Re-Registration Of The Plant Protection Product, Folpet Eiprovalicarb, Based On The File From 06361579 To Annex Iii, In The Light Of The Uniform Principles For Evaluation And Plant Protection Products In Accordance With Regulation Autorizzazionedei (C. ..

Original Language Title: Ri-registrazione del prodotto fitosanitario, a base di folpet eiprovalicarb, sulla base del dossier UVP 06361579 di Allegato III,alla luce dei principi uniformi per la valutazione e l'autorizzazionedei prodotti fitosanitari, ai sensi del regolamento (C...

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-03&atto.codiceRedazionale=15A01426&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 review; and 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 Legislative Decree March 31, 1998, 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 article 119 establishing «Permissions»; Having regard to law no November 13, 2009. 172 regarding ' 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 article 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 under article 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 February 11, 2003 transposing Directive 2002/48/EC of May 30, 2002 on the inclusion in annex I of the Legislative Decree March 17, 1995, # 194, of a number of active substances which are now found in the reg. (EU) 540/2011 and 541/2011 of the Commission, including the active substance iprovalicarb; Having regard to the Ministerial Decree of April 26, 2007 implementing Directive 2007/5/EC of February 7, 2007 concerning the inclusion in annex I of the Legislative Decree March 17, 1995, # 194, of a number of active substances which are now found in the reg. (EU) 540/2011 and 541/2011 of the Commission, including the active substance folpet; See in particular that the approval of the active substance folpet decade on September 30, 2017, as indicated in the annex to reg. (EU) 540/2011; Having regard to the Decree of authorisation and for use of the plant protection product as set out in the annex to this Decree; Having regard to the request submitted by the brand owner to obtain re-registration of the plant protection product according to the uniform principles set out in the annex to this Decree, on the basis of the dossier relating to the plant protection product ' Melody Care» hour «Melody Combi», presented by the company Bayer Cropscience S.r.l., comply with the requirements laid down in annex III of the aforementioned legislative decree n. 194/1995, transposed in reg. (EC) n. 545/2011 of the Commission; Given that the brand owner of authorization of the plant protection product in question has complied with that envisaged by decrees transposing, in terms of timing and forms from it established and according to the conditions defined for the active substance folpet and iprovalicarb; After consulting the Advisory Committee on pesticides under art. March 17, 1995, 20 of Legislative Decree n. 194, on the assessment of the aforementioned file FROM 06361579, conducted by the University of Milan in order to re-register the plant protection product concerned until 30 September 2017, new conditions of use and composition; Having regard to the Protocol Office note # 47345 on December 24, 2014 by which has been called the company Bayer Cropscience S.r.l. owner of file documentation and additional scientific and technical data indicated by the aforementioned Institute to be submitted within twelve months from the date thereof; View the note with which the enterprise registration holder of the plant protection product as set out in the annex to this Decree, 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 and currently on the market bear the label according to directives 67/548/EEC and 1999/45/EC; Decided to rerecord until September 30, 2017 expiry date of the approval of the active substance folpet, the plant protection product referred to in the annex to this Decree, the conditions defined by the evaluation according to the uniform principles provided for in annex VI to Regulation (EC) No 546/2011, on the basis of the dossier complies with the requirements laid down in annex III of the aforementioned legislative decree n. 194/1995 , transposed in reg. (EC) n. 545/2011 from the Commission on the plant protection product ' Melody Care» hour «Melody Combi»; Saw the deposit pursuant to Ministerial Decree of July 9, 1999 on "determination of tariffs relating to the placing on the market of plant protection products and coverage of sustained performance and made on demand»;
Decrees: are re-register until September 30, 2017, due date of the approval of the active substance folpet, the plant protection product referred to in the annex to this Decree recorded the number, date and name of company alongside indicated, authorized with new composition and formulation under conditions and on the crops indicated in labels attached to this Decree laid down pursuant to the uniform principles. Are authorised modifications of composition and formulation as well as changes to the plant protection product listed in the annex to this Decree. Plant protection products placed on the market at the date of this Decree, with the previous composition and formulation and bearing the label previously authorized, may be marketed until April 30, 2015; the use is allowed until May 31, 2015. The production of plant protection products on the market of new composition and formulation with appropriate labels according to the uniform principles with classification according to directives 67/548/EEC and 1999/45/EC, are permitted no later than May 31, 2015; the marketing and use are allowed until 1 St June 2017, pursuant to art. 61 of Regulation (EC) no 1272/2008. It did however unless each subsequent performance and adjustment of the conditions of authorisation of plant protection products, also according to Community measures and other conditions relating to those active substances components. The aforementioned company Bayer Cropscience S.r.l. held presentation of additional scientific and technical data above within the period referred above. It did however unless each subsequent performance and adjustment of the conditions of authorisation of plant protection products, also according to Community measures and other conditions relating to those active substances components. This Decree will be published in the official journal of the Italian Republic and communicated to the undertaking concerned. Data relating to the above product (s) are available on the website of the Ministry of Health www.salute.gov.it, in the section «database».
Rome, February 10, 2015 Director General: Rajput