The Safe Foods for Canadian Act (the Act), which received Royal Assent in November 2012, set the stage for important changes to Canada’s food safety system. The Act is expected to come into force at the beginning of 2015, and Health Canada and the Canadian Food Inspection Agency (CFIA) have been working with industry and consumer groups to develop new Regulations to support the Act. A discussion document – A New Regulatory Framework for Federal Food Inspection Overview of Proposed Regulations (the Proposed Regulatory Framework) – was released in June of this year for broad consultation. The Proposed Regulatory Framework is intended to draw together federal food inspection regulations into one overarching system. It also provides an overview of the regulations proposed under the Act, including draft regulatory text for key elements of the proposed regulations such as licensing, preventive control requirements and traceability, and highlights other significant regulatory proposals.
The Act provides the legislative base to consolidate all food inspection regulations in Canada currently administered by the CFIA (e.g., the Fish Inspection Act, the Meat Inspection Act and the Canada Agricultural Products Act). The Proposed Regulatory Framework intends to implement similar requirements across all federally regulated food commodities, enabling the CFIA to apply consistent regulatory requirements and inspection approaches. The Proposed Regulatory Framework is also intended to provide stronger safety requirements and new powers for the CFIA, allowing it to more rapidly trace and identify unsafe foods and to remove them from the supply chain.
The Proposed Regulatory Framework would make food manufacturers, importers, exporters, packagers and labellers subject to licensing, record-keeping, safety and recall requirements. In addition to the Act, the Food and Drugs Act (FDA) and theFood and Drug Regulations (FDR) will continue to apply to all food sold in Canada.
The Proposed Regulatory Framework requires anyone who is importing or preparing food for export or interprovincial trade to be licensed, with some limited exceptions. A condition of licensure will be compliance with both the Act and the FDA, and the regulations promulgated under each statute. Licence requirements apply to foods and entities that have not previously been required to be licensed. It is further proposed that where food is sent or conveyed interprovincially or internationally, it must be prepared by a licence holder. This is to ensure that those who send and convey food (e.g., brokers, distribution centers and internet sales) receive their food from a licence holder.
Where food is exported internationally, the Proposed Regulatory Framework requires that it meet foreign requirements in addition to the regulations under the Act. Where there is a conflict between the Canadian regulations and the foreign requirements, the foreign requirements may apply.
Under the Proposed Regulatory Framework importers also require a licence, but Canadian residency is not required if the importer has a fixed place of business in a foreign country that has a food safety inspection system similar to Canada’s and recognized by the Minister, and provided the imported food originates from that foreign country.
Regulated parties will be allowed to apply for multiple licences (for each establishment, activity or food commodity) or a single licence (for all their establishments, activities and food commodities).
Based on the information contained in the licence application, an inspection prior to the issuance, renewal or amendment of a licence may be required depending on the product risk and the compliance history. An inspection prior to issuance of a licence will most likely be required for food that has traditionally been recognized has having a higher food safety risk such as fish, meat, dairy and eggs.
Where there is non-compliance, the Proposed Regulatory Framework will allow the CFIA to suspend a licence. These suspensions can be immediate, with notice, where there is a risk of injury to human health.
There are some limited exceptions from the licensing regime under the Proposed Regulatory Framework, including food for personal use, foods that are not intended for human consumption (i.e., pet food), alcoholic beverages and food additives. Ministerial exemptions from the licensing and other requirements may also be possible to allow test marketing of foods.
Food Safety Requirements
The Proposed Regulatory Framework establishes minimum food safety requirements for anyone who imports, prepares, grows or harvests food for interprovincial trade or export, regardless of the commodity or size of the operation. Under the Proposed Regulatory Framework, such entities are required to implement food safety requirements during the manufacturing, preparing, storing, packaging and labelling of a food commodity. The food safety requirements regulate seven key aspects of the manufacturing and agricultural process:
- products and control processes;
- sanitation, pest control, sanitizers, biocontainment, biosecurity and chemical agents;
- hygiene and competencies, employee training;
- design and maintenance of equipment and conveyances to be used in an establishment;
- physical structure and maintenance of the establishment;
- receiving, transportation and storage; and
- investigation and notification, complaints and recall procedures, traceability.
In addition to the baseline requirements mentioned above, the Proposed Regulatory Framework also includes commodity-specific requirements necessary for food safety. Furthermore, all regulated parties must continue to comply with all elements of the FDA and FDR.
Preventative Control Plans
Under the Proposed Regulatory Framework, regulated parties are required to prepare, keep and maintain a system-based Preventative Control Plan (PCP) that is consistent with Hazard Analysis and Critical Control Points (HACCP). Exporters will be required to have a PCP in order to be issued an export certificate. The PCP will identify and document the potential risks and hazards associated with their food commodity and process, and consider and demonstrate by evidence how those risks and hazards will be controlled and monitored, and deviations corrected. The focus of the PCP is preventative and requires regulated parties to take a proactive approach to food safety.
The PCP will be a critical tool used by the CFIA to verify compliance with the legislation as measured against the seven food safety elements discussed above by: observing physical conditions; reviewing documentation processes and example documents; assessing the knowledge of staff on the implementation and processes; reviewing product testing; and measuring processes and review outcomes.
The Proposed Regulatory Framework provides that smaller businesses with a total food revenue of less than $30,000 in the prior 12 months are exempt from the requirement for a written PCP but must still obtain a licence and must meet all regulatory requirements for preventative controls.
Traceability and Records
Under the Proposed Regulatory Framework, anyone who imports, exports or prepares food commodities for interprovincial trade is required to keep and maintain records pertaining to food safety investigations, recalls or withdrawals. The Proposed Regulatory Framework applies the international standard for traceability established by Codex Alimentarius to all regulated parties. The Codex standard requires tracing records to track food forward to the immediate customer and backward to the immediate supplier. The Proposed Regulatory Framework requires the food tracing records to be retained for a period of three years for all products, including those that are perishable. The requirements are aimed at enhancing consumer protection during a food safety incident by facilitating the fast identification of the origin and movement of a food product through the commercial food supply chain.
Furthermore, the Proposed Regulatory Framework stipulates that traceability information must be provided upon request. Records will not be required to be stored in Canada; however, if requested, they must be provided electronically in plain text and in a format that can be imported and manipulated by standard commercial software.
In addition to the basic food safety requirements that apply to all regulated parties, the Proposed Regulatory Framework maintains some commodity-specific requirements from the current regulations. Most commodity-specific requirements not related to food safety (e.g., grades, labelling requirements, standards of identity) will continue to be maintained.
Coming into Force Plan
The projected coming into force plan reflects the different levels of readiness between sectors. There are three categories of sector readiness: federally registered, fresh fruit and vegetables, and non-registered. Federally registered represents industry participants that are licensed under current regulations. They are already under the CFIA oversight and would largely meet the proposed requirements. For this sector, there will be minimal changes. As such, they will be required to be licensed and to develop, implement and document their PCP in 2015.
Sector members that fall into the fresh fruits and vegetables category currently meet many existing requirements but have implemented few preventative controls. The FDA applies to them, however, they do not have substantive food safety provisions. As such, the licence requirements will apply in 2015 but the PCP requirement will not apply until 2016.
Those who are non-registered are those to whom the FDA still applies but may be unaware of the CFIA requirements. For this sector, the licence requirements will apply in 2016 and the PCP requirements will apply in 2017.
Implications for Food-Related Franchisors
Under the Proposed Regulatory Framework, franchisors who import food products will have to implement the regulated food safety requirements and develop, maintain and retain PCPs. They will also have to develop systems to meet the new “one step forward one step backward” traceability requirements and will need to ensure compliance with new record-keeping requirements. For those who currently meet the requirements and are subject to oversight by the CFIA, the majority of the preparation will be related to developing and documenting a PCP and creating record-keeping practices that are compliant with the regulations.
Although the comment period for the Proposed Regulatory Framework closed on August 29, 2014, stakeholders will have another opportunity to comment on the full set of proposed regulations during the formal 75-day consultation period following publication in Canada Gazette Part I, which is expected to occur in the late fall of this year.
For more information about the new Regulations and other developments regarding Canada’s new food regulatory regime, please contact the authors of this update.