Canada: Food, Natural Health Products & Cosmetics Law: June 21, 2012 - Volume 1, Number 1

Last Updated: July 2 2012
Edited by Chris Oates and Laura Gomez

Bill S-11: Safe Food for Canadians Act

By: Lewis Retik

On June 7, 2012 the federal government introduced the proposed Safe Food for Canadians Act (the Act). The proposed Act which must be passed by Parliament and may be subject to change, would apply to all persons and establishments that manufacture, prepare, store, package or label foods and/or beverages, as would its associated regulations. It remains unclear what these regulations would look like.

As part of a wider Government of Canada effort to modernize the federal regulatory framework for food safety, the Act's primary purpose is to make food as safe as possible for Canadians, in part by targeting unsafe practices, increasing penalties and requiring licensing and registration. If enacted, it would consolidate and replace the Canadian Agricultural Products Act, the Meat Inspection Act, the Fish Inspection Act, and the food provisions of the Consumer Packaging and Labelling Act. The federal government has indicated that the Act would provide more consistency with respect to rules and regulations and better align our system with those of trading partners such as the United States.

Registration and Licences

One of the most significant developments under the Act would be a mandatory licensing and registration regime for all persons who deal with foods that move between provinces, either imported or exported. A licence or registration would also be required to engage in any activity (i.e., manufacturing, preparation, storage, packaging, or labelling) with respect to such foods. At this time we do not have specifics about the proposed licensing and registration regime; however, even companies currently operating under a licence or registration system for a specific food product should expect to be subject to new requirements regarding the movement of goods both within Canada and internationally.

The Minister would have the power to grant, suspend and revoke non-transferable licences or registration for persons and establishments.  Such licences would prescribe the food product and the activity(s) in which the licensee can engage with regards to the food, as well as any conditions that the Minister might choose to prescribe, either when the licence is granted or at a later date. The process for a person to apply for and obtain a licence or registration is unknown at this time.

Prohibitions and Offences

The sections of the proposed Act dealing with prohibitions and offences contain further substantial changes from existing legislation. The proposed Act includes a number of prohibitions targeting unsafe practices such as deception and erroneous impression and tampering. Under the proposed Act, penalties for offences would increase significantly. For example, the maximum fine for most minor offences would be $250,000 for a first offence, and $500,000 for subsequent offences. More serious offences would carry a maximum fine of $5 million and for certain serious offences the fine could be set even higher at the discretion of the court.

Inspection

Another large component of the proposed Act is the creation of a more consistent food inspection regime. Inspection authorities would be the same for all food products. This would support the aims of the new food inspection model recently outlined in a Canadian Food Inspection Agency (CFIA) discussion paper which focuses on a standardized approach across all industries, with frequency and scope of inspection activities based on risk level.

The powers of inspectors would be the same, generally, as under the current regime, but the proposed Act uses more modern language in an effort to make the authorities clear to all parties. It proposes that inspectors would benefit from explicit authority to pass through or over private property to gain access to a place for inspection purposes and from the ability to request a warrant by telephone.

Imports, Exports and Traceability

While other stated priorities of the federal government are increased import controls, strengthened food traceability and increased export opportunities through product certifications,, the proposed Act establishes the ability to enact regulations pertaining to these matters, but does not elaborate. The full impact of the proposed Act on industry will be difficult to assess in the absence of any indication of new or amended regulations.

Other food safety modernization initiatives announced to date include the elimination of standard container sizes, the establishment of a CFIA Complaints and Appeals Office, and a major shift in the approach to food inspection.

For further details or to access the content of the Safe Food for Canadians Act, visit http://www.parl.gc.ca/LegisInfo/BillDetails.aspx?billId=5654811&Language=E&Mode=1

Article prepared with assistance from Katrina Coughlin.



New Flexibility Tools for Food Directorate

By: Joel B. Taller

On April 26, 2012, Bill C-38, entitled the Jobs, Growth and Long-term Prosperity Act was introduced to the House of Commons by the Minister of Finance, Jim Flaherty. The Act amends the current Food and Drugs Act (FDA) and includes provisions that aim to dramatically change aspects of the regulatory framework for food in Canada. To keep pace with changing technologies and developments in nutritional science, the new legislation is geared at cutting red tape and streamlining government processes, allowing more timely approvals of safe, innovative products, in order to better respond to industry advancements.

Under current legislation, approval of a new food additive, vitamin, mineral nutrient or health claim can be held up for years before it is addressed by a legislative change: this is despite Health Canada's food scientists having already made the requisite safety decisions. These delays limit Canadians' access to many novel products and limit industry's ability to respond to new scientific information. 

A Health Canada briefing outlined how the Act will affect the landscape of food regulation for industry participants. Division 19 will enable two major changes to the manner in which food is regulated under Part B of the Food and Drug Regulations (FDR):

1.     Replacement of the current interim marketing authorization (IMA) process with new ministerial powers

Section 416 of the Act provides the Minister with a new marketing authorization tool that utilizes "administrative lists" to expedite regulatory change. Unlike the current IMA process which is subject to a three-year waiting period and may be used only to augment existing legislation (i.e.,  it applies only to currently approved food additives), this new tool allows the introduction of new provisions to the FDR and extends what exemptions may be permitted from compliance with the FDR. This is expected to significantly reduce the timeframes associated with getting new products such as novel food additives to market.

2.     Incorporation by reference

The Act also allows the FDR to reference established lists, rather than necessitating the inclusion of each individual ingredient in the FDR itself. This will allow a faster response to new scientific developments in the industry, as authorizations canextend to new products as lists become updated, without the requirement that each new food or ingredient go through the regulatory process.

Although the Bill must follow the usual legislative course given that it relates to the implementation of the federal budget, it will likely receive a swift passage. As such, the Food Directorate of the Health Products & Food Branch of Health Canada is already exploring how to incorporate these changes into the Regulations. Once the Act has been approved, Health Canada will be able to consult with industry and other stakeholders on any new developments.

Health Canada has indicated that the first stage in the new regulatory shift is to transition all food additives currently regulated under Part B of the FDR to the new regime. The Food Directorate intends to include foods currently under an IMA in this switch. Further, all new food additives will be exclusively addressed by the Food Directorate under this new framework. Health Canada's projected performance standards entail a six-month waiting period for adding a new ingredient to a list to allow for a risk assessment and administrative processing.

The Act is expected to considerably reduce procedural hurdles to gaining market access and to significantly speed up approvals of new foods and food ingredients. Bill C-38 represents what will hopefully be a welcome change to industry members and consumers alike.

The full text of Bill C-38 can be viewed at: http://parl.gc.ca/HousePublications/Publication.aspx?Docid=5524772&file=4

Article prepared with assistance from Colleen McMullin.



The Case for Change: CFIA Releases Discussion Document on New Food Inspection Model

By: Joel B. Taller

With $100 million in funding over five years, the Canadian Food Inspection Agency (CFIA) has undertaken a number of initiatives to modernize food regulation and inspection with the aim of further strengthening Canada's food safety system. Among the announced changes are the elimination of standard container sizes from the Processed Products Regulations and the establishment of a CFIA Complaints and Appeals Office. On June 1, 2012, the CFIA released a discussion document describing the current food inspection context and outlining the proposed new inspection model. It can be accessed at http://www.inspection.gc.ca/about-the-cfia/accountability/inspection-modernization/case-for-change/eng/1337194116466/1337194257540 The proposed changes will have a very significant impact on industry stakeholders, and as such, the government is seeking input. Comments and feedback can be submitted until July 31, 2012 by email to modele-inspection-model@inspection.gc.ca or fax (613-773-7569), or by completing the online survey at http://inspection.sondages-surveys.ca/surveys/CFIA-ACIA/copy-inspection-modernization-the-case-for-chan-3/?l=eng

The new model proposed by CFIA would create a systems-based approach that puts the onus on food producers, processors and importers to develop and implement programs that ensure food safety and controls risks, with oversight by the CFIA. This approach is expected to result in "consistent and appropriate oversight across all regulated food commodities . . . based on risk and focused on prevention of non-compliance, using science and technology." To achieve this, the CFIA has identified the following significant changes to Canada's food safety model.

Licensing/Registration: All industries that import or export food, or operate as manufacturers or processors of food products for trade between provinces will be required to obtain a licence/registration to operate. This will ensure that the CFIA knows the identity of regulated parties, what they produce and how they produce it. To become licensed/registered, a party will need to demonstrate a commitment to providing safe and compliant food, and to developing and implementing a suitable preventative control plan based on the product(s), operations and risk profile. The CFIA will have the power to suspend or revoke licences in cases of critical or repeated non-compliance. The discussion paper does not propose an ability to modify or place conditions on a licence as an alternative to suspension or revocation for non-compliance.

Food Safety Systems: Globalization and innovation have lead to new food safety risks and the development of mass distribution networks that can result in the quick spread of food incidents beyond national borders. To manage this risk, the CFIA is moving towards a more preventative and systems-based approach and is looking to the best practices of international food inspection partners and at the recommendations of the Codex Alimentarius Commission. As an example, the CFIA suggests that the Hazard Analysis and Critical Control Points (HACCP) system, which is currently mandatory in two of the CFIA's food programs (meat and poultry, fish and seafood) can be incorporated into preventative controls across all commodities.

CFIA Oversight: The CFIA's new role will be to verify that industry plans "appropriately prevent, eliminate or reduce hazards to acceptable levels.". The extent of oversight the CFIA exerts over an industry (normal, enhanced or reduced) will depend on a CFIA determination of the residual risk in the industry. The CFIA will consider the effectiveness of the preventative plan developed and implemented by the industry and the industry's compliance history to determine residual risk. CFIA also plans to modernize user fees and service standards.

Inspection: The frequency and scope of inspections will be based on residual risk and a consideration of the size and complexity of a party's operations. The actual inspection and verification approach will be standardized for all food commodities, with new resources being developed to improve service delivery (e.g., new training and tools for inspectors).The CFIA will be modernizing its science facilities and equipment, most notably increasing its testing capacity. The new model potentially allows for third-party verification on behalf of the retail sector to complement CFIA inspections; however, this possibility has not yet been considered in detail. A system to recognize third-party verifiers and to incorporate their inspection activities with those of the government has yet to be proposed.

Compliance and Enforcement: The new model will aim to ensure that compliance and enforcement will be transparent, predictable, graduated according to risk and appropriate to the level of non-compliance. The onus will be on industry to take appropriate action to correct any non-compliance found by CFIA. The discussion paper does not expand on the mechanisms (e.g. standardized protocols) that will be used to achieve the consistency promised by the new model.

Legislative Reforms: In addition to the new food inspection model, the government tabled the Food Safety for Canadians Act (the Act)on June 7, 2012, , which brings together various pieces of legislation related to food safety. Included in the Act are provisions increasing penalties for offences to as high as $5 million versus the current maximum of $250,000. The CFIA's legislative modernization also aims to address food safety concerns such as tampering, traceability and import controls not covered by current legislation.

The new food inspection model represents a major shift in Canada's approach to food safety. The benefits of a consistent and flexible system focused on prevention and science must be considered against the backdrop of increased responsibility for producers, processors and importers. Input and feedback from industry early in this process will be important to help shape the new food inspection model.

Article prepared with assistance from Laura Gomez and Katrina Coughlin.



New Guidance for Temporary Marketing Authorization for Caffeinated Energy Drinks

By: Joel B. Taller

On March 29, 2012, Health Canada released its long awaited category specific guidance document on Temporary Marketing Authorization ("TMA") for Caffeinated Energy Drinks ("Energy Drinks"). The guidance document outlines the TMA process that will be used to transition Energy Drinks from a Natural Health Product ("NHP") to a food and are regulated accordingly. The guidance document provides details regarding the eligibility criteria for participation in the current TMA process for Energy Drinks, compositional criteria, permitted labelling, advertising and claims, as well as research and reporting requirements.

Although the guidance document is restricted to the specific requirements for Energy Drinks, it is relevant for all companies with food-like NHPs as Energy Drinks may just be the first products to transition to foods from NHPs, but they will not likely be the last. Health Canada has been holding off on licensing many food-like NHPs such as vitamin waters, gums and bars in order to develop a strategy to transition these types of products over to foods. Likely within the next few weeks, other food-like NHPs will be re-classified as foods based on Health Canada's assessment of consumption patterns, history of use and marketing of these products. This long-awaited regulatory shift has already begun with certain NHP licence holders and applicants receiving notices that their products have been re-classified as foods and will continue as Health Canada continues the process of classification of products at the food-NHP interface.

1. Temporary Marketing Authorization Letter ("TMAL") Process

The transition of food-like NHPs to foods will begin with the issuance of Temporary Marketing Authorization Letters (TMALs), a mechanism built into the Food and Drugs Regulations ("FDR") that allows Health Canada to issue a temporary authorization for the sale of a food which is determined to be safe but is otherwise not compliant with the FDR in order to generate information in support of a regulatory amendment. With respect to the transition process, the timelines and requirements vary depending on the market access of the product and the status of its Product Licence Application ("PLA").

2. TMAL Eligibility Criteria

In order to be issued a TMAL as an Energy Drink, products must contain caffeine, must be water based and in beverage form. Currently, products such as powders, syrups and shots, or products that are dairy or juice based, will not form part of the transition. Products must meet the following specific criteria outlined in the guidance document with respect to the quantity of certain ingredients that may be added to the Energy Drink:

  • Caffeine - must contain a minimum of 200 ppm (mg/L) caffeine to be classified as an Energy Drink. Cannot contain more than 400 ppm (mg/L) caffeine, with a maximum amount of 180 mg per single serve container and per serving of 500 mL for multi-serve containers.
  • Taurine - cannot contain more than 3000 mg/day.
  • Vitamins & Mineral Nutrients - if added, must provide 5% of the Daily Value and cannot exceed maximum levels outlined in guidance document.
  • NHP Ingredients - quantities based on NHPD monographs or other authoritative sources. It is possible that certain NHP Ingredients may be considered Novel Food ingredients and will require pre-market assessment prior to being authorized for use in food products. A Novel Food notification involves demonstrating that a substance has a history of safe use as a food at levels that are similar to those expected or intended as a result of consumption of the food product. The review of the Novel Food submission would occur concurrent with the life of the TMAL.
  • Prohibited ingredients - Alcohol, Folic Acid and Vitamin A (retinol). See guidance document Appendix for additional prohibited ingredients.
  • Food Additives, Flavours & Colours - must comply with FDR and guidance document. See guidance document Appendix for prohibited ingredients.

Please note: This list is not exhaustive - the guidance document and FDR should be consulted for details and other requirements.

3. TMA Labelling and Advertising

In order to be issued a TMAL, products must meet (or will meet by December 2013) the specific labelling requirements outlined in the guidance document and the FDR including:

  • Nutrition Facts Table – must appear on label and be compliant with FDR.
  • Reference Amount – set at 500 mL for Energy Drinks.
  • Serving Size – all containers up to 750 mL will be considered  single-serving containers; all non-resalable containers will be considered single-serving containers; only re-sealable containers above 750 mL will be considered multi-serving containers for which the serving size will be the reference amount (500 mL).
  • Daily Consumption Limits – recommended maximum number of containers/servings per day must not result in total daily vitamins, minerals, amino acids, NHP ingredients or other ingredients that are in excess of maximum limits as set out in the guidance document, monographs or authoritative references (as applicable).
  • Caffeine, Taurine and NHP Ingredient content label declaration -  must appear, on a per container basis for single-serving containers; must appear, on a per serving basis (500 mL) for re-sealable multi-serving containers. Should immediately follow Nutrition Facts table or be adjacent to ingredient listing.
  • Other Ingredient content declarations – quantitative declarations of ingredients other than caffeine must comply with FDR and guidance document as applicable (i.e. artificial sweeteners). Should immediately follow Nutrition Facts table or be adjacent to ingredient listing.
  • "High caffeine content" - statement  or equivalent must appear on the product label.
  • Caution Statements – should appear grouped together, in bold or preferably under a bolded heading (i.e. Caution/Attention): "Do not consume more than (X) container(s)/servings daily" or "Usage: (X) container(s)/serving(s) maximum daily"; "Not recommended for children, pregnant or breastfeeding women and individuals sensitive to caffeine"; "Do not mix with alcohol".
  • Toll Free Number - should be provided on the product label adjacent to the company name/principal place of business to facilitate reporting of consumption incidents.
  • Claims – claims must be in accordance with FDR and guidance document (see section 3.5) as applicable. An exemption from the reference amount requirement may be obtained to enable some products to make "calorie-free" and "sugar-free" claims. Issues arising from these exemptions will be reviewed during the life of the TMAL.
  • Advertising – must be compliant with the Food and Drugs Act and Regulations, Consumer Packaging and Labelling Act and Regulations. For certain types of media (i.e. television) advertising preclearance may be required by industry-imposed self-regulation mechanisms.

Please note: This list is not exhaustive - the guidance document and FDR should be consulted for details and other requirements.

 4. TMA Research and Other Requirements

The purpose of the TMA process is to permit the sale of energy drinks so that Health Canada and the beverage industry have time to gather necessary information such as consumption data and incident reports that will aid the government in designing an appropriate food regulatory framework for these products.  As such, in order to be issued a TMAL, manufacturers have to agree to:

  • Either directly or through trade associations, and in partnership with Health Canada, undertake a series of consumer research projects in order to generate data on the consumption of Energy Drinks and reporting health-related incidents.  While Health Canada will have a hand in designing the framework for these studies, it is shifting the burden and cost of gathering this information to industry. 
  • Withdraw the product from sale if Health Canada determines it is in the public interest to do so.

5. Conclusion

The decision to transition Energy Drinks to foods brings Canada in line with other major trading partners such as the U.S. and the E.U., and will provide a framework for the transition of other food-like NHPs to the food regulatory framework. The Food Directorate has worked closely with industry to establish the above criteria and the timeframe for industry to transition to the new food labelling, balancing the consumer interest in the new information to be found on the food labels and the impact to industry required to make the above changes.  The second step in the transition of Energy Drinks to foods will begin once the analysis of consumer-generated data is completed by Health Canada, with the hope that regulatory amendments will soon follow.

Article prepared with assistance from Laura Gomez.



Several Changes Are Coming That Will Have a Significant Impact on Canadian Food Law and Practice

By: Ronald L. Doering

Repeal of standard container size regulations

To everyone's surprise, the government has announced its intention to repeal the famous standard container size regulations that are set out in the Processed Products Regulations (PPR). These stipulate mandatory requirements for grades and standards, including standard container sizes, for canned and frozen fruits and vegetables that are imported, exported or that are traded interprovincially. The regulations are voluminous — there are 73 sections and 12 schedules with dozens of pages of mind numbing detail. Most consumers don't even know they exist. How many know, for example, that vegetable soup and pork and beans can be in 10- and 14-fl oz cans, but it is an offence to use 12-fl oz cans? Or that ketchup containers must be 375-, 575-, or 750-mL sizes?

Changes to the PPR have been a divisive issue for years because they create winners and losers. For some, the PPR is a small but helpful protectionist measure; for others, a barrier to the importation of new or cheaper products. It did provide modest consumer protection, but the Canadian Food Inspection Agency (CFIA) wasted resources and wrongly, in my view, even applied it to the importation of wholesale bulk product to manufacturers who used it for further processing.

The announcement in the 2012 federal budget was limited to the repeal of "regulations related to container standards to enable industry to take advantage of new packaging formats and technologies, while removing an unnecessary barrier for the importation of new products from international markets." Other changes to the PPR will be done as part of the broader legislative consolidation of CFIA regulations that is coming very soon.

A new CFIA Complaints and Appeals Office

Kudos to Agriculture Minister Ritz and CFIA president George da Pont for bringing into force an important new administrative redress mechanism for the CFIA. Readers of this column will know that I have argued for over a decade that the scope of discretion and the range of CFIA authorities required a step-wise process to have regulatory decisions reviewed in an independent and timely way. If industry is not satisfied with CFIA staff actions in the enforcement of rules, if there has been undue delay in decisions or if the regulated party disagrees with decisions made by CFIA employees related to licensing, registration, permits, orders, inspection results, seizure, labelling or other regulatory action, then the CFIA now has a clear process to address the complaint in a timely way and provide redress if warranted.

After trying to resolve the matter directly with the employee, the regulated party now has automatic access to a formal written complaint procedure with a new Complaints and Appeal Office. The new Office will be guided by the recently released CFIA Statement of Rights and Service for Producers, Consumers and Other Stakeholders. Done right, this modest regulatory innovation could significantly improve the quality of agriculture and food law enforcement in Canada and could provide a useful precedent for other areas of regulation.

More changes coming

By the time this is published, we'll have details on legislative consolidation at the CFIA and, from Health Canada, some decisions on food-like Natural Health Products. And following the budget commitment to "streamline and accelerate the process for how foods are regulated," the introduction of modest amendments to the Food and Drugs Act to expedite, inter alia, the process for additive changes.



Rural romanticism and "natural" foods

By: Ronald L. Doering

The proliferation on our grocery shelves of foods with "natural" claims shows no sign of abating. With the growing recognition that organic food is not any safer, tastier, more nutritious or more sustainable, in spite of the higher price, consumers now want foods that are produced the old fashioned way on the small family farm. That's because consumers think that these foods are free of chemicals and more "natural," whatever that means.

Not surprisingly, food companies are turning themselves inside out to try to meet this demand. So we see ads with handsome farm families beside their green fields, no doubt providing natural, no-additive, chemical-free, home-style, no-preservative, artisanal "real" food.

Read the full article - Rural romanticism and "natural" foods



Health Canada Plans to Amend Food Colouring Declaration Requirements

By: Christopher Oates

During a recent conference call for its Chemical Management Plan Phase II, Health Canada indicated that it would be proceeding with amendments to the food colouring declaration requirements under the Food and Drug Regulations. This proposal stems from Health Canada's 2010 consultation on a proposal to eliminate the option of listing food colours in the list of ingredients under the general term "colour" and instead require food colours to be identified by their common name or a numerical identifier. Health Canada indicated that no decisions have been made as to the nomenclature that would be required under the revised regulations.

As of writing, no draft regulations have been published. It is expected that there will be a significant comment period for the industry following the publication of draft regulations in the Canada Gazette.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions