Authorisation Of The Plant Protection Product ' Systhane Lsc».

Original Language Title: Autorizzazione all'immissione in commercio del prodotto fitosanitario«Systhane LSC».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-26&atto.codiceRedazionale=15A01117&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 containing "Division of powers" and art. 119 regarding "authorizations"; Having regard to law no 172 on November 13, 2009 "establishment 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, no. 44 concerning "regulation on the reorganization of collective bodies and other bodies active in the Ministry of health, in accordance with art. 2, paragraph 4, of law November 4, 2010, # 183 "; 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 on the "General Directorate of 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, regarding "regulation for the simplification of the procedures for authorising the production, placing on the market and sales of plant protection products and related processing", as amended; Having regard to the Legislative Decree March 14, 2003, n. 65, on "implementation of directives 1999/45/EC and 2001/60/EC relating to the classification, packaging and labelling of dangerous preparations, and its subsequent amendments; Having regard to the Legislative Decree of August 14, 2012, n. 150 on "implementing directive 2009/128/EC establishing a framework for Community action to achieve a sustainable use of pesticides '; Having regard to the Ministerial Decree January 22, 2014 on "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 made in August 6, 2013 date by the company Dow AgroSciences Italy Srl, with registered office in Milano, via f. Albani, 65, intended to obtain the authorisation of the plant protection product called Systhane LS, later re-named SYSTHANE LSC, containing the active ingredient myclobutanil, equal to the reference product called GF-1985, still pending within the meaning of art. 33 of Regulation (EC) 1107/2009, of the enterprise; Given the managerial Decree of 1 October 2014 by which has been granted marketing authorisation for the reference product GF-1985, now called Thiocur LSC, recorded at 15439 number; Noted that technical and administrative verification of the Office has confirmed the existence of the requirements for the application of art. 10 of the aforementioned Decree of the President of the Republic April 23, 2001, # 290, in particular that:-the product is equal to the quoted reference product Thiocur LSC, recorded at 15439 number; Detected so it's not requested the opinion of the Advisory Committee on pesticides, under art. Legislative Decree 20 March 17, 1995, # 194; Having regard to Council Regulation (EU) 540/2011 in which the active ingredient myclobutanil was considered approved in accordance with Regulation (EC) 1107/2009, under the same conditions laid down in annex I to Directive 91/414/EEC; Decided to give the product concerned validity till May 31, 2021, expiration date attributed to the reference product pursuant to art. 29 of Reg. (EC) 1107/2009; 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;

Decreta: from the date of this order until May 31, 2021, the company Dow Agrosciences Italy Srl, with registered office in Milano, via f. Albani, 65, is authorized for placing on the market of the plant protection product called SYSTHANE LSC with the composition and conditions indicated on the label attached to this Decree. 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 other conditions relating to those active substances components. The product is packaged in sizes L 0.50-1-3-5-10. The plant protection product is imported in bundles by the establishment of foreign firm employment: Dow AgroSciences Ltd-King's Lynn, England. The product is prepared in establishments of enterprises: Diachem S.p.A. – Caravaggio (BG);
STI-Solfotecnica Italiana S.p.A.-Cotignola (RA);
Isagro S.p.a.-Aprilia (LT);
Dow AgroSciences Italy srl-Mozzanica (BG), as well as packaged at the factory: Sipcam S.p.A.-Salerano sul Lambro (LODI), Italy Althaller S.r.l.-s. Colombano al Lambro (MI). The above mentioned product is recorded at # 16173. 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 notified, by administrative means, to the undertaking concerned and published in the official journal of the Italian Republic.
Rome, December 9, 2014 General Manager: Rajput