Overview
Safety doesn’t stop at the border.
Canada and the United States have many things in common: our love for hockey; an affinity for maple syrup; and a shared commitment to the health and safety of our citizens when it comes to food packaging materials, just to name a few. …OK, maybe that third one didn’t come immediately to mind!
Canada has a sophisticated and well-established system for the regulation and assessment of food-contact materials and articles. In contrast with many of the "mandatory" jurisdictions around the world, however – where regulated substances must be the subject of a regulation; must appear in a positive list; or must be the subject of an applicable exemption or exception – Canada relies, instead, on a combination of certain threshold safety requirements, and a largely "voluntary" process whereby primary responsibility is placed on industry to ensure that materials and articles are safe, suitable, and otherwise appropriate for their intended use from a technical standpoint.
This system of regulation may soon change, however, as detailed in our September 2026 update, available here. In the meantime, this edition of our StepLadder Series discusses the current state of regulation of food-contact materials and articles by our neighbors "north of the border," in Canada.
Regulatory Framework
All food placed on the market in Canada is subject to the Food and Drugs Act of 1953, as most recently amended, in relevant part, in 2012.[1] The term "food," "includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever."[2] While the term "food packaging" is not specifically defined, Food Packaging Materials are specifically addressed in Division 23, Section B.23.001 of the Act, which states:
No person shall sell any food in a package that may yield to its contents any substance that may be injurious to the health of a consumer of the food.
It is, therefore, the specific act of placing for sale of food in a package that subjects food packaging to the jurisdiction of the Canadian authorities in accordance with the requirements of Canada’s Food and Drugs Act of 1953. Primary responsibility for ensuring the safety of packaging used in food-contact applications rests with the manufacturer and/or distributor of such packaging material, and no preemptive involvement from Health Canada is specifically required, except in limited instances where further assessment (in the form of a mandatory Letter of No Objection (LONO), described more fully below) for sensitive subpopulations or unique applications is needed.[3]
Food – and by extension, food packaging materials – also are subject to the Canadian Food Inspection Act of 1997 (herein "CFIA"), which provides the Canadian Ministry of Justice with authority to require the recall of food products that pose a risk to the health or safety of the public. More specifically, Section 19(1) of the CFIA states, in relevant part: "[w]here the Minister believes on reasonable grounds that a product…poses a risk to public, animal or plant health, the Minister may, by notice served on any person selling, marketing or distributing the product, order that the product be recalled or sent to a place designated by the Minister."[4]
Finally, food and food packaging materials may be subject to additional regulation under the Safe Food for Canadians Act of 2012 (herein "SFCA"), which consolidated the previous authorities set forth under the Fish Inspection Act, the Meat Inspection Act, the Consumer Packaging and Labelling Act, and the Canada Agricultural Products Act.[5]
Demonstrating Safety
Although Canada does not maintain positive lists of materials and articles that are safe and suitable for use in food-contact applications, per se, Health Canada does make available a table of Acceptable Polymers for Use in Food Packaging Applications.[6] More specifically, this Table describes those polymers that have received favorable LONO responses from Health Canada. As of the date of this article, the Table describes 13 independent categories of materials that may be used in food-contact applications, including: (1) polyethylenes (PE); (2) polypropylenes (PP); (3) poly(ethylene- vinyl acetates) (PVA); (4) polystyrenes (PS); (5) polyvinyl chlorides (PVC); (6) ionomers (I); (7) polyethylene terephthalates (PET); (8) poly(ethylenes-vinyl alcohol) (PVAc); (9) polycarbonates (PC); (10) polyamides (PA); (11) polyvinyl alcohols (PVOH); (12) polyvinylidene chlorides (PVDC); and (13) others (O).
Consistent with other jurisdictions that maintain sophisticated pre- and post-market assessment procedures, such as those administered by the European Food Safety Authority (EFSA) and the US Food and Drug Administration (FDA), Health Canada has historically accepted safety justifications – when submitted either voluntarily or under an applicable mandatory requirement in the case of the unique applications described above – based on the same principles that are commonly relied upon in those jurisdictions. In other words, much of the same quality and quantity of information needed to support safety in the EU and US has historically been considered acceptable to demonstrate safety in Canada as well. As one such example, Health Canada often accepts the same or similar chemistry and toxicology information contained in Food Contact Notifications (FCNs) submitted to FDA as suitable evidence of safety in Canada.[7]
While Health Canada retains ultimate authority to agree or disagree with a safety justification in its own right, the consistent application of well-established scientific principles used elsewhere around the world in Canada provides an important degree of stability and predictability to international companies that intend to enter the Canadian food packaging market.
Letters of No Objection (LONO)
Although Canada presently maintains a voluntary system of compliance for many food packaging applications, Health Canada recognizes that written assurances are often helpful for companies intending to demonstrate to their downstream customers – whether those customers are converters, manufacturers of finished products, or consumers themselves – that their material is safe and suitable for the intended use. In the absence of a specific "approval" process for such materials in Canada, Health Canada offers instead the ability to request and obtain a Letter of No Objection (LONO).
A LONO is exactly what it purports to be – a letter from Health Canada stating that it has "no objection" to the proposed use of a food-contact material or article. Importantly, a LONO is issued based on the information that Health Canada has before it in the moment, as evaluated based on the state of the safety (i.e., chemistry, exposure, toxicological, and other relevant data) in the moment. A LONO does not have a specific validity period or expiration date.[8] Because a LONO is issued based on the specific data and information presented to Health Canada at a given point in time, it is a good indicator that a safety assessment is sound and reasonable, but it is not considered a form of premarket authorization or approval. In the event that the underlying migration, exposure, toxicology, or safety data should change, a LONO may no longer be considered current.
Companies that are interested in submitting a request for a LONO to Health Canada are advised to consult the guidance available on Health Canada’s website.[9] In practice, and as discussed above, much of this information overlaps significantly with the information that is otherwise required for an FCN submission, including:
- Product Identity: chemical name, trade name, structure, composition, specifications, and chemical/physical properties.
- Proposed Usage: form of finished package, dimensions of package, packaging ratios (weight of food/unit area of packaging material), time and temperature conditions of use, and estimated market volume.
- Migration/Extraction Data used to Develop an Exposure Assessment: calculations, modeling, or test data demonstrating the propensity of a substance to migrate from packaging to food and its corresponding "concern level" based on the following Probable Daily Intake (PDI) values:
|
Concern Level |
PDI (ug/kg body weight) |
|
Threshold |
< 0.025 |
|
1. Very Low |
0.025-0.1 |
|
2. Low |
0.1-2.5 |
|
3. Medium |
2.5-25 |
|
4. High |
> 25 |
- Toxicological Data: one or more of structure/activity, genotoxicity, short-term and/or long-term feeding studies, and additional supporting information, depending on the "concern level" identified above.
The LONO submission process itself is changing as of the date of this article. In the past, Health Canada has historically accepted LONO requests via E-mail to one or more appropriate individuals at the Agency. However, as we move into 2027 and beyond, Health Canada intends to transition to a fully electronic submission process via an online portal. Therefore, it will be especially important for applicants interested in obtaining a LONO to have familiarity with both the substantive aspects of a LONO request, as well as the mechanics of the new electronic submission process (or work with appropriate legal counsel such as Steptoe that can provide the necessary support).
Provided that Health Canada agrees that a LONO is appropriate in a given instance, the LONO is provided electronically in a form letter format containing a unique "KS" Reference Number used for identification purposes. The timeframe for issuance of a LONO varies depending on the workload of Agency staff and the complexity of the request, but typical turnaround times range from two to four weeks following receipt of a complete request. LONOs can then be provided by the recipient to their downstream customer(s) – with appropriate redactions as the case may be – as evidence of the safety of a food packaging material for the intended use.
Concluding Thoughts
While Canada has long maintained a voluntary system for ensuring safety of food packaging materials and articles with a significant track record of success, a changing landscape and additional consumer scrutiny on packaging materials is likely to result in increased oversight regarding the regulation of such materials in Canada and elsewhere in the coming years. Companies that have not previously considered engaging with Health Canada via the LONO process may find specific benefits to doing so when this transitional period occurs. In any event, given the consistency with other jurisdictions from a safety assessment standpoint, and the relative historical stability of the Canadian regulatory process, companies would be well-advised to consider Canada as a willing partner in both protecting its constituents and supporting innovation by industry in the months and years ahead.
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About the Steptoe StepLadder Series
Steptoe LLP is pleased to publish the StepLadder series of articles for our clients, prospective clients, and interested companies as a way of educating attorneys and non-attorneys alike about legal and regulatory principles related to food packaging in meaningful ways. While there are many sources of information available online, the StepLadder series is intended to be accessible to, and understandable by all, to help support business decisions related to food packaging compliance.
This information is provided for educational purposes only, is not legal advice, and does not establish an attorney-client relationship with Steptoe. Our lawyers made us write that. If you have legal questions, please consult an attorney. Preferably from a team well-versed in food packaging regulation – and definitely from a group of attorneys that have a good sense of humor. Because you are what you eat… unless your food packaging isn’t a ‘food additive,' in which case you’re not food packaging.
[1] See https://laws-lois.justice.gc.ca/eng/Regulations/C.R.C.,_c._870/index.html.
[2] Id. at Section A.01.010.
[3] These applications include: special dietary uses, infant formula packaging, and novel foods and are regulated by Health Canada under Divisions 24, 25, and 28 of the Act, respectively. See also, https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/packaging-materials.html.
[4] See https://laws-lois.justice.gc.ca/eng/acts/c-16.5/FullText.html#h-68060.
[5] See https://laws-lois.justice.gc.ca/eng/acts/s-1.1/index.html.
[6] The list is updated periodically and available at: https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/lists-acceptable-polymers-use-food-packaging-applications.html.
[7] For this reason, it may be particularly advantageous and efficient for companies that obtain an effective FCN from FDA to consider submitting a LONO request to Health Canada in due course.
[8] https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/packaging-materials.html.
[9] Id.
