Re-Registration Of Plant Protection Products, Bromoxynil, Based On The File Ca1216 Of Annex Iii, In The Light Of The Principiuniformi For The Evaluation And Authorisation Of Prodottifitosanitari In Accordance With Regulation (Ec) No 546/2011. ...

Original Language Title: Ri-registrazione di prodotti fitosanitari, a base di bromoxynil,sulla base del dossier CA1216 di Allegato III, alla luce dei principiuniformi per la valutazione e l'autorizzazione dei prodottifitosanitari, ai sensi del regolamento (CE) n. 546/2011. ...

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-16&atto.codiceRedazionale=15A02897&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; and in particular art. 80 on "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 Legislative Decree March 31, 1998, 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, 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 '; Having regard to the Ministerial Decree of June 18, 2004 transposing Directive 2004/58/EC of April 23, 2004 concerning the inclusion in annex I of the Legislative Decree March 17, 1995, # 194, of a number of active substances which are now found in the reg. (EU) 540/2011 and 541/2011 of the Commission, including the active substance bromoxynil; See in particular that the approval of the active substance bromoxynil decade on February 28, 2015, as set out in the annex to reg. (EU) 540/2011; Saw the reg. (EU) No 1197/2012 of December 13, 2012 amending reg. (EU) No 540/2011 by extending the periods of approval until July 31, 2017 of some active substances including the active substance bromoxynil; Having regard to the decrees of the marketing authorisation and for use of plant protection products set out in the annex to this Decree; Having regard to the applications brought by the business owner seeking re-registration of plant protection products according to the uniform principles set out in the annex to this Decree, on the basis of the dossier relative to the reference plant protection product Emblem, presented by the company Nufarm S.A.S., comply with the requirements laid down in annex III of the aforementioned legislative decree 194/1995, transposed in reg. (EC) no 545/2011; Given that the brand owner of authorisations of plant protection products on the market in question has complied with the provisions of the Decree June 18, 2004, on time and in the forms laid down by it and according to the conditions defined for the active substance bromoxynil; Considered that the Advisory Commission of plant protection products under art. Legislative Decree 20 March 17, 1995, # 194, took note of the conclusion of the evaluation of the aforementioned file CA1216, carried out by the International Centre for pesticides and health prevention in order to re-register the plant protection products concerned until April 30, 2018, to new conditions of employment and with possible adjustment to the composition of the plant protection product; Having regard to the Protocol Office note 16390 on April 24, 2014 by which has been called the company Nufarm S.A.S. holder dossier documentation and additional scientific and technical data stated by the aforementioned Institution within twelve months from the date thereof; Having regard to the notes with which the undertaking which owns recordings of plant protection products set out in the annex to this Decree, has complied with the requirements of the Office; See the press release of January 14, 2014, on the application of Regulation (EC) no 1272/2008 on the classification, labelling and packaging of substances and mixtures; Whereas plant protection products referred to in the annex to this Decree and currently on the market bear the label according to directives 67/548/EEC and 1999/45/EC; View the note with which the brand owner announced that it had provided for the classification of pesticides below, under Regulation (EC) no 1272/2008; Decided to rerecord until July 31, 2017, due date of the approval of the active substance bromoxynil, plant protection products referred to in the annex to this Decree, the conditions defined by the evaluation according to the uniform principles provided for in annex VI to Regulation (EC) No 546/2011, on the basis of the dossier complies with the requirements laid down in annex III of the aforementioned legislative decree 194/1995 , transposed in the reg. (EU) n. 545/2011 of the Commission establishing a reference plant protection product Emblem; 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".
Decrees: are re-registered until July 31, 2017 expiry date of the approval of the active substance bromoxynil, plant protection products referred to in the annex to this Decree recorded the number, date and name of company alongside indicated, authorized with 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. The business licence holder is required to Relabel the plant protection product EMBLEM n. Reg. 10483 bearing the label previously authorized, 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. For the plant protection product GEODIS n. Reg. 14426 entered the market at the date of this Decree, with the previous composition and bearing the label previously authorized, may be marketed until April 30, 2015; the use is allowed until May 31, 2015. The production of plant protection products on the market of new composition with appropriate labels according to the uniform principles with classification according to directives 67/548/EEC and 1999/45/EC, are permitted no later than May 31, 2015; the marketing and use are allowed until 1 St June 2017, pursuant to art. 61 of Regulation (EC) no 1272/2008. It did however unless each subsequent performance and adjustment of the conditions of authorisation of plant protection products, also according to Community measures and other conditions relating to those active substances components. The aforementioned company Nufarm S.A.S. held the presentation of additional scientific and technical data above within the period referred above. 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. 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".
Roma, March 26, 2015 Director General: Rajput