Re-Registration Of Plant Protection Products Containing Clodinafop Sostanzaattiva, Based On The Evaluation Of The Dossier, You Look So A8424R, The Uniform Principles Laid Down In Regulation (Ec) No 546/2011.

Original Language Title: Ri-registrazione dei prodotti fitosanitari contenenti la sostanzaattiva clodinafop, basata sulla valutazione del dossier A8424R, allaluce dei principi uniformi di cui al regolamento (UE) n. 546/2011.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-27&atto.codiceRedazionale=15A00421&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

The GENERAL MANAGER for hygiene and food safety and nutrition having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of February 23, 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC and the subsequent regulations amending annexes II and III to that regulation as regards maximum residue levels for individual active substances in or on certain products; Having regard to Council Regulation (EC) no 1272/2008 of the European Parliament and of the Council of December 16, 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, as amended; Having regard to Council Regulation (EC) No 1107/2009 of the European Parliament and of the Council of October 21, 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and subsequent implementing regulations and/or changes in particular art. 80 on ' transitional measures '; Having regard to Directive 1999/45/EC of the European Parliament and of the Council of May 31, 1999 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, as amended, for the part still in force; Having regard to Directive 2009/128/EC of the European Parliament and of the Council of October 21, 2009 establishing a framework for Community action to achieve a sustainable use of pesticides; Having regard to the March 31, 1998 Legislative Decree n. 112 on "transfer of administrative functions and tasks of the State to the regions and local authorities, in the implementation of chapter I of law March 15, 1997, # 59», and in particular articles 115 establishing a" Division of powers "and art. 119 establishing «Permissions»; Having regard to act November 13, 2009 # 172 on ' institution of the Ministry of health and increase the total number of State Secretaries of State "and subsequent amendments; Having regard to the Decree of the President of the Republic March 28, 2013, # 44, on «regulations containing the reorganization of collective bodies and other bodies active in the Ministry of health, in accordance with art. 2, paragraph 4, of law no 183 November 4, 2010»; Having regard to the Decree of the President of the Council of Ministers in February 11, 2014, # 59 on ' organisational regulations of the Ministry of health», and in particular art. 10 establishing a ' general direction for food safety and nutrition '; Having regard to the Legislative Decree March 17, 1995, n. 194 on "implementation of Directive 91/414/EEC concerning the placing of plant protection products ', as amended; Having regard to the Decree of the President of the Republic April 23, 2001, # 290 concerning the regulation of simplification of procedures for authorization for the production, marketing and sales of plant protection products and related processing», as amended; Having regard to the Legislative Decree March 14, 2003, n. 65 on «implementing directives 1999/45/EC and 2001/60/EC relating to the classification, packaging and labelling of dangerous preparations, as amended; Having regard to the Legislative Decree of August 14, 2012, n. implementing directive 2009/150 incorporating «128/EC establishing a framework for Community action to achieve a sustainable use of pesticides; Having regard to the Ministerial Decree January 22, 2014 bearing ' Adoption of the national action plan for the sustainable use of plant protection products on the market, in accordance with art. 6 of Legislative Decree No August 14, 2012. 150 laying: "implementing directive 2009/128/EC establishing a framework for Community action to achieve a sustainable use of pesticides '; Having regard to the Ministerial Decree of June 23, 2006 transposing Directive 2006/39/EC of the European Commission concerning the inclusion in annex I to Directive 91/414/EEC of active substances which are now found in the annex to Regulation (EC) 540/2011 of the European Commission, including the active substance clodinafop; See in particular that the approval of the active substance clodinafop expires January 31, 2017, as indicated in the said Annex to reg. (EU) 540/2011; Having regard to Council Regulation (EU) no 487/2014 of the European Commission amending reg. (EU) No 540/2011 by extending to April 30, 2018, the approval period for certain active substances, including the active substance clodinafop; Having regard to the decrees of the marketing authorisation and for use of plant protection products set out in the annex to this Decree containing the active substance clodinafop; Given the instances presented by it owner of the recordings referred to in the annex, aimed at achieving the re-registration in accordance with the uniform principles laid down in Regulation (EC) No 546/2011, on the basis of the A8424R meets the requirements required by the application of the Regulation (EU) No. 545/2011 of the European Commission; Considered that the Advisory Commission of plant protection products under art. Legislative Decree 20 March 17, 1995, # 194, took note of the conclusion of the evaluation of the aforementioned dossier A8424R carried out by the University of Pisa in order to re-register the plant protection products concerned, until April 30, 2018, the conditions of use laid down by Directive 2006/39/EC of inclusion of the active substance; Having regard to the note with which the enterprise registration holder of these pesticides, has complied with the requirements of the Office; See the press release of January 14, 2014, on the application of Regulation (EC) no 1272/2008 on the classification, labelling and packaging of substances and mixtures; Whereas plant protection products referred to in the annex to this Decree are currently marketed under the label according to directives 67/548/EEC and 1999/45/EC; Also view the note with which the company owner of the recordings announced that it had provided for reclassification in accordance with Regulation (EC) no 1272/2008; As for the plant protection products concerned shall be annexed to this Decree, both labels that conform to these directives on the classification, packaging and labelling of dangerous substances that labels provided by the undertaking which owns, in compliance with the obligation of classification in accordance with Regulation (EC) no 1272/2008; Decided to rerecord until April 30, 2018, expiration date of the approval of the active substance clodinafop, plant protection products referred to in the annex, as assessed in accordance with the uniform principles laid down in Regulation (EC) No 546/2011 of the European Commission on the basis of the dossier submitted meets the requirements in Regulation (EU) no 545/2011 and in view also of the conditions laid down in Directive 2006/39/EC; Saw the deposit pursuant to Ministerial Decree on September 28, 2012 «Restatement of tariffs relating to the placing on the market of plant protection products to cover sustained performance and made a request, in the implementation of Regulation (EC) 1107/2009 of the European Parliament and the Council. '
Decrees: are re-register until April 30, 2018, expiration date of the approval of the active substance clodinafop plant protection products set out in the annex of the company Syngenta Italy s.p.a, according to the composition, conditions and crops indicated on the labels attached to this Decree. Changes are authorized and listed in the annex to this Decree. Are approved as an integral part of this Decree the labels attached, adapted according to the uniform principles, both with 67/548/EEC classification according to directives and 1999/45/EC, both with classification established by the owner in accordance with Regulation (EC) no 1272/2008. The production with the labels in accordance with directives 67/548/EEC and 1999/45/EC, are permitted no later than May 31, 2015. The marketing and use of plant protection products already adequate stocks according to the uniform principles but not the criteria laid down by this Regulation (EC) no 1272/2008, shall be granted until 1 St June 2017, pursuant to art. 61 of the said regulation. It did however unless each subsequent performance and adjustment of the conditions of authorisation of plant protection products, also according to Community measures and additional provisions concerning the active substance component. The business licence holder is required to relabel plant protection products bearing the label previously authorized, not yet put on the market and to provide retailers with a facsimile of the new label for the product in stock at the retail end of its delivery to the purchaser/end user. It is also required to take any action in respect of users, to ensure proper use of plant protection products in accordance with the new provisions. This Decree will be published in the official journal of the Italian Republic and communicated to the undertaking concerned. The above data products are available on the website of the Ministry of Health www.salute.gov.it, in the section «database».
Rome, November 25, 2014 General Manager: Rajput