Performance criteria for preventive controls and traceability elements and sub-elements – Feeds Regulations, 2024

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Introduction

The Feeds Regulations, 2024 were published in the Canada Gazette, Part II (CGII) on July 3, 2024. To provide stakeholders time to adjust to the new and amended regulatory requirements, the Canadian Food Inspection Agency (CFIA) chose a staggered coming into force for the Feeds Regulations, 2024 over a period of 18 months.

The new regulatory requirement to prepare, implement, keep and maintain a preventive control plan (PCP), are in effect as of June 17, 2025, 12 months after CGII publication. Under the Feeds Regulations, 2024, most livestock feed (feed) businesses will require a written PCP that describes how an establishment's hazards are identified and controlled as well as how compliance with other regulatory requirements are met.

Purpose

This document is intended to help feed businesses to better understand how to prepare, implement and comply with PCP requirements.

What is included

This document provides information on:

  • preventive control plan requirements
  • legal authorities for preventive control requirements
  • elements of a preventive control plan, including sub-elements, their outcome, rationale and performance criteria

Roles and responsibilities

Stakeholders that conduct livestock feed-related activities are responsible for complying with preventive control requirements in the Feeds Regulations, 2024. They must demonstrate compliance by ensuring that feeds and processes employed at feed establishments meet all regulatory requirements.

We verify the compliance of a feed business by conducting activities that include inspection and surveillance. When a non-compliance is identified, the CFIA takes appropriate compliance and enforcement actions.

Preventive control plans

A PCP describes a systems-based approach developed by regulated parties that focuses on prevention and control of potential hazards as a way to achieve compliance.

An effective PCP suitable to the operations being performed must be developed, documented, implemented and maintained. Operators are responsible for monitoring and controlling their operations, correcting any non-compliance as it occurs and maintaining ongoing compliance. Depending on the nature of the operation, PCPs will include some or all the elements outlined subsequently. The requirement for an effective PCP is set out and referenced in the regulatory text. PCPs must be made available to us upon request.

The process of managing a PCP will continually generate new information that could be used to actively improve operations in ways that foster regulatory compliance. The commitment of management is essential to the implementation and ongoing maintenance of an effective PCP. Management must ensure that employees and service providers are:

  • trained
  • capable of performing the duties
  • able to demonstrate an understanding of compliance

The PCP approach provides the regulated party with flexibility to meet the outcomes of the requirements in more than 1 way. Regulated parties may use private certification schemes (for example, FeedAssure®, Global Food Safety Initiative (GFSI), the International Organization for Standardization (ISO)) or other existing programs like on-farm food safety systems in the design of their plan. If a regulated party already has a system in place, it may meet all or most of the regulatory requirements. Regulated parties will need to ensure that their PCPs address all regulatory requirements (for example, human health, animal health and the environment). This flexibility should allow for a smooth transition to the new regulations.

Elements of a preventive control plan

Depending on the nature of the operation, PCPs will include the following 7 elements, as applicable.

The information presented for each element and sub-element is organised as follows:

  • outcome: a state where the preventive control (PC) achieves regulatory compliance
  • rationale: explains the potential impacts of the PC on the outcome in each sub-element
  • performance criteria: based on regulatory requirements; can be used by industry to help them achieve regulatory requirements and by inspectors to help them verify regulatory requirements

The legal authorities for PCPs come solely from the Feeds Regulations, 2024. However, the Feed Program operates under the Health of Animals Regulations as well. The CFIA is supportive of feed establishments choosing to utilize PCPs to meet their regulatory obligations of the Health of Animals Regulations as well as the Feeds Regulations, 2024. In addition, general prohibitions are found in the Feeds Act and requirements related to organic feeds are found in the Safe Food for Canadian Regulations.

  • Feeds Act
    • Prohibitions: 3, 3.1, 3.2, 3.3, 3.4
  • Feeds Regulations, 2024
    • Incorporated by reference (IBR) Documents: 2
    • Standards: 34, 35
    • Packaging requirements: 43
    • Identification and analysis of biological, chemical and physical hazards: 56
    • PCP: 57-60
    • Import of feeds: 65, 66, 67, 68
    • Traceability: 71, 72
  • Health of Animals Regulations
    • Specified risk material: 6.4
    • Meat, meat by-products or carcasses in feeds: 112, 113, 113.1
    • Food for ruminants, livestock and poultry, rendering plants, fertilizers and fertilizer supplements: Part XIV
  • Safe Food for Canadians Regulations
    • Organic products: Part 13

Element 1: Process and product controls

Sub-element 1.1a: Incoming inputs

Note: this sub-element covers the sourcing/purchasing of incoming inputs, including imported inputs, while sub-element 6.1 covers the receiving step.

Outcome

The sourcing of incoming inputs is controlled to achieve regulatory compliance.

Rationale

Inadequate input controls could result in non-compliance or unsafe feeds (for example, product contamination, inadequate processing, misrepresentation of the product, infestation, residues, etc.).

Performance criteria

When sourcing for incoming inputs (for example, ingredients, raw materials, medicating ingredients, packaging materials and chemicals (including incidental feed additives or facilitating agents)), the facility should ensure that hazards are identified and control measures are in place to ensure that the incoming inputs are suitable for their intended use and do not provide a source of contamination.

Sub-element 1.1bc: Product formulation, specifications and processing

Outcome

The process is controlled to achieve regulatory compliance.

Rationale

  • inaccurate product formulation and/or mixing could result in non-compliance (for example, product adulteration, inadequate mixing, drug or pesticide residues, etc.)
  • inadequate process control measures could lead to biological, chemical and physical hazards that present a risk of contamination of a feed

Performance criteria

For product formulation and specifications, the operator:

  • has formulas for each feed product that is being prepared
  • has specifications for each feed product
  • uses inputs (that is additives and other substances) that are permitted in the feed product

Processes have:

  • a description of:
    • processing steps, associated control measures and critical limits (if applicable)
    • product movement (for example, process flow diagram)
    • product changeover procedures (for example, cleanout or sequencing)
  • critical limits supported by evidence to be effective (for example, validated using scientific data)
  • measures in place to meet the applicable other regulatory provisions
Sub-element 1.2: Product controls

Outcome

Products meet regulatory requirements including appropriate packaging and product identification (labelling).

Rationale

Inadequate feed controls could result in:

  • inaccurate and/or incomplete information on product identification
  • product that is not compliant

Performance criteria

  • product identification: information is complete, truthful and not misleading
    • it also accurately represents the feed and its content and meets regulatory requirements
  • product specification: product is evaluated for compliance with regulatory requirements where they exist and as per operator's specification
Sub-element 1.3: Import controls

Note: this sub-element will apply to feed products which are directly imported solely for sale and distribution in its imported state. For example, when an operator conducts both import and domestic activities, any imported feed products that they use as ingredients in their process will be covered under sub-element 1.1a. Imported feed products, for direct sale and distribution in its imported state, will be assessed under sub-element 1.3. The following table can be used as a guide to determine when to use sub-elements 1.1a and 1.3, as well as where to capture the associated inspection findings.

Activity Details of the activities Sub-element 1.1a Sub-element 1.3
Import activity only The feed is imported and only sold in its imported condition no yes
Import and domestic preparation (mix/process /manufacture) activities All imported feeds are mixed/processed/manufactured, none are sold in their imported condition. yes no
Import and domestic preparation (mix/process/manufacture) activities Where some imported feeds are sold in its imported condition and some imported feeds are mixed/processed/manufactured. yes
applicable to feeds further processed		 yes
applicable only to feeds sold in their imported condition

Outcome

Imported feed products meet regulatory requirements.

Rationale

Ineffective strategies to source and verify imported feed products could result in feeds not meeting Canadian requirements or posing a risk of introducing or vectoring disease into Canada.

Performance criteria

Control measures and sourcing are done to ensure that feeds meet Canadian requirements. The importer must demonstrate that the imported feed has been manufactured, stored, packaged and labelled in a manner and under conditions that provide at least the same level of protection as that provided by subsections 56(1) and (2) and sections 59 to 63. Possible strategies include:

  • selecting suppliers whose exports are certified by a foreign country competent authority
  • selecting suppliers who are identified on a list of eligible exporters, where available, by a foreign country competent authority
  • selecting suppliers who are subject to internationally recognized third-party evaluations (for example Safe Feed Safe Food, FAMIQ, International Organization for Standardization (ISO), etc.)
  • evaluation to confirm suppliers can meet Canadian requirements
  • selecting suppliers who conduct regular sampling and testing and provide certificates of analysis; and use accredited or recognized sampling and testing laboratories to do testing
Sub-element 1.4: Export controls

Note: this sub-element will apply to operators who manufacture, store, process, package, label or sell feed for export.

Outcome

Exported feeds meet Canadian regulatory requirements or have demonstrated that they meet the requirements of the importing country and/or the importer.

Rationale

Lack of controls may result in feeds being distributed that could result in negative impacts both domestically and internationally.

Performance criteria

  • written procedures and records can demonstrate that the feed to be exported meets regulatory requirements including those of Canada, the importing country and/or the importer
  • where a feed intended for export does not meet Canadian regulatory requirements, controls are in place to ensure segregation

Element 2: Sanitation, biosecurity, bio-containment, pest control and chemicals

Sub-element 2.1: Sanitation, biosecurity and bio-containment

Outcome

Effective cleaning and sanitation of equipment, tools, containers and premises is in place to prevent contamination of the feed and ensure effective biosecurity and bio-containment to prevent the introduction, establishment or spread of biological hazards.

Rationale

Improper or inadequate sanitation/biosecurity/bio-containment activities can lead to contamination of feeds, premises, equipment, packaging materials and contact surfaces or the spread of biological hazards.

Performance criteria

  • the establishment is kept clean and in a sanitary condition
  • any conveyance or equipment in the establishment used for manufacturing, storing, processing, packaging or labelling of livestock feeds is kept clean and in a sanitary condition
  • the establishment as well as any conveyance or equipment are cleaned in a manner that does not present a risk of contamination to the feed
  • written procedures, if required, are in place and capable of effectively delivering the requirements of the sanitation program and/or biosecurity/bio-containment program
  • effectiveness of cleaning, sanitizing (if applicable) and/or biosecurity/bio-containment is assessed using accepted methods or procedures, as applicable, such as:
    • contact surfaces are free from contamination
    • swabbing/sampling is conducted in accordance with approved procedures
    • validated methods are chosen (example flush validation)
    • dedication of equipment and processing lines
Sub-element 2.2: Pest control

Outcome

An effective control program is in place for pests to prevent entry, to detect and to eliminate pests that present a risk of contamination of a feed.

Rationale

Pests (for example, insects, rodents, birds, wild animals) can contaminate feeds, inputs, packaging materials and contact surfaces.

Performance criteria

  • the establishment is protected against the entry of any pest that presents a risk of contamination to the feed
  • the control measures used by the establishment do not present a risk of contamination of that feed
  • there is a documented program for the prevention, control and removal of pests, if required
  • there is a schedule for monitoring for evidence of pest activity, if required
Sub-element 2.3: Chemicals

Outcome

Chemicals are stored and used in a manner and under conditions that do not present a risk of contamination of a feed.

Rationale

  • the use of improper chemical concentration, application or rinsing procedures can lead to both chemical and biological contamination
  • improperly stored chemicals can lead to contamination of feed products

Performance criteria

  • all cleaning agents, agronomic inputs and non-feed chemical agents that are in the establishment are properly and clearly identified
  • all cleaning agents, agronomic inputs and non-feed chemical agents are suitable for their intended use and do not present a risk of contamination of the feed
  • all cleaning agents, agronomic inputs and non-feed chemical agents are handled and used
    • in a manner that does not present a risk of contamination to the feed; and
    • according to any manufacturer's instructions
  • specification sheets for chemicals used in biosecurity/bio-containment, sanitation, treatment and pest control are maintained
  • if required, documentation is maintained that supports appropriate use of chemicals and prevents contamination of feeds, equipment, tools or contact surfaces

Element 3: Hygiene, biosecurity and employee training

Sub-element 3.1: Hygiene and biosecurity

Outcome

Employees and visitors are not a source of contamination.

Rationale

Employees and visitors who do not follow hygienic and biosecurity practices can cause contamination or spread diseases.

Performance criteria

  • to prevent the contamination of a livestock feed, any person who enters or is in an area of an establishment where a feed is manufactured, processed, stored, packaged or labelled:
  • wears clothing, footwear and protective coverings (such as gloves, hairnets, beard nets and coveralls, etc., as applicable), that are in good condition, clean and in a sanitary condition, appropriate for the feed and the activity being conducted
  • refrains from unnecessarily contacting the feed and acting in any other way that presents a risk of contamination of the feed and from wearing or using any object or substance that may present a risk of contamination of the feed
  • maintains appropriate personal cleanliness:
    • by cleaning and if necessary, by sanitizing their hands etc. at a frequency appropriate for the feed and the activity being conducted
    • by maintaining appropriate cleanliness of protective coverings and footwear
  • area and facility access, including flow patterns are established so the movement of materials, products and people do not contribute to product contamination
Sub-element 3.2: Employee training

Outcome

Employees have adequate technical knowledge and understanding of operations or processes for which they are responsible and of how they may impact human health, animal health and the environment, as applicable.

Rationale

Proper training promotes an understanding of the risk of biological, chemical and physical contamination and the employee's role in maintaining hygiene and biosecurity.

Performance criteria

  • any person involved in the manufacturing, storing, processing, packaging or labelling of a feed has the competencies and qualifications necessary to carry out their duties
  • if required, a written description of training requirements and training records for employees responsible for activities under the PCP are in place and maintained
  • effectiveness of training or competencies is verified

Element 4: Equipment design and maintenance

Sub-element 4.1: Equipment design and maintenance

Outcome

  • equipment, tools and containers are:
  • designed, maintained and used in a manner that does not result in contamination of feed products or packaging materials
  • effective for the purpose for which they are intended
  • if necessary, controlling or measuring devices, including scales and metering devices used to meet regulatory requirements or process control requirements, are calibrated for accuracy according to the manufacturer's instructions

Rationale

  • poor design and installation can impair cleaning and maintenance of equipment
  • improper maintenance and use of equipment may lead to contamination
  • improper calibration of controlling/measuring devices may lead to inadequate processing or incorrect formulation

Performance criteria

  • the conveyances or equipment that are used to manufacture, process, store, package or label livestock feed are:
    • appropriate to the feed and activity conducted and function as intended
    • designed, constructed and maintained to prevent contamination of the feed
    • constructed of and maintained using materials that are suitable for the manufacturer's intended use
    • equipped with instruments to control, indicate and record any parameters that are necessary to prevent contamination of the feed
    • accessible for cleaning, sanitizing, maintenance and inspection
    • able to be disassembled for cleaning and sanitizing, if necessary
  • if the material used in the construction or maintenance of conveyances or equipment presents a risk of contamination to the feed, the material is:
    • corrosion-resistant
    • durable
    • capable of withstanding repeated cleaning and, if necessary to prevent contamination of the feed, sanitizing, unless the equipment is intended for single-use
    • free of substances that present a risk of harm to humans, livestock, or the environment
  • the surfaces of the conveyances or equipment that may come into contact with feed and which may present a risk of contamination of the feed are:
    • smooth
    • free from pitting, cracks and flakes
    • non-absorbent
  • the conveyances or equipment used to manufacture, process, store, package or label livestock feed are used, maintained and, if necessary, calibrated:
    • according to the manufacturer's instructions
    • in a manner that does not present a risk of contamination of the feed
  • the conveyances or equipment that are used for handling any contaminated materials, any waste, or any other things not intended for a feed,
    • are dedicated, or
    • if these conveyances or equipment come into contact with livestock feeds, (for example, cross-utilization) they must meet the applicable requirements found in section 59(2) of the Feeds Regulations, 2024

Element 5: Physical structure, surroundings and maintenance

Sub-element 5.1: Premises and surroundings

Outcome

Conditions of the premises and surroundings do not contribute to contamination, infection or infestation of regulated feeds.

Rationale

Outside sources of contamination can compromise the safety, health and/or quality of the feed.

Performance criteria

  • the surroundings/roadways are maintained to minimize contaminants and pest harbourage areas that could pose a contamination risk to livestock feed
  • if any land presents a risk of contamination of the feed, measures are taken to prevent or eliminate the risk or reduce it to an acceptable level
  • if any establishment is located near any place or environment that presents a risk of contamination of the feed, measures are taken to prevent or eliminate the risk or reduce it to an acceptable level
  • establishment and surroundings are protected against the entry of any animal that presents a risk of contamination to the feed
Sub-element 5.2: Buildings

Note: buildings may include establishments, facilities, conveyances, vessels where regulated activities are conducted

Outcome

Buildings are designed, constructed and maintained to support the activity being conducted; support cleaning and sanitation; and prevent the entry of pests and contaminants.

Rationale

  • proper facility design, construction and maintenance prevent or mitigate the entry of pests and contaminants
  • cleanable surfaces will support effective cleaning and minimize the build-up of unsanitary conditions (for example, presence of bacteria, mould)
  • separation or control between incompatible operations helps to prevent cross-contamination

Performance criteria

Exterior and interior building structures

  • the interior and exterior of any facility or conveyance where feed is manufactured, processed, stored, packaged or labelled, is designed, constructed and maintained to meet regulatory requirements

Hygienic flow and separation

  • where there is potential for cross-contamination, incompatible operations are controlled by physical separation or other effective means

Lighting

  • there is sufficient light to allow the intended activity to be conducted effectively

Ventilation and humidity control systems

  • if the facility or conveyance where feed is manufactured, processed, stored, packaged or labelled is equipped with a heating, cooling or humidity-control system, the system functions as intended to not pose a risk of contamination or harm to livestock feed

Employee facilities

  • when present, the location, design, construction and installation of employee facilities (for example, washrooms, cleaning and sanitization stations, lunchrooms and change rooms) do not contribute to or cause contamination of feeds or production areas
Sub-element 5.3: Water, ice and steam

Outcome

  • water, ice and/or steam that comes into contact with regulated feeds is safe for its intended use
  • water, ice and/or steam which is used in the facility is safe and adequate for its intended use

Rationale

  • water, ice and steam can be used for a variety of purposes (for example, sanitation, hand washing, as a feed component, water provided to livestock); it is important that water be safe for its intended use
  • water, ice and steam can be a source of biological, chemical or physical contaminants

Performance criteria

  • any water, ice and steam that may contact feed is
    • potable, unless there is no risk of contamination of the feed if it is not potable
    • protected against contamination
  • as appropriate to the feed and activity being conducted in an establishment which is supplied with water, ice and steam that are safe and adequate for their intended use
  • any systems that supply water that might come into contact with feed are not cross-connected with any other system, unless measures are taken to eliminate any risk of contamination to the feed
  • any treatment of water, steam or ice is applied in a manner that does not present a risk of contamination of the feed
  • equipment is designed, installed and maintained in a manner that will not jeopardize the safety of water
Sub-element 5.4: Waste disposal

Outcome

Liquid and solid waste handling, storage and disposal systems are designed, constructed and maintained to prevent contamination of regulated feeds and the environment.

Rationale

  • an effective waste removal and disposal system reduces pest harbourage and the risk of contamination of the environment, feeds, inputs, packaging material, contact surfaces or the safe water supply
  • cleanable and properly identified containers and tools used for waste and inedible prevent cross-contamination
  • the presence of mechanisms, if necessary, to avoid backflow (for example, trapping, venting) prevents sewer gases, pests, micro-organisms or other contaminants from entering the establishment through the plumbing system

Performance criteria

  • equipment and areas designated for the handling of waste are identified, of suitable capacity, secured and cleaned to avoid attracting pests
  • contaminated materials and waste are removed and/or disposed of at a sufficient frequency and in a manner that prevents contamination of the feed
  • waste disposal does not contaminate feeds, preparation areas or the environment

Element 6: Receiving, transportation and storage

Sub-element 6.1: Receiving, transportation and storage

Outcome

If applicable, livestock feeds (including inputs, for example, ingredients, raw materials, packaging materials and chemicals) are transported, received and stored in conditions that maintain integrity and prevent damage, spoilage and contamination.

Rationale

  • proper loading, unloading and storage prevents contamination and ensures feeds reach their destination in a suitable condition
  • proper temperature and humidity control prevents spoilage and contamination of the feeds

Performance criteria

Conveyances

  • conveyances used for the transport of feed to, from and within the premises:
    • are clean and protect the feed from contamination, damage and deterioration (including temperature and humidity controls, if necessary)
    • are not being used to transport any material or substance that might cross-contaminate or adulterate the feed unless:
      • dedicated to the conveyance or
      • properly cleaned for identified hazards between uses
    • are loaded, arranged and unloaded in a manner that prevents damage and contamination of the inputs and/or end products (for example, packaging damaged during unloading)

Storage areas

  • storage areas allow the:
    • separation of feeds and other materials, including returned feeds
    • protection of the feed product and other materials (that is packaging materials) from contamination
    • when required, control of temperature and humidity to prevent deterioration and spoilage (for example, enzyme products not exposed to extreme temperatures, or environment for prolonged periods)
    • stock to be rotated to maintain suitability, quality and safety (for example, older stock is used first)

Element 7: Traceability, control and complaints

Sub-element 7.1: Traceability and control

Outcome

  • feeds are adequately identified to enable removal from the marketplace or facilitate other movement restrictions
  • non-compliant feeds are effectively controlled by preventing entry into commerce or rapid retrieval if distributed and disposed of, as appropriate
  • where required by the act or regulations, we are notified of a non-compliant product

Rationale

Identifying, controlling and removing affected feeds quickly and effectively minimizes health risk to the public.

Performance criteria

  • the facility must be able to:
    • trace feeds/inputs to the incoming source level, for example ingredients
    • trace feeds to the next point of distribution
    • maintain accurate traceability records
  • the control system (notification and recall) must be able to:
    • stop any further distribution and sale of implicated feeds
    • contact customers and the CFIA
    • retrieve the implicated feeds, including segregation if needed
Sub-element 7.2: Complaints

Outcome

Complaints related to product safety and product quality or misrepresentation are investigated to determine root cause and corrective actions are taken.

Rationale

If complaints are not investigated to mitigate risks, this could lead to the production, distribution and/or sale of unsafe feed and/or product misrepresentation.

Performance criteria

  • the operator prepares, keeps and maintains a document that describes the feed complaint procedure used for receiving, investigating and responding to complaints related to feed, including imported feed
  • upon receiving a feed complaint, including a complaint on an imported feed, the operator implements a feed complaint procedure
  • the operator prepares a document that describes the
    • details of the complaint
    • results of the investigation
    • actions taken based on the results of the investigation
  • the operator keeps the document for at least 2 years after the day on which they have completed the actions taken because of the investigation
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