Standards Development

Scope

This document provides definitions and requirements for scientifically substantiated “beneficially bioactive substances” contained in fresh agricultural produce or minimally processed agricultural products.

This document provides examples of representative agricultural produce, their beneficially bioactive substances, and evidence of expected effects. 

This document describes beneficially bioactive substances that are intrinsic to fresh produce or enhanced through agricultural practices like biofortification, but does not describe synthetic compounds that are used in dietary supplements or added to foodstuffs.

This document does not describe the labelling of beneficially bioactive substances in the final products, and individual methods for testing beneficially bioactive substances.

This document does not include Bee products.

Purpose

The demand for healthy diets has increased consumer interest in bioactive substances that have been scientifically shown to contribute to specific health objectives, and the market for functional food products containing such substances continues to expand internationally. In particular, fresh agricultural produce and minimally processed agricultural products (e.g. frozen vegetables) that intrinsically contain bioactive substances are expected diet to contribute to healthy diet significantly, and consumer interest is growing. In order to facilitate international trade in response to this interest, standardisation of methods for quantifying these substances is considered necessary. However, a major challenge lies in the lack of international consensus on terminology describing such substances. As the market for functional foods containing such substances has expanded, multiple definitions of these substances have been reported. Some describe them as 'extra-nutritional' components naturally present in small quantities in the food matrix, while others define them as natural or synthetic compounds with the ability to interact with one or more components in living tissues and exert a wide range of effects (Kitts DD. Bioactive substances in food: identification and potential uses. Can J Physiol Pharmacol. 1994 Apr;72(4):423-34. doi: 10.1139/y94-062. PMID: 7922875.). However, the definitions and perceptions of such substances in agricultural products vary considerably across countries and regions, and international consensus has not yet been reached. As a result, standardisation in international trade, most crucially standardised methods for measuring such substances, has not yet advanced. In this proposal, the term “beneficially bioactive substance” describing these substances contained in agricultural produce, encompasses two essential aspects. First, these substances are chemical compounds whose quantities can be measured. Second, the beneficial effects of these substances on human health have been demonstrated or validated through scientific research. In agricultural produce, the diversity and complexity of matrices often make method selection appropriately for quantification difficult for laboratories even though methods for quantifying chemical compounds are already addressed in existing standards, such as harmonised protocols, because selection of an appropriate method needs to be based on the characteristics of both the analyte and the matrix. Standardising quantification methods for these substances contained in agricultural produce that are compatible with diverse matrices allows broader and more consistent implementation across laboratories. Against this background, this document aims to contribute to international consensus building by providing terminology, definitions, and fundamental concepts related to these substances in agricultural produce. By clarifying the scientific requirements for demonstrating their effects and by describing the concepts that underpin harmonised measurement methods, this document seeks to support accurate and consistent communication of the content of these substances in agricultural produce. In most cases, the labelling of food ingredients is regulated at the national level. Accordingly, this document does not address labelling for agricultural products and does not seek regulatory recognition. Rather, it aims to promote a shared scientific understanding of laboratory, food manufacturer, and general consumers. (Please use this field or attach an annex)