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Order Pre/839/2010, Of 29 March, Amending Annex I To Royal Decree 2163 / 1994 Of 4 November, Whereby The Community Harmonized System Of Authorization Is Implanted To Market And Use Of Plant Protection Products, To Fi...

Original Language Title: Orden PRE/839/2010, de 29 de marzo, 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 fi...

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TEXT

Council Directive 91 /414/EEC of 15 July 1991 concerning the placing of plant protection products on the market includes in Annex I the active substances which have been authorised for incorporation in products plant protection. This Directive is incorporated into the Spanish legal order under Royal Decree No 2163/1994 of 4 November 1994 imposing a harmonised Community system of authorisation to market and use plant protection products. Furthermore, in the Order of 14 April 1999, Annex I to that Royal Decree, under the name 'Community list of active substances', as defined in Article 2.16 of that Royal Decree, as the list of substances, is hereby set out in the order of 14 April 1999. active plant protection products accepted by the European Commission and whose incorporation will be made public by national provisions, issued under the relevant Community rules.

Council Directive 91 /414/EEC of 15 July 1991 has been amended by successive Directives in order to include certain active substances in Annex I thereto. The active substance 2-phenylphenol has been included in Commission Directive 2009 /160/EC of 17 December 2009. Also, by Commission Directive 2006 /135/EC of 11 December 2006, the active substance carbendazim was included, that inclusion expires on 31 December 2009, by Commission Directive 2009 /152/EC of 30 November 2009 amending the date of expiry of the inclusion of this active substance in Annex I to Commission Directive 2008 /116/EC of 15 December 2008 included the active substance metazachlor, with a maximum level of 0,01% toluene being established as a manufacturing impurity, Commission Directive 2009 /155/EC of 30 November 2009 amending the degree of purity of the active substance metazacloro.

This order incorporates the internal legal order, amending Council Directive 91 /414/EEC, Commission Directive 2009 /152/EC of 30 November 2009 on the date of expiry of the date of the entry into force of the the active substance carbendazim, Commission Directive 2009 /155/EC of 30 November concerning the degree of purity of the active substance metazacloro and Directive 2009 /160/EC of 17 December 2009, including the substance of the substance active 2-phenylphenol and, it is dictated according to the final disposition of the Royal Decree 2163/1994 of 4 November, which entails the amendment of Annex I to Royal Decree 2163/1994 of 4 November, to incorporate these Directives into our internal order.

The Inter-Ministerial Commission for Food Management has issued a mandatory report on this provision. In addition, the autonomous communities and the sectors concerned have been consulted.

In its virtue, on the proposal of the Minister for the Environment, and the Rural and Marine Environment and the Minister of Health and Social Policy, I have:

Single item. Amendment of Annex I to Royal Decree 2163/1994 of 4 November imposing the harmonised Community system of authorisation to place plant protection products on the market and use.

Annex I to Royal Decree 2163/1994 of 4 November 1994 laying down the harmonised Community system of authorisation for the placing on the market and use of plant protection products is amended as follows:

One. -Active substance 2-phenylphenol is included, as specified in the Annex to this Order.

Two.-The conditions for the inclusion of the active substance carbendazim are modified, as regards the date of expiry of the inclusion, as specified in the Annex to this Order.

Three. The conditions for the inclusion of the active substance metazachlor are modified as regards the degree of purity of the active substance, as specified in the Annex to this Order.

Single additional disposition. Review of the authorizations.

1. In order to verify compliance with the conditions for inclusion and renewals set out in the Annex to this Order, provisional authorisations for plant protection products containing the active substances concerned, granted with Prior to the commencement of their period of inclusion or renewal, they shall be reviewed by adopting and applying the relevant resolutions before the expiry of the respective time limit set out in that Annex.

2. The verification of compliance with the documentation requirements specified in Article 29.1.a of Royal Decree No 2163/1994 of 4 November 1994 contained in Annex III to the Order of 4 August 1993 laying down the requirements for applications for authorisations for plant protection products, and the assessment in accordance with the uniform principles set out in the Annex to the Order of 29 November 1995 laying down the uniform principles for the assessment and authorisation of plant protection products shall be carried out by adopting and applying the corresponding resolutions before the expiry of the respective period for the implementation of those uniform principles, which for each of the active substances are set out in the Annex to this Order, taking into account also the conditions the final version of the relevant evaluation report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health.

3. The official register of products and plant protection material of the Directorate-General for Agricultural and Livestock Resources, the Ministry of the Environment, and the Rural and Marine Environment, shall be made available to interested parties in the review report. European Commission, as referred to in the previous paragraph, as well as that of the Commission for the Evaluation of Plant Protection Products provided for in Article 3 of Royal Decree No 2163/1994 of 4 November 1994. All this with the exception of confidential information as defined in Article 32 of that Royal Decree.

Final disposition first. Incorporation of Community law.

This Order incorporates into Spanish law Commission Directive 2009 /152/EC of 30 November 2009 on Commission Directive 2009 /155/EC of 30 November 2009 and Commission Directive 2009 /160/EC of 17 December 2009 on the December, amending Council Directive 91 /414/EEC concerning the inclusion of the active substance 2-phenylphenol, the modification of the date of expiry of the inclusion of the active substance carbendazim, and the modification of the grade of purity of the active substance metazachlor.

Final disposition second. Entry into force.

This provision shall enter into force on the day following that of its publication in the "Official Gazette of the State", without prejudice to the provisions of the single additional provision.

Madrid, March 29, 2010. -First Vice-President of the Government and Minister of the Presidency, María Teresa Fernández de la Vega Sanz.

ANNEX

Amendment of Annex I "Community list of active substances" of Royal Decree 2163/1994 of 4 November 1994 imposing a harmonised Community system of authorisation to place on the market and use products Phytosanitary

Conditions for the inclusion of the active substance carbendazim

Deadline for inclusion: 1 January 2007 to 31 December 2010.

Conditions for the inclusion of the active substance metazacloro

Minimum purity of the substance: ≥ 940 g/kg of the technical product. Toluene manufacturing impurity is considered to be of toxicological importance and a maximum level of 0,05% has been established.

Conditions for the inclusion of the active substance 2-phenylphenol

Features:

Common name: 2-phenylphenol (including its salts, such as sodium salt).

CAS: 90-43-7.

N. CIPAC: 246.

Chemical name (IUPAC): Biphenyl-2-ol.

Minimum purity of the substance: ≥ 998 g/kg.

Conditions of inclusion:

Part A:

Uses: Can only be used as a post-harvest fungicide for interiors in draining (cabin shower).

Part B:

For the implementation of the uniform principles, on the basis of the conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 27 November 2009, shall be addressed in particular to:

Establishment of appropriate waste management practices to address the residual solution resulting from the application, including the cleaning water of the draining system. Where waste water is permitted to be evacuated to the sanitation network, a local risk assessment shall be ensured.

The notifier/s of the active substance should provide further information on the risk of skin depigmentation of workers and consumers for possible exposure to the metabolite 2-phenyl-hydroquinone (PHQ). presents on the skin of citrus fruits.

The notifier/s of the active substance shall submit further information to confirm that the analytical method applied in the residue tests correctly quantifies the residues of 2-phenylphenol, PHQ and their conjugates.

This information must be provided by December 31, 2011.

Deadline for inclusion: From 1 January 2010 to 31 December 2019.

Deadline for implementation of the conditions of inclusion: 31 December 2009.

Deadline for implementation of the requirements of an Annex II: 30 June 2010 to provide that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2014 for products containing 2-phenylphenol as the only active substance, or as one of several active substances included in their entirety in the Annex I of Royal Decree 2163/1994 for that date, or if it is later, on the deadline set by the Order for which the active substances concerned are included, in Annex I to that Royal Decree.

Data protection: For being 2-phenylphenol an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.