Marketing Authorisation For The Product Fitosanitariolibrax, Issued After Zonal Assessment Procedure.

Original Language Title: Autorizzazione all'immissione in commercio del prodotto fitosanitarioLIBRAX, rilasciata in seguito a procedura di valutazione zonale.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-03&atto.codiceRedazionale=15A02499&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; 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 art. 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 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 request submitted by the company on July 7, 2012 BASF Italy S.p.A. with registered office in Cesano Maderno (MB), Via Marconato 8, aimed at granting an authorisation of the plant protection product LIBRAX pursuant to art. 33 of Regulation (EC) No 1107/2009, which contains the active substance metconazole, fluxapyroxad and pointing to the Italy which Member country rapporteur pursuant to art. 35 of the regulation; 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; Having regard to Council Regulation (EU) No 540/2011 by which the active substance metconazole was considered approved in accordance with Regulation (EC) 1107/2009, until May 31, 2017, under the same conditions laid down in annex I to Directive 91/414/EEC; Having regard to Council Regulation (EU) no 878/2014 whereby it was extended until April 30, 2018 the expiry of the approval period of the active substance metconazole; Having regard to Council Regulation (EU) no 589/2012 by which the active substance fluxapyroxad is approved, until December 31, 2022, according to Regulation (EC) 1107/2009; Having regard to the report of preliminary registration (draft registration report-DRR) placed at the disposal of the Member States, the Advisory Committee referred to in art. Legislative Decree 20 March 17, 1995, # 194 and of the applicant, by the rapporteur Member State Italy on March 31, 2014; Given the comments on the report of the preliminary assessment, formulated by the Member States concerned, by experts of the Advisory Commission as referred to in art. Legislative Decree 20 March 17, 1995, # 194 and by the applicant, pursuant to art. 36, paragraph 1, of Regulation (EC) 1107/2009; Considered that the documentation provided by the company for the granting of the zonal authorisation of the plant protection product in question was examined by the rapporteur Member State Italy with favorable outcome as final registration report (registration report-RR); View the Office note dated August 4, 2014 by which has been called the documentation of completion of the permitting procedure and additional scientific and technical data to be presented within 18 and 24 months from the date of this Decree; Having regard to the note received on September 26, 2014 by which the undertaking has submitted the documentation of completion of the approval process;
Decreta: from the date of this Decree and until April 30, 2019, the BASF company Italy S.p.A. with registered office in Cesano Maderno (MB), Via Marconato 8, is authorized, in accordance with Regulation (EC) 1107/2009, for placing on the market of the plant protection product called LIBRAX, with composition and conditions indicated on the label attached to this Decree. The abovementioned undertaking held the presentation of additional scientific and technical data above within the period referred above. It is without prejudice to any subsequent fulfilment and adapting the conditions for authorisation of the plant protection product, in conformity to Community measures and additional provisions concerning the active substances. The product is packaged in sizes 1-3 -0.25 -0.50-0.15-5-10 L. The plant protection product is prepared in the following establishments: BASF Española SL-Tarragona-Spain; BASF Agri Production S.A.S.-Genay-Spain. The plant protection product that is registered at # 15500. It is approved as an integral part of this Decree the attached label with which the product is to be marketed. This Decree will be published in the official journal of the Italian Republic and communicated to the undertaking concerned. The data relating to the above product can be found on the website of the Ministry of Health www.salute.gov.it, under "database".
Roma, March 4, 2015 Director General: Rajput