Has Mutual Recognition in the EU Failed?—A Legal-Empirical Analysis on the Example of Food Supplements Containing Botanicals and Other Bioactive Substances

Warda, R.; Purnhagen, K.; Molitorisová, M. Article — Published Version Has Mutual Recognition in the EU Failed?—A Legal-Empirical Analysis on the Example of Food Supplements Containing Botanicals and Other Bioactive Substances Journal of Consumer Policy Provided in Cooperation with: Springer Nature Suggested Citation: Warda, R.; Purnhagen, K.; Molitorisová, M. (2024) : Has Mutual Recognition in the EU Failed?—A Legal-Empirical Analysis on the Example of Food Supplements Containing Botanicals and Other Bioactive Substances, Journal of Consumer Policy, ISSN 1573-0700, Springer US, New York, NY, Vol. 47, Iss. 3, pp. 425-443, https://doi.org/10.1007/s10603-024-09571-0 This Version is available at: https://hdl.handle.net/10419/315245 Standard-Nutzungsbedingungen: Die Dokumente auf EconStor dürfen zu eigenen wissenschaftlichen Zwecken und zum Privatgebrauch gespeichert und kopiert werden. 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If the documents have been made available under an Open Content Licence (especially Creative Commons Licences), you may exercise further usage rights as specified in the indicated licence. http://creativecommons.org/licenses/by/4.0/ Vol.:(0123456789) Journal of Consumer Policy (2024) 47:425–443 https://doi.org/10.1007/s10603-024-09571-0 1 3 ORIGINAL PAPER Has Mutual Recognition intheEU Failed?—A Legal‑Empirical Analysis ontheExample ofFood Supplements Containing Botanicals andOther Bioactive Substances R.Warda1 · K.Purnhagen1,2· M.Molitorisová3 Received: 9 February 2023 / Accepted: 13 June 2024 / Published online: 19 July 2024 © The Author(s) 2024 Abstract The European Union lacks comprehensive legislation pertaining to food supplements containing botanical or bioactive substances other than nutrients, resulting in disparate regulatory frameworks among European Member States. Previous studies predominantly focused on the doctrinal analysis of these diverse regulations at both European and national levels, offering limited insights into their practical implementation by governing bodies. This 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, this approach involved a meticulous examination of the regulatory landscape governing food supplements at both EU and Member State levels. Simultaneously, an 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. These 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, this 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. Keywords Food supplements· Doctrinal analysis· Empirical analysis· Botanicals· Mutual recognition * R. Warda [email protected] 1 Faculty ofLife Sciences: Food, Nutrition andHealth, University ofBayreuth, Bayreuth, Germany 2 Faculty ofLaw andEconomics, University ofBayreuth, Bayreuth, Germany 3 Faculty ofPharmacy, Comenius University Bratislava, Bratislava, Slovakia 426 R.Warda et al. 1 3 Introduction Food supplements represent products positioned at the juncture of food and pharmaceuticals. As food and pharmaceutical regulation are mutually exclusive, defining criteria for when food supplements are defined as food or pharmaceuticals has been a judicial and scholarly challenge (Domínguez Díaz etal. 2020). In the European Union (EU), Directive 2002/46/EC defines most of the products which are intended to complement the regular diet as food supplements (Directive 2002/46/EC 2002; Konik etal. 2011), leaving, however, the assessment and enforcement to national authorities. This regulatory system poses two challenges, which will be addressed in this paper. First, food supplements are increasingly bought by consumers for their features which are more related to pharmaceuticals, and these food supplements also show risks which are typically assessed in pharmaceutical authorisations, which calls for a unified approach across the EU to effectively manage these risks (Domínguez Díaz etal. 2020). Second, as national authorities are entrusted with the interpretation and enforcement of the Directive, there is a possibility that exactly this risk is dealt with in a fragmented manner across the EU, as EU law may not be applied at all or not efficiently. Regarding the first challenge, there is an evolving consumer perception where health-centric supplements are increasingly viewed as viable means to support individual health goals (Colombo etal. 2020; Knopf 2017); hence, consumers purchase these products more with a view to features associated with pharmaceuticals, despite of their characterization and risk assessment as food supplements. This is even more worrying, as supplements containing botanicals or other bioactive substances have been associated with toxicological or quality-related risks which are associated with risk assessment for pharmaceuticals (Gurley etal. 2022; Srivatsav etal. 2020). This presents a challenge concerning ensuring of product safety and quality for both regulatory authorities and consumers alike (Low etal. 2017; Stephan 2017). Regarding the second challenge, the existing EU legislation lacks comprehensive harmonizing regulatory mechanisms for food supplements, such as positive or negative lists, safe maximum levels, or defined conditions of use for substances, across European Member States (EMS) (Breitweg-Lehmann 2017; Noble 2017). Prior studies have evaluated the regulatory systems within various EMS, revealing a fragmentation marked by individual EMS implementing disparate regulatory frameworks for supplements containing botanical or other bioactive substances (Coppens and Pettman 2018; Domínguez Díaz etal. 2020). Yet, empirical data illustrating variations among competent authorities in their regulatory practices for supplements, and the impact of Union law aimed at reducing fragmentation on these practices, remain limited. Therefore, this study investigates if the potential fragmentation of legal systems transposes into practices regarding regulation of botanicals and other bioactive substances in supplements by national competent authorities. Further, the influence of Union law intended to harmonize the regulation of food supplements on their regulatory practices is evaluated. A doctrinal legal analysis was carried out to outline the framework conditions for these substances at the EU level and in seven different EMS. Results from an empirical legal analysis by means of expert interviews with representatives from competent national authorities were used to complement the insights obtained from the doctrinal legal analysis. 427 Has Mutual Recognition intheEU Failed?—A Legal‑Empirical… 1 3 Methodology Methods Doctrinal Legal Analysis Doctrinal legal analysis describes the collection and ordering of the available legal material, including legislation, jurisprudence, and legal literature, its syntax, and norms (Hutchinson and Duncan 2014). Our doctrinal legal research comprised two sequential components. Initially, we conducted a detailed analysis of the wording and syntax of EU secondary law. Subsequently, we examined the national legislation and pertinent soft law governing the regulation of food supplements across seven EMS: Austria, Belgium, Czech Republic, Ireland, Italy, Slovakia, and Sweden. Including all EMS would have surpassed the scope of this analysis. Hence, our objective was to capture the overarching approaches to food supplement regulation employed in the EU by focusing on a select group of EMSs characterized by diverse regulatory systems. This EMS selection facilitated a thorough examination of varied approaches to food supplement regulation through a comprehensive comparative legal analysis (Hutchinson 2015). We merged doctrinal legal research with empirical insights garnered through expert interviews, embodying an interdisciplinary comparative approach to regulation (compare Hutchinson 2015; Purnhagen etal. 2021; van Hoecke 2015). Empirical Legal Analysis The functional approach of comparative legal analysis has been advocated to be enhanced through insights from social sciences (van Hoecke 2015). In striving for a comprehensive understanding on law in practice, particularly when elucidating a foreign legal system, integrating stakeholder interviews into the comparative approach is suggested, broadening the research beyond a reliance solely on case law and legal documents (van Hoecke 2015). Following this methodological stance, previous research has effectively employed expert interviews in comparative legal research (Purnhagen et al. 2021). Therefore, we conducted structured expert interviews to obtain further information on practical aspects of supplement regulation not covered by publicly available documents of the EMS selected for the doctrinal legal analysis (compare Anderson 2010). We opted for expert interviews as our empirical method, recognizing their capacity to furnish pertinent information and institutional insights crucial for the research, which might otherwise be challenging to access (compare Bogner etal. 2009; Helfferich 2022). Expert interviews typically involve a limited number of participants, constituting to a small sample size because it is a method of qualitative research that focuses on analysing the content of generated data rather than generalizing a research subject based on the generated data as quantitative research does (Kaiser 2014; Lamnek and Krell 2016a, 2016b). In qualitative research, an expert can be considered representative of an institution based on his or her process knowledge (Bogner and Menz 2002; Bogner etal. 2014). 428 R.Warda et al. 1 3 Study Materials EU Legislation Databases used to retrieve European legislation and other information were EUR-LEX, Curia, DocsRoom, and N-Lex. Only the latest available consolidated versions of each document were used. National Legislation Specific national food law provisions and other documents like reports, statements, or guidelines were obtained from N-Lex and other national legislative databases of the respective EMS. Only the latest consolidated versions of each document were used. Older versions of laws were used for reference purposes. Interviews Conducting the doctrinal legal analysis enabled the identification of facets within supplement regulation that squarely fall under the jurisdictional purview of food safety authorities. Based on these findings, we developed a questionnaire containing 13 closed questions with predefined multiple-answer choices to be used in the expert interviews (Schnell 2019a). Questions centred on the particular priority accorded by authorities to addressing key aspects: Ensuring food supplement quality and safety, delineating differentiation procedures between supplements and medicinal products, and the utilization of mutual recognition procedures concerning food supplements within the respective EMS. A series of interviews with experts from competent national authorities, specialized in the regulation of food supplements within their respective departments, were conducted via online video calls (Misoch 2019). Each interview session extended approximately 60min, providing ample time for interviewees to respond to the questions and select one or more answers from the questionnaire (Schnell 2019b). Interview candidates were provided with consent forms for personal data protection and non-disclosure agreements. Contact information was retrieved from publicly available governmental registries. In total, four competent authorities from Austria, Belgium, the Czech Republic, and Ireland participated in the expert interviews. The competent authority from Slovakia did not participate in the interview but answered and commented on the questionnaire via email communication. Authorities from Sweden and Italy abstained from participating in the interviews, instead referring to publicly available information. The interview questionnaire is contained in the supplementary material to this manuscript. Data Extraction Interview sessions were recorded and anonymised. Interview questions and answer choices were identical for all participants. We applied thematical analysis as laid down by Braun and Clark (2006) as qualitative analytical method. This method is considered suitable for examining different perspectives of research participants and highlighting differences or 429 Has Mutual Recognition intheEU Failed?—A Legal‑Empirical… 1 3 similarities within or across empirical data sets (Clarke and Braun 2016; Nowell etal. 2017). It provides flexibility to qualitative data analysis as it can be applied to small sample sizes and heterogenous data sets and is commonly used for analysis of interviews or qualitative surveys (see Braun and Clarke 2012, 2006; Lack etal. 2011). As we aimed to complement the doctrinal legal research by providing empirical insights not accessible via legal documents, we chose an inductive coding approach, where the identification of themes and codes is primarily derived from the examination of generated data (Braun and Clarke 2006; Swain 2018). Initially, the chosen answer options from the questionnaire in the expert interviews were compiled in a table using Microsoft Word Version2013. Subsequently, initial codes were manually devised to initiate the grouping of the answer options. A semantic approach was employed to identify corresponding themes. Through continued data analysis, two key topics and 11 codes were ultimately affirmed (Braun and Clarke 2006; Ilkić etal. 2023). This allowed for qualitative data analysis and interpretation by identification of patterns within the codes in combination with the individual interview material of the different competent authorities (Anderson 2010; Sutton and Austin 2015). One member of the research team was tasked with the identification and development of codes and themes. Study Limitations The study was subject to several limitations. National legislation or administrative documents were not always accessible and often had to be translated from the original language into English. Language barriers also could have impacted the interviews, as not all participants were fluent in English. A significant issue was the acquisition of interview candidates, as many regulatory authorities have strict internal legal policies which prevent employees from participating. All obtained data from the interviews had to be anonymised due to non-disclosure agreements. Additionally, countries hosting larger supplement markets did not participate in the interviews. Outcomes: The European Regulatory Framework General Food Law Provisions Primary EU law, particularly provisions concerning the free movement of goods, serves as the foundational framework for EU food law. The European Court of Justice (CJEU) introduced what is later known as the principle of conditional mutual recognition in its Cassis de Dijon decision (Röttger-Wirtz 2020). This principle aims to strike a balance between preserving the diversity of foodstuffs within the Union and establishing unified standards for the free movement of these products (Möstl 2010; Weatherill 2014). If any foodstuff is lawfully sold in one EU country, it can be sold in another, if the respective country cannot present any recognized reason for justification not to sell it (van Cleynenbreugel 2018). Despite of the fact that its significance decreased with the coming into force of Regulation (EC) No 178/2002 (General Food Law), it was introduced into secondary legislation in 2008 (see Regulation (EC) No 764/2008 2008; Weatherill 2017). According to Article 2 of the Mutual Recognition Regulation, a product which is not subject to fully harmonized EU legislation but is lawfully marketed in an EMS may not be denied market access in another EMS (Regulation (EC) No 764/2008 2008). Article 14 (9) General Food Law stipulates 430 R.Warda et al. 1 3 that, in the absence of harmonizing rules at the Union level, food shall be deemed to be safe when it conforms to the specific provisions of national food law of the Member State in whose territory the food is marketed (Regulation (EC) No 178/2002 2002). In 2019, the EU reaffirmed its commitment to mitigating trade barriers stemming from diverse national regulations imposed on products sold across the Union, particularly in the absence of unified legislation, through the adoption of the updated Mutual Recognition Regulation (Regulation (EU) 2019/515 2019). The most fundamental measure of EU food law is the General Food Law, which stipulates the establishment of the internal market, consumer protection, and health protection as major goals of food legislation (Regulation (EC) No 178/2002 2002). Article 14 General Food Law concerns the major principle of market access for foods in the EU, namely that food must not be unsafe for human consumption. This “not unsafe test” combines scientific criteria in the form of risk assessments (Art. 6 General Food Law) and protection of consumers from unfair practices (Art. 8 General Food Law) (Regulation (EC) No 178/2002 2002). To promote fair market conditions and to protect consumers from scientifically unsubstantiated product claims, Regulation (EC) No 1924/2006 established an EU Register for nutrition and health claims approved by the European Food Safety Authority (EFSA) (see Gulati and Berry Ottaway 2006; Regulation (EC) No 1924/2006 2006a). While 267 claims, mainly regarding nutrients, were approved, more than 2000 botanical claims were put on hold by the European Commission in 2010 due to a controversy regarding EFSA’s evaluation procedures (Gulati etal. 2014). Food business operators retain the option to utilize these unevaluated claims, subject to approval by the respective national authority (Gulati etal. 2014). Further horizontal legal provisions which apply to food supplements are the Novel Food Regulation (Regulation (EU) 2015/2283 2015) or concern hygiene of foodstuffs (Regulation (EC) No 852/2004 2004), maximum levels for pesticide residues (Regulation (EC) No 396/2005 2005) and contaminants (CommissionRegulation (EC) No 1881/2006 2006), and the condition of use of additives (Regulation (EC) No 1333/2008 2008). Specific Food Supplement Legislation Food supplement regulation within the Union is specifically addressed by the Food Supplements Directive 2002/46/EC (see further Noble 2017). It defines supplements as concentrated sources of nutrients or other substances to supplement the normal diet, marketed in a pre-dosed form (Directive 2002/46/EC 2002). While the Directive aims to establish an encompassing legal framework, the regulation primarily focuses on harmonization concerning nutrients (Directive 2002/46/EC 2002). Article 2b defines nutrients as minerals and vitamins, while Annexes I and II contain positive lists for nutrients and their molecular forms permitted for supplement use (Directive 2002/46/EC 2002). However, the development of safe upper levels for nutrients, as required by Article 5, was only recently continued by EFSA (EFSA NDA Panel etal. 2022). Substances other than nutrients are vaguely defined in recital 6 as herbal extracts, amino acids, essential fatty acids, fibre, and plants (Directive 2002/46/EC 2002). Additionally, the establishment of further specific regulations for those substances was postponed by Article 4(8) until more scientific data would be available (Directive 2002/46/EC 2002). Until then, EFSA published guidance documents in 2009 and 2014 for the safety assessment of botanicals intended for supplement use (EFSA Scientific Committee 2009, 2014). EFSA also published its Compendium on Botanicals, a database of botanicals and naturally occurring substances of potential toxicological 431 Has Mutual Recognition intheEU Failed?—A Legal‑Empirical… 1 3 concern to humans, to assist regional authorities in their product safety assessments (European Food Safety Authority 2012). Although the risks of differing national regulations due to lack of Union legislation, such as the creation of trade barriers, have been emphasized in Directive 2002/46/EC, certain aspects of regulation were left to the individual Member States (Directive 2002/46/EC 2002). These include safety measures such as establishing product notification procedures and suspending or restricting potentially hazardous products in their territory (Directive 2002/46/EC 2002). Though utilizing approved health claims in the marketing of food supplements is permitted by law, Article 6(2) of the Food Supplements Directive explicitly forbids their presentation as treatments or management options for medical conditions (Colombo etal. 2020; Directive 2002/46/EC 2002). The use of food products in medical conditions was prominently addressed by the CJEU in case C-418/21. To classify a food product as food for special medical purposes (FSMP), as defined by Regulation (EU) 609/2013, there needs to be a causal relationship between a medical condition and the resulting nutritional need, which is to be specifically met by the product (Orthomol (2022)). A general nutritional benefit in the management of a medical condition alone which the product might provide to consumers is not enough to delineate it from regular food, including food supplements (Orthomol (2022)). Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods is another relevant legal act to be considered. It defines other substances as substances other than nutrients that have a physiological or nutritional effect (Regulation (EC) No 1925/2006 2006b). Under the provisions of Article 8 and Annex III, the use of certain substances in food in the EU can, following a scientific assessment by the EMS or EFSA, be restricted or be placed under scrutiny, such as monacolins from red yeast rice, or prohibited as it is the case for Yohimbe and Ephedra preparations. However, to this date, only a few substances have been placed in the annexes (Regulation (EC) No 1925/2006 2006). The Commission’s Position In 2007, the Commission published a study that evaluated the need for further market harmonization and EMS’ approaches to regulating botanicals and other substances. Notification procedures, decreased trade barriers, and the establishment of a robust legal framework were identified as influential factors affecting the market. The conclusion drawn was that the regulation of various substances in the EU continues to exhibit fragmentation, primarily attributed to diverse national regulatory practices, the intricate overlap of botanical substances, especially concerning the pharmaceutical market, and sporadic implementation of mutual recognition (EAS Strategies Ltd 2007). In 2008, per Article 4(8) of the Food Supplements Directive, the Commission submitted a report on the feasibility of establishing specific legislation for other substances to the Council and the European Parliament (European Commission 2008). In the report, existing Union legislation was considered sufficient to harmonize regulation in the EU. The concept of mutual recognition, as substantiated further by Regulation (EC) No 764/2008, has been addressed as essential to assure the free movement of supplements in the EU. Additionally, it was anticipated that adopting the Health Claims Regulation would significantly reduce borderline issues between supplements and medicinal products. Finally, Article 8 and Annex III of Regulation (EC) No 1925/2006 were seen as critical tools to harmonize the conditions of use 432 R.Warda et al. 1 3 for certain other substances (EAS Strategies Ltd 2007). Overall, the Commission considered establishing further specific rules for botanical and bioactive substances other than nutrients scientifically challenging and of limited effectiveness, but also unnecessary (European Commission 2008). Outcomes: Regulation atMember State Level Fragmentation ofNational Regulatory Systems In the seven investigated EMS, food safety authorities are responsible for the regulation of supplements and are subordinate to the respective national ministry responsible for health or agriculture (European Commission 2005). They may be integrated as departments within the respective ministry or independent bodies (European Commission 2005). Austrian authorities are further assisted in carrying out their tasks by a state agency (European Commission 2005). Most of these EMS require food business operators to notify the responsible authority before placing a supplement on the market (Directive 2002/46/EC 2002; European Commission 2017). Austria or Sweden renounced notification procedures because food supplements are foodstuffs that must not be unsafe according to the General Food Law (European Commission 2017; Regulation (EC) No 178/2002 2002). Additionally, notification fees for food business operators vary between the Member States, while others completely waive them (European Commission 2017). A product is usually notified by submission of a notification file, whose requirements and scope differ between countries (European Commission 2017). Table1 shows the classification of the national regulatory approaches of the investigated EMS regarding the use of botanicals and bioactive substances other than nutrients as ingredients for food supplements. Table2shows different measures applied in the EMS to regulate the use in botanicals and bioactive substances as ingredients in food supplements. The measures include notification procedures, positive and negative ingredient lists, ingredient-specific warning labels, restrictions of use, and maximum daily amounts. Guideline‑Based Approaches Swedish, Austrian, and Irish authorities refer to guidance documents to which they operate and which companies should consider. 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Varieties of European economic law and regulation (pp. 401–418). Springer International Publishing. https:// doi. org/ 10. 1007/ 978-331904903-8_ 19 442 R.Warda et al. 1 3 Weatherill, S. (2017). The principle of mutual recognition: It doesn’t work because it doesn’t exist. European Law Review, forthcoming. Oxford Legal Studies Research Paper No. 43/2017. Accessed on SSRN at https:// ssrn. com/ abstr act= 29989 43 Cases European Union Orthomol (Case C-418/21) ECLI:EU:C:2022:831. Legislation Belgium Arrêté royal du 31 août relatif à la fabrication et au commerce de compléments alimentaires contenant d’autres substances que des nutriments et des plantes ou des préparations de plantes. (2021). Moniteur Belge, 191(274), 104790. Arrêté royal du 29 août relatif à la fabrication et au commerce de denrées alimentaires composées ou contenant des plantes ou préparations de plantes. (2021). Moniteur Belge, 191(274), 104793. Czech Republic Act No. 258/2000 Coll. on the protection of public health and on amendments to certain related acts (2000) [Zákon č. 258/2000 Sb.: Zákon o ochraně veřejného zdraví a o změně některých souvisejících zákonů (2000)]. Sbírka Zákonů, 2000(74), 3622. European Union Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (2006) OJ L 364/5. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (2002) OJ L 183/51. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (2002) OJ L 31/1. Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (2004) OJ L 139/1. Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (2005) OJ L 70/1. Regulation (EC) No 1924/2006a of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (2006) OJ L 404/9. Regulation (EC) No 1925/2006b of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods OJ L 404/26. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (2008) OJ L 354/16. Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (2008) OJ L 218/21. Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and 443 Has Mutual Recognition intheEU Failed?—A Legal‑Empirical… 1 3 repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001. (2015). OJ L, 327/1. Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (2019) OJ L 91/1. 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