Source: https://www.global-regulation.com/translation/italy/621068/authorisation%252c-in-accordance-with-the-procedure-of-mutual-programs-of-the-plant-protection-product--osiris--containing-active-substances-epoxiconazo.html
Timestamp: 2017-10-21 14:06:19
Document Index: 639917983

Matched Legal Cases: ['art. 119', 'art. 2', 'art. 10', 'art. 6', 'art. 40', 'art. 40']

Machine Translation of "Authorisation, In Accordance With The Procedure Of Mutual Programs Of The Plant Protection Product ' Osiris ' Containing..." (Italy)
Authorisation, In Accordance With The Procedure Of Mutual Programs Of The Plant Protection Product ' Osiris ' Containing Active Substances Epoxiconazole And Metconazolodaminozide, The Company Basf Italy S.p.a. Issued To ...
Original Language Title: Autorizzazione all'immissione in commercio, secondo la procedura diriconoscimento reciproco, del prodotto fitosanitario «Osiris»contenente le sostanze attive epossiconazolo e metconazolodaminozide, dell'impresa Basf Italia S.p.a. rilasciata a...
Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-18&atto.codiceRedazionale=15A02887&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 "regulations containing the reordering of the organs and other bodies collegiall operatiti at 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 manufacturing authorisation. the placing on the market 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 submitted on August 6, 2014 (Prot. n. 32027) from Basf Company Italy S.p.a. with registered office in Cesano Maderno (MB) Via Marconato 8, 20811 aimed at granting an authorisation of the plant protection product OSIRIS based of active substances epoxiconazole and metconazole systemic fungicide against diseases of cereal, in accordance with the procedure of mutual recognition foreseen by art. 40 of Regulation (EC) No 1107/2009; Considered that the documentation submitted by the company to issue such authorization, already registered for the same use and with comparable agricultural practices in another Member State, it was assessed and evaluated positively by a group of experts who belong to the Advisory Committee of plant protection products; Having regard to the subsequent opinion of the Advisory Committee of PPP, expressed on December 17, 2014, confirming what is expressed by the experts of the group belonging to the aforementioned Advisory Commission of PPPs; Having regard to the notes of the last on February 26, 2015 (Prot. # 6492) with which the undertaking has been requested by the company Basf Italy S.p.a. to send the relevant documentation needed to complete this authorization of the plant protection product; Having regard to the last notes on March 9, 2015 (Prot. n. 8167) with which the enterprise has passed the required documentation and necessary for the completarnento of granting the marketing authorisation of the plant protection product OSIRIS; Considered therefore to authorise the plant protection product until April 30, 2019, expiration date of the approval of the active substance metconazole as described in reg. (EU) No 540/2011; 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" Decrees: the company Basf Italy S.pa. a. with registered office in Milan, Via Marconato 8, 20811 is authorized for placing on the market of the plant protection product OSIRIS, based on the active substance epoxiconazole as fungicide metconazole and sisitemico against diseases of cereals, with the composition and conditions indicated on the label attached to this Decree. The plant protection product OSIRIS is authorized in accordance with the procedure of mutual recognition pursuant to art. 40 of Regulation (EC) No 1107/2009, therefore, the reference product is authorized for the same use and with comparable agricultural practices in another Member State. The enrollment is confirmed until April 30, 2019, expiration date of the approval of the active substance metconazole, as reported in the reg. (EU) No 540/2011. The product is prepared in the factory: BASF Española S.L. 43006 Tarragona (Spain) and Basf Agri-production S.A.S. 69727, Genay (France) the product is packaged in sizes from 1-2-3-5 litre-10-20. The plant protection product that is registered at no. 16137. 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 additional provisions concerning the active substance component. It is approved as an integral part of this Decree annex facsimile of the label by 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 abovementioned product data are available in the "database" of the area dedicated to plant protection products of the portal www.salute.gov.it Rome, March 18, 2015 Director General: Rajput