Order Pre/1784/2011, 24 June, Amending Annex I To Royal Decree 2163 / 1994 Of 4 November, Whereby The Community Harmonized System Of Authorization Is Implanted To Commercialize And Use Pesticides, F...

Original Language Title: Orden PRE/1784/2011, de 24 de junio, por la que se modifica el Anexo I del Real Decreto 2163/1994, de 4 de noviembre, por el que se implanta el sistema armonizado comunitario de autorización para comercializar y utilizar productos fitosanitarios, a f...

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Directive 91/414/EEC of the Council of 15 July 1991, concerning the placing of plant protection products, includes in its annex I active substances which have been authorised for incorporation in plant protection products. Said directive is incorporated into the Spanish legal system pursuant to the Royal Decree 2163 / 1994 of 4 November, whereby the community harmonised authorisation system is implanted to market and use of plant protection products. On the other hand, the order of 14 April 1999, establishes the annex I of this Royal Decree, under the name "Community of active substances list", which is defined in article 2.16 of this Royal Decree, as the list of pesticides active substances accepted by the European Commission and whose incorporation will be made public by means of national provisions issued under cover of the relevant Community rules.

Directive 91/414/EEC of the Council of 15 July 1991, has been amended by subsequent directives to include in annex I active substances determined. Thus through the directive 2010/82/EU Commission of November 29, 2010, expands the use of the active substance tetraconazol, through the directive 2010/83/EU Commission of 30 November 2010, includes the active substance napropamida, directive 2010/86/EU Commission on December 2, 2010, includes the active substance Haloxyfop-P , directive 2010/92/EU, Commission of December 21, 2010, includes the active substance bromuconazol and by Directive 2011/6/EU, January 20, 2011, includes the active substance buprofezin.

The previous rules are incorporated into the domestic legal order by this order, resulting in all amending Annex I to Directive 91/414/EEC of the Council of 15 July 1991.

This order is issued in accordance with the first final provision of the Royal Decree 2163 / 1994, on 4 November, resulting in the modification of annex I of the same, as a result of the incorporation.

The inter-ministerial Commission for food management has issued mandatory report on this provision. Likewise, in its processing have been consulted the autonomous communities and the sectors concerned.

By virtue, on the proposal of the Minister of the environment and Rural and Marine Affairs and the Minister of health, Social policy and equality, and in accordance with the Council of State, I have: single article. Modification of annex I of Royal Decree 2163 / 1994 of 4 November, whereby the community harmonised authorisation system is implanted to market and use of plant protection products.

Amending Annex I of Royal Decree 2163 / 1994 of 4 November, whereby the community harmonised authorisation system is implanted to market and use of plant protection products in the following way, as specified in the annex to this order.

One.-expands the use of the substance activates tetraconazol and modifies the order PRE/2383/2010, September 13, in what corresponds to the removal of the restrictions laid down in part A of the inclusion of the active substance in annex I of Royal Decree 2163 / 1994 of 4 November.

Two.-includes the substances active napropamida and Haloxyfop-P, bromuconazol, buprofezin.

Sole additional provision. Review of authorisations.

1 in order to verify compliance with the conditions of inclusion and renewal set out in the annex to this order, provisional authorisations for plant protection products containing the active substances concerned, granted prior to the start of his term of inclusion or renewal, will be reviewed by adopting and implementing relevant resolutions before the expiry of the respective period specified in that annex.

2 the verification of compliance with the requirements of the documentation specified in article 29.1. to) of the Royal Decree 2163 / 1994, on 4 November, contained in annex III of the order of 4 August 1993, that establish the requirements for applications for authorisations of plant protection products, and evaluation according to the uniform principles content in the annex to the order of 29 November 1995 which establishes the uniform principles for evaluation and authorisation of plant protection products, must be carried out by adopting and implementing relevant resolutions before the expiry of the respective time limit for the application of uniform principles, which are indicated in the annex to this order, for each of the active substances, taking into account Moreover, conditions of the final version of the corresponding report of the European Commission's assessment approved by the Standing Committee on the food chain and Animal health.

3. in the registry official products and material standing of the General Directorate of agricultural resources and livestock, the Ministry of the environment, and Rural and marine, will be available to stakeholders the review report of the European Commission, referred to in the previous paragraph, as well as the Committee on evaluation of plant protection products referred to in article 3 of the Royal Decree 2163 / 1994 , 4 November. All of this with the exception of the confidential information as defined in article 32 of the Royal Decree.

First final provision. Incorporation of Community law.

By this order are incorporated into Spanish law Directive 82/2010/EU of the Committee, on 29 November 2010, with regard to the extension of use of the substance activates tetraconazol, directive 2010/83/EU Commission of November 30, 2010, for the inclusion of the substance activates napropamida, Commission Directive 86/2010/EU December 2, 2010, for the inclusion of the substance Haloxyfop-P active, directive 2010/92/EU Commission of December 21, 2010, for the inclusion of the substance activates bromuconazol and directive 2011/6/EU, the Commission, on January 20, 2011, which includes the substance activates buprofezin.

Second final provision. Entry into force.

This provision will enter into force the day following its publication, without prejudice to the provisions of the sole additional provision.

Madrid, June 24, 2011.-the Minister of the Presidency, Ramon Jauregui Atondo.

Annex amendment to the annex I «Community list of active substances» of the Royal Decree 2163 / 1994 of 4 November, whereby the Community harmonized system of authorization is implanted to commercialize and use pesticides conditions of the extension of use of the active substance Tetraconazol conditions of inclusion part A: - applications: can only be used as a fungicide.

Conditions for inclusion of the active substance Napropamida features - common name: Napropamida.

-CAS NO.: 15299-99-7.

-Chemical name (IUPAC): (RS) N, N-Diethyl-2-(1-naftiloxi) metabolism.

-Minimum purity of the substance: g/kg technical product ≥930 (racemic mixture). Relevant impurity: toluene (maximum 1.4 g/kg).

Conditions of inclusion part A: - applications: can only be used as a herbicide.

Part B: in the overall evaluation according to the uniform principles, according to the European Commission's assessment report, approved by the Standing Committee on the food chain and animal health at its meeting on October 28, 2010, you should pay particular attention a: - safety of operators, and include in the authorisations of plant protection products, where appropriate , the requirement of the use of appropriate personal protective equipment.

-The protection of aquatic organisms, and include in the authorisations of plant protection products, where appropriate, risk mitigation measures, such as appropriate buffer zones.

-The safety of consumers in regards to the presence in the groundwater of the metabolite of acid 2-(1-naftiloxi) propionic, hereinafter «metabolite NOPA».

The notifier (s) shall submit before 31 December 2012, information confirming the surface water exposure assessment with regard to the metabolites of photolysis and the metabolite NOPA and information aimed at the evaluation of the risk of aquatic plants.

-Inclusion period: from 1 January 2011 to 31 December 2020.

Data protection: for being the napropamida active substance new, applies the corresponding data protection regime envisaged in article 30 of the Royal Decree 2163 / 1994.

Conditions for inclusion of the active substance Haloxyfop-P features - common name: Haloxyfop-P.

-CAS No.: Acid: 95977-29-0; Ester: 72619-32-0.

-No. CIPAC: Acid: 526; Ester: 526.201.

-Chemical name (IUPAC): acid: acido(rs)-2-[4-(5-trifluorometil-2-piridiloxi)fenoxi]propionico.

Ester: methyl (R)-2-{4-[3-cloro-5-(trifluorometil)-2-piridiloxi]fenoxi}propionato.

-Minimum purity of the substance: ≥940 g/kg. (Haloxyfop-P-methyl ester).

Conditions of inclusion part A: - applications: can only be used as a herbicide.

Part B: in the overall evaluation according to the uniform principles, according to the European Commission's assessment report, approved by the Standing Committee on the food chain and animal health at its meeting on October 28, 2010, you should pay particular attention a: - safety of operators, and include in the authorisations of plant protection products, where appropriate , the requirement of the use of appropriate personal protective equipment.


-The protection of aquatic organisms, and include in the authorisations of plant protection products, where appropriate, risk mitigation measures, such as appropriate buffer zones.

-The safety of consumers concerning the presence in the groundwater of the metabolites of-535 piridinol and DE-535 piridinona.

The notifier (s) shall submit before 31 December 2012, information confirming the groundwater exposure assessment with regard to the active substance and its metabolites from soil phenol-535, 535 piridinol and DE-535 piridinona.

-Inclusion period: from 1 January 2011 to 31 December 2020.

Data protection: for being an active substance Haloxyfop-P new, applies the corresponding data protection regime envisaged in article 30 of the Royal Decree 2163 / 1994.

Conditions for inclusion of the active substance Bromuconazol features - common name: Bromuconazol.

-CAS NO.: 116255-48-2.

-NO. CIPAC: 680.

-Chemical name (IUPAC): 1-[(2RS, 4RS;2RS, 4SR)-4-bromo-2-(2,4-diclorofenil)tetrahidrofurfuril]-1H-1,2,4-triazol.)]

-Minimum purity of the substance: ≥960 g/kg technical product.

Conditions of inclusion part A: - applications: can only be used as a fungicide.

Part B: in the overall evaluation according to the uniform principles, according to the European Commission's assessment report, approved by the Standing Committee on the food chain and animal health at its meeting of November 23, 2010, it must pay particular attention a: - safety of operators, and include in the authorisations of plant protection products, where appropriate , the prescription of the use of appropriate personal protective equipment.

-The protection of aquatic organisms, and include in the authorisations of plant protection products, where appropriate, risk mitigation measures, such as appropriate buffer zones.

The notifier (s) will present on January 31, 2013:-additional information on residues of metabolite from triazole in primary cultures, rotating crops and products of animal origin.

-Information to continue managing the risk in the long term for herbivorous mammals.

The notifier shall submit additional information about potential endocrine disruption of the brumoconazol properties in the two years following the adoption of the guidelines essay guidelines agreed in the EU or OECD test about endocrine disruption.

-Term of inclusion: on February 1, 2011 to January 31, 2021.

Data protection: for being the brumoconazol active substance new, applies the corresponding data protection regime envisaged in article 30 of the Royal Decree 2163 / 1994.

Conditions of the inclusion of the active substance Buprofezin features - common name: Buprofezin.

-CAS NO.: 953030-84-7.

-NO. CIPAC: 681.

-Chemical name (IUPAC): (Z)-2-tert-butilimin-3-isopropil-5-fenil-1,3,5-tiadiacinan-4-ona.

-Minimum purity of the substance: ≥985 g/kg technical product.

Conditions of inclusion part A: - applications: can only be used as insecticide and acaricide.

Part B: in the overall evaluation according to the uniform principles, according to the European Commission's assessment report, approved by the Standing Committee on the food chain and animal health at its meeting of November 23, 2010, it must pay particular attention a: - safety of operators, and include in the authorisations of plant protection products, where appropriate , the prescription of the use of appropriate personal protective equipment.

-The dietary exposure of consumers to the metabolites of the bruprofezin (aniline) and processed foods.

-The respect of an appropriate rotation in greenhouse crops - waiting period the protection of aquatic organisms, and include in the authorisations of plant protection products, where appropriate, risk mitigation measures.

The notifier (s) shall submit the January 31, 2013 confirmatory information with regard to the processing and conversion factors used in the assessment of the risk to consumers.

-Term of inclusion: on February 1, 2011 to January 31, 2021.

Data protection: for being the buprofezin an active substance new, applies the corresponding data protection regime envisaged in article 30 of the Royal Decree 2163 / 1994.

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