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Biocides (Amendment) Regulations, 2011

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Malta Government Gazette — Legal Notice 2011 92 — Biocides (Amendment) Regulations, 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 :-

Malta Government Gazette — Legal Notice 2011 92 — Biocides (Amendment) Regulations, 2011

(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.

Malta Government Gazette — Legal Notice 2011 92 — Biocides (Amendment) Regulations, 2011

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

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

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

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

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

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$/(6.)

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)-.&

Identification Numbers

BH&I+J&KLMN;O;NO&

H9D&I+J&:KMN=PNO

0/(3+#&4"+?"4.&

IUPAC Name

Common Name

0/(3+#&

4"+?"4.

No

FG

ensure that appropriate measures are

(1) Product shall only be sold to and

addressed in the European level risk

(2) Appropriate measures to protect

used by professionals trained to use

taken to protect bystanders, such as

When assessing the application for

that have not been representatively

authorisation, Member States shall

exposure scenarios and those risks

(3) Appropriate measures shall be

availability of personal protective

exclusion from the treatment area

operators shall be taken to ensure

4.$+#2)(/).2&)-/)&("262&0/#&3.&

to compartments and populations

assess the risks and subsequently

particular product, those uses or

imposed in order to mitigate the

Member States shall ensure that

authorisations are subject to the

Annex VI, Member States shall

(.4%0.4&)+&/00.')/35.&5.1.52X&

accordance with Article 5 and

assess, when relevant for the

minimum risk, including the

authorisation of a product in

taken or specific conditions

during fumigation.” ; and&

equipment if necessary.

When granting product

following conditions

identified risks.

assessment.

them.

18&

31 October

2022&

31 October 2014&

November

2012&

990 ml/l&

representatively addressed in the

European level risk assessment.&

particular product, those uses or

for authorisation of a product in

for authorisation of a product in

Annex VI, Member States shall

When assessing the application

When assessing the application

populations that have not been

accordance with Article 5 and

accordance with Article 5 and

exposure scenarios and those

assess, when relevant for the

risks to compartments and

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C(+4%0)&

)*'.

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31 October

"#05%2"+#

30 April

+,&

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

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31 October 2014

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1 May

with both the

shall comply

RTZ isomer

'(+4%0)&/2&

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!"#"$%$&

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The active

Sum of all

'%(")*&+,&

substance

following

minimum

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754 g/kg

930 g/kg

850 g/kg

isomers

purities

$/(6.)

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"#&)-.&

)-.&

)-.&

(1RS,3RS;1SR,3SR)- 2,2-dimethyl-3-

(methoxymethyl)benzyl-(1R,3R)-2,2-

prop-1-enylcyclopropanecarboxylate

enyl)cyclopropanecarboxylate

(methoxymethyl)benzyl (EZ)-

dimethyl-3- (Z)-(prop-1-

Identification Numbers

CAS No: 240494-71-7

CAS No: 240494-70-6

CAS No: 168316-95-8

2,3,5,6-tetrafluoro-4-

2,3,5,6-tetrafluoro-4-

Sum of all isomers

EC No: 434-300-1

IUPAC Name

RTZ isomer

EC No: n.a.

EC No: n.a.

Metofluthrin

Common

Spinosad

Name

“36

No

In particular, products

spraying shall be used

representatively addressed in the

professional users can

particular product, those uses or

Member States shall ensure that

product authorisation

authorisations are subject to the

Annex VI, Member States shall

in the application for

mitigation measures.

feed, Member States

can be demonstrated

shall verify the need

Authorisations shall

equipment, unless it

populations that have not been

containing spinosad

professional use by

acceptable level by

personal protective

residues in food or

exposure scenarios and those

assess, when relevant for the

maximum residue

amended existing

to set new and/or

with appropriate

be reduced to an

that may lead to

appropriate risk

risks to compartments and

EU level risk assessment.

levels (MRLs)

authorised for

others means.

For products

be subject to

according to

that risks to

following conditions

—

—

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

Spinosad is a mixture of 50-95 % spinosyn

mannopyranosyl)oxy]- 13-[[(2R,5S,6R)-5-

mannopyranosyl)oxy]- 13-[[(2R,5S,6R)-5-

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

(dimethylamino)tetrahydro-6- methyl-2H-

(dimethylamino)tetrahydro-6- methyl-2H-

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

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

indaceno[3,2- d]oxacyclododecin-7,15-

indaceno[3,2-d]oxacyclododecin-7,15-

tetradecahydro-4,14- dimethyl-1H-as-

2-[(6-deoxy-2,3,4-tri-O- methyl-!-L-

2-[(6-deoxy-2,3,4-tri-O- methyl-!-L-

tetradecahydro-14-methyl- 1H-as-

A and 5-50 % spinosyn D.

pyran-2-yl]oxy]-9-ethyl-

pyran-2-yl]oxy]-9-ethyl-

CAS No: 131929-60-7

CAS No: 131929-63-0

Spinosyn A

Spinosyn D

dione

dione

applicable MRLs are

mitigation measures

Regulation (EC) No

Regulation (EC) No

any appropriate risk

396/2005, and take

ensuring that the

470/2009 and/or

not exceeded.” .

€0.56

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