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Food Control System in India
Food Control System in India
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  1. 1. SUBBURAJ.M M.Sc,M.Phil (CHEM)M.Sc Env.Sc,B.Ed,BLISC DEPUTY DIRECTOR FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA
  2. 2. MODULES  1. Introduction to FSS Act, 2006, FSSAI, FSM  2. Introduction to Various Regulations Impacting thr FBOs  3. Licensing and Registration Regulations and Guidance on Product Categorization  4. FLRS & FoSCoS  5. FLRS & FoSCoS Online Demo  6. Organic Endorsement/Fortification endorsement/Form D submission /Salient points on FICS
  3. 3. MODULE -1 Introduction to FSS Act, 2006, FSSAI
  4. 4. FOOD SAFETY AND STANDARDS ACT, 2006  An Act to consolidate the laws relating to food and to establish the Food Safety and Standards Authority of India for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption and for matters connected therewith or incidental thereto. 4 FSS Act, 2006 Module- 1
  5. 5. Food Safety and Standards Act, 2006 Prevention of Food Adulteration Act, 1954 Fruit Products Order, 1955 Meat Food Products Order, 1973 Vegetable Oil Products (Control) Order, 1947 Edible Oils Packaging (Regulation) Order, 1998 Solvent Extracted Oil, Deoilded Meal, and Edible Flour (Control) Order, 1967 Milk and Milk Products Order, 1992 Any other order under Essential Commodities Act, 1955 relating to food 5 FSSA : The Single reference point for all matters relating to food safety and standards FSS Act, 2006 Module- 1
  6. 6. Food Safety and Standards Act ,2006 - passed by Indian Parliament and notified on 24th August, 2006 Authority Established- in Sept, 2008 FSS Regulations Notified -3rd August, 2011 New Act operationalised- 5th August,2011 All Food Business Operators in India to get Licensed/Registered with Food Safety Authority FSS Act, 2006 Module- 1
  7. 7. FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA (FSSAI) A Statutory Body governing the Food Safety of the country MANDATE: Ensure availability of safe and wholesome food for human consumption 7 FSS Act, 2006 Module- 1
  8. 8. ROLE OF FSSAI: Framing of Rules, Regulations, Science based Standards and guidelines in relation to articles of food Issue of Food License to FBO’s and ensuring Food Safety through Risk Based Inspection System Ensure the entry of safe food in to the country through Import clearance system Guidelines for accreditation of certification bodies/ Laboratories Scientific advice and technical support to the Central Government and State Governments in matters of framing the policy and rules in areas related to food safety and nutrition 8 FSS Act, 2006 Module- 1
  9. 9. ROLE OF FSSAI: Creating Information Dissemination Network across the country about food safety Capacity Building for various stakeholders Contribute to development of International Technical Standards for Food products, Sanitary and Phyto-Sanitary Standards Promote general awareness about Food Safety and Food Standards Procedure and guidelines for Risk Analysis methodologies, food safety plans etc. Collect and collate data on food consumption, Incidence and Prevalence of biological risk, Contaminants in food, Residues of contaminants in food and introduction of rapid alert system 9 FSS Act, 2006 Module- 1
  10. 10. 101 Sections 1-3 Title, Definitions 4-17- Establishment of FSSAI 18 General Principles in Administration 19-24 General Provisions(Contaminants, Toxins, Sec 22, Packaging , labelling, Advertisements, ) 25- Food Imports 26-28 FBOs responsibility 29-42 Enforcement of Act (Food safety commissioners, DO, FSO, 31- Licensing, 32-Improvement Notice, Prosecution) 43-47 Food Analysis 48-67 Offences and Penalties 68-80 Adjudication and Tribunal FSS Act, 2006 MODULE-1
  11. 11. Business without License FSS Act, 2006
  12. 12. Offence Penalty Imprisonment Without License 5 Lakhs 6 months Substandard 5 Lakhs Misbranded 3 Lakhs Extraneous Matter 1 lakh For contavention with no speciifc penalty defined 2lakhs Misleading advertisement 10 lakhs Failure to comply with the directions of FSO 2 lakhs Unhygienic or unsanitary processing or manufacturing of food 1 lakh Unsafe food. Non Injurious – 1lakh Non grievous injury - 3 lakh Grievous injury - 5 lakhs Death – 10 lakhs 6 months 1yr 6 yrs 7ys-life Possessing adulterant Not Injurious- 2 lakh Injurious- 10 lakhs FSS Act, 2006
  13. 13. AN INITIATIVE BY FSSAI FSS Act, FSM MODULE-1
  14. 14. WHY FSM?  FSSAI is creating an ecosystem of Food Safety Mitras (FSM) who will help FBOs with licensing and registration, training and auditing hygiene at different institutions such as Schools, Colleges and Corporate campuses.  Through FSM, FSSAI aims to enable individuals with entrepreneurial mindset to become certified licensing and registration professionals . With adequate training FSM will become self employed last mile solution providers for FBO’s FSS Act, 2006, FSM MODULE-1
  15. 15. :  Digital Mitra (Licensing & Registration ) : Individuals with entrepreneural mindset and IT skills can help food businesses with their compliances .  Hygiene Mitra (Hygiene Auditors) : Domain experts from food industry are encouraged to get associated under FSM to become hygiene auditors.  Trainer Mitra (Food Safety Training): Any persons who are in food business or food professionals can be certified as Food Safety trainers. FSS Act, 2006 MODULE-1
  16. 16. ROLES AND RESPONSIBILITIES : •Filing of new application for License/Registration •Further online correspondence regarding queries raised by Authorities •Filing application for modification of License/Registration •Filing of Annual Returns/ Declarations •Filing applications for approval of Product/ label/ Advertisement Claim •Filing appeal for revocation of Suspended Licenses/Registration FSS Act, 2006 MODULE-1
  17. 17. MODULE 2 FSS Regulations impacting FBO’s
  18. 18. Understanding the FSS Legislations 1. Licensing and Registration of Food Businesses Regulation, 2011 2.Food Product Standards and Food Additives Regulation, 2011 3.Prohibition and Restriction on Sales Regulation, 2011 4.Packaging and Labelling Regulation, 2011 5. Contaminants, Toxins and Residues Regulation, 2011 6. Laboratory and Sampling Analysis Regulation, 2011 8.Food Recall Procedure Regulation, 2017 7.Food or Health Supplements Regulations, 2016 9. Import Regulation, 2017 10.Approval for Non- Specified Food and Food Ingredients Regulations, 2017. 11.Organic Food Regulation, 2017. 12.Alcoholic Beverages Regulations, 2018 13.Fortification of Foods Regulations, 2018 14.Food Safety Auditing Regulations, 2018 15.Recognition and Notification of Laboratories Regulations, 2018. 16.Advertising and Claims Regulations, 2018. 17.Packaging Regulations, 2018 18. Food Safety and Standards (Recovery and Distribution of Surplus food) Regulation, 2019 FSS Regulations impacting FBO’s MODULE-2
  19. 19. 1. 2.1 DAIRY PRODUCTS AND ANALOGUES 2. 2.2 FATS, OILS AND FAT EMULSIONS 3. 2.3 FRUIT & VEGETABLE PRODUCTS 4. 2.4 CEREALS AND CEREAL PRODUCTS 5. 2.5 MEAT AND MEAT PRODUCTS 6. 2.6 FISH and FISH PRODUCTS 7. 2.7 SWEETS & CONFECTIONERY 8. 2.8 SWEETENING AGENTS INCLUDING HONEY 9. 2.9 SALT, SPICES, CONDIMENTS AND RELATED PRODUCTS 10. 2.10 BEVERAGES, (Other than Dairy and Fruits & Vegetables based) 11. 2.11 OTHER FOOD PRODUCT AND INGREDIENTS 12. 2.12 PROPRIETARY FOOD 13. 2.13 RADIATION PROCESSING OF FOOD 14. 2.14 GLUTEN FREE FOOD 15. 3.1 FOOD ADDITIVES 16. APPENDIX A: .FOOD CATEGORY SYSTEM 17. APPENDIX B: MICROBIOLOGICAL REQUIREMENTS FSS Regulations impacting FBO’s MODULE-2
  20. 20. 2.4 CEREALS AND CEREAL PRODUCTS 2.4.1 ATTA Atta or resultant atta means the coarse product obtained by milling or grinding clean wheat free from rodent hair and excreta It shall conform to the following standards:— It shall be free from rodent hair and excreta Moisture Not more than 14.0 per cent (when determined by heating at 130- 133oC for 2 hours). Total ash Not more than 2.0 per cent (on dry weight basis). Ash insoluble in dilute HCl Gluten Not more than 0.15 percent (on dry weight basis). Not less than 6.0 per cent Alcoholic acidity (with 90 per cent alcohol) expressedas H2SO4(on dry weight basis) Not more than 0.18 per cent FSS Regulations impacting FBO’s MODULE-2
  21. 21. 2.12 Proprietary Food  * Proprietary food means an article of food that has not been standardised under these regulations,but does not include foods for special dietary uses, foods for special medical purposes, functional foods, nutraceuticals, health supplements and such other food articles which the Central Government may notify in this behalf.  Proprietary food shall contain only those ingredients other than additives which are either standardised or permitted for use in the preparation of food products under the Food Safety Standards and Regulations  Provided that a proprietary food may also contain vitamins and minerals in quantities not exceeding one Recommended Dietary Allowance of the respective micronutrients  Proprietary food shall use only such additives and at such levels, as specified for the Category or Sub-category under Appendix A of these Regulations, to which the food belongs. Such Category or Sub-category shall be clearly mentioned on the label along with the generic name, nature and composition of the proprietary food. FSS Regulations impacting FBO’s MODULE-2
  22. 22. Food or Health Supplements Regulations, 2016  The regulation – 7 categories of foods and VIII Schedules covering the permissible ingredients and additives along with labeling requirements and claims 1. Health Supplements 2. Nutraceuticals 3. Food for special Dietary use 4. Food for special medical purpose 5. Specialty food containing plant or botanicals 6. Foods containing probiotics 7. Foods containing prebiotics FSS Regulations impacting FBO’s MODULE-2
  23. 23. Schedules under the Regulation Schedule I Vitamins, Minerals and their components Table A - Vitamins Table B – Minerals Table C - Permissible overages Schedule II Amino acids Table A -Essential Amino Acids Table B – Non- Essential Amino Acids Table C - Nucleotides Schedule III Vitamins, minerals and trace elements allowed to be used in FSDU / FSMP Table 1 - Vitamins Table 2 - Minerals Schedule IV Plant or botanical ingredients (*400 ingredients in regulation) Schedule V Schedule VA to VF – List of permissible Additives Schedule VI Ingredients as Nutraceuticals Part A – Ingredients with Purity Criteria Part B – Ingredients alone Schedule VII Probiotics Ingredients Schedule VIII Prebiotic compounds *More ingredients approved under Implementation_Health_Suppliments, F. No. Stds/Nutra(DCGI)/FSSAI/2017(Pt1) dated 29/12/2017 MODULE-2 FSS Regulations impacting FBO’s
  24. 24. Food categories 13.3 Dietetic foods intended for special medical purposes (excluding products of food category 13.1) 13.4 Dietetic formulae for slimming purposes and weight reduction 13.5 Dietetic foods (e.g. supplementary foods for dietary use) excluding products of food categories13.1‐ 13.4 and 13.6 13.6 Food Supplements/health supplements; Nutraceuticals; Speciality food containing plant botanical ingredients with safe history of usage; and prebiotics/probiotics (excluding foods containing prebiotics/probiotics covered under any other category) FSS Regulations impacting FBO’s MODULE-2
  25. 25. 01 Dairy products and analogues, excluding products of food category 2.0. 02 Fats and oils, and fat emulsions 03 Edible ices, including sherbet and sorbe 04 Fruits and vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweeds, and nuts and seeds 05 Confectionery 06 Cereals and cereal products, derived from cereal grains, from roots and tubers, pulses,legumes and pith or soft core of palm tree, excluding bakery wares of food category 7.0 07 Bakery products 08 Meat and meat products including poultry 09 Fish and fish products, including molluscs, crustaceans, and echinoderms 10 Eggs and egg products 11 Sweeteners, including honey 12 Salts, spices, soups, sauces, salads and protein products 13 Foodstuffs intended for particular nutritional uses 14 Beverages, excluding dairy products 15 Ready-to-eat savouries 16 Prepared Foods 99 Substances added to food FSS Regulations impacting FBO’s MODULE-2
  26. 26. 05 Confectionery  05.1 Cocoa products and chocolate products including analogues and chocolate substitutes  05.1.1 Cocoa mixes (powders) and cocoa mass/cake  05.1.2 Cocoa mixes (syrups)  05.1.3 Cocoa and Chocolate products  05.1.4 Chocolate substitute and their products  05.2 Confectionery including hard and soft candy, nougats etc. other than food categories 5.1, 5.3, and 5.4  05.2.1 Hard Candy  05.2.2 Soft Candy  05.2.3 Nougats and marzipans  05.3 Chewing gum  05.4 Decorations (e.g. For fine bakery wares), toppings (non-fruits), and sweet sauces MODULE-2
  27. 27. 11. Microbiological Requirements for Fish and Fishery products Microbiological Requirements for Fish and Fishery products -Hygiene Indicator Organisms (Table 1A) Microbiological Requirements for Fish and Fishery products –Safety Indicator Organisms (Table 1B) 2. Microbiological Standards for Milk and Milk Products Microbiological StandardsforMilkand MilkProducts–Process HygieneCriteria (Table 2A) Microbiological Standards forMilkand MilkProducts– Food SafetyCriteria (Table-2B) 3. Microbiological Parameters for spices (Table 3) 4. Microbiological Standards for Fruits and Vegetables and their Products Microbiological Standards for Fruits and Vegetables and their Products – Process Hygiene Criteria (Table 4A) Microbiological Standards for Fruits and Vegetables and their Products-Food Safety Criteria (Table 4B) 5. Microbiological Standards for Meat and Meat Products- Microbiological Standards for Meat and Meat Products- Process Hygiene Criteria (Table 5A) Microbiological Standards for Meat & Meat Products- Food Safety Criteria (Table 5B) 6. MICROBIOLOGICAL REQUIREMENTS OF OTHER PRODUCTS (Table 6) 7. Microbiological Requirements for Non-Carbonated Water Based Beverages (Non Alcoholic) (Table 7 ) MODULE-2
  28. 28. MODULE -3 FOOD SAFETY AND STANDARDS (LICENSING AND REGISTRATION OF FOOD BUSINESSES), REGULATIONS
  29. 29. FSSAI STATE REGISTERATION STATE LICENSING CENTRAL CENTRAL LICENSING 30 FSS (L&R) MODULE-3
  30. 30. Food Licensing : Types Central Licensing Authority (More Than 2 MT of production/day ) State License (Upto 2 MT of production per day) Registration (Less than 12 lakhs turnover) Designated Officer appointed by the Chief Executive Officer of the Food Authority of India in his capacity of Food Safety Commissioner Food Safety Officer or any official in Panchayat,Municipal Corporation or any other local body in an area, notified as such by the State Food Safety Commissioner for the purpose of registration Designated Officers appointed under Section 36(1) of the Act by the Food Safety Commissioner of a State or UT for the purpose of licensing and monitoring. 31 FSS (L&R) MODULE-3
  31. 31. PETTY FOOD MANUFACTURER Any Food manufacturer, who * Manufactures or sells any article of food or apetty retailer, hawker, itinerant vendor or temporary stall holer: MODULE-3
  32. 32. FSS (L&R) MODULE-3
  33. 33. FSS (L&R) MODULE-3
  34. 34. FSS (L&R) MODULE-3
  35. 35. FSS (L&R) MODULE-3
  36. 36. FSS (L&R) MODULE-3
  37. 37. FSS (L&R) MODULE-3
  38. 38.  E-commerce  Novel and Non specified-foods/ingredients FSS (L&R) MODULE-3
  39. 39. FEE-STRUCTURE MODULE-3
  40. 40. Standardized Food Proprietary Food: Functional Foods Non Specified Food All products for which standards have been defined under the FSSR (Food Product Standards and Food Additives) All foods which are not standardized in • FSSR (Food Product Standards and Food Additives) & •FSSR (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food, and Novel Food). As per this regulation any food product prepared using those ingredients which are either standardized or permitted to be used in standardized products does not require any separate approval. However, safety requirements as prescribed under FSSR shall be complied Products whose Standards are defined under FSSR (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Specialty food containing plant or botanicals, Foods containing Probiotics, Foods containing Prebiotics and Novel Foods All food product which have not been standardized in any of the Regulations and hence prior approval is required to be obtained and is granted by the Food Authority after the risk analysis is carried out by the Scientific Panels. MODULE-3
  41. 41. Product - Food Categorization MODULE-3
  42. 42. FOOD CATEGORIZATION CODE FOOD PRODUCT STANDARDS (For Regulation No) Refer https://foodlicensing.fssai.gov. in/PDF/Food_Categorization_ Code.pdf Refer: https://www.fssai.gov.in/upload/up loadfiles/files/Food_Additives_Reg ulations.pdf Product - FC MODULE-3
  43. 43. 1. 2.1 DAIRY PRODUCTS AND ANALOGUES 2. 2.2 FATS, OILS AND FAT EMULSIONS 3. 2.3 FRUIT & VEGETABLE PRODUCTS 4. 2.4 CEREALS AND CEREAL PRODUCTS 5. 2.5 MEAT AND MEAT PRODUCTS 6. 2.6 FISH and FISH PRODUCTS 7. 2.7 SWEETS & CONFECTIONERY 8. 2.8 SWEETENING AGENTS INCLUDING HONEY 9. 2.9 SALT, SPICES, CONDIMENTS AND RELATED PRODUCTS 10. 2.10 BEVERAGES, (Other than Dairy and Fruits & Vegetables based) 11. 2.11 OTHER FOOD PRODUCT AND INGREDIENTS 12. 2.12 PROPRIETARY FOOD 13. 2.13 RADIATION PROCESSING OF FOOD 14. 2.14 GLUTEN FREE FOOD 15. 3.1 FOOD ADDITIVES 16. APPENDIX A: .FOOD CATEGORY SYSTEM 17. APPENDIX B: MICROBIOLOGICAL REQUIREMENTS FSS Regulations impacting FBO’s MODULE-2
  44. 44. 01 Dairy products and analogues, excluding products of food category 2.0. 02 Fats and oils, and fat emulsions 03 Edible ices, including sherbet and sorbe 04 Fruits and vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweeds, and nuts and seeds 05 Confectionery 06 Cereals and cereal products, derived from cereal grains, from roots and tubers, pulses,legumes and pith or soft core of palm tree, excluding bakery wares of food category 7.0 07 Bakery products 08 Meat and meat products including poultry 09 Fish and fish products, including molluscs, crustaceans, and echinoderms 10 Eggs and egg products 11 Sweeteners, including honey 12 Salts, spices, soups, sauces, salads and protein products 13 Foodstuffs intended for particular nutritional uses 14 Beverages, excluding dairy products 15 Ready-to-eat savouries 16 Prepared Foods 99 Substances added to food FSS Regulations impacting FBO’s MODULE-2
  45. 45. Eg: Biscuit Manufacturer Eligibility : Registration / State FSSAI/ Central FSSAI License ??  Production Capacity/Turnover based?  Compare with Annexure I of FSS (Licensing and Registration of Food Businesses) Regulations, 2011 Whether product is standardised as per FSS regulations?  Refer the FSS(Food Products Standards and Food Additives) Regulation, 2011 and its amendments. Which Food category does Biscuit fall under? Food Category 7.2.1 - for Biscuits What ingredients are permitted? Refer Regulation number for Biscuits is 2.4.15 . What additives are permissible?  List of permitted additives for Food Category 7.2.1 - for Biscuits 46 Product - FC MODULE-3
  46. 46. 47 Product - FC MODULE-3
  47. 47. 48  FBO wants to apply for an improvised product like cream biscuit to stand out from the market This product is not mentioned anywhere in the FSS standards!! Then how to apply for license ??!!!  Gather product formulation from FBO – Ingredients & Additives, their quantity and forms used Product - FC MODULE-3
  48. 48. 49 Product - FC MODULE-3
  49. 49. Standardised Food Vs Proprietary Food Biscuits - Standardised Cream Biscuits - Proprietary Regulation No 2.4.15 NA Food Category 7.2.1 Nearest Food Category 7.2.1 Ingredients flour, salt, butter, cereals and their products, cocoa, fruit and fruits products, dry fruit and nuts, egg, edible vegetable products, milk and milk products, edible oilseeds, spices and condiments, edible starches ,sugar and sugar products and other nutrients and vitamins: Biscuits : Ingredient as per FSSR + Cream: Cream made of vegetable oil, fats, flavours, Any other standardised ingredient which are not mentioned for the Biscuits Additives As per Food category 7.2.1 As per Food category 7.2.1 No relaxation for Additives 50 Proprietary food shall contain only those ingredients permitted anywhere in the regulations, additives can be only from the relevant food category MODULE-3
  50. 50. FBO wants to further improvise by adding Bifidobacterium adoloscentis in Biscuits to improve health benefits  Check: Is Bifidobacterium adoloscentis permitted in the regulation?? No – Not yet  So product is not applicable for license as under Proprietary food  Now WHAT ?  Apply for Product approval - FSSAI HQ Product - FC MODULE-3
  51. 51. FSS ACT, 2006, FSSAI FOOD Safety MITRA Food Safety and Standards Regulations Licensing and Registration Regulations Types of Licensing Standardised Food, Proprietary Food Neutraceutical Products Continue Tomorrow in Session-II… FLRS,FOSCOS MODULE-1, 2 and 3
  52. 52. FSSAI, Southern Regional Office Central Documentation Complex, Opp. to Customs House, Rajaji Salai, Chennai 600001 Phone: 044-25223213; Fax: 044-25223212 e.mail: dochennai@fssai.gov.in

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