Recent regulatory and policy changes from Health Canada introduce new compliance considerations for food manufacturers, as they relate to the use of essential oils, oleoresins, and natural extractives in food products, among other substances.
Amendments to food additive regulations
On December 18, 2024, Health Canada published its final Regulations Amending Certain Regulations Concerning Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis of Food. One of the significant changes in these amendments was the removal of exemptions that previously excluded certain botanically sourced substances from the definition of a food additive under the Food and Drug Regulations (FDR). Food additive is defined as "any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of or affecting the characteristics of a food," subject to certain enumerated exemptions. Previously, based upon a plain reading of the definition, natural extractives, oleoresins, and essential oils were exempted as food additives, regardless of their role in food products. As a result of these new amendments, these substances, when used for a non-flavouring, or nutritive, technical effect in food, now fall squarely within the scope of the food additive definition.
In Canada, food additives must be used per the Lists of Permitted Food Additives (LPFA). An often-lengthy premarket approval is required for any new food additive or new food additive use. A food is considered adulterated if it contains a food additive that is not used in compliance with the LPFA. However, since the coming into force of the amendments, and as of April 2025, no new essential oils, natural extractives, or oleoresins have been added to LPFA, raising uncertainty about the regulatory status of some formulations that have remained unchanged for years, even in absence of any health or safety concerns.
Discontinuation of LONOs
Adding to the complexity, Health Canada has stopped issuing Letters of No Objection (LONOs) for food processing aids and incidental additives. Processing aids are not defined by regulation. however, Health Canada policy describes a processing aid as a "substance that is used for a technical effect in food processing or manufacture, the use of which does not affect the intrinsic characteristics of the food and results in no or negligible residues of the substance or its by-product in or on the finished food."1
While these letters were not mandatory, because of the partial overlap of the definition of food additive and processing aid (both substances are used to impart a technical effect), LONOs provided a level of clarity for manufacturers by confirming that the use of a given substance would not be regulated as a food additive. With LONOs being discontinued, companies may find it more difficult to distinguish, with certainty, between food additives and processing aids, particularly given the ambiguity around what constitutes "negligible residues" for processing aids. These regulatory and policy changes were implemented without significant transition periods, and the combined effect of these changes is that some manufacturers may now need to quickly reassess whether commonly used ingredients are compliant under the revised framework. In some cases, reformulation, or a formal submission to Health Canada for food additive approval, may be required. In other cases, whether reformulation will be required is less obvious. For example, with the food additive exemption for natural extractives, oleoresins and essential oils now removed from FDR, it is unclear how Canadian regulators may treat an ingredient that is added for, or simply by its nature has, multiple functions in a food product. In any case, these changes have quickly added new considerations for food manufacturers.
This article originally appeared in Food in Canada and is republished with the permission of the publisher.
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