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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 2009/128/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 establishing a" Division of powers "and art. 119 establishing «Permissions»; Having regard to act November 13, 2009 # 172 on ' institution 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, # 44, on «regulations containing the reorganization of collective bodies and other bodies active in the Ministry of health, in accordance with art. 2, paragraph 4, of law no 183 November 4, 2010»; 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 bearing ' Directorate-General for the hygiene and safety of food 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 concerning the regulation of simplification of procedures for authorization for the production, marketing and sales of plant protection products and related processing», as amended; Having regard to the Legislative Decree March 14, 2003, n. 65 on «implementing directives 1999/45/EC and 2001/60/EC relating to the classification, packaging and labelling of dangerous preparations, as amended; Having regard to the Legislative Decree of August 14, 2012, n. implementing directive 2009/150 incorporating «128/EC establishing a framework for Community action to achieve a sustainable use of pesticides '; Having regard to the Ministerial Decree January 22, 2014 bearing ' 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 the managerial Decree of January 16, 2004 interim marketing authorization and the use of the plant protection product active substance bispyribac based NOMINEE, registered under number 12070, and subsequent re-registration of temporary managerial Decree July 14, 2011 until July 31, 2021; Given the managerial Decree of January 23, 2012 marketing authorisation and for use of the plant protection product, of the active substance bispyribac ALTRAZ, registered under number 15329 until July 31, 2021; Having regard to the questions presented on January 31, 2012 and February 2, 2012 respectively, by the company Bayer CropScience S.r.l. with registered office in Milan in Viale Certosa 130, aimed at re-registration of plant protection products ALTRAZ and NOMINEE pursuant to art. 80 of Regulation (EC) no 1107/2009, containing the active substance bispyribac, pointing to the Italy which Member country rapporteur in accordance with the procedure of voluntary work-sharing; Saw the deposit pursuant to Ministerial Decree of July 9, 1999 on "determination of tariffs relating to the placing on the market of plant protection products and coverage of sustained performance and made on demand»; Having regard to Council Regulation (EU) No 540/2011 by which the active substance bispyribac was considered approved in accordance with Regulation (EC) 1107/2009, until July 31, 2021, under the same conditions laid down in annex I to Directive 91/414/EEC; Having regard to the report of preliminary re-registration (draft registration report-DRR) placed at the disposal of the Member States, the Advisory Committee referred to in art. Legislative Decree 20 March 17, 1995, # 194 and of the applicant, by the rapporteur Member State Italy on March 13, 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. Legislative Decree 20 March 17, 1995, # 194 and by the applicant, pursuant to 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 favourable results as indicated in the report of the final re-registration (registration report-RR); View the Office note on August 13, 2014 by which has been called the documentation of completion of the permitting procedure and additional scientific and technical data to be submitted by 6 and 24 months of the date of this Decree; Having regard to the note received at the October 27, 2014 date by which the undertaking has submitted the documentation of completion of the approval process; Whereas plant protection products referred to in the annex to this Decree are currently marketed under the label according to directives 67/548/EEC and 1999/45/EC; As for the plant protection products concerned shall be annexed to this Decree, both labels that conform to these directives on the classification, packaging and labelling of dangerous substances that in accordance with the Regulation (EC) no 1272/2008; Decided to rerecord until July 31, 2021, expiration date of the approval of the active substance bispyribac, plant protection products referred to in the annex, as assessed in accordance with the uniform principles laid down in Regulation (EC) No 546/2011 of the European Commission on the basis of the dossier submitted meets the requirements in Regulation (EU) no 545/2011 and in view also of the conditions laid down in Directive 2006/39/EC;
Decrees: are re-registered until July 31, 2021, expiration date of the approval of the active substance bispyribac plant protection products set out in the annex of the company Bayer CropScience S.r.l., in accordance with the composition, the conditions and the crops listed on labels attached to this Decree. The following changes are authorized production and packaging establishments: 1) are added the following establishments between label production workshops: Bayer Viet Nam Ltd.-Bien Hoa city-Viet Nam;
Bayer S.A.S.-Marle sur Serre-France;
2) were deleted from the labels for the following workshops: Bayer Portugal S.A., Casal Colaride-Agualva-Cacem, Portugal;
Bayer CropScience Srl-filago (Bergamo). 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, either with a classification in accordance with Regulation (EC) no 1272/2008. The production with the labels in accordance with directives 67/548/EEC and 1999/45/EC, are permitted no later than May 31, 2015. The marketing and use of plant protection products already adequate stocks according to the uniform principles but not the criteria laid down by this Regulation (EC) no 1272/2008, shall be granted until 1 St June 2017, pursuant to art. 61 of the said regulation. It did however unless each subsequent performance and adjustment of the conditions of authorisation of plant protection products, also according to Community measures and additional provisions concerning the active substance component. The business licence holder is required to re-label plant protection products bearing the label previously authorized, not yet put on the market 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 use of plant protection products in accordance with the new provisions. This Decree will be published in the official journal of the Italian Republic and communicated to the undertaking concerned. The above data products are available on the website of the Ministry of Health www.salute.gov.it, in the section «database».
Rome, December 3, 2014 General Manager: Rajput
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