RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.8 Flavouring agents

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Registration requirements of flavouring agents

Flavouring ingredients

Single flavouring ingredients must be approved by the CFIA prior to their importation, manufacture, or sale, for use in livestock feeds. The approval process consists of an evaluation of each flavouring ingredient, and single flavouring ingredients that are approved and listed in Schedule V, Part I or II, of the Feeds Regulations. If possible, the maximum concentration of the ingredient to be used in feeds is established during the review.

Flavouring ingredients can be found listed in Schedule V of the Feeds Regulations, available on the Feed Program's web page on the CFIA web site. A number of flavouring ingredients are also listed in Schedule IV. Any feed ingredient that does not appear on these lists requires approval, as per Chapter 2.3 and 2.4 (Single Ingredient Feed Evaluation Requirements). Information to conduct a complete safety evaluation must be supplied as part of the new flavouring ingredient submission.

Flavouring agents

All flavouring agents require registration. Flavouring agents are generally made up of flavouring ingredients and facilitating agents, and they are present in feed at very low levels. Both flavouring and facilitating agents must be listed in either Schedule IV or V of the Feeds Regulations. Typical inclusion rates for flavouring agents are 100-1,000 g/tonne (ppm) of complete feed, with maximum levels of 3,000 g/tonne. Common flavouring ingredient levels range from 10 to 50 ppm in complete feed, while maximum use levels seen are approximately 100 ppm. When formulating a flavouring agent product, please ensure that a maximum inclusion rate for the product is selected such that none of the individual flavouring ingredients exceed their specified maximums in complete feed as per Schedule V of the Feeds Regulations, and no individual flavouring ingredient exceeds 100 ppm in complete feed.

Recognized facilitating agents (commonly called "carriers") for flavouring agents include, but are not limited to, corn, wheat, silicon dioxide, sodium carbonate, propylene glycol, and ethyl alcohol. Please note that fermentation products, and other feed ingredients such as sodium bentonite, calcium bentonite, montmorillonite clay, sepiolite, zeolite ore, or microbial products, are not considered to be acceptable facilitating agents. This is not a complete list, but it identifies the products commonly misused as carriers in flavour formulations.

Administrative requirements

The standard registration requirements include a cover letter, application form, proposed label, product formulation, and the application fee. General administrative information regarding the procedures for application for feed registration can be found in Chapter 1 (Application for Feed Registration and Ingredient Approval).

Labelling

The proposed label must include the product name, reflecting the purpose of the product and the intended species; a complete list of ingredients by generic name, as listed in Schedule IV or V of the Feeds Regulations; registration numbers for any Part II ingredients or mixed feeds included in the formulation; directions for use to permit safe and effective use of the feed; a cautionary or warning statement (if applicable); the net amount (metric measure); and the name and address of the registrant.

Requirements for flavouring agents containing sodium saccharin

A list of each intended species is required in the product name rather than stating the term "livestock" (e.g., "Flavouring agent for non-lactating dairy cattle, beef, sheep, poultry and swine feeds");
The following cautionary statement is required on the label: "This product contains sodium saccharin, a non-nutritive sweetener which shall not be used in lactating dairy feeds".

Additional labelling requirements for liquid flavouring agents

For liquid flavouring agents, the registrant must provide the specific gravity of the product. Please note that specific gravity does not have units and should be measured at 20°C.
The following statement is required: "The viscosity of this product will vary inversely with temperature".

Product formulation

The product formulation, listing the amount of each ingredient by generic name as per Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds, is required. The amounts of the individual ingredients in the formulation may be presented as percentages totalling 100%, or amounts comprising a total of 1,000 kg (1 tonne) of the product. Ingredient levels must not exceed maximums in complete feed as per Schedules IV and V. The applicant should include calculations verifying that the concentration of each ingredient in the flavouring agent does not exceed their respective maximum tolerance levels when the product is used at the maximum inclusion rate.

Example calculation:

Proportion of ingredient A in flavouring agent product [2%] × maximum inclusion rate of flavouring agent product in complete feed [200 g/tonne] = inclusion rate of ingredient A in complete feed [= 4 g/tonne complete feed (or 4 ppm)]

Notes:

some maximums are specified as GMP or "Good Manufacturing Practices" in Schedule V of the Feeds Regulations. Ingredients marked with this term must be employed at a level which is appropriate for the purpose, i.e., a typical use level. As mentioned above, they must not exceed the specified 100 ppm maximum in complete feed. The same policy applies to ingredients where the maximum is specified as "". Information on typical levels may be obtained from a recognized flavour reference (e.g., Fenaroli's Handbook of Flavour Ingredients).
all ingredients present in the flavouring agent must be stated on the formulation statement. No "and/or" statements are permitted.
all ingredients present at a level of 0.1% or below may be declared as a range between 0% and 0.1%, but must not be 0%.
the safety evaluation of ingredients for which a formulation range is provided will be performed using the upper limit stated in the formulation range.
if the formulation lists previously registered products as ingredients, the registrant must ensure that these registrations are valid at the time of registration or renewal.

All formulations are treated as confidential and are protected as outlined under the Canadian Access to Information and Privacy Act.

Renewal and amendment to registered flavouring agent

As with all registered products, flavouring agents are registered for a 3-year period, renewable by March 31 of the third year after the registration date. All application(s) for renewal or amendment to a registered feed must be accompanied by an application form, appropriate fees, labels as per Chapter 1 (Application for Feed Registration and Ingredient Approval), and complete product formulation. Additional information may be requested if safety concerns emerge between the time of registration and renewal.

Changes made to the formulation of approved flavouring agents are considered new registrations and require the applicable fee (see Chapter 1). Flavouring agents submitted at the time of renewal with a change in formulation will necessitate payment of the fee for the registration of the new formulation in addition to the renewal fees.

Product claims

Flavouring ingredients listed in Schedule V of the Feeds Regulations are approved as non-nutritive ingredients for use in livestock feed. Please be aware that products intended to prevent, mitigate or treat disease, or restore, correct or modify organic function in animals, may be considered drugs rather than feeds in Canada and are regulated by the Veterinary Drugs Directorate (VDD) at Health Canada.

For more information please contact VDD at:

Veterinary Drugs Directorate
Health Canada
Tower A
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address Locator - 3000A

Registration checklist for flavouring agents

Administrative registration requirements

Completed application package per Chapter 1

Proposed label

brand name (optional)
product name reflecting purpose of the product and the intended species

Note: Flavouring agents containing sodium saccharin need to list each intended species in the product name instead of stating the term "livestock". Non-lactating dairy may be included as one of the intended species.

complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations including valid registration numbers for Part II ingredients or mixed feeds as required
directions for use to permit safe and effective use of feed
liquid flavouring agents require the following additional information on the label (see section 4.2):
- - specific gravity - the reference point temperature for specific gravity is measured at 20°C. Please note that specific gravity does not have units.
- - the statement "The viscosity of this product will vary inversely with temperature."
caution and/or warning statements (if applicable)

Note: If product contains sodium saccharin then the following cautionary statement is required: "This product contains sodium saccharin, a non-nutritive sweetener which shall not be used in lactating dairy feeds".

name and address of registrant
net amount (metric measure)
registration number (to be added)

Product composition

formulation / percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of Feed Regulations including registration numbers for Part II ingredients or mixed feeds
verify the level of ingredients when used at the maximum inclusion rate to ensure each ingredient does not exceed maximums per Schedules IV or V.

Note: As per the Registration Requirements of Flavouring Agents (see above), flavouring agents should consist of only flavouring ingredients and facilitating agents. Fermentation and microbial products are not considered to be facilitating agents.

Promotional claims (including internet and advertising)

consistent with stated purpose of product

Note: Further information may be required after a review of the preliminary submission.

Sample label: flavouring agent

Brock's Flavour-Ade
Flavouring Agent for Swine, Beef, Poultry, Horse,
Sheep, Goats and Non-lactating Dairy Feeds

Registration No.: (to be added)

Ingredients

Vanillin, butyric acid, fenugreek seed extract, sodium saccharin, fine ground corn cobs dehydrated

Directions for Use

Use 500 to 1000 ml per tonne of complete feed.

Caution

This product contains sodium saccharin, a non-nutritive sweetener, which
shall not be used in lactating dairy feeds.

The viscosity of this product will vary inversely with temperature.

Lot No.: AA205/01

Net Volume: 20 L

Specific Gravity: 1.10 @ 20°C

Registered by:

Brock's Flavours
24 Cherry Drive
Blueberry, Ontario
N0M 1T0

Sample Label: Flavouring Agent

Confidential Formula