The GENERAL MANAGER for hygiene and food safety and nutrition Saw art. 6 April 30, 1962, law n. 283, amended by art. 4 February 26, 1963, law No. 441; Having regard to the Legislative Decree March 30, 2001, # 165, that such general rules about ordering of labor employed by public administrations; 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 "; Having regard to the Decree of the President of the Republic March 11, 2011, # 108, regarding the Regulation of reorganization of the Ministry of health; Having regard to the Decree of the Minister of health on August 2, 2011 transitional organizational discipline of the Ministry of health; Having regard to the Legislative Decree March 17, 1995, n. 194 concerning the implementation of Directive 91/414/EEC concerning the placing of plant protection products, as well as the circular of June 10, 1995, # 17 (S.O. O.j. # 145 of June 23, 1995) concerning "application of the new rules for the authorisation of plant protection products '; Having regard to the Decree of the President of the Republic April 23, 2001, no. 290 on the regulation for the simplification of procedures for authorization for the production, marketing and sale of pesticides and related adjuvants, as amended by the Decree of the President of the Republic, February 28, 2012 # 55 on the regulation amending the Decree of the President of the Republic April 23, 2001 , # 290; 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 in particular art. 80 on ' transitional measures '; Having regard to Commission Regulation (EU) No. 540/2011, 541/2011, 542/2011, 544/2011, 545/2011, 546/2011, 547/2011, implementing Regulation (EC) No 1107/2009; Having regard to Legislative Decree March 14, 2003, n. 65, corrected and supplemented by Legislative Decree July 28, 2004, n. 260, and the Ministerial Decree of April 3, 2007, relating to the implementation of directives 1999/45/EC, 2001/60/EC and 2006/8/EC relating to the classification, packaging and labelling of dangerous preparations; Having regard to Council Regulation (EC) no 1272/2008 of the European Parliament and of the Council of December 16, 2008 and the subsequent Commission Regulation No 790/2009 of August 10, 2009 of adaptation to technical and scientific progress, relating to classification, labelling and packaging of substances and mixtures; Having regard to Council Regulation (EC) No 396/2005 of the European Parliament and of the Council of February 23, 2005 and subsequent updates concerning maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC; Having regard to the Ministerial Decree July 9, 1999, determination of tariffs relating to the placing on the market of plant protection products to cover sustained performance and made a request; Having regard to the Decree of the Ministry of health in 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; Given the managerial Decree of September 25, 2001 provisional authorization to the placing on the market and use of the plant protection product AURA, of the active substance profoxydim, registered under number 11012, and subsequent decrees to extend the authorization according to corresponding Community decisions; Having regard to Directive 2011/14/EU of February 24, 2011 concerning the inclusion in annex I to Directive 91/414/EEC of the active substance profoxydim; Having regard to the ministerial decree implementing directive April 14, 2011 2011/14/EU of February 24, 2011; See in particular, art. 1 of the Ministerial Decree April 14, 2011 indicating the expiration July 31, 2021 which of the inclusion of the active substance profoxydim, in annex I to the Decree March 17, 1995, # 194; Having regard to the Commission's implementing Regulation (EU) 706/2011 of July 20, 2011, which provides that the active substance profoxydim is considered approved in accordance with Regulation (EC) 1107/2009, late in the annex to Regulation (EU) 540/2001; Having regard to the request submitted by the undertaking by the company Basf Italy Spa holder of the authorization of the plant protection product AURA, designed to obtain re-registration of the said plant protection product on the basis of the dossier BAS-62504H in accordance with annex III of the aforementioned legislative decree 194/1995, pursuant to art. 80 of Regulation (EC) no 1107/2009, in which the undertaking designated Italy as rapporteur Member State in accordance with the procedure of voluntary work-sharing; Saw the deposit to D.M. July 9, 1999, in force on the date of application; Considering that the company holder of the authorisation of the plant protection product in question has complied with the provisions of art. 2, paragraph 2, of the aforementioned Decree February 24, 2011, within the time and in the forms laid down by it and according to the conditions defined for the active substance profoxydim; Given the comments on the report of the preliminary assessment, formulated by the Member States concerned and by the experts of the Advisory Commission for plant protection products referred to in art. Legislative Decree 20 March 17, 1995, # 194, pursuant to art. 36, paragraph 1, of Regulation (EC) 1107/2009; Considered that the documentation submitted by the undertaking for the re-registration of plant protection product AURA was examined by the rapporteur Member State Italy with favourable results as well as re-registration report concluded; View the Office note # 124521163 on July 16, 2013 which has been called the company Basf Italy Spa, owner of file documentation and additional scientific and technical data to be submitted by the dates laid down; Having regard to the note of August 9, 2013, integrated with note of August 19, 2013, with which the enterprise registration holder of the plant protection product as set out in the annex to this Decree, has complied with as prompted by the Office; Decided to rerecord until July 31, 2021, expiration date of the approval of the active substance profoxydim, the plant protection product AURA under the conditions defined in the light of the uniform principles laid down in annex VI of the Legislative Decree of March 17, 1995, # 194, on the basis of the dossiers BAS-62504H subject to All. III of the aforementioned legislative decree;
Decreed: it's re-registered until July 31, 2021, expiration date of the approval of the active substance profoxydim, the plant protection product AURA, recorded at the date September 25, 2001 11012 number and company name Basf Italy Spa, on crops and conditions indicated on the label attached to this Decree laid down pursuant to the uniform principles. It is without prejudice to any subsequent fulfilment and adjustment of the conditions of authorisation of plant protection products, also according to Community measures and other conditions relating to those active substances components. The marketing and use of stocks Recumbents, bearing labelling previously approved, permitted according to the following modalities: 8 months from the date of this Decree for the marketing authorization holder and the sale by retailers and/or distributors;
12 months from the date of this Decree for use by end users. 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 in administrative channels to the undertaking concerned and will be published in the official journal of the Italian Republic.
Rome, September 13, 2013 Director General: Borrello