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Confirmation Of The Re-Registration, According To Uniform Principles, Plant Protection Product Relating To The Dossier Gf All 894. Iii A Base Of Scientific Books, Integrativatecnico-Mancozeb Request Without Prejudice.

Original Language Title: Conferma della ri-registrazione, secondo principi uniformi, deiprodotti fitosanitari afferenti al dossier GF 894 di All. III a basedi mancozeb, a seguito della documentazione integrativatecnico-scientifica richiesta senza pregiudizio.

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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; and in particular article 80 relating to "transitional measures"; 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 article 119 on "Permissions"; 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 article 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 under article 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 Decree of re-registration of plant protection products, May 16, 2013, on the basis of the dossier's GF mancozeb 894 of annex III, in the light of the uniform principles for evaluation and authorisation of plant protection products in accordance with Regulation (EC) No 546/2011. View the Office note prot. 12241 of March 28, 2013 with which it was requesting additional documentation and technical and scientific data indicated by the International Centre for pesticides and health prevention; View the note with which the enterprise Indofil Industries LTD presented, within the time limits laid down by the said Office note, documentation and additional scientific and technical data; Having regard to the opinion of the aforementioned Centre regarding the documentation submitted by the undertaking Indofil Industries LTD in support of the confirmation of authorisation of plant protection products referred to in the annex to this Decree;

Decrees are confirmed the re-recordings until January 31, 2018, expiration date of the approval of the active substance mancozeb, of plant protection products referred to in the annex to this Decree recorded the number, date and name of company alongside indicated, authorized with the composition, the conditions and on the crops indicated in labels attached to this Decree laid down pursuant to the uniform principles. Changes are permitted for each plant protection product listed in the annex to this Decree. Are approved as an integral part of this Decree the labels attached, adapted according to the uniform principles, both with 67/548/EEC classification according to directives and 1999/45/EC, both with classification established by the owner in accordance with Regulation (EC) no 1272/2008. Within 30 days of the notification of this Decree, the licensee is required to Relabel the plant protection product not yet marketed and to provide retailers with a facsimile of the new label for the product in stock at the retail end of its delivery to the purchaser/end user. It is also required to take any action in respect of users, to ensure proper operation of the plant protection product according to the new provisions. This Decree will be published in the official journal of the Italian Republic and communicated to the undertaking concerned. Data relating to the above product (s) are available on the website of the Ministry of Health www.salute.gov.it, under "database".
Rome, 1 St April 2015 Director General: Rajput