The Director-General of the food and nutrition security in view of article 6 of the law no April 30, 1962. 283, amended by article 4 of the law No 441 February 26, 1963 concerning the hygienic discipline of food; Having regard to the Legislative Decree March 17, 1995, n. 194, implementing Directive 91/414/EEC concerning the placing of plant protection products, as amended; 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 the Decree of the President of the Republic of April 23, 2001, no. 290 on the regulation for the simplification of the procedures for authorising the production, marketing and sales of plant protection products and adjuvants; Having regard to Council Regulation (EC) No 396/2005 of the European Parliament and of the Council of February 23, 2005 and subsequent modifications, concerning maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC; Vista reads November 13, 2009, no. 172 concerning ' institution of the Ministry of health and increase the total number of Undersecretaries of States '; Having regard to Council Regulation (EC) no 790/2009 of August 10, 2009, amending for the purposes of adapting to technical and scientific progress, Regulation (EC) 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures; Having regard to the Decree of the Minister of health April 26, 2007, implementation of European Commission Directive 2007/5/EC of February 7, 2007, concerning the inclusion of certain active substances-including folpet-in annex I to the said decree # 194 of 1995 with the chemical definition and under the conditions set out in the annex to the Decree, published in the official journal of the Italian Republic General series # 204 of September 3, 2007; Given the managerial Decree July 24, 2008, withdrawal of the authorisation of certain plant protection products containing the active substance folpet by source Sapec Agro SA/Belchim Crop Protection NV/SA, other than those included in annex I to the Decree March 17, 1995, # 194 by Decree of the Ministry of health April 26, 2007», published in the official journal-General series 240 of September 3, 2007; Having regard to the request for re-examination of the abovementioned provision of the withdrawal of authorisation of plant protection products containing the active substance folpet by source Sapec Agro SA/Belchim Crop Protection NV/SA, on the equivalence of the same in the light of the explanations provided by the undertakings concerned; Having regard to the revision of the previous March 31, 2008 assessment technical report, prepared by the University of Milan-Department of Pharmacological Sciences on the basis of the above information; Views in particular the conclusions contained therein, which ensure the toxicologically and ecotoxicologically equivalence of the active substance by active substance/Belchim than the source reference Sapec inscribed in annex I; Considered that the dossier in accordance with annex II of the aforementioned legislative decree n. 194/95, presented by companies Sapec/Belchim to support your source of active substance folpet pursuant to art. 2, paragraph 2, of the Ministerial Decree of April 26, 2007, it appears that meets the requirement of completeness; Whereas, therefore, plant protection products containing the active substance folpet Sapec/Belchim source with access to documentation of annex II, satisfy the conditions laid down by Ministerial Decree April 26, 2007 of inclusion of the active substance folpet; Considering also that all plant protection products containing the active substance folpet alone, will have to be reviewed according to the uniform principles by September 30, 2011 registration, in accordance with Directive 2007/5/EC; Considered, finally, that plant protection products containing active substances should be mixed with other folpet re-examined according to the uniform principles within the time limits laid down by the last include directive relating to active substances components; Considered, therefore, for the reasons set out above, to proceed with the withdrawal of the managerial Decree July 24, 2008;
Decreed: it is revoked the managerial Decree July 24, 2008. Are subject to additional obligations, provided for the substance folpet by Ministerial Decree of April 26, 2007, referred in the introduction, and those laid down in Regulation (EC) 396/2005, as amended, and Regulation (EC) 790/2009. This provision is notified holders of authorisations in question and published in the official journal of the Italian Republic.
Rome, February 8, 2011 Director General: Borrello