NHP allergen labelling is one of the quieter changes in Health Canada's 2022 labelling amendments, yet it reaches back into your formula sheet. A natural health product must now declare food allergens, gluten sources and added sulphites on its label. Many brand owners come from the food world and assume food rules apply as written. They are close, but not identical. So this guide covers what triggers a declaration, where it goes and which ingredients to question before you lock a formula.
Key Takeaways
- NHP allergen labelling covers priority food allergens, gluten from five cereals and added sulphites at 10 ppm or more.
- The declaration sits in bold under an Allergens heading in the Warnings section of the Product Facts table.
- Cross-contamination alone does not trigger the mandatory statement under the NHP Regulations.
- Non-medicinal ingredients such as glycerin, ethanol, lecithin and capsule shells often decide whether you need a declaration.
- Ask every supplier for allergen and source documentation before formulation, not after the label is designed.
What NHP allergen labelling requires
The rules sit in the Natural Health Products Regulations. They define a "food allergen source, gluten source and added sulphites statement". In plain terms, your label must name the source of any food allergen or gluten in the product. It must also flag added sulphites once the total reaches 10 ppm.
The food allergen list mirrors the familiar priority list. It includes tree nuts, peanuts, sesame, wheat and triticale, eggs, milk and soy. It also includes crustaceans, molluscs, fish and mustard. Gluten is defined separately. It means gluten protein from barley, oats, rye, triticale or wheat, including hybrid strains.
Here's what that means in practice: NHP allergen labelling is about the source food, not the ingredient name. For example, a soy-derived excipient is declared as "soy", even when the ingredient list uses a chemical name.
Where the allergen statement goes on the label
On a Product Facts table, the statement appears under the Warnings heading. First comes the word "Allergens / Allergènes" in bold type. Then the source statement follows, also in bold. Small-package formats that are exempt from the full table still need the same bold statement in their required label text.
Gluten has its own naming rule. In the allergen statement, you write "gluten" followed by the cereal in parentheses, such as "gluten (oats)". Sulphites must appear as "sulphites", "sulfites" or "sulphiting agents". If you already list them in the non-medicinal ingredients, specific naming rules apply there too.
Because this sits inside the facts table, timing matters. Our earlier guide to the NHP Product Facts table covers the June 2028 deadline for labels already in market. Plan the allergen line during that relabel, not as a separate print run.
Ingredients that trigger NHP allergen labelling in herbal products
Most single-herb tinctures never trigger a declaration. However, the non-medicinal ingredients often do. This is where most brands run into trouble.
Start with the solvent. Ethanol can be made from wheat, corn or other feedstocks. Distillation generally removes protein, but you still need the source and supplier documentation on file. Glycerin can come from soy, palm or coconut oil. Again, ask the supplier which, and whether any protein carries through.
Next, check the herbs themselves. Avena sativa, for instance, is oat, and oats are one of the five gluten cereals. A milky oat tops tincture therefore needs a careful look. Mustard seed, sesame and wheatgrass raise the same question. Also review capsule fills, softgel shells and gummy bases. Lecithin often comes from soy, and some fillers contain milk-derived lactose.
Finally, sulphites. They appear in some dried fruit, certain wine-based ingredients and a few preserved botanicals. As a result, a sulphite-treated input can push a finished product over the 10 ppm line.
Cross-contamination versus intentional ingredients
The regulations draw a clear line here. If a food allergen, gluten or added sulphites are present only through cross-contamination, the mandatory statement does not apply. In other words, the rule targets ingredients that are part of the formula.
That said, the exemption is not a reason to skip the question. Retailers, distributors and allergic consumers still ask about shared equipment and shared facilities. Also, a supplier change can turn a trace issue into an intentional ingredient overnight. For example, a new glycerin lot from a different oil source changes the analysis.
The practical implication: keep the allergen review tied to your specification sheets. Then any supplier change prompts a fresh look at the label, rather than a surprise during a distributor audit.
Planning NHP allergen labelling at the formulation stage
NHP allergen labelling is cheapest to handle before the first label exists. Once a design is printed, every change costs plates, stock and time. So build the review into formulation.
First, list every medicinal and non-medicinal ingredient, including carriers, solvents and processing aids. Second, ask each supplier for an allergen statement and the source material. Third, screen each ingredient against the NHP Ingredients Database entries you rely on; our guide to the NHP Ingredients Database explains how. Fourth, decide whether a declaration applies, and record why.
Also check that the declaration matches your product licence application. The non-medicinal ingredients on your licence, your label and your batch documentation should tell the same story. Any mismatch tends to surface during a Health Canada review or a retailer onboarding check.
Bringing it together
NHP allergen labelling is a short line on the label, but it depends on decisions made much earlier. Brands that settle solvent sources, carriers and herb choices at formulation avoid late relabels. They also give retailers clear answers when the allergen questions arrive.
If you're developing a new tincture, glycerite or tea, see how our contract manufacturing services fit your launch plan. You can also contact Perfect Herbs to talk through your formula and labelling timeline.
Published: October 27, 2026