
Through a notification dated 26 October 2020 the FSSAI has proposed the Draft Food Safety and Standards (Food Product Standards and Food Additives) Amendment Regulations, 2020 related to standards of
- raw edible oil
- multi-source edible vegetable oil
- dehydrated vegetables
- protein rich atta
- multigrain atta
- mixed millet flour
- revised standards of honey,
- requirements for animal feed
- dry sweet basil, hemp seed
- use of food additives in iced tea,
- microbiological standards for food grain
The objections or suggestions, if any, may be addressed as per format, to the Chief Executive Officer, Food Safety and Standards Authority of India, Food and Drug Administration Bhawan, Kotla Road, New Delhi – 110002 or via email to [email protected] within 60 days from uploading of draft notification which is 28 October 2020. Format for sending objections or suggestions is available at
https://fssai.gov.in/upload/uploadfiles/files/Format_Draft_Notification_Oil_
Atta_Flour_Grain_28_10_2020.pdf Comments may also be sent online at https://fssai.gov.in/comments/Bestviewwl.aspx?NOTIFICATION_ID=2095
Draft Regulations
These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2020. They shall come into force with effective date for implementation to be either 1st January or 1st July subject to a minimum of 180 days from the date of their final publication in the official Gazette.
In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, in regulation 1.2 related to ‘Definitions’, the following clause is proposed to be added inserted
“27. “Raw edible oils” are obtained by mechanical procedures e.g expelling and pressing, with or without application of heat. They may be purified by washing with water, settling, filtering and centrifuging. Such oils are fit for human consumption. They shall conform to the provisions mentioned under sub-regulation 2.2.1 prescribed for specific vegetable oil except the standards laid down under regulation 2.2.1 (16)”
Amendments in regulation 2.2 relating to Fats, Oils and Fat Emulsions,
in sub-regulation 2.2.1 relating to Oils
- In clause 1 relating to Coconut oil (naryal ka tel), for the entry against the words and figures ‘Refractive Index at 40°C’, shall be changed from1.4481-1.4491 to the following “1.4480- 1.4500”
- In clause 24 the words ‘Blended Vegetable Oil’ is proposed to be replaced with the following “Multi-sourced Edible vegetable Oil”
Amendments in regulation 2.3 relating to Fruit and Vegetable Products
In sub-regulation 2.3.3 relating to Thermally Processed Vegetables,
- in clause 1, item (c) under sub-clause (i) Liquid Pack (c) Mushroom packed in sauce will be replaced with (c) Edible fungi\vegetables including baked beans packed in sauce 0 percent of net weight of contents”
in sub-regulation 2.3.31 relating to ‘Jam, Fruit Jellies and Marmalades’,
- clause 7 is proposed to be amended
The total soluble solids content, in the case of jams shall be not less than 65 per cent. by weight and not less than 60 per cent. by weight in case of jellies and marmalades.
And substituted with the following
“The total Soluble Solid content, in the case of jams shall not be less than 65 percent, by weight and not less than 60 percent by weight in case of jellies and marmalades. To be called as a reduced sugar product, Jam, Jellies and marmalades must not have TSS more than 45 %.”
- Clause 13 “Standards specified in this sub-regulation shall not apply to—”
shall be substituted with the following
“Standards specified in this sub-regulation shall not apply to the products which are clearly intended or labelled as intended for special dietary uses”
- sub-regulation 2.3.36 relating to “Dehydrated Vegetables” shall be substituted with following, namely: –
“2.3.36 Dehydrated Vegetables:
- Dehydrated Vegetables means the product, prepared from edible portions of suitable variety of sound vegetable, free from insect or fungal infection, free from blemishes, suitably prepared, from which moisture has been removed under suitable conditions of temperature, pressure, humidity & airflow, to the extent that the product is preserved by any suitable method.
- It may be whole, sliced, quarters, pieces, flakes, kibbled granules or powdered. The finished product shall have uniform colour and shall be free from discolouration due to scorching or enzymatic reaction. It shall be free from stalks, peels, stems and extraneous matter. When in powder form, it shall be free flowing and free from agglomerates.
- The product may contain food additives permitted in these regulations including Appendix A. The product shall conform to the microbiological requirements given in Appendix B. It shall meet the requirements as given in the Table below
S. N |
Name of the Vegetable |
Moisture not more than (percent) |
Ash insoluble in dilute HCl not more than (percent) |
Peroxidase Test |
1. |
All dehydrated vegetables |
8.0 |
0.5 |
Negative |
2. |
Powders of all vegetables |
5.0 |
0.5 |
Negative |
Amendments in regulation 2.4 relating to Cereal and Cereal Products,
in sub-regulation 2.4.1 ATTA
- Clause 3 relating to ‘Protein rich (paushtik) atta’, shall be substituted with the following
“3. Protein rich atta (Protein prachur atta)
- Description
Protein rich atta (Protein prachur atta) means the product obtained by mixing wheat atta with Solvent extracted groundnut flour, Solvent extracted Soya flour and Whey Protein powder; either singly or a combination of these, up to an extent of 15.0 per cent. Soya flour individually shall not be more than 10.0 per cent and Whey Protein powder should not be more than 5.0 per cent. It shall not contain added flavouring and colouring agents. The product shall be free from abnormal flavours, odours, living insects, visible mould, filth (impurities of animal origins, including dead insects).
It shall conform to the following standards:
Parameters |
Limit |
Moisture % by mass, Not more than |
12.0 |
Ash insoluble in dilute hydrochloric acid, % by mass (on dry basis), Not more than |
0.1 |
Total Protein (N x 6.25), % by mass (on dry basis), Not less than |
15.0 |
Total Dietary Fibre, % by mass (on dry basis), Not less than |
7.0 |
Alcoholic acidity (with 90 percent alcohol) expressed as H2SO4,% Not more than |
0.12 |
Gluten, % by mass (on dry basis), Not less than |
6.0 |
Urease activity, Not more than |
0.02 |
Uric Acid, mg/kg, Not more than |
100 |
- in sub-regulation 2.4.2, clause 3 relating to ‘Protein rich (paushtik) maida’, shall be substituted with the following, namely-
“3. Protein rich refined wheat flour (Protein prachur maida)
- Description
Protein rich refined wheat flour (protein prachur maida) means the product obtained by mixing maida (refined wheat flour) with solvent extracted groundnut flour, or solvent extracted soya flour, Whey Protein flour; either singly or a combination up to an extent of 15.0 per cent. Soya flour individually shall not be more than 10.0 per cent and Whey Protein powder should not be more than 5.0 per cent. It shall not contain added flavour and colouring agents. The product shall be free from abnormal flavours, odours, living insects, visible mould, filth (impurities of animal origins, including dead insects).
It shall conform to the following standards
Parameters |
Limit |
Moisture % by mass, Not more than |
12.0 |
Ash insoluble in dilute hydrochloric acid, % by mass (on dry basis), Not more than |
0.1 |
Total Protein (N x 6.25), % by mass (on dry basis), Not less than |
15.0 |
Total Dietary Fibre, % by mass (on dry basis), Not less than |
3.0 |
Alcoholic acidity (with 90 percent alcohol) expressed as H2SO4,% Not more than |
0.12 |
Gluten, % by mass (on dry basis), Not less than |
6.0 |
Urease activity, Not more than |
0.02 |
Uric Acid, mg/kg, Not more than |
100 |
The following sub-regulations are proposed to be added to regulation on Cereals and Cereal Products
“2.4.35 Multigrain Atta and Wheat flour (atta) with other grain flour
- Description:
- a) Multigrain Atta: Multigrain atta means the product obtained by milling/grinding blend of clean whole wheat and other permitted ingredients or mixing their flours. The product shall have flour composition obtained from maximum 50% of whole wheat and rest of the flour composition shall be from other permitted ingredients singly or in combination. The product shall be free from abnormal flavours, odours, living insects, visible mould, filth (impurities of animal origins, including dead insects).
- b) Wheat flour (atta) with other grain flour means the product obtained by milling/grinding blend of clean whole wheat and other permitted ingredients or mixing their flours. The product shall have flour composition obtained from minimum 80% of whole wheat and other permitted ingredients in the range of10%-20% singly or in combination. The product shall be free from abnormal flavours, odours, living insects, visible mould, filth (impurities of animal origins, including dead insects).
Other Permitted Ingredients – Processed Soybean, Cereals, Pulses, Millets, Psyllium husk, Gluten, wheat bran and fenugreek seeds.
It shall conform to the following standards:
S. N |
Parameters |
Limit |
(i) |
Moisture, % by mass, Not more than |
12.0 |
(ii) |
Acid Insoluble Ash on dry basis, % by mass, Not more than |
0.15 |
(iii) |
Gluten, % by mass (on dry basis), Not less than |
Multigrain Atta – 3.5 Whole Wheat flour (atta) with other grains flour – 5.5 |
(iv) |
Protein (N x 6.25), % by mass (on dry basis), Not less than |
10.0 |
(v) |
Total Dietary Fibre, % by mass (on dry basis), Not less than |
12.0 |
(vi) |
Alcoholic acidity (with 90 percent alcohol) expressed as H2SO4, % on dry mass basis, Not more than |
0.15 |
(vii) |
Particle size, Not less than |
98% should pass through 40 mesh |
(viii) |
*Urease activity, Not More Than |
0.02 |
(ix) |
Uric acid, mg/kg, Not more than |
100 |
*The test of urease activity is applicable in case soya is used.
- Percentage of Wheat flour (Atta) in the product shall be declared on the label
2.4.36 Mixed Millet Flour
- Description:
Mixed millet flour means the product obtained by milling/grinding blend of clean millets/pseudomillets or by blending flour obtained from clean millets. The product shall be free from abnormal flavours, odours, living insects, visible mould, filth (impurities of animal origins, including dead insects).
Note: – Note: – Millets/pseudomillets are Sorghum/Jowar (Sorghum bicolor), Pearl Millet/Bajra (Pennisetum glaucum), Finger Millet/Ragi/Mandua (Eleusine coracana),Foxtail Millet/Kanngani/kakun (Setaria italica), Proso Millet/Cheena (Panicum milliaceum), Kodo Millet/Kodo (Paspalum scrobiculatum), Barnyard Millet/Sawa/Sanwa/Jhangora (Echinochola crus-galli) , Little Millet/Kutki (Panicum sumatrense) , Brown top millet
(Brachiaria ramosa) and pseudo-millets areBuck wheat/Kuttu (Fagopyrum esculentum) , Amaranth/Chaulai (Amaranthus cruentus).
- It shall conform to the following standards:
S. N |
Parameters |
Limits |
(i) |
Moisture % by mass, Not more than |
11.0 |
(ii) |
Acid insoluble Ash on dry basis % by mass, Not more than |
0.15 |
(iii) |
Total Protein (N x 6.25), % by mass (on dry basis), Not less than |
8.0 |
(iv) |
Alcoholic acidity (as H2SO4) with 90 percent alcohol) expressed as H2SO4, % by mass (on dry basis), Not more than |
0.15 |
(v) |
Dietary fiber, % by mass (on dry basis), Not less than |
12.0 |
(vi) |
Particle size, Not less than |
98% should pass through 40 mesh |
(vii) |
Urease activity, Not More Than |
0.02 |
(viii) |
Uric acid, mg/kg, Not more than |
100 |
Amendment proposed for the note given under sub-regulation 2.5.2 related to Meat and Meat Products,
- the sentence ‘All the products listed in regulation 2.5.2 under clause 7, 8, 9, 10, 11, 12 shall comply with following requirements is proposed to be changed to shall be “All the products listed in regulation 2.5.2 shall comply with following requirements:”
- Under note (c) shall be amended from
(c) Meat producing animals except poultry shall not be fed with feed containing meat or bone meal including internal organs, blood meal and tissues of bovine or porcine origin materials except milk and milk products.
Amended to
“(c) Milk and meat producing animals except poultry, pig and fish shall not be fed with feed containing meat or bone meal including internal organs, blood meal and tissues of bovine or porcine origin materials except milk and milk products. Commercial feeds shall comply with the relevant BIS standards, as may be specified by the Food Authority from time to time, and carry BIS certification mark on the label of the product.”
Amendment in regulation 2.6, relating to Fish and Fish Products
in sub-regulation 2.6.1, clause 6 relating to the standards of ‘Dried shark fins’ shall be omitted.
Amendment in regulation 2.8 relating to Sweetening agents including Honey
in the sub-regulation 2.8.3 related to Honey and its by products
- under Clause (1) related to Honey, the item (I) is proposed to be amended to the following
“(I) Honey is the natural sweet substance produced by honey bees from the nectar of plants or from secretions of living parts of plants or excretions of plant sucking insects on the living parts of plants, which the bees collect, transform by combining with specific substances of their own, deposit, dehydrate, store and leave in the honey comb to ripen and mature.
- a) Blossom Honey or Nectar Honey is the honey which comes from nectars of plants.
- b) Honeydew Honey is the honey which comes mainly from excretions of plant sucking insects (Hemiptera) on the living parts of plants or secretions of living parts of plants.
- Parameters and limits are amended to the following
*∆δ13C Max. is the maximum difference observed between all possible isotopic ratios measured (∆δ13C fructose
S. N |
Parameters |
Limits |
1. |
Specific gravity at 27° C, Min |
1.35 |
2 |
Moisture, per cent. by mass, Max. |
20 |
3. |
Total reducing sugars, per cent. by mass, Min. (a) For the Honey not listed below (b) Carviacallosa and Honeydew honey (c) Blends of Honeydew honey with blossom honey |
65 60 45 |
4. |
Sucrose, per cent. by mass, Max. (a) For the Honey not listed below 5.0 (b) Carviacallosa and Honeydew honey, Max. |
5.0 10 |
5. |
Fructose to Glucose ratio (F/G Ratio) |
0.95-1.50 |
6. |
Total Ash, per cent. by mass, Max. |
0.50 |
7. |
(a)Acidity expressed as formic acid, per cent. by mass, Max. (b) Free Acidity milliequivalents acid/ 1000 g, Max |
0.20 50.0 |
8. |
Hydroxymethylfurfural (HMF) mg/kg, Max. |
80.0 |
9. |
Diastase activity, Schade units per gram, Min. |
3 |
10. |
Water insoluble matters, per cent. by mass, Max. (a) For the Honey not listed below (b) For Pressed honey |
0.10 0.3 |
11. |
C4 Sugar, per cent. by mass, Max. |
7.0 |
12. |
Pollen count and plant element/g, Min. |
5000 |
13. |
2-Acetylfuran-3-Glucopyranoside (2-AFGP) as Marker for Rice Syrup |
Absent ** |
14. |
Foreign oligosaccharides (Max. Percent Peak) |
0.7 |
15. |
Proline, mg/kg, Min |
180 |
16. |
Electrical Conductivity: (a) Honeys not listed under Honeydew, Max. (b) Honeys listed under Honeydew, Min. |
0.8 S/cm 0.8 mS/cm |
17. |
(a) Δδ13C Max*. (Maximum difference between all measured δ13C values); per mil |
± 2.1 |
(b) Δδ13CFru – Glu (The difference in 13C/12C ratio between fructose and glucose); per mil |
± 1.0 |
|
(c) Δδ13C Protein – Honey (The difference in 13C/12C between honey and its associated protein extract); per mil |
≥ – 1.0 |
disaccharides/∆δ13C fructose-trisaccharides/∆δ13C fructose -protein/∆δ13C glucose-disaccharides/∆δ13C glucose-trisaccharides/∆δ13C glucoseprotein/∆δ13C disaccharides-trisaccharides/ ∆δ13C disaccharides-protein/∆δ13C trisaccharides-protein).
**Minimum Required Performance Level- 1mg/kg
the item (VII) and (VIII) under Honey and its by products shall be substituted with the following,
(VII) In addition to the labelling provisions as given in the Food Safety and Standards (Packaging and Labelling) Regulations, 2011, the following specific provisions shall be applicable for labelling of honey:
(a) Honey shall be labelled as:
- Honeydew Honey – If the product complies with the definitions given in part I (a) of this standard;
- Blend of Honeydew Honey and Blossom Honey – If the product is mixture of Blossom or Nectar Honey and Honeydew honey
- Carvia Callosa Honey – If the honey is derived from flower of Carviacallosa plant which is described as thixotrophic and is gel like extremely viscous when standing still and turns into liquid when agitated or stirred.
- If the honey is obtained by pressing brood-less combs, honey shall be labelled as “Pressed Honey”. If honey belongs to any of the categories mentioned at a) above and also falling into the category of pressed honey, it shall be labelled as “Pressed Honeydew Honey” or “Pressed and Blend of Honeydew Honey and Blossom Honey” or “Pressed Carvia Callosa Honey”.
(VIII) Honey may be labelled as follows, according to floral or plant source, if it comes from any particular source and has the organoleptic, physicochemical and microscopic properties corresponding with that origin. It shall be in addition to the labelling requirements as given at (vii) above:
- Monofloral Honey – If the minimum pollen content of the plant species concerned is not less than 45 percent of total pollen content;
- Multi Floral Honey – If the pollen content of any of the plant species does not exceed 45 percent of the total pollen content;”
Item (IX) has been added to honey and its by products namely:
“(IX) The said standards are applicable to packaged/ processed honey.”
Amendment in regulation 2.9 – Salt, Spices, Condiments and Related Products
Standards for the following sub-regulations are proposed to be added
“2.9.40 Dried Sweet Basil Leaves
- Dried sweet basil leaves are obtained from the species Ocimum basilicum L., belonging to the family Lamiaceae. Dried sweet basil leaves shall have characteristic colour, odour and flavour. It shall be free from visible moulds, living/dead insects, insect fragments and rodent contamination. The product shall be free from foreign odours, flavours, any other harmful substances and added colouring matters.
It shall conform to the following requirements:
S. N |
Requirements |
Limit |
i. |
Moisture content, per cent by mass (Maximum) |
12.0 |
ii. |
Total Ash, per cent by mass on dry basis, (Maximum) |
16.0 |
iii. |
Acid-insoluble ash, per cent by mass on dry basis, (Maximum) |
2.0 |
iv. |
Volatile oil content, ml/100g, on dry basis (Minimum) |
0.3 |
v. |
Foreign matter, per cent m/m, (Maximum) |
1.0 |
vi. |
Extraneous vegetable matter percent m/m, (Maximum) |
3.0 |
vii. |
Yellow or Brown leaves, per cent m/m, (Maximum) |
5.0 |
Explanations:
Foreign matter: Any visible objectionable matter or material not usually associated with the natural components of the spice plant such as sticks, stones, burlap bagging, metal etc.
Extraneous vegetable matter: Vegetative matter associated with the plant from which the product originates – but is not accepted as part of the final product.”
Amendment in regulation 2.10 – Beverages (Other than Dairy and Fruits & Vegetables based),
in sub-regulation 2.10.6, BEVERAGES NON-ALCOHOLIC – CARBONATED under 1. carbonated water the following paragraph has been changed from
[Provided that the products which contain aspertame, acesulfame or any other artificial sweetener for which special labeling provisions have been provided under regulations 2.4.5 (24,25,26, 28 and 29) of Food Safety and Standards (Packaging and Labelling) Regulations, 2011, shall not be packed, stored, distributed or sold in returnable containers.]
Amended to the following
[“Provided that the products which contain aspartame, acesulfame-K or any other artificial sweetener for which special labelling provisions have been provided under regulations 2.4.5 (24, 25, 26, 28 and 29) of Food Safety and Standards (Packaging and Labelling) Regulations, 2011, may be packed, stored, distributed or sold in returnable containers subject to the compliance of these labelling provisions for artificial sweeteners prominently on the bottle but not on crown.”]
Addition of new regulation for Hemp Seeds and seed products
2.16. Hemp seeds and seed products:
- For the purpose of these regulations, hemp seed means the hulled1, non-viable2, seeds3 obtained from of industrial variety of Cannabis sativa plants in which the concentration of THC4 is 0.3% w/w or less.
- The hemp seed and its products can be sold as food or used as an ingredient in a food for sale subject to conforming to the following standards:
- i) Hemp seed
S. No |
Parameters |
Requirements |
1. |
Moisture, per cent m/m, Max. |
7.0 |
2. |
Protein (N x 6.25), per cent m/m, Min |
30.0 |
3. |
Fat, per cent m/m, Min. |
45.0 |
4. |
Ash, per cent m/m, Max. |
6.0 |
5. |
Total THC5 mg/kg, Max. |
5.0 |
(ii) Oil extracted from hemp seed
S. No |
Parameters |
Requirements |
1. |
Free fatty acid, per cent m/m, Max. |
0.50 |
2. |
Peroxide value, mEq/kg, Max. |
1.0 |
3. |
Total THC5 mg/kg, Max. |
10.0 |
iii) The total THC shall not exceed 0.2 mg/kg in any beverages made from hemp seeds.
- iv) The total THC shall not exceed 5mg/kg in hemp flour.
- The level of cannabidiol6 (CBD) in any food for sale consisting of hemp seed or seed products shall not exceed 75 mg/kg.
- Cannabinoids7 in any food for sale consisting of hemp seed or seed products shall only be present naturally in or on the seeds.
- The food for sale that consists of hemp seed or seed products shall not be labelled or otherwise presented for sale in a form which expressly or by implication suggests that the product has a psychoactive effect.
- The label for the food containing hemp seed or seed products for sale shall not include:
(a) a nutrition content claim about cannabidiol; or
(b) a health claim about cannabidiol; or
(c) an image or representation of any part of the Cannabis sativa plant (including the leaf of that plant) other than the seed; or
(d) the words ‘cannabis’, ‘marijuana’ or words of similar meaning.
- The label for the food containing hemp seed or seed products for sale may include the word ‘Hemp’.
- The food products containing hemp seed or seed products are intended for the general population (age 2 and above) and are not intended to be added to any foods intended for infants.
- The cultivation of Cannabis sativa for the purpose of hemp seeds in India shall comply with Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985 and rules made thereunder.
Note:
- Hulled seeds mean seeds from which the outer coat or hull of seeds has been removed.
- Non-viable seeds mean seeds that are not able to germinate.
- Seeds include a part of a seed.
- THC means delta-9-tetrahydrocannabinol.
- Total THC means the total amount of delta 9-tetrahydrocannabinol (THC) and delta 9-tetrahydrocannabinolic acid.
- Cannabidiol (CBD) is the non-psychoactive component of Cannabis sativa.
- Cannabinoids means any of various naturally-occurring, biologically active, chemical constituents such as cannabidiol or cannabinol of Cannabis sativa including some that possess psychoactive properties like delta 9-tetrahydrocannabinol (THC).
Amendments in Chapter 3, under Appendix A Food category names have been amended
- under the heading ‘I. FOOD CATEGORY SYSTEM’ the food category ‘8.2.3 Frozen processed meat and poultry products in whole pieces or cuts’ shall be substituted with the following, namely-
“8.2.3 Frozen raw, flavoured/marinated, processed meat and poultry products in whole pieces or cuts”
- under the heading ‘II. FOOD CATEGORY DESCRIPTIONS’,
- a) the description for the food category 4.2.2.4 regarding Canned or bottled (pasteurized) or retort pouch vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), and seaweeds, shall be substituted with the following, namely-
Fully preserved product in which fresh vegetables are cleaned, blanched, and placed in cans or jars in liquid (e.g. brine, water, oil or sauce), and heat-sterilized or pasteurized such as canned peas, canned baby corn, asparagus packed in glass jars, canned and/or cooked/ baked beans, canned tomato paste/ puree and canned tomatoes (pieces, wedges or whole), canned mushrooms, canned chestnuts etc.”
- b) the food category 8.2.3 and the related description shall be substituted with the following, namely-
“8.2.3 Frozen raw, flavoured/marinated, processed meat and poultry products in whole pieces or cuts – Includes raw, flavoured/marinated raw and cooked meat cuts that have been frozen”.
Amendments n Table 14, under the heading ‘IV. USE OF FOOD ADDITIVES IN FOOD PRODUCTS’,
- in the Food Category System 14.1.4, Water-based flavoured drinks, including “sport,” “energy,” or “electrolyte” drinks and particulated drinks includes carbonated fruit
beverages, carbonated beverages with fruit the food additive ‘Tatrazine’ and the related entries are omitted.
in the Food Category Systems 14.1.4.2, Non-carbonated water-based flavoured drinks, including punches and Ades, ginger cocktail (ginger beer and gingerale), thermally processed fruit beverages/ fruit drinks/ready to serve fruit beverages the following has been included
“No colours permitted in iced tea and iced tea mixes”
- the food additive ‘Tatrazine’ and ‘Sunset yellow FCF’ and the entries relating entries are omitted.
- in the Food Category Systems 14.1.4.3, Concentrates (liquid or solid) for water-based flavoured drinks (synthetic syrups for dispensers, sharbat (synthetic syrup)*, squashes, crushes, fruit syrups, cordials and barley water in the column for food additives the following has been added
“No colour s permitted in iced tea and iced tea mixes”
Amendments in Chapter 3, in Appendix B, Table – 9 has been added
“Table-9 Microbiological Standards of Food Grains and their Products
Table 9A: Microbiological Standards of Food Grains Products – Process Hygiene Criteria
S.N |
Product Description |
Yeast and Mould Count (cfu/g) |
Staphylococcus aureus count (cfu/g) |
Enterobacteriacae count (cfu/g) |
|||||||||||||||||
|
|
Sampling plan |
Limit |
Sampling plan |
Limit |
Sampling plan |
Limit |
||||||||||||||
|
|
n |
c |
m |
M |
n |
c |
m |
M |
n |
c |
m |
M |
||||||||
1. |
Sprouted grains, sweet corn cob or packed wet grains for direct consumption |
NA |
NA |
|
|
||||||||||||||||
2. |
Batters and doughs (Ready to Cook) |
NA |
5 |
2 |
102 |
103 |
5 |
2 |
102 |
103 |
|||||||||||
3. |
Fermented products other than batters and doughs (ready to cook) including bread, cakes and doughnuts, other ready to eat grain products, malted milk food, instant noodles, and pasta products |
NA |
NA |
5 |
2 |
10 |
102 |
||||||||||||||
4. |
Test Methods |
IS: 5403/ISO 21527 Part 1 and Part 2 |
IS:5887, Part 2 and IS 5887 part 8 (Sec 1)/ISO 6888-1 or IS:5887 Part 8 (Sec2)/ISO 6888-2 |
IS/ISO 7402/ISO 21528 Part 2 |
Table 9B: Microbiological Standards of Food Grains Products – Food Safety Criteria
S. N |
Product Description |
Salmonella |
Listeria monocytogenes |
||||||||||||
|
|
Sampling plan |
Limit |
|
|
||||||||||
|
|
n |
c |
m |
n |
c |
m |
||||||||
1, |
Sprouted grains, sweet corn cob or packed wet grains for direct consumption |
5 |
0 |
Absent 25g |
5 |
0 |
Absent 25g |
||||||||
2, |
Batters and Doughs (Ready to Cook) |
NA |
NA |
||||||||||||
3, |
Fermented products other than batters and doughs (ready to cook) including bread, cakes, doughnuts, other ready to eat grain products, malted milk food, instant noodles, and pasta products |
5 |
0 |
Absent 25g |
5 |
0 |
Absent 25g |
||||||||
4, |
Test Methods |
IS: 5887, Part3/ ISO:6579 |
IS: 14988, Part 1/ISO 11290-1 |
Definitions
Definitions related to Cereal and Cereal Products are as provided in FSS (Food Products Standards and Food Additives) Regulations 2011.
Stage where the Microbiological Standards shall apply:
The microbiological standards with respect to the product categories specified in Table-9A (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 the food law. These shall be applicable at the end of the manufacturing process. The Microbiological Standards in Table-9B (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- 9A, the FBO shall:
- check and improve process hygiene by implementation of guidelines in Schedule 4 of FSS (Licensing and Registration of Food Businesses) Regulations; and,
- ensure that all food safety criteria as specified in Table -9B (Food Safety Criteria) are complied with
Sampling Plan and Guidelines:
For Regulator: The sampling for different microbiological standards specified in Table-9A and 9B 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-9A & 9B 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 eg if n=5, then total no. of samples 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 9B), 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 done as per the methods given in the Table “Reference Test Methods”
For FBO: Food Business Operator (FBO) shall perform testing as appropriate as per the microbiological standards in Table-9A & 9B to ensure verification of compliance with the microbiological requirements. FBO shall decide themselves, subject to the 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 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 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 Test 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.
Reference test methods– latest version 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. |
Yeast and Mould Count |
Method for Yeast and Mould Count of Food Stuffs and Animal feed- IS 5403 Microbiology of food and animal feeding stuff-Horizontal method for the enumeration of yeasts and moulds-Part1: Colony count technique in products with water activity greater than 0.95-ISO 21527-1 Microbiology of food and animal feeding stuff-Horizontal method for the enumeration of yeasts and moulds-Part2: Colony count technique in products with water activity less than 0.95-ISO 21527-2 |
2. |
Enterobacteriaceae count |
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. |
Staphylococcus Aureus count |
Methods for detection of bacteria responsible for food poisoning: Part 2 Isolation, identification and enumeration of Staphylococcus aureus and faecal streptococci- IS 5887 Part 2 Methods for Detection of Bacteria Responsible For Foo Poisoning Part 8 Horizontal. Method For Enumeration of Coagulase-Positive Staphylococci/ (Staphylococcus aureus and other species) Section 1 Technique using baird-parker agar medium – IS 5887 (Part 8/Sec 1: /ISO 6888-1: 1999) Methods For Detection Of Bacteria Responsible For Food Poisoning Part 8 Horizontal Method For Enumeration Of Coagulase-Positive Staphylococci/ (Staphylococcus aureus And Other Species) Section 2 Technique using rabbit plasma fibrinogen agar medium– IS 5887 (Part 8/Sec 2) /ISO 6888-2: 1999) |
4. |
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.- ISO 6579 |
5. |
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 Food and Feeding Stuffs – Horizontal method for Detection and Enumeration of Listeria Monocytogenes, Part 1: Detection Method -IS 14988-1 |
Source : FSSAI
Subhash Shah says
Saurabhji , You are providing very good information and simplify the nitification.