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Safe Re-Registration Of Plant Protection Products Based On Active Dellasostanza Disodium Phosphonate Approved By Regulation (Eu) No 832/2013 The Commission, In Accordance With Regulation (Ec) No 1107/2009 And Amending The Annex To Reg. ..

Original Language Title: Ri-registrazione provvisoria dei prodotti fitosanitari a base dellasostanza attiva fosfonato di disodio approvata con regolamento (UE)n. 832/2013 della Commissione, in conformita' al regolamento (CE) n.1107/2009 e recante modifica dell'allegato del reg...

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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 2009/28/EC of the European Parliament and 1 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 "Providing administrative functions and tasks of the State say to the regions and local authorities, in the implementation of chapter I of law March 15, 1997, # 59", and in particular articles 115, regarding "Division of powers" and art. 119, regarding "authorizations"; Having regard to law no 172 on November 13, 2009 "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, regarding "the Directorate-General 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, regarding "regulation for the simplification of the procedures for authorising the production, placing on the market and sales of plant protection products and related processing", 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 "implementing 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 '; Given that the active substance disodium phosphonate was approved by Regulation (EU) no 832/Commission 2013 until January 31, 2024, according to Regulation (EC) No 1107/2009 and adjusting accordingly the annex to Regulation (EU) No 540/2011; Whereas, in particular, for this first phase of adjustment it is intended that PPP authorisation holders are in possession of a dossier satisfying the requirements of Regulation (EU) No. 544/2011, or alternatively, can still demonstrate that you can access them and demonstrate also to abide by the terms of the annex to reg. (EU) no 832/2013 with the exception of those listed in the column for specific provisions; Since the temporary re-registration of plant protection products on the market in question can be granted until January 31, 2024, expiration date of the approval of the active substance itself, without prejudice to the presentation within the time limits provided for in Regulation (EU) No. 832/2013 Commission of an appropriate dossier to the prescription laid down in Regulation (EU) No. 545/2011 from the Commission with the data is not present at the time of temporary registration of plant protection products on the market, which took place in accordance with art. 80 of Regulation (EC) No 1107/2009, as well as to the data indicated in column of the "specific provisions" of the annex to regulation of approval of the active substance concerned; Considered that the appropriate dossier will undergo a new evaluation according to the uniform principles provided for in art. 29, paragraph 6 of Reg. 1107/2009, according to the times set forth in art. 2, par. 2, part a) of Regulation (EU) No 1175/2013; Decided to re-record tentatively PPPs concerned, until January 31, 2024, after the approval of the active substance disodium phosphonate, without prejudice to the abovementioned obligations on time and to the terms laid down in Regulation (EU) No 1175/2013; Saw the deposit pursuant to Ministerial Decree September 28, 2012;
Decrees: are re-registered provisionally, until January 31, 2024, expiration date of the approval of the active substance disodium phosphonate, plant protection products set out in the annex to this Decree. Are subject to the withdrawal of authorisation of plant protection products on the market in question, the formalities and the adjustments laid down in Commission Regulation (EU) No. 832/2013 of the approval of the active substance thereof, which provides for the submission of a dossier adapted to the requirements of Regulation (EU) no 545/2011 as well as to the data indicated in column of the "specific provisions" of the annex to regulation of the approval of the active substance, disodium phosphonate. These dossiers will be assessed in the light of the uniform principles laid down in art. 29, paragraph 6 of Regulation (EC) No 1107/2009. 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, February 11, 2015 Director General: Rajput