What We Heard Report: Proposed new livestock feed ingredient – D-Panthenol

Introduction

The Canadian Food Inspection Agency (CFIA) led a 30-day consultation on a new single ingredient feed (SIF) description for D-panthenol from May 17, 2023 to June 17, 2023. The purpose of the consultation was to seek comments and feedback on the proposed addition of D-panthenol to the Canadian Feed Ingredients Table (CFIT) under Subclass 5.4.2 (Vitamins excluding those from fermentation processes) of Class 5 (Nutritional ingredients) in part 1 of the CFIT.

A summary of the comments received during this consultation period are available below.

Background

The Feeds Regulations require a proponent to submit a pre-market application for SIFs that are new, have been modified such that they differ from an approved SIF, or are for a new purpose. The CFIA evaluates the information in the application to establish that the SIF is safe, effective, and labelled correctly.

The CFIA completed a detailed evaluation of an application seeking approval for the use of D-panthenol as a precursor of D-pantothenic acid (vitamin B5) in supplements for drinking water for poultry and swine.

The evaluation considered information related to:

• the safety of feeding this SIF to livestock with respect to animal health
• the safety of people who consume food derived from livestock that eat this SIF
• the safety of workers/bystanders exposed to this SIF
• environmental safety
• an evaluation of the fit-for-purpose and efficacy for this SIF, for the intended livestock species

Following the evaluation, the CFIA consulted on the new SIF description for D-panthenol.

What we heard

The CFIA received a total of 2 sets of comments and feedback from stakeholders during the 30-day consultation period. The CFIA appreciates the feedback received on this consultation.

Comment: a respondent commented that in their experience, it is uncommon for animals to show D-pantothenic acid (vitamin B5) deficiency or for recommendations to be made for vitamin B5 supplementation given that sufficient levels of vitamin B5 are provided in premixes for animal use. They indicated that this SIF will likely not be used very much in livestock feeds.

CFIA response: the CFIA appreciates this information, however, the approval of D-panthenol, which has been evaluated to be efficacious and safe, is another source of vitamin B5 for the feed industry to use in meeting the nutrient requirements of livestock.

The CFIA does not base its decisions on the expected uptake of a product by producers.

Comment: the other respondent commented on the usage rates found in the additional information section of the consultation document. They also requested clarification on how this information (usage rates) would be included in the SIF description in the CFIT and if the exact usage rates would be required on the SIF label as part of the directions for use.

CFIA response: the information included in the additional information section of the consultation document will not be included as part of the SIF description in the CFIT. This additional information was included in the consultation to provide stakeholders with some examples of recommended usage rates of this SIF in livestock feeds.

Neither respondent provided any comments on the actual SIF description. The comments and feedback received did not result in any changes to the SIF description.

Final SIF description

Following the CFIA's evaluation and determination of the safety and efficacy of this SIF, and since no significant concerns were raised during consultation, the CFIA has approved the use of D-panthenol with the following description:

Part 1
Class 5 – Nutritional Ingredients
Subclass 5.4.2 – Vitamins excluding those from fermentation processes

D-Panthenol (or dexpanthenol or D(+)-pantothenyl alcohol)

is the product synthesized by the condensation of D-pantolactone with 3-aminopropanol, and having the Chemical Abstracts Service (CAS) number 81-13-0. It is an alcohol analogue of D-pantothenic acid, and contains a minimum of 98% D-panthenol.

This ingredient is approved for use as a precursor of D-pantothenic acid (vitamin B5) in supplements for drinking water for poultry and swine.

It shall be labelled with the following statement:

"This ingredient is approved for use as a precursor of D-pantothenic acid (vitamin B5) in supplements for drinking water for poultry and swine."

To address worker safety concerns, it shall be labelled with the following statement:

"This ingredient may cause eye, skin and respiratory irritation and/or sensitization. Appropriate protective equipment must be worn during handling. / Cet ingrédient peut causer une irritation des yeux, de la peau et des voies respiratoires et/ou une sensibilisation. Un appareil de protection approprié doit être porter lors de la manutention."

It shall be labelled with guarantees for minimum percent D-panthenol, minimum milligrams of D-pantothenic acid equivalent per kilogram, maximum percent D-pantolactone, maximum percent 3-aminopropanol, and maximum percent moisture.

This description has been added to the CFIT.

Comments on the Notice to industry: consultations on new or amended single ingredient feed descriptions

Since D-panthenol is the first SIF to pilot the new consultation process for new or amended SIF descriptions and some comments on the process were provided, the CFIA will update the Notice to industry: Consultations on new or amended single ingredient feed descriptions. The updates to this notice to industry will provide clarification on the SIF consultation process and updating the CFIT. Any new or amended SIF descriptions will continue to be consulted on between now and when the proposed Feeds Regulations, 2024 are published in Canada Gazette, Part II (CGII). During the transition phase between now and CGII, new or amended SIF descriptions will be considered approved for use and the final SIF description will be in the consultation summary report for the SIF. The consultation summary report will be the record of new or amended SIF descriptions being approved. Once the proposed Feeds Regulations, 2024 come into effect at the time of publication in CGII, all the new or amended SIF descriptions that had been consulted on, and therefore the final SIF descriptions found in the consultation summary reports, will be added to the CFIT. During this transition phase, stakeholders can continue to request a copy of Schedules IV and V and may also refer to the consultation summary reports to see what SIFs are approved for use in livestock feeds in Canada. Once the proposed Feeds Regulations, 2024 come into effect at CGII, there will be a 12 month transition period where stakeholders can follow the final version of Schedules IV and V or the CFIT. After this 12 month transition period, one must follow the CFIT.

Next steps

The CFIA would like to thank everyone who participated in the consultation process for contributing their time and sharing their views.

We are committed to reviewing any new scientific information on the safety of any SIF. Anyone who becomes aware of new scientific information respecting the safety of D-panthenol is encouraged to contact the CFIA.

This new SIF (with the finalized description above) has been added to the CFIT for inclusion with the publication of the proposed Feeds Regulations, 2024.

Related information

• Feeds Regulations
• Feeds Act
• Consultations on proposed regulatory and policy changes
• Share your thoughts: Proposed new livestock feed ingredient – D-Panthenol - Canadian Food Inspection Agency (canada.ca)
• Notice to industry: Consultations on new or amended single ingredient feed descriptions

Contact us

Animal Feed Program (AFP)
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario K1A 0Y9

Email: cfia.afp-paa.acia@inspection.gc.ca