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Exporting food supplements from Canada

In Canada, supplements are usually natural health products licensed by Health Canada, but a destination may treat them as food. The CFIA can then certify them, if the exporter and manufacturer hold Safe Food for Canadians licences. Third parties issue International Trade Certificates for licensed products, and products made only for export can use section 37.

Updated · Each section links to the official source it comes from

Food-type export certificates
The CFIA, under SFCR section 17(2)
Licences for a CFIA certificate
Exporter and manufacturer both licensed under the SFCR
Regulatory status certificate
International Trade Certificate, issued by third parties since 2 September 2013
Made only for export
A sworn export certificate under section 37 of the Food and Drugs Act
Export declaration
To the CBSA, for most destinations other than the US

Before the goods leave

The questions to answer, in the order they usually come up.

  1. 1Does the destination treat the product as a food and ask for a government certificate? Read more
  2. 2Do the exporter and the manufacturer hold Safe Food for Canadians licences and preventive control plans? Read more
  3. 3Does the buyer ask for a certificate of the product's status in Canada? Read more
  4. 4Is the product made only for export, and not for sale in Canada? Read more
  5. 5Is an export declaration needed, and will the importer claim a preferential rate? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

CFIA export certificates for natural health products

When a product that is a natural health product (NHP) in Canada is a food in the destination, the CFIA can certify it as a food commodity.

  • NHPs are not regulated as foods under the Safe Food for Canadians Regulations, so NHP manufacturers need no CFIA licence when the products are sold only in Canada.
  • A product that is an NHP in Canada may be a food in another country. If that country requires a certificate for a food commodity of plant or animal origin, the CFIA can issue one under SFCR section 17(2).
  • The party requesting the certificate must be licensed under the SFCR with the activity "exporting food", and the manufacturer with the appropriate food preparation activity. Both need preventive controls and a written preventive control plan.
  • The Export requirements library has certification requirements for food supplements, nutritional supplements and nutraceuticals for destinations including the EU, India, Korea, Mexico, Türkiye and the United States.
  • Imported ingredients of animal origin may limit where a product can be exported; the exporter may need official documents from the ingredients' country of origin.

How we help: Compliant Always keeps both licences, the preventive control plan and the origin documents for animal-derived ingredients with each product, dated, and shows what a certificate request lacks. Ask about this

International Trade Certificates

A document on a natural health product's regulatory status in Canada, or on the Canadian site that makes, packages or labels it.

  • There are three types: an NHP with a product licence (NPN) and site licence; a homeopathic medicine with a DIN-HM and site licence; and a site licence only.
  • International Trade Certificates are not required under the Natural Health Products Regulations.
  • Since 2 September 2013 Health Canada has transferred their issuance to independent third parties, and no longer accepts new applications itself.
  • Health Canada keeps no public list of issuers; it suggests contacting your industry association.
  • Issuers should have no conflict of interest, may not be regulated under the NHP Regulations, and have the certificates notarised by a Notary Public or Commissioner of Oaths.

How we help: Compliant Always keeps the certificate with the product licence and site licence it rests on, and shows when either changes after the certificate was issued. Ask about this

Health Canada rules on exported health products

What a licensed product must still meet when exported, and how a product made only for export can be exempted under section 37 of the Food and Drugs Act.

  • A licensed health product may be exported commercially if its sale complies with the Act: at a minimum it must not be adulterated, made in unsanitary conditions, sold in a false or misleading way, or injurious to users.
  • Section 37 exempts a packaged product made in Canada for export only, not made or sold for use in Canada, if a certificate states that it does not contravene any known requirement of the importing country's law.
  • The certificate is signed by the exporter in the form in Appendix III of the Food and Drug Regulations, with the package marked "Export", and declared before a Commissioner for Taking Oaths. Section 101 of the NHP Regulations applies this to NHPs.
  • Health Canada asks exporters to notify it of their intention to use section 37 on form FRM-0038, and to keep manufacturing records and copies of export certificates.
  • Section 37 cannot be used for products within a mutual recognition agreement shipped to that partner, and it does not apply to products being imported.

How we help: Compliant Always keeps the sworn export certificate and the notification with each lot made for export, dated, and reads the label against the destination's requirements you record. Ask about this

Export declaration and reporting to the CBSA

How commercial goods are reported to the Canada Border Services Agency before they leave Canada, and what the exporter keeps afterwards.

  • In most cases an export declaration is needed for commercial goods. The most common exceptions are goods exported for consumption in the United States and non-restricted goods valued at less than CAN $2,000.
  • Goods moving through the United States to another destination, including goods entering the US on a transportation and exportation (T and E) bond, need a declaration.
  • Restricted goods, those controlled, regulated or prohibited under Canadian law, need their permit, certificate or licence whatever their value; going to the US they need no declaration, but the permit must still be presented.
  • Declarations are made through the Canadian Export Reporting System (CERS) or G7 EDI, with a business number and RM export program identifier. The exporter gives the carrier the proof of report number.
  • Minimum time limits: 2 hours before loading for air and rail, 48 hours before loading for marine, 2 hours before delivery to the post office, and immediately before export by highway.
  • The exporter may delegate reporting to a customs service provider but remains responsible for the information, and keeps export records in Canada for 6 years.

How we help: Compliant Always keeps the proof of report number, permits and export records with each shipment, dated, and shows what is missing before the goods are loaded. Ask about this

Certificates of origin under trade agreements

The document that lets the importer claim a preferential duty rate under one of Canada's free trade agreements, such as CUSMA, CETA or CPTPP.

  • A certificate of origin certifies that the good meets a free trade agreement's rules of origin; the importer must have it to claim preferential tariff treatment.
  • Under CETA, the Canada-UK TCA, CEFTA and CUFTA it is an origin declaration on an invoice or other commercial document. Canadian exporters enter their Business Number in the CETA declaration.
  • Under CUSMA and CPTPP it is a set of minimum data elements with no prescribed format, which the importer, exporter or producer may complete.
  • A certificate can cover one shipment, or identical goods over a blanket period of up to 12 months. It is valid for four years from signature.
  • Whoever certifies origin keeps the certificate and supporting records for six years, and must tell everyone they gave it to of any change affecting its accuracy.

How we help: Compliant Always keeps each origin declaration with the products and shipments it covers, shows when a blanket period runs out, and answers importers' origin questions from the record. Ask about this

Who answers for what

WhoWhat they answer forHow we help
ExporterThe SFCR licence to export where a CFIA certificate is sought, the section 37 certificate where used, and the export declaration.Licences, certificates and declarations kept with each shipment.
ManufacturerThe NHP site licence, an SFCR licence for its preparation activity where a CFIA certificate is sought, and the preventive control plan.Site and product licences kept with each product, with their dates.
Third-party certificate issuerIssuing International Trade Certificates against the product and site licensing status published by Health Canada.The certificate checked against the licences it names.
CFIAIssuing export certificates for NHPs that the destination treats as food.Certificate requests read against the destination's conditions.

Where are the goods going?

Most of what food supplements have to meet is set where they are sold. Each guide sets out the rules on arrival, with the official source for each.

Questions businesses ask

Do I need a CFIA licence to export supplements from Canada?
Not to sell natural health products in Canada. To get a CFIA export certificate, the exporter must be licensed under the Safe Food for Canadians Regulations for "exporting food", and the manufacturer for its food preparation activity, both with a written preventive control plan.
Can the CFIA issue an export certificate for a natural health product?
Yes, where the destination treats the product as a food and requires a certificate for a food commodity of plant or animal origin. The CFIA issues it under section 17(2) of the Safe Food for Canadians Regulations.
What is an International Trade Certificate for natural health products?
A document on a product's regulatory status in Canada and/or on the Canadian site that makes, packages or labels it. There are three types, for products with an NPN, homeopathic medicines with a DIN-HM, and sites only.
Does Health Canada still issue International Trade Certificates?
No. Since 2 September 2013 Health Canada has transferred issuance to independent third parties and stopped taking new applications. It keeps no public list of issuers and suggests asking your industry association.
Can I export a supplement that is not licensed for sale in Canada?
Under section 37 of the Food and Drugs Act, a packaged product made in Canada only for export, not sold for use in Canada, is exempt if the exporter issues a sworn certificate that it does not contravene any known law of the importing country.
What does a section 37 export certificate say?
That the product, packaged, labelled and marked "Export", is made in Canada, is not made or sold for use in Canada, and does not contravene any known requirement of the destination's law. The exporter signs it and declares it before a Commissioner for Taking Oaths.
Do imported animal ingredients affect exporting a supplement from Canada?
They can. The CFIA says imported ingredients of animal origin may limit export eligibility to some countries, and the exporter may need official documents from the ingredients' country of origin showing the destination's requirements are met.
Where are the destination requirements for Canadian food supplements?
The CFIA Export requirements library lists certification requirements for NHPs, including food supplements, nutritional supplements and nutraceuticals, for destinations such as the EU, India, Korea, Mexico, Türkiye and the United States.
Do I need an export declaration to ship supplements from Canada?
For most commercial shipments to countries other than the United States, yes, when the goods are worth CAN $2,000 or more. Non-restricted goods exported for consumption in the US need none.
Who can sign a CUSMA certification of origin for supplements?
The importer, exporter or producer of the goods. It has no prescribed form, but must include the minimum data elements set out in Annex 5-A of CUSMA and the certifying statement.
How does Compliant Always help with exporting from Canada?
Our team reads the rules for the routes you ship. Compliant Always shows which export documents apply to your product, keeps them with the shipment beside what the destination asks for, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

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