Tanzania Food, Drugs and Cosmetics (Control of Food Promotion) Regulations, 2010 (G.N. No. 159 of 2010)

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 wcll­ defined 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 ditiolls ;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.! :--<: , I I' 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