Overview of FSS Act, Rules & Regulation_2012

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  • 1. Overview  of  FSS  Act,  Rules  and   Regulations  New  Food  Regulatory  Regime  in  INDIA         CHANGES ! CHALLAENGES ! AND WAY AHEAD   1 Oct  12,  2012  
  • 2. Postgraduate with 17 years Techno-‐Commercial Experience. Native of Himalaya Foothills Dehradun, Uttrakhand. Key Competencies : Regulatory Affairs, QMS & FSMS, Quality Assurance/Quality Control Manufacturing & Operations; Co-‐Manufacturing Operations Certified QMS/FSMS/ISO 14000 LA Courses DNV/BVQI Regulatory Affairs South Asia QA/QC/RSA/ Co-Manufacturing QA/QC/QMS/FSMS/Manufacturing Regulatory Affairs Microbiologist/Chemist /QMS 2
  • 3. History  &  Evolution  of  FSSAI.  Why  Change.  Paradigm  Shift.  Difference  between  Act,  Rule  and  Regulation.  Food    Definition  &  Types  of  Food.  Offences  under  Food  Law.  Organizational  Structure.  Powers  and  Duties  of  Authority.  Food  Safety  and  Standards  Regulations,  2011.  Impact  of  FSSA  on  Industry.  Way  forward.   3
  • 4. By  mid  1900s  food  processing  sectors  laws  framed  in  a  veritable  grid  of  regulation  including  a  multitude  of  states  law  e.g.  FPO,  MMPO,  Export  Act,  Insecticide  Act,  MFPO,  BIS,  EPA,  Infant  Milk  substitute,  APA,  Essential  commodity  act,  VOPO  etc.  etc.  1998  PM  council  on  Trade  &  Industry  suggested  for  unified  single  food  regulatory  authority.  In  2002  National  Non  profit  association  has  been  constituted  to  deliberate  on  subject.  In  2003  MoH  expert  group  proposed  to  create  new  food  law  to  regulate  functional  food  and  dietary  supplement.    In  2005  number  of  committees  including  standing  committee  on  parliament  on  agricultural  submitted  its  12th  report  where  the  need  of  single  food  regulatory  body  and  integrated  food  law  has  emphasized.     4
  • 5. Finally  Indian  food  safety  standard  bill  2005  is  signed  into  law.  In  2006  Food  Safety  and  Standards  Act,  2006  came  into  enforcement  with  two  objective  :   To  introduce  a  single  statute  relating  to  food  and     To  provide  for  scientific  development  of  the  food  processing  industry            On  5th  Aug  2008  FSSAI  is  constituted.  On  5th  May  2011  FSS  Rules  are  notified  in  to  the  Gazette.  On  5th  Aug  2011  FSS  Rules  and  Regulation  came  into  enforcement.       5
  • 6. 1   2   3   4   5  Ministry  of                Ministry  of  Food       Ministry  of              Ministry  of  Health  &   Ministry  of        &   Commerce   Food  Processing        Family  Welfare   Agriculture    Consumer  Affairs   (DGFT)   Industries     Agricultural Produce Essential Com. Act Imports & Exports Fruit products & Marking Act Standards of Weights Regulations order (AGMARK) & Measures Act Export Inspection Meat & Meat Packaged Commodities Agency (EIA) Products order Rules Tea Board Consumer Protection Act B.I.S. Act Milk and Milk Product Order Coffee Board (MMPO) Coffee Act & Rules VOP Control Order VOP (Std of Quality) SEO Control Order 6 Contd..  
  • 7. 6   7   8   9  Ministry of Rural Ministry of Ministry of HRD Ministry ofDevelopment Forest & (Department of Science & (AMA) Environment Women& Child Welfare) TechnologyAgricultural Trade in Infant Milk Substitutes, Atomic Energy Endangered Produce Species Act Feeding Bottles & Act-­1962 Grading & InfantFoods (Regulation Ecomark-­CPCB Control of Irradiation Marking of production, supply & of Foods Rules,1991 Act 1937 distribution) Act & Rules GM & Organic foods (AGMARK) Packaging material 7
  • 8. Industry  wanted  just  one  window  to  deal  with  all  the  food  regulations.  Standards  are  rigid  and  non-­‐responsive  to  scientific  advancements  and  modernization.  Varied  Quality/Safety  standards  restricting  innovation  in  food  products.  Integrated  response  to  strategic  issues  like  Novel  foods,  GM  foods,  international  trade  etc.  Decentralization  of  licensing  for  food  products  .  Achieve  high  degree  of  consumer  confidence  in  quality  &  safety  of  food.  Investors  friendly  regulatory  mechanism  with  emphasis  on  self  regulations  and  capacity  building.  Emphasis  on  gradual  shift  from  regulatory  regime  to  self  compliance.  Consistency  required  between  domestic  and  international  food  policy  .  Mechanism  for  speedy  disposal  of  cases  (special  courts/Special  tribunals).   8
  • 9. PFA FSSAIMultiple Authorities Single Authority, Single Reference PointAdulteration Food SafetyInspection/Control (regulatory Monitoring Surveillance (selfregime) compliance)Insufficient Full time Food Safety Officer andEnforcement/Personnel Designated Officers Under FSCDirect prosecution by court no Graded fine & penalties for offencesappeal before moving to court through adjudication process. Food Safety TribunalsNo provisions of improvement Provision of improvement noticesnoticesGMP/GHP Not mandate GMP/GHP Mandatory (Schedule -‐4)Improper Control on Import Proper Import Control/Structure Less Court Cases but HEAVY PANELTIES ! 9
  • 10. Act Rules/ RegulationsPrimary legislation. Form of secondary legislation. Are made to regulate the action of Acts. REGULATIONLegal document (in written form) Rules are framed against the Act by thePassed by Parliament, which is the authorized body of Parliament.highest form of law in the land. Can be struck down by a court.What to Regulate. FSS REGULAT Specify enforcement mechanism ION 2011 How a Act will be Enforced. FSS RULES Who will enforce. 2011 Actionable points e.g. particular set of FSSAI 2006 standards.Frequent amendment is not These are by laws.possible. Can be framed/amended (need based) in line with particular section of the Act. Outside the parliament. 10
  • 11. The  Food  Safety  And  Standards  Act,  2006   Passed  by  parliament  with  the  intention:   to  converge  08  different  food  laws  in  to  one  comprehensive  act   to  have  single  regulatory  body        FSSAI   FSSAI  Constituted  on  5  Sep  2008     FSSAI  is  a  Statutory  Regulatory  Body  under  Ministry  of  Health  &  Family   Welfare,  Government  of  India     Mandate  of  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.   11
  • 12. 1.  Legislations  Replaced  with  New  Food  Act.   The  Prevention  of  Food  Adulteration  Act,  1954.   The  Fruit  Products  Order,  1955.   The  Meat  Food  Products  Order,  1973.   The  Vegetable  Oil  Products  (Control)  Order,  1947.   The  Edible  Oils  Packaging  (Regulation)  Order,  1998.   The  Solvent  Extracted  Oil,  De  oiled  Meal,  and  Edible  Flour  (Control)   Order,  1967.   The  Milk  and  Milk  Products  Order,  1992.   Any  other  order  issued  under  the  Essential  Commodities  Act,  1955  (  10   of  1955)  relating  to  food.  2.  Compels  the  establishment  of  food  recall  procedures.    3.  Mandatory  licensing  and  registration  of  food  business.    4.  Only  registration    Petty  FBO.  5.  Mandatory    to  follow  Food  Safety  System  e.g.  HACCP/FSMS       12
  • 13. 6.  Provision  of  Improvement  Notice  by  DO.  7.  Compounding  and  Adjudication  of  cases.    8.  Special  Tribunals  -­‐  expedite  the  disposal  of  cases.  9.  Prohibits  advertisements  which  are  misleading  or  deceiving  or  contravenes  the  provisions  of  the  Act  (stakeholders  at  source  may  be  prosecuted).    10.  All  imports  of  articles  of  food  are  covered.    11.  Self  Regulation  by  FBOs  to  ensure  that  the  articles  of  food  satisfy  the  requirements  of  this  Act  at  all  stages  of  production,  processing,  import,  distribution  and  sale  within  the  businesses  under  his  control.  12.  Provision  for  graded  penalties  where  offenses  like  manufacturing,  storing  or  selling  misbranded  or  sub-­‐standard  food  is  punished  with  a  fine,  and  more  serious  offences  with  imprisonment  or  both.     13
  • 14. Food  Authority:     means  the  Food  Safety  and  Standards  Authority  of   India  (FSSAI)  established  under  Section  4.   the  Central  Government  shall,  by  notification,   establish  a  body  to  be  known  as  FSSAI  to  exercise   the  powers  conferred  on,  and  to  perform  the   functions  assigned  to,  it  under  the  Act.    Local  Area:  means  any  area,  whether  urban  or  rural  notified  by  the  Commissioner  of  Food  Safety,  to  be  a  local  area  for  the  purposes  of  this  Act   14
  • 15. Commissioner  fo  Food  Safety:  means  the  Commissioner  of   Food  Safety  appointed  under  Section  30.     -­‐  The  State  Government  shall  appoint  the  Commissioner  of   Food  Safety  for  the  state  for  efficient  implementation  of  food   safety  and  standards  and  other  requirements  laid  down  under   this  Act  and  the  rules  and  regulations  made  there  under.     Designated  Officer:  means  the  Officer  appointed  under   Section  36.     -­‐  The  Commissioner  of  Food  Safety  shall,  by  order,  appoint  the   Designated  Officer,  who  shall  not  be  below  the  rank  of  a  sub-­‐ divisional  Officer,  to  be  in-­‐charge  of  food  safety  administration   in  such  areas  as  may  be  specified  by  Regulations.   15
  • 16. Food  Business:  means  any  undertaking,  whether  for  profit  or  not  and  whether  public  or  private,  carrying  out  any  of  the  activities  related  to  any  stage  of  manufacture,  processing,  packaging,  storage,  transportation,  distribution  of  food,  import  and  includes  food  services,  catering  services,  sale  of  food  or  food  ingredients.  Package:  means  a  pre-­‐packed  box,  bottle,  casket,  tin,  barrel,  case,  pouch,  receptacle,  sack,  bag,  wrapper,  or  such  other  things  in  which  an  article  of  food  is  packed.  Premises:  include  any  shop,  stall,  hotel,  restaurant,  airline  services  and  food  canteens,  place  or  vehicle  or  vessel  where  any  article  of  food  is  sold  or  manufactured  or  stored  for  sale.   16
  • 17. means  any  substance,  whether  processed,  partially   processed  or  unprocessed,  which  is  intended  for  human   consumption  and  includes  primary  food  to  the  extent  defined  in   clause  (zk),  genetically  modified  or  engineered  food  or  food   containing  such  ingredients,  infant  food,  packaged  drinking   water,  alcoholic  drink,  chewing  gum,  and  any  substance,   including  water  used  into  the  food  during  its  manufacture,   preparation  or  treatment  but  does  not  include  any  animal  feed,   live  animals  unless  they  are  prepared  or  processed  for  placing   on  the  market  for  human  consumption,  plants,  prior  to   harvesting,  drugs  and  medicinal  products,  cosmetics,  narcotic   or  psychotropic  substances  :       Provided  that  the  Central  Government  may  declare,  by  notification  in  the   Official  Gazette,  any  other  article  as  food  for  the  purposes  of  this  Ac  having   regards  to  its  use,  nature,  substance  or  quality;       17
  • 18. Standardized  Food  -­‐  for  which  standards  is  provided  in  FSS(Food  Product  Standards  &  Food  Additives)  Regulations,  2011  under  FSSA.  Primary  Food  (zk)  -­‐  Any  article  of  food,  being  a  produce  of  agriculture  or  horticulture  or  animal  husbandry  and  dairying  or  aquaculture  in  its  natural  form,  resulting  from  the  growing,  raising,  cultivation,  picking,  harvesting,  collection  or  catching  in  the  hands  of  a  person  other  than  a  farmer  or  fisherman.  Proprietary  Food  -­‐  an  article  of  food  for  which  standards  have  not  been  specified  but  is  not  unsafe.     18
  • 19. Genetically  modified  foods  -­‐   food  and  food  ingredients  composed  of  or  containing  genetically  modified  or  engineered  organisms  obtained  through  modern  biotechnology,  or  food  and  food  ingredients  produced  from  but  not  containing  genetically  modified  or  engineered  organisms  obtained  through  modern  biotechnology  Organic  foods  -­‐  means  food  products  that  have  been  produced  in  accordance  with  specified  organic  production  standards.   19
  • 20. Functional  foods-­‐   means:     (a)  foods  which  are  specially  processed  or  formulated  to  satisfy   particular  dietary  requirements  which  exist  because  of  a   particular  physical  or  physiological  condition  or  specific  diseases   and  disorders  and  which  are  presented  as  such,  wherein  the   composition  of  these  foodstuffs  must  differ  significantly  from  the   composition  of  ordinary  foods  of  comparable  nature,  if  such   ordinary  foods  exist,  and  may  contain  one  or  more  of  the   following  ingredients,  namely:-­‐     (i)  plants  or  botanicals  or  their  parts  in  the  form  of  powder,  concentrate  or  extract  in  water,  ethyl  alcohol  or   hydro  alcoholic  extract,  single  or  in  combination;     (ii)  minerals  or  vitamins  or  proteins  or  metals  or  their  compounds  or  aminoacids  (in  amounts  not  exceeding   the  Recommended  Daily  Allowance  for  Indians)  or  enzymes  (within  permissible  limits);     (iii)  substances  from  animal  origin;     (iv)  a  dietary  substance  for  use  by  human  beings  to  supplement  the  diet  by  increasing  the  total  dietary  intake;   20
  • 21. (  (b)  (i)  a  product  that  is  labelled   Food  for  special  dietary  uses  or   functional  foods  or  nutraceuticals  or  health  supplements  or  similar   such  foods use  as  a  conventional  food   and  whereby  such  products  may  be  formulated  in  the  form  of   powders,  granules,  tablets,  capsules,  liquids,  jelly  and  other  dosage   forms  but  not  parenterals,  and  are  meant  for  oral  administration;     (ii)  such  product  does  not  include  a  drug  as  defined  in  clause  (b)  and   ayurvedic,  sidha  and  unani  drugs  as  defined  in  clauses  (a)  and  (h)  of   section  3  of  the  Drugs  and  Cosmetics  Act,  1940  (23  of  1940)  and   rules  made  thereunder;     (iii)  does  not  claim  to  cure  or  mitigate  any  specific  disease,  disorder   or  condition  (except  for  certain  health  benefit  or  such  promotion   claims)  as  may  be  permitted  by  the  regulations  made  under  this  Act;     (iv)  does  not  include  a  narcotic  drug  or  a  psychotropic  substance  as   defined  in  the  Schedule  of  the  Narcotic  Drugs  and  Psychotropic   Substances  Act,  1985  (61  of  1985)  and  rules  made  thereunder  and   substances  listed  in  Schedules  E  and  EI  of  the  Drugs  and  Cosmetics   Rules,  1945;   21
  • 22. Penalty  for  substandard  food   Rs  5  lacs   Penalty  for  misbranded  food   Rs  3  lacs   Penalty  on  misleading  advertisement   Rs  10    lacs   Food  containing  extraneous  matter   Rs  1  lac   Penalty  for  failure  to  comply  with  food   Three  months  of   safety  officer/False  &  Misleading  Info   imprisonment/Rs  2  lacs   Penalty  for  unhygienic  processing  of  food   Rs  1  lacs   Punishment  for  unsafe  food  -­‐  Which                    Does  not  result  in  injury     6  Months  Imp  and  1  lakhs                  Non-­‐grievous  injury     1  Year  Imp  and  3  Lakh                  Grievous  injury     6  Y  Imp  and  5  Lakh                  Death   7Y  or  Life  Imp  and  10  Lakh   Unhygienic  or  unsanitary  conditions   1  lakh  rupees   Not  having  valid  license   6  M  Imp  and  5  Lakhs  Compensation  to  consumer                                    Death   5  lakh  rupees                                  Grievous  injury     3  Lakh                                  Injury   1  Lakh   22
  • 23. Consisting of 23 members including Central Government one chairperson Food Authority Secretariat Central Advisory Scientific Panel Scientific Committee Enforcement CommitteeConsisting of 48 members 8-numbers need based 1 from each scientific panel + 6 expert members State Food Safety Authority State Food Safety Food Analyst Commissioner Designated Officer Food Safety Officer 23
  • 24. Food  Authority   Consists  of  22   members  and   Chairperson   Agriculture   Retailer     (1)     Commerce   Organization   (1)     (1)   Farmer     Consumer   Organization   Affairs     (2)   (1)   Food  State  &  UT    Processing   (5)*   Chairperson   (1)   Food     Health     Technologist   (1)   (3)   Consumer   Legislative     Organization   Affairs   (2)   Food     Small  scale   (1)   Industry     Industries   (2)   (1)   * On rotation basis for every three years 24
  • 25. Some duties and functionsPrepare the standards and guidelines to regulate safety of food.Setting of Limits for food additives, contaminants, Residues,processing aids etc.Accreditation of certification bodies engaged in certification of FSMS.Procedure and the enforcement of quality control.Accreditation of laboratories and their notification to stakeholders.Method of sampling, analysis and exchange of information amongenforcement authorities.Food labeling standards including claims on health, nutrition, specialdietary uses and food category systems for foods. 25
  • 26. Some duties and functions CAC  ensures  close  co-­‐operation   between  Food  Authority  and  the   enforcement  agencies.   CEO (1) BIS, ICMR, Food   Farmer Org Industry (3) (2) Advise  to  Food  Authority  on   Proposal  for    work  program.   Invitees Agriculture Prioritization  of  work.   (5) (2) Identifying  potential  risks.   Central advisory Knowledge  Pooling.   committee such  other  functions  as  may  be   Chairperson Scientific Consumer Organization specified  by  regulations.   Committee (1) (2)   CAC   meet   regularly   -­‐   min   thrice   a   Coommissioners R&D Of Food Institutes year  or  upon  invitation.   Safety (28) (2) Food Labs (2) 26
  • 27. Some duties and functions Method  of    FA  constitutes  need  based  Scientific   Sampling  (1)   Food additives,panel.   flavorings, Labeling     (1)   processing aids & materials in contactConsist   of   independent   Scientific   with food (1)expert.    Provide   Science   based   opinion   on   Contaminants in Food     Pesticides andrespective  subject  to  FA.   the food chain (1) Authority   Antibiotics residues   (1)    Scientific  panel  can  invite  relevant  industry  and  consumer  organizations.   Genetically   Biological hazards modifiedFA  time  to  time  may  re-­‐constitute  the   (1) Organisms & Foodscientific  panel  by  adding  new   Functional foods, Nutraceuticals,   (1)  members  or  by  omitting  the  existing   dietetic pdts & otheror  by  changing  name  of  panel  as  the   similar productscase  may  be.   (1)   27
  • 28. Some duties and functions Responsible  for  providing  scientific  opinion   Independent to  Food  Authority.   Scientific Experts (6)     Provide   opinion   on   multi-­‐sector   issues   falling   within   the   scope   of   more   than   one   scientific   panel  or  beyond  the  scope  of  any  panel.   Food       Authority   Set  up  working  group  for  establishing   scientific  opinion  particularly  in  the  case  of   subjects  where  Scientific  Panel  does  not  exist.   E.g  Fisheries  Products;  vegetable  products  etc.   Chairpersons of Scientific Panels     28
  • 29. Food Safety Commissioner Food Safety Special CourtsReferral Appellate (whenever Lab Tribunal required)Accredited Lab Designated Officer Adjudicating Officer Food Analyst Food Safety Officer 29
  • 30. MISBRANDED AND UNSAFESUBSTANDARD FOOD FOODADJUDICATING COURTS Fine with FINE Punishment 30
  • 31. Powers & Duties Prohibit in the interest of public health, the manufacture, storage, distribution, or sale of any article of food. Carry out survey of the food processing units in the state to find out compliance of standards. Conduct training programs for the personnel engage in the food safety. Ensure efficient and uniform implementation of the standards and other requirements. Sanction prosecution for offences punishable with imprisonment under this Act. 31
  • 32. Powers & DutiesIssue or cancel license of Food Business Operator.Prohibit sale in contravention of this Act.Receive report and samples of articles of food from Food SafetyOfficer and get them analyzed.Make recommendation to the Commissioner of Food Safety forsanction to launch prosecutions.Sanction prosecution.Maintain record of all inspections made by Food Safety Officers.Get investigated complaints in respect of any contravention of theprovision of this Act or against FSO. 32
  • 33. Powers & DutiesPower to take a samples of any food or any substance, to beintended for sale or to have been sold for human consumption.Seize any articles of food which appears to be in contravention ofthis Act.Enter and inspect any place where the food is manufactured, orstored for sale.May after giving notice to the food business operator cause thefood to be destroyed which is unfit for human consumption.Seize any adulterant found in possession of a manufacture ordistributor of any article of food.Penalty for harassment of food business operator and also forfalse complaint. 33
  • 34. Food  Safety  &  Standards  Regulations  (FSSR),  2011  is  divided  into  six  parts:   FSS  (Licensing  and  Registration)  Regulations,  2011   FSS  (Packaging  and  Labeling)  Regulations,  2011   FSS  (Food  Product  Standard  &  Food  Additive)  Regulations,  2011   FSS  (Prohibition  and  Restriction  on  Sales)  Regulations,  2011   FSS  (Contaminants,  Toxins  and  Residues)  Regulations,  2011   FSS  (Laboratory  and  Sampling  Analysis)  Regulation,  2011   34
  • 35. Every  FBO  is  covered.  Licensing  and  registration  segregated.  Petty  food  business  operators  need  to  apply  for  Registration  only.  Conversion  of  existing  Licenses  is  extended  till  Feb,  2013.  25.06.2012  -­‐  A  Table  containing  food  categorization  and  food  codes  is  uploaded  on  FSSAI  website.  Food  Categorization  is  based  on  harmonization  of  CODEX  and  Indian  products.    Two tier system of licensing Central & State60 days time limit for processing of license / 30 days forRegistration.Introduction of exhaustive Safety, Sanitary and Hygienic conditionsmandatory for registration/licensing 35
  • 36. Necessary  access  to  licensing  authority.  Communicate  any  change  in  the  documents  or  Mfg  lines.  One  Technical  person  for  Production  with  Science  degree.  Periodic  Annual  Return  to  be  submitted  before  31st  of  May.  Comply  with  Schedule  4  (GMP/GHP).  Maintain  Daily  Record  of  Production/Purchase  and  Sales.    Source  and  Standards  of  RM  of  Optimum  Quality.     36
  • 37. Testing of RM/PM/FG for Physical, Chemical and MicrobiologicalParameters once in a six months/Own or NABL recognised lab.Required Temperature conditions Throughout the supply chain.Buy or Sale from only licensed or registered vendors.CIP to be followed for cleaning and sanitation of equipment.Well equipped laboratory facility.Register for edible oil RM , Nature, Purchase/Produced/Soldrecords.Can not sold/offer/distribute edible oil without packaging/Markingand Labeling. 37
  • 38. 38
  • 39. Product  approval  process  is  simplified.  Only  Broader  category  wise  product  approval  is  required.  If  one  FBO  has  taken  approval,  other  FBOs  need  not  to  be  applied  for  the  exact  same  product  (with  permitted  variations).  For  Novel/new  products  whose  safety  is  not  established  need  product  approval  before  applying  for  license.  Product  approval  not  required  for  Traditional  foods.  If  product  has  safe  history  of  use  in  other  countries  will  be  accepted  (Case  to  case  basis).  NOC  will  be  issued  for  1  Year.  In  case  of  Novel  food,  application  will  be  sent  to  scientific  committees  for  approval.  No  claim  will  be  made  on  novel  food  without  prior  approval.     39
  • 40. Create Your ID & Password Fill in Form B Upload Required DocumentsOnline Fill in DD Details Acknowledgement No. Will be Generated Print Out Ackn No. sheetOnline Printout online filled Form -‐ B Prepare DD of Required Fees Collect all the required documents (e.g. Blue Print or Layout Plan, Form B, DD, HACCP Certificate, Affidavit, Nomination Details, Recall Plan, Water Testing Report, Memorandum of Article, Source Details for Milk and Meat Processing, NOC from PCB, List of Directors, Equipment List and theirPhysical Installed Capacity, Photo ID of Authorized Signatory or Nominee, List of Food Category desired to be Manufactured, Proof of possession of Premises, NOC from Manufacturers in case of Re-‐labelers. Submit to the DO of your Region
  • 41. Go to Licensing Portal Go to Modification Tab Select Lic. No. to be Modified. Online Revise Form B Upload Revised Documents Print Out Ackn No. sheet Printout online filled Form -‐ B Online Prepare DD of Required Fees (for one year only) Collect all the required documents (e.g. changed blue Print or Layout Plan, Form B, Fee -‐ DD, HACCP Certificate, Affidavit, NominationPhysical Details, Recall Plan, Water Testing Report, Equipment List and their Installed Capacity, List of Food Category desired to be Manufactured.Changes in nominations and Directorsdetails, Capacities etc. Needs to becommunicated to the FSSAI.
  • 42. Trade/  Brand  name  &  FSSR  category/  Food  Descriptor  Ingredients  in  descending  order.  Vegetarian  Symbol.  Non  Veg  Symbol.  Net  Weight              Date  of  manufacturing  or  packing  Best  Before                                                                                Manufactured  and  Marketed  By    Lot  No.  MRP  Nutritional  information  Consumer  contact  details   48
  • 43. Best Before: mmm/yyyy in CAPS up to which the product is best forconsumption needs to be mentionedManufacturing date: mmm/yyyy: Best Before Date > 3 months dd/mmm/yyyy: Best Before Date < 3 monthsUse by date/recommended last consumption date/expiry date:-‐ The use by date/recommended last consumption date/expiry date shall be given,-‐ in case of package of Aspartame, which shall be not more than three years from the date of packing; in case of infant milk substitute and infant foods. 49
  • 44. Height of any numeral in the declarationrequired under rules, on the principal displaypanel shall not be less than. Sl. No Net Quantity in Minimum height of weight/Volume numeral 1 Upto 50g/ml 1 2 Above 50g/ml upto 200g/ml 2 3 Above 200g/ml upto 1kg/litre 4 4 Above 1Kg/litre 6 50
  • 45. Nutritional Information: Nutrient Unit Value* Energy kcal 0 decimal Protein g 1 decimal Carbohydrate g 1 decimal Sugar g 1 decimal Fat g 1 decimalClaims No food should be described or presented in a manner that is false, misleading or deceptive Claims should be justifiable. No health claim on proprietary/Novel food/Functional foods without FSSAI approval. 51
  • 46. Chapter  1  title  and  commencement,  Definitions     Chapter  2    Food  Product  Standards   Regulation  2.1  Dairy  Products  and  Analogues   Regulation  2.2    Fats,  Oils  and  Fat  Emulsions   Regulation  2.3    Fruit  &  Vegetable  Products   Regulation  2.4    Cereals  and  Cereal  Products   Regulation  2.5    Meat  and  Meat  Products   Regulation  2.6    Fish  and  Fish  Products   Regulation  2.7    Sweets  &  Confectionery   52
  • 47. Regulation  2.8    Sweetening  Agents  including  Honey  Regulation  2.9    Salt,  Spices,  Condiments  and  Related  Products  Regulation  2.10    Beverages  (other  than  Dairy  and  Fruits  &    Vegetables  based)  Regulation  2.11  Other  Food  Products  &  Ingredients  Regulation  2.12    Proprietary  Food  Regulation  2.13    Irradiation  of  Food   53
  • 48. Definitions and Standards of Quality e.g. Atta 54
  • 49. Natural Coloring Matter (Regulation 3.1.2:2): Natural Coloring matters which may be used: Beta-‐carotene No  Restriction  except     Chlorophyll Annatto specifically  mentioned     Riboflavin Saffron in  standards   Caramel Curcumin Allowed Synthetic Food Colors (Regulation 3.1.2:4) Ponceau 4R Sunset Yellow FCF Carmoisine Indigo Carmine Erythrosine Brilliant Blue FCF Tartrazine Fast Green FCFRestricted  Usage:  Provisions  for  specific  use  in  FSS   (Food Product Standards & Food Additives) Regulations, Chapter 3  and  Appendix  A   55
  • 50. Preservative: Means a substance which when added to food, iscapable of inhibiting, retarding or arresting the process offermentation, acidification or other decomposition of food.Class I Preservatives: *Addition   of   Class   I   Preservative   Common Salt Spices allowed   in   any   food   is   not   Sugar Vinegar restricted,   unless   otherwise   provided  in  the  rules   Dextrose Honey Glucose Syrup Edible Vegetable OilClass II Preservatives: Restricted Usage: Provisions for specific use in Chapter 2 and Appendix A. Use of more than 1 class 2 preservatives in a food NOT ALLOWED, unless provided specifically. 56
  • 51. Antioxidant: Means a substance which whenadded to food retards or prevents oxidativedeterioration of food and does not include sugar,cereal oils, flours, herbs and spices.Allowed Antioxidants in any food: Lecithin Ascorbic acid TocopherolOther antioxidants: Restricted Usage-‐ Provisionsfor specific use in FSS (Food Product Standards &Food Additives) Regulations, Chapter 2 andAppendix A of this Regulation. 57
  • 52. Regulation 3.1.6: 1: Definition: substances, which whenadded to food are capable of facilitating a uniformdispersion of oils and fats in aqueous media or vice versaRegulation 3.1.6: 2: No emulsifying and stabilizing agentshall be used in any article of food, except where use isspecifically permitted. Regulation 3.1.6:3: Use of Starch Phosphate. Regulation 3.1.6:4: Use of modified starches. Regulation 3.1.6:5: Use of emulsifier and stabilizer in flavours. Regulation 3.1.6:6: Use of emulsifier and stabilizer in fruit products. Regulation 3.1.6:7: Use of emulsifier and stabilizer in frozen desserts. 58
  • 53. Flavoring agents may be of following three types: Natural Flavors and Natural Flavoring Substances: are flavor preparations and single substance respectively, acceptable for human consumption, obtained exclusively by physical processes from vegetable, for human consumption. Nature Identical Flavoring Substances: are substances chemically isolated from aromatic raw materials or obtained synthetically; they are chemically identical to substances present in natural products intended for human consumption, either processed or not. Artificial Flavoring Substances: are those substances which have not been identified in natural products intended for human consumption either processed or not.The Flavoring agents may contain permitted anti-‐oxidants,emulsifying and stabilizing agents and food preservatives as perRegulation 3.1.10 (3). 59
  • 54. For the purpose of the standards specified in FSS (Food ProductStandards & Food Additives) Regulations, Chapter 2, the "Carry Over"principle applies to the presence of additives such as colours,flavouring agents, antioxidants, anti-‐caking agents, emulsifying andstabilizing agents, and preservative in food, as a result of the use ofraw material or other ingredients in which these additives were used.The presence of contaminants is not covered for this purpose.The presence of an additive in food through the application of thecarry over principle is admissible in general unless otherwisespecifically prohibited in any FSSR or in FSS (Food Product Standards& Food Additives) Regulations, Chapter 2 provided the total additiveincluding the carry over through the raw material or otheringredients does not exceed the maximum amounts sopermitted. 60
  • 55. Appendix AAdditives which can be added to different category of food Appendix BMicrobiological Requirements 61
  • 56. Appendix A lists down various food additives allowed in differentcategories of food Table 1 List of food additives for use in Bread & Biscuits Table 2 List of food additives for use in Foods Table 3 List of food additives for use in foods not specified Table 4 List of food additives for use in edible oils & fats Table 5 List of food additives for use in fish & fish products Table 6 List of food additives for use in Thermally Processed Fruits Table 7 List of food additives for use in Thermally Processed Vegetables Table 8 List of food additives for use in food products Table 9 -‐ List of food additives for use in food products (Fruits & Veg) 62
  • 57. Appendix A lists down various food additives allowed indifferent categories of food Table 10 -‐ List of food additives for use in food products (Fruits & Vegetables) Table 11 -‐ List of food additives for use in food products (Fruits & Vegetables) Table 12 -‐ List of food additives for use in Sugars & Salt Table 13 -‐ List of food additives for use in Cocoa Powder, Chocolate, Sugar Boiled Confectionery, Chewing Gum/Bubble Gum. Table 14 -‐ List of food additives for use in Milk products Table 15 -‐ List of food additives for use in individual variety of cheese 63
  • 58. Appendix B lists microbiological requirements in differentcategories of food: Table 1 Microbiological requirements for sea foods Table 2 Microbiological parameters for milk products Table 3 Microbiological parameters for spices Table 4 Microbiological requirements for food products (Fruits & Vegetables) 64
  • 59. Chemicals described in monographs of the IndianPharmacopeia when used in foods, shall not containmetals contaminants beyond the limit specified inthe appropriate monographs of the IndianPharmacopeia for the time being in force.List of Metal Contaminants as per FSSR: Lead Cadmium Copper Mercury Arsenic Methyl Mercury Tin Chromium Zinc Nickel 65
  • 60. Crop contaminants: Means any substance not intentionallyadded to food, but which gets added to articles of food inthe process of their production (including operationscarried out in crop husbandry, animal husbandry andveterinary medicine), manufacture, processing,preparation; treatment, packing, packaging, transport orholding of articles of such food as a result ofenvironmental contamination. Naturally occurring toxic substances mg/kg (Regulation 2.2.2) Agaric acid Max 100 Hydrocyanic acid Max 5 Hypericin Max 1 Safrole Max 10 Aflatoxin (Regulation 2.2.1) 0.03mg/kg 66
  • 61. Residues: no insecticides shall be used directly on articles offood.Provided that nothing in this regulation shall apply to thefumigants which are registered and recommended for use assuch on articles of food by the Registration Committee,constituted under section 5 of the Insecticides Act, 1968 (46of 1968). 67
  • 62. Major  benefits:        Broad  based  product  standards.      Additives  if  allowed  in  Codex,  may  be  easily  requested  to  be   allowed  in  local  standards.      Single  authority  instead  of  multiple  ministries  controlling  the  food   industry.        Possible  disadvantages:      Stringent  contaminant  limits  (e.g.:  pesticide  residues,  antibiotics,  mycotoxins  etc..)      Higher  penalties  along  with  imprisonment  in  case  of  standard  violations.   68
  • 63. FSSI  proposes  12th  Five  year  plan  2012-­‐2017  which  includes  :     Food  safety  needs  to  be  the  part  of  Education  System  -­‐  NCERT   Foods  for  Special  Dietary  Use  (FSDU)  Regulation.   Specify  standards  and  guidelines  in  relation  to  food  items,  limits  for   food  additives,  Labeling  &  Quality  control.     Designate  and  finalise  upgradation  plans  for  Referral  labs  and  food   laboratory  infrastructure.   Regulation  for  Safety  and  Quality  of  Water/Milk  &  Meat  Industry.   Trans  Fats  and  Saturated  Fats  Standards.   Regulations  for  Labeling  and  claims  especially  for  functional  foods.   69
  • 64. Develop  procedures  for  establishment  and  working  of  Adjudicating  officers  and    Food  Safety  Tribunals.    Food  Safety  Surveillance  Mechanism,  Recall  Mechanism.  Review  standards  for  Organic  Food,  GAP  and  GMP.  Harmonization  of  standards  with  other  Food  Regulations  and  CODEX.  Consumer  awareness  for  food  safety,  disaster  management.  Critical  studies  on  (e.g.  through  NIN)   Diet  Surveys,     Data-­‐base  for  Food  Safety  Regulations,  Trans  Fatty  Acids   Import  regulation  regime  etc.       70
  • 65. 72