T-4-125 - Notification of Source Change - process and timelines
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The Canadian Food Inspection Agency (CFIA) recognizes that availability and prices of ingredients and primary materials used in the manufacture of fertilizers and supplements fluctuate in the marketplace thus necessitating changes in suppliers and/or sources. However, Section 7 of the Fertilizers Regulations states that "No change in the label, chemical composition or ingredients of a fertilizer or supplement that is registered shall be made unless the registration is changed accordingly". In accordance with the current procedures and definitions in the CFIA Fees Notice, a change in the source of an ingredient or primary material requires a major amendment (AM) to the product registration. Major Amendments are associated with a fee of $350 + Ontario HST (13%) and may take up to 530 working days to approve if three reviews are required and the company does not respond promptly to CFIA information requests. In addition, product proponents are not permitted to change sources until the review of the AM has been completed and the change(s) have been approved by the CFIA. An AM may be submitted at the time of re-registration; however, additional fees are applicable if a full safety review is required. The processing of an AM between registration periods results in a new registration fee and an altered expiry date for the product registration (36 months from the date registration is amended).
|Submission Type||Pre- Screening||Registrant Response Time||1st Review/ Queue time||Registrant Response Time||2nd Review/ Queue time||Registrant Response Time||3rd Review/ Queue Time||Total|
Due to lengthy processing times and the cost associated with Major Amendments, manufacturers frequently change sources of ingredients either prior to obtaining CFIA approval or without notifying the CFIA at all. This, is a contravention of the Fertilizers Regulations and may have implications on the safety of the final fertilizer or supplement product. This is of particular significance as some ingredients originating from developing markets may prove to be of low quality and/or be contaminated with substances of concern (both biological and chemical) that ultimately jeopardize the safety and performance of Canadian fertilizers and supplements.
In order to promote industry compliance with the Fertilizers Act and Regulations and encourage notification of any changes in source of ingredients, the Fertilizer Safety Section has introduced a new submission category (Notification of Source Change or NSC). These applications would be processed free of charge and in accordance with a new service delivery standard of 30 days. The outcome of the NSC review may be either Approval or Request for Major Amendment:
- Approval. Approvals of the NSC without further review will be granted if the change in the source of ingredient(s) does not pose any concerns with respect to the safety or identity of the final fertilizer or supplement product. A note will be added to the product file indicating that the new source has been reviewed and is deemed acceptable.
- Request for Major Amendment. Changes in source of ingredients that may impact the safety or identity of the fertilizer or supplement product will require more detailed review by the CFIA and, potentially, submission of supporting data. In these cases, NSC will not be approved and proponents will be directed to submit for an AM prior to implementing the change in source.
Each NSC application must include:
- a cover letter clearly explaining the intent of the submission;
- all new sources;
- MSDS and CAS numbers for the ingredients that have changed source(s) if available; and
- a scientific rationale clearly demonstrating that the change(s) in source does not negatively impact the safety or identity of the final fertilizer or supplement product.
Moving to this format is believed to encourage companies to comply with the requirement to notify the CFIA prior to changing sources of ingredients, and also improve tracking of sources and primary materials used in the manufacture of fertilizers and supplements in Canada. In addition to the new submission type that allows for more expeditious and streamlined process of approving changes to ingredient sources, the Fertilizer Safety Section encourages companies to submit a list of all potential suppliers of ingredients at the time of registration or re-registration. Product proponents who provide this type of information at the time of registration or re-registration will not be required submit an NSC or AM when switching between any of the pre-approved suppliers or sources.
Please note that the NSC submission type is reserved for changes in sources or suppliers of ingredients only and a Major Amendment will still be required for any other change made to the product, unless it pertains to:
- the name or address of the registrant;
- the colour or format of the label;
- the product name.
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