Canada has gained global recognition for having a top-notch food regulatory system. However, a string of recent international high-profile food recalls, paired with increased global rates of dietary-related chronic disease, has collectively prompted the Canadian government to evaluate its existing food regulatory system.
Coupled with these issues are longstanding industry complaints that the rigidity of the existing Canadian Food Regulations makes product innovation a challenge.
In an effort to update existing regulations, the Canadian government has engaged in multiple regulatory modernization efforts in the food sector. There are several primary goals of these regulatory initiatives:
• To expand the overall safety of the Canadian food supply;
• To improve operational efficiencies (i.e. better use of government resources);
• To increase transparency in regulatory processes;
• To modernize portions of existing regulations to allow for continued development of innovative health products.
Two branches of the government currently regulate the Canadian food industry: the Canadian Food Inspection Agency (CFIA), and Health Canada’s Food Directorate. Both parties are currently undergoing broad regulatory modernization initiatives, which will bring about significant changes to all aspects of Canada’s existing food safety and labelling legislation.
CFIA’S FOOD REGULATORY MODERNIZATION INITIATIVES
The CFIA bears responsibility for safeguarding all products in the Canadian food supply. The Agency is in the process of implementing new food safety legislation (The Safe Food for Canadians Act and Regulations) as well as modernizing non-safety related aspects of food labelling. CFIA recently communicated the goals of these modernization efforts to the Canadian food industry. Using a risk-based approach, the Agency is striving to achieve consistency in program delivery; food inspection processes; and other CFIA services. Looking forward to 2017, CFIA will provide additional resources (i.e. online tools, technology and training) to help industry navigate the multitude of changes in the regulations governing food safety and labelling. Two of these digital tools are “Ask CFIA” (a new digital service), and “My CFIA” (an online service portal), which are scheduled for release by year-end, 2016.
FOOD SAFETY MODERNIZATION – THE SAFE FOOD FOR CANADIANS ACT AND PROPOSED REGULATIONS
Canadian food safety modernization has been underway for the past several years, and saw its first major milestone achieved with the passing of the Safe Food for Canadians Act (SFCA) in 2012. Having received Royal Assent, the SFCA:
• Applies to all foods imported into and exported out of Canada, as well as foods prepared for distribution between provinces and territories;
• Consolidates 4 food-related statutes (The Canada Agricultural Products Act; The Fish Inspection Act; The Meat Inspection Act; and food-related provisions of the Consumer Packaging and Labelling Act) and 10 food provisions into a single set of food inspection regulations;
• Aims to improve Canada’s food safety system in three key ways: by streamlining food legislative authorities; by improving oversight of food safety; and by increasing domestic and export market opportunities for Canadian businesses.
Approval of final regulations supporting the SFCA is a requirement to implement the Act into law. In the spring of 2015, a draft version of proposed Safe Food for Canadians Regulations (SFCR) was released for industry consultation, in two stages:
• The first stage of the 2015 industry consultation considered the major impact that the SFCA would have on small- to medium-sized enterprises (SMEs) in the Canadian food sector. Several possible strategies to minimize the future regulatory burden for SMEs were suggested, as was a potential exemption threshold from requirements of the SFCR.
• The second stage of the 2015 industry consultation was focused on the content of the proposed Regulations. Three important components of the Regulations have been created help to improve food traceability and recall processes in Canada:
1. Licensing Requirements. All companies importing a food(s) across a provincial or national border; or manufacturing, processing, treating, preserving, grading, packaging, or labelling food for export or trade across provinces; must apply for a food license, which carries a $250 application fee (good for 2 years).
2. Traceability of imported foods. Retailers importing a food across a provincial or national border will be required to keep records of these sales for a 2-year period. This requirement will help to improve traceability of food products throughout the supply chain (i.e. to help trace their movement) in the event of a recall process.
3. Preventive control plan for food suppliers. A preventive control plan is a written plan outlining the measures and actions taken to ensure that a food is safe to consume; and that the food meets all Canadian labelling and safety requirements. A preventive control plan will provide detailed documentation regarding potential hazards associated with the production of the food, as well as necessary safety measures to prevent these hazards.
In an effort to help members of industry come into compliance with the proposed Regulations, CFIA has created various online resources (i.e. fact sheets) to assist industry with the pending requirements for licensing, traceability, and preventive control plans. These resources are available on the CFIA website.
CFIA anticipates that the SFCR will be published in Canada Gazette I (CGI) in late 2016 or early 2017. Once published in CGI, a formal industry consultation period will be launched prior to publication of the final Regulations in Canada Gazette II (CGII). Food companies should seek out regulatory resources in advance of the forthcoming changes, and initiate internal processes to work towards attaining compliance with the future requirements for food safety in the Canadian marketplace.
MODERNIZATION OF CANADIAN FOOD LABELLING
In 2015, the CFIA and Health Canada’s Food Directorate launched simultaneous yet independent nutrition labelling modernization efforts. Once approved, these proposed changes will represent the first formal amendment to the existing Food and Drug Regulations issued in over 50 years. CFIA and Health Canada’s labelling modernization efforts are focused on non-safety related aspects, and safety-related aspects, of food labels, respectively. When taking both modernization initiatives into consideration, every single food label in Canada will be required to change over the next few years. The independent aspects of the respective modernization platforms are discussed below.
HEALTH CANADA’S NUTRITION LABELING REGULATIONS
The proposed Regulations Amending the Food and Drug Regulations: Nutrition Labelling, Other Provisions, and Food Colours [Nutrition Labelling Regulations] was published in Canada Gazette I in June of 2015. Various changes were proposed in these Regulations, with the overall goal of providing the consumer with the ability to make more informed choices about the nutritional content of their foods. The following key changes have been proposed:
• Format changes to ingredient listings: grouping common ingredients together, and making the ingredient panel more readily visible to the consumer.
• Changes to reference amounts and standardization of serving sizes in the Nutrition Facts Table (NFT).
• Various changes in requirements for % Daily Values (%DVs) in the NFT to better identify components of health concern (i.e. sugar), as well as beneficial components (i.e. fibre, carbohydrates).
• Various changes to required declarations of vitamins and minerals within the NFT.
• Emphasis on %DV of the NFT: “5% is a little, 15% is a lot”.
• Changes to food colour listings and certifications for synthetic colours, which will better align Canada’s labelling standards, internationally.
• Approval of a new health claim for fruits and vegetables and reduced risk of cardiovascular disease.
CFIA’S FOOD LABELLING INITIATIVE
In June of 2015, CFIA released its proposed food labelling modernization initiative for industry consultation. This consultation identified proposed changes to various non-safety related aspects of food labels, including:
• Standardization of the format of “best before” dates, to allow for consistent and visible placement.
• Expanding and revising ingredient class names to provide additional details about ingredients being added to foods. This will better align Canadian food labels internationally, and with CODEX.
• Changes to % ingredient declarations, to highlight the % ingredient content of ingredients when advertised (i.e. blueberry muffins containing 10% blueberries).
• Updates to legibility requirements (i.e. improved rules for contrast, prominence, etc.).
• Updates to dealer name & address requirements to include digital contact information (i.e. email).
• Update to existing food standards to allow for incorporation by reference.
GMOS – THE ELEPHANT IN THE ROOM
Of interest, neither CFIA nor Health Canada’s food labelling modernization initiatives have addressed the potential for labelling of foods containing Genetically Modified Organisms (GMOs). Mandatory labelling of GMOs is a highly contested issue in the Canadian food industry, and has been largely ignored at this stage of labelling modernization. Industry trade organizations, such as the Canadian Health Food Organization (CHFA) are lobbying for mandatory GMO labelling in order to allow Canadian consumers to make more informed food choices.
NEW GUIDANCE FOR FORTIFIED FOODS
The food industry has often sought out ways to provide foods with added health benefits to Canadians. The process of food fortification allows for the addition of certain ingredients (i.e. vitamins, minerals) to improve the nutritional composition of foods. Food fortification has presented a major challenge for the food industry in Canada, as these foods are non-compliant with the Canadian Food Regulations and require a regulatory amendment to be sold in the Canadian marketplace. The Regulations outline processes by which food companies can gain Temporary Marketing Authorization or Interim Marketing Authorization for foods. Despite these processes, recent regulatory changes in permissibility for food fortification have resulted in major confusion for this product category.
In 2015, Health Canada’s Food Directorate issued draft guidance on food fortification for a new category of health products called “Supplemented Foods”. This guidance was formalized in February of 2016 with the release Category Specific Guidance for Temporary Marketing Authorization: Supplemented Foods. This formal guidance outlined:
• The types of ingredients that can be added to foods (i.e. vitamins, minerals, amino acids, herbals, or bioactive ingredients);
• The types of products that can be fortified (i.e. beverages, beverage mixes and concentrates, powders, bars, and certain types of confectionary products).
In the category-specific guidance, Health Canada established maximum fortification levels for vitamins and minerals, to ensure safe consumption of supplemented foods within the context of the overall diet. A two-tiered approach (i.e. Tier 1 and Tier 2 products) has been defined to help consumers determine the risk profile of supplemented foods (i.e. potential for adverse health effects). Higher risk (Tier 2) supplemented foods will be subject to additional labelling requirements, such as cautionary statements, and/or direction of use statements.
Supplemented foods require pre-market review and issuance of a Temporary Marketing Authorization (TMA) by Health Canada prior. Receiving a TMA renders a supplemented food temporarily eligible for sale, despite being non-compliant with the Canadian Food Regulations. Food companies are required to gather consumption data (i.e. sales data), as well as safety data, and to submit this data to Health Canada for review to maintain the TMA. By means of this process, Health Canada can evaluate the intake of foods fortified with vitamins, minerals, and other ingredients in the context of the overall diet, as it pertains to health.
Health Canada is also investigating the potential for a product identifier for supplemented foods. This may take the form of an approval number, a symbol, or text stating “supplemented food”. The goal of this product identifier is to differentiate fortified foods from traditional foods at the retail level.
The Canadian food industry is experiencing an unprecedented period of regulatory modernization with respect to food safety and food labelling, governed concurrently, yet independently, by the CFIA and Health Canada (respectively). The Safe Food for Canadians Act and proposed Safe Food for Canadians Regulations aim to improve the overall safety of the Canadian food supply chain by implementing licensing and traceability procedures to improve the overall efficiency of the food supply chain. CFIA’s food labelling modernization aims to provide clarity in non-safety related aspects of food labelling. Health Canada’s proposed Nutrition Labelling Regulations aim to help consumers better identify and understand the nutritional content of their foods. New guidance for supplemented foods promises to offer a new pathway for innovation in food fortification in the Canadian marketplace.
Overall, changes to food safety and labelling Regulations will impact all aspects of the Canadian food supply chain, and will result in changes to every nutrition label in Canada. The end goal of these regulatory modernization initiatives is to enhance the food safety system in Canada, and to enable consumers to have the maximum potential to understand the nutritional content of the foods they purchase and consume. Having better access to safe and healthy food will ultimately improve the well-being of all Canadians, allowing Canadians to yield the reward for robust regulatory modernization initiatives.
ABOUT THE AUTHOR
Krista Coventry is the Director of Regulatory Services at Source Nutraceutical Inc., a Canadian contract research organization specializing in food and health product regulations. Visit www.sourcenutra.com for more information.