Archived - Proposal – Permissible Claims on Feed Labels

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June 2016

Purpose

The Canadian Food Inspection Agency (CFIA) has embarked on a comprehensive change agenda to strengthen its foundation of legislation, regulatory programs and inspection delivery. This direction has set the context for the renewal of the federal Feeds Regulations (Regulations).

The current modernization of the Regulations is providing an opportunity to review regulatory requirements and policies regarding the inclusion of claims (those that are general, nutritional or performance-related in nature) on livestock feed labels. This proposal identifies an approach for amendments to current requirements and policies regarding the terms under which claims can be included on feed labels.

Current Situation

In Canada, labelling information provided on livestock feed labels, including explicit or implied claims, is subject to requirements of the Regulations and oversight by the CFIA. A claim is considered to be any representation which states, suggests, or implies that a feed or feed ingredient has particular characteristics relating to its origin, nutritional properties, nature, purpose, production, processing, and/or composition, or any characteristic that relates to animal productivity, animal health, food characteristics, food quality or the environment.

Currently, feed manufacturers wishing to include a claim on their livestock feed labels are subject to mandatory registration of the product making the claim and must provide substantiating evidence to support each label claim during the pre-market assessment and authorization process conducted by the CFIA.

Section 28 of the Feeds Regulations provides the regulatory context for claims being permitted on feed labels:

A label shall not contain

1. any variation in the character, size, colour or placing of the printing that obscures or emphasizes any part of the information required to be shown on that label unless such variation is to draw attention to the caution statements or warning statements required to be shown on the label;
2. any incorrect or misleading information or mark;
3. any claim for a mixed feed or any ingredient in the feed unless evidence has been assessed or evaluated and has been found to support the claim; or
4. any claim for a single ingredient feed unless evidence has been assessed or evaluated and has been found to support the claim.

As a result of consultation activities with stakeholders to date and as indicated in the CFIA's November 2013 Feed Ingredient Assessment and Authorization – Regulatory Framework Proposal, the CFIA is redefining its role regarding the oversight of claims for feeds on labels.

Preliminary Consultations

A proposal by the Animal Nutrition Association of Canada (ANAC) for a Risk-Based Framework for Feed Ingredients (January 2013) submitted to the CFIA recommended that a positive list of permissible claims be developed and pre-approved for use with feed ingredients. This list would allow for the use of specific claims without requiring further efficacy assessment. ANAC's proposal was shared and discussed at a multi-stakeholder workshop on feed ingredient assessment and authorization hosted by the CFIA in January 2013. There was general stakeholder support for such an approach to be taken within the scope of a modernized feed regulatory framework.

Amendments to the Feeds Act, by way of the Agricultural Growth Act that came into effect in February 2015, included the addition of a new authority to allow for the incorporation of documents by reference (Section 5.1(1)). Given the potential opportunities this new authority might provide, discussions between the CFIA's Animal Feed Division and ANAC's Nutrition Committee were initiated in May 2015 to consider current regulatory oversight measures for feed (ingredients and mixed feeds) label claims and to identify potential alternatives for a future approach. This preliminary collaboration between ANAC and the CFIA laid the ground work for the establishment of a proposed positive list of pre-approved permissible claims for use on livestock feed labels within the scope of a modernized framework.

Proposal

It is proposed that a Permissible Claims List be developed to allow the labelling of certain ingredients and mixed feeds with claims set out in the list without the need for pre-market assessment and approval by the CFIA of claims on a product-by-product basis.

It is also proposed that the Permissible Claims List would be incorporated by reference in the Regulations, thus providing greater flexibility in amending the document as required. Incorporation of documents by reference is a drafting technique that brings the content of a document into a regulation, without the need to reproduce the document in the regulation itself. The CFIA has developed an Incorporation by Reference Policy to articulate a clear and comprehensive process for identifying documents that could be incorporated by reference. A pathway for adding, modifying, and removing claims on the list in the future will be developed.

When using a claim from the Permissible Claims List, regulated parties would be expected to:

• adhere to the conditions (feed, label, or statement) stipulated in the Permissible Claims List for the specified claim; and
• make information available upon request by customers or the CFIA to demonstrate that their claims are truthful and properly substantiated.

Feeds with labels providing claims set out in the Permissible Claims List would not require registration for approval of the claim. If a regulated party wishes to include a claim that is not on the list, the product would require registration and additional information would be required to support the labelling of the claim.

Appendix I consists of a proposed initial list of pre-approved claims to be permitted on livestock feed labels, the conditions that would have to be met prior to using a pre-approved claim, and general instructions on the use of the Permissible Claims List.

Stakeholders are advised that any label claims or statements which indicate or imply an improved health status would continue to be considered therapeutic in nature, regulated by the Veterinary Drugs Directorate of Health Canada and thus not acceptable as a pre-approved claim on the Permissible Claims List for livestock feeds in Canada (Guidance document on classification of veterinary drugs and livestock feeds).

Anticipated Outcomes

This proposal is favourably aligned with the goal of renewing the Regulations, i.e., to develop a modernized risk- and outcome- based regulatory framework for feeds which:

• provides feed manufacturers and distributors with the flexibility to market their products with permitted claims quickly and effortlessly;
• reduces regulatory burden by not having to register livestock feeds providing certain label claims;
• attains a more effective and efficient balance between fair and competitive trade in the market;
• allows for the list to be updated in a more timely manner, as new claims or statements are requested; and
• safeguards feeds and the food production continuum by allowing the CFIA to maintain enforceable regulatory oversight for health and safety-type claims that may negatively impact human or animal health or the environment.

For claim(s) that may have an adverse animal health effect or food safety risk(or both), where a product fails to perform as claimed, such claims will not be eligible for inclusion on the Permissible Claims List and will continue to require pre-market assessment and registration.

We strongly encourage you to provide your input and feedback, which is critically important to the success of the regulatory modernization initiative. Written comments may be forwarded by July 15, 2016 to:

Sergio Tolusso
Canadian Food Inspection Agency
Animal Feed Division
59 Camelot Drive
Ottawa, ON K1A 0Y9
Email: Sergio.tolusso@inspection.gc.ca
Fax: 613-773-7565

Appendix I – Permissible Claims List

General Instructions for use of Permissible Claims List:

The Permissible Claims List has been sub-divided into three (3) distinct categories based on the type of claims being made:

• General Claims – related to composition or manufacture of the product;
• Nutrition Claims – related to animal nutrition parameters; and
• Performance Claims – related to animal performance.

Column one (1) of the Permissible Claims List (Type of claim) describes:

• the overarching "purpose" of a particular claim.

Column two (2) of the Permissible Claims List (Conditions-Feed) describes:

• the conditions that must be met for the feed in question prior to the use of the associated claim, for example:
  • if the claim indicates that the product contains a specific ingredient, that ingredient must be included;
  • any "source of" claims must provide at least a minimum percentage of the animal's minimum daily requirement as determined by NRC or other publically available scientific data and as listed in Column 2.

Column three (3) of the Permissible Claims List (Conditions-Label) describes:

• any additional requirements (e.g., guarantees for a specific ingredient) that must be included on the product's label, as applicable.

Column four (4) of the Permissible Claims List (Conditions – Approved Statement or Claim) describes:

• the approved wording that must be used for any claim or statement included on the product label;
  • claims must not include modifier words (e.g., very; good; excellent; high in; extra; etc.) before or after, or in association with the claim, unless a specific condition has been set out for that modifier word/phrase.

Any feed label using a claim or statement which is not included in the Permissible Claims List or does not adhere to the conditions for the feed, label or approved wording (stipulated in columns 2, 3 and 4 respectively) would no longer meet the exemption from registration criteria proposed in this document and thus would be required to undergo pre-market assessment of the product to substantiate the claim or statement.

Table 1: General Claims (Related to the composition/manufacture of the product)

	Column 1 Type of Claim	Column 2 Conditions – Feed	Column 3 Conditions – Label	Column 4 Conditions – Approved Statement or Claim
1.	Claims respecting animal products in feeds	Feed may not contain any animal products including fish, gelatin, blood, Vitamins sourced from animals (Vit D), zooplankton, insect meal, etc. Feed must be manufactured in a facility that does not handle any animal products.	Full list of ingredients must be on label. No collective terms.	Manufactured in a facility that does not use any animal products.
2.	Claims respecting medications in feeds	Must be manufactured in a facility that does not use any antibiotics/medications. Feed may not contain antibiotics. Feed may not contain ingredients manufactured using antibiotics such as distillers grains.		Manufactured in a facility that does not handle antibiotics or accept ingredients manufactured with antibiotics.
3.	Unmedicated	Feed may not contain any intentionally added medications. May be made in accordance with the proper sequencing of feeds that contain medications (as per the sequencing guide).		Unmedicated
4.	Highlight presence of ingredient	Must contain the named ingredient. May indicate the purpose of that ingredient as per its approved label or classification in the "Approved List of Feed Ingredients".		Contains XX Contains XX as a [purpose] (e.g., Contains ethoxyquin as an antioxidant).
5.	Phytase (or other enzyme	Must contain the enzyme at the approved use rate.	Guarantee the activity level.	Contains XX (ingredient) as a source of phytase
6.	Organic	The feed must meet all of the conditions of the Organic Products Regulations		Organic Contains x% organic ingredients

Table 2: Nutritional Claims (Related to animal nutrition parameters)

	Column 1 Type of Claim	Column 2 Conditions – Feed	Column 3 Conditions – Label	Column 4 Conditions – Approved Statement or Claim
1.	Source of nutrient (vitamin, mineral, energy, fat, fibre)	The feed must contain the named nutrient at a level that meets at least 10% of the animal's minimum daily requirement. No qualifiers such as "good" "high in" "excellent" may be added to the claim.	The named nutrient must be guaranteed in the guaranteed analysis.	Source of XX
2.	Related to digestibility	Phytases – contains an approved source of phytase at the approved level	Guarantee for phytase on the label	Promotes phosphorus and calcium digestibility
		NSP Enzymes – contains one or more of the following enzymes at the approved level Xylanases B-Glucanases Cellulases Pectinases Proteases Mannases	a) Guarantee for the enzyme on the label	a) Promotes energy and amino acid digestibility
		b) Lecithin – contains lecithin at the approved level	b) Guarantee for lecithin on the label	b) Promotes fat digestibility

Table 3: Performance Claims (Related to animal performance parameters)

	Column 1 Type of Claim	Column 2 Conditions – Feed	Column 3 Conditions – Label	Column 4 Conditions – Approved Statement or Claim
1.	Anionic supplement	Must contain sources of anions. When used as directed results in reduced dietary cation/anion balance (DCAB)	Guarantees for Ca, P, Na, Cl, S. Actual cation/anion balance expressed in mEq/kg. Indicate formula used to determine DCAB (Dietary Cation/Anion Balance). Directions for use to indicate feeding to dry dairy cows during 1 to 4 weeks prepartum.	Contributes to reduction of the risk of hypocalcaemia in dairy cows.
2.	Buffer supplement/feed	Fed to ruminants only. Must contain sources of buffering ingredients; Sodium bicarbonate and/or, magnesium oxide. 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 Two to three 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.	List of ingredients, no collective terms. 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. 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.	"to improve butter fat test in dairy cows" "buffer" "buffered"