Could Pharmacopoeial Reference Standards Serve as a Platform to Enhance the Quality and Safety Control Systems of European Food Supplement Businesses?

Abstract Previous research has highlighted several quality-related concerns regarding food supplements available on the market, which compromise their safe consumption. This study evaluates whether the adoption of the European Pharmacopoeia (Ph. Eur.) as a framework for improving supplement quality could enhance quality and safety control practices. The findings are derived from a comparative legal analysis of the Canadian and U.S. legal systems. The results suggest that its application in the Canadian market may serve as an illustration of the Brussels effect in practice. Simultaneously, the European Food Safety Authority (EFSA) already encourages EU Food Business Operators (FBOs) to utilise the Ph. Eur. when assessing food supplement ingredients. Nevertheless, careful consideration is necessary regarding the extent of regulatory compliance by FBOs to mitigate potential conflicts with existing EU legislation and to prevent delays in innovative developments within the supplement market.

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Publication Details

Journal
European Journal of Risk Regulation
Published
2025-09-29
DOI
https://doi.org/10.1017/err.2025.10053
Citations
1
Primary Topic
Agricultural safety and regulations
Type
article
Field-Weighted Citation Impact
1.16

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article

Could Pharmacopoeial Reference Standards Serve as a Platform to Enhance the Quality and Safety Control Systems of European Food Supplement Businesses?

Kai Purnhagen, Roman Warda, Milica Molitorisová
1 citations
European Journal of Risk Regulation
Agricultural safety and regulations
1.16
article

Could Pharmacopoeial Reference Standards Serve as a Platform to Enhance the Quality and Safety Control Systems of European Food Supplement Businesses?

Kai Purnhagen, Roman Warda, Milica Molitorisová
article en
1 citations

Abstract

Abstract Previous research has highlighted several quality-related concerns regarding food supplements available on the market, which compromise their safe consumption. This study evaluates whether the adoption of the European Pharmacopoeia (Ph. Eur.) as a framework for improving supplement quality could enhance quality and safety control practices. The findings are derived from a comparative legal analysis of the Canadian and U.S. legal systems. The results suggest that its application in the Canadian market may serve as an illustration of the Brussels effect in practice. Simultaneously, the European Food Safety Authority (EFSA) already encourages EU Food Business Operators (FBOs) to utilise the Ph. Eur. when assessing food supplement ingredients. Nevertheless, careful consideration is necessary regarding the extent of regulatory compliance by FBOs to mitigate potential conflicts with existing EU legislation and to prevent delays in innovative developments within the supplement market.

European Journal of Risk RegulationVol. 17(1)
University of Bayreuth (DE), Comenius University Bratislava (SK)
University of Cambridge
Openalex Percentile: Top 17%
Agricultural safety and regulations
1.16
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