products containing CBD on the basis of pharmaceutical legislation. These products were previously sold as food supplements, which is not allowed.
In cases where the products are not considered to be drugs, the extracts of Cannabis sativa L containing cannabinoids are considered novel foods, because no history of consumption has been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient, as provided in the EU Novel Food Catalogue.
Food for special medical purposes
Foodstuffs within this category are products used for the dietary management of various “diseases, disorders or medical conditions”. These foods are intended for the exclusive or partial feeding of people whose nutritional requirements cannot be met by normal foods.