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Safety Assessment and Regulations for Food Ingredients Derived from Plant In Vitro Systems

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Bioprocessing of Plant In Vitro Systems

Part of the book series: Reference Series in Phytochemistry ((RSP))

Abstract

Plant cell and tissue cultures present numerous advantages for the production of food ingredients. This technology has made a great progress in the past two decades, with a few examples of products reaching the market. Safety assessment of plant in vitro products is a key issue for the development of sustainable commercial processes. Experts have proposed various strategies and methods for assessing the potential risks for the end product arising from the production processes, and throughout the years these have been implemented as guidelines and national regulations. The international approach in safety assessment of single chemically defined plant and cell culture food ingredients is based on the concept of substantial equivalence developed for other categories for novel food products. For products in the form of complex mixtures, conventional metabolism and toxicokinetic studies should be provided for toxicologically relevant constituents with known or demonstrable biological or toxicological activity on a case-by-case basis. The present chapter gives an overview of the current international regulatory basis and proposed schemes for the safety assessment of plant cell and tissue culture-derived food ingredient with some suggestions for the future needs in this field.

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Abbreviations

ADME:

Absorption distribution metabolism excretion

ANS:

Panel on Food Additives and Nutrient Sources Added to Food

CE:

Council of Europe

EC:

European Commission

EFSA:

European Food Safety Authority

EU:

European Union

FAIM:

Food Additive Intake Model

FAO:

Food and Agriculture Organization of the United Nations

FDA:

U.S. Food and Drug Administration

FEDCA:

Federal Food, Drug and Cosmetic Act

FEMA:

Panel of the Flavor and Extract Manufacturers Association

GMPs:

Good Manufacturing Practices

GRAS:

Generally Recognized As Safe

IFBC:

International Food Biotechnology Council

LOD:

Limit of Detection

LOQ:

Limit of Quantification

NDA:

Panel on Dietetic Products, Nutrition and Allergies

PCTC:

Plant Cell and Tissue Cultures

QSAR:

Quantitative structure-activity relationship

SAR:

Structure-activity relationship

SE:

Substantial equivalence

TTC:

Threshold of Toxicological Concern

WHO:

World Health Organization

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Angelov, A., Gotcheva, V. (2018). Safety Assessment and Regulations for Food Ingredients Derived from Plant In Vitro Systems. In: Pavlov, A., Bley, T. (eds) Bioprocessing of Plant In Vitro Systems. Reference Series in Phytochemistry. Springer, Cham. https://doi.org/10.1007/978-3-319-54600-1_17

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