The court ruled that since maximum permitted levels (MPLs) have not yet been mandated at EU level, an EFSA recommendation is not binding.
In October 2013, the local authority in Gävle, Sweden, ordered supplement manufacturer Great Earth Scandinavia to reduce levels of vitamin B6 (pyridoxine) in its supplements to “below the European Food Safety Authority (EFSA) set upper limit value of 25 mg per day”.
Sweden is one of four European countries without maximum levels for vitamins and minerals. The authority therefore based its decision on a 2006 report produced by the EFSA on tolerable upper limits for vitamins and minerals.
The report recommended an upper limit of 25 mg of vitamin B6 per day for adults, but it also acknowledged the need for “further developmental neurotoxicity studies”, as neurotoxicity had only been recorded after prolonged periods of treatment at high doses.
On 1st September this year, following an action brought by Great Earth Scandinavia with support from Svensk Egenvård – the Swedish trade association for manufacturers of nutritional products – a court repealed the local authority’s decision.
Sales ban has ‘no basis in law’
The administrative court ruled that the local authority’s decision “has no basis in law” and that the EFSA report has no legal status in Sweden.
“Non-compliance cannot be found because in Swedish and European Union law because no statutory legislation exists for upper limits for vitamins and minerals. It is the producer who is responsible for ensuring that its products are safe for the consumer,” the court stated in its decision.
The court pointed out that the EFSA report cited by the authority was intended as an advisory for the European Commission to inform the establishment of MPLs for vitamins and minerals.
“The Commission has, however, no timetable at this time with regards to if and when the maximum levels are to be determined,” said the court.
The court cited a 2012 review published on the EFSA website which indicated that the upper limits originally recommended for vitamin B6 were too low.
Great Earth isn’t the only supplement manufacturer to have been pulled up by Swedish authorities for exceeding the EFSA-recommended upper limits for vitamin B6.
A test case
Mats Nilsson, managing director of Svensk Egenvård, 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.”
As a result of the recent ruling, sales bans have been lifted on several vitamin B6 products containing up to 75 mg of the micro-nutrient, including those sold by Great Earth Scandinavia.
Nilsson described the court decision as “a huge win for the industry”.
“I’m very pleased as it defends the law as it is meant to work. This whole problem occurred when municipalities started to use the EFSA report as some kind of law. This is a misinterpretation of the law. The court ruling clearly states that the law has not changed.”
He added: “If there ever is a consensus within the EU regarding vitamin B6 levels I’m sure Sweden will adopt and follow it to the letter. However, I don’t see that happening for many years.”
Although the ruling represents a victory for the industry, it could be short-lived, as Nilsson warned that the decision would most likely be challenged.
“The court was only the first of three levels of administrative courts in Sweden. We expect this to go higher but we haven’t heard from the authorities yet,” he said.
There are 10 approved claims for vitamin B6 under the EU nutrition and health claims regulation (NHCR) including its role in metabolism, the nervous system, psychological functions, red blood cell formation, immune function, battling fatigue and hormonal regulation. EFSA's opinion on that is here.