Re-Registration Of Plant Protection Products, Based On Nicosulfuron, On The Basis Of The Dossier Nicosh 4% Sc Of Annex Iii, The Light Deiprincipi Uniforms For The Evaluation And Authorisation Of Prodottifitosanitari In Accordance With Regulation (Ec) N...

Original Language Title: Ri-registrazione di prodotti fitosanitari, a base di nicosulfuron,sulla base del dossier NICOSH 4% SC di Allegato III, alla luce deiprincipi uniformi per la valutazione e l'autorizzazione dei prodottifitosanitari, ai sensi del regolamento (CE) n. 546/2...

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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 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 April 29, 2008 transposing Directive 2008/40/EC of March 28, 2008 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 nicosulfuron; See in particular that the approval of the active substance nicosulfuron decade on December 31, 2018, as indicated in the annex to reg. (EU) 540/2011; Having regard to the decrees of the marketing authorisation and for use of plant protection products set out in the annex to this Decree; Having regard to the applications brought by the business owner seeking re-registration of plant protection products according to the uniform principles set out in the annex to this Decree, on the basis of the dossier relative to the reference plant protection product NICOSH, presented by the enterprise in accordance with Europe b.v.b.a. Sharda requirements contained in annex III of the aforementioned legislative decree 194/1995, transposed in reg. (EC) no 545/2011; Given that the brand owner of authorisations of plant protection products on the market in question has complied with the provisions of the Decree April 29, 2008, on time and in the forms laid down by it and according to the conditions defined for the active substance nicosulfuron; Considered that the Advisory Commission of plant protection products under art. Legislative Decree of 20 March 17, 1995, # 194, took note of the conclusion of the evaluation of the aforementioned file NICOSH 4% SC, carried out by the International Centre for pesticides and health prevention in order to re-record the pesticides in question until December 31, 2018, to new conditions of employment and with possible adjustment to the composition of the plant protection product; Having regard to the Protocol Office note 16544 on April 23, 2013 which has been called with prejudice to the company owner of file documentation and Sharda Europe b.v.b.a. technical and scientific data add-indicated by the aforementioned Institute; Having regard to the note with which the undertaking which owns recordings of plant protection products set out in the annex to this Decree, has complied with the requirements of the Office; Given the success of further evaluation of studies technical-scientific breakthrough by the same above Center with prejudice in order to re-record the pesticides in question in the light of the uniform principles in accordance with Regulation (EC) No 546/2011. 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 December 31, 2018, expiration date of the approval of the active substance nicosulfuron, plant protection products 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 194/1995 , transposed in the reg. (EU) n. the Commission 545/2011 on the NICOSH reference plant protection product; 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-registered until December 31, 2018, expiration date of the approval of the active substance nicosulfuron, plant protection products referred to in the annex to this Decree recorded the number, date and name of company alongside indicated, authorized with the new wording, the conditions and on the crops indicated in labels attached to this Decree laid down pursuant to the uniform principles. Wording changes are permitted in adjustment to the reference product as well as the changes mentioned for each 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 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 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 June 1, 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 abovementioned undertaking Sharda Europe b.v.b.a. held the presentation of additional scientific and technical data without prejudice above within the time limit mentioned in the introduction. The production of plant protection products on the market of new composition 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.
Rome, February 17, 2015 Director General: Rajput