Permissible Claims on Feed Labels Proposal
Consultation Summary – Respondent Comments and CFIA Responses
June 13, 2016 – July 15, 2016
Table of contents
- About the Consultation
- What We Heard
- Next Steps
The Canadian Food Inspection Agency (CFIA) has embarked on a comprehensive change agenda to strengthen its foundation of legislation, regulatory programs and inspection delivery. These directions set the context for the renewal of the Feeds Regulations (Regulations).
The goal of modernizing the Regulations is to reduce compliance burden and support innovation, while ensuring feeds are safe and contribute to the production and maintenance of healthy livestock, safe foods of animal origin, and that they do not pose a significant risk to the environment. The modernization of the Regulations is being designed to benefit the collective Canadian feed industry, which includes livestock producers, commercial feed manufacturers, retailers, importers, exporters, ingredient manufacturers, and food processors. As well as aligning with other international feed regulatory regimes, modernization also maintains the objective of enhancing animal health and food safety for the Canadian public.
The oversight of claims on feed ingredient and mixed feed labels is just one aspect of the Regulations that is being reviewed as part of the modernization project. Currently, feed manufacturers who want to include a claim on their livestock feed labels are subject to mandatory registration of the product and must often provide substantiating evidence to support each label claim as part of a CFIA pre-market assessment and registration process. The CFIA is redefining its role regarding the oversight of general, nutritional, performance, and other claims for feeds on labels that do not have health or safety implications to livestock or food production, and recognizes that pre-market registration represents a cost and compliance burden to regulated parties.
In responding to a suggestion from the Animal Nutrition Association of Canada and following some preliminary collaboration with association members, the CFIA undertook a consultation from June 13, 2016 to July 15, 2016 on a proposal to allow pre-approved ("permissible") claims on feed labels as an alternative approach to the current regulatory oversight requirements.
This report consolidates and summarizes the comments received on the permissible claims on feed labels proposal and the CFIA's response to those comments.
The CFIA would like to thank everyone who participated in the consultation for contributing their time to the consultation process and sharing their views.
About the Consultation
The primary mode of consultation involved the preparation and posting of the Proposal – Permissible Claims on Feed Labels – on the CFIA website, and outreach directly to industry stakeholders, government partners and CFIA staff. Thirty-one (31) sets of written comments were received in response to the permissible claims proposal.
What We Heard
|Category of Respondent||Distribution|
|Feed Industry – Individual||11|
|Feed Industry – Association||9|
|Livestock Producer – Individual||0|
|Livestock Producer – Association||2|
|Other Feed Inputs||2|
|Government (Canadian Federal/Provincial)||7|
The feed industry association comments represent Canadian and American commercial feed manufacturers, as well as some larger feed ingredient supplier organizations. The Canadian feed manufacturers association represents 90 percent of commercial feed manufactured in Canada, while the US association represents about 75 percent of commercial feed manufactured in the US. The "Other Feed Inputs" listed in the table above were comments from an industry consulting firm and a US-based animal health company dealing primarily with concentrated medicated products.
Key Respondent Messages
There was considerable interest among respondents regarding the alternative oversight approach presented in this proposal. Respondents indicated they agreed with the concept of allowing pre-approved statements or claims on feed labels and felt it would:
- provide greater flexibility and efficiency in labelling feeds with claims;
- support industry's need to communicate with their customers; and,
- reduce regulatory burden by eliminating mandatory registration requirements.
While stakeholders provided many suggestions for improvement regarding the content of the approved statement list, the CFIA did not receive any comments indicating an outright disagreement with the proposed concept.
Very few comments were received from livestock producers or their associations; however, the limited comments the CFIA did receive focused mostly on the importance of the CFIA maintaining oversight for label claims to ensure their appropriate use in the market.
Feedback on Proposed Categories and Claims
The proposal presented a number of claims and associated conditions of use, grouped into three (3) categories:
- General Claims;
- Nutritional Claims; and
- Performance Claims
The CFIA has an objective to align, to the extent possible, feed claims that relate to food claims where animal production/husbandry practices contribute to the truthfulness/accuracy of claims on food products (such as "raised without the use of antibiotics", or "Fed no" or "Raised without" animal products, etc.). The guidelines on natural claims, feed claims, antibiotic and hormone claims for food can be found in CFIA's Food Labelling Guidance to Industry, Method of Production Claims for Meat, Poultry and Fish Products.
The following sections of the report outline the respondent feedback and the CFIA's responses to the categories and specific claims proposed. While the CFIA did not specifically invite stakeholders to provide suggestions on additional claims in the proposal, some were provided and these are discussed in the following sections as well.
Table 1 of Appendix I of the proposal consisted of an initial list of pre-approved claims to be permitted on livestock feed labels relating specifically to the composition or manufacture of the feed.
Claims respecting animal products in feeds
With respect to the pre-approved statement, "Manufactured in a facility that does not use any animal products" presented in Table 1, the proposal suggested that the feed must not contain any animal products including vitamins sourced from animals (e.g. Vitamin D) and that feed must be manufactured in a facility that does not handle any animal products. Eleven (11) respondents suggested that the conditions outlined for the use of this claim should be amended. Respondents indicated concern regarding a facility's ability to meet the proposed conditions, given that the addition of Vitamin D in livestock rations is essential; however, a legally approved non-animal source of vitamin D is not yet available in Canada for livestock other than poultry. They went on to further suggest that Vitamin D no longer be considered an animal product under the Regulations. Respondents felt that the conditions, as defined, would require a facility to be dedicated to the manufacture of feeds without animal products or by-product ingredients in order to be able to use this claim, given that there are no clean out provisions suggested in the proposal.
Additionally, respondents provided several suggestions for amending the approved statement or claim to improve clarity, including:
- "Manufactured in a facility that does not use any mammalian/avian products";
- "Manufactured in a facility that does not use any animal products or by-products";
- "Contains only plant-based proteins" or "Manufactured in a facility using only plant-based ingredients"; and
- "No products of animal origin"
The CFIA recently revised the food label guidance document, Method of Production Claims for Meat, Poultry and Fish Products, to allow an exception for products containing Vitamin D3:
"An exception to the above is that for swine and ruminants, until a legally approved non-animal source of vitamin D3 is available in Canada for use in feed, a meat product of these species fed vitamin D3 derived from lanolin of sheep's wool may bear these claims (e.g. "Fed no animal by-products"), as long as a statement is added to inform the consumer of the source of vitamin D3."
In an attempt to align with CFIA policy, where possible, and to increase flexibility for industry to use this claim, the same exception will be adopted for livestock feed labels. Until a CFIA-approved, non-animal source of vitamin D3 is available in Canada for use in feed, labels for swine and ruminant feed containing vitamin D3 derived from lanolin of sheep's wool may bear the approved claim, as long as a statement is added to inform the consumer of the source of vitamin D3.
It is important to note that the allowance mentioned above is only applicable to the use of this approved claim on livestock feed labels. Animal food products containing lanolin-derived Vitamin D will continue to be subject to all regulatory requirements outlined in the Health of Animals Regulations. No further changes with respect to the classification of Vitamin D as an animal product is being proposed in the Regulations at this time.
The CFIA appreciates the suggestions provided from respondents regarding the approved statement and commits to amending the statement to read, "Manufactured in a facility that does not use any animal products or by-products", to ensure clarity and consistency with the use of approved claims on livestock feed labels.
Claims respecting the absence of medications in feeds
With respect to the pre-approved statement, "Manufactured in a facility that does not handle antibiotics or accept ingredients manufactured with antibiotics" presented in Table 1, the proposal suggested that the feed must be manufactured in a facility that does not use any antibiotics/medications and feed may not contain ingredients manufactured using antibiotics such as distillers' dried grains. Four (4) respondents felt that the conditions proposed for this claim should be amended to remove the specific reference of distillers' dried grains (DDGs) considering they are not medicated feeds and the antibiotic products used at the facilities are not viable or active in the final feed ingredient. Furthermore, it was suggested that as long as a facility could obtain a certificate of analysis demonstrating that there are no antibiotic residues in the product, DDGs should not be considered as an ingredient manufactured with antibiotics for the purpose of this claim.
In addition, respondents felt that a provision should be provided to allow for proper sequencing and flushing procedures, rather than the stipulation that medications not be used or handled in the facility at all.
With respect to the pre-approved statement, "Un-medicated" presented in Table 1, the proposal suggested that the feed may not contain any intentionally added medications, but may be made in accordance with proper sequencing procedures. Two (2) respondents indicated that the use of the term "un-medicated" should be amended to "non-medicated" to better align with industry terminology. Furthermore, two (2) additional respondents considered the use of the approved statement, "un-medicated", redundant and suggested that it should be removed from the proposed list of permissible claims.
The CFIA agrees with the respondents that a specific feed type should not be identified in the conditions section for the approved claim and thus will remove the reference to distillers' dried grains.
Purchasers have a reasonable expectation that food products containing the label claim, "Raised without the use of antibiotics", would be free of antibiotics and their residues. As a result, it seems appropriate that the facility manufacturing livestock feeds for these animals would not be permitted to use or handle any antibiotics. To increase the flexibility of this approved claim, the CFIA commits to removing the term "medications" from the conditions so the use and handling of medications – other than antibiotics, hormones or ß-agonists – will not prohibit the application of this approved claim.
In an attempt to further align feed claims which relate to food claims, the CFIA will include an additional approved statement to be used on livestock feed labels, that is, "Manufactured in a facility that does not handle hormones or ß-agonists or accept ingredients manufactured with hormones or ß-agonists." The conditions that must be met prior to a facility applying this claim on livestock feed labels will align, to the extent possible, with the conditions for food claims and will be outlined in the document submitted as part of the formal Canada Gazette Part I publication.
The CFIA agrees with the respondents that the use of the statement "un-medicated" is redundant and will remove it from the proposed approved claims list.
Highlight presence of ingredient; Phytase (or other enzyme) and Organic
With respect to the pre-approved statement, "Contains [ingredient name]" or "Contains [ingredient name] as a [purpose statement]" presented in Table 1, the proposal suggested that the feed must contain the named ingredient. Three (3) respondents felt additional conditions were necessary for this approved claim, such as:
- specify a minimum level that must be present where the claim is verifiable and supported by science;
- amend the approved statement or claim to read "Contains XX in approved amounts"; and,
- the label conditions should require a guarantee for the presence of XX.
With respect to the pre-approved statement, "Contains [ingredient] as a source of phytase" presented in Table 1, the proposal suggested that the feed must contain the enzyme at the approved use rate. Six (6) respondents commented on this aspect of the proposal, suggesting the following amendments:
- specify a definition of activity, e.g. "Guarantee the activity level and the definition of the unit of activity";
- clarify whether the approved level refers to the manufacturers recommended rate or a rate approved by CFIA;
- amend the approved statement or claim to read "Contains XX as a source of enzyme"; and,
- clarify if the XX (ingredient) is the brand name or the strain of phytase.
With respect to the pre-approved statement, "Organic" presented in Table 1, the proposal suggested that the feed must meet all the conditions of the Organic Products Regulations (OPR). Two (2) respondents suggested the following:
- include an additional claim for "Approved for use in organic feed"; and,
- this item is not needed, as there is already an entire certification program regulating organic claims.
The approved statement with respect to highlighting the presence of an ingredient is meant to allow manufacturers the flexibility to indicate to their purchasers that a specific ingredient has been included in the feed they are purchasing. While the statement must be truthful, verifiable and accurate, the use of this approved claim is meant solely for identifying the presence of the ingredient and is not meant as a guarantee of a specific amount of that ingredient. These types of claims may be captured when using the approved statement "Source of XX", as outlined in the Nutritional Claims section of the proposal.
While there exists a universal analytical method for determination of the phytase activity guarantee, manufacturers/registrants are also permitted to use their own analytical method as long as the supporting data submitted during the registration process demonstrates the methodology being used supports the amount being guaranteed. As a result, there are currently no requirements for a standardized definition of the unit of activity to be included on labels containing phytase guarantees.
As part of the document submitted in the formal Canada Gazette Part I publication, the CFIA commits to providing additional clarification with respect to the conditions regarding the use of the approved statement "Contains XX ingredient as a source of phytase". Most notably, the final document will clarify that it is the manufacturers' approved use rate that must be followed when using this approved statement. In addition, and as suggested by respondents, the source of the phytase product will be required to be displayed on the livestock feed label as part of the approved statement, for example:
- Contains 6-phytase produced by Arffung japonica as a source of phytase; or
- Contains Pluto AJ 10000 MPA22 (Registration # 123456) as a source of phytase. Phytase is an enzyme that increases availability of phytin-bound phosphorus in pig and poultry feeds.
While the brand name of the phytase product will also be permitted to be displayed on the label, it will be voluntary, for example:
- Digital Digit Sky Phytase – Contains 6-phytase produced by Arffung japonica as a source of phytase; or
- Palm Pamps Phytase – Contains Pluto AJ 10000 MPA22 (Registration # 123456) as a source of phytase.
The Organic Product Regulations, 2009 (OPR) stipulates the standards for products, including feed, when using the organic claim or displaying the Canada Organic logo on the product label. Any changes to this regulatory requirement, including additional claims, are outside the scope of this proposal. While there is currently a robust certification and inspection program in place for organic products in Canada, the scope of these regulations domestically apply exclusively to inter-provincial sale. As a result, livestock feeds sold solely within a province and labelled as organic currently require mandatory registration with CFIA to substantiate that claim. The addition of "Organic" on the approved claim list will allow increased flexibility and reduce regulatory burden for those producers selling organic products intra-provincially.
Table 2 of Appendix I of the Proposal presented an initial list of pre-approved claims to be permitted on livestock feed labels relating specifically to animal nutrition parameters of the feed.
Claims respecting source of nutrient and digestibility
For labels to carry the approved statement "Source of XX" the proposal suggested that the feed must contain the named nutrient at a level that meets at least ten (10) percent of the animal's minimum daily requirement. Of the six (6) respondents who commented on this aspect of the proposal, four (4) raised concerns with respect to the 10 percent standard, requesting that clarity be provided regarding the source, e.g. National Research Council (NRC). Another respondent commented that 10 percent is not an adequate minimum to define a major nutrient source.
In addition, two respondents suggested that amino acids should also be included in the list as claims for sources of nutrients.
For labels to carry the approved statement related to digestibility the proposal suggested that the feed must contain the approved source of the enzyme. The respondents commenting on this aspect of the proposal suggested amendments to the proposed conditions, such as:
- clarify the required units to be declared;
- expand the approved statements to include "promotes digestibility of XX [specific substrate]", for example, " xylans for xylanase, present in feed"; and,
- include the following 4 classes of enzymes:
- Carbohydrases – promotes energy digestibility
- Lipases – promotes fat digestibility or energy digestibility
- Proteases – promotes protein digestibility
- Phytases – promotes phosphorus and calcium digestibility
To ensure the accuracy of the claim and to align as closely as possible with other regulatory agencies/jurisdictions, the CFIA will introduce a threshold level of 25% of the animal's minimum daily requirement for stakeholders wanting to utilize the approved statement "Source of XX". The ability to incorporate this approved statement on a livestock feed label would require the feed in question to contain the named nutrient at a level that meets 25% of the animal's minimum daily requirement, as defined by the National Research Council (NRC) (2012). For example,
- the NRC minimum value for zinc in swine (lactating/gestating sows) rations is currently set at 100 mg/kg, thus for a label to include a "Source of zinc" statement on their livestock feed label, the feed must contain a minimum of 25 mg/kg of zinc, i.e. 25% of the NRC daily requirement minimum standard.
The CFIA commits to further defining the conditions regarding the use of the approved statement "Source of XX" by clarifying this reference as part of the document submitted in the formal Canada Gazette Part I publication.
The use of the approved statement "Source of XX" will not be permitted for amino acids at this time. Considering that minimum requirements for all amino acids across all species have yet to be established by the NRC, validating the conditions for the acceptable use of the statement, i.e. the feed contains 25% of the animal's minimum daily requirement of the stated nutrient, would be challenging. Alternatively, a facility may wish to use the "Contains [ingredient name]" or "Contains [ingredient name] as a [purpose statement]" presented in Table 1 to highlight the presence of an amino acid.
Regarding the nutritional claim relating to digestibility and enzymes specifically, the CFIA agrees that additional flexibility could be achieved by including additional classes of enzymes in the conditions that must be met. As a result, the current list of specific enzymes included in this section of the document will be replaced with the following enzyme classes and associated claims:
- Carbohydrases – promotes energy digestibility
- Lipases – promotes fat digestibility or Lipase is an enzyme that hydrolyzes lipids
- Proteases – promotes protein digestibility
- Phytases – promotes phosphorus and calcium digestibility
Table 3 of Appendix I of the Proposal presented an initial list of pre-approved claims to be permitted on livestock feed labels relating specifically to animal performance parameters of the feed.
Claims respecting anionic and buffer supplement
For labels to carry the approved statement "Contributes to reduction of the risk of hypocalcaemia in dairy cows", the proposal suggested that the feed must contain sources of anions and reduce dietary cation/anion balance. A respondent requested clarity regarding the term "Anionic supplement" stating the required guarantees identified in the proposal consisted of anions and cations, and as a result they suggested that the "Type of claim" should state "Anion/Cation supplement" or "DCAB [Dietary Cation Anion Balance] supplements". In addition, another respondent suggested using a stated range of DCAB instead of the actual cation/anion balance.
For labels to carry the approved statement "To improve butter fat test in dairy cows" or "Buffer" or "Buffered", the feed must contain sources of buffering ingredients at specified levels. One respondent commented that the list of buffering ingredients is not sufficiently broad as it does not encompass many of the common buffering agents used (e.g. sodium sesquicarbonate). This respondent also suggested that the inclusion levels detailed in the "conditions" should be removed since this does not pose a food safety risk.
The CFIA appreciates the suggestions provided from respondents regarding the "Type of Claim" wording currently proposed in the document and commits to amending the title to read, "Anion/Cation supplement", to ensure clarity and consistency with the use of approved claims on livestock feed labels.
The CFIA agrees with the suggested revision of including sodium sesquicarbonate to the list of buffering agents. In addition, the CFIA also agrees that the conditions for buffering agents outlined in the proposal are not linked to health and safety requirements, and will therefore remove them from the document submitted in the formal Canada Gazette Part I publication.
Process to update document
Comments from respondents were also received regarding the policy and procedures for this document to be incorporated by reference in the Regulations. Seven (7) respondents requested clarification from CFIA regarding the procedures to update or amend the approved statements or claims in this proposal, including:
- the data required to substantiate a claim;
- if a user of a permissible claim can use existing data for substantiating the claim; and,
- whether a claim must be relevant to all target species in order to be used.
In keeping with the CFIA's Incorporation by Reference Policy, the CFIA will provide a plan regarding the frequency and process for the review and revision of the incorporated document as part of the formal Canada Gazette Part I publication. Respondents will be provided the opportunity at this time to review and provide additional comments on the proposed procedures.
In addition to the suggested improvements provided from stakeholders mentioned above, the CFIA received a number of additional recommendations to be included as approved statements, which are listed below.
Respondents suggested adding the following general claims:
- Non-genetically modified organism (non-GMO) ingredients;
- Odour control; and,
- Approved for use in organic feed.
Respondents suggested adding the following nutritional-type claims:
- Modifier words such as "good," "good source of," "excellent," "very high in," etc.;
- Amino acids, as it relates to sources of nutrients;
- Saccharomyces cerevisiae, as it relates to improving digestibility;
- Approved sources of enzymes/microorganisms/probiotics/acidifiers, as it relates to digestibility;
- Improved weight gain, as it relates to viable microbial organisms;
- Improved feed conversion, as it relates to viable microbial organisms; and,
- Improved milk production, as it relates to viable microbial organisms.
Respondents suggested adding the following performance-type claims:
- Reduction of digesta viscosity in poultry, as it relates to enzymes; and,
- Improved energy digestibility may result in improved overall feed efficiency, as it relates to enzymes.
In addition, two (2) respondents raised concerns over the omission of zoo technical additives and the proposed changes to Health Canada's regulating of drugs and veterinary health products, and inquired as to how CFIA will manage overlap between the two agencies.
The initial list of approved statements consisted of recommendations previously provided by stakeholders, and that are widely accepted within the industry as being truthful, verifiable, accurate, would pose no risk to human and animal health or the environment, and would not be controversial in nature.
The CFIA appreciates the effort and time expended by stakeholders articulating their suggestions for improving the approved statement/claims list. Given the complicated nature of the suggested claims, in addition to the review and assessment process required for each additional claim, it is not possible to include the proposed statements/claims to the approved list at this time. In keeping with the CFIA's Incorporation by Reference Policy, the CFIA will provide a plan regarding the frequency and process for the review and revision of the incorporated document as part of the formal Canada Gazette Part I publication.
Health Canada continues to implement changes to their regulatory oversight with respect to drugs, (Regulations Amending the Food and Drug Regulations (Veterinary Drugs – Antimicrobial Resistance), including establishing a list of veterinary health products (VHPs) that may provide an additional pathway for products and their inclusion to feeds. Once Health Canada has finalized its oversight approach, CFIA will explore possible opportunities within policy guidance and development that may provide added flexibility regarding the additions of VHPs to livestock feeds.
CFIA will continue to work with our partners at Health Canada to assist in differentiating products as drugs or feeds (Guidance document on classification of veterinary drugs and livestock feeds).
The CFIA is preparing a formal regulatory proposal for publication in the Canada Gazette Part I (anticipated in 2017) which will incorporate the comments received on all the consultation proposals, public meetings, stakeholder workshops and submissions, and other outreach activities that have been used over the course of the project. A draft of the Permissible Claim List will be available for public review and comment at the time of the Canada Gazette publication.
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