FDA Phil Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods

REPUBLIC OF THE PHILIPPINES

DEPARTMENT OF HEALTH

FOOD AND DRUG ADMINISTRATION Filinvest Corporate City

Alabang, Muntinlupa City

BUREAU CIRCULAR 29 February 2012

NO. _______s. 2012

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. Adaption of approved CODEX Alimentarius Commision

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 1-7. 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 recognized references:

1. FDA Bacteriological Analytical Manual published by the AOAC

2. Compendium of Analytical Methods of the Canadian Health Protection Branch

3. 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 International Commission on Microbiological

Specifications for Foods (ICMSF)

6. Codex Alimentarius Commission Guidelines

7. International Standards Organization (ISO) Microbiological Methods

This FDA Circular shall take effect immediately and supersede other regulations or

guidelines inconsistent herewith.

SUZETTE H. LAZO, MD, FPSECP

Acting Director IV

Legend: n – number of sample units selected from a lot of food to be examined

m – 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 or more samples would cause the lot to be rejected as this indicates potential health hazard or imminent spoilage

c – maximum allowable number of defective or marginally acceptable units Page 2 of 12

Annex A

BC ____ s ____

TABLE 1. MILK AND DAIRY PRODUCTS ANNEX A

FOOD

DESCRIPTION

TEST/MICROORGANISM

Reference Criteria

n c m M

Milk Powders (whole, nonfat or

filled milk,

buttermilk, whey &

whey protein

concentrate)

Bacillus cereus, cfu/g

S. aureus (coagulase +), cfu/g 1Coliforms, cfu/g

Salmonella/25g, normal routine for high risk population

SPC/APC, cfu/g

5

5

5

5

15

5

1

2

1

0

0

2

102

10

10

0

0

5x104

103

102

102

2x105

Sweetened

Condensed Milk

1Coliforms, cfu/g

MYC, cfu/g

SPC/APC, cfu/g

5

5

5

1

1

1

10

10

103

102

102

104

Liquid Milk (evaporated or ready

to drink) &

Cream (UHT/sterilized)

Commercial Sterility 6 0 Commercially

sterile

Pasteurized Milk

1Coliforms, cfu/mL

Salmonella/25mL

Listeria monocytogenes/25 mL

Psychrotrophic bacteria, cfu/mL

SPC/APC, cfu/mL

� for flavored milk

5

5

5

5

5

5

1

0

0

1

1

2

102

0

0

10

5x104

5x104

103

102

105

106

Pasteurized Cream

1Coliforms, cfu/mL

Salmonella/25mL

Listeria monocytogenes/25 mL

Psychrotrophic bacteria, cfu/mL

SPC/APC, cfu/mL

5

5

5

5

5

1

0

0

1

1

102

0

0

10

5x104

103

102

105

Yogurt and other

fermented milk

S. aureus (coagulase +), cfu/mL 1Coliforms, cfu/mL

Salmonella/25mL

Lactic Acid, cfu/mL

(required minimum level: ≥106)

5

5

5

-

2

2

0

-

10

10

0

-

102

102

-

Butter (whipped,

pasteurized)

Enterococci, cfu/g

MYC, cfu/g

Proteolytic bacteria, cfu/g

Coliforms, cfu/g

S. aureus (coagulase +), cfu/g

Psychrotrophic bacteria, cfu/g

SPC/APC, cfu/mL

5

5

5

5

5

5

5

1

1

1

1

0

1

1

10

20

102

10

102

10

5x104

102

102

103

102

102

105





Annex A

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TABLE 1. MILK AND DAIRY PRODUCTS continued ANNEX A

FOOD

DESCRIPTION

TEST/MICROORGANISM

Reference Criteria

n c m M

Butter made from

unpasteurized milk

or milk products

Coliforms, cfu/g

E.coli, MPN/g


Salmonella/25g

Listeria monocytogenes/25g

SPC/APC, cfu/g

5

5

5

5

5

5

1

1

1

0

0

1

10

<3

10

0

0

5x104

102

11

102

105

Margarine


Faecal Coliform, MPN/g


Salmonella/25g

SPC/APC, cfu/g

MYC, cfu/g

5

5

5

5

5

5

0

2

0

0

2

2

<10

50

0

0

2.5x104

50

5x102

2.5x105

5x102

Cheese and Cheese

Products;

e.g. Cottage Cheese;

Soft and Semi-soft

cheese (moisture ≥39%,

pH > 5)


E.coli, MPN/g

Coliforms, MPN/g


Salmonella/25g


5

5

5

5

5

5

2

1

1

2

0

0

102

<11

<11

102

0

0

103

<110

103

103

All Raw Milk Cheese;

Raw Milk Un-

ripened cheese

w/ moisture >50%,

pH > 5.0

Campylobacter/25g

Salmonella/25g



E.coli, MPN/g

5

5

5

5

5

0

0

0

2

1

0

0

0

102

10

103

102

Processed Cheese

Spread

1Coliforms, cfu/g


SPC/APC, cfu/g

5

5

5

1

1

2

10

10

104

102

102

5x104

Ice Cream &

Sherbet (plain and flavored)

1Coliforms, cfu/g


Salmonella/25g

SPC/APC, cfu/g


5

5

5

5

5

1

0

0

2

1

10

0

0

104

10

103

5x104

102

Ice Cream with

added ingredients (nuts, fruits, cocoa

etc.)

1Coliforms, cfu/g


Salmonella/25g

SPC/APC, cfu/g


5

5

5

5

5

2

1

0

2

0

10

10

0

5x104

0

103

102

2x105

1 Coliforms must be negative for E. coli





Annex A

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TABLE 2. FOOD FOR INFANTS AND YOUNG CHILDREN ANNEX A

FOOD

DESCRIPTION

TEST/MICROORGANISM

Reference Criteria

n c m M

Powdered Infant

Formula with or

without added

Lactic acid

producing cultures

Routine analysis:

Cronobacter sakazakii / 10g

*Salmonella / 25 g

Bacillus cereus , cfu/g

S. aureus (coagulase +), cfu/g 1Coliforms, MPN/g

E. coli, MPN/g

SPC/APC, cfu/g

(prior to addition of lactic acid

producing cultures)

For complaint investigation (additional to

routine analysis):

Cl. perfringens, cfu/g

Listeria monocytogenes / 25g

30

10

5

5

5

10

5

5

5

0

0

0

0

2

2

2

1

0

0

0

102

<10

<3

<1.8

103

<1

0

11

11

104

10

Infant Formula -

liquid (UHT/sterilized)


Sterile

Baby foods in

hermetically sealed

containers


Sterile

Dried and Instant

products requiring reconstitution

1Coliforms, MPN/g

SPC/APC, cfu/g

*Salmonella /25g


5

5

60

5

1

2

0

0

<3

103

0

0

20

104

Dried products

requiring

reconstitution and

boiling before

consumption

1Coliforms, cfu/g

Salmonella/25g

SPC/APC, cfu/g

5

5

5

2

0

3

10

0

104

102

105

Coated or Filled,

Dried Shelf-Stable

Biscuits

1Coliforms, MPN/g

Salmonella/25g

5

10

2

0

<3

0

20

Cereal based foods

for infants

Bacillus cereus, cfu/g

Clostridium perfringens, cfu/g

Staphylococcus aureus, cfu/g

Listeria monocytogenes /25g

SPC/APC, cfu/g

Salmonella/25 g

Coliforms, MPN/g

5

5

5

5

5

10

5

1

1

1

0

2

0

2

102

10

10

0

103

0

<3

103

102

102

104

20

1 Coliforms must be negative for E. coli

*25g sample units may be composited to a quantity not to exceed 400g

n = 60 → 4 x 15 (25g) composite units





Annex A

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TABLE 3. MEAT** AND POULTRY PRODUCTS ANNEX A

FOOD

DESCRIPTION

TEST/MICROORGANISM

Reference Criteria

n c m M

Dried Animal

Products



Salmonella/25g

5

5

10

1

1

0

102

102

0

104

104

Meat Paste & Paté (heat treated)

Salmonella/25g


S. aureus (coagulase +), cfu/g 1Coliforms, cfu/g

SPC/APC, cfu/g

5

5

5

5

5

0

2

2

2

2

0

102

102

10

104

103

103

102

105

Cold Cuts, Frozen &

Chilled Hot Dogs,

Corned Beef,

Luncheon Meat

E.coli, MPN/g

Salmonella/25g


SPC/APC, cfu/g

5

10

5

5

0

0

2

2

<1.8

0

102

105

103

106

Packaged cooked

cured/salted meat (ham, bacon)


Salmonella/25g


5

5

5

2

0

0

102

0

0

103

Fermented,

comminuted meat, not cooked (dry &

semi-dry fermented

sausages)

E.coli, MPN/g


Salmonella/25g

5

5

5

0

1

0

<1.8

103

0

104

Cooked Poultry

Meat, Frozen to be

reheated before eating (e.g. prepared

frozen meals)


Salmonella/25g

5

5

1

0

103

0

104

Cooked Poultry

Meat, Frozen,

Ready to Eat (e.g. Turkey Rolls)


Salmonella/25g

5

10

1

0

103

0

104

** 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.





Annex A

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TABLE 3. MEAT** AND POULTRY PRODUCTS continued ANNEX A

FOOD

DESCRIPTION

TEST/MICROORGANISM

Reference Criteria

n c m M

Cured/Smoked

Poultry Meat


Salmonella/25g

10

10

1

0

103

0

104

Dehydrated Poultry

Products Salmonella/ 25g 10 0 0

Fresh/Frozen Raw

Chicken (during processing)

SPC/APC, cfu/g (at 20°C) 5 3 5x105

107

Meat Products in

hermetically sealed

containers

Commercial sterility 6 0 Commercially

sterile

Pasteurized Egg Products (liquid,

frozen or dried)

Coliforms, cfu/g

Salmonella/25g

MYC, cfu/g (for dried products)

SPC/APC, cfu/g

5

10

5

5

2

0

0

0

10

0

<10

2.5x104

103

105

Salad Dressing,

pH ≤ 4.6 (e.g. Mayonnaise,

Thousand Island,

Ranch, French)

SPC/APC, cfu/g

MYC, cfu/g

Salmonella/25g


5

5

5

5

2

2

0

0

<10

<10

0

0

102

102

1Coliforms 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.





Annex A

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TABLE 4. FISH AND SHELLFISH PRODUCTS ANNEX A

FOOD

DESCRIPTION

TEST/MICROORGANISM

Reference Criteria

n c m M

Fresh Frozen Fisha

and Cold-Smokedb

E.coli, MPN/g


V. parahaemolyticus, cfu/g

Salmonella/25g

SPC/APC, cfu/g

5

5

5

5

5

3

2

2

0

3

11

103

102

0

5x105

<500

104

103

107

Pre-Cooked

Breaded Fish

E.coli, MPN/g


SPC/APC, cfu/g

5

5

5

2

1

2

11

103

5x105

<500

104

107

Frozen Raw

Crustaceans c

E. coli, MPN/g


Salmonella /25g


SPC/APC, cfu/g

5

5

5

5

5

3

2

0

1

3

11

103

0

102

106

<500

104

103

107

Frozen Cooked

Crustaceans

E. coli, MPN/g


Salmonella /25g


SPC/APC, cfu/g

5

5

20

10

5

2

0

0

1

2

11

102

0

102

5x105

<500

103

5x106

Cooked, Chilled &

Frozen Crabmeatd

E. coli, MPN/g



SPC/APC, cfu/g

5

5

10

5

1

0

1

2

11

103

102

105

<500

103

106

Fresh & Frozen

Bivalve Molluscse

E. coli, MPN/g

Salmonella/25g


SPC/APC, cfu/g

5

20

10

5

0

0

1

0

16

0

102

5x105

103

Fish & Shellfish

products in

hermetically sealed

containers

(thermally processed)


sterile

a 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. b Test for S. aureus recommended for smoked fish. c Test for S. aureus recommended for breaded products. Salmonella and V. parahaemolyticus applied to products from

waters or harvested during summer. d SPC/APC for frozen products only e Criteria to be used only for mollusks from approved harvesting areas where waters are free from enteric bacteria or virus

contamination and no significant contamination by toxic metals or chemicals may be accumulated by animals Test for Salmonella and V. parahaemolyticus recommended for molluscs from endemic areas or harvested from warm

waters during summer.





Annex A

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TABLE 5. FRUITS,VEGETABLES AND NUTS ANNEX A

FOOD

DESCRIPTION

TEST/MICROORGANISM

Reference Criteria

n c m M

Frozen Vegetables

& Fruits (pH >4.5)

E.coli, MPN/g 5 2 <110

103

Fermented

Vegetables, Ready to Eat (e.g. Kimchi)

Molds and Yeast, cfu/g

Coliforms, MPN/g

E.coli, MPN/g

Salmonella /25g

Staphylococcus aureus, cfu/g

5

5

5

5

5

2

0

0

0

0

102

<3

<3

0

<10

104

Fruits & Vegetable

products in

Hermetically sealed

containers (thermally processed)

Commercial sterility 6 0 Commercially

sterile

Dried Vegetables E. coli, MPN/g 5 2 <110 103

Coconut (desiccated) Refer to PNS/BAFPS 25:2007

Yeast Salmonella/25g 20 0 0

Peanut Butter &

other Nut Butters

� consumed

without heating

or other

treatment to

destroy

microbes

� used as

ingredient in

high moisture

food

Salmonella/ 25g

Salmonella/ 25g

10

20

0

0

0

0

Sun Dried Fruits

Molds, cfu/g

Osmophilic Yeasts, cfu/g

E.coli, MPN/g

5

5

5

2

2

2

102

10

<3

104

103

11





Annex A

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TABLE 5. FRUITS,VEGETABLES AND NUTS continued ANNEX A

FOOD

DESCRIPTION

TEST/MICROORGANISM

Reference Criteria

n c m M

Spices Molds, cfu/g

SPC/APC, cfu/g

5

5

2

2

102

104

104

106

Spices (ready to eat)

1Coliforms, cfu/g


Salmonella/ 25g

Molds, cfu/g

SPC/APC, cfu/g

5

5

5

5

5

2

2

0

2

2

102

102

0

102

104

103

104

104

106

Cocoa Powder

Molds, cfu/g

Salmonella/ 25g

Coliforms, MPN/g

SPC/APC, cfu/g

5

5

5

5

2

0

2

2

102

0

<1.8

104

104

10

106

Chocolate Products

Molds, cfu/g

Salmonella/ 25g

Coliforms, MPN/g

SPC/APC, cfu/g

5

10

5

5

2

0

2

2

102

0

<1.8

104

104

102

106

Chocolate

Confectionaries (chocolate bars,

blocks, bonbons)

Molds, cfu/g

Salmonella/ 25g

Coliforms, MPN/g

SPC/APC, cfu/g

5

5

5

5

2

0

2

2

102

0

<1.8

103

103

102

106

Sugar

Confectionaries (Hard candies,

toffees, caramel,

fondants, creams and

pastes)

Molds, cfu/g

Salmonella/ 25g

Coliforms, MPN/g

SPC/APC, cfu/g

5

5

5

5

2

0

2

2

10

0

<1.8

104

102

102

106

1Coliforms must be negative for E.coli





Annex A

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TABLE 6. CEREAL AND CEREAL/LEGUME –BASED PRODUCTS ANNEX A

FOOD

DESCRIPTION

TEST/MICROORGANISM

Reference Criteria

n c m M

Cereals/Cereal

Grains

MYC, cfu/g

SPC/APC, cfu/g

Coliform, cfu/g

E.coli, MPN/g

5

5

5

5

2

2

2

2

102

102

102

102

104

106

104

103

Cultured seeds and

grains (e.g. bean sprouts,

alfalfa etc.)

E. coli, cfu/g

Coliforms, cfu/g

Salmonella/25g

5

5

5

2

2

0

10

102

0

102

104

Breakfast Cereals

and Snack Foods

Molds, cfu/g

Yeast & Yeastllike fungi, cfu/g

Coliform, cfu/g

SPC/APC, cfu/g

5

5

5

5

2

2

2

2

10

10

10

10

103

102

102

102

Soya Flours,

Concentrates and

Isolates

Molds, cfu/g

Salmonella/25g

5

5

2

0

103

0

105

Flour, Corn meal,

Corn grits, Semolina

Molds, cfu/g

Yeast & Yeastllike fungi, cfu/g

Coliform, cfu/g

Bacillus subtilis, cfu/g

“rope spores”

5

5

5

5

2

2

2

2

102

10

10

10

104

102

102

102

Frozen Bakery

products (ready to

eat) with low-acid or

high aw fillings or

toppings


Salmonella/ 25g

5

5

1

0

102

0

104

Frozen Bakery

Products (to be

cooked) with low-

acid or high aw

fillings or toppings (e.g. meat pies,

pizzas)


Salmonella/ 25g

5

5

1

0

102

0

104

Frozen entrees

containing Rice or

Corn Flour as main

ingredient

B. cereus, cfu/g 5 1 102 10

4

Baked Goods (microbiologically

sensitive types e.g

containing eggs &

dairy products)


MYC, cfu/g

SPC/APC, cfu/g

Coliforms, cfu/g

5

5

5

5

2

2

2

2

102

102

104

50

104

104

106

103





Annex A

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TABLE 6. CEREAL AND CEREAL/LEGUME-BASED PRODUCTS continued ANNEX A

FOOD

DESCRIPTION

TEST/MICROORGANISM

Reference Criteria

n c m M

Frozen and

Refrigerated Doughs (Chemically

leavened)

Molds, cfu/g

Yeasts & Yeastlike Fungi, cfu/g

Coliforms, cfu/g


SPC/APC, cfu/g

Salmonella/ 25g

S. aureus (coagulase +) , cfu/g

E. coli, MPN/g

5

5

5

5

5

5

5

5

2

2

2

2

2

0

2

0

102

105

10

10

102

0

102

<3.0

104

106

102

103

107

104

Frozen &

Refrigerated Doughs

Molds, cfu/g

Yeasts & Yeastlike Fungi, cfu/g

Coliforms, cfu/g


SPC/APC, cfu/g

5

5

5

5

5

2

2

2

2

2

102

105

10

10

103

104

106

102

103

106

Soy Protein

Coliforms, cfu/g

E. coli, MPN/g



Molds and Yeast, cfu/g

Salmonella / 25g

SPC/APC, cfu/g

5

5

5

5

5

5

5

2

1

2

2

2

0

2

102

10

102

<10

10

0

102

103

102

104

102

102

105

Tofu

B. cereus, cfu/g

E. coli, MPN/g


5

5

5

2

0

2

102

<1.8

102

103

103

Pasta Products and

Noodles Uncooked (wet & dry)

Coliforms, cfu/g

MYC, cfu/g


Salmonella / 25g

SPC/APC, cfu/g

5

5

5

5

5

2

2

1

0

2

10

102

102

0

103

103

105

104

105

Dry Mixes for Soup

and Sauces


MYC, cfu/g

Coliforms, cfu/g

SPC/APC, cfu/g

Salmonella/25g

5

5

5

5

5

2

3

3

2

0

102

102

10

104

0

103

104

103

106

Starch

Coliforms, cfu/g

MYC, cfu/g

Salmonella/25g

SPC/APC, cfu/g

5

5

5

5

2

2

0

2

10

102

0

103

102

103

5x104





Annex A

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TABLE 7. NON-ALCOHOLIC BEVERAGES ANNEX A

FOOD

DESCRIPTION

TEST/MICROORGANISM

Reference Criteria

n c m M

Non Alcoholic

Beverages (e.g. Ready to drink,

softdrinks, iced tea,

energy drinks)

MYC, cfu/mL

Coliforms, cfu/mL

SPC/APC, cfu/mL

5

5

5

0

0

1

<1

<1

10

102

Frozen Juice

Concentrate

SPC/APC, cfu/mL

MYC, cfu/mL

5

5

2

1

102

<10

105

50

Powdered Beverages (e.g. iced tea, powdered

juices/mixes)

SPC/APC, cfu/g

Coliforms, cfu/g

5

5

2

0

3x103

<10

Flavored Ice (e.g. Ice candy)

SPC/APC, cfu/g

Coliforms, MPN/g

MYC, cfu/g

Salmonella /25g

5

5

5

5

2

0

2

0

102

<3.0

102

0

104

Documents

FDA Phil Revised Guidelines for the Assessment of Microbiological Quality of Processed Foods