Authorisation Of The Plant Protection Product ' Rufast Nova».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-04&atto.codiceRedazionale=15A03192&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 request made by the firm on December 3, 2014 Cheminova Agro Italy Srl, with registered office in Bergamo, via F.lli Bronzetti, 32/28, intended to obtain the authorisation of the plant protection product called RUFAST NOVA, containing active substances abamectin and acrinathrin, equal to the reference product called Ardent Nova recorded at # 12656 with D.D. on May 20, 2014 , of the enterprise; 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 Ardent Nova recorded at # 12656;

exist legitimate agreement between the company Cheminova Agro Italy Srl and the undertaking which owns the reference product; 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 the annex to Regulation (EU) No. 540/2011 of May 25, 2011 laying down provisions implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances with which the active substance abamectin is considered approved until April 30, 2019; Having regard to Council Regulation (EU) No. 974/2011 of September 29, 2011 approving the active substance acrinathrin, until December 31, 2021, according to Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and amending the annex to Regulation (EU) No. Commission 540/2011 and the decision 2008/934/EC; Considering also that the reference product was evaluated according to the uniform principles provided for in annex VI of decree 194/95 on the basis of a dossier in accordance with annex III; Considered to limit the validity of the authorization to the December 31, 2021, expiration date assigned to the reference product; 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 Decree and until December 31, 2021, the company Cheminova Agro Italy Srl, with registered office in Bergamo, via F.lli Bronzetti, 32/28, is authorized to enter the plant protection product on the market called RUFAST NOVA 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 from mL: 10-25-50-100-250-500; L 1-2.5-5. The product concerned is imported into bundles for use by foreign companies: Cheminova A/S-Thyborønvej 76-78 DK 7673 Harboøre (Denmark);
Cheminova Deutschland GmBh & co. KG-26-28-D-21683 Stade Elbstrasse Stader (Germany);
SBM Formulation-Avenue Jean Foucault, CS 621, 34 535 (Z.I.), Beziers Cedex (France). The product concerned is prepared at the establishment of the company: Althaller Italy Srl-Str. Com. the campaign, 5-20078 s. Colombano al Lambro (MI). The above mentioned product is recorded at # 16230. The label attached to this Decree, by which the plant protection product must be placed on the market, it is equivalent to that proposed by the undertaking which owns the reference product, suitable for grading the conditions laid down in reg. 1272/2008, according to the press release of the Ministry of health of January 14, 2014. 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, February 16, 2015 Director General: Rajput