As of 4 April 2018 the FSSAI has published the final notification of the Food Safety and Standards (Food Products Standard and Food Additives) Fourth Amendment Regulations, 2018 relating to revised microbiological standards for fruits and vegetables and their products. These regulations will come into force on the date of their publication in the Official Gazette and Food Business Operator shall comply with all the provisions of these regulations by 1st January 2019.
In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, in APPENDIX B, TABLE 4 dealing with the Microbiological Standards for Fruits and Vegetables and their Products – Process Hygiene Criteria has been changed. Table 4A gives the sampling plan and limits for Aerobic Plate Count, Yeast and Mould Count, Enterobacteriaceae, and Staphylococcus aureus (Coagulase +ve)
On the other hand Table 4B gives the Sampling plan and limits for Salmonella Listeria, monocytogenes, E. Coli 0157 and Vero or Shiga toxin producing E coli and Vibrio cholera in the following products
- Fresh fruits and vegetables
- Cut or minimally processed and packed, including juices (Non-thermally processed
- Fermented or pickled or acidified or with preservatives
- Pasteurized Juices
- Carbonated Fruit beverages
- Frozen
- Dehydrated or dried
- Thermally processed (other than pasteurization at less than 100°C)
- Retort processed
- Test Methods
Definitions of fruits and vegetables and their products
- Fresh: The whole fruits and vegetables that are sold fresh.
- Cut or minimally processed and packaged including juices: Fruits and vegetables which are washed or sanitized or peeled or cut up and made into juice and packed.
- Fermented or pickled or acidified or with preservatives: Fruits and vegetables including their products which are preserved using living ferments like yeast, bacterium, mould, enzyme or in brine to produce lactic acid or marinating and storing it in an acid solution, usually vinegar (acetic acid), salt and sugar and edible vegetable oil.
- Pasteurized Juices: Fruit and vegetable juices that are subjected to pasteurization to destroy or inactivate harmful microorganisms
- Carbonated fruit beverages (and fruit drinks): Any beverage or drink which is prepared from fruit juice and water or carbonated water and containing sugar, dextrose, invert sugar or liquid glucose either in single or in combination which may contain peel oil and fruit essences. It may also contain any other ingredients appropriate to the products.
- Frozen: Fruits and vegetables including their products which are subjected to a freezing process and maintained at the temperature of -180
- Dehydrated or dried: Fruits and vegetables including their products which are preserved by removing most of their water content following an appropriate dehydrating process.
- Thermally processed (other than pasteurization at less than 100°C): Fruits and vegetables including their products which are processed by heat in an appropriate manner before or after being sealed in a container so as to prevent spoilage.
- Retort processed: Fruits and vegetables including their products which are canned or flexible packaged, processed by retorting.
- The category “Fresh” shall be regulated in accordance with the Good Manufacturing Practices and Good Hygiene Practices specified under Schedule 4 of Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011.
- In case of fermentation process involving yeast/ mould, the respective standard for yeast and mould count does not apply.
- Carbonated fruit beverages and pasteurized fruit juices can be excluded for testing of Listeria, where the pH is below 4.4.
- The retort processed foods shall be tested after incubation at 37°C for 10 days and at 55°C for 7 days.
The stage where the Microbiological Standards shall apply:
The microbiological standards with respect to the products categories specified in Table-4A (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.
Action in case of an unsatisfactory result:
In case of non-compliance in respect of process hygiene criteria specified in Table- 4A, the FBO shall:
- check and improve process hygiene by an 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 -4B (Food Safety Criteria) are complied with.
The Microbiological Standards in Table-4B (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.
Sampling Plans and Guidelines
For Regulator
The sampling for different microbiological standards specified in Table-4A and 4B 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 is given in Table16. 4A & 4B shall be taken from same batch/lot and shall be submitted to the notified laboratory. The testing in the laboratory shall be ensured as per reference test methods are 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-4A & 4B to ensure validation and verification of compliance with the microbiological requirements. FBO shall decide themselves the necessary sampling and testing frequencies to ensure compliance with the specified microbiological requirements. FBO may use analytical methods other than those described in reference test methods given below for in-house testing only. However, these methods shall not be applicable for regulatory compliance purpose.
Sampling Plan:
The terms n, c, m and M used in this standard have the following meaning:
n = Number of units comprising a sample.
c = Maximum allowable number of units having microbiological counts above m for 2- class sampling plan and between m and M for 3- class sampling plan.
m = Microbiological limit that separates unsatisfactory from satisfactory in a 2- class sampling plan or acceptable from satisfactory in a 3-class sampling plan.
M = Microbiological limit that separates unsatisfactory from satisfactory in a 3-class sampling plan.
Interpretation of Results
2-Class Sampling Plan (where n, c, and m are specified) | 3-Class Sampling Plan (where n, c, m, and M are specified) |
1. Satisfactory, if all the values observed are m2. Unsatisfactory, if one or more of the values observed are >m or more than c values are >m | 1. Satisfactory, if all the values observed are m2. Acceptable, if a maximum of c values are between m and M and the rest of the values are observed as m
3. Unsatisfactory, if one or more of the values observed are > M or more than c values are >m |
Reference test methods
The following test methods shall be applied as reference methods.
(Reference test methods- latest version shall apply. In the case where an ISO method adopted by the BIS is specified (e.g. IS XXXX / ISO YYYY), the latest version of the ISO method
(or its BIS equivalent, if available) shall apply.)
S. No | Parameter | Reference Test Method |
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 5403Microbiology of food and animal feeding stuff-Horizontal method for the enumeration of yeasts and moulds-Part1: Colony count technique in products with a 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 |
3. | Enterobacteriaceae | Microbiology – General Guidance for the Enumeration of Enterobacteriaceae without Resuscitation – MPN Technique and Colony count Technique- IS/ISO 7402Microbiology 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 2Methods 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 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) |
5. | E. Coli 0157 and Vero or Shiga toxin producing E Coli | Methods for detection, isolation, and identification of pathogen i.e. E.coli in foods- IS: 14397 |
6. | Salmonella | Methods for detection of bacteria responsible for food poisoning – Part 3: General Guidance on Methods for the Detection of Salmonella- IS 5887: Part 3Microbiology of food and animal feeding stuff – Horizontal method for the detection of Salmonella spp.- ISO 6579 |
7. | Listeria monocytogenes | Microbiology of the food chain – Horizontal method for the detection and enumeration of Listeria monocytogenes and other Listeria spp. – Part 1: Detection method – IS: 14988, Part 1 / ISO 11290-1 |
8. | Sulfite-Reducing Bacteria | Microbiology of food and animal feeding stuff – Horizontal method for the enumeration of sulfate-reducing bacteria growing under anaerobic conditions- ISO 15213 |
9. | Vibrio cholerae | Isolation, identification, and enumeration of Vibrio cholera and Vibrio parahaemolyticus – IS:5887, (Part V)Microbiology of food and animal feeding stuff-Horizontal method for the detection of potentially enteropathogenic Vibrio spp.-Part1 Detection of Vibrio parahaemolyticus and Vibrio cholerae-ISO/TS 21872-1”. |
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