Process Pre-market notification for a new novel food Pre-market assessment for new substances than (Division B.28.002-3): novel foods and food additives: The manufacturer or importer of the novel food must notify Presently there is no published pre-market assessment the Director (of Health Canada) in writing of their intention to procedure for new substances (other than novel foods and sell or advertise for sale the novel food, with accompanying food additives) for use in infant formula. Specific guidance is information. provided on a case-by-case basis to companies. Within 45 days receiving a notification, the Director will Health Canada also reviews packaging materials for infant review the information and either notify the applicant that the formulas, and this review and approval is considered as a information is sufficient to establish that the novel food is pre-requisite to submitting a pre-market notification for an safe for consumption, or that additional information is infant formula product. necessary in order to assess the safety of the novel food. Within 90 days of receiving the additional information requested the Director shall assess it and, if it establishes that the novel food is safe for consumption, notify the applicant in writing that the information is sufficient. Assessment criteria is outlined in the At present, there is no relevant published guidance for the Data & information Guidelines for the requirements for inclusion Safety Assessment of Novel Foods: pre-market assessment for new substances. However, a in any notification/ pre-market notification for an infant formula product would If a manufacturer/seller of the food wishes for it to be assessment documents: not be accepted by Health Canada unless the following used in infant formula, then evidence for safety in infants is information had been assessed. required. Must show evidence to support safety Must show evidence of efficacy (level/form to Form and amount of the substance in achieving the stated While the novel food regulations are silent on efficacy, a achieve stated purpose) purpose would be considered. notification for an infant formula product must include evidence relied on to establish that the infant formula is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions of use.
Process Pre-market notification for a new novel food (Division B.28.002-3): The manufacturer or importer of the novel food must notify the Director (of Health Canada) in writing of their intention to sell or advertise for sale the novel food, with accompanying information. Within 45 days receiving a notification, the Director will review the information and either notify the applicant that the information is sufficient to establish that the novel food is safe for consumption, or that additional information is necessary in order to assess the safety of the novel food. Within 90 days of receiving the additional information requested the Director shall assess it and, if it establishes that the novel food is safe for consumption, notify the applicant in writing that the information is sufficient. Pre-market assessment for new substances than novel foods and food additives: Presently there is no published pre-market assessment procedure for new substances (other than novel foods and food additives) for use in infant formula. Specific guidance is provided on a case-by-case basis to companies. Health Canada also reviews packaging materials for infant formulas, and this review and approval is considered as a pre-requisite to submitting a pre-market notification for an infant formula product. Data & information requirements for inclusion in any notification/ assessment documents: Assessment criteria is outlined in the Guidelines for the Safety Assessment of Novel Foods: If a manufacturer/seller of the food wishes for it to be used in infant formula, then evidence for safety in infants is required. At present, there is no relevant published guidance for the pre-market assessment for new substances. However, a pre-market notification for an infant formula product would not be accepted by Health Canada unless the following information had been assessed. Must show evidence to support safety Must show evidence of efficacy (level/form to achieve stated purpose) While the novel food regulations are silent on efficacy, a notification for an infant formula product must include evidence relied on to establish that the infant formula is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions of use. Form and amount of the substance in achieving the stated purpose would be considered.
P1028-Consult-SD2-SafetyTechnology.docx