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# Canada Food Contact Materials: Health Canada Division 23 and CFIA Compliance

Canada's food contact materials framework sits at the intersection of Health Canada's Division 23 positive list, CFIA enforcement authority under the Safe Food for Canadians Act, and alignment with US FDA 21 CFR requirements. For packaging and electronics manufacturers supplying food processors, dairies, or beverage facilities, understanding which materials are permitted, what migration testing is expected, and where CFIA enforcement intersects with your supply chain determines your market access.

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At a glance

Key regulation

Food and Drug Regulations Division 23

Enforcement

CFIA (Canadian Food Inspection Agency)

BPA

Prohibited in baby bottles since 2010

Testing

EN 1186 / ASTM E1784 migration tests

## Key regulatory concepts for food contact compliance

### Division 23 of the Food and Drug Regulations — The Positive List Framework

Health Canada's primary regulatory instrument for food contact materials is Division 23 of the Food and Drug Regulations (CRC c. 870), which establishes a positive list of permitted packaging materials, including polymers, adhesives, coatings, and printing inks. Only materials on the positive list, or materials that comply with a referenced standard such as the US FDA's 21 CFR Parts 176–179, may be used in food contact applications. Division 23 does not prescribe specific migration limits in the same detail as EU Regulation 10/2011 — instead it relies on the positive list plus specific prohibitions for substances like BPA in baby bottles.

### CFIA Enforcement Role — Safe Food for Canadians Act and SFCR

The Canadian Food Inspection Agency enforces food safety requirements at the food processing and retail level through the Safe Food for Canadians Act (SFCA, SC 2012 c 24) and its implementing regulations, the Safe Food for Canadians Regulations (SFCR, SOR/2018-108). CFIA inspectors verify that food packaging and food contact materials used at licensed food processing establishments comply with Health Canada's requirements. CFIA does not license packaging manufacturers directly — responsibility for compliance sits with the food manufacturer or processor who uses the packaging. Packaging suppliers are expected to provide declarations of compliance to their food industry customers.

### Plastics for Food Contact — BPA, Phthalates, and PFAS Restrictions

Canada was the first country to declare BPA (bisphenol A) a toxic substance under the Canadian Environmental Protection Act, 1999 (CEPA), and polycarbonate baby bottles and infant formula cans with BPA-based epoxy linings have been prohibited since 2010. Phthalate plasticizers (DEHP, DBP, BBP) are restricted in food contact plastics used for fatty foods under Division 23 compliance guidance. PFAS (per- and polyfluoroalkyl substances) are under increasing regulatory scrutiny — Health Canada is actively reviewing PFAS use in food packaging and restrictions are expected in the near term, tracking the US FDA's voluntary phase-out and EU restrictions under REACH.

### Electronics in Food Environments — IP Ratings, NSF/ANSI 169, and 3-A Sanitary Standards

Electronic devices installed in food processing environments — sensors, controllers, HMIs, weighing equipment — are expected to meet hygienic design standards that prevent microbial harborage and withstand chemical cleaning regimes. NSF/ANSI 169 (Special Purpose Food Equipment and Devices) covers equipment that contacts food incidentally or is used in food processing environments but does not require NSF-certified food contact surfaces. 3-A Sanitary Standards (3-A SSI) are the accepted benchmark for dairy, beverage, and pharmaceutical food contact equipment. Stainless steel 316L enclosures with crevice-free welds, IP69K pressure-wash ratings, and NSF-compliant gasket materials are the practical requirements for food-zone electronics.

### Migration Testing — EN 1186 and ASTM E1784 Recognized Methods

While Canada does not mandate specific migration test methods under Division 23, Health Canada's guidance documents recognize EN 1186 (Materials and articles in contact with foodstuffs — plastics) and ASTM E1784 as appropriate methods for demonstrating compliance. Overall migration limits in Canada are generally aligned with EU Regulation 10/2011 at 10 mg/dm² (60 mg/kg food simulant). Fatty food simulant testing (isooctane or ethanol/water) is required for materials likely to contact high-fat foods. Specific migration limits for regulated substances must be assessed against Division 23 and any applicable CEPA toxic substance declarations.

### Import Requirements and Cross-Border Compliance with FDA 21 CFR

Canada accepts compliance with US FDA 21 CFR Parts 176 (paper and paperboard components), 177 (polymers), 178 (adjuvants and production aids), and 179 (irradiation in production) as an acceptable route to Division 23 compliance, given the significant alignment between the two frameworks. CFIA import requirements for food packaging materials do not require pre-clearance but expect importers to maintain compliance declarations. Exporters shipping food contact materials to Canada should have supplier declarations confirming Division 23 or equivalent 21 CFR compliance, available for CFIA inspection on request.

## Food contact compliance process — step by step

01

Determine whether your product is a direct food contact material (surfaces touching food during processing, packaging, or storage), an indirect food contact material (packaging outer layers, labels), or food-zone equipment (incidental contact in processing environments) — the applicable requirements differ significantly.

02

Cross-reference Division 23 of the Food and Drug Regulations against your specific material composition — confirm all polymer types, additives, adhesives, coatings, and printing inks are permitted under the positive list or covered by an acceptable reference standard such as FDA 21 CFR Parts 176–179.

03

Review Health Canada's Guidance Document on Packaging Materials (available from Health Canada's Food Safety portal) for your specific polymer category — the guidance provides substance-specific restrictions and compliance pathways beyond the base regulation text.

04

Commission migration testing using EN 1186 or ASTM E1784 at an accredited third-party laboratory. Select appropriate food simulants based on the worst-case food type your packaging will contact — aqueous (A), acidic (B), alcoholic (C), or fatty (D) simulants per the EU simulant classification that Canadian labs routinely use.

05

Check for specific Canadian restrictions on BPA (prohibited in baby bottle polycarbonate), phthalate plasticizers in fatty food contact applications, and emerging PFAS restrictions affecting fluoropolymer coatings and PTFE-based non-stick surfaces.

06

Obtain written supplier material declarations (SDS plus food contact compliance letters) from all raw material suppliers confirming Division 23 or 21 CFR compliance for each substance used in the formulation — these declarations are your primary compliance evidence.

07

Prepare a customer-facing compliance declaration for food manufacturer customers, confirming Division 23 compliance, test method used, overall migration result, and any specific migration test results for regulated substances — CFIA inspectors may request this documentation during facility audits.

08

If your electronics or equipment operates in a food processing environment, assess NSF/ANSI 169 or 3-A Sanitary Standards certification requirements and confirm that enclosure materials, gaskets, and surface finishes are appropriate for the cleaning chemicals and temperatures used in that environment.

## Frequently asked questions

### What regulations govern food contact materials in Canada?

The primary instrument is Division 23 of the Food and Drug Regulations (CRC c. 870), which establishes a positive list of permitted packaging materials. Health Canada has regulatory authority over the safety of food contact materials. The Canadian Food Inspection Agency enforces food safety at food processing facilities under the Safe Food for Canadians Act (SC 2012 c 24) and Safe Food for Canadians Regulations (SOR/2018-108). There is no standalone 'food contact materials regulation' equivalent to EU Regulation 10/2011 — compliance is achieved through Division 23 and Health Canada's guidance documents, which accept FDA 21 CFR Parts 176–179 as an aligned compliance pathway.

### Is BPA restricted in food packaging in Canada?

Yes — Canada declared BPA a toxic substance under the Canadian Environmental Protection Act, 1999 (CEPA) and banned polycarbonate baby bottles in 2008, effective 2010. Epoxy linings in infant formula cans containing BPA-based resins have also been prohibited. For general food contact packaging (adult beverage can linings, food storage containers), BPA is not universally prohibited but is subject to risk assessment under Health Canada's continuous monitoring framework. The food industry has largely transitioned away from BPA voluntarily, but manufacturers should still conduct a substance-specific assessment. PFAS restrictions affecting food packaging coatings are the next significant restriction expected in Canada.

### What migration testing is required for food contact plastics?

Division 23 does not prescribe specific migration test methods, but Health Canada's guidance recognizes EN 1186 (European Standard for plastic food contact materials migration testing) and ASTM E1784 as appropriate methods. Overall migration limits are aligned with the EU at 10 mg/dm² or 60 mg/kg food simulant equivalent. Testing should use simulants matching the worst-case food type — distilled water (simulant A) for aqueous foods, 3% acetic acid (simulant B) for acidic foods, 10% or 50% ethanol (simulant C) for alcoholic foods, and isooctane or HB307 (simulant D) for fatty foods. Test temperatures and durations should reflect the conditions of use (refrigerated storage vs. microwave heating vs. retort processing).

### Do electronics used in food facilities need special certification?

It depends on the food zone in which the equipment operates. Equipment in the food zone (direct contact or splash zone) should meet 3-A Sanitary Standards or NSF/ANSI 2 (Food Equipment) or NSF/ANSI 169 (Special Purpose Food Equipment). Equipment in the non-food zone (equipment rooms, external surfaces) has lower requirements but still needs to withstand cleaning chemical exposure and meet HACCP-driven hygienic design principles. IP69K rating (high-pressure steam cleaning) is the practical minimum for food-zone electronics. NSF certification is not legally mandated by CFIA regulations — but it is effectively required by food manufacturer customers and is audited as part of GFSI-recognized food safety certification schemes (SQF, BRC, FSSC 22000).

**Disclaimer:** Educational resource only. Regulatory requirements change. Consult a qualified compliance specialist before making decisions.

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