Safe Re-Registration Of Plant Protection Products Based On Active Dellasostanza Metam Approved By Regulation (Eu) No 359/2012Della Commission Pursuant To Regulation (Ec) No 1107/2009 Erecante Review Of The Annex Of The Rules Of Procedure By Se ...

Original Language Title: Ri-registrazione provvisoria dei prodotti fitosanitari a base dellasostanza attiva metam approvata con regolamento (UE) n. 359/2012della Commissione, in conformita' al regolamento (CE) n. 1107/2009 erecante modifica dell'allegato del regolamento di ese...

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-28&atto.codiceRedazionale=15A00458&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 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 establishing a" Division of powers "and article 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 article 2, paragraph 4, of law November 4, 2010, # 183» See 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 establishing a ' general direction 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 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 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 Council decision 2009/562/EC concerning the non-inclusion of the active substance metam in annex I to Directive 91/414/EEC; Considering that in under strict conditions designed to minimize risks to human health, animals and the environment, was granted the possibility to States for applicants, a longer grace period to use the active substance metam; See the annex to this decision which reported the list of Member States, including Italy, which kept authorisations of plant protection products containing metam and the authorized uses for individual Member States, deemed essential, until December 31, 2014; Saw the subsequent Commission Regulation (EU) No 359/2012 the Commission which approved the metam according to Regulation (EC) No 1107/2009, based on new data presented and evaluated by the rapporteur Member State by EFSA and the European Commission; Whereas that regulation repealed decision 2009/562/EC while still maintaining valid until December 31, 2014 the longest grace period granted to requesting Member States; Having regard to article 2 of Regulation (EU) No. 359/2012 the European Commission establishing the times, to adapt the plant protection products containing the active substance metam, the specific provisions contained in part A of the annex to the said regulation «»; Considered that enterprises, owners of plant protection products set out in the annex to this Decree, have complied, for this first phase, within the time and in the forms laid down in the rules of the approval of the active substance metam, adapting the labels to those specific provisions; Since the temporary re-registration of plant protection products on the market in question can be granted until June 30, 2022, expiration date of the active substance itself, without prejudice to the presentation within the time limits laid down in Regulation (EC) No 359/2012 the Commission approval, a file appropriate 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 under article 80 of Regulation (EC) No 1107/2009, as well as the values given in the "part B" of specific provisions of the annex to regulation of the approval of the active substance; Considered that the appropriate file will be evaluated according to the uniform principles provided for in art. 29, para. 6 of Reg. 1107/2009, according to the times set forth in art. 2 par. 2 part a) of Regulation (EU) No 359/2012; 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; Also view the note with which the business owners reported registrations effected the reclassification in accordance with Regulation (EC) no 1272/2008; As for the plant protection products concerned shall be annexed to this Decree, both the labels provided by the undertaking which owns, in compliance with the obligation of classification in accordance with Regulation (EC) no 1272/2008; Decided to re-record tentatively PPPs concerned, until June 30, 2022, after the approval of the active substance metam, without prejudice to the abovementioned obligations on time and to the terms laid down in Regulation (EU) No 359/2012; 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: are re-registered provisionally, until June 30, 2022, expiration date of the approval of the active substance metam 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. 359/2012 by 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 the data set out in part B of the "specific provisions" of the annex to regulation of the approval of the active substance metam. These dossiers will be assessed in the light of the uniform principles laid down in article 29, paragraph 6 of Regulation (EC) No 1107/2009. Are approved as an integral part of this Decree the labels attached, adapted to «Part» of the specific provisions in annex to the rules of the approval of the active substance metam, 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. 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 inadequate inventory criteria laid down by Regulation (EC) no 1272/2008, shall be granted until 1 St June 2017, under section 61 of the said regulation. The business owners of the permissions required to relabel, by December 31, 2014, 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 17, 2014 General Manager: Rajput