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Order Of 19 July 2001, Which Include The Active Substances Called Metsulfuron-Methyl And Triasulfuron, Esfenvalerate, Bentazone And Lambda-Cyhalothrin In Annex I Of Royal Decree 2163 / 1994 Of 4 November, Whereby It Is Implanted...

Original Language Title: ORDEN de 19 de julio de 2001, por la que se incluyen las sustancias activas denominadas metsulfuron-metil, triasulfuron, esfenvalerato, bentazona y lambda-cihalotrin, en el anexo I del Real Decreto 2163/1994, de 4 de noviembre, por el que se implanta ...

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TEXT

Directive 91 /414/EEC of the Council of 15 July

,

on the marketing of plant protection products,

includes an annex, entitled " Active substances whose

incorporation into plant protection products is authorized ".

This Directive is incorporated into legal order

Spanish by virtue of Royal Decree 2163/1994, of 4

November by which the system is implanted

Community harmonised authorization to market

and use plant protection products. On the other hand, in the

Order of 14 April 1999, set out in Annex I

of that Royal Decree 2163/1994, under the

name "Community List of Active Substances", which is

defines in Article 2 (16) of that rule,

as the list of active substances for products

PPPs accepted by the European Commission and whose

incorporation will be made public by provisions

national, as a result of other community actions.

Using each of the

Commission 2000 /49/EC, of 26 July 2000 /66/EC, of 23 of

October, 2000 /67/EC, October 23, 2000 /68/EC,

of 23 October and 2000 /80/EC, of 4 December,

metsulfuron-methyl active substances are included,

triasulfuron, esfenvalerate, bentazone and

lambda-cyhalothrin, respectively in Annex I of the

Directive 91 /414/EEC, setting the conditions for which

the placing of plant protection products on the market

contain no harmful health effects

human or animal health or groundwater,

do not have unacceptable impacts for the media

environment.

This Order incorporates legal order

internal Directives 2000 /49/EC, 2000 /66/EC,

2000 /67/EC, 2000 /68/EC and 2000 /80/EC, using

the inclusion of metsulfuron-methyl active substances,

triasulfuron, esfenvalerate, bentazone and

lambda-cyhalothrin, in Annex I to Royal Decree 2163/1994.

This Order, which is dictated by disposition

final first of Royal Decree 2163/1994, has been

informed favourably by the Inter-Ministerial Commission

for Food Management and its processing have

the sectors affected were consulted.

In its virtue, at the proposal of the Ministers of

Agriculture, Fisheries and Food, Economy, Health

and Consumer and Environment, I have:

Single item.

1. Active substances called

metsulfuron-methyl, triasulfuron, esfenvalerate, bentazone and

lambda-cyhalothrin, are included in Annex I of the Royal

Decree 2163/1994 of 4 November, for which you are

implements the Community Harmonized System of Authorization

to market and use plant protection products, with

the characteristics and conditions that for each of

they are specified in the Annex to this Order.

2. The inclusion of the active substances to which they are

refers to paragraph 1 with the review of the

authorisations granted for plant protection products that

contain them, in accordance with current national regulations

prior to the entry into force of the Royal

Decree 2163/1994, as it is active substances

then already on the market whose authorizations must be

modified or removed, when necessary, with the

to apply the provisions of that Royal Decree to the

plant protection products containing those referred to

active substances.

3. Such review as well as the granting of

new authorizations, will be performed according to

uniform principles for assessment and authorization

of plant protection products, taking into account further

the conclusions of the final version of the respective

European Commission review reports, approved

in the Standing Committee on Plant Health on dates that,

for each of the referred active substances,

indicate in the Annex to this Order,

particularly Appendices I and II. However, compliance

of the documentation requirements for

the preparations and decisions according to the

uniform principles for assessment and authorization

of the same will be required within the deadlines that are

specify in that Annex.

4. In the Official Register of Plant Protection Products

from

Ministry of Agriculture's Directorate-General for Agriculture

Agriculture, Fisheries and Food, will be left to

stakeholder disposition of the Review Report of the

European Commission referred to in the previous paragraph, as well

such as the Evaluation Commission in the

Article 3 of Royal Decree 2163/1994. All with

exception of sensitive information that is defined

in Article 32 of that Royal Decree.

Single end disposition. Entry into force.

This provision will take effect on the day

next to that of your publication in the "Official State Bulletin".

Madrid, 19 July 2001.

LUCAS GIMENEZ

Excmo. Mr. Deputy Prime Minister of the Government for

Economic Affairs and Minister of Economy, H.E.

Mr. Minister of Agriculture, Fisheries and Food,

Excma. Ms Minister for Health and Consumer Affairs and H.E.

Mr. Minister for the Environment.

ANNEX *

7. Conditions for the inclusion of the active substance

metsulfuron-methyl.

Features:

Common name: Metsulfuron-methyl.

CAS Number: 74223-64-6.

EEC number: 441.

Chemical name (IUPAC):

2-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoylsulfamoyl)-benzonate of

methyl.

Minimum purity of the substance: 960 g/kg of product

technical.

Conditions of inclusion:

Uses: Can only be used as a herbicide.

In the global assessment based on the principles

uniforms, taking into account the European Commission report

approved by the Standing Committee on Plant Health in your

meeting of June 16, 2000, must be:

Pay special attention to water protection

underground.

Care especially for the incident on

aquatic organisms. The authorization conditions

must include, where appropriate, reduction measures

at risk.

Deadline for inclusion: 1 July 2001 to 30

June 2011.

Deadlines for the implementation of the uniform principles:

a) June 30, 2005 for all authorization

of plant protection products whose composition includes the

metsulfuron-methyl substance will be performed according to the

uniform principles for assessment and authorization

of plant protection products.

(b) In the case of plant protection products, which

contain another active substance, deadline will be set

in the conditions of inclusion of this other substance,

in case the latter is longer.

Data Protection: By being the metsulfuron-methyl one

existing substance will apply the regime

corresponding data protection provided in Article 30 of the

Royal Decree 2163/1994.

9. Conditions for the inclusion of the active substance

triasulfuron.

Features:

Common name: Triasulfuron.

CAS Number: 82097-50-5.

CIPAC Number: 480

Chemical name (IUPAC):

1-[2-(2-chloroethoxy) phenylsulfonyl] -3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl) urea.

Minimum Purity of the Technical Active Substance (such and

as manufactured): 940 g/kg.

Conditions of inclusion:

Uses: Can only be used as a herbicide.

In the global assessment based on the principles

uniforms, taking into account the Commission review report

European approved by the Plant Health Committee

Permanent at its meeting of July 13, 2000, will be:

a) Pay special attention to the protection of the

groundwater.

b) Pay special attention to the incident on

aquatic organisms and determine the measures that

(*) The numbering of the headings corresponds to the encoding

carried out by Directive 2000 /80/EC.

must be set as authorization conditions

to mitigate the risks, if any.

Deadline for inclusion: From 1 August 2001 to 31

July 2011.

Deadlines for the implementation of the uniform principles:

The deadline set for the completion of the review

existing authorizations will end:

a) July 31, 2005 for formulations

simple.

b) In the case of mixtures with other substances

active, not yet included in Real Annex I

Decree 2163/1994, four years after the inclusion of

the last of those substances in that Annex I.

Data Protection: For being the triasulfuron a

existing active substance will be applied to the regime

corresponding data protection provided in the

Article 30 of Royal Decree 2163/1994.

10. Conditions for the inclusion of the substance

active esfenvalerate.

Features:

Common Name: Esfenvalerate.

CAS Number: 66230-04-4.

CIPAC Number: 481.

Chemical name (IUPAC):

(S)-alpha-cyano-3-phenoxybenzyl-(S) -2-(4-chlorophenyl) -3-methylbutyrate.

Minimum Purity of the Technical Active Substance (such and

as manufactured): 830 g/kg.

Conditions of inclusion:

Uses: It can only be used as an insecticide.

In the global assessment based on the principles

uniforms, taking into account the European Commission report

approved by the Standing Committee on Plant Health in your

meeting of July 13, 2000, must be:

a) Pay special attention to the potential impact

on aquatic organisms and on arthropods not

objective.

b) Determine the measures to be set

as conditions of the authorization to mitigate the

risks.

Deadline for inclusion: From 1 August 2001 to 31

July 2011.

Deadlines for the implementation of the uniform principles:

The deadline set for the completion of the review

existing authorizations will end:

a) July 31, 2005 for formulations

simple.

b) In the case of mixtures with other substances

active, not yet included in Real Annex I

Decree 2163/1994, four years after the inclusion of

the last of those substances in that Annex I.

Data Protection: By being the esfenvalerate one

existing active substance will be applied to the regime

corresponding data protection provided for in Article 30

of Royal Decree 2163/1994.

11. Conditions for the inclusion of the substance

active bentazone.

Features:

Common Name: Bentazone.

CAS Number: 25057-89-0.

CIPAC Number: 366.

Chemical name (IUPAC): 2.2-dioxide

3-isopropyl-(1H) -2,1,3-benzothiazidin-4-(3H)-one.

Minimum Purity of the Technical Active Substance (such and

as manufactured): 960 g/kg.

Conditions of inclusion:

Uses: Can only be used as a herbicide.

In the global assessment based on the principles

uniforms, taking into account the European Commission report

approved by the Standing Committee on Plant Health in your

meeting of July 13, 2000, must be addressed

especially the protection of groundwater.

Deadline for inclusion: From 1 August 2001 to 31

July 2011.

Deadlines for the implementation of the uniform principles:

The deadline set for the completion of the review

existing authorizations will end:

a) July 31, 2005 for formulations

simple.

b) In the case of mixtures with other substances

active, not yet included in Real Annex I

Decree 2163/1994, four years after the inclusion of

the last of those substances in that Annex I.

Data Protection: For being the bentazone one

existing active substance will be applied to the regime

corresponding data protection provided for in Article 30

of Royal Decree 2163/1994.

12. Conditions for the inclusion of the substance

active lambda-cyhalothrin.

Features:

Common name: Lambda-cyhalothrin.

CAS Number: 91465-08-6.

CIPAC Number: 463.

Chemical name (IUPAC): Blend 1: 1 of

(z)-(1R, 3R) -3-(2-chloro-3,3,3-trifluoropropenyl) -2,

2-dimethyl-cyclopropane-carboxylate (S) (-cyano-3-phenoxybenzyl

and (z)-(1S, 3S) -3-(2-chloro-3,3,3-trifluoropropenyl) -2,

2-dimethyl-cyclopropane-carboxylate of (R)-

(-cyano-3-phenoxybenzyl).

Minimum Purity of the Technical Active Substance (such and

as manufactured): 810 g/kg.

Conditions of inclusion:

Uses: It can only be used as an insecticide.

In the global assessment based on the principles

uniforms, taking into account the report of the Commission review

European approved by the Plant Health Committee

Permanent at its meeting on October 19, 2000, will be required

attend especially to:

a) The safety of the operators.

b) The potential impact on organisms

aquatic and non-target arthropods, including bees,

including when appropriate reduction measures

of the risk.

c) The presence of residues in products

food and, above all, its acute effects.

Deadline for inclusion: From 1 January 2002 to 31

December 2011.

Deadlines for the implementation of the uniform principles:

The deadline set for the completion of the review

existing authorizations will end:

a) January 1, 2006 for formulations

simple.

b) In the case of mixtures with other substances

active, not yet included in Real Annex I

Decree 2163/1994, four years after the inclusion of

the last of those substances in that Annex I.

Data Protection: By being the lambda-cyhalothrin an

existing active substance will be applied to the regime

corresponding data protection provided in the

Article 30 of Royal Decree 2163/1994.