What are food supplements?
Food supplements are concentrated sources of nutrients the purpose of which is to supplement the intake of nutrients found in the normal diet because, although under ordinary circumstances, an adequate and balanced diet provides all the nutrients necessary for the normal development and maintenance of a healthy body, research has shown that such an ideal situation is not always the case in practice in respect of all nutrients nor is it the case for all groups of the population.
Food supplements should be taken at the daily dose recommended on the product label and must not be exceeded.
Food supplements may not substitute for a balanced diet. A varied diet rich in fruit and vegetables may provide all the nutrients (vitamins and minerals) that are required.
What substances are present in food supplements?
There is a wide range of nutrients and other elements that may be present in food supplements, which include vitamins, minerals, amino acids, essential fatty acids, fibre and different plants and herbal extracts.
In the case of vitamins and minerals, it is essential that the chemical substances used in the manufacture of food supplements are not only safe but are also absorbed by the body, the reason for which a positive list of these substances has been compiled by regulation.
The substances that have been approved by the Scientific Committee on Human Food can also be used in the manufacture of food supplements on the basis of the criteria indicated for use in the manufacture of foods intended for infants and young children and other foods for particular nutritional uses.
In compliance with Community legislation currently in force, national law only lays down specific rules governing the vitamins and minerals for use as ingredients in food supplements, while the specific rules governing other nutrients and ingredients for use in food supplements, such as amino acids, essential fatty acids, fibre and different plants and vegetable elements may be regulated at a later stage once adequate scientific data are available.
By application of the principle of mutual acknowledgement, food supplements that contain ingredients other than the vitamins and minerals indicated in the authorised lists may be placed on the Spanish market only in the event that it is verified that the product in question may be placed on the market legally in another European Union Member State. It is not, however, permitted to apply said acknowledgement to products coming from countries that do not belong to the European Union.
Levels of consumption
Bearing in mind that consumers may decide to supplement their intake of nutrients by consuming these products and given that an excessive, prolonged intake of said products may be hazardous to health, maximum levels for certain nutrients must be established to ensure that the normal use of these products according to the instructions of use provided by the manufacturer does not pose a risk to consumers.
Until such time as maximum levels of nutrients and other substances with a nutritional or physiological effect are not regulated by the European Union in respect of food supplements the pertinent reports compiled by the Scientific Committee on Human Food and by other international bodies of acknowledged scientific renown will be taken into account.
In addition, to guarantee that these substances can fulfil the purpose of supplementing the intake of vitamins and minerals in the normal diet, significant amounts of said substances have to be present in food supplements.
Authorisation and notification of food supplements
Prior authorisation is not required to be entitled to place food supplements on the market in Spain.
Nonetheless, to facilitate the effective control of food supplements, the person responsible for the placing of the product on the market in Spain has to notify the competent authorities of its placing on the national market and send them a sample of the product label prior to or simultaneously with the first placing of the product on the Spanish market.
Labelling, presentation and advertising
The general criteria of labelling, presentation and advertising of food supplements must be adhered to.
They must be placed on the market under the name of «food supplement».
The labelling, presentation or advertising of food supplements may not include any claim declaring that a balanced and varied diet does not provide sufficient amounts of nutrients in general, nor may they attribute to food supplements the property of preventing, treating or curing a human illness or disease nor refer in any way to such properties.
Labelling is required by law to indicate the following:
- The name of the categories of nutrients or substances that characterise the product or an indication relating to the nature of said nutrients or substances;
- the dose of the product recommended for daily consumption;
- a warning not to exceed the daily dose expressly recommended;
- an Express affirmation that food supplements must not be used as a substitute for a balanced diet;
- an indication that the product must be kept out of the reach of younger children.
The amount of nutrients or substances having a nutritional or physiological effect on the product must be numerically stated on the label.
Frequently asked questions
Metabolic hypothesis relating to hepatic toxicity associated with the consumption of certain food supplements and foodstuffs intended for special diets, which might derive from slimming diets. A report compiled by the Scientific Committee of the AESAN