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The Canadian Food Inspection Agency's Regulatory Framework: Safe and Responsive

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Part I: Setting the stage

1. Introduction

The Government of Canada is committed to protecting and advancing the public interest in health, safety and security, the quality of the environment, and the social and economic well-being of Canadians through an effective, efficient, and accountable regulatory system.

The Canadian Food Inspection Agency (CFIA) derives its legislated mandate from, the Canadian Food Inspection Agency Act (1997). In its day to day activities, the CFIA safeguards and strengthens Canada's food supply system; protects animal and plant health; supports market access for Canada's food, plant and animal products; and enhances service delivery to industry and the public. As the sectors that the CFIA regulates constantly evolve in their business models and technologies, the CFIA is adapting to this pace of change by balancing different regulatory approaches to mitigate risks to food safety, plant and animal health.

To optimize its regulatory framework, the CFIA uses a broad spectrum of instruments to implement public policy. The CFIA uses both regulatory instruments (for example, acts and regulations) and non-regulatory instruments (for example, guidance documents and best practices) to pursue its policy objectives and deliver its mandate. The choice of instrument (referred to as "instrument choice") includes a number of important considerations. When regulations are employed, the regulations CFIA develops are both safe and responsive. They maintain high standards for health and safety, while providing flexibility for industry to innovate and compete globally.

The CFIA applies principles and practices of risk management when selecting and developing regulatory and non-regulatory instruments, to ensure that each instrument proportionately addresses the degree and type of risk. Within CFIA's integrated risk management framework, the Agency manages risk in an integrated, systematic and transparent way to reduce risks to the extent possible.

This document describes CFIA's regulatory development process, should a regulatory instrument be selected, and details two main regulatory approaches, prescriptive and outcome-based, which the CFIA will consider.

2. Objective

The objective of this framework is to provide an overview of the CFIA's approach to regulating and developing regulatory requirements.

3. Regulations as the instrument of choice

The CFIA has a number of public policy instruments that it leverages to support its activities.

The process of instrument choice is embedded in government decision-making and is an integral part of the CFIA's policy development process. As per the government-wide direction in the Treasury Board of Canada Secretariat Cabinet Directive on Regulation, the CFIA considers the effectiveness and appropriateness of instruments for achieving policy objectives early on in the policy development process.

Instrument choice is not about selecting a single instrument to address a single issue; issues can be complex, and often require using a variety of policy instruments to address them.

The instruments that the CFIA uses can be grouped as follows:

  1. Voluntary instruments: Information, compliance promotion or guidance material; voluntary agreements and best practices. These help regulated parties understand their obligations and encourage compliance; and
  2. Mandatory instruments: Laws / legislation (Acts and Regulations and documents incorporated by reference into a regulation, including codes of practice or standards). Generally, these set out mandatory requirements that can apply to individuals, industry, or government departments and agencies, along with accompanying sanctions and authorities that are intended to influence behaviour.

There are advantages and disadvantages to every instrument. A particular regulatory or non-regulatory approach is only chosen after identifying and assessing risks and considering the full range of possible instruments.

Some of the factors that the CFIA assesses in selecting a policy instrument include, risks across the Agency's mandate, domestic and international obligations, legal implications, benefits and costs, science, effectiveness of the proposed instrument, readiness of the Agency and stakeholders, and others. Careful consideration and appropriate use of a variety of instruments helps contribute to a more effective regulatory framework.

This framework focuses on mandatory instruments, specifically the development and approaches used for selecting regulations.

Part II: Elements of the framework

Legislation (Acts and Regulations) are an important instrument choice and central to upholding the Agency's commitment to safeguard food, animals and plants. The authority to make regulations is specified in an Act (also known as statute), which sets out the broad principles and provides specific regulation-making powers to develop the details and express them in regulations.

Regulations not only serve to support health, safety and protection, but can also act as an enabler.

A safe, responsive and effective regulatory system provides clarity, consistency, fairness, and transparency; establishes the rules for fair markets; enables alignment with trading partners; and supports innovation, productivity, and competition.

4. Regulatory development process

Once the decision is made to choose a regulatory instrument, the CFIA follows a rigorous regulatory development process that is aligned with Government of Canada policy with respect to regulation-making. In the pre-consultation phase, the Agency works with stakeholders to inform the proposed development process. Assessing potential risks, impacts, costs and burden of certain regulatory options, allows the CFIA to determine the best approach prior to seeking the drafting of the regulations by the Department of Justice and having them published for further consultation in the Canada Gazette.

The CFIA employs a mix of regulatory approaches, which are supported by the best available evidence. Two of the main approaches used by the CFIA are prescriptive (that is, describes a specific standard, requirement, process or action that must be followed) and outcome-based (in other words, describes an outcome or result that must be met). This mix of regulatory approaches allows the Agency to manage risks across sectors, and support industry adoption of new technology.

Choosing which regulatory approach to apply in a given situation is based on a number of factors. Some of the factors include, the potential impacts and the level of risk to health, safety, and protection associated with regulated parties' activities, and the anticipated benefits of flexibility or innovation. When developing regulations, the CFIA complies with Canada's international trade obligations, including specific requirements for technical regulations that are contained in international agreements to which Canada is a party.

5. Prescriptive and Outcome-based approaches to regulating

5.1 Prescriptive regulatory requirements

A prescriptive regulatory requirement sets out a specific standard, requirement or process to follow or actions that a regulated party must take in order to achieve compliance.

An example of a prescriptive regulatory requirement:
"Where a low temperature is required for the preservation of a meat product, the temperature in a room or area in which that meat product is processed, packaged, labelled or handled must not exceed 10 degrees Celsius."

In this example, a specific standard (such as, 10 degrees Celsius) that regulated parties must meet is specified in the regulatory text.
The prescriptive regulatory approach has the advantage of being clear and precise in terms of what must be achieved by regulated parties. Prescriptive regulatory requirements may be more appropriate when specific minimum or maximum standards, requirements or processes are necessary to mitigate risks.

5.2 Outcome-based regulatory requirements

Outcome-based regulations allow the CFIA to maintain high standards for health, safety and protection while providing flexibility for industry to innovate, and enables the regulations to keep pace with advances in science and technology. This type of regulation specifies the desired result that regulated parties must meet, rather than describing the means by which it must be achieved.

An example of an outcome-based regulatory requirement:
"The temperature and humidity in a facility where a food is manufactured, prepared, stored, packaged, and labelled must be maintained at levels that are appropriate for the food and the activity being conducted."

In this example, the outcome (such as, maintenance of temperature and humidity at appropriate levels for the food and activity) is described in the regulatory text.

By focusing on outcomes instead of prescribing processes or actions, regulated parties are able to choose the process by which they will meet the requirement.

Outcome-based regulatory requirements may be used where the outcomes can be readily measured, and there are multiple options that can be used to meet regulatory requirements and achieve health, safety and protection standards.

6. Principles of regulatory excellence

In developing and administering regulations, the CFIA observes the following principles of regulatory excellence.

Evidence-based decision making

Regulatory requirements and decisions are supported by the best available evidence, including science. Decision-making will consider the economic, social and environmental impacts of regulating.


Affected parties are engaged regularly during the regulatory process and have an opportunity to provide input so that the regulatory system is accountable and serves the public interest. Regulatory requirements are readily accessible and are communicated in a clear, precise, consistent and understandable fashion. Guidance materials to support compliance promotion are also developed and communicated to help regulated parties understand their obligations.


The people, tools and systems are in place to support regulatory excellence.


The regulatory system is predictable and coherent with other government departments at the federal, provincial and territorial level and strives to minimize regulatory differences with key trading partners, while respecting Canada's international trade obligations.


The regulatory framework has the capacity to evolve to address changing circumstances; support innovation; provide opportunities to enhance health, safety, and protection; reduce costs; and, maintain relevance and effectiveness over time.


Regulatory requirements are proportionate to the degree and type of risk.

The above principles help guide the CFIA in selecting the best regulatory approach. The type of regulatory approach that is used is decided on a case-by-case basis for each regulation. The CFIA examines whether specific prescriptive standards or processes, or a combination of prescriptive and outcome-based approaches should be used to achieve the highest level of health, safety and protection. The CFIA will continue to work with stakeholders to enhance its safe and responsive regulatory framework by identifying, selecting and administering instruments that best mitigate emerging and evolving risks, as well as promote innovation and confidence in the safety and protection of Canada's plant, animal and food resources.

7. Other relevant documents

To learn about upcoming or ongoing consultations, including proposed federal regulations, visit the Canada Gazette and Consultations and feedback websites.

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