Key Benefits:
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 AgricultureAgriculture, 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.