The National Food Agency’s (Sweden) instructions contravene Swedish and EU law

The Supreme Administrative Court of Sweden has affirmed in its judgment of 13 November 2018: Swedish municipalities that imposed a sales ban on food supplements acted in contravention of applicable Swedish and EU law.

In 2015, the National Food Agency issued a handbook to Sweden’s municipalities comprising instructions on how to implement controls of such items as food supplements. The agency handbook addressed the so-called recommended ULs (Upper Limits) levels from EFSA* (2006) on vitamins and minerals, although ULs are not officially prescribed as legally binding maximum permitted levels (MPL ́s) threshold values – neither in Sweden nor the rest of the EU.

Consequently, Swedish municipalities banned companies and retail stores from selling completely safe and legal products. This has entailed Swedish consumers missing out on products and caused companies to suffer considerable economic losses.

In accordance with the Supreme Administrative Court’s judgment of case number 3160-17, Swedish municipalities are not entitled to institute local sales bans on food supplements deemed to be safe in accordance with the Food Supplement Directive (FSD). Therefore, municipalities that have imposed a sales ban on a food supplement in reference to its quantity (levels) of vitamins or minerals have done so entirely without statutory support.

The National Food Agency’s handbook, Kontrollwiki, contains gross errors

“There are no official, legally binding maximum permitted levels (MPL ́s) threshold values for vitamins or minerals, neither under Swedish law nor within the regulatory framework of the European Commission. 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,” explains Rolf Forslund of Kenkou Selfcare AB, one of the companies seriously impacted by the National Food Agency’s erroneous information to municipalities.

Protests by both business owners and lawyers against the erroneous information in the National Food Agency’s control handbook were lodged with municipalities, government agencies and the minister responsible. However, no amendments have been made to the misleading information. Municipalities are still being encouraged to impose sales bans and to submit reports to the EU’s safety-alert system for hazardous substances in foodstuffs, the Rapid Alert System for Food and Feed (RASFF), if food supplements are found to exceed the so-called UL values.

 

“This means that Swedish municipalities are being encouraged to act arbitrarily, without any legal basis and that the crucial RASFF system is being abused,” Rolf Forslund continued. “This is very dangerous, as it undermines the system’s vital functions. RASFF is meant to warn of the presence of hazardous substances like poisons, heavy metals and bacteria (i.e. Salmonella) in food, not for vitamins in completely safe doses.”

A judgment by the Supreme Administrative Court is precedent-setting

“Now that this is a judgment by the Supreme Administrative Court, precedent has been set. “ Marcus Angström, attorney at 7Wise Law firm explains.

“It is completely unacceptable for companies and consumers to be subjected to such arbitrary treatment by Swedish government agencies. As business owners, we already apply the principles referred to in the Food Supplement Directive by means of clear labelling and the stipulated control procedures,” explains Patrick Wahlberg of Greatlife Group AB, which recently received an amendment to the previous ruling against its product with a daily dose of vitamin D 125 μg.

Government agencies must now conform to the court judgment

“I have 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 judgment so that correct information from now on will go out to all the Swedish municipalities.” says Marcus Angström, attorney at 7WISE Law Firm.

“If and when maximum permitted levels (MPL ́s) threshold values for vitamins or minerals are imposed within the EU or at a national level in Sweden, the Court of Justice of the European Union (CJEU) has already in related verdicts clearly stated that the most recent research has 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.” Rolf Forslund says.

“However, maximum permitted levels (MPL ́s) threshold values are not really needed, neither nationally or within the EU. Again, the Court of Justice of the European Union (CJEU) has already clearly established that food supplement labelling that gives the consumer clear information is the most proportionate measure that allows free trade between the Member States to continue whilst at the same time provides adequate protection to the consumers. Many EU countries already practice this. Västerås Municipality in Sweden has also recently begun to apply this principle since several administrative court verdicts have confirmed the validity of this practice. ” concludes Rolf Forslund.

The Judgment of case no. 3160-17 can be read in its entirety here: http://www.hogstaforvaltningsdomstolen.se/Templates/Pages/DV News.aspx?id=60310

Facts about the Supreme Administrative Court of Sweden: The Supreme Administrative Court of Sweden is the highest authority among Sweden’s administrative courts. Its primary function is to set precedents. The court tries the appeals of judgments and verdicts announced by the country’s four administrative courts of appeal. Out of the 9000+ applicants for rights to appeal in this court only about 2% (approx. 200 cases per year) gets approval to be looked at, when/if precendent-setting verdicts are needed.

Facts about the Nordic Food Supplement Alliance: In 2015, when erroneous instructions from the National Food Agency began to be applied, 12 of the companies impacted by the sales bans decided to jointly examine the decisions by legal means.

The companies in the alliance comprise: Alpha Plus AB, Bättre Hälsa AB, Edura AB (Thorne Research), Egenvårdspoolen AB, Great Earth AB, Greatlife Group AB (Innate Response), Holistic Sweden AB, Hälsokraft (chain store), Kenkou Selfcare AB (Lamberts), Nordic Premium Group AB (Solgar, Terranova, Nordiq), RevivaBio AB, Au Naturel Inc (Solaray). The legal and scientific coordinators comprised of Rolf Forslund and Lennart Holmgren, as well as Marcus Angström of 7WISE Law Firm.

*History: Sweden is divided into 290 municipalities, each being independently governing control authorities. The control handbook issued by the Swedish National Food Administration is presently known as Kontrollwiki. It is the means by which municipalities are informed that they can impose sales bans on food supplements exceeding so-called Upper Limit values derived from the informal preparatory work report for the discussion paper presented in 2006 by the European Food Safety Authority, EFSA. The contents of food supplements are regulated by the Food Supplement Directive 2002/46/EC, issued with the aim of simplifying trade in food supplements and increasing consumer protection. This directive is incorporated into Swedish law.

For further information, please contact:

Marcus Angström, 7WISE Advokatbyrå.

Rolf Forslund, Kenkou Selfcare AB.

Patrick Wahlberg, Greatlife Group AB.

Lennart Holmgren, Scientific Adviser.

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