1、 CAN/CGSB-32.315-2004 Reaffirmed March 2016 National Standard of Canada Voluntary labelling and advertising of foods that are and are not products of genetic engineering Canadian General Standards Board The CANADIAN GENERAL STANDARDS BOARD (CGSB), under whose auspices this standard has been develope
2、d, is a government agency within Public Services and Procurement Canada. CGSB is engaged in the production of voluntary standards in a wide range of subject areas through the media of standards committees and the consensus process. The standards committees are composed of representatives of relevant
3、 interests including producers, consumers and other users, retailers, governments, educational institutions, technical, professional and trade societies, and research and testing organizations. Any given standard is developed on the consensus of views expressed by such representatives.CGSB has been
4、accredited by the Standards Council of Canada as a national standards-development organization. The standards that it develops and offers as National Standards of Canada conform to the criteria and procedures established for this purpose by the Standards Council of Canada. In addition to standards i
5、t publishes as National Standards of Canada, CGSB produces standards to meet particular needs, in response to requests from a variety of sources in both the public and private sectors. Both CGSB standards and CGSB national standards are developed in conformance with the policies described in the CGS
6、B Policy and Procedures Manual for the Development and Maintenance of Standards.CGSB standards are subject to review and revision to ensure that they keep abreast of technological progress. CGSB will initiate the review of this standard within five years of the date of publication. Suggestions for t
7、heir improvement, which are always welcome, should be brought to the notice of the standards committees concerned. Changes to standards are issued either as separate amendment sheets or in new editions of standards.An up-to-date listing of CGSB standards, including details on latest issues and amend
8、ments, and ordering instructions, is found in the CGSB Catalogue at our Web site www.tpsgc-pwgsc.gc.ca/ongc-cgsb/index-eng.html along with more information about CGSB products and services.Although the intended primary application of this standard is stated in its Scope, it is important to note that
9、 it remains the responsibility of the users of the standard to judge its suitability for their particular purpose.The testing and evaluation of a product against this standard may require the use of materials and/or equipment that could be hazardous. This document does not purport to address all the
10、 safety aspects associated with its use. Anyone using this standard has the responsibility to consult the appropriate authorities and to establish appropriate health and safety practices in conjunction with any applicable regulatory requirements prior to its use. CGSB neither assumes nor accepts any
11、 responsibility for any injury or damage that may occur during or as the result of tests, wherever performed.Attention is drawn to the possibility that some of the elements of this Canadian standard may be the subject of patent rights. CGSB shall not be held responsible for identifying any or all su
12、ch patent rights. Users of this standard are expressly advised that determination of the validity of any such patent rights is entirely their own responsibility.LanguageIn this Standard, “shall” states a mandatory requirement, “should” expresses a recommendation and “may” is used to express an optio
13、n or that which is permissible within the limits of this Standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Annexes are designated normative (manda
14、tory) or informative (non-mandatory) to define their application.Further information on CGSB and its services and standards may be obtained from:The Manager Standards Division Canadian General Standards Board Gatineau, Canada K1A 1G6A National Standard of Canada is a standard developed by an SCC- ac
15、credited Standards Development Organization (SDO), and approved by the Standards Council of Canada (SCC), in accordance with SCCs: Requirements and Guidance-Accreditation for Standards Development Organizations, and Requirements and Guidance-Approval of National Standards of Canada Designation. More
16、 information on National Standard requirements can be found at www.scc.ca. An SCC-approved standard reflects the consensus of a number of experts whose collective interests provide, to the greatest practicable extent, a balance of representation of affected stakeholders. National Standards of Canada
17、 are intended to make a significant and timely contribution to the Canadian interest. SCC is a Crown corporation within the portfolio of Industry Canada. With the goal of enhancing Canadas economic competitiveness and social well-being, SCC leads and facilitates the development and use of national a
18、nd international standards. SCC also coordinates Canadian participation in standards development, and identifies strategies to advance Canadian standardization efforts. Accreditation services are provided by SCC to various customers, including product certifiers, testing laboratories, and standards
19、development organizations. A list of SCC programs and accredited bodies is publicly available at www.scc.ca. Users should always obtain the latest edition of a National Standard of Canada from the standards development organization responsible for its publication, as these documents are subject to p
20、eriodic review.The responsibility for approving standards as NSCs rests with:Standards Council of Canada 55 Metcalfe Street, Suite 600 Ottawa, Ontario K1P 6L5, CANADAby telephone 819-956-0425 or 1-800-665-2472by fax 819-956-5740by mail CGSB Sales Centre Gatineau, Canada K1A 1G6in person Place du Por
21、tage Phase III, 6B1 11 Laurier Street Gatineau, Quebecby email ncr.cgsb-ongctpsgc-pwgsc.gc.caon the Web www.tpsgc-pwgsc.gc.ca/ongc-cgsb/index-eng.htmlHow to order Publications:NATIONAL STANDARD OF CANADA CAN/CGSB-32.315-2004 Reaffirmed March 2016 Voluntary labelling and advertising of foods that are
22、 and are not products of genetic engineering CETTE NORME NATIONALE DU CANADA EST DISPONIBLE EN VERSIONS FRANAISE ET ANGLAISE. Published April 2004 by the Canadian General Standards Board Gatineau, Canada K1A 1G6 HER MAJESTY THE QUEEN IN RIGHT OF CANADA, as represented by the Minister of Public Works
23、 and Government Services, the Minister responsible for the Canadian General Standards Board (2004). No part of this publication may be reproduced in any form without the prior permission of the publisher. ICS 55.020 CGSB 2016 All rights reserved CAN/CGSB-32.315-2004 CANADIAN GENERAL STANDARDS BOARD
24、Committee on Voluntary Labelling of Foods Obtained or not Obtained Through Genetic Modification (Voting membership at date of reaffirmation) General interest category Bourbonnire, L. Health Canada Chancey, G. Canadian Seed Growers Association Harvey, B. University of Saskatchewan Hurteau, M-C. Canad
25、ian Food Inspection Agency Kennedy, A. Agriculture and Agri-Food Canada Miles, G. Canadian Grain Commission Rupasinghe, V. Canadian Institute of Food Science not misleading; not deceptive; not likely to create an erroneous impression of afoods character, value, composition, merit or safety; and in c
26、ompliance with all other regulatory requirements setout in the Food and Drugs Act, the Food and Drug Regulations, the Consumer Packaging and Labelling Act andConsumer Packaging and Labelling Regulations, the Competition Act and any other relevant legislation, as well asthe Guide to Food Labelling an
27、d Advertising. If claims related to the health, safety, nutrition and/or environmentalimpacts of foods are made, such claims must be truthful, verifiable, not misleading, and in compliance with allCanadian regulations.The National Standard of Canada Voluntary Labelling and Advertising of Foods That
28、Are and Are Not Products ofGenetic Engineering was developed to ensure that any such claims are consistent with an appropriate set ofparameters, including being informative, understandable, verifiable, and not false or misleading. Should a claim bemade pursuant to this standard, it must meet the req
29、uirements applicable to the type of claim being made, as outlinedin this standard. This standard was developed to provide consumer choice and does not imply the existence of healthor safety concerns for products within its scope.It is important to note that the standard permits verification of claim
30、s by several processes including audit tracking(identity preservation) as well as chemical analysis. However, acceptable Canadian or international verificationprocesses or methods for validating ingredient claims, as outlined in section 7 of the standard, may not be availableat the time of issuing t
31、his standard. As with all labelling claims, where acceptable verification processes, includingsuch systems as audit tracking, do not currently exist, voluntary claims will not be made until an acceptableverification process is developed. Currently work is underway internationally and domestically to
32、 develop theseprocesses.It has been recognized that the term genetic modification is sometimes used as a synonym for genetic engineering asdefined in this standard. However, to genetically modify a plant, animal, or micro-organism implies making anychange to the genetic makeup of the organism by any
33、 intentional means whatsoever and is defined in this manner inthe Food and Drug Regulations. Because of the broad nature of this definition, many food products would beconsidered genetically modified, and very few could be considered non-genetically modified. In order to meet theneeds of consumers f
34、or information about the application of specific techniques of biotechnology, the standardlimits itself to claims about the use of genetic engineering in the production of foods and food ingredients.The standard was developed by a Committee, with representation from food producers, manufacturers, di
35、stributors,consumers, general interest, and government groups. While mindful of international implications, including ongoingCodex Alimentarius work towards a labelling guideline, the Committee reached a consensus based on a voluntarycode for products available in Canada.1Government of Canada, Food
36、and Drug Regulations. C.R.C., c. 870, s. B.28.001.iiiCAN/CGSB-32.315-2004CANADIAN GENERAL STANDARDS BOARDVOLUNTARY LABELLING AND ADVERTISING OF FOODSTHAT ARE AND ARE NOT PRODUCTS OF GENETIC ENGINEERING1. SCOPE1.1 The standard applies to the voluntary labelling and advertising of food in order to dis
37、tinguish whether or not suchfoods are products of genetic engineering, or contain or do not contain ingredients that are products of geneticengineering, irrespective of whether the food or ingredient contains DNA or protein.1.2 The standard defines terms, and sets out criteria for claims and for the
38、ir evaluation and verification.1.3 The standard applies to food sold to consumers in Canada, regardless of whether it is produced domestically orimported.1.4 The standard applies to the labelling and advertising of food sold prepackaged or in bulk, as well as to food preparedat the point of sale.1.5
39、 Under this standard, processing aids, enzymes below 0.01% by weight in a food as offered for sale (exception, seepar. 6.2.7 a.), veterinary biologics, animal feeds, and substrates for micro-organisms (where the substrate itself is notpresent in the finished food product) do not affect whether a foo
40、d or ingredient is considered to be or not to be aproduct of genetic engineering.1.6 This standard does not preclude, override, or in any way change legally required information, claims or labelling, orany other applicable legal requirements.2. REFERENCED PUBLICATIONS2.1 As in the case of all foods
41、sold in Canada, the labelling and advertising of foods that are and are not products ofgenetic engineering must be truthful and not misleading, as required by subsection 5(1) of the Food and Drugs Actand section 7 of the Consumer Packaging and Labelling Act, and in compliance with all other regulato
42、ryrequirements as set out in the Food and Drug Regulations, the Consumer Packaging and Labelling Regulations, theCompetition Act and any other relevant legislation, as well as the Guide to Food Labelling and Advertising. Thedefinition for genetic engineering is adapted from the Report of the 28th Se
43、ssion of the Codex Committee on FoodLabelling, Ottawa, Canada, May 5 to 9, 2000.2.2 A reference to an act, regulation, or guide is always to the latest amendment.3. DEFINITIONS AND TERMINOLOGY3.1 The following definitions and terms apply in this standard:Advertisement (Publicite ou annonce)Any repre
44、sentation, by any means whatever, for the purpose of promoting directly or indirectly the sale or disposalof any food. (Food and Drugs Act)Audit procedure (Procedure daudit)A control procedure that is sufficiently documented to determine the origin and supply chain of any food or foodingredient labe
45、lled in accordance with this standard.Claim (Allegation)Any statement made in labelling or advertising about a food or food ingredient that is intended to highlight thepresence or absence of a specific characteristic of a food or an ingredient or the food or ingredient itself.1Enzyme (Enzyme)A prote
46、in of animal, vegetable, or microbial origin that acts as a catalyst to increase the speed of a biologicalreaction without being altered, consumed, or destroyed during the reaction stage.Food (Aliment)Includes any article manufactured, sold, or represented for use as food or drink for human beings,
47、chewing gum, andany ingredient that may be mixed with food, for any purpose whatever. (Food and Drugs Act)Genetic engineering (Genie genetique)Refers to techniques by which the genetic material of an organism is changed in a way that does not occur naturallyby multiplication and/or natural recombina
48、tion. Examples of the techniques used in genetic engineering include butare not limited to the following:a. recombinant DNA (rDNA) techniques that use vector systemsb. techniques involving the direct introduction into the organism of hereditary materials prepared outside theorganismc. cell fusion (i
49、ncluding protoplast fusion) or hybridization techniques that overcome natural physiological,reproductive, or recombination barriers, where the donor cells/protoplasts do not fall within the same taxonomicfamilyUnless the donor/recipient organism is derived from any of the above techniques, examples of excluded techniquesinclude but are not limited to the following:a. in vitro fertilizationb. conjugation, transduction, transformation, or any other natural processc. polyploidy inductiond. mutagenesise. cell fusion (including protoplast
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