The European Court of Justice’s decision that garlic extract powder capsules cannot be classified as a medicinal product has been welcomed by the European Botanical Forum (EBF).
The long awaited Judgment was handed down on Thursday, November 15 in the case between the European Commission and the Federal Republic of Germany.
The case was taken to the Court of Justice by the Commission for failure to fulfil obligations after the German authorities refused to allow the importation and marketing of "garlic extract powder capsules" claiming that the capsules did not constitute a food supplement, but a medicinal product.
The Commission however, took the case forward with the view that classifying the product as medicinal was incompatible with the principle of the free movement of goods.
“This judgment is historic,” said Patrick Coppens, secretary-general of the EBF. “It lays down very specific criteria that Member States must respect when making the distinction between food use and medicinal use of botanicals. It confirms the principles of the regulatory model that EBF experts published earlier this year. The judgment which will have far-reaching consequences for Member States that consider specific botanicals as medicinal by function.”
The Court of Justice’s final decision held that garlic extract powder capsules do not correspond to the definition of a medicinal product either by presentation or by function, and therefore cannot be classified as a medicinal product.
Welcoming the result Manfred Ruthsatz, chairman of the EBF, said that the judgement confirmed a number of basic principles, including that the criterion of ‘physiological effect’ is not limited to medicinal products; and that for a product to be defined as medicinal by function, it must have the function of preventing or treating disease.
He said: “Beneficial effects for health in general, such as those of garlic, are not sufficient to classify food supplements as medicinal products.”
The European Botanical Forum aims to consolidate the efforts undertaken by national associations and individual companies to work to protect national systems currently in place, contribute to the creation of appropriate national systems where not currently in place, and build a pan-European system for the trade of herbs under food law.
The EBF regulatory model was published earlier in Annals of Nutrition and Metabolism. Ref: Ann Nutr Metab 2006;50:538–554
For more information contact Patrick Coppens, European Botanical Forum, 50 Rue de l’Association, 1000 Brussels, tel: (+32) (0)2 209 11 50.