Overview of FSS Act, Rules & Regulation_2012

1. Overview'of'FSS'Act,'Rules'and'
Regulations'
New'Food'Regulatory'Regime'in'INDIA'''
'
CHANGES ! CHALLAENGES ! AND WAY AHEAD '
Oct'12,'2012'
1

2. €Postgraduate with 17 years Techno5Commercial Experience.
€Native of Himalaya Foothills ² Dehradun, Uttrakhand.
€Key Competencies :
ƒRegulatory Affairs, QMS & FSMS, Quality Assurance/Quality Control
ƒManufacturing & Operations; Co5Manufacturing Operations
ƒCertified QMS/FSMS/ISO 14000 LA Courses ² DNV/BVQI

2
Regulatory Affairs
South Asia
QA/QC/QMS/
FSMS/Manufacturing
Microbiologist/Chemist
/QMS
QA/QC/RSA/
Co-Manufacturing
Regulatory Affairs

3. €History(&(Evolution(of(FSSAI.(
€Why(Change.(
€Paradigm(Shift.(
€Difference(between(Act,(Rule(and(Regulation.(
€Food(t(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(12
th
(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(:(
ƒTo(introduce(a(single(statute(relating(to(food(and((
ƒTo(provide(for(scientific(development(of(the(food(processing(industry((((((
€On(5
th
(Aug(2008(FSSAI(is(constituted.(
€On(5
th
(May(2011(FSS(Rules(are(notified(in(to(the(Gazette.(
€On(5
th
(Aug(2011(FSS(Rules(and(Regulation(came(into(enforcement.(
(
(
5

6. (( ((((Ministry(of(Food((( ((((
((&(
(Consumer(Affairs(
Ministry(of((
Agriculture(
‡Agricultural Produce
& Marking Act
(AGMARK)





¾Milk and Milk
Product Order
(MMPO)
‡ Essential Com. Act
‡ Standards of Weights
& Measures Act
‡ Packaged Commodities
Rules
‡ Consumer Protection Act
‡ B.I.S. Act




¾ VOP Control Order
¾ VOP (Std of Quality)
¾ SEO Control Order
2' 3' 4'
(Ministry(of(
Food(Processing(((((((
Industries(
(
Contd..'
5'
‡ Imports & Exports
Regulations
‡ Export Inspection
Agency (EIA)
‡ Tea Board




¾ Coffee Board
¾ Coffee Act & Rules
Ministry(of((
Commerce(
(DGFT)(
1'
Ministry(of((
Health(&(
Family(Welfare(
‡ Fruit products
order
‡ Meat & Meat
Products order

6

7. 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
ActR1962
‡Control of Irradiation
of Foods Rules,1991
‡GM & Organic foods
Ministry of
Forest &
Environment
‡Trade in
Endangered
Species Act

‡EcomarkRCPCB



‡Packaging
material
Infant Milk Substitutes,
Feeding Bottles &
InfantFoods (Regulation
of production, supply &
distribution) Act & Rules
7' 8' 9'
7

8. ‡Industry(wanted(just(one'window'to(deal(with(all(the(food(regulations.(
‡Standards(are(rigid'and'nonMresponsive'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. 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 ² 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 54)
Improper Control on Import Proper Import Control/Structure
9

10. 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
REGULAT
ION 2011

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. 2.(Compels(the(establishment(of(food(recall(procedures.((
3.(Mandatory(licensing(and(registration(of(food(business.((
4.(Only'registration't'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

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:((
ƒmeans(the(Food(Safety(and(Standards(Authority(of(
India((FSSAI)(established(under'Section'4.'
ƒthe(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(inMcharge'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'M(for(which(standards(is(provided(in(
FSS(Food(Product(Standards(&(Food(Additives)(Regulations,(
2011(under(FSSA.(
€Primary'Food'(zk)'M(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'M'^‰Œ}‰Œ]šŒÇvv}Ào(}}_uv
an(article(of(food(for(which(standards(have(not(been(
specified(but'is'not'unsafe.'
(

18

19. €Genetically'modified'foods'M'^Pvš]ooÇvP]vŒ
}Œu}](](}}_uv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'M'means(food(products(that(have(been(
produced(in(accordance(with(specified'organic'production'
standards.'
19

20. €Functional'foodsM'^&}}(}Œ^‰]o]šŒÇh~&^h}Œ
&µvš]}vo(}}}ŒEµšŒµš]o}Œ,ošZµ‰‰ouvš_
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_ÁZ]Z]v}šŒ‰Œvš(}Œuse'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. 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'M'Which'
''''''''Does'not'result'in'injury''
''''''''NonMgrievous'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'

23. 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 Advisory
Committee
Scientific Panel Scientific Committee Enforcement
State Food Safety
Authority
State Food Safety
Commissioner
Designated Officer
Food Safety Officer
Food Analyst
23

24. 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

25. €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

26. 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(
ƒProposal(for(&[(work(program.(
ƒPrioritization(of(work.(
ƒIdentifying(potential(risks.(
ƒKnowledge(Pooling.(
ƒsuch(other(functions(as(may(be(
specified(by(regulations.(
(
€CAC(meet(regularly(_(min(thrice'a'
year(or(upon(invitation.(
26
Some duties and functions

27. 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'reMconstitute'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

28. 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. 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. 30
ADJUDICATING COURTS
MISBRANDED
AND
SUBSTANDARD
FOOD
UNSAFE
FOOD
FINE
Fine with
Punishment

31. ‡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

32. ‡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

33. ‡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

34. €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:'

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'M'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 ² 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

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'31
st
'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 Microbiological
Parameters once in a six months/Own or NABL recognised lab.
€Required Temperature conditions ² 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 ² RM , Nature, Purchase/Produced/Sold
records.
€Can not sold/offer/distribute edible oil without packaging/Marking
and 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

46. Online
‡Create Your ID & Password
‡Fill in Form ² B
‡Upload Required Documents
‡ Fill in DD Details
‡Acknowledgement No. Will be Generated
Online
‡Print Out Ackn No. sheet
‡ Printout online filled Form 5 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 ReUlabelers.
‡Submit to the DO of your Region

47. 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 5 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 5 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.

48. €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

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

€Manufacturing date:
ƒmmm/yyyy: Best Before Date > 3 months
ƒdd/mmm/yyyy: Best Before Date < 3 months

€Use by date/recommended last consumption date/expiry date:5
ƒThe use by date/recommended last consumption date/expiry
date shall be given,5
|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

50. €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

51. €Nutritional Information:





€Claims
ƒNo food should be described or presented in a manner that is
false, misleading or deceptive
ƒClaims should be justifiable.
ƒNo 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

52. €Chapter'1'title'and'commencement,'Definitions'
'
€Chapter'2''Food'Product'Standards'
ƒRegulation(2.1t(Dairy(Products(and(Analogues(
ƒRegulation(2.2(t(Fats,(Oils(and(Fat(Emulsions(
ƒRegulation(2.3(t(Fruit(&(Vegetable(Products(
ƒRegulation(2.4(t(Cereals(and(Cereal(Products(
ƒRegulation(2.5(t(Meat(and(Meat(Products(
ƒRegulation(2.6(t(Fish(and(Fish(Products(
ƒRegulation(2.7(t(Sweets(&(Confectionery(
52

53. ƒRegulation(2.8(t(Sweetening(Agents(including(Honey(
ƒRegulation(2.9(t(Salt,(Spices,(Condiments(and(Related(
Products(
ƒRegulation(2.10(t(Beverages((other(than(Dairy(and(Fruits(
&((Vegetables(based)'
ƒRegulation(2.11t(Other(Food(Products(&(Ingredients(
ƒRegulation(2.12(t(Proprietary(Food(
ƒRegulation(2.13(t(Irradiation(of(Food(
53

54. € Definitions and Standards of Quality e.g.
ƒAtta

54

55. €Natural Coloring Matter (Regulation 3.1.2:2): Natural Coloring
matters which may be used:
ƒBeta5carotene
ƒChlorophyll
ƒRiboflavin
ƒCaramel
€Allowed Synthetic Food Colors (Regulation 3.1.2:4)
ƒPonceau 4R
ƒCarmoisine
ƒErythrosine
ƒTartrazine
No#Restriction#except##
specifically#mentioned##
in#standards#
²Annatto
²Saffron
²Curcumin
²Sunset Yellow FCF
²Indigo Carmine
²Brilliant Blue FCF
²Fast Green FCF
Restricted#Usage:#Provisions#for#specific#use#in#FSS#
(Food Product Standards & Food Additives) Regulations,
Chapter 3#and#Appendix#A#
55

56. €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:
ƒCommon Salt
ƒSugar
ƒDextrose
ƒGlucose Syrup
€Class II Preservatives:
ƒRestricted Usage: Provisions for specific use in Chapter 2 and
Appendix A.
ƒUse of more than 1 class 2 preservatives in a food NOT
ALLOWED, unless provided specifically.

²Spices
²Vinegar
²Honey
²Edible Vegetable Oil
*Addition#of#Class#I#Preservative#
allowed#in#any#food#is#not#
restricted,#unless#otherwise#
provided#in#the#rules#
56

57. €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:
ƒLecithin
ƒAscorbic acid
ƒTocopherol
€Other antioxidants: Restricted Usage5 Provisions
for specific use in FSS (Food Product Standards &
Food Additives) Regulations, Chapter 2 and
Appendix A of this Regulation.


57

58. €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.
ƒRegulation 3.1.6:3: Use of Starch Phosphate.
ƒRegulation 3.1.6:4: Use of modified starches.
ƒRegulation 3.1.6:5: Use of emulsifier and stabilizer in flavours.
ƒRegulation 3.1.6:6: Use of emulsifier and stabilizer in fruit products.
ƒRegulation 3.1.6:7: Use of emulsifier and stabilizer in frozen
desserts.
58

59. €Flavoring agents may be of following three types:
ƒNatural 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.
ƒNature 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.
ƒArtificial 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 antiUoxidants,
emulsifying and stabilizing agents and food preservatives as per
Regulation 3.1.10 (3).
59

60. €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, anti5caking 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

61. Appendix A
Additives which can be added to different category of food
Appendix B
Microbiological Requirements
61

62. €Appendix A lists down various food additives allowed in different
categories of food
ƒTable 1 ² List of food additives for use in Bread & Biscuits
ƒTable 2 ² List of food additives for use in Foods
ƒTable 3 ² List of food additives for use in foods not specified
ƒTable 4 ² List of food additives for use in edible oils & fats
ƒTable 5 ² List of food additives for use in fish & fish products
ƒTable 6 ² List of food additives for use in Thermally Processed
Fruits
ƒTable 7 ² List of food additives for use in Thermally Processed
Vegetables
ƒTable 8 ² List of food additives for use in food products
ƒTable 9 5 List of food additives for use in food products (Fruits &
Veg)
62

63. €Appendix A lists down various food additives allowed in
different categories of food
ƒTable 10 5 List of food additives for use in food products (Fruits &
Vegetables)
ƒTable 11 5 List of food additives for use in food products (Fruits &
Vegetables)
ƒTable 12 5 List of food additives for use in Sugars & Salt
ƒTable 13 5 List of food additives for use in Cocoa Powder,
Chocolate, Sugar Boiled Confectionery, Chewing Gum/Bubble
Gum.
ƒTable 14 5 List of food additives for use in Milk products
ƒTable 15 5 List of food additives for use in individual variety of
cheese
63

64. €Appendix B lists microbiological requirements in different
categories of food:

ƒTable 1 ² Microbiological requirements for sea foods
ƒTable 2 ² Microbiological parameters for milk products
ƒTable 3 ² Microbiological parameters for spices
ƒTable 4 ² Microbiological requirements for food products
(Fruits & Vegetables)





64

65. €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

66. €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

67. €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

68. 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

69. FSSI'proposes'12
th
'Five'year'plan'2012M2017'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

70. €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

71. 72