Source: https://fssai.gov.in/comments/Bestviewwl.aspx?NOTIFICATION_ID=1091
Timestamp: 2019-08-22 03:41:31
Document Index: 59113675

Matched Legal Cases: ['art 1', 'art 2', 'art 1', 'art 3', 'art 3', 'art 1', 'art 2', 'art 1', 'art 2']

Last Date For Commments On This Draft Is September 05, 2019
Draft “Food Safety and Standards (Food Product Standards and Food Additives) Amendment Regulation, 2019 relating to Amendment to Regulation 2.3, Fruit and Vegetable Products: (a) Inclusion of standard of Monk fruit under 2.3.6 “Processed Fruit Juices”;(ii) 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;(iii) Amendment to Regulation 2.8 Sweetening agents including Honey (a) Sucralose;(iv) Amendment to Regulation 2.9 Salt, Spices, Condiments and Related Products (a) Cumin (Whole & Powder)(b) Iron Fortified Common Salt (c)Dried Thyme (v) 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 (a)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 (vii) Amendment to Appendix B: Microbiological Requirements (a) Microbiological Standards for Egg and Egg Products (b) Procedures /protocols for retesting of microbiologically contaminated samples.”
(2) 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.
2. In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011,-
2 sub-regulation 2.3.6
(1) In regulation 2.3, in sub-regulation 2.3.6, relating to “Processed Fruit Juices” under clause 4, in table, after the entries at S. No. 72 relating to “juice of two or more fruits”, following shall be inserted, namely: -
3 sub-regulation 2.4.2, for clause (1)
(2) In regulation 2.4,-
(a) In the sub-regulation 2.4.2, for clause (1), the following shall be substituted, namely:-
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:-
Granularity %( Not less than)
shall pass through 212 micron IS sieve (70 mesh)
5 For sub-regulation 2.4.3
(b) For sub-regulation 2.4.3, the following shall be substituted, namely:-
(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).
7 sub-regulation 2.4.6, for clause (4)
(c) In the sub-regulation 2.4.6, for clause (4), the following shall be substituted, namely:-
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.
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.
9 sub-regulation 2.4.15, for clause (1) and (2)
(d) In the sub-regulation 2.4.15, for clause (1) and (2), the following shall be substituted, namely: -
1. Biscuit.- (1) Biscuit is a baked product leavened or non-leavened , coated or uncoated, center-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 (made with milk solids and sugar) 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/or 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 & 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, Fat powder, 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:-
11 Bread and Bread-Type Products
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 & 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/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/or 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/or their extracts, herbs, seasonings, fruit and/or fruit products, Edible Vegetable and/or vegetable Products, Dry fruits, nuts and/or nut products , maltodextrin, oligofructose (max 15%) ,vinegar or any other ingredient as specified in Food Safety and Standards Regulations.
(4) it shall be free from dirt, insect and insect fragments, larvae, rodent hairs.
13 For sub-regulation 2.4.17
(e) For sub-regulation 2.4.17, following shall be substituted, namely:-
2.4.17 Pearl Millet Flour.- (1) “Pearl Millet flour” means the product obtained from pearl millet grains (Pennisetum americanum L. or Pennisetum typhyoideum) through a process of milling.
(2) It shall be free from abnormal flavours, odours, living insects, filth (impurities of animal origin including dead insects).
Protein (N×5.7)(per cent on dry matter basis), Not less than
shall pass through 1mm sieve (18 mesh).
14 For sub-regulation 2.4.18
(f) For sub-regulation 2.4.18, the following shall be substituted, namely:-
2.4.18 Sorghum Flour.- (1) Sorghum flour means the product obtained from grains of Sorghum bicolor (L.) Moench through a process of milling.
Protein (N x 5.7)(on dry matter basis), Not less than, % by m/m basis
Crude Fat (on dry matter basis), Not more than % by m/m basis
Minimum 80 per cent shall pass through a 1 mm sieve (18 mesh).
15 After sub-regulation 2.4.34
(g) After sub-regulation 2.4.34, following sub-regulations shall be inserted, namely-
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 coextruding with chocolate, fruit, vegetables, nuts or any other such nutritious fillings in sweet or savory 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 flavoring 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 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 possess a characteristic taste and odor and shall be free from rancid, musty, sour and other undesirable tastes and odors.
(7) It shall conform to the following requirements, namely:-
Moisture content (% by weight), Not more than
Products containing dehydrated/candied fruits, seeds, nuts whole grains etc. –10%
All others - 7.5%
Acid insoluble ash in dilute HCL (% on dry weight basis), Not more than
17 sub-regulation 2.8.11
(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-
18 in sub-regulation 2.9.8, for clause (1) and (2)
(4) In regulation 2.9,
(a) in sub-regulation 2.9.8, for clause (1) and (2), following shall be substituted, namely:-
1. Cumin (Safed Zeera) whole means the dried mature seeds of CuminumcyminumL. 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.
Dead insects, insect fragments, rodent contamination , percent by mass (Maximum)
Animal excreta (mg/kg) , (Maximum)
Uric Acid , mg/kg on dry basis (Maximum)
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.
(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.
2. Cumin (SafedZeera) 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.
Acid insoluble ash, percent by mass on dry basis. (Maximum)
20 after sub-regulation 2.9.39
(b) after sub-regulation 2.9.39, following sub-regulation shall be inserted, namely:
(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 geo-climatic 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.
b) Crushed/rubbed: processed into varying degrees ranging from a coarse to fine crush.
Dead insects, Insect fragments and rodent contaminant, percent by mass, (Maximum)
Stalk exceeding 10 mm in length or 2 mm in diameter percent by mass, (Maximum)
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.
21 regulation 2.14, for sub-regulation (3)
(5) In regulation 2.14, for sub-regulation (3), the following shall be substituted, namely:-
“(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 and also free from contaminant gluten”.
22 Regulation 2.15
(6) Regulation 2.15 shall be omitted.
23 In regulation 3.3, for sub-regulation 3.3.4
(7) In regulation 3.3, for sub-regulation 3.3.4, following shall be substituted, namely:-
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) For achieving functional and technological objectives, Trehalose may be used upto 1 % (max, m/m) in any category of 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 product only where upper limit of sugar has been specified in the quality standards of that food product specified in any of the regulations made under Food Safety and Standards Act, 2006.
(4) It shall conform to the following requirements, namely:-
(5) Trehalose may be added as an ingredient subject to label declaration under clause (49) of regulation 2.4.4 of the Food Safety and Standards (packaging and labelling) Regulations, 2011, without health claims.
24 In Appendix A, IV.Use of Food Additives in Food Products
(8) 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, in column (3), after the food additive ‘Tatrazine’ and entries relating thereto, the following food additive and entries relating thereto shall be inserted, namely: -
“TOCOPHEROLS
XS243;”
(b) In the said regulations, 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: -
25 after Regulation 3.3, in table 4
(9) In Chapter 3 relating to SUBSTANCES ADDED TO FOOD, after Regulation 3.3 relating to other substances for use in food products,
(a) in table 4, in column (2), after the processing aid “Oleic Acid ” and entries relating thereto, the following processing aids and entries shall be inserted in column (1) to (4), namely:-
(INS 322(i) )
Calcium, Magnesium, Sodium salts of stearic acid
(INS 170 (i) )
Confectionery, bakery wares, salts, spices, soups, cereal products
26 after Regulation 3.3, in table 11
(b) in table 11, in column (2), after the enzyme “Glucose isomerise (or xylose isomerase) (EC No. 5.3.1.5)” and entries relating thereto, the following enzymes and entries shall be inserted in column (1) to (4), namely:-
Lipase (Triacylglycerol)
rugosa(cylindracea)
Pregastric bovine (calf) tissue
Pregastric ovine (lamb) tissue
(Mucor circinelloides f. circinelloides)
(EC No. 3.1.1.4)
(EC No. 3.1.1.5)
(EC No. 3.1.4.1)
(EC No. 3.2.1.2)
(4-β-D-glucan 4-glucanohydrolase)
Rasamsonia (Talaromyces) emersonii
Beta-glucanase (or endo-beta glucanase or endo-1,3-beta-glucanase)
Rasamsonia(Talaromyces)emersonii
reesei(longibrachiatum)
(EC No. 3.2.1.17)
Gallus gallus egg
(mannan endo-1,4-β-mannosidase)
Endo-1,3-β-xylanase
(EC No. 3.2.1.32)
(EC No. 3.4.22.2)
(EC No. 3.4.22.33)
Ananas species
(Pepsin A –
EC No. 3.4.23.1)
(Chymosin –
EC No. 3.4.23.4)
Fore stomach of domesticated ruminants (cattle, buffalos, goats and sheeps)
Endo(thia)peptidase
(EC No. 3.4.23.22)
Cryphonectria (Endothia) parasitica
(EC No. 3.4.23.23)
(EC No. 3.5.4.6)
27 after Regulation 3.3, in table 12
(c) in table 12, in column (2), after the processing aid “Citric acid (INS 330)” and entries relating thereto, the following enzymes and entries shall be inserted in column (1) to (4), namely:-
(INS 500(i) )
Liquified anhydrous ammonia
(INS 290 )
(INS 471 )
Protein hydrolysing agent
28 Appendix B, after table 7
(10) In Appendix B, after table 7, following table shall be inserted, namely-
Table-7 Microbiological Standards of Eggs and Egg Products
Pasteurized Liquid egg products (whole, yolk or albumin liquid)
Cooked/ready-to-eat egg products including mayonnaises
IS: 14988, Part 1 & Part 2 / ISO 11290-1& 2
Definition related to Egg and Egg products are the same as provided in FSS (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 FSS (Licensing and Registration of Food Businesses) Regulations, 2011.
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 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-7B (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.
· 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 -7B (Food Safety Criteria) are complied with.
For Regulator: The sampling for different microbiological standards specified in Table-7A and 7B 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-7A & 7B shall be taken from same batch/lot and shall be submitted to the 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 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-7A & 7B 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.
3-Class Sampling Plan (where n,c,m and M are specified)
2. Unsatisfactory, if one or more of the values observed are >m or more than c values 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
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.
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.
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
Microbiology - General Guidance for the Enumeration of Enterobacteriaceae without Resuscitation - MPN Technique and Colony-count Technique- IS/ISO 7402
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
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 11290-1
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