1. Introduction

1.1 Background

The globalization of the food supply, the demand for more food sources globally, and the rapid advances in food science and technology have resulted in the introduction of foods not previously available in the Canadian marketplace. Novel whole foods and food constituents may result from the importation of new products into Canada, the introduction of a new food source, the use of new processing techniques, and/or changes in the genetic make-up of the microorganisms, plants and animals from which foods are derived.

Advances in transportation technology and lower transportation costs have increased the variety of food and food products imported into Canada. Changing consumer food preferences driven by cultural and ethnic traditions as well as nutritional and health concerns, have also resulted in the diversification of our food supply. In addition, the increasing global population continues to drive the introduction of new food sources worldwide. Foods considered non-traditional in Canada may be widely consumed in other parts of the world. In some cases, adverse effects may be associated with their consumption or traditional methods may be needed to prepare the food prior to consumption. In these situations, consumers need to be informed of potential risks and appropriate preparation techniques. Foods derived from sources not previously used as human foods must be evaluated for safety as they may contain toxins, contaminants and/or anti- nutritional factors.

On a global level, new techniques for food preservation and processing continue to be developed to expand the shelf life of foods and food products, to reduce energy requirements for processing, and for many other purposes. As new processing techniques have the potential to alter the characteristics of a food, including nutritional and any toxic characteristics, human health impacts must be considered.

Genetic modifications to improve the agronomic, production, processing or nutritional characteristic of microorganisms, plants and animals may be achieved through traditional breeding techniques or modern gene technologies. The application of genetic modification through either traditional breeding or genetic engineering is not considered inherently to increase or decrease the risk associated with consuming the organism as a food. However, the wide variety of manipulations possible through genetic modification, and the potential for the introduction of toxic compounds, unexpected secondary effects and changes in the nutritional and toxic characteristics of the foodstuff may give rise to safety concerns.

Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of all food, including novel foods, sold in Canada. The mechanism by which Health Canada controls the sale of novel foods in Canada is a pre-market notification process specified under Division 28 of the Food and Drug Regulations.

The pre-market notification approach used for novel foods entails the submission of information to Health Canada regarding the product in question so that a determination can be made with respect to its acceptability as food prior to sale. Thus petitioners of novel foods must submit data of a sufficiently high calibre to meet the criteria specified by Health Canada.

The safety criteria for the assessment of novel foods outlined in the current document were derived from internationally established scientific principles developed through the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for the flexibility required to determine the need for notification and the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances.

1.2 Purpose of Guidelines

These guidelines define the criteria and basic information requirements that must be considered in assessing the safety of novel whole foods and food constituents. They are intended to provide a basis for dialogue between petitioners and the Health Products and Food Branch (HPFB). These guidelines are not intended to explicitly define all the data that might be required in the course of a safety assessment as further data requirements may be identified during the safety assessment process.

1.3 Scope

This document encompasses all novel whole foods, novel food products, and novel foods used as ingredients that are derived from plant and microbial sources. Safety assessment criteria for novel foods derived from animals are under development and will be available for external consultation in 2004.

Under Section B.28.001 of the Food and Drug Regulations, a "novel food" is defined as follows:

"novel food" means

a) a substance, including a microorganism, that does not have a history of safe use as a food;

b) a food that has been manufactured, prepared, preserved or packaged by a process that