Through a notification dated 30 July, 2019 the FSSAI has proposed to make amendments in several regulations of the Food Safety and Standards (food product Standards and Food Additives) Regulations 2011. The FSSAI has also invited suggestions and comments from stakeholders which are to reach the FSSAI by 5 September, 2019. The draft amendment is related to
- Amendments to Regulation 2.3, Fruit and Vegetable Products:
(a) Inclusion of standard of Monk fruit under 2.3.6 “Processed Fruit Juices”
- Amendment to Regulation 2.4 Cereal and Cereal Products:
(a) Biscuits
(b) Bread and Bread-Type Products
(c) Jowar (Sorghum grains)
(d)Maida (Refined Wheat flour)
(e)Semolina (Suji or Rawa)
(f) Breakfast Cereal
(g)Pearl Millet Flour
(h)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/k
- Review of Gluten free and Low gluten product standard(vi)
- Amendment to Chapter 3: Substances added to Food & Appendix A
(a) Trehalose
(b)Inclusion of TOCOPHEROLS in the FC 1.7 “Dairy based Dessert”
(c)Limits of BENZOATES in the food category 14.1.4 and 14.1.4.2
(d)Additional processing aids for use in various Food Categories
- Amendment to Appendix B: Microbiological Requirements
(a) Microbiological Standards for Egg products and Egg Products
(b) Procedures /protocols for retesting of microbiologically contaminated samples.
These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2019. They shall come into force with effective date for implementation to be either 1 January or 1 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, under regulation 2.3FRUIT & VEGETABLE PRODUCTS in the category related to “Thermally Processed Fruit Juices” (2.3.6) under clause “juice of two or more fruits”, the FSSAI has proposed to add standards for Monk Fruit
73. |
Monk Fruit |
Siraitiagrosvenorii |
14.0 |
0.013 |
(2) In regulation 2.4 CEREALS AND CEREAL PRODUCTS
In the sub-regulation 2.4.2 MAIDA the standards are proposed to be amended as follows
- Maida (Refined Wheat flour)
- 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 essentiallyremoved, 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).
- It shall conform to the following requirements:
Table
S. No |
Requirements |
Limits |
1. |
Moisture, % by weight (Not more than) |
13.0 |
2. |
Total ash, % on dry weight basis (Not more than) |
1.0 |
3. |
Ash insoluble in dilute HCl, % on dry weight basis (Not more than) |
0.1 |
4. |
Gluten, % on dry weight basis (Not less than |
7.5 |
5. |
Alcoholic acidity (with 90 percent alcohol) expressed as H2SO4, % on dry weight basis, Not more than |
0.12 |
6. |
Granularity % (Not less than) |
98 shall pass through 212 micron IS sieve(70 mesh) |
7. |
Uric acid (Not more than), mg/kg |
100 |
In the sub-regulation Semolina (Suji or Rawa) the standards are proposed to be amended as follows
2.4.3 Semolina (Suji or Rawa)
- Semolina (suji or rawa) means the product obtained from clean grains of wheat by grinding or milling processes inwhich the bran and germ are wholly/ partiallyremoved, 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)
- It shall conform to the following requirements:
Table
S. No |
Requirements |
Limit |
1. |
Moisture, % by weight (Not more than) |
13.0 |
2. |
Total ash, % on dry weight basis (Not more than) |
1.0 |
3. |
Ash insoluble in dilute HCl, % on dry weight basis (Not more than) |
0.1 |
4. |
Gluten, % on dry weight basis (Not less than) |
6.0 |
5. |
Alcoholic acidity (with 90 percent alcohol) expressed as H2SO4, % on dry weight basis, Not more than |
0.15 |
6. |
Uric acid (Not more than), mg/kg |
100 |
Suggested Amendments 2.4.6 for Food grainsJOWAR
JOWAR (Sorghum grains)
Sorghum grains are whole or decorticated grains obtained from species of Sorghum Vulgare Pers. These shall besweet, hard, clean and wholesome.
(a) Whole sorghum grains: These are sorghum grains obtained as such after a complete threshing without anyfurther treatment.
(b) Decorticated (pearled) sorghum grains: These are sorghum grains from which the external casings andwhole or parts of the germ have been removed in an appropriatemanner, using mechanical treatment.
It shall conform to the following requirements
Table
S. No |
Requirements |
Limits |
1. |
Moisture % by weight (Not more than) |
13.0 |
2. |
Extraneous matter |
Not more than 1 percent by weight out of which not more than 0.25 percent by weight shall be mineral matter and not more than 0.10 percent by weight shall be impurities of animal origin. |
3. |
Other edible grains, % by weight, Not more than |
3.0 |
4. |
Damaged grains, % by weight, Not more than |
6 percent by weight 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 weight |
8.0 |
7. |
Uric acid, (Not more than) mg/kg |
100 |
In 2.4.15, BAKERY PRODUCTS under biscuits clause (1) and (2) are amended as follows
Biscuit
(1) Biscuit is a baked product leavened or non-leavened, coated or uncoated, centre-filledpartially orwholly such as but not limited to wafer biscuits, coated wafers, cookies, crackers,centre-filled biscuits, enrobed biscuits,sandwich biscuits, crème biscuit (made with milksolids and sugar) including fat free/ low fat or sugar free/ low sugarvariants.
(2) Biscuit can be made from cereal and cereal products including millets/pulses/legumes and/or mixtures. It may alsocontain Fats and Oils, including fat emulsions etc. or mixture thereof, Baking powder, sugar and sugar products, ediblecommon salt including salt substitutes, Dairy products & Analogues, nutritive and non-nutritive sweeteners,honey, invert sugar, jaggery, dextrose, edible molasses, liquid glucose/Glucose syrup (High Maltose/High fructose), fruits andvegetables 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, egg products, maltand malt products, milk and milk products, oilseeds and its products including oilseed flours, all edible starches andedible flours, spices, condiments, herbs and their extracts, seasonings, vinegar, Fat powder, edible seeds, proteinconcentrates/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 StandardsRegulations.
It shall conform to the following requirements:
Table
S. No |
Requirements |
Limits |
1. |
Ash insoluble in dilute HCl, % on dry basis (m/m), Not more than |
0.1 |
2. |
Acidity of extracted fat (as oleic acid), %, Not more than |
2.0 |
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 otherfermentive medium or leavening medium. It includes the different varieties of breads, rusks etc.
(2) It may also contain Dairy products & Analogue, Gluten, Sweetening Agents including Honey(such as- sugar andsugar 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/or flour, edible cereals,grains and/or pulses or their flour, products, Semolina, Edible seeds including oilseeds and/or their flour, Edible Bran,Edible Fibre rich ingredients or concentrates, Trehalose (Max.10%) , Coconut and/or coconut products, cocoa and/orproducts derived from cocoa, prebiotic, probiotic, egg and egg products, Tea, coffee, chicory and their extract, proteinconcentrates 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/or their extracts, herbs, seasonings, fruit and/or fruit products, Edible Vegetableand/or vegetable Products, Dry fruits, nuts and/or nut products , maltodextrin, oligofructose (max 15%) ,vinegar or anyother ingredient as specified in Food Safety and Standards Regulations.
It shall conform to the following requirements:
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. N NaOH per 100 g 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 weight basis, m/m), Not more than |
0.2 |
It shall be free from dirt, insect and insect fragments, larvae, rodent hairs.
Suggested Amendments for 2.4.17Pearl Millet Flour
“Pearl Millet flour” means the product obtained from pearl millet grains (Pennisetum americanum L. or Pennisetum typhyoideum) through a process of milling.
It shall be free from abnormal flavours, odours, living insects, filth (impurities of animal origin including deadinsects).
It shall conform to the following requirements:
TABLE
S. No. |
Requirements |
Limits |
1. |
Moisture (% by weight), Not more than |
13.0 |
2. |
Acid Insoluble Ash, % by mass (on dry basis), Not more than |
0.15 |
3. |
Protein (N×5.7) (per cent on dry matter 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 percent alcohol) expressed as H2SO4, % on dry weight basis, Not more than |
0.15 |
7. |
Particle Size |
shall pass through 1mm sieve (18mesh) |
8. |
Uric acid (Not more than), mg/kg |
100 |
|
Suggested Amendments for 2.4.18Sorghum Flour
- Sorghum flour means the product obtained from grains of Sorghum bicolor (L.) Moenchthrough a process of milling.
- It shall be free from abnormal flavours, odours, living insects, filth (impurities of animal origin including deadinsects).
It shall conform to the following requirements:
Table
S. No |
Requirements |
Limits |
1. |
Moisture (% by mass), Not more than |
11.0 |
2. |
Acid Insoluble Ash, % by mass (on dry basis), Not more than |
0.15 |
3. |
Protein (N x 5.7) (on dry matter basis), Not less than, % by m/m basis |
8.5 |
4. |
Crude Fat (on dry matter basis), Not more than % by m/m basis |
4.7 |
5. |
Alcoholic acidity (with 90 percent alcohol) expressed as H2SO4, % on dry weight basis, Not more than |
0.15 |
6. |
Particle size |
Minimum 80 per cent shall pass through a 1 mm sieve (18 mesh). |
7. |
Uric acid (Not more than), mg/kg |
100 |
Additional sub-regulation for Breakfast Cereals have been proposed
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 breakfastcereals, cereal bars, muesli and extruded-type breakfast cereals made from grain flour or powder or meals. This categoryalso 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 coextruding with chocolate, fruit, vegetables, nuts or any other such nutritious fillingsin 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 ofone 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, fruitsolids/ 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 in breakfast cereal shall be 25% dry weight.The product shall contain minimum 50% of cereals/pseudo cereals/grains taken together
(5) The grains and other ingredients used in the processing of Breakfast cereals shall be of good quality and shall possessa 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.
It shall conform to the following requirements:
TABLE
S. No |
Requirements |
Limits |
1. |
Moisture content (% by weight), Not more than |
Products containing dehydrated/ candied fruits, seeds, nuts whole grains etc. –10% All others – 7.5% |
2. |
Acid insoluble ash in dilute HCL (% on dry weight basis), Not more than |
0.1 |
Proposed Amendments in regulation 2.8, Sweetening agents including Honey
in the sub-regulation 2.8.11 Sucralose at the end of paragraph, the words and figures
“water not morethan 0.2 %”
Amendment to the following
“water not more than 2.0%”;
Proposed Amendments In regulation 2.9,SALT, SPICES, CONDIMENTS AND RELATED PRODUCTS Under 2.9.8, Cumin (Safed Zeera) the following have been
Cumin (Safed Zeera) whole means the dried mature seeds of CuminumcyminumL. of the Apiaceae family. It shallhave characteristic colour, aroma and flavour. It shall be freefrom live insects, any foreign odour or flavour andmustiness. It shall be free from addedcolour and harmful substances.
It shall conform to the following requirements:
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/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 ofinfestation of insects so as to affect the quality of the materials.
(e) Cracked: Broken into two or more pieces.
- Cumin (SafedZeera) powder means the powder obtained by grinding the dried mature seeds of Cuminumcyminum Lof the Apiaceae family. It shall have characteristic aroma and flavour. It shall be free from any foreign odour or flavourand mustiness. It shall be free from mould, living and dead insects, insect fragments and rodent contamination. Theproduct shall be free from added colour and harmful substances.
It shall conform to the following requirements:
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 |
FSSAI has also proposed standards for Dried Thyme under these regulations; which are as follows:
2.9.40 DRIED THYME
(1) Dried thyme is the product prepared from leaves/ flowers of Thymus spp. of Lamiaceae family. Dried thyme shallhave a characteristic odour and flavour of volatile oil (such as thymol, carvacrol, and linalool), which can vary dependingon geo-climatic factors/conditions. Dried thyme shall be free from any foreign odour or flavour and especially frommustiness. Dried thyme shall have a characteristic colour varying from green ash to brownish grey. It shall be free fromliving insects.
(2) It may be presented in following styles:
- a) Whole / intact
- b) Crushed/rubbed: processed into varying degrees ranging from coarse to fine crush.
- c) Ground: processed into powders
It shall conform to the following requirements:
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, 5.0(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
Extraneous vegetable matter: Vegetative matter associated with the plant from which the product originates – butis not accepted as part of the final product.
Foreign matter: Any visible objectionable foreign detectable matter or material not usually associated with thenatural components of the spice plant; such as sticks, stones, burlap bagging, metal etc.
Stalk: The proportion of stalks which have dimensions exceeding 10 mm in length or 2 mm in diameter.
Suggested amendment for regulation 2.14, Gluten Free Food the following
(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’
Amended to
“(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 byits nature gluten free and also free from contaminant gluten”.
Regulation 2.15 is OMITTED
2.15 Food specially processed to reduce gluten content to a level 20 -100mg/kg
Suggested amendments in regulation 3.3Other substances for use in food products the related to3.3.4 Trehalose
(1) Trehalose shall be in the form of white or almost white crystals; soluble in water, slightly soluble inethanol.
(2) For achieving functional and technological objectives, Trehalose may be used upto 1 % (max, m/m) in any categoryof food specified in any of the regulations made under Food Safety and Standards Act, 2006, except in infant food.
(3) Trehalose above 1 % (m/m) and up to 75% (m/m) may be used as a sugar replacer for total sugar in a food productonly where upper limit of sugar has been specified in the quality standards of that food product specified in any of theregulations made under Food Safety and Standards Act, 2006.
It shall conform to the following requirements:
Table
S. No |
Parameters |
Limits |
1. |
Loss on drying (%) |
Not more than 1.5 |
2. |
Total Ash (%) |
Not more than 0.05 |
(5) Trehalose may be added as an ingredient subject to label declaration under clause (49) of regulation 2.4.4 of the FoodSafety and Standards (packaging and labelling) Regulations,2011, without health claims.
(6) Methods of analysis for Trehalose shall be as specified in JECFA (2000).”
Suggested Amendments in In Appendix A, under the heading “IV.Use of Food Additives in Food Products”
(a) In Table 1, in the food category system 1.7Dairy based dessertsthe following entries shall be inserted
Food Additive |
INS. NO |
Recommended maximum level |
Note |
TOCOPHEROLS |
|
500mg/kg |
XS243 |
Under Notes on Food Additives mentioned in the Table 1 to 15, after the following will be added
“XS243: Excluding products conforming to the standard for fermented milks”
In Chapter 3 relating to SUBSTANCES ADDED TO FOOD, after Regulation 3.3 relating to other substancesfor use in food products. Processing aids added after the existing processing aids are as follows
S. No |
Name of the Processing aid |
Product category |
Residue Level (mg/kg) (Not more than) |
15. |
Hydrogenated vegetable oil (HVO) |
All foods |
GMP |
16. |
Lecithin (INS 322(i)) |
All foods |
GMP |
17. |
Liquid Paraffin (INS 905 e) |
Confectionery and gums |
GMP |
18. |
Glycerine/ Glycerol (INS 422) |
All foods |
GMP |
19. |
Calcium, Magnesium, Sodium salts ofstearic acid (INS 470(i)) |
Confectionery and gums |
GMP |
20. |
Icing sugar |
Confectionery and gums |
GMP |
21. |
Rice starch |
Confectionery and gums |
GMP |
22. |
Calcium carbonate (INS 170 (i)) |
All foods |
GMP |
23. |
Palm Oil |
Salts, spices, soups, cereal products |
GMP |
24. |
Sunflower Oil |
Salts, spices, soups, cereal products |
GMP |
25. |
Coconut oil |
Confectionery, bakery wares, salts,spices, soups, cereal products |
GMP |
In table 11the following enzymes and entries have been added
In table 12the followingenzymes and entries shall be inserted in column
S. No |
Name of the processing aid |
Functional/ Technological Purpose |
Product Category |
Residue Level (mg/kg) (Not more than) |
42. |
Sodium bicarbonate (INS 500 (ii)) |
pH control agent |
All foods |
GMP |
43. |
Sodium carbonate (INS 500(i)) |
pH control agent |
All foods |
GMP |
44. |
Potassium carbonate (INS 501(i)) |
pH control agent |
Cocoa mixes (powders) and cocoa mass /cake |
GMP |
45. |
Ammonium carbonate (INS 503(i)) |
pH control agent |
Cocoa mixes (powders) and cocoa mass/cake |
GMP |
46. |
Potassium dihydrogen phosphate (INS 340) |
pH control agent |
All foods |
GMP |
47. |
Sodium dihydrogen phosphate (INS 339) |
pH control agent |
All foods |
GMP |
48. |
Sodium hydroxide (INS 524) |
pH control agent |
All foods |
GMP |
49. |
Nicotinamide |
Microbial nutrient |
All foods |
GMP |
50. |
Biotin |
Microbial nutrient |
All foods |
GMP |
51. |
Vitamin B12 |
Microbial nutrient |
All foods |
GMP |
52. |
Liquified anhydrous ammonia |
Bacterial nutrient |
All foods |
GMP |
53. |
Vitamin C |
Microbial nutrient |
All foods |
GMP |
54. |
Carbon dioxide (INS 290) |
Gassing /aerating Agent |
All foods |
GMP |
55. |
Nitrogen gas (INS 941) |
Foaming agent |
All foods |
GMP |
56. |
Silicon Dioxide (INS 551) |
Free flowing agent |
All foods |
GMP |
57. |
Mono and diglycerides of fatty acids (INS 471) |
Emulsifier in extrusion |
Extruded foods |
GMP |
58. |
Hydrochloric acid (INS 507) |
Protein hydrolysing agent |
Protein products |
GMP |
59. |
Liquid Paraffin (INS 905 e) |
Polishing agent |
Confectionery and gums |
GMP |
60. |
Glycerine/ Glycerol (INS 422) |
Polishing agent |
All foods |
GMP |
61. |
Calcium, Magnesium, Sodium salts of stearic acid (INS 470(i)) |
Polishing agent |
Confectionery and gums |
GMP |
62. |
Icing sugar |
Polishing agent |
Confectionery and gums |
GMP |
63. |
Rice starch |
Polishing agent |
Confectionery and gums |
GMP |
64. |
Calcium carbonate (INS 170 (i)) |
Polishing agent |
All foods |
GMP |
|
In Appendix B, after table 7, the following table shall be inserted, namelyTable-7
Microbiological Standards of Eggs and Egg Products
Table 7A: 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 Products |
NA |
|||||||||||||
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 7B: Microbiological Standards of Eggs and Egg Products – Food Safety Criteria
S. N |
Product Description |
Salmonella/25g (cfu/g) |
Listeria monocytogenes (cfu/g) |
||||||
|
|
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 FSS (Food Products Standards and FoodAdditives) Regulations 2011.
The category “Table egg products” shall be regulated in accordance with the Good Manufacturing Practices and Code of GoodHygiene Practices notified under Schedule 4 of FSS (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-7A (Process Hygiene Criteria)indicate the acceptable functioning of the production process. These are not to be used as requirements for releasing theproducts 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-7B (Food Safety Criteria) define the acceptability of a batch/lot and shall bemet in respect of the products at the end of the manufacturing process and the products in the market during their shelflife.
Action in case of unsatisfactory result:
In case of non-compliance in respect of process hygiene criteria specified in Table- 7A, the FBO shall:
- check and improve process hygiene by implementation of guidelines in Schedule 4 of FSS (Licensing andRegistration of Food Businesses) Regulations
- Ensure that all food safety criteria as specified in Table -7B (Food Safety Criteria) are complied with.
For Regulator: The sampling for different microbiological standards specified in Table-7A and 7B shall be ensuredaseptically at manufacturing units and/or at retail points, as applicable, by a trained person with specialized knowledge inthe 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 bestored 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 ofsample units as per sampling plan given in Table-7A & 7B shall be taken from same batch/lot and shall be submitted tothe notified laboratory. A set (n) of five samples shall be tested from three different accredited laboratories and the final decision shall be drawn based on three test results.There will be no provision for retesting or resampling formicrobiological testing.The testing in laboratory shall be ensured as per reference test methods given below in referencetest methods for regulatory compliance.
For FBO: Food Business Operator (FBO) shall perform testing as appropriate as per the microbiological standards inTable-7A & 7B to ensure validation and verification of compliance with the microbiological requirements. FBO shalldecide 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. FBOmay 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 arespecified) |
1. Satisfactory, if all the values observed are ≤ m
2. Unsatisfactory, if one or more of the valuesobserved are >m or more than c values are >m |
1. Satisfactory, if all the values observed are ≤ m 2. Acceptable, if a maximum of c values are betweenm and M and the rest of the values are observedas ≤m 3. Unsatisfactory, if one or more of the valuesobserved are > M or more than c values are >m |
Reference test methods: The following test methods shall be applied as reference methods. Test methods prescribed inFSSAI Manual of Method of Analysis of Foods (Microbiological Testing) may also be referred along with the IS/ISOmethods 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. ISXXXX / ISO YYYY), latest version of the ISO method (or its BIS equivalent, if available) shall apply.
S. No |
Parameter |
Reference Test methods |
1. |
Aerobic Plate Count |
Microbiology of the food chain — Horizontal method for the enumeration ofmicroorganisms — Part 1: Colony count at 30 °C by the pour plate technique- IS5402/ 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 detectionand enumeration of Enterobacteriaceae- Part 2: Colony- count method-ISO 21528-2 |
3. |
Salmonella |
Methods for Detection of Bacteria Responsible for Food Poisoning – Part 3: GeneralGuidance on Methods for the Detection of Salmonella- IS 5887: Part 3 Microbiology of food and animal feeding stuffs — Horizontal method for thedetection of Salmonella spp.- ISO6579 |
4. |
Listeria monocytogenes |
Microbiology of the food chain — Horizontal method for the detection andenumeration of Listeria monocytogenes and of Listeria spp. — Part 1: Detectionmethod –ISO 11290-1 Microbiology of the food chain — Horizontal method for the detection andenumeration of Listeria monocytogenes and of Listeria spp. — Part 2: enumerationmethod –ISO 11290-1
Microbiology of Food and Feeding Stuffs – Horizontal method for Detection andEnumeration of Listeria Monocytogenes, Part 1: Detection Method -IS 14988-1 Microbiology of Food and Animal Feeding Stuffs – Horizontal Method for theDetection and Enumeration of Listeria monocytogenes, Part 2: Enumeration Method – IS 14988-2 |
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