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Lifting Barriers to Food Supplements Trade in the EU: The EU’s Novel Toolbox Under Regulation (EU) 2019/ 515

Magdalini Selanikli


Mutual Recognition was first adopted as a principle by the ECJ in the ‘Dassonville’ judgment and then in the well known Cassis de Dijon case’. As per the principle applicable in several non- harmonised fields of legislation, products lawfully marketed in one EU Member State should be allowed in the market of another Member State, except if there are conditions of protection of public health and safety. Since the early 80s, when the first ECJ Decisions were delivered, the EU has adopted several regulations, with the last one, Regulation (EU) 2019/515, bringing several elements to the legal apparatus of the Union. Moreover, the first European Commission Opinion on applying the principle of Mutual Recognition was delivered in late September 2021 to prove that the Regulation works and businesses can trigger the EU amicable mechanisms like SOLVIT to intervene and address problems of market access across the EU. The following article deals with applying the Mutual Recognition Regulation in a particular case, that of food supplements. It also addresses the extent to which the Mutual Recognition Regulation can provide a fruitful ground for the growth of a ‘culture of compliance across the EU.

Director for Regulatory Affairs and Quality Assurance for Southeast Europe in ISO PLUS SA, and the Vice-Chair of the European Federation of Associations of Health Product Manufacturers (EHPM)

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