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RG-1 Regulatory guidance:
Chapter 2 - Data requirements for single ingredient approval and feed registration

2.9 Data flexibility for production performance endpoints and associated claims

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The CFIA is introducing flexible approaches to the data required to fulfill the efficacy portion of a pre‑market submission. This guidance explains the flexibility being allotted with regards to the studies required to support production performance claims.

Previously, in order to make a specific production performance claim for a feed, an applicant had to provide data to support the claims from at least 3 independent studies per species and production class. Some examples (not an exhaustive list) of specific endpoints for which production performance claims may be made are:

There are now three ways where flexibility may be gained to support these types of claims without compromising the safety of a product.

  1. Combining specific endpoints to make a general production performance claim
  2. Extrapolating data between similar physiological species
  3. Strength of claim – adding more flexibility with the p-value

In all cases, the applicant is responsible for clearly describing to the CFIA how their efficacy data will utilize these flexibilities. This means that the submission package must include a summary detailing any linkages between the studies submitted and the proposed claims. In no case can these flexibilities be considered in place of submitting required safety studies/data.

I. Combining specific endpoints to make a general production performance claim

Consistency in the reporting of, or significance of, specific endpoints across different studies (in-house or published) in relevant species and/or production classes of livestock can make it difficult to meet the 3-study threshold for a specific claim. However, it is now possible to make a general production performance claim. Where at least 3 independent studies demonstrate significant beneficial endpoints, even if they are different, a general production performance claim can be made. Some examples of how specific and non-specific/general claims may be assessed are presented in Table 1.

Table 1: Examples of non-specific and non-specific/general improved production performance claims
Efficacy data provided Claim

An application for a dairy feed supplement

  • 3 studies show increased milk production (p ≤ 0.05) and increased feed intake (p ≤ 0.05)
Increased milk production and feed intake in dairy cows

An application for a dairy feed supplement

  • 3 studies show increased milk production (p ≤ 0.05)
  • 2 studies only show increased feed intake (p ≤ 0.05)
Increased milk production in dairy cows

An application for a dairy feed supplement

  • 2 studies show increased milk production (p ≤ 0.05)
  • 1 study only shows increased feed intake (p ≤ 0.05)
Increased production performance in dairy cows

An application for a growing swine feed supplement

  • 3 studies show increased average daily gain (p ≤ 0.05) and increased feed intake (p ≤ 0.05)
Increased average daily gain and feed intake in growing swine

An application for a growing swine feed supplement

  • 3 studies show increased average daily gain (p ≤ 0.05)
  • 2 studies showed increased feed intake (p ≤ 0.05)
Increased average daily gain in growing swine

An application for a growing swine feed supplement

  • 2 studies show increased average daily gain (p ≤ 0.05)
  • 1 study showed increased feed intake (p ≤ 0.05)
Increased production performance in growing swine

II. Extrapolating data between similar physiological species

An approach for some feed claims where the extrapolation of efficacy data from certain species to other physiologically related species could be used to reduce the total number of studies needed to substantiate a claim for multiple physiologically similar species.

In general, conclusions from studies in animals raised for meat can be extended to include animals of the same species that are reared for reproduction but before reproduction occurs (e.g., from broiler chickens to replacement chickens reared for laying/breeding (pre-layers/replacement hens pre-breeding), from beef cattle to replacement heifers intended for breeding or milking, but before reproduction or milk production occurs). Efficacy data cannot generally be extrapolated between categories of the same species at different production classes (e.g., from broiler chickens to laying or breeding hens).

When a feed application covers several target species in the same production class, it is recognized that it may be unrealistic to expect studies in all potential target species for which an application is made. Therefore, interspecies extrapolation of data can be applied.

In principle, data can be extrapolated between physiologically similar species (Table 2) in the same production class. The degree to which species are physiologically related is judged predominantly in terms of gastrointestinal physiology and function. Similarities in metabolism are also considered. Interspecies extrapolation can be applied in cases where:

  1. the animals are raised for the same purpose, i.e., meat production or reproduction (including milk or egg production)
  2. the product mode of action can reasonably be presumed to be the same between species
  3. the effect(s) claimed is(are) the same
  4. the minimum effective in-feed concentration in the physiologically related species must be the same as that established in the species/category from which data was extrapolated
Table 2: Extrapolation of efficacy data from certain species to other physiologically related species
Major species Characteristics Physiologically related species
Broiler chickens Chickens raised for meat production Other poultry (for example, turkeys, ducks, geese, pheasants, quail, guinea fowl etc.) raised for meat and laying/breeding poultry prior to laying (replacement hens pre-breeding/pre-layers)
Laying hens Productive female birds held for egg production purposes Other laying poultry used for egg production and breeding (for example, turkeys, ducks, geese, pheasants, quail, guinea fowl etc.)
Weaned piglets Young animals having completed the suckling period Other weaned Suidae
Growing pigs Animals intended for meat production until the day of transport to the slaughterhouse Other growing Suidae
Sows Female animals having been inseminated or mated Other reproductive Suidae
Calves Calves which are reared for reproduction, veal production or beef production prior to rumination Other young ruminants prior to rumination (for example, sheep (lambs), goats (kids), buffalo)
Growing cattle Bovine animals that have completed the weaning period with fully developed rumen Other growing ruminants (for example sheep, goat, buffalo)
Dairy cows Lactating or prepartum female bovine Other dairy ruminants (for example, goat, sheep, buffalo) at the corresponding developmental stage
Salmon fish Growing salmonids Other salmonids (for example, trout, arctic char)
Horses Horses kept for performance or meat production Other Equidae
Breeding Mares Mares that have become pregnant at least once Other breeding Equidae
Rabbits Rabbits that are reared for reproduction or meat production Other Leporidae at the corresponding developmental stage at the corresponding developmental stage
Breeding Doe Rabbits Does that have become pregnant at least once Other breeding Leporidae

When the application covers multiple species/classes, the minimum number of independent studies showing the intended effect is shown in Table 3. For applications covering all food-producing animal species, efficacy should be demonstrated in species with different digestive systems. Therefore, studies should be provided to support efficacy for all pigs, all poultry, all ruminants and all fin fish, according to Table 3. Companies can apply to have applications expanded over time to add additional species/classes of livestock as data becomes available.

Table 3: Minimum number of independent studies required for the assessment of efficacy in applications intended to multiple species/categories
Application For Number of studies required and species
All meat and growing poultry species 3 in broiler chickens Table note a
All laying and breeding poultry species 3 in laying chickens Table note a
All poultry species 3 in chickens raised for meat Table note a
+ 3 in laying hens Table note a
All growing pigs 3 in weaned piglets Table note a
+ 3 in growing pigs Table note a
All pigs 3 in weaned piglets Table note a
+ 3 in sows Table note a
All growing ruminants (see below) 3 in calves (pre-ruminants) Table note a
+ 3 in grower cattle Table note a
All ruminants 3 in calves Table note a
+ 3 in cows Table note a
All fin fish 3 in salmonids
+ 3 in (1 each) in other species
All horses 3 covering both growing and reproductive animals
All rabbits 3 covering both growing and reproductive animals

III. Strength of claim – adding more flexibility with the p-value

Historically, the CFIA has followed the standard used by peer-reviewed scientific journals for research when defining the statistical significance p ≤ 0.05 (α=0.05). Considering the following points will allow for flexibility in the significance level and reduced endpoint specificity and allow a predictable strength of claim approach.

Table 4: Strength of claim options
p-value 3 Studies for specific production performance endpoints 3 Studies with different production performance endpoints (see Section I above)
p ≤ 0.05 Improves specific endpoint Improves production performance
0.05 < p ≤ 0.10 May improve specific endpoint May improve production performance
p > 0.10 Not acceptable Not acceptable
Table 5: Examples of strength of claim options
Study overview p-values Claim
3 Studies showing improved feed conversion ratio in beef cattle All studies p ≤ 0.05 Improves feed conversion ratio in beef cattle
3 studies showing increased feed intake in growing and finishing swine All studies p ≤ 0.10 (some could be ≤ 0.05) May increase feed intake in growing and finishing swine
2 studies showing increased daily gain in growing swine and
1 study showing increased feed intake growing swine
All studies p ≤ 0.05 Improves production performance in growing swine
2 studies showing increased daily gain in beef cattle and 1 study showing increased feed intake in beef cattle All studies p ≤ 0.10 May improve production performance in beef cattle
3 studies showing increased feed intake in laying hens One study p ≤ 0.05
Two studies p ≤ 0.10
May increase feed intake in laying hens
2 studies showing increased daily gain and
1 study showing increased feed intake in growing swine
Two studies p ≤ 0.05
One study p ≤ 0.10
May improve production performance in growing swine
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