RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.4 Buffer feeds

Registration of Buffer Feeds for Ruminant Animals

Feeds containing buffering ingredients have been acceptable for registration and have been labelled with the terms "Buffer" or "Buffered" in the brand or feed name providing the directions for use indicated that such feeds were only to be used for ruminants receiving high grain or concentrate rations.

Claims

Previously, claims were not permitted on the label of buffer feeds. As scientific evidence has been submitted to support the nutritional claim "to improve butter fat test in dairy cows" such a claim, for a specific combination of buffer ingredients (see Registration Checklist for Buffer Feeds), has been accepted on a buffer feed label. Other nutritional claims may be accepted provided satisfactory evidence to support the claim is presented with the application for registration.

Ingredient Listing

The name and amount of each ingredient used in a Buffer Feed shall be attached to the application for registration pursuant to sections 8(1) and (2)(b) of the Feeds Regulations. A complete list of ingredients must appear on the label.

Permitted Guarantees

Feeds containing both buffer ingredients and other nutrient sources shall guarantee only the nutrients normally shown for a similar feed not containing buffer ingredients. Labels may also show the actual level of the buffer ingredient(s).

Feeds consisting of a mixture of buffer ingredients shall be registered under the provisions of Feed Article 7 of Table 3 of Schedule 1 of the Feeds Regulations. The actual level of the buffer ingredient(s) may be shown on the label. No other guarantee will be permitted.

Registration Checklist for Buffer Feeds

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name (optional)
• Product name reflecting purpose of the product and the intended ruminant species
• Product claim statement
• Guaranteed analysis:

1. Feeds consisting of a mixture of buffer ingredients:
   • No nutrient guarantees permitted;
   • The actual level of buffer ingredient(s) may be shown on the label.
2. Feeds containing both buffer ingredients and other nutrient source
   • Guarantees for nutrients normally shown for a similar feed not containing buffer ingredients (e.g. sodium from sodium bicarbonate cannot be included in the guaranteed analysis);
   • The actual level of buffer ingredient(s) may be shown on the label.

• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds as required
• Directions for use to permit safe and effective use of feed and must indicate that the feed is to be used for the intended ruminant species receiving high grain or concentrate diets.
• Caution and/or warning statements (if applicable)
• 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 the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds
• Formulation / Ingredients - verify level of ingredients does not exceed maximums per Schedules IV and V.

Scientific Studies

• Scientific studies are not required if the product supplies one of the following: either the recommended levels of Sodium Bicarbonate, or the recommended level of MgO, or the recommended levels for a combination of these 2 mineral salts, pursuant to the "Nutrient Requirements of Dairy Cattle" published by the National Research Council in 1989 (NRC 1989), as follows:
  • Sodium Bicarbonate at 1.2 - 1.6 % of the dairy ration, or 0.6 - 0.8 % of the total diet dry matter
  • MgO at 0.4 - 0.6 % of the dairy ration, or 0.2 - 0.4 % of the total diet dry matter
  • 2 to 3 parts Sodium Bicarbonate mixed with one part MgO at 1.6 - 2.2 % of the dairy ration or 0.8 - 1.2 % of the total diet dry matter.
• If the product supplies less than these recommended amounts or uses other buffer ingredients, scientific studies are required to support the rumen buffering claim for the product when used as directed.
• Studies carried out by qualified personnel
• Suitable methods used in studies
• Studies designed to facilitate statistical analysis
• Data analysed by appropriate statistical methods
• Studies conducted under conditions similar to those that may be expected to occur in Canada
• Studies show a significant difference (P<0.05) between the control and treated groups
• Where results of these studies have not been published in a refereed journal, copies of the raw data and printouts of statistical analysis are required for our review.

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.

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