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T-3-149 - REGISTRATION REQUIREMENTS OF FLAVOURING AGENTS

March 2, 2004

FLAVOURING INGREDIENTS

Single flavouring ingredients must be approved by the Canadian Food Inspection Agency (CFIA) prior to their use in livestock feeds. Prior to approval, each flavouring ingredient is evaluated for safety, and those deemed to be safe are listed in Schedule V of the Feeds Regulations. If possible, a toxicological standard for the maximum concentration of each approved flavouring ingredient allowed in feed is established during the review.

Flavouring ingredients can be found on the Feed's web page of the Canadian Food Inspection Agency’s web site. Any feed ingredient that does not appear on these lists will require approval, as per Trade Memorandum T-3-141(Single Ingredient Feed Evaluation Requirements) and its supplement 1. (Generic Data Requirements for  Safety Evaluations of  Single Ingredients). Information to complete a safety evaluation must be supplied as part of the new ingredient submission.

FLAVOURING AGENTS

All flavouring agents require registration. Flavouring agents are generally made up of flavouring ingredients and facilitating agents and are present in feed at very low levels. Fermentation and other microbial products are generally not considered to be facilitating agents.

Administrative Requirements:

The standard registration requirements include a cover letter, application form, proposed label and the application fee. General administrative information regarding the application for feed registration procedures can be found in Trade Memorandum T-3-20 (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 and/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 flavoring agents, the registrant must also provide the specific gravity of the product. Please note that specific gravity does not have units and should be measured at 20°C.

• The statement "The viscosity of this product will vary inversely with temperature." is required on the label.

Formula:

The product formula, 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. Ingredient levels must not exceed maximums 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 used at the maximum inclusion rate.

Note:

• 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 above 0.1% must be stated within a 10% range of the actual level.

• 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 currently valid.

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

Renewal and Amendment to Registered flavouring agent:

As with all registered products, flavouring agents are registered for a three 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 Trade Memorandum T-3-20 (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 a fee of $302.10. Flavouring agents submitted at the time of renewal with a change in formulation will necessitate the fee of $302.10 for the registration of the new formulation in addition to the renewal fees.

Questions regarding this memorandum may be directed to:

Canadian Food Inspection Agency
Animal Health and Production Division
Feed Section
59 Camelot Drive
Ottawa, Ontario (Canada)
K1A 0Y9

Tel.: 613-225-2342
Fax: 613-228-6614