Authorisation, In Accordance With The Procedure Of Mutual Programs Of The Plant Protection Product «Atelier» Containing Active Substances Protioconazolo And Tebuconazole.

Original Language Title: Autorizzazione all'immissione in commercio, secondo la procedura diriconoscimento reciproco, del prodotto fitosanitario «Atelier»contenente le sostanze attive protioconazolo e tebuconazolo.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-26&atto.codiceRedazionale=15A00399&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 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 bearing ' Directorate-General for the hygiene and safety of food 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 on May 20, 2014 (Prot. n. 20113) by the company Bayer CropScience s.r.l. with registered office in Milan 20156, viale Certosa 130-aimed at granting an authorisation of the plant protection product active substances based ATELIER protioconazolo and tebuconazole as systemic fungicide for cereals, in accordance with the procedure of mutual recognition foreseen by art. 40 of Regulation (EC) No 1107/2009; Considered that the documentation submitted by the company to issue such authorization, already registered for the same use and with comparable agricultural practices in another Member State, it was assessed and evaluated positively by a group of experts who belong to the Advisory Committee of plant protection products; Having regard to the subsequent opinion of the Advisory Committee of PPP, heard via computer, confirming what is expressed by the experts of the group belonging to the aforementioned Advisory Commission of PPPs; Having regard to the notes whose last on 14 November (Prot. n. 42785) with which the undertaking has been requested by the company Bayer CropScience s.r.l. to send the relevant documentation needed to complete this authorization of the plant protection product; Having regard to the last notes on November 26, 2014 (Prot. n 44157) with which the enterprise has passed the required documentation and necessary for the completion of the granting of the authorisation of the plant protection product ATELIER; Considered therefore to authorise the plant protection product until August 31, 2019, expiration date of the approval of the active substance tebuconazole as described in reg. (EU) No 540/2011; 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 ';

Decrees: the company Bayer CropScience S.r.l., with registered office in Milan 20156, viale Certosa 130-are authorized to place on the market the plant protection product on the basis of protioconazolo active substances and ATELIER, tebuconazole, as a systemic fungicide for the cereal with the composition and conditions indicated on the label attached to this Decree. The ATELIER is authorized plant protection product in accordance with the procedure of mutual recognition pursuant to art. 40 of Regulation (EC) No 1107/2009, therefore, the reference product is authorized for the same use and with comparable agricultural practices in another Member State. The subscription is valid until August 31, 2019, expiration date of the approval of the active substance tebuconazole as described in reg. (EU) # 540/2011. The product is prepared in the factory: Bayer CropScience AG-Dormagen (Germany); Bayer CropScience S.r.l.-Filago (Bergamo); Bayer CropScience AG-Industriepark Hoechst, Frankfurt (Germany); Bayer Türk Kimya San. Ltd. Sti. Bayer CropScience-Gebze (Turkey); Bayer SAS-Marle sur Serre (France); Bayer SAS-Villefranche (France); Bayer CropScience LP-Kansas City (USA); SBM Formulation S.A. -Beziers (France); SCHIRM GmbH-Schönebeck (Germany); Bayer CropScience S.L.-Quart de Poblet-Valencia (Spain); Bayer (Pty) Ltd.-Nigel (South Africa); Bayer CropScience AG-Hürt (Germany). The product is packaged in sizes liters: 1-2-3-10. The plant protection product that is registered at no. 16108. 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 substance component. It is approved as an integral part of this Decree annex facsimile of the label by 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 is available in the section «database» plant protection products area of the portal www.salute.gov.it.
Rome, December 3, 2014 General Manager: Rajput