The widespread use of food supplements, the lack of regulation or differences between countries and the free movement of goods have made it necessary to introduce uniform regulations in the European Union. The European regulation comprises several stages. The first determines which vitamins and minerals may be used. In the second stage, they are quantified, while in the third stage a decision is expected on “other” nutrients and ingredients. The European directive, the first stage of the legislation, was adopted in 2002 and gave member states one year to incorporate it into their national law. Following accession in May 2004, Hungary was almost the first of the new Member States to implement the relevant EU-compliant legislation, which is contained in the EC Regulation on Food Safety and Health (Regulation No. 37/2004 (26.4.2004)). The new legislation represents a change from the previous, very strict national legislation.
In line with EU requirements, the prior mandatory authorisation has been abolished and replaced by a so-called notification requirement. This means nothing other than that the product label and the fiche must be submitted to the OÉTI no later than the day the product is placed on the market.
The system is not designed to prevent the product from being placed on the market, it only facilitates market surveillance by immediately notifying the State Health and Veterinary Service (ÁNTSZ), which is the primary competent authority, when a problem or hazard is identified, and this market surveillance authority is entitled to take further action. Many Member States do not even make use of the notification option; the authorities’ work is based solely on complaints or random checks.
The regulation specifies which vitamins and minerals may be used in food supplements, which compounds may be used and what minimum amounts of vitamins and minerals may be contained in the daily dose of a product (15% of the recommended daily dose). Unfortunately, the Regulation does not quantify the maximum amounts of vitamins and minerals that may be present in the daily intake of a product. Instead, it lists the factors to be taken into account when determining the maximum amount.
These are:
- the maximum safe amount of vitamins and minerals.
- the intake of vitamins and minerals from other foods.
- the recommended daily allowance (RDA) for vitamins and minerals for the population.
The maximum safe amount of vitamins and minerals should be established by a scientific risk assessment based on generally accepted scientific data, taking into account the individual sensitivities of different consumer groups. The maximum safe amount is the maximum amount of a nutrient that, when consumed regularly throughout the day, is not harmful to any member of the population. Representative nutritional epidemiological surveys of the population can be used to assess the nutrient intake of the population and different population groups.
This assessment should also take into account fortified foods. The new legislation is quite flexible regarding the amounts of vitamins and minerals, but it is clear that regular long-term consumption of vitamin and mineral supplements that are multiples of the recommended daily allowance is unnecessary and even undesirable.
Other substances of nutritional importance (e.g. proteins, amino acids, fatty acids, L-carnitine, taurine, natural antioxidants, plant components, extracts) will only be regulated at EU level at a later stage. Until then, these substances will be subject to national provisions, but these should not affect the free movement of goods. The free movement of goods will not be affected if a product is classified in a different product group in different Member States under the provisions (e.g. a food supplement becomes a food supplement or a medicinal product instead of a food supplement).