The French law which rejects food supplements from other EU countries with vitamins and minerals above the French national limits is contrary to EU law, according to a recent ruling of the Court of Justice of the EU.
The Court found that, whilst France could maintain its own maximum levels, the absence of a procedure for authorizing food supplements marketed in other EU countries with levels above those limits made the legislation contrary to the principle of mutual recognition.
It is expected that the ruling puts an end to a long-standing practice in France of refusing food supplements with vitamin and mineral levels above informally established maximum limits, irrespective of whether the products have been lawfully marketed in other EU countries.
The ruling may have a significant impact on food supplement sellers in France, who so far have been prevented from using vitamins and minerals exceeding informally established maximum levels (often slightly higher than the legal limits), even if the products are lawfully marketed in other Member States.
These informal levels correspond with recommendations of the French Food Safety Agency, sometimes decades old. In practice, new scientific information cannot be successfully invoked since the authorities base their assessment exclusively on the old recommendations. This has resulted in France maintaining certain stricter standards compared to the rest of the EU.
For example, France applies a maximum vitamin C level of 250 mg/day in food supplements, while Belgium and Italy have raised their maximum levels to 1000 mg/day since they acknowledge that no toxicity has been established for this level in the generally accepted scientific data, including the most recent national and international scientific publications.
COURT REMINDS FRANCE HOW MAXIMUM LEVELS SHOULD BE SET
Furthermore, the Court reminded France that setting maximum limits should be done on a case-by-case basis, taking into account the upper safe levels established after a comprehensive scientific assessment of the risks for public health. The analysis should be based not on general or hypothetical considerations, but on relevant scientific data.
The Court left to the national court to determine the conformity to EU law of the French system, which is based on the adoption of maximum limits in relation to the recommended daily allowances (RDAs) i.e. a value equal to three times the RDA for nutrients presenting the least risk, equal to RDAs for those presenting a risk of the upper safe level being exceeded and a value below those allowances or even zero for the nutrients involving the most risk.
SCIENTIFIC REPORTS CANNOT BE NATIONAL ONLY
Finally, the Court confirmed that maximum limits should be based on the most reliable scientific data available and the most recent results of international research. They may not be based merely on national scientific opinions, if recent international scientific opinions concluding in favor of the possibility of setting higher limits are also available on the date of the adoption of the measure at issue.
CONSULT LATEST DATA, COURT SAYS
The ruling explains that France should first of all implement a procedure in their legislation enabling firms to obtain the authorization to use levels of vitamins and minerals above the legal limits for food legally marketed or manufactured in other EU Countries.
In addition, since the most recent scientific data concluding in favor of higher limits should be taken into account when establishing legal maximum levels, any new scientific data should also be taken into account when assessing products marketed or manufactured in other EU Countries. Referring to old assessments if new information has become available, nationally or internationally, would run counter to the principles set out in the ruling.