Marketing Authorisation For The Product Fitosanitariodimix.

Original Language Title: Autorizzazione all'immissione in commercio del prodotto fitosanitarioDIMIX.

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-06&atto.codiceRedazionale=15A01643&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 containing "Division of powers" and art. 119 regarding "authorizations"; Having regard to act November 13, 2009 # 172 on "establishment 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, no. 44 concerning "regulation on the reorganization of collective bodies and other bodies active in the Ministry of health, in accordance with art. 2, paragraph 4, of law November 4, 2010, # 183 "; 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 on the "General Directorate of 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 on "regulation for the simplification of procedures for authorization for the production, marketing and sale of pesticides and related adjuvants", as amended; Having regard to the Legislative Decree March 14, 2003, n. 65, on "implementation of directives 1999/45/EC and 2001/60/EC relating to the classification, packaging and labelling of dangerous preparations, and its subsequent amendments; Having regard to the Legislative Decree of August 14, 2012, n. 150 on the "implementation of Directive 2009/128/EC establishing a framework for Community action to achieve a sustainable use of pesticides; Having regard to the Ministerial Decree January 22, 2014 on "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 March 7, 2013 Agriphar S.A. with registered office at Rue de Renory, 26/1-B-4102 Ougree (Belgium), aimed at granting an authorisation of the plant protection product DAVE pursuant to art. 33 of Regulation (EC) no 1107/2009, containing the active substance dimethomorph, indicating the Italy which Member country rapporteur pursuant to art. 35 of the regulation; 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; Having regard to Council Regulation (EU) No 540/2011 under which the active substance dimetomorf has been considered approved in accordance with Regulation (EC) 1107/2009 until September 30, 2017, under the same conditions laid down in annex I to Directive 91/414/EEC; Having regard to the report of preliminary registration (draft registration report-DRR) placed at the disposal of the Member States, the Advisory Committee referred to in art. March 17, 1995, 20, of Legislative Decree No. 194 and the applicant, by the rapporteur Member State Italy on March 21, 2014; Given the comments on the report of the preliminary assessment, formulated by the Member States concerned, by experts of the Advisory Commission as referred to in art. March 17, 1995, 20, of Legislative Decree No. 194 and the applicant, in accordance with art. 36, paragraph 1, of Regulation (EC) 1107/2009; Considered that the documentation provided by the company for the granting of the zonal authorisation of the plant protection product in question was examined by the rapporteur Member State Italy with favorable outcome as final registration report (registration report-RR); View the Office note dated November 17, 2014 by which has been called the documentation of completion of the permitting procedure and additional scientific and technical data to be presented within 18 months from the date of this Decree; Having regard to the note received on November 26, 2014 by which the undertaking has submitted the documentation of completion of the approval process;
Decreta: from the date of this Decree and until October 31, 2018, the enterprise Agriphar S.A. with registered office at Rue de Renory, 26/1-B-4102 Ougree (Belgium), is authorized, in accordance with Regulation (EC) 1107/2009, for placing on the market of the plant protection product called DAVE, with the composition and conditions indicated on the label attached to this Decree. The abovementioned undertaking held the presentation of additional scientific and technical data above within the period referred above 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 substances. The product is packaged in sizes 5-10 1-0.5-L-20. The plant protection product is prepared in the following plant: Chimac s.a., rue de Renory 26/2, B-4102 n. Ougree (Belgium);
Agriphar Italy S.r.l., via Nino Bixio n. 6-44042 Cento (Ferrara). The plant protection product that is registered at # 16282. 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 published in the official journal of the Italian Republic and communicated to the undertaking concerned. The data relating to the above product can be found on the website of the Ministry of Health www.salute.gov.it, under "database".
Rome, February 10, 2015 Director General: Rajput