RG-1 Regulatory Guidance:
Chapter 1 – Administrative requirements for pre-market assessment and product registration of livestock feed
1.5 Making changes to feed registrations
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Registrants wishing to make a change to a feed registration at any time must first submit an application for an "amendment to registration" with the proposed changes to the AFP for approval using the Application for Feed Registration or Renewal (CFIA/ACIA 0009). Fees charged to registrants for an amendment to the existing terms of a registered product are based on whether the amendment is an "administrative amendment" or if it involves a "significant change", as defined in the Feeds Regulations.
1.5.1 Significant change
Significant change includes any change in:
- the brand of the feed
- the name of the feed
- the type or level of medicating ingredient in the feed
- the guaranteed level of a nutrient, unless the nutrient is listed in Table 4 of Schedule I for the species of livestock for which the feed is intended and both the former and revised guaranteed levels are within the limits set out in that Table for that nutrient
- any statement, phrase or claim appearing on the label that relates to the purpose or function of the feed in general or to any medicating ingredient, nutrient or other ingredient present in the feed
- the directions for the use of the feed; or
- the ingredients present in the feed, if it is a feed required to be labelled with the name of each ingredient as described in the Feeds Regulations (Section 26.(1)(j))
The submission type code 3260 is to be used on the application form for these types of changes. Please note that submission code 3260 is only applicable to the significant changes described in a., b. or c.
Any other significant change, including items d.-g. in the list above, is equivalent to a re-registration for that product type, and the application submitted must use the same submission code and pay the same fee as if it was a completely new application.
1.5.2 Administrative amendment
Any change to the terms of a feed registration not involving a "significant change" is regarded as an administrative amendment. Some examples would be: a company name change, a change of company address, or a registration transfer. The fee for an administrative amendment is $10.00 plus applicable taxes, as per Appendix A.
1.5.3 Amendment fees combined with renewal fees
Fees for administrative or significant changes at the time of renewal are of the sum of the renewal fee plus the applicable application fee. For example:
- if you change the brand name of your registration that is due for renewal, you would select the submission code 3260 + 3259 on the application form and pay the applicable fees
- if you change an ingredient and your registration (flavouring agent) is due for renewal, the submission code would be: 3253 + 3259 + applicable fees for each submission code
- if your company moves to another city and your registration is due for renewal, the submission code would be: 3261 + 3259 + applicable fees for each submission code
Note: All fees are for each registration.
1.5.4 Registrant name and/or address change
If a registrant changes its name and/or address the following is required:
- A letter from the registrant advising us that they are changing their name and/or address. The letter must be signed by an authorized representative currently on file in the AFP or the letter must bear the corporate seal of the company. (In the case of a company acquisition involving a company name change, if the letter is not signed by an authorized representative currently on file, supporting legal documents proving the acquisition must also be supplied).
- An application form for each valid registration owned by the company. The forms must be filled out and signed.
- 3 copies of each label, showing the new name and/or address of the registrant.
- Applicable fees for each registration. If the only change is the registrant's name and address, the fee is for an administrative amendment only. If the change is done at the time of renewal, the fee is in addition to the renewal fee.
Note that the following changes to an address only require a letter from the registrant: box number, suite number, street address and postal code. Application forms, new labels and fees are not required unless the change involves the city.
To ensure that files are kept up to date, the letter advising of the name and/or address change should be sent as soon as the change is known with a note saying that the actual amendment submission (with forms, labels and fees) will follow within X weeks. An acceptable time frame for sending the amendment submission would be 30-60 days.
A current listing of valid registrations may be requested at any time, but can only be provided to an authorized representative with signing authority. It can be requested by emailing the PASO at firstname.lastname@example.org.
A Resident Canadian Agent cannot request the list of valid registrations of a company unless he or she is also on the signing authority list for the company.
1.5.5 Changes to signing authority or resident canadian agent
The AFP must be advised immediately of any changes to the signing authority list or Canadian agent(s). In general, there are no fees for changes to the signing authority list and/or Canadian agents, unless if this results in a change to the information that appears on your registered label. For more information, please consult subsection 1.2.3 above.
1.5.6 Transfer of a registration
A registration may be transferred from one registrant to another. The following is required:
- A letter from the current registrant advising us that they are transferring the registration(s) and all data associated with it/them. The letter must be signed by an authorized representative currently on file with the AFP, or the letter must bear the corporate seal of the (current) company.
- A letter from the new registrant advising us that they are taking over the registration(s). This letter must be signed by an authorized representative on file with the AFP. If this registrant does not already have a file opened with the AFP, they must establish signing authority as outlined above.
- An application form for each registration to be transferred. The form must be filled out and signed.
- 3 copies of each label, showing the company name and address of the new registrant.
- Applicable fees for each registration. If the only change is the registrant name and address, the fees are for administrative amendments only.
Any other changes (for example brand name, ingredients, nutrient levels) are considered significant changes and the applicable fees will differ, depending on the extent of the change.
If the transfer is done at the time of renewal, the fee is in addition to the renewal fee.
If the change to the registration/label involves the company name or address and a significant change, both amendment fees are required (administrative and significant).
The transfer letter must list the products by registration number and by name and it needs to state that "the registration and all related data are to be transferred".
This type of amendment package needs to be sent in one complete submission.
Amendments to private labels
Applications for amendments to private label registrations will be evaluated on a case-by-case basis according to the following criteria:
1.5.7 Mandatory amendments
For mandatory registration amendments (that is amendments initiated by the AFP), the AFP will inform all holders of a registration for the type of product affected by the amendment, including private label registrants. Mandatory amendments must be made to both private labels and parent product labels. There will be no charge for such amendments.
In cases where an application is made for a private label for which the status of the original product registration would not satisfy new mandatory requirements (due to concerns with efficacy and/or safety data), the private label application will be refused until the original product meets all registration requirements. The holder of the original registration will be notified of the situation.
Minor mandatory amendments required by the AFP will be made to a private label product immediately upon registration or registration renewal, even though the label for the parent product may not yet comply with the new amendment. In these cases, the private label will be corrected before the original product label. Minor mandatory amendments to the original label will be made at the time of renewal or when an application for significant change is submitted to the AFP.
1.5.8 Voluntary amendments
When the original registrant is granted an amendment (for example revised guarantee, addition of a claim, changes in the formulation), the original registrant is responsible for notifying the private label registrant(s) of these amendments. In such cases, private label registrants are not obliged to update their registration to reflect the change(s) made to the original registration as long as the private label continues to comply with the Feeds Regulations. However, should the private labelling company choose to include the new information, an application package for a significant change must be submitted.
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