FOOD_ DRUGS AND DISINFECTANTS ACT_ No. 13 of 1929 REGULATIONS

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FOOD_ DRUGS AND DISINFECTANTS ACT_ No. 13 of 1929 REGULATIONS Powered By Docstoc
					FOO D, DRUG S AND DI S INFECTANT S ACT , No. 13 of 1929
                         REG UL AT I ONS



     P ublished under Government Notice No. 574 & 575 of 28/3/1930
                            As amended by:
              Governm ent Notice No. R. 345 of 27/2/1931
              Governm ent Notice No. R. 407 of 24/3/1933
             Governm ent Notice No. R. 1615 of22/11/1993
              Governm ent Notice No. R. 739 of 29/5/1935
              Governm ent Notice No. R. 1372 of23/8/1940
              Governm ent Notice No. R. 367 of 16/2/1951
              Governm ent Notice No. R. 368 of 16/2/1951
              Governm ent Notice No. R. 1565 of29/6/1951
              Governm ent Notice No. R. 1931 of30/9/1951
               Governm ent Notice No. R.952 of 2/5/1952
               Governm ent Notice No. R. 941 of 8/5/1953
              Governm ent Notice No. R. 2096 of25/9/1953
             Governm ent Notice No. R. 2401 of26/11/1954
             Governm ent Notice No. R.2402 of26/11/1954
             Governm ent Notice No. R. 2517 of10/12/1954
             Governm ent Notice No. R. 2518 of10/12/1954
             Governm ent Notice No. R. 2519 of10/12/1954
             Governm ent Notice No. R. 2520 of10/12/1954
              Governm ent Notice No. R. 1578 of12/8/1955
               Governm ent Notice No. R. 15 of 6/1/1956
               Governm ent Notice No. R. 164 of 3/2/1956
              Governm ent Notice No. R. 1788 of28/9/1956
             Governm ent Notice No. R. 1963 of26/10/1956
               Governm ent Notice No. R. 837 of 7/6/1957
               Governm ent Notice No. R. 838 of 7/6/1957
              Governm ent Notice No. R. 1913 of6/12/1957
               Governm ent Notice No. R. 85 of 17/1/1958
               Governm ent Notice No. R. 43 of 15/1/1960
             Governm ent Notice No. R. 1795 of11/11/1960
               Governm ent Notice No. R. 525 of 5/4/1962
               Governm ent Notice No. R. 526 of 5/4/1962
              Governm ent Notice No. R. 1295 of17/8/1962
              Governm ent Notice No. R. 1296 of17/8/1962
              Governm ent Notice No. R. 798 of 30/5/1963
              Governm ent Notice No. R. 1009 of5/7/1963
                                                               2




                                     Governm ent Notice No. R. 1239 of16/8/1963
                                     Governm ent Notice No. R. 1191 of13/8/1965
                                       Governm ent Notice No. R. 159 of 4/2/1966
                                      Governm ent Notice No. R. 515 of 14/4/1967
                                      Governm ent Notice No. R. 850 of 16/6/1967
                                     Governm ent Notice No. R. 1231 of18/8/1967
                                     Governm ent Notice No. R. 1294 of25/8/1967
                                     Governm ent Notice No. R. 2130 of29/12/1967
                                      Governm ent Notice No. R. 1351 of9/8/1968
                                      Governm ent Notice No. R. 3228 of5/9/1969
                                       Governm ent Notice No. R. 16 of 8/1/1971
                                      Governm ent Notice No. R. 418 of 19/3/1971
                                     Governm ent Notice No. R. 1265 of23/7/1971
                                     Governm ent Notice No. R. 1484 of25/8/1972
                                     Governm ent Notice No. R. 1655 of14/9/1973
                                     Governm ent Notice No. R. 1881 of12/10/1973
                                     Government Notice No. R . 2064 of 2/11/1973
                                     Governm ent Notice No. R. 2162 of16/11/1973
                                       Governm ent Notice No. R. 70 of 18/1/1974
                                      Governm ent Notice No. R. 230 of 18/2/1977
                                         Governm ent Notice No. R. 908 of 1977
                                         Governm ent Notice No. R. 956 of 1977
                                        Governm ent Notice No. R . 1724 of 1977
                                      Governm ent Notice No. R. 756 of 20/5/1978
                                     Governm ent Notice No. R. 2307 of30/10/1981
                                     Governm ent Notice No. R. 2254 of14/10/1983
                                       Governm ent Notice No. R. 92 of 17/1/1986
                                     Governm ent Notice No. R. 2627 of12/12/1986
                                     Governm ent Notice No. R. 2398 of25/11/1988
                                     Governm ent Notice No. R. 2486 of26/10/1990
                                     Governm ent Notice No. R. 1468 of13/8/1993
                                      Governm ent Notice No. R. 1518 of9/9/1994
                                       Governm ent Notice No. R. 996 of 7/7/1995
                                     Governm ent Notice No. R. 1316 of16/8/1996
                                     Governm ent Noti ce No. R. 692 of16/5/1997



A PP L I C AT IO N O F C E R T AI N P RO VIS IONS T O S O AP, TO BACCO AND CE RT AIN OT H ER
A RT IC L E S
T he M i n is t e r o f P u b li c Health, in the exercise ofthe powers vested in him by section thirty-six of the F ood,
D ru g s a n d D is i n fe c t an t s A c t, N o. 1 3 o f 1 92 9 , has been pleased to apply, as from 1 st April 1930, to any
o in t m e n t , c r ea m , p o wd e r o r s i m i l a r s u bs tance for application to or use for the human skin or hair, soap,
t ob a c co , ci g ar s , ci g ar e t t es , sn u ff, c he w in g gum and surgical dressings, the provisions contained in the
fo ll o wi n g s e ct i o ns of the said Act, nam ely: Sections two to seven inclusive; nine to twelve inclusive; twenty
                                                                              3




t o t h i rt y- fi ve i nc l us i v e; a nd t hi r t y- s ev e n t o fo r t y -fo ur i nc l us i v e.
                                             - - -- - - -- - - - -- - - -- - - - -- - - -- - - - -- - - -- - - - -


R E G UL AT I O N S U ND E R T H E F O O D , D RU G S AND DIS INFECTANTS ACT , No. 13 of 1929
T he M i n is t e r o f Public Health, in the exercise of the powers vested in him by sections thirteen, thirty-six and
fo rt y- t wo o f t h e F oo d , D r ug s an d Di s in fe ct a nts Act, No. 13 of 1929, and after due com pliance with the
p ro c e du r e m en t i oned in sections thirty-six and forty-two (see Government Notices Nos. 1223 and 1224 of 5 th
J ul y 19 2 9, a nd No s . 2 2 60 a nd 22 6 1 o f 27 th December 1929, and No. 574 of 28 th March 1930), has been
p le a s ed t o m ak e th e fo l l ow i ng r eg u la t i ons to be in force throughout the Union, with effect from 1 st April
1 93 0 .
R E G UL AT I O N S R E G AR DI N G FO O D , DR UG S A ND DI S I N FE CT A NT S
( F r a m e d un d er s ec t i on s th i r te e n, fo ur t e en , ni n eteen, thirty-three and forty-two of Act No. 13 of 1929).


G en e ra l
1.. . . [ R e g . 1 r e pe a l ed b y G .N . R . 2 39 8 d d . 2 5 .1 1 . 19 8 8. ]


L ab e ll i n g
2.. . . [ R e g . 2 re p e al e d b y G . N. R . 9 0 8 o f 1 9 77 , w. e . f. 2 7. 5 . 19 7 8. ]


P ro h ib i t io n o f Un wh o le s om e o r Po i so n ou s S u b s t an c e s i n F oo d
3.         ( 1)                                                                                                ood shall be of
                       N o p ac k a ge , wr a pp e r, c on t a in e r , o r a ppliance used in connection with f
                       s uc h co m po s it i o n or nature as to yield, or be liable to yield, to its food contents, or to food
                       w it h wh i ch i t c o m e s i n co n t ac t , a ny unwholesom e, injurious or poisonous substance.
          ( 2)     . . . [ S u b r. ( 2) a m e n de d by G. N .R . 838 dd. 7.6.1957 and G.N.R. 3228 dd. 5.9.1969 and
                           d el e t ed b y G .N . R . 1 51 8 d d . 9 . 9. 1 9 94 . ]
P ro h ib i t io n o f Ar t ic l e s, De v i ce s or Ap p li a n c e s u s ed f o r Pu r p o s es of A d u l te r at i o n
4.. . . [ R e g . 4 re p e al e d b y G . N. R . 2 3 98 dd . 25 . 1 1. 1 98 8 .]


P re s e rv a ti v e s i n F oo d
5.. . . [ R e g . 5 re p e al e d b y G . N. R . 9 56 o f 1 9 77 , w . e .f. 3. 1 2 .1 9 77 . ]


C ol o u r i n g , Fl a vo u ri n g, T h i c ke n in g a n d A rt i f ic i a l S we e t en i n g S u b st a n c e s i n F o od
6.( 1)    . . . [ S u b r. ( 1) r e pe a le d by G. N .R . 23 9 8 d d. 2 5. 1 1 .1 9 88 . ]
 ( 2)     . . . [Subr. (2) substituted by G.N.R . 367 dd. 16.2.1951 and am ended by G.N.R s. 1565 dd. 29.6.1951,
                1 93 1 dd . 3 0 . 9. 1 95 1 , 4 3 d d . 1 5 . 1. 1 96 0 , 525 dd. 5.4.1962, 526 dd. 5.4.1961 and 1296 dd.
                1 7. 8 . 19 6 2 a nd r ep e a le d by G. N .R . 75 6 d d . 2 0 .5 . 1 97 8 .]
  (3). . . [ S u b r. ( 3) s ub s t it u t ed by G.N.R . 1294 dd. 25.8.1967 and repealed by G.N.R . 908 of 1977, w.e.f.
          2 7. 5 . 19 7 8. ]
(4 ). . . [ S u b r. ( 4) r e pe a le d by G. N .R . 23 9 8 d d. 2 5. 1 1 .1 9 88 . ]
(5 ). . . [ S u b r. ( 5) r e pe a le d by G. N .R . 90 8 o f 19 7 7, w .e . f. 2 7 .5 . 1 97 8 .]
(6 )( a) . . . [ S u b r. ( 6) ( a) s ub s ti t u te d by G. N .R . 368 dd. 16.2.1951 and repealed by G.N.R. 1881 dd.
                1 2. 1 0. 1 9 73 . ]
( b). . . [ P a r . ( b) s ub s ti t u te d by G. N .R . 15 dd. 6.1.1956 and repealed by G.N.R. 1881 dd. 12.10.1973.]
                                                                   4




Mi l k a n d M il k Pr o d u c ts
7.. . . [ R e g . 7 su b st i t ut e d b y G. N .R . 2520 dd. 10.12.1954 and repealed by G.N.R . 1724 of 1977, w.e.f.
           2 .3 . 1 97 8 .]
C re a m
8.. . . [ R e g . 8 re p e al e d b y G . N. R . 2 3 07 dd . 30 . 1 0. 1 98 1 .]


B u t t er , Ma r ga r in e an d G h e e
9.. . . [ R e g . 9 am e nd e d b y G . N. R . 1 3 72 dd . 23.8.1940 and repealed by G.N.R. 2307 dd. 30.10.1981.]


C h e e se
10.. . . [ R e g . 1 0 substituted by G.N.R . 2399 dd. 26.11.1954 and repealed by G.N.R. 2398 dd. 25.11.1988.]


I ce - C re a m a n d Ic e- C re a m P ro d u c t s


1 1.         ( 1)      I c e- c r ea m M i x s ha l l be the unfrozen, pasteurized and hom ogenized product prepared from
                       o ne o r m or e of t he following: Fresh cream, butter, m ilk, skim-m ilk, sweetened condensed
                       m il k , u n sw e et e n ed c on d en s ed m i l k , s we e t ened condensed skim -m ilk, unsweetened
                       c on d en s e d s ki m - m ilk, butterm ilk powder, m ilk powder and skim-m ilk powder. T o these
                       m ay be a dd e d g l uc o se , de x t ro s e , sucrose, invert sugar, stabilizer, emulsifier and water.
             T he fin i s he d a r t i cl e sh a ll contain no added preservative, not more than 1 per cent of stabilizer and
             e m u l si fi e r, n ot l es s th a n 3 3 ¹/ 3 p er cent by weight of total solids and not less than 10 per cent by
             w ei g ht o f m i lk -fa t.
             N o fa t o t he r th a n m i lk -fat shall be perm itted and the Reichert-M eissl value of the extracted fat shall
             n ot b e l o we r th a n 2 1 .
             ( 2)      I c e- c r ea m s h al l be t he fr oz e n o r se m i-frozen food made from the homogenized m ixture
                       p re p a re d fr o m t h e i n gr e di e n ts m e n t io n ed u nd e r s u bsection (1) with the addition of
                       h ar m le s s fl a vo u r ing and perm itted colouring m atter, with or without the addition of cocoa
                       o r c h oc o l at e sy r up , fru it, nuts or confections and shall contain not less than 33¹/3 per cent
                       b y w ei g h t o f to t al solids and not less than 10 per cent by weight ofm ilk fat. Every package
                       c on t a in i ng i ce c r ea m s h al l be a r a l a be l wi t h t h e w or d s “ i c e c r ea m ” i n t y pe D.
             O ne ga l l on o f i c e- c r ea m s h al l c ontain not less than 1,7 lb. of total solids, exclusive of any added
             fr ui t or n ut s , a n d s h al l c on t ai n n o a dd e d p r es e r va t i ve .
             T he t ot a l n u m b e r o f or g an i s m s sh a ll n ot exceed 50,000 per m l. and E. coli type 1 shall not be
             p re s e nt i n 0 , 1 m l. t e st e d a t 44°C . T he presence of E. coli type 1 shall be confirmed by performing
             t he i nd o l e t e st . No pa t h og e ni c or g a ni s m s sh a ll b e p r es e n t.
             N o fa t o t he r th a n m i lk -fat shall be perm itted and the Reichert-M eissl value of the extracted fat shall
             n ot b e l o we r th a n 2 1 .


             ( 3)      M i l k sh a ke s ha l l b e pr e pa r e d w it h i ce -c r ea m and m ilk or milk powder and harm less
                       fl av o ur i n g a nd p er m it t e d c ol ouring m atter. It m ay be sweetened with one or more of the
                       fo ll o wi n g: Gl u c os e , d e xt r o se , su c r os e a n d i n ve r t su g ar .


             ( 4)      S he r be r t sh a ll b e fr o ze n or s em i- fr oz e n fo od, other than ice-cream , m ade from a milk
                                                                                       at,
                       p ro d uc t wi t h o r wi t hout water, wholesom e edible f sweetening agent, fruit or fruit juice
                       a nd p er m it t e d fl av ouring and colouring agents. Stabilizers and em ulsifiers m ay be present
                                                                5




                    i n a m ou n ts n ot e xc e ed i ng 1 p e r c e n t by weight ofthe finished product. Every package
                    c on t a in i ng s he r b er t sh a l l b e ar a l a be l wi t h t h e w o rd “ S h e rb e rt ” i n t y pe D.
          T he t ot a l n u m b e r o f or g an i s m s sh a ll n ot exceed 50,000 per m l. and E. coli type 1 shall not be
          p re s e nt i n 0 , 1 m l. t e st e d a t 44°C . T he presence of E. coli type 1 shall be confirmed by performing
          t he i nd o l e t e st . No pa t ho g e ni c or g an i s m s sh a ll b e p r es e n t.


C er e al s
12.. . . [ R e g . 1 2 ( 1 ) , (2), (3), (4), (7), (8) and (9) deleted by G.N.R . 1655 dd. 14.9.1973 and subregs. (5) and
         ( 6) r e pe a le d by G. N . R . 23 9 8 d d . 2 5. 1 1 .1 9 88 . ]


B ak i n g Po w d e r a n d O th e r L ea v e n i n g S u b s ta n ce s
13.. . . [ R e g . 1 3 wi t hdrawn by G.N.R . 2486 dd. 26.10.1990 with effect from a date six m onths from the date
          o f p u bl i c at i o n t h er e of. ]


Me a t a n d F is h an d t h ei r Pr e p a r at i o n s : E d ib l e F a ts a n d E d ib l e O i ls
1 4.      ( 1)      ( a)       M e a t sh a ll b e t h e c l ea n , sound and wholesom e f  lesh of anim als or birds used as
                               fo od . M e at o th e r t h a n t h at o f b o vines, sheep, pigs and goats shall bear a label
                               i nd i c at i n g i t s n a tu r e .
                    ( b)       A ny pr e p ar a t io n or m ixture of meat, other than that of bovines, sheep, pigs, goats
                               a nd p ou l tr y sh a l l b e ar a label stating the kind, composition or origin of the m eat
                               a nd s ha l l c o r re s po n d t o th e de s cr i p ti o n o r la b e l.

                    ( c)       L ea n m e a t s h al l be m e a t w i t ho u t a n y a dh e r in g fa t .


          ( 2)      ( a)       M i n c ed m e a t s h a ll b e t h e m in c e d s keletal m usculature of any anim al used for
                               fo od an d sh a ll c ontain not less than 60 per cent oflean m eat with a minimum of 2
                               p er c en t of p r ot e in n it r ogen. It shall not contain any preservative, farinaceous or
                               o th e r fo r ei g n s u bs t a nc e .

                 ( b) – ( e) . . . [P a r s. ( b) t o ( e) r ep e al e d b y G. N .R . 2 3 98 d d. 2 5. 1 1. 1 98 8 . ]


          ( 3)      ( a)       P ro c e ss e d m ea t , si m pl e or m i x ed s ha l l be meat which has been subjected to
                               c oo k i ng , c u r in g, drying, smoking and any com bination of such processes. It may
                               c on t a in c om mon salt, salpetre, sodium or potassium nitrite, sugar, vinegar, spices
                               a nd / o r p e rm itted colouring m atter, but no other foreign substances. The minimum
                               t ot a l m e a t c o nt e nt s ha l l b e 95 p er cent and the am ount of nitrite calculated as
                               s od i u m n it r i te, shall not exceed 200 p.p.m. in the f        inished article. If packed in any
                               c on t a in e r , fa t a g ar - a ga r a nd / o r g e la t i n m ay be u sed as a packing m edium.
                 ( b) . . . [ P a r . ( b) a dd e d by G.N.R . 1351 dd. 9.8.1968 and repealed by G.N.R . 908 of 1977,
                            w .e . f. 2 7 .5 . 1 97 8 .]


          ( 4)      (i )     M a n u fa c t ur e d m ea t products shall be m eat products which have undergone one or
                             m or e of t he p rocesses enum erated in 14 (3) in addition to m incing and/or grinding,
                             a nd i nc l u de po l o ni e s, s av e l oy s , m e at pastes, brawn, meat loaves or rolls and
                             s i m i l ar a rt i c le s containing m eat, but exclude food products of the nature of sausage
                             r ol l s an d m e at p ie s .
                    ( i i)     M a n u fa c t ur e d m ea t products shall be m ade from meat as defined in regulation 14
                               ( 1) ( a) wi t h s p i ce s and flavouring with or without milk, eggs, agar-agar, gelatin
                               a nd wh o l es o m e far i n ac e ou s or o th er vegetable substances. They m ay contain
                               a dd e d p h os p ha te s, not exceeding 0,5 per cent of the final product, added ascorbic
                                                                 6




                               a ci d , pe r m i t t ed pr e s er v a ti v es and colouring m atter, salpetre, and potassium or
                               s od i u m n it r i te : pr ovided that the finished article shall not contain more than 200
                               p .p . m . o f n i t ri t e calculated as sodium nitrite. T he total m eat content shall not be
                               l e ss t ha n 7 5 pe r ce n t . I f pa c ke d in a ny co ntainer, brine, fat, agar-agar and/or
                               g el a t in m a y be u se d as a p a ck i n g m ed i um .
                    ( i ii )   T he s ta n da r d s o f com position of canned meat products under this Act shall be the
                               c om p ul s or y st a n dard specification for the m anufacture, processing or treatm ent of
                               c an n e d m ea t pr o du cts declared by the Minister ofEconom ic Affairs under section
                               fi ft e e n ( 1 ) ( a) a nd ( i) o f t h e S t an d ar d s Act, No. 24 of1945. T he com pulsory
                               s t an d ar d sp e ci fi ca t i on s sh a l l a l so a pp l y to im ported canned meat products.
                    ( i v)     M e t h od s of c al c ul a t i on .
                    I n a l l c a s es wh e r e i t is n ec essary to calculate total meat under regulations 14 (1), (2), (3)
                    a nd ( 4) , t he for m ul a us e d s h al l be :—
                    P er c e nt a ge L ea n M e at = ( P e rc e nt a g e P r ot e in Ni t r og e n × 30 ) .
                    P er c e nt a ge T ot a l M ea t = ( P er c e nt a ge L ea n M e at + P e r ce n ta g e F a t ).


         ( 5)       ( a)       M e a t ex t ra c t sh a ll b e t h e p r od uct obtained by extracting fresh m eat with water
                               a nd c on c en t r at i n g t h e l i qu i d portion by evaporation after the rem oval of fat and
                               s ha l l co n ta i n n o t less than 75 per cent oftotal solids ofwhich not over 27 per cent
                               s ha l l be as h , a n d n o t o v er 12 per cent shall be sodium chloride (calculated from
                               t he t ot a l ch l or i n e p r es e nt ) , not over six-tenths per cent shall be fat and not less
                               t ha n 8 p e r c e nt s ha l l b e ni t r og e n.
                    ( b)       M e a t ju i ce s ha l l be t he flu i d p o rt i o n o f m uscle fibre obtained by pressure or
                               o th e r wi s e a n d m ay b e c on c e nt r a ted by evaporation at a tem perature below the
                               c oa g ul a t ion point of the solube proteins. The solids shall contain not m ore than 15
                               p er c en t of a s h, no t m o r e t h an 2,5 per cent of sodium chloride (calculated from
                               t he t ot a l ch l or i n e present), not m ore than 4 per cent and not less than 2 per cent of
                               p ho s ph o r ic a ci d (P ²O³) a nd no t le s s t h a n 1 2 p e r c e nt n it r o ge n .
                    (c)        P ep t on e s s h a ll be products prepared by the digestion ofprotein material by m eans
                               o f e n zy m es o r o t he r wi s e a nd shall contain not less than 50 per cent of proteoses
                               a nd p ep t on e s .


        ( 6)     . . . [ S u b r. ( 6) r e pe a le d by G. N .R . 20 6 4 d d. 2 . 11 . 19 7 3. ]


        ( 7) – ( 11 ) . . . [ S u br e gs . (7 ) t o 1 1 d e le t e d b y G . N. R . 1 31 6 dd . 16 . 8. 1 99 6 . ]


        ( 12 )   . . . [ S u b r. ( 12 ) re p e al e d b y G . N. R . 9 2 d d . 1 7 . 1. 1 98 6 .]


        ( 13 )   . . . [ S u b r. ( 13 ) re p e al e d b y G . N. R . 2 2 54 dd . 14 . 1 0. 1 98 3 .]
[ R e g . 1 4 su b st i t uted by G.N.R. 2517 dd. 10.12.1954 and am ended by G.N.R s. 164 dd. 3.2.1956, 1788 dd.
2 8. 9 . 19 5 6, 1 96 3 d d . 2 6 .1 0 . 19 5 6, 85 dd. 17.1.1958, 1795 dd. 11.11.1960, 1009 dd. 5.7.1963, 1191 dd.
1 3. 8 . 19 6 5 a nd 1 59 dd . 4. 2 . 19 6 6. ]


1 4b is . . . . [ R e g . 1 4b is i ns e r ted by G.N.R . 952 dd. 2.5.1952 and repealed by G.N.R. 230 dd. 18.2.1977.]




T ea
                                                                7




15.      T ea i s t h e l e av e s a n d l e af b ud s of s pe c i es ofThea prepared by fermenting and drying or firing. It
          s ha l l no t c o n ta i n a n y e x ha u st e d o r pa rtly exhausted leaves (that is leaves from which the active
          c on s t it u e nt s ha v e b e en wh ol l y o r pa r t ia lly rem oved by previous boiling or otherwise) nor any
          fo re i gn s ub s t an c e.


C of f ee , Co f f e e Mi x t u r es an d P r ep a ra t i on s o f Co f f e a


1 6.      ( 1)      C offe e i s th e se e d o f on e o r m o r e s p ec i e s o f c of f e a .


          ( 2)      G ro u nd c offe e i s co ffee r oa s t ed an d gr ound or otherwise prepared in a form suitable for
                    m ak i ng a n i n fu s i on or decoction. It shall not contain any exhausted or partially exhausted
                    c offe e , n or a ny for e i gn s ub s ta n c e.
          ( 2) b is . D e ca ffe in a t ed co ffe e s ha l l be c offe e fr om wh i ch a la r ge portion of caffeine has been
                      r e m o ve d . I t sh a l l n o t c o nt ain m ore than 0,1 per cent of caffeine and shall be labelled “de-
                      c affe i na t e d c offe e ” i n t y p e G .


          ( 3)      E ve r y m i xt u re p ac k e d or sold as “ Mixed C offee”or “ Coffee M ixture” or under any similar
                    n am e , n o i n g re d ie n t o t h er t ha n co ffee being m entioned in the name ofthe article, shall
                    c on s i st s ol e l y o f c o ffe e an d chicory, coffee constituting not less than three-quarters of its
                    w ei g ht . T h e na m e o f e v er y su c h m i xt u r e s ha l l be pr i n te d on the label in type D.


          ( 4)      T he l ab e l o f ev e r y m ix t ur e c on t ai n i ng coffee including “ M ixed Coffee” as described in
                    s ub r e gu l at i o n ( 3 ) h e re o f s h a ll b ea r a s t at e m e n t in type G, showing the names ofthe
                    i ng r e di e nt s a nd th e ap p r ox i m a t e p r op o rt i o n o r percentage of each. T he names ofthe
                    i ng r e di e nt s s ha l l b e st a te d in the order oftheir respective proportions, that present in the
                    l a rg e st p ro p or t i on being stated first. In addition, where the nam es ofthe ingredients appear
                    a ny w he r e e l s e o n t h e l a be l or c on t a in e r , t h ey s ha l l b e in type ofunif orm size and
                    p ro m in e nc e a nd t he nam e of the ingredient which constitutes the highest proportion shall
                    b e m en t i on e d fi r st .


          ( 5)      C offe e e s se n ce o r c o ffe e ex t r act shall be prepared only from coffee, with or without sugar
                    ( s uc r os e ) , o r o t h er e di b l e c a rb o hy d ra t es and shall contain not less than 0,5 per cent of
                    c affe i ne .


          ( 6)                                                                                           ee
                    C offe e a n d c hi c o ry e ss e nc e or e xt r a ct shall be prepared from coff and chicory with or
                    w it h ou t su g a r o r o t h er e di b le carbohydrates. It shall contain not less than 50 per cent of
                                                                                                                        ee
                    c offe e e x t ra c t a n d n o t l e ss than 0,25 per cent of caffeine, and shall be labelled “C off and
                    C hi c or y Es s e nc e ” o r “ C o ffe e a n d C h ic o r y E xt r a ct ” in t yp e D.


          ( 7)                                                                                    ee
                    C offe e a n d m il k sh a l l b e p r e pa r ed only from milk, sugar and coff or coffee extract and
                    s ha l l co n ta i n n o t l e s s t h an 0, 1 2 p e r c e nt ca ffei n e .


C h i c or y


17.      C hi c or y is t he d ri e d r o a st ed root of Cichorium intybus and shall contain no foreign substance other
          t ha n a t r a ce of e a rt h or s and unavoidably mixed with it during the process of collection and a trace
                                                               8




         o f fa t ty m a t t er u se d in r oa st i ng . It s ha l l y ield not m ore than 7,5 per cent total ash, and the ash
                                                              or
         r e m a i ni n g u nd i s so l ve d aft e r b oiling f five m inutes in an aqueous solution of Hydrochloric acid
         c on t a in i ng 1 0 p e r c e nt o f p u re HC L , s h al l no t ex c ee d 3 p e r c e nt .


C oc o a a n d Ch o co l at e


18 .     ( 1)     C oc o a b e an s ar e th e se e ds ofTheobroma cacao; cocoa nibs or cracked cocoa is the roasted
                  b ro k e n c oc o a b e an fr ee d fr o m i t s s h el l or h us k , w i th o r w i th o ut t he g er m .


         ( 2)      C oc o a p a st e , i n c lu d in g cocoa m ass, cocoa slab, unsweetened block chocolate, and cocoa
                   l i qu o r, i s t h e solid or sem i-solid mass produced by grinding cocoa nibs and containing the
                   w ho l e o f th e fa t na t u ra l l y p r es e nt i n t h e n i bs . It shall contain in its water and fat-free
                   r e si d ue n ot m o r e t h a n 8 per cent oftotal ash nor more than 5,5 per cent of ash insoluble in
                   w at e r , n o r m or e th a n 6 ½ p e r c e n t o f c r u de fib r e .


         ( 3)      C oc o a o r c o c oa po w de r is p owdered cocoa paste deprived or not ofa portion of its fat. Its
                   w at e r a n d fa t- fr ee r es i d ue s ha l l c o nt a i n n or m or e th a n 6 ½ p e r c e nt of crude fibre.
                   N ot wi t hs t an d i ng t he pr o v is i on s ofsubregulation (2) of regulation 3 it shall contain not
                   m or e th a n 7 0 p a r ts p er m i l l io n of c op p er .


         ( 4)      S ol u bl e co c o a, Du t c h process cocoa, or cocoa essence, is the product obtained by treating
                   c oc o a p a st e de p r iv e d o r no t of portion of its fat, with alkali or alkaline salts. It shall not
                   c on t a in m o r e t h a n 5 pe r ce nt of total water soluble alkali (that is water soluble alkali and
                   a l ka l in e sa l t s n a tu r a ll y present, together with added alkali or alkaline salts) calculated as
                   p ot a s si um c a r bo n at e . I t s wa t er a nd fat - fr ee and water soluble alkali-free residue shall
                   c on fo rm to t he s ta n d ar d fo r co c oa i n c l au s e ( 3 ) h e r eo f.


         ( 5)      P re p a re d , c o m p o un d ed , ho m e o pa t h ic or sweetened cocoa or soluble cocoa m ixed with
                   o th e r w h ol e s om e fo od s ub s t an c es. Every package thereof shall bear a label stating, after
                   t he n am e o f t he preparation (which shall be in type C ) the words “ C ontaining not less than
                   . . . ( he r e i n s er t th e nu m b e r o f parts per cent) parts per cent of dry, fat-free cocoa” in type
                   H.


         ( 6)      C ho c ol a t e p as t e , c o nfe c ti o n er ’s chocolate, chocolate coatings and chocolate powder are
                   c oc o a p a st e a s d efi ned in clause (2) hereof, with or without sugar, eggs, butterfat, spices or
                   h ar m le s s fl a vo u r in g s. Every such preparation shall contain not less than 10 per cent of f at-
                   fr ee c oc o a, a nd s ha l l b e fr e e fr o m c o co a h u s ks , any weighting substance, paraffin, or
                   fo re i gn fa t o t he r th a n b u tt e r fa t .


         ( 7)      C oc o a a n d m il k , c h oc o l at e and milk, or m ilk chocolate, shall be prepared from milk and
                   c oc o a w i th o r w i th o ut s ug a r , w ho l e so m e foo d su b st ances and harm less flavouring
                   s ub s t an c es a nd s ha l l c o nt a i n n o t l e ss t ha n 4 p er c e nt of fa t- fr ee c oc o a.


         ( 8)      C ho c ol a t e c o nfe ct i o na r y s h al l c on sist solely of wholesom e food substances covered or
                   c om p ou n de d w i t h c ho c o la t e p a st e or m il k ch o co la t e a s defined in this regulation.




C u s t ar d P o wd e r a n d Pu d d i n g P ow d er
                                                                   9




1 9.     . . . [ R e g . 1 9 r e p ea l ed b y G .N . R . 2 39 8 d d . 2 5 . 11 . 19 8 8. ]


C u r r y P ow d er an d T u rm e ri c Co mp o u n d
2 0.     . . . [ R e g . 2 0 r e p ea l ed b y G .N . R . 1 46 8 d d . 1 3 . 8. 1 99 3 .]


C h i l l i P ow d er
2 0 b is . . . . [ R eg. 20 bis inserted by G.N.R . 1231 dd. 18.8.1967 and repealed by G.N.R. 1468 dd. 13.8.1993.]


G in g er
2 1.     . . . [ R e g . 2 1 r e p ea l ed b y G .N . R . 1 46 8 d d . 1 3 . 8. 1 99 3 .]


C oc o n u t
2 1 b is . . . . [ R e g . 2 1 b is a dd e d b y G.N.R . 407 dd. 24.3.1933 and repealed by G.N.R. 692 dd. 16.5.1997.]


Mu s t ar d
2 2.     . . . [ R e g . 2 2 r e p ea l ed b y G .N . R . 1 46 8 d d . 1 3 . 8. 1 99 3 .]


P ep p er
2 3.     . . . [ R e g . 2 3 r e p ea l ed b y G .N . R . 1 46 8 d d . 1 3 . 8. 1 99 3 .]


C lo v es a n d O t h e r S p i ce s
2 4.     . . . [ R e g . 2 4 r e p ea l ed b y G .N . R . 1 46 8 d d . 1 3 . 8. 1 99 3 .]


S au c es a n d Ch u t n e y s
2 5.     . . . [ R e g . 2 5 r e p ea l ed b y G .N . R . 2 39 8 d d . 2 5 . 11 . 19 8 8. ]


J am , C o n s e rv e , M ar m al a d e , Fr u it - J el l y , e t c.
2 6.     ( 1)      . . . [ S u b r. ( 1) w it h dr a w n b y G . N. R . 2 62 7 dd . 1 2 . 12 . 19 8 6. ]
         ( 2) – ( 7)     . . . [ S u b re g s. ( 2 ) t o ( 7 ) r e p ea l e d b y G . N. R . 2 62 7 dd . 12 . 12 . 19 8 6 .]
         ( 8) – ( 11 ) . . . [ S u b re g s. ( 8 ) to (11) renumbered by G.N.R . 16 of8.1.1971 and repealed by G.N.R.
                            2 39 8 dd . 2 5 . 11 . 19 8 8. ]


S u g a r, Co n f e c t io n ar y , D e x t r os e an d I c in g S u ga r


2 7.        ( 1)        S ug a r ( s uc r o se ) is t he p ro d uc t obtained from the juice ofthe sugar cane and/or the sugar
                        b ee t .
                        ( a)      R efi n ed s ug a r s h al l be white, dry, odourless, granulated sucrose, readily soluble
                                  i n c o ld w at e r. It shall have no taste other than sweetness. Its sulphated ash content
                                  s ha l l no t e x c ee d 0,03 per cent and not m ore than 0,03 per cent of reducing sugars.
                                  I t s h a ll n ot c on t ai n m o r e t h an 0 ,0 6 p e r c e n t o f m o is t u re .
                        ( b)      M i l l- w hi t e s u ga r sh a l l b e a l m o s t w h it e, dry, odourless, granulated sucrose,
                                                                      10




                                     s ol u b le i n c o ld water. Its sweet taste shall be not more than slightly suggestive of
                                     t ha t of m o la s s es . Its sulphated ash content shall not exceed 0,01 per cent and not
                                     m or e th a n 0 , 03 pe r c en t of r ed ucing sugar shall be present. It shall not contain
                                     m or e th a n 0 , 06 pe r c en t of m o i s tu r e.
                       ( c)          G ov e rn m en t gr ade sugar shall be not m ore than light golden brown in colour, and
                                     s ha l l be r ea d il y so l u bl e in c ol d w a t er . T h e taste shall be sweet and m ay be
                                     s ug g es t i ve o f m ol a s se s .
                       ( d)          C as t or s ug a r s h a ll b e r e fined sugar of such fineness ofgrain that not m ore than 3
                                     p er c en t wi l l fa i l to pass through a sieve with 35 m eshes to the inch and not m ore
                                     t ha n 5 p e r c e nt s ha l l p a s s t h ro ugh a sieve with 150 m eshes to the inch. It may
                                     c on t a in t ri c a lc i u m p ho s phate in an am ount not exceeding 1 per cent or starch in
                                     a n a m o u nt n ot e xc e e di n g 3 pe r ce n t .
                       ( e)        . . . [ P a r . ( e) r ep e al e d b y G . N. R . 6 92 dd . 16 . 5. 1 9 97 . ]


           ( 2)        ( a)          D ex t r os e ( a n hy d ro u s dextrose) shall be a white crystalline or granular, odourless
                                     p ow d er , re a d il y so l ub l e i n co l d w a ter and with a sweet taste free from foreign
                                     fl av o ur . I t s h all contain not less than 99,9 per cent of anhydrous dextrose and may
                                     c on t a in n ot m o r e t h an 0 ,1 p er c en t of sulphate ash, 0,018 per cent of free acid,
                                     c al c u la t e d a s h y dr o c hl o ri c a cid, 20 parts per m illion of copper and 15 parts per
                                     m il l i on of i r on .
                       ( b)          D ex t r os e m o no h ydrate (purified glucose) shall conform to the sam e specifications
                                     l a id do w n fo r a n hy d ro u s d e xtrose, after correction for its water of crystalization
                                     w hi c h fo r t h e p u rp o s e o f t h i s r e gu l a ti o n i s ta k en a s 9 , 1 p e r c e nt .

                       ( c)          L iq u i d glucose is a colourless to light straw coloured, odourless, viscid syrup with
                                     a sw e et t as t e fr e e fr o m for e i gn fl av o ur . It c on s ists ofa m ixture of dextrose,
                                     m al t os e , de x tr i n a n d w a te r . It m ay contain not m ore than 0,6 per cent sulphate
                                     a sh , 0·0 4 5 p e r c e nt free acid, calculated as hydrochloric acid, 20 parts per m illion
                                     o f c o pp e r a n d 2 0 p a r ts p er m i l l i on of i r on .
                       ( d)        . . . [ P a r . ( d) r ep e al e d b y G. N .R . 6 9 2 d d . 1 6 .5 . 19 9 7. ]


           ( 3)        I c in g s u g ar i s a po w de r e d s ug a r p r e pared from refined sugar. It may contain tricalcium
                       p ho s ph a t e i n a n am o un t n o t exceeding 1 per cent or starch in an amount not exceeding 3
                       p er c en t an d pe r m itted colouring m atter. T he grains shall be of such fineness that not more
                       t ha n 2 p e r c e nt s ha l l r e m a i n on a sieve with 100 m eshes to the inch and not less than 65
                       p er c en t sh a l l p a ss t hr o ug h a s i ev e wi t h 2 0 0 m e sh e s t o t h e i n c h.


           ( 4)        C on fec t i on a r y i s t h e p r o du c t m ade from sugar (sucrose), dextrose and other sweetening
                       s ub s t an c es u se d for food, with or without perm itted colouring matter, harm less flavouring
                       s ub s t an c es , em u ls i fi er s or t hi c ke n i ng s ub s ta n ce s , a n d with or without other food
                       s ub s t an c es , su c h a s bu t t er , wh o le some edible fats, fresh eggs, milk, chocolate, nuts or
                       fr ui t s . I t sh a ll n ot c on t a in a ny r es i n o r an y fo r ei g n m i ne r a l s u bs t an c e s.


F ru i t J u ic e s , D i lu t ed Fru it Ju ices, Sweeten ed Diluted Fru it Ju ices, Con cen trated Fruit Juices, Fruit
P u r e es a n d Fr u it Ne c t ar s
 2 8.     . . . [ R e g . 2 8 r e p ea l ed b y G .N . R . 7 0 d d. 1 8. 1 . 19 7 4. ]


2 8 b is . . . . [ R e g . 2 8 b is r ep e al e d b y G. N .R . 7 0 dd . 18 . 1. 1 97 4 . ]


P er i s h a b l e Ar t i cl e s
                                                                   11




 2 9.      . . . [ R e g . 2 9 r e p ea l ed b y G .N . R . 2 39 8 d d. 25 . 1 1. 1 98 8 .]


P re s e rv a ti v e s t o b e u s ed b y i n s p ec t or s
 3 0.      . . . [ R e g . 3 0 r e p ea l ed b y G .N . R . 2 16 2 d d . 1 6 . 11 . 19 7 3. ]


D ru g s
 3 1.      . . . [ R e g . 3 1 r e p ea l ed . ]


D u t c h M ed i ci n es
3 1 b is . . . . [ R e g . 3 1 b is r ep e al e d .]


D is i n f e c ta n ts
 3 2.      . . . [ R e g . 3 2 r e p ea l ed b y G. N. R . 2 3 98 d d. 25 . 1 1. 1 98 8 .]


C h e wi n g- G u m
 3 3.      . . . [ R e g . 3 3 r e p ea l ed b y G .N . R . 2 39 8 d d . 2 5 . 11 . 19 8 8. ]


T ob a cc o , C i ga r s, Ci g a re t t es an d S n u f f
 3 4.      . . . [ R e g . 3 4 r e p ea l ed . ]


O in t me n ts , Cr e am s a n d P ow d e r s
 3 5.      . . . [ R e g . 3 5 r e p ea l ed b y G .N . R . 2 39 8 d d . 2 5 . 11 . 1 98 8 .]


T oo t h P as t e , T oo t h P ow d er s an d M ou t h W as h es
3 5 b is . ( a)          T oo t h p o wd er s s ha l l b e fr e e fr o m a ny h ar m fu l in g r edient and shall not contain any
                         fl uo r i de .
             (b )                                                            ul
                         M o u t h w as h es s ha l l be fre e from any harm f ingredient and shall not contain any added
                         fl uo r i de .
            ( c)         T oo t hp a st e s ha l l b e free from any harm ful ingredients. It may contain not m ore than 1 500
                         p ar t s pe r m i l lion fluoride ion. When fluoridated, toothpaste shall contain not less than 750
                         p ar t s pe r m i l li o n fl u or i de i on .

            ( d)    . . . [ P a r . ( d) r ep e al e d b y G. N. R . 9 0 8 o f 19 7 7, w. e . f. 2 7. 5 . 19 7 8. ]


S oa p
 3 6.      ( 1)     . . . [ S u b r. ( 1) r e pe a le d by G. N .R . 23 9 8 d d. 2 5. 1 1 .1 9 88 . ]
           ( 2)     . . . [ S u b r. ( 2) r e pe a le d by G. N . R . 9 0 8 o f 19 7 7, w. e . f. 2 7 .5 . 19 7 8. ]
           ( 3) – ( 7)    . . . [ S u b re g s. ( 3 ) t o ( 7 ) r e p ea l e d b y G . N. R . 2 39 8 dd . 2 5. 1 1. 1 9 88 . ]




D u t i es o f A n a l ys t s , P at h o lo g is t s a n d I n s p ec t o rs
                                                                                     12




 3 7.        . . . [ R e g . 3 7 r e p ea l ed b y G .N . R . 2 16 2 d d . 1 6 . 11 . 19 7 3. ]


R eg i st r a ti o n o f G e n e r al W a r ra n ty
3 8.           ( 1)            A pp l ic a t io n s fo r r e g is t r at i on of general warranties, and certificates of registration of such
                               w ar r a nt i e s, s ha l l b e on t he for m s h ow n i n An n ex u re C .
               ( 2)            T he fee s fo r r eg i st r a ti o n o f ge n e ra l wa r ra n t ie s sh a l l b e :
                                                                                                                £     s.     d.

               ( a)        F or e ve r y i n i ti a l r e g is t r at i o n, a nd t o c ov e r t h e p e r io d
                           ending 31st M a rch next ensuing. . .. . . .. . . . .. . . .. . . .                  5     5      0

               ( b)        F or ea ch rene wal up to 31st M arch next ensuing. . ..                             1     1      0
                                                                                              ore
               S uc h fe e s m u st b e p ai d t o t he S ec r e ta r y fo r Health bef the certificate can be issued. Original
               c er t i fic a t es o f r e gi s t ra t i on s ho u ld a cc o m p a ny a ll a pp l i ca t i on for r en e wa l s.


V it a mi n s
 3 9.        . . . [ Reg. 39 substituted by G.N.R . 805 dd. 19.5.1944 and repealed by G.N.R. 2398 dd. 25.11.1988.]


E d i b le G e l a ti n
3 9 b is . ( 1)           . . . [S u br . ( 1) r ep e al e d b y G. N .R . 6 9 2 d d . 1 6 .5 . 19 9 7. ]
         ( 2)                                                                             orm a colloidal solution which on
                  E di b l e g el a t i n s ha l l di s so lve completely in hot water to f
c oo li ng s et s t o a je l l y, a nd s hall be free from objectionable taste and off   ensive odour when examined in a 5
p er c en t aq u e ou s s o l ut i on a t 6 0 °C .
          ( 3)     T he ge l a ti n sh a l l c o nfo r m t o t h e fo ll o wi ng requirem ents, based on 16 per cent m oisture
c on t e nt , ex c ep t t he wa te r c o nt e n t, w hi c h i s de t er m in e d o n th e sa m p l e a s r ec e iv e d —
                                                                                    M ini mu m             M ax i mu m
Water cont ent. . .. . . .. . . . .. . . .. . . . .. . . .. . . . .. . .                  -               1 6 p e r c e nt
Ash content. . .. . . .. . . . .. . . .. . . . .. . . .. . . . .. . . . .                 -              2 .5 p er c en t
P .H. value . . .. . . .. . . . .. . . .. . . . .. . . .. . . . .. . . . ..            4.0                     8 .4
S ulphur dioxide. . .. . . .. . . . .. . . .. . . . .. . . .. . . . ..                    -      1 ,0 0 0 p a rt s pe r m i l l io n
A rsenic (exp ressed as arsenious oxide ). . .. . . ..                                    -       3 .5 p ar t s p e r m i l l i on
L ead. . .. . . .. . . . .. . . .. . . . .. . . .. . . . .. . . . .. . . .. . .           -        1 0 p a rt s pe r m i l l io n
C opper. . .. . . .. . . . .. . . .. . . . .. . . .. . . . .. . . . .. . . ..             -        3 0 p a rt s pe r m i l l io n
Zinc . . .. . . .. . . . .. . . .. . . . .. . . .. . . . .. . . . .. . . .. . .           -       1 00 p ar t s p e r m i ll i o n
T in . . .. . . .. . . . .. . . .. . . . .. . . .. . . . .. . . . .. . . .. . . .         -       2 50 p ar t s p e r m i ll i o n
             ( 4)        . . .
             ( 5)        . . .
             ( 6)        . . .
[ S u b r eg s . ( 4 ) - ( 6) r ep e a le d by G. N .R . 69 2 d d . 1 6 .5 . 1 99 7 .]
             ( 7)        T he c on t ai n e rs s ha l l b e cl e a rl y l a be l le d “ E d ib l e G e la t i n”.
[ R e g . 3 9 b is i ns e r te d by G. N . R . 9 4 1 d d . 8 . 5. 1 95 3 an d a m en d ed b y G .N . R. 837 dd. 7.6.1957.]


H on e y
                                                                    13




 4 0.     . . . [ R e g . 4 0 s u bs t i tu t e d b y G . N. R . 2 51 9 dd . 10 . 12 .1954 and repealed by G.N.R . 2398 dd.
                 2 5. 1 1. 1 9 88 . ]
S al t
 4 1.     . . . [ R e g . 4 1 re p ea l e d b y G . N. R . 9 96 d d. 7 .7 . 19 9 5 w . e. f. 1. 1 2. 1 99 5 . ]
4 1 b is . . . . [ R e g . 4 1 b is inserted by G.N.R . 888 dd. 19.6.1964 and repealed by G.N.R. 439 dd. 19.3.1976.]


V in e ga r
4 1 t e r . . . . [ R e g . 4 1 t e r i ns e r te d by G. N .R . 21 3 0 d d. 2 9. 1 2. 1 967 and repealed by G.N.R . 2307 dd.
                  3 0. 1 0. 1 9 81 . ]
P en a lt i e s
 4 2.     . . . [ R e g . 4 2 r e pe a led . ]
                                                         ANNEXURE A
Me t h od of De t e rm i n i n g t h e Ca r b o l i c A ci d Co e f f i c ie n t o f L i q u i d G er m ic i d e s
          T he m e t ho d of d et e r m i n in g the germ icidal power ofefficacy ofliquid germ icides for the purposes of
t he F oo d , D r ug s a n d D i si n fec t a nt s Ac t , No. 13 of1929, shall be in accordance with the B ritish standard
t e ch n iq u e fo r d e t er m in i ng the R ideal-Walker coef  ficient of disinfectants as laid down in pamphlet No. 541,
1 93 4 , p u bl i s he d b y th e B r i t is h S t a ndards Institution, 28 Victoria S treet, London, S .W .1, and reprinted
h er e u nd e r: —
B RI T I S H S T A ND AR D T E CH NI Q U E F O R DE T E R MI NI N G T H E R I DE AL - W A L K E R
                           C O E FF I CI E N T O F D IS I NF E CT AN T S
N ot e :—
          (i )     I n t h e d e ve l o pm en t of t he p re s e nt t ec h ni q u e of the R ideal-Walker test every stage ofthe
p ro c e du r e h a s b e en t he s ub j ec t of the closest analysis, as the result of which inquiry it has becom e evident
t ha t t he s tr i c te s t a d he r e nc e to e ve r y detail is essential if concordance results are to be secured by different
w or k er s .
         ( i i)  C le a nl i n es s of working throughout the test is essential to avoid accidental contamination. T he
t e st s ho u ld b e c on d uc t e d i n a l a bo r at o r y fr ee fr om du s t a n d d r au g ht s .
      ( i ii )     O rg a ni s m s t ha t ha v e survived the action of a disinfectant shall in no circum stances be used in
t he te st .
                                                             A p p ar a t u s
                                                        I no c u la t i ng Lo o p
           A l o o p, 4m m . in internal diam eter, is formed at one end of a length of28 S.W .G. (.0148 in. dia.) wire
o f p l a ti n um , or pl a t i nu m i r i dium alloy, which is made 38 mm . long from the loop to the holder, the latter
c on s i st i n g o f a t h i n m et a l r o d o r tu b e .
           T he l oo p i s be n t a t su c h a n an g le to the length of the wire as will facilitate the rem oval of the loop
v er t i ca l l y fr o m t he s ur fa ce o f t h e l i qu i d w h il e ke e pi n g t h e p l a ne of t h e l o op ho r i zo n ta l .

                                                              I nc u b at o r
          A n i n cu b at o r , s e t a n d m ai n ta i n ed a t a temperature of 37°C . ± 1°C. C are should be taken to ensure
t ha t t he t em pe r a tu r e t h r ou g ho u t t h e i n cu b a to r is r ea s o na b ly c on s ta n t .

                                                               P ip e t te s
          S ev e r al a cc u ra t e ly s ta n d ar d iz e d p i p et t e s, m a d e w i th a c a p ac i t y o f 5 m l .

                                                        D ro p pi n g P i pe t t e
          A s t e ri l e d ro p pi n g p i pe t t e m ad e to d el i v er 0 .2 m l . (i n ab o ut fi ve d ro p s) .
                                                                     14




                                                     M ed i ca t i on Tu b e s
          F iv e st e r il e pl u g ged 5 in. x ¾ in. test tubes. Alternatively, special bottles m ay be used. S uch vessels
s ho u l d b e m ad e in fus e d silica, in two parts, dimensioned as in F ig. 1. T he upper part or cover to the bottle
s ho u l d fi t l o os e l y a s s h ow n .


                                                          1¼ i n.




                                                            1 in .



                                                           ¾i n.




                                                                          1¼ i n.




                                                                            2½ i n.




                                                          1¼ i n.




                                                             F ig . 1


          S li g h t v a ri a t io n s fr o m the dimensions indicated in the figure are perm issible so long as the capacity
o f t h e b o tt l e (a p pr o x im a te l y 3 0 m l . ) r e m a i ns t he s am e a n d t h e t o p fi t s l o os e ly o ve r it .

                                                          B ro t h T u be s
         A bo u t t w o d oz e n 5 i n. x ¾ i n. h ar d gl a ss t es t t ub e s.

                                                   M ea s ur i ng C yl i n de r s
         O ne s to p pe r e d 1 li t r e c y li n de r gr a d ua t e d t o 1 0 m l .
        O ne s to p pe r e d 5 00 ml. cylinder graduated to 10 ml., and having an external diam eter of not less than
4 8 m m . a nd no t gr e a te r th an 53 mm . and a capacity above the graduated portion of not less than 70 m l. and
n ot g re a t er t ha n 12 0 m l .
         F iv e st o pp e r ed 1 00 m l . c yl i nd e r s g r ad u at e d t o 1 m l.
         A ll a pp a r at u s m us t be s cr u p ul o us l y c l e an an d st e r il e i m m ed i at e l y b e fo r e u s e .
                                                            R ea g en t s


                                                               B ro t h
         A s t a nd a rd R id e al - W a l k er - b ro t h , p r ep a r ed as fo ll o ws :—
         T we n ty gr m . o f La b -L em c o, 20 grm. of peptone (Allen and Hanbury’s Eupeptone), and 10 grm . of
s od i u m c hl o ri d e a r e dissolved in 1,000 m l. of distilled water. The solution is boiled for 30 m inutes, cooled,
a nd m a d e u p to 1, 0 0 0 m l. with freshly boiled distilled water. Twenty-five m l. of the broth is then titrated at
3 7°C wi t h N /1 0 s od i u m h yd r ox i de s ol u t io n , using 0,1 m l. of 0,5 per cent phenolphthalein solution as
                                                                       15




i nd i c at o r .
          B y c a lc u la t i on fr om th i s t i t ra t i on t he b ul k of the broth is then neutralized at 37°C with norm al
s od i u m h yd r ox i de s ol u t io n . T h e m ixture is brought to the boil or steam ed for half    -an-hour to bring down
p ho s ph a t es , wh i ch a re removed by filtration whilst the broth is hot. T he broth is then adjusted to a pH value
o f 7 , 6 b y t h e a d d it i o n o f n o rmal hydrochloric acid, using a com parator with phenol red. The alkali and the
a ci d sh o ul d be a dd e d s l ow l y a n d w it h vi g o ro u s s h ak i ng .
                                                                                                 or
          T he br o t h i s th e n s t er i l i ze d i n bu lk, either by autoclaving once f 20 m inutes at one atmosphere
p re s s ur e , o r by s te a m i n g fo r 2 0 m i nu t e s o n e a c h o f t h r ee s uc c es s i ve d ay s .
            I t i s t he n fi l t er e d t hr o ugh filter paper, and placed in quantities of5 m l. in the 5 in. x ¾ in. hard glass
b ro t h t u b es , wh i ch ha v e p r e vi o us l y b e en c le a n ed , plugged and sterilized. The tubes of media are then
s t er i l iz e d e i t he r by autoclaving for 10 minutes at one atm osphere pressure, or by steaming for 20 m inutes on
t hr e e su c ce s s iv e da y s. T h e fin a l r e a ct i on o f t h e m e di u m s ho u ld l i e b et w e en pH 7,3 and pH 7,5.
           W h e n o n ce s te r i li z e d, t he broth keeps indef initely in bulk. When in the broth tubes, evaporation is
l i ab l e t o ta k e p la ce t hr o u gh t he pl u g s i f th e tu b es a re k ep t fo r a l o ng p er i o d b efo r e u s e.
           F ur t h er r st e r il i z at i o n i n b u l k o r i n tu b es i s n o t p e rm i ss i b le .
                                                                 O rg a ni s m
           T he or g a ni s m u s ed i s B ac i l lu s ty p ho s us , of w hich a suitable culture shall be obtained from :—
                    T he C u r a to r ,
                         N at i o na l C o l le c t io n o f T y p e C ul t u re s ,
                                L is t e r I n st i t ut e ,
                                      C he l se a Ga r de n s , L on d on , S . W .1 .
           T he pu r p os e fo r wh i ch t he c ul t ur e i s r e qu i r ed sh a l l b e s p e ci fi ed .
           T he e xt r em e im po r t an c e o f us i n g t he s t an d ar d st r a in i s e m p h as i z ed .
           F or t he p ur p os e of t he te s t , a little of the growth is placed in a tube of the R ideal-Walker broth and
i nc u b at e d fo r 2 4 ho u rs at 37°C. A standard loopful is then transferred to a second tube, which is incubated as
b efo r e. T hi s is d on e fo r at l ea s t t h r ee s uc c e ss i ve g enerations in broth before a test is carried out. Sub-
c ul t u ri n g m u st b e l i m i t ed t o fourteen days. It is convenient to start a fresh series from the agar each week.*
          I t i s ad v i sa b le t ha t a fr e sh culture be obtained each month and started in this way in broth. If this be
i m p r ac t i ca b l e, c ar e m u s t be taken to ensure that the organism satisfies the requirem ents ofthe test, as stated
b el o w, w it h i n t h e l i m i t s o f th e sp e ci fi e d c ar b o li c ac i d d i l ut i o ns .
          W h e n a t es t is t o b e ca r r ie d ou t , t h e p l ug o fthe broth culture tube is replaced by the plug of the
d ro p pi n g p i p et t e ; t h e t i p o f th is pipette should be below the surface ofthe culture, which should be m ixed
t ho r o ug h ly a nd al l o we d t o se t t l e fo r h a lf- a n- h ou r at 1 7 – 1 8°C b e for e us e .
           C ul t ur e s sh o wi n g s i gn s o f c lu m p i n g m us t be di s ca r d ed .

                                                S ta n da r d P h en o l ( C ar b ol i c A c i d)
          P ur e ph e no l ha v in g a c r ys t a ll i z in g point of not less than 40,5°C must be used. A 5 per cent stock
s ol u t io n in s te r i le d is t i lled water (containing 5 grm . of pure phenol in each 100 ml. of solution) is prepared
a nd i s u s ed for m a k i ng t he c on t ro l di l u ti o ns , wh i c h a r e t o b e in t he fol l o wi n g p r oportions:—
                    1 gr m . o f p u r e p he n ol i n e a c h 9 5 m l. o f s o l ut i on m a d e .
                    1 gr m . o f p u r e p he n ol i n e a c h 1 00 m l . of s ol u t io n m a d e.
                    1 gr m . o f p u r e p he n ol i n e a c h 1 05 m l . of s ol u ti on m a d e .
                    1 gr m . o f p u r e p he n ol i n e a c h 1 10 m l . of s ol u t io n m a d e.
                    1 gr m . o f p u r e p he n ol i n e a c h 1 15 m l . of s ol u t io n m a d e.
           T he s e d i lu t i on s sh a ll n ot b e k e pt for m or e th a n a we e k.
                                                                  16




                                                             Me t h od
          T he s am pl e of d i si n fec t an t t o b e t e st e d s h a ll b e well m ixed imm ediately before any portion is
                                                            erring it to a dry vessel of sufficient size for the purpose. The test
w it h dr a w n fo r t e st i n g, i f n e ce s s ar y transf
p or t i on s ha l l b e wi t hd r a wn fr o m t h e m id d l e o f t h e s a m p l e .
* In cases where, on a particular day , sub-culturing would be impossible, a 48-hour culture may be used for subsequent sub-culturing,
p r ov id ed that during the 48-hour period the culture has been kept in the incubator, but in such circumstances a further 24-hour sub-
c ultu r in g mu s t b e ca r r ied o ut b ef o r e a tes t is p e r fo r m ed .
          T he t es t po r t io n o f 5 ml. shall be taken as above, by means of a 5 m l. capacity pipette, which is f      illed
t o a b ov e th e mark, wiped clean outside with sterile cotton wool and run down to the m ark. The contents shall
t he n be a ll o wed to discharge into the 500 m l. m easuring cylinder, previously filled to about the 480 m l. mark
w it h st e r il e di s t il l e d w t er at a temperature between 17°C and 18°C, with the nozzle of the pipette below the
s ur fa ce o f t h e w a te r . T h e p i pe t t e s h al l be rinsed out three tim es, or more in the case of viscous fluids, by
d ra w i ng up a nd r et u rn i n g fr om the clear portion of the liquid. T he whole shall then be m ade up to 500 ml.
w it h st e r il e di s t il l e d w a te r, the cylinder stoppered, and the contents thoroughly m ixed by inverting with a
c or k- s cr e w m o ti o n fi fty t i m e s.
                                                                                          rom this stock solution, using sterile
            S ui t a bl e te s t d i l ut i o ns sh a l l t h en be im mediately prepared f
d is t i l le d wa t er ( se e Ap p en d ix A) .
         I n t h e c a se o f s o l id s ub s tances m iscible with water, the stock solution shall be prepared by weight.
          F iv e m i l li l i t re s of t he four dilutions chosen shall be placed in each of four of the plugged sterile 5 in.
x ¾ i n. m ed i ca t i on t ub e s o r bo t tl e s , s t ar t i ng w ith the weakest solution. (When the coefficient is quite
u nk n ow n , i t is n ec e ss a r y t o pe r for m o n e or more ranging tests with broadly separated dilutions). T hese
m ed i ca t i on t ub e s s h al l t he n b e pl a c ed i n a ra c k ( p r ov i ded with a water bath m aintained at a constant
t e m p er a t ur e , w h ic h sh a l l l i e between 17°C and 18°C.), with the strongest disinfectant on the left. T he fifth
m ed i ca t i on t ub e , c o nt a i ni n g 5 m l . of t he particular carbolic acid control, shall be placed on the right. A
s ep a r at e pi p e tt e m u s t b e u s ed for t a ki n g t h e 5 m l . of c ar b ol i c ac i d s o lu t i on .
          S ta r t in g at z er o ti m e, 0 , 2 m l . o f th e cultur shall be added from the special pipette to the left-hand
m ed i ca t i on t ub e , w h ic h sh a ll then be shaken. Thirty seconds after that addition, the next tube on the right
s ha l l be i no c ul a t ed wi t h 0 , 2 m l . o f cu l tu r e in a sim ilar m anner, and so on with each successive tube, at
i nt e r va l s o f 30 s ec o nds, until, finally, the carbolic acid control has been inoculated. T hirty seconds after this
l a st a dd i ti o n ( i . e. 2 ½ m in u t es from zero), a loopful of the well-shaken contents of the tubes on the extrem e
l e ft s ha l l b e wi t hd r a wn an d p l aced in a tube containing 5 m l. of the R ideal-Walker broth, this tube having
p re v i ou s ly b ee n m a r ke d “ I”. Thirty seconds after this loopful has been withdrawn, a sim ilar operation shall
b e p e rfo r m e d o n th e se c on d m e di c a ti o n tube, the loopful being transferred to a tube ofbroth m arked “ 2”.
T he pr o c ed u re s ha l l be r ep e at e d at intervals of30 seconds with each of the five medication tubes, working
fr om le ft to r ig h t , u nt i l 4 sets of cultures have been made: i.e. at 2½, 5, 7½ and 10 m inutes respectively after
e xp o su r e . T he t ub e s s hall be shaken imm ediately after m edication. In each withdrawal, precautions shall be
t a ke n t o en s ur e t ha t th e lo o p i s rem oved vertically from the surface ofthe liquid with its place horizontal.
          T he l oo p s h a ll b e sterilized by flam ing between each operation, care being taken that the loop is cold
b efo r e b e in g ag a in u se d .
        T he s e t w en t y t u be s sh a l l then be incubated for not less than 48 hours and not m ore than 72 hours at
3 7°C ., w he n th e tu b es c on t ai n i ng B ac i l lus typhosus will be recognized by the opalescence of the broth.
                                             C al c u l a t io n o f Co e f f i ci e n t
         T he R i d e al - W a l k er c oe ffic i ent shall be obtained by dividing that dilution ofthe disinfectant which
s ho w s l i fe i n 2 ½ an d 5 m i n u te s but no life thereafter, by that dilution ofcarbolic acid (1:95, 1:100, 1:105,
1 :1 1 0 o f 1: 1 15 ) wh i ch s ho w s l i fe i n 2 ½ a n d 5 m i n ut e s b u t n o li fe th e re a ft er .
           I t i s co n ve n i en t to refer to a tube showing life of Bacillus typhosus by a + sign and a tube showing no
l i fe , or n o B ac i l lu s ty p ho s us b y a – s ig n .
          W h e n n o p r e vi o us t es t s ha v e b e en carried out, so that the necessary carbolic acid strength is quite
u nk n ow n , i t is n ec e ss a r y t o c a r ry o ut a separate test with the five carbolic acid dilutions only, in order to
o bt a i n t h e c o nt r ol d il u t io n of carbolic acid which satisfies the above requirem ents. When a num ber oftests
                                                                  17




h av e to b e c a rr i e d o ut a t the sam e tim e, however, a different carbolic acid dilution m ay be used for each test,
t hu s av o i di n g t h e n e ce s si t y fo r a s eparate carbolic acid test to obtain the control dilution of carbolic acid.
                                                             E x a mp l e
         A t y p ic a l s e t o f r es u lt s i s s ho w n i n t h e fo l l ow i ng ta b l e: —

S am p l e Disinf ectan t          D il u t io n          T im e c u l tu r e was ex posed to action of
                                                          d is i n f e c ta n t i n m i n u t es .
                                                               2½            5            7½       10
             A                      1 :1 0 00                  —             —            —        —
             A                      1 :1 1 00                  +             —            —        —
             A                      1 :1 2 00                  +             +            —        —
             A                      1 :1 3 00                  +             +            +        —
C ar b ol i c Ac i d . . .           1 :1 0 0                  +              +           —        —

                                R id e al - W a l k er c oe ffic i e nt = 1 2 00 / 1 00 = 1 2, 0 .
                                                                                    ficient over the range ofdilution of
           A t a b le i s i n cl u d ed i n A pp e ndix A showing R ideal-Walker coef
d is i n fe c t an t fro m 1 : 10 0 to 1 :2 5 00 .
          No te . — T h e R i d ea l -W a l k er t es t as s pecified above, is applicable only to water-soluble or water-
m is c i bl e su b st a nces. It m ay be applied to a water-insoluble or water-imm iscible substance, provided that the
                                                                                     ied
m et h od o f b r in g i ng th e su b stance into solution or suspension is specif in detail in the report on the test.
                                                          A pp end i x A
                                                                                  luid in 500 ml. of the stock solution.
         T he s to c k s o lu t ion ofdisinfectant contains 5 ml. of disinfectant f
           F iv e m l . of t hi s st ock solution is diluted for the purpose ofthe test by die addition ofwater to make a
t ot a l vo l um e s h ow n in C o l um n 1 o f t h e fo llowing table. The proportion of original disinfectant to final
d il u t io n is s ho w n i n C o lu m n 2 of t he t ab l e .

                               C oe f f icient when growth s in d isin f ectant d ilution eq ual to
C ol u mn      C ol u mn
                                g r ow t h s i n p h e n ol d i l u ti o n o f o n e p ar t in —
    1              2
                                   95              1 00            1 05            1 10           1 15
  1 25         1 :2 5 00          26,3             25,0            23,8           2 2, 7           2 1, 7
  1 20         1 :2 4 00          2 5, 3           2 4, 0          2 2, 9         2 1, 8           2 0, 9
  1 15         1 :2 3 00          2 4, 2           2 3, 0          2 1, 9         2 0, 9           2 0, 0
  1 10         1 :2 2 00          2 3, 2           2 2, 0          2 1, 0         2 0, 0           1 9, 1
  1 05         1 :2 1 00          2 2, 1           2 1, 0          2 0, 0         1 9, 1           1 8, 3
  1 00         1 :2 0 00          2 1, 1           2 0, 0          1 9, 0         1 8, 2           1 7, 4
    95         1 :1 9 00          2 0, 0           1 9, 0          1 8, 1         1 7, 3           1 6, 5
    90         1 :1 8 00          1 8, 9           1 8, 0          1 7, 1         1 6, 4           1 5, 7
    85         1 :1 7 00          1 7, 9           1 7, 0          1 6, 2         1 5, 5           1 4, 8
    80         1 :1 6 00          1 6, 8           16,0            1 5, 2         1 4, 5           1 3, 9
    75         1 :1 5 00          1 5, 8           1 5, 0          1 4, 3         13 ,6            1 3, 0
    70         1 :1 4 00          1 4, 7           1 4, 0          1 3, 3         1 2, 7           1 2, 2
    65         1 :1 3 00          1 3, 7           1 3, 0          1 2, 4         1 1, 8           1 1, 3
    60         1 :1 2 00          1 2, 6           1 2, 0          1 1, 4         1 0, 9           1 0, 4
    55         1 :1 1 00          1 1, 6           1 1, 0          1 0, 5         1 0, 0            9 ,6
    50         1 :1 0 00          1 0, 5           1 0, 0            9 ,5          9 ,1             8 ,7
    45          1 :9 0 0            9 ,5             9 ,0            8 ,6          8 ,2             7 ,8
    40          1 :8 0 0            8 ,4             8 ,0            7 ,6          7 ,3             7 ,0
    35          1 :7 0 0            7 ,4             7 ,0            6 ,7          6 ,4             6 ,1
    30          1 :6 0 0            6 ,3             6 ,0            5 ,7          5 ,5             5 ,2
    25          1 :5 0 0            5 ,3             5 ,0            4 ,8          4 ,5             4 ,3
    20          1 :4 0 0            4 ,2             4 ,0            3 ,8          3 ,6             3 ,5
                                                                    18




         F or we a k er g er m ic i des 20 m l. of the stock solution is diluted by the addition of water to m ake a total
v ol u m e s ho wn i n C olum n 1 ofthe f  ollowing table. T he proportion of original disinfectant to final dilution is
s ho w n i n C o lu m n 2 .

                               C oe f f icient when growth s in d isin f ectant d ilution eq ual to
C ol u mn      C ol u mn
                                g ro w th s in p h e n ol d i l u ti o n o f o n e p ar t in —
    1              2
                                    95          1 00          1 05           1 10          1 15
    70          1 :3 5 0            3 ,7            3,5                  3,3              3,2           3, 0
    60          1 :3 0 0             32             3 ,0                 2 ,9             2 ,7          2 ,6

                               C oe f f i c i en t wh e n g ro w th s in d i s i n f e ct a n t d ilution
C ol u mn      C ol u mn               e q u a l t o g r ow t h s i n p h e n ol d i l u ti o n
    1              2                                   o f o n e p ar t in —
                                    95           1 00            1 05          1 10             1 15
    50          1 :2 5 0             2,6              2,5                2,4              2,3             2,2
    40          1 :2 0 0             2 ,1             2 ,0               1 ,9             1 ,8            1 ,7
    30          1 :1 5 0             1 ,6             1 ,5               1 ,4             1 ,4            1 ,3
    20          1 :1 0 0             1 ,1             1 ,0                 —                —               —

          N ot e .— T h e s e t a bl e s a r e i n t en d ed t o fa ci l i t at e th e calculation of the results and should not be
r e ga r de d as i m p os i n g a n y l i m i t s o n t h e d i l ut i on s to b e u s ed . T h e y m ay be extended as desired.

                              [ An n e xu r e A s ub s titu te d b y G . N. R. 73 9 dd . 29 . 5 . 19 3 5. ]

                                                       ANNEXURE B
                       [ An n e xu r e B a me n de d by G. N . R. 7 39 d d 2 9 . 5. 1 9 35 a nd r ep e a le d . ]

                                                       ANNEXURE C
                                                    [ An n e xu r e C r ep e a le d . ]

                                                       ANNEXURE D
                     [ An n e xu r e D a me n de d by G. N . R. 1 61 5 dd . 2 2. 1 1 .1 9 3 3 a n d r e pe a led . ]

				
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