Order Pre/1376/2002, Of 5 June, Which Include Active Substances Called Acibenzolar-S-Methyl, Ciclanilida, Ferric Phosphate, Pymetrozine And Piraflufeno-Ethyl In Annex I Of Royal Decree 2163 / 1994, On 4 November, Whereby...

Original Language Title: ORDEN PRE/1376/2002, de 5 de junio, por la que se incluyen las sustancias activas denominadas acibenzolar-S-metilo, ciclanilida, fosfato férrico, pimetrozina y piraflufeno-etilo, en el anexo I del Real Decreto 2163/1994, de 4 de noviembre, por el que...

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The Directive 91/414/EEC, the Council, of 15 July, on the marketing of plant protection products, includes an annex, entitled "Active substances whose inclusion in plant protection products is authorized".


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 2163 / 1994, under the name "Community list of active substances", which is defined in paragraph 16 of article 2 of this standard as the list of active substances of plant protection products accepted by the European Commission and whose incorporation will be made public by means of national provisions , as a result of other community.


By Directive 2001/87/EC, of the Committee, on 12 October, the active substance acibenzolar-S-methyl, ciclanilida, ferric phosphate, pymetrozine and piraflufeno-ethyl, are included in annex I to Directive 91/414/EEC, setting conditions so the marketing of plant protection products containing the active substances concerned do not have harmful effects for human health or animal health or for the groundwater or have unacceptable influence on the environment.


This order adds to the domestic legal system Directive 2001/87/EC, by the inclusion of the active substance acibenzolar-S-methyl, ciclanilida, ferric phosphate, pymetrozine and piraflufeno-ethyl in annex I of Royal Decree 2163 / 1994, and is issued in accordance with the option provided in the first final provision of the aforementioned Royal Decree.


The inter-ministerial Commission for food management has issued mandatory report on this provision. In addition, in its processing have been consulted the affected sectors.


By virtue, on the proposal of the Ministers of agriculture, fisheries and food and environment and Minister of health and consumption, have: single article. Inclusion of active substances in annex I of Royal Decree 2163 / 1994.


1 active substances called acibenzolar-S-methyl, ciclanilida, ferric phosphate, pymetrozine and piraflufeno-ethyl are included in annex I of Royal Decree 2163 / 1994 of November 4, which implements is the Community harmonized system of authorization to market and use of plant protection products, with the characteristics and conditions that are specified in the annex to this order for each of them.


2. the inclusion of the active substances referred to in paragraph 1 shall entail the revision of provisional authorisations for plant protection products containing them, granted in accordance with the provisions of article 23 of the Royal Decree 2163 / 1994, and, where appropriate, will be replaced with full authorizations.


3 these revisions, as well as the granting of new permits, will be carried out in accordance with the uniform principles for evaluation and authorisation of plant protection products, taking into account also the conclusions of the final version of the review of the European Commission reports, approved by the Standing Committee on the dates that, for each of the active substances concerned listed in the annex to this order, particularly Appendices I and II. However, compliance with documentation requirements for preparations and decisions in accordance with the uniform principles for evaluation and authorisation of these are required within the time limits that are specified in that annex.


4. in the official register of products plant protection of the direction General of Agriculture of the Ministry of agriculture, fisheries and food will be available to stakeholders the review reports of the Commission referred to in the previous paragraph, as well as the Evaluation Commission envisaged in article 3 of the Royal Decree 2163 / 1994. All of this with the exception of confidential information which is defined in article 32 of the Royal Decree.


Sole final provision. Entry into force.


This provision will enter into force the day following its publication in the "official bulletin of the State".


Madrid, June 5, 2002 LUCAS GIMÉNEZ Excellencies. Messrs Ministers of agriculture, fisheries and food and environment, and H.e. Ms. Minister of health and consumption.


ANNEX (*) 20. Conditions for the inclusion of the active substance acibenzolar-S-methyl: features: common name: Acibenzolar-S-methyl.


CAS NO.: 135158-54-2.


CIPAC NO.: 597.


Chemical name (IUPAC): Benzo (1,2,3 (thiadiazole-7-carbotioato de S-metilo.


Minimum purity of the substance: 970 g/kg technical product.


The inclusion conditions: applications: can only be used as an activator of the plant resistance.


In the overall assessment, according to the uniform principles, it will serve to the review of the European Commission report approved by the Standing Committee at its meeting of June 29, 2001.


The inclusion times: November 1, 2001 to October 31, 2011.


Deadlines for the implementation of the uniform principles: to) on March 31, 2003, for simple formulations.


((b) in the case of mixtures with other active substances not yet included in annex I of Royal Decree 2163 / 1994, the period referred to in paragraph to) will be expanded as contemplating an application longer period the provisions that established the conditions for the inclusion of these active substances.


Data protection: for being acibenzolar-S-methyl a substance active new applies the corresponding data protection regime envisaged in article 30 of the Royal Decree 2163 / 1994.


21 conditions of inclusion of the active substance ciclanilida: characteristics: common name: Ciclanilida.


CAS NO.: 113136-77-9.


CIPAC NO.: 586.


Chemical name (IUPAC): not available.


-(*) The numbering of the headings correspond to the coding carried out by Directive 2000/80/EC.


Chemical name (C.A.): amino acid 1-[(2,4-diclorofenil)] [Carbonyl] ester.


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


The inclusion conditions: applications: can only be used as a plant growth regulator.


In the global evaluation according to the uniform principles, based on the review of the European Commission report approved by the Standing Committee at its meeting of 29 June 2001, is must pay particular attention a: max 2 impurity content, 4-diclo-roanilina (2, 4-DCA) in the active substance as it leaves factory will be 1 g/kg.


The inclusion times: November 1, 2001 to October 31, 2011.


Deadlines for the implementation of the uniform principles: to) on March 31, 2003, for simple formulations.


((b) in the case of mixtures with other active substances not yet included in annex I of Royal Decree 2163 / 1994, the period referred to in paragraph to) will be expanded as contemplating an application longer period the provisions that established the conditions for the inclusion of these active substances.


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


22 conditions of inclusion of the active substance ferric phosphate.


Features: Common name: ferric phosphate.


CAS NO.: 10045-86-0.


CIPAC NO.: 629.


Chemical name (IUPAC): ferric phosphate.


Minimum purity of the substance: 990 g/kg technical product.


The inclusion conditions: applications: can only be used as a molluscicide.


In the overall assessment, according to the uniform principles, it will serve to the review of the European Commission report approved by the Standing Committee at its meeting of June 29, 2001.


The inclusion times: November 1, 2001 to October 31, 2011.


Deadlines for the implementation of the uniform principles: to) on March 31, 2003, for simple formulations.


((b) in the case of mixtures with other active substances not yet included in annex I of Royal Decree 2163 / 1994, the period referred to in paragraph to) will be expanded as contemplating an application longer period the provisions that established the conditions for the inclusion of these active substances.


Data protection: as ferric phosphate a substance active new applies the corresponding data protection regime envisaged in article 30 of the Royal Decree 2163 / 1994.


23 conditions of inclusion of the active substance pymetrozine.


Features: Common name: Pymetrozine.


CAS NO.: 123312-89-0.


CIPAC NO.: 593.


Chemical name (IUPAC): (E)-6-metil-4[(piridin-30il-metileno)amino]-4,5-dihidro-2H[1,2, 4] triazin-3-one.)


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


The inclusion conditions: applications: can only be used as an insecticide.


In the global evaluation according to the uniform principles, based on the review of the European Commission report approved by the Standing Committee at its meeting of 29 October 2001, is must pay particular attention a: the protection of aquatic organisms.


The inclusion times: November 1, 2001 to October 31, 2011.


Deadlines for the implementation of the uniform principles: to) on March 31, 2003, for simple formulations.



((b) in the case of mixtures with other active substances not yet included in annex I of Royal Decree 2163 / 1994, the period referred to in paragraph to) will be expanded as contemplating an application longer period the provisions that established the conditions for the inclusion of these active substances.


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


24 conditions of inclusion of the active substance piraflufeno-ethyl.


Features: Common name: Piraflufeno-ethyl CAS No.: 129630-19-9 # CIPAC: 605 chemical name (IUPAC): 2-cloro-5(4-cloro-5-difluorometoxi-1 methylpyrazole-3-YL) - 4 - ethyl fluorofluoxiacetato.


Minimum purity of the substance: 956 g/kg technical product.


The inclusion conditions: applications: can only be used as a herbicide.


In the global evaluation according to the uniform principles, based on the review of the European Commission report approved by the Standing Committee at its meeting of 29 October 2001, is must pay particular attention a: the protection of algae and aquatic plants and include as a condition in the corresponding authorizations, where appropriate, risk mitigation measures.


The inclusion times: November 1, 2001 to October 31, 2011.


Deadlines for the implementation of the uniform principles: to) on March 31, 2003, for simple formulations.


((b) in the case of mixtures with other active substances not yet included in annex I of Royal Decree 2163 / 1994, the period referred to in paragraph to) will be expanded as contemplating an application longer period the provisions that established the conditions for the inclusion of these active substances.


Data protection: be piraflufeno-ethyl a substance active new applies the corresponding data protection regime envisaged in article 30 of the Royal Decree 2163 / 1994.

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