The 'addition of vitamins and minerals and of certain other substances' to food regulation (AVM) came into force on July 1, 2007, and like the Food Supplements Directive of 2002, is built around positive lists of vitamin and mineral forms that companies can add to products - in this case, certain foodstuffs.
The FSA guidance highlights key areas for companies to consider when adding nutrients to foods.
Minimums and maximums If companies wish to make claims in relation to an added nutrient, there must be a significant amount in the food - generally 15 per cent of established Recommended Daily Intakes (RDIs) per 100g or 100ml for most nutrients on the positive lists.
However, minimum amounts can be established for specific foods or categories that may differ from the established norms.
With this in mind, an up-to-date list of minimum amounts is available at the EU government website's food, labelling and vitamins section.
"We would strongly advise you check this to ensure you comply with the correct minimum amount," FSA said.
If nutrients are simply replacing those lost in processing and no claims are made, then no such concerns over minimum amounts are necessary.
EU work being carried out on both minimum and maximum safe levels would apply to the AVM when it was complete, perhaps in 2009.
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It is worth noting that, just as with minimum levels, maximum levels will apply to the total amount of a vitamin or mineral in the product after addition and will take into account naturally present levels," FSA stated.
The FSA noted a regulatory review was underway for cases where vitamins and minerals were combined with other nutrients to make nutritional compounds.
Nutrients added to the FSD positive lists would not automatically be added to the AVM list, as they would need to be verified in food use and require a separate evaluation.
Jurisdictions The regulation stipulates unprocessed foodstuffs such as fruits, vegetables, meat, poultry and fish cannot be fortified in any circumstance.
In accordance with the FSD, 'certain other substances' such as probiotics, fatty acids and nutrients such as glucosamine and chondroitin are being considered for inclusion to the AVM's positive lists.
The AVM applies only to foods and not food supplements or other categories such as flour and margarine, alcohol and genetically modified foods that are covered by specific pan-EU or national regulations.
Foods for particular nutritional purposes (PARNUTS) are also governed by separate legislation as are ingredients employed purely as additives, the addition of fluoride to water and novel foods and ingredients.
If substances are not included on the list, but can demonstrate a history of safe use in foods and beverages, they may continue to be used until 2014 as long as a dossier supporting their safe use has been submitted to the European Commission (EC).
If a negative verdict is returned by the EC in the meantime, then foods containing the substance will be required to be withdrawn from any of the EU's 27 member states in which they are present.
The vitamins listed in annex 1 of the AVM are vitamins A, C, D, E, K, B1, B2, niacin (B3), pantothenic acid (B5), B6, folic acid (B9), B12 and biotin (B7).
The minerals are calcium, magnesium, iron, copper, iodine, zinc, manganese, sodium, potassium, selenium, chromium, molybdenum, fluoride, chloride and phosphorus.
Derivative forms of these vitamins and minerals are listed in Annex 2.
The guidance document can be found at: http://www.food.gov.uk/multimedia/pdfs/ec19252006complianceguide.pdf.