Maltese Laws

No

Common Name, Identification Numbers

IUPAC Name

Purity!

Entry into force

Expiration of inclusion

Specific provisions

“305

2-Phenylphenol (including its salts such as the sodium salt)

CAS No 90-43-7

CIPAC No 246

biphenyl-2-ol

! 998 g/kg

1 January

2010

31

December

2019

PART A

Only uses as a post-harvest fungicide for indoor use may be authorised.

PART B

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 finalised in the Standing Committee on the Food Chain and Animal Health on 27 November

2009, as amended in the Standing Committee on

the Food Chain and Animal Health on 28

October 2010, shall be taken into account.

In this overall assessment Member States must pay particular attention:

— to the protection of operators and workers and ensure that conditions of use prescribe the application of adequate personal protective equipment,

— to put in place appropriate waste management practices to handle the waste solution remaining after application, including the cleaning water of the

No

Common Name, Identification Numbers

IUPAC Name

Purity!

Entry into force

Expiration of inclusion

Specific provisions

drenching and other application systems. Member States permitting the release of

wastewater into the sewage system, shall ensure that a local risk assessment is carried out.

The Member States concerned shall ensure that the notifier submits to the Commission:

— further information on the potential for skin depigmentation for workers and consumers due to possible exposure to the metabolite 2- phenylhydroquinone (PHQ) on citrus peel,

— further information to confirm that the analytical method applied in residue trials correctly quantifies the residues of 2- phenylphenol, PHQ and their conjugates.

They shall ensure that the notifier provides such information to the Commission by 31 December

2011.

Furthermore, the Member States concerned shall ensure that the notifier submits to the Commission further information to confirm the residue levels occurring as a result of application techniques other than those in drench chambers.

They shall ensure that the notifier provides such information to the Commission by 31 December

2012.”; and

No

Common Name, Identification Numbers

IUPAC Name

Purity!

Entry into force

Expiration of inclusion

Specific provisions

“315

Napropamide

CAS No: 15299-

99-7

(RS)-N,N-diethyl-

2-(1- naphthyloxy)prop ionamide

! 930 g/kg

(Racemic

mixture) Relevant impurity Toluene: not more than 1,4 g/kg

1 January

2011

31

December

2020

PART A

Only uses as herbicide may be authorised. PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on napropamide, 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 taken into account.

In this overall assessment Member States shall pay particular attention to:

— operator safety: conditions of use shall prescribe the use of adequate personal protective equipment, where necessary,

— protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones,

— consumer safety as regards the occurrence in groundwater of the metabolite 2-(1- naphthyloxy) propionic acid, hereinafter

No

Common Name, Identification Numbers

IUPAC Name

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Entry into force

Expiration of inclusion

Specific provisions

“NOPA”.

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 the risk assessment of aquatic plants.;

316

Quinmerac

CAS No: 90717-

03-6

CIPAC No: 563

7-chloro-3- methylquinoline-

8- carboxylic acid

! 980 g/kg

1 May

2011

30 April

2021

PART A

Only uses as herbicide may be authorised. PART B

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 taken into account.

In this overall assessment Member States shall pay particular attention to:

— the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

— the dietary exposure of consumers to residues of quinmerac (and its metabolites) in succeeding rotational crops

No

Common Name, Identification Numbers

IUPAC Name

Purity!

Entry into force

Expiration of inclusion

Specific provisions

— the risk to aquatic organisms and the long term risk for earthworms. Conditions of use

shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of information as regards:

— the potential of plant metabolism to result in an opening of the quinoline ring;

— residues in rotational crops and the long term risk for earthworms due to the metabolite BH 518-5.

They shall ensure that the applicant provides such confirmatory data and information to the Commission by 30 April 2013.;

317

Haloxyfop-P

CAS No: Acid:

95977-29-0

Ester: 72619-32-0

CIPAC No: Acid: 526

Ester: 526.201

Acid: (R)-2-[4-(3- chloro-5- trifluoromethyl-2- pyridyloxy)pheno xy]propanoic acid

Ester: Methyl

(R)-2-{4-[3- chloro-5- (trifluoromethyl)-

2-

pyridyloxy]pheno

! 940 g/kg (Haloxyfop-P- methyl ester)

1 January

2011

31

December

2020

PART A

Only uses as herbicide may be authorised. PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on haloxyfop-P, 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 taken into account.

In this overall assessment Member States shall

No

Common Name, Identification Numbers

IUPAC Name

Purity!

Entry into force

Expiration of inclusion

Specific provisions

xy}propionate

pay particular attention to:

— operator safety: conditions of use shall prescribe the use of adequate personal protective equipment;

— protection of aquatic organisms: conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones;

— consumer safety as regards the occurrence in groundwater of metabolites DE-535 pyridinol and DE-535 pyridinone.

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 as regards the active substance and its soil metabolites DE-535 phenol, DE-535 pyridinol and DE-535 pyridinone.;

318

Pyridaben

CAS No: 96489-

71-3

CIPAC No: 583

2-tert-butyl-5-(4- tert- butylbenzylthio)-

4- chloropyrididazin

-3(2H)- one

> 980 g/kg

1 May

2011

30 April

2021

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pyridaben, and in particular Appendices I and II thereof, as finalised in the

No

Common Name, Identification Numbers

IUPAC Name

Purity!

Entry into force

Expiration of inclusion

Specific provisions

Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account.

In this overall assessment Member States shall 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 and mammals,

— 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 and as appropriate.

The Member States concerned shall request the submission of confirmatory information as regards:

— the risks for the water compartment resulting from the exposure to aqueous photolysis metabolites W-1 and B-3,

— the potential long term risk for mammals,

— the assessment of fat soluble residues.

No

Common Name, Identification Numbers

IUPAC Name

Purity!

Entry into force

Expiration of inclusion

Specific provisions

They shall ensure that the applicant provides such confirmatory information to the Commission by 30 April 2013.;

319

Metosulam

CAS No: 139528-

85-1

CIPAC No: 707

2",6"-dichloro-5,7- dimethoxy- 3"- methyl[1,2,4]triaz olo [1,5- a]pyrimidine-2- sulfonanilide

! 980 g/kg

1 May

2011

30 April

2021

PART A

Only uses as herbicide may be authorised. PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on metosulam, 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 taken into account.

In this overall assessment Member States shall pay particular attention to:

— the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

— the risk to aquatic organisms;

— the risk to non-target plants in the off-field area. Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall ensure that the applicant submits to the Commission, by 30

October 2011, further information on the

specification of the active substance as

No

Common Name, Identification Numbers

IUPAC Name

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Expiration of inclusion

Specific provisions

manufactured.

The Member States concerned shall ensure that the applicant submits to the Commission, by 30

April 2013, confirmatory information as regards:

— potential pH dependence of soil adsorption, groundwater leaching and surface water exposure for metabolites M01 and M02;

— potential genotoxicity of one impurity.;

320

Zinc phosphide

CAS No: 1314-84-

7

CIPAC No: 69

Trizinc diphosphide

! 800 g/kg

1 May

2011

30 April

2021

PART A

Only uses as rodenticide in the form of ready-to- use baits placed in bait stations or target locations may be authorised.

PART B

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 Animal Health on 28 October 2010, shall be taken into account.

In this overall assessment Member States should pay particular attention to:

— the protection of non-target organisms. Risk mitigation measures should be applied as appropriate in particular to avoid the spread

No

Common Name, Identification Numbers

IUPAC Name

Purity!

Entry into force

Expiration of inclusion

Specific provisions

of baits where only part of the content has been consumed.;

321

Fenbuconazole

CAS No: 114369-

43-6 CIPAC No:

694

(R,S) 4-(4- chlorophenyl)-2- phenyl- 2-(1H-

1,2,4-triazol-1- ylmethyl)butyroni trile

! 965 g/kg

1 May

2011

30 April

2021

PART A

Only uses as fungicide may be authorised. PART B

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 taken into account.

In this overall assessment Member States shall pay particular attention to:

— the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,

— the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs),

— the risk to aquatic organisms and mammals.

Conditions of use shall include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory data on residues of

No

Common Name, Identification Numbers

IUPAC Name

Purity!

Entry into force

Expiration of inclusion

Specific provisions

triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin.

They shall ensure that the applicant provides such studies to the Commission by 30 April

2013.

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 guidelines.;

322

6-Benzyladenine

CAS No 1214-39-7

CIPAC No 829

N6 - benzyladenine

! 973 g/kg

1 June

2011

31 May

2021

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 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

No

Common Name, Identification Numbers

IUPAC Name

Purity!

Entry into force

Expiration of inclusion

Specific provisions

the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate.;

323

Bromuconazole

CAS No: 116255-

48-2

CIPAC No: 680

1- [(2RS,4RS:2RS,4

SR)-4- bromo-2- (2,4- dichlorophenyl) tetrahydrofurfury l]-1H-1,2,4- triazole

! 960 g/kg

1

February

2011

31

January

2021

PART A

Only uses as fungicide may be authorised. PART B

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 shall be taken into account.

In this overall assessment, Member States shall pay particular attention to:

— operator’s safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate,

— protection of aquatic organisms. Conditions of authorisation shall include risk mitigation measures, where appropriate, such as adequate buffer zones.

The Member States concerned shall ensure that the applicant presents to the Commission:

— further information on residues of triazole

Specific provisions

derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin,

— information to further address the long-term risk to herbivorous mammals. They shall ensure that the applicant at whose request bromuconazole has been included in this Annex provides such confirmatory information to the Commission by 31

January 2013 at the latest.

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 guidelines.”.

Expiration of inclusion

Entry into force

Purity!

IUPAC Name

Common Name, Identification

No