The European Court of Justice’s (ECJ) judgement against Spain for not applying the principle of mutual recognition in its policy on botanical food supplements has been welcomed by the European Botanical Forum.
The judgment was handed down on Thursday March 5, in the case between the European Commission and the Kingdom of Spain.
The Commission took the case to the Court of Justice in response to Spain’s practice of systematically considering products that contain herbs as medicinal, despite these products being lawfully manufactured in other Member States as food supplements.
The Commission’s view, subsequently echoed by the ECJ judgement, was that the process of the Spanish authorities to classify such products as medicinal is incompatible with the principle of the free movement of goods.
“This judgment is a huge step in the right direction for mutual recognition,” said Patrick Coppens, Secretary General of the European Botanical Forum. “It confirms once again the very specific criteria that Member States must respect when making the distinction between food use and medicinal use of herbs. It confirms the principles of the regulatory model that EBF experts published last year. It will mean a substantial support for companies that are confronted with similar practices in other Member States”.
The Court of Justice’s final decision held that substances which, while having an effect on the body, do not significantly affect the metabolism or change the way in which the body functions should not be classified as medicinal products by function.
The Judgment stated: “The mere fact that one or more medicinal herbs are among the constituents of a product is not sufficient to permit the conclusion that that product contributes to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.”
Manfred Ruthsatz, Chairman of the EBF, said that the judgement confirmed a basic principle that it is completely inappropriate to apply medicinal product legislation to products that are not intended nor marketed to treat or prevent diseases, such as botanical food supplements which are intended to promote health.
He said: “Beneficial effects for health in general, such as those of botanical food supplements, are not sufficient to classify food supplements as medicinal products.”