Regulatory Affairs Directorate
Market Surveillance Directorate

Food Supplements (Consumers Perspective)

What are food supplements?

Food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect whose purpose is to supplement the normal diet. Most importantly, they are marketed 'in dose' form i.e. as pills, tablets, capsules, liquids in measured doses etc. since these are to be consumed according to a maximum recommended daily dose,  as indicated on product packaging.

Supplements may be used to correct nutritional deficiencies or maintain an adequate intake of certain nutrients. However, in some cases excessive intake of vitamins and minerals may be harmful or cause unwanted side effects; therefore, maximum levels are necessary to ensure their safe use in food supplements.                                                                                  

Are food supplements covered by a specific piece of legislation?

At European Union level, food supplements are covered by Directive 2002/46/EC relating to food supplements and which sets out harmonized rules for the labeling of food supplements, and introduces specific rules on vitamins and minerals in food supplements. 

The ultimate aim is to harmonise the legislation across European Union Member State markets as well as to ensure that products are safe and labeled in such a way that consumers can make informed choices.

At national level, food supplements are covered by the Food Supplements Regulations (Legal Notice 239/2003), and its subsequent amendments.  This legal notice is a reflection of Directive 2002/46/EC.  It however includes also specific rules for the Maltese market, such as the Third Schedule which sets out the maximum allowed doses for vitamins and minerals.  These were worked out taking into consideration Maltese nutritional habits and requirements.

Food supplements are also covered by the Labelling, Presentation & Advertising of Foodstuffs Regulations (Legal Notice 483/2004) with respect to aspects such as:-

  • A name;
  • A list of ingredients;
  • The amount of certain ingredients used;
  • A date mark;
  • Any special storage conditions or conditions of use;
  • The name and address of the manufacturer, packer or seller in the European Community;
  • Instructions for use;
  • The place of origin of the food; if failure to give it might mislead.

What kind of information should a food supplement label provide?

Food supplements have their own specific labeling requirements and a food supplement product label must include the following indications, as set out by regulation 6.4 of Legal Notice 239/2003:-

  • 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 portion of the product recommended for daily consumption;
  • a warning not to exceed the stated recommended daily dose;
  • a statement to the effect that food supplements should not be used as a substitute for a varied diet;
  • a statement to the effect that the products should be stored out of the reach of young children.

Moreover, the labeling, presentation and advertising of food supplements shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.

Very importantly, the labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties.

How can I be sure that the food supplement I am buying has been checked by the local authorities?

In order to place a food supplement (for sale) on the Maltese market, the manufacturer or importer is required by law to notify the Food Safety Commission by forwarding a model of the label used for the product, as set out by regulation 8.1 of Legal Notice 239/2003.

When purchasing food supplements, consumers may question the seller on whether or not a particular food supplement has been notified with the Malta Competition and Consumer Affairs Authority.  

What about herbal products? Can herbal products be used safely by everyone?

Food supplements containing herbs and/or botanicals (parts of plants which may include even bark or roots) are becoming very popular these days due to the purported safety of use.  Consumers may be told that such products are safe because they are ‘natural’.  Notwithstanding, one must exercise caution when dealing with such products since their effects may cause undesired interactions in persons who are already taking prescribed medication.  Therefore one is to always consult with their physician prior to consuming such products.