Biocides (Amendment) Regulations, 2011 (L.N. 92 of 2011)

B 1203VERŻJONI ELETTRONIKA A.L. 92 tal-2011 ATT DWAR IL-KONTROLL TAL-PESTIĊIDI (KAP. 430) Regolamenti ta’ l-2011 li jemendaw ir-Regolamenti dwar il-Bijoċidi BIS-SAĦĦA tas-setgħat mogħtija bl-artikoli 4 u 5 ta’ l-Att dwar il-Kontroll tal-Pestiċidi, il-Ministru għar-Riżorsi u Affarijiet Rurali, wara li kkonsulta lill-Prim Ministru u lill-Ministru għas Saħħa, l-Anzjani u Kura fil-Komunità, għamel dawn ir-regolamenti li ġejjin: 1. (1) It-titolu ta’ dawn ir-regolamenti hu Regolamenti ta’ l-2011 li jemendaw ir-Regolamenti dwar il-Bijoċidi, u għandhom jinqraw u jiftiehmu ħaġa waħda mar-Regolamenti ta’ l-2010 dwar il-Bijoċidi, hawn iżjed ’il quddiem imsejħin “ir-regolamenti prinċipali”. (2) L-iskop ta’ dawn ir-regolamenti hu li jitrassponu d-Direttiva tal-Kummissjoni 2010/71/UE tal-4 ta’ Novembru 2010 li temenda d-Direttiva 98/8/KE tal-Parlament Ewropew u tal-Kunsill biex il-metoflutrin ikun inkluż bħala sustanza attiva fl-Anness I għaliha, Direttiva tal-Kummissjoni 2010/72/UE tal-4 ta’ Novembru 2010 li temenda d-Direttiva 98/8/KE tal-Parlament Ewropew u tal-Kunsill biex tinkludi l-ispinosad bħala sustanza attiva fl-Anness I għaliha, Direttiva tal-Kummissjoni 2010/74/ UE tad-9 ta’ Novembru 2010 li temenda d-Direttiva 98/8/KE tal Parlament Ewropew u tal-Kunsill biex testendi l-inklużjoni fl Anness I għaliha tas-sustanza attiva tad-dijossidu tal-karbonju għall-prodotti tat-tip 18. 2. It-Taqsima A tas-Skeda I li tinsab mar-regolamenti prinċipali, għandha tiġi amendata kif ġej: (a) minflok il-partita Nru. 7 tagħha, għandu jidħol dan li ġej: Titolu u skop. A.L. 525 ta’ l-2010. Jemenda Skeda I li tinsab mar regolamenti prinċipali. Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,718, 11 ta’ Marzu, 2011 Taqsima B B 1204 VERŻJONI ELETTRONIKA N o C o m m o n N a m e IU P A C N a m e Id e n ti fi c a ti o n N u m b e rs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ŻJONI ELETTRONIKA C ( + 4 % 0 )& / % ) + ( "2 / )" + # &0 / # &+ # 5* &3 . & @ ( / # ). 4 &8 . ( . &) . &/ ' ' 5" 0 / )" + # & 4 . $ + # 2 )( / ). 2 &) / )& ( "2 6 2 &0 / # &3 . & ( . 4 % 0 . 4 &) + &/ 0 0 . ' )/ 3 5. &5 . 1 . 52 X& 9 9 0 m l/ l& 1 N o v e m b e r 2 0 1 2 & 3 1 O c to b e r 2 0 1 4 & 3 1 O c to b e r 2 0 2 2 & 1 8 & W h e n a ss e ss in g t h e a p p li c a ti o n f o r a u th o ri sa ti o n o f a p ro d u c t in a c c o rd a n c e w it h A rt ic le 5 a n d A n n e x V I, M e m b e r S ta te s sh a ll a ss e ss , w h e n r e le v a n t fo r th e p a rt ic u la r p ro d u c t, t h o se u se s o r e x p o su re s c e n a ri o s a n d t h o se r is k s to c o m p a rt m e n ts a n d p o p u la ti o n s th a t h a v e n o t b e e n r e p re se n ta ti v e ly a d d re ss e d i n t h e E u ro p e a n l e v e l ri sk a ss e ss m e n t. W h e n g ra n ti n g p ro d u c t a u th o ri sa ti o n , M e m b e r S ta te s sh a ll a ss e ss t h e r is k s a n d s u b se q u e n tl y e n su re t h a t a p p ro p ri a te m e a su re s a re ta k e n o r sp e c if ic c o n d it io n s im p o se d i n o rd e r to m it ig a te t h e id e n ti fi e d r is k s. M e m b e r S ta te s sh a ll e n su re t h a t a u th o ri sa ti o n s a re s u b je c t to t h e fo ll o w in g c o n d it io n s: (1 ) P ro d u c t sh a ll o n ly b e s o ld t o a n d u se d b y p ro fe ss io n a ls t ra in e d t o u se th e m . (2 ) A p p ro p ri a te m e a su re s to p ro te c t o p e ra to rs s h a ll b e t a k e n t o e n su re m in im u m r is k , in c lu d in g t h e a v a il a b il it y o f p e rs o n a l p ro te c ti v e e q u ip m e n t if n e c e ss a ry . (3 ) A p p ro p ri a te m e a su re s sh a ll b e ta k e n t o p ro te c t b y st a n d e rs , su c h a s e x c lu si o n f ro m t h e t re a tm e n t a re a d u ri n g f u m ig a ti o n .” ; u & B 1206 VERŻJONI ELETTRONIKA (b ) m in n u fi h w a ra l p a rt it a N ru . 3 5 t a g ! h a , g ! a n d h o m j id ! lu d a w n i l p a rt it i " o d d a l i " e jj in : N o C o m m o n N a m e IU P A C N a m e Id e n ti fi c a ti o n N u m b e rs ! "# "$ % $ & ' % ( ") * &+ ,& ) . & / 0 )" 1 . & 2 % 3 2 )/ # 0 . & "# &) . & 3 "+ 0 "4 / 5& ' ( + 4 % 0 )& / 2 & ' 5/ 0 . 4 &+ # & ) . & $ / ( 6 . ) 7 / ). &+ ,& "# 0 5% 2 "+ # 7 . / 4 5" # . &, + ( & 0 + $ ' 5" / # 0 . &8 ") & 9 ( )" 0 5. &: ; <= >& <. ? 0 . ' )& ,+ ( &' ( + 4 % 0 )2 & 0 + # )/ "# "# @ & $ + ( . &) / # &+ # . &/ 0 )" 1 . & 2 % 3 2 )/ # 0 . A& ,+ ( &8 "0 &) . & 4 . / 4 5" # . &) + &0 + $ ' 5* & 8 ") &9 ( )" 0 5. &: ; <= >& 2 / 55 &3 . &) . & + # . &2 . )& + % )& "# &) . &5 / 2 )& + ,& ) . & "# 0 5% 2 "+ # &4 . 0 "2 "+ # 2 & ( . 5/ )" # @ &) + &" )2 & / 0 )" 1 . &2 % 3 2 )/ # 0 . 2 > B ? ' "( * &4 / ). & + ,& "# 0 5% 2 "+ # C ( + 4 % 0 )& )* ' . D ' . 0 ", "0 &' ( + 1 "2 "+ # 2 &< E > “ 3 6 M e to fl u th ri n R T Z i so m e r: 2 ,3 ,5 ,6 t e tr a fl u o ro 4 (m e th o x y m e th y l) b e n z y l (1 R ,3 R ) 2 ,2 d im e th y l 3 (Z ) (p ro p 1 e n y l) c y c lo p ro p a n e c a rb o x y la te E C N o : n .a . C A S N o : 2 4 0 4 9 4 7 1 7 S u m o f a ll i so m e rs : 2 ,3 ,5 ,6 t e tr a fl u o ro 4 (m e th o x y m e th y l) b e n z y l (E Z ) (1 R S ,3 R S ;1 S R ,3 S R ) 2 ,2 d im e th y l 3 p ro p 1 e n y lc y c lo p ro p a n e c a rb o x y la te E C N o : n .a . C A S N o : 2 4 0 4 9 4 7 0 6 T h e a c ti v e su b st a n c e sh a ll c o m p ly w it h b o th t h e fo ll o w in g m in im u m p u ri ti e s: R T Z i so m e r: 7 5 4 g /k g S u m o f a ll is o m e rs : 9 3 0 g /k g 1 M a y 2 0 1 1 N o t a p p li c a b le 3 0 A p ri l 2 0 2 1 1 8 W h e n a ss e ss in g t h e a p p li c a ti o n fo r a u th o ri sa ti o n o f a p ro d u c t in a c c o rd a n c e w it h A rt ic le 5 a n d A n n e x V I, M e m b e r S ta te s sh a ll a ss e ss , w h e n r e le v a n t fo r th e p a rt ic u la r p ro d u c t, t h o se u se s o r e x p o su re s c e n a ri o s a n d t h o se ri sk s to c o m p a rt m e n ts a n d p o p u la ti o n s th a t h a v e n o t b e e n re p re se n ta ti v e ly a d d re ss e d i n t h e E u ro p e a n l e v e l ri sk a ss e ss m e n t. & B 1207VERŻJONI ELETTRONIKA 3 7 S p in o sa d E C N o : 4 3 4 3 0 0 1 C A S N o : 1 6 8 3 1 6 9 5 8 S p in o sa d i s a m ix tu re o f 5 0 9 5 % s p in o sy n A a n d 5 5 0 % s p in o sy n D . S p in o sy n A (2 R ,3 a S ,5 a R ,5 b S ,9 S ,1 3 S ,1 4 R ,1 6 a S ,1 6 b R ) 2 [ (6 d e o x y 2 ,3 ,4 t ri O m e th y l # L m a n n o p y ra n o sy l) o x y ] 1 3 [ [( 2 R ,5 S ,6 R ) 5 (d im e th y la m in o )t e tr a h y d ro 6 m e th y l 2 H p y ra n 2 y l] o x y ] 9 e th y l 2 ,3 ,3 a ,5 a ,5 b ,6 ,9 ,1 0 ,1 1 ,1 2 ,1 3 ,1 4 ,1 6 a ,1 6 b te tr a d e c a h y d ro 1 4 m e th y l 1 H a s in d a c e n o [3 ,2 d ]o x a c y c lo d o d e c in 7 ,1 5 d io n e C A S N o : 1 3 1 9 2 9 6 0 7 S p in o sy n D (2 S ,3 a R ,5 a S ,5 b S ,9 S ,1 3 S ,1 4 R ,1 6 a S ,1 6 b S ) 2 [ (6 d e o x y 2 ,3 ,4 t ri O m e th y l # L m a n n o p y ra n o sy l) o x y ] 1 3 [ [( 2 R ,5 S ,6 R ) 5 (d im e th y la m in o )t e tr a h y d ro 6 m e th y l 2 H p y ra n 2 y l] o x y ] 9 e th y l 2 ,3 ,3 a ,5 a ,5 b ,6 ,9 ,1 0 ,1 1 ,1 2 ,1 3 ,1 4 ,1 6 a ,1 6 b te tr a d e c a h y d ro 4 ,1 4 d im e th y l 1 H a s in d a c e n o [3 ,2 d ]o x a c y c lo d o d e c in 7 ,1 5 d io n e C A S N o : 1 3 1 9 2 9 6 3 0 8 5 0 g /k g 1 N o v e m b e r 2 0 1 2 3 1 O c to b e r 2 0 1 4 3 1 O c to b e r 2 0 2 2 1 8 W h e n a ss e ss in g t h e a p p li c a ti o n fo r a u th o ri sa ti o n o f a p ro d u c t in a c c o rd a n c e w it h A rt ic le 5 a n d A n n e x V I, M e m b e r S ta te s sh a ll a ss e ss , w h e n r e le v a n t fo r th e p a rt ic u la r p ro d u c t, t h o se u se s o r e x p o su re s c e n a ri o s a n d t h o se ri sk s to c o m p a rt m e n ts a n d p o p u la ti o n s th a t h a v e n o t b e e n re p re se n ta ti v e ly a d d re ss e d i n t h e E U l e v e l ri sk a ss e ss m e n t. M e m b e r S ta te s sh a ll e n su re t h a t a u th o ri sa ti o n s a re s u b je c t to t h e fo ll o w in g c o n d it io n s: — A u th o ri sa ti o n s sh a ll b e s u b je c t to a p p ro p ri a te r is k m it ig a ti o n m e a su re s. In p a rt ic u la r, p ro d u c ts a u th o ri se d f o r p ro fe ss io n a l u se b y sp ra y in g s h a ll b e u se d w it h a p p ro p ri a te p e rs o n a l p ro te c ti v e e q u ip m e n t, u n le ss i t c a n b e d e m o n st ra te d in t h e a p p li c a ti o n f o r p ro d u c t a u th o ri sa ti o n th a t ri sk s to p ro fe ss io n a l u se rs c a n b e r e d u c e d t o a n a c c e p ta b le l e v e l b y o th e rs m e a n s. — F o r p ro d u c ts c o n ta in in g s p in o sa d th a t m a y l e a d t o re si d u e s in f o o d o r fe e d , M e m b e r S ta te s B 1208 VERŻJONI ELETTRONIKA sh a ll v e ri fy t h e n e e d to s e t n e w a n d /o r a m e n d e d e x is ti n g m a x im u m r e si d u e le v e ls ( M R L s) a c c o rd in g t o R e g u la ti o n ( E C ) N o 4 7 0 /2 0 0 9 a n d /o r R e g u la ti o n ( E C ) N o 3 9 6 /2 0 0 5 , a n d t a k e a n y a p p ro p ri a te r is k m it ig a ti o n m e a su re s e n su ri n g t h a t th e a p p li c a b le M R L s a re n o t e x c e e d e d .” . B 1209VERŻJONI ELETTRONIKA L.N. 92 of 2011 PESTICIDES CONTROL ACT (CAP. 430) Biocides (Amendment) Regulations, 2011 IN exercise of the powers conferred by articles 4 and 5 of the Pesticides Control Act, the Minister for Resources and Rural Affairs, in consultation with the Prime Minister and with the Minister for Health, the Elderly and Community Care, has made the following regulations : 1. (1) The title of these regulations is the Biocides (Amendment) Regulations, 2011 and they shall be read and construed as one with Biocides Regulations, 2010, hereinafter referred to as “the principal regulations”. (2) The scope of these regulations is to transpose Commission Directive 2010/71/EU of 4 November 2010 amending Directive 98/8/EC of the European Parliament and of the Council to include metofluthrin as an active substance in Annex I thereto, Commission Directive 2010/72/EU of 4 November 2010 amending Directive 98/8/EC of the European Parliament and of the Council to include spinosad as an active substance in Annex I thereto and Commission Directive 2010/74/EU of 9 November 2010 amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion in Annex I thereto of the active substance carbon dioxide to product type 18. 2. Part A of Schedule I to the principal regulations shall be amended as follows: (a) for item No. 7 thereof, there shall be substituted the following: Title and scope. L.N. 525 of 2010. Amends Schedule I to the principal regulations. B 1210 VERŻJONI ELETTRONIKA N o C o m m o n N a m e IU P A C N a m e Id e n ti fi c a ti o n N u m b e rs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ŻJONI ELETTRONIKA 4 . $ + # 2 )( / ). 2 &) / )& ( "2 6 2 &0 / # &3 . & ( . 4 % 0 . 4 &) + &/ 0 0 . ' )/ 3 5. &5 . 1 . 52 X& 9 9 0 m l/ l& 1 N o v e m b e r 2 0 1 2 & 3 1 O c to b e r 2 0 1 4 & 3 1 O c to b e r 2 0 2 2 & 1 8 & W h e n a ss e ss in g t h e a p p li c a ti o n f o r a u th o ri sa ti o n o f a p ro d u c t in a c c o rd a n c e w it h A rt ic le 5 a n d A n n e x V I, M e m b e r S ta te s sh a ll a ss e ss , w h e n r e le v a n t fo r th e p a rt ic u la r p ro d u c t, t h o se u se s o r e x p o su re s c e n a ri o s a n d t h o se r is k s to c o m p a rt m e n ts a n d p o p u la ti o n s th a t h a v e n o t b e e n r e p re se n ta ti v e ly a d d re ss e d i n t h e E u ro p e a n l e v e l ri sk a ss e ss m e n t. W h e n g ra n ti n g p ro d u c t a u th o ri sa ti o n , M e m b e r S ta te s sh a ll a ss e ss t h e r is k s a n d s u b se q u e n tl y e n su re t h a t a p p ro p ri a te m e a su re s a re ta k e n o r sp e c if ic c o n d it io n s im p o se d i n o rd e r to m it ig a te t h e id e n ti fi e d r is k s. M e m b e r S ta te s sh a ll e n su re t h a t a u th o ri sa ti o n s a re s u b je c t to t h e fo ll o w in g c o n d it io n s: (1 ) P ro d u c t sh a ll o n ly b e s o ld t o a n d u se d b y p ro fe ss io n a ls t ra in e d t o u se th e m . (2 ) A p p ro p ri a te m e a su re s to p ro te c t o p e ra to rs s h a ll b e t a k e n t o e n su re m in im u m r is k , in c lu d in g t h e a v a il a b il it y o f p e rs o n a l p ro te c ti v e e q u ip m e n t if n e c e ss a ry . (3 ) A p p ro p ri a te m e a su re s sh a ll b e ta k e n t o p ro te c t b y st a n d e rs , su c h a s e x c lu si o n f ro m t h e t re a tm e n t a re a d u ri n g f u m ig a ti o n .” ; a n d & B 1212 VERŻJONI ELETTRONIKA (b ) i m m e d ia te ly a ft e r it e m N o . 3 5 t h e re o f, t h e re s h a ll b e a d d e d t h e f o ll o w in g n e w i te m s: N o C o m m o n N a m e IU P A C N a m e Id e n ti fi c a ti o n N u m b e rs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“ 3 6 M e to fl u th ri n R T Z i so m e r: 2 ,3 ,5 ,6 t e tr a fl u o ro 4 (m e th o x y m e th y l) b e n z y l (1 R ,3 R ) 2 ,2 d im e th y l 3 (Z ) (p ro p 1 e n y l) c y c lo p ro p a n e c a rb o x y la te E C N o : n .a . C A S N o : 2 4 0 4 9 4 7 1 7 S u m o f a ll i so m e rs : 2 ,3 ,5 ,6 t e tr a fl u o ro 4 (m e th o x y m e th y l) b e n z y l (E Z ) (1 R S ,3 R S ;1 S R ,3 S R ) 2 ,2 d im e th y l 3 p ro p 1 e n y lc y c lo p ro p a n e c a rb o x y la te E C N o : n .a . C A S N o : 2 4 0 4 9 4 7 0 6 T h e a c ti v e su b st a n c e sh a ll c o m p ly w it h b o th t h e fo ll o w in g m in im u m p u ri ti e s: R T Z i so m e r: 7 5 4 g /k g S u m o f a ll is o m e rs : 9 3 0 g /k g 1 M a y 2 0 1 1 N o t a p p li c a b le 3 0 A p ri l 2 0 2 1 1 8 W h e n a ss e ss in g t h e a p p li c a ti o n fo r a u th o ri sa ti o n o f a p ro d u c t in a c c o rd a n c e w it h A rt ic le 5 a n d A n n e x V I, M e m b e r S ta te s sh a ll a ss e ss , w h e n r e le v a n t fo r th e p a rt ic u la r p ro d u c t, t h o se u se s o r e x p o su re s c e n a ri o s a n d t h o se ri sk s to c o m p a rt m e n ts a n d p o p u la ti o n s th a t h a v e n o t b e e n re p re se n ta ti v e ly a d d re ss e d i n t h e E u ro p e a n l e v e l ri sk a ss e ss m e n t. & 3 7 S p in o sa d E C N o : 4 3 4 3 0 0 1 C A S N o : 1 6 8 3 1 6 9 5 8 8 5 0 g /k g 1 N o v e m b e r 2 0 1 2 3 1 O c to b e r 2 0 1 4 3 1 O c to b e r 2 0 2 2 1 8 W h e n a ss e ss in g t h e a p p li c a ti o n fo r a u th o ri sa ti o n o f a p ro d u c t in a c c o rd a n c e w it h A rt ic le 5 a n d B 1213VERŻJONI ELETTRONIKA S p in o sa d i s a m ix tu re o f 5 0 9 5 % s p in o sy n A a n d 5 5 0 % s p in o sy n D . S p in o sy n A (2 R ,3 a S ,5 a R ,5 b S ,9 S ,1 3 S ,1 4 R ,1 6 a S ,1 6 b R ) 2 [ (6 d e o x y 2 ,3 ,4 t ri O m e th y l ! L m a n n o p y ra n o sy l) o x y ] 1 3 [ [( 2 R ,5 S ,6 R ) 5 (d im e th y la m in o )t e tr a h y d ro 6 m e th y l 2 H p y ra n 2 y l] o x y ] 9 e th y l 2 ,3 ,3 a ,5 a ,5 b ,6 ,9 ,1 0 ,1 1 ,1 2 ,1 3 ,1 4 ,1 6 a ,1 6 b te tr a d e c a h y d ro 1 4 m e th y l 1 H a s in d a c e n o [3 ,2 d ]o x a c y c lo d o d e c in 7 ,1 5 d io n e C A S N o : 1 3 1 9 2 9 6 0 7 S p in o sy n D (2 S ,3 a R ,5 a S ,5 b S ,9 S ,1 3 S ,1 4 R ,1 6 a S ,1 6 b S ) 2 [ (6 d e o x y 2 ,3 ,4 t ri O m e th y l ! L m a n n o p y ra n o sy l) o x y ] 1 3 [ [( 2 R ,5 S ,6 R ) 5 (d im e th y la m in o )t e tr a h y d ro 6 m e th y l 2 H p y ra n 2 y l] o x y ] 9 e th y l 2 ,3 ,3 a ,5 a ,5 b ,6 ,9 ,1 0 ,1 1 ,1 2 ,1 3 ,1 4 ,1 6 a ,1 6 b te tr a d e c a h y d ro 4 ,1 4 d im e th y l 1 H a s in d a c e n o [3 ,2 d ]o x a c y c lo d o d e c in 7 ,1 5 d io n e C A S N o : 1 3 1 9 2 9 6 3 0 A n n e x V I, M e m b e r S ta te s sh a ll a ss e ss , w h e n r e le v a n t fo r th e p a rt ic u la r p ro d u c t, t h o se u se s o r e x p o su re s c e n a ri o s a n d t h o se ri sk s to c o m p a rt m e n ts a n d p o p u la ti o n s th a t h a v e n o t b e e n re p re se n ta ti v e ly a d d re ss e d i n t h e E U l e v e l ri sk a ss e ss m e n t. M e m b e r S ta te s sh a ll e n su re t h a t a u th o ri sa ti o n s a re s u b je c t to t h e fo ll o w in g c o n d it io n s: — A u th o ri sa ti o n s sh a ll b e s u b je c t to a p p ro p ri a te r is k m it ig a ti o n m e a su re s. In p a rt ic u la r, p ro d u c ts a u th o ri se d f o r p ro fe ss io n a l u se b y sp ra y in g s h a ll b e u se d w it h a p p ro p ri a te p e rs o n a l p ro te c ti v e e q u ip m e n t, u n le ss i t c a n b e d e m o n st ra te d in t h e a p p li c a ti o n f o r p ro d u c t a u th o ri sa ti o n th a t ri sk s to p ro fe ss io n a l u se rs c a n b e r e d u c e d t o a n a c c e p ta b le l e v e l b y o th e rs m e a n s. — F o r p ro d u c ts c o n ta in in g s p in o sa d th a t m a y l e a d t o re si d u e s in f o o d o r fe e d , M e m b e r S ta te s sh a ll v e ri fy t h e n e e d to s e t n e w a n d /o r a m e n d e d e x is ti n g m a x im u m r e si d u e le v e ls ( M R L s) a c c o rd in g t o B 1214 VERŻJONI ELETTRONIKA R e g u la ti o n ( E C ) N o 4 7 0 /2 0 0 9 a n d /o r R e g u la ti o n ( E C ) N o 3 9 6 /2 0 0 5 , a n d t a k e a n y a p p ro p ri a te r is k m it ig a ti o n m e a su re s e n su ri n g t h a t th e a p p li c a b le M R L s a re n o t e x c e e d e d .” . Ippubblikat mid-Dipartiment tal-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta Mitbugħ fl-Istamperija tal-Gvern fuq karta riċiklata — Printed at the Government Printing Press on recycled paper Prezz/Price €0.56