Archived - Guidelines for the Use of Food Additives and/or Processing Aids Intended for Fresh Fruits and Vegetable
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This document is intended to provide information to the Canadian industry on the use of food additives and processing aids and on the use of new chemical agents (other than agricultural chemicals and pesticides) in the production of fresh fruit and vegetables, including fresh herbs, spinach, mushrooms, sprouts and fresh-cut produce. This document provides background information on the approval process of new additives and different classes of substances permitted for use in fresh produce. It also provides guidance on the labelling of pre-packaged fresh fruit and vegetable products.
There is a wide variety of substances in the marketplace, intended for food application, that are currently being used as processing aids and/or food additives by the fresh produce industry. Some of these applications include the use of: organic acids as antimicrobial agents; inhibitors of enzymatic browning in fresh-cut produce; bleaching agents in fresh mushrooms; hyper-chlorinated washes for use on fresh produce; various chemical treatments to improve the shelf-life of fresh-cut produce (e.g., sliced mushrooms); waxes and coating on various fruits and vegetables; and other chemicals that come in contact with food products in the course of food processing.
The Canadian Food Inspection Agency (CFIA) is reminding the Canadian produce industry of its responsibility and legal obligation, under Part I.1, Section 3.1 (1)b of the Fresh Fruit and Vegetable Regulations and, Section 4 (a) of the Food and Drugs Act to ensure that produce is not adulterated, and that all chemicals used as processing aids or food additives are suitable for use as such and do not pose a health risk to consumers. Also, any produce that is imported and marketed in Canada must comply with all Canadian regulatory requirements pertaining to food safety and labelling including, in the case of pre-packaged foods, the declaration of food additives and nutritional information.
Regulatory Requirements for Use of Food Additives
Division 1, Part B, of the Food and Drug Regulations defines a food additive as "any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food."
There are no standards in the Food and Drug Regulations for individual fresh fruits and vegetables. In this regard, fresh fruit and vegetables are, under the Food and Drug Regulations, "unstandardized foods."
Permitted food additives and their allowable areas of use and maximum levels of use are listed in the Tables of Division 16 of the Food and Drug Regulations. Individual food additives may not be used at levels greater than their respective inscribed maximum levels of use. When a maximum level of "Good Manufacturing Practice" is specified, the level used must not be greater than the amount required to accomplish the purpose for which that additive is permitted to be added to that food (Section B.01.044, Food and Drug Regulations).
Prior to the use of any substance as a food additive, the CFIA recommends that the packers/processors refer to Division 16 of the Food and Drug Regulations that the additive is listed in the Food Additive Tables for its intended use.
Often food additives may be offered for sale as formulations and sold under different brand names by manufacturing companies. In this case the industry should consult the company that manufactures or supplies the product for more information on the active ingredients and the permitted use of these additives. In any case, the ingredients should be declared quantitatively on the label of the preparation or "Directions for Use" should appear such that use of the preparation as instructed will not violate final food area of use or maximum level of use provisions.
Some food additives (for example ozone) may be Generally Recognized As Safe (GRAS) for food contact application in the U.S. However, the substance must also comply with the Canadian regulatory requirements and, if a food additive, be approved for use in Canada. If a substance is not listed in the Food and Drug Regulations, Division 16 Tables, the CFIA advises that, prior to using the product, the industry consult with the manufacturing company that markets the product and inquire whether or not it ever requested a Letter of Opinion from Health Canada's Bureau of Chemical Safety. Such letters are not required to be obtained from Health Canada but, if issued upon request, at least confirm the regulatory status of the product in terms of the Food and Drug Regulations.
At this time, petitioners wishing to make a Food Additive Submission or to request an expansion of uses for food additives already listed under Division 16, are advised to refer to Section B.16.002 Food and Drug Regulations or visit Health Canada website.
Declaration of Food Additives on the Labels of Pre-packaged Foods
Food additives are considered to be ingredients in a final pre-packaged product. Added ingredients must be included in the list of ingredients and accompanied by nutrition facts table (with the exception of wax coating compounds and their components that are not required to be shown on the label of a prepackage fresh fruit or fresh vegetable as an ingredient or component thereof (Section B.01.008 (7), Food and Drug Regulations )). Additional information on the labelling requirements for fresh produce and added ingredients can be found in the Labelling Guide for Fresh Fruit and Vegetables.
So-called "processing aids" do not fit the definition of a food additive (Section B.01.001, Food and Drug Regulations). This is because they are used early on in food processing, are not intended to be functional in the final food product, and leave no residues. Because they are not food additives, they are not required to be declared in the List of Ingredients on the label of a pre-packaged food.
As general advice, before purchasing and using chemicals for processing aid functions, the fresh produce industry is encouraged to consult instructions outlined on the label or to contact the manufacturers of these products for more information. Manufacturing or distributing companies should be able to provide information concerning the product use, residues, its safety, and acceptability in Canada. If still in doubt, the industry should contact their food industry associations; or the CFIA.
Health Canada's Bureau of Chemical Safety offers Letters of Opinion to manufacturers of food additive and processing aid formulations, on a case-specific basis, as to the acceptability of individual substances believed to be processing aids. The Bureau will only consider issuing such letters upon receipt of complete formulation details, specifications of the chemicals used therein, directions for application and use of the formulation, and information on residues of formulation components in treated foods. Such letters are only issued upon request and are not mandatory.
Originally issued February 10, 2006 (Notice to Canadian Manufacturers)
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