FSSAI Gazette Notification Relating to Amendments in Standards for Certain Food Products

The FSSAI has Gazette notified the Food Safety and Standards (Food Product Standards and Food Additives) Amendment Regulation, 2019 relating to the following

Amendment to Regulation 2.3 Fruit and Vegetable Products:

2.3.6 Processed Fruit Juices

• Inclusion of standard of Monk fruit

Amendment to Regulation 2.4 Cereal and Cereal Products:

• Biscuits
• Bread and Bread-Type Products
• Jowar (Sorghum grains)
• Maida (Refined Wheat flour)
• Semolina (Suji or Rawa)
• Breakfast Cereal
• Pearl Millet Flour
• Sorghum flour

Amendment to Regulation 2.8 Sweetening agents including Honey

• Sucralose

Amendment to Regulation 2.9 Salt, Spices, Condiments and Related Products

• Cumin (Whole & Powder)
• Iron Fortified Common Salt
• Dried Thyme

Amendment to Regulation 2.14 and 2.15 Gluten free food and Foods specially processed to reduce gluten content to a level 20-100 mg/kg

Review of Gluten free and Low gluten product standard

Amendment to Chapter 3: Substances Added to Food

Regulations

These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) First Amendment Regulations, 2021. They shall come into force on the date of their publication in the Official Gazette and food business operator shall comply with all the provisions of these regulations with effect from 1st day of the January, 2022.

In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011

Amendment in regulation 2.3 Fruit and Vegetable Products

In sub-regulation 2.3.6 relating to “Processed Fruit Juices’ under clause 4, in table the following entry shall be added

S. No	Name of the Fruit	Botanical name	Total Soluble Solids in  °Brix (Min)	Acidity expressed as Citric Acid Max. (%)
72	Monk Fruit	Siraitiagrosvenorii	14.0	0.013

Amendment in regulation 2.4 CEREALS AND CEREAL PRODUCTS

For 2.4.2 Maida the amendments are as follows

1. Maida (Refined Wheat flour) – (1) Maida (Refined wheat flour) means the product obtained from the clean grains of wheat by grinding or milling processes in which the bran and germ are essentially removed and the remainder is comminuted to a suitable degree of fineness. It shall be free from abnormal flavours, odours, living insects, filth (impurities of animal origin including dead insects).
2. It shall conform to the following requirements, namely:

TABLE

S. No	Requirements	Limit
1.	Moisture, % by mass (not more than)	14.0
2.	Total ash, % on dry mass (not more than)	1.0
3.	Ash insoluble in dilute HCl, % on dry mass basis (not more than)	0.1
4.	Gluten, % on dry mass basis (not less than)	7.5
5.	Alcoholic acidity (with 90 percent alcohol) expressed as H2SO4, % on dry mass basis, not more than	0.12
6.	*Granularity % (not less than)	98 shall pass through 212 microns IS sieve (70 mesh)
7.	Uric acid (not more than), mg/kg	100

* The parameter ‘Granularity’ will not be applicable for intermediate products which are not meant for direct consumption.

for sub-regulation 2.4.3, the amendments are as follows

2.4.3 Semolina (Suji or Rawa)

(1) Semolina (suji or rawa) means the product obtained from clean grains of wheat by grinding or milling processes in which the bran and germ are wholly / partially removed and the remainder is comminuted to a suitable degree of fineness. It shall be free from abnormal flavours, odours, living insects, filth (impurities of animal origin including dead insects).

(2) It shall conform to the following requirements, namely: –

TABLE

S. No	Requirements	Limit
1.	Moisture, % by mass (not more than)	14.5
2.	Total ash, % on dry mass (not more than)	1.0
3.	Ash insoluble in dilute HCl, % on dry mass basis (not more than)	0.1
4.	Gluten, % on dry mass basis (not less than)	6.0
5.	Alcoholic acidity (with 90 percent alcohol) expressed as H2SO4, % on dry mass basis, not more than	0.15
6.	Uric acid (not more than) mg/kg	100

For sub-regulation 2.4.6, for clause (4) amendments are as follows

4. JOWAR (Sorghum grains)

1) Sorghum grains are whole or decorticated grains obtained from species of Sorghum Vulgare Pers. These shall be sweet, hard, clean and wholesome.

(a) Whole sorghum grains – These are sorghum grains obtained as such after a complete threshing without any further treatment.

(b) Decorticated (pearled) sorghum grains – These are sorghum grains from which the external casings and whole or parts of the germ have been removed in an appropriate manner, using mechanical treatment.

(2) It shall conform to the following requirements, namely: –

TABLE

S. No	Requirements	Limit
1.	Moisture % by mass (not more than)	14.5
2.	Extraneous matter	Not more than 1.0 percent by mass out of which not more than 0.25 percent by mass shall be mineral matter and not more than 0.10 percent by mass shall be impurities of animal origin.
3.	Other edible grains, % by mass, not more than	3.0
4.	Damaged grains % by mass, not more than	6.0 percent by mass out of which ergot affected grains shall not exceed 0.05 percent by count.
5.	Weevilled grains, % by count, not more than	6
6.	Immature and Shrivelled grains, % by mass, not more than	8.0
7.	Uric acid, (not more than) mg/kg	100

in sub-regulation 2.4.15, for clause (1) and (2) the amendments are as follows

1. Biscuit.

(1) Biscuit is a baked product leavened or non-leavened, coated or uncoated, centre-filled partially or wholly such as but not limited to wafer biscuits, coated wafers, cookies, crackers, centre-filled biscuits, enrobed biscuits, sandwich biscuits, crème biscuit including fat free/ low fat or sugar free/ low sugar variants.

(2) Biscuit can be made from cereal and cereal products including millets/pulses/legumes and/ mixtures. It may also contain fats and oils, including fat emulsions etc. or mixture thereof, baking powder, sugar and sugar products, edible common salt including salt substitutes, dairy products and analogues, nutritive and non-nutritive sweeteners, honey, invert sugar, jaggery, dextrose, edible molasses, liquid glucose/glucose syrup (High Maltose/High fructose), fruits and vegetables and their products (including dried fruits and vegetables), cocoa and its products including chocolates, tea, coffee, chicory and their extracts, coconut and its products, eggs and egg products, gluten, nut and nut products, malt and malt products, milk and milk products, oilseeds and its products including oilseed flours, all edible starches and edible flours, spices, condiments, herbs and their extracts, seasonings, vinegar, edible seeds, protein concentrates/isolates, Yeast and its products including yeast extract, enzymes, nutrients like vitamins and minerals, edible fibres, maltodextrin, oligofructose, trehalose and any other ingredients as specified in Food safety and Standards Regulations.

(3) It shall conform to the following requirements, namely: –

TABLE

S. No	Requirements	Limits
1.	Ash insoluble in dilute HCl, % on dry mass basis, not more than	0.1
2.	Acidity of extracted fat (as oleic acid), %, not more than	2.0

 2.Bread and Bread-Type Products

1) Bread and bread type products such as rusks means the baked product prepared from a mixture of atta (whole wheat flour) and/or maida (refined wheat flour), water, salt, yeast or other fermentive medium or leavening medium. It includes the different varieties of breads, rusks etc.

(2) It may also contain dairy products and analogue, gluten, sweetening agents including honey (such as- sugar and sugar products, invert sugar, jaggery, dextrose, edible molasses, invert sugar, jaggery, liquid glucose/glucose syrup (High Maltose/High fructose), date syrup, malt products and their extracts, edible starches and flour, edible cereals, grains and pulses or their flour, products, semolina, edible seeds including oilseeds and their flour, edible bran, edible fibre rich ingredients or concentrates, trehalose (maximum 10%), coconut and coconut products, cocoa and products derived from cocoa, prebiotic, probiotic, egg and egg products, tea, coffee, chicory and their extract, protein concentrates and isolates, other minerals, nutrients, vitamins, vanaspati, margarine or refined edible oil of suitable type, Interesterified vegetable fat, or butter or ghee or their mixture or any other type of edible fat / oil, albumin, lime water, lysine, spices and condiments and their extracts, herbs, seasonings, fruit and fruit products, edible vegetable and vegetable Products, dry fruits, nuts and nut products, maltodextrin, oligofructose (maximum 15%) ,vinegar or any other ingredient as specified in Food Safety and Standards Regulations.

(3) It shall conform to the following requirements, namely: –               

TABLE

S. No	Requirements	Limits
1.	Alcoholic acidity (with 90 per cent. alcohol) (for breads)	shall not be more than equivalent of 7.5 ml. 1N NaOH per 100 grams of dried substances
2.	Acidity of extracted fat as oleic acid, % (for rusks), not more than	1.5
3.	Ash insoluble in dilute HCl (% on dry mass basis), not more than	0.2

(4) It shall be free from dirt, insect and insect fragments, larvae, rodent hair.

Amendments for sub-regulation 2.4.17 are as follows

2.4.17 Bajra Flour (Pearl Millet Flour)

(1) Bajra flour (pearl millet flour) means the product obtained from pearl millet grains (Pennisetum americanumL. Pennisetum typhyoideum, Pennisetum glaucum) through a process of milling.

(2) It shall be free from abnormal flavours, odours, living insects, filth (impurities of animal origin including dead insects).

(3) It shall conform to the following requirements, namely: –

TABLE

S. No	Requirements	Limits
1.	Moisture (% by mass), not more than	13.0
2.	Acid Insoluble Ash, % on dry mass basis, not more than	0.15
3.	Protein (N×6.25) (per cent on dry mass basis), not less than	8.0
4.	Fat (% on dry mass basis), not more than	7.0
5.	Crude Fibre (per cent on dry mass basis), not more than	2.5
6.	Alcoholic acidity (with 90 per cent. alcohol) expressed as H2SO4, % on dry mass basis, not more than	0.25
7.	*Particle size	shall pass through 1mm sieve (18 mesh)
8.	Uric acid (not more than), mg/kg	100

* The parameter “Particle size” will not be applicable for intermediate products which are not meant for direct consumption.

Amendment for sub-regulation 2.4.18 are as follows

2.4.18 Jowar Flour (Sorghum Flour)

(1) Jowar Flour (Sorghum Flour) means the product obtained from grains of Sorghum bicolor (L.) moench through a process of milling.

(2) It shall be free from abnormal flavours, odours, living insects, filth (impurities of animal origin including dead insects).

(3) It shall conform to the following requirements, namely: –

TABLE

S. No	Requirements	Limits
1.	Moisture (% by mass), not more than	12.0
2.	Acid Insoluble Ash, % on dry mass basis, not more than	0.15
3.	Protein (N×6.25) (per cent on dry mass basis), not less than	8.5
4.	Crude Fibre (per cent on dry mass basis), not more than	4.7
5.	Alcoholic acidity (with 90 per cent. alcohol) expressed as H2SO4, % on dry mass basis, not more than	0.18
6.	*Particle size	Minimum 80 percent shall pass through 1mm sieve (18 mesh)
7.	Uric acid (not more than), mg/kg	100

* The parameter ‘Particle size’ will not be applicable for intermediate products which are not meant for direct consumption.

New sub-regulation 2.4.35 has been added to the regulation on Cereals and Cereal Products

2.4.35 Breakfast Cereal

(1) Breakfast cereal refers to ready to eat and quick or regular cooking cereal products. Examples include: puffed, powdered, flaked, cereals or grains, multi-grain (e.g., rice, wheat, oats, millets, barley, pulses, corn etc.) breakfast cereals, ready to eat or cook cereal products made from soy or edible bran, granola-type breakfast cereals, cereal bars, muesli and extruded-type breakfast cereals made from grain flour or powder or meals. This category also includes ready to eat or instant cooking broken or flattened cereals sold as porridge.

(2) Breakfast cereals can be prepared by one or more methods involving cooking, frying, flaking, baking, roasting, puffing, pearling and extruding or co -extruding etc. with chocolate, fruit, vegetables, nuts or any other such nutritious fillings in sweet or savoury taste.

(3) Breakfast cereals shall be prepared from one or more of milled/whole grains and it can be mixed with the products of one or more of legumes, seeds, edible tubers or pseudo-cereals with or without addition of suitable flavouring agents, spices or spice extracts, seasonings, malt derivatives, nutritive and natural sweeteners, salt, dried or candied fruits, fruit solids/ extracts or concentrates, vegetables and their dried formats or extracts, nuts, cocoa and its products, maltodextrin, milk and its derivatives and any other ingredients as specified in Food Safety and Standards regulations.

(4) In case of wholegrain breakfast cereal minimum amount of whole grain shall be 25% on dry weight basis. The product shall contain cereals/pseudo cereals/grains when taken together as the first ingredient in the ingredient list

(5) The grains and other ingredients used in the processing of breakfast cereals shall be of good quality and shall possess a characteristic taste and odour and shall be free from rancid, musty, sour and other undesirable tastes and odours.

(6) Breakfast cereals shall be free from insects, rodent excreta and other such foreign matters.

(7) It shall conform to the following requirements, namely: –

TABLE

S. No	Requirements	Limits
1.	Moisture content (% by mass), not more than	Products containing dehydrated/candied fruits, seeds, nuts, whole grains etc. –10.0% All others – 7.5%
2.	Acid insoluble ash in dilute HCl (% on dry mass basis), not more than	0.1

(3) in regulation 2.8, in the sub-regulation 2.8.11, at the end of paragraph, the words and figures ―water not more than 0.2 %‖ shall be substituted with the following words and figures, namely: –

 ―water not more than 2.0%‖;

Amendments in regulation 2.9 SALT, SPICES, CONDIMENTS AND RELATED PRODUCTS

Amendments in sub-regulation 2.9.8, for clause (1) and (2), are as follows

1. Cumin (Safed Zeera) whole – means the dried mature seeds of Cuminumcyminum L. of the Apiaceae family. It shall have characteristic colour, aroma and flavour. It shall be free from live insects, any foreign odour or flavour and mustiness. It shall be free from added colour and harmful substances.
2. It shall conform to the following requirements, namely: –

                                                                        TABLE

S. No	Requirements	Limits
1.	Moisture content, percent by mass (maximum)	10.0
2.	Total ash, percent by mass on dry basis (maximum)	12.0
3.	Acid insoluble ash, percent by mass on dry basis (maximum)	4.0
4.	Volatile oil content, ml/100g, on dry basis (minimum)	1.5
5.	Extraneous vegetable matter content, percent by mass (maximum)	3
6.	Foreign matter content, percent by mass (maximum)	0.5
7.	Mouldy seeds, percent by mass (maximum)	1.0
8.	Proportion of damaged/defective fruits, percent by mass (maximum)	5.0
9.	Broken, percent by mass (maximum)	3.0
10.	Dead insects, insect fragments, rodent contamination, percent by mass (maximum	0.5
11.	Insect-damaged matter, percent by mass (maximum)	1.0
12.	Animal excreta (mg/kg), (maximum)	1.0
13.	Uric Acid, mg/kg on dry basis (maximum)	100

Explanations – for the purpose of this sub-regulation, –

(a) Extraneous vegetable matter – Vegetative matter associated with the plant from which the product originates – but is not accepted as part of the final product‖

(b) Foreign matter – Any visible objectionable foreign detectable matter or material not usually associated with the natural components of the spice plant; such as sticks, stones, burlap bagging, metal etc.

(c) Damaged or defective fruits – Damaged, discoloured, shrivelled and immature seeds.

(d) Insect-damaged matter – Cumin seeds that are damaged, discoloured or showing signs of bores as a result of infestation of insects so as to affect the quality of the materials.

(e) Cracked – Broken into two or more pieces.

2. Cumin (Safed Zeera) powder

(1) Cumin (Safed Zeera) powder means the powder obtained by grinding the dried mature seeds of Cuminumcyminum L of the Apiaceae family. It shall have characteristic aroma and flavour. It shall be free from any foreign odour or flavour and mustiness. It shall be free from mould, living and dead insects, insect fragments and rodent contamination. The product shall be free from added colour and harmful substances.

(2) It shall conform to the following requirements, namely:

TABLE

S. No	Requirements	Limits
1.	Moisture content, percent by mass (maximum)	10.0
2.	Total ash, percent by mass on dry basis (maximum)	9.5
3.	Acid insoluble ash, percent by mass on dry basis (maximum)	1.5
4.	Volatile oil content, ml/100g, on dry basis (minimum)	1.3
5.	Uric Acid, mg/kg on dry basis (maximum)	100

New regulation 2.9.39 has been added.

2.9.40 DRIED THYME

(1) Dried thyme is the product prepared from leaves / flowers of Thymus spp. of lamiaceae family. Dried thyme shall have a characteristic odour and flavour of volatile oil (such as thymol, carvacrol, and linalool), which can vary depending on geoclimatic factors/conditions. Dried thyme shall be free from any foreign odour or flavour and especially from mustiness. Dried thyme shall have a characteristic colour varying from green ash to brownish grey. It shall be free from living insects.

(2) It may be presented in following styles:

(a) Whole or intact.

(b) Crushed or rubbed: processed into varying degrees ranging from a coarse to fine crush.

(c) Ground: processed into powders.

(3) It shall conform to the following requirements, namely

TABLE

S. No	Requirements	Limits
1.	Moisture content, percent by mass (maximum)	12.0
2.	Extraneous vegetable matter, percent by mass, (maximum)	0.5
3.	Foreign matter, percent by mass, (maximum)	0.5
4.	Insect damaged leaves/ flowers, percent by mass, (maximum)	1.0
5.	Dead insects, Insect fragments and rodent contaminant, percent by mass, (maximum)	1.0
6.	Animal excreta (mg/kg), (maximum)	1.0
7.	Stalk exceeding 10 mm in length or 2 mm in diameter percent by mass, (maximum)	5.0
8.	Total Ash, percent by mass on dry basis, (maximum)	12.0
9.	Acid-insoluble ash, percent by mass on dry basis, (maximum)	3.5
10.	Volatile oil content, ml/100g, on dry basis (minimum)	1.0
11.	Uric Acid, mg/kg on dry basis (maximum)	100

Explanations – For the purpose of this regulation

(i) Extraneous vegetable matter – Vegetative matter associated with the plant from which the product originates – but is not accepted as part of the final product.

(ii) Foreign matter – Any visible objectionable foreign detectable matter or material not usually associated with the natural components of the spice plant; such as sticks, stones, burlap bagging, metal etc.

(iii) Stalk – The proportion of stalks which have dimensions exceeding 10 mm in length or 2 mm in diameter.

Amendments in regulation 2.14 Gluten Free Food clause (3) is as follows

(3) A food which, by its nature, is suitable for use as part of a gluten free diet shall not be named as “special dietary”, “special dietetic’ or any other equivalent term, however, such food may bear a statement on the label that “This food is by its nature gluten free’

Provided that it complies with the essential composition provisions for gluten free food as set out in sub-regulation 2.14 (4) and such a statement does not mislead the consumer.

in sub-regulation (4), the proviso – (Provided that it complies with the essential composition provisions for Gluten Free food and such a statement does not mislead the consumer) shall be omitted.

2.15 Food specially processed to reduce gluten content to a level 20 -100mg/kg is Omitted

Amendment in regulation 3.3, Other substances for use in food products

Amendments for sub-regulation 3.3.4, is as follows

3.3.4 Trehalose

(1) Trehalose shall be in the form of white or almost white crystals; soluble in water, slightly soluble in ethanol.

(2) Trehalose shall be added at the level of good manufacturing practices (GMP) in all food categories except infant food provided that the standard specifications of such food products as prescribed under Food Safety and standards Regulations, 2011 are not altered with.

(3) It shall conform to the following requirements, namely: –

TABLE

S. No	Parameters	Limits
1.	Loss on drying (%)	Not more than 1.5
2.	Total ash (%)	Not more than 0.05

(4) Trehalose may be added as an ingredient subject to label declaration under the provisions 1.8 of schedule-II of the Food Safety and Standards (Labelling and Display) Regulations, 2020, without health claims.

(5) Methods of analysis for trehalose shall be as specified in Joint FAO/WHO Expert Committee on Food Additives (JECFA) (2000)

in Appendix A, under the heading ―IV. Use of Food Additives in Food Products

(a) in Table 1, in the food category system 1.7, Dairy based desserts, the food additive tocopherols has been added.

Food Additive	INS	Recommended Maximum Level	Note
TOCOPHEROLS		500mg/kg	XS243

(b) in the Notes to the Food Additives mentioned in the Table 1 to 15, after the Note No. XS98 and the entries relating thereto, the following Note No. and entries shall be inserted, namely:

XS243: Excluding products conforming to the standard for fermented milks”

In Appendix B new Tables have been added which is as follows

Table-8 Microbiological Standards of Eggs and Egg Products

Table 8A: Microbiological Standards of Eggs and Egg Products – Process Hygiene Criteria

S. N	Product Description	Aerobic Plate Count (cfu/g)				Enterobacteriacae (cfu/g)
		Sampling plan		Limit (cfu)		Sampling plan			Limit (cfu)
		n	c	m	M	n		c	m	M
1.	Table Egg
2.	Pasteurized Liquid egg products (whole, yolk or albumin liquid)	5	2	104	105	5		2	101	102
3.	Frozen /dried/ egg products	5	2	104	105	5	2		101	102
4.	Cooked/ready-to-eat egg products including mayonnaises	5	2	104	105	5	2		101	102
	Test Methods	IS: 5402/ISO:4833				IS/ISO 7402/ISO 21528 Part 2

Table 8B

Table 8B: Microbiological Standards of Eggs and Egg Products – Food Safety Criteria

S. N	Product Description	Aerobic Plate Count (cfu/g)			Listeria monocytogenes (cfu/g)
		Sampling plan		Limit (cfu)	Sampling plan		Limit (cfu)
		n	c	m             M	n	c	m             M
1.	Table Egg	NA
2.	Pasteurized Liquid egg products (whole, yolk or albumin liquid)	5	0	Absent/25 g	5	0	Absent/25 g
3.	Frozen /dried/ egg products	5	0	Absent/25 g	5	0	102/g
4.	Cooked/ready-to-eat egg products including mayonnaises	5	0	Absent/25 g	5	0	Absent/25 g
	Test Methods	IS: 5887 Part3 / ISO:6579			IS: 14988, Part 1 & Part 2 / ISO 11290-1& 2

Definition– Definition related to egg and egg products are the same as provided in Food Safety and Standards (Food Products Standards and Food Additives) Regulations 2011. The category ― “Table egg” shall be regulated in accordance with the good manufacturing practices and code of good hygiene practices notified under Schedule 4 of Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.

Stage where the Microbiological Standards shall apply– The microbiological standards with respect to the products categories specified in Table-8A (Process Hygiene Criteria) indicate the acceptable functioning of the production process. These are not to be used as requirements for releasing the products in the market. These are indicative values above which corrective actions are required in order to maintain the hygiene of the process in compliance with food law. These shall be applicable at the end of the manufacturing process. The microbiological standards in Table-8B (Food Safety Criteria) define the acceptability of a batch/lot and shall be met in respect of the products at the end of the manufacturing process and the products in the market during their shelf- life.

Action in case of unsatisfactory result:

In case of non-compliance in respect of process hygiene criteria specified in Table- 8A, the FBO shall:

• check and improve process hygiene by implementation of guidelines in Schedule 4 of Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations; and,
• Ensure that all food safety criteria as specified in Table -8B (Food Safety Criteria) are complied with.

Sampling Plans and Guidelines

For Regulator – The sampling for different microbiological standards specified in Table-8A and 8B shall be ensured aseptically at manufacturing units and/or at retail points, as applicable, by a trained person with specialized knowledge in the field of microbiology following guidelines in the Food Safety and Standards (Food Products and Food Additives) Regulations, 2011 and ISO:707 (Latest version). The samples shall be stored and transported in frozen condition at -18°C(±2°C) or under refrigerated conditions at 2-5°C as applicable except the products that are recommended to be stored at room temperature by the manufacturer to enable initiation of analysis within 24 hours of sampling. Preservatives shall not be added to sample units intended for microbiological examination. The desired number of sample units as per sampling plan given in Table-8A and 8B shall be taken from same batch/lot and shall be submitted to the notified laboratory. Three sets, each containing ‘n’ number of samples (n as defined in the sampling plan e.g., if n=5, then total number of samples to be drawn is 15) shall be drawn. Each of these three sets shall be tested in three different accredited laboratories. The final decision shall be based on the results of three accredited laboratories. In the case of food safety criteria (Table 8B), results from all the three laboratories should indicate compliance with specified criteria. There will be no provision for retesting or resampling for microbiological testing. The testing in laboratory shall be ensured as per reference test methods given below in reference test methods for regulatory compliance.

For FBO – Food Business Operator (FBO) shall perform testing as appropriate as per the microbiological standards in Table-8A and 8B to ensure validation and verification of compliance with the microbiological requirements. FBO shall decide themselves subject to minimum prescribed under FSSR (Licensing and Registration of Food Businesses), the necessary sampling and testing frequencies to ensure compliance with the specified microbiological requirements. FBO may use analytical methods other than those described in reference test methods given below for in-house testing only. However, these methods shall not be applicable for regulatory compliance purpose.

Sampling Plan

The terms n, c, m and M used in this standard have the following meaning:

n = Number of units comprising a sample.

c = Maximum allowable number of units having microbiological counts above m for 2- class sampling plan and between m and M for 3- class sampling plan.

m = Microbiological limit that separates unsatisfactory from satisfactory in a 2- class sampling plan or acceptable from satisfactory in a 3-class sampling plan.

M = Microbiological limit that separates unsatisfactory from satisfactory in a 3-class sampling plan.

Interpretation of Results:

2-Class Sampling Plan (where n, c and m are specified)	3-Class Sampling Plan (where n, c, m and M are specified)
1. Satisfactory, if all the values observed are ≤ m 2. Unsatisfactory, if one or more of the values observed are >m	1. Satisfactory, if all the values observed are ≤ m 2. Acceptable, if a maximum of c values are between m and M and the rest of the values are observed as ≤m 3. Unsatisfactory, if one or more of the values observed are > M or more than prescribed c values are >m

Reference test methods: The following test methods shall be applied as reference methods. Test methods prescribed in FSSAI Manual of Method of Analysis of Foods (Microbiological Testing) may also be referred along with the IS/ISO methods specified for Process Hygiene Criteria and Food Safety Criteria. Latest version of test methods shall apply. In case where an ISO method adopted by the BIS is specified (e.g., IS XXXX / ISO YYYY), latest version of the ISO method (or its BIS equivalent, if available) shall apply.

S. N	Parameter	Reference Test methods
1.	Aerobic Plate Count	Microbiology of the food chain — Horizontal method for the enumeration of microorganisms — Part 1: Colony count at 30 °C by the pour plate technique- IS 5402/ ISO:4833
2.	Enterobacteriaceae	Microbiology – General Guidance for the Enumeration of Enterobacteriaceae without Resuscitation – MPN Technique and Colony-count Technique- IS/ISO 7402 Microbiology of Food and Animal feeding stuff –Horizontal methods for the detection and enumeration of Enterobacteriaceae Part 2: Colony- count method-ISO 21528-2
3.	Salmonella	Methods for Detection of Bacteria Responsible for Food Poisoning – Part 3: General Guidance on Methods for the Detection of Salmonella- IS 5887: Part 3 Microbiology of food and animal feeding stuffs – Horizontal method for the detection of Salmonella spp.- ISO6579
4.	Listeria monocytogenes	Microbiology of the food chain — Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. — Part 1: Detection method – ISO 11290-1 Microbiology of the food chain — Horizontal method for the detection and enumeration of Listeria monocytogenes and of Listeria spp. — Part 2: enumeration method – ISO 11290-2 Microbiology of Food and Feeding Stuffs – Horizontal method for Detection and Enumeration of Listeria Monocytogenes, Part 1: Detection Method -IS 14988-1 Microbiology of Food and Animal Feeding Stuffs – Horizontal Method for the Detection and Enumeration of Listeria monocytogenes, Part 2: Enumeration Method- IS 14988-2‖;

Amendments in Appendix C

Table 4 has been substituted

TABLE 4: LUBRICANTS, RELEASE AND ANTISTICK AGENTS

It can be accessed on Pages 43 and 44 at the following link Fssai.Gov.in

Table 11 has been substituted

TABLE 11: ENZYMES (for treatment or processing of raw materials, foods, or ingredients)

The table may be accessed on pages 44-49 from the above given FSSAI link.

Table 12, has been substituted

TABLE 12: GENERALLY PERMITTED PROCESSING AIDS

The table can be accessed on pages 49- 54 from the above given FSSAI link.

Source : FSSAI