Authorisation Of The Plant Protection Product ' Cupromet Sc».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-05&atto.codiceRedazionale=15A03204&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 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 article 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 under article 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 December 24, 2014 by the company «Sapec Agro Italy Srl» headquartered in Saronno (VA), via Varese n. 25/D, in order to obtain the authorisation of the plant protection product containing those active substances as ' copper Cupromet SC hydroxides and metalaxyl, equal to the reference product called Qubic R recorded at n. 14433 with D.D. on July 31, 2009 amended subsequently by decrees whose last on February 28, 2013, Enterprise «Cheminova Agro Italy», having its registered office in Bergamo, via F.lli Bronzetti # 32/28; Given that the technical-administrative verification of the Office has established 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 Qubic R recorded at # 14433;

There is a legitimate agreement between the enterprise «Sapec Agro Italy» 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 Ministerial Decree dated September 15, 2009 implementing directive 2009/37/EC relating to copper as an active substance in annex I to the legislative decree 194/95; Having regard to the Ministerial Decree of December 30, 2010 transposing Directive 2010/28/EC concerning the inclusion of the active substance metalaxyl in annex I to the legislative decree 194/95; Given that Directive 91/414/EEC has been replaced by reg. (EC) No 1107/2009 and therefore the active substances concerned are now considered approved under that regulation and listed in annex to Regulation EU no 540/2011; Considering that the plant protection product the company has complied with the provisions of art. 2, paragraph 2 of the aforementioned Decree transposing for both active substances; Considering also that the product will have to be reassessed in accordance with the uniform principles laid down in Regulation (EC) 1107/2009 of the European Parliament and of the Council implementing Regulation (EU) No. Commission 546/2011 and annex VI of Decree No. 194/95, on the basis of a dossier satisfying the requirements of regulations (EC) No 544/2011 and no. 545/2011 and annex III of Legislative Decree No 194/95; Considered to limit the validity of the authorization of the product in question at the June 30, 2020, expiration date assigned to the reference product, subject to the formalities and adjustments in accordance with the uniform principles laid down in Regulation (EC) 1107/2009 of the European Parliament and of the Council implementing Regulation (EU) No 546/2011 the Commission; Considering also that for the reference plant protection product has already been presented a dossier satisfying the requirements of Regulation (EC) no 545/2011, and in accordance with art. Ministerial Decree of 3 December 30, 2010, within the time prescribed by the latter; 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 June 30, 2020 Enterprise «Sapec Agro Italy Srl» headquartered in Saronno (VA), via Varese n. 25/D, is authorized to enter the plant protection product on the market called CUPROMET SC 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 0.1-0.2-0.25-0.5 L-1-5-10-20-25. The product is imported into ready-to-use packages from abroad: Sapec Agro S.A.-Setubal (Portugal). The above mentioned product is recorded at # 16254. 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 on the portal of the Ministry of Health www.salute.gov.it in the area dedicated to plant protection products 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