05.06.10
An EC Court (Third Chamber) published its review of a French court’s decision on maximum amounts of vitamins and minerals in food supplements in late April.
The Council for Responsible Nutrition (CRN), Washington, D.C., considers the new decision to be uneven and harmful overall, although certain issues were treated logically and fairly. CRN considers the court’s decision to permit Member States to enact their own requirements for maximums appropriate even though the European Commission has not yet published maximum values, if those values are identified through the letter and spirit of the Food Supplements directive. CRN finds the decision to be within the letter, but not always within the spirit, of that directive.
CRN is pleased the court determined that the risk assessment procedure specified in Article 5 of the FSD applies to actions taken independently by the Member States while the European Commission has not yet set the values. CRN is concerned that some Member States will judge the data on intakes from other sources to be highly unreliable in order to limit the amounts in food supplements to zero without genuine scientific justification.
CRN also said it believes the court correctly prohibited the application of maximums for children to all population groups, but permitted manufacturers to use labeling to instruct consumption of a product by the appropriate group.
CRN is highly concerned that maximums for substances with no known adverse effects will be set arbitrarily and unnecessarily low because there is no official risk assessment value (no UL). The court, of course, reacted to the FSD as it was written in 2002, and did not consider that a procedure for eradicating the problem of the absence of a UL was published in the 2006 FAO/WHO report on nutrient risk assessment. The FAO/WHO report defines a Highest Observed Intake (with sufficient data to exclude adverse effects) to be used for nutrients with no observed adverse effects. For example, in the absence of a UL for vitamin B 12, France has established on a strictly political basis a maximum of 3 micrograms in supplements and required higher potency products to be regulated as drugs and sold only through pharmacists.
Conversely, the UK identified a “guidance level” analogous to the Highest Observed Intake of 2000 micrograms using a scientific risk assessment as prescribed by the FSD. However, the court’s multiple acknowledgements of the precautionary principle could encourage some Member States to exaggerate uncertainty or refuse to identify an HOI in order to set unjustifiably low maximums and thwart the spirit of the FSD.
The Council for Responsible Nutrition (CRN), Washington, D.C., considers the new decision to be uneven and harmful overall, although certain issues were treated logically and fairly. CRN considers the court’s decision to permit Member States to enact their own requirements for maximums appropriate even though the European Commission has not yet published maximum values, if those values are identified through the letter and spirit of the Food Supplements directive. CRN finds the decision to be within the letter, but not always within the spirit, of that directive.
CRN is pleased the court determined that the risk assessment procedure specified in Article 5 of the FSD applies to actions taken independently by the Member States while the European Commission has not yet set the values. CRN is concerned that some Member States will judge the data on intakes from other sources to be highly unreliable in order to limit the amounts in food supplements to zero without genuine scientific justification.
CRN also said it believes the court correctly prohibited the application of maximums for children to all population groups, but permitted manufacturers to use labeling to instruct consumption of a product by the appropriate group.
CRN is highly concerned that maximums for substances with no known adverse effects will be set arbitrarily and unnecessarily low because there is no official risk assessment value (no UL). The court, of course, reacted to the FSD as it was written in 2002, and did not consider that a procedure for eradicating the problem of the absence of a UL was published in the 2006 FAO/WHO report on nutrient risk assessment. The FAO/WHO report defines a Highest Observed Intake (with sufficient data to exclude adverse effects) to be used for nutrients with no observed adverse effects. For example, in the absence of a UL for vitamin B 12, France has established on a strictly political basis a maximum of 3 micrograms in supplements and required higher potency products to be regulated as drugs and sold only through pharmacists.
Conversely, the UK identified a “guidance level” analogous to the Highest Observed Intake of 2000 micrograms using a scientific risk assessment as prescribed by the FSD. However, the court’s multiple acknowledgements of the precautionary principle could encourage some Member States to exaggerate uncertainty or refuse to identify an HOI in order to set unjustifiably low maximums and thwart the spirit of the FSD.