Marketing Authorization Of Plant Protection Product 'grandor Cereals'.

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-21&atto.codiceRedazionale=15A01102&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

The Director General for the hygiene and food safety and nutrition Given the Regulation (EC) No. 396/2005 of the European Parliament and of the Council of 23 February 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 as well as' the next Regulations amending Annexes II and III of that Regulation, as regards the maximum residue levels of individual active substance in or on certain products; Having regard to Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling 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 Regulation (EC) No. 1107/2009 of the European Parliament and of the Council of 21 October 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 modification , and in particular art. 80 on "Transitional measures"; Having regard to Directive 1999/45 / EC of the European Parliament and of the Council of 31 May 1999 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, as amended , for the part still in force; Having regard to Directive 2009/128 / EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve a sustainable use of pesticides; Given the legislative decree 31 March 1998 n. 112 on "Contribution of administrative functions and duties of the State to the regions and local authorities, in implementing Chapter I of the Law of 15 March 1997, no. 59", and in particular Articles 115 concerning "Assignment of duties" and the ' art. 119 on the "Permissions"; Given the Law of 13 November 2009, no. 172 on "Establishment of the Ministry of Health, and increase the total number of Secretaries of State", as amended; The Order of the President of the Republic of 28 March 2013, n. 44 on "Regulation reordering of the governing bodies and other bodies working in the Ministry of Health, pursuant to art. 2, paragraph 4, of Law 4 November 2010, n. 183"; The Order of the President of the Council of Ministers of 11 February 2014, n. 59 on "Rules of organization of the Ministry of Health", and in particular art. 10 entitled "General Directorate for Food Safety and Nutrition"; Given the legislative decree 17 March 1995 n. 194, on "Implementation of Directive 91/414 / EEC on the placing on the market of plant protection products', as amended; The Order of the President of 23 April 2001, n. 290 on "Rules of simplification of authorization procedures for the production, marketing and sale of plant protection products and their carriers", as amended; Given the legislative decree 14 March 2003 n. 65, on "Implementation of Directive 1999/45 / EC and 2001/60 / EC relating to the classification, packaging and labeling of dangerous preparations", as amended; Given the legislative decree 14 August 2012, n. 150, "Implementation of Directive 2009/128 / EC establishing a framework for Community action to achieve a sustainable use of pesticides"; Given the inter-ministerial decree 22 January 2014 entitled "Adoption of the National Action Plan for the sustainable use of plant protection products, in accordance with art. 6 of the legislative decree of August 14, 2012, n. 150, entitled:" Implementation of Directive 2009 / 128 / EC establishing a framework for Community action to achieve a sustainable use of pesticides "View the application submitted on 21 October 2014 by the Dow AgroSciences Italy Srl, headquartered in Milan, Via F. Albani, 65, intended to obtain the marketing authorization of the plant protection product called Grandor CEREALS containing the active substance 2.4 D, equal to the reference product called Malerbane Cereals registered no. 4090 with DD on 1 December 1980 , later modified by decrees of which the last on December 18, 2013, Enterprise Diachem SpA, with registered office at Albano S. Alessandro (BG), via Tonale, 15; Considered altresi 'that the reference product and' was re-registered in accordance 'Annex III of Legislative Decree 194/95 and evaluated according to uniform principles of Annex VI on the basis of the dossier GF 1387; Noted that an assessment technical administrative office has determined that the requirements for the application of Article. 10 of the aforementioned decree of the President of April 23, 2001, n. 290 and in particular that the product and 'equal to the cited reference product Malerbane Cereals registered at n. 4090; It detected and therefore not 'sought the opinion of the Advisory Commission for plant protection products, as per art. 20 of Legislative Decree 17 March 1995 n. 194; Given the Ministerial Decree of 9 August 2002 implementing Directive 2001/103 / EC on the recognition of the active substance 2.4 D in Annex I of Legislative Decree 194/95; Given the Ministerial Decree of 30 December 2010 implementing Directive 2010/77 / EU concerning the extension of the active substance 2.4 D in Annex I until 31 December 2015; Since Directive 91/414 / EEC and 'was replaced by Reg. (EC) n. 1107/2009 and that therefore the active substance in question and now 'deemed approved under that Regulation and listed in Annex to the EU Regulation. 540/2011; Considering that the plant protection product, the Company has complied with the requirements provided for by art. 2, paragraph 2 of the above mentioned decree of transposition for the active substance; Decided to limit the validity 'of the authorization to 31 December 2015, expiration date assigned to the reference product; Due to the payment made in accordance with the Ministerial Decree 28 September 2012 on "Reassessment of fees for the placing of plant protection products in respect of contributions paid and made available on request, in the implementation of Regulation (EC) 1107/2009 of the Parliament and of the Council "; Decrees: From the date of this decree and until 31 December 2015, the company Dow AgroSciences Italy Srl, headquartered in Milan, Via F. Albani, 65, and 'authorized to place on the market the plant protection product called Grandor CEREALS with the composition and conditions indicated on the label attached to this decree. And 'subject to any subsequent adjustment and fulfillment of the conditions of authorization of plant protection product, in accordance' with Community measures and additional provisions on substances active components. The product and 'packaged in sizes L from 0.250 to 0.5 - 1 - 2 - 5 to 10 - 20 to 50 - 100 - 200. The product and' prepared at the plants Company: Dow AgroSciences Italy Srl - Mozzanica (Bergamo ); Diachem UP SpA Sifa - Caravaggio (Bergamo). The product in question and 'registered under No. 16186. The label attached to this decree, with which the plant protection product is to be marketed, and 'along the lines proposed by the Company holder for the reference product, suitable for classification as provided in Reg.1272 / 2008, as indicated in the communiqué of the Ministry of Health of 14 January 2014. This decree will be 'published in the Official Gazette of the Italian Republic and communicated to the Company concerned. Data for the above mentioned product can be found in the "Database" of the area dedicated to the Phytosanitary Portal www.salute.gov.it. Rome, December 9, 2014 The Director General: Ruocco