
Through a notification issued on 15 April, 2019 the FSSAI has drafted the Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulation, 2019 which amends theFood Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, to include Sorbitan Monostearate for use in various food categories, including yeast and like products as also microbiological requirements for spices and herbs. The FSSAI has also invited objections and suggestions which are to reach the FSSAI by 3 June 2019. The Amendment Regulations shall come into force on the date of their final publication in the official Gazette.
Draft Regulations
In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011in the regulation 2.4 CEREALS AND CEREAL PRODUCTS under category ATTA and MAIDA the standards given for
- Fortified Atta are proposed to be omitted
- Fortified Maida are proposed to be omitted
Under 2.9.30, EDIBLE COMMON SALT
Category “IODISED SALT” is proposed to be omitted
Category “IRON FORTIFIED COMMON SALT” is proposed to be omitted
Category “Iron Fortified Iodized Salt (double fortified salt)” the following standards are proposed to be omitted
1. “Iron Content (as Fe) 850-1100 parts per million
2. Iodine content: a. Manufacturers level Not less than 30 ppm
b. Distribution Channel Not less than 15 ppm including Retail level
In regulation 2.10 BEVERAGES, (Other than Dairy and Fruits & Vegetables based)
the category 2.10.5 “Beverage- ALCOHOLIC” shall be omitted.
Amendments in Appendix A
Under “IV. USE OF FOOD ADDITIVES IN FOOD PRODUCTS”
In Table 5 – Confectionary
- Against the entries relating to Food Category System 5.1.3 Cocoa and chocolate products in the following entries shall be inserted
Food Additive | INS Number | Recommended Maximum level | Note |
“SORBITAN ESTERS OF FATTY ACIDS | 10,000 mg/kg | 101 |
- Against the entries relating to Food Category System 5.2, pertaining to confectionery including hard and soft candy,nougats etc. other than food categories 5.1, 5.3 and 5.4 the entry
Paraffin wax or liquid paraffin (Food Grade) | GMP |
shall be substituted with the following
Food Additive | INS Number | Recommended Maximum level | Note |
Liquid parafin | 905e | GMP |
In Table 7 Bakery products
Against the entries relating to Food Category System 7.1.2, Crackers the following shall be food additive has been added
Food Additive | INS Number | Recommended Maximum level | Note |
SORBITAN ESTERS OF FATTY ACIDS | 10.000mg/kg | 11 |
- Against the entries relating to Food Category System 7.1.3, Other ordinary bakery products the following food additive has been added
Food Additive | INS Number | Recommended Maximum level | Note |
SORBITAN ESTERS OF FATTY ACIDS | 10.000mg/kg | 11 |
- Against the entries relating to Food Category System 7.1.4, Bread-type products, including bread stuffing and bread crumbs the following food additive has been added
Food Additive | INS Number | Recommended Maximum level | Note |
SORBITAN ESTERS OF FATTY ACIDS | 10.000mg/kg | 11 |
- Against the entries relating to Food Category System 7.1.5Steamed breads and buns the following food additives have been added
Food Additive | INS Number | Recommended Maximum level | Note |
SORBITAN ESTERS OF FATTY ACIDS | 10.000mg/kg | 11 |
- Against the entries relating to Food Category System 7.1.6,Mixes for bread and ordinary bakery wares the following food additive has been added
Food Additive | INS Number | Recommended Maximum level | Note |
SORBITAN ESTERS OF FATTY ACIDS | 10.000mg/kg | 11 |
- Against the entries relating to Food Category System 7.2, Fine bakery wares (sweet, salty, savoury the following food additive has been added
Food Additive | INS Number | Recommended Maximum level | Note |
SORBITAN ESTERS OF FATTY ACIDS | 10.000mg/kg | 11 |
In Table 12Salts, spices, soups, salads and protein products
- Against the entries relating to Food Category System 12.8Yeast and like products the following food additive has been added
Food Additive | INS Number | Recommended Maximum level | Note |
“Sorbitan monostearate | 491 | 10,000 mg/kg |
In Table 14Beverages, excluding dairy products
- Against the entries relating to Food Category System 14.1.2.1, Fruit juices (fruit juices for industrial use, thermally processed fruits juices, the following food additives have been added
Food Additive | INS Number | Recommended Maximum level | Note |
Nisin | 234 | 5000 IU | FSO4b |
- Against the entries relating to Food Category System 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, for the entry “The following additivespermitted in synthetic syrups for dispensers”, the following has been substituted
*The following additives permitted in synthetic syrups for dispensers | 127 |
- Against the same Food Category System 14.1.4.3“*The following additivesare permitted in sharbat (synthetic syrup)”, the following shall be substituted,
*The following additives are permitted in sharbat (synthetic syrup) | 127 |
In table 15 Ready-to–eat savouries
- Against the entries relating to Food Category System 15.1 Snacks and savouries –potato, cereal, flour or starch based (from roots and tubers, pulses and legumes). the following food additives have been added
Food Additive | INS Number | Recommended Maximum level | Note |
Paprika oleoresin | 160c(i) | GMP | |
Curcumin | 100(i) | GMP | |
Turmeric | 100(ii) | GMP |
Under Notes to the Food Additives mentioned in the Table 1 to 15, the following shall be inserted
Note No | Notes to the Food Additives mentioned in the Table 1 to 15 |
FSO4b | For use in pre-packed coconut water only. |
In Appendix B relating to “Microbiological Requirements”
for TABLE 3the following table and the entries shall be substituted,
Table: 3 Microbiological Standards for Spices and Herbs
Table -3 A Microbiological Requirements for Spices and Herbs –Process Hygiene Criteria
To view the details of this table, please see the original document of the draft regulation on the FSSAI website.
Table -3 B Microbiological Requirements for Spices and Herbs – Food Safety Criteria
To view the details of this table, please see the original document of the draft regulation on the FSSAI website.
NA-Not applicable
Definitions:
Fresh: The spices and herbs that are consumed fresh.
Dried or dehydrated: The product obtained by drying/ removal of most of the moisture byanysuitable method which ensures characteristics of fresh spices on rehydration without bleaching orpre-cooking.
Ground or powdered: Ground or powdered product obtained by grinding or crushing of cleandried/dehydrated fruits, capsules, buds, seeds, rhizomes, aril, kernel, berries, stigmas and/ or oleoresins etc.
Extracted: Products of the spices and herbs which are produced by extracting in a concentratedform.
Wet ground (paste)/preserved or pickled: Semi solid, preserved product using brine, vinegarand other permitted preservatives or physical methods.
For detailed product definition, refer to Food Safety & Standards (Food Product Standards & Food Additives)Regulations, 2011.
IiThe category “Fresh” shall be regulated in accordance with the Good Manufacturing Practices and Codeof Good Hygiene Practices notified under Schedule 4 of FSS (Licensing and Registration of FoodBusinesses) Regulations, 2011.
Stage where the Microbiological Standards shall apply:
The microbiological standards with respect to the product categories specified in Table-3A (Process HygieneCriteria) indicate the acceptable functioning of the production process. These are not to be used asrequirements for releasing the products in the market. These are indicative values above which correctiveactions are required in order to maintain the hygiene of the process in compliance with food law. These shallbe applicable at the end of the manufacturing process.
The Microbiological Standards in Table-3B (FoodSafety Criteria) define the acceptability of a batch/lot and shall be met in respect of the products at the end ofmanufacturing 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- 3A, the FBO shall:
- check and improve process hygiene by implementation of guidelines in Schedule 4 of FSS(Licensing and Registration of Food Businesses) Regulations
- Ensure that all food safety criteria as specified in Table -3B are complied with.
Sampling Plans and Guidelines
For Regulator: The sampling for different microbiological standards specified in Table-3A and 3B shall beensured aseptically at manufacturing units and/or at retail points, as applicable, by a trained person withspecialized 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 bestored 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 toenable initiation of analysis within 24 hours of sampling. Preservatives shall not be added to sample unitsintended for microbiological examination. The desired number of sample units as per sampling plan given inTable-3A & 3B shall be taken from same batch/lot and shall be submitted to the notified laboratory. A set offive 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 microbiologicalstandards in Table-3A & 3B to ensure validation and verification of compliance with the microbiologicalrequirements. FBO shall decide themselves the necessary sampling and testing frequencies to ensurecompliance 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 shallnot 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 planand between m and M for 3- class sampling plan.
m = Microbiological limit that separates unsatisfactory from satisfactory in a 2- class sampling plan oracceptable 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 |
Reference test methods: The following test methods shall be applied as reference methods. Test methodsprescribed in FSSAI Manual of Method of Analysis of Foods (Microbiological Testing) may also be referredalong 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 isspecified (e.g. IS XXXX / ISO YYYY), latest version of the ISO method (or its BIS equivalent, if available)shall apply.
S.N | Parameter | Reference Test methods |
1. | Aerobic Plate Count | Microbiology of the food chain — Horizontal method for the enumeration of microorganisms — Part 1: Colony count at 30 °C by the pour plate technique- IS 5402/ ISO:4833 |
2. | 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-ISO21527-1 Microbiology of food and animal feeding stuffHorizontal method for the enumeration of yeasts and moulds-Part2: Colony count technique in products with water activity less than 0.95-ISO 21527-2 |
3. | Enterobacteriaceae | Microbiology – General Guidance for the Enumeration of Enterobacteriaceae without Resuscitation- MPN Technique and Colony-count Technique- IS/ISO 7402 Microbiology of Food and Animal feeding stuff –Horizontal methods for the detection and enumeration of Enterobacteriaceae- Part 2: Colony- count method-ISO 21528-2 |
4. | Staphylococcus aureus | 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 Food Poisoning Part 8 Horizontal Method For Enumeration of Coagulase-Positive Staphylococci/ (Staphylococcus aureus and other species) Section 1 Technique using bairdparker 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 68882: 1999 |
5. | 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 |
6. | Sulfite-Reducing Bacteria | Microbiology of food and animal feeding stuffs — Horizontal method for the enumeration of sulfite-reducing bacteria growing under anaerobic conditions- ISO 15213 |
7. | Bacillus cereus | Microbiology of Food and Animal Feeding Stuffs-Horizontal Method for the Enumeration of Preservative Bacillus Cereus, Part 6 Colony –count Technique at 30°C- IS 5887-6 Microbiology of food and animal feeding stuffs-Horizontal method for the enumeration of presumptive Bacillus cereus-Colony- count technique at 30degrees C.-ISO 7932. |
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