Resolution No. 92/1 of 1998 establishing the requirements for agricultural medicines package and the necessary information on it

Label specifications: (Product Name) l.i.J~I ,...'ii • (Common name of the :tJ\alll iJL...11 • Active Ingredient) ~) ~I , ~ rLJI ~'JI ;-S~ ( u-ill ~ (.)'Q ~ y:.l (Composition) ~Jill • ~ Ulaill .ll - -11 · JS 4..J...i...i • <~ • .., , . (.)-A • .J (Active ingredients & other U~I .ll , .JI ingredients) (Annexes 1 & 2 '\' .J ' ~I ~1.J) (Formulation type) ~Jill e,.Jl • (EC,WP .•. J4ll ¼ti O.J.ly, ".•l,i,ne) (Summary of .l;, 11,:i.;ll ~'ii "°f+J • uses) ( .. -(j.;bi '(j JiA - ~' t~) (Mode of action) ~I ~~ • ·(systemic, Contact... ,~ '(iJlt+) (Registration number) Jn · 11iJI ~.J • . .l.s:.IJjll iJjJ u--~~I~~~ (Batch number) WJJl/4Jll...}'il ~.J • (Net content) ~I (S~I • ~ UJJI ~.JJl,,,:;JI ulJ4allJ J.,.t.;ll • (Hazard Symbols) .,Jl.lai.'il wl ~ ,(Annex 3 r ~.J Ja,l.JI ~1.J) J~ w- 7. , o w--c. j-)I J ,.J,:. J..i:i 'J , ~ ~ 'il ~ J..i; 'J wl ~ J....-1.JI w..,$i wl .J ,(Annex 4 f ~I ~I .J) '\' ~ ~I , ~I , ~ ~~ ~.J:!~I ul .J4-JI 1-l.+ rl...i ..,, rl...i ,c.s.;:.'JI u4bS.II (.)'Q ~ (.)'I JL,.I ,Harmful .Jl....:a ,(Toxic or very toxic) ,Caution ,.'4.c.l.Jjll .J:ljJ wl C:.!.JLJ '\ o • , r-.l .J r ,-....i ,.JI ~ ~ ~ ,(4...efi:JI ~) , '\ '\ '/" /V ¢,:=.JU Arv, r-.l .J r ,-....i ,.JI ~. ~ ~ ( ~I .JJll o) j.., f Jt; ii) , '\,A/,/ A ,~.la:i , C:.!.Ju o • r '\ r-.l .J r ,-....i ,.JI ~ ~ ~ o.J~ ½•;\;iill ~..,.. ..-jll) , '\A'\' /r'/Y '\ ,(~1.Jjll ~ ,JJI (.)'I.J.l ~, ~' ~ ~ ~~ ~.J.l~I wl~ ~ J.-,:al.JI ul..i....:.I ,.. ,~I.Jjll t..c:.I.JJll o)J.., rLc. .J:l.l..o clfaj ~ ~~ ,~I.Jjll ~.J.l~I ~ /J4J.J :~ L. .J~ ~.J .ll~j \:j4 l.a.l.. ~ i)J'il oJW\ · • .. - t l- ~I jll ~ .l~I J l.w I ~ r .. .J .. .J .J .J ~ o.l) .,JI uL. ,1..JI , ul..i...al ,..ll J.w:t.WI l~ 'J I~..)-?.~ 'i~I.., ,Ji ,.JI J ,.l?,ll . J ;ill 11\ (.)'Q w..e I.Jl+ic-1 J >.ill I~ ~ Y o.lWI . , '\'\'\/'/' w-e ~.., ) ;.ill t:u ~ r o.lLJI ·rY:: , '\'\A )-;11 '\' • , } ,u ,~ .'4.c. I .Jjll .J:lj.J 'i .J ,:i..ls ~ ~ (First aid) ~J~I ulila., .. m • ~ (Medical advice) 4:J::all t+n,,...31 • L....s oJ-.,.+J ~ ~ Antidote ~JUI ;.Sj .;~ c.,s, ~L...11 J~!» o.;t+ .;Sj ~ .«1.;,.,i ~I ,.~J:i.w.!J ~ '-"" ,.:;JI :u.;WI ul~I u,.-~I ~.):a• ,Disposal of Pesticide Containers ~ ,. . ,: ·-'·'I u. f • .. ~ ~J ~ ~ u-,-1 ~. ~ '-""~ ~I ~ ~ .;;~ uJ1.. ul ~ ~I e Ui.;! u,.- 7. , o c.,s, ~ :6Jll4~ I~ 4...,aL.JI.J 4...,aL..Jl d~ ...r=-,\tl (Toxic & Very Toxic) (Harmful) o }~.a.II d~ ;i.-\tl (Caution) (U"faj) d~ J.Jj\tl (Non ~I 4ill d~ ~\ti hazardous in normal use) (Annex 3 r ~I ~1.J) ~J ~,»ill '-'4~ ,o;U • ~I ul.,H&ll (Physico-Chemical Properties) ~/..All'. ~ ~ ~jl ½..>.ib:ill d.J4--ll.J j.J-.G )I ~ .J Y-?:l J~ . ...J ,4-.Jjl.w..iS : ,;11 ·~ ~I ~ ...... .J:~ c...,.aJ • : .l..1.1..JI • -< -· (..)..,.. (Corrosive) JS\:ill ~ (Explosive) .)4,.i.yll ~ti (Flammable) ( ~~ .J Jjl...a) ~ ~ti (~L...JI j.J---=!".J ~) ~ ~LJ (Flammable, Water reactive) (Highly Flammable) J~\tl ,l:!~ (Irritant) y~I ~ ( Oxidizing) o.l....lS ya ojl..i ~ 7., • w,.c, j..A)I J..,la Ji; \t wl ~ f .J '\ (J Ji> I JI t--?'I .J) J • al oll J..,. b ( Annexes 4 & 6 t.~ u\Jwl.. ½.,lhJI wl..o ,la.JI .JI j.J-4 )I ~ Ll:..J • ~ ,.it.ill ~ ~ ytll u.a Y':! ~IJ:al l rJ,4~ ,-..,. .; JI J., ..; • (Pictograms) ~.,SI ,:,,c, o yUI.J 4.ii yJI o y!illl ~ ~ ;i Global Crop Protection.J F AO J\ ~ t--?-1.J) (~::" GIFA:..JI) Federation (GCPF) ~ U-9.JJ: ~.J (Annex 5 o ~I wl .J ~ wl Y----?:!.J l:U . ~' ~L-.i. w-o w~l Jl\tl ~ wU.-WI ~ ~ : ~ .J ~..>.ib:ill d .J4-ll .J J.JA )I J.J~ w-.c- ,~ Jl.... wts.. ~ ~.fJ ~\tl • J\.-:i,..i \t I ~ J.,..uc. j (Producer/ t iu0..JI ul.J--SJ.~I • Manufacturer's Name & Address) (Importer's J,JJi 111 tll ul.J-S, J ,.........1 • Name & Address) (Distributer's e,l.,--.JI ul.J-S-J ,.........1 • Name & Address) l ;,~I ,-L.f.:iJ!J [t.J.a~I ~.;W. (Manufacturing & Expiry dates) :ia1 •.I • I . L 1 • .. t,, t-11 wi'-Wal A..i.0 &.I ™ ~ IO •1J e , ~~..., . .. . . :~ uo.11 ,-1.flilJ [Cu~I ~.;U . 4JI ,.ic. .J (Packed by) ~I ~ y!i (Compatability) [J,.JI ~ • (Direction J\..&&--~I u\JW.;IJ ~.):a • & Rate of use) ~ J.JI~ ~ ~.J .JI ~ts ,:fi...J ;-S~ ~ c.5.fa.l w~.J 4J';il.J w4l}I t ,.i (Optimal PH range for the ~ ..,-.ll J.l.AA '. 1 111, ! o .J.J~I .l...Jc. pesticide solution) • .l..1.1..JI ~ ·~ · c...,.aJ ~ J (preharvest Interval) ul.t~I o .,;1i • J..hll ~J J-+i .;~~I o.;li ,-~I ,(Reentry period) (Safety-Precautions) ~I cJJ,l;h! • Keep out of reach of children, Toxic if swallowed, Avoid contact with skin, mouth or eyes, irritating to eyes, wear face shield, respirator, ovelllllS 6 Chloroform 7 p-Dichlorobenzene 8 Di-(2-ethylhexyl) adipate 9 1,2-Dichloropropane 10 Di-ethylhexylphthalate 11 Dimethylfonnamide 12 Dioxane 13 Epichlorohydrin 14 2-ethoxyethanol 15 Ethanol ethoxyacetate 16 Ethylene dichloride 17 Ethylene glycol monomethyl ether 18 Ethyl acrylate 19 n-Hexane 20 Hydrazine 21 Isophorone 22 Lead Compounds 23 Malachite green 24 Methyl n-butyl Ketone 25 Methyl chloride 26 Methylene chloride 27 Nonylphenol 28 Perchloroethylene 29 Phenol 30 o-Phenylphenol 31 Propylene oxide 32 Pyrethrins 33 Rhodamine B 34 Sodium dichromate 35 Toluene disocyanate 36 1, 1,2-Trichloroethane 37 Tributyl tin oxide 38 Trichloroethylene 39 Tri-orthocresylphosphate (TOCP) ~ c,I Y-?:! ~:u:i.b.:i..11 d .J~I ~ • ~ Joai 111411 .b.:JI W"' ~I .JI u,a:iy:. ~ J:i; Y c,I Y--?:! 'iiJI.J ~I ~ ~ts.II ~~Points .bl.ii (F ")/\~I'\ ,jc, (Annex 4) o y,a-11 ~~ rU .JYI .JI ~) jiJI ~ .J ~ • .oy,a-11 ) ~I ~ (Inkjet .Ji Tippo) d~ 41jlj ~I Ii.Au~• ~I~ ,,o..o..A/0../' W"' j:.l~j ~I O • • • qt) o · · .:. · -11 d - ·- 11 ~ -ui (.)-A u-=i ~ ~ • • wLi ,l...JI .fi~ ~ l..i:is:)' I ~ ( rl .JC ) ~ wLi ,l...JI ~.fJ ~~I~ ~\...}JI V r-9 .J ~I ~ ~ o y!u ~ c.S ft 'JI .Annex 7 4-......1~ YI ~ d · ·- ~ tL.ul "--l....::l,,J • .,,. ~ jJ ·- •• .,. rLJ.I ~~ ~ .l.J.J Li~ ~I.J)I.J (Guidelines on Good Labelling , 0.. 0.. o .Practice for Pesticides, FAO 1995) ' el.;~ Annex 1 List 1 Inerts of Toxicological Concern No. Chemical Name 1 Aniline 2 Asbestos Fiber 3 1,4 - Benzenediol 4 Cadmium compounds 5 Carbon tetrachloride 31 2-Benzyl-4-chlorophenol 32 Chloroethane 33 p-Chloro-m-xylenol 34 Dichlorophene 35 Ethyl benzene 36 Mercaptobenzothiazole 37 Methyl bromide 38 Chlorodifluoromethane 39 Dichloromonofluoromethane 40 1, 1-Difluoroethane 41 l -Chloro-1, 1-difluoroethane 42 Isopropyl phenols Petroleum hydrocarbons 43 Xylene 44 p-Nitrophenol 45 Butylene oxide 46 Nitroethane 47 Acetonitrile 48 l, 1, I-Trichloroethane 49 Triethanolamine 50 Diethanolamine 51 Butyl methacrylate 52 Methyl methacrylate Xylene - range aromatic solvents 53 2,5-Dichloroaniline 54 3, 4-Dichloroaniline 55 3,5-Dichloroaniline 56 2, 4-Dichloroaniline 57 2,3-Dichloroaniline 58 2,6-Dichloroaniline 59 Diphenyl ether 60 Trichlorotrifluoroethane 61 Dichlorodifluoromethane 62 Dichlorotetrafluoroethane " ,J.; ~ Annex2 List 2 Potentially Toxic Inerts / High Priority for Testing No. Chemical Name 1 Butyl benzyl phthalate 2 Dibutyl phthalate 3 Diethyl phthalate 4 Dimethyl phthalate 5 Dicotyl phthalate 6 2-Chlorotoluene 7 Cresols 8 o-Cresol 9 p-Cresol 10 m-Cresol 11 Cyclohexanone 12 o-Dichlorobenzene 13 Diethylene glycol monobutyl ether 14 Diethylene glycol mo~oethyl ether 15 Diethylene glycol monomethyl ether 16 Dipropylene glycol monomethyl ether 17 2-Butoxy-l-ethanol 18 l-Butoxy-2-propanol 19 1-Butoxyethoxy-2-propanol 20 1-Methoxy-2-propanol 21 Propylene glycol monobutyl ether 22 Tripropylene glycol monomethyl ether 23 Mesityl oxide 24 Methyl isobutyl ketone 25 Methyl ethyl ketoxime 26 Monochlorobenzene 27 Nitromethane 28 Toluene 29 Tolyl triazole 30 1, 2, 3-Benzotriazole .. J. • J. ~ ..:i· ,o ~ J. I l ' > I Q >--.--< .,.. .,.. f ~.)~ Annex3 Table 1: Determination of WHO hazard classification based on acute LD 50 (rat)offormulated product (mg/Kg) Information to appear on Label Acute LD 50 (rat) of formulation (mg/kg) WHO Hazard Hazard Band Colour Hazard Symbols& ORAL Class Stetement Symbol Words Solid la Extremely VERY PMS Red ~ ~- 5 or Less hazardous TOXIC 199C V~rvToxic lb Highly hazardous TOXIC PMS Red ~ ~ 5-50 199C Toxic II Moderately HARMFUL PMS Yellow X ~ 50-500 hazardous C III Slightly hazardous CAUTION PMS Blue Caution > 500 293C Products unlikely to PMS Green >2000 present a hazard in 347C normal use PMS is a colour mathching system mainly used by printers, devised and patented by Pantone, Inc. USA See Table 5 of the WHO Recommended Classification of Pesticides by Hazard Bibliography. ==:::::::.:== Liquid 20 or Less 20-200 200-2000 >2000 >3000 DERMAL Solid Liquid 10 or Less 40 or Less 10-100 40-400 100-1000 400-4000 > 1000 >4000 < l • l ~ 1' ,o ~ .J l q' > I 0 >--.--< .,.. .,.. Ancillary panel (safety) SAFETY PRECAUTIONS WARNING PHRASES GOOD AGRICULTURAL PROCTICE COMPATIBILITY FIRST AID ADVICE TO DOCTORS DISPOSAL OF CONTAINERS Main panel (identification) PRODUCT NAME Common Name, concentration, Formulation Type, Mode of Action Description Of Product And Summary Of Uses KEEP LOCKED UP OUT OF REACH OF CHILDREN Registration number Manufacturer: Importer: Distributer: Manufactur and Expiry Date: Batch number: Net content: I WHO Hazard Classification colour band: (Annex 3) should be not less than 15% of label area * Some formulations may require more than one hazard symbo Ancillary panel (instructions) DIRECTIONS AND RA TE OFUSE RE-ENTRY PERIOD PRE-HARVEST INTERVAL LEGAL RESPONSIBILITIES ~ .:J' ,o ~ J. I 1 ' > I 0 >---.--< ..-.. > l • l Ancillary panel (safety) ~lw\.1,4:h) ,Y...):!b.:i wl .J°4c ~ ~I J.,.w,.,.'jl 1:;:j.JI ¼l.9 4}11 wl!b'jl ~41,)\.l~L-.i ~ Jill wl~I LJ"' ~I t ~..)~ Annex4 Main panel (identification) ci Jl+il\ ~'i' ,4+,!Sjill t~ ,j,!Sjill ,4..!Wll oJWI ~I~.)., J-:i....'il ¼+" ~I dl..:11 ,.. JW=a~I J.,u:i.. ~ I~~ ~I ~.J ~I J.1 ,:i....JI tJ ,.JI ~I ~~)J ~I 6;J:i }L-11 c.5 ,h..JI 41......1'il ~.J I WHO Hazard Classification colour band: ('r r9 ) J:i...L,i) should be not less than 15% of label area * Some formulations may require more than one hazard symbo Ancillary panel (instructions) TI --~ '1\ ~ wlJL..!i I u ............ , . J .J. Ji.JI JF-J Ji! J.l,w'jl o fa wL.~I •fa ~~Lill 4~1 ~ ;i• ,o ~ J. I 1 ,.., ' > I 0 >--.--< rr rr ' )-. • )-. Annex4 F AO Directives for Labeling 1) Arrangement of information on the Facing or Main Area Colored Band (refer to the WHO Classification table, chapter 4/d) Toxicity Symbol (refer to the WHO Classification table, chapter 4/c2) Symbol of Physical and Chemical properties (see Chapter 4/e) Brand Name of the product Obligatory information. All typeface upper case (refer to the WHO Classification table, chapter 4/c2) Composition and type of Formula: • Active ingredient contents clearly indicated in grams / kilo or grams / liter • Nature and content of solvents of particular danger. IMainuses Net contents of the labeled package Name and address of the Manufacturer 2) Arrangement of Information on the Sides or Secondary Sectors: I Precautions for use: in a window minimum 8 point typeface. Indication «read the instructions supplied before using this product». Warnings and advise for use: to frame, minimum 8 point typeface. Instructions in the event of an accident: to frame, minimum 8 point type face. Isolate in a frame: • Registration n° • Batch n° • Date of manufacture e Instructions for use N Special agricultural information (crop rotation, pre-harvest interval etc.). Typeface information (except for n°sl0, 11, and 12 above, for which the strict minimum size is 8 points), the minimum 6 point size is obligatory for all texts. • '#-# • l ~ .:i· ,., :i.., J. l G' ► I 0 >--.--< r r FAO Instructions - Information Layout Side Label 0 Safety Precautions • Warnings and recommendations for use Facing I 0% I •• Physico - Chemical Property Symbols e Product Brand Name 8 First aid instructions and advice to doctors I O Obligatory warnings on Toxicity • Registration number Batch number Date fo manufacture .'r-: t~B >· = ·=-;/i < '/i; < · ,: ; · , ~••·"· , ,i~~d:-··,,·.· v,-:>:· ,t.J• . . ··•f ?titZiftt~,~,l~ · 0 Active Ingredient (Solvents if required) • Summary of Uses 0 Net Contents O Name and address of manufacturer Side Label 4D Instructions for use 8 Crop rotation (if required) O Pre-harvest interval (if required) 0 ,iJ~ Annex 5 PICTOGRAMS - REVISIONS AND ADDITIONS Since their introduction in 1988, GIFAP/FAO pictograms have now been adopted in well over 70 countries, with many more expected to join the programme in the near future. Although successful in their objective of communicating and emphasising key safety information at a glance, the need for clarification of certain pictograms along with further representations of good agricultural practice has led to the modification of three exisitng pictograms and the introduction of a further two new pictograms. The 'wear Boots', 'Wash After Use' and 'wear Eye Protection' pictograms have now been modified and 'Wear Protective Apron' and 'Wear Protective Overalls' have been added to complete the set. When incorporating pictograms the following points must always be considered: Pictograms used should relate to the safety text and should never contradict it or make it less clear. The use of pictograms must not conflict with national regulations or agreed national or international codes of practice. The preferred size for pictograms is 15 x 15mm, the minimum 7 x 7mm. The new complete set ofGIFAP/FAO pictograms is given below: STORAGE ACTIVITY ADVICE ~ C2.. ~ ?t ; '"f} ';;\ I~ ·t-?!F--"\ '111Jt· 1111 .... 1'41 [i] [i] 0 : "l I "' WARNING It is recommended that governments and industry act together to incorporate these pictograms on all agrochemical labels, and to educate pesticide users wherever and whenever possible regarding their meaning and significance. AMENDED PICTOGRAMS Existing design Wear bo.ots Wash after use Wear eye protection Q Replace with new design ADDITIONAL PICTOGRAMS t Wear protective overalls Wear protective apron FLAMMABLE (WATER REACTIVE) Black symbol on blue background. The symbol indicates substances which in contact with water emit flammable gases. IRRITANT Black symbol on yellow or orange background. Xi This symbol indicates irritant substances. Note: This symbol is NOT required if the TOXIC or HARMFUL symbol in Appendix A. l OR the CORROSIVE symbols are used. HIGHLY FLAMMABLE Black symbol on white background for upper half and red background for lower half of the diamond F+ The symbol indicates substances liable to spontaneous combustion. OXIDIZING Black symbol on yellow or orange background. 0 This symbol indicates oxidizing substances. For further information on use of these symbols, consult the appropriate local or international legislation on transport of hazardous goods. CORROSIVE Black symbol on a yellow or orange background for upper half and white print on a black background for lower halfof the diamond. C The symbol indicates spilling ofliquid from two glass vessels, one attacking a hand, the other metal. FLAMMABLE (LIQUID) Black symbol on red background The symbol indicates flammable liquids. Annex 6 EXPLOSIVE Black symbol on a yellow or orange background. E The symbol indicates an exploding bomb. FLAMMABLE (SOLID) Black symbol on white background with vertical red stripes The symbol indicates flammable. ~ ,l' \Cl ~ J. 1 ' > I 0 >--.--< .,.. .,.. 0 ...... • )-. V~,;~ Annex 7 Key information on the label is repeated in the packaging leaflet. An example for separation of information on label and packaging leaflets is given below. LABEL * Product name * Active ingredient (name and content) * Formulation type * Summary of uses * Registration number * Formulation data * Batch number * Net contents * Manufacturer * Distributor I agent / registrant * Warning phrases * Safety precautions * First aid, advice for doctors * Hazard symbols, pictograms * Manufacturing and Expiry Dates "Before using product, read leaflet" * Product name * Directions for use * Re-Entry period * Pre-harvest interval * Legal responsibility * Manufacturer PACKAGING LEAFLET Safety precautions Warning phrases * Good Agricultural Practices * First aid * Advice to doctors "Before using product, read leaflet"