Quality Smart Solutions offers compliance solutions for your ingredients to meet the regulations of Canada and USA. Each country has their unique requirements, some easier than others. We’ll walk you through these opportunities so you can make an informed decision to ultimately help increase your sales in North America.
Novel Food Submission
Foods that are new to the supply chain or genetically modified among other features may be considered novel in Canada and must be evaluated for their safety. As such, a pre-market notification must be prepared, submitted to Health Canada and approved (Health Canada would issue a notice of no objection) prior to sale of the new food in Canada. First, Quality Smart Solutions conducts a comprehensive evaluation of the food to determine if it is novel. If it is novel we prepare a dossier complete with safety data, manufacturing details and engage with Health Canada for the duration of the notification until a final decision is made.
Food Additive Submission
Food additives are ingredients that serve the purpose such as flavouring, sweetening, preservatives, food enzymes, anti-caking and many other purposes. A list of permitted food additives in Canada can be found here. Before a new food additive can be used in food products for sale in Canada a food additive submission must be prepared and submitted. A scientific assessment dossier is prepared to ensure its purpose of use and safety. When this dossier is submitted to Health Canada, a notice of proposal will be publicly posted on their website for public consideration and commenting. If new evidence is raised, modification to the submission will be required.
Ingredient Natural Product Number
Historically, Natural Product Numbers (NPN) have been and are still issued for finished products. A Master File application has been submitted for ingredients that will be used in natural health products (called dietary supplements in the United States). But given the limitation in value that a Master File number offers for an ingredient the shift has been to obtain a NPN for an ingredient with approved health claims. The license number can be shared with a client using their ingredient and they can reference the number on their product license application to obtain their own NPN. This could help expedite licensing or at least help minimize the questions Health Canada will ask about the ingredient’s safety and efficacy. Licensing can take 60 to 210 days depending on what classification the ingredient will be categorized. Quality Smart Solutions has filed over 5000 NPNs since 2007 with over 50 ingredient NPN licenses with global ingredient suppliers.
Generally Regarded as Safe (GRAS)
Any substance added to food excluding colour additive, food additives or other pre-approved ingredients, according to FDA regulations under sections 201(s) and 409 of the Federal Food, Drug and Cosmetic Act requires premarket review and approval including review by qualified experts. The value of GRAS has increased over the past years.
Safety and technical evidence to support the substance’s use in the food chain in the United States is required. Evidence must be reviewed by scientists who have experience and scientific knowledge and training. These scientists comprise an expert panel.
GRAS notifications are voluntary. The term “Self-GRAS” pertains to a substance that has been internally assessed (and preferably a full review and dossier with safety evidence prepared at the same level as a GRAS notification but not submitted to the FDA) is kept on hand.
Quality Smart Solutions offers GRAS or self-GRAS services. Our first step is conducting an ingredient feasibility review which would determine any gaps before proceeding with GRAS notice. Literature search, review and summarizing, and, if required, coordinating toxicological studies to support the food ingredient’s safety profile. We will prepare a dossier and coordinate an expert panel review. Upon preparation of and submission of the FDA dossier the FDA will issue a file number (GRN No.). All questions and feedback with the FDA are responded to by our technical team through to FDA’s final decision.
FDA maintains a database of every GRAS notice filed since 1998.
New Dietary Ingredient Notification (NDIN)
Dietary ingredients that have not been marketed in the United States as a dietary supplement before October 15, 1994 require a new dietary ingredient submission. Evidence to conclude the dietary ingredient’s use as being safe must be proven. Note that this limits its use to dietary supplements. If the intended use is in both dietary supplements and foods it is recommended that the GRAS route be taken.
Novel Food submission
FDA has not defined a “novel food”. As such, these types of ingredient must go through a voluntary GRAS notification as described above.
Food Additive Petition
These ingredients are used to make foods. There are over 3000 such ingredients in FDA’s database. FDA tightly regulates such additives. To be allowed to use a new food or colour additive a petition must be filed for its approval. Safety evidence in all its forms and ways it will be used must be provden. The aspects FDA evaluates when determining its acceptance include composition and properties of the substance, the amount that would be consumed, short and long term health effects and various safety factors.