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Order Pre / 1702/2006 Of 29 May, Which Are Included In Annex I Of Royal Decree 2163/1994, Of November 4, By The Community Harmonized Authorization System Implanted For Marketing And Use Of Plant Protection Products , ... D

Original Language Title: ORDEN PRE/1702/2006, de 29 de mayo, por la que se incluyen en 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, d...

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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 the 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 Regulation, is hereby established as the list of active substances of plant protection products accepted by the European Commission and whose incorporation will be made public by national provisions, as a result of other Community provisions. Directive 91 /414/EEC has been amended by successive Directives in order to include certain active substances in Annex I thereto. Therefore, by Commission Directive 2005 /53/EC of 16 September the active substances chlorothalonil, chlorotoluron, cypermethrin, daminozide and thiophanate-methyl are included by Commission Directive 2005 /54/EC of 19 September 2005. includes the active substance tribenuron, by Commission Directive 2005 /57/EC of 21 September including the active substances MCPA and MCPB, by Commission Directive 2005 /58/EC of 21 September including active substances bifenazate and milbemectin, and by Commission Directive 2005 /72/EC of 21 October include the active substances chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb and metiram. The above provisions lay down the conditions for the placing on the market of plant protection products containing those active substances which have no harmful effects on human health or animal health or on groundwater, they have no unacceptable impact on the environment, as well as for the review of existing authorisations for plant protection products containing one of the active substances listed in Annex I to Directive 91 /414/EEC, by modifying or removing them, in accordance with the provisions set out in that effect Directive. This Order incorporates Directives 2005 /53/EC, 2005 /54/EC, 2005 /57/EC, 2005 /58/EC and 2005 /72/EC into national law by the inclusion of the active substances chlorothalonil, chlorotoluron, cypermethrin, daminozide, thiophanate-methyl, tribenuron, MCPA, MCPB, bifenazate, milbemectin, chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb and metiram in Annex I to Royal Decree 2163/1994, and is given in accordance with the faculty established in the final Disposition of the Royal Decree. 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 a proposal from the Ministries of Agriculture, Fisheries and Food, Health and Consumer Affairs and the Environment, I have:

Single item. Inclusion of active substances in Annex I to Royal Decree No 2163/1994 of 4 November imposing the harmonised Community system of authorisation to place plant protection products on the market and use.

1. The active substances chlorothalonil, chlortoluron, cypermethrin, daminozide, thiophanate-methyl, tribenuron, MCPA, MCPB, bifenazate, milbemectin, chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb and metiram are included in Annex I to Royal Decree 2163/1994, (a) on 4 November the harmonised Community system of authorisation for the placing on the market and use of plant protection products is implemented.

2. In order to verify compliance with the conditions of inclusion set out in the Annex to this Order, existing authorisations and provisional authorisations for plant protection products containing the active substances concerned, granted prior to the commencement of their period of inclusion, shall be reviewed, adopted and implemented by the relevant resolutions before the expiry of the respective time limit set out in that Annex. 3. The verification of compliance with the documentation requirements specified in Article 29 (1) (a) of Royal Decree No 2163/1994 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 contained in Annex VI to Directive 91 /414/EEC, which is incorporated into our legal order by the Order of 29 November 1995, by laying down uniform principles for the assessment and authorisation of products In the case of plant protection, the Commission shall adopt and implement the relevant resolutions before the expiry of the relevant period for the implementation of these uniform principles, which for each of the active substances are indicated in the Annex to this Regulation. This Order, taking into account also the conclusions of the final version of the relevant evaluation report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health. 4. In the Official Register of Plant Health Products and Material of the Directorate-General for Agriculture, the Ministry of Agriculture, Fisheries and Food, the European Commission's review reports will be available to interested parties. refers to the previous paragraph, as well as those of the Commission for the Evaluation of Plant Protection Products provided for in Article 3 of Royal Decree 2163/1994. All this with the exception of confidential information as defined in Article 32 of the Royal Decree.

Final disposition first. Competence title.

This Order is issued pursuant to the provisions of Article 149.1.13., 16. and 23. of the Constitution, which attributes to the State exclusive competence in the field of bases and coordination of the general planning of the economic activity, bases and general coordination of health, and basic legislation on environmental protection, respectively.

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.

Madrid, 29 May 2006.

Fernandez de la Vega Sanz

Sras. Ministers for Agriculture, Fisheries and Food, Health and Consumer Affairs and the Environment.

ANNEX (*)

102. Conditions for the inclusion of the active substance chlorothalonil

Features: Common Name: Chlorothalonil.

Nª CAS: 1897-45-6. Nª CIPAC: 288. Chemical name (IUPAC): tetrachloroisophthalonitrile. Minimum purity of the substance: 985 g/kg of technical product.

Hexachlorobenzene: max. 0,01 g/kg.

Decachlorobiphenyl: max. 0.03 g/kg.

Include conditions:

Uses: It can only be used as a fungicide.

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 15 February 2005, should be particularly addressed to:

the protection of aquatic organisms, and include as a condition in the corresponding authorisations, where appropriate, risk mitigation measures.

the protection of groundwater, in particular with regard to the active substance and its metabolites R417888 and R611965 (SDS46851), when the substance is applied in areas of vulnerable soil delicate climatic conditions.

Deadline for inclusion: 1 March 2006 to 28 February 2016.

Deadline for implementation of the conditions of inclusion: 31 August 2006. Deadlines for the implementation of the uniform principles: 28 February 2010 for formulations containing colorothalonil as the only active substance or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994, within the deadline of 28 February 2006. (*) The numbering of the headings corresponds to the codification made by Directive 2000 /80/EC. Data protection: for being the chlorothalonil an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

103. Conditions for the inclusion of the active substance chlorotoluron

Features: Common Name: Clorotoluron.

CAS number 15545-48-9. Nª CIPAC: 217. Chemical name IUPAC: 3-(3-chloro-p-tolyl)-1,1-dimethylurea. Minimum purity of the substance: 975 g/kg of technical product.

Conditions of inclusion:

Uses: Can only be used as a herbicide.

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 15 February 2005, should be particularly addressed to:

the protection of groundwater when the active substance is applied in areas with vulnerable soil characteristics or sensitive climatic conditions, and include as a condition in the relevant authorisations, when the risk mitigation measures are appropriate.

Deadline for inclusion: 1 March 2006 to 28 February 2016.

Deadline for implementation of the conditions of inclusion: 31 August 2006. Deadlines for the implementation of the uniform principles: 28 February 2010 for formulations containing chlorotoluron as the only active substance or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994, within the deadline of 28 February 2006. Data protection: as a chlorotoluron an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree No 2163/1994 shall apply.

104. Conditions for the inclusion of the active substance cipermethrin

Features: Common name: Cipermethrin.

Nª CAS: 52315 -07-8. Nª CIPAC: 332. Chemical name (IUPAC): trans-3-(2,2-dichlorovinyl)-2,2-dimethylcycle-propanocar-alpha-cyano-3-phenoxybenzyl boxylate (4 pairs of isomers: cis-1, cis-2, trans-3, trans-4). Minimum purity of the substance: 900 g/kg of technical product.

Conditions of inclusion:

Uses: It can only be used as an insecticide.

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 15 February 2005, should be particularly addressed to:

the protection of aquatic organisms, bees and arthropods not subject to treatment, and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures.

the safety of operators, and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures.

Deadline for inclusion: 1 March 2006 to 28 February 2016.

Deadline for implementation of the conditions of inclusion: 31 August 2006. Deadlines for the implementation of the uniform principles: 28 February 2010 for formulations containing cypermethrin as the only active substance or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994, within the deadline of 28 February 2006. Data protection: for cypermethrin an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

105. Conditions for the inclusion of the active substance daminozide

Features: Common Name: Daminozide.

CAS NO: 1596-84-5. CIPAC No 330. Chemical name (IUPAC): N-dimethylamino-succinamic acid. Minimum purity of the substance: 990 g/kg of technical product. Impurities: N-Nitrosodimethylamine: max. 2.0 mg/kg. 1,1-dimethylhydrazine: max. 30 mg/kg.

Conditions of inclusion:

Uses: It can only be used as a growth regulator in non-edible crops.

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 15 February 2005, should be particularly addressed to:

the safety of operators and workers after re-entry, and include as a condition in the relevant authorisations, where appropriate risk mitigation measures are appropriate.

Deadline for inclusion: 1 March 2006 to 28 February 2016.

Deadline for implementation of the conditions of inclusion: 31 August 2006. Deadlines for the implementation of the uniform principles: 28 February 2010 for formulations containing daminozide as the only active substance or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994, within the deadline of 28 February 2006. Data protection: the data protection regime provided for in Article 30 of Royal Decree No 2163/1994 shall apply for the daminozide of an old active substance.

106. Conditions for the inclusion of the active substance thiophanate-methyl

Features: Common Name: Tiofanato-methyl.

CAS NO: 23564-05-8. CIPAC No 262. Chemical name (IUPAC): Dimethyl 4,4 '-(o-phenylene) bis (3-thioallophanate). Minimum purity of the substance: 950 g/kg of technical product.

Conditions of inclusion:

Uses: It can only be used as a fungicide.

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 15 February 2005, should be particularly addressed to:

the protection of aquatic organisms, earthworms and other soil macroorganisms, and include as a condition in the corresponding authorisations, where appropriate, risk mitigation measures.

Deadline for inclusion: 1 March 2006 to 28 February 2016.

Deadline for implementation of the conditions of inclusion: 31 August 2006. Deadlines for the implementation of the uniform principles: 28 February 2010 for formulations containing thiophanate-methyl as the only active substance or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994, within the deadline of 28 February 2006. Data protection: for being the thiophanate-methyl an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

107. Conditions for the inclusion of the active substance tribenuron

Features: Common Name: Tribenuron.

CAS NO: 106040-48-6 (tribenuron). CIPAC No 546. Chemical name (IUPAC): 2-[4-methoxy-6methyl-1,3,5-triazin-2-yl (methyl) carbomoylsulfamoyl] benzoic acid. Minimum purity of the substance: 950 g/kg of technical product (expressed as tribenuron-methyl).

Conditions of inclusion:

Uses: Can only be used as a herbicide.

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 15 February 2005, should be particularly addressed to:

the protection of land-based plants not subject to treatment, higher aquatic plants and groundwater in vulnerable situations, and to include as a condition in the relevant authorisations, when Risk mitigation measures are appropriate.

Deadline for inclusion: 1 March 2006 to 28 February 2016.

Deadline for implementation of the conditions of inclusion: 31 August 2006. Deadlines for the implementation of the uniform principles: 28 February 2010 for formulations containing tribenuron as the only active substance or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994 within the period ending on 28 February 2006. Data protection: for being the tribenuron an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

108. Conditions for the inclusion of the active substance MCPA

Features: Common Name: MCPA.

CAS NO: 94-74-6. CIPAC No: 2. Chemical name (IUPAC): 4-chloro-o-tolyloxyacetic acid. Minimum purity of the substance: ≥ 930 g/kg of technical product.

Conditions of inclusion:

Uses: Can only be used as a herbicide.

In the overall assessment, in accordance with the uniform principles, on the basis of the evaluation report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 15 April 2005, Special attention must be given to:

the risk of groundwater contamination when the active substance is applied in areas with vulnerable soil characteristics or delicate climatic conditions.

the protection of aquatic organisms, and include as a condition in the corresponding authorisations, where appropriate, risk mitigation measures, such as buffer zones.

Deadline for inclusion: 1 May 2006 to 30 April 2016.

Deadline for implementation of the conditions of inclusion: 31 October 2006. Deadline for the implementation of the uniform principles: 30 April 2010, for formulations containing MCPA as the only active substance, or as one of several active substances included in their entirety in Annex I to Royal Decree 2163/1994, within the period ending on 30 April 2006. Data protection: For the MCPA an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

109. Conditions for the inclusion of the active substance MCPB

Features: Common Name: MCPB.

CAS NO: 94-81-5. CIPAC No 50. Chemical name (IUPAC): 4 (4-chloro-o-tolyloxy) butyric acid. Minimum purity of the substance: ≥ 920 g/kg of technical product.

Conditions of inclusion:

Uses: Can only be used as a herbicide.

In the overall assessment, in accordance with the uniform principles, on the basis of the evaluation report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 15 April 2005, Special attention must be given to:

the risk of groundwater contamination when the active substance is applied in areas with vulnerable soil characteristics or delicate climatic conditions.

the protection of aquatic organisms, and include as a condition in the corresponding authorisations, where appropriate, risk mitigation measures, such as buffer zones.

Deadline for inclusion: 1 May 2006 to 30 April 2016.

Deadline for implementation of the conditions of inclusion: 31 October 2006. Deadline for the implementation of the uniform principles: 30 April 2010, for formulations containing MCPB as the only active substance, or as one of several active substances included in their entirety in Annex I to Royal Decree 2163/1994, within the period ending on 30 April 2006. Data protection: For being the MCPB an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

110. Conditions for the inclusion of the active substance bifenazate

Features: Common Name: Bifenazate.

CAS NO: 149877-41-8. CIPAC No 736. Chemical name (IUPAC): Isopropyl 2-(4-methoxybiphenyl-3-yl) hydrazinoformat. Minimum purity of the active substance: ≥ 950 g/kg of technical product.

Conditions of inclusion:

Uses: It can only be used as acaricide.

The assessment report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 3 June 2005, will be taken into account in the overall assessment, according to the uniform principles.

In the assessment of applications for authorisation of plant protection products containing bifenazate for other uses than those for ornamental plants in the greenhouse, special attention shall be paid to the requirements referred to in Article 15 of Royal Decree 2163/1994, all the data and information necessary for its authorization must be provided. Deadline for inclusion: 1 December 2005 to 30 November 2015. Deadline for the implementation of the conditions of inclusion: 31 May 2006. Deadline for the implementation of the uniform principles: 31 May 2007 for formulations containing bifenazate as the only active substance or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994, within the deadline of 30 November 2005. Data protection: For the bifenazate to be a new active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

111. Conditions for the inclusion of the active substance milbemectin

Features: Common name: Milbemectin (milbemectin is a mixture of M. A3 and M. A4).

CAS #:

M. A3: 51596-10-2.

M. A4: 51596-11-3.

CIPAC NO: 660.

Chemical name (IUPAC):

M. A3: (10E, 14E, 16E, 22Z)-(1R, 4S, 5 'S, 6R, 6' R, 8R, 13R, 20R, 21R, 24S) -21, 24-dihydroxy-5 ', 6', 11, 13, 22-pentamethyl-3,7, 19-trioxatetracyclo [15.6.1.14 ,8,020, 24] pentacostale-10, 14, 16, 22-tetraeno-6-spiro-2 '-tetrahydropyran-2-one.

M. A4: (10E, 14E, 16E, 22Z)-(1R, 4S, 5 'S, 6R, 6' R, 8R, 13R, 20R, 21R, 24S) -6 '-ethyl-21, 24-dihydroxy-5', 11, 13, 22-tetramethyl-3, 7, 19-trioxatetracyclo [15.6.1.14,8020, 24] pentacostale-10, 14, 16, 22-tetraeno-6-spiro-2 '-tetrahydropyran-2-one.

Minimum purity of the substance: ≥ 950 g/kg of technical product. Conditions of inclusion:

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

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 3 June 2005, Special attention must be given to:

the protection of aquatic organisms, and include as a condition in the corresponding authorisations, where appropriate, risk mitigation measures.

Deadline for inclusion: 1 December 2005 to 30 November 2015.

Deadline for implementation of the conditions of inclusion: 31 May 2006. Deadline for the implementation of the uniform principles: 31 May 2007 for formulations containing milbemectin as the only active substance or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994, within the deadline of 30 November 2005. Data protection: For milbemectin a new active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

112. Conditions for the inclusion of the active substance chlorpyrifos

Features: Common Name: Chlorpyrifos.

CAS NO: 2921-88-2. CIPAC No 221. Chemical name (IUPAC): O, O-diethyl-=-3,5,6-trichloro-2-pyridyl thiophosphate. Minimum purity of the substance: ≥ 970 g/kg of technical product.

Conditions of inclusion:

Uses: Can only be used as an insecticide.

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 3 June 2005, Special attention must be given to:

the protection of birds, mammals, aquatic organisms, bees and arthropods not subject to treatment, and include as a condition in the relevant authorisations, where appropriate, reduction measures risk.

The notifiers at the instance of which chlorpyrifos has been included in Annex I to Royal Decree 2163/1994 will provide the European Commission with additional studies to confirm the risk assessment for birds and birds. Mammals, within two years, from the entry into force of this Order.

Deadline for inclusion: 1 July 2006 to 30 June 2016. Deadline for the implementation of the conditions of inclusion: 31 December 2006. Deadline for the implementation of the uniform principles: 30 June 2010 for formulations containing chlorpyrifos as the only active substance or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994, within the deadline of 30 June 2006. Data protection: For chlorpyrifos an active substance old, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

113. Conditions for the inclusion of the active substance chlorpyrifos-methyl

Features: Common Name: Chlorpyrifos-methyl.

CAS NO: 5598-13-0. CIPAC No 486. Chemical name (IUPAC): O, O-dimethyl-o-3,5,6-trichloro-2-pyridyl thiophosphate. Minimum purity of the substance: ≥ 960 g/kg of technical product.

Include conditions:

Uses: It can only be used as an insecticide.

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 3 June 2005, Special attention must be given to:

the protection of birds, mammals, aquatic organisms, bees and non-target arthropods, and should include as a condition in the relevant authorisations, where appropriate, measures to reduce risk.

The notifiers at the instance of which chlorpyrifos-methyl has been included in Annex I to Royal Decree 2163/1994 shall provide the European Commission with additional studies to confirm the risk assessment for birds. and mammals within two years of the entry into force of this Order.

Deadline for inclusion: 1 July 2006 to 30 June 2016. Deadline for the implementation of the conditions of inclusion: 31 December 2006. Deadline for the implementation of the uniform principles: 30 June 2010 for formulations containing chlorpyrifos-methyl as the only active substance or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994, within the deadline of 30 June 2006. Data protection: For chlorpyrifos-methyl an active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree No 2163/1994 shall apply.

114. Conditions for the inclusion of the active substance maneb

Features: Common Name: Maneb.

CAS NO: 12427-38-2. CIPAC No 61. Chemical name (IUPAC): Ethylenebis (dithiocarbamate) manganous (polymeric). Minimum purity of the substance: ≥ 860 g/kg of technical product. The impurity of ethylentiourea manufacture is considered to be of toxicological importance and must not exceed 0,5% of the maneb content.

Conditions of inclusion:

Uses: It can only be used as a fungicide.

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 3 June 2005, Special attention must be given to:

the possibility of groundwater contamination, when the active substance is applied in areas with vulnerable soil and/or extreme weather.

waste in food and assess the exposure of consumers through food. the protection of birds, mammals, aquatic organisms and arthropods not subject to treatment, and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures

The notifiers at the request of which the maneb has been included in Annex I to Royal Decree 2163/1994 will provide the European Commission with additional studies to confirm the risk assessment for birds and birds. Mammals, within two years, from the entry into force of this Order.

Deadline for inclusion: 1 July 2006 to 30 June 2016. Deadline for the implementation of the conditions of inclusion: 31 December 2006. Deadline for the implementation of the uniform principles: 30 June 2010, for formulations containing maneb as the only active substance, or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994, within the deadline of 30 June 2006. Data protection: For being the maneb an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

115. Conditions for the inclusion of the active substance mancozeb

Features: Common Name: Mancozeb.

CAS NO: 8018-01-7 (previously 8065-67-5). CIPAC No 34. Chemical name (IUPAC): Ethylenebis (dithiocarbamate) complex (polymeric) manganous with zinc salts. Minimum purity of the substance: ≥ 800 g/kg of technical product. The impurity of ethylentiourea manufacture is considered to be of toxicological importance and must not exceed 0,5% of the content of mancozeb.

Conditions of inclusion:

Uses: It can only be used as a fungicide.

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 3 June 2005, Special attention must be given to:

the possibility of groundwater contamination, when the active substance is applied in areas with vulnerable soil and/or extreme weather.

waste in food and assess the exposure of consumers through food. the protection of birds, mammals, aquatic organisms and arthropods not subject to treatment, and shall include as a condition in the relevant authorisations, where appropriate, risk mitigation measures.

The notifiers at the request of which the mancozeb has been included in Annex I to Royal Decree 2163/1994 will provide the European Commission with additional duties to confirm the risk assessment for birds and birds. Mammals, within two years, from the entry into force of this Order.

Deadline for inclusion: 1 July 2006 to 30 June 2016. Deadline for the implementation of the conditions of inclusion: 31 December 2006. Deadline for the implementation of the uniform principles: 30 June 2010, for formulations containing mancozeb as the only active substance, or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994, within the deadline of 30 June 2006. Data protection: For being the mancozeb an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

116. Conditions for the inclusion of the active substance metiram

Features: Common Name: Metiram.

CAS NO: 9006-42-2. CIPAC No: 478. Chemical name: ethylenebis (dithiocarbamate) zinc-poly [ethylenebis (thiourama disulfide)] ammoniate. Minimum purity of the substance: ≥ 840 g/kg of technical product. The impurity of ethylentiourea manufacturing is considered to be of toxicological importance and should not exceed 0,5% of metiram content.

Conditions of inclusion:

Uses: It can only be used as a fungicide.

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 3 June 2005, Special attention must be given to:

the possibility of groundwater contamination, when the active substance is applied in areas with vulnerable soil and/or extreme weather.

waste in food and assess the exposure of consumers through food. the protection of birds, mammals, aquatic organisms and arthropods not subject to treatment, and shall include as a condition in the relevant authorisations, where appropriate, risk mitigation measures.

The notifiers at the request of which metiram has been included in Annex I to Royal Decree 2163/1994 will provide the European Commission with additional duties to confirm the risk assessment for birds and birds. Mammals, within two years, from the entry into force of this Order.

Deadline for inclusion: 1 July 2006 to 30 June 2016. Deadline for the implementation of the conditions of inclusion: 31 December 2006. Deadline for the implementation of the uniform principles: 30 June 2010, for formulations containing metiram as the only active substance, or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994, within the deadline of 30 June 2006. Data protection: For being the metiram an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.