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 changes 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 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 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 adopting the national action plan for the sustainable use of plant protection products on the market, in accordance with art. 6 of Legislative Decree No 150 amending August 14, 2012: "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 which approved the metam according to Regulation (EC) No 1107/2009, on the basis of 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; Given the managerial Decree of December 17, 2014 which re-registered plant protection products containing the active substance metam; Considered that the plant protection product METAM (Reg. # 3745), contains the active substance metam to source other than approved at Community level to specifications, methods of analysis and production process; Considering they are still under way by the rapporteur Member State for the necessary checks to assess the chemical equivalence and the completeness of the dossier on the active substance metam of different source; Considering that it is necessary to re-register the plant protection product METAM (reg. # 3745) LAINCO undertaking until June 30, 2015 to give time to the rapporteur Member State to conclude with the checks in place; View the note with which the enterprise registration holder announced that it had provided for reclassification in accordance with Regulation (EC) no 1272/2008; Given that the plant protection product concerned is annexed to this Decree, both the label sent by the undertaking which owns, in compliance with the obligation of classification in accordance with Regulation (EC) no 1272/2008 the label according to directives 67/548/EEC and 1999/45/EC; Considering also that the label of the plant protection product concerned must be adapted to specific conditions described in the «Part» of the annex to regulation of the approval of the active substance metam; 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 ';
Decreed: it changes the managerial Decree of December 17, 2014 interim re-registration of plant protection products on the basis of active substance metam approved by Regulation (EU) No. 359/2012 of the Commission, in accordance with Regulation (EC) no 1107/2009, to insert in the list annexed to the Decree, the plant protection product METAM (reg. # 3745) of the enterprise LAINCO containing the same active substance metam of different source. This re-registration, it is restricted to June 30, 2015, in order to allow the Member State acting as Rapporteur to conclude the necessary checks to assess the chemical equivalence and the completeness of the dossier on the active substance in the plant protection product to source other metam. It is approved as an integral part of this Decree the attached label, 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 stocks of the plant protection product already inadequate criteria laid down by Regulation (EC) no 1272/2008, shall be granted until 1 St June 2017, pursuant to art. 61 of the said regulation. The business licence holder is required to relabel, the plant protection product 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. 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, February 11, 2015 Director General: Rajput