·J L~ C OO a, caO. Q]' w ~r x O~ E O, E (D, Pg Ec a BATCo document for legal Senrices : Health Canada 21 May lass O r liJ O r: O O m~ S P p'O E O d] O E L ~11 O [1 ~i a, V] r dl o Q] a~ r a E L~ O oz ~ 5 CO Q1 m 5 o ~m E O o lT) a a, m r: >1 , a L(r) a a, tn O~ V) r a C i(l .~ 111 5 L)Id (If 5b) 7 Z1 Y L~ a~, O =lm ·I ~ Oiia) a.ca r BATCo document f6t Legal Services : Health Canada 21 May 1999 v, co E e r o a, Q) r a~ nr a vi m o a~ r OQ~ > r, ~cl D U) m L Q] 9 C9Q)O 1 OW o E' d d) dOQ] ~01 V) mm E " c~ )~Lm I u,z~ O o o a~ a~ ro a OE E3: err cn m UI m o ~ C ~ m,Op q)Q1 C BATCo document for legal Services : Health Canada 21 IYlay 1999 5 'P u. m ri ca >1 O I cl ~~ c~ LC a C]e ~ L O OI mOYE o E I~co a mmE a, ~Wo V) E a~ ·o O I~ i· > O tij Oo mPn r a] a ~~ (3 ~11. a) a) C e m~a li·j (II d~m~c>l o LC ~ YV)~~ 5 ~~ ~ O~ ~3C)V]y~W cnQ] ql~ m~m bbb a (0(0N E 111 111'111 V1 111 eo bbbb (r, bb, X V)VJ (D~COCOcl W rrl~rrrr~ BATCo document for Legal Services : Health Canada 21 May 1999 CCI cn E I= =i E E x E c a~ 3 cl X S L (a a (II E, a) 0 y3 ~ P a~n le E P O O (P 3 a) r r c ~E >1 O P~ Q~ o mE S] D C~ u. ex Q1 v, a, c ~cl o cl a cn a> >1 E (O Ilcl(II QJ a, m i ~JC (II o ·I Q1 g >I m~ = 0]~$"' ·p m oP) r a, a~ d](ll O0 3 r 5 +J -1 5 zE BATCo document for Legal Services : Health Canada 21 May 1999 CCI d O rl L a, b] r r V1 It 111 ~v, ·c~ d, r: n 7 ~J O T E 'j O U] O o E~ Ia) +Icrr E cn d, b or a c " OE a, loo~ 3 ~E "' "E PI 3 O rP a It)II 'mE O?" 'E I BATCo document for Legal Services : Health Canada 21 May 1999 m x X 3 X U1" a, x o P P]E (11 O L mE a, O Om t· T~ E x x E a, a~ E a, Q1 O o , o o o C= (IIO tiij E I=[II rCEI 3E[O (II~ a] X X ~a, ma, a, 0 [11 'Eo 0 E9 OP c~ 'a ~ t m BATCo document for Legal Services : Health Canada 21 May 1999 "f LU r LI( vl m r w O er lu4 m LL O3aS o u] ~u m (I z Y O r (I, 15MG TAR 1,3MG NICOTINE a c w w f~l a BATCo document for legal Services : Health Canada 21 May 1999 O O O O O O O O d (I) YY I r a: O BATCo document for Legal Services : Health Canada 21 May 1999 nlE MPhCT OF REtUWTORY ~17HORmES O~ THE PRODOef p L~ rJ BATCo document for Legal Services : Health Canada 21 May 1999 IIIP~C~ DF RECI'MTORY ~LiTHORITIES O~ THE PRODUCT Ne li~r in 3 ~Fcrid li~a~ ii ~cernei 3v re~uiations and this 3pplies 13 the robacc6 Indusrrv 3~1 cluch. linot more. than Jnlr~vi~e:e rise. ReZularo? ~ulbontles impact on the Product in man!' ways, rucn Is: io the maainis which are pcnnitrej to be Idde~ to the ~roduc!. in Ihe viel~ ~irhr vanour snoke csmponenrs, in lot bbeiling in rrrmr cihilh :varninJs ad rmoice yield Ibc!l;n: in Sow:he orodu;: mav be mari;cred and advenistd, ~iar.v oTI& war in which tSe product can be modified to oclomm to rc~arions have been descobed in other talks by previous Fresenlea. The paper 'Niil attempt to describe hcw r:~bions and rbe I~r~o,iries that impiemear ~h:m a~f~c: the envinnn:nr 1~ which the orcduc: is said InS :~ereibrc, how the produc; has had:o be mcditied to aeer rhae ctsllm~es Hawevtr, it is ~nr necessary to understand how we have s~nved v:he current rcSuiaicr! situation and then we will ~o on and tfi to predict how this mq change in the future. Resllations rtiaring to i: Tojacc3 Indusrri have existed to from:ine, but were mainiv conrined to additives and moirrure content relative to taxation. In this paper we shall diKfll additives in S'rt detll, bet it musr be remembered that the Industty;s nor free to add anrthing t liites to the product. There ar:very stringent rules around the world reiaulg to tobacco additives and within BAT the hddit~es and ~ataials Guidance Par,ei (A~1GP) located ;n rhe ETC mug je advised of ny proposed additive and clearance qvee by them before I: is actually used. Sinc:~te:rry 1010'4 more and more re~e~ulationi have been introduced as the debate on jmoi;inE and R~~irh has ~rown. Iviost;obacco regular;3a are nominaily to provide BA~TCo document for Legal Services : Health Canada 21 May 1999 iniornlrioa aid pnrecion to I~e consu~ne: Honcve: this ~rdretlion hs meant that the industrl, las had to modiijl its produc::o live lower and lower yields :vhilsr still ~ivine ti~e consumer the taste Ind tllvour he recks, Some csamples oElhe his~o~ ot':e~ulalions are given below: Ilre IlfO's l;fi Dcp:lrraent ul' Hr:dtb;atd Soti;ll Sectlritp The 1'F; were one oi' rl;e firs; counlrcs to lnl:rocuce Itqac table testing, This was a voiunran· n~reement arnved d( niier consultation ber!veen Government and industry The a2rerment stated ihar prodacs would be sampler; and tested to 3 cecaa regme and that the data would be 3ubiished, Subserjuenri~ the printing of tar Sands and Health Warnings on packs ~vaS also introduced as par: oitbe voiuntar)r aSreeaenr 1950's11960's 1'Sr\ Federal Tnde Cammissioll The US~ through the F~C introduced a Code of P:actiee in the jO's and 60's that covered the use of numbers reiatin!: to smoke yields i,e. Tar and Zu'icorine figures in any advertising marenll. Thir Cpde.j:;ll applies and baricaiiy means bat if a.Manuiac!ura wishes to use numbers as a markerin~ tool then those numbers must have Seen measured lollowin~ a certain samptin~ mt ~estinJ regime. ~rlV 1960'1 India Covernnlent In a bid to protect the Indian Tobacco farmer and ens~re that the local corta~e indusay manufacrured a product that Contained a ~ajoriry oitcbacco and did not contain at quantir;es of dust etc. the bdian Government introduced, without consultation a specitiwlion for ciaretta. Tl~e rpcelriation covered all spear of the product from in p~sicl ?anmgerj to itr smokr conit~enn. Thir specification tar been altered over the years but still exists, BATCo document for Legal Services : Health Canada 21 May 1999 i, Ihe late aGi Jeu :ad~ "O'j Co\Fr·rr,rari. 4qui"'cr; bodier and Consumer Onsnisalions raegnred jroii;0i snd .anlHlln re~uiarionr ilround ~ir world. Thc!e ~as little ·~ny sroldarcii~o3n L~[· !:6e rr:ri:noar and;""' ~ve~e prodccd by tes;in·. Other orSanlwrions saw 'Cruslderr. wh3 li;nled to Isd li~~ worid In taalc;l sitali li;ar could be routinely appiie? in ,comme,cinl c~iue in altr,ding the range :iysrra md ·""illlgd r~g:"lio:r Irsrdingl bmclor of Ibit Iwo li~~' b' 0leanisatlCn are Yn.. Filllli~h C3yllllllltlll Tyllille la~01:1101i~l Belilvec:nar ha~v:neair, i:IC and cJdm:um r!c.. in ;msKe were a major hdrh risk. ~ir IJCjl [iieY ;,jaded rhr :iac ckcmicis shovid be ,alltin:!v mearured ?nd repontd. tglj. Slvit~crialld · HmTeld Inda consumer or~anisaaon to HEnjde 8a I sdn: compny ecp;~yed by l~sllS prepare~nlndaClhi;il$ill5odhaili;niioiilglracl'~0"ldbalompar~ In nieorine, carbon monoudt~ nitne oxide and his first ;nde~ ~tnie!d me~s~red tar. acrolein conrce:s of ciSarere snol;e, aoplied weiginncs a Inere compmenn i success ot' this inda he anitr~ Ihcm in in index. FlilowioS on from r~e apparent ;nrrodulcC a jrond Ihat a;nde::he 5rr~ by Idding Icerald$dr formaldch~dt the la ot~analyse~. ~i~ilst this index was benzene, is~or:r~e and i~~dropn c~mide on never actually -l~e law it are very close wavride. F~rstly because the onSind In:eren iP bbi there issues have t8.i:en by the diminished and secofidly concemr :rpr:rrld over the various components have now bl~u~rt cirh::sn md icmphilv oi~oodurtig lia loili on a mutin, jaiir tesiinl were established wor!d·Hide By ~~e !sSO'I:~iiationr wi~b replrd to lotarco and i~e:e 3eisE a:ended by jodbs I~ich y the Wotid Heli~h orSanisatian The 1~10 BATCo document for Legal Services : Health Canada 21 May 1999 iunl::d ;he:irenrs!e on smoiiiny re·illionr md laired dneiaping cous~na on ~E rrce ~:!eeislllioo to inrrsCua. i Scod :slepie or' this ii S:ny". Kccy~ pli rccn y o,,::.:i: nos~ dr.~ 3F(C ibar;ll.llcrr sirh 3 long lera rrile ~nrironu~l and it :ia I·:ld;$! ahr j(ll.F1 :nCSdUF:I: J:hen eouiC $liOlv ibe ~HO o8end Ihe :?Ouj :ndh cip?rn:e iuc6c3i3n a ~ isod cyllnple to loilow ieip;le the bc~ riw~ it tr i-n ic::oducej Sr ~e~ Cdni:~ ::lioni. jpff;ic to iPci~ and da7i;e many of Ihe snai\·ja within it bcin~ ssee!dej ct abandoned. i~e i:nv~n Bilc:~u of j:,,Clcj Fro:u~ti 1 Dnir 9lecircticn for Cigrnlres based o, i,: indian rt~sdlrd rnr BouiC i;~e:Hde Ihe 3roducton 31 jie Bis:~~ees or:he inrro:·aion of ne?r F'"d.J~ti "mn:il. diificuil. Tbc! wore liio oi the ntitude lhat :~n ~inr~C to Ic:d.i~rl i*:ening and not ~llo~v arjbi;ihed gTcceiurer Lpd tiie\ier~ in:he world Ti:e iajui~h.,:hrol~ conluirlrian an! nelotiaooc. worked that gave the Bure~u:vhat it wanted sioscic with the 9ure3u to s:are 3 SpeClnCallOn abd ~:I gave the indurl~ the jroFe to eonlinue manuhcture, i parr of dtis co~~iratior: the e~i~cl on rcbar;o hrmerr ~irhin Kenyr had airs to be conddercd, ~l~r r:silit uas J.jpcciile~licn Ih1I rtill COnllDljed rmoke -eids nnd Qave the cocnmer rr!e\an: information whiiir not ale~m,iy ra;nc;iq the indus4,~hetbs Ihat be the manuicturn or orherr arrocistcd 'iiirh $e Indun~. The ~10 also iatoCu::i rtning:e:imer to the ?iliddle Eu; Tie Middle E~JI laumria are unuruai in rha~ rbel do nor produce iobacco, iave no mdlu8ctldog pianli and have no ndusrq axdal~ wiltlbacco In 198; thriCit:ha Ihci were a 'dumpinS Qro"nd' for nienor ?mCuc:r iron Ihe rest cf the world. ThN Ihaciorc, Crided that :hw too sould lead 11:e world ic tobacco reguiaicns. Through:le Esia Yedile::;n~~n R~;lon Orglmelion (EblROI bired in E~pr 1"4 introduced in ien~l~cs~la~ion jn!in~ risl Ibe m~Iimun vieid $r tar aC nicotine in cigarette imor~ riauid be tim? m~ Im~ nrFec!i4!y These 6bures wee Imved a Irbinarily BATCo document for Legal Senrices : Health Canada 21 May 1999 s~nd rook no account of unusual and unnurai ~ar to nicotine liD that the:: implied. Since then these iiz!lres iave been rrj,a~ to :]m~ &d r~~lmg and:he:e;r 1 consrylr threat to reduce Ihcm to IOe~ Ind O ~lng Since Jii :he;lbore re~ullrioos I:ai'e ben isrroduitc. Ibev have been nadijd or lietrened 3,r,d most au!ilorilies no:v rcqulr~ !le31th r~rain~s to be priered on :te pack. ~s vou w;ii srr:Qe regularo~ arena in which the Inhm: has to work is ~onsed and non·stlncardis~~, Howsec rbis.s beginning to chln~e and in the mid lr,81)'s the European Comn?niry IEC) produc:d a pra~ramme entiried 'E:Npc.~Btjssr Cancer, a inil:arne rind at rcduangemoving all t~rms oi;lna: ~oj slrhin:he EC Part at' this ioiri~ve'Nas aimed jpeciiidiy at snokicS. is a result re~ularibns jave been introduced into the EC nin~ thr ail Products produced in the EC ier Is: Ianua~ 191! wiil have to conplli with a tar ma~uima of Ijm~ icf aliddle East) Slacks alre3dy produced or in the marker wee rceepr untii ist lanua~ 1993 when they rco will had to be irhdrawn. This mau~rca will fail to i?lg (a~a n ci Ivliddle East) on i st Janua~ 1'198 Tnis is the firr instance where a large group of countries must follow :he same re~uhuons, hs a model ior other countries it is likely that this direcive wiil be adopted by ;nany other countries tbrouchout the world. Pan of this directive stna that product produe?d, tested and pack marked in one member stare must be given ~ee admission to another member state. The renting rcsmes cseC in d~e various staler therefore come unde: scrutiny. ~t that time a pndu:lproducd and tested in Cermafili bur sold in France would have hnd 3 lower vieid :bn a similar product produced and tested in the I'K, purely because oithe differe3r smoi;ing regna used in he tad COUnlnES. ~j a relu:f PirhiS the Industr! BATCo document far Legal Services : Health Canada 21 May 1999 hr.~~i Epdr :O paloha ~ ildLt bZai s 31 ~hnac IIOYP5 mlc~ne b 6~ the dl~ pomred *~ bt cenpllac This hmolsdon ~a aa~sl r molr =dui Iso~tg rn;lohines led e~ o~~cdl ad ~: jubsc(uenr ~e daP oi 60 IrClds ~4da! to dg*~~ nP~sZ vLI clol pob:! :: is igCidl m ma~a be IroYle Tromh Ice Tht w;fv I ·Sd ic pc·= ii pl~d ·d Le data a;oni ii F~'bpO"L ~d ~I ~o ~~ been ~d~ard in lhe ~bed WO ~~nd~d~ F31d~l tc be comp~s~es pae~ r~dde dth p.ss pnhb ·hY rv a Isi r enYe i 31~1 ~ \n ~I at ic: i obC Pd I~C CPP~fl on m~·Pa ndd SCrl rd Y! bnnrr mp e~d* ~PL j Pdl by nnil. ~1Pa~ hhidm o(lahuP is de gslat psY~ mda ~r *1 b( tYa~ n~~ I1P~c~~~ba ~urz tobaF;3 hl·~ni pod~: i is apppd i ,e: rYd is qil 1·ld 7aha ·d de dp~Er h Jan tirted wiih a 8r~ dt is ~ besr ~di~ ColCd ~ Lac v~nPtl is rhc mcbod of p~dlahn and nn~g r~ch vl increase Be vdlb~g p~ Ip!nba bb Icsa 6u ~no pAbP ·~~n a PC~e is to e~ the rnzvima ~ Latba;oldg *ii Ic c;i~bl le Q~a ~Cd Br ~r pmduc: Iln be ~I well below rhe ~ai~a. T~I is ullc~paYe mi !scl~ abltoa have l~~ti I dcnr: r·d 1 Pailo ·Y~ lo·! br Y1 Cdr: iiZF However. this toleraooe 5 nor 1 means oi ~odudn~ grodun aiwavs ~d~ng above ~e mlximem ~ mkaPce is la i6caoP 1~ bPb Y1 )e above 1~ bdOY the ttOd dul So iar we have dtd pdoldy BI~ ~dd 611 but Igd~o0 II ta lhe Producr prhCa a tn' d b ~prab yd[ m·ia or bk an jdb and ~tl wlminSI ~Cb ~nd on b: ~b and Lc·l rhac ~d how mulh d me P~ ~I be a~~i bl oac ·Imip. BYm mt EC J pxnl F~$g ont 5e q~d m de BATCo document for Legal Services : Health Canada 21 May 1999 front ofle oxg and ne oia senes oi;orationai w;lmir.S3 must he Ippiir? to Ihe hack J(lhl pacl;. T:lese !ilminel mat ocapy ~r Icsl ~ib oilr 71d her :ithe:, ire in Jee b·ulrc. Bib li:ivC langut~a Ind S91 if Ihret. TI:e area is ctie·htri a the ~clline cilne pnnr ~eC the:e:brr ;I Ili~w:e or' ·r;pe: rnd iolue: nle:viii Icee3r bi~ber I~s sFpe':ae ~ioer in ro ne cllunriia ii~err se proponir to redut: iii pacis to a ~nme deri~n IF1Iil :I.Yfl ~C: gym over to haili~ io~oradon and oniy the procuce ame Jlowed in colour. Hspeillv n:ve bye gone Ihrough the various :qlladons int tow ib tave been aewiopei it i:ar le~~ :i~idenr loiv :hey tdec~ Ihe product. E~Teeliveiy me ire iiving in 1 world where !ve cannot gve the consumer ~aac:i~ ~i~har he wants. We acst design aroducrs and given consumer jalisthcrion and ver, at the same time. canrorn to very r:3aSent mles ~a: re~iions The consumer ~imrciT. ai:ls a: does ramethinS sbour it. ir forced by these same:epinrions to x::pl these chansa to hir product. ~s time gees by \Le may oe forced to reduce yields further and funhu unless through consultation and n::criaoon we can convince regilalors that:here Is an optimum )oeid below which ii is impraaid and un~iie to go Europe has rirady aarted on this route and ilir ike!v that tte result of the world will follow suit. There may also be an ~pansien of the anaiyses mwured and :cporred. ~r sbwn aboa attempts have been made in Ihe past and the are likely to be rerisitcd or others round. Ihe Induffq will also ilct controls upon itself in order to be seen a responsible and leadinP smokine issues lather than conforming:o extemalpm~rr This can be seen in the Bh~Co directi\e that none or`itr products wiii yield more than 19mg Tar Id that all products wiil display a hnirj wamiog whe:ha:eclcired or lot, BATCo document for Legal Services : Health Canada 21 May 1999 We bye concenmrta on cipre!les in this presentation. however. re:ulaionr apply to ~i tobacco prod~ar includ;n~ dgari, roll your own ?roduc, pipe lottceos and wy snud In a very short timt the too will wry yield data and we will ncni to brar:hir in mind when deeeiopin8 these Frcdu~!s in Il~e ri~rure. Wr liic i ~ ionlnclin~ ~corid Ihar is beie~ iesliat$ more and ;nore Ho~vever. this doer lot impiy !hsr ~li ir:iosm Rquillions bye forced us to look mP!e ?e~~iy ia the oradud and tiad novel ways ol-~vin: !he consumer the taste and il~vour he xtkr whiin compiy;nE ;vid re/llin~ions. \Vr have learned a lot in terms of tobacco prcceiin: and criliaion, b:eoding ci;arale derBn, msnufaa3r~ and Ijch~in~ ytd will ~sntinue :o lenm Tie p:oducr ci roda~ hears very iitlic relationship to the prbdu:: oirhe ~O's and jO's and yet it still has a very large maricer. BATCo document far Legal Services : Health Canada 21 May 1999 O 3 cl L·CJ I: O0 ~ ~L, E cira a, O)C 'C Q]' 111 c0 O~ ~ ~a, a, OI- E ~C1 mt a~ ao Er C1 3 BATCo document for legal Services : Health Canada 21 May 1999 O a, C r O O 8~ s O Pa E O o o E L O a a o m r OO o r a E L~ O m u a oo 'O t r m o ~Q E O o P P g Q e P a L~ O~ a ~ a r oO 3 L O~ a Y Y ~8 o P)) mo I g O IP > a I BATCo document for legal Services : Health Canada 21 May 1999 to ca E a r a, o a) a, cl P m V1 cn o c, Oa, w > ~Pmm e P edp P " Isao O iO ~ nrm E ro )yL8 Im~0000' ro a OE EI a) ot r O a lr Q Or Oe oo p O8 C aS ~ BATCo document for Legal Services : Health Canada 21 May 1999 D 8 a" F I OQ E O I, Fm e v- C N 1 L O O )O~E 0 ; E I11 c maE a o~o ~Eo~g I~ > O ; Oc mm~ r a] a~O r~a 6~ m e C r mya d OqB~ ~O Y~~~~er~ O C Y~W 0~ "'' bbb a 00~ 8 E \Q\ 8' 8 bbbb ~000 X aaaaaaaRI rr~rrrr~ BATCo document for legal Services : Health Canada 21 May 1949 ~I I E [II E Q] X E c lu [11 7 cl '7 rE ~~ X 7 111 L m 'P E to E 6~ P E P YF O U ~I 7 Q1 r r r mE >1 O u P~ " o mE P C P C~ ct c I11 e a~ 11 e, cE [P ~OriJ ' P d) >1 vl m e a~ 7 m t~ cn o'~ ~ C: m m ij g>I ca rw'' ca 9~ [II iipl Q1 C~ d)m O0 ~ ~ ~i zE BATCo document for Legal Services : Health Canada 21 May 1999 O 'C~ L a~ P C r a~ c I: r O d) m E o o ;;, e O L E a O a Pb ~ O cp j e~ OE O rE ~x O ~m r ~" ~E I BATCo document for legal Services : Health Canada 21 May 1999 m x X J X to" Q), x O c r a~ E (If O 1=3 L CO E O Om ~E x CI~ cnr o Eo c E ~O o o o o O e r CQ 8 Em a E m~ o x X g~ ma) O a] O Eo a EB O 'a $ $ BATCo document for Legal Services : Health Canada 21 May 1999 1: d U r v) W (I vl vl r P~Z o nt 5 Wg ~n 111' 3 O r (I] W V] (3 Z O r v) 15MG TAR 1~3MG NICOTINE a o LJ h Fu BATCo document for Legal Services : Health Canada 21 lay 1999 i~3 PI