Safe Food for Canadians Regulations (SOR/2018-108)
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Regulations are current to 2024-10-30 and last amended on 2022-06-21. Previous Versions
PART 4Preventive Controls (continued)
DIVISION 5Investigation, Notification, Complaints and Recall (continued)
Marginal note:Recall procedure
84 (1) An operator must prepare, keep and maintain a document that sets out a recall procedure that enables the effective recall of a food, the name of a contact person who is responsible for the procedure and the name of a contact person who is responsible for conducting recalls.
Marginal note:Recall simulation
(2) The operator must, at least once every 12 months,
(a) conduct a recall simulation, based on the recall procedure; and
(b) prepare a document that sets out the details of how the recall simulation was conducted and the results of the simulation, and keep that document for two years after the day on which the recall simulation is completed.
Marginal note:Recall — notice to Minister
(3) If an operator determines that a food should be recalled because it presents a risk of injury to human health, the operator must immediately notify the Minister.
Marginal note:Recall — implementation
(4) If a food is the subject of a recall because it presents a risk of injury to human health, the operator must
(a) immediately implement the recall procedure; and
(b) prepare a document that sets out the details of the recall, including any information that substantiates its effectiveness, and keep the document for two years after the day on which the recall is initiated.
Marginal note:Imported food
85 The holder of a licence to import must comply with sections 82 to 84 in respect of a food that is imported.
DIVISION 6Preventive Control Plan
Marginal note:Licence holders
86 (1) A licence holder must prepare, keep and maintain a written preventive control plan that meets the requirements of section 89 for any activity identified in their licence that they conduct in respect of a food or food animal.
Marginal note:Exception — food to be exported
(2) Despite subsection (1), a preventive control plan is not required to be prepared, kept or maintained for any activity that the licence holder conducts in respect of a food, other than fish or a meat product, that is exported, unless a certificate or other document referred to in section 48 of the Act is sought in respect of the food.
Marginal note:Exception — sales of $100,000 or less
(3) Despite subsection (1), if a licence holder’s gross sales that are derived from food are $100,000 or less for the 12 months before the day on which they most recently made an application for the issuance, renewal or amendment of a licence, a preventive control plan must be prepared, kept and maintained only for any activity that they conduct in respect of
(a) a food animal, meat product, fish, dairy product, egg, processed egg product or processed fruit or vegetable product that is identified in their licence; and
(b) a food in respect of which a certificate or other document referred to in section 48 of the Act is sought.
Marginal note:Growers or harvesters of fresh fruits or vegetables
87 Any person who grows or harvests fresh fruits or vegetables must prepare, keep and maintain a written preventive control plan that meets the requirements of section 89 for any activity that they conduct in respect of those fresh fruits or vegetables if they are
(a) to be exported and a certificate or other document referred to in section 48 of the Act is sought in respect of the fresh fruits or vegetables; or
(b) to be sent or conveyed from one province to another and the person’s gross sales that are derived from food are more than $100,000 for the previous 12 months.
Marginal note:Implementation
88 Any person who is required to prepare, keep and maintain a preventive control plan must implement that plan.
Marginal note:Content of preventive control plan
89 (1) The preventive control plan must include
(a) a description of the measures for ensuring that the applicable requirements of sections 201 and 205, subsection 206(1), sections 208, 218, 221, 296, 306, 307, 316, 317, 321, 322, 324 to 326 and 328 are met;
(b) a description of the measures for ensuring that the food is packaged and labelled in a manner that does not contravene subsection 6(1) of the Act;
(c) in relation to the applicable requirements of these Regulations,
(i) a description of the biological, chemical and physical hazards that are identified under subsection 47(1) as presenting a risk of contamination of a food, of the control measures for preventing or eliminating those hazards or reducing them to an acceptable level and of the evidence that the control measures are effective,
(ii) a description of the critical control points, of the related control measures and of the evidence that the control measures are effective,
(iii) a description of the critical limits for each critical control point,
(iv) the procedures for monitoring the critical control points in relation to their critical limits,
(v) the corrective action procedures for each critical control point,
(vi) the procedures for verifying that the implementation of the preventive control plan results in compliance with the provisions of the Act and these Regulations, and
(vii) documents that substantiate that the preventive control plan has been implemented with respect to subparagraphs (i) to (vi); and
(d) in relation to the applicable requirements of sections 128 to 136, paragraphs 140(b) and (c) and sections 141 to 144,
(i) a description of the measures for preventing or eliminating a risk of avoidable suffering, injury or death to the food animals during their handling, and of the evidence that those measures are effective,
(ii) a description of the measures for preventing or eliminating a risk of avoidable suffering or injury to the food animals during their slaughtering, and of the evidence that those measures are effective,
(iii) a description of the performance criteria for evaluating the effectiveness of each of those measures,
(iv) the procedures for monitoring each of those measures,
(v) the corrective action procedures for each of those measures,
(vi) the procedures for verifying that the implementation of the preventive control plan results in compliance with the provisions of the Act and these Regulations,
(vii) the procedures for auditing, on a regular basis, the outcome of the implementation of the preventive control plan, and
(viii) documents that substantiate that the preventive control plan has been implemented with respect to subparagraphs (i) to (vii); and
(e) supporting documents that show evidence of the information recorded under paragraphs (a) and (b), subparagraphs (c)(i) to (vi) and (d)(i) to (vii).
Marginal note:Retention period of documents
(2) Each document referred to in subparagraphs (1)(c)(vii) and (d)(viii) must be kept for two years after the day on which it is prepared.
Marginal note:Exception — game animals
(3) The preventive control plan of the holder of a licence to slaughter a game animal is not required to include any information specified in subsection (1) other than the information specified in subparagraphs (1)(c)(i) and (d)(i).
Marginal note:Additional content — import
(4) The preventive control plan of the holder of a licence to import must also include the information specified in subparagraphs (1)(c)(i) to (vii) in relation to the requirements of section 11.
Marginal note:Additional content — export
(5) The preventive control plan of the holder of a licence to export must also include the information specified in subparagraphs (1)(c)(i) to (vii) in relation to the requirements of subsection 15(1).
Marginal note:Additional content — post-mortem programs
(6) The preventive control plan of a licence holder who is authorized under subsection 160(3) to conduct a post-mortem examination program or a post-mortem defect management program must also include the information specified in subparagraphs (1)(c)(i) to (vii) and paragraph (1)(e) in relation to that program and must meet the requirements that are set out in
(a) in the case of a post-mortem examination, the document entitled Fundamentals of the Post-mortem Examination Program, prepared by the Agency and published on its website, as amended from time to time; or
(b) in the case of a post-mortem defect management program, the document entitled Fundamentals of the Post-mortem Defect Management Program, prepared by the Agency and published on its website, as amended from time to time.
PART 5Traceability
Marginal note:Documents
90 (1) Any person who sends or conveys a food from one province to another, or who imports or exports it, any holder of a licence to slaughter a food animal, to manufacture, process, treat, preserve, grade, store, package or label a food or to store and handle an edible meat product in its imported condition and any person who grows or harvests fresh fruits or vegetables that are to be sent or conveyed from one province to another or exported must, if they provide the food to another person, prepare and keep documents that set out
(a) the common name of the food, a lot code or other unique identifier that enables the food to be traced and the name and principal place of business of the person by or for whom the food was manufactured, prepared, produced, stored, packaged or labelled;
(b) except if they provide the food to another person as a sale at retail, the date on which it was provided and the name and address of the person to whom it was provided;
(c) if they were provided the food by another person, the name and address of that person and the date on which it was provided; and
(d) the name of any food commodity that they incorporated into the food or from which they derived the food and, if they were provided the food commodity by another person, the name and address of that person and the date on which it was provided.
Marginal note:Documents — retail sale
(2) Any person who sells a food at retail, other than a restaurant or other similar enterprise that sells the food as a meal or snack, must prepare and keep documents that include the information specified in paragraphs (1)(a), (c) and (d).
Marginal note:Retention period of documents
(3) The documents referred to in subsections (1) and (2) must be kept for two years after the day on which the food was provided to another person or sold at retail, and must be accessible in Canada.
Marginal note:Production of documents
91 (1) Any person who has received a request from the Minister for a document referred to in section 90, or any part of such a document, must provide it to the Minister
(a) within 24 hours after receipt of the request, or within
(i) any shorter period that is specified by the Minister, if the Minister believes that it is necessary in order to identify or respond to a risk of injury to human health associated with a food commodity, or
(ii) any longer period that is specified by the Minister, if the Minister believes that the document is not necessary for a recall that is or may be ordered under subsection 19(1) of the Canadian Food Inspection Agency Act; and
(b) if provided electronically, in a single file and in plain text that is capable of being imported into and manipulated by standard commercial software.
Marginal note:Definition of plain text
(2) In paragraph (1)(b), plain text means data that is not encrypted and whose semantic content is available.
Marginal note:Labelling
92 (1) Any person referred to in subsection 90(1) or (2) must ensure that a label that bears the information specified in paragraph 90(1)(a) is applied or attached to any food, or accompanies any food, that is provided to another person.
Marginal note:Consumer prepackaged food
(2) In the case of consumer prepackaged food that is not packaged at retail, the unique identifier referred to in paragraph 90(1)(a) must be a lot code.
Marginal note:Exception
(3) Subsections (1) and (2) do not apply in respect of
(a) a food at the time of its export;
(b) a food, other than a consumer prepackaged food, at the time of its sale at retail; or
(c) a prepackaged food described in paragraphs 213(a) to (c) at the time of its sale at retail.
Marginal note:Exception — foods described in paragraphs 219(1)(a) and (b)
(4) Despite subsection (1), any food described in paragraph 219(1)(a) or (b) is not required to be labelled with the common name of the food at the time of its sale at retail.
Marginal note:Exception — foods described in section 220
(5) Despite subsection (1), any food described in section 220 is not required to be labelled with the name and principal place of business of the person by or for whom the food was manufactured, prepared, produced, stored, packaged or labelled.
PART 6Commodity-specific Requirements
DIVISION 1Application
Marginal note:Application — import, interprovincial trade and export
93 (1) The requirements of this Part apply in respect of
(a) any foods that have been imported or any foods that are to be sent or conveyed from one province to another or exported; and
(b) any food animals from which meat products that are to be sent or conveyed from one province to another or exported may be derived.
Marginal note:Application — food animals
(2) The requirements of sections 128 to 136 apply in respect of food animals that are in an establishment that is identified in a licence to slaughter.
DIVISION 2Dairy Products
Marginal note:Preparation
94 Any milk or cream that is used in preparing a dairy product that is to be sent or conveyed from one province to another or exported must meet the applicable requirements of the legislation of the province in which the dairy product is prepared.
DIVISION 3Eggs
Marginal note:Pasteurization
95 (1) A licence holder may pasteurize eggs in the shell only if they are graded Canada A or Grade A.
Marginal note:Import — eggs pasteurized in shell
(2) Eggs that are pasteurized in the shell and that are imported must have been graded Grade A before pasteurization.
Marginal note:Import — foreign official document
96 The holder of a licence to import may import eggs only if the licence holder provides an inspector with an official document issued by the foreign state, in a form approved by the President, that states that the eggs meet the requirements that are set out in the Act and these Regulations.
Marginal note:Import — Grade C or Grade Nest Run
97 A licence holder who imports eggs that are graded Grade C or Grade Nest Run must deliver them directly to an establishment where eggs are processed and treated by a licence holder.
Marginal note:Import — ungraded eggs
98 (1) Despite subsection 306(1), a licence holder may import ungraded eggs if they
(a) before the import, notify the Minister in writing of the quantity of ungraded eggs that are intended to be imported, the date of the import and the name of the licence holder and address of the establishment referred to in paragraph (c);
(b) package them in a container that is labelled with the expression “Ungraded Eggs” or “oeufs non classifiés”; and
(c) deliver them directly to an establishment where eggs are processed and treated by a licence holder.
Marginal note:Removal — imported ungraded eggs
(2) Any imported ungraded eggs delivered to an establishment referred to in paragraph (1)(c) may be removed from that establishment if
(a) the eggs have been processed and treated by a licence holder; or
(b) the eggs are delivered directly to another establishment where eggs are processed and treated by a licence holder.
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