1

WP2746.13
IN THE HIGH COURT OF JUDICATURE AT BOMBAY
ORDINARY ORIGINAL CIVIL JURISDICTION
WRIT PETITION NO. 2746 OF 2013
1. Vital Nutraceuticals Private Limited )
A company incorporated under te )
!ompanies Act" 1#$6 and a mem%er o& )
'ndia (ru) *anu&acturers+ Association a )
representative %ody o& te (ru)s )
*anu&acturers ,Parmaceuticals) %ein) )
an institution &ormed %y te )
manu&acturers across te country )
re)istered under te -ocieties .e)istration )
Act" 1/60 and avin) te re)istered 1&&ice )
at 10223" +A Win)+" Poonam !am%ers" (r. )
Annie 3esant .oad" Worli" *um%ai 400 01/ )
trou) its (irector" *r. 4anes Vital )
5amat. )
)
2. 'ndian (ru) *anu&acturers+ Associaiton )
a representative %ody o& te (ru)s )
*anu&acturers ,Parmaceuticals) %ein) an )
institution &ormed %y te manu&acturers )
across te country re)istered under te )
-ocieties .e)istration Act" 1/60 and avin) )
its re)istered 1&&ice at 10223" +A Win)+" )
Poonam !am%ers" (r. Annie 3esant .oad" )
Worli" *um%ai 400 01/. )...Petitioners.
V6s
1. 7nion o& 'ndia trou) -ecretary *inistry )
o& 8ealt and 9amily Wel&are" 4overnment )
o& 'ndia" ,(epartment o& 9ood) Nirman )
3avan" Ne: (eli ; 110 011 )
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2. 9ood -a&ety and -tandards Autority )
o& 'ndia. 9(A 3avan" Near 3al 3avan" )
5otala .oad" Ne: (eli2110 002. ).....espondents.
222
*r. '. *. !a)la" -enior !ounsel :it *r. .iya< !a)la :it
*r. .a=eev >alasi?ar &or te Petitioners.
(r. 4... -arma :it *r. 4.8ariaran :it *r. -.(. 3osale
&or .espondent No.1.
*r. *emood Praca :it *r. '.A. 5an i6% *6s. Le)al A@is &or
.espondent No.2.
2222
CORAM V. M. !ANADE "
GIRISH S. !UL!ARNI# JJ.

J$%&'()* +(,(+-(% .) 22/01/2014
J$%&'()* 0+.).$)1(% .) 22/1/2014

ORAL JUDGMENT 3Per V.M. Kanade, J.4
1. 8eard.
2. .ule. .ule is made returna%le &ort:it. .espondents
:aive service. 3y consent o& parties" matter is ta?en up &or
&inal earin).
3. 3y tis Petition :ic is &iled under Article 226 o& te
!onstitution o& 'ndia" Petitioners" inter alia" are see?in) an
appropriate :rit" order or direction &or stri?in) do:n or
declarin) as null and void all te te advisories :ic ave
%een issued %y .espondent No.2 and more particularly an
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advisory dated 1160$62013 primarily on te )round tat
.espondent No.2 does not ave po:er or autority to issue
tese advisories :ic ave an e&&ect o& amendin)
.e)ulations :ic ave %een &ramed under section #2 o& te
9ood -a&ety and -tandards Act" 2006 and tat tey are
ille)al and :itout any statutory &orceA tey %ein) issued
neiter under section #2 o& te Act nor avin) %een in
consonance :it section 16,2) and 1/,2),d) o& te Act.
4. 1n te oter and" it is contended %y te learned
!ounsel appearin) on %eal& o& .espondent No.2 tat
.espondent No.2 ; 9ood -a&ety and -tandards Autority o&
'ndia as a po:er and autority to issue tese Advisories %y
e@ercisin) po:er vested in it under sections 16,1) and 16,$)
and under sections 1/ and 22 o& te Act and tat tey ave
%een issued :ile e@ercisin) &unctions o& te !ie& B@ecutive
1&&icer under section 10 o& te said Act. 't is also contended
tat it is also in consonance :it .e)ulation 2.1.2 and 2.1.7
o& te 9ood -a&ety and -tandards ,Licensin) and .e)istration
o& 9ood 3usinesses) .e)ulations" 2011.
FACTS
$. Petitioner No.1 is a Private Limited !ompany
incorporated under te provisions o& te !ompanies Act"
1#$6 and is en)a)ed in %usiness o& manu&acture and supply
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o& &oods &or special dietary use" &unctional &oods"
nutraceuticals" ealt supplements" a&ter o%tainin) reCuisite
license under te erst:ile Act :ic :as in &orce vi<.
Prevention o& 9ood Adulteration Act" 1#$4. >is license :as
converted %y issuance o& &res license under te provisions
o& te 9ood -a&ety and -tandards Act" 2006 ,ereina&ter sall
%e re&erred to &or te sa?e o& %revity as D9-- Act" 2006E)
6. Petitioner No.2 is a re)istered Association o& dru)s F
parmaceutical manu&acturers in 'ndia and is a -ociety
re)istered under te provisions o& te -ocieties .e)istration
Act" 1/60. .espondent No.2 ; 9ood -a&ety and -tandards
Autority is a %ody corporate avin) perpetual succession
and a common seal and is esta%lised under section 4 o& te
9-- Act" 2006.
7. Petitioners ave &iled tis Petition &or Cuasin) te
instructions6directives termed as Advisories issued %y
.espondent No.2 to te various 9ood 1&&icers under te Act
and also !entral F -tate Autorities and oter 1&&icers &rom
time to time. >ese advisories ave %een issued %y
.espondent No.2 since 2010 and %y te advisory dated
1160$62013" te earlier advisories :ere superseded and" as
suc" te Petitioners tere&ore are no: only callen)in) te
advisory dated 1160$62013.
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/ An a&&idavit2in2reply as %een &iled %y .espondent No.2
dated 1160162014 and terea&ter a&&idavit2in2re=oinder as
%een &iled on %eal& o& te Petitioners on 2060162014.
REASONS
#. 3e&ore ta?in) into consideration te rival su%missions" it
:ould %e relevant i& te provisions o& 9-- Act" 2006 are ta?en
into consideration. 3y virtue o& te 9-- Act" 2006 te Acts
mentioned in te -econd -cedule :ere repealed and te
9-- Act" 2006 came into &orce :it e&&ect &rom 2460/62006.
3y tis Act" te &ollo:in) Acts ave %een repealed.
D1. >e Prevention o& 9ood Adulteration Act" 1#$4 ,37 o&
1#$4)
2. >e 9ruit Products 1rder" 1#$$.
3. >e *eat 9ood Products 1rder" 1#73
4. >e Ve)eta%le 1il Products ,!ontrol) 1rder" 1#47
$. >e Bdi%le 1ils Pac?a)in) ,.e)ulation) 1rder" 1##/.
6. >e -olvent B@tracted 1il" (e oiled *eal" and Bdi%le
9lour ,!ontrol) 1rder" 1#67.
7. >e *il? and *il? Products 1rder" 1##2
/. Any oter order issued under te Bssential
!ommodities Act" 1#$$ ,10 o& 1#$$)E
>e reason :y te said Acts :ere repealed can %e seen
&rom te pream%le o& te ne: Act and also -tatement o&
1%=ects and .easons" :ic read as underG2
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DS*5*('()* .6 O78(1*, 5)% R(5,.),.2*ultiplicity
o& &ood la:s" standard settin) and en&orcement
a)encies pervades di&&erent sectors o& &ood" :ic
creates con&usion in te minds o& consumers" traders"
manu&acturers and investors. (etailed provisions
under various la:s re)ardin) admissi%ility and levels
o& &ood additives" contaminants" &ood colours"
preservatives" etc." and oter related reCuirements
ave varied standards under tese la:s. >e
standards are o&ten ri)id and non2responsive to
scienti&ic advancements and modernisation. 'n vie:
o& multiplicity o& la:s" teir en&orcement and standard
settin) as :ell as various implementin) a)encies are
detrimental to te )ro:t o& te nascent &ood
processin) industry and is not conducive to e&&ective
&i@ation o& &ood standards and teir en&orcement.
2. 'n as early as in te year 1##/" te Prime
*inister+s !ouncil on >rade and 'ndustry appointed a
-u%=ect 4roup on 9ood and A)ro 'ndustries" :ic ad
recommended &or one compreensive le)islation on
&ood :it a 9ood .e)ulatory Autority concernin)
%ot domestic and e@port mar?ets. Hoint
Parliamentary !ommittee on Pesticide .esidues in its
report in 2004 empasised te need to covera)e all
present &ood la:s and to ave a sin)le re)ulatory
%ody. >e !ommittee e@pressed its concern on pu%lic
ealt and &ood sa&ety in 'ndia. >e -tandin)
!ommittee o& Parliament on A)riculture in its 12
t
.eport su%mitted in April" 200$ desired tat te
muc2needed le)islation on 'nte)rated 9ood La:
sould %e e@pedited.
3. As an on)oin) process" te ten mem%er2
-ecretary" La: !ommission o& 'ndia" :as as?ed to
ma?e a compreensive revie: o& 9ood la:s o& various
developin) and developed countries and oter
relevant international a)reements and instruments on
te su%=ect. A&ter ma?in) an indept survey o& te
'nternational scenario" te ten *em%er2-ecretary
recommended tat te ne: 9ood La: %e seen in te
overall perspective o& promotin) nascent &ood
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processin) industry )iven its income" employment
and e@port potential. 't as %een su))ested tat all
acts and orders relatin) to &ood %e su%sumed :itin
te proposed 'nte)rated 9ood La: as te international
trend is to:ards modernisation and conver)ence o&
re)ulations o& 9ood -tandards :it te elimination o&
multi2level and multi2departmental control. Presently"
te empasis is on ,a) responsi%ility :it
manu&actures" ,%) recall" ,c) )enetically modi&ied and
&unctional &oods" ,d) emer)ency control" ,e) ris?
analysis and communication and ,&) &ood sa&ety and
)ood manu&acturin) practices and process control"
vi<." 8a<ard Analysis and !ritical !ontrol Point.
4. 'n tis %ac?)round" te 4roup o& *insters
constituted %y te 4overnment o& 'ndia" eld
e@tensive dele%rations and approved te proposed
'nte)rated 9ood La: :it certain modi&ications. >e
'nte)rated 9ood La: as %een named as D>e 9ood
-a&ety and -tandard 3ill" 200$E. >e main o%=ective
o& te 3ill is to %rin) out a sin)le statute relatin) to
&ood and to provide &or a systematic and scienti&ic
development o& 9ood Processin) 'ndustries. 't is
proposed to esta%lis te 9ood -a&ety and -tandards
Autority o& 'ndia" :ic :ill &i@ &ood standards and
re)ulate 6 monitor te manu&acturin)" import"
processin)" distri%ution and sale o& &ood" so as to
ensure sa&e and :olesome &ood &or people. >e
9ood Autority :ill %e assisted %y -cienti&ic
!ommittees and Panels in &i@in) standards and %y a
!entral Advisory !ommittee in prioriti<ation o& te
:or?. >e en&orcement o& te le)islation :ill %e
trou) te -tate !ommissioner &or 9ood -a&ety" is
o&&icers and Pancayati .a= 6 *unicipal %odies.
$. >e 3ill" inter alia, incorporates te salient
provisions o& te Prevention o& 9ood Adulteration Act"
1#$4 ,37 o& 1#$4) and is %ased on international
le)islations" instrumentalities and !ode@ Alimentaries
!ommission ,:ic related to &ood sa&ety norms). 'n
a nutsell" te 3ill ta?es care o& 'nternational
practices and invisa)es on overarcin) policy
&rame:or? and provision o& sin)le :indo: to )uide
and re)ulate persons en)a)ed in manu&acture"
mar?etin)" processin)" andlin)" transportation"
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import and sale o& &ood. >e main &eatures o& te 3ill
areG
,a) movement &rom multi2level and multi2
departmental control to inte)rated line o& commandA
,%) inte)rated response to strate)ic issues li?e
noval 6 )enetically modi&ied &oods" international
tradeA
,c) licensin) &or manu&acture o& &ood
products" :ic is presently )ranted %y te !entral
A)encies under various Acts and 1rders" :ould
stand decentralised to te !ommissioner o& 9ood
-a&ety and is o&&icerA
,d) sin)le re&erence point &or all matters
relatin) to 9ood -a&ety and -tandards" re)ulations
and en&orcementA
,e) si&t &rom mere re)ulatory re)ime to
sel&2compliance trou) 9ood -a&ety *ana)ement
-ystemsA
,&) responsi%ility on &ood %usiness
operators to ensure tat &ood processed"
manu&actured" imported or distri%uted is in
compliance :it te domestic &ood la:sA and
,)) provision &or )raded penalties
dependin) on te )ravity o& o&&ence and
accordin)ly" civil penalties &or minor o&&ences and
punisment &or serious violations.
6. >e a%ovesaid 3ill is contemporary"
compreensive and intends to ensure %etter
consumer sa&ety trou) 9ood -a&ety *ana)ement
-ystems and settin) standards %ased on science and
transparency as also to meet te dynamic
reCuirements o& 'ndian 9ood >rade and 'ndustry and
'nternational trade.
>e 3ill see?s to acieve te a&oresaid
o%=ectives.E
10. Perusal o& te said -tatement o& 1%=ects and .easons
reveals tat te intention o& te le)islature :as to ta?e care
o& 'nternational practices and also to provide &or sin)le
:indo: to )uide and re)ulate persons en)a)ed in
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manu&acture" mar?etin)" processin)" andlin)"
transportation" import and sale o& &ood. >e Act" tere&ore"
appears to ave %een %rou)t into &orce to armoni<e te
interests o& consumers and manu&acturers to ,1) ensure
&ood sa&etyA ,2) protect te interest o& te consumersA
,3) ensure sa&e and :olesome &ood &or te people and" at
te same time to ensure te )ro:t o& te nascent &ood
processin) industry.
11. 't :ill %e necessary to consider te -ceme o& te 9--
Act" 2006. 3y virtue o& te said Act" 9ood -a&ety and
-tandards Autority o& 'ndia as %een esta%lised. !apter2''
o& te Act lays do:n te various autorities :ic ave %een
esta%lised. 't lays do:n te &unctions o& te 9ood Autority
as also te &unctions o& !entral Advisory !ommittee.
!apter2''' o& te Act lays do:n )eneral principles o& &ood
sa&ety in section 1/ o& te said Act. !apter2'V lays do:n te
)eneral provisions as to articles o& &ood. -ection 22 is in
respect o& )enetically modi&ied &ood" or)anic &oods"
&unctional &oods" proprietary &oods" etc and see?s to impose
special responsi%ility on te &ood %usiness operators.
-ection 27 also prescri%es te lia%ility o& manu&acturers"
pac?ers" :olesalers" distri%utors and sellers. -ection 2/
envisa)es te procedure :ic as to %e &ollo:ed %y te
manu&acturers &or te purpose o& recallin) &ood products.
!apter2V deals :it provisions relatin) to import. !apter V'
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deals :it special responsi%ilities as to &ood sa&ety. !apter
2V'' deals :it te en&orcement o& te Act and te autorities
:ic are responsi%le &or te said en&orcement. 3y virtue o&
-ection 30" te duties o& !ommissioner o& 9ood -a&ety o& te
-tate as %een prescri%ed and -ection 31 deals :it
licensin) and re)istration o& &ood %usiness. >e said !apter
also envisa)es situations :ere emer)ency proi%ition
notices could %e issued and te proi%ition orders could %e
passed %y te autorities under te Act &or te purpose o&
en&orcement o& te provisions o& te Act. 't also )ives po:er
to te autorities o& searc" sei<ure" investi)ation and
prosecution. >e procedure &or launcin) te prosecution is
laid do:n under section 42 o& te Act. !apter2V''' deals
:it analysis o& &ood and prescri%es te procedure &or
reco)nition and accreditation o& la%oratories" researc
institutions and re&erral &ood la%oratory" appointment o& te
&ood analyst and &unctions o& te &ood analyst. !apter2'I
deals :it o&&ences and penalties. !apter2I is in respect o&
ad=udication and &ood sa&ety appellate tri%unal and te
po:er vested in te said appellate tri%unal to ad=udicate
issues :ic are re&erred to it. 7nder section 76" appeal is
provided to 8i) !ourt. !apter2I' deals :it 9inance
Accounts" Audit and .eports and te last !apter2I'' deals
:it po:er o& te !entral 4overnment to issue directions to
te 9ood Autority and te procedure :ic is reCuired to %e
&ollo:ed in respect o& ta?in) approval &rom te Parliament in
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respect o& .ules and .e)ulations :ic are &ramed eiter %y
te !entral 4overnment or %y te 9ood Autority. -ection
#7 deals :it repeal and savin)s.
12. >e relevant provisions :ic are )ermane &or te
purpose o& decidin) te issue raised in tis Petition :ill %e
separately dealt :it at te appropriate sta)e.
13. 'n te present case" te sort issue :ic &alls &or
consideration %e&ore tis !ourt is G :eter te advisories
:ic ave %een issued %y te 9ood Autority are :itout
autority o& la: and :eter te 9ood Autority as te
po:er to issue tese Advisories6directions :itout &ollo:in)
te due procedure laid do:n under sections #2 and #3 o& te
9-- Act" 2006J
14. >e contention o& te Petitioners in tis case is tat te
advisories :ic ave %een issued are :itout po:er and
autority :ic can %e e@ercised %y te 9ood Autority and"
tere&ore" are ar%itrary" ille)al and ultra vires te provisions
o& te 9-- Act" 2006 and te .ules and .e)ulations &ramed
tereunder.
1$. A detailed a&&idavit2in2reply as %een &iled on %eal& o&
.espondent No.2 and tou) in te reply it as not %een
stated :at is te e@act source o& po:er vested in te 9ood
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Autority &or issuance o& tese advisories" it as %een stated
in te a&&idavit2in2reply tat &rom con=oint readin) o&
sections 10" 16,1)" 16,$)" 1/" 22 as also section 2#" po:er o&
te 9ood Autority in issuin) tese advisories can %e seen.
An a&&idavit2in2re=oinder as %een &iled on %eal& o& te
Petitioner denyin) tese contentions and averments :ic
are made in te a&&idavit2in2reply.
16. 3e&ore :e )o into te rival contentions on te
interpretation :ic is sou)t to %e made %y te learned
-enior !ounsel appearin) on %eal& o& te Petitioners and
te learned -enior !ounsel appearin) on %eal& o& te
.espondents o& te said provisions" it :ould %e necessary to
ave a loo? at te advisories :ic ave %een issued.
.espondent No.2 ; 9ood Autority :as pleased to issue
various advisories :ic ave %een mentioned as Press Note
cum Advisory etc. &rom time to time. >e &irst advisory
:ic as %een issued is dated 1360762010 and te last one
is dated 116$62013. -ince in te last advisory :ic as
%een issued" it is stated tat te said advisory as %een
issued in supersession o& earlier advisories" it may not %e
necessary to re&er to and deal :it earlier advisories :ic
ave %een issued &rom time to time &rom 2010 to 2012. >e
Petition" tere&ore essentially callen)es te advisory dated
1160$62013 :ic as %een put on te :e%site o& te
.espondents. >e said advisory6circular mentions te
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su%=ect as underG2
D-u%=ectG 4uidelines to %e &ollo:ed &or product
approval procedure.E
'n para 1 o& te said advisory" it is stated tat in vie: o& &eed
%ac? received &rom various sta?eolders re)ardin) te
comple@ity and time lines &or product approval and in order
to streamline te product approval procedure :it due
consideration to te sa&ety o& &ood and pu%lic ealt" te
&ood products &or :ic te standards are not speci&ied
under te 9-- Act" 2006" .ules and .e)ulations made
tereunder :ill %e )ranted product approval su%=ect to te
procedure :ic is to %e &ollo:ed. >e procedure is re&erred
to in para 1,a)" 1,%)" 1,c) and 1,d) and te oter clauses o&
te said advisory. !lause / re&ers to te application &ee o&
.s 2$"00062 :ic is paya%le in respect o& eac application.
>e product approval application &orm and te &ormat o& te
a&&idavit are also anne@ed to te said advisory.
17. *r. !a)la" te learned -enior !ounsel appearin) on
%eal& o& te Petitioners su%mitted &irstly tat under te
provisions o& 9-- Act" 2006 and te .ules and .e)ulations
&ramed tereunder" te concept o& prior product approval o&
products :ic are already in te mar?et and in respect o&
e@istin) products manu&actured %y Petitioner No.1 :o ad a
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valid license under te erst:ile 9ood Adulteration Act :as
not envisa)ed under te provisions o& te ne: Act and te
.ules and .e)ulations &ramed tereunder. 't is" tere&ore"
su%mitted tat te said concept o& prior product approval
:as not in consonance :it te provisions o& te Act and te
.ules and .e)ulations &ramed tereunder. 't is su%mitted
tat te 9ood Autority as assumed te po:er to issue
tese Advisories and set up a ne: re)ime o& o%tainin) prior
product approval o& e@istin) products. 8e su%mitted tat
Petitioner No.1 :as re)istered and :as )ranted license
under te 9ood Adulteration Act and :as te manu&acturer o&
products &or te te last 1021$ years. 8e su%mitted tat %y
virtue o& te savin) clause under section #7,3)" e@istin)
licenses ave %een saved and" as suc" tere is no
reCuirement under te ne: Act &or suc manu&acturers to
ten apply &or product approval o& teir e@istin) products
:ic are in te mar?et %e&ore applyin) &or re)istration
under .e)ulation No.2.1.2 o& te 9ood -a&ety and -tandards
,Licensin) and .e)istration o& 9ood 3usiness) .e)ulations"
2011 :ic came into &orce &rom 0160/62011 a&ter it :as
pu%lised in te 4overnment 4a<ette. 't is su%mitted tat
te only :ay in :ic te 9ood Autority could %rin) into
&orce te ne: procedure is %y issuin) te .e)ulation under
section 16,2) o& te Act a&ter it is ta%led %e&ore %ot te
8ouses o& te Parliament as envisa)ed under section #3 o&
te said Act. >e learned -enior !ounsel appearin) on
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%eal& o& te Petitioners tere&ore su%mitted tat te said
procedure :ic as no: %een prescri%ed is ille)al and
:itout any autority o& la:.
1/. 1n te oter and" te learned !ounsel appearin) on
%eal& o& te 9ood Autority su%mitted tat tose
manu&acturers :ose products &ell in -cedule21 o& te
9-- ,Licensin) and .e)istration o& 9ood 3usiness)
.e)ulations" 2011 ave to o%tain licenses &rom te !entral
A)ency or te -tate A)ency. 8e su%mitted tat te product
:ic as %een manu&actured %y te Petitioners &ell in
!ate)ory2V''' o& -cedule21 and" tere&ore" it :as necessary
to ma?e an application under .e)ulation No.2.1.2 o& te said
.e)ulations" 2011. -econdly" e su%mitted tat te 9ood
Autority could esta%lis tat te action ta?en %y it in issuin)
te said advisory :as =usti&ied %ot on moral and le)al
)round. 8e su%mitted tat e :ould &irst try to point out
o: te 9ood Autority :as morally =usti&ied in issuin) te
said direction and at te end o& is ar)ument e :ould so:
te source o& po:er :ic is e@ercised %y te 9ood Autority
in issuin) te said advisory.
1#. >e learned !ounsel appearin) on %eal& o& te
.espondents &irstly su%mitted tat various products :ere
%ein) dumped in te country and some o& tese products
:ere manu&actured %y te !inese manu&acturers and tat it
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:as %rou)t to te notice o& te 9ood Autority tat te said
products contained steroids :ic :ere arm&ul and te &ood
:as unsa&e &or uman consumption. 8e ten su%mitted tat
since te Act :as at a nascent sta)e" it :as not possi%le to
&ormulate various .e)ulations in respect o& all cate)ories o&
&ood. 8e su%mitted tat only in respect o& 377 products"
.e)ulations could %e issued re)ardin) various in)redients
:ic :ere to %e accepted. 8e su%mitted tat" o:ever" in
respect o& proprietary &ood and oter cate)ories o& &ood"
.e)ulations ad not %een &ramed and" tere&ore" in te
interest o& pu%lic at lar)e and in order to ensure tat &ood
:ic :as supplied to te consumer :as not unsa&e &ood" te
9ood Autority :as constrained to issue tese advisories. 8e
ten invited our attention to section 10 o& te 9-- Act" 2006
in respect o& &unctions o& te !ie& B@ecutive 1&&icer. 8e
ten pointed out tat under section 22 o& te said Act no
manu&acturers could manu&acture products mentioned in te
said section. 8e su%mitted tat Petitioner No.1 :as
manu&acturin) te products :ic ave %een mentioned in
-ection 22 o& te said Act. 8e ten su%mitted tat section
16,1) o& te said Act autori<es te 9ood Autority to
re)ulate and monitor te activities in respect o&
manu&acture" processin)" distri%ution" sale and import o&
&ood products. 8e su%mitted tat %y virtue o& te said
section" 9ood Autority ad a po:er to re)ulate and monitor
not only te manu&acturin) activities %ut all types o&
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activities related to &ood product and" tere&ore" under te
said provision te 9ood Autority ad complete po:er and
=urisdiction to issue suc advisories. 8e ten su%mitted tat
su%2section ,2) o& -ection 16 clearly stated tat :itout
pre=udice to te provisions o& su%2section ,1)" te 9ood
Autority may issue .e)ulations in respect o& various items
mentioned section 16,2),a) to 16,2),i). 't is" tere&ore"
su%mitted tat in vie: o& use o& te :ord DmayE in su%2
section ,2)" a discretion is vested in te 9ood Autority in
preparin) .e)ulations" tou) it is not necessary in vie: o&
provisions o& section 16,1) :ic )ives complete po:er and
autority to te 9ood Autority to issue
)uidelines6re)ulations to all te manu&acturers and &ood
product operators. 8e su%mitted tat te provisions o&
section 16,$) o& te said Act clearly envisa)ed tat te 9ood
Autority could issue directions to te !ommissioner o& 9ood
-a&ety and oter autorities :ic are %indin) on tem. 8e
su%mitted tat" tere&ore" in vie: o& te said provisions" te
9ood Autority as te po:er to issue te impu)ned
advisory.
20. 1n te oter and" *r. !a)la" te learned -enior
!ounsel appearin) on %eal& o& te Petitioners su%mitted
tat use o& te :ord DmayE in section 16,2) o& te 9-- Act"
2006 :ill ave to %e interpreted as DsallE. 8e su%mitted
tat tis is a%undantly clear on te con=oint readin) o&
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various provisions o& te Act and more particularly sections
#2 and #3 o& te said Act :ic made it mandatory &or te
9ood Autority to place te said .e)ulation %e&ore %ot te
8ouses o& te Parliament as envisa)ed under section #3. 't
is su%mitted tat so &ar as section 16,$) is concerned" te
said section merely empo:ers te 9ood Autority to )ive
directions to te !ommissioner o& 9ood. 8e" o:ever"
su%mitted tat tese directions could not %e outside te
purvie: o& te Act and te .ules and .e)ulations &ramed
tereunder.
21. >a?in) into consideration te said su%missions"
tere&ore" it :ill %e necessary to ave a loo? at te relevant
provisions.
22. -ection 10 o& te said Act reads as &ollo:sG2
D10 - Functions of the Chief Executive Officer.-
,1) >e !ie& B@ecutive 1&&icer sall %e te le)al representative
o& te 9ood Autority and sall %e responsi%le &or22
(a) the day-to-day administration of the Food Authority;
(b) drawing up of proposal for the Food Authority's work programmes in
consultation with the Central Advisory Committee;
(c) implementing the work programmes and the decisions adopted by the
Food Authority;
(d) ensuring the provision of appropriate scientific technical and
administrative support for the !cientific Committee and the !cientific
"anel;
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(e) ensuring that the Food Authority carries out its tasks in accordance
with the re#uirements of its users in particular with regard to the
ade#uacy of the services provided and the time taken;
(f) the preparation of the statement of revenue and e$penditure and the
e$ecution of the budget of the Food Authority; and
(g) developing and maintaining contact with the Central %overnment and
for ensuring a regular dialogue with its relevant committees&
(') (very year the Chief ($ecutive )fficer shall submit to the Food Authority
for approval--
(a) a general report covering all the activities of the Food Authority in the
previous year;
(b) programmes of work;
(c) the annual accounts for the previous year; and
(d) the budget for the coming year&
(*) +he Chief ($ecutive )fficer shall following adoption by the Food Authority
forward the general report and the programmes to the Central %overnment
and the !tate %overnments and shall have them published&
(,) +he Chief ($ecutive )fficer shall approve all financial e$penditure of the
Food Authority and report on the Authority's activities to the Central
%overnment&
(-) +he Chief ($ecutive )fficer shall e$ercise the powers of the Commissioner
of Food !afety while dealing with matters relating to food safety of such
articles&
(.) +he Chief ($ecutive )fficer shall have administrative control over the
officers and other employees of the Food Authority&/
-ection 16 re&ers to te duties and &unctions o& te 9ood
Autority. -ection 16 o& te said Act reads as underG2
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D16 - Duties and functions of Food Authority.-
,1) 't sall %e te duty o& te 9ood Autority to re)ulate and
monitor te manu&acture" processin)" distri%ution" sale and
import o& &ood so as to ensure sa&e and :olesome &ood.
(') 0ithout pre1udice to the provisions of sub-section (2) the Food Authority
may by regulations specify--
(a) the standards and guidelines in relation to articles of food and
specifying an appropriate system for enforcing various standards notified
under this Act;
(b) the limits for use of food additives crop contaminants pesticide
residues residues of veterinary drugs heavy metals processing aids
myco-to$ins antibiotics and pharmacological active substances and
irradiation of food;
(c) the mechanisms and guidelines for accreditation of certification bodies
engaged in certification of food safety management systems for food
businesses;
(d) the procedure and the enforcement of #uality control in relation to any
article of food imported into 3ndia;
(e) the procedure and guidelines for accreditation of laboratories and
notification of the accredited laboratories;
(f) the method of sampling analysis and e$change of information among
enforcement authorities;
(g) conduct survey of enforcement and administration of this Act in the
country;
(h) food labelling standards including claims on health nutrition special
dietary uses and food category systems for foods; and
(i) the manner in which and the procedure sub1ect to which risk analysis
risk assessment risk communication and risk management shall be
undertaken&
(*) +he Food Authority shall also--
(a) provide scientific advice and technical support to the Central
%overnment and the !tate %overnments in matters of framing the policy
and rules in areas which have a direct or indirect bearing on food safety
and nutrition;
(b) search collect collate analyse and summarise relevant scientific and
technical data particularly relating to--
(i) food consumption and the e$posure of individuals to risks related to
the consumption of food;
(ii) incidence and prevalence of biological risk;
(iii) contaminants in food;
(iv) residues of various contaminants;
(v) identification of emerging risks; and
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(vi) introduction of rapid alert system;
(c) promote co-ordinate and issue guidelines for the development of
risk assessment methodologies and monitor and conduct and forward
messages on the health and nutritional risks of food to the Central
%overnment !tate %overnments and Commissioners of Food !afety;
(d) provide scientific and technical advice and assistance to the Central
%overnment and the !tate %overnments in implementation of crisis
management procedures with regard to food safety and to draw up a
general plan for crisis management and work in close co-operation with
the crisis unit set up by the Central %overnment in this regard;
(e) establish a system of network of organisations with the aim to
facilitate a scientific co-operation framework by the co-ordination of
activities the e$change of information the development and
implementation of 1oint pro1ects the e$change of e$pertise and best
practices in the fields within the Food Authority's responsibility;
(f) provide scientific and technical assistance to the Central %overnment
and the !tate %overnments for improving co-operation with international
organisations;
(g) take all such steps to ensure that the public consumers interested
parties and all levels of panchayats receive rapid reliable ob1ective and
comprehensive information through appropriate methods and means;
(h) provide whether within or outside their area training programmes in
food safety and standards for persons who are or intend to become
involved in food businesses whether as food business operators or
employees or otherwise;
(i) undertake any other task assigned to it by the Central %overnment
to carry out the ob1ects of this Act;
(1) contribute to the development of international technical standards for
food sanitary and phyto-sanitary standards;
(k) contribute where relevant and appropriate to the development of
agreement on recognition of the e#uivalence of specific food related
measures;
(l) promote co-ordination of work on food standards undertaken by
international governmental and non-governmental organisations;
(m) promote consistency between international technical standards and
domestic food standards while ensuring that the level of protection
adopted in the country is not reduced; and
(n) promote general awareness as to food safety and food standards&
(,) +he Food Authority shall make it public without undue delay--
(a) the opinions of the !cientific Committee and the !cientific "anel
immediately after adoption;
(b) the annual declarations of interest made by members of the Food
Authority the Chief ($ecutive )fficer members of the Advisory
Committee and members of the !cientific Committee and !cientific "anel
as well as the declarations of interest if any made in relation to items on
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the agendas of meetings;
(c) the results of its scientific studies; and
(d) the annual report of its activities&
(-) +he Food Authority may from time to time give such directions on
matters relating to food safety and standards to the Commissioner of Food
!afety who shall be bound by such directions while e$ercising his powers
under this Act;
(.) +he Food Authority shall not disclose or cause to be disclosed to third
parties confidential information that it receives for which confidential
treatment has been re#uested and has been acceded e$cept for information
which must be made public if circumstances so re#uire in order to protect
public health&/
>e ne@t section o& te said Act :ic as %een
re&erred to %y te learned !ounsel appearin) on %eal& o& te
.espondents is section 1/,1),a) to section 1/,1),)) and su%2
section ,2) o& section 1/ :ic read as underG2
418 - General rinciles to !e follo"ed in ad#inistration of Act-
>e !entral 4overnment" te -tate 4overnments" te 9ood
Autority and oter a)encies" as te case may %e" :ile
implementin) te provisions o& tis Act sall %e )uided %y te
&ollo:in) principles" namelyG22
(2) (a) endeavour to achieve an appropriate level of protection of human
life and health and the protection of consumers' interests including fair
practices in all kinds of food trade with reference to food safety standards
and practices;
(b) carry out risk management which shall include taking into account the
results of risk assessment and other factors which in the opinion of the
Food Authority are relevant to the matter under consideration and where
the conditions are relevant in order to achieve the general ob1ectives of
regulations;
(c) where in any specific circumstances on the basis of assessment of
available information the possibility of harmful effects on health is
identified but scientific uncertainty persists provisional risk management
measures necessary to ensure appropriate level of health protection may
be adopted pending further scientific information for a more
comprehensive risk assessment;
(d) the measures adopted on the basis of clause (c) shall be proportionate
and no more restrictive of trade than is re#uired to achieve appropriate
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level of health protection regard being had to technical and economic
feasibility and other factors regarded as reasonable and proper in the
matter under consideration;
(e) the measures adopted shall be reviewed within a reasonable period of
time depending on the nature of the risk to life or health being identified
and the type of scientific information needed to clarify the scientific
uncertainty and to conduct a more comprehensive risk assessment;
(f) in cases where there are reasonable grounds to suspect that a food
may present a risk for human health then depending on the nature
seriousness and e$tent of that risk the Food Authority and the
Commissioner of Food !afety shall take appropriate steps to inform the
general public of the nature of the risk to health identifying to the fullest
e$tent possible the food or type of food the risk that it may present and
the measures which are taken or about to be taken to prevent reduce or
eliminate that risk; and
(g) where any food which fails to comply with food safety re#uirements is
part of a batch lot or consignment of food of the same class or
description it shall be presumed until the contrary is proved that all of
the food in that batch lot or consignment fails to comply with those
re#uirements&
(') +he Food Authority shall while framing regulations or specifying standards
under this Act--
(a) take into account--
(i) prevalent practices and conditions in the country including
agricultural practices and handling storage and transport conditions;
and
(ii) international standards and practices where international
standards or practices e$ist or are in the process of being formulated
unless it is of opinion that taking into account of such prevalent practices and
conditions or international standards or practices or any particular part thereof
would not be an effective or appropriate means for securing the ob1ectives of
such regulations or where there is a scientific 1ustification or where they would
result in a different level of protection from the one determined as appropriate
in the country;
(b) determine food standards on the basis of risk analysis e$cept where it
is of opinion that such analysis is not appropriate to the circumstances or
the nature of the case;
(c) undertake risk assessment based on the available scientific evidence
and in an independent ob1ective and transparent manner;
(d) ensure that there is open and transparent public consultation directly
or through representative bodies including all levels of panchayats during
the preparation evaluation and revision of regulations e$cept where it is
of opinion that there is an urgency concerning food safety or public health
to make or amend the regulations in which case such consultation may be
dispensed with5
"rovided that such regulations shall be in force for not more than si$
months;
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(e) ensure protection of the interests of consumers and shall provide a
basis for consumers to make informed choices in relation to the foods they
consume;
(f) ensure prevention of--
(i) fraudulent deceptive or unfair trade practices which may mislead or
harm the consumer; and
(ii) unsafe or contaminated or sub-standard food&/
>e ne@t relevant section o& te said Act is section 22
:ic reads as underG2

4$$ - Genetically #odified foods% or&anic foods% functional foods%
rorietary foods% etc-
-ave as oter:ise provided under tis Act and re)ulations made
tereunder" no person sall manu&acture" distri%ute" sell or
import any novel &ood" )enetically modi&ied articles o& &ood"
irradiated &ood" or)anic &oods" &oods &or special dietary uses"
&unctional &oods" neutraceuticals" ealt supplements"
proprietary &oods and suc oter articles o& &ood :ic te
!entral 4overnment may noti&y in tis %eal&.
($planation&--For the purposes of this section--
(2) 6foods for special dietary uses or functional foods or nutraceuticals
or health supplements6 means5
(a) foods which are specially processed or formulated to satisfy
particular dietary re#uirements which e$ist 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 e$ist and may
contain one or more of the following ingredients namely5--
(i) plants or botanicals or their parts in the form of powder
concentrate or e$tract in water ethyl alcohol or hydro alcoholic
e$tract single or in combination;
(ii) minerals or vitamins or proteins or metals or their compounds
or amino acids (in amounts not e$ceeding the 7ecommended 8aily
Allowance for 3ndians) or en9ymes (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;
(b) (i) a product that is labelled as a 6Food for special dietary uses
or functional foods or nutraceuticals or health supplements or
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similar such foods6 which is not represented for use as a
conventional food and whereby such products may be formulated in
the form of powders granules tablets capsules li#uids 1elly 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 * of the 8rugs and Cosmetics Act 2:,;('* of 2:,;)
and rules made thereunder;
(iii) does not claim to cure or mitigate any specific disease disorder
or condition (e$cept 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 !chedule of the <arcotic 8rugs and "sychotropic
!ubstances Act 2:=-(.2 of 2:=-) and rules made thereunder and
substances listed in !chedules ( and (3 of the 8rugs and Cosmetics
7ules 2:,-;
(') 6genetically engineered or modified food6 means 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;
(*) 6organic food6 means food products that have been produced in
accordance with specified organic production standards;
(,) 6proprietary and novel food6 means an article of food for which
standards have not been specified but is not unsafe5
"rovided that such food does not contain any of the foods and
ingredients prohibited under this Act and the regulations made
thereunder&/
Lastly" section 2# o& te said Act reads as underG2
4$' - Authorities resonsi!le for enforce#ent of Act-
,1) >e 9ood Autority and te -tate 9ood -a&ety Autorities sall
%e responsi%le &or te en&orcement o& tis Act.
(') +he Food Authority and the !tate Food !afety Authorities shall monitor
and verify that the relevant re#uirements of law are fulfilled by food business
operators at all stages of food business&
(*) +he authorities shall maintain a system of control and other activities as
appropriate to the circumstances including public communication on food
safety and risk food safety surveillance and other monitoring activities
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covering all stages of food business&
(,) +he Food !afety )fficers shall enforce and e$ecute within their area the
provisions of this Act with respect to which the duty is not imposed e$pressly
or by necessary implication on some other authority&
(-) +he regulations under this Act shall specify which of the Food !afety
)fficers are to enforce and e$ecute them either generally or in relation to
cases of a particular description or a particular area and any such regulations
or orders may provide for the giving of assistance and information by any
authority concerned in the administration of the regulations or orders or of
any provisions of this Act to any other authority so concerned for the
purposes of their respective duties under them&
(.) +he Commissioner of Food !afety and 8esignated )fficer shall e$ercise
the same powers as are conferred on the Food !afety )fficer and follow the
same procedure specified in this Act&/
23. 3e&ore :e deal :it te said provisions" it :ill %e
necessary to also consider te repeal and savin)s clause in
te 9-- Act" 2006 under section #7,3). -ection #7,3) reads
as underG2
4'( - )eeal and savin&s.-
,1) Wit e&&ect &rom suc date as te !entral 4overnment may
appoint in tis %eal&" te enactment and 1rders speci&ied in te
-econd -cedule sall stand repealedG
"rovided that such repeal shall not affect5--
(i) the previous operations of the enactment and )rders under repeal
or anything duly done or suffered thereunder; or
(ii) any right privilege obligation or liability ac#uired accrued or
incurred under any of the enactment or )rders under repeal; or
(iii) any penalty forfeiture or punishment incurred in respect of any
offences committed against the enactment and )rders under repeal; or
(iv) any investigation or remedy in respect of any such penalty
forfeiture or punishment
and any such investigation legal proceedings or remedy may be instituted
continued or enforced and any such penalty forfeiture or punishment may be
imposed as if this Act had not been passed5
(') >&&&&&&&&&&&
(*) <otwithstanding the repeal of the aforesaid enactment and )rders the
licences issued under any such enactment or )rder which are in force on
the date of commencement of this Act shall continue to be in force till the
date of their e$piry for all purposes as if they had been issued under the
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provisions of this Act or the rules or regulations made thereunder&
(,) >&&&&&&&/
-u%2clause ,3) o& section #7" tere&ore" clearly saves te
licenses :ic ave %een issued under te old Act and it
clearly states tat te said licenses sall continue to %e in
&orce till te date o& teir e@piry &or all purposes as i& tey
ad %een issued under te provisions o& te said Act and
rules and re)ulations made tereunder.
24. 'n te present case" Petitioners ad o%tained license
under te old Act. >e 9ood -a&ety and -tandards ,Licensin)
and .e)istration o& 9ood 3usinesses) .e)ulations" 2011 ave
%een pu%lised in te 4a<ette o& 'ndia on 0160/62011 and"
tere&ore" te said .e)ulations came into &orce on te
pu%lication o& te said .e)ulations in te 4a<ette. >e said
.e)ulations lay do:n tat te &ood %usiness operators ave
to %e re)istered or licensed in accordance :it te
procedures laid do:n under te said .e)ulations. .e)ulation
2.1.2 is in respect o& license &or &ood %usiness. >e said
.e)ulation %ein) relevant &or decidin) te contentions raised
in tis Petition" it :ould %e pro&ita%le to reproduce te said
.e)ulation.
D2.1.2 L'!BN-B- 91. 911( 37-'NB--
,1) -u%=ect to .e)ulation 2.1.1" no person sall commence any &ood
%usiness unless e possesses a valid license. Provided tat any
person or 9ood 3usiness 1perator carryin) on &ood %usiness on te
date o& noti&ication o& tese .e)ulations" under a license" re)istration
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or permission" as te case may %e" under te Acts or 1rders
mentioned in te -econd -cedule o& te Act sall )et teir e@istin)
license converted into te license6re)istration under tese
re)ulations %y ma?in) an application to te Licensin)6.e)isterin)
Autority a&ter complyin) :it te sa&ety reCuirements mentioned in
te -cedule 4 contained under di&&erent Parts dependent on nature
o& %usiness" :itin one year o& noti&ication o& tese .e)ulations. 'n
case o& di&&iculty" te licensin) autority :it te approval o& te
9ood -a&ety !ommissioner in te -tate :ill determine te
advisa%ility o& applyin) any speci&ic condition ?eepin) in vie: te
need to ensure sa&ety o& &ood and pu%lic interest. No license &ee :ill
ave to %e paid &or te remainin) period o& te validity o& te earlier
license or re)istration )ranted under any o& te said Acts or 1rders.
Non2compliance :it tis provision %y a 9ood 3usiness 1perator :ill
attract penalty under section $$ o& te Act. Provided &urter tat any
&ood %usiness operator oldin) .e)istration6License under any oter
Act61rder as speci&ied under scedule 2 o& te 9-- Act" 2006 :it
no speci&ic validity or e@piry date" and oter :ise entitled to o%tain
a license under tese re)ulations" sall ave to apply and o%tain a
.e)istration6License under tese .e)ulations :itin one year &rom
te date o& noti&ication %y payin) te applica%le &ees.
,2) Not:itstandin) te provisions contained in .e)ulation 2.1.2,1)
a%ove or in any o& te re)istration or license certi&icates issued
under e@istin) Acts or 1rders mentioned in te second scedule o&
te Act" te Licensin) Autority" i& it as reason to %elieve tat te
9ood 3usiness 1perator as &ailed to comply :it all or any o& te
conditions o& te e@istin) re)istration or license or te sa&ety
reCuirements )iven in -cedule 4" may )ive appropriate direction to
te 9ood 3usiness 1perator to comply :it.
,3) License &or commencin) or carryin) on &ood %usiness" :ic &alls
under -cedule 1" sall %e )ranted %y te !entral Licensin)
Autority" provided tat 9ood Autority may trou) noti&ication
ma?e suc can)es or modi&y te list )iven in te -cedule ' as
considered necessary.
,4) License &or commencin) or carryin) on &ood %usiness" :ic are
not covered under -cedule 1" sall %e )ranted %y te concerned
-tate67>Ks Licensin) Autority.
,$) >e 9ood 3usiness 1perator sall ensure tat all conditions
o& license as provided in Anne@ure 2 o& 9orm 3 in -cedule 2 and
sa&ety" sanitary and y)ienic reCuirements provided in te -cedule
4 contained under di&&erent Parts dependin) on nature o& %usiness
are complied :it at all times. Provided tat te Licensin) Autority
sall ensure periodical &ood sa&ety audit and inspection o& te
licensed esta%lisments trou) its o:n or a)encies autori<ed &or
tis purpose %y te 9--A'.
Provided &urter tat no person sall manu&acture" import" sell"
stoc?" e@i%it &or distri%ution or sale any article o& &ood :ic as
%een su%=ected to te treatment o& irradiation" e@cept under a
license o%tained &rom (epartment o& Atomic Bner)y under te
Atomic Bner)y ,!ontrol o& 'rradiation o& 9ood) .e)ulations" 1##6.E
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9rom te a&oresaid .e)ulation" it can %e seen tat in vie: o&
su%2clause ,3)" license &or commencin) or carryin) on &ood
%usiness :ic &alls under -cedule21" as to %e )ranted %y
te !entral Licensin) Autority. 'n -cedule22 o& te said
.e)ulations various &orms and &ormats ave %een
mentioned. 9orm2A is a 9orm :ic is to %e &illed in :ile
applyin) &or .e)istration6.ene:al o& .e)istration under te
9ood -a&ety and -tandards Act" 2006. 9orm23 prescri%es
Application &or License6.ene:al o& license under 9ood -a&ety
and -tandards Act" 2006. Anne@ure22 to te said -cedule
mentions te documents :ic are to %e enclosed &or ne:
application &or license to -tate6!entral Licensin) Autority
and clause ,6) mentions te list o& &ood cate)ory desired to
%e manu&actured . !lause ,/) re&ers to Analysis report etc.
License 9ormat is re&erred to in 9orm2!. 9orm (21 is te
&ormat o& Annual .eturn :ic as to %e su%mitted %y te
licensee. >e said .e)ulations practically lay do:n te
entire procedure &or te purpose o& eiter o%tainin) ne:
license or &or rene:al o& license in terms o& .e)ulation 2.1.2
o& te said .e)ulations.
2$. 8avin) seen te procedure &or o%tainin) te license" :e
:ill ave to revert %ac? to te relevant sections reproduced
ereina%ove to see :eter te 9ood Autority ad te
po:er or =urisdiction to issue te impu)ned advisory dated
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WP2746.13
1160$62013.
26. A&ter avin) perused te a&oresaid provisions" in my
vie:" tere is no provision in te Act on te %asis o& :ic
te 9ood Autority can trace te po:er to issue te
advisory6)uidelines6circular :ic as %een callen)ed in
tis Petition. >e a&&idavit2in2reply &iled %y te .espondents
does not state tat te 9ood Autority as a po:er to issue
tese advisories under section 16,1) o& te 9--A" 2006 as
as %een ar)ued across te %ar %y te learned !ounsel
appearin) on %eal& o& te .espondents. >e a&&idavit2in2
reply re&ers to various sections :ic are reproduced
ereina%ove and it is stated tat on con=oint readin) o&
tese sections" it can %e seen tat te 9ood Autority could
issue tese advisories in te interest o& pu%lic at lar)e.
-ince it as %een orally ar)ued tat section 16,1) )ives
po:er to te 9ood Autority to issue tese advisories" it :ill
%e necessary to re&er to section 16,1) and 16,2). '& te
lan)ua)e used in section 16,1) is ta?en into consideration" it
is a%undantly clear tat te po:er as %een )iven to te
9ood Autority to re)ulate and monitor various sta)es o&
manu&acture" processin)" distri%ution" sale and import o&
&ood products. -ection 16,2) on te oter and %e)ins :it
te prase DWitout pre=udice toE te provisions o& su%2
section ,1)" te 9ood Autority may ma?e te .e)ulations in
respect o& te matters prescri%ed in section 16,2),a) to
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WP2746.13
section 16,2),i). 8ere in tis case" o%viously" te :ords
DWitout pre=udice toE :atever is stated in sus%2section ,1)
ave to %e interpreted in te conte@t in :ic tey are used.
't o%viously means tat :ile ma?in) te .e)ulations" care
sould %e ta?en tat tere is no su%2dele)ation o& po:er or
tat po:er o& te 9ood Autority is not diluted %y su%2
dele)atin) its po:er or in oter :ords %y ?eepin) te said
po:er :ic is vested in it intact te .e)ulations ave to %e
made %y te 9ood Autority. 1n proper interpretation"
tere&ore" o& te said su%2section ,2) o& section 16" in our
vie:" tat %y itsel& does not )ive an un%ridled or un&ettered
po:er to te 9ood Autority to re)ulate or monitor various
activities in &ood production. 't is o%vious tat te said
autority as to %e :itin te po:er and procedure :ic is
prescri%ed %y te various provisions o& te Act. A re&erence
can also %e made to te o%servations o& noted Hurist Hustice
4.P. -in) in is 3oo? Principles o& -tatutory 'nterpretation
,11
t
Bdition 200/) on pa)e 3$$" :ic read as underG2
D........ A provision enacted +:itout
pre=udice+ to anoter provision as not
te e&&ect o& a&&ectin) te operation o&
te oter provision and any action ta?en
under it must not %e inconsistent :it
suc provision
1
1 '>1 v. 4:alior .ayon -il? *anu&acturin) ,Weavin)) !o. Ltd" A'." 1#76 -! 43" p.
47........ A'. 2006 -! 1301 ,construction o& s.$6 o& 9B.A :ic commences :it
te :ords +:itout pre=udice+).
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WP2746.13
-ection 16,2) on te oter and tou) mentions tat te
9ood Autority may ma?e .e)ulations" te said :ord Dmay+
o%viously :ill ave to %e interpreted as DsallE in vie: o& te
oter provisions :ic are &ound in te statute vi< -ections
#2 and #3 o& te said Act. >e provisions o& sections #2 and
#3 clearly reveal tat te said .e)ulation as to to %e placed
%e&ore %ot te 8ouses o& te Parliament and only terea&ter
it :ould ave statutory &orce. 'n tis conte@t" a)ain" :e can
)ain&ully re&er to te o%servations made %y te noted Hurist
Hustice 4.P. -in) in is 3oo? on Principles o& -tatutory
'nterpretation ,11
t
Bdition" 200/) on pa)e 4$0 :ic read as
underG2
D>e :ord +may+ may also %e used in te
sense o& +sall+ or +must+ %y te Le)islature
:ile con&errin) po:er o& a i) di)nitary.
1

Wen te conte@t so:s tat te po:er is
coupled :it an o%li)ation" Dte :ord +may+
:ic denotes discretion sould %e
construed to mean a commandE.
2
>e use o&
te :ord +may+ in suc cases is Dout o&
de&erence to te i) status o& te autority
on :om te po:er and te o%li)ation are
1 -tate o& 7.P. Vs Ho)endra -in)" A'." 1#63 -! 161/" p.1620G1#64,2) -!. 1#7
2 '%idG .an)as:ami" >e@tile !ommissioner vs. -a)ar >e@tile *ills ,P.) Ltd" A'. 1#77
-! 1$16" p. 1$17G ,1#77) 2 -!! $7/
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WP2746.13
intended to %e con&erred and imposedE.
1
't
:as" tere&ore" eld tat te :ords +te
4overnment may" in respect o& a )a<etted
4overnment servant on is o:n reCuest"
re&er is case to te >ri%unal" +in te conte@t
o& .ule 4,2) o& te 7.P. (isciplinary
Proceedin)s ,Administrative >ri%unal) .ules"
1#47" con&erred a po:er coupled :it an
o%li)ation on te 4overnor to e@ercise te
po:er :en a reCuest :as made %y a
)a<etted 4overnment -ervant in tat %eal&
and tat te 4overnor ad no discretion in
te matter.
2
.ule 30 o& te .a=astan *inor
*ineral !oncession .ules" 1#$$" :ic is to
te e&&ect tat +a minin) lease may %e
)ranted &or a period o& &ive years unless te
applicant imsel& desires a sorter period+"
as %een construed to con&er no discretion
on te 4overnment to &i@ a period less tan
&ive years i& te applicant did not desire a
sorter period.E
27. -imilarly" te provisions o& section 16,$) also do not
)ive any un%ridled po:er to te 9ood Autority to )ive any
directions to te !ommissioner or oter autorities. >e said
1 -tate o& 7.P. vs. Ho)endra -in)" A'. 1#63 -! 161/" p.1620 G 1#64 ,2) -!. 1#7.
2 '%id
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WP2746.13
directions" tere&ore" ave to %e :itin te &rame:or? o& la:
enacted %y te Parliament and te .ules and .e)ulations
&ramed tereunder. 9rom te a&oresaid provisions" tere&ore"
it is clear tat it is open &or te 9ood Autority to issue
)uidelines or advisories :ic are :itin te &rame:or? o&
te la: and tese advisories or .e)ulations" in order to ave
&orce o& la:" ave to %e approved %y %ot te 8ouses o&
Parliament.
2/. 'n te present case" perusal o& te said
)uidelines6circular6advisory reveals tat procedure o&
product approval as envisa)ed in te said advisory does not
&ind place at least in respect o& e@istin) manu&acturers and in
respect o& te products :ic are already in te mar?et. '&
te 9ood Autority or any o& its 1&&icers &ind tat te )eneral
standards :ic are mentioned in various .e)ulations are
not &ollo:ed" it is al:ays open &or te 9ood Autority to ta?e
various steps as envisa)ed under te provisions o& te Act
and .e)ulations eiter ,a) &or issuin) te proi%itory order
&or recallin) te &ood products ,%) &or cancellation6suspension
o& license or ,%) &or launcin) a prosecution and ta?in) oter
steps in order to ensure tat te &ood :ic is manu&actured"
supplied and distri%uted %y suc manu&acturers is
:olesome &ood and is sa&e &or te pu%lic consumption.
>ou) a Cuery :as made %y tis !ourt as to :eter te
said advisory :as issued only in respect o& ne: products
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:ic :ere to %e introduced in mar?et &or te &irst time" te
learned !ounsel appearin) on %eal& o& te 9ood Autority
veemently ar)ued tat all te manu&acturers includin)
e@istin) manu&acturers o& all te products :ould ave to
apply &or product approval in respect o& te items :ic are
mentioned in -cedule21 o& te .e)ulations.
2#. 'n my vie:" tere is muc su%stance in te su%missions
made %y te learned -enior !ounsel appearin) on %eal& o&
te Petitioners. -o &ar as te =ud)ment on :ic reliance is
placed in te a&&idavit2in2reply is concerned" te ratio o& te
said =ud)ment :ill not apply to te &acts o& te present case.
>e a&oresaid decision relates to te dispute concernin)
&i@ation o& tari&& %y te !ommission pursuant to te e@press
po:er con&erred on suc !ommission under te Adra
Prades Blectricity .e&orms Act ,30 o& 1##/). 'n te &acts o&
tat case" te Ape@ court as a&&irmed te vie: ta?en %y te
8i) !ourt tat re)ulatory !ommission ad &i@ed tari&& in
accordance :it te provisions o& te said Act. 'n te
present case" o:ever" te impu)ned advisories ave %een
issued :itout complyin) :it te mandatory provisions o&
te Act and :enever it is &ound tat te decision as %een
ta?en :itout &ollo:in) te proper procedure and is contrary
to te provisions o& te Act" !ourts ave &ull po:er to
inter&ere :it suc decisions. >e said principle is Cuite :ell
settled and it is not necessary to re&er to various =ud)ments
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WP2746.13
o& te Ape@ !ourt. Wen a statutory autority is reCuired to
do a tin) in a manner provided under te statute" te same
must %e done in tat manner or not at all.
30. 'n tis conte@t it :ill %e relevant to re&er to >reaties on
Administrative La: %y 8.W... Wade F !.9. 9orsyt in Part V
:erein it is o%served as underG2
-7..BN(B." A3('!A>'1N" ('!>A>'1N
Power in the wrong hands
!losely a?in to dele)ation and scarcely
distin)uisa%le &rom it in some cases" is any
arran)ement %y :ic a po:er con&erred upon one
autority is in su%stance e@ercised %y anoter. >e
proper autority may sare its po:er :it
someone else" or may allo: someone else to
dictate to it %y declinin) to act :itout teir
consent or %y su%mittin) to teir :ises or
instructions. >e e&&ect ten is tat te discretion
con&erred %y Parliament is e@ercised" at least in
part" %y te :ron) autority" and te resultin)
decision is ultra vires and void. -o strict are te
courts in applyin) tis principle tat tey condemn
some administrative arran)ements :ic must
seem Cuite natural and proper to tose :o ma?e
tem.......E
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WP2746.13
-imilarly" in te same >e@t" on te concept o& dele)ated
le)islation particularly issuance o& departmental circulars"
te autor as Cuoted para)rap &rom te =ud)ment o&
-treat&ield H.
D........ A =ud)ment nota%le &or its &orce&ul
lan)ua)e" as :ell as &or its a:areness o& te :ide
constitutional implications" :as delivered %y -cott
LH :o ad &ormerly %een cairman o& te
!ommittee on *insiters+ Po:ers and :as inclined
to deplore te &ailure to implement its report. 8e
descri%ed some o& te events as +an e@ample o&
te very :orst ?ind o& %ureaucracy+. 3ut te root o&
te trou%le may :ell ave %een te di&&iculty o&
tellin) :ere le)islation %e)an and ended.
'n a case o& te same ?ind" :ere te reCuisition
:as eld invalid &or non2o%servance o& te
condition in te circular reCuirin) notice to %e
)iven to te o:ner" -treat&ield H saidG
DWereas ordinary le)islation" %y passin) trou)
%ot 8ouses o& Parliament or" at least" lyin) on te
ta%le o& %ot 8ouses" is tus t:ice %ased" tis type
o& so2called le)islation is at least &our times cursed.
9irst" it as seen neiter 8ouse o& ParliamentA
secondly" it is unpu%lised and is inaccessi%le even
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3/
WP2746.13
to tose :ose valua%le ri)ts o& property may %e
a&&ectedA tirdly" it is =um%le o& provisions"
le)islative" administrative" or directive in
caracter" an sometimes di&&icult to disentan)le
one &rom te oterA and" &ourtly" it is e@pressed
not in te precise lan)ua)e o& an Act o& Parliament
or an 1rder in !ouncil %ut in te more colloCuial
lan)ua)e o& correspondence" :ic is not al:ays
suscepti%le o& te ordinary cannons o&
construction.E
'n my vie:" present advisory )oes %eyond te scope o& te
Act and is contrary to te provisions o& te Act itsel& since
te process o& product approval at least o& old e@istin)
products :ic are in te mar?et &or decades is not
envisa)ed under te Act and contention o& .espondent No.2
tat introduction o& product approval is consistent :it
section 1/ is misconceived. >e impu)ned advisory instead
o& clari&yin) te .e)ulations as :idened and overreaced
te scope o& te Act and te .ules and .e)ulations &ramed
tereunder. Bven te po:er con&erred %y section 16,$) is
restricted to te issuance o& directions :itin te &rame:or?
o& te Act and suc directions cannot e@ceed te scope o&
te Act or its purpose as provided under section 16,$).
31. A&ter te old Act :as repealed" e@istin) licenses :ere
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WP2746.13
saved and %y virtue o& te 9ood -a&ety and -tandards
,Licensin) and .e)istration o& 9ood 3usinesses) .e)ulations"
2011" any person or 9ood 3usiness 1perator carryin) on &ood
%usiness on te date o& noti&ication o& tese .e)ulations"
under a license" re)istration or permission" as te case may
%e" under te Acts or 1rders mentioned in te -econd
-cedule o& te Act sall )et teir e@istin) license converted
into te license6re)istration under tese re)ulations %y
ma?in) an application to te Licensin)6.e)isterin) Autority
under te said .e)ulation No.2.1.2. >e &orm in :ic te
said application is to %e made as %een speci&ied in te
&orms :ic are anne@ed to te said .e)ulation o& 2011.
Perusal o& tese &orms and te &orms :ic are no: anne@ed
to te impu)ned advisory :ill reveal tat several ne: &actors
ave no: %een introduced %ye2passin) te .e)ulations
:ic ave approved te &ormat in te -cedule anne@ed to
te .e)ulations.
32. Apart &rom tat" te said Advisory also reCuires te
applicants to &ill in te a&&idavit in te &ormat :ic is
prescri%ed in te advisory :ic is not contemplated even
under te .e)ulations :ic ave %een approved %y placin)
tem %e&ore %ot te 8ouses o& Parliament. '& te 9ood
Autority is permitted to carry out te e@ercise :ic is
devised %y te Autority" it :ould result in a caotic situation
:ere all te e@istin) manu&acturers :o ad valid license
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WP2746.13
&or several decades :ill no: %e reCuired under te )ar% o&
tis advisory to o%tain product approval even in respect o&
te e@istin) products and till suc time te product approval
is not )ranted" tey :ould %e precluded &rom mar?etin) te
said products :ic ave %een in te mar?et &or su&&iciently
lon) time. 1& course" it does not mean tat te 9ood
Autority does not ave po:er to re)ulate6monitor te
process o& manu&acture" distri%ution" sale etc and i& it &inds
tat certain products" a&ter analysis" do not con&orm to te
international standards or oter standards :ic are to %e
&ound in sections 1/ and 22" it can al:ays ta?e action :ic
is permitted under te various provisions o& te Act in order
to ensure tat suc &ood items :ic are unsa&e &or uman
consumption are removed &rom te mar?et. >e main
purpose o& %rin)in) tis ne: Act into &orce :as not only to
e&&ectively &i@ te &ood standards and to monitor tem %ut
also to ensure tat ri)id and non2responsive standards :ere
reCuired to %e can)ed so tat te &ood processin) industry
:ould not %e &aced :it several di&&iculties.
FINDINGS
33. 'n vie: o& te a&oresaid reasons" in my vie:" tere&ore"
te said advisory so &ar as it ma?es compulsory even to
e@istin) manu&acturers to o%tain product approval %e&ore
o%tainin) te license under .e)ulation 2.1.2 o& te said
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WP2746.13
.e)ulations" 2011 is" tere&ore" ultra vires te provisions o&
te Act and te .ules and .e)ulations &ramed tereunder
and" tere&ore" in my vie:" te 9ood Autority cannot issue
suc Advisories :ic are contrary to te provisions o& te
Act and te .ules and .e)ulations &ramed tereunder unless
tey are approved as per te provisions o& sections #2 and
#3.
34. 't is clari&ied tat te 9ood Autority can issue suc
Advisories :ic are :itin te con&inement o& te provisions
o& te 9-- Act" 2006 and te .ules and .e)ulations &ramed
tereunder.
3$. 'n my vie:" tis Petition :ill ave to %e allo:ed and is
allo:ed. >e impu)ned advisory dated 1160$62013 so &ar as
it relates to e@istin) manu&acturers :o ad licenses and
re)istration prior to te present 9-- Act" 2006 and
.e)ulations o& 2011 comin) into &orce" are Cuased and set
aside.
3V.M. !ANADE# J.4
36. At tis sta)e" my learned %roter 4iris -. 5ul?arni" H.
e@pressed tat e is una%le to a)ree :it te vie: ta?en %y
me and" tere&ore" e :ould li?e to )ive a di&&erin) =ud)ment.
8e" o:ever" needs some more time to deliver a di&&erin)
=ud)ment.
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WP2746.13
37. -tand over &or one :ee? in order to ena%le my learned
%roter 4iris -. 5ul?arni" H. to deliver a di&&erin) =ud)ment.
3GIRISH S. !UL!ARNI# J. 4 3V.M. !ANADE# J.4

ORAL JUDGMENT P(+ G.S.!UL!ARNI# J. 3dissenting4
R(,(+-(% .) 22
*9
J5)$5+:# 2014
P+.).$)1(% .) 4
*9
F(7+$5+:# 2014
1. ' ave ad te privile)e o& )oin) trou) te
erudite =ud)ment o& my learned %roter *r.Hustice
V.*.5anade. 8avin) deli%erated over te ar)uments
advanced %y te learned !ounsel &or contestin) parties in
te li)t o& te statutory provisions and autoritative
pronouncement o& te -upreme !ourt" ' deeply re)ret my
ina%ility to persuade mysel& to sare te vie: o& my learned
%roter. 8ence" tis Hud)ment.
2. .ule. .ule is made returna%le &ort:it. 3y
consent o& parties " eard &inally.
3. 3y tis petition &iled under Article 226 o& te
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43
WP2746.13
!onstitution o& 'ndia" t:o petitioners vi<. Vital Nutraceuticals
Private Ltd.2Petitioner no.1 and 'ndian (ru) *anu&acturers+
Association2Petitioner no.2 avin) 6#0 mem%ers as listed in
te -tatement anne@ed at +B@i%it !+ to te petition" ave
inter alia callen)ed te action o& .espondent no.2 vi<. 9ood
-a&ety and -tandards Autority o& 'ndia ,ereina&ter re&erred
to as +te 9ood Autority+) in issuin) advisories in respect o&
various issues &allin) under te 9ood -a&ety and -tandards
Act"2006 and more particularly te advisory dated 11.$.2013
:ic lays do:n te )uidelines to %e &ollo:ed &or te
+Product Approval Procedure+. >e callen)e as %een
con&ined to tis advisory.
4. >e &acts relevant &or ad=udication o& dispute in te
present proceedin)s are as underG2
>e Parliament enacted te 9ood -a&ety and
-tandards Act"2006 ,ereina&ter re&erred to as D9--
Act"2006E) repealin) te Prevention o& 9ood Adulteration
Act"1#$4" te 9ruit Products 1rder"1#$$" te *eat 9ood
Products 1rder"1#73" te Ve)eta%le 1il Products ,!ontrol)
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44
WP2746.13
1rder"1#47" te Bdi%le 1ils Pac?a)in) ,.e)ulation)
1rder"1##/" te -olvent B@tracted 1il" (e oiled *eal" and
Bdi%le 9lour ,!ontrol) 1rder"1#67" te *il? and *il? Products
1rder"1##2" any oter orders issued under te Bssential
!ommodities Act"1#$$ relatin) &ood. All tese repealed Acts
and 1rders are enumerated in te -econd -cedule o& te
9-- Act &ormin) part o& te repeal provision %ein) -ection #7
o& te 9-- Act. >e pream%le o& te 9-- Act recites tat it is
an Act to consolidate te la:s relatin) to &ood and to
esta%lis te 9ood -a&ety and -tandards Autority o& 'ndia &or
layin) do:n science2%ased standards &or articles o& &ood and
to re)ulate teir manu&acture" stora)e" distri%ution" sale and
import" to ensure availa%ility o& sa&e and :olesome &ood &or
uman consumption and &or matters connected tere:it or
incidental tereto.
$. >e -tatement o& 1%=ects and .easons o& te 9--
Act inter2alia sets out in detail tat te ten *em%er2
-ecretary" La: !ommission o& 'ndia" :as as?ed to ma?e a
compreensive revie: o& 9ood La:s o& various developin)
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WP2746.13
and developed countries and oter relevant international
a)reements and instruments on te su%=ect. >at a&ter
ma?in) an indept survey o& te 'nternational scenario" te
ten *em%er2 -ecretary recommended tat te ne: 9ood
La: %e seen in te overall perspective o& promotin) nascent
&ood processin) industry )iven its income" employment and
e@port potential. >at it as %een su))ested tat all acts
and orders relatin) to &ood %e su%sumed :itin te proposed
inte)rated 9ood La: as te international trend is to:ards
moderni<ation and conver)ence o& re)ulations o& 9ood
-tandards :it te elimination o& multi2level and multi2
departmental control. >at presently" te empasis :as on
,a) responsi%ility :it manu&acturers" ,%) recall" ,c)
)enetically modi&ied and &unctional &oods" ,d) emer)ency
control" ,e) ris? analysis and communication and ,&) &ood
sa&ety and )ood manu&acturin) practices and process
control" vi<. 8a<ard Analysis and !ritical !ontrol Point. 't
&urter recites tat in tis %ac?)round" te 4roup o& *inisters
constituted %y te 4overnment o& 'ndia" eld e@tensive
deli%erations and approved te proposed 'nte)rated 9ood
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46
WP2746.13
La: :it certain modi&ications. >e 'nte)rated 9ood La: :as
named as D>e 9ood -a&ety and -tandards 3ill"200$E. >at
te main o%=ect o& te 3ill :as to %rin) out a sin)le statute
relatin) to &ood and to provide &or a systematic and scienti&ic
development o& 9ood Processin) 'ndustries. >at it :as
proposed to esta%lis te 9ood -a&ety and -tandards
Autority o& 'ndia" :ic :ill &i@ &ood standards and
re)ulate6monitor te manu&acturin)" import" processin)"
distri%ution and sale o& &ood" so as to ensure sa&e and
:olesome &ood &or te people. >at te 9ood Autority :ill
%e assisted %y -cienti&ic !ommittees and Panels in &i@in)
standards and %y a !entral Advisory !ommittee in
prioriti<ation o& te :or?. >us" te main &eatures o& te 3ill
as enumerated in para)rap ,$) and ,6) o& te -tatement o&
1%=ects and .easons are as &ollo:sG2
D$. >e 3ill" inter alia" incorporates te
salient provisions o& te Prevention o& 9ood
Adulteration Act"1#$4 ,37 o& 1#$4) and is %ased on
international le)islations" instrumentalities and
!ode@ Alimentaries !ommission ,:ic related to
&ood sa&ety norms). 'n a nutsell" te 3ill ta?es care
o& 'nternational practices and invisa)es on
overarcin) policy &rame:or? and provision o& sin)le
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:indo: to )uide and re)ulate persons en)a)ed in
manu&acture" mar?etin)" processin)" andlin)"
transportation" import and sale o& &ood. >e main
&eatures o& te 3ill areG
,a) movement &rom multi2level and multi2
departmental control to inte)rated line o& commandA
,%) inte)rated response to strate)ic issues li?e
noval6 )enetically modi&ied &oods" international
tradeA
,c) licensin) &or manu&acture o& &ood products"
:ic is presently )ranted %y te !entral A)encies
under various Acts and 1rders" :ould stand
decentrali<ed to te !ommissioner o& 9ood -a&ety
and is o&&icerA
,d) sin)le re&erence point &or all matters relatin) to
9ood -a&ety and -tandards" re)ulations and
en&orcementA
,e) si&t &rom mere re)ulatory re)ime to sel&
compliance trou) 9ood -a&ety *ana)ement
-ystemsA
,&) responsi%ility on &ood %usiness operators to
ensure tat &ood processed" manu&actured" imported
or distri%uted is in compliance :it te domestic
&ood la:sA and
,)) provision &or )raded penalties dependin) on
te )ravity o& o&&ence and accordin)ly" civil penalties
&or minor o&&ences and punisment &or serious
violations.
>e a%ovesaid 3ill is contemporary"
compreensive and intends to ensure %etter
consumer sa&ety trou) 9ood -a&ety *ana)ement
-ystems and settin) standards %ased on science and
transparency as also to meet te dynamic
reCuirements o& 'ndian 9ood >rade and 'ndustry and
'nternational trade.E
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-ceme o& te 9-- Act"2006.
6. 1n te a&oresaid le)islative %ac?)round 9--
Act"2006 :as enacted and :as %rou)t into &orce at di&&erent
dates as provided &or in su%2section ,3) o& -ection 1 :ic
reads as underG2
1. -ort title" e@tent and commencement2
,3) 't sall come into &orce on suc date as
te !entral 4overnment may" %y noti&ication
in te 1&&icial 4a<ette" appoint" and di&&erent
dates may %e appointed &or di&&erent
provisions o& tis Act and any re&erence in
any suc provision to te commencement o&
tis Act sall %e construed as a re&erence to
te comin) into &orce o& tat provision.E
>e provisions o& -ections 16 and 1/ ,%ot inclusive)" and te
provisions o& -ection /1 to /6" #2 and #3 :ere %rou)t into
&orce on 1/.11.200/.
7. -ome o& te provisions :ic are necessary to
decide te moot issue in te present petition are reproduced
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erein%elo: &or te sa?e o& convenience.
-ection 3. (e&initions ; ,1) 'n tis Act" unless te
conte@t oter:ise reCuires"2
222 222 222 222 222 222
,=) D&oodE means any su%stance" :eter
processed" partially processed or unprocessed"
:ic is intended &or uman consumption and
includes primary &ood to te e@tent de&ined in clause
,<?)" )enetically modi&ied or en)ineered &ood or &ood
containin) suc in)redients" in&ant &ood" pac?a)ed
drin?in) :ater" alcoolic drin?" ce:in) )um" and
any su%stance" includin) :ater used into te &ood
durin) its manu&acture" preparation or treatment %ut
does not include any animal &eed" live animals
unless tey are prepared or processed &or placin) on
te mar?et &or uman consumption" plants prior to
arvestin)" dru)s and medicinal products"
cosmetics" narcotic or psycotropic su%stancesE
Provided tat te !entral 4overnment may
declare" %y noti&ication in te 1&&icial 4a<ette" any
oter article as &ood &or te purposes o& tis Act
avin) re)ards to its use" nature" su%stance or
CualityA
,m) D9ood AutorityE means te 9ood -a&ety and
-tandards Autority o& 'ndia esta%lised under
section 4A
,n) D&ood %usinessE means any underta?in)"
:eter &or pro&it or not and :eter pu%lic or
private" carryin) out any o& te activities related to
any sta)e o& manu&acture" processin)" pac?a)in)"
stora)e" transportation" distri%ution o& &ood" import
and includes &ood services" caterin) services" sale o&
&ood or &ood in)redientsA
,o) D&ood %usiness operatorE in relation to &ood
%usiness means a person %y :om te %usiness is
carried on or o:ned and is responsi%le &or ensurin)
te compliance o& tis Act" rules and re)ulations
made tereunderA
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,C) D&ood sa&etyE means assurance tat &ood is
accepta%le &or uman consumption accordin) to its
intended useA
,<c) Dmanu&actureE means a process or adoption or
any treatment &or conversion o& in)redients into an
article o& &ood" :ic includes any su%2process"
incidental or ancillary to te manu&acture o& an
article o& &oodA
,<d) Dmanu&acturerE means a person en)a)ed in
te %usiness o& manu&acturin) any article o& &ood &or
sale and includes any person :o o%tains suc
article &rom anoter person and pac?s and la%els it
&or sale or only la%els it &or suc purposesA
,<)) Dnoti&icationE means a noti&ication pu%lised in
te 1&&icial 4asetteA
,<=) Dprescri%edE means prescri%ed %y rules made
%y te !entral 4overnment or te -tate
4overnment" as te case %e under tis ActA
,<o) Dris? assessmentE means a scienti&ically %ased
process consistin) o& te &ollo:in) stepsG ,') a<ard
identi&ication" ,ii) a<ard caracterisation" ,iii)
e@posure assessment" and ,iv) ris? caracterisationA
,<u) DstandardE" in relation to any article o& &ood"
means te standards noti&ied %y te 9ood AutorityA
,<<) Dunsa&e &oodE means an article o& &ood :ose
nature" su%stance or Cuality is so a&&ected as to
render it in=urious to ealtG2
,i) %y te article itsel&" or its pac?a)e
tereo&" :ic is composed" :eter :olly or in
part" o& poisonous or deleterious su%stancesA or
,ii) %y te article consistin)" :olly or in
part" o& any &ilty" putrid" rotten" decomposed or
diseased animal su%stance or ve)eta%le su%stanceA
or
,iii) %y virtue o& its uny)ienic processin) or
te presence in tat article o& any arm&ul
su%stanceA or
,iv) %y te su%stitution o& any in&erior or
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ceaper su%stance :eter :olly or in partA or
,v) %y addition o& a su%stance directly or as
an in)redient :ic is not permittedA or
,vi) %y te a%straction" :olly or in part" o&
any o& its constituentsA or
,vii) %y te article %ein) so coloured"
&avoured or coated" po:dered or polised" as to
dama)e or conceal te article or to ma?e it appear
%etter or o& )reater value tan it really isA or
,viii) %y te presence o& any colourin) matter
or preservatives oter tan tat speci&ied in respect
tereo&A or
,i@) %y te article avin) %een in&ected or
in&ested :it :orms" :eevils or insectsA or
,@) %y virtue o& its %ein) prepared" pac?ed
or ?ept under insanitary conditionsA or
,@i) %y virtue o& its %ein) mis2%randed or
su%2standard or &ood containin) e@traneous matterA
or
,@ii) %y virtue o& containin) pesticides and
oter contaminants in e@cess o& Cuantities speci&ied
%y re)ulations.E
>e e@tensive nature o& te de&inition clause
indicates te various aspects :it :ic te Act deals :it
te sole o%=ect to interalia ensure sa&ety o& &ood &or uman
consumption.
/. -ection 4 o& 9-- Act provides &or esta%lisment o&
9ood -a&ety and -tandard Autority o& 'ndia ,ereina&ter
re&erred to as Dte 9ood AutorityE) :ic is impleaded as
.espondent no.2 in te present petition. -ections $ to # o&
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te 9-- Act pertains to te composition o& 9ood Autority and
various aspects concernin) its :or?in). -ection 10 &or :ic
re&erence attri%uted on %eal& o& respondent no.2 pertains to
&unctions o& te !ie& B@ecutive 1&&icer :ic :o sall %e
le)al representative o& te 9ood Autority responsi%le &or day
to day administration o& 9ood Autority and it is is duty
under te said provision to implement te :or? pro)ramme
and te decisions adopted %y te 9ood Autority and to inter
alia ensure tat te provision o& appropriate scienti&ic"
tecnical and administrative support &or te scienti&ic
committee and speci&ic panel" and tat o& ensurin) tat te
9ood Autority carries out its tas? and in accordance :it
te reCuirements o& its users in particular :it re)ard to te
adeCuacy o& service provided and te time ta?en etc.
-ection 11 provides &or esta%lisment o& !entral Advisory
!ommittee %y te 9ood Autority. -ection 12 provides &or
&unctions o& !entral Advisory !ommittee. -ection 13
provides &or scienti&ic panels to %e esta%lised %y te 9ood
Autority. -ection 14 provides &or -cienti&ic !ommittee to %e
constituted %y te 9ood Autority. -ection 1$ provides &or
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procedure &or -cienti&ic !ommittee and -cienti&ic Panel. All
tese provisions so: te di&&erent :in)s under :ic te
9ood Autority :ould &unction to attain te o%=ect o& layin)
do:n science %ased standards &or articles o& &oods and &or
re)ulatin) te manu&acture and oter incidental matters to
ensure availa%ility o& sa&e and :olesome &ood &or uman
%ein). -ection 16 o& te 9-- Act provides &or duties and
&unctions o& te 9ood Autority.
#. >e provisions o& -ection 16" 1/ and 22 on :ic
muc deli%eration as ta?en place in te conte@t o& te
present dispute are reproduced erein%elo: &or te sa?e o&
convenienceG2
16. Duties and functions of Food Authority.
(1) It shall be the duty of the Food Authority to regulate and
monitor the manufacture,processing, distribution, sale and import
of food so as to ensure safe and holesome food.
(!) "ithout pre#udice to the pro$isions of sub%section (1),the Food
Authority may by regulations specify &
(a) the standards and guidelines in relation to articles of food and
specifying an appropriate system for enforcing $arious standards
notified under this Act'
(b) the limits for use of food additi$es, crop contaminants,
pesticide residues, residues of $eterinary drugs, hea$y metals,
processing aids, myco%to(ins, antibiotics and pharmacological
acti$e substances and irradiation of food'
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(c) the mechanisms and guidelines for accreditation of certification
bodies engaged in certification of food safety management
systems for food businesses'
(d) the procedure and the enforcement of )uality control in relation
to any article of food imported into India'
(e) the procedure and guidelines for accreditation of laboratories
and notification of the accredited laboratories'
(f) the method of sampling, analysis and e(change of information
among enforcement authorities'
(g) conduct sur$ey of enforcement and administration of this Act
in the country'
(h) food labelling standards including claims on health, nutrition,
special dietary uses and food category systems for foods' and
(i) the manner in hich and the procedure sub#ect to hich ris*
analysis, ris* assessment, ris* communication and ris*
management shall be underta*en.
(+) ,he Food Authority shall also &
(a) pro$ide scientific ad$ice and technical support to the -entral
.o$ernment and the /tate .o$ernments in matters of framing the
policy and rules in areas hich ha$e a direct or indirect bearing on
food safety and nutrition'
(b) search, collect, collate, analyse and summarise rele$ant
scientific and technical data particularly relating to &
(i) food consumption and the e(posure of indi$iduals to ris*s
related to the consumption of food'
(ii) incidence and pre$alence of biological ris*'
(iii) contaminants in food'
(i$) residues of $arious contaminants'
($) identification of emerging ris*s' and
($i) introduction of rapid alert system'
(c) promote, co%ordinate and issue guidelines for the de$elopment
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of ris* assessment methodologies and monitor and conduct and
forard messages on the health and nutritional ris*s of food to the
-entral .o$ernment, /tate .o$ernments and -ommissioners of
Food /afety'
(d) pro$ide scientific and technical ad$ice and assistance to the
-entral .o$ernment and the /tate .o$ernments in implementation
of crisis management procedures ith regard to food safety and to
dra up a general plan for crisis management and or* in close
co%operation ith the crisis unit set up by the -entral .o$ernment
in this regard'
(e) establish a system of netor* of organisations ith the aim to
facilitate a scientific co%operation frameor* by the co%ordination
of acti$ities, the e(change of information, the de$elopment and
implementation of #oint pro#ects, the e(change of e(pertise and
best practices in the fields ithin the Food Authority0s
responsibility'
(f) pro$ide scientific and technical assistance to the -entral
.o$ernment and the /tate .o$ernments for impro$ing co%
operation ith international organisations'
(g) ta*e all such steps to ensure that the public, consumers,
interested parties and all le$els of panchayats recei$e rapid,
reliable, ob#ecti$e and comprehensi$e information through
appropriate methods and means'
(h) pro$ide, hether ithin or outside their area, training
programmes in food safety and standards for persons ho are or
intend to become in$ol$ed in food businesses, hether as food
business operators or employees or otherise'

(i) underta*e any other tas* assigned to it by the -entral
.o$ernment to carry out the ob#ects of this Act'
(#) contribute to the de$elopment of international technical
standards for food, sanitary and phyto%sanitary standards'
(*) contribute, here rele$ant and appropriate to the de$elopment
of agreement on recognition of the e)ui$alence of specific food
related measures'
(l) promote co%ordination of or* on food standards underta*en by
international go$ernmental and nongo$ernmental organisations'
(m) promote consistency beteen international technical standards
and domestic food standards hile ensuring that the le$el of
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protection adopted in the country is not reduced' and
(n) promote general aareness as to food safety and food
standards.
(1) ,he Food Authority shall ma*e it public ithout undue delay%
(a) the opinions of the /cientific -ommittee and the /cientific
2anel immediately after adoption'
(b) the annual declarations of interest made by members of the
Food Authority, the -hief 3(ecuti$e 4fficer, members of the
Ad$isory -ommittee and members of the /cientific -ommittee
and /cientific 2anel, as ell as the declarations of interest if any,
made in relation to items on the agendas of meetings'
(c) the results of its scientific studies' and
(d) the annual report of its acti$ities'
(5) ,he Food Authority may from time to time gi$e such
directions, on matters relating to food safety and standards, to the
-ommissioner of Food /afety, ho shall be bound by such
directions hile e(ercising his poers under this Act'
(6) ,he Food Authority shall not disclose or cause to be disclosed
to third parties confidential information that it recei$es for hich
confidential treatment has been re)uested and has been acceded,
e(cept for information hich must be made public if
circumstances so re)uire, in order to protect public health.
(emphasis supplied)
Section 18. General principles to be followed in Administration
of Act.
,he -entral .o$ernment, the /tate .o$ernments, the Food
Authority and other agencies, as the case may be, hile
implementing the pro$isions of this Act shall be guided by the
folloing principles namely6%
(1) (a) endea$our to achie$e an appropriate le$el of protection of
human life and health and the protection of consumer0s interests,
including fair practices in all *inds of food trade ith reference to
food safety standards and practices'
(b) carry out ris* management hich shall include ta*ing into
account the results of ris* assessment and other factors hich in
the opinion of the Food Authority are rele$ant to the matter under
consideration and here the conditions are rele$ant, in order to
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achie$e the general ob#ecti$es of regulations'
(c) here in any specific circumstances, on the basis of assessment
of a$ailable information, the possibility of harmful effects on
health is identified but scientific uncertainty persists, pro$isional
ris* management measures necessary to ensure appropriate le$el
of health protection may be adopted, pending further scientific
information for a more comprehensi$e ris* assessment'
(d) the measures adopted on the basis of clause (c) shall be
proportionate and no more restricti$e of trade than is re)uired to
achie$e appropriate le$el of health protection, regard being had to
technical and economic feasibility and other factors regarded as
reasonable and proper in the matter under consideration'
(e) ,he measures adopted shall be re$ieed ithin a reasonable
period of time, depending on the nature of the ris* to life or health
being identified and the type of scientific information needed to
clarify the scientific uncertainty and to conduct a more
comprehensi$e ris* assessment'
(f) in cases here there are reasonable grounds to suspect that a
food may present a ris* for human health, then, depending on the
nature, seriousness and e(tent of that ris*, the Food Authority and
the -ommissioner of Food /afety shall ta*e appropriate steps to
inform the general public of the nature of the ris* to health,
identifying to the fullest e(tent possible the food or type of food,
the ris* that it may present, and the measures hich are ta*en or
about to be ta*en to pre$ent, reduce or eliminate that ris*' and
(g) here any food hich fails to comply ith food safety
re)uirements is part of a batch, lot or consignment of food of the
same class or description, it shall be presumed until the contrary is
pro$ed, that all of the food in that batch, lot or consignment fails to
comply ith those re)uirements.
(!) ,he Food Authority shall, hile framing regulations or
specifying standards under this Act&
(a) ta*e into account &
(i) pre$alent practices and conditions in the country including
agricultural practices and handling, storage and transport
conditions' and
(ii) international standards and practices, here international
standards or practices e(ist or are in the process of being
formulated, unless it is of opinion that ta*ing into account of such
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pre$alent practices and conditions or international standards or
practices or any particular part thereof ould not be an effecti$e or
appropriate means for securing the ob#ecti$es of such regulations
or here there is a scientific #ustification or here they ould
result in a different le$el of protection from the one determined as
appropriate in the country'
(b) determine food standards on the basis of ris* analysis e(cept
here it is of opinion that such analysis is not appropriate to the
circumstances or the nature of the case'
(c) underta*e ris* assessment based on the a$ailable scientific
e$idence and in an independent, ob#ecti$e and transparent manner'
(d) ensure that there is open and transparent public consultation,
directly or through representati$e bodies including all le$els of
panchayats, during the preparation, e$aluation and re$ision of
regulations, e(cept here it is of opinion that there is an urgency
concerning food safety or public health to ma*e or amend the
regulations in hich case such consultation may be dispensed ith
6
2ro$ided that such regulations shall be in force for not more than
si( months'
(e) ensure protection of the interests of consumers and shall
pro$ide a basis for consumers to ma*e informed choices in
relation to the foods they consume'
(f) ensure pre$ention of &
(i) fraudulent, decepti$e or unfair trade practices hich may
mislead or harm the consumer' and
(ii) unsafe or contaminated or sub%standard food.
(+) ,he pro$isions of this Act shall not apply to any farmer or
fisherman or farming operations or crops or li$estoc* or
a)uaculture, and supplies used or produced in farming or products
of crops produced by a farmer at farm le$el or a fisherman in his
operations. (emphasis supplied)
Section 22. Genetically modified foods, organic foods,
functional foods, proprietary foods, etc
Sa!e as otherwise pro!ided under this Act and regulations
made thereunder, no person shall manufacture, distribute, sell
or import any no!el food, genetically modified articles of food,
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irradiated food, organic foods, foods for special dietary uses,
functional foods, neutraceuticals, health supplements,
proprietary foods and such other articles of food which the
"entral Go!ernment may notify in this behalf.
3(planation.& For the purposes of this section,&
(1) foods for special dietary uses or functional foods or
nutraceuticals or health supplements7 means6
(a) foods hich are specially processed or formulated to satisfy
particular dietary re)uirements hich e(ist because of a particular
physical or physiological condition or specific diseases and
disorders and hich are presented as such, herein the
composition of these foodstuffs must differ significantly from the
composition of ordinary foods of comparable nature, if such
ordinary foods e(ist, and may contain one or more of the
folloing ingredients, namely6%
(i) plants or botanicals or their parts in the form of poder,
concentrate or e(tract in ater, ethyl alcohol or hydro alcoholic
e(tract, single or in combination'
(ii) minerals or $itamins or proteins or metals or their compounds
or amino acids (in amounts not e(ceeding the 8ecommended
Daily Alloance for Indians) or en9ymes (ithin permissible
limits)'
(iii) substances from animal origin'
(i$) a dietary substance for use by human beings to supplement the
diet by increasing the total dietary inta*e'
(b) (i) a product that is labelled as a Food for special dietary uses
or functional foods or nutraceuticals or health supplements or
similar such foods7 hich is not
represented for use as a con$entional food and hereby such
products may be formulated in the form of poders, granules,
tablets, capsules, li)uids, #elly and other dosage forms but not
parenterals, and are meant for oral administration'
(ii) such product does not include a drug as defined in clause (b)
and ayur$edic, sidha and unani drugs as defined in clauses (a) and
(h) of section + of the Drugs
and -osmetics Act, 1:1; (!+ of 1:1;) and rules made thereunder'
(iii) does not claim to cure or mitigate any specific disease,
disorder or condition (e(cept for certain health benefit or such
promotion claims) as may be permitted by the regulations made
under this Act'
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(i$) does not include a narcotic drug or a psychotropic substance
as defined in the /chedule of the <arcotic Drugs and 2sychotropic
/ubstances Act, 1:=5 (61 of 1:=5) and rules made thereunder and
substances listed in /chedules 3 and 3I of the Drugs and
-osmetics 8ules, 1:15'
(!) genetically engineered or modified food7 means food and
food ingredients composed of or containing genetically modified
or engineered organisms obtained through modern biotechnology,
or food and food ingredients produced from but not containing
genetically modified or engineered organisms obtained through
modern biotechnology'
(+) organic food7 means food products that ha$e been produced
in accordance ith specified organic production standards'
(1) proprietary and no$el food7 means an article of food for
hich standards ha$e not been specified but is not unsafe6
2ro$ided that such food does not contain any of the foods and
ingredients prohibited under this Act and regulations made
thereunder. (emphasis supplied)
!apter V o& te 9-- Act pertains to te provisions
in relation to &ood import. !apter V' o& te 9-- Act pertains
to special responsi%ilities as to &ood sa&ety under :ic
-ection 26 provides &or responsi%ilities o& te 9ood 3usiness
1perator. !apter V''' provides &or en&orcement o& te Act"
under :ic -ection 2# provides tat te 9ood -a&ety and
-tate 9ood -a&ety Autorities :o sall %e responsi%le &or
en&orcement o& te Act.
10. -ection 31 provides &or licensin) and re)istration o&
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&ood %usiness and stipulates tat no person sall commence
or carry on any &ood %usiness e@cept under a licence. -u%2
section ,2) o& -ection 31 e@empts a petty manu&acturer :o
imsel& manu&actures or sells any article o& &ood or a petty
retailer" a:?er" itinerant vendor or a temporary stall older
or small scale or cotta)e or suc oter industries relatin) to
&ood %usiness or tiny &ood %usiness operator. 8o:ever" it
provides tat tey sall re)ister temselves :it suc
autority and in suc manner as may %e speci&ied %y
.e)ulations" :itout pre=udice to te availa%ility o& sa&e and
:olesome &ood &or uman consumption or a&&ectin) te
ealt o& te consumers. -u%2section ,3) o& tis section
provides tat any person desirous to commence or carry on
any &ood %usiness sall ma?e an application &or )rant o& a
license to te (esi)nated 1&&icer in suc manner containin)
suc particulars and &ees as may %e speci&ied %y re)ulations.
-u%2section 4 provides tat te (esi)nated 1&&icer on receipt
o& an application under su%2section ,3)" may eiter )rant te
license or a&ter )ivin) te applicant an opportunity o& %ein)
eard and &or reasons to %e recorded in :ritin)" re&use to
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)rant a license to any applicant" i& e is satis&ied tat it is
necessary so to do in te interest o& pu%lic ealt and sall
ma?e availa%le to te applicant a copy o& te order. Proviso
to su%2section ,4) stipulates tat i& a license is not issued
:itin t:o monts &rom te date o& ma?in) te application or
is application is not re=ected" te applicant may start is
&ood %usiness a&ter e@piry o& te said period and in suc a
case" te (esi)nated 1&&icer sall not re&use to issue a
license %ut may" i& e considers necessary" issue an
improvement notice" under section 32 and &ollo: procedures
in tat re)ard. -u%2-ection / o& -ection 31 provides &or an
appeal a)ainst te order o& re=ection &or te )rant o& license
:ic sall lie to te !ommissioner o& 9ood -a&ety. Proviso
to su%2section # stipulates tat i& an application &or rene:al
o& a license is made %e&ore te e@piry o& te period o& validity
o& te license" te license sall continue to %e in &orce until
orders are passed on te application.
11. -ection #1 provides &or te po:ers o& te !entral
4overnment to ma?e rules inter2alia on te various matters
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:ic are provided under su%2section 2 o& te said provision.
-ection #2 o& 9-- Act provides &or po:er o& te 9ood
Autority to ma?e re)ulations inter2alia on te matters :ic
are provided under su%2section 2 :ic enumerates under
clauses ,a) to ,v) o& su%2section ,2) to noti&y standards and
)uidelines in relation to articles o& &ood meant &or uman
consumption" under su%2section ,2) o& -ection 16. -ection #3
provides &or layin) do:n rules and re)ulations %e&ore
Parliament. -ection #7 is te repeal and savin) clause. -u%2
section ,3) o& -ection #7 provides tat not:itstandin) te
repeal o& te a&oresaid enactment and orders" te licenses
issued under any suc enactment or order" :ic are in &orce
on te date o& commencement o& te 9-- Act" sall continue
to %e in &orce till te date o& teir e@piry &or all purposes" as i&
tey ad %een issued under te provisions o& te 9-- Act or
te rules or re)ulations made tereunder.
12. 'n e@ercise o& po:ers con&erred %y !lause ,e) o&
su%2section ,2) o& -ection #2 read :it -ection 16 9-- Act"
te 9ood Autority as made te 9ood -a&ety and -tandard
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,9ood Products -tandards and 9ood Additives)
.e)ulations"2011 ,ereina&ter re&erred to as Dte 9ood
Products -tandard .e)ulationsE). >ese re)ulations ave
come into &orce on $./.2011 e@cept certain re)ulations as
mentioned in .e)ulation 1.1.2 :ic are noti&ied to come
into &orce a&ter si@ monts &rom $./.2011. >e proviso to
.e)ulation 1.1.2 stipulates tat :enever te standards gi$en
in these regulations are at $ariance ith any of the pro$isions of the licenses
already granted, Food >usiness 4perator shall comply ith the pro$isions of
these regulations ithin si( months from the date of commencement of these
regulations. ,hese regulations e(tensi$ely deal ith safety aspect in relation
to food and food products standards.
1+. Further, the Food Authority in e(ercise of the poers conferred
under -lause (o) of sub%section (!) of /ection :! read ith /ection +1 of the
F// Act has made the #ood Safety Standards ($icensing % &egistration
of #ood 'usiness) &egulations,2(11. ,hese regulations are brought into
force on 5.=.!;11 and inter alia pro$ide for $arious matters in regard to the
licensing and registration of food business (hereinafter referred to as the
?icensing and 8egistration 8egulations7). 8egulation !.1 pro$ides for
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registration and licensing of food business. 8egulation !.1.1 pro$ides for
registration of petty food business. 8egulation !.1.! pro$ides for licence for
food business and stipulates that sub#ect to 8egulation !.1.1 no person shall
commence any food business unless he possesses a $alid license. It further
pro$ides that any person or Food >usiness 4perator carrying on food
business on the date of notification of these 8egulations, under a license,
registration or permission, as the case may be, under the Act or 4rders
mentioned in the /econd /chedule of the Act shall get their e(isting license
con$erted into the license@registration under these regulations by ma*ing an
application to the ?icensing@8egistering Authority after complying ith the
safety re)uirements mentioned in the /chedule 1 dependent on nature of
business, ithin one year of the notification of ?icensing and 8egistration
8egulations. It pro$ides that in case of difficulty, the licensing authority ith
the appro$al of the Food /afety -ommissioner in the /tate ill determine the
ad$isability of applying any specific condition *eeping in $ie the need to
ensure safety of food and public interest. It further pro$ides that no license
fee ill ha$e to be paid for the remaining period of the $alidity of the earlier
license or registration granted under any of the said Acts or 4rders. It further
pro$ides that non%compliance ith this pro$ision by a Food >usiness
4perator ill attract penalty under section 55 of the Act. In the pro$iso to
the said 8egulation, it is stipulated that any food business operator holding
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8egistration@?icense under any other Act@4rder as specified under /econd
schedule of the F// Act, !;;6 ith no specific $alidity or e(piry date, and
otherise entitled to obtain a license under these regulations, shall ha$e to
apply and obtain a 8egistration@?icense under these 8egulations ithin one
year from the date of notification by paying the applicable fees. /ub%clause
(!) of 8egulation !.1.! pro$ides that notithstanding the pro$isions
contained in 8egulation !.1.!(1) or in any of the registration or license
certificates issued under e(isting Acts or 4rders mentioned in the second
schedule of the Act, the ?icensing Authority, if it has reason to belie$e that
the Food >usiness 4perator has failed to comply ith all or any of the
conditions of the e(isting registration or license or the safety re)uirements
gi$en in /chedule 1, may gi$e appropriate direction to the Food >usiness
4perator to comply ith the said re)uirements. /ub%regulation (+) of
8egulation !.1.! pro$ides that ?icense for commencing or carrying on food
business, hich falls under /chedule 1, shall be granted by the -entral
?icensing Authority, pro$ided that Food Authority may through notification
ma*e such changes or modify the list gi$en in the /chedule I as considered
necessary. /ub%regulation (1) of this 8egulation pro$ides that ?icense for
commencing or carrying on food business, hich are not co$ered under
/chedule 1, shall be granted by the concerned /tate@A,0s ?icensing
Authority. /chedule 1 hich concerns ith 8egulation !.1.! (+) pro$ides for
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list of businesses falling under the pur$ie of -entral ?icensing Authority.
Item BIII of this /chedule concerns all food business operators
manufacturing any article of food containing ingredients or substances or
using technologies or processes or combination thereof hose safety has not
been established through these regulations or hich do not ha$e a history of
safe use or food containing ingredients hich are being introduced for the
first time into the country.
11. ,he Food Authority in e(ercise of poers conferred under
clause (*) of /ub%section (!) of /ection :! read ith /ection !+ of F// Act
has also made #ood Safety and Standards ()ac*aging and $abelling)
&egulations,2(11, hich inter alia pro$ide for $arious matters pertaining to
pac*aging and labelling of food products.
15. After considering the aforesaid scheme of the F// Act and the
8egulations framed thereunder, it is necessary to refer to the $arious actions
hich the Food Authority has ta*en under the F// Act. ,he Food Authority
from time to time has issued $arious ad$isories7 in respect of different food
products. ,hese ad$isories are anne(ed to the rit petition. It ould be
rele$ant to mention about the nature of the said ad$isories issued from time
to time so as to appreciate the concern of the Food Authority. >riefly the
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ad$isories are issued on the folloing issues6%
(I) Ad!isory on the products containing Steroid+ steroid li*e
substances mar*eted as dietary supplement, hich inter alia states that
steroid containing products present a ris* of acute li$er in#ury to product
users. In addition, steroids may cause other serious long%term ad$erse health
conse)uences in people including children. ,hese may include male
infertility, masculinisation of omen, breast enlargement in males, short
stature in children, ad$erse effects on blood lipid profile and increased ris*
of heart attac* and stro*e and death. It is stated that general public is ad$ised
to understand the ris* in$ol$ed in usage of such products and refrain from
using such products. A list of such 65 products is anne(ed to the said
ad$isory.
(II) Ad!isory on standards for honey and prohibition of antibiotics.
(III) Ad!isory on "hemicals present in fruits and !egetables and their
health effects.
(IB) Ad!isory on sale of contaminated mil* in the country.
(B) Ad!isory on ban on import of diary products from "hina.
(BI) Ad!isory on misbranding+misleading claims.
(BII) Ad!isory on i ssue of licensing of mil* and mil* products .
(BIII) Ad!isory on r efused gelatine contaminated with clostridium
difficile from ,S #-A.
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(IC) Ad!isory on iron fillings in tea.
(C) Ad!isory on use of stearic acid as lubricant in sugar based+
sugar free confectionery, lo.enges and chewing gum+ bubble gum.
(CI) Ad!isory on licensing+&egistration of Alcoholic -rin*s.
(CII) Ad!isory on outbrea* of salmonellosis in the ,SA and /ew
0ealand lin*ed to 1ahini Sesame )aste from 1ur*ey'
(CIII) Ad!isory on u se of gla.ing agents Shellac, 'eeswa2 (white
and yellow), gum arabic and pectin in chocolates at G3) le!el.
(CIB) Ad!isory on the procedure adopted by #ood Authority for
appro!al of proprietary products+ ingredients already being
manufactured under licenses of erstwhile Acts+4rders. dated 22.5.2(12.
16. Apart from specific ad$isories issued in respect of different food
products, the Food Authority had issued the folloing ad$isories6%
-r.no (ate -u%=ect o& Advisories
1.
2.
3.
$.7.2011
1.3.2012
Advisory re)ardin) rene:al6trans&er o&
licence durin) transition period
Appointment o& &ood 'nspectors
employed %y te *unicipal
!orporations6!ouncils" as te 9ood
-a&ety 1&&icer and (esi)nated o&&icer
under te provisions o& 9ood -a&ety F
-tandards Act"2006.
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4.
$.
6.
24.1.2012
23.3.2012
2.4.2012
'ssue o& licensin) o& 931 at Airports F
Ports
'ssue o& -tate6!entral Licensin) ;
!lari&ication on =urisdiction.
4uidelines related to 9ood 'mport
!learance Process %y 9--A'+s
autori<ed o&&icers.
9-*- Plan6!erti&icates
It may be mentioned that no dispute has been raised by the
2etitioners on the aforesaid ad$isories.
1D. Eoe$er, the area of dispute is on the ad$isories on )roduct
Appro!al7. ,he folloing are the ad$isories issued by the Food Authority
in regard to the )roduct Appro!al76%
(I) Ad!isory dated 25.6.2(12 hich states that in continuation to
the ad$isories on 2roduct Appro$al <o.2.15;!5@!1:@!;11%2A@F//AI and
<o.2.15;!5@!1@!;1!%2A@F//AI, it is clarified that pro$isional <4- ill be
issued for one year in case of e(isting license holders@importers for
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proprietary food products@ingredients and also for ne products@ingredients
hich ha$e had a pro$en record for safety for human consumption in other
countries. It states that products@ingredients hich are absolutely ne and
ha$e ne$er been used in any country and their safety assessment has not been
carried out shall not be issued a pro$isional <4-. ,heir applications ill be
forarded to the /cientific 2anel@ /cientific -ommittee. It states that
manufactures of traditional foods and local cuisine li*e Atta, /u#i, Dal,
sa$ouries li*e /amosa, >hu#ia, .ulab#amun etc. hich are most commonly
used by the consumers need not submit their applications for product
appro$al as a proprietary food. It is further stated that the applicant shall
submit the applications for product appro$al in the prescribed format ith
the fees of 8s.!5,;;;@% (non refundable) ith soft copies and gist of the
dossiers irrespecti$e of number of products@ingredients for hich the
dossiers and applications ha$e been submitted for single category.
(II) Ad!isory dated 1(.7.2(12.6% ,his ad$isory is issued in regard to
the details of the licenses issued ithout 2roduct Appro$al7 (cases here
2roduct Appro$al as re)uested). It states that this ad$isory is issued in
continuation ith the /tatutory Ad$isory issued on 1.D.!;1! regarding
issuance of licenses for proprietary foods ithout product appro$al. It states
that F// Act,!;;6 stipulates that all manufactures@processors@importers ho
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ill be introducing any such ne product hich is not as per the appro$ed
list of products under F// 8egulations, need to obtain product appro$al. In
this regard, the /tate Food /afety -ommissioner is re)uested to pro$ide
details of all such cases here licenses ere issued for such products. It
states that the cases here licenses ere issued for such products hich ere
not appro$ed and product appro$al as re)uired from -entral Authority as
per /ection !!, may be sent to F//AI so that further action can be ta*en. All
such products ill ha$e to be granted pro$isional <4- or referred to the
2anel as per procedure for further action. It further pro$ides that after
obtaining product appro$al, licenses may be issued by the /tate or -entral
authorities as per the production capacity@turno$er (as the case may be). It is
stated that till the time product has not been appro$ed by F//AI and F>4 is
or*ing on the <4-, the F>4 needs to ta*e -entral ?icense. It is stated that
this is necessary as the product is only pro$isionally alloed and is not an
appro$ed product and ill thus be co$ered under /ection !!.
(III) Ad!isory issued on 5(.1.2(126% >y this ad$isory the Food
Authority has stated that the Food /afety and /tandards (?icensing and
8egistration of Food >usinesses) 8egulations,!;11, pro$ide a list of food
businesses falling under pro$ision of -entral ?icensing Authority. It is
stated that it co$ers all food business operators manufacturing any article of
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food containing ingredients or substances or using technologies or processes
or combination thereof hose safety has not been established through these
regulations or hich do not ha$e a history of safe use or food containing
ingredients hich are being introduced for the first time into the country. It
is stated that they need to apply for 2roduct Appro$al at F//AI Eead)uarters
before applying for ?icence. A copy of the application format is anne(ed to
the said ad$isory.
(IB) Ad!isory issued on 16.2.2(126% ,his ad$isory is issued for
clarification relating to 2roduct Appro$al 2rocedure. It is stated that the
applicants should apply for the appro$al of each product@ingredient
separately for ne product@ingredient Appro$al in the prescribed format and
applications should be addressed to Director (2A), Food /afety and
/tandards Authority of India, FDA >ha$an, Fotla 8oad, <e Delhi%11;;;!.
It is clarified that for obtaining product appro$al the Food >usiness 4perator
ill ma*e an application in the prescribed format ith an initial payment of
non refundable I<8 !5;;; in the form of Demand Draft dran in fa$our of
/enior Account 4fficer, F//AI toards initial screening of the application
by the Appro$al /creening -ommittee7. ,he Appro$al /creening
-ommittee ill decide hether the product is falling under the -ategory A
or -ategory >. It is stated that in case of -ategory A the Appro$al /creening
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-ommittee ill deliberate and decide for the appro$al or re#ection of the
same on the basis of the information submitted by the applicant. It is stated
that in case it re)uires further assessment in respect of safety etc. the
application ill come in -ategory%> and the matter ill be assessed by the
scientific panel@e(pert group and thereafter scientific committee for the
appro$al or re#ection of the same for hich additional payment of I<8
!5;;; (non refundable) to be remitted by the applicant.
(B) Ad!isory issued on 22.5.2(12. It pertained to procedure
adopted by F//AI for appro$al of proprietary products@ingredients already
being manufactured under licenses of ersthile Acts@4rders. ,his ad$isory
records decisions of the Food Authority ta*en to facilitate the ongoing trade
of the food and inter alia states that the applicant may submit the application
in the prescribed format ith the fees (non refundable) and include all the
documents and scientific #ustification of the safety of the product being
manufactured and also may submit the e$idence such as license obtained
under ersthile Acts and 4rders for manufacturing of such product. 8t
further states that e2isting licence holders under the earlier Acts,
&egulations and 4rders may apply for con!ersion to #SS licence in
respect of products already under manufacture but whose safety
assessment has not been carried out. It is stated that in such cases the
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2roduct Appro$al Di$ision on receipt of completed application ill gi$e
<4- for issuance of a pro$isional F// license for a period of one year or till
the ris* assessment process is completed hiche$er is earlier. It is stated that
an importer of proprietary products@ingredients shall also submit the
application to the product appro$al di$ision ith the prescribed fees,
re)uired data and the e$idence that applicant as in the trade of import of
such products till the date of filing the application. It is stated that on receipt
of the application, 2roduct Appro$al Di$ision ill proceed in the same
manner as pro$ided in respect of e(isting licence holder under the old Act
and orders. It is stated that pro$isional license shall be issued sub#ect to such
other conditions as may be necessary to ensure safety and public health.
(BI) Ad!isory issued on 9.8.2(12. >y this ad$isory, it is stated that
/ection !! of F// Act, !;;6 read ith /ections 16 and 1= of F// Act, and as
per /chedule 1 the Food safety and /tandards (?icensing and 8egistration of
Food >usinesses) 8egulations,!;11 pro$ide that all food business operators
manufacturing any article of food containing ingredients or substances or
using technologies or processes or combination thereof hose safety has not
been established through these regulations or hich do not ha$e a history of
safe or food containing ingredients hich are being introduced for the first
time into the country need to apply for product appro$al before applying for
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licence. It states that the applicant may ma*e application in prescribed
format ith the fees of 8s.!5,;;;@% (non refundable) ith soft copies of
dossier alongith a 3(ecuti$e /ummary documents etc. It also states that
pro$isional <4- ill be issued for one year in case of e(isting licence
holders@ importers for proprietary food products@ ingredients and also for
ne products@ ingredients hich ha$e had a pro$en record for safety for
human consumption in other countries. It further states that the products@
ingredients hich are absolutely ne and ha$e ne$er been used in any
country and their safety assessment has not been carried out shall not be
issued a pro$isional <4-. It states that their applications ill be forarded
to the /cientific 2anel@/cientific -ommittee. It clarifies that manufacturers of
traditional food and local cuisine li*e Atta, /u#i, Dal /a$ouries li*e /omasa,
>hu#ia, .ulab#amun etc., hich are most commonly used by the consumers
need not submit their applications for product appro$al as a proprietary
food. It is stated that application complete in all respect shall be placed
before 2roduct Appro$al /creening -ommittee on a ee*ly basis for
consideration and on the basis of <4- issued by the 2roduct Appro$al
/creening -ommittee, -entral@/tate ?icensing 4fficer ill issue licence for
manufacturing on the basis of turno$er of the company, and that the import
licence shall be issued by the -entral Designated 4fficer. It further states that
all license holders ho ere issued licenses pre$iously under the Acts or
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4rders mentioned in the /econd /chedule of the F// Act shall be alloed to
continue ith their business including import for hich such licences ha$e
been issued hile there application for 2roduct Appro$al in the prescribed
format are processed for issuance of an <4- or final appro$al.
(BII) Ad!isory issued on 29.1(.2(12. ,his ad$isory is issued to
clarify the 2roduct Appro$al ad$isory dated 6.=.!;1! and more particularly
paragraph 1 of the said ad$isory.
(BIII) Ad!isory issued on 29.1(.2(12. ,his ad$isory inter alia states
that 2roduct Appro$al Di$ision of Food /afety and /tandards Authority of
India issued pro$isional <4- for a period of one year or till the outcome of
ris* assessment of the product hiche$er is earlier to $arious
manufacturer@importer sub#ect to the conditions that the applicant shall get
the product@ingredient appro$al ith proof of safety pro$ided by the
applicant in stipulated time. It is stated that if the final product appro$al is
negati$e and not granted@cancelled the <4- must be ithdran. It is stated
that ?icensing /ection must be informed about the recalling of the product
from the mar*et and not introduce such product hich is a$ailable ith the
F>4s and possibly cancellation of license. It is stated that Food /afety
-ommissioner as ell as the concerned D4Gs ill be informed for
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cancellation, recall and to stop continued release of the product in mar*et. It
is stated that the /tate .o$ernment issuing the licence on the basis of <4-,
should be informed to carry out these three operations and report compliance
to the Food Authority.
(IC) Ad!isory dated 11.12.2(12. ,his ad$isory pro$ides for a
procedure regarding ne product appro$al. It is inter alia stated that
se!eral ad!isories relating to procedures for obtaining )roduct
Appro!al before application for license ha!e been issued and published
by #ood Authority on ebsite and for hich se$eral )ueries and concerns
ere recei$ed from the Food >usiness 4perators regarding the comple(ity
and time lines for product appro$al. It is stated that further to streamline the
product appro$al procedure and the licensing of these foods in a timely
manner ith due consideration to the safety of foods and public health as
ell as for the smooth continuance of trade a detailed procedure is set out.
It is stated that all ad$isories and clarifications regarding product appro$al
issued pre$iously ill be superseded ith the ne procedure referred as
<e 2roduct Appro$al 2rocedure7. Detail guidelines ere set out in
paragraph (1) to paragraph (+), inter alia in regard to grant of product
appro$al licensing conditions and fees. 2aragraph 1 of these guidelines
hich is of rele$ance hich reads as under6%
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1. Foods or food categories co$ered under the <2A
procedure and re)uired to obtain product appro$al6
a. 2roprietary Foods that ha$e been granted license
under pre$ious Acts@ 4rders (2FA, HH24, HF24 etc.)
and ha$e been in the mar*et prior to +1
st
Harch,!;11 or
ne food products intended to be placed on the mar*et
and do not contain <o$el Foods, Functional Foods, Food
/upplements, Irradiated Foods, .enetically Hodified
Foods, Foods for /pecial Dietary Ases or e(tracts or
concentrates of botanicals, herbs or of animal sources
shall be granted product appro$al under the folloing
condition6
i. ,he F>4 has pro$ided a complete list of
ingredients and food additi$es as mentioned on the label
(-opy of label to be attached for products in mar*et) and
ii. ,he F>4 has pro$ided the category number as
applicable under the Indian Food -ategory -ode.
iii. "here the application is in accordance to
conditions as in 1(a) abo$e and in the format (Format 1a)
%F//AI shall grant 2roduct Appro$al and the F>4 may
proceed to obtaining a license as pro$ided under
paragraph (!) belo
b. Foods labelled as proprietary foods, hether
licensed under pre$ious Act@4rders or are intended to be
placed on the mar*et and contain <o$el Foods,
Functional Foods, Food /upplements, Irradiated Foods,
.enetically Hodified Foods, Foods for /pecial Dietary
Ases or e(tracts or concentrates of botanicals, herbs or
of animal sources shall be apply for product appro$al
and grant of pro$isional <4- as pro$ided under
paragraph (!) belo.
c. Foods products re)uiring product appro$al shall
be made in the application form as pro$ided by F//AI
(Format 1b). Furthermore
i. /afety documentation is re)uired for all
ingredients e(cept for $itamin and minerals or food
additi$es appro$ed under F//8 !;11 or -ode( (I3-FA)
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ii. ,he F>4 shall also declare the category
under hich he intends to mar*et the product as
specified under /ection !! & namely food supplement,
food for special dietary uses, functional food etc. or any
other recognised under international regulations.7
A-:8S4&; ,/-<& "=A$$</G<.
(C) Ad!isory dated 11.>.2(15. ,his ad$isory hich from its
contents appear to incorporate se$eral traits of the earlier ad$isories on
product appro$al (supra) has been issued in superceding of all earlier
ad$isories in regard to 2roduct Appro$al. It sets out the guidelines to be
folloed by the Food Authorities for product appro$al procedure. ,he
challenge of the petitioners is confined to this final ad$isory and therefore,
the contents of the same are re)uired to be considered in detail as under6%
It is stated in this ad$isory that the earlier ad$isories relating to
procedure for 2roduct Appro$al ere posted on the ebsite of the Food
Authority and that a feed bac* on the same as recei$ed from $arious sta*e
holders regarding the comple(ity and time lines for product appro$al. It is
stated that to streamline the product appro$al procedure ith due
consideration to the safety of food and public health, in supersession of
earlier ad$isories, food products for hich the standards are not specified
under F// Act !;;6, 8ules and 8egulations made thereunder ill be granted
product appro$al. It is stated that the procedure as set out in paragraphs 1 to
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: ould come into force ith immediate effect. ,he rele$ant portions of this
ad$isory read as under6%
1(a) Food products here the safety of its ingredients present
are *non and are permitted under F// 8egulation,!;11@-ode(
and other regulatory bodies li*e 3A@F/A<J@A/FDA etc. and the
food product does not contain plants or botanicals or substances
from animal origin ill be granted product appro$al. ,he
application in form 1(a) alongith the affida$it to be submitted by
the Food >usiness 4perator (F>4) for the product appro$al shall
be accompanied by folloing documents6
i -omplete list of ingredients (specify the le$el of its use)
ii. -opy of the label for products in the mar*et@ to be placed
in the mar*et.
iii. -ategory number of the product as applicable under the
Indian Food -ategory -ode.
After scrutiny of the application and documents and on the
condition that the documents submitted by the F>4 are
satisfactory, 2roduct Appro$al Di$ision (2AD) shall grant the
product appro$al.
1(b) Food products here the safety of its ingredients present
are *non and are permitted under F// 8egulation, !;11@-ode(
and other regulatory bodies li*e 3A@F/A<J@A/FDA etc. and the
food product contain ingredients including plants or botanicals or
substances from animal origin shall be considered for 2roduct
appro$al@<4-. 2A ill be gi$en to all products here safety
assessment is completed. <4- ill be granted to food products
in mar*et here license has been granted under pre$ious
Act@4rders. ,he application in form 1(b) along ith the affida$it
to be submitted by the Food >usiness 4perator (F>4) for the
product appro$al ill be accompanied by folloing documents6
i. -omplete list of ingredients (specify the le$el of its use)
ii. copy of the label for products in the mar*et@ to be placed
in the mar*et.
iii. -ategory number of the product under the Indian Food
-ategory -ode.
1(c) Food products falling under category 1(b) abo$e prima
facie here safety of the ingredients is insufficient to ma*e a
safety determination ould be referred to respecti$e /cientific
2anels. 2roduct appro$al shall be granted@denied on the basis of
ris* assessment.
1(d) 2roducts for hich the safety of its ingredients and their
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conditions of use as stated therein and published by F//AI or
products hose ingredients are standardi9ed or permitted under
F//8 !;11 ill not re)uire further safety assessment e(cept for
authori9ation of the ingredients contained therein. ,he
application in form 1(d) along ith the affida$it to be submitted
by the Food >usiness 4perator (F>4) for the product appro$al
ill be accompanied by folloing documents6
i. -omplete list of ingredients (specify the le$el of its use)
ii. -opy of the label for products in the mar*et@ to be placed
in the mar*et.
iii. -ategory number of the product under the Indian Food
-ategory -ode.
i$. -opy of 2A@<4- issued by F//AI.
!. /afety data here$er re)uired should be pro$ided for all
the ingredients.
+. ,he use of minerals@ $itamins@ proteins@ metals@ amino
acids@ their compounds should not e(ceed the 8ecommended
Daily Alloance for Indians. In this regard, F>4 shall follo the
guidelines issued by Indian -ouncil of Hedical 8esearch
(I-H8) @ <ational Institute of <utrition (<I<)@ "orld Eealth
4rgani9ation ("E4)@ Food and Agriculture 4rgani9ation (FA4)
1. In case of re#ection of application under the appro$al
procedure, the product under reference shall be recalled as per the
pro$isions laid don in F// (?icensing and 8egistration of Food
>usinesses) 8egulations !;11.7
,his ad$isory has been anne(ed ith the forms of affida$it and other details
hich are re)uired to be pro$ided by the Food >usiness 4perators.
1=. After considering the aforesaid details of the $arious ad$isories
on 2roduct Appro$al, it is necessary to ha$e a loo* at the other materials as
produced by the 2etitioners. ,he petitioners ha$e anne(ed to the rit
petition, application@letter of one of the members of 2etitioner no.! hich
appear to ha$e been filed on 11.11.!;1! addressed to the Food Authority
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being an application for appro$al of ne product $i9. 3<38.KA Fle(i Food
L 3<38.KA Forti Food hich are described to be dietetic products under
category 1+.6 as health supplement. A prescribed application ith fees of
8s.!5,;;;@% as paid by the said company to see* product appro$al
alongith necessary information. ,hereafter, by another letter, further
documents ere submitted by the said company to see* a product appro$al.
In reply to the same, the Food Authority addressed a letter dated !+.:.!;1+ in
respect of one of the products submitted for appro$al namely 3nbergya
Fortifood (Hango Fla$our)7. ,he Food Authority stated that the application
for product appro$al of the said product as e(amined and discussed in the
D1
st
2roduct Appro$al L /cientific -ommittee meeting held on 1;.:.!;1+
herein it as recommended by the G2roduct Appro$al and /cientific
-ommitteeG that <4- may not be issued to the said product as the product
has large number of $itamins and minerals and the case may be forarded to
/cientific 2anel for Functional Foods, <utraceuticals, Dietetic 2roducts and
other similar products, and hence, a fresh application as re)uested to be
submitted as per the prescribed format.
1:. ,he petitioners ha$e also anne(ed a letter of the Food Authority
dated =.1;.!;1+ hich is a reply to an application under 8,I by hich
information is gi$en by the Food Authority that the application fees of
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8s.!5,;;;@% for appro$al of <utraceuitical product has not been prescribed
under the Food /afety and /tandards Act, 8ules and 8egulations made
thereunder, but hoe$er, it has been prescribed in the guidelines issued for
product appro$al issued under /ection 16(5) of Food /afety and /tandards
Act,!;;6. It is also stated that additional fee of 8s.!5,;;;@% for referring the
application to /cientific 2anel has not been charged since 5.:.!;1+.
20. 1n te conspectus o& te a&oresaid &acts and te
le)al position as envisa)ed under te 9-- Act and te
relevant .e)ulations" :e ave eard *r.'.*.!a)la" learned
-enior !ounsel alon):it *r..iya< !a)la learned !ounsel
appearin) on %eal& o& te Petitioners" (r. 4...-arma
alon):it *r. 4.8ariaran learned !ounsel appearin) on
%eal& o& .espondent no.1 and *r.*emood Praca
alon):it *r.'.A.5an learned !ounsel appearin) on %eal&
o& .espondent no.2 :o is contestin) te :rit petition.
21. 1n %eal& o& te Petitioners" te &ollo:in)
su%missions are made in support o& te callen)e as raised
in te petitionG2
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,') >at 9ood Autority does not ave any autority"
po:er or =urisdiction under te 9ood -a&ety and -tandards
Act"2006 ,ereina&ter re&erred to as +9--A+) read :it .ules
and .e)ulations &ramed tereunder to issue te impu)ned
advisory dated 11
t
*ay"2013 providin) &or product approval.
>at .espondent no.2 cannot act in te a%sence o& a speci&ic
po:er con&erred on it under te 9ood -a&ety and -tandards
,9ood Products -tandards F 9ood Additives)
.e)ulations"2011 and 9ood -a&ety and -tandards ,Licensin)
and .e)istration o& 9ood 3usinesses) .e)ulations"2011. 't is
su%mitted tat tese re)ulations con&er speci&ic po:er and
autority in re)ard to licensin) and re)istration o& &ood
%usinesses. 't is su%mitted tat te concept o& product
approval in no manner is contemplated under tese
.e)ulations and ence" te impu)ned advisory is per se
ar%itrary and ille)al" %ein) contrary to te provisions o& te
Act" .ules and .e)ulations.
,'') 't is su%mitted tat te 9ood Autority %ein) a
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dele)ate empo:ered to &rame re)ulations under -ection #2
o& te Act" is duty %ound to e@ercise po:ers in te manner
prescri%ed %y la: and in no oter manner. 't is su%mitted
tat te 9ood Autority as already &ramed te 9--
,Licensin) and .e)istration o& 9ood 3usinesses)
.e)ulations"2011. 't is su%mitted tat a procedure &or
licensin) and re)istration as %een set out under .e)ulation
2.1 and in its various su%2re)ulations. 't is su%mitted tat
te clauses o& tese re)ulations no :ere provide &or a
product approval to %e o%tained %y te manu&acturers :o
are oldin) a valid licence and :o are already
manu&acturin) te &ood products under an e@istin) license.
't is su%mitted tat in vie: o& te speci&ic provisions o& tese
.e)ulations" suc oter procedure to see? a product
approval cannot %e imposed on suc cate)ory o&
manu&acturers. 't is &urter su%mitted tat te only metod
to adopt suc a procedure is to &rame re)ulations to tat
e&&ect in e@ercise o& te po:ers con&erred on te 9ood
Autority under -ection #2 and -ection #3 read :it -ection
16,2) o& te 9-- Act. 't is &urter su%mitted tat te
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impu)ned advisory is per2se %eyond te purvie: and scope
o& te re)ulations" ence ultra vires.
,''') 't is su%mitted tat te impu)ned advisory is
in&rin)in) te ri)ts o& te petitioners as )uaranteed under
Articles 14" 1#,1),)) and 300A o& te !onstitution o& 'ndia
inasmuc as te Petitioners :o are &ood manu&actures are
un:arranta%ly reCuired to under)o te procedure o& product
approval as a condition &or rene:al o& te licence or to
conduct te 9ood 3usinesses" :ic is :olly un:arranted in
vie: o& te &act tat te Petitioners are already oldin) a
valid licence to underta?e manu&acturin) o& &ood products.
,'V) 'n support o& te a&oresaid su%missions
*r.'.*.!a)la" learned -enior !ounsel appearin) on %eal& o&
te petitioners as made ela%orate su%missions and as
ta?en te !ourt trou) various provisions o& 9ood -a&ety
and -tandards Act"2006" te .ules and te di&&erent
.e)ulations &ramed tereunder and various averments as
made in te :rit petition.
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22. 1n %eal& o& te 9ood Autority *r.*emood
Praca learned !ounsel as made e@tensive su%mission on
varied o& issues o& &ood sa&ety and te endeavour o& te 9ood
Autority to ma?e :olesome &ood availa%le to te
consumers. >e 9ood Autority as &iled an a&&idavit in reply
to te :rit petition opposin) te relie&s in te :rit petition.
>e learned !ounsel appearin) on %eal& o& 9ood Autority
as contended tat te advisories issued &rom time to time
are :ell :itin te &rame:or? and po:ers vested under te
9-- Act and serve as a )uidin) &actor as to o: and in :at
manner te particular issue is to %e dealt :it dependin)
upon di&&erent products &or :ic tat particular advisory as
%een issued. 't is su%mitted tat any order passed in te
:rit petition :ould amount to a very precarious situation as
te advisories are released in consonance :it te -tatute
&or layin) do:n science %ased standard &or articles o& &ood
and to re)ulate teir manu&acture" stora)e" distri%ution" sale
and import" to ensure availa%ility o& sa&e and :olesome
&ood &or uman consumption. 't is stated tat te o%=ect o&
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9--A' is to ensure availa%ility o& sa&e and :olesome &ood &or
uman consumption. 't is stated tat tere are 377 e@istin)
standards :ic are present in te re)ulations and in tat all
proprietary &ood items :ic are not standardised ave to %e
assessed &or teir sa&ety and &or some o& tem standards
need to %e developed. 't is stated tat in order to address
tese items and &acilitate industry and &ood processin) units
in te country" an administrative system :as put in place to
ensure tat all non2standardised &ood is screened &or sa&ety.
't is stated tat te Product Approval ,PA) is sou)t %y 9ood
3usiness 1perators &or all products :ic do not ave
prescri%ed standards as per 9--. and it is to:ards tis
endeavour te 9ood -a&ety Autority as issued )uidelines
&rom time to time :ic ave %een modi&ied &or simpli&ication
&or use %y sta?e olders and :it active participation o& all
concerned :it an intention to acieve o%=ective and scope
%y te statute. 't is stated tat ad tere %een no advisories
issued %y te 9ood Autority" it could ave led to caotic
situation :ere tere :ould not ave %een uni&ormity in
approac and sta?e olders in particular :ill not %e a:are o&
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te procedure and reCuirements under te statute. 't is
&urter su%mitted tat te 9ood -a&ety Autority under te
re)ime o& te present Act and .e)ulations &ramed
tereunder is at nascent sta)e and is evolvin) day %y day. 't
is stated tat te approac o& te Autority as %een
transparent ?eepin) a%reast te scope and o%=ect o& te Act
and .ules and .e)ulations &ramed tereunder and to
promote )eneral a:areness as to &ood sa&ety and &ood
standards. 't is &urter su%mitted tat &rom time to time te
9ood Autority as ta?en into consideration te &eed%ac?"
su))estions etc. &rom te sta?e olders and accordin)ly
&ormulated and issued various orders and advisories etc. &or
ma?in) te 9ood Autority model consumer &riendly :ic
:ould elp in acievin) te %asic o%=ect o& sa&e and secured
&ood &or te pu%lic at lar)e. 't is su%mitted tat a duty as
%een cast upon te 9ood Autority to promote" co2ordinate"
issue )uidelines &or development o& ris? assessment
metodolo)ies and to monitor" conduct and &or:ard
messa)es on te ealt and nutritional ris?s o& &ood to all
concerned. 't is &urter su%mitted tat no actions" policy
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decisions" po:ers e@ercised" etc. impu)ned in te present
petition can %e termed as ar%itrary or %ad2in2la:. 't is stated
tat till date no representation :atsoever %y any o& te
petitioners as %een made and ence" on te lac? o& any
representation %ein) made" te petition is lia%le to %e
dismissed on tat count. 't is tere&ore" su%mitted tat te
Advisories issued are consistent :it te provisions o& te
Act and are issued in vie: o& te po:ers con&erred under Act
:it an intention to acieve o%=ect and scope under te
-tatute" and ence" tey are neiter unconstitutional nor
ille)al or impossi%le to per&orm. 't is &urter su%mitted tat
te advisories are neiter unconstitutional nor ille)al or
impossi%le to per&orm as tey ave %een issued a&ter
consultation and ta?in) into consideration international
practice under te su%=ect. 't is su%mitted tat it is %ased on
international le)islations" instrumentalities and !ode@
Alimentarius !ommission :ic is related to &ood sa&ety
standards and norms :ic are ta?en as re&erence points in
te &rame:or? o& W>1. 't is su%mitted tat te advisories
are issued in te lar)er pu%lic interest to inter alia ensure
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%etter &ood sa&ety to set and re)ulate standards %ased on
science and transparency includin) &air practices in all ?inds
o& &ood trade :it re&erence to &ood sa&ety" standards and
practice. 't is &urter su%mitted tat te advisories are
issued :it an intention to acieve o%=ect and scope o& te
-tatute and &or %etterment o& pu%lic at lar)e and are layin)
principles &or te o&&icials o& 9ood 3usiness 1perators ,&or
sort D931+sE) and are %ased on po:ers con&erred on te
Autority under -ection 16 and 1/ o& te Act. 't is &urter
su%mitted tat te o%=ect o& 9-- Act is to eliminate dan)er to
uman li&e &rom te sale o& unsa&e &ood and to ensure tat
:at is sold is :olesome &ood. 't is stated tat te 9ood
Autority :as esta%lised in te year 200/ and is in &orce
:it e&&ect &rom $./.2011 and tat in last t:o years te 9ood
Autority as initiated central licensin)" operationalised its
re)ional 6 su%2re)ional import o&&icers and on2line licences
and re)istration system and &ood import control system. 't is
su%mitted tat it as also constituted scienti&ic aidin) and
nine scienti&ic panels as per te provisions o& te Act. 't is
su%mitted tat te tas? o& re)ulatin) &ood and esta%lisin)
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en&orcement structure is onerous" %ut te autority is doin)
its %est not only to acieve te )oals and ensure sa&e &ood
%ut also to set science %ased standard &or &ood items. 't is
su%mitted tat te Act as %een made &ully operational :it
e&&ect &rom $./.2011 and is still in its nascent sta)e and
.e)ulations in num%er o& areas are yet to %e &ramed.
23. 't is &urter su%mitted on %eal& o& te 9ood
Autority tat under te 9-- Act it is responsi%ility o& te
9ood Autority to promote consistency :it te relevant
international standards and tat tis :ould &acilitate
availa%ility o& sa&e &ood to te consumer. 't is stated tat te
standard and oter )uidelines adopted %y !ode@
Alimentaries !ommission" 7nited Nations" anoter
4overnments" set up o& 9A16W81 are te relevant
international standards and also re&erence o& te &rame:or?
o& W>1. 't is su%mitted tat in e@ercise o& te said po:ers 6
duties te 9ood Autority as already started process o&
revie: and armoni<in) te standards as :ell as laid do:n
ne: standards consistin) :it !ode@ -tandards and oter
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international %ased products. 't is stated tat as per Point
V''' o& -cedule ' o& te Licence .e)ulations" licence to all
9ood %usiness 1perators manu&acturin) any article o& &ood
containin) in)redients or su%stance or usin) tecnolo)ies or
processes or com%ination tereo& :ose sa&ety as not %een
esta%lised trou) tese re)ulations or :ic do not ave a
istory o& sa&e use or &ood containin) in)redients :ic are
%ein) introduced &or te &irst time into te country are %ein)
issued %y !entral Licensin) Autority. 't is su%mitted tat
sa&ety o& said products is not determined and relevant
re)ulations re)ardin) sa&ety o& suc product are under
process" and tat te product in Cuestion cannot %e le&t
unre)ulated. 't is stated tat accordin)ly &or monitorin)
manu&acture" distri%ution" stora)e and sale or import o& suc
&ood so as to ensure sa&e and :olesome &ood &or uman
consumption te process o& product approval is &ramed
:ic is consistent :it te provisions and tat it is
consistent :it te provisions o& -ections 16 and 1/. 't is
&urter stated tat under provisions o& -ection /2,2) o& te
9-- Act te 9ood Autority under recommendation o& !entral
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Advisory committee as po:er to speci&y a )raded &ee &rom
licensed &ood %usiness operator" accredited la%oratories or
&ood sa&ety auditors to %e car)ed %y te !ommissioner o&
9ood -a&ety. 't is su%mitted tat in pursuance o& te
provisions under -ection /2,2) o& te 9-- Act" te !entral
Advisory !ommittee in its /t meetin) as recommended
tat any unit manu&acturin) novel &ood" )enetically modi&ied
&ood" irradiated &ood" or)anic &oods" nutraceuticals"
proprietary &oods etc. ave to apply &or product approval in
te prescri%ed &ormat %e&ore o%tainin) !entral license. 't is
su%mitted tat &or te ris? assessment" te 9ood Autority
as constituted te -cienti&ic Panels6!ommittees :ic are
its ris? assessment %odies and tese panels6committees
meet on re)ular %asis to consider various applications o&
931+s and every suc sin)le meetin) costs a%out .s.2.$0 to
.s.3 la?s on a conservative estimate. 't is tere&ore"
su%mitted tat impu)ned advisories are issued &ollo:in) te
procedure prescri%ed under te Act. 't is su%mitted tat in
&act te en&orcement o& te Act may also reCuire te 9ood
Autority to issue Advisories6)uidelines &rom time to time
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consistent :it te provisions o& te Act &or smoot and
transparent implementation o& te Act. 'n te a&&idavit o& te
9ood Autority" it is also su%mitted tat te intention o& te
le)islature in ma?in) te provision o& su%2section 3 o& -ection
#7 and accordin)ly &ramin) o& re)ulation 2.1.2 ,1) o& te
Licensin) .e)ulations %y te 9ood Autority :as to ave
suc provisions to &acilitate si&tin) o& &ood %usiness
operators ,931) into ne: re)ime :it ne: license num%er
and tus a provision :as ?ept tat e need not to pay license
&ee till te date an old license :as valid. 't is stated tat tis
:ould &acilitate a proper data %ase o& 931s :ose licenses
are )oin) to e@pire :itin one year o& transition period and
tat te 931 as to rene: is license %e&ore te e@istin)
license e@pires. 't is &urter su%mitted tat durin) tis period
o& transition -tate as :ell as !entral autorities are also
under)oin) administrative can)es and :ere ad=ustin) to te
procedural can)es under te 9-- Act. 't is su%mitted tat
te sta&& is inadeCuate in most o& te -tate and despite %est
e&&orts tere is lac? o& clarity amon) 931s. 't is stated tat
e@pectation o& non compliance in P9A ,Prevention o& 9ood
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Adulteration Act) continued and tat -cedule 'V o& te
licensin) re)ulations provides &or )ood manu&acturin)
practices and tat ne: Act as provision o& 9-*- plan. 't is
stated tat 9ood 3usiness 1perators are not prepared at tis
point o& time and may ta?e time &or ad=ustin) to te ne:
e@pectations. .e&erence in tat re)ard is made in .e)ulation
2.1.7,6) :ic provides tat 9ood 3usiness 1perator avin)
valid certi&icate o& an accredited &ood sa&ety auditor or &rom
an a)ency accredited %y 9ood Autority or any oter
or)anisation noti&ied %y &ood Autority &or tis purpose :ill
not %e normally reCuired to %e inspected %e&ore rene:al o&
license" provided tat te (esi)nated 1&&icer may order an
inspection %e&ore rene:al i& considered necessary &or
reasons to %e recorded in :ritin). 't is su%mitted tat 9--
Act as %een made &ully operational &rom $./.2011 and still it
is in nascent sta)e and ence tere is notin) ar%itrary or
ille)al in te 9ood Autority underta?in) Product Approval. 't
is su%mitted tat te same is issued in te lar)er pu%lic
interest and &or te ultimate sa&ety o& uman ealt so tat
:olesome &ood is availa%le &or uman consumption and
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ence te 9ood Autority is also morally correct in insistin)
on a product approval. 't is su%mitted tat te
implementation o& te Act" .ules and .e)ulations primarily
rests :it te 4overnment o& di&&erent -tates6 7nion
>erritories and te role o& te 9ood Autority is to monitor
and coordinate :it te -tates67.>. 4overnments &or e&&icient
implementation o& te Act. 't is stated tat te advisories
and )uidelines issued %y te 9--A' &rom time to time :ere to
)uide te sta?e2olders and &ood Autority6 -tate
4overnment o&&icers responsi%le &or Ate implementation o&
te Act &or te sa?e o& uni&ormity and transparency in
application o& te .ules" .e)ulations and Procedures. 't is
stated tat te advisories and )uidelines issued %y te 9ood
Autority are consistent :it te provisions o& te Act" .ules
and .e)ulations made tereunder.
24. 1n te a&oresaid rival su%missions" te Cuestion
:ic arises &or consideration is as to :eter te impu)ned
advisory dated 11.$.2013 providin) &or a product approval
procedure as %een issued %y te 9ood Autority under valid
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autority and po:ers under te 9-- Act.
2$. >o ans:er te said Cuestion" te provisions o&
-ection 16" 1/ and 22 o& te Act are reCuired to %e care&ully
e@amined. -ection 22 provides &or )enetically modi&ied
)oods" or)anic &oods" &unctional &oods" proprietary &oods etc.
and stipulate tat save as oter:ise provided under te 9--
Act and re)ulations made tereunder" no person sall
manu&acture" distri%ute" sell or import any novel &ood"
)enetically modi&ied articles o& &ood" irradiated &ood" or)anic
&oods" &oods &or special dietary uses" &unctional &oods"
neutraceuticals" ealt supplements" proprietary &oods and
suc oter articles o& &oods :ic te !entral 4overnment
may noti&y in tis %eal&. >e e@planation under te said
provision de&ines as to :at is meant %y D9ood &or special
dietary uses or &unctional &oods or nutraceuticals or ealt
supplementsE. B@planation ,4) to -ection 22 o& te Act
de&ines Dproprietary and novel &oodE :ic means an article
o& &ood &or :ic standards ave not %een speci&ied %ut is
not unsa&e. Proviso to -ection 22 o& te Act de&ines tat
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suc &ood does not contain any o& te &oods and in)redients
proi%ited under tis Act and te re)ulations made
tereunder.
26. >e provisions o& -ection 22" tere&ore" indicates
tat te cate)ory o& &oods as &allin) under te said provisions
are &ully controlled in respect o& its manu&acture" distri%ution"
sale or import e@cept as oter:ise provided under te Act
and te re)ulation :ic may %e made" tey cannot %e dealt
in any manner. >e e&&ect o& tis provision is tat no 9ood
3usiness 1perator :ould %e permitted to manu&acture"
distri%ute" sale or import any novel &ood" )enetically modi&ied
articles o& &ood" irradiated &ood"or)anic &oods" &oods &or
special dietary uses" &unctional &oods" neutraceuticals" ealt
supplements" proprietary &oods and suc oter articles o&
&ood :ic te !entral 4overnment may noti&y in tis %eal&"
unless te Act or te .e)ulations made tereunder oter:ise
so permit. >e em%ar)o as created %y te said provision is
not only to manu&acture %ut also &or distri%ution" sale or
import o& suc cate)ory o& &ood. >e intention o& te said
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provision appears to %e tat ri)t &rom te manu&acture o&
suc &ood till it reaces te consumer only i& so made
permissi%le %y te concerned Autorities &rom te point o&
vie: o& &ood sa&ety and its e&&ects on te uman %ody.
27. >o consider te operation o& -ection 22 and its
implementation at te ands o& te Autorities" te e&&ect o&
te provisions o& -ections 16 and 1/ is also reCuired to %e
e@amined. -ection 16 de&ines duties and &unctions o& 9ood
Autority. .elevant provisions %ein) -u%2sections ,1)" ,2)"
,$) o& -ection 16 reads as underG2
16. Duties and functions of Food Authority%
(1) It shall be the duty of the Food Authority to regulate and
monitor the manufacture, processing, distribution, sale and import
of food so as to ensure safe and holesome food.
(!) "ithout pre#udice to the pro$isions of sub%section (1), the
Food Authority may by regulations specify%
(5) ,he Food Authority may, from time to time gi$e such
directions, on matters relating to food safety and standards, to the
-ommissioner of Food /afety, ho shall be bound by such
directions hile e(ercising his poers under this Act'7
(emphasis supplied)
A plain reading of /ub%/ection (1) /ection 16 of the Act indicates that it is
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the duty of the Food Authority to regulate and monitor the manufacture,
processing, distribution, sale and import of food so as to ensure safe and
holesome food. ,he pro$ision, therefore, encompasses a duty and an
obligation on the Food Authority to e(ercise complete control and
monitoring on matters of manufacture, processing, distribution, sale and
import ith an ob#ect to ensure safe and holesome food. ,he ords Gto
regulateG and GmonitorG are of considerable significance inasmuch as the Food
Authority ould ha$e all the poers to control and monitor such of the
attributes of manufacture, processing, distribution, sale and import of food
hich ould be ultimately made a$ailable for human consumption.
!=. Further it is apparent that the duty hich is being imposed by
sub%section (1) of /ection 16 of the Act on the Food Authority to regulate
and monitor manufacture, processing, distribution, sale and import of food so
as to ensure safe and holesome food, is distinct and independent, for the
reason that sub%section (!) hich begins ith the ords without pre?udice
to the pro!isions of sub@section (1), the #ood Authority may by
regulations specify7, indicate that the ?egislature in ma*ing the pro$isions
of sub%section (!) has consciously *ept sub%section (1) uninfluenced by the
contents of the said subse)uent pro$ision. ,his indicates that, an unfettered
duty is cast on the Food Authority to regulate and monitor the manufacture,
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processing, distribution, sale and import ith the ultimate ob#ect to ensure
safe and holesome food for human consumption hich has been *ept
undisturbed by the subse)uent pro$isions of this section, the intention being
that the said poers are re)uired to be e(ercised by the Food Authority to
achie$e the ob#ect of pro$iding safe and holesome food. In order to enable
the Food Authority to e(ercise its functions in that direction, the ?egislature
has also made a further pro$ision in the nature of sub%section (5) of /ection
16 hich pro$ides that the Food Authority may, from time to time gi$e such
directions, on matters relating to food safety and standards, to the
-ommissioner of Food /afety, ho shall be bound by such directions hile
e(ercising his poers under this Act. ,his indicates that in e(ercise of this
poer, the Food Authority can ma*e such directions on matters pertaining to
the administration of the Act that is relating to food safety and standards to
be issued from time to time i.e. in different situations hich may or may not
be contemplated under the 8egulations. It is, therefore, difficult to accept the
contentions of the petitioners that the Food Authority is ithout any
authority and poer to issue ad$isories as also the impugned ad$isory dated
11.5.!;1+ hich has the intention to bring about a regime of appro$ed Food
2roducts a$ailable for human consumption. It is contended on the part of
the Food Authority that the ad$isories are issued ith an intention to achie$e
the ob#ecti$e and scope of the /tatute and are for betterment of the public at
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large and that they are the guiding principles for officials, F>4 (Food
>usiness 4perators) and other persons etc. concerned and dealing ith the
/tatute and are based on the poers conferred on the Food Authority under
/ections 16 and 1=, and that the Food Authority in issuing the impugned
ad$isory is competent to act in e(ercise of poers under /ection 16. ,here is
considerable substance in the submission made by the learned -ounsel for
the Food Authority. In my opinion, in $ie of the clear pro$isions of
/ection 16 sub%section (1) and sub%section (5), it ould not be correct to say
that the Food Authority is ithout any poer and authority to pro$ide for a
2roduct Appro$al so as to achie$e the ob#ect and purpose of the Act and that
hate$er food product hich is ultimately a$ailable for human consumption
is only a product hich is appro$ed and nothing less. If such is an ob#ect of
the Food Authority to bring a regime of only appro$ed food product to be
made a$ailable in the mar*et, it cannot be said that the Food Authority is
acting arbitrarily. If the 2etitionersG contention is accepted that the Food
Authority does not ha$e an authority to issue the impugned ad$isory, the
$ery ob#ect to bring about a regime of appro$ed products a$ailable for
human consumption ould stand defeated as also, the pro$isions of /ection
16(1) and 16(5) ould be rendered meaningless. ,he ?egislature has
abundantly clothed the Food Authority ith poers to perform its duty to
ensure safe and holesome food for human consumption by pro$iding in no
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unclear terms ith e$ery aspect not only in regard to the manufacture but in
processing, in distribution, in sale, in import, ith an ob#ect to ensure safe
and holesome food. ,he intention of the legislature is apparent from the
plain reading of sub%section (1) of /ection 16 hich #ust cannot be
o$erloo*ed. Furthermore the pro$isions of sub%section (5) permits and
empoers the Food Authority from time to time to gi$e such directions on
the matters relating to food safety and standards7. If due meaning as is
pro#ected by the ords used in both these pro$isions is o$erloo*ed, the
functioning of the Food Authority to attend the ob#ect of pro$iding safe and
holesome food and to achie$e food safety and its standard can seriously be
#eopardi9ed. ,he Food Authority therefore ould be entitled and #ustified to
act under the mandate of the said legislati$e pro$isions and by such e(ercise
of its poers is authorised to issue the impugned ad$isories. It therefore
cannot be said that such action is in any manner ithout authority in that
regard.
!:. Apart from the aforesaid position, /ection 1= of F// Act
pro$ides for general principles to be folloed in administration of the Act by
the G-entral .o$ernmentG, G/tate .o$ernmentG and the GFood AuthorityG and
other agencies, as the case may be, hile implementation of the pro$isions of
the Act. ,his pro$ision stipulates that the said Authorities ould be guided
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by the folloing principles as en$isaged in sub%section (1) of /ection 1=6%
(1) (a) endea$our to achie$e an appropriate le$el of
protection of human life and health and the protection of
consumersG interests, including fair practices in all *inds of food
trade ith reference to food safety standards and practices'
(b) carry out ris* management hich shall include
ta*ing into account the results of ris* assessment, and other
factors hich in the opinion of the Food Authority are rele$ant to
the matter under consideration and here the conditions are
rele$ant, in order to achie$e the general ob#ecti$es of regulations'
(c) here in any specific circumstances, on the basis of
assessment of a$ailable information, the possibility of harmful
effects on health is identified but scientific uncertainty persists,
pro$isional ris* management measures necessary to ensure
appropriate le$el of health protection may be adopted, pending
further scientific information for a more comprehensi$e ris*
assessment'
(d) the measures adopted on the basis of clause (c)
shall be proportionate and no more restricti$e of trade than is
re)uired to achie$e appropriate le$el of health protection, regard
being had to technical and economic feasibility and other factors
regarded as reasonable and proper in the matter under
consideration'
(e) the measures adopted shall be re$ieed ithin a
reasonable period of time, depending on the nature of the ris* to
life or health being identified and the type of scientific
information needed to clarify the scientific uncertainty and to
conduct a more comprehensi$e ris* assessment'
(f) in cases here there are reasonable grounds to
suspect that a food may present a ris* for human health, then,
depending on the nature, seriousness and e(tent of that ris*, the
Food Authority and the -ommissioner of Food /afety shall ta*e
appropriate steps to inform the general public of the nature of the
ris* to health, identifying to the fullest e(tent possible the food or
type of food, the ris* that it may present, and the measures hich
are ta*en or about to be ta*en to pre$ent, reduce or eliminate that
ris*' and
(g) here any food hich fails to comply ith food
safety re)uirements is part of a batch, lot or consignment of food
of the same class or description, it shall be presumed until the
contrary is pro$ed, that all of the food in that batch, lot or
consignment fails to comply ith those re)uirements.7
It is, therefore, apparent that the entire endea$our of the Food Authority is to
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achie$e an appropriate le$el of protection of human life and health and the
protection of consumersG interests, including fair practices in all *inds of
food trade ith reference to food safety standards and practices. ,his
includes determination of harmful effect on health to be identified to ensure
appropriate le$el of health protection and all scientific steps be ta*en in that
regard. "here$er there are reasonable grounds to suspect that certain food
may present a ris* of human health then depending upon the nature and
seriousness and to the e(tent of that ris*, it is mandatory that the Authorities
are re)uired to ta*e appropriate steps to protect the health and e$ery possible
measure in relation to that as is clear from the reading of the aforesaid
principles enshrined in sub%section (1) of /ection 1=. Eence, hile
implementing the pro$isions of the Act, if the Food Authority is underta*ing
an e(ercise to ha$e a 2roduct Appro$al so as to ascertain the ingredients of a
product in the method as en$isaged by it, irrespecti$e of the fact that it is a
licensed product, it cannot be said that the Food Authority is acting in any
manner contrary to the said substanti$e pro$isions of the Act, hich in fact
casts duty and obligation to achie$e not only Food /afety and /tandards but
the ultimate ob#ect of protecting the human li$elihood hich ould
otherise be seriously affected if unsafe and sub%standard or dangerous food
is left for consumption of the innocent people ho ill be hardly aare of
the ha9ardous nature of ingredients of such food.
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+;. In the present case, the Ad$isories hich are issued are in
respect of a category of food falling under /ection !! of F// Act hich
creates a bar on any person ho manufacture, distribute, sale or import any
no$el food, genetically modified articles of food, irradiated food, organic
foods, foods for special dietary uses, functional foods, neutraceuticals, health
supplements, proprietary foods and such other articles of food hich the
-entral .o$ernment may notify in this behalf, hich can be so dealt only
otherise pro$ided under the Act and the 8egulations made thereunder. If
the category of foods as specified under /ection !! more particularly in
3(planation (1), is sought to be monitored, controlled or regulated for the
purpose of product appro$al by issuance of ad$isories by the Food Authority
and that if such poer to monitor, control or regulate is a$ailable under
/ection 16(1) read ith /ection 16(5) and the pro$isions of /ection 1=, it
cannot be said that the Food Authority is acting arbitrarily or ithout any
authority and poer.
+1. It is then contended on behalf of the petitioners that the
8egulations framed under the Act do not pro$ide for the concept of 2roduct
Appro$al. It is further contended that the petitioners ha$e $alid licences and
therefore, to sub#ect the petitioners to ha$e a 2roduct Appro$al as a condition
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for reneal of their licenses or for registration of Food >usiness 4perators,
is an act hich is outside the pur$ie of the ?icensing 8egulations. It is
contended that the impugned action on the part of the Food Authority to see*
2roduct Appro$al from the e(isting licenced food manufacturers is ultra
$ires to the pro$isions of the Act and the 8egulations. It is also contended
that there is clear $iolation of 8egulation !.1.! by imposing a procedure of
product appro$al under the impugned ad$isory dated 11.5.!;1+. It is
contended on behalf of the petitioners that such a procedure for product
appro$al necessarily ought to ha$e formed part of the regulations as
contemplated under the pro$isions of sub%section (!) of /ection 16 of the
F// Act. It is contended that this ould entail e(ercise of poers by the
Food Authority as per the re)uirements of /ection :! and /ection :+ of the
Act in as much as once such regulations are made they ould be re)uired to
be placed before both the Eouses of 2arliament and then after the procedure
as contemplated under /ection :+ is folloed, on the appro$al of both
houses of 2arliament such a rule ould come into effect. It is contended that
in $ie of this re)uirement of /ection :! and /ection :+ the concept of
product appro$al as being en$isaged under the impugned ad$isory is
rendered arbitrary and illegal and ithout any authority. ,hese contentions
on behalf of the 2etitioners cannot be accepted. I ha$e already obser$ed
hereinbefore that /ection 16 sub%section (!) hich pro$ides that the Food
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Authority GmayG by regulations specify different norms as contemplated in
clauses (a) to (e) of /ub%section (!) ould not bring about any embargo to
the operation of /ection 16 /ub%section (1). In other ords, there is no fetter
on the e(ercise of poers by the Food Authority under /ection 16 /ub%
section (1) read ith the pro$isions of /ub%section (5). Furthermore,
/ection 1= lays don the principles to be folloed in the administration of
the Act by $arious authorities including the Food Authority. A cumulati$e
reading of these pro$isions lea$es no manner of doubt that the pro$isions of
/ections :! and :+ cannot in any manner affect the e(ercise of the
independent poers of the Food Authority as conferred under /ection 16
sub%section (1) and sub%section (5) and /ection 1=. ,his contention on the
part of the petitioners therefore, cannot be accepted. Depending on the
situation pre$ailing from time to time, the Food Authority can alays frame
regulations for effecti$e administration and management of the Act and to
further the purpose and ob#ect it desires to achie$e. Eoe$er, it cannot be
countenanced that only because the regulations are silent on the issue of
product appro$al the Food Authority is rendered poerless to achie$e its
ob#ect to ha$e Gappro$ed foodG a$ailable for human consumption hich is of
paramount consideration. Further it cannot be accepted that the subordinate
legislation can control the operation of the substanti$e pro$isions. A licence
is a creature of a /tatute and necessarily in$ol$es compliance of all the
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standards of food safety so as to conform from time to time the standards in
relation to $arious ingredients as set don by all Food Authority. A licence
holder cannot ta*e a position contrary to this that a product appro$al is not
acceptable to him hen he has already sub#ected himself to 8egulations
!.1.!. If an action is initiated by the Food Authority to achie$e the purpose
and ob#ect of the Act to pro$ide safe and holesome food products the
licence pro$isions hich are subser$ient to the substanti$e pro$isions cannot
be ta*en recourse by the 2etitioners to contend that in the absence of
8egulations, the Food Authority ould be ithout any authority and poer
to fulfill the re)uirements of /ection !! as sought to be achie$ed by the Food
Authority by e(ercise of poers under /ection 16(1) and /ection 16(5) read
ith /ection 1= of the F// Act. Another aspect hich is important in the
present conte(t is to appreciate that hat is being dealt by the 2etitioners is
food ha$ing a direct ne(us to the life and li$elihood of a person. It is ell
settled that right to li$elihood includes right to li$e ith dignity.
-onsumption of any substandard food ould definitely affect the health of a
person. In this conte(t, the mandate of Article !1, Article +: clause (e) and
(f) read ith Article 1D of the -onstitution cannot be o$erloo*ed. ,hese
constitutional pro$isions recogni9e the human right to ha$e safe and
holesome food apart from the pro$isions of the F// Act. If inferior and
substandard food is supplied in the mar*et, it ould not only affect the
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/ociety at large but it ould definitely ta*e aay these $aluable
constitutional re)uirements. Eence, the submissions on the part of the
petitioners that in the absence of specific 8egulations or specific pro$isions
in the Act the concept of 2roduct Appro$al cannot be issued by the Food
Authority, is de$oid of any merit. ,hus the right to do business in food
under a licence cannot be placed on such high pedestal that it ould ta*e
aay the mandate of Article !1 read ith Article +: (e) and (f) and Article
1D of the -onstitution. ,he licence to deal in food business necessarily
ould contemplate the fulfillment of the re)uirement of the said
-onstitutional mandate hich is sought to be fulfilled by the Food Authority
by bringing about a regime of Gappro$ed foodG to be made a$ailable for
human consumption by introducing the concept of product appro$al.
,herefore, the petitionersG contention that in the absence of regulations )ua
product appro$al the Food authority cannot function is misconcei$ed and
cannot be accepted as this ould defeat the purpose and ob#ect of the Act
and the -onstitutional re)uirement as aforesaid. ,he legislature has
strengthened the hands of the Food Authority ith sufficient pro$isions as
discussed hereinabo$e and if such an authority and poer is e(ercised hile
issuing the impugned ad$isory, the Food Authority is #ustified in so doing
and this action cannot be said to be an illegal action or ultra $irus the Act or
regulations framed thereunder. It is for the Food Authority hich is an
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e(pert body to determine the re)uirements hich are necessary to fulfill its
ob#ects for pro$iding food safety and a$ailability of holesome food for
human consumption. It ould be inappropriate to accept a situation that due
to ant of some regulations to be framed, the Food Authority ould be
crippled to e(ercise its poers and duties that are reposed in it by the
mandate of section 16 (1)(5), /ection 1= and /ection !! of the Act read ith
the re)uirement to achie$e the mandate of Article !1 read ith section +:
(e) and (f) and Article 1D of the -onstitution. ,he contention of the
petitioners that poers must be e(ercised in a manner it is conferred and in
no other manner therefore cannot be accepted in the present conte(t.
It is further clear that the Food Authority had issued the first
Ad$isory on the G2roduct Appro$alG on +;.1.!;1! and thereafter has been
consistently insisting on the product appro$al re)uirement as is clear from
the subse)uent ad$isories dated 11.!.!;1!, !!.+.!;1!, 6.=.!;1!, 1;.:.!;1!,
!6.1;.!;1!, !6.1;.!;1!, 11.1!.!;1!, 5.!.!;1+, and 11.5.!;1+. Further
nothing is placed on record by the petitioners to sho any resistance on the
part of any of the petitioners on the product appro$al procedure. In fact it
appears from the documents anne(ed as 3(hibit 3 to the "rit 2etition that in
fact application for product appro$al as made. It therefore, appears from
the record that the petitioners ha$e not seriously disputed the Ad$isories
issued from time to time and in fact ha$e accepted the same. If such is the
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conduct on the part of the petitioners in shoing their illingness to the
concept of product appro$al, it deser$es to be appreciated, as it ould be a
step on the part of the Food manufacturers to support the cause of healthy
and holesome food a$ailable to the society of hich they are an integral
part. /trangely the conduct of the petitioners appears to be an absolute
parado( as seen from the legal issues as raised in the present petition.
Horeo$er, in such a situation, a demand for mandamus as per the
re)uirement of la cannot stand and the petition ought to fail on this count as
ell. As obser$ed abo$e the Food Authority is not immobili9ed in the
absence of regulations from functioning under the statute. ,here is no
embargo on the poers of the Food Authority to fill in the gaps in the
regulations. It is $ery ell ithin its poers to issue the impugned Ad$isory
as per the mandate of /ection 16 sub%section (1) read ith sub%section (5) to
achie$e the ob#ect and principles enumerated under /ection 1= of the Act.
4nly on such e(ercise of poer, /ection 16 (1), (5) and /ection 1= become
meaningful. It cannot be said that if such an e(ercise is underta*en the same
becomes inconsistent ith the pro$isions of the Act or regulations. It is clear
that the guidelines under the impugned Ad$isory are eminently issued in
public interest and toards the fulfillment of the ob#ect and purpose of the
Act. 4nce such an authority has been conferred on the Food Authority to
carry out the policy and purpose of the Act, it cannot be accepted that the
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authority has acted arbitrarily or the impugned action on the part of the Food
Authority to issue the Ad$isory dated 11.5.!;1+ is ultra $ires.
+!. It as then contended on behalf of the petitioners that the ord
may7 appearing in /ection 16(!) shall be read as shall7 inasmuch as it
ould be obligatory on the Food Authority to ha$e 8egulations framed in
respect of any product appro$al as being sought by impugned ad$isory or in
other ords the impugned ad$isory not being contemplated under the
regulations, the same becomes ultra $ires and illegal. In my opinion, this
argument cannot be accepted for the reasons that the conte(t in hich the
ord may7 has been referred, cannot be read to be shall7 as desired by the
petitioners, inasmuch as the pro$isions of sub%section (!) of /ection 16 in no
manner can influence the operation of the pro$ision of sub%section (1) of
/ection 16 hich confers independent poer on the Food Authorities to do
se$eral acts so as to ensure safe and holesome food, read ith further
specific poer as conferred under sub%section (5) of /ection 16. It is ell
settled that the ord may7 can ne$er be construed as mandatory if such
construction is to defeat the purpose and ob#ect of the Act or if such
construction ould lead to un#ust result. If such construction as contended by
the 2etitioner is accepted it ould defeat the paramount purpose and ob#ect
for hich the legislation stands. 3$en if the ord may7 is construed to be
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shall7 as used in sub%section (!) of /ection 16 (hich does not in my $ie),
it cannot abdicate the operation, ob#ect and the rigour of sub%section (1) of
section 16 as also sub%section (5) of section 16. It is further not acceptable
that only because the regulations do not contemplate a procedure for product
appro$al, the Food Authority is abdicated of its poer to bring out a regime
of only appro$ed products a$ailable for human consumption hich it can
fulfill from the abundant poers as a$ailable under /ections 16(1), 16(5)
read ith /ections 1= and !!. /uch construction as contended on behalf of
the petitioners in the present conte(t ould defeat the substanti$e pro$isions
of the F// Act.
++. ,he learned -ounsel for the Food Authority has dran the
attention of the -ourt to the recent #udgment of the /upreme -ourt (referred
at page !5 of the Affida$it in reply of the Food Authority) in the case of
-entre for 2ublic Interest ?itigation Bs. Anion of India L 4rs. (<4"
reported in AI8 !;11 /- 1:)7. In the conte(t of an issue dealing ith the
harmful effect of soft drin*s on human health and in considering the
pro$isions of F// Act on $arious principles of food safety as enshrined in
/ection 1= and other pro$isions of the Act, the /upreme -ourt has held that
a paramount duty is cast on the /tates and its authorities to achie$e an
appropriate le$el of protection to human life and health hich is a
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fundamental right guaranteed to the citi9ens under Article !1 read ith
Article 1D of the -onstitution of India. It is held that any food article hich
is ha9ardous or in#urious to public health is a potential danger to the
fundamental right to life guaranteed under Article !1 read ith Article 1D of
the -onstitution of India. It is held that the pro$isions of F// Act and the
8ules and 8egulations framed thereunder are re)uired to be interpreted and
applied in the light of the -onstitutional principles and an endea$our has to
be made to achie$e appropriate le$el of protection of human life and health.
It is held that considerable responsibility is cast on the Authorities as ell as
other officers functioning under the Act to achie$e the desired results. It is
also held that the parties are also obliged to maintain a system of control and
other acti$ities as appropriate to the circumstances, including public
communication on food safety and ris*, food safety sur$eillance and other
monitoring acti$ities co$ering all stages of food business. It ould be
profitable to reproduce the rele$ant paragraphs of the said #udgment of the
/upreme -ourt in the present conte(t.6%
1:. Article !1 of the -onstitution of India guarantees the right
to li$e ith dignity. ,he right to li$e ith human dignity denies
the life breach from the Directi$e 2rinciples of the /tate 2olicy,
particularly clauses (+) and (f) of Article +: read ith Article 1D
of the -onstitution of India.
Article 1D reads as follos6%
1D. Duty of the /tate to raise the le$el of nutrition and the
standard of li$ing and to impro$e public health. ,he /tate shall
regard the raising of the le$el of nutrition and the standard of
li$ing of its people and the impro$ement of public health as
among its primary duties and, in particular, the /tate shall
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WP2746.13
endea$our to bring about prohibition of the consumption e(cept
for medicinal purposes of into(icating drin*s and of drugs hich
are in#urious to health.7
!;. Article 1! of the International -o$enant on 3conomics,
/ocial and -ultural 8ights,1:66 reads as follos6%
1!%(1) ,he /tates 2arties to the present -o$enant
recogni9e the right of e$eryone to the en#oyment of the highest
attainable standard of physical and mental health.
(!) ,he steps to be ta*en by the /tates 2arties to the
present -o$enant to achie$e the full reali9ation of this right shall
include those necessary for6
(a) ,he pro$ision for the reduction of the still birth%rate
and of infant mortality and for the healthy de$elopment of the
child'
(b) ,he impro$ement of all aspects of en$ironmental
and industrial hygiene'
(c) ,he pre$ention, treatment and control of epidemic,
endemic, occupational and other diseases'
(d) ,he creation of conditions hich ould assure to a
medical ser$ice and medical attention in the e$ent of sic*ness.7
!1. "e may emphasi9e that any food article hich is
ha9ardous or in#urious to public health is a potential danger to the
fundamental right to life guaranteed under Article !1 of the
-onstitution of India. A paramount duty is cast on the /tates and
its authorities to achie$e an appropriate le$el of protection to
human life and health hich is a fundamental right guaranteed to
the citi9ens under Article !1 read ith Article 1D of the
-onstitution of India.
!!. "e are, therefore, of the $ie that the pro$isions of the
F// Act and 2FA Act and the rules and regulations framed
thereunder ha$e to be interpreted and applied in the light of the
-onstitutional 2rinciples, discussed abo$e and endea$our has to
be made to achie$e an appropriate le$el of protection of human
life and health. -onsiderable responsibility is cast on the
Authorities as ell as the other officers functioning under the
abo$e%mentioned Acts to achie$e the desired results. Authorities
are also obliged to maintain a system of control and other
acti$ities as appropriate to the circumstances, including public
communication on food safety and ris*, food safety sur$eillance
and other monitoring acti$ities co$ering all stages of food
business.
!+. 3n#oyment of life and its attainment, including right to life
and human dignity encompasses, ithin its ambit a$ailability of
articles of food, ithout insecticides or pesticides residues,
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$eterinary drugs residues, antibiotic residues, sol$ent residues,
etc. %%%% %%% %%% %%%%7 (emphasis supplied)
+1. It is thus seen from the aforesaid binding principles as laid don
by the /upreme -ourt that it is not only a statutory re)uirement for the food
Authorities to ha$e a regime of safe food products to be made a$ailable to
the consumer but a constitutional re)uirement emanating from the pro$isions
of Article !1 read ith Article +: and 1D of the -onstitution of India.
+5. It cannot be o$erloo*ed that if a discipline to recogni9e access to
ample and nutritious food as a part of re)uirement of fulfillment of human
rights is being achie$ed by the Food Authority, such an effort cannot be
scuttled on such rigid technicalities as can$assed by the 2etitioners. In the
present conte(t, human rights are paramount and food is a $ital issue
affecting human rights at all le$els. It is ell settled that right to li$elihood
ould encompasses right to li$e ith dignity i.e. to ha$e healthy life hich
is possible only if safe and holesome food is a$ailable for human
consumption. It cannot be o$erloo*ed that the issue of food safety and right
to ha$e holesome food is a matter of national as ell as international
concern. A right to safe food being part of the right to li$elihood is the
re)uirement of Article !1 of -onstitution of India as held by the /upreme
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-ourt. ,herefore, there is nothing improper on the part of the Food
Authority to bring about a regime to ha$e a concept of 2roduct Appro$al for
e(isting licence holders or in relation any food business.
+6. In $ie of the foregoing reasons, the impugned food ad$isory
dated 11.5.!;1+ as also the other food ad$isories issued from time to time
are clearly ithin the ambit of the authority and poer conferred on the Food
Authority under the pro$isions of /ection 16(1) read ith /ection 16(5) and
/ections 1= and !! of F// Act and further the Food Authority is #ustified in
ha$ing the concept of 2roduct Appro$al hich in fact is a recognition and
implementation of the mandate of human rights and right to li$elihood as
falling under Article !1 read ith clauses (e) and (f) of Article +: and Article
1D of the -onstitution.
+D. In these circumstances, the rit petition fails and is accordingly
re#ected.
+= <o order as to costs.
(.I8I/E /.FA?FA8<I, I.)
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In $ie of difference of opinion beteen us on the issue in$ol$ed in
this matter, the folloing order is passed6%
4 & - < &
4ffice is directed to place this matter before the EonGble -hief Iustice
so that the issues framed belo can either be referred to a third #udge or
larger >ench6%
(1) "hether the impugned Ad$isories hich ha$e
been issued by 8espondent <o.! ha$e the force of
la and are ithin the ambit and scope of the poer
conferred on 8espondent <o.! & Food Authority
under the pro$isions of the said Act and the 8ules
and 8egulations framed thereunderM
(!) "hether 8espondent <o.! & Food Authority
had the poer and authority to issue these
Ad$isories under section 16(1) read ith section
16(5) read ith sections 1= and !! of the said Act
ithout folloing the procedure laid don under
sections :! and :+ of the Act of placing the
Ad$isories@8egulations before both the Eouses of
2arliamentM
(.I8I/E /. FA?FA8<I, I.) (B.H. FA<AD3, I.)
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