Plant Protection Products (Amendment) (No. 3) Regulations,

L.N. 394 of 2010

PESTICIDES CONTROL ACT

(CAP. 430)

Plant Protection Products (Amendment) (No. 3) 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 Title and scope.

Products (Amendment) (No. 3) Regulations, 2010 and they shall

be read and construed as one with Plant Protection Products

Regulations, 2009, hereinafter referred to as “the principal L.N. 358 of 2009.

regulations”.

(2) The scope of these regulations is to transpose

Commission Directive 2010/25/EU of 18 March 2010 amending

Council Directive 91/414/EEC to include penoxsulam, proquinazid

and spirodiclofen as active substances, Commission Directive

2010/27/EU of 23 April 2010 amending Council Directive 91/414/

EEC to include triflumizole as active substance, Commission

Directive 2010/28/EU of 23 April 2010 amending Council

Directive 91/414/EEC to include metalaxyl as active substance,

Commission Directive 2010/29/EU of 27 April 2010 amending

Council Directive 91/414/EEC to include flonicamid (IKI-

220) as active substance, Commission Directive 2010/34/EU of

31 May 2010 amending Annex I to Council Directive 91/414/

EEC as regards an extension of the use of the active substance

penconazole, Commission Directive 2010/38/EU of 18 June 2010

amending Council Directive 91/414/EEC to include sulfuryl

fluoride as active substance, Commission Directive 2010/39/EU of

22 June 2010 amending Annex I to Council Directive 91/414/EEC

as regards the specific provisions relating to the active substances

clofentezine, diflubenzuron, lenacil, oxadiazon, picloram and

pyriproxyfen, Commission Directive 2010/42/EU of 28 June 2010

amending Council Directive 91/414/EEC to include FEN 560

(fenugreek seed powder) as active substance.

Schedule I to the principal regulations shall be amended Amends Schedule

as follows: -

(a) in row 177, relating to clofentezine, in the column

“Specific provisions”, Part B is being substituted as follows

“PART B

For the implementation of the uniform principles of Annex

VI, the conclusions of the review report on clofentezine, and in

particular Appendices I and II thereof, as finalised in the Standing

Committee on the Food Chain and Animal Health on 11 May 2010

shall be taken into account.

In this overall assessment Member States must pay particular

attention to

— the specification of the technical material as

commercially manufactured must be confirmed and supported

by appropriate analytical data. The test material used in the

toxicity dossiers shall be compared and verified against this

specification of the technical material;

— the operator and worker safety and ensure that

conditions of use prescribe the application of adequate

personal protective equipment, where appropriate;

— the potential for long range transport via air;

— the risk to non target organisms. Conditions of

authorisation shall include risk mitigation measures, where

appropriate.

The Member States concerned shall ensure that the notifier

presents to the Commission a monitoring programme to assess the

potential for long-range atmospheric transport of clofentezine and

the related environmental risks by 31 July 2011. The results of that

monitoring programme shall be submitted as a monitoring report

to the rapporteur Member State and to the Commission by 31 July

2013. The Member States concerned shall ensure that the notifier

submits to the Commission confirmatory studies on clofentezine

metabolites relating to their toxicological and environmental risk

assessment by 30 June 2012.”;

(b) in row 180, relating to diflubenzuron, in the column

“Specific provisions”, Part B is being substituted as follows

“PART B

For the implementation of the uniform principles of Annex

VI, the conclusions of the review report on diflubenzuron, and in

particular Appendices I and II thereof, as finalised in the Standing

Committee on the Food Chain and Animal Health on 11 May 2010

shall be taken into account.

In this overall assessment Member States must pay particular

attention to

— the specification of the technical material as

commercially manufactured must be confirmed and supported

by appropriate analytical data. The test material used in the

toxicity dossiers shall be compared and verified against this

specification of the technical material;

— the protection of aquatic organisms;

— the protection of terrestrial organisms;

— the protection of non-target arthropods including

bees.

Conditions of use shall include adequate risk mitigation

measures, where appropriate.

The Member States concerned shall ensure that the notifier

submits to the Commission further studies to address the

potential toxicological relevance of the impurity and metabolite

4-chloroaniline (PCA) by 30 June 2011.”;

(c) in row 182 concerning lenacil, in the column

“Specific provisions”, Part B is being substituted as follows

“PART B

For the implementation of the uniform principles of Annex

VI, the conclusions of the review report on lenacil, and in particular

Appendices I and II thereof, as finalised in the Standing Committee

on the Food Chain and Animal Health on 11 May 2010 shall be

taken into account.

In this overall assessment Member States must pay particular

attention to

— the risk to aquatic organisms, especially algae and

aquatic plants. Conditions of authorisation shall include risk

mitigation measures, such as bufferzones between treated

areas and surface water bodies;

— the protection of the groundwater, where the active

substance is applied in regions with vulnerable soil or

climatic conditions. Conditions of authorisation shall include

risk mitigation measures and monitoring programmes shall be

initiated to verify potential groundwater contamination from

the metabolites IN-KF 313, M1, M2 and M3 in vulnerable

zones, where appropriate.

The Member States concerned shall ensure that the notifier

submits to the Commission confirmatory information on the

identity and characterisation of soil metabolites Polar B and Polars

and metabolites M1, M2 and M3 which occurred in lysimeter

studies and confirmatory data on rotational crops, including

possible phytotoxic effects. They shall ensure that the notifier

provides such information to the Commission by 30 June 2012.

If a decision on the classification of lenacil under Directive

67/548/EEC identifies the need for further information on the

relevance of the metabolites IN-KE 121, IN-KF 313, M1; M2, M3,

Polar B and Polars, the Member States concerned shall request the

submission of such information. They shall ensure that the notifier

provides that information to the Commission within six months

from the notification of such a classification decision.”;

(d) in row 183, relating to oxadiazon, in the column

“Specific provisions”, Part B is being substituted as follows

“PART B

For the implementation of the uniform principles of Annex

VI, the conclusions of the review report on oxadiazon, and in

particular Appendices I and II thereof, as finalised in the Standing

Committee on the Food Chain and Animal Health on 11 May 2010

shall be taken into account.

In this overall assessment Member States must pay particular

attention to

— the specification of the technical material as

commercially manufactured must be confirmed and supported

by appropriate analytical data. The test material used in the

toxicity dossiers shall be compared and verified against this

specification of the technical material;

— the potential for ground water contamination by the

metabolite AE0608022 where the active substance is applied

in situations for which prolonged anaerobic conditions may

be expected to occur or in regions with vulnerable soil or

climatic conditions. Conditions of authorisation must include

risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier

submits to the Commission

— further studies to address the potential toxicological

relevance of an impurity in the proposed technical

specification;

— information to further clarify the occurrence of

metabolite AE0608033 in primary crops and rotational crops;

— further trials on rotational crops (namely root crops

and cereals) and a metabolism study on ruminants to confirm

the consumer risk assessment;

— information to further address the risk to earthworm-

eating birds and mammals, and the long-term risk to fish.

They shall ensure that the notifier provides such information

to the Commission by 30 June 2012.”;

(e) in row 184 relating to picloram, in the column

“Specific provisions”, Part B is being substituted as follows

“PART B

For the implementation of the uniform principles of Annex

VI, the conclusions of the review report on picloram, and in

particular Appendices I and II thereof, as finalised in the Standing

Committee on the Food Chain and Animal Health on 11 May 2010

shall be taken into account.

In the overall assessment Member States must pay particular

attention to

— the potential for ground water contamination where

picloram is applied in regions with vulnerable soil or climatic

conditions. Conditions of authorisation must include risk

mitigation measures, where appropriate;

The Member States concerned shall ensure that the notifier

submits to the Commission

— further information to confirm that the monitoring

analytical method applied in residue trials correctly quantifies

the residues of picloram and its conjugates;

— a soil photolysis study to confirm the evaluation of

picloram degradation.

They shall ensure that the notifier provides such information

to the Commission by 30 June 2012.”;

(f) in row 185, relating to pyriproxyfen, in the column

“Specific provisions”, Part B is being substituted as follows

“PART B

For the implementation of the uniform principles of Annex

VI, the conclusions of the review report on pyriproxyfen, and in

particular Appendices I and II thereof, as finalised in the Standing

Committee on the Food Chain and Animal Health on 11 May 2010

shall be taken into account.

In the overall assessment Member States must pay particular

attention to

— the operator safety and ensure that conditions of

use prescribe the application of adequate personal protective

equipment, where appropriate;

— the risk to aquatic organisms. Conditions of use shall

include adequate risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the notifier

submits to the Commission further information confirming the

risk assessment in respect of two points, namely the risk posed to

aquatic insects by pyriproxfen and the metabolite DPH-pyr and the

risk posed by pyriproxfen to pollinators. They shall ensure that the

notifier provides such information to the Commission by 30 June

2012.”;

(g) in row 222, relating to imidacloprid, in the column

“Specific provisions”, Part A the following shall be added

after the last sentence

“— the conditions of the authorisation, in particular

for spray applications, include, where appropriate, risk

mitigation measures to protect honey bees,

— monitoring programmes are initiated to verify

the real exposure of honey bees to imidacloprid in areas

extensively used by bees for foraging or by beekeepers,

where and as appropriate.”;

(h) in row 292, relating to penconazole, the column

“Specific provisions” is being amended as follows

(i) for part A there shall be substituted the following

“PART A

Only uses as fungicides may be authorised.”;

(ii) In the fourth paragraph of Part B for the words “The

Member States concerned shall request the submission of further

information on the fate and behaviour of the soil metabolite U1.”,

there shall be substituted the words “The Member States concerned

shall request the submission of further information on the fate and

behaviour of the soil metabolite CGA179944 in acidic soils.”; and

(i) immediately after item 306 “Malathion” there shall be

added the following new items

the conclusions of the review report on penoxsulam, 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

— the protection of groundwater when the active substance is

applied in regions with vulnerable soil and/or climatic

Conditions of authorisation shall include risk mitigation

The Member States concerned shall ensure that the notifier

submits to the Commission further information to address the

off-field risk to higher aquatic plants. They shall ensure that the

notifier provides such information to the Commission by 31 July

The Rapporteur Member State shall inform the Commission in

accordance with Article 13(5) on the specification of the

For the implementation of the uniform principles of Annex VI,

— the dietary exposure of consumers to residues of the

assessment, Member States must pay particular attention to

metabolite BSCTA in succeeding rotational crops,

technical material as commercially manufactured.

Specific provisions

Only uses as fungicide may be authorised.

Only uses as herbicide may be authorised.

— the protection of aquatic organisms,

measures, where appropriate.

conditions.

PART A

PART A

PART B

PART B

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

2012. of inclusion

Expiration

31 July 2020

31 July 2020

1 August 2010

1 August 2010

Entry into

Page 10 of 15

force

2-chloro-4-[2-(2-chloro-

pyrimidinyl)hydrazino]-

5- methoxypyrimidine

impurity Bis-CHYMP

g/kg in the technical

must not exceed 0,1

Purity !

> 980 g/kg The

5-methoxy-4-

> 950 g/kg

material

dimethoxy[1,2,4]triazol

3-(2,2-difluoroethoxy)-

o[1,5- c]pyrimidin-2-

6-iodo-2-propoxy-3-

IUPAC Name

trifluorotoluene-2-

propylquinazolin-

sulfonamide

4(3H)-one

yl)-!,!,!-

N-(5,8-

Common Name,

CAS No 219714-96-2

CAS No 189278-12-4

Identification

Numbers

CIPAC No 758

CIPAC No 764

Penoxsulam

Proquinazid

!

No

“307

For the implementation of the uniform principles of Annex VI,

the conclusions of the review report on proquinazid, 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

— to the long-term risk to earthworm-eating birds for uses in

— the dietary exposure of consumers to proquinazid residues

in products of animal origin and in succeeding rotational

Conditions of authorisation shall include risk mitigation

The Rapporteur Member State shall inform the Commission in

accordance with Article 13(5) on the specification of the

For the implementation of the uniform principles of Annex VI,

the conclusions of the review report on spirodiclofen, and in

particular Appendices I and II thereof, as finalised in the

Standing Committee on the Food Chain and Animal Health on 22

In this overall assessment, Member States must pay particular

assessment, Member States must pay particular attention

Only uses as acaricide or insecticide may be authorised.

technical material as commercially manufactured.

— to the long-term risk to aquatic organisms,

Specific provisions

January 2010 shall be taken into account.

— to the risk to aquatic organisms,

measures, where appropriate.

— to the risk to bee brood.

— to the operator safety.

— to the operator safety,

grapevine,

crops,

attention

PART A

PART B

of inclusion

31 July 2020

Expiration

1 August 2010

Entry into

Page 11 of 15

force

following

impurities must not

exceed a certain amount

technical

3-(2,4-

oxaspiro[4.5] dec-3-en-

2-one (BAJ- 2740 enol)

N,N-

dimethylacetamide: ! 4

dichlorophenyl)-4-

Purity !

g/kg

hydroxy-1-

> 965 g/kg

the

material

g/kg

The

in

!

3-(2,4-dichlorophenyl)-

oxaspiro[4.5]dec-3-en-

IUPAC Name

dimethylbutyrate

2-oxo- 1-

4-yl 2,2-

Common Name,

CAS No 148477-71-8

Identification

Numbers

CIPAC No 737

Spirodiclofen

No

Conditions of authorisation shall include risk mitigation

For the implementation of the uniform principles of Annex VI,

the conclusions of the review report on flonicamid, 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

- the risk to bees. Conditions of authorisation shall include risk

The Member States shall inform the Commission in accordance

with Article 13(5) on the specification of the technical material as

Only uses as insecticide/nematicide (fumigant) applied by

(b) where conditions of use ensure that consumer exposure is

For the implementation of the uniform principles of Annex VI,

the conclusions of the review report on sulfuryl fluoride, and in

particular Appendices I and II thereof, as finalised in the

Standing Committee on the Food Chain and Animal Health on 11

May 2010 shall be taken into account. In this overall assessment,

assessment, Member States must pay particular attention to

Member States must pay particular attention to

Specific provisions

Only uses as insecticide may be authorised.

- the risk to operators and re-entry workers,

mitigation measures where appropriate.

professional users in sealable structures

measures, where appropriate.

commercially manufactured.

(a) which are empty; or

may be authorised.

acceptable;

PART A

PART A

PART B

PART B

August

October

of inclusion

Expiration

1 September

1 November

Entry into

Page 12 of 15

force

must not exceed 3 g/kg

The impurity toluene

Purity !

in the technical

> 994 g/kg

" 960 g/kg

material.

(trifluoromethyl)nicotin

IUPAC Name

N-cyanomethyl-4-

Sulfuryl fluoride

amide

Common Name,

CAS No 158062-67-0

CAS No 002699-79-8

Flonicamid (IKI-220)

Identification

Numbers

Sulfuryl fluoride

CIPAC No 763

CIPAC No 757

No

contaminated products, such as flour and bran that remained in

the mill machinery during fumigation, or grain stored in silos in

the mill. Measures are required to ensure that such products do

when re-entering a fumigated structure after aeration. Measures

are required to ensure that they wear self containing breathing

the risk to bystanders by applying an appropriate

— the mill processing conditions necessary to ensure that

residues of fluoride ion in flour, bran and grain do not exceed the

detection for the analysis shall be at least 0,5 ppt (equivalent to

— estimates of sulfuryl fluoride atmospheric lifetime based on

They shall ensure that the notifier provides such information to

For the implementation of the uniform principles of Annex VI,

the risk posed by inorganic fluoride through

the risk to operators and the risk to workers, such as

Conditions of authorisation shall include risk mitigation

The Member States concerned shall ensure that the notifier

submits to the Commission further information and in particular,

— tropospheric concentrations of sulfuryl fluoride. Measured

concentrations should be updated regularly. The limit of

worst case scenario, with respect to the global warming potential

the conclusions of the review report on metalaxyl, and in

apparatus or other appropriate personal protective equipment,

2,1 ng sulfuryl fluoride/m3 of tropospheric air),

exclusion zone around the fumigated structure.

Specific provisions

Only uses as fungicide may be authorised.

the Commission by 31 August 2012.

not enter the food and feed chain,

measures, where appropriate.

natural background levels,

confirmatory data on

PART A

PART B

(GWP).

!

!

!

of inclusion

30 June 2020

Expiration

Entry into

1 July 2010

Page 13 of 15

force

and a maximum level of

toxicological concern

dimethylaniline was

The impurity 2,6-

Purity !

considered of

950 g/kg

(methoxyacetyl)-N-(2,6-

IUPAC Name

xylyl)-DL-alaninate

Methyl N-

Common Name,

Identification

CAS No 57837-19-1

Numbers

CIPAC No 365

Metalaxyl

No

particular Appendices I and II thereof, as finalised in the

Standing Committee on the Food Chain and Animal Health on 12

particular attention to the potential contamination of groundwater

with vulnerable soil and/or climatic conditions. Risk mitigation

the conclusions of the review report on FEN 560 (fenugreek seed

powder), and in particular Appendices I and II thereof, as

Conditions of authorisation shall include risk mitigation measures

For the implementation of the uniform principles of Annex VI,

the conclusions of the review report on triflumizole, and in

particular Appendices I and II thereof, as finalised in the

Standing Committee on the Food Chain and Animal Health on 12

In this overall assessment Member States shall pay particular

March 2010 shall be taken into account. Member States must pay

by the active substance or its degradation products CGA 62826

and CGA 108906 when the active substance is applied in regions

Only uses as elicitor of the crop’s self-defence mechanisms may

For the implementation of the uniform principles of Annex VI,

finalised in the Standing Committee on the Food Chain and

Animal Health on 11 May 2010 shall be taken into account. In

this overall assessment, Member States must pay particular

attention to the risk to operators, workers and bystanders.

Only uses as fungicide in greenhouses on artificial substrates may

- the operator and worker safety: conditions of use shall prescribe

measures should be applied where appropriate.

Specific provisions

March 2010 shall be taken into account.

where appropriate.

be authorised.

be authorised.

attention to

PART A

PART A

PART B

PART B

October

of inclusion

30 June 2020

Expiration

1 November

Entry into

1 July 2010

Page 14 of 15

force

Toluene: not more than

100 % fenugreek seed

1 g/kg is established.

being of human food

powder without any

extraction; the seed

Purity !

additive and no

grade quality.

Impurities

" 980 g/kg

1 g/kg

propoxy- ethylidene)-o-

IUPAC Name

(E)-4-chloro-!,!,!-

imidazol-1-yl-2-

trifluoro-N- (1-

Not applicable

toluidine

fenugreek or fenugreek

The active substance is

prepared from the seed

Common Name,

CAS No: 99387-89-0

powder of Trigonella

Identification

FEN 560 (also called

foenum-graecum L.

Numbers

CIPAC No None

CIPAC No: 730

CAS No None

seed powder)

Triflumizole

(fenugreek).

No

- the potential impact on aquatic organisms and must ensure that

the conditions of authorisation include, as appropriate, risk

the use of adequate personal protective equipment,

Specific provisions

mitigation measures.”

of inclusion

Expiration

Entry into

Page 15 of 15

force

Purity !

IUPAC Name

Common Name,

Identification

Numbers

No