Safe levels of vitamins and minerals
The issue of safe levels of vitamins and minerals in food supplements has been a controversial one. After years of national-level court cases between the producers and representatives of regulatory authorities, the European Court of Justice finally took a closer look at the issue.
In the judgment of the Court of 27 April 2017, in case C‑672/15, the court ruled as follows:
- Member States (MS) are expected to establish procedures which allow marketing of food supplements which are legally marketed in other MS and which contain vitamins and minerals in amounts exceeding the limits established by the target MS as lack thereof should be considered an infringement of the free movement of goods rule as well as Directive 2002/46/EC.
- Establishment of upper limits for vitamins and minerals must be done on grounds of scientific risk assessment, taking into consideration the available data and on a case-by-case basis, which includes:
- upper limits for respective substances,
- upon scientific risk analysis for public health,
- based on appropriate scientific data, not general or hypothetic.
It is up to national courts to decide whether these requirements have been met.
- While establishing their maximum levels for vitamins and minerals, MS may not refer only to national scientific opinions while there are new, multinational opinions available, which allow for higher doses of vitamins and minerals.
- In order to withhold the product from marketing on grounds of public health and safety (art. 36 of the Treaty) MS must be able to demonstrate on grounds of trustworthy and up to date, multinational data that consumption of the respective supplement poses a real threat to public health.
Full text of the judgement is available under this link:
The reason for the judgement was the peculiar practice of French authorities aiming to establish maximum levels for vitamins and minerals according to three rules:
- for low-risk nutrients the maximum level equals three times the recommended daily allowance
- for medium-risk nutrients the maximum level equals the recommended daily allowance
- for high-risk nutrients the maximum level is below the recommended daily allowance
This practice was controversial as it was unjustified, which led to many products not being allowed to be sold in France, despite being legally sold in other MS.
It is noteworthy that there are no EU laws on maximum levels for vitamins and minerals in food supplements. Pursuant to
art. 5 sub. 4 of Directive 2002/46/EC, the European Commission is allowed to establish such levels but has yet to do so.
In lack of EU law on this subject, regulatory authorities throughout many MS refer to scientific opinions, such as the
Orientation paper which is a working document prepared for the Commission. This document has no legal power and therefore it is debatable whether or not regulatory authorities may refer to it while issuing decisions in individual cases. This problem was already assessed by a Swedish court which ruled that the said document may not be used to justify legally binding decisions (Great Earth Scandinavia case).
The judgement of the ECJ is of vital importance to companies planning to sell their products in France, as well as for all regulatory authorities of the MS as it provides an important guideline as regards the free movement of goods rule, in this case – of food supplements.