Antimicrobial Processing Aids for Which Health Canada Has Issued a Letter of No Objection (LONO) or an interim Letter of No Objection (ilono)

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1 Antimicrobial s for Which Health Canada Has Issued a Letter of No Objection (LONO) or an interim Letter of No Objection (ilono) December 17, 2015 Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch 1

2 Table of Contents Background Table 1: List of Antimicrobial s for Which Health Canada Has Issued a Letter of No Objection (LONO) Table 2: List of Antimicrobial s for Which Health Canada Has Issued an interim Letter of No Objection (ilono) Background This document contains two lists which will be routinely updated. The first (Table 1) is a list of antimicrobial processing aids that have been evaluated by Health Canada and for which Letters of No Objection (LONO) have been issued for specific uses on meat and poultry surfaces. The absence of a particular substance, a particular use of a substance, or a specific condition from this list would generally mean only that it has not been evaluated by Health Canada. The second list (Table 2) contains antimicrobial processing aids for which interim Letters of No Objection (ilono) have been issued for specific uses on meat and poultry surfaces in accordance with Health Canada s Policy for Issuing an Interim Letter of No Objection (ilono) for a Food (July 2015) ). The absence of a particular substance, a particular use of a substance, or a specific condition from the ilono list would generally mean only that a corresponding request has not been received by Health Canada. Substances on the ilono list may be transferred to the LONO list at such time that Health Canada completes a full assessment of that substance. These lists do not include antimicrobial food additives. Approved antimicrobial food additives may be found by consulting the Lists of Permitted Food Additives, specifically, the List of Permitted Preservatives, which is available on Health Canada s website. Processing aids are substances whose described use on foods is considered to fall outside the regulatory definition of a food additive that appears in the Food and Drug Regulations. These Regulations require that food additives be pre-cleared by Health Canada and added to the Lists of Permitted Food Additives before they may be used in foods sold in Canada. The Regulations do not require that processing aids be pre-approved by Health Canada. However, upon request, Health Canada will evaluate and issue opinions on the acceptability, from a chemical safety perspective, of specific uses of processing aids. For meat and poultry in particular, programs administered by the Canadian Food Inspection Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch 2

3 Agency require that processing aids used in federally-registered meat establishments be the subject of a Health Canada-issued LONO or ilono. LONOs and ilonos issued by Health Canada for specific uses of antimicrobial processing aids on meat and/or poultry products include a description of specific conditions of use as well as general provisions which must be met as a condition of Health Canada s letter of no objection. The most common provisions that must be met for antimicrobial processing aids, including those appearing in Tables 1 and 2 below, include: The water used in or to dilute the antimicrobial product is potable and all other components in the product meet their respective food-grade specifications set out in the most recent edition of the Food Chemicals Codex or established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA); The product is only used in situations where such use is considered necessary; The product is used in accordance with good manufacturing practices and as part of an acceptable quality control program wherein it is shown to be efficacious for its intended purpose; and No or negligible residues of any of the components of the antimicrobial product remain on the treated meat or poultry product (e.g., carcasses, parts, trim or ) following application. The use of a potable water rinse may be necessary in order to achieve this objective. Additional information: Policy for Differentiating Food Additives and s A Guide for Preparing Food Submissions Priority Scheduling and Expedited Handling of Submissions that have the Capacity to Enhance Food Safety Policy for Issuing an Interim Letter of No Objection (ilono) for a Food Table 1: List of Antimicrobial s for Which Health Canada Has Issued a Letter of No Objection (LONO) Acidified sodium chlorite 1) Red meat carcasses, parts and 2) Poultry carcasses, poultry parts, and trim applied prior to Applied as spray or dip at levels between 500 and 1200 ppm of sodium chlorite prepared by acidifying the sodium chlorite solution with food-grade acid (i.e., citric acid, phosphoric acid or Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch 3

4 Bacteriophage preparation (E. coli O157:H7 targeted) Bacteriophage preparation (Listeria monocytogenes targeted) Calcium hypochlorite immersion in a pre-chiller or chiller tank On hides of live cattle in holding pens prior to slaughter and hide removal Various ready-to-eat (RTE) meat and poultry products Red meat carcasses down to a quarter of a carcass On whole or eviscerated poultry carcasses prior to immersion in a pre-chiller or chiller tank hydrochloric acid) to achieve a ph of 2.2 to 3.0, equivalent to 50 to 266 ppm chlorous acid formed when prepared in the same manner as above to achieve a ph of 2.5 to 2.9 Applied as a spray on the hides of live cattle 1 to 4 hours prior to slaughter and hide removal Applied on the surface of the product to achieve a level of 1x10 7 to 1x10 9 phage per gram of product exceed 20 ppm calculated as free application followed by a potable water rinse. NOTE: In the case of pork carcasses, potable water rinse not required if pork carcasses held for a minimum of 12 hours prior to further processing application Cetylpyridinium chloride (CPC) containing 1.5 times its (i.e., CPC) weight of propylene glycol Poultry chiller water Raw poultry carcasses before or after air or immersion chilling available chlorine (measured in the incoming potable water) Not to exceed 1% aqueous solution of cetylpyridinium chloride and not to exceed 1.5% propylene glycol applied to raw poultry carcasses followed by a potable water rinse Chlorine dioxide Red meat carcasses and parts Not to exceed 20 ppm chlorine dioxide followed by a rinse with potable water On whole or eviscerated poultry Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch 4

5 Chlorine gas carcasses prior to immersion in pre-chiller and chiller tanks Poultry chiller water Red meat carcasses down to quarter of a carcass On whole or eviscerated poultry carcasses prior to immersion in a pre-chiller or chiller tank exceed 50 ppm chlorine dioxide, without subsequent potable water rinse Not to exceed 50 ppm chlorine dioxide in pre-chiller or chiller tank water with no more than 3 ppm residual chlorine dioxide in the chiller overflow water exceed 20 ppm calculated as free application followed by a potable water rinse. NOTE: In the case of pork carcasses, potable water rinse not required if pork carcasses held for a minimum of 12 hours prior to further processing application Citric acid DBDMH (1,3-dibromo- 5,5-dimethylhydantoin) Poultry chiller water Beef carcasses, parts, trim and 1) In water applied to beef hides, carcasses, heads, parts, and ; and 2) Recycled product in water applied to beef hides available chlorine (measured in the incoming potable water) Not to exceed a 2.5% solution 1) At a level not to exceed that needed to provide the equivalent of 300 ppm available bromine (corresponding to a maximum level of 270 mg DBDMH/kg of water) sprayed one-time for 20 seconds maximum 2) Following the application of DBDMH solution applied to beef carcasses and heads, recovered water containing DBDMH from the initial use on dressed carcasses may be reused once on beef carcasses with hides, for the purpose of Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch 5

6 rinsing Electrolytically generated hypochlorous acid Hypobromous acid 1) In water applied to poultry carcasses via an Inside-Outside Bird Washer (IOBW); 2) In water used in poultry processing for poultry carcasses, parts and ; and 3) In water supplied to ice machines to make ice intended for general use in poultry processing In poultry carcass chiller water Red meat carcasses down to a quarter of a carcass On whole or eviscerated poultry carcasses prior to immersion in a pre-chiller or chiller tank Poultry chiller water For use in water applied as a spray on pork carcasses In each application, at a level not to exceed that needed to provide the equivalent of up to 100 ppm available bromine (corresponding to a maximum level of 90 mg DBDMH /kg of water) At a level not to exceed that needed to provide the equivalent up to 100 ppm available bromine (corresponding to a maximum level of 90 mg DBDMH /kg of water). The resulting solution will be in direct contact with poultry carcasses submersed in water chiller for approximately 45 to 90 minutes exceed 20 ppm calculated as free application followed by a potable water rinse application available chlorine (measured in the incoming potable water) For either application, generated on-site from an aqueous mixture of hydrogen bromide and a hypochlorite salt (such as sodium, potassium, or calcium hypochlorite) sprayed once for less than 30 seconds at a maximum concentration of 900 mg/l (ppm) available bromine Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch 6

7 Lactic acid For use in water applied as a spray on beef carcasses Red meat carcasses, primals, subprimals, trim and offal (i.e., liver and kidney) Poultry carcasses 1) Generated on-site from an aqueous mixture of hydrogen bromide and a hypochlorite salt (such as sodium, potassium, or calcium hypochlorite) sprayed once for less than one minute at a maximum concentration of 300 mg/l (ppm) available bromine 2) Generated on-site from an aqueous mixture of hydrogen bromide and a hypochlorite salt (such as sodium, potassium, or calcium hypochlorite) sprayed once for less than 30 seconds at a maximum concentration of 900 mg/l (ppm) available bromine Up to 5 % lactic acid solution followed by a rinse with potable water. Rinsing with potable water not necessary if measures are taken to minimize the presence of chemical residues Up to 4.25 % lactic acid solution followed by a rinse with potable water Lactic acid (45-60%), citric acid (20-35%), and potassium hydroxide (>1%) blend Beef, pork, and lamb carcasses, primals, sub-primals, trimmings, heads, tongues, tails, and offal (i.e., liver and kidney) exceed 2.5% solution by weight for the appropriate amount of time for the technical effect. Potable water rinse not required if appropriate measures are put in place NOTE: Not to be applied to single cuts of meat (e.g., steaks) to be packaged and offered directly to consumers Lactoferrin Beef carcasses Not to exceed 2% activated lactoferrin followed by rinse with lactic acid and then a rinse with potable water Ozone Hot dogs (frankfurters) and chicken drumsticks An aqueous solution of ozone, generated on-site, to be sprayed for up to 5 seconds Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch 7

8 acetic acid, sulphuric acid (optional), and 1- hydroxy-ethylidene- 1,1-diphosphonic acid peroxyoctanoic acid, acetic acid, octanoic acid and 1- hydroxyethylidene-1,1- diphosphonic acid acetic acid, and 1-hydroxy-ethylidene- 1,1-diphosphonic acid 1) Red meat carcasses, parts, trim, and 2) Poultry carcasses, parts, and 1) Red meat parts, trim and 2) Applied during poultry scalding, feathering, evisceration; pre-chiller washing of carcasses; in the chiller and on post-chill carcasses, parts and 1) Process water to treat red meat carcasses, trim, parts and 2) Process water to treat poultry carcasses, parts and directly onto hot dogs or raw drumsticks at a level not to exceed 3 ppm 1) The level of use in water that yields a concentration no greater than 220 ppm peroxyacetic acid, a concentration of hydrogen peroxide no greater than 150 ppm, and a concentration of HEDP no greater than 13 ppm 2) The level of use in water that yields a concentration no greater than 220 ppm peroxyacetic acid, a concentration of hydrogen peroxide no greater than 110 ppm, and a concentration of HEDP no greater than 13 ppm 1) The level of use in water that yields a concentration of total peroxyacids no greater than 220 ppm expressed as peroxyacetic acid, a concentration of hydrogen peroxide no greater than 150 ppm, and a concentration of HEDP no greater than 13 ppm 2) The level of use in water that yields a concentration of total peroxyacids no greater than 220 ppm expressed as peroxyacetic acid, a concentration of hydrogen peroxide no greater than 110 ppm, and a concentration of HEDP no greater than 13 ppm In either application, the level of peroxyacetic acid will not exceed 220 ppm, hydrogen peroxide will not exceed 162 ppm and HEDP will not exceed 13 ppm 1) In process water or ice used to In either application, the level of Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch 8

9 acetic acid, and 1-hydroxy-ethylidene- 1,1-diphosphonic acid treat (e.g., wash, rinse or cool) red meat carcasses, parts, trim, and 2) In process water or ice to treat (e.g., spray, wash, rinse, dip, chiller water or scald water) poultry carcasses, poultry parts and peroxyacetic acid will not exceed 204 ppm, hydrogen peroxide will not exceed 280 ppm and HEDP will not exceed 8.4 ppm NOTE: One LONO has been issued for this use. More commonly, LONOs are issued for a maximum level of 150 ppm hydrogen peroxide for use on red meat products (carcasses, parts, trim and ) and 110 ppm hydrogen peroxide on poultry products (carcasses, parts, and ) peroxyoctanoic acid, acetic acid, octanoic acid and 1- hydroxyethylidene-1,1- diphosphonic acid Sodium hypochlorite Red meat carcasses Red meat carcasses down to a quarter of a carcass On whole or eviscerated poultry carcasses prior to immersion in a pre-chiller or chiller tank Poultry chiller water The level of use in water that yields a concentration of total peroxyacids no greater than 220 ppm expressed as peroxyacetic acid, a concentration of hydrogen peroxide no greater than 75 ppm, and a concentration of HEDP no greater than 10 ppm exceed 20 ppm calculated as free application followed by a potable water rinse NOTE: In the case of pork carcasses, potable water rinse not required if pork carcasses held for a minimum of 12 hours prior to further processing application available chlorine (measured in the incoming potable water) Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch 9

10 Table 2: List of Antimicrobial s for Which Health Canada Has Issued an interim Letter of No Objection (ilono) subject of ilonos Bromine generated from 1,3-dibromo-5,5- dimethylhydantoin (DBDMH) acetic acid, 1-hydroxy- ethylidene- 1,1-diphosphonic acid Red meat products including beef hides, heads and ; pig, goat, and sheep carcass, parts and 1) Whole, half or quarter poultry carcasses and poultry carcass parts and 2) Poultry carcass, parts and Applied at up to 900 ppm of available bromine in water or ice, for up to 30 seconds 1) Applied once by low-temperature immersion bath (less than 40 degrees F), at levels not exceeding 2000 ppm peroxyacetic acid and 136 ppm HEDP, for 30 to 60 seconds 2) Applied at up to 2000 ppm peroxyacetic acid, 750 ppm and 136 ppm HEDP 3) Whole or cut red meat, including carcasses, parts, trim and 3) Applied in process water used for washing, rinsing, or cooling at up to 400 ppm peroxyacetic acid, 350 ppm and 22.5 ppm HEDP 4) Processed and preformed red meat and poultry products 4) Applied in process water or ice for washing, rinsing, storing, or cooling at up to 230 ppm peroxyacetic acid, 165 ppm and 14 ppm HEDP 5) Whole, half, or quarter red meat carcasses 5) Applied once by spray, at up to 400 ppm peroxyacetic acid, 267 and 27 ppm HEDP, for 1 to 2 minutes contact time prior to further processing Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch 10

11 subject of ilonos 6) Red meat carcass parts, trim and 6) Applied as parts, trim and which are tumbled, dipped or immersed in solution, at up to 400 ppm peroxyacetic acid, 267 ppm and 27 ppm HEDP, for 1 to 2 minutes prior to further processing acetic acid, 1-hydroxy- ethylidene- 1,1-diphosphonic acid (HEDP), sulfuric acid, dipicolinic acid (an aqueous Sulfuric acid and sodium sulfate (equivalent to sodium bisulfate) Bacteriophage preparation (E. coli O157:H7 targeted) Bacteriophage preparation (Salmonella enterica targeted) Red meat carcasses Meat and poultry surfaces Red meat parts and trim prior to grinding Ready-to-eat (RTE) poultry products prior to slicing and on raw poultry prior to grinding or after grinding Applied in process water at up to 460 ppm peroxyacetic acid, 100 ppm hydrogen peroxide, 2 ppm HEDP and 0.5 ppm dipicolinic acid Spray, wash, or dip, at levels not to exceed those needed to achieve a target ph range of on the meat or poultry surface Applied as a spray, at a level not greater than 2 ml diluted solution per 500 cm 2 of surface area food, equivalent to 3x10 6 PFU per gram of food Applied as a spray, at a level of approximately 1x10 6 to 1x10 7 plaqueforming units (PFU) per gram of food Ozone (aqueous solution) Raw, fresh meat and poultry An aqueous solution of ozone, generated onsite, applied directly by spray at up to 2.5 ppm ozone, for up to 5 seconds Bureau of Chemical Safety, Food Directorate, Health Products and Food Branch 11

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE WASHINGTON, DC

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE WASHINGTON, DC FSIS DIRECTIVE 7120.1 Rev. 31 11/24/15 SAFE AND SUITABLE INGREDIENTS USED IN THE PRODUCTION OF MEAT, POULTRY, AND