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Order Pre-631-2011, Of 23 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/631/2011, de 23 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 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. The active substance fluopicolide is included in Commission Directive 2010 /14/EU of 3 March, including the active substance fluopicolide, by Directive 2010 /15/EU of 8 March 2010, by Directive 2010 /25/EU of the European Parliament and of the European Union (3 March). Commission, of 18 March, the active substances penoxsulam, proquinazid and spirodiclofen are included, by Commission Directive 2010 /27/EU of 23 April the active substance triflumizole is included and by Commission Directive 2010 /28/EU of 23 April, the active substance metalaxyl is included.

By Directive 2008 /69/EC of the European Parliament and of the Council of 1 July 2008, the active substances clofentecine, diflubenzuron, lenacil, oxadiazon, picloram and pyriproxyfen were included in that Annex. Commission Directive 2010 /39/EU of 22 June 2009 amended the specific provisions of Part B of the inclusions of those active substances in Annex I to Council Directive 91 /414/EEC of 15 July 1991. Commission Directive 2008 /69/EC of 1 July 2008 has been incorporated into the internal legal order by Order PRE/777/2009 of 26 March, which is included in Annex I to Royal Decree No 2163/1994 of 4 November 1994 imposing a the harmonised Community authorisation system for placing on the market and use of plant protection products, the active substances bifenox, diflufenican, fenoxaprop-P, fenpropidin, quinoclamine, clofentecine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram, pyriproxyfen, tritosulfuron and diuron.

By Commission Directive 2003 /31/EC of 11 April the active substance iprodione was included, for which the extension of the use of the active substance is available by Commission Directive 2010 /58/EU of 23 August. Iprodione, in Annex I to Council Directive 91 /414/EEC of 15 July 1991. Commission Directive 2003 /31/EC of 11 April 2003 has been transposed into national law by Order PRE/3476/2003 of 9 December 2003, including the active substances imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl, cyazofamide, 2,4-DB, beta-cyfluthrin, cyfluthrin, iprodione, linuron, maleic hydrazide, pendimethalin, propineb and propyzamide in Annex I to Royal Decree 2163/1994 of 4 November imposing the harmonised system Community authorisation to market and use plant protection products.

This order incorporates into national law Directive 2010 /14/EU of the Commission of 3 March on the inclusion of the active substance heptamaloxyloglucan, Commission Directive 2010 /15/EU of 8 December 2010. March, the inclusion of the active substance fluopicolide, Commission Directive 2010 /25/EU of 18 March, inclusion of the active substances penoxsulam, proquinazid and spirodiclofen, Commission Directive 2010 /27/EU of 23 April 2010 on the inclusion of the active substance fluopicolide The inclusion of the active substance triflumizole, Commission Directive 2010 /28/EU of 23 April of the inclusion of the active substance metalaxyl, Commission Directive 2010 /39/EU of 22 June, as regards the specific provisions relating to clofenecin, diflubenzuron, lenacyl, oxadiazon, picloram and pyriproxyfen and the Commission Directive 2010 /58/EU of 23 August concerning the extension of the use of the active substance iprodione, all of which are amending Annex I to Council Directive 91 /414/EEC of 15 July 1991 and is hereby established in accordance with the the final provision of Royal Decree No 2163/1994 of 4 November 1994, 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.

Under the proposal of the Minister for the Environment, and the Rural and Marine Environment and the Minister for Health, Social Policy and Equality, according to the Council of State, 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 active substances heptamaloxyloglucan, fluopicolide, penoxsulam, proquinazid, spirodiclofen, triflumizole and metalaxyl are included.

Two. The specific provisions for the inclusion of active substances clofentecine, diflubenzuron, lenacil, oxadiazon, picloram and pyriproxyfen are amended.

Three. The use of the active substance iprodione is extended.

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, authorisations for plant protection products containing the active substances concerned, granted prior to the the start of their period of inclusion or renewal shall be reviewed by adopting and implementing 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 Directive 2010 /14/EU of the Commission of 3 March amending Council Directive 91 /414/EEC in order to include the active substance in the Directive Heptamaloxyloglucan, Commission Directive 2010 /15/EU of 8 March amending Council Directive 91 /414/EEC to include the active substance fluopicolide, Commission Directive 2010 /25/EU of 18 March 2010 on the amend Council Directive 91 /414/EEC in order to include the active substances penoxsulam, proquinazid and spirodiclofen, Commission Directive 2010 /27/EU of 23 April amending Council Directive 91 /414/EEC to include in it the active substance triflumizole, Commission Directive 2010 /28/EU of 23 April 2010 on the amending Council Directive 91 /414/EEC in order to include in it the active substance metalaxyl, Commission Directive 2010 /39/EU of 22 June amending Council Directive 91 /414/EEC as regards the specific provisions relating to clofenecin, diflubenzuron, lenacyl, oxadiazon, the picloram and pyriproxyfen and Commission Directive 2010 /58/EU of 23 August amending Annex I to Council Directive 91 /414/EEC concerning the extension of the use of the active substance iprodione.

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, March 23, 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 inclusion of the active substance Heptamaloxyloglucan

Features:

Common name: Heptamaloxyloglucan.

CAS No. 870721-81-6.

CIPAC No.: Not available.

Chemical name (IUPAC): {[α-D-Xyl p-(1→ 6)]-ß-D-Glc p-(1→ 4)} {[α-L-Fuc p-(1→ 2)-ß-D Gal p-(1→ 2)-α -D-Xyl p-(1→ 6)]-ß-D-Glc p-(1→ 4)}-D Glc-ol.

Xyl p: xylopyranosyl; Glc p: glucopyranosyl; Fuc p: fucopyranosyl; Gal p: galactopyranosyl; Glc-ol: glucitol.

Minimum purity of the substance: ≥780 g/kg of technical product. The impurity patulin must not exceed 50 µ g/kg in the technical material.

Conditions of inclusion:

Part A. Uses: It can only be used as a plant growth regulator.

Part B: In the overall assessment, according to the uniform principles, the evaluation report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 27 September, will be addressed. November 2009.

Deadline for inclusion: From 1 June 2010 to 31 May 2020.

Deadlines for the implementation of the uniform principles: 30 November 2011 for formulations containing heptamaloxyloglucan as the only active substance or as one of several active substances included in their entirety in Annex I to Royal Decree 2163/1994.

Data Protection: For being the heptamaloxylocan 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 Fluopicolide

Features:

Common Name: Fluopicolide.

CAS No. 239110-15 -7.

N. CIPAC: 787.

Chemical name (IUPAC): 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl] benzamide.

Minimum purity of the substance: ≥970 g/kg of technical product. Toluene impurity must not exceed 3 g/kg in the technical material.

Conditions of inclusion:

Part A. Uses: It may 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 of 27 November 2009, shall be addressed in particular to:

The protection of aquatic organisms.

The protection of groundwater when the active substance is applied in areas with vulnerable soil or unfavourable climatic conditions.

The risk that operators run during the application.

The potential for air transport over long distances.

Where appropriate, the conditions of authorisation shall include risk mitigation measures, and surveillance programmes shall be initiated to control the possibility of accumulation and exposure in vulnerable areas.

The notifier shall submit further information on the relevance of the metabolite M15 in the groundwater by 30 April 2012 at the latest.

Deadline for inclusion: From 1 June 2010 to 31 May 2020.

Deadlines for the implementation of the uniform principles: 30 November 2011 for formulations containing fluopicolide as the only active substance or as one of several active substances included in their entirety Annex I to Royal Decree 2163/1994.

Data protection: For being fluopicolide 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 Penoxsulam

Features:

Common name: Penoxsulam.

CAS No. 219714-96-2.

NO CIPAC: 758.

Chemical name (IUPAC): 3-(2,2-difluoroethoxy) -N-(5,8-dimethoxy [1,2, 4] triazolo [1,5-c] pyrimidin-2-yl)-α, α, α-trifluorotoluene-2-sulfonamide.

Minimum purity of the substance: ≥980 g/kg of technical product. The impurity Bis-CHYMP 2-chloro-4-[-2-(2-chloro-5-methoxy-4-pyrimidinyl) hydrazino] -5-methoxypyrimidine must not exceed 0,1 g/kg in the technical material.

Conditions of inclusion:

Part A. Uses: 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 22 January In 2010, special attention should be given to:

The protection of aquatic organisms.

The exposure of consumers, through food, to residues of the metabolite BSCTA in subsequent rotation crops.

The protection of groundwater, when the active substance is applied in areas with vulnerable soil or unfavourable climatic conditions.

Where appropriate, the conditions of authorisation shall include risk mitigation measures.

The notifier will present additional information to control the risk to higher aquatic plants off the ground. That information shall be provided by 31 July 2012 at the latest. The rapporteur Member State shall also report on the specifications of the commercially manufactured technical material.

Deadline for inclusion: From 1 August 2010 to 31 July 2020.

Deadlines for the implementation of the uniform principles: 31 January 2012 for formulations containing penoxsulam as the only active substance or as one of several active substances included in their entirety in Annex I of Royal Decree 2163/1994.

Data protection: For penoxsulam 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 Proquinazid

Features:

Common Name: Proquinazid.

CAS number: 189278-12-4.

No. CIPAC: 764.

Chemical name (IUPAC): 6-iodo-2-propoxy-3-propylquinazolin-4 (3H)-one.

Minimum purity of the substance: ≥ 950 g/kg of the technical material.

Conditions of inclusion:

Part A. Uses: It may 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 22 January In 2010, special attention should be given to:

The long-term risk of use in vineyards for birds that feed on earthworms.

The risk to aquatic organisms.

The exposure of consumers, through food, to proquinazid residues in products of animal origin and in subsequent rotation crops.

The security of the operators.

Where appropriate, the conditions of authorisation shall include risk mitigation measures.

The rapporteur Member State shall report on the specifications of the commercially manufactured technical material.

Deadline for inclusion: From 1 August 2010 to 31 July 2020.

Deadlines for the implementation of the uniform principles: 31 January 2012, for formulations containing proquinazid as the only active substance, or as one of several active substances included in their entirety in Annex I of Royal Decree 2163/1994.

Data Protection: For being the proquinazid 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 Espirodiclofen

Features:

Common name: Espirodiclofen.

CAS No. 148477-71-8.

N. CIPAC: 737.

Chemical name (IUPAC): 2,2-dimethylbutyrate of 3-(2,4-dichlorophenyl) -2-oxo-1-oxaspiro [4.5] dec-3-en-4-yl.

Minimum purity of the substance: ≥ 965 g/kg of the technical material. The following impurities should not exceed a certain amount in the technical material: 3-(2,4-dichlorphenyl) -4-hydroxy-1-oxaspiro [4.5] dec-3-en-2-one (low-2740 enol): ≤ 6 g/kg. N, N-dimethylacetamide: ≤ 4 g/kg.

Conditions of inclusion:

Part A. Uses: It can only be used as acaricide or insecticide.

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 22 January In 2010, special attention should be given to:

The long-term risk to aquatic organisms.

The security of the operators.

The risk to bee breeding.

Where appropriate, the conditions of authorisation shall include risk mitigation measures.

Deadline for inclusion: From 1 August 2010 to 31 July 2020.

Deadlines for the implementation of the uniform principles: 31 January 2012 for formulations containing spirodiclofen as the only active substance, or as one of several active substances included in their entirety in the Annex I to Royal Decree 2163/1994.

Data Protection: For being the spirodiclofen 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 Triflumizol

Features

Common name: Triflumizol.

CAS: 99387-89-0.

NO CIPAC: 730.

Chemical name (IUPAC): (E)-4-chloro-α, α, α-trifluoro-N-(1-imidazole-1-yl-2-propoxyetilidene)-o-toluidine.

Minimum purity of the substance: ≥ 980 g/kg of the technical material. The impurity Toluene: 1 g/kg maximum.

Conditions of inclusion:

Part A. Uses: It may only be used as a fungicide in greenhouses on artificial substrates.

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 12 March In 2010, special attention should be given to:

The safety of workers and workers. The conditions of use shall require the use of appropriate personal protective equipment

The possible impact on aquatic organisms. Where appropriate, the conditions of authorisation shall include risk mitigation measures.

Deadline for inclusion: From 1 July 2010 to 30 June 2020.

Data Protection: 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 Metalaxil

Features:

Common name: Metalaxil.

CAS No. 57837-19-1.

No. CIPAC: 365.

Chemical name (IUPAC): N- (methoxyacetyl) -N- (2,6-xylyl) -DL-Alaninate methyl.

Minimum purity of the substance: 950 g/kg of the technical material. Impurity 2,6-dimethylaniline is considered to be of toxicological importance and a maximum content of 1 g/kg. is established

Conditions of inclusion:

Part A. Uses: It may 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 12 March In 2010, special attention should be given to:

The possibility of groundwater contamination by the active substance or its degradation products CGA 62826 and CGA 108906, when the active substance is applied in zones of climatic or soil characteristics vulnerable. Risk mitigation measures shall be taken where relevant.

Where appropriate, the conditions of authorisation shall include risk mitigation measures.

Deadline for inclusion: From 1 July 2010 to 30 June 2020.

Deadline for implementation of the conditions of inclusion: 31 December 2010

Deadlines for the implementation of the uniform principles: 30 June 2014, for formulations containing metalaxyl as the only active substance, or as one of several active substances included in their entirety in Annex I of Royal Decree 2163/1994.

Data protection: for being metalaxyl an old 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 Clofentecine

Conditions of inclusion:

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 11 May In 2010, special attention should be given to:

The specifications of the technical material, as commercially manufactured, should be confirmed and documented by appropriate analytical data; the test material used in the toxicity dossiers shall be compare and verify in relation to these specifications of the technical material.

The safety of operators and other workers, to the effect that the use of appropriate personal protective equipment should be stipulated in the conditions of use where appropriate.

The potential for long distance transportation through the air.

The risk to organisms not subject to treatment, and include risk mitigation measures under the conditions of authorisation.

The notifier shall submit, by 31 July 2011, a monitoring programme for the clofentecin to assess its potential for long-distance atmospheric transport and the associated environmental risks. The results of that monitoring programme shall be submitted to the rapporteur Member State and to the Commission by 31 July 2013.

In addition, before 30 June 2012, the notifier shall submit studies confirming the toxicological and environmental risks of the metabolites of the clofenecin.

Conditions for the inclusion of the active substance Diflubenzuron

Conditions of inclusion:

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 11 May In 2010, special attention should be given to:

The specifications of the technical material, as commercially manufactured, should be confirmed and documented by appropriate analytical data; the test material used in the toxicity dossiers shall be compare and verify in relation to these specifications of the technical material.

The protection of aquatic organisms.

The protection of terrestrial organisms.

Protection of arthropods, not subject to treatment, including bees.

E include as a condition in the corresponding authorizations, where appropriate, risk reduction measures.

The notifier shall submit by 30 June 2011 other studies on the possible toxicological significance of the impurities of diflubenzuron and the metabolite 4-chloroaniline (PCA).

Conditions for the inclusion of the active substance Lenacil

Conditions of inclusion:

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 11 May In 2010, special attention should be given to:

The risk to aquatic organisms, especially algae and aquatic plants, and to include as a condition in the corresponding authorisations, where appropriate, risk mitigation measures, as buffer zones between Fumigated areas and surface water bodies.

The protection of groundwater, when the active substance is applied in areas with vulnerable soil or unfavourable climatic conditions. The conditions for authorisation must include risk mitigation measures and, if necessary, surveillance programmes should be initiated in vulnerable areas to monitor the potential for groundwater contamination by the use of the metabolites IN-KF 313, M1, M2 and M3.

The notifier shall submit confirmation information on the identity and characterization of the metabolites of the soil Polar B and Polars and the metabolites M1, M2 and M3 observed in studies with lysimetres and confirmatory data. on rotation crops, including potential phytotoxic effects, by 30 June 2012 at the latest.

If a decision on the classification of lenacil under Directive 67 /548/EEC establishes the need for further information on the importance of the metabolites IN-KE 121, IN-KF 313, M1, M2, M3, Polar B and Polars, it will be required to submit that information. The notifier shall provide that information to the Commission within six months from the date of notification of the classification decision.

Conditions for the inclusion of the active substance Oxadiazon

Conditions of inclusion:

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 11 May In 2010, special attention should be given to:

The specifications of the technical material, as commercially manufactured, should be confirmed and documented by appropriate analytical data; the test material used in the toxicity dossiers shall be compare and verify in relation to these specifications of the technical material.

The possibility of groundwater contamination by the metabolite AE0608022 when the active substance is applied in situations where prolonged anaerobic conditions, or in areas of characteristics, can be expected vulnerable edaphic or extreme weather conditions; and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures.

The notifier shall submit by 30 June 2012 at the latest:

Further studies on the possible toxicological significance of oxadiazon impurities in the proposed technical specification.

Information to clarify the occurrence of metabolite AE0608033 in primary and rotation crops.

Other trials in rotation crops (specifically, between tubers and cereal crops) and a metabolic study with ruminants to confirm the risk assessment for consumers.

Information to detail the risks to birds and mammals that feed on earthworms and the long-term risks to fish.

Conditions for the inclusion of the active substance Picloram

Conditions of inclusion:

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 11 May In 2010, special attention should be given to:

The possibility of groundwater contamination by picloram, when the active substance is applied in areas with vulnerable soil characteristics or extreme weather conditions. Risk mitigation measures shall be taken where appropriate.

The notifier shall submit by 30 June 2012 at the latest:

Learn more to confirm that the analytical method of monitoring applied in the residue trials is useful for correctly quantifying the residues of picloram and its conjugates.

A soil photolysis study confirming the assessment of the degradation of picloram.

Conditions for the inclusion of the active substance Piriproxyfen

Conditions of inclusion:

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 11 May In 2010, special attention should be given to:

The safety of operators, to which the use of appropriate personal protective equipment should be stipulated in the conditions of use where appropriate.

The risk to aquatic organisms, and include as a condition in the relevant authorisations, where appropriate, appropriate risk mitigation measures.

The notifier shall submit, by 30 June 2012 at the latest, more information on the risk assessment confirming two points: the risk to aquatic insects of pyriproxyfen and its metabolite DPH-pyr and the that pyriproxyfen poses for pollinators.

Conditions for the inclusion of the active substance Iprodione

Features:

Common name: Iprodione.

CAS: 36734-19-7.

NO CIPAC: 278.

Chemical name (IUPAC): 3-(3,5-dichlorophenyl) -N-isopropyl-2,4-dioxoimidazolidine-1-carboxylide.

Minimum purity of the substance: 960 g/kg of the technical material.

Conditions of inclusion:

Uses: It can only be used as fungicide and nematicide.

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 3 December 2002, should be particularly addressed to:

The possibility of groundwater contamination when the active substance is applied at high doses (especially when used in peat) in acidic soils (pH below 6) in areas with climatic characteristics. vulnerable.

The risk to aquatic invertebrates if the active substance is used directly in the proximity of surface water, and include as a condition in the relevant authorisations, where appropriate, appropriate measures risk reduction.

Deadline for inclusion: From 1 January 2004 to 31 December 2013.