Overview  of  FSS  Act,  Rules  and  Regulations  

New  Food  Regulatory  Regime  in  INDIA        

CHANGES ! CHALLAENGES ! AND WAY AHEAD  

Oct  12,  2012  1

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

2

Regulatory Affairs South Asia

QA/QC/QMS/ FSMS/Manufacturing

Microbiologist/Chemist /QMS

QA/QC/RSA/ Co-Manufacturing

Regulatory Affairs

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

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

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

           Ministry  of  Food                  &  

 Consumer  Affairs  

Ministry  of    Agriculture  

Agricultural Produce & Marking Act (AGMARK)

Milk and Milk Product Order (MMPO)

Essential Com. Act Standards of Weights

& Measures Act Packaged Commodities

Rules Consumer Protection Act B.I.S. Act

VOP Control Order VOP (Std of Quality) SEO Control Order

2   3   4    Ministry  of  Food  Processing              Industries    

Contd..  

5  

Imports & Exports Regulations Export Inspection

Agency (EIA) Tea Board Coffee Board Coffee Act & Rules

Ministry  of    Commerce  (DGFT)  

1  Ministry  of    Health  &  Family  Welfare  

Fruit products order Meat & Meat

Products order

6

Ministry of Rural Development

(AMA)

Agricultural

Produce

Grading &

Marking

Act 1937

(AGMARK)

6   Ministry of HRD (Department of Women& Child Welfare)

Ministry of Science & Technology

Atomic Energy

Act-­1962

Control of Irradiation

of Foods Rules,1991

GM & Organic foods

Ministry of Forest &

Environment

Trade in Endangered Species Act Ecomark-­CPCB Packaging

material

Infant Milk Substitutes,

Feeding Bottles &

InfantFoods (Regulation

of production, supply &

distribution) Act & Rules

7   8   9  

7

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

Less Court Cases but HEAVY PANELTIES !

PFA FSSAI Multiple Authorities Single Authority, Single Reference Point

Adulteration Food Safety

Inspection/Control (regulatory regime)

Monitoring Surveillance (self compliance)

Insufficient Enforcement/Personnel

Full time Food Safety Officer and Designated Officers Under FSC

Direct prosecution by court no appeal before moving to court

Graded fine & penalties for offences through adjudication process. Food Safety Tribunals

No provisions of improvement notices

Provision of improvement notices

GMP/GHP Not mandate GMP/GHP Mandatory (Schedule -‐4)

Improper Control on Import Proper Import Control/Structure

9

Act Rules/ Regulations

Primary legislation.

Form of secondary legislation. Are made to regulate the action of Acts.

Legal document (in written form) Passed by Parliament, which is the highest form of law in the land.

Rules are framed against the Act by the authorized body of Parliament. Can be struck down by a court.

What to Regulate. Specify enforcement mechanism How a Act will be Enforced. Who will enforce. Actionable points e.g. particular set of standards.

Frequent amendment is not possible.

These are by laws. Can be framed/amended (need based) in line with particular section of the Act. Outside the parliament.

10

REGULATION

FSSAI 2006

FSS RULES 2011

FSS REGULATION 2011

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

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      

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.  

12

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

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

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

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

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

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

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

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

(  (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  safety  officer/False  &  Misleading  Info  

Three  months  of  imprisonment/Rs  2  lacs  

Penalty  for  unhygienic  processing  of  food   Rs  1  lacs  

Punishment  for  unsafe  food  -­‐  Which                  Does  not  result  in  injury                    Non-­‐grievous  injury                    Grievous  injury                    Death  

 6  Months  Imp  and  1  lakhs  1  Year  Imp  and  3  Lakh  6  Y  Imp  and  5  Lakh  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                                  Grievous  injury                                    Injury  

 5  lakh  rupees  3  Lakh  1  Lakh  

Consisting of 23 members including one chairperson

Consisting of 48 members 8-numbers need based 1 from each scientific panel

+ 6 expert members

Central Government

Food Authority

Secretariat

Central AdvisoryCommittee Scientific Panel Scientific Committee Enforcement

State Food Safety Authority

State Food Safety Commissioner

Designated Officer

Food Safety Officer

Food Analyst

23

Retailer    Organization  

(1)  Farmer    

Organization  (2)  

State  &  UT  (5)*  

Food    Technologist  

(3)  

Consumer  Organization  

(2)   Food    Industry    (2)  

Small  scale  Industries  (1)  

Legislative    Affairs  (1)  

Health    (1)  

Food    Processing  

(1)  

Consumer  Affairs    (1)  

Commerce  (1)    

Agriculture  (1)    

Chairperson  

* On rotation basis for every three years

Food  Authority  Consists  of  22  members  and  Chairperson  

24

Prepare 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 among enforcement authorities. Food labeling standards including claims on health, nutrition, special dietary uses and food category systems for foods.

25

Some duties and functions

BIS, ICMR, Farmer Org

(3)

Invitees (5)

Chairperson Scientific Committee

(1)

Coommissioners Of Food

Safety (28) Food Labs

(2)

R&D Institutes

(2)

Consumer Organization

(2)

Agriculture (2)

Food Industry

(2)

CEO (1)

Central advisory

committee

CAC  ensures  close  co-­‐operation  between  Food  Authority  and  the  enforcement  agencies.    Advise  to  Food  Authority  on  Proposal  for    work  program.  Prioritization  of  work.  Identifying  potential  risks.  Knowledge  Pooling.  such  other   functions  as  may  be  specified  by  regulations.    

CAC  meet   regularly   -­‐  min   thrice  a  year  or  upon  invitation.  

26

Some duties and functions

Labeling  (1)  

Contaminants in the food chain

(1)

Biological hazards (1)

Functional foods, Nutraceuticals,

dietetic pdts & other similar products

(1)

Genetically

modified Organisms & Food

 (1)  

Pesticides and Antibiotics residues  

(1)  

Food additives, flavorings,

processing aids & materials in contact

with food (1)

Method  of    Sampling  (1)  

Food    Authority  

FA  constitutes  need  based  Scientific  panel.    Consist   of   independent   Scientific  expert.    Provide   Science   based   opinion   on  respective  subject  to  FA.    Scientific  panel  can  invite  relevant  industry  and  consumer  organizations.    FA  time  to  time  may  re-­‐constitute  the  scientific  panel  by  adding  new  members  or  by  omitting  the  existing  or  by  changing  name  of  panel  as  the  case  may  be.    

27

Some duties and functions

Chairpersons of Scientific Panels  

 

Independent Scientific Experts

(6)  

Food    Authority  

Responsible  for  providing  scientific  opinion  to  Food  Authority.    Provide   opinion   on  multi-­‐sector   issues   falling  within   the   scope   of  more   than   one   scientific  panel  or  beyond  the  scope  of  any  panel.    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.  

28

Some duties and functions

29

Food Safety Commissioner

Referral Lab

Accredited Lab

Food Analyst

Designated Officer

Food Safety Officer

Food Safety Appellate Tribunal

Special Courts (whenever required)

Adjudicating Officer

30

ADJUDICATING COURTS

MISBRANDED AND

SUBSTANDARD FOOD

UNSAFE FOOD

FINE Fine with Punishment

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

Powers & Duties

Issue or cancel license of Food Business Operator. Prohibit sale in contravention of this Act. Receive report and samples of articles of food from Food Safety Officer and get them analyzed. Make recommendation to the Commissioner of Food Safety for sanction to launch prosecutions. Sanction prosecution. Maintain record of all inspections made by Food Safety Officers. Get investigated complaints in respect of any contravention of the provision of this Act or against FSO.

32

Powers & Duties

Power to take a samples of any food or any substance, to be intended for sale or to have been sold for human consumption. Seize any articles of food which appears to be in contravention of this Act. Enter and inspect any place where the food is manufactured, or stored for sale. May after giving notice to the food business operator cause the food to be destroyed which is unfit for human consumption. Seize any adulterant found in possession of a manufacture or distributor of any article of food. Penalty for harassment of food business operator and also for false complaint.

33

Powers & Duties

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

Food  Safety  &  Standards  Regulations  (FSSR),  2011  is  divided  into  six  parts:  

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 & State 60 days time limit for processing of license / 30 days for Registration. Introduction of exhaustive Safety, Sanitary and Hygienic conditions mandatory for registration/licensing

35

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

Testing of RM/PM/FG for Physical, Chemical and Microbiological Parameters 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/Sold records. Can not sold/offer/distribute edible oil without packaging/Marking and Labeling.

37

38

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

Online

Create Your ID & Password Fill in Form B Upload Required Documents Fill in DD Details Acknowledgement No. Will be Generated

Online

Print Out Ackn No. sheet Printout online filled Form -‐ B

Physical

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 their 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

Online

Go to Licensing Portal Go to Modification Tab Select Lic. No. to be Modified. Revise Form B Upload Revised Documents

Online

Print Out Ackn No. sheet Printout online filled Form -‐ B

Physical

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, Nomination Details, Recall Plan, Water Testing Report, Equipment List and their Installed Capacity, List of Food Category desired to be Manufactured.

Changes in nominations and Directors details, Capacities etc. Needs to be communicated to the FSSAI.

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

Best Before: mmm/yyyy in CAPS up to which the product is best for consumption needs to be mentioned Manufacturing date:

mmm/yyyy: Best Before Date > 3 months dd/mmm/yyyy: Best Before Date < 3 months

Use 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

Height of any numeral in the declaration required under rules, on the principal display panel shall not be less than. Sl. No Net Quantity in

weight/Volume Minimum height of 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

Nutritional Information:

Claims

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.

Nutrient Unit Value* Energy kcal 0 decimal Protein g 1 decimal Carbohydrate g 1 decimal

Sugar g 1 decimal Fat g 1 decimal

51

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

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

Definitions and Standards of Quality e.g. Atta

54

Natural Coloring Matter (Regulation 3.1.2:2): Natural Coloring matters which may be used:

Beta-‐carotene Chlorophyll Riboflavin Caramel

Allowed Synthetic Food Colors (Regulation 3.1.2:4) Ponceau 4R Carmoisine Erythrosine Tartrazine

No  Restriction  except    specifically  mentioned    

in  standards  

Annatto Saffron Curcumin

Sunset Yellow FCF Indigo Carmine Brilliant Blue FCF Fast Green FCF

Restricted  Usage:  Provisions  for  specific  use  in  FSS  (Food Product Standards & Food Additives) Regulations,

Chapter 3  and  Appendix  A  55

Preservative: Means a substance which when added to food, is capable of inhibiting, retarding or arresting the process of fermentation, acidification or other decomposition of food. Class I Preservatives:

Common Salt Sugar Dextrose Glucose Syrup

Class 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.

Spices Vinegar Honey Edible Vegetable Oil

*Addition   of   Class   I   Preservative  allowed   in   any   food   is   not  restricted,   unless   otherwise  provided  in  the  rules  

56

Antioxidant: Means a substance which when added to food retards or prevents oxidative deterioration of food and does not include sugar, cereal oils, flours, herbs and spices. Allowed Antioxidants in any food:

Lecithin Ascorbic acid Tocopherol

Other antioxidants: Restricted Usage-‐ Provisions for specific use in FSS (Food Product Standards & Food Additives) Regulations, Chapter 2 and Appendix A of this Regulation.

57

Regulation 3.1.6: 1: Definition: substances, which when added to food are capable of facilitating a uniform dispersion of oils and fats in aqueous media or vice versa Regulation 3.1.6: 2: No emulsifying and stabilizing agent shall be used in any article of food, except where use is specifically 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

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 per Regulation 3.1.10 (3).

59

For the purpose of the standards specified in FSS (Food Product Standards & 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 and stabilizing agents, and preservative in food, as a result of the use of raw 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 the carry over principle is admissible in general unless otherwise specifically prohibited in any FSSR or in FSS (Food Product Standards & Food Additives) Regulations, Chapter 2 provided the total additive including the carry over through the raw material or other ingredients does not exceed the maximum amounts so permitted.

60

Appendix A Additives which can be added to different category of food

Appendix B Microbiological Requirements

61

Appendix A lists down various food additives allowed in different categories 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

Appendix A lists down various food additives allowed in different 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

Appendix B lists microbiological requirements in different categories 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

Chemicals described in monographs of the Indian Pharmacopeia when used in foods, shall not contain metals contaminants beyond the limit specified in the appropriate monographs of the Indian Pharmacopeia for the time being in force.

List of Metal Contaminants as per FSSR:

Lead Copper Arsenic Tin Zinc

Cadmium Mercury Methyl Mercury Chromium Nickel

65

Crop contaminants: Means any substance not intentionally added to food, but which gets added to articles of food in the process of their production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation; treatment, packing, packaging, transport or holding of articles of such food as a result of environmental contamination.

Naturally occurring toxic substances (Regulation 2.2.2) mg/kg

Agaric acid Max 100

Hydrocyanic acid Max 5

Hypericin Max 1

Safrole Max 10

Aflatoxin (Regulation 2.2.1) 0.03mg/kg

66

Residues: no insecticides shall be used directly on articles of food. Provided that nothing in this regulation shall apply to the fumigants which are registered and recommended for use as such on articles of food by the Registration Committee, constituted under section 5 of the Insecticides Act, 1968 (46 of 1968).

67

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

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

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

72