Safe Food for Canadians Act

and regulations
Safe Food for Canadians Act was enacted into law on November 2012. 
The SFCR were published on June 13, 2018, and came into force on 15
January 2019. 
Safe Food for Canadians Act and Regulations
• Interpretation
• Prohibitions on movement of food
• Registration and Licensing – importers, exporters & manufacturers
• Administration and enforcement
• Disclosure of information (Enhanced inspector authority)
• Regulations
• Incorporation by reference
Interpretation
• Establishment
• Prepare
• Conveyance or equipment
• Document and record
• Person vs individual
• Consumer prepackaged
• prepackaged other than consumer prepackaged foods
• prepackaged” food can include both of those: consumer prepackaged
foods or prepackaged other than consumer prepackaged foods
Administration and enforcement (not a
complete list)
• Certification
• Inspection (authority enhanced)
• Dealing with seized things
• Offences
Prohibition (not a complete list)
• It is prohibited for a person to import a food commodity the selling of which is
prohibited under section 4 of the Food and Drugs Act.
• It is prohibited for a person to sell a food commodity that is the subject of a recall
order referred to in subsection 19(1) of the Canadian Food Inspection Agency Act.
• Deception, erroneous impression, etc.
• Labelled or packaged contrary to regulations
• Tampering
• Communicating false or misleading information
• Use of inspection mark or grade name
What does the SFCA do?
Shifts point of enforcement to port
of entry or provincial boundary
Common legislative, regulatory &
oversight framework for all food
Disclosure of personal and
confidential business information
Criminal law
• 6. (1) (2) It is prohibited to manufacture, prepare,
package, label, sell, import a product that is
labeled or packaged in contravention of a
provision of the regulations
• 10.(2) It is prohibited for a person to send or
convey from one province to another-or to import
or export a food unless the person is authorized to
do so by a registration, license or both
• 10. (3) It is prohibited for a person to send or
convey from one province to another — or to
import or export — a prescribed food commodity
unless the food commodity meets the
requirements of the regulations.
What does the SFCA do?
Shifts point of enforcement to port of
entry or provincial boundary
Common legislative, regulatory &
oversight framework for all food
Disclosure of personal and
confidential business information
Criminal law
• 12. It is prohibited for a person to have in their
possession for the purpose of sending or conveying from
one province to another — or for the purpose of
exporting — a prescribed food commodity, unless it
meets the requirements of the regulations.
• 13. (1) It is prohibited for a person to conduct a
prescribed activity in respect of a prescribed food
commodity that has been imported — or that is to be
exported or to be sent or conveyed from one province to
another — unless the activity is conducted in accordance
with the regulations.
• 13. (2) It is prohibited for a person to conduct a
prescribed activity in respect of a prescribed food
commodity that has been imported — or that is to be
exported or to be sent or conveyed from one province to
another — unless the person is authorized to conduct
that activity by a registration, a licence or by both
Food Safety Prohibitions (SFCA)
7. It is prohibited for a person to tamper with any food commodity, its
label or its package with intent to
• (a) render the food commodity injurious to human health; or
• b) cause a reasonable apprehension in others that the food commodity is
injurious to human health.
8. It is prohibited for a person to threaten to render a food commodity
injurious to human health.
General
• Disclosure of information • Regulations
• Disclosure to public • A number of regulations
• Recall disclosure incorporated
General
• Incorporation by reference • Costs and liabilities
• static or closed, and ambulatory or
open, Internal and third party
 SFCA Regulations
• Licensing
• Enhanced trade, food safety &
compliance requirements
• Fresh fruit & vegetable
• Consumer Packaging & Labelling
Regulations
• Meat Inspection Regulations
• Fish Inspection Regulations
• Processed Products Regulations
• Dairy Products Regulations
• Egg Regulations
• Honey Regulations
• Livestock and Poultry Carcass
Grading Regulations
• Maple Products Regulations
• Processed Egg Regulations
• Organic Products Regulations
SFCR
 Interpretation
• The SFCA defines “establishment” as meaning “any place, including a conveyance where a food is manufactured, prepared, stored,
packaged, or labelled”. The definition of establishment is quite broad, and extends beyond the physical structure. It includes
conveyances on which certain activities are conducted or open areas that are not contained by a building (for example, fields). A
conveyance is considered an “establishment” when the food is manufactured, 5 prepared, stored, packaged, or labelled in the
conveyance. For example: a fishing vessel that processes, freezes, and packages scallops.
• The SFCA defines “prepare”, in respect of a food commodity, as meaning “include to process, treat, preserve, handle, test, grade,
code or slaughter it or to do any other activity in respect of it that is prescribed.” In the SFCR, growing and harvesting of fresh
fruits or vegetables, is also a prescribed acxzxtivity under the definition of “prepare.” This means growing and harvesting is
included anytime the term “prepare” is used in the SFCR
• “Document” is a broad term that can include many different types of information, for example, a scheduled process. A record is a
type of document that is kept as proof that something happened, for example, complaints received or monitoring a piece of
equipment. What are commonly known as records are covered by the broader term “document.”
• The SFCA defines “conveyance” as meaning “a vessel, aircraft, train, motor vehicle, trailer or other means of transportation,
including a cargo container.”
• When the term “individual” is used, the scope of the definition is limited to one individual as opposed to an organization. The term
“person” is defined more broadly and its meaning can range from one individual to one organization.
• “Consumer prepackaged” foods are in their final packaging, and ready for sale to an individual to be used for non-commercial
purposes. The term “prepackaged other than consumer prepackaged” food includes food packaged in shipping or other bulk
containers and usually sold to a person rather than an individual and for commercial purposes (see above clarification on the term
“person” in item 34. A “prepackaged” food can include both of those: consumer prepackaged foods or prepackaged other than
consumer prepackaged foods.
Trade
• Who requires a licence
• General food safety requirements
• Address requirements for imported food: the SFCR permits the import
of food without a Canadian address
• Exports
• Return of exports
 Horizontal Requirements:
Licensing
• Licensing allows CFIA to authorize activity and attach specific conditions. It
also allows CFIA to identify who is preparing or importing food in Canada,
where food businesses are located and what activities they are conducting.
• The regulations:
• broaden licensing requirements so everyone who imports or prepares
food for inter-provincial trade would be required to have a licence
• Applies to many who were not covered by CFIA regulations in past
• Allow regulated parties to apply for multiple licenses – for example for
each physical location, for a number of locations or by activity
• The license would be valid for two years.
• A fee applies for the licenses.
PCPs
Preventive control plan
(Plan de contrôle préventif)
A combination of control measures that, when taken as a whole, provide for a science-based
approach to managing risks posed by hazards and contribute to achieving compliance with
regulatory requirements.

Systems-based approach
(Approche axée sur un système)
An integrated, flexible, multi-faceted approach to analysing and managing risk that considers the
actions of all of the steps or processes and controls that make up commodity production or
preparation

• From CFIA website 2017

 Horizontal Requirements: Preventive
Control Plans (PCPs)
• Preventive control plan (PCP) sets out in writing how food safety and
other regulatory requirements (e.g. related to labelling, product
composition, allergens) will be achieved.
• PCPs recognized internationally as best way to demonstrate that food
safety risks and hazards are controlled because it focuses on prevention
and systems-based examination of potential hazards.
• The regulations entrench management responsibility by requiring
licence holders to have a PCP that demonstrates how they achieve
regulatory requirements (safety and other requirements) and describe
how management controls their operations, including how they
monitor, verify and correct deviations, and respond to unforeseen food
safety situations.
 PCP

Canadian Food Inspection Agency, "

Industry Resource: Key Preventive Safety Controls Infographic"
PCP divisions (6)
• Division 1: Interpretation and Application
• Division 2: Biological, Chemical and Physical Hazards
• Division 3: Treatments and Processes
• Division 4: Maintenance and Operation of Establishment o Requires that establishments be
maintained and operated in a way that meets the preventive control requirements
• Subdivision A: Responsibility of operator
• Subdivision B: Sanitation, Pest Control and Non-Food Agents
• Subdivision C: Conveyances and
• Subdivision D: Conditions Respecting Establishments
• Subdivision E: Unloading, Loading and Storing
• Subdivision F:
• Subdivision G: Hygiene
• Division 5: Investigation, Notification, Complaints, and Recall
• Division 6: Preventive Control Plan
How to conduct Hazard analysis?
 Preventive control plan
Preventive Control Elements
• Determination of Biological, Chemical and
Physical Hazards
• Treatments and Processes
• Maintenance and Operation of
Establishments
• Sanitation, Pest Control and Nonfood Agents
• Conveyances and Equipment
• Conditions Respecting Establishments
• Unloading, Loading & Storing
• Employee Competency
• Employee Hygiene
• Communicable Diseases and Lesions
• Investigation, Notification and Recall
Control Plan Content
• Description of biological, chemical &
physical hazards
• Control measures for each
• Evidence to validate control measure
effectiveness
• Description of Critical Control Points
• Description of the Critical Limits for CCPs
• Corrective action procedures for each CCP
• Verification procedures that assure
compliance to SFCA & Regulations
• Substantiating documentation
• Elements specific to meat & commodities
 Exemptions to Preventive control plan
Exemptions
• Food additives
• Alcoholic beverages
• Taxonomic families
• Rubiaceae: coffee beans
• Malvaceae: cocao beans
• Poaceae: corn, wheat, rice barley
Cannabacea: hops
• ? Unpasteurized milk
Criteria for exemptions
• Unprocessed-will be
manufactured, processed or
treated in Canada
• Labelled “For further preparation
only”
• Not a consumer prepackaged food
• Bring into compliance within 3
months of importation or
interprovincial transfer
 Horizontal Requirements: Outcome-
based Requirements
• Move from prescriptive commodity-specific rules that
cover some food commodities, to system of expected
outcomes and regulatory requirements for all food
traded across borders.
• Depending on nature of operation, PCPs would
include some or all of following elements:
• processes and products
• equipment design and maintenance
• sanitation and pest control
• employee hygiene and training
• receiving, transportation and storage
• physical structure and maintenance of the
establishment
• recall and complaints
Examples :
Floors, Walls, Ceilings
• Floors, walls, and ceilings shall be constructed of material
that is durable, impervious to moisture, smooth, cleanable,
and suitable for the production conditions in the area.
• Floors shall have drainage that prevents standing or pooled
water
Water/Ice/Steam
• The quality and safety of water, ice and steam in direct
contact with food or food contact surfaces is controlled to
prevent contamination.
• Water shall be potable or clean and shall be suitable for the
process being undertaken
• Water, ice and steam shall be sampled, tested and
analyzed to confirm their safety for the intended purpose.
 Overview of Inspection Approach
• New food regulations will draw together federal food inspection
regulations in Canada into one overarching system that:
• Is focused on prevention and greater industry accountability
• Is capable of rapidly mitigating risks to food safety in a way that reduces
impacts on consumers
• Enables a risk-based approach to inspection of food commodities and
establishments that pose greatest risk
• Helps identify and prevent emerging food safety issues
• Puts the emphasis on expected safety outcomes to allow all enterprises,
especially small and medium enterprises to achieve compliance in way
that can be tailored to their operational needs, and
• Enables the CFIA to apply consistent regulatory requirements and
inspection approaches
• Replace with single set of regulations that includes:
• Horizontal provisions applying to all food imported and prepared for trade
inter-provincially (e.g licensing, preventive controls, traceability, record-
keeping)
• Commodity–specific food safety requirements (e.g. fresh fruit and
vegetables)
• Commodity-specific trade requirements and consumer protection provisions
(e.g. standards of identity, grades, container sizes, inspection marks, labelling)
• Complementary regulations regarding disclosure of information and
administrative monetary penalties

• The new regulations would not apply to food traded solely within a
province or territory
 Inspection Approaches
• The CFIA uses three approaches to regulation as appropriate: prescriptive,
systems-based, and outcome-based
• Prescriptive regulation (technology- or standards-based)
• Process or procedure requirements are defined in regulation
• Regulated parties have little or no choice regarding how to comply
• Systems-based regulation (management-based)
• e.g. Quality Management Plan in fish, HACCP for meat
• Regulated parties required to develop valid internal risk management plans and
the Agency verifies that the plans are properly and effectively implemented
• Outcome-based regulation (performance-based)
• Required outcome or level of performance is written into regulation
Outcome-based Inspection
• Foundations of outcome-based regulation
Emphasis on specific and measurable outcomes versus
prescriptive provisions:
 Clear definition of the outcomes in regulation (the what), and how compliance will be
measured
 Regulated parties choose method to achieve the outcome (the how)
• Example from the Safe Foods for Canadians Act: Requirement for Preventive
Control Plan - Product Coding and Labelling Control
Outcome: each food commodity shall be marked with a code mark on
the label or container
Performance indicators:
 The code mark shall be applied in a legible and permanent manner.
 The exact meaning of the code shall be available to the inspector.
Traceability and record keeping
• Documented & exercised food traceability & recall plan
• Document retention and formatting requirements
• Available in Canada within 24 hours of request or sooner
• Electronic documents: single file, plain text, imported into & manipulated
with standard commercial software
• Non encrypted = plain text
• Documents retained for two (2) years
• Lot numbers on all products
• Enhanced product data reporting
 Traceability
• The regulations apply Codex standard of maintaining records
on inputs and distribution, “One step forward, one step
backwards”, to every stage of food supply chain, from
primary producer to retailer
• Regulations require that operators:
• collect and maintain traceability information in an
accessible, useable format, in English or in French.
• provide records to CFIA on request , un-encrypted and
within 24 hours in a format which can be imported
and manipulated by standard commercial software
• Operator who believe that food is not in compliance with
food safety requirements would have to :
• immediately initiate procedures to withdraw the food
from the market
• inform the CFIA
• inform consumers if it could have reached them and
recall if necessary
• Retailers, restaurants and catering companies will not be
required to collect information about consumer purchases.
• All records would need to be maintained and accessible at
an address in Canada for a period of not less than three
years.
 Horizontal Requirements: Suspension and Cancellation of
License
• Minister may suspend a licence if:
• licence holder has not complied with conditions of licence or any provision of Act or
regulations
• licence holder has unpaid fees
• reasonable to believe that public health may be endangered if licence holder continues to
import, export or prepare a food commodity for export or inter-provincial trade.
• Minister may cancel a licence if:
• The licence was issued on the basis of false or misleading information, or false or falsified
documents submitted in or with the application
• reason for suspension cannot be resolved within 90 days following day on which licence was
suspended - a longer time period may be granted upon request of licence holder;
• licence holder continued to import, export, or prepare a food commodity for export or inter-
provincial trade while their licence is under suspension
Commodity Specific Safety Requirements:
Fresh Fruit and Vegetables

• The regulations
• establish produce safety outcomes/requirements for fresh fruit
and vegetables .
• extend PCP requirements to farms who ship product directly to
market in another province or to another country.
• New requirements are consistent with Good Agricultural
Practices and CanadaGAP, which has been CFIA
recognized and internationally benchmarked.
 Commodity Specific Trade and Consumer
Protection Provisions – FDA-SFCA overlap

• Labelling and standards of identity provisions exist in Food and Drug Regulations (FDR)
administered and in regulations under CAPA, MIA, FIA and CPLA.
• Labelling and standards of identity sections under new CFIA food regulations include:
- reference to the FDR where appropriate;
- requirements currently under CAPA, FIA, MIA, CPLA not already covered in the FDR;
and
- commodity specific requirements
• When the duplication between the current sets of regulations cannot simply be
eliminated, a provision by provision analysis is done to determine which provision will
be maintained taking into consideration industry preference and consumer protection.
Link to the regulations
A copy of the proposed regulations is available on UMLearn