Scientific Opinion on a Qualified Presumption of Safety (QPS) approach for the safety assessment of botanicals and botanical preparations

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doi:10.2903/j.efsa.2014.3593

Cited by 19 publications

(2 citation statements)

References 20 publications

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“…Recently, 61 citrus species, chosen as representatives of the genetic diversity of the species, were analysed to determine the contents of these compounds in peels and pulps [6]. Among them, a large amount of FCs was found in grapefruit (Citrus Paradisi), where they are responsible for the so called "grapefruit juice effect", which consists of the dangerous interaction with drug metabolism, specifically in the inhibition of the enzymes involved in the European Medicines Agency [48] and the European Food Safety Authority's [49] suggestions, the European Parliament did not impose any limit of their content in food.…”

Section: Introductionmentioning

confidence: 99%

Dietary Intake of Coumarins and Furocoumarins through Citrus Beverages: A Detailed Estimation by a HPLC-MS/MS Method Combined with the Linear Retention Index System

Arigò

Rigano

Russo

et al. 2021

Foods

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Official regulations concerning the maximum number of substances in food are introduced as a consequence of possible adverse effects, after oral administration. In this regard, analytical methods are necessary in order to determine specific targets. Among oxygen heterocyclic compounds (OHCs, that are furocoumarins, coumarins and polymethoxyflavones), only coumarin is subject to restriction by the Regulation (EC) No 1334/2008 of the European Parliament. Furocoumarins are known for their phototoxicity and other side effects due to their dietary intake; however, an official limit about the maximum content of these compounds in food is still missing. The lack of information about the real amount of these compounds in food is responsible for the conflicting opinions about the introduction of an official limit. The HPLC-MS/MS method here proposed, in combination with the linear retention index system, represents an innovative analytical strategy for the characterization of OHCs in citrus beverages. Several types of drinks were analysed in order to quantify 35 OHCs in total. This method is suitable for the quality control of OHCs in food and the obtained results may be considered as informative data useful for the regulatory authorities in the emission of new opinions and for a potential new regulation in this field.

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Section: Introductionmentioning

confidence: 99%

Dietary Intake of Coumarins and Furocoumarins through Citrus Beverages: A Detailed Estimation by a HPLC-MS/MS Method Combined with the Linear Retention Index System

Arigò

Rigano

Russo

et al. 2021

Foods

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“…Regarding level A, available data from large population groups exposed to the ingredient (at a known level) can allow for conclusions regarding the absence of adverse effects. Actually, the EFSA has published the 'Scientific Opinion on a Qualified Presumption of Safety (QPS) approach for the safety assessment of botanicals and botanical preparations' [36] to be used as an extension of the guidelines on botanicals and botanical preparations. Regarding level B, the toxicity testing approach suggested is the one included in the scientific opinion prepared by the EFSA in 2012 for the submission of food additive evaluations [32].…”

Section: Botanicalsmentioning

confidence: 99%

European Regulatory Framework and Safety Assessment of Food-Related Bioactive Compounds

et al. 2020

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A great variety of functional foods, nutraceuticals, or foods with bioactive compounds are provided nowadays to consumers. Aware of the importance of the safety aspects, the food industry has to comply with different legal requirements around the world. In this review, the European regulatory framework for food-related bioactive compounds is summarized. The term ‘bioactive compound’ is not defined in the European regulations, however, since they can be part of food supplements, fortified foods, or novel food, they are included within the legal requirements of those corresponding types of foods or supplements. Lists of authorized compounds/foods appear in the correspondent regulations, however, when a new compound/food is going to be launched into the market, its safety assessment is essential. Although the responsibility for the safety of these compounds/foods lies with the food business operator placing the product on the market, the European Food Safety Authority (EFSA) carries out scientific evaluations to assess the risks for human health. To facilitate this procedure, different guidelines exist at the European level to explain the tier toxicity testing approach to be considered. This approach divides the evaluation into four areas: (a) toxicokinetics; (b) genotoxicity; (c) subchronic and chronic toxicity and carcinogenicity; and (d) reproductive and developmental toxicity.

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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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Scientific Opinion on a Qualified Presumption of Safety (QPS) approach for the safety assessment of botanicals and botanical preparations

Cited by 19 publications

References 20 publications

Dietary Intake of Coumarins and Furocoumarins through Citrus Beverages: A Detailed Estimation by a HPLC-MS/MS Method Combined with the Linear Retention Index System

Dietary Intake of Coumarins and Furocoumarins through Citrus Beverages: A Detailed Estimation by a HPLC-MS/MS Method Combined with the Linear Retention Index System

European Regulatory Framework and Safety Assessment of Food-Related Bioactive Compounds

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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