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Pesticides Control Act (Cap. 430) Biocides (Amendment) Regulations, 2011 (L.N. 92 Of 2011 )



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.

No

Common Name

IUPAC Name

Identification Numbers

!"#"$%$&

'%(")*&+,&)-.&

/0)"1.&

2%32)/#0.&"#&

)-.&

3"+0"4/5&

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8")-&

9()"05.&:;<=>&

<.?0.')&,+(&'(+4%0)2&

0+#)/"#"#@&

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0+$'5*&

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)-.&

+#.&2.)&+%)&"#&)-.&5/2)&+,&

)-.& "#05%2"+#&4.0"2"+#2& (.5/)"#@&)+&")2&

/0)"1.&2%32)/#0.2>

B?'"(*&4/).&

+,& "#05%2"+#

C(+4%0)&

)*'.

D'.0","0&'(+1"2"+#2&<E>

FG

0/(3+#&

4"+?"4.

0/(3+#&4"+?"4.& BH&I+J&KLMN;O;NO& H9D&I+J&:KMN=PNO

OOL&$5Q5

:& I+1.$3.(& KLLO

=:&R0)+3.(&KL::

=:&R0)+3.(& KL:O

:M

S-.#&/22.22"#@&)-.&/''5"0/)"+#&

,+(&/%)-+("T/)"+#&+,&/&'(+4%0)&"#&

/00+(4/#0.&8")-&9()"05.&U&/#4&

9##.?&VWA&!.$3.(&D)/).2&2-/55&

/22.22A&8-.#&(.5.1/#)&,+(&)-.&

'/()"0%5/(&'(+4%0)A&

)-.&'+'%5/)"+#2&)-/)&$/*&3.&

.?'+2.4&)+&)-.&'(+4%0)&/#4&)-.&

%2.&+(&.?'+2%(.&20.#/("+2&)-/)&

-/1.&#+)&3..#&(.'(.2.#)/)"1.5*&

/44(.22.4&

/)&)-.&H+$$%#")*&5.1.5&("26&

/22.22$.#)X&

&

S-.#&@(/#)"#@&'(+4%0)&

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2-/55&/22.22&)-.&("262&/#4&

2%32.Y%.#)5*&.#2%(.&)-/)&

/''(+'("/).&$./2%(.2&/(.&)/6.#&

+(&

2'.0","0&0+#4")"+#2&"$'+2.4&"#&

+(4.(&)+&$")"@/).&)-.&"4.#)",".4& ("262X&

&

C(+4%0)&/%)-+("2/)"+#&0/#&+#5*&3.&

@(/#).4&8-.(.&)-.&/''5"0/)"+#&

4.$+#2)(/).2&)-/)&("262&0/#&3.& (.4%0.4&)+&/00.')/35.&5.1.52X&

990 ml/l&

1

November

2012&

31 October 2014&

31 October

2022&

18&

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively

addressed in the European level risk assessment.

When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions

imposed in order to mitigate the identified risks.

Member States shall ensure that authorisations are subject to the following conditions:

(1) Product shall only be sold to and used by professionals trained to use them.

(2) Appropriate measures to protect operators shall be taken to ensure minimum risk, including the availability of personal protective equipment if necessary.

(3) Appropriate measures shall be taken to protect bystanders, such as exclusion from the treatment area during fumigation.” ; and&

(b) immediately after item No. 35 thereof, there shall be added the following new items:

No

Common

Name

IUPAC Name

Identification Numbers

!"#"$%$&

'%(")*&+,&

)-.&

/0)"1.&

2%32)/#0.& "#&)-.&

3"+0"4/5&

'(+4%0)&/2&

'5/0.4&+#&

)-.&

$/(6.)

7/).&+,& "#05%2"+#

7./45"#.&,+(&

0+$'5"/#0.&8")-&

9()"05.&:;<=>&

<.?0.')&,+(&'(+4%0)2&

0+#)/"#"#@&

$+(.&)-/#&+#.&/0)"1.&

2%32)/#0.A&

,+(&8-"0-&)-.&

4./45"#.&)+&0+$'5*&

8")-&9()"05.&:;<=>&

2-/55&3.&)-.&

+#.&2.)&+%)&"#&)-.&5/2)&

+,&)-.& "#05%2"+#&4.0"2"+#2& (.5/)"#@&)+&")2&

/0)"1.&2%32)/#0.2>

B?'"(*&4/).&

+,& "#05%2"+#

C(+4%0)&

)*'.

D'.0","0&'(+1"2"+#2&<E>

“36

Metofluthrin

RTZ isomer:

2,3,5,6-tetrafluoro-4- (methoxymethyl)benzyl-(1R,3R)-2,2- dimethyl-3- (Z)-(prop-1- enyl)cyclopropanecarboxylate

EC No: n.a.

CAS No: 240494-71-7

Sum of all isomers:

2,3,5,6-tetrafluoro-4- (methoxymethyl)benzyl (EZ)- (1RS,3RS;1SR,3SR)- 2,2-dimethyl-3- prop-1-enylcyclopropanecarboxylate

EC No: n.a.

CAS No: 240494-70-6

The active substance shall comply with both the following minimum purities:

RTZ isomer:

754 g/kg

Sum of all isomers:

930 g/kg

1 May

2011

Not applicable

30 April

2021

18

When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the European level risk assessment.&

37

Spinosad

EC No: 434-300-1

CAS No: 168316-95-8

850 g/kg

1

November

2012

31 October 2014

31 October

2022

18

When assessing the application

for authorisation of a product in

accordance with Article 5 and

Spinosad is a mixture of 50-95 % spinosyn

A and 5-50 % spinosyn D.

Spinosyn A

(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-

2-[(6-deoxy-2,3,4-tri-O- methyl-!-L- mannopyranosyl)oxy]- 13-[[(2R,5S,6R)-5- (dimethylamino)tetrahydro-6- methyl-2H- pyran-2-yl]oxy]-9-ethyl-

2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b- tetradecahydro-14-methyl- 1H-as- indaceno[3,2-d]oxacyclododecin-7,15- dione

CAS No: 131929-60-7

Spinosyn D

(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-

2-[(6-deoxy-2,3,4-tri-O- methyl-!-L- mannopyranosyl)oxy]- 13-[[(2R,5S,6R)-5- (dimethylamino)tetrahydro-6- methyl-2H- pyran-2-yl]oxy]-9-ethyl-

2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-

tetradecahydro-4,14- dimethyl-1H-as- indaceno[3,2- d]oxacyclododecin-7,15- dione

CAS No: 131929-63-0

Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the EU level risk assessment.

Member States shall ensure that authorisations are subject to the following conditions:

— Authorisations shall be subject to appropriate risk mitigation measures. In particular, products authorised for professional use by spraying shall be used with appropriate personal protective equipment, unless it can be demonstrated

in the application for

product authorisation that risks to professional users can be reduced to an acceptable level by others means.

For products containing spinosad that may lead to residues in food or feed, Member States shall verify the need to set new and/or amended existing maximum residue levels (MRLs) according to

B 1214 VERŻJONI ELETTRONIKA

Ippubblikat mid-Dipartiment tal-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — VallettaMitbugħ fl-Istamperija tal-Gvern fuq karta riċiklata — Printed at the Government Printing Press on recycled paper <.. image removed ..>Prezz/Price€0.56


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