7i:mzania Food. Drugs and Cosmetics ACI (;overnmeHt N ol icc! .\'0 159 (c o11ldJ

T il E TA NZ AN IA FOOD, DR UGS AN D COSMET ICS ACT (CW. 219)

REG ULATIONS

(.I[ade under sec/iollS 95 (1/'1(/ J ]](Jj ( I~)

1'111 ,. T Al'ZM, IA FOOl), DRl'C iS :\ t\ \) COSMETI C S (CO:-;TROI. 0 1: FOOl) PRO\10 T IO'( ) RFC iULATIO NS. 20 I 0

I':\ RT I Pr(J-l.I \ lI~ .\ R\, p~ (;\' > !()"

I . l"hcsc Regulations 1TI<J.; :--. ~, cikd as the Tanzania Food. Drugs and Cosmdics (C nntro ! ., :' Il'~)C Promo tion) Regulat ions.

:>IlI O.

In these Rcg. u lati oll ~ . t i :: ~ ~' 3 " : ;,~ Cl\[l tcx t otherwise

r' : ~: r-:...: -".-\(:" m~,l!1S the Tanzania Food, Dru~ ::- ~:~. :. Cns l11 cl ics t\ct ~ ",:l : \ ~ rti~ ClllClli " 11 \1.,; anS and includes 2' . .:r:, : ~,,:r l!l of ad\'cI1i sing.

w l1t:thc r ill a pub licat ion, or by 1:: 2' :: : ~;;:~l~ ~, ( ~m y not ice or by mea ns l lj' any catalog ue, price li,,1. :.?t1 ~-:- . '.d:;!thcr c ircul ar o r add ressed to a parti cular pc r~\' :-. • : ::- :- :. :;: ~ I"~ ,,hib ition of a photog raph or a c i ncl1l a t og r~w:-: ::.:~:. ,'; h~ \ ', ay o f sound reco rding, sOlll H..i broadcasti n~ . c::- ~::,". i ... :\)!1 o r an~ \)ther means o f commun icati on:

"A ut ho rity" means the Tanzani~! : .\..~''': ~ :::~: [)r;'i;;s :\lllhor it~ or the a<.: w nylll "TFDI\" establish.: ... : : .... ~ ' ':'': ·.: l'J: · ; ofth\.-' ;\ <.: 1;

"c la im" me ans any \l1~s~a~.: t)[ : · ...'~:-.:; ..'r: ~ J~ HJn im: luui llg pi cto rial. g raph ic . or sym b!Jlic r"· r: ·~ ~.:I:: :l : :l'!L \" hich stales. suggests o r .imp li es that a ro ~)d has ~)3r: io.: ll:ar ch arac h:: ri st ics rel at ing to its ()ri ~ in . T1utriti()1l3i properties. fu nction . natu re. product io n. prpccssing . composi t iun or an~ other charac teri stics:

"cO l1l parat i y~ cla im" r:1cans a claim that com pares the nutrient ingredient Jc\ds and o r energ y valuc o f t\'{o o r more

/()ods . "foud" mean s an> article incl uding food s upp lement other than

d rug , cosm dics ond tobacco used as food or d rink fo r human co nsumption and include any s ubstancc used :n the mall u facturt.: or tr~3tm~nt offood;

" fond p ro moti o n" means any l11 ethod of introduc ing, famil iari z ing 181

Jill1zaniu Food. f)ruf;s and Coslllelics Act

Governmen, Solice .\'0. /59 (conlJ.) or ellc6uragll ig a person to usc a particular food Pl'Ouuct:

'~rood 'i upplcrncm··. -- nut ritional supplement"', "dictar) suppkmellt" or ": lU;: rac~llt ical" means a product other than tobacco intended w "':J ~p l cJl1 ent the diet. and shall incillde al1 oftht: followi ng cli<r l".!'::i:('ri srics-

(a) Cl1lltaillS one or !:m :-e 0f :he followi ng: vi ta!llill s; lTlilll:rals;

herbs; amino acid~ : ess.: :--:: iii : o ils or an) combination of allY of the above;

(0) is intended to be taken 0 :- 3.:!: :!lihc form of tablet. capsule. PO\\ der, soltgcl, gclcap. g :-~:ll: ; e ..... l;" li quid;

(c) is not represented for usc <~ ~ a Co.:::'. :r:l io nal rood or as a :-()lc

item ora meal or the dil...'t : (d) is labelled as li)()u slipplemc:J:. "health claim" IllC;:lrl:-:. all) n,;p rc'>': fii;:; : :,~:; :h,~i ... tale~. ~ltgg(:st s or

impl ie ~ that a relationship I..!;\. bt..., :- ':: ',\ ~'~~j :! IlWd catcgor), a !<lDd (II' one of its CO!1<.;titLlCf1 rS ~! :, , : :-:~' : : :Ii ~. :llcl ucJinp. nutrient function (:1<J.illl~ and reduction n ( d!."'~'J< ~:-;... ,--, !a ims:

"Iabel" llleallS any tag, brand. Illar!.-. p iCh \::.l:. VI "tilc l' de~cripti\\.: matter. writh:lI, printed, stcneil k:d. ;L::l;:"~· .. :' emb ossed, or impressed on or attached 10 a container l~ :' . ! ~::, ;'~l\)d f' roduct;

"l\Llnuf'actnrL:r" 1l1CtlllS ~l person or a lin n : !1 ~~ : j " L'!l ~ agcd in pn)(iuctioII. preparatilm. procc~sln~ . c,l:n poundi ng, fOflllulatin1-!, filling. relilling, tranSftJrll laW'i :, ;:~;cki lll-!.

packaging. re-packaging and labelling of fo od: "nutrient" t!leans protein, carhohyuratc, nu. librL'. " ita:n in<..; and

mi!ll:!ral s and substances. which IJl~lo lig to or al L' com pom:: nb ufone of these categories;

"nutriellt function claim" means a fllJtritioll clai!ll lilat Jl.':-, crihc" the physiological roll.' or till:: Ilutrient in grO\\ Ih. dl::\ 1.'Iop!J1eni and normal functions or the bod:; \\hich 111(1 ) include; "Calcium aids in the dcvelopment of strong bOfll.' :-; and teet h". Protein helps build and rcpair body tiss!lcs", Iro n i:-. a factor in red blood cell forlllation ", Vitaillill E protects the Lit ill hod) tisslle from oxidation", "hllic acid cO[ltribllte~ HI the [lonnal growth or llldlls":

"Ilutrition cla im" means an:; claim \\hich slat l~s , ~l lggests ur i!tlrlie ~ that a food has particlIbr Ilutrition propcrtic<.; due to­

(iJ) the energy (calorific value) it pro\'idc~. prnvidcs at a reduced or i!lcreased rate o r docs not proviJe, and o r

(b) the Ilutrients or other substallce:., it contain,>, contaills In

reduced or increased proportions or dOl::~ 110t cOJ1tain; "product" It)r the purpose of these regulations llleall~ food. "food promotion" means acl\'ertising, giving or samples or gift or

materials or information or decorations related to a food , tile <.!f!cct or which being to induce supply, purchase alld or u~c or food rroduct;

IX2

"

'/llll::unia Fo()d f)rugs and ('()smelics Ael

(;m'ernmefll ,\otil'e \ '0 . 151) ((,(JIIld J

"proll1()tillual ll1 at ~ ri al" I1 H.:ans ,HI) n:pn,::s~l1tati OIl t:ollc~mil\g. the qu:liii), of a product Corl\'C~ l'd b) :Illy Il lt' a llS \\'1l:!lC\'l'r for thl' rlll q HI!->l: t)re J h:o\ l ra~ i ng the llsag l' o ra li..l{)( 1 p rod llCt:

"I'I,.'\IlH.:t ioll oj' di .... c:Isl..: ri sk (.;1:lilll" illcan~ any I1c"111h daim th3t '-.la ks . "';ll ~!ges l s or implic:.. tha t the consu mption or a rood catc~()r). a rood or onc l)( its constituent s significantly Icdu('c .... ~l li~k f~lcto r in the J c\clopmc nt o r a human di scase :

'Sell" or "Sal c" 111CanS scll hy \\ho1c~ak or retail and incluue impo rt. offer. adn:rt is.:-. kt.:t.::p. expose. display, transmit. cO !l sit'l l. com·l..!) ur li::li\ t.::!' for :-.a lc or authorize. direct to alh}\\ .1 ... ak III pn'::"i.l: ': u r P 0<"\l':-'S for pllrposc:-. of salc. and h;! !·t ,~·:· ,': ~" ... ,-.: .. : : ~ .:.:~' " ::ff'~ : ,Jr d ispost.:: nr to any person '. '. : ..... ~ ~ . ~'. · l·~.J" ...... ~:\... :- ,t :d i: Pi o :her\\' ist.:::

•. :.. .. T.l!l: :::::: ::: ,: .. : : ~ ;2W\\ !11.

PART II P R()\\{l [ !(J\.

\ ;1";!':-OIl :-ol1all 110t !~ :-' \: ~:\K;..· ;! : l ; l ~) l ll l product in a ·.:i !: :::1,.., .. :. mislL'ad ill,!.!. ,if ... i. ... ..: .... p: ;\ .... (1r j ,.., liJ...c!~ to crL'a tc

,, '" : :f'r(,."~"ion rcgarJin~!. ii\ c:k.:ai,. ! ,~,.'r. \;! !u(: . quan tit).

:; ,1:: , :lh.'r it or safety as th i,: (;:1;-'(' lll a~ ! ~ I.!' .

(.=:) : \ p(""rsoll shall flot lise all) pre: ~: ,1t :llI:a J 1~ 1~!h.'ria l unless ib cOllknt j"" aCC W'at l·. inf'o rlll ;lI i\t.:. up h ) I,~ ;H ': ~: ! ~ d:n !!-ood lastt.::.

(:1) A person shall llOt (1 ,\ (' ;II1Y j1!'O!H,1t : l1 t;a l matt.:r ia ! to p r~)mlll(' all) rood produu un l e~ ... he .:pp iiL·'" ,;::.i b ... ir..,s lI l..'d wi th a \\rittl'[ l a ppr<nal fro mlhc :\ lJl lwf'it) .

(·I) Til..: applit.::nilH] for a [,('['m i t tt' l l'-~~ a pnHlIotio;lalmatL'ria l shall be made t o the :\llthorit~ b: :-'llh !lIinillt! ~l dul l; filled ill

:\pp li cati on h)J'1lI !(l!' .'\ppro\'al t)r Proll Hlliullal MalL'rial as set 01 1t ill th...: Fir~t SchL'duk tn thC Sl' R(" ~ubtion:-..

f)) 1'\Lr~ appli(.;i.Itioll fo r d p\..'rmit III li se pro lTloti onal lll<ltl..'r ia l ;-,hall be acco!llpafli l~ d b) r(,;I,,~~ ,IS prescribed ill the T;Ul/;\llia Fooo ])rugs and (\]~ll1..::lic ~ (h~cs and Charg es) Reg tl la ti olls. ~O()5,

((}) All app lica l1 t /()r rood promotion which rclate to Trade Fairs shall obtain Permit from th e Aut hority.

183

7imzania Food. Drugs and Cosmetics Act GuvernmCII( X Ofir' {' ,\ 'n J _' Y /con!d j

c;'.\, 1\'0, ·Ul} uf2005

Prohihilt!J c.:IClims

(7) Subject to sub regulati on 6. the applicant shall suhmit a dully filled Appli cation Form set out in the Second Schedule to these Regulations accompanied by fees as prescribed ill tile Tanzania Food_ Drugs and Cosmetics (recs and C harges) Regulations_ ~005,

(8) The Authority shall if satisfied that the proposed promotional material complie,;; with the requirements prescr ibed in these Regulations, issue a Permit for Advc!1isement with such conditions as it may consider nec(!ssary as set out in the Third Schedule to these Regulation s.

il, The fo llowing clai ms \\ h clh~T r..:-presc llted ill woros, pictorial representations, marks 0 :- 2.:i; descriptions an,: prohibited:-(a) claims which make reference to genc!':.'!. :, !l c; :-J -spcc ific benefits

of the nutrient or f{)od for overa ll good ~e3. : : r. or we ll-being; (0) c laims which make reference to f'...,~cr1O Iogical and

behavioural func t io ns; (c) cla ims which make reference to s lim mi:1f; ~") r v,~ight control.

or to the rate of amount ofwcighr loss \\Il:::-h r: 1J.; result fro m their lise or to a reduction in the scnse n :' hun§! l.'r or an increase in sense of sat iety or to the rcd uctio :l u :-: r. e 2,\'3.i labl c ~ncrg)' from diet;

(d) c lai ms \vhich make reference to the ad\'ice O :- (;ll C Or s or other

health professionals, or their profcssi or.~ J ::!s5vc iat ions, or char ities, or sugges t that health cou:d be affected by not consuming {he rood;

(e) claims \vhich re fe r to ('Ir.;::....~ : ::-.Z: : ~ :-:s . 3.550c ia1ions and foundations exccpt if the I;::c-~ ! .l: :::~ ::., ... j ";),,>~us an indication to the effect that the foo d is 5::,:.3':-:': :';:0:- !..:s ;;;- 0:- manu factured in accordance \\' ith t h;? i ~ :":-':::01:.:'l 0 :· tr. ·..! organisation , association or foundat ion :

( f) claims as to the suitabi l:t; c :': r:. .. ..:"j : ... : '...:.s. ~ in the diagnosis, prevention. alleviation, !l : i : i ;:"::": ~" - '-~:::: ..?:1: o r cure of <l

disease, disorder. abnofl':12. , :- \-:-' : :~ : ::t a l state lJr particular phys iological cord _: ,--

(g) claims stating that any gi\~ :: : ,~ : .. 7'~~':': =:: 3.dcquate source of al l essential n ut r i :, ~: ~_ ~_,.( - -::-!' w _, ~ of wcll­defined products for w ili L' i-; : ~ ~ \..,.;r _ ~ -l:'- 2. :.:eptcd the products to be an adequate S 0~~::? --:-.:;:" !"l'~";' -: urients;

(Il) claims im plying that a ba iar:c. .. "'J ..: ~ .. iJC. ~ ~~'lods cannot supp ly adequate amounts of a: : ::t:::"": ..:.-~ ..

( i ) claims that cannot be subs:<i:::::Lel 0 ..: .=-' ; -.:3, I ~ accepted scienti fic data;

(j) claims which could give ri se :" ~ l'u:: =,, __ : : c::" safet) o f

184

('nndil iOIl~ ror ll!'>illg IH11.ritioll

daitll~

1im=ania Food. f)rugs lind Cosmetic.\' Act

G{Jl'"rllment SOlin: S o 159 t, ::; ::~i

simi lar fo od o r ,,,.-hich ~ollid bring. or is likely to bring lJr cXl1loil fear or di stress 10 indi\'iduals or community.

(2) Ilcaltll citlilll," shall only be allowed if:-(a) ;u':l.'OIllpallicd by thl.: inl()J"Jlw l ion which is trt l lhJ"ul and 11011-

l1li ~ lcadiJlg to hdl1 COnS IlJJ1 t:T~ choose 11I.:altily diets: t b) acco1l1panied by a statement indicating th..: illlp0l1ancc ~)r a

hal anced diet alld a hl.!;dthy l ifestyle: , :" sho \\ the quality of the food and pattern of consumpt ion

requ ired to obtain the cla imcd henefic ial crfcct~ ": j ncc\lll1panicd by an appropriate statement addressed to

persons who should avoid lIsing the food; s : ~H.:co lllran ied by i.I \\"arnint; not to cxceed quant iti es or the

product thilt 1ll,1: rcpre sL":nt a ris k to hC'a/rh.

5.-( I ) t\ pcrson s/1<I11 nor usc Ille \\·ord.<.; "health " or " healthy" or other wo rds or symbols implying that the rOlld has hC<llth-1-!i \ illg prnpcrtie~ . or "\\ holesnme" or "nut ri tious" as p<lIi oj" the mllI H': or description o!"tile fooJ.

(2) Il ca lth c la ims shal! only be allO\\'cd if:-(a) by the in fornwtion which is truthrul and nOl I m is ll.!aciing

COJlSUll1ers on choosi ng health) diets; (b) b) a statclIll.:nt ind icating the importance or a halanced

diet alld j.\ health) lilcst)' le: (c) sho\\" the quality of thl: (ODd and patterll nf cOllslllnption

rcqui rL":d to obtain the daimed beneficia l effect; (d) appropr iate statement addressed to persons who should

avoid usi ng the J"l1od; and (c) a warning not to exceeds (luanti lic-s of l ilt..' prod uct that

may represent a risk to health.

(3) Be\'erages that contains Illo re thun 1.2~/!) by vo lulllc of ah.:ohol shall not bear health c laims. nu tri tional claims ,

6.-( I) /\I1Y nutrition claim made s hall com pi) wi th thc lr.; vcb prt.!~c r i bt.!d ill the re s pccti\"\~ sc hedules a ~ rol ]0\\":-> : -

(a) the dainl . 'high" or "ric h" whclI apr ljed in relation 10 Proteins. dietary fibres, calciu l ll. Iron. vitalllin HI \"itamin 13:~ vitamin B(, \·itamin BI::. niacin. Pantothenic acid . biot in. vitamin C" vitam in /\, vitamin J). vitam in E ami Fo lit: acid. shall compl) ' .... ith levcls as provided In

the Fou rth Schedu le to thesc Rc!!uJations; (h) the claim. ' source of the nut ri ent or forti fi ed witb' a

nu tril.:rlt when app licd in rclation to Protei ns. Dietary

\85

t'omparilt l \C daiillS

j i.m::(mi(l Food, I)rags wu/ ( ·(}slIlelic.\ .·1('[

fihn: !:o. CalcitHlI. lron, \ it:ll11in HI \:iacin \ itamin B .~

\ il:ulI in nr, vitamin Il l.! . \'itallli ll C . \ 'ilaill ill !\. \ ita l1lin I) .

\ i:<lmin !-: and Folic acid, Pantothenic <Kid . ~haJi L\)lllp ly ..•. it!! k' \c!s a~ provided ill tile j:if"th ScJll.: d,ilc to Ihl...:<.;l'

Rl~~:ubtiolls;

I .: : ::_. ciail ll . ·!"rel...:. Icm. lH 11(1111.:" \\111...:11 app li ed ill n:lalin n to ..: : !. ,~ri :.: . l ~ll. s.lt uratcd !"atty ;Ie-ius, c lio kslc ro 1.. :-i illlpk , .. :;:<lb ~h <l!l cOlllpl; with k\cls ~~ set 0111 in !hl' Si xth ..... c :ll.'Ju k·:

\ 1..: 1 : : ...... .:I ai m ·l ,n\. lc~ .... . reduced. llr ( Ilt urr \\!Jel l arpli~d ill

r,· · .. ! ~ :{' : ! to cncrg.~ .. lill .. sat ura ted l ~l1t; ac id ..... c ll ole~tcr(l1.

"": ::IPl..: :o.ugars or !--odiuIlI shall eompl; \\'ilh It:\ds as ~Cl ,1l~ 1 i ll th l..: Se\ eil lil Schedul e 10 ihese Re g l1lat i on s~

l' ;al!l1s rt:lating to thc runctil))} of" <.l nutr iell t in the > , )\~ :, ~m: pl'rl ililkd subject to th~ follo\\ ill~ c() IlJitioll~ -

( ;! I il l:: :, Ij1l)~ l' ("~ ~cll tja l Ilotrknt..; ( pm1l'i n .... (" arboilyd rate~.

~ .l t .. \ Italtl it1!-. and min<.:ral s) shall b~ i ll.: '>l lbjcct of a !! ::;:ri .:1lt i'UIH.:: ti Ofl claim:

:. :-- , ! t:..: it.l\ )d lin wldcll the c laim is Jlladl: sI1.] !! b~ :1 ..;ig f1ifiL·,tll{

..,(ll:rL;'; llf!il t: Illltricnt ill thl..' d il:t. (c ~ :~: ;.: llut ril..'llt fllnction claim shall nn l; !' l' : ::P :>(" :!Ppro\ cd

h: the :\ ulhmit!: {ti l t:1l' claim shall not imply o r incl\1d~ ~l!1; < .. ::n: .. 'i: : to the

err~L't that thc Ilutr icnt \\(Hdd afford :l Lt.: \..' • . ~ : .-:! t:n;,; ni

f()]" or pwtectiO ll from disease . . t .' ) \\ 'hl're a nutrition cl aim is made. and \'. !! :'.' ;--;'" . ~ '.: .... ' ! Jl :"

natun: 1<'1\\ in or free of tire Ilutricnt lira l i:-, t ~ : .... ... . l> ; .:~· : l': :11'..:' claim. th~ krill dc:-.cribing the !e\el of the n u !.r: ;.· ~ :: ~::: ~: : :wi illl plcd ia tely pn.:cedc tire f~)jJll oj' il 10\\ (naming nutriel\t) t"rt.:l' f()(H1.

nam e of the t()od h!lt ~:: . ! ...... ' " the nutrient) food , ~ l

(. j.) Reli!!io,ls daillls ~lIc ll as Ii alal or rii l !.: ~ ?:- ..: :-- .. l~ .l : :t) ::~ or food llla; be claimed pro\'idt:u tbat til l' !(h l ,: L' ~) : ~: ~' ~ I :~ " :c ti!l.: req ui relllcnt ofllie appropriate re li g ion or ritl!a; .1 :.: :1\1:-:t l..: ... .

7 .-( I ) "\:0 c laint which co mpares th:.: J HH~ ~ :: I! [ ,~\ _' J o r :.:neq..'.y value of t \\"(l or more silTlila r fo od "hi!i] ;' 1.' c l;lI k' ill a ll adn!rl iseJllCIlI or a rood . unJe~s Ill': !()IJO\" i n~ .... 't\nditiolls ;ll"e

complied \\"ith:-( tI ) Ihe food bei l1g COll1pared ... houili he d i rkn': Jl! \ er~ipll~ of

th.: :-',11 11 1..' c atcgor~ I()fll.l:

( b) ti ll' l ()od being c(lmpar~d ~hal! be c !earl ~ id t:n tilicd: a statemellt of tlr t: ;l1llmmt o f diffcrl.!ncl.: ill th~ ~ncr~y \'a ILl e or Ilutrient content.. l'xprcsscd a~ a pt.:rcl·1l1ag~. and the

186

,

, •

"

hlll~(lIIiCl Food. Drugs and Cosme/ics .·lel

kknlit) or tlie rood In \\h icb the Jl)OJ is bei!lg Cl;:l :; ) ~ : ... ·_. shall appear ill close prnximity to the t:olTlpa rali\':'; I.-i.!::::. · (i) the cOll1pari son shall be ba~cd Oil <I rl..~;:! : : ·. _~

Lliffcn:n cc of at least 251~.'~) in tb~ CJlcr~: \ ~: ;.: :...' :: Jlutrient content of an equi\"a] c llt mass or \ nI U:l : ..... :

( ii) the cOIl1 [J;l r isoll !-oha ll be ba~cJ nil il !"1 .. ' :all ",':

diffc n': IKt.: of at lea')! 2:'° 0 ill the energy \ ;!Iw..: ,.'j

nutrient conkllt. cxcept for llt i <.: ron l Jlr i l: J1t ~ \ \ i:I.': '.,..'

;\ IO() o d ilTen:llcc in the ;--J IHric llt Rclcn.'llcc \ 'alll~

-"ha ll be acceptable:.

( a) a Ilut r it ion clail]] \\ h ich cOJl lparc:-. the l\uantit: (,I' a

!JlIlrkllt or tile I.'llcrgy \ altlc or a f(){H I \\ ilh fomb ()f the

sallK' category sha ll un I: hl' tIl ack i f ti l(' IlHJds bci n~!

compal'i.!d arc casil: idcll ti licu b: the aycrage C(lIl S ll lll~T

or clearly indicated, The Jirkrcnct,' ill the q llallti!; nf a ll utri~n t ~)[' the energy vallll' slJall be ~takU il nd t h ~

l.; oll1p:Jri~oll ~ i1all rL'late to the sam \.! q uan t ity nf hHlU: (h~ (ornpar:l1i\ C lltHrilion claims shall cOl nparc the

COlllpositioll oflhc I()od in questioll \\itll a range of fo ods of the sa tnt.: catcyory, \\ hieh do not han~ a co mposit ion. wiJicJI allow~ th ... ·rn hI bear ;\ claim. illl: l uJi ng r()(llh of

o ll1 ... ·r brands.

Ih::-.t ric llOtlS 1I1 1 S.-( I ) Nt) person shall cond uct an .. 1(,1\ crtiscIJlellt oj' food ill ,Uh":rll:-. ill! ', th .... limn o r Breast :\1ilk suhstituk (BMS) and ~ksig ll;l tcd prod \lct

(HJC Ill\! alld

1\:11 <11 1.\

.... ol1 "urnabk h; in fa nts in an: form that s hall appear llIi s lcatl i n~~.

(~ ) r\ (l\ crti :-.e JIH; IlI ~ of food produd ill tile Cnnn nr Ihea:--t

!'vlilk :-'llbstiltilC (13\r1S) and Jcsi gnalcd produch ... hal! oll h be :H..h'crtiscd UpO i1l)blaill i lll~ the appf'O\ill urlhe !\lIl hori ty_

(3) A ll ad\crt; sl.:lI1CIl\ I.lj'a rOllll product ~h<l1lllol n:kr to th..: ;\ c1. or all) dcp:lrtlllc llt or oflic iail)!'lhc :\ulhority.

PART III 0 1-1 L\C I-' .. I 'iJ 1'1 -' _\1 II'

(). An; rcrson who conlra\ 'cJ1C ~ all) pro\ blOn \)( :. : ~''''~'

r .... gIJ !at ion .... or reqlJi rclll Lnt ~ as ind icat ed ;1\ th o.! sc hcduk ... t p iL'~,-'

rL"~ U l ali lIJl s cOlllm its ,III offence and upon cU1l\' ictitlll i.., ;i;!-~ L':

(a) il' slJch a person is ti ll indi\"iJual a fin .... Iwt ~t.'~ - :-_­

o ne hundred tho llsallds shill ing:-- or 1(' in:r : : ..... ~.- _.-:

f()[' a IeI'm not k ss thal1 t\\"O week s or :1.' .. "_ ~ ... .

Ii!!c and imrri solllllCIII;

187

/ctnztllliu Food, f)rugs and Cosmetics Ac( (im'I' rtlfl/I:1I1 .YOllce .\0 159 /com.i. j

('()ll; p()unJitl~ \)(

onCill .. r.::~

r'-Ialcrial USI..'J for !non: than Im.: I\"(.' m11:11h"

(h) if such a person is a body corporate or association to a fine o fll ot less than one million sbi ll in !;! ~ .

10.-(1) l\:otwithstanding the provisions of regulation () the J)ircctor Gencral or the Food Inspector al:t ing on his behalf may. subject to and in accordance \'v'jth the provisio ns o f the ACL if circumstances show that a persoll. corporate or unincorporated hody has committed any (')ffl;I1Ce against thc~e rc!!ulations ill

respe ct to which he has sltmvcu willin.g ncss to pay a fi ne. compound sllc h o nel1cc by <\C.ccp;ing the tine in rcspect of the offence is comOlittcJ .

(2) The Dircl:tor GCllcrnl or an Inspector authori .led 10 'K't 011

his behalf heron: accepting a lilll: from the persnn rdi: rrcd ullder !-Iu b n:gulalion ( I ) shall req uire s lIch a per!-lon :0 fill in a Compoundi ng Forlll as Sl!t OIl! in thc i'! int h SclledulL .

(3) Subject to Ihe provisions of the~l! rcgl1 l at i on~ a:l:hori/i ng any mcasun.:s that may be takl! 11 ptl\"slIant to an order ()f tilL" C(ll!rt .

110 fUl1hcr cr im inal proceedi ngs shall he takell agai': ..... 1 ,l re:-~n!l ill

res peci of \\ IHlm a po wer 10 compound DfICn c..... :1~!'" OCCtl I,!;o..:en:i sed.

I',\RT I V (J U"';U~ :\l . Pf{()VI~ION

1 I . Mat erials used for promoti on tha t c;o..:cecd s l\\\.! h L' n:llmbs must be rc-ce ni ticd at intervals o f not mon:: than 12 \ i r~ : 1 : :11., to e nsure tha t continuou~ compliance with thcsl! 1{l! 1! I!li.! : io:~:-. l !-l

Illaimaincd .

188

1 r -., ;; J-w::i. Drugs and Cosmefic.)' Act

(JOl'l'rtl llu:nt :\"oli('(: .\ '() 159 ((IIr'!rt/ I

FIRST SCHEDUL!';

/-t lade under regulation 3(.J))

TFDA FORM NO ..... .

THE TANZANIA FOOD AND DRUGS AUTHORITY

TFDA - ~. • ,: ,- I.. ,, \! oJ ' . .' . :~ r " ~,'. :, l ' 1 j .

APPLICATION FORM FOR APPROVAL OF PROMOTIONAL MATERIALS

NB: Giving false or misleading information is an offence

(All iTlj()nfw .. lioH slip/J/ied it' thisJann must be either typed or written in block c({pltullellers)

1. Applicant .E.articulars r -" -- . • - -

Name of Applicant:

Postal address:

St rn't / Rd . .Plot/House Number ..

Con tcJ('l person: ...... E · mail: . .. .. ..

Te\cphfme Number: .. Fax Numlwr:

2.:... Spo~sor p~rticl!.JaTs (I~llfl crcnl fro..!!!_ubovci

I Name of Sponsor: ...... ....... .

I Postal address:

I I

Str('( : l/ l~d ... .... .

Contact p('r~on '.

~·("kPhOn<. ~umb=- .

.Plot /l louse Numbr-r

. ............. J'>mail:

.. ..... . .. Fax Number: ... _

189

I i

I -'

,

J

lil1l:':({lIi({ l'l}()eI, Drugs and Cosmetics Act (Jon'rnm('nl .YO/icc .Yo. 159 (cun/d )

3 . Product Particulars 1 ---/ fa ) Product Na me / s , ..

J fb) Nutritional composition

I i

~.

,1.

...... ... ........... . ...... .......... ... ...... .

I 4.

I c) l'rod~'i;., rl'gi"ra'i~~~;";:; ~~Y:I:~'L)~ (please ll(~ '~~~;";Jrl'!1" ) ;()~) l J('gistt~r(:d [ l_ Not i<egistered I J

,4. Prom..?.!~onal. m.~tcr~al {Pk:y.sc !.i.ck H.r~riat c !!~ . _ I Poster [ ! Leaflet I J Cinematograph [ J Ou tdoor/ Btiiho.! :--<: ,

II' In / On puhllC T ransport f I Wall painting [ I Magn:t.tn"s/ ~·{ ... , . .... ~~ppr : I Lit<:ntt Ul {, I I I<adio [ J TeJc\'ision J J S t ickers I I i t) th('!""s r I PI(,ase spcci(\" . i i This promotlOnal rnd1crial will be used at (rncn l 1or: :-::a::r-' !c:- a

I dU!:~l.!l!)fl ............ ........ . ...... : .. _.=:. and ~imc (where ''P.l)-,opna lt~ _'--".- __ .

5. This form shall be accompanied by:

r I A copy ofthc' proposed advert (script, sketch, audio lapr, \'CD , ce . Ldeo cas:,wl t e).

J Applicat ion fee.

,6.. _ ~pplica,!!'p!!.clarati~E... __ .

/' I,. . .. . . ..... _. ... declare 'hat 'h<' In fnrmil'mn cocow::1cd

-- ' I

within thIs apphcallon I S trtH' and <;orr('{'l

I Slgn(:;d , ......,... Dm r, ' " ,

Dl'stgnatlOn . OfflcwI stamp ,

FOR OFFICIAL USE ONLY

I~("ccipt No .. '" of .. Perm it granted/not gran ted because ... .. , .. .....

......... .. ... ............... ...... . .. . . . . . . . . .. ........,.......,., Permit No ...... Approved by .. , ........ .. , ........... of

Date Director General

190

i j

-i

i I !

I i I j

'. !

, •

. ,

.: ..... .

( Marie wldc'r NC'fjlf/a l ic)II Jrl))

TFDA FORM NO ..... .

THE TANZANIA FOOD AND DRUGS AUTHORITY

TFDA

APPLICATION FORM FOR TRADE FAIR PERMIT

ND: Giving false or misleading information is an offence

(:\1/ inf{JrI /lotiolt supUliec/ tr1 rl IIS/OTIII /lIll s t 1)(' either typ('d or wrirtc'/1 ill hlodr Cfl/Jli(II {('llen.;)

1. Applica~t P~!tic~la~s

II Name of applicant:

Address: .

I I I ! COTl tac1 pt·.s()n:: .

i TcI( 'phone [\"u rniw c

Name of Sponsor: .

Address:

Contac t TH ' r'SOIl: ..

Telephone Nu mbe r:

..... e: mail: . 'j

.. . Fax:'\'urnh('r:

I': lll ail : .. ..

FnC Sl mik Num llt'r:

191

I i I

... I ,

limzanill Food. Drugs and Cosmelics Act

(;O\'('rIIIl1f!f/f .\'olice ,Yo. JjY (c:ollld)

3 . Produc ts Partic ulars S'/N -.~ . Nam-c"oi""p"c-Oduc£ - -- _._.

Registered? Registration 1- Type pr Material

I

! n umber I ____ --" __ lif_=YL _, . ___ ___ .

_l_ NO ---.1------... -i I

,t-·-~--I I , I

:! -(Add : lS many rows a s you can)

Y es

-+- --___ I

i , 1

i I

I I

- ---j

No t e: Type of materia ls i ncludes: Pos tt:r, Leaflet, Cm c-:r: ,;:! . i! ::':::;n::-d Lltcratun:,

Sample of product s (:1(;.

This promotion will tnk(: place at , (m('ntion place) for a duration of. .. " .

This form sha ll b e a ccompa nied by: NIJ: l'lcas{' t.ic~ .~)!:P.<]!_~_!5.C!..~..!...i l ctn~ !)!~l.ow:

I· II I A copy of adv(,rts (script , audio tape, CD, Video Cf1ss('1!~ .

I Appl i<:ntion tee.

t

4 . Appli'?~t.It De~Jarati~t.I

I, . .... ........ " ................... .

information contained within th is a pplication is true and cn=r't"'Q

S igned : Date : ..

FOR OFFICIAL USE ONLY

Fees ..... l<eceipt No .... .. . of ,. ,., . ..

J)ermit granted/not gnmtrd hecause ....

Permit No ........ .. .. " ....... .... . . . ,. ........... ...... 01' ...

Date Dirc t:tor General.

192

:

, •

>

li.1II::aJIia Food. nyu>!..\' und ( '()sn1el ics .riC! {i ot'(' I'IWl(' ll! .\'ofU·«' .\'0. 15 CJ ( (.OIIId. /

( Made l11uicr j{e[Jli/otirll! .'S(/))

TFDA FORM NO .. . .. .

THE TANZANIA FOOD AND DRUGS AUTHORiTY

TFDA

APPLICATION FORM FOR TRADE FAIR PERMIT

NB: G iving fals e or misleading informa tion is an offe n c e

(/w i' ~/(mll(7ti()1l SUPI)li('cI rn IfIIS jemn II/[-lst ve eit her ty ped or w rittell i" lJ/o('k (,(II)Jto[ [eller . ..;)

1. Applica~t P~.rtic~Iars

Name of applicant:

Addres s: .. .. '

I, .... ] I (. . ! ~on lH(' t j'l t ';,,:->on:; .....

f Telephone f'\ urnlwr: '.

Name of Sponsor: .

Address:

Contacl p('rso n: .

Telephon e Number :

I'; rmul :.

Fax :'\u m h{' J' :

.. I·: mail:.

191

I .. i

I

"

Jill/zullia Food, Drup and Cosmelics Aer

THIRLJ SCIIEDULE

(Ma de under NeglJ.latlOl1 J(S))

TFDA FORM NO ......

THE TANZANIA FOOD AND DRUGS AUTHORITY

TFDA ", "

PERMIT FOR TRADE FAIR ADV£RTISEMENT

Pc~rmit No ....... . . .. . . .... . .

Permil is tll'n'by ~~T<lnrt'd to M I S . . . ........ for advertiscrtH'Tlt 01

required by t h(' 1m ... and it

th rou/zh subject to the rnamtt:nan c(' of record s !'>uch as

shall not be tran sfcrabk.

The vaJictit)-, or this permit expi res on: ....... .

Granted by of .... ....... .

'i'an7.ania Food and Drur,s Authority . ... 20 . ...

DIRECTOR GENERAL

193

th is . . . ... d<l ~·

Illl1:;(1l1ill Food f)rugs and CO,'imetic,"i Ael

f ;/Jt'('rl/tlh'l/! .\ ollc(' .Yo. ! YJ (nmfd j

[ ,\1Hcle I.l ll(icr r('UIllnIIOTI 6 ( 1 )(0)/

TFDA FORM NO ......

THE TANZANIA FOOD AND DRUGS AUTHORITY

TFDA , .. '. ~' • ! .

CLAIMS USING TERMS, HIGH OR RIC H

Nutrient

1'1'01 CUI

1 ) It'lary ti bres CalClllm

Min imum le v e l

Solid Liqui~ , .

II _ .. l?~~~ 'Gj l o.9~ ; S! .g/ i. !?~! ml . 'I' .. 1 b ,O g/ JJJQe 'l' 3 gL 100ml i

Iron

II NUHjn ._.- - ..

J )antot h{'LI.i~~-'lCid l. B Iotin

.. t ... ?J5?·~)!!,IJ;llQ0.g_ . I(r)rng/ l()():~~ i _ 0.~~ t.~g/.19.9g! loR mg/ lOOml .!

4. :) mgjl00g ; ' ).3 mt~!lOOn:l; 1. 5 g/ I OOg! .~.:? · r!.~~LF)~)~l:

Sl.9_~.Ej_ Jgqg ~ ,1 .:; rng/ 100m1 :

I Fo \J c and, . I y~I .<,. min B: . \/1tamin B )

\

' \f ltaITlI~1 IJt, Vl l .unm i~1.' Vll,nnm C Vi l amm A -- .. _- _ . . _.

'I yl l a l!~~} . D Vitamin E

, flO,O mgl IOO!;.. 30 mgflOOml

"\'.' _ , Q_' .;~~~f!lglIOOg O.1;:i· ~~7 !60,~~. ,_ 0,33 rngl lODg , 11.)3 mllf 100m:

. 1 ·-iJ~45·.m g/ JOOg \' 0,/.3 rod J:60m; :-0:1,", mgl. J oOu .. O,3(, .. ,!,S! ~ OOmJ ,

:~_o mg/ l ()(~.l~: . _.1,:; II:g/ IOD::-.l . _. 1 hJ. ' ~!U"!'QIJ g.. il J rng/ lOUd .

. _ Q:~~ mgj}<}Og 0 .38 I1!gi : OfJ rr:i .. i .,~·9,!:ng/ l OOg. J.5 .m.g! 1_00mi

191\

Energy j () Itlg j 1 O()~(~ ; ~l f

:~ rr:g / 1 O()k(, ~I .l _ ! __ .? O mg/ lOOkc<li I

1..:' m~1 } (JOke-al 1. :; rn g/ l DO k t:'ll IJ.~O mel } (JOke,,} :U) ,~gjl ()( )kcai' I :J.() mt~i [OOkcal ~ .

0 . 10 m~/ l t)() k ('al " o -; 1 mt' 1 1 001'("' J : , . ' .... 1 ' '-" ,J ' _0 .1:-; 109/ 1 OOk{'~t1 .

IU rngfl OOke"J 1 {} I.ng/.l·()()kn li · ;),1 mgt l OOkcal

() 'XS IIlgj l OOkenl ~ I 0 mgl \Oo:~:;.;i -

,-

> . • ,

l~ll~allia Food, f)rugs and Cosmetics Ae/

(lm'ermllL'1/f S Ol icc S o 15f) (erJIII.! J

/Mode under rc~yUI(ltlOlI 6(J)(lJ)/

TFDA FORM NO .. .. . .

THE TANZANIA FOOD AND DRUGS AUTHORITY

TFDA " .,'" I' C , ' " ,. " :. , ,I.

CLAIMS USING TERM CONTAINING, SOURCE THE NUTRIENT OF OR FORTIFIED WITH A NUTRIENT

.. __ . .- . Nutrient Minimum level

Solid 1 ~iqui4 t . Ener~ " I ] 'rot t" II: I? _mg/ 1 OU ~-J :}_ r:ng/ l O () r!~!. I _. )_ .~-g(I-()gk~:_~_l !

[)1{' { : 1!"~ fiil J(' ,) mg/. 109_g---< .I .:~_!~£l ~oor!~L I ._ L. ~) IT!g/100~~'~~1 ~ Calcium 10:'> mg / lOO e J ~.3 ITlIJ/ lOO .~n. l .. JS n~g/l.90 kcal ~ Iron . 8 mgl lOO ~ . 0.9 rng/lOO ml . O.u rng! 100 kCalj :\'lan~~ ._. . .. _ ). 3 .I!lgj 100 g II ~ _~ n.:!gLLQ~)_ .m l . ___ .. O.S I~l.g/ l 0.0 1~_~1} .

... l'anlOrhcn!c aCICI. I--{) 75 rngj I~) g Q.·;~~ _",gn 0.0 mi .. . .. O.?5 rngf.100 kcal 111<)('ri. _ __' j ___ " . 'EgllOQ.g-1---- 2 3mgL! DO. rnl ____ 1_ S m~1100 kcal.

r J'~'!"".a(",d _ .. __ _ 30."2gjl 00 $_ 15 mgj 100 m 1... 1 _ _ _____ I 0 mr;(}OO kcal \:ht~~_1_!1 I} I .. ___ . . 9."!' ~ '!!..gL ~2Q &. _ • Q Q.~...tE.gL 100 !.,n1 ~ __ . q <)5 ~ng/ l OO_ kcai VJta.!1lI1.'Jl.~ .. _ " OX'_.IT2SUQQJ; _ O.0'L~LJ.2.0 m~ i'" 9 Qr> IIIg/ IOU1:'cal

.Vna..m.!'! .Bf> ... "-'J' .. ()23_'!'.gL.lOO g.!- .. 9 . .1 I meLI OO_cr:!L _ .. O·Q.8.lTlg/ 1 00 kcal V2!.£Ul1J.n .B.!.? .. _ . . _ .. _D,~6-",.si}OO &.:_() .. J.!l..."2&L!.Oo..lTl!. ...... O.l ?- mg{lOO._kcal. '-':i!"rtli n C .. ... ..... 1..'i . .rng/.!.2Q.~> ___ ~2!'g{'!'QQ..rI1.I. ... . !; mg,l IOO knd : LVl t all~!, ~ .. I. 81_.rngLIOO _ _ 41 r:r:.gj lQO IId_ . ___ /'·/m.gfIOOkcal .

I. Vl ta rni,!.!.?. . _ .. _, O,:lil-''!!iLJ.O() g . . .2J2.!'!gL1...QO .!1I 1 .. . __ D.J.}.J11gj 100k!:al ; '. '!i.tamin}-; ... ..l.S mg/I()Q.!l; .. [)c8 mgjlOQ. ml D.5 mg/ IOD kcal .J

195

J(m :::unja Food, Drugs and Cosmetics Act

(jOl'('YfIiI/('1l1 S u rnT So. /:;1) (conrd /'

SI.'\ I I I SCllf':DULi';

I fI.{ude unde r reyu/rdioTl of 1 )(c)/

TFDA F ORM :;0 ....

THE TANZANIA FOOD AND DRUGS AUTHORlTY

Item ... - _. I-<:nn!;..\ . ['"a t . . ._ .. '

Sal III att'u .!a tt y . al"1 ~! l:ho\c'st (' ro l

TFDA .. . ' . ., '

CLAIMS USING TERMS FREE, ZERO OR NONE

_I ~axim~.~..1cvcl I :.1, k(~al / ~ og Jnlli(lui~1 , . : . ~) .:; .m.gj iOI) n~.g _ __. ... . . ..

. j 0 : I lT ~ g/ 1 00 t::,_~hd!ij ~". O. i 1..1 9_(~.n.l. l ( li<Ju5_(.~sJ i :llllg/ 100 v. ( ~ol i d s .j or :-, JTlI~/ 100 m l (liqu ids) I l. ~ mg s<lwrated fa tty He idi ! 00 mg (solid) 0 :1:') {', ; SilWr:lIcd fatty <H·ld .! 1 00 rIll f.llquid), a nd Ell('q~\'

j: derivcd !'n>rn satu rated fatty aCid: and ,I O\!'o of

saturated fa t i ._. _ _ ~)".~l In'gi ~Q~2.!Iig (sol{~!~L9!~,6-.j m '[i JJ OO ~~r(l; ~i'ui~lsl .' j

.. ' .~ i S_mg/lOO mg(sohdsJ.o r 100 .. ml ...

l _ .. _, ___ .. _ ... -: .~\~g!~..r~_, ._ .. ___ _ , Sodium I - ___ .J S},·:l% \·(! hl~!.: _ by YO!UrTlc •. __ ... ; Akohol

196

!ill1~{/ni{J I'(u)(/. f)rugs £llId ( ,'o.l'lI/die.l' Ael

(;rJ\ 't:rnme lli SOlice So. 151) Iconrd I

,W\i I';~TII SellEI )UIY

TFDA FORM NO .....

THE TANZANIA FOOD AND DRUGS AUTHORITY

TFDA C :""-\ruS e SL'iG TEInIS LOW, LESS, REDUCED, OR CeT OFF

Maximum level. ·10 k"a l i 17[JEYI/ ; DO g (solidi

1,)0 kcal f/H~k")/l()(! . m ! (LHll: 15}) . -t :~ g/ I OO g tSohd i I :; g/IOCLfIll ,(Ll<juid) J .: l g/] 00 g (so lid) 0 ,7 5 g/ 1 00 rnl (L1CPJ1(lJ and j·:n ('q?,.\' denved from ~at\lra{(~d fa ll y a c id ilnd Hn;, of

.,th<.: .lOt ~1 ('n ~: rg)' __ _ Cl lOh's\tTol 20rng/IOO g (solidi

SUdllllIl

1 Omgj ! 00 ml (Liquid ) 1.:' g saturated fatty acid/1 0 0 g (solid) O.'I=-; g satu rated ratt~· acid I 100 ml (liquid], and Ener~ fit-rived from saturated fatty acid: IOU;, orth('

to~~~ I. ~:!- :<TJJ,r ._ D,;; g/lOO g (solid)

l () ,;;g/ .1.f!O,'!!.lJl.'!5Iuidt_, ,; _, ),O.rr'g/l 00 g_ , ,_ , __ __

Note: This requirement docs not apply to a food for which the single serving size is 15g or less and in which saturated fatty acid accounts fOT 15% or less of the total fatty acid.

197