RG-1 Regulatory Guidance:
Chapter 4 – Labelling and guarantees

4.0 General guidance on labelling

This guidance provides useful information under the Feeds Regulations, 1983 and is complementary to the template labels available in Chapter 4 4.1 Labelling of livestock feed.

4.1 Labelling of livestock feed

According to Section 26 of the Feeds Regulations all livestock feed (bagged or bulk) manufactured, sold or imported must be properly labelled. In the case of bulk feed it should be emphasized that a label must accompany the shipment.

The CFIA has exempted most categories of livestock feed from presale evaluation and registration. As a result of this, the responsibility for labelling of livestock feeds rests with the feed manufacturer.

CFIA inspectors routinely visit feed mills and verify labels for compliance with feed labelling standards. In this regard, particular attention is paid to the labelling of medicated feeds. Mislabelled medicated feed can adversely affect livestock health and livestock production, and lead to drug residues. Label violations for medicated products are considered serious and unacceptable.

This section provides a regulatory overview of the labelling of feed, set up as a series of commonly encountered labels. It should be emphasized that this is just an overview; to ensure compliance with prescribed labelling standards, you must obtain a copy of the Feeds Act, the Feeds Regulations, and the "Compendium of Medicating Ingredient Brochures", 8^th Edition. These documents are available on the main Livestock Feeds web page.

Sample labels for common mixed feeds:

Medicated feed

• brand name (optional)
• feed name
• form of feed (if other than mash)
• medication, level and approved claim (per Medicating Ingredient Brochure [MIB])
• registration number (if required)
• this feed contains added selenium at ? mg/kg (if selenium is added)
• guaranteed analysis
• required guarantees per table 3 for the specific feed type
• either a complete list of ingredients (if required for that feed type) or the following statement: "a list of ingredients used in this feed may be obtained from the manufacturer or registrant"
• directions for use (per MIB for medication level/claim)
• warnings (per MIB for medication level/claim)
• cautions (per MIB for medication level/claim)
  selenium caution(s) if selenium added per (6): "Directions for use must be carefully followed" (all species) and "do not use in association with another feed containing supplemental selenium" (ruminants only)
• notes (if required by the MIB for medication level/claim)
• BSE statement if feed contains "prohibited material": "feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animals Act."
• registrant's name and address (if registered);
  or
  name and address of manufacturer or person who caused it to be manufactured (if not registered)
• net weight (kg)

Medicated feed customer formula

• brand name (optional)
• feed name
• feed form (if other than mash)
• medication, level and approved claim (per MIB)
• name and address of the person who caused the feed to be manufactured
• directions for use (per MIB for medication level/claim)
• warnings (per MIB for medication level/claim)
• cautions (per MIB for medication level/claim)
• notes (if required by the MIB for medication level/claim)
• BSE statement if feed contains "prohibited material": "feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animals Act."
• name and address of the supplier of the feed
• net weight (kg)

Medicated feed veterinary prescription

• brand name (optional)
• feed name (must include name and amount of medicating ingredient)
• medication and level (per vet prescription)
• medication claim (per vet prescription, if any)
• name and address of the person who caused the feed to be manufactured
• name of veterinarian who issued prescription
• form of feed (if other than mash)
• this feed contains added selenium at ? mg/kg (if selenium is added)
• guaranteed analysis
• required guarantees per table 3 for the specific feed type
• either a complete list of ingredients (if required for that feed type) or the following statement: "a list of ingredients used in this feed may be obtained from the manufacturer or registrant"
• directions for use (including duration of use as per vet prescription)
• warnings (per vet prescription)
• cautions (per vet prescription)
  selenium caution(s) if selenium added per (8): "directions for use must be carefully followed" (all species) and "do not use in association with another feed containing supplemental selenium" (ruminants only)
• BSE statement if feed contains "prohibited material": "feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animals Act."
• name and address of manufacturer
• net weight (kg)

Medicated feed consultant formula

• brand name (optional)
• feed name
• form of feed (if other than mash)
• medication, level and approved claim (as per MIB)
• name and address of purchaser of feed
• this feed contains added selenium at ? mg/kg (if selenium is added)
• guaranteed Analysis
• required guarantees per table 3 for the specific feed type
• either a complete list of ingredients (if required for that feed type) or the following statement: "a list of ingredients used in this feed may be obtained from the manufacturer or registrant"
• directions for use (per MIB for medication level/claim)
• warnings (per MIB for medication level/claim)
• cautions (per MIB for medication level/claim)
  selenium caution(s) if selenium added per (6): "directions for use must be carefully followed" (all species) and "do not use in association with another feed containing supplemental selenium" (ruminants only)
• notes (if required by the MIB for medication level/claim)
• BSE statement if feed contains "prohibited material": "feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animals Act."
• name and address of the manufacturer or person who caused it to be manufactured
• net weight (kg)

Non-medicated feed customer formula

• brand name (optional)
• feed name
• name of the supplier of the formula (if shipped in bags)
  or
  name and address of the supplier of the formula (if shipped in bulk)
• BSE statement if feed contains "prohibited material": "feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animals Act."
• net mass of individual packages of feed and number of packages in the lot (if shipped in bags);
  or
  net weight of feed in shipment (if shipped in bulk)

Non-medicated feed

• brand fame (optional)
• feed name
• registration number (if required)
• this feed contains added selenium at ? mg/kg (if selenium is added)
• guaranteed analysis
• required guarantees per table 3 for the specific feed type
• Either a complete list of ingredients (if required for that feed type) or the following statement: "a list of ingredients used in this feed may be obtained from the manufacturer or registrant"
• directions for use
• selenium caution(s) if selenium added per (4): "directions for use must be carefully followed" (all species) "do not use in association with another feed containing supplemental selenium" (ruminants only)
• BSE statement if feed contains "prohibited material": "feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animals Act."
• registrant's name and address (if registered);
  or
  name and address of the manufacturer or person who caused it to be manufactured (if not registered)
• net weight (kg)

Non-medicated feed consultant formula

• brand name (optional)
• feed name
• name and address of purchaser of feed
• this feed contains added selenium at ? mg/kg (if selenium is added)
• guaranteed analysis
• required guarantees per table 3 for the specific feed type
• either a complete list of ingredients (if required for that feed type) or the following statement: "a list of ingredients used in this feed may be obtained from the manufacturer or registrant"
• directions for use
• selenium caution(s) if selenium added per (4): "directions for use must be carefully followed" (all species) "do not use in association with another feed containing supplemental selenium" (ruminants only)
• BSE statement if feed contains "prohibited material": "feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animals Act."
• name and address of the manufacturer or person who caused it to be manufactured
• net weight (kg)

4.2 Liquid feed standards

Liquid feeds require additional labelling statements, compared to dry feeds. The additional information required on labels for liquid feeds is as follows:

1. The label for a liquid feed shall contain a weight per unit volume statement. The reference point temperature for the volumetric measurement is 20°C (i.e., "Density at 20°C = kg/L").
2. Liquid feeds containing ingredients which do not stay in suspension for up to 60 days shall have on their labels the following statement: "This product must be agitated while being dispensed or fed."
3. The label of a liquid feed must bear the statement: "The viscosity of this product will vary inversely with temperature."
4. Considering the narrow therapeutic index of selenium, feeds for administration through drinking water cannot contain supplemental selenium

4.3 Vitamin A and Beta Carotene guarantees

Vitamin A guarantees on feed labels account for the total vitamin A activity of the feed, and include the activity from both vitamin A and beta-carotene (a vitamin A precursor). Beta-carotene is a single ingredient feed and is listed in Part II of Schedule IV of the Feeds Regulations. Therefore, only registered sources of this vitamin can be used in livestock feeds.

As requirements for beta-carotene have been well established in most livestock species, the Feed Program will allow guarantees on feed labels for minimum mg/kg of beta-carotene in addition to vitamin A guarantees.

Feeds with label guarantees for beta-carotene require registration as Category 2 (see Chapter 1) products, with the appropriate application fees. The registration will include additional requirements for the name and source of beta-carotene and the product formula. The feed label will have to indicate that the vitamin A guarantee includes vitamin A activity from beta-carotene.

For example:
Vitamin A^Footnote 1 - minimum - 200,000 IU/kg
Beta-carotene - minimum - 100 mg/kg

In such cases, the following conversion factors (depending on species) will be used to determine the vitamin A activity from beta-carotene in the feed:

Standard mixed feeds containing registered sources of beta-carotene may be exempted from registration as long as there is no reference by name (other than in the list of ingredients, if present) and/or guarantee to this ingredient on the label, and all other criteria for exemption from registration under the Feeds Regulations are met.

4.4 Vitamin guarantees for ruminant and horse feeds

Dietary requirements of three fat soluble vitamins (vitamins A, D, and E) for ruminants and horses have been well established. Dietary sources of other vitamins, such as vitamin C, vitamin K, and the B vitamins, including niacin and choline, have not been proven to provide any specific benefits to these species. As such, the CFIA's Feed Program has established the following guidelines for vitamin guarantees for ruminant and horse feeds.

1. Guarantees for levels of vitamins A, D, and E shall be stated on the label of ruminant and horse feeds as outlined in the Feeds Regulations.
2. Feed manufacturers may guarantee levels of vitamins other than vitamins A, D, and E in feeds for calves (up to three months of age), kids, and lambs (up to two months of age). This is essentially the pre-ruminant stage of the animal, when the rumen has not become fully functional.
3. Feeds for horses may guarantee levels of riboflavin, pyridoxine, and thiamine, in addition to the vitamin A, D, and E guarantees.
4. Vitamin guarantees other than those indicated in items 1, 2, and 3 above will only be allowed on feeds for horses, cattle, goats or sheep provided the following "Note(s)", where appropriate, appear(s) on the feed label:
   • cattle feeds:

     "Feeding vitamins other than vitamins A, D, and E to cattle older than three months of age may not have a beneficial effect".

   • sheep feeds:

     "Feeding vitamins other than vitamins A, D, and E to sheep older than two months of age may not have a beneficial effect".

   • goat feeds:

     "Feeding vitamins other than vitamins A, D, and E to goats older than two months of age may not have a beneficial effect".

   • horse feeds:

     "feeding vitamins other than vitamins A, D, E, riboflavin, pyridoxine, and thiamine to horses may not have a beneficial effect".

Please note that feeds for ruminants and horses with vitamin guarantees other than vitamins A, D, and E require registration, and the addition of any new guarantees to a product label will be considered significant changes and will require an amendment to registration.

This section will be amended as dietary requirements are established for vitamins other than those stated above. Changes to registered ruminant product labels as a result of the current amendment will be required on registration renewal. Companies are reminded that they may submit any information pertaining to this issue to the Feed Program for evaluation.

4.5 Vitamin D₃ and 25 - Hydroxyvitamin D₃ guarantees

Crystalline 25-Hydroxyvitamin D₃ is a single ingredient feed that is approved as a source of vitamin D₃ activity in complete feeds and supplements for drinking water for chickens and turkeys and complete feeds for swine in Canada. Crystalline 25-Hydroxyvitamin D₃ is listed in Part II of Schedule IV of the Feeds Regulations, which means that only registered sources of this vitamin can be used in feeds in Canada. As there is no standard analytical method to determine the vitamin D₃ activity from 25-hydroxyvitamin D₃ in mixed feeds, the following policy will apply.

Vitamin D₃ guarantees on labels for complete feeds and supplements for drinking water for chickens and turkeys and complete feeds for swine will be considered as the sum total of the Vitamin D₃ activity from D-activated animal sterol, Vitamin D₃, and crystalline 25-hydroxyvitamin D₃. The amount of Vitamin D₃ activity supplied by crystalline 25-hydroxyvitamin D₃ will depend upon the label guarantee of each registered source. Presently, the only approved source of crystalline 25-hydroxyvitamin D₃ supplies the following activity: 1 mg of 25-hydroxyvitamin D₃ = 40,000 IU of Vitamin D₃ activity.

Mixed feeds containing crystalline 25-hydroxyvitamin D₃ may be exempt from registration, as long as there is no reference to this ingredient (other than the ingredient name and registration number, when a list of ingredients is present on the label) either by name, guarantee or claim on the label, and all other criteria for exemption from registration under the Feeds Regulations are met.

If the presence of crystalline 25-hydroxyvitamin D₃ is highlighted on the label for a mixed feed, the mixed feed must be registered, and the following additional information (compared to a standard product registration) will be required as part of the application for registration:

1. a label with a guarantee for the minimum concentration of 25-hydroxyvitamin D₃, in mg/kg;
2. the vitamin D₃ guarantee on the label will have to specify that it includes all sources of vitamin D₃ activity;
3. the complete and detailed product formula (i.e., indicating the inclusion rate of each ingredient in the formulation, either on a weight/weight or percent basis), which will be used to verify both the label guarantee and the use of a registered crystalline 25-hydroxyvitamin D₃ source;
4. either the brand name or the approved single ingredient feed name (i.e., crystalline 25-hydroxyvitamin D₃) in addition to the registration number of the source of crystalline 25-hydroxyvitamin D₃ are to be indicated on the labels for standard mixed feeds and supplements; and
5. the appropriate fees for a category 2 type application, as per Chapter 1 of the Regulatory Guidance.

For registered feeds, any proposed changes to the registration (e.g., product formulation, label guarantee(s), directions for use, intended species, the source of crystalline 25-hydroxyvitamin D₃ used in the feed, etc.) must be first approved by the Animal Feed Division, via an application for a significant change to the registration that is accompanied by registration fees for a Category 2 type submission. Also please note that at registration renewal, the product formula must be submitted in support of the previously approved source and inclusion rate of crystalline 25-hydroxyvitamin D₃.

Note: Additional information may be requested by the Animal Feed Division.

4.6 Selenium supplementation of livestock feeds

Livestock species excluding dry and lactating dairy cows

The levels of supplemental selenium (Se) permitted in livestock feed, excluding lactating and dry dairy cattle are:

A) Complete feeds

• in complete feeds for swine, chickens, turkeys, ducks, geese, beef cattle, growing dairy cattle (non-lactating heifers, bulls and steers), sheep and goats, at a level not to exceed 0.3 mg/kg.
• in the dry material of milk replacers for calves, lambs, colts and piglets, at a level not to exceed 0.3 mg/kg.
• in complete feeds for rabbits and salmonid fish, at a level not to exceed 0.1 mg/kg.
• in complete feeds for non-food producing livestock, at nutritional levels.

B) Limit fed feeds

• at a level not to exceed an intake of 3 mg Se/head/day for beef cattle and 0.7 mg Se/head/day for sheep.

C) Free-choice trace mineralized salts and free-choice mineral feeds

• in free-choice trace mineralized salts for all classes of beef cattle at a level not to exceed 120 mg/kg;
• in free-choice trace mineralized salts for all classes of sheep at a level not to exceed 90 mg/kg;
• in a free-choice mineral feed for all classes of beef cattle on range at a level not to exceed 30 mg/kg.

Dry and lactating dairy cows

Per Table 4 of the Feeds Regulations, a complete feed for dairy cows refers to the grain ration. The Sixth Revised Edition (1989) of the Nutrient Requirements of Dairy Cattle suggests a selenium requirement of 0.3 mg/kg of total ration dry matter for dry and lactating dairy cows. The amount of grain ration fed to dairy cows is dependent on a number of factors including; forage quality, body size and condition, milk production, stage of lactation and age. To allow dry and lactating dairy cows access to an appropriate level of supplemental selenium, values have been established with input from industry which would incorporate some of these factors and permit an increased level of selenium supplementation.

The levels of supplemental selenium permitted in feeds for lactating and dry dairy cattle are found in Table 2. These values were calculated based on expected dry matter intakes for dairy cows weighing between 400 and 700 kg using Table 6-1 of Sixth Revised Edition (1989) of the Nutrient Requirements of Dairy Cattle. Values used in the calculation of maximum daily selenium intakes are found in Table 1.

Table 1: Values used to calculate maximum allowable daily selenium intakes

Table 2: Maximum allowable daily selenium intakes

The feed manufacturer will be responsible for the development of a table of maximum allowable daily intakes for each product for body weights from 400 to 700 kg. This table will be required to appear on the label of each product. It will be calculated using the maximum daily selenium intakes (95% dry matter, as fed basis) shown in Table 2.

Values for developing the table for the label are obtained using the following equation where all values are expressed on an as fed basis:

Maximum daily intake of product (kg/day) = maximum daily selenium intake (mg/day) ÷ product selenium level (mg/kg)

For example:

1. a dairy grain ration containing 0.6 mg/kg added selenium (as fed) would have on its label the following table (not including calculations shown in bold):

   Body Weight (BW)	400 kg	500 kg	600 kg	700 kg
   Maximum daily intake of product (as fed)	4.10 ÷ 0.6 = 6.8 kg	4.99 ÷ 0.6 = 8.3 kg	5.99 ÷ 0.6 = 10.0 kg	6.38 ÷ 0.6 = 10.6 kg

2. a protein supplement containing 3.0 mg/kg added selenium (as fed) would have on its label one or both of the following tables depending on feeding directions:

   a. Top dressing

   Body Weight (BW)	400 kg	500 kg	600 kg	700 kg
   Maximum daily intake of product	1.4 kg	1.7 kg	2 kg	2.1 kg

   b. Mixed at 150 kg/tonne finished feed (Ration = 0.45 mg/kg Se)

   Body Weight (BW)	400 kg	500 kg	600 kg	700 kg
   Maximum daily intake of dairy ration	9.1 kg	11.1 kg	13.3 kg	14.2 kg

3. a mineral supplement containing 25.0 mg/kg added selenium (as fed) would have on its label one or both of the following tables depending on feeding directions:

   a. Top dressing

   Body Weight (BW)	400 kg	500 kg	600 kg	700 kg
   Maximum daily intake of product	164 g	200 g	240 g	256 g

   b. Mixed at 30 kg/tonne finished feed (Ration = 0.75 mg/kg Se)

   Body Weight (BW)	400 kg	500 kg	600 kg	700 kg
   Maximum daily intake of dairy ration	5.5 kg	6.7 kg	8 kg	8.5 kg

   Labels for all feeds containing selenium for dry and/or lactating dairy cows, regardless of product selenium level, must contain the aforementioned table indicating maximum product intakes. Any labels which do not contain the aforementioned table will be considered in violation of the Feeds Act and Regulations and will be subject to enforcement action.

   Any products containing the higher selenium levels will, of course, be required to bear labels reflecting the higher supplemental levels and the required table prior to being marketed.

   Note 1: Beef cattle, sheep, goats and dairy cattle may receive only one source of supplemental Se.

   Note 2: The minimal level of supplemental Se may be as low as 30% of the maximum permitted.

Labelling requirements for all species including dry and lactating dairy cows

The following information is required on the labels of feed containing supplemental Se in addition to the specific requirements for feeds designed for feeding to dry and lactating dairy cows:

• immediately above the guaranteed analysis
  "this feed contains added selenium at mg/kg"
• "Caution" to appear on all feed labels:
  "directions for use must be carefully followed"
• "Caution" to appear on cattle, goat and sheep feed labels:
  "do not use in association with another feed containing supplemental selenium"

Additional label information

Permission has been granted under Section 30 (b) of the Feeds Regulations to allow a "total" actual selenium guarantee, expressed in mg/kg to appear on feed labels.

In order to proceed with a "total" guarantee, manufacturers must notify the Animal Feed Division and receive approval for the guarantee. In addition, the company must provide the feed formulation to justify the level guaranteed, as well as submit information on manufacturing quality control to demonstrate that the total guaranteed will be maintained consistently.

Based on statistical analysis of analytical results, a permitted analytical tolerance of plus/minus (40% of the selenium guarantee + 0.02 mg/kg) will be utilized to determine compliance of any product to its guaranteed level of "total" actual selenium.

The level of "added" selenium is still required to be stated on the feed label.

Mixing ability

No difficulties have been encountered by feed manufacturers in mixing supplemental Se when producing feeds using macro-premixes or supplements containing Se. Firms using either a macro-premix or supplement from a firm previously cleared for mixing supplemental Se will not have to show proof of mixing ability.

If, however, a feed mill is manufacturing any of the following types of feed, a clearance demonstrating Se mixing ability is required:

• selenium premixes (Se and carrier)
• micro-premixes containing selenium
• a feed where one of the above types of premixes has been used

  In order to obtain a clearance, we would ask that you submit one sample from each third of a batch (total 3 samples) of feed to a reputable laboratory for a Se assay. The results of that assay should be maintained at the feed mill and be made available to CFIA upon request.

Veterinary prescriptions

Pursuant to Section 5 (2)(g)(v) of the Feeds Regulations, all veterinary prescriptions which prescribe supplemental selenium levels in excess of 0.3 mg/kg, in the total diet, for any class of livestock, must be submitted by the manufacturer of the feed, within 10 working days of the time of initial manufacture of the veterinary prescription feed.

4.7 Selenium supplementation of feeds for lactating or dry cows

As a result of the modifications in section 4.6, free-choice feeds, including feed blocks for lactating or dry dairy cows, may no longer contain supplemental selenium.

Members of the feed industry have requested that feed blocks designed for feeding to lactating and/or dry dairy cows be permitted to continue to contain supplemental selenium. After consultation with the Veterinary Drugs Directorate regarding this request, it was decided that inclusion of supplemental selenium in feed blocks for lactating or dry dairy cows may be appropriate where appropriate voluntary consumption data for the feed block is submitted for evaluation.

Voluntary consumption data will be required for each specific formulation for which selenium supplementation is requested. This voluntary consumption data must be collected on a biweekly basis, for a minimum of 90 days, under the suggested feeding regime (e.g. pasture) for both lactating and dry dairy cows. Selenium assay data for the blocks used and an estimate of the coefficient of variation (% CV) must be supplied for each study. A minimum of three (3) studies are required.

4.8 Salt guarantees

An actual guarantee for salt is permitted on labels of complete feeds, supplements and macro-premixes, in addition to a guarantee for actual sodium. This is in accordance with the Feeds Regulations, Section 30 (for example, it conveys useful information to the feed purchaser). Such feeds will continue to be exempt from registration if they meet the other exemption requirements listed in regulation 5(2)(d) of the Feeds Regulations (for example, the nutrient levels guaranteed are within the limits stated in Table 4 of Schedule I).

4.9 Amino acid guarantees on livestock feed labels

The importance of the amino acid content of livestock feeds, especially for monogastric animals, is well documented, and acceptable laboratory methodologies for the verification of amino acid guarantees in feeds are available. The Science Branch of the CFIA has developed analytical tolerances for specific amino acids, which allow for the addition of amino acid guarantees on livestock feed labels.

At this time, only two amino acids have been considered, namely lysine and methionine. Both of these amino acids can be analyzed using the Association of Official Analytical Chemists (AOAC) International Official Methods of Analysis suitable for total amino acid analysis: AOAC International 994.12, "Amino Acids in Feeds", Performic Acid Oxidation with Acid Hydrolysis - Sodium Metabisulfite Method, or AOAC International 985.28, "Sulfur Amino Acids in Food and Feed Ingredients", Ion Exchange Chromatographic Method, or AOAC International 982.30, "Protein Efficiency Ratio", Part E - Sample Hydrolysis. For additional details of lysine and methionine testing, refer to the collaborative study for AOAC International 994.12 in the Journal of AOAC International Volume 77, Number 6, 1994, pages 1362 to 1402, by C. Llames & J. Fontaine, "Determination of Amino Acids in Feeds: Collaborative Study". The AOAC International methods mentioned above will be used by the CFIA for regulatory and compliance purposes.

2-Hydroxy-4-(methylthio) butanoic acid (HMB), which is commercially known as Methionine Hydroxy Analog, may be used as an alternative source of methionine activity in livestock rations; however, analytical methods for methionine determination cannot quantify HMB. For analytical determination of HMB content of livestock feeds, the methodology described by Ontiveros et al. (Journal of Agricultural and Food Chemistry (1987) 35 pages 692-694) has been reviewed by Science Branch and found acceptable.

The Feed Program of the CFIA allows for lysine and/or methionine guarantees (including methionine equivalent from HMB) only on labels of feeds designed for feeding to swine and poultry. These guarantees will be permitted on labels for swine and poultry feeds where all of the following conditions are met:

1. As amino acid guarantees are not required pursuant to Schedule I, Table 3 of the Feeds Regulations, all products labelled with lysine and/or methionine guarantees are required to be registered. Please note, there is no exemption from this requirement with respect to customer and/or consultant formula feeds, or any other feed presently exempt from registration.
2. Lysine and/or methionine guarantees will be permitted only on labels of feeds designed for feeding to swine and poultry. Amino acid guarantees for feeds designed for multiple livestock species will be permitted only if mixing directions are presented for swine and/or poultry and the amino acid content of the mixed feed is acceptable for those species.
3. Only guarantees for minimum per cent of total lysine and/or methionine activity (including methionine equivalent from HMB) will be permitted. Guarantees for added lysine and/or methionine activity are not acceptable. Manufacturers will be required to submit a certificate of analysis stating the actual amount of lysine and/or methionine (including HMB where applicable) found for three different batches of the product, or copies of the actual product formula complete with calculated amino acid and HMB (where applicable) content.
4. Where the feed is a complete feed, the amino acid guarantee must provide at least the minimum requirement recommended in the latest version of the Nutrient Requirements for Swine or Poultry published by the National Academy Press (for the age or class of animal for which the feed is designed), or be substantiated by other scientific information. Where the feed is designed for further mixing (i.e., supplements, macropremixes or micropremixes), the amino acid guarantee must result in a final feed which provides at least the minimum requirement, when the feed is manufactured as indicated on the label.
5. Where the feed contains HMB as a source of supplemental methionine activity, the presence of HMB must be indicated on the label, beside the methionine guarantee (e.g. "this feed contains HMB as a source of supplemental methionine"), to ensure that the lab and/or analyst has the appropriate information to enable verification of label guarantees. A guarantee for minimum %HMB may also appear on the label, but will not be required.
6. The analytical tolerance used for guarantee verification shall not exceed a deficiency of 20 per cent of the guaranteed amount.
7. For amino acids manufactured using fermentation and extraction processes, the source of fermentation (bacteria, yeast or fungi) must be an approved source as per Schedule IV of the Feeds Regulations. Unapproved fermentation sources will have to undergo an ingredient safety evaluation prior to being used as an amino acid source. For fermentation sources containing a novel trait (e.g. genetically modified), the sources will be individually evaluated on a case-by-case basis, according to the Guidelines for the Safety Assessment of Novel Feeds: Microbial Sources.

For consideration of any additional amino acid guarantees (for other species or other amino acids) on livestock feed labels, valid scientific evidence in support of the nutritional requirement for the amino acid and a valid analytical method must be presented.

4.10 Fibre guarantees for livestock feeds

Revised: 2010-10-19

For a number of years, livestock nutritionists have been using Acid Detergent Fibre (ADF) and/or Neutral Detergent Fibre (NDF) as indicators of dietary energy and intake, particularly in ruminant rations. As a result, these fibre fractions have replaced crude fibre (CF) in ration formulations. AOAC International has published methods for ADF and NDF determination in livestock feeds (Method #973.18 and Method #2002.04, respectively) and these methods are publicly available.

Given the above, the Animal Feed Division will allow guarantees for maximum per cent ADF and/or maximum percent NDF on feed labels, as per the following options:

Ruminant livestock feeds:

• CF guarantee, or
• ADF and/or NDF guarantees in addition to CF guarantee.

Non-ruminant livestock feeds:

• CF guarantee only.

Single ingredient feeds:

• CF guarantee, or
• ADF and NDF guarantees in addition to a CF guarantee.

Multi-species feeds (ruminant and non-ruminant livestock):

• CF guarantee, or
• ADF and/or NDF guarantees in addition to a CF guarantee.

The presence of ADF and NDF guarantees on feed labels (as per product type above) that meet all other criteria for exemption from registration under the Feeds Regulations will not require registration by the Animal Feed Division.

4.11 International/multilingual labels

revised: 2015-02-03

Scope

The products to which this guidance applies are limited to single ingredient feeds or pre-mixtures used to provide select nutrients in the manufacture of livestock feeds.

Requests for multi-country/multilingual labelling have been periodically received by the Animal Feed Division. These are requests to include the labelling requirements and languages for foreign countries, in addition to those of Canada, on the same label.

Under the Feeds Act and Regulations, the definition of a label encompasses all the information (including symbols, marks or designs) that is applied or attached to, belonging to or accompanying any feed or package. This includes any details that may be intended for other countries.

Additional label information and requirement for registration

Labels for livestock feeds must contain the labelling information required by the Feeds Regulations. Any extra label information could be contrary to the standards outlined in the Feeds Regulations. Therefore, any company wishing to manufacture, import or sell a feed labelled with additional information must submit an "Application for Feed Registration" for the product in question, to the Animal Feed Division for review and assessment.

Additional languages

The Feeds Regulations specify that "any information required to be shown on a label shall be printed conspicuously, legibly and indelibly in English or French or both languages."

The Animal Feed Division will consider additional labelling information that is beyond what is required by the Feeds Regulations, such as languages other than French or English on livestock feed labels, provided that an Application for Feed Registration or Renewal (CFIA/ACIA 0009) is submitted to our office in order to have a multi-lingual label approved for a given feed.

All products with additional label information or with languages other than French and/or English on the label must be registered, even if they would otherwise be exempt from registration. This includes single ingredient feeds listed in part I of Schedules IV and V of the Feeds Regulations.

A complete translation of the label information (other than French or English) must be included with the application for registration in order to determine if there are any statements and/or claims that contravene the Feeds Act and Regulations (e.g. therapeutic uses or claims, rates of use in excess of maximum safety limits for the ingredient, feeds for species that are not regulated under the Canadian Feeds Act and Regulations).

Such supporting information must be accompanied by a Certificate of Translation, or attestation that the translations are accurate (see Appendix I as an example).

Registration and labelling requirements

The information required in order to comply with the Feeds Regulations must appear on the main panel of the package and must be presented in a manner that is not confusing, nor provide conflicting information to the user. Additional or alternative guarantees may be allowed on a case-by-case basis so long as they provide useful information to the purchaser and do not conflict with any requirements of the Feeds Regulations.

The requirement for a Certificate of Translation or attestation regarding the accuracy of the translation for multilingual labels is in addition to the registration requirements outlined in Chapter 1 of the RG-1 for the various feed types; there is no additional fee over and above that which is outlined in the RG-1.

If inspectors find unregistered products with additional label information, or in languages other than French and/or English on the label during their inspection activities the product will be considered non-compliant, and require corrective action.

If a company is uncertain whether their product requires registration, they should contact their local CFIA office or e-mail the Animal Feed Division at: cfia.afp-paa.acia@inspection.gc.ca for guidance.

Appendix I
Sample attestation of translation
multilingual livestock feed labels

Company (Registrant) Name

Address

Date

To whom it may concern:

The information on the label for the following product:

Brand and Product Name (for example, "Joe's lysine supplement")

is listed in the following languages:

Name of languages (for example, Spanish, German, Chinese, etc.)

The information that appears in these languages is:

• Spanish to English and/or French
• German to English and/or French
• Chinese to English and/or French

I hereby attest this to be a true and accurate translation of the information that appears in all languages on the label.

Sincerely,

(Authorized representative or professional translator)

Copy of the label for the above mentioned product is attached

4.12 Permissible claims policy for livestock feed

• Scope
• Current state
• Benefits
• Permissible claims guidance
  • Introduction of permissible claims
  • Permissible claims list
  • Labelling requirements when using a permissible claim
  • Compliance and enforcement
  • Process for adding or removing permissible claims to the label of a registered livestock feed
• Next steps
• Appendix 1
  • Permissible claims related to the quality and content of the feed
  • Permissible statements and logos related to national or international industry certifications, or endorsements or marketing and promotional practices about the company

Scope

This document sets out guidance on permissible claims that may be used on livestock feed labels without the need for product registration. Once published, this policy will take effect immediately.

Current state

All information on livestock feed labels, including words, pictures, and logos, contribute to the overall impression created about a feed product. It is the responsibility of the feed manufacturer or seller to comply with the labelling, and other regulatory requirements of the Feeds Act and regulations.

A claim is considered to be any representation which states, suggests, or implies that a mixed feed or single ingredient feed has particular characteristics relating to its origin, nutritional properties, nature, purpose, production, processing, quality or composition, or any characteristic that relates to animal productivity, animal health, food characteristics, food quality or the environment.

Benefits

This policy will allow certain claims (pre-approved or permissible claims) that are on the permissible claims list to be added to livestock feed labels without the need for mandatory product registration by the Canadian Food Inspection Agency (CFIA). The benefits and anticipated outcomes for permissible claims include:

• providing feed manufacturers and distributors with the flexibility to market their feeds with permitted claims quickly
• reducing regulatory burden by not registering feeds with certain label claims
• allowing the CFIA to maintain enforceable regulatory oversight and focus on health and safety-related claims that may negatively impact animal health, human health or the environment

Permissible claims guidance

• Introduction of permissible claims
• Permissible claims list
• Labelling requirements when using a permissible claim
• Compliance and enforcement

Introduction of permissible claims

To provide greater flexibility, the CFIA has developed a new policy to allow certain claims to appear on livestock feed labels without requiring registration of the feed. A list of permissible claims (pre-approved claims) can be found in Appendix 1. Claims that are considered suitable for this policy:

• must not have an impact on health or safety
• are not product specific
• are easily verifiable
• perform consistently, and
• may be applied to a feed that is otherwise exempt from registration

In all cases, claims must be accurate and truthful.

Permissible claims list

The permissible claims list consists of pre-approved claims that may be used on livestock feed labels and the conditions that need to be met prior to using that claim. Appendix 1 is divided into 4 tables. Tables 1 to 3 contain both general and method of production claims. Table 4 contains statements related to endorsement, marketing or promotional information about the company or business practices rather than the feed itself.

Feeds that are exempt from registration will be able to include claims set out in the permissible claims list without requiring product registration if the feed meets the conditions as listed for that claim.

When using a claim from the permissible claims list from Tables 1 to 3 of Appendix 1, the regulated party:

• must use the claim wording found in the "Approved claim" column
• may also include the wording found in the "Optional claim" column
  • if using the optional claim, the full wording of the approved claim must also appear on the label, however, the optional claim may appear in a product name with an asterisk directing people to the approved claim elsewhere on the label
• must follow the conditions found in the "Conditions – feed" column
  • this includes any compositional or manufacturing restrictions
• must follow the conditions found in the "Conditions – label" column
  • this may include additional labelling statements or requirements for the list of ingredients on the label

Regulated parties must have information available to substantiate the claim in the event that the CFIA requests it.

Claims that do not meet all of the above requirements would be considered out of compliance with the permissible claims policy.

If a regulated party wishes to use a claim that is not on the list, the feed will require registration and information supporting that claim must be submitted as part of the application.

Feeds that require registration for reasons other than a claim will still require product registration even if they are labelled with a permissible claim.

Labelling requirements when using a permissible claim

Feed claims may be found as a statement on a label or as part of the feed name. If a mixed feed has a specialty purpose mentioned in the feed name or stated in another part of the livestock feed label, this would be considered a claim. For example, a label states that, either as part of the feed name or somewhere else on the label, a mixed feed is an odour control agent or is a mould inhibitor. Since these claims are not included on the permissible claims list, the mixed feed would require registration.

All claims on livestock feed labels must be accurate, truthful, and must not mislead or deceive the purchaser of the feed.

Compliance and enforcement

During compliance verification activities carried out by the CFIA, regulated parties may be required to provide information to substantiate or support the permissible claim. This could be:

• during an inspection
• follow-up to a complaint regarding the truthfulness of the claim or statement, or
• during the feed registration process for a feed that requires product registration

All documents used to substantiate a permissible claim must be made available to the CFIA upon request. Enforcement actions may be taken and follow up may be required if there is a reason to question the truthfulness of the claim or statement.

For method of production claims, acceptable ways to substantiate the claim may include:

• third party audits
• documentation (for example, production records), or
• non-government certification programs

For some of the method of production claims (for example, raised without the use of antibiotics claim), sequencing and flushing documentation is an example of documentation that substantiates these particular claims and may be requested by a CFIA inspector.

For endorsements or promotional or marketing statements, acceptable ways to substantiate these statements may include:

• documentation of national or international certifications
• documentation to support endorsements made (for example, letter from official sponsor)
• documentation to support marketing or promotional practices (for example, letters from charities)

With regards to a feed label having a logo of a third party certification program (for example, FeedAssure®, HACCP, GMP+, Non-GMO Project Verified, etc.), the CFIA would verify that the company is enrolled in or part of the program for that particular logo, but the CFIA would not verify that they meet the standards or criteria of that program. As part of routine inspection activities, the CFIA could verify that the company is in good standing with that program.

For the endorsement, promotional or marketing statements on feed labels (for example, logos of third party certification programs, etc.), information explaining what those logos and statements mean would need to be publically available so customers would be able to understand the statements being made.

Even though, the Non-GMO Project Verified logo is one of the logos that the CFIA would allow on a feed label (provided certain conditions are met), label claims or statements respecting novel traits or genetic modification such as genetically modified organism free, would not be considered acceptable under this policy.

Process for adding or removing permissible claims to the label of a registered livestock feed

The addition or removal of permissible claims to a label of a registered livestock feed is considered an administrative amendment. The addition of permissible claims to a label of a registered livestock feed is allowed, provided that all of the conditions for that permissible claim have been met. An application for an administrative amendment to the feed registration, along with copies of the updated label and application fees would be required. If this is submitted at the time of renewal, the administrative amendment fees are in addition to the applicable renewal fees for the livestock feed product. Please refer to CFIA's Fees Notice for current fee amounts.

If a regulatory party requests market access documents (for example, certificates of free sale) from the Animal Feed and Veterinary Biologics Division, they must provide the most recent label for their livestock feed product. Any updates to the registered livestock feed label must be addressed through an application form, labels and applicable fees, before such documents are issued by the CFIA.

Additional information on the administrative requirements for pre-market assessment and product registration for livestock feed can be found in Chapter 1 of RG-1.

Next steps

The CFIA is working on changes to the Feeds Regulations which would propose to introduce the permissible claims approach into regulation through the use of incorporation by reference (IbR). A proposed Tables of Permissible Claims on Feed Labels would be incorporated into the regulations and would allow claims to be made for livestock feeds similar to how it is described in this policy.

If you have any comments, questions or feedback on this policy, please contact the Animal Feed and Veterinary Biologics Division.

Appendix 1 : Permissible claims list

• Permissible claims related to the quality and content of the feed
  • Table 1: Claims respecting organic
  • Table 2: Claims respecting method of production
  • Table 3: Claims respecting the absence of ingredients in the feed
• Permissible statements and logos related to national or international industry certifications, or endorsements or marketing and promotional practices about the company
  • Table 4: Permissible statements and logos

Permissible claims related to the quality and content of the feed

Tables 1 to 3 outline the permissible claims currently allowed for feeds. In the approved claim column, options for wording of the claim are listed. Regulated parties may choose which of these approved claims is suitable for their livestock feed, if applicable. The optional claim column provides options for the wording of other claims that may be added. Feed products making a permissible claim must use the approved claim, but may also include an optional claim. The optional claim (for example, raised without antibiotics (RWA)) can be part of the product name on the feed label and an asterisk can be used to link to the approved claim on the label. All of the information found in conditions for the feed column and conditions for the label column must be met to be able to use the permissible claim.

Permissible statements and logos related to national or international industry certifications, or endorsements or marketing and promotional practices about the company

This table is not exhaustive and provides examples of what statements, logos or information would be acceptable on labels for mixed feeds or single ingredient feeds. Note that the following acceptable statements, logos and other information can appear on accompanying documentation as well as on the feed labels.

4.13 Responsibilities regarding the Labelling of Livestock Feed Products under the Workplace Hazardous Material Information System (WHMIS)

Introduction

This section provides a brief description of the WHMIS and outlines responsibilities with respect to WHMIS labelling on livestock feeds, as well as describing the relevant legislation for livestock feed products. Health Canada has established the national WHMIS regulations, and all enquiries regarding WHMIS should be directed to Health Canada at the WHMIS web site, or the address listed below.

What is WHMIS?

WHMIS is Canada's standard for hazard communication. Complying with WHMIS requires the cautionary labelling of containers of hazardous materials, the provision of Material Safety Data Sheets (MSDSs), and worker education programs. The Hazardous Products Act (HPA) establishes the supplier/importer labelling and MSDS requirements of WHMIS. Section 12 of the HPA establishes exemptions from these requirements for certain product categories such as food, pesticides and medical devices. Feeds and feed supplements are not encompassed by any of these exemptions, and thus may be subject to the WHMIS requirements legislated under the HPA. Feeds and feed supplements are also subject to the employer requirements set out by federal, provincial and territorial regulatory authorities responsible for Occupational Health and Safety (OHS).

The Government of Canada has established administrative arrangements with federal, provincial and territorial OHS regulators to conduct inspections for compliance with the WHMIS requirements of the HPA. However, Health Canada remains ultimately responsible for the administration of the HPA and it is the WHMIS program officials at Health Canada who set national regulatory, compliance, and enforcement policies. The WHMIS Web site was developed, and is maintained, by Health Canada's WHMIS program, on behalf of all federal, provincial and territorial government WHMIS regulatory authorities. The site provides a single window for national policies and information related to the administration of the WHMIS program in Canada.

Labelling

The requirements for WHMIS labelling are not administered under the Feeds Act and Regulations. However, when a WHMIS label is used on a product subject to the Feeds Act, the information contained within the WHMIS label must not contravene the requirements of the Feeds Act and Regulations.

Cautionary statements required by both the Feeds Act and WHMIS need only appear in the WHMIS section of the label. Label information required under the Feeds Act, but not required under WHMIS, including guaranteed analysis, registration numbers, etc., must be placed outside the hatched border of the WHMIS label. For products regulated under the Feeds Act, WHMIS labelling is required for most processing aids, acids, mineral products, and any other product that has the potential to be used in the workplace. Medicated feeds are not WHMIS-controlled, however, MSDSs must be maintained and provided upon request. Please contact Health Canada if you are unsure whether your product requires WHMIS labelling. It is the responsibility of the supplier/importer to ensure that product labelling complies with both the Feeds Act and WHMIS.

WHMIS References

All information pertaining to WHMIS labelling, MSDS requirements, classifications, exemptions, and enforcement can be found in the WHMIS Reference Manual. The WHMIS Reference Manual provides a section-by-section discussion of the federal legislation which sets out labelling and MSDS requirements for Canadian suppliers and Canadian importers. The manual, which includes a comprehensive index, can be obtained from the national WHMIS Web site.

or by contacting Health Canada at:

WHMIS Program, Health Canada
MacDonald Building
123 Slater Street, 4^th Floor
Address Locator: 3504D
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-2342

4.14 Labelling on livestock species

Feeds for the following species of livestock are currently regulated under the Feeds Act and regulations: cattle, horses, sheep, goats, swine, poultry (chickens, turkeys, ducks, geese), foxes, mink, rabbits and fish.

The livestock species or categories, age group or production stage for which a feed is intended to be used must be indicated on a label. This document provides guidance on the interpretation of terms that can be used on livestock feed labels.

4.15 Livestock feed forms

This document provides an interpretation on the forms of feed that may appear on livestock feed labels. The information is complementary to the Chapter 4.0 General guidance on labelling.

4.16 Toll manufacturing extra label drug use veterinary prescription feeds

Summary of memorandum

This document provides clarification on the acceptability of toll manufacturing extra label drug use veterinary prescription (vet Rx) feeds and further describes the documentary evidence that would be required to manufacture veterinary prescription feeds that meet federal regulatory requirements.

Glossary definitions

Feed

Feed means any substance or mixture of substances containing amino acids, anti-oxidants, carbohydrates, condiments, enzymes, fats, minerals, non-protein nitrogen products, proteins or vitamins, or pelletizing, colouring, foaming or flavouring agents and any other substance manufactured, sold or represented for use

• for consumption by livestock,
• for providing the nutritional requirements of livestock, or
• for the purpose of preventing or correcting nutritional disorders of livestock, or any substance for use in any such substance or mixture of substances; (aliments)

Toll manufacturing

An agreement where one facility subcontracts out the manufacture or processing of a feed to another facility, which has specialized equipment or processes that are better suited to manufacture the feed in question.

Veterinary prescription

Veterinary prescription means an order prescribing a medicated feed made in writing by a veterinarian licensed to practise in the province in which the feed is to be fed to livestock; (ordonnance)

Extra Label Drug Use Veterinary prescription feed

Extra Label Drug Use Veterinary prescription feed is a feed manufactured pursuant to a veterinary prescription which instructs the manufacture of a feed with a medication for a purpose or at a level not indicated in the Compendium of Medicating Ingredients Brochures (CMIB)

Question/issue

The Canadian Food Inspection Agency (CFIA) has received an inquiry from the feed manufacturing industry requesting clarification on whether it is possible by regulation to have an extra label drug use veterinary prescription feed be manufactured and medicated at more than one facility. It is proposed that the premix used to formulate the off label medicated feed be manufactured to include the medication at one facility, while the medicated premix would then be purchased and used by a 2^nd commercial feed mill to manufacture the complete feed as directed in the veterinary prescription. This proposal can also include a facility having a second facility complete a specialized processing step (such as pelleting, vacuum coating, etc.), prior to reaching the end user.

Background

Toll manufacturing is an acceptable manufacturing relationship between two feed mills. There is no restriction on the type of feed (premix, supplement or complete feed) that may be toll manufactured. The feeds may also be medicated as long as they are manufactured in accordance with the CMIB or a veterinary prescription.

However, there is a gap in policy related to the manufacture of off-label vet Rx feeds by two different facilities. More specifically in situations where one facility manufactures a medicated component (i.e., premix) to be used as an ingredient in the final feed, it is unclear what prescription and labelling standards must be met at time of sale by this toll manufacturer for the medicated premix.

As per section 5(1) of the Feeds Regulations, all feeds must be registered, except for those feeds described in section 5(2) of the Feeds Regulations.  Section 5(2)(g) of the Feeds Regulations identifies the information that is required to be on a veterinary prescription and Section 26 of the same regulations stipulates the information required to be on the label attached to the feed. The following are examples of information for the components of the feed that may not be accurately reflected when manufactured at a toll manufacturer.

On the Veterinary prescription:

• The type (premix, supplement or complete feed) and amount of feed to be manufactured
• Feeding/use instructions
• the name and level of inclusion in the feed of the medicating ingredient prescribed by the veterinarian

On the label attached to the product:

• The name of the feed
• The directions for use as indicated on the veterinary prescription
• Cautions and warnings as indicated on the veterinary prescription

How the requirements of sections 5(2)(g) and 26 are to apply to a toll manufacturer, who is only producing a component of the final extra label drug use veterinary prescription feed, has been unclear. The guidance provided in this policy will clarify the veterinary prescription and labelling requirements when an extra label drug use medicated feed is manufactured by two different facilities in a toll-manufacturing scenario.

Program response

The manufacture of an extra label drug use veterinary prescription feed by two or more different feed manufacturers is permissible. Indeed, adding a medication to a premix which is then blended into the final complete feed is considered to be a good manufacturing practice. Additionally, subcontracting the manufacture of a component of the medicated complete feed to another facility which has the specialized equipment and expertise to manufacture or process that component in a medicated formulation is also supported. As with all feed manufacturing, it is the responsibility of the feed manufacturers to be able to trace all components of the feed in the event of a recall.

An inspector must be able to determine whether a toll manufactured extra label drug use prescription feed has been manufactured in compliance with the applicable regulations. As per sub-paragraph 5(2)(g(iii))(v) and sub-section 15(4) of the Feeds Regulations, the manufacturer is required to have the signed veterinary prescription in hand during the manufacturing process in its entirety (i.e., before manufacturing starts). To achieve this, it is necessary for each separate manufacturer to have copies of the veterinary prescription under which the premix and the feed which contains the premix have been manufactured. However, it is not necessary to have multiple veterinary prescriptions issued for separate components of the final feed in a toll manufacturing relationship; only one veterinary prescription is required for the final feed.

For the facility that is toll manufacturing or receiving the premix it is necessary to have documentation available which provides the following information:

• The name of the medicated premix/supplement
• The level of medication in the premix/supplement
• The name of the facility for whom the extra label drug use medicated premix/supplement/complete feed is toll manufactured and sold to.

The toll manufacturer is also required to have in their possession a copy of the veterinary prescription under which the feed was manufactured. Furthermore, a label must be attached to the medicated premix/supplement that provides all the necessary labelling information for a veterinary prescription feed, including:

• the actual amount of medicating ingredient in the premix/supplement
• directions in sufficient detail to permit the safe use of the medicated premix/supplement by the secondary manufacturer that ultimately results in the level of medication indicated on the veterinary prescription
• name and address of the toll manufacturer
• name of the producer to whom the prescription was issued and
• name and address of the feed mill which caused the feed to be toll manufactured

Since the premix component of the toll manufactured feed is intended to be mixed further, the label attached by the premix manufacturer does not need to agree with the type and amount of feed indicated on the prescription.

Notes

• This policy does not supersede RG 1: Chapter 3.12 Micro Premixes.
• If non-compliance is identified, corrective actions may have to be conducted at one or all facilities involved in the toll manufacture of the veterinary prescription feed.
• If in doubt, questions and requests for clarification should be directed through the established communication pathways.