Ingredient Review
A thorough review of all ingredients to ensure they are permitted for use under Canadian regulations. This includes assessing whether any ingredients are restricted or require special labeling.
Health Canada is the federal department responsible for helping Canadians maintain and improve their health. Part of their mandate includes regulating substances and ingredients used in foods, cosmetics, natural health products, and other consumer goods to ensure they are safe for public use.
Ingredient compliance involves ensuring that all components used in your products meet Health Canada’s stringent safety and labeling requirements. This process is crucial for companies wishing to enter or maintain their presence in the Canadian market.
A thorough review of all ingredients to ensure they are permitted for use under Canadian regulations. This includes assessing whether any ingredients are restricted or require special labeling.
A scientific evaluation of the safety data for each ingredient, particularly for new or novel substances, to confirm they meet Health Canada's safety standards.
Ensuring that product labels meet all of Health Canada’s requirements, including accurate ingredient lists, health claims, and bilingual (English and French) labeling.
For certain products, a submission to Health Canada may be required to demonstrate compliance. This could include a Product License Application for natural health products or a Novel Food Notification for new food ingredients.
GRAS Experts streamlines your journey towards Health Canada ingredient compliance. We guide you through the application processes for:
Obtain a Natural Product Number, signifying Health Canada approval for your ingredient’s safety and use in Canadian NHPs.
Develop a confidential dossier containing detailed information about your ingredients and manufacturing processes for efficient NHP submissions.
Secure approval for using a specific additive in your food products sold in Canada, demonstrating its safety and suitability.
Bring your groundbreaking food innovation to market by obtaining Health Canada’s approval for its safe consumption.
Navigate the complex regulatory landscape with confidence and ensure your product’s safety and market readiness with GRAS Experts.
We’ve been doing this for over 18 years, with over 2,000 happy clients!
No time to waste! We help you get to the market quickly without compromising quality.
Every ingredient is unique, and so is our approach. We tailor our services to your specific needs.
Safety is our top priority. We make sure your ingredients meet all the requirements.
Avoid costly delays, fines and potential product recalls with our expert guidance.
Regulations can change. We’ll keep you compliant for the long haul.
NPN stands for Natural Product Number and is issued for natural health products (dietary supplements) finished products or single ingredients.
The value of an ingredient NPN is that there are approved health claims associated with the NPN. This NPN can be shared with the ingredient buyer so they can reference your NPN and associated health claims (with your permission) on their own NHP Licence to sell their finished product in Canada.
This could help the assessment officer to review their application more expeditiously. This adds value and could provide a competitive advantage compared to other similar ingredients.
Depending on the NHP class Health Canada can issue an NPN in as little as 60 days to as long as 210 days.
You can prepare a letter of authorization with the NPN license number so they can reference this on their product license application.
NPN license is publically listed on the Health Canada website and its details ie. Medicinal ingredient quantity and respective approved health claims. An NHP Mater file would be kept confidential with Health Canada and, when an ingredient supplier references the NHP-MF on their product license Health Canada will review the master file and any questions from the file will be directed both to the product license applicant and to the master file holder. The ingredient buyer will not be able to see the contents of the master file.
NPNs are used for natural health products and for the purpose of raw material suppliers, the ingredient for the intended use in NHPs/Dietary Supplements in Canada. A novel food submission is to be used in foods with no health claims, just safety substantiation. You cannot use an NPN to support a novel food that would be used in a food format and used for food consumption.
The performance standard is 410 days which Health Canada has historically met 90 percent of the time. This does not include pre-submission consultation and meetings that may be arranged.
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