Plant Protection Products (Amendment) (No. 2) Regulations,

L.N. 95 of 2011

PESTICIDES CONTROL ACT

(CAP. 430)

Plant Protection Products (Amendment) (No. 2) Regulations,

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) The title of these regulations is the Plant Protection

Products (Amendment) (No. 2) Regulations, 2011 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 2010/81/EU of 25 November 2010

amending Council Directive 91/414/EEC as regards an extension

of the use of the active substance 2-phenylphenol, Commission

Directive 2010/82/EU of 29 November 2010 amending Council

Directive 91/414/EEC as regards an extension of the use of the

active substance tetraconazole, Commission Directive 2010/83/EU

of 30 November 2010 amending Council Directive 91/414/EEC to

include napropamide as active substance, Commission Directive

2010/85/EU of 2 December 2010 amending Council Directive

91/414/EEC to include zinc phosphide as active substance and

amending Decision 2008/941/EC, Commission Directive 2010/86/

EU of 2 December 2010 amending Council Directive 91/414/

EEC to include haloxyfop-P as an active substance, Commission

Directive 2010/87/EU of 3 December 2010 amending Council

Directive 91/414/EEC to include fenbuconazole as active substance

and amending Decision 2008/934/EC, Commission Directive

2010/89/EU of 6 November 2010 amending Council Directive

91/414/EEC to include quinmerac as active substance and

amending Decision 2008/934/EC, Commission Directive 2010/90/

EU of 7 December 2010 amending Council Directive 91/414/

EEC to include pyridaben as active substance and amending

Decision 2008/934/EC, Commission Directive 2010/91/EU of

10 December 2010 amending Council Directive 91/414/EEC to

include metosulam as active substance and amending Decision

2008/934/EC, Commission Directive 2010/92/EU of 21 December

2010 amending Council Directive 91/414/EEC to include

bromuconazole as active substance and Commission Directive

2011/1/EU of 3 January 2011 amending Council Directive 91/414/

EEC to include 6-Benzyladenine as active substance and amending

Decision 2008/941/EC.

Schedule I to the principal regulations shall be amended Amends Schedule

as follows: -

(a) In item number 298 relating to Tetraconazole in

the coloumn “Specific provisions”, for the words “Part A” to

the words “and grapes must not be authorize” there shall be

substituted the following

“PART A.

Only uses as fungicide may be authorised”;

For the implementation of the uniform

principles of Annex VI, the conclusions of the

review report on 2-phenylphenol, and in

particular Appendices I and II thereof, as

2009, as amended in the Standing Committee on

In this overall assessment Member States must

the application of adequate personal

management practices to handle the waste

solution remaining after application,

Only uses as a post-harvest fungicide for indoor

finalised in the Standing Committee on the Food

Chain and Animal Health on 27 November

the Food Chain and Animal Health on 28

— to the protection of operators and workers

and ensure that conditions of use prescribe

— to put in place appropriate waste

including the cleaning water of the

October 2010, shall be taken into account.

Specific provisions

protective equipment,

pay particular attention

use may be authorised.

PART A

PART B

Further details on identity and specification of active substances are provided in the review report.

of inclusion

Expiration

December

for item number 305 there shall be substituted the following

1 January

Entry into

force

Purity !

! 998 g/kg

IUPAC Name

biphenyl-2-ol

such as the sodium

(including its salts

Common Name,

CAS No 90-43-7

(b)

Identification

2-Phenylphenol

CIPAC No 246

Numbers

salt)

!

“305

No

drenching and other application systems.

ensure that a local risk assessment is carried

The Member States concerned shall ensure that

— further information on the potential for skin

analytical method applied in residue trials

Furthermore, the Member States concerned shall

Commission further information to confirm the

Member States permitting the release of

wastewater into the sewage system, shall

depigmentation for workers and consumers

due to possible exposure to the metabolite 2-

— further information to confirm that the

correctly quantifies the residues of 2-

They shall ensure that the notifier provides such

information to the Commission by 31 December

ensure that the notifier submits to the

residue levels occurring as a result of application

They shall ensure that the notifier provides such

information to the Commission by 31 December

techniques other than those in drench chambers.

phenylhydroquinone (PHQ) on citrus peel,

phenylphenol, PHQ and their conjugates.

the notifier submits to the Commission

Specific provisions

2012.”; and

out.

2011. of inclusion

Expiration

Entry into

force

Purity !

IUPAC Name

Common Name,

Identification

Numbers

No

For the implementation of the uniform principles

of Annex VI, the conclusions of the review

report on napropamide, and in particular

Standing Committee on the Food Chain and

In this overall assessment Member States shall

— operator safety: conditions of use shall

prescribe the use of adequate personal

— protection of aquatic organisms: conditions

of authorisation shall include risk mitigation

measures, where appropriate, such as

groundwater of the metabolite 2-(1-

naphthyloxy) propionic acid, hereinafter

Appendices I and II thereof, as finalised in the

Animal Health on 28 October 2010, shall be

— consumer safety as regards the occurrence in

protective equipment, where necessary,

Only uses as herbicide may be authorised.

Specific provisions

adequate buffer zones,

pay particular attention to

(c) immediately after item number 314 “Triflumizole” there shall be added the following new items

taken into account.

PART A

PART B

Further details on identity and specification of active substances are provided in the review report.

of inclusion

Expiration

December

g/kg 1 January 31

Entry into

force

Relevant

impurity Toluene

not more than 1,4

Purity !

(Racemic

mixture)

g/kg

(RS)-N,N-diethyl- !

naphthyloxy)prop

IUPAC Name

ionamide

CAS No: 15299- 2-(1-

Common Name,

Identification

Numbers

Napropamide

99-7

!

“315

No

The Member States concerned shall ensure that

the applicant presents to the Commission, by 31

December 2012 at the latest, information

confirming the surface water exposure

assessment as regards the photolysis metabolites

and the metabolite NOPA and information for

For the implementation of the uniform principles

of Annex VI, the conclusions of the review

report on quinmerac, and in particular

Appendices I and II thereof, as finalised in the

Standing Committee on the Food Chain and

Animal Health on 28 October 2010 shall be

In this overall assessment Member States shall

— the protection of groundwater when the

active substance is applied in regions with

— the dietary exposure of consumers to

residues of quinmerac (and its metabolites)

vulnerable soil and/or climatic conditions;

Only uses as herbicide may be authorised.

the risk assessment of aquatic plants.;

in succeeding rotational crops

Specific provisions

pay particular attention to

taken into account.

“NOPA”.

May 30 April PART A

PART B

of inclusion

Expiration

Entry into

force

Purity !

! 980 g/kg

8- carboxylic acid

CAS No: 90717- methylquinoline-

IUPAC Name

7-chloro-3-

Common Name,

CIPAC No: 563

Identification

Numbers

Quinmerac

03-6

No

The Member States concerned shall request the

— residues in rotational crops and the long

They shall ensure that the applicant provides

For the implementation of the uniform principles

Standing Committee on the Food Chain and

— the risk to aquatic organisms and the long

term risk for earthworms. Conditions of use

shall include risk mitigation measures,

— the potential of plant metabolism to result in

term risk for earthworms due to the

such confirmatory data and information to the

of Annex VI, the conclusions of the review

report on haloxyfop-P, and in particular

Appendices I and II thereof, as finalised in the

Animal Health on 28 October 2010 shall be

In this overall assessment Member States shall

Only uses as herbicide may be authorised.

submission of information as regards

an opening of the quinoline ring;

Specific provisions

Commission by 30 April 2013.;

metabolite BH 518-5.

where appropriate.

taken into account.

PART A

PART B

of inclusion

Expiration

December

g/kg 1 January 31

Entry into

force

(Haloxyfop-P-

trifluoromethyl-2- methyl ester)

Purity !

Acid: (R)-2-[4-(3- !

Methyl

xy]propanoic acid

pyridyloxy)pheno

pyridyloxy]pheno

(trifluoromethyl)-

IUPAC Name

(R)-2-{4-[3-

chloro-5-

chloro-5-

Ester

2-

CAS No: Acid

Ester: 72619-32-0

Common Name,

Identification

Ester: 526.201

Numbers

Haloxyfop-P

CIPAC No

95977-29-0

Acid: 526

No

as regards the active substance and its soil

Only uses as insecticide and acaricide may be

For the implementation of the uniform principles

— operator safety: conditions of use shall

prescribe the use of adequate personal

— protection of aquatic organisms: conditions

of authorisation shall include risk mitigation

measures, where appropriate, such as

— consumer safety as regards the occurrence in

groundwater of metabolites DE-535

The Member States concerned shall ensure that

the applicant presents to the Commission, by 31

December 2012 at the latest, information

confirming the groundwater exposure assessment

metabolites DE-535 phenol, DE-535 pyridinol

of Annex VI, the conclusions of the review

report on pyridaben, and in particular

Appendices I and II thereof, as finalised in the

pyridinol and DE-535 pyridinone.

Specific provisions

adequate buffer zones;

pay particular attention to

protective equipment;

and DE-535 pyridinone.;

authorised.

May 30 April PART A

PART B

of inclusion

Expiration

Entry into

force

Purity !

> 980 g/kg

chloropyrididazin

butylbenzylthio)-

2-tert-butyl-5-(4-

IUPAC Name

xy}propionate

-3(2H)- one

tert-

4-

CAS No: 96489-

Common Name,

CIPAC No: 583

Identification

Numbers

Pyridaben

71-3

No

Standing Committee on the Food Chain and

Animal Health on 28 October 2010 shall be

In this overall assessment Member States shall

— the operator safety and ensure that

conditions of use prescribe the application of

adequate personal protective equipment

— the risk to non target arthropods including

honeybees. Conditions of authorisation

should include risk mitigation measures and

monitoring programmes should be initiated

to verify the real exposure of honeybees to

pyridaben in areas extensively used by such

bees for foraging or by beekeepers, where

The Member States concerned shall request the

submission of confirmatory information as

— the risks for the water compartment resulting

from the exposure to aqueous photolysis

— the risk to aquatic organisms and mammals,

— the potential long term risk for mammals,

— the assessment of fat soluble residues.

Specific provisions

metabolites W-1 and B-3,

pay particular attention to

and as appropriate.

where appropriate,

taken into account.

regards

of inclusion

Expiration

Entry into

force

Purity !

IUPAC Name

Common Name,

Identification

Numbers

No

B

the

to

For the implementation of the uniform principles

Standing Committee on the Food Chain and

The Member States concerned shall ensure that

They shall ensure that the applicant provides

of Annex VI, the conclusions of the review

report on metosulam, and in particular

Appendices I and II thereof, as finalised in the

Animal Health on 28 October 2010 shall be

In this overall assessment Member States shall

— the protection of groundwater when the

active substance is applied in regions with

— the risk to non-target plants in the off-field

area. Conditions of use shall include risk

the applicant submits to the Commission, by 30

October 2011, further information on the

specification of the active substance as

vulnerable soil and/or climatic conditions;

mitigation measures, where appropriate.

Only uses as herbicide may be authorised.

information

— the risk to aquatic organisms;

Specific provisions

Commission by 30 April 2013.;

pay particular attention to

confirmatory

taken into account.

May 30 April PART A

PART B

such

of inclusion

Expiration

Entry into

force

Purity !

2",6"-dichloro-5,7- ! 980 g/kg

3"-

[1,5-

methyl[1,2,4]triaz

a]pyrimidine-2-

IUPAC Name

sulfonanilide

dimethoxy-

olo

CAS No: 139528-

Common Name,

CIPAC No: 707

Identification

Numbers

Metosulam

85-1

No

The Member States concerned shall ensure that

the applicant submits to the Commission, by 30

April 2013, confirmatory information as

— potential pH dependence of soil adsorption,

groundwater leaching and surface water

Only uses as rodenticide in the form of ready-to-

use baits placed in bait stations or target

For the implementation of the uniform principles

of Annex VI, the conclusions of the review

report on zinc phosphide, and in particular

Appendices I and II thereof, as finalised in the

Standing Committee on the Food Chain and

In this overall assessment Member States should

— the protection of non-target organisms. Risk

mitigation measures should be applied as

appropriate in particular to avoid the spread

Animal Health on 28 October 2010, shall be

exposure for metabolites M01 and M02;

— potential genotoxicity of one impurity.;

Specific provisions

locations may be authorised.

pay particular attention to

taken into account.

manufactured.

May 30 April PART A

regards

PART B

of inclusion

Expiration

Entry into

force

Purity !

! 800 g/kg

IUPAC Name

CAS No: 1314-84- diphosphide

Trizinc

Common Name,

Identification

Zinc phosphide

CIPAC No: 69

Numbers

No

of baits where only part of the content has

For the implementation of the uniform principles

of Annex VI, the conclusions of the review

report on fenbuconazole, and in particular

Appendices I and II thereof, as finalised in the

Standing Committee on the Food Chain and

Animal Health on 28 October 2010 shall be

In this overall assessment Member States shall

— the operator safety and ensure that

conditions of use prescribe the application of

adequate personal protective equipment

— the dietary exposure of consumers to the

residues of triazole derivative metabolites

— the risk to aquatic organisms and mammals.

Conditions of use shall include risk

The Member States concerned shall request the

submission of confirmatory data on residues of

mitigation measures, where appropriate.

Only uses as fungicide may be authorised.

Specific provisions

pay particular attention to

where appropriate,

been consumed.;

taken into account.

(TDMs),

May 30 April PART A

PART B

of inclusion

Expiration

Entry into

force

Purity !

4-(4- ! 965 g/kg

2-(1H-

ylmethyl)butyroni

chlorophenyl)-2-

IUPAC Name

1,2,4-triazol-1-

phenyl-

(R,S)

trile

CAS No: 114369-

43-6 CIPAC No

Common Name,

Identification

Fenbuconazole

Numbers

No

triazole derivative metabolites (TDMs) in

They shall ensure that the applicant provides

such studies to the Commission by 30 April

The Member States concerned shall ensure that

the applicant submits to the Commission further

information addressing the potential endocrine

disrupting properties of fenbuconazole within

two years after the adoption of the OECD test

guidelines on endocrine disruption or,

alternatively, of Community agreed test

Only uses as plant growth regulator may be

For the implementation of the uniform principles

of Annex VI, the conclusions of the review

report on 6-Benzyladenine, and in particular

Appendices I and II thereof, as finalised in the

Standing Committee on the Food Chain and

Animal Health on 23 November 2010 shall be

taken into account. In this overall assessment

Member States shall pay particular attention to

primary crops, rotational crops and products of

Specific provisions

animal origin.

guidelines.;

authorised.

May PART A

PART B

2013. of inclusion

Expiration

June 31

Entry into

force

Purity !

- ! 973 g/kg

IUPAC Name

benzyladenine

CAS No 1214-39-7

Common Name,

6-Benzyladenine

Identification

CIPAC No 829

Numbers

No

the protection of aquatic organisms. Risk

mitigation measures such as buffer zones shall

For the implementation of the uniform

principles of Annex VI, the conclusions of the

review report on bromuconazole, and in

particular Appendices I and II thereof, as

finalised in the Standing Committee on the Food

Chain and Animal Health on 23 November 2010

In this overall assessment, Member States shall

— operator’s safety and ensure that conditions

of use prescribe the application of adequate

personal protective equipment where

— protection of aquatic organisms. Conditions

of authorisation shall include risk mitigation

measures, where appropriate, such as

The Member States concerned shall ensure that

— further information on residues of triazole

Only uses as fungicide may be authorised.

the applicant presents to the Commission

Specific provisions

be applied, where appropriate.;

shall be taken into account.

pay particular attention to

adequate buffer zones.

appropriate,

PART A

PART B

of inclusion

Expiration

January

Entry into

February

force

Purity !

! 960 g/kg

SR)-4- bromo-2-

[(2RS,4RS:2RS,4

tetrahydrofurfury

dichlorophenyl)

IUPAC Name

l]-1H-1,2,4-

triazole

(2,4-

1-

CAS No: 116255-

Common Name,

CIPAC No: 680

Bromuconazole

Identification

Numbers

48-2

No

B

confirmatory

risk to herbivorous mammals. They shall

bromuconazole has been included in this

derivative metabolites (TDMs) in primary

crops, rotational crops and products of

— information to further address the long-term

ensure that the applicant at whose request

information to the Commission by 31

The Member States concerned shall ensure that

the applicant submits to the Commission further

information addressing the potential endocrine

disrupting properties of bromuconazole within

two years after the adoption of the OECD test

guidelines on endocrine disruption or,

alternatively, of Community agreed test

Specific provisions

such

January 2013 at the latest.

provides

animal origin,

guidelines.”.

Annex

of inclusion

Expiration

Entry into

force

Purity !

IUPAC Name

Common Name,

Identification

Numbers

No

€1.40