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 is laid down, under the name 'Community list of active substances', as defined in Article 2.16 of that royal decree, as the list of substances 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. That is the case by Commission Directive 2010 /82/EU of 29 November 2010 extending the use of the active substance tetraconazole by means of Commission Directive 2010 /83/EU of 30 November 2010 including the active substance napropamide, by Commission Directive 2010 /86/EU of 2 December 2010, includes the active substance haloxyfop-P, by Commission Directive 2010 /92/EU of 21 December 2010, including the active substance bromuconazole and by means of the Directive 2011 /6/EU of 20 January 2011 the active substance buprofezin is included.

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

This Order is issued in accordance with the final provision of Royal Decree 2163/1994 of 4 November, which entails the amendment of Annex I thereto, as a result of such incorporation.

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, Social Policy and Equality, and according to the State Council, 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 No 2163/1994 of 4 November 1994 imposing a harmonised Community system of authorisation to place plant protection products on the market and use of plant protection products is hereby amended as follows: specifies in the attachment of this order.

One. -The use of the inclusion of the active substance tetraconazole is extended and Order PRE/2383/2010 of 13 September 2010 is amended, in accordance with the withdrawal of the restrictions set out in Part A of the inclusion of the active substance in Annex I to Royal Decree 2163/1994 of 4 November 1994.

Two. -Active substances napropamide, haloxyfop-P, bromuconazole and buprofezin are included.

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 2010 /82/EU of 29 November 2010 on the extension of the use of the active substance tetraconazole, Directive 2010 /83/EU of the European Parliament and of the Council Commission Directive 2010 /86/EU of 30 November 2010 on the inclusion of the active substance napropamide, Commission Directive 2010 /86/EU of 2 December 2010 on the inclusion of the active substance haloxyfop-P, Commission Directive 2010 /92/EU of 21 December 2010 December 2010, for the inclusion of the active substance bromuconazole and Commission Directive 2011 /6/EU, of 20 January 2011, including the active substance buprofezin.

Final disposition second. Entry into force.

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

Madrid, June 24, 2011. -Minister of the Presidency, Ramón Jáuregui Atondo.

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 extension of use of the active substance Tetraconazole

Conditions of inclusion

Part A:

-Uses: It can only be used as a fungicide.

Conditions for the inclusion of the active substance Napropamide

Features

-Common name: Napropamide.

-CAS No. 15299-99-7.

-Chemical name (IUPAC): (RS) N, N-diethyl-2-(1-naphthyloxy) propionamide.

-Minimum purity of the substance: ≥930 g/kg of technical product (racemic mixture). Relevant impurity: toluene (maximum 1,4 g/kg).

Conditions of inclusion

Part A:

-Uses: It can only be used as a herbicide.

Part B:

In the overall assessment, in accordance with the uniform principles, on the basis of the European Commission's assessment report, approved by the Standing Committee on the Food Chain and Animal Health at its meeting on 28 October 2010, should be particularly addressed to:

-The safety of operators and include in the authorisations of plant protection products, where appropriate, the requirement for 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 as appropriate buffer zones.

-The safety of consumers in respect of the presence in the groundwater of the metabolite of 2-(1-naphthyloxy) propionic acid, hereinafter referred to as the "NOPA metabolite".

The notifier/s shall submit by 31 December 2012 information confirming the assessment of surface water exposure as regards the metabolites of photolysis and the metabolite NOPA and information intended for the risk assessment of aquatic plants.

-Deadline for inclusion: 1 January 2011 to 31 December 2020.

Data protection: as napropamide is a new active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

Conditions for the 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: (RS) -2-[4-(5-trifluoromethyl-2-pyridyloxy) phenoxy] propionic acid.

ester: (R) -2-{4-[3-chloro-5-(trifluoromethyl) -2-pyridyloxy] phenoxy} methyl propionate.

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

Conditions of inclusion

Part A:

-Uses: It can only be used as a herbicide.

Part B:

In the overall assessment, in accordance with the uniform principles, on the basis of the European Commission's assessment report, approved by the Standing Committee on the Food Chain and Animal Health at its meeting on 28 October 2010, should be particularly addressed to:

-The safety of operators and include in the authorisations of plant protection products, where appropriate, the requirement for 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 as appropriate buffer zones.

-The safety of consumers as regards the presence in the groundwater of the metabolites DE-535 pyridinol and DE-535 pyridinone.

The notifier/s shall submit by 31 December 2012 information confirming the assessment of the groundwater exposure as regards the active substance and its soil metabolites DE-535 phenol, DE-535 pyridinol and DE-535 pyridinone.

-Deadline for inclusion: 1 January 2011 to 31 December 2020.

Data protection: for being the haloxyfop-P a new active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

Conditions for the inclusion of the active substance Bromuconazole

Features

-Common name: Bromuconazole.

-CAS No: 116255-48-2.

-NO CIPAC: 680.

-Chemical name (IUPAC): 1-[(2RS, 4RS; 2RS, 4SR) -4-bromo-2-(2,4-dichlorophenyl) tetrahydrofurfuryl] -1H-1,2,4-triazole.

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

Conditions of inclusion

Part A:

-Uses: It can only be used as a fungicide.

Part B:

In the overall assessment, in accordance with the uniform principles, on the basis of the European Commission's assessment report, approved by the Standing Committee on the Food Chain and Animal Health at its meeting on 23 November 2010, should be particularly addressed to:

-The 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 as appropriate buffer zones.

The notifier/s will present on January 31, 2013:

-Additional information on residues of triazole-derived metabolites in primary crops, rotating crops and products of animal origin.

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

The notifier will present additional information on the potential endocrine disrupting properties of brumoconazole within two years of the adoption of the OECD test guidelines on endocrine disruption. or test guidelines agreed in the EU.

-Deadline for inclusion: 1 February 2011 to 31 January 2021.

Data protection: for being the brumoconazole a new active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

Conditions for 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-butylimin-3-isopropyl-5-phenyl-1,3,5-thiadiacynin-4-one.

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

Conditions of inclusion

Part A:

-Uses: It can only be used as an insecticide and acaricide.

Part B:

In the overall assessment, in accordance with the uniform principles, on the basis of the European Commission's assessment report, approved by the Standing Committee on the Food Chain and Animal Health at its meeting on 23 November 2010, should be particularly addressed to:

-The safety of operators, and include in the authorisations of plant protection products, where appropriate, the prescription of the use of appropriate personal protective equipment.

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

-Respect for an appropriate waiting period in greenhouse rotation crops

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

The notifier/s will present on January 31, 2013 confirmatory information regarding the processing and conversion factors used in the risk assessment for consumers.

-Deadline for inclusion: 1 February 2011 to 31 January 2021.

Data protection: for being the buprofezin a new active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.