Plant Protection Products (Amendment) (No. 2) Regulations, 2010 (L.N. 282 of 2010)

B 3085VERŻJONI ELETTRONIKA A.L. 282 ta’ l-2010 ATT DWAR IL-KONTROLL TAL-PESTIĊIDI (KAP. 430) Regolamenti ta’ l-2010 li jemendaw ir-Regolamenti dwar Prodott għall-Ħarsien tal-Pjanti (Emenda Nru. 2) 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 mal-Prim Ministru u mal-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-2010 li jemendew ir-Regolamenti dwar Prodotti għall-Ħarsien tal-Pjanti (Emenda Nru. 2), u dawn għandhom jinqraw u jiftiehmu bħala ħaġa waħda mar-Regolamenti ta’ l-2009 dwar Prodotti għall Ħarsien tal-Pjanti, hawn iżjed ’il quddiem imsejħin “ir-regolamenti prinċipali”. (2) L-iskop ta’ dawn ir-regolamenti hu li jiġu trasposti Direttiva tal-Kummissjoni 2010/14/UE tat- 3 ta’ Marzu 2010 li temenda d-Direttiva tal-Kunsill 91/414/KEE għall-inklużjoni tal-heptamaloxyloglucan bħala sustanza attiva, Direttiva tal Kummissjoni 2010/15/UE tat-8 ta’ Marzu 2010 li temenda d-Direttiva tal-Kunsill 91/414/KEE biex jiġi inkluż il-fluopicolide bħala sustanza attiva, Direttiva tal-Kummissjoni 2010/17/UE tad-9 ta’ Marzu 2010 li temenda d-Direttiva tal-Kunsill 91/414/ KEE biex tinkludi l-malatajon bħala sustanza attiva u Direttiva tal-Kummissjoni 2010/20/UE tad-9 ta’ Marzu 2010 li temenda d-Direttiva tal-Kunsill 91/414/KEE biex jitneħħa t-tolylfluanid bħala sustanza attiva u dwar l-irtirar tal-awtorizzazzjonijiet għall prodotti li jipproteġu l-pjanti li fihom dik is-sustanza. 2. Skeda I li tinsab mar-regolamenti prinċipali għandha tiġi emendata kif ġej: (a) il-partita 122, dwar it-tolylfluanid, għandha titħassar; (b) minnufih wara l-partita 302 “Cyflufenamid” għandhom jiżdiedu dawn il-partiti ġodda li ġejjin: Titolu u skop. A.L. 358 ta’ l-2009. Jemenda Skeda I li tinsab mar regolamenti prinċipali. Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,591, 11 ta’ Mejju, 2010 Taqsima B B 3086 VERŻJONI ELETTRONIKA P a g n a 3 m in n 5 N u m r u Is e m k o m u n i, n u m r i ta ’ id e n ti fi k a z z jo n i Is e m I U P A C P u r it a ! D ! u l fi s se ! ! S k a d e n z a t a ’ l in k lu " jo n i D is p o " iz z jo n ij ie t sp e # if i# i “ 3 0 3 F lu o p ic o li d e C A S N o 2 3 9 1 1 0 1 5 7 C IP A C N o 7 8 7 2 ,6 d ic h lo ro N [ 3 c h lo ro 5 (t ri fl u o ro m e th y l) 2 p y ri d y lm e th y l] b e n z a m id e ! 9 7 0 g /k g T h e im p u ri ty t o lu e n e m u st n o t e x c e e d 3 g /k g i n t h e te c h n ic a l m a te ri a l. 1 J u n e 2 0 1 0 3 1 M a y 2 0 2 0 P A R T A O n ly u se s a s fu n g ic id e m a y b e a u th o ri se d . P A R T B F o r th e i m p le m e n ta ti o n o f th e u n if o rm p ri n c ip le s o f A n n e x V I, th e c o n c lu si o n s o f th e re v ie w re p o rt o n fl u o p ic o li d e , a n d in p a rt ic u la r A p p e n d ic e s I a n d II th e re o f, a s fi n a li se d in th e S ta n d in g C o m m it te e o n t h e F o o d C h a in a n d A n im a l H e a lt h o n 2 7 N o v e m b e r 2 0 0 9 s h a ll b e t a k e n i n to a c c o u n t. I n t h is o v e ra ll a ss e ss m e n t, M e m b e r S ta te s m u st p a y p a rt ic u la r a tt e n ti o n t o : — th e p ro te c ti o n o f a q u a ti c o rg a n is m s, — th e p ro te c ti o n o f g ro u n d w a te r w h e n t h e a c ti v e s u b st a n c e is a p p li e d i n r e g io n s w it h v u ln e ra b le s o il a n d /o r c li m a ti c c o n d it io n s, — to t h e r is k t o o p e ra to rs d u ri n g a p p li c a ti o n , — th e p o te n ti a l fo r lo n g r a n g e t ra n sp o rt v ia a ir . C o n d it io n s o f a u th o ri sa ti o n sh a ll in c lu d e ri sk m it ig a ti o n m e a su re s a n d m o n it o ri n g p ro g ra m m e s sh a ll b e in it ia te d to v e ri fy p o te n ti a l a c c u m u la ti o n a n d e x p o su re in v u ln e ra b le a re a s, w h e re a p p ro p ri a te . T h e M e m b e r S ta te s c o n c e rn e d sh a ll e n su re th a t th e n o ti fi e r su b m it s to th e C o m m is si o n fu rt h e r in fo rm a ti o n o n th e re le v a n c e o f th e m e ta b o li te M 1 5 f o r g ro u n d w a te r b y 3 0 A p ri l 2 0 1 2 a t th e l a te st . ! F u rt h e r d e ta il s o n i d e n ti ty a n d s p e c if ic a ti o n o f a c ti v e s u b st a n c e s a re p ro v id e d i n t h e r e v ie w r e p o rt . B 3087VERŻJONI ELETTRONIKA P a g n a 4 m in n 5 3 0 4 H e p ta m a lo x y lo g lu c a n C A S N ° 8 7 0 7 2 1 8 1 6 C IP A C N ° N o t a v a il a b le F u ll I U P A C n a m e i n f o o tn o te 1 X y l p : x y lo p y ra n o sy l G lc p : g lu c o p y ra n o sy l F u c p : f u c o p y ra n o sy l G a l p : g a la c to p y ra n o sy l G lc o l : g lu c it o l > 7 8 0 g /k g T h e im p u ri ty P a tu li n m u st n o t e x c e e d 5 0 " g /k g in th e te c h n ic a l m a te ri a l. 1 J u n e 2 0 1 0 3 1 M a y 2 0 2 0 P A R T A O n ly u se s a s p la n t g ro w th r e g u la to r m a y b e a u th o ri se d . P A R T B F o r th e i m p le m e n ta ti o n o f th e u n if o rm p ri n c ip le s o f A n n e x V I, th e c o n c lu si o n s o f th e r e v ie w r e p o rt o n h e p ta m a lo x y lo g lu c a n , a n d i n p a rt ic u la r A p p e n d ic e s I a n d I I th e re o f, a s fi n a li se d i n t h e S ta n d in g C o m m it te e o n t h e F o o d C h a in a n d A n im a l H e a lt h o n 2 7 N o v e m b e r 2 0 0 9 s h a ll b e t a k e n i n to a c c o u n t. ” ; u (# ) m in n u fi h w a ra l p a rt it a 3 0 5 “ 2 p h e n y lp h e n o l” g $ a n d h o m j i% d ie d u d a w n i l p a rt it i & o d d a l i & e jj in : N u m r u Is e m k o m u n i, n u m r i ta ’ id e n ti fi k a z z jo n i Is e m I U P A C P u r it a ! D ! u l fi s se ! ! S k a d e n z a ta ’ l in k lu " jo n i D is p o " iz z jo n ij ie t sp e # if i# i “ 3 0 6 M a la th io n C A S N o : 1 2 1 7 5 5 C IP A C N o : 1 2 d ie th y l (d im e th o x y p h o sp h in o th i o y lt h io )s u c c in a te o r S 1 ,2 b is (e th o x y c a rb o n y l) e th y l O ,O d im e th y l p h o sp h o ro d it h io a te ra c e m a te ! 9 5 0 g /k g Im p u ri ti e s: Is o m a la th io n : n o t m o re th a n 2 g /k g 1 M a y 2 0 1 0 3 0 A p ri l 2 0 2 0 P A R T A O n ly u se s a s in se c ti c id e m a y b e a u th o ri se d . A u th o ri sa ti o n s sh a ll b e l im it e d t o p ro fe ss io n a l u se rs . P A R T B F o r th e im p le m e n ta ti o n o f th e u n if o rm p ri n c ip le s o f A n n e x V I, th e c o n c lu si o n s o f th e re v ie w re p o rt o n m a la th io n , a n d i n p a rt ic u la r A p p e n d ic e s I a n d I I th e re o f, a s fi n a li se d i n t h e S ta n d in g C o m m it te e o n t h e F o o d C h a in a n d A n im a l H e a lt h o n 2 2 Ja n u a ry 2 0 1 0 sh a ll b e ta k e n 1 ” ! F u rt h e r d e ta il s o n i d e n ti ty a n d s p e c if ic a ti o n o f a c ti v e s u b st a n c e s a re p ro v id e d i n t h e r e v ie w r e p o rt . I ~ ~ I Q I ti I ,-.. N t = I ~ ~ I Q I <:c:l.. I ,-.. N t = ,-.. "Sf" t = I ~ ~ c.:, I Q c I ~ c.:, I <:c:l.. Q ~,-AJ....., ,-.. '-0 t = --= ~ c.:, I Q I <:c:l.. I B 3088 VERŻJONI ELETTRONIKA P a g n a 5 m in n 5 N u m r u Is e m k o m u n i, n u m r i ta ’ id e n ti fi k a z z jo n i Is e m I U P A C P u r it a ! D ! u l fi s se ! ! S k a d e n z a ta ’ l in k lu " jo n i D is p o " iz z jo n ij ie t sp e # if i# i in to a c c o u n t. In th is o v e ra ll a ss e ss m e n t M e m b e r S ta te s sh a ll p a y p a rt ic u la r a tt e n ti o n t o : " th e o p e ra to r a n d w o rk e r sa fe ty : c o n d it io n s o f u se s h a ll p re sc ri b e th e u se o f a d e q u a te p e rs o n a l p ro te c ti v e e q u ip m e n t; " th e p ro te c ti o n o f a q u a ti c o rg a n is m s: c o n d it io n s o f a u th o ri sa ti o n sh a ll in c lu d e ri sk m it ig a ti o n m e a su re s, w h e re a p p ro p ri a te , su c h a s a d e q u a te b u ff e r z o n e s; " th e p ro te c ti o n o f in se c ti v o ro u s b ir d s a n d h o n e y b e e s: c o n d it io n s o f a u th o ri sa ti o n sh a ll in c lu d e ri sk m it ig a ti o n m e a su re s, w h e re a p p ro p ri a te . A s re g a rd s b e e s, t h e n e c e ss a ry i n d ic a ti o n s sh a ll b e p ro v id e d o n th e l a b e ll in g a n d t h e a c c o m p a n y in g i n st ru c ti o n s a s to a v o id e x p o su re . M e m b e r S ta te s sh a ll e n su re th a t m a la th io n b a se d fo rm u la ti o n s a re a c c o m p a n ie d b y th e n e c e ss a ry in st ru c ti o n s to a v o id a n y ri sk o f fo rm a ti o n o f is o m a la th io n in e x c e ss o f th e p e rm it te d m a x im u m q u a n ti ti e s d u ri n g s to ra g e a n d t ra n sp o rt . W h e re a p p ro p ri a te , c o n d it io n s o f a u th o ri sa ti o n sh a ll in c lu d e f u rt h e r ri sk m it ig a ti o n m e a su re s. T h e M e m b e r S ta te s c o n c e rn e d sh a ll e n su re th a t th e n o ti fi e r p re se n ts t o t h e C o m m is si o n : in fo rm a ti o n c o n fi rm in g th e c o n su m e r ri sk a ss e ss m e n t a n d th e a c u te a n d lo n g t e rm ri sk a ss e ss m e n t fo r in se c ti v o ro u s b ir d s; in fo rm a ti o n o n th e q u a n ti fi c a ti o n o f th e d if fe re n t p o te n c y o f m a la o x o n a n d m a la th io n .” . B 3089VERŻJONI ELETTRONIKA L.N. 282 of 2010 PESTICIDES CONTROL ACT (CAP. 430) Plant Protection Products (Amendment) (No. 2) Regulations, 2010 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 Plant Protection Products (Amendment) (No. 2) Regulations, 2010 and they shall be read and construed as one with Plant Protection Products Regulations, 2009, hereinafter referred to as “the principal regulations”. (2) The scope of these regulations is to transpose Commission Directive 2010/14/EU of 3 March 2010 amending Council Directive 91/414/EEC to include heptamaloxyloglucan as active substance, Commission Directive 2010/15/EU of 8 March 2010 amending Council Directive 91/414/EEC to include fluopicolide as active substance, Commission Directive 2010/17/ EU of 9 March 2010 amending Council Directive 91/414/EEC to include malathion as active substance and Commission Directive 2010/20/EU of 9 March 2010 amending Council Directive 91/414/EEC to remove tolylfluanid as active substance and on the withdrawal of authorisations for plant protection products containing that substance. 2. Schedule I to the principal regulations shall be amended as follows: (a) row 122, concerning tolylfluanid, shall be deleted; (b) immediately after item 302 “Cyflufenamid” there shall be added the following new items: Title and scope. L.N. 358 of 2009. Amends Schedule I to the principal regulation. B 3090 VERŻJONI ELETTRONIKA P a g e 3 o f 5 N o C o m m o n N a m e , Id e n ti fi c a ti o n N u m b e r s IU P A C N a m e P u r it y ! E n tr y i n to fo r c e E x p ir a ti o n o f in c lu si o n S p e c if ic p r o v is io n s “ 3 0 3 F lu o p ic o li d e C A S N o 2 3 9 1 1 0 1 5 7 C IP A C N o 7 8 7 2 ,6 d ic h lo ro N [ 3 c h lo ro 5 (t ri fl u o ro m e th y l) 2 p y ri d y lm e th y l] b e n z a m i d e ! 9 7 0 g /k g T h e im p u ri ty t o lu e n e m u st n o t e x c e e d 3 g /k g i n t h e te c h n ic a l m a te ri a l. 1 J u n e 2 0 1 0 3 1 M a y 2 0 2 0 P A R T A O n ly u se s a s fu n g ic id e m a y b e a u th o ri se d . P A R T B F o r th e i m p le m e n ta ti o n o f th e u n if o rm p ri n c ip le s o f A n n e x V I, th e c o n c lu si o n s o f th e re v ie w re p o rt o n fl u o p ic o li d e , a n d in p a rt ic u la r A p p e n d ic e s I a n d II th e re o f, a s fi n a li se d in th e S ta n d in g C o m m it te e o n t h e F o o d C h a in a n d A n im a l H e a lt h o n 2 7 N o v e m b e r 2 0 0 9 s h a ll b e t a k e n i n to a c c o u n t. I n t h is o v e ra ll a ss e ss m e n t, M e m b e r S ta te s m u st p a y p a rt ic u la r a tt e n ti o n t o : — th e p ro te c ti o n o f a q u a ti c o rg a n is m s, — th e p ro te c ti o n o f g ro u n d w a te r w h e n t h e a c ti v e s u b st a n c e is a p p li e d i n r e g io n s w it h v u ln e ra b le s o il a n d /o r c li m a ti c c o n d it io n s, — to t h e r is k t o o p e ra to rs d u ri n g a p p li c a ti o n , — th e p o te n ti a l fo r lo n g r a n g e t ra n sp o rt v ia a ir . C o n d it io n s o f a u th o ri sa ti o n sh a ll in c lu d e ri sk m it ig a ti o n m e a su re s a n d m o n it o ri n g p ro g ra m m e s sh a ll b e in it ia te d to v e ri fy p o te n ti a l a c c u m u la ti o n a n d e x p o su re in v u ln e ra b le a re a s, w h e re a p p ro p ri a te . T h e M e m b e r S ta te s c o n c e rn e d sh a ll e n su re th a t th e n o ti fi e r su b m it s to th e C o m m is si o n fu rt h e r in fo rm a ti o n o n th e re le v a n c e o f th e m e ta b o li te M 1 5 f o r g ro u n d w a te r b y 3 0 A p ri l 2 0 1 2 a t th e l a te st . ! F u rt h e r d e ta il s o n i d e n ti ty a n d s p e c if ic a ti o n o f a c ti v e s u b st a n c e s a re p ro v id e d i n t h e r e v ie w r e p o rt . B 3091 V E R Ż JO N I E L E T T R O N IK A Page 4 of 5 304 Heptamaloxyloglucan CAS N° 870721-81-6 CIPAC N° Not available Full IUPAC name in footnote 1 Xyl p : xylopyranosyl Glc p : glucopyranosyl Fuc p : fucopyranosyl Gal p : galactopyranosyl Glc-ol : glucitol >780g/kg The impurity Patulin must not exceed 50 "g/kg in the technical material. 1 June 2010 31 May 2020 PART A Only uses as plant growth regulator may be authorised. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on heptamaloxyloglucan, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.”; and (c) immediately after item 305 “2-phenylphenol” there shall be added the following new item: No Common Name, Identification Numbers IUPAC Name Purity 2 Entry into force Expiration of inclusion Specific provisions “306 Malathion CAS No: 121-75-5 CIPAC No: 12 diethyl (dimethoxyphosphinothi oylthio)succinate or S-1,2 bis(ethoxycarbonyl)ethyl O,O-dimethyl phosphorodithioate racemate ! 950 g/kg Impurities: Isomalathion: not more than 2 g/kg 1 May 2010 30 April 2020 PART A Only uses as insecticide may be authorised. Authorisations shall be limited to professional users. PART B For the implementation of the uniform principles of Annex VI, the conclusions of the review report on malathion, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account. In this overall assessment Member States shall pay 1 ” 2 Further details on identity and specification of active substance are provided in the review report. { ~ - D - Xyl p - (1 - 6 )]- /3 - D - Glc p - (1 - 4) X ~ -L - Fuc p - (1 - 2 )- /3 - D - Gal p - (1 - 2 )- a - D - Xyl p - (1 - 6 )] /3 - D - Glc p - (1 - 4) } D - Glc - ol B 3092 VERŻJONI ELETTRONIKA P a g e 5 o f 5 N o C o m m o n N a m e , Id e n ti fi c a ti o n N u m b e r s IU P A C N a m e P u r it y 2 E n tr y i n to fo r c e E x p ir a ti o n o f in c lu si o n S p e c if ic p r o v is io n s p a rt ic u la r a tt e n ti o n t o : " th e o p e ra to r a n d w o rk e r sa fe ty : c o n d it io n s o f u se s h a ll p re sc ri b e th e u se o f a d e q u a te p e rs o n a l p ro te c ti v e e q u ip m e n t; " th e p ro te c ti o n o f a q u a ti c o rg a n is m s: c o n d it io n s o f a u th o ri sa ti o n sh a ll in c lu d e ri sk m it ig a ti o n m e a su re s, w h e re a p p ro p ri a te , su c h a s a d e q u a te b u ff e r z o n e s; " th e p ro te c ti o n o f in se c ti v o ro u s b ir d s a n d h o n e y b e e s: c o n d it io n s o f a u th o ri sa ti o n sh a ll in c lu d e ri sk m it ig a ti o n m e a su re s, w h e re a p p ro p ri a te . A s re g a rd s b e e s, t h e n e c e ss a ry i n d ic a ti o n s sh a ll b e p ro v id e d o n th e l a b e ll in g a n d t h e a c c o m p a n y in g i n st ru c ti o n s a s to a v o id e x p o su re . M e m b e r S ta te s sh a ll e n su re th a t m a la th io n b a se d fo rm u la ti o n s a re a c c o m p a n ie d b y th e n e c e ss a ry in st ru c ti o n s to a v o id a n y ri sk o f fo rm a ti o n o f is o m a la th io n in e x c e ss o f th e p e rm it te d m a x im u m q u a n ti ti e s d u ri n g s to ra g e a n d t ra n sp o rt . W h e re a p p ro p ri a te , c o n d it io n s o f a u th o ri sa ti o n sh a ll in c lu d e f u rt h e r ri sk m it ig a ti o n m e a su re s. T h e M e m b e r S ta te s c o n c e rn e d sh a ll e n su re th a t th e n o ti fi e r p re se n ts t o t h e C o m m is si o n : in fo rm a ti o n c o n fi rm in g th e c o n su m e r ri sk a ss e ss m e n t a n d th e a c u te a n d lo n g t e rm ri sk a ss e ss m e n t fo r in se c ti v o ro u s b ir d s; in fo rm a ti o n o n th e q u a n ti fi c a ti o n o f th e d if fe re n t p o te n c y o f m a la o x o n a n d m a la th io n .” . 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 €0.37