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Country Report: Canada

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Genetic Technology and Food Safety

Part of the book series: Ius Comparatum - Global Studies in Comparative Law ((GSCL,volume 14))

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Abstract

Genetically modified organisms are at the heart of the Canadian economy. Generally speaking, GMOs are perceived more as foodstuffs capable of fostering trade rather than a threat to people’s health. WTO litigation or the absence of EU-Style labeling suggest that GMO enjoy great support from the government and the population. Although some municipalities declare themselves GMO-free, “moratoria” or “thresholds” are extraneous to the Canadian GMO-legislation. In addition, private law reveals itself quite incapable of compensating damages sustained by GMO activity. In synthesis, Canada aligns itself to liberal attitudes to GMO farming.

Marie-Eve Arbour in collaboration with Steven Hoeung

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Notes

  1. 1.

    Art. 95, Constitution Act, 1867 (UK), 30 & 31 Vict, c 3, ss 91–92, reprinted in RSC 1985, App II, No 5 [1867 Constitutional Act].

  2. 2.

    Art. 91 (27), 1867 Constitution Act.

  3. 3.

    Food and Drugs Act, RCS 1985, c F-27. See R v Wetmore, [1983] 2 S.C.R. 284 at 288–289, 2 DLR (4th) 577; Berryland Canning Co v Canada, [1974] 1 F.C. 91 at 7–8, 44 DLR (3d) 568: “The said legislation, with a view to a public purpose, is primarily designed to protect the health of Canadians by prohibiting the adulteration of foods and to suppress fraud in the distribution of food products. Hazards coming from drugs, cosmetics and devices, as therein defined, also fall within the scope of this legislation.”

  4. 4.

    Food and Drug Regulations (C.R.C., c. 870).

  5. 5.

    This so, pursuant to art. 92 (13) of the Constitutional Act.

  6. 6.

    Canadian Food Inspection Agency Act (S.C. 1997, c. 6). “WHEREAS the Government of Canada wishes to enhance the effectiveness and efficiency of federal inspection and related services for food and animal and plant health by consolidating them; WHEREAS the consolidation of those services under a single food inspection agency will contribute to consumer protection and facilitate a more uniform and consistent approach to safety and quality standards and risk-based inspection systems; WHEREAS the Government of Canada wishes to have that food inspection agency deliver those services in a cost effective manner; […]”.

  7. 7.

    See 19. (1) of the Canadian Food Inspection Agency Act: “Where the Minister believes on reasonable grounds that a product regulated under an Act or provision that the Agency enforces or administers by virtue of section 11 poses a risk to public, animal or plant health, the Minister may, by notice served on any person selling, marketing or distributing the product, order that the product be recalled or sent to a place designated by the Minister”. A website is dedicated to these: see e.g. “Allergy Alert – Undeclared milk in certain Clic brand strawberry flavored marshmallow”, oct. 26th, 2013, online at http://www.inspection.gc.ca/about-the-cfia/newsroom/food-recall-warnings/complete-listing/2013-10-26/eng/1382809101752/1382809117917

  8. 8.

    Such as Environment Canada (for microorganisms and GM animals); Fisheries and Oceans Canada (who will eventually set its own procedure for the dissemination of GM aquatic microorganisms, for now under the surveillance of Environment Canada).

  9. 9.

    At the national level, see e.g. Hategekimana and M. Beaulieu, “Genetically modified crops: Steady growth in Ontario and Quebec”, 2002, in Vista on the Agri-Food Industry and the Farm Community [www.statcan.gc.ca/pub/21-004-x/21-004-x2002112-eng.pdf], which highlights that “[GM] soybeans and corn in Quebec and Ontario accounted for a large share of the total Canadian production. In 2001, 29 % of Canadian corn production was grown from modified corn seeds. Modified soybeans represented 24 % of Canadian soybean production” (at p. 2). At the provincial level, see e.g. Institut de la Statistique du Québec, Superficie des grandes cultures génétiquement modifiées, rendement à l’hectare et production, par région administrative, Québec, 2012, which shows that GM soya crops represent 59 % (165 000 ha) of soya crops; and GM maize represents 83 % of Quebec’s production.

  10. 10.

    Technically, “GMO” is defined by the Canadian General Standards Board’s Organic Agriculture Standards (approved by the Standards Council of Canada) as follow: “All organisms, and products thereof, produced through techniques of genetic engineering and modification including, but not restricted to recombinant DNA, cell fusion, encapsulation, macro and micro injection, gene deletion or magnification, and other techniques for altering the genetic composition of living organisms in ways, or with results, that do not occur in nature through mating or through traditional breeding techniques such as conjugation, hybridization, or transduction”.

  11. 11.

    Government of Canada, Agriculture and Agri-Food Canada, Government of Canada Proposed Domestic Policy on the Management of Low-Level Presence of Genetically Modified Crops in Imports and its Associated Implementation Framework, 2012, retrieved from www5.agr.gc.ca/resources/prod/doc/pol/consult/llp/pol_llp_pfq_e.pdf

  12. 12.

    Redfern Research, Policy Approaches for Managing Low-Level Presence of Genetically Modified Crops Imported into Canada – Report on Stakeholder Consultations, 2011 [http://www.cban.ca/content/download/1915/11400/file/LLP%20Consultations%20report.pdf] Following this consultation, a draft policy was published on the website of Agriculture and Agri-Food Canada to outline the current position of the Government of Canada.

  13. 13.

    See specifically Z. Komirenko, M. M. Veeman and J. R. Unterschultz, “Do Canadian Consumers Have Concerns about Genetically Modified Animal Feeds ?” (2010) 13 The Journal of Agrobiotechnology Management & Economics, p. 248–249, or The British Columbia Fruit Growers’ Association, Survey Finds Risk of Consumer Backlash on GMOs, 2012 [www.bcfga.com/files/file/GMO%20Survey%20July%203,%202012.pdf] In response to the following question: “Are you in favour or the approval of this [genetically engineered] apple by Health Canada?” 69 % of respondents were not in favour.

  14. 14.

    Léger & Léger, Sondage auprès des consommateurs quant à leurs perceptions à l’égard des OGM (Omnibus), May 2001, at p. 11, cited in Gouvernement du Québec, Contexte social, online at http://www.ogm.gouv.qc.ca/info_contexte.html

  15. 15.

    La Pressse canadienne and Léger Marketing, Étude sur les perceptions des Canadiens à l’égard des Organismes Génétiquement Modifiés, 2001, at p. 2. cited in Gouvernement du Québec, Contexte social, supra. Cfr. Decima Research, Emerging Technologies Tracking Research, 2006, retrieved from http://www.ic.gc.ca/eic/site/icgc.nsf/vwapj/Decima-June2006_EN.pdf/$file/Decima-June2006_EN.pdf, whereby a report submitted to Industry Canada showed that “Canadians express reticence about the impact of some applications of technology over this period. Some examples include GM animals (where 58 % believe it will make life worse over the next 20 years), GM fish (54 %), and GM foods (50 %). These are all seen to have a more negative than positive effect” (pp. 3–4).

  16. 16.

    See Food and Agriculture Organization of the United Nations. Rome Declaration on World Food Security and World Food Summit Plan of Action, 1998 [http://www.fao.org/docrep/003/w3613e/w3613e00.HTM].

  17. 17.

    Agriculture and Agri-Food Canada, Canada’s Action Plan for Food Security, 1998 [http://www.agr.gc.ca/misb/fsec-seca/pdf/action_e.pdf].

  18. 18.

    G. Parent, “Droit économique et sécurité alimentaire: un couple mal assorti?”, (2012) 4 Rev. int. de droit écon., p. 15 (at p. 16).

  19. 19.

    For the purpose of this Report, “food safety” and “food security” will be used indistinctly, following the FAO’s will after the Summit held in Rome in 1996 (on the merging of these concepts, see G. Parent, ibid.).

  20. 20.

    See e.g., in British Columbia, the Food Safety Act, SBC 2002, c 28.

  21. 21.

    B-C. Food Safety Act, SBC 2002, c 28, art. 2.

  22. 22.

    A national outbreak of listeriosis associated with cold cuts from a Maple Leaf Foods plant in Toronto, Canada, occurred in 2008. Out of the 57 confirmed cases, 22 people died after consuming the product. The plant responsible for spreading this disease has undergone intense sanitation under the inspection of Maple Leaf Foods’ officials. On December 2008, four separate class-action lawsuits were settled after the company promised to compensate the victims for 27 millions dollars: see The Globe and Mail, “Listeria lawsuits against maple leaf settled for $27-million”, Dec. 18, 2008 [www.theglobeandmail.com/news/national/listeria-lawsuits-against-maple-leaf-settled-for-27-million/article1067849/].

  23. 23.

    In September 2008, the government of Quebec ordered the shutdown of several cheese manufacturers and the destruction of their products on sale in the wake of an outbreak of listeriosis. 28 people were infected with one deceased after consuming the commercialized cheese. The government was initially criticized for refusing to compensate the financial loss of cheese manufacturers, yet this situation was easily overcome based upon the increased turnover in the upcoming months. Cheeses made from raw milk are closely regulated by public agencies since the event. See Le Devoir, « Listériose–Québec pourrait aider l’industrie de fromage », Sept. 18, 2008, [http://www.ledevoir.com/politique/quebec/206306/listeriose-quebec-pourrait-aider-l-industrie-du-fromage].

  24. 24.

    On this issue, see I. J. Mauro, S.M. McLachlan & R. C. Van Acker, “Farmer knowledge and a priori risk analysis: pre-release evaluation of genetically modified Roundup Ready wheat across the Canadian prairies”, (2009) 16 Environmental Science and Pollution Research, p. 689.

  25. 25.

    I.J. Mauro, S. M. McLachlan & R. C. Van Acker, “Farmer knowledge and a priori risk analysis: pre-release evaluation of genetically modified Roundup Ready wheat across the Canadian prairies”, (2009) 16 Environmental Science and Pollution Research, at p. 689. See also J. M. Marcoux and L. Létourneau, “A distorted regulatory landscape: Genetically modified wheat and the influcnece of non-safety issues in Canada”, (2013) 40 Science and Public Policy, p. 514.

  26. 26.

    International Covenant on Economic, Social and Cultural Rights, 16 December 1966, 993 UNTS 3, 6 ILM 368 (entered into force 3 January 1976) available at: http://www.refworld.org/docid/3ae6b36c0.html [accessed 4 November 2013].

  27. 27.

    United Nations, Human Rights Council, G. A., Report of the Special Rapporteur on the right to food, Olivier De Schutter, A/HRC/22/50/Add.1, 24 Dec. 2012 [www.ohchr.org/Documents/HRBodies/HRCouncil/RegularSession/Session22/AHRC2250Add.1_English.PDF].

  28. 28.

    Id., p. 4.

  29. 29.

    Id., p. 9.

  30. 30.

    Royal Society of Canada, Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada, 2001 [http://rsc-src.ca/sites/default/files/pdf/GMreportEN.pdf].

  31. 31.

    Health Canada, In response to the Royal Society of Canada’s Expert Panel Report titled: “Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada, 2001 [http://www.hc-sc.gc.ca/sr-sr/alt_formats/hpfb-dgpsa/pdf/pubs/rsc_response-reponse_src-eng.pdf].

  32. 32.

    According to Health Canada, biotechnology is merely “an umbrella term that covers a broad spectrum of scientific tools and techniques, including genetic modification and genetic engineering”. Semantically speaking, genetic modification refers as “[a]n organism, such as a plant, animal or bacterium, […] if its genetic material has been altered through any method, including conventional breeding. A “GMO” is a genetically modified organism”, whilst “Genetically engineered” are those organisms “genetically modified using techniques that permit the direct transfer or removal of genes in that organism. Such techniques are also called recombinant DNA or rDNA techniques” (Health Canada website, id.).

  33. 33.

    See http://www.cban.ca/Resources/Topics/GE-Free-Zones

  34. 34.

    Division 28 of Part B of the Food and Drugs Regulations.

  35. 35.

    Pursuant to art. B.28.001 of the Food and Drugs Regulations, novelty is defined as “(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 (i) has not been previously applied to that food, and (ii) causes the food to undergo a major change; and (c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that (i) the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism, (ii) the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or (iii) one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism.The centrality of the scientific expertises is further explored by Jean-Michel Marcoux and Lyne Létourneau, “A distorted regulatory landscape: Genetically modified wheat and the influence of non safety issues in Canada”, (2013) 40 Science and Public Policy, p. 514.

  36. 36.

    http://www.hc-sc.gc.ca/sr-sr/pubs/biotech/reg_gen_mod-eng.php

  37. 37.

    See for example CFIA, “DD2005-53: Determination of the Safety of Monsanto Canada Inc.’s Roundup Ready® Alfalfa (Medicago sativa L.) Events J101 and J163”, http://www.inspection.gc.ca/plants/plants-with-novel-traits/approved-under-review/decision-documents/dd2005-53/eng/1311630531051/1311631992012

  38. 38.

    R. c. Petit, 2001 CanLII 27032 (QC CM) [http://canlii.ca/t/1t8vf].

  39. 39.

    Pursuant to art. 430 of the Criminal Code (a federal law).

  40. 40.

    Id., art. 429(2).

  41. 41.

    Civil disobedience can only be invoked to justify a damage done to a public good with the objective to revolt against an oppressive law. These conditions have not been met. The defence of necessity is also rejected, because the defendants did not demonstrate the imminent danger surrounding the use of GMO.

  42. 42.

    See specifically J. M. Glenn, “Damage Caused by GMOs under Canadian Law”, in Bernhard A. Koch (ed.,), Damage Caused by Genetically Modified Organisms – Comparative Survey of Redress Options for Harm to Persons, Property or the Environment, De Gruyter, at p. 663 [Glenn, “Damage”].

  43. 43.

    For further description of this context, see Sophie Lavallée and Geneviève Parent, « Qu’y a-t-il derrière l’étiquette “bio” ? Une étude de l’encadrement juridique de l’agriculture et de la certification biologiques au Canada », (2005) 50 McGill L.J. 89. Provincial laws could be adopted to regulate intraprovincial trade : there nonetheless seems to be a natural alignment towards the federal model, compulsory whenever there is “exportation” of an organic product in another province (interprovincial trade).

  44. 44.

    SOR/2009-176 [2009 Regulations]. These regulations were adopted pursuant to the Canada Agricultural Products Act, RSC 1985, c 20 (4th Supp) [http://canlii.ca/t/hxzr].

  45. 45.

    Id., at art. 11.

  46. 46.

    Public Works and Government Services Canada, Permitted Substances List, CAN/CGSB 32.310 [http://www.tpsgc-pwgsc.gc.ca/ongc-cgsb/programme-program/normes-standards/internet/bio-org/permises-permitted-eng.html].

  47. 47.

    The list is available at CFIA, http://www.inspection.gc.ca/food/organic-products/certification-and-verification/certification-bodies/eng/1327860541218/1327860730201

  48. 48.

    The article goes on stating that “(2) The application shall contain (a) the name of the organic product packaged and labelled; (b) a statement naming the substances used in the packaging and labelling of the organic product and describing the manner in which those substances are used; and (c) a report setting out in detail the packaging and labelling methods used and the control mechanisms in place to ensure that those methods comply at all times with the requirements set out in CAN/CGSB 32.310”.

  49. 49.

    2009 Regulations, art. 24(1). “Organically grown”, “organically raised”, “organically produced” or similar expressions are acceptable.

  50. 50.

    See Glenn, “Damage”, at p. 663.

  51. 51.

    Article 1457 C.c. reads: “Every person has a duty to abide by the rules of conduct which lie upon him, according to the circumstances, usage or law, so as not to cause injury to another.

    Where he is endowed with reason and fails in this duty, he is responsible for any injury he causes to another person by such fault and is liable to reparation for the injury, whether it be bodily, moral or material in nature.

    He is also liable, in certain cases, to reparation for injury caused to another by the act or fault of another person or by the act of things in his custody”.

  52. 52.

    Article 976 C.c. reads: “Neighbours shall suffer the normal neighbourhood annoyances that are not beyond the limit of tolerance they owe each other, according to the nature or location of their land or local custom”.

  53. 53.

    See generally J. M. Glenn, “Footlose: Civil responsibility for GMO gene wandering in Canada”, (2003–2004) 43 Washburn Law Journal, p. 547 [Glenn, “Footlose”].

  54. 54.

    Monsanto Canada Inc. v. Schmeiser [2004] 1 S.C.R. 902 [Schmeiser].

  55. 55.

    Schmeiser. The dissenting bench rather held that “the plant cell claim cannot extend past the point where the genetically modified cell begins to multiply and differentiate into plant tissues, at which point the claim would be for every cell in the plant” (par. 138, per J. Arbour).

  56. 56.

    Probably anticipating polemics, the Supreme Court itself had narrowed down the scope of the case: “[…] we emphasize from the outset that we are not concerned here with the innocent discovery by farmers of “blow-by” patented plants on their land or in their cultivated fields. Nor are we concerned with the scope of the respondents’ patent or the wisdom and social utility of the genetic modification of genes and cells — a practice authorized by Parliament under the Patent Act and its regulations” (at para. 2, J. McLachlan and Fish).

  57. 57.

    In our opinion, accidental contamination is not anything resembling the “use” of the invention: see Pfizer Corp. v. Ministry of Health, [1965] A.C. 512 (H.L.), whereby Lord Wilberforce observed that “if it can positively be proved that the possession was innocent of any actual use or intention to use, the defendant will not be held to have infringed” (p. 572) (cited in Schmeiser, at para. 55, J. McLachlan and Fish).

  58. 58.

    J. M. Glenn, “Footlose”, supra, at p. 554.

  59. 59.

    Id., at p. 554.

  60. 60.

    Id., at p. 555.

  61. 61.

    Environmental Management and Protection Act, S.S.198384, c. E-10.2 (at art. 15) [EMPA].

  62. 62.

    J. M. Glenn, “Footlose”, supra, at p. 558.

  63. 63.

    EMPA.

  64. 64.

    Hoffman v. Monsanto Canada Inc., 283 DLR (4th) 190; [2007] 6 WWR 387; 293 Sask R 89, 2007 SKCA 47 (CanLII) (leave to appeal to SCC refused) [http://canlii.ca/t/1rg03] [Hoffman].

  65. 65.

    These parties were in fact « shadow plaintiffs », as the action was throughout driven by the Saskatchewan Organic Directorate-Organic Agriculture Protection Fund, who was eagerly in search of a cause of action.

  66. 66.

    Environmental Management and Protection Act, S.S.1983–84, c. E-10.2.

  67. 67.

    Hoffman v. Monsanto Canada Inc., 2005 SKQB 225 (CanLII), http://canlii.ca/t/1kwr2 [Hoffman I].

  68. 68.

    Queen’s Bench for Saskatchewan, at par. 71, per J. Smtih [emphasis added]. The Court of appeal approved the underlying logic (see par. 59).

  69. 69.

    See J. M. Glenn, “Damages”, supra, at p. 688.

  70. 70.

    Hoffman I, at par. 208 [emphasis in original text].

  71. 71.

    Cfr. J. M. Glenn, “Damages”, supra, at p. 668, more nuanced as she notes that some feature of the Canadian approval system (such as its lack of transparency, poor post-market surveillance) may well be more similar to a regulation failures raising “operational liability”.

  72. 72.

    See Glenn, “Footlose”, supra, at p. 557.

  73. 73.

    According to art. 1726, al. 1 of the Civil code, “[t]he seller is bound to warrant the buyer that the property and its accessories are, at the time of the sale, free of latent defects which render it unfit for the use for which it was intended or which so diminish its usefulness that the buyer would not have bought it or paid so high a price if he had been aware of them”. The provision may be of relevant, but the Consumer Act provides for greater protection (see infra, this section “Product liability”).

  74. 74.

    Note that the introduction of the impossilité de cumul between contractual and extracontractual rules has enhanced the disparity problem existing between “contractual victims” and extracontractual ones.

  75. 75.

    EU inspired, it states: “The manufacturer, distributor or supplier of a movable property is not liable to reparation for injury caused by a safety defect in the property if he proves that the victim knew or could have known of the defect, or could have foreseen the injury.

    Nor is he liable to reparation if he proves that, according to the state of knowledge at the time that he manufactured, distributed or supplied the property, the existence of the defect could not have been known, and that he was not neglectful of his duty to provide information when he became aware of the defect”.

  76. 76.

    See e.g. Gilles-Éric Séralini et al., “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize”, (2012) 50 Food and Chemical Toxicology, p. 4221, who demonstrated a risk for animal health, as “[t]he results […] demonstrate that lower levels of complete agricultural glyphosate herbicide formulations, at concentrations well below officially set safety limits, induce severe hormone-dependent mammary, hepatic and kidney disturbances. Similarly, disruption of biosynthetic pathways that may result from overexpression of the EPSPS transgene in the GM NK603 maize can give rise to comparable pathologies that may be linked to abnormal or unbalanced phenolic acids metabolites, or related compounds”. Following a known controversy, the article was removed from the scientific periodical.

  77. 77.

    See M.-E. Arbour, “Portrait of Risk Development as A Young Defence”, (2014) 59 Revue de droit de McGill, p.1.

  78. 78.

    Art. 53, par. 1, Consumer Protection Act.

  79. 79.

    J. De Beer, “The Rights and Responsibilities of Biotech Patent Owners”, (2007) 40 University of British Columbia Law Review, p. X. See similarly K. Black and J. Wishart, “Containing the GMO Genie: Cattle Trespass and the Rights and Responsibilities of Biotechnology Owners”, (2008) 46 Osgoode Hall Law Journal, p. X.

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Annex I – Risk Assessment Process – Novel Foods

Annex I – Risk Assessment Process – Novel Foods

Food and Drug Regulations – Division 28 (“Novel Foods”)

Interpretation

B.28.001. The definitions in this section apply in this Division.

  • “genetically modify”

  • “genetically modify” means to change the heritable traits of a plant, animal or microorganism by means of intentional manipulation. (modifier génétiquement)

  • “major change”

  • “major change” means, in respect of a food, a change in the food that, based on the manufacturer’s experience or generally accepted nutritional or food science theory, places the modified food outside the accepted limits of natural variations for that food with regard to

  1. (a)

    the composition, structure or nutritional quality of the food or its generally recognized physiological effects;

  2. (b)

    the manner in which the food is metabolized in the body; or

  3. (c)

    the microbiological safety, the chemical safety or the safe use of the food. (changement majeur)

  • “novel food”

  • “novel food” means

  1. (a)

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

  2. (b)

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

    1. (i)

      has not been previously applied to that food, and

    2. (ii)

      causes the food to undergo a major change; and

  3. (c)

    a food that is derived from a plant, animal or microorganism that has been genetically modified such that

    1. (i)

      the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism,

    2. (ii)

      the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or

    3. (iii)

      one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism. (aliment nouveau)

Pre-market notification

B.28.002

  1. (1)

    No person shall sell or advertise for sale a novel food unless the manufacturer or importer of the novel food

    1. (a)

      has notified the Director in writing of their intention to sell or advertise for sale the novel food; and

    2. (b)

      has received a written notice from the Director under paragraph B.28.003(1)(a) or subsection B.28.003(2).

  2. (2)

    A notification referred to in paragraph (1)(a) shall be signed by the manufacturer or importer, or a person authorized to sign on behalf of the manufacturer or importer, and shall include the following information:

    1. (a)

      the common name under which the novel food will be sold;

    2. (b)

      the name and address of the principal place of business of the manufacturer and, if the address is outside Canada, the name and address of the principal place of business of the importer;

    3. (c)

      a description of the novel food, together with

      1. (i)

        information respecting its development,

      2. (ii)

        details of the method by which it is manufactured, prepared, preserved, packaged and stored,

      3. (iii)

        details of the major change, if any,

      4. (iv)

        information respecting its intended use and directions for its preparation,

      5. (v)

        information respecting its history of use as a food in a country other than Canada, if applicable, and

      6. (vi)

        information relied on to establish that the novel food is safe for consumption;

    4. (d)

      information respecting the estimated levels of consumption by consumers of the novel food;

    5. (e)

      the text of all labels to be used in connection with the novel food; and

    6. (f)

      the name and title of the person who signed the notification and the date of signing.

B.28.003

  1. (1)

    Within 45 days after receiving a notification referred to in paragraph B.28.002(1)(a), the Director shall review the information included in the notification and

    1. (a)

      if the information establishes that the novel food is safe for consumption, notify the manufacturer or importer in writing that the information is sufficient; or

    2. (b)

      if additional information of a scientific nature is necessary in order to assess the safety of the novel food, request in writing that the manufacturer or importer submit that information.

  2. (2)

    Within 90 days after receiving the additional information requested under paragraph (1)(b) the Director shall assess it and, if it establishes that the novel food is safe for consumption, notify the manufacturer or importer in writing that the information is sufficient.

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Arbour, ME., Hoeung, S. (2016). Country Report: Canada. In: Norer, R. (eds) Genetic Technology and Food Safety. Ius Comparatum - Global Studies in Comparative Law, vol 14. Springer, Cham. https://doi.org/10.1007/978-3-319-23995-8_10

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