Has Mutual Recognition in the EU failed? : A legal-empirical Analysis on the Example of Food Supplements containing Botanicals and other Bioactive Substances

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Warda, Roman ; Purnhagen, Kai ; Molitorisová, Milica:
Has Mutual Recognition in the EU failed? : A legal-empirical Analysis on the Example of Food Supplements containing Botanicals and other Bioactive Substances.
In: Journal of Consumer Policy. Bd. 47 (2024) . - S. 425-443.
ISSN 1573-0700
DOI: https://doi.org/10.1007/s10603-024-09571-0

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Abstract

The European Union lacks comprehensive legislation pertaining to food supplements containing botanical or bioactive substances beyond nutrients, resulting in disparate regulatory frameworks among Member States. Previous studies predominantly focused on doctrinal analyses of these diverse regulations at both European and national levels, offering limited insights into their practical implementation by governing bodies. Our research endeavours to scrutinize administrative practices governing legislation on food supplements featuring botanical or other bioactive constituents, which are subject to varying approaches across Member States. Employing a combination of doctrinal and empirical legal research methodologies, our approach involved a meticulous examination of the regulatory landscape governing food supplements at both EU and Member State levels. Simultaneously, our empirical investigation, conducted through expert interviews, aimed to elucidate whether discrepancies among national legal systems translate into discernible variations in the operational strategies of competent authorities. Additionally, this empirical inquiry shed light on the efficacy of specific EU directives aimed at harmonizing food supplement regulations at the national level. Our findings delineate a fragmented regulatory environment for botanical and bioactive food supplements across Member States. Noteworthy disparities were observed not only in national legislative frameworks but also in the enforcement practices of regulatory authorities. Union-level governance efforts in particular by adopting a mutual recognition approach to mitigate fragmentation proved ineffective. Consequently, our research underscores an urgent imperative to expedite the harmonization of regulations governing botanicals and other bioactive substances present in food supplements across the European Union.