Commission Memo (MEMO/06/199), 16 May 2006
Why are vitamins and minerals added to food?
Vitamins and minerals can be added to foods for various reasons. They may replace some of the nutritional value lost when the food is being manufactured or stored. For example, iron and several types of vitamin B are added to wheat flour after processing.
They can be added to substitute foods that resemble ordinary food. The best known example of this is margarine. Vitamins A and D are added to margarine during production so it will have a similar vitamin level to butter.
Nutrients may also be added to foods to fortify or enrich them even if the vitamins and minerals added are not normally contained in that food. Calcium is often added to fruit juices and this can provide an important source for people who do not eat dairy products. Many studies show that not all EU citizens have a diet which provides all the nutrients they need. The growing popularity of convenience foods indicates that people have less time to shop for and prepare a meal which offers plenty of nutritional variety. It is estimated that in countries where manufacturers voluntarily add vitamins A and D to margarine and spreadable fats, this contributes about 20% of the recommended intake of vitamin A and about 30% of vitamin D for some groups of the population. Iron-enriched breakfast cereals have become the principal source of iron in young children's diets in the UK , replacing meat which was the main source of iron in the 1950s. Foods enriched or fortified with vitamins and minerals can therefore make a significant contribution to nutrient intakes.
That said, there are risks from over-consumption of certain vitamins and minerals. For example, pregnant women are advised against excessive intakes of Vitamin A, as this is thought to increase the risk of birth defects.
What would the Regulation on fortified foods do?
The proposed Regulation on Fortified Foods sets out harmonised EU rules for adding vitamins and minerals to food. It creates a list of the vitamins and minerals which could be added to foods and establishes the criteria for setting the minimum and maximum levels for such nutrients added to food, on the basis of scientific advice. All foods which contain added nutrients would have to be labelled to inform consumers about their nutritional value.
The proposed Regulation would not apply to foods intended to meet special nutritional requirements. Examples of these are: foods for infants and young children, foods to promote weight loss or foods for special medical purposes. These are covered by separate EU legislation. There is also separate EU legislation on food supplements, such as vitamin pills, which are clearly sold as concentrated sources of nutrients.
What about other substances added to food?
In recent years there has been a trend towards adding substances such as herbal extracts, amino acids and proteins to foods. Their addition is usually associated with a claim that the substance and the product may have a good effect on the customer's health. These substances are often found naturally in food, and yet are sometimes also added to foods in high concentrations. There is currently very little scientific evidence to show whether these substances are safe when they are taken in large quantities. The Regulation would establish a procedure involving the European Food Safety Authority (EFSA) which, for the first time, would allow the examination of these substances to assess any possible risk to human health. On the basis of the EFSA Opinion, a decision on possible restrictions on these substances will be taken by Commission and Member States through Comitology procedure.
Would the proposed Regulation affect compulsory fortification in some Member States?
No. Manufacturers often add nutrients to food voluntarily but in some Member States it is compulsory to add certain vitamins or minerals to some foods, such as adding the mineral iodine to salt to prevent iodine deficiency diseases. These national rules are dictated by public health considerations that are relevant to national or regional level and the rationale for their mandatory nature cannot be applied at Community level Therefore, the EU Regulation does not affect the compulsory addition of nutrients.
Would there be any restrictions on adding vitamins and minerals to certain foods?
Vitamins, minerals and other substances could be added to foods as long as the product did not pose a risk to the health of consumers. An important exception would be fresh food such as fruit, vegetables or meat that should be preserved in their natural state. Adding vitamins or minerals to alcoholic drinks would not be allowed, except for a specific”tonic wine” preparation manufactured in UK and Ireland .
Consumer organisations and some Member States are against adding nutrients to foods high in salt, sugars or fat which do not have a “desirable” nutritional profile.
They fear that adding vitamins or minerals would make these foods more attractive. These concerns are taken into consideration in the Regulation on nutrition and health claims which propose the establishment of nutritional profile for foods, taking into account their salt, fat or sugar content (see MEMO/06/200). Foods with added vitamins and minerals would have to respect the labelling rules as outlined in the nutrition and health claims legislation, which would mean that foods without a desirable nutritional profile would not be able to make such claims.
 This refers to the Population Reference Intake (PRI).
 Dietetic Foods intended for particular nutritional uses are covered by Council Directive 89/398/EEC which was amended by Directives 96/84/EC and 1999/41/EC.
 Food supplements are covered by Directive 2000/46.
 Agreed by the Commission and Member States , within the framework of the Standing Committee on the Food Chain and Animal Health