The Swedish municipality of Naka’s Planning and Environmental Services Committee instructed Greatlife Group, to stop selling vitamin D supplements citing the product’s daily dose of 123 micrograms (μg) to be a health risk to consumers.
However, Sweden’s final court of appeal reversed the decision made by the National Food Agency, which instructed Sweden’s municipalities on recommended ULs (Upper Limits) levels on vitamins and minerals.
‘No official, legally binding maximum permitted levels’
“There are no official, legally binding maximum permitted levels (MPLs) threshold values for vitamins or minerals, neither under Swedish law nor within the regulatory framework of the European Commission,” explained Rolf Forslund of Kenkou Selfcare.
“On the other hand, food supplement contents are regulated by the Food Supplement Directive 2002/46/EC, issued by the EU Commission with the aim of harmonising the trade of food supplements, and which is incorporated into Swedish law.”
The ruling received unanimous praise from the Nordic Food Supplements Alliance, formed in 2015 as a response to instructions issued by the National Food Agency, which the Alliance said had hurt sales.
In 2016, Swedish courts overturned a decision made in October 2013, by the local authority in Gävle, Sweden, which ordered Great Earth Scandinavia to reduce vitamin B6 (pyridoxine) levels of its supplements to “below the European Food Safety Authority (EFSA) set upper limit value of 25 mg per day”.
Mats Nilsson, managing director of Svensk Egenvård, another firm affected by Swedish authorities’ demands told NutraIngredients: “This last year we’ve seen several sales bans and both the industry as well as the authorities have been waiting for this court ruling for guidance. One other case has been closed with the same ruling and it refers to this one.”
The latest ruling
Court documents seen by NutraIngredients state the Committee’s decision was based on ‘the food supplement possibly entailing health risks for consumers and therefore not being regarded as safe in accordance with the EU law rules for food’.
As grounds for this assessment, the Committee referred to the European Food and safety Authority (EFSA) as having assessed the maximum safe daily dose of vitamin D to be 100μg.
Swedish-based Greatlife Group, distributor of the vitamins made by US Company Foodstate, countered arguing that the Committee did not conduct its own risk analysis.
The firm added that the Committee based its decision on the report by EFSA that was conducted back in 2012 and that it should not have been deemed ‘the authority’ in this matter.
“The issue concerned is of a working tool for the Commision’s ongoing work to produce supplementary rules,” the document stated.
“Subsequent research shows that significantly higher daily doses of vitamin D do not have any harmful or adverse effects.
“As no limits for vitamins in food supplements have been determined, the company has not breached any rules and there are therefore no grounds to intervene against the sale.”
Most recent research crucial
Speaking after the verdict, Forslund said if and when MPLs vitamin or mineral threshold values were imposed within the EU or at a national level, the EU’s Court of Justice (CJEU) had already stated that the most recent research had to be taken into account.
“The balance between risk and benefit must also be given more careful consideration according to the European Commission and risk assessment institutions like TNO,” he added.
“However, MPLs threshold values are not really needed, neither nationally or within the EU. Again, the CJEU has already clearly established that food supplement labelling that gives the consumer clear information is the most proportionate measure.
“This allows free trade between the Member States to continue whilst at the same time provides adequate protecting to the consumers. Many EU countries already practice this.”
Marcus Angström, attorney at 7WISE Law Firm and Greatlife Group’s legal representatives said he had great sympathy for the affected companies suffering from the National Food Agency’s and many municipalities’ ‘erroneous actions’.
“I now presume that the National Food Agency will immediately align its instructions according to this verdict so that correct information from now on will go out to all the Swedish municipalities,” he added.