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Extension Of Cautionary Suspension Impiegoper Permission Tanning Of Seed Of Plant Protection Products Containing Clothianidin, Thiamethoxam, Imidacloprid And Fipronil As Active Lesostanze, June 28, 2011 Decree.

Original Language Title: Proroga della sospensione cautelativa dell'autorizzazione di impiegoper la concia di sementi dei prodotti fitosanitari contenenti lesostanze attive clothianidin, thiamethoxam, imidacloprid e fipronil,di cui al decreto 28 giugno 2011.

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The GENERAL MANAGER for hygiene and food safety and nutrition Saw art. 6 April 30, 1962, law n. 283, amended by art. 4 February 26, 1963, law No. 441; Having regard to the Legislative Decree March 30, 2001, # 165, that such general rules about ordering of labor employed by public administrations; Having regard to law no November 13, 2009. 172 regarding ' institution of the Ministry of health and increase the total number of Undersecretaries of State. ' Having regard to the Decree of the President of the Republic March 11, 2011, # 108, regarding the regulation of reorganization of the Ministry of health; Having regard to the Decree of the Minister of health on August 2, 2011 transitional organizational discipline of the Ministry of health; Having regard to the Legislative Decree March 17, 1995, n. 194 concerning the implementation of Directive 91/414/EEC concerning the placing of plant protection products; Having regard to the Decree of the President of the Republic April 23, 2001, no. 290 on the regulation for the simplification of procedures for authorization for the production, marketing and sales of plant protection products and adjuvants; 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 in particular art. 80 on ' transitional measures '; Having regard to Commission Regulation (EU) No. 540/2011, 541/2011, 544/2011, 545/2011, 546/2011, 547/2011, implementing Regulation (EC) No 1107/2009; Having regard to Legislative Decree March 14, 2003, n. 65, corrected and supplemented by Legislative Decree July 28, 2004, n. 260, and the Ministerial Decree of April 3, 2007, relating to the implementation of directives 1999/45/EC, 2001/60/EC and 2006/8/EC relating to the classification, packaging and labelling of dangerous preparations; Having regard to Council Regulation (EC) no 1272/2008 of the European Parliament and of the Council of December 16, 2008 and the subsequent Commission Regulation No 790/2009 of August 10, 2009 of adaptation to technical and scientific progress, relating to classification, labelling and packaging of substances and mixtures; Having regard to Council Regulation (EC) No 396/2005 of the European Parliament and of the Council of February 23, 2005 and subsequent updates concerning maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC; Given that the active substance clothianidin, thiamethoxam, imidacloprid and fipronil are included in annex I to the Decree March 17, 1995, n. 194, which shows the list of active substances authorised for contained in plant protection products; Having regard to Council Regulation (EC) 178/2002 of the European Parliament and of the Council laying down the General principles and requirements of food law, establishing the European food safety authority and laying down procedures in matters of food safety, and in particular art. 7, which establishes the principle of precaution; Given the managerial Decree September 17, 2008, published in the Gazzetta Ufficiale-serie generale-# 221 of September 20, 2008, concerning the "precautionary Suspension of the authorisation to use for tanning of seed of plant protection products containing the active substances clothianidin, thiamethoxam, imidacloprid and fipronil, pursuant to art. 13, paragraph 1, of the Decree of the President of the Republic April 23, 2001, # 290 '; Given the managerial Decree June 28, 2011, published in Gazzetta Ufficiale-serie generale-# 150 of June 30, 2011 on the "extension of the suspension uses permission cautionary for tanning of seed of plant protection products containing the active substances clothianidin, thiamethoxam, imidacloprid and fipronil, pursuant to art. 13, paragraph 1, of the Decree of the President of the Republic, April 23, 2001 Executive Decree # 290 September 16, 2010»; Having regard to Council directive 2010/21/EU of March 12, 2010 amending Annex I to Directive 91/414/EEC as regards the specific provisions for the active substance clothianidin, imidacloprid and fipronil thiametoxam, appropriate mitigation measures, including to non-target organisms, with particular reference to honeybees; Considered that the implementation of the measures provided for in that directive by the Member States involve verifying the actual feasibility of implementation of those provisions, with particular regard to the method of preparation of seed and equipment used for seeding, in order to ensure a high degree of incorporation of the seed in the soil and minimize the losses and the release of dust; Whereas that directive 2010/21/EU was transposed by Ministerial Decree of October 15, 2010, published in the Gazzetta Ufficiale-serie generale-# 12 of January 17, 2011; Having regard to the report by the Institute for environmental protection and research (ISPRA) on the technical and cognitive investigation on the phenomenon of bee mortality in natural environments or semi-natural and agricultural land lying within protected natural areas, aiming to complete the cognitive framework of the research project APENET; Considering that on the request of the Directorate-General for the hygiene and safety of food and nutrition on studies and monitoring carried out in other EU countries affected by the same phenomenon of depopulation and death of bees, are received by those relating to only one Member State; Considering also that are not received by the regions most directly involved in the production maidicola, the opinions requested by the Executive Board concerning the use for the tanning of corn of plant protection products containing the active substances concerned and the data of any monitoring carried out at the local level; Having regard to the documents produced by the trade associations of producers of plant protection products on the economic impact assessment of the replacement of tanning in Italian maize breeding and documentation information transmitted by the Trade Association of beekeepers; Having regard to the report on the activities carried out and the results obtained in the APENET project for issue «effects of corn dressed on bees»-Year 2011, drawn up by the Council for agricultural experimentation (CRA) of the Ministry of agricultural food and forestry policies; Given that the report shows a complex picture and still not exhaustive in relation to risk factors for bee health essentially related to the dispersion of powders containing the active substances concerned and lethal and sub lethal effects associated with the presence of residues of neonicotinoids and fipronil, as well as to the different situation of bees in damp dusting; Given that the aforementioned relationship emerged, as regards the use of seeding machines, need to change the same according to criteria currently only experimental, in order to ensure a high degree of incorporation of the seed in the soil and minimize the losses and the release of dust containing the active substances concerned; Given that the Advisory Commission of plant protection products on the market, at its meeting of October 18, 2011, detected the presence of criticality above and listed in the report itself; Taking into account also, that in the course of the meeting it was emphasized the need for involvement of the regions directly affected the production maidicola in order to check the actual applicability of technical measures mentioned in the report, to define the resulting APENET operational solutions and to provide territorial monitoring and control plans; Given that emerged, in the course of that meeting, the need to inform the European Commission and acquire a scientific opinion on the findings of investigations conducted at national level, by the European food safety authority (EFSA), for an overall assessment to be submitted to the Advisory Committee; Considered that the Advisory Committee, during the same meeting, has identified the need to extend, as a precaution, for the reasons set out above, the interruption referred to in the managerial Decree June 28, 2011, for the period of time necessary to the definition of criticality found, even with the regions concerned, and waiting to record the opinion of that authority; Considered in the light of the above, having to perform, as a precautionary measure, to the extension of the suspension of Executive Decree June 28, 2011 for more eight months in order to be able to acquire the necessary documentation and submit the matter to the Advisory Committee;
Decrees: Art. 1 1. The period laid down in art. 1, paragraph 1, of the Executive Decree of June 28, 2011, it is extended until June 30, 2012. This Decree will be notified to the undertakings enjoying authorizations of plant protection products on the market in question and shall enter into force on the day of its publication in the official journal of the Italian Republic.
Rome, October 25, 2011 Director General: Borrello