Safe and Suitable Ingredients Used in the Production of Meat, Poultry, and Egg Products - Revision 58
FSIS directive
7120.1
Series Type
7,000 Series: Processed Products
Issue Date
Jun 21, 2023
Full Directive
- PURPOSE
This directive provides inspection program personnel (IPP) with the latest updates to the list of substances that may be used in the production of meat, poultry, and egg products. As a reminder, this directive no longer provides the complete listing of approved substances, On-Line Reprocessing (OLR) and Off-Line Reprocessing (OFLR) Antimicrobial Intervention Systems. Instead, it only provides a list of the latest changes. The complete listing of OLR and OFLR Antimicrobial Intervention Systems is available at the link above. FSIS is also providing a link to the complete list of safe and suitable ingredients and the list in 9 CFR 424.21(c) of additional acceptable food ingredients. This Directive and its associated documents do not supersede regulations, including standards of identity (9 CFR 319 and 9 CFR 381 subpart P). Establishments are to ensure that their use of the listed substances is compliant with all regulatory requirements. - CANCELLATION
FSIS Directive 7120.1, Revision 57 Safe and Suitable Ingredients Used in the Production of Meat, Poultry, and Egg Products, 10/24/22 - LATEST UP-DATE TO THE LIST OF SUBSTANCES
Table 1: Summary of Updates to list of substances1) The use of the substances is consistent with FDA’s labeling definition of a processing aid., 2) Generally Recognized as Safe (GRAS), 3) Secondary Direct Food Additive, 4) Direct Food Additive, 5) Color Additive, 6) Food Contact Substance (FCS) subject to food contact notifications (FCN) is defined as any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food. Substance Intended Use of Product Amount Reference Labeling Requirements Acidifiers/Alkalizers Citric Acid An acidifier in water
used in poultry and
red meat processingCitric acid, sufficient for purpose 9 CFR 424.21(c) None under the accepted conditions of use (1) Antimicrobials A combination of natural source of nitrite and dextrose As an antimicrobial agent in comminuted meat products that will be heat-treated and processed to be NRTE or RTE. For use as a component in the product formulation by ingoing weight at a minimum level of 150 ppm nitrite from a natural source and a minimum level of 6700 ppm (0.67%) dextrose.
NOTE: Maximum limits for nitrite in cured products in 9 CFR 424.21(c) apply to natural sources used instead of pure sodium nitrite. Maximum limits for dextrose in 9 CFR 424.21(c) also apply to this use.Acceptability
determinationListed by common or usual name in the ingredients statement.
Products required to contain curing agents and sometimes cure accelerators approved for use in 9 CFR 424.21(c) as part of a standard of identity in 9 CFR 319 or 317.17(b) but instead are formulated with natural sources of these ingredients must be labeled as uncured under 9 CFR 317.17 and 319.2.
The statement 'no nitrates or nitrites added' needs to be qualified with the statement *except for those naturally occurring in [insert name natural source of nitrate]Bacteriophage preparation (EP75, EP335, or a mixture of EP75 and EP335; E. coli O157:H7 targeted) On the hides of live animals (cattle, buffalo, bison, wisent, goats, sheep) within holding pens, lairage, restraining areas, stunning areas, and other stations prior to hide removal Applied as a spray, mist, rinse, or wash to the hides of live animals at a final concentration up to 1x10^8 PFU/cm2. GRN 757, Acceptability determination None under the accepted conditions of use (1) An aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (HP), glycerol, and optionally, acetic acid or sulfuric acid (1) Whole and cut meat carcasses, parts, trim, and organs; and (2) whole or cut poultry carcasses, parts, trim, and organs. (1) Not to exceed 1800 ppm PPA and not to exceed 1215 HP (2) not to exceed 2000 ppm PAA and not to exceed 1474 ppm HP pH range for all applications: 2.5 - 12.5;
Spray, wash, rinse, dip, or scald water:
-Pressure: 25 - 45 psi (spray application);
-Contact time: 3 - 60 seconds
Chiller water:
-Contact time: 10 seconds - 120 minutesFood Contact Substance Notification No. FCN 1783 None under the accepted conditions of use (6) Dried Vinegar Added to trace lean pork trimmings for use in sausage and pork patties. Up to 0.4 percent dried vinegar to be added to trace lean pork trimmings where the amount of dried vinegar in the finished product does not exceed 0.06 percent of the total product formulation. Acceptability Determination None under the accepted conditions of use (1) An aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (HP), acetic acid, 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), and optionally, octanoic acid and peroxyoctanoic acid Process water or ice used in washing, rinsing, or cooling whole or cut meat carcasses, parts, trim, and organs. Not to exceed 1800 ppm PAA, 1050 ppm HP, and 117 ppm HEDP; spray contact time: minimum 2 seconds; wash and rinse contact time: minimum 2 seconds; and dip dwell time: minimum 2 seconds. Food Contact Substance Notification No. FCN 2236 None under the accepted conditions of use (1) Binder Maltodextrin As a binder in egg products Maltodextrin sufficient for purpose Acceptability determination; 21 CFR 184.1444 Listed by common or usual name "maltodextrin" in the ingredients statement (2) Rice starch As a binder in egg products Rice starch sufficient for purpose Acceptability determination Listed by common or usual name "rice starch" in the ingredients statement (2) Coloring Agent Annatto As a color preservative in egg products where standards of identity permit such use Annatto sufficient for purpose Acceptability determination; 21 CFR 73.30 List by common or usual name in the ingredients statement as "annatto (added for color)" or "colored with annatto" (2), or as "spice and color," "spice including annatto for color," "flavor or natural flavor including annatto for color," or "flavor or natural flavor and color" Beta carotene As a color preservative in egg products where standards of identity permit such use Beta carotene sufficient for purpose Acceptability determination; 21 CFR 73.95 List by common or usual name in the ingredients statement as "beta carotene (added for color)" or "colored with beta carotene" (2) Mixture of rice starch, maltodextrin, gum acacia, and vegetable juice As a color preservative in egg products where standards of identity permit such use Sufficient for purpose Acceptability determination; 21 CFR 184.1444, 21 CFR 184.1330, 21 CFR 73.260 List by common or usual name in the ingredients statement as "rice starch, maltodextrin, gum acacia, and vegetable juice (added for color)" (2); List the specific name/type of vegetable in the product formulation Vegetable juice As a color preservative in egg products where standards of identity permit such use Vegetable juice sufficient for purpose Acceptability determination; 21 CFR 73.260 List by common or usual name in the ingredients statement as "vegetable juice (added for color)" or "colored with vegetable juice" (2); List as the specific name/type of vegetable in the product formulation Emulsifying Agent Gum acacia (acacia, gum arabic) As an emulsifier or color preservative in egg products where standards of identity permit such use Gum acacia sufficient for purpose Acceptability determination; 21 CFR 184.1330 Listed by common or usual name "gum acacia (added for color)," "acacia (added for color)," "gum arabic (added for color)," "colored with gum acacia," "colored with acacia," or "colored with gum arabic," in the ingredients statement Sodium citrate An emulsifying agent in fried poultry snacks Sodium citrate not to exceed 2 percent of the product formulation applied prior to emulsification or cooking as a dry ingredient blend. 21 CFR 184.1751 and acceptability determination Listed by common or usual name in the ingredient statement. (2) Miscellaneous Hydrogen peroxide Processing aid in pasteurization of liquid egg whites In accordance with good manufacturing practices Acceptability determination None under the accepted conditions of use (1) Phosphate Buffered Saline (PBS) solution containing potassium chloride (KCl), potassium phosphate monobasic anhydrous (KH2PO4), sodium chloride (NaCl), and sodium phosphate dibasic anhydrous (Na2HPO4) Used as a wash in post-harvest to remove media components from cell-cultured poultry food products Levels not to exceed 0.05 g/L KCl, 0.05 g/L KH2PO4, 2.0 g/L NaCl, and 0.29 g/L Na2HPO4 Acceptability Determination and FDA Cell Culture Consultation Notification CCC 000002 None under the accepted conditions of use (1) Sodium chloride solution Used as a wash in post-harvest to remove media components from cell-cultured poultry food products Sodium chloride not to exceed 0.45% Acceptability Determination and FDA Cell Culture Consultation Notification CCC 000001 Listed by "salt" in the ingredient statement (2) Packaging System Carbon dioxide as part of modified atmosphere packaging (MAP) Not Shelf Stable Ready-to-Eat (RTE) meat and poultry products Two component gas mixture of carbon dioxide (20-40%) and nitrogen (60-80%) Acceptability determination Product labeled with a "Use By" or a "Use or Freeze By" date
Table 2: Summary of Updates to list of Approved On-Line Reprocessing (OLR) and Off-Line Reprocessing (OFLR) Antimicrobial Systems for PoultryList of Approved On-Line Reprocessing (OLR) Antimicrobial Systems for Poultry Approved OLR
SystemCompany Name/
DistributorSubstance PPM Concentration Method of
ApplicationInterox ProxiViv 15 Interox ProxiViv 22 Solvay Chemicals, Inc. An aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (HP), acetic acid, 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), dipicolinic acid (DPA) and sodium hydroxide. FCN 1641 PAA not to exceed 2000 ppm, HP will not exceed 933 ppm, HEDP will not exceed 120 ppm, and DPA will not exceed 0.5 ppm; pH range: 2-10; spray contact time: maximum of 15 seconds; spray pressure: 5-120 psi; dip/dwell contact time: 5-40 seconds Spray
DipHydrishield HC Hydrite Chemical Co. A concentrated formula of peroxyacetic acid (PAA), hydrogen peroxide (HP), acetic acid, and optionally 1-hydroxyethylidine-1,1-disphonic acid (HEDP), or dipicolinic acid (DPA). FCN 1806 The concentrated PAA formula is diluted and is to be supplied to the application at a concentration of: PAA between 80-2000 ppm, HP will not exceed 770 ppm, HEDP will not exceed 100 ppm or DPA will not exceed 4.00 ppm; pH 2.0 - 7.0, spray cabinet contact time: 15 - 120 seconds; dip contact time: 5 - 40 seconds. Dip
Spray CabinetHydriShield PA 22 SF Hydrite Chemical Co. An aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (HP), acetic acid, 1-hydroxyethylidene-1,1- diphosphonic acid (HEDP), and optionally sulfuric acid. FCN 1872 PAA between 20-2000 ppm, HP will not exceed 1436 ppm, HEDP will not exceed 100 ppm; pH 2.0 - 8.0; Pressure: 5 - 150 psi; exposure time: 5 - 60 seconds. Spray Cabinet
Wash
IOBWList of Approved Off-Line Reprocessing (OFLR) Antimicrobial Systems for Poultry Approved OFLR
SystemCompany Name/
DistributorSubstance PPM Concentration Method of
ApplicationInterox ProxiViv 15 Interox ProxiViv 22 Solvay Chemicals, Inc. An aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (HP), acetic acid, 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP), dipicolinic acid (DPA) and sodium hydroxide. FCN 1641 PAA not to exceed 2000 ppm, HP will not exceed 933 ppm, HEDP will not exceed 120 ppm, and DPA will not exceed 0.5 ppm; pH range: 2-10; spray contact time: maximum of 15 seconds; spray pressure: 5-120 psi; dip/dwell contact time: 5-40 seconds Spray
DipHydrishield HC Hydrite Chemical Co. A concentrated formula of peroxyacetic acid (PAA), hydrogen peroxide (HP), acetic acid, and optionally 1-hydroxyethylidine-1,1-disphonic acid (HEDP), or dipicolinic acid (DPA). Spray: FCN 1132 Spray Cabinet: FCN 1806 Spray: The concentrated PAA formula is diluted and is to be supplied to the application at a concentration of: PAA between 80-400 ppm, HP will not exceed 385 ppm, HEDP will not exceed 50 ppm or DPA will not exceed 4.00 ppm; pH 2.0 - 7.0, contact time: 15 - 120 seconds.
Spray Cabinet: The concentrated PAA formula is diluted and is to be supplied to the application at a concentration of: PAA between 80-2000 ppm, HP will not exceed 770 ppm, HEDP will not exceed 100 ppm or DPA will not exceed 4.00 ppm; pH 2.0 - 7.0, contact time: 15 - 120 secondsSpray
Spray CabinetHydriShield PA 22 SF Hydrite Chemical Co. An aqueous mixture of peroxyacetic acid (PAA), hydrogen peroxide (HP), acetic acid, 1-hydroxyethylidene-1,1- diphosphonic acid (HEDP), and optionally sulfuric acid. FCN 1872 PAA between 20-2000 ppm, HP will not exceed 1436 ppm, HEDP will not exceed 100 ppm; pH 2.0 - 8.0, Pressure: 5 - 150 psi; Exposure time: 5 - 60 seconds. Spray Cabinet
Wash
IOBW - QUESTIONS
Refer questions regarding this directive to your supervisor or as needed to the Office of Policy and Program Development through askFSIS or by telephone at 1-800-233-3935. When submitting a question, complete the web form and select New Technology, Innovations for the Inquiry Type. For labeling questions select Labeling for the Inquiry Type.
NOTE: Refer to FSIS Directive 5620.1, Using askFSIS, for additional information on submitting questions.