Ps REPUBLIC OF THE PHILIPPINES = Mia DEPARTMENT OF HEALTH Food ant Dray Admerstration FOOD AND DRUG ADMINISTRATION PHILIPPINES Filinvest Corporate City Alabang, Muntinlupa City FDA CIRCULAR 27 February 2013 NO. 2033-630 TO: ALL CONCERNED SUBJECT: REVISED GUIDELINES FOR THE ASSESSMENT OF MICROBIOLOGICAL QUALITY OF PROCESSED FOODS As part of the mandate of the Food and Drug Administration to protect the public health and pursuant to the provisions of Republic Act No. 9711 otherwise known as the “Food and Drug Administration Act of 2009”, the Bureau Circular No. 01-A s. 2004 Guidelines for the Assessment of Microbiological Quality of Processed Food is hereby revised with the following considerations: 1. Addition of new food category/products, 2. The need to update old references, 3, Adoption of approved CODEX Alimentarius Commission Guidelines. This FDA Circular is hereby issued to serve as guidelines for the assessment of microbiological quality of certain processed foods; and help ensure that food manufacturers comply with Good Manufacturing Practices (GMP). The reference criteria are prescribed in Tables 1-14. The tables contain a description of the food to which a criterion applies, the required test(s) or the microorganisms considered to be acceptable, marginally acceptable or critical, and the number of samples which should conform to the limits The methods used for the enumeration or detection of specified microorganisms shall be those that have been internationally established. Such methods, as well as the cited specifications were obtained from the following internationally recognized references: 1. FDA Bacteriological Analytical Manual published by the AOAC 2. Compendium of Analytical Methods of the Canadian Health Protection Branch Compendium of Methods for the Microbiological Examination of Foods compiled by the American Public Health Association (APHA) 4. Specifications and Standards for Foods, Food Additives, etc., Japan External Trade Organization 5. Microorganisms in Foods by the Intemational Commission on Microbiological Specifications for Foods (ICMSF) Codex Alimentarius Commission Guidelines International Standards Organization (ISO) Microbiological Methods Australia New Zealand Food Authority (ANZFA) ere This FDA Circular shall take effect immediately and supersede other regulations or ‘guidelines inconsistent herewith.TABLE 1. MILK AND DAIRY PRODUCTS, FOOD DESCRIPTION TEST/MICROOR r ier Powders (e.g. whole, nonfat or filled milk, buttermilk, | Salmonella/25g, normal routine 10 }0 }0 whey & whey protein forhigh risk population |30 | 0 | 0 concentrate) SPC/APC, cfu/g 5 2 | 5x10? | sxio* (intended for children Enterobacteriaceae cfw/g 5 1 }10 10° more than 36 months of age and adults) "Coliforms, cfg 5 |i [to [10 Smectened Condensed Yeast and Molds Count, cfg [5 [1 | 10 | 102 ____| SPC/APC, cfg 5 1 [10° 10° Liq (evaporated or ready to | Commercially drink) & Commercial Sterility 6 Cream (UHTisterilized) sterile Coliforms, cfu/mL 10 10° Salmonellal2SmL. 0 1 Listeria monocytogenes/25 ml. 0 Pastcaraed Mille Psychrotrophic bacteria, cfu/ml 10 | 10? SPC/APC, cfw/mL Sx10* | 108 >_for flavored milk Sx10*_| 108 "Coliforms, cfu/g 10 10° Salmonella/25g | Pasteurized Cream Listeria monocytogenes/25g 0 10 10° Sxio* | 10° | 10 10° 10 10 Psychrotrophic bacteria, efu/g SPCIAPC, cfu/g ‘S. aureus (coagulase +), efwmL ‘Coliforms, cfu/mL Salmonella/2SmL Lactic Acid, cfwmL (required minimum level: >10°) | - outs 5 enn -codpeooces| ° Yogurt and other fermented milk " Coliforms must be negative for E. coli Legend: a— number of sumple units selected from alot of food to be ex acceptable level of microorganism determined by a spec achievable under GMP DM. evel which when exceeded in one or more samples would cause the lot to be rejected as hazard or im scat potential health Page of 11TABLE 1. oy Treas MILK AND DAIRY PRODUCTS cont. TTA aL c Cheese and Cheese Products; e.g. Cottage Cheese; Soft and Semi-soft cheese (moisture >39%, pH > 5) Processed Cheese Spread | All Raw Milk Cheese; Raw Milk Un-ripened cheese w/moisture>50%, S. aureus (coagulase +), ofwg |S |2 [10 | 10 E.coli, MPNig $ 1 1 110 Coliforms, MPN/g se la (iu 10° Psychrotrophic bacteria, cfg | 5 2 |10 10° Salmonella/25g 5 jo jo | Listeria monocytogenes/25g Sy x | Gian) | "Coliforms, cfwg 5 1 {10 107 S. aureus (coagulase +), cfwg | 5 1 | 10, 10° SPCIAPC, cfu/g 5 |2) jaf 5x10" Campylobacter/25g 5s fo |o Salmonella/25g 5s lo |o Listeria monocytogenes/25g 5 jo Jo S._aureus (coagulase +), cfg _|5 2_ [10 10° | pH > 5.0 Ne anon! | | Butter (whipped, pasteurized) Coliforms must be negative for E. coli TABLE 2. FATS, OILS AND FAT EMULSIONS TUTE ROT ST feerrarex ener Enterococci, cfuw/g YMC, efu/g Proteolytic bacteria, cfulg Coliforms, cfu/g S. aureus (coagulase +), cfulg Psychrotrophic bacteria, efu/g SPC/APC, cfwmL Butter made from unpasteurized milk or milk products Coliforms, cfg E.coli, MPN/g S. aureus (coagulase +), cfu/g Salmonellal25g Listeria monocytogenes/25¢ SPC/APC, cfu Margarine S. aureus (coagulase +), chulg Faecal Coliform, MPN/g Listeria monocytogenes/25g Salmonellal25g SPCIAPC, cfu/g YMC, efu/g 5x10? 2.5x10° 5x10" ‘Legend: — number of sample units ler GMP M.~ evel which when exceeded in one or more samples would cause the lotto be rejected ected from 2 10tof fod to be examined acceptable level of microorganism determined by a speciied method; the values are gene based on levels that are ‘his indicates potential health Page3 of 11TABLE 3. EDIBLE ICES, INCLUDING SHERBET AND SORBET [eee a ME TAO CEO NT Reference Criteria ‘Coliforms, cfu/g 10 | 10 - Listeria monocytogenes/25g 0 et yt Salmonellal2Sg 0 Glen aes SPCIAPC, cfu/g 10° | sxto* 10 10m. 45) lL | YMC, cfu/g 5 20 Fermented Vegetables, | Coliforms, MPN/g, 5 jo |3 Ready to Eat (e.g. E.coli, MPN/g 5s jo |3 Kimehi) Salmonella /25g 5s jo |o | Staphylococcus aureus, cfg |5 _|0 | 10 Fruits & Vegetable products in Hermet sealed containers (thermally processed) | 9 | Commercially sterile Commercial sterility 6 Dried Vegetables E.coli, MPN/g 5 [2 [110 [10 |[Caeeeay cancientasay Refer to PNS/BAFPS 25:2007 | Peanut Butter & other | | Nut Butters | | > consumed without | | heating or other Salmonella/ 25g 10 |o jo | treatment to destroy microbes > used as ingredient in high moisture Salmonella/ 25g 20 0 0 food +3 Molds, cfu/g 5 2 [10 10° Sun Dried Fruits Osmophilic Yeasts, efu/g 5 [2/10 eh 107 3 E.coli, MPNig. Is 2oale u ‘Coliforms must be negative for E.coli TABLE 6. EGG AND EGG PRODUCTS [exe a ON EN TANT LOO UNTN Reference Criteria Coliforms, efu/g 5 | ae Ese Salmonellal25g 10 |o YMC, cfulg (for dried products) | 5 (liquid, frozen or dried) SPC/APC, efw/g slo Legend: — number of sample units selected from ato of fond ta be examined ‘m~ acceptable level of microorganism determined by a specified methods the values are generally based on levels that are achievable under GMP M evel which when exceeded in one or more samples would cause the lt to be rejected as this indicates potenti hazard or imminent spoilage ‘¢— masimum allowable numberof defective or margi rh ceptable units Page S of 1TABLE 7. CEREALS AND CEREAL PRODUCTS FOOD DESCRIPTION TEST/MICROORGANISM M Pecranexes Molds, cfu 5 [2 [io J10, Yeast & Yeastllike fungicfwg |5 [2 |10 | 10% poe core Coliform, efu/g 5 |2 J10 | 10? SPCIAPC, cfg 5 | |aoesarot YMC, cf/g 5 2/10 10" Ni SPC/APC, cfu/g 5 |2 |i {10 Coreals/Cereal Grains Csr, cfule 3 12 lie |r! E.coli, MPNig 5 2 {107 10° Saar seedsiand E.coli, MPN/g 5 2 10, Jao Coliforms, cfu/g 5 2) -/107 10° Ss bean sprouts, alfalfa | scfmonellal25@ |5 lo jo Soya Flours, Lae 5 Goes Gaal Molds, cfu/g js |2 J10 J 10 Salmonella/25g |5 jo Jo Isolates i | Molds, cfu’g {5 2 [107 10 orn | Yeast & Yeastllike fungi,cfvg §— |5 |2 [10 | 10 Flour, Corn meal, Corn | Cotiform, cfivg 3 |2 |10 J 10? a one Bacillus subtilis, cfulg, 5 |i (os 10° “rope spores” | Frozen entrees containing Rice or Corn | B. cereus, cfwg 5 1 }10 | 108 Flour as main ingredient Coliforms, efu/g 5 [2 [tom pla E. coli, MPN/g, 5 1 10 10° Psychrotrophic bacteria, cfwe | 5 2 | 10? 10° Soy Protein Clostridium perfringens, clwg | 5 2 110 10? YMC, cfu/g 5 2 |10 10° Salmonella | 25g 5s jo jo SPC/APC, cfu/g s 2 10° 10° B. cereus, cfulg 5 2 [107 10° Tofu E.coli, MPN/g 5 jo 18 S.aureus (coagulase +), cfwg | 5 2 | 10? 10° Coliforms, cfu/g. $ 2 10, 10° Pasta Products and YMC, cfu/g 5 2 | 10? 10° Noodles Uncooked (wet | S. aureus (coagulase +), cfwg | 5 1 | 10? 108 & dry) Salmonella | 25g 5 0 jo | E SPC/APC, cfw/g 5 _|2....| 101s /a07 Coliforms, cfu/g S [2 (dome jao YMC, efu/g 5 [2 | a0ee 2 itor Sere Salmonellar2se 5 jo lo SPC/APC, cfw/g 5__|2 [10° | Sxio* Legend: n numberof simple units selected frm lot of fod tobe examined ‘m—aeceptabl evel of microorganism determined hy a specied method; the values are generally based on levels that are achievable under GMP IM level which when exceeded in one or more samples would cause the lot to be rejected as this indicates potential health hnazardor imminent spoilage ‘¢~ maximum allowable numberof defective or marginally acceptable units Page 6 of 1TABLE 8. BAKERY PRODUCTS Texel TON ME T UNCOOL ET DT Reference Criteria Frozen Bakery products . (ready to eat) with low- | S. aureus (coagulase +), cfwg | | 1 | 10? | 10° | acid or high ay fillings or | Salmonella/ 25g s fo jo | toppings _ Frozen Bakery Products (to be cooked) with low- meee ls a lat Slat acid or high a fillings oF | Smprertease en ® | 4 Lg toppings (c.g. meat pies, pizzas) Molds, efu/g 5 loa alto Yeasts & Yeastlike Fungi,cfwe|5 | | 49° | 10 i Coliforms, cfu/g, 5 2 |10 10° Frozen and Refrigerated | psychrotrophic bacteria, cfg |3 |2 10 | 108 ae a SPC/APC, efu/g 5s |2 {10% J 10? » Salmonella! 25g so jo. pel 'S. aureus (coagulase +), cfu/g | 5 2 | 10° Gee) E. coli, MPN/g oe | Cale | Molds, efu/g 5 12 lie lio | Yeasts & Yeastlike Fungi, cfwg|5 |2 |10° | 10° Frozen & Refrigerated | Cciovms, ful 5 la gee Ho? poses Psychrotrophic bacteria, cfg |5 |2 | 10 10° SPCIAPG, cfg 5. [2a toe ot Baked Goods - 2 yt 7 2 (eiicepaly | Soregonmmme cts |x [2 |i |g | sensitive types e.g SPCIAPC, efulg § fale a0" containing eggs & dairy | Cotiforms, cfug 5s |2 |50 | 10° products) a z 2 Coated or Filled, Dried | ’Coliforms, MPNig 3s (2 [3 20 | shelf-Stabl i Salmonella/25; __lio_|o fo Coliforms must be negative for E.coli TABLE 9. READY TO EAT SAVOURIES FOOD DESCRIPTION TEST/MICROORGANISM LoCo OE Molds, efu/g Yeast & Yeastlike fungi, cfwig Snack Foods Colfer, oly L SPC/APC, cfu/g Legend: n— numberof sample units selected fom lot of food oe examined 1m ~ acceptable level of microorganism determined by a specified method: the values are generally based on levels that are achievable under GMP M~ level which when exceeded in one oF more samples Would cause the lotto be rejected as this indicates potential health hazard oF imminent spoilage {€— maximum allowable number of defetive or marginally acceptable units Page of 11TABLE 10. MEAT AND MEAT PRODUCTS** Taye TAO OTT 'S. aureus (coagulase+),cfwg [5 | 1 | Dried Animal Products | Clostridium perfringens, cfwg | 5 1 | 107 10r5\| Salmonellal25\ 10 {lo |o | Salmonellal25g 5 [o fo. ae Clostridium perfringens, cfg |5 |2 | 10? | 10 (aes ease S aureus (coagulase +),efwg |5 |2 |10 | 10° ‘Coliforms, cfw/g 5 2 110 1° | SPC/APC, cfw/g 1s 2_ | 10* 10° Gold Cuts, Frozen & | E.coli, MPNig 3 jo {18 Chilled Hot Dogs, Salmonellal25g 10 |o Jo Corned Beef, Luncheon | S. aureus (coagulase +), cfu/g 5 2 |10 10° Meat SPC/APC, cfw/g 5 2_|10° 10° Packaged cooked 'S. aureus (coagulase +), cfg | 5 a ee 10° cured/salted meat (ham, | Salmonella/25g s jo jo bacon) Listeria monocytogenes/25| slo |o Fermented, comminuted 2 E.coli, MPN/g 5 fo |18 Be ne eu & | 5 aureus (coagulase+),cfwg |5 [1 |10° | 10" Sua eT Salmonellal25g 5 fo Jo sausages) " Cooked Poultry Meat, Frozen to be reheated S. aureus (coagulase +), cfw/g 5 1 }10 10* before eating (c.g. Salmonellal25g 5 jo |o | prepared frozen meals) : Cured/Smoked Poultry | S. aureus (coagulase +), cfwe [10 [1 [10° | 10° Meat Salmonellal25g, 10 _|o |o fe rier ocala _{ Salmoneltal 58 10 Jo |o Fresh/Frozen Raw Chicken SPC/APC, cfu/g (at 20°C) 5 3. | 5x10° | 107 (during processing) | Meat Products in e hermetically sealed Commercial sterility 6 | | Commercially containers a | "Coliforms must be negative for E.coli ** Effective 16 February 2010, all meat and meat products are being handled and regulated by the National Meat Inspection Service (NMIS) of the Department of Agriculture as mandated by RA 9296 “Meat Inspection Code of the Philippines and DA-DOH joint Administrative Order No.1 s 2009”. Any guidelines set by the NMIS shall supersede the specifications herein stated once it is made available. Legend: — number of sample unite selected from alot of fond to be examined ‘m— acceptable level of microorganism determined by a specified methods the values are generally based on levels that are ‘chievable under GMP M.~ level which when exceeded in one or more samples would cause the lotto be rejected as tis indicates potential health hazard or imminent spoilage ‘¢~ maximum allowable number of defective or marginally acceptable units Page 8 of 1TABLE 11. FISH AND FISH PRODUCTS Fee SO HOTT a ieee errr E.coli, MPNig. 7 7 1 i 500 a S. aureus (coagulase +),cfwg |5 |2 | 10° | 10% aes and’ ly parahdemohueercalE 5s |2 |10? 10° | Salmonella/25e 5 |o jo SPC/APC, cfu/g 5 3__| sxi0®_| 107 | Ecoli, MPN/g. 5 248 500 oe ees S. aureus (coagulase +), cfg | 5 1 | 10 , | lot SPC/APC, cfg 5 |2_| sxi0*_|10’ E.coli, MPN/g 5 )3 fil 500 S. aureus (coagulase +), cfw/g 5 ai |) 10° Frozen Raw Crustaceans © | Salmonella /25g 5 0 0 V. parahaemolyticus, cfulg 5 1 |10 | 10° SPC/APC, ofu/a 5 [3 [1 [10 E.coli, MPNig os j2ee iB 500 S. aureus (coagulase +), cfwg |5 |0 |1 ee iGooked ‘Salmonella (25g 20 |0 |o PE ees V. parahaemolyticus, cfu/e 10 |1 | 10? 10° SPC/APC, cfw/g 5 |2_ [5x10 | 5x108 E.coli, MPNig 5 {1 [1 [500 Cooked, Chilled & S. aureus (coagulase +), cfg /5 |0 |10 | Frozen Crabmeat* V. parahaemolyticus, cfu/g 10/1 | 10? | 10° SPC/APC, cfu/g S|) Sate aed? E.coli, MPNig 3 [0 (16 Fresh & Frozen Bivalve | Salmonella/25g, 20 |o |o Molluses* V. parahaemolyticus, cfu/g 10 |1 | 10° 10° SPC/APC, cfg 5 o [5x10 | Fish & Shellfish | products in hermetically | Cossmercial Sterility \6 | | Commercially sealed containers sterile (thermally processed) | “For fish derived from inshore/inland waters of doubtful bacteriological quality, particularly warm areas or harvested during summer. Tests for Salmonella and V. parahaemolyticus recommended if fish is to be eaten raw. Test for S. aureus recommended for smoked fish ‘Test for S. aureus recommended for breaded products. Salmonella and V. parahaemolyticus applied to products from waters or harvested during summer. 4SPCIAPC tor frozen products only * Criteria to be used only for molluses from approved harvesting arcas where waters are free from enteric bacteria or virus contamination and no significant contamination by toxic metals or chemicals may be accumulated by animals ‘Tests for Salmonella and ¥- parahaemolyticus recommended for molluscs from endemic areas or harvested from warm weters during summer. Legend: a— number of sample units selected from alot of fd to be examined ‘m~ acceptable level of microorganism determined by x specified method; the values are generally based om levels that are achievable under GMP M.~ level which when exceeded in one or more samples would cause the lotto be rejected as this indicates potential health hazard or imminent spoilage {€— maximum allowable number of defective or marginally acceptable wits Page of LITABLE 12. SPICES, SOUPS, SAUCE: Tree anon TEST/MICROORC Refe SALADS AND PROTEIN PRODUCTS see 2 ] ‘ 5 YMC, cfu/g 5 3 10 | | Dry Mixes for Soup and | cotitorms i 5s {3 1 | SPC/APC, cfu/g 5 2 10° | Salmonellal25g 510 | Yeast Salmonella/25 20 [0 a Molds, cfu/g 5 2 10° res SPC/APC, cfg 5 2 10° ‘Coliforms, cfwg 5 (2 10° S. aureus (coagulase +), fwg |5 |2 10° | Spices (ready to eat) Salmonella/ 25g 5 0 | Molds, cfwg 5 2 10° | SPC/APC, cfu 5 2 10° — oe SPCIAPC, cfg s 2 J10 10? | (ex Ma a YMC, cfg 5 2 |10 10 | Thousand Island, Ranch, | Silmonella/25g 2 eae French) Listeria monocytogenes/25g 5 |o |o "Coliforms must be negative for E.coli TABLE 13. BEVERAGES Tayo Ne aT Ong Non Alcoholic Beverages Ae Le OTN Reerseen oer) juices/mixes) B YMC, efwmL 5 (Ge Readyito atin Coliforms, efwmL. 5 softdrinks, iced tea, SECIS chai 3 energy drinks) Bee Frozen Juice SPC/APC, cfu/mL 5 /2ra(aor 10 Concentrate YMC, cfu/mL E 1_|10 50 perrdered Beverages (CE: SPC/APC, cfu/s § ° eodieareanased Coliforms, efulg 3 [odo Legend: n— number of sample units selected from alo of food t be examined 1m — acceptable level of microorganism determined by a specified method; the achievable under GMP M~ evel which wh ‘exceeded in one oF more samples would cause hazard or imminent spoilage ‘c= maximum allowable numberof detective or marginally acceptable units re generally based on levels that are to be rejected as this indicates potential health Page 10 of 1TABLE 14. FOOD FOR INFANTS AND YOUNG CHILDREN Oe TON M oes ‘Routine analysis Cronobacter spp. / \0g 30 0 0 *Salmonella/25 Powdered Infant ik 6 | jo Formula with or without | For oman esa (tts De routine analysis) ee ees le su i g io! 1, a (intended for 0 to 6 Ecol ENE. | months old) *Process Hygiene Indicators: x 5 SPC/APG, cfw/g 5 |2. | sx10® | sxi0’ Enterobacteriaceae/ 10g 10 |2 |0 °NA Routine analysis Follow-up Formuta/Mitk | “S#monella/25 e 60 |o |o ‘Supplement For compli investigation atonal 9 (intended for infants 6 eee 5s |2 |3 ul months on and for young | coktene, Mr Nig io Ji Vie (10 | children 12-36 months of | # ¢0/% MPN/g | | ge) Process Hygiene Indicators: . 5 | SPCIAPC, efug 5 |2 | Sxt0® | sx10 Enterobacteriaceae! 10g 10 |2 |0 'NA Infant Formula -liquid | ¢, a Commercially (Uittisterlized) Commercial Sterility 6 0 lamas Baby foods in . . hermetically sealed ‘Commercial Sterility 6 0: | Commeccally Sterile containers | : ‘Coliforms, MPN/g 5 re8 20 fecal - pecans SPCIAPC, efu/g 5s {2 |10° | 10° ee - peas “Salmonella /25g 60 10 0 recon: imation Listeria monocytogenes/25g 5 0 lo Dried prodects requiving | 1-1/forms, cfi'g s 2 J10 10 reconstitution and Seen Salmonellal25g s jo jo peer SPCIAPC, efu/g 5 |3-7| qty ea} 10% consumption Cereal based foods for | Bacillus cereus, cfu/g 10 J1 | 10" 10° infants Clostridium perfringens, cfwg | 5 1 10. 10° SPCIAPC, cfu/g S$ [2° 10s esto Salmonella!2s 10 Jo Jo Coliforms, MPN/g S$ -)2 ‘3 20 Coliforms must be negative for E. coli ig sample units may be composited to a quantity not to exceed 400g n= 60 4x 15 (258) composite units * Process hygiene criteria to be applied to the finished product (powder form) or at any other previous point that Provides the information necessary for the purpose of verification. The criteria is intended to be used by the ‘manufacturer as a means of ongoing assessment of their hygiene programs. (CAC/RCP 66-2008) ® NA = not applicable Lewend: — number of sample units selected from a lot of food to be examined ceptable level of microorganism determined by a specified method; the values are generally based on levels that are stchievable under GMP M— level which when exceeded in one or more samples would cause the lt to be rejected as tis indicates potential health hazard or imminent spoilage €~ maximum allowable number of defective or marginally acceptable units Page 11 of 11