Re-Registration Of Plant Protection Products, Metiram, Sullabase Dossier Bas 222 28 F Of Annex Iii, In The Light Of The Principiuniformi For The Evaluation And Authorisation Of Prodottifitosanitari In Accordance With Regulation (Ec) No 546/201 ...

Original Language Title: Ri-registrazione di prodotti fitosanitari, a base di metiram, sullabase del dossier BAS 222 28 F di Allegato III, alla luce dei principiuniformi per la valutazione e l'autorizzazione dei prodottifitosanitari, ai sensi del regolamento (CE) n. 546/201...

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-10&atto.codiceRedazionale=15A00831&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 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 March 7, 2006 transposing Directive 2005/72/EC of October 21, 2005 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) 540/541/2011 2011 and of the Commission, including the active substance metiram; See in particular that the approval of the active substance metiram decade on June 30, 2016, as indicated in the annex to reg. (EU) 540/2011; Saw the reg. (EU) no 762/2013 of August 7, 2013 amending reg. (EU) n. 540/2011 by extending periods of approval until January 31, 2018 of some active substances including the active substance metiram; 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 undertaking which owns aimed at achieving the 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 concerning plant protection product POLYRAM DF, presented by the company Basf Italy S.r.l., comply with the requirements laid down in annex III of the aforementioned legislative decree # 194/1995, transposed in reg. (EC) no 545/2011; Given that the brand owner of authorization of the plant protection product in question has complied with the provisions of the Decree March 7, 2006, on time and in the forms laid down by it and according to the conditions defined for the active substance metiram; 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 file BAS 222 28 F, carried out by the International Centre for pesticides and health prevention in order to re-register the plant protection product concerned until January 31, 2018, the new conditions of use; 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 classification, labelling and packaging of substances and mixtures; Considered that the plant protection product 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 January 31, 2018, expiration date of the approval of the active substance in the annex to the plant protection product metiram, 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 reg. (EC) n. 545/Commission on the plant protection product 2011 POLYRAM DF; Having a favourable opinion with regard to scientific and technical studies requested by the International Centre without prejudice for pesticides and health prevention and presented by the brand owner; 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».
Decreed: it's re-registered until January 31, 2018, expiration date of the approval of the active substance in the annex to the plant protection product metiram, this Decree recorded the number, date and name of company alongside indicated, permitted, with the new composition, the conditions and on the crops indicated in labels attached to this Decree laid down pursuant to the uniform principles. Changes are permitted for the plant protection product listed in the annex to this Decree. 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. 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. 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. 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. 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. 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, December 22, 2014 General Manager: Rajput