The Regulatory Situation in Europe and Other Continents

Coppens, Patrick; Pettman, Simon

doi:10.1007/978-3-319-62229-3_2

Cited by 3 publications

(2 citation statements)

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“…In a Regulatory Affairs Report from 2018, Coppens states: "After the adoption of the Food Supplements Directive 2002/46, the Commission published a report in 2008 on further harmonization in this area" (Commission of the European Communities, 2008). He concluded that harmonization would be difficult to achieve given the different positions of the Member States and the scientific issues that must first be resolved (Coppens, 2018). Member States with undefined maximum levels feared that EU harmonization would limit their market (Government of the UK, Expert Group on Vitamins and Minerals, 2003).…”

Section: Intake Of Vitamin E Through Supplementationmentioning

confidence: 99%

Beneficial and adverse effects of vitamin E on the kidney

Baltušnikienė

Stanevičienė²,

Jansen³

2023

Front. Physiol.

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This article reviews the beneficial and adverse effects of high-dose vitamin E supplementation on the vitamin E status and renal function in human and rodent studies. The high doses of vitamin E, which can cause renal effects, were compared to upper limits of toxicity (UL) as established by various authorities worldwide. In recent mice studies with higher doses of vitamin E, several biomarkers of tissue toxicity and inflammation were found to be significantly elevated. In these biomarker studies, the severity of inflammation and the increased levels of the biomarkers are discussed together with the need to re-evaluate ULs, given the toxic effects of vitamin E on the kidney and emphasizing oxidative stress and inflammation. The controversy in the literature about vitamin E effects on the kidney is mainly caused by the dose-effects relations that do not give a clear view, neither in human nor animals studies. In addition, more recent studies on rodents with new biomarkers of oxidative stress and inflammation give new insights into possible mechanisms. In this review, the controversy is shown and an advice given on the vitamin E supplementation for renal health.

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Section: Intake Of Vitamin E Through Supplementationmentioning

confidence: 99%

Beneficial and adverse effects of vitamin E on the kidney

Baltušnikienė

Stanevičienė²,

Jansen³

2023

Front. Physiol.

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“…In fact, their use can enter into conventional medicine, or, as in some European countries (e.g., Germany), in "Traditional Herbal Medicinal Products (THMPs)". THMPs must guarantee their safety in the expected conditions of use and their biological activity/efficacy must be plausible on the basis of a chronic use and of available experience [10].…”

Section: Other Categoriesmentioning

confidence: 99%

Botanicals in Functional Foods and Food Supplements: Tradition, Efficacy and Regulatory Aspects

et al. 2020

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In recent decades, the interest in products containing botanicals and claiming “functional” properties has increased exponentially. Functional foods, novel foods and food supplements have a special impact on the consumers, who show significant expectation for their well-being. Food supplements with botanical ingredients are the food area that has witnessed the greatest development, in terms of the number of available products, budget, and consumer acceptability. This review refers to and discusses some open points, such as: (1) the definitions and regulation of products containing botanicals; (2) the difficulty in obtaining nutritional and functional claims (botanical ingredients obtaining claims in the EU are listed and summarized); (3) the safety aspects of these products; and (4) the poor harmonization between international legislations. The availability of these “new” products can positively influence the well-being of the population, but it is essential to provide the consumers with the necessary recommendations to guide them in their purchase and use.

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

Warda,

Purnhagen,

Molitorisová

2024

J Consum Policy

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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.

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The Regulatory Situation in Europe and Other Continents

Cited by 3 publications

References 0 publications

Beneficial and adverse effects of vitamin E on the kidney

Beneficial and adverse effects of vitamin E on the kidney

Botanicals in Functional Foods and Food Supplements: Tradition, Efficacy and Regulatory Aspects

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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