Last November, Health Canada proposed regulations to amend the definitions of agricultural chemical and food additive which would recategorize essential oils, oleoresins, and natural extractives as food additives.
Currently, the definitions of both agricultural chemical and food additive in the FDR (B.01.001 [1]) exclude spices, seasonings, flavouring preparations, essential oils, oleoresins, and natural extractives. But if the proposed regulation is enacted, the references to essential oils, oleoresins, and natural extractives would also be removed.
If the proposed amendment is enacted as proposed, food that is currently on the market containing these may be prohibited from sale under the Food and Drug Regulations, and subject to pre-approval. That means that manufacturers wishing to use, or continue use of, any of these as food additives would need to request permission from Health Canada, through the agency’s food additive submission pre-market review process. The submissions would need to include administrative information, chemical safety, assessment of potential dietary exposure for the general population, toxicological safety, allergenic safety, nutritional safety, molecular biological and microbiological safety, additional considerations, and proposed food additive label.
Once submitted, a scientific evaluator in the Food Directorate’s Bureau of Chemical Safety (BCS) coordinates the scientific screening and evaluation of the submission against the requirements of section B.16.002 of the Food and Drug Regulations. The scientific screening is completed in 55 calendar days. If information needed to start the review is missing, the Food Directorate will request the information be submitted within 15 calendar days. During the review, clarification of specific information may be requested, and consultation may be required with appropriate stakeholders who will be affected by any proposed regulatory changes arising as a result of an acceptable food additive submission. The time needed for completion of the submission can be affected by the number of consultations needed, along with the initial quality and completeness of the submission, and the timeliness of petitioner responses to requests for clarification.
If, however, an essential oil, oleoresin, or natural extractive were to be used as a flavouring preparation, it would continue to be excluded from the definition of a food additive, as paragraph (c) will continue to exclude flavouring preparations from the definition.
Although Health Canada initially requested comment by February 2024, the proposal is still pending with some recent industry awareness of and engagement on it. So impacted businesses may want to provide comment in case they are still being reviewed.
