Authorisation Of The Plant Protection Product ' Century Sl».

Original Language Title: Autorizzazione all'immissione in commercio del prodotto fitosanitario«Century SL».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-23&atto.codiceRedazionale=15A01112&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 modification, 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 establishing a" Division of powers "and art. 119 establishing «Permissions»; Having regard to law no November 13, 2009. 172 regarding ' 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 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 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 request made by the firm on August 8, 2014 Luxembourg Pamol (Cyprous) Ltd, with registered office at 3, Demetiou Vikella, Nicosia 1061-Cyprus, aiming to obtain the authorisation of the plant protection product as ' Century SL», containing the active substance potassium phosphonate, equal to the reference product named LBG-01F34 registered provisionally to n. 15008 with D.D. on August 26, 2013, amended subsequently by Decree on January 17, 2014, Enterprise; Noted that technical and administrative verification of the Office has confirmed the existence of the requirements for the application of art. 10 of the aforementioned Decree of the President of the Republic April 23, 2001, # 290, in particular that: the product is equal to the quoted reference product LBG-01F34 recorded at # 15008; Detected so it's not requested the opinion of the Advisory Committee on pesticides, under art. Legislative Decree 20 March 17, 1995, # 194; Having regard to the Commission's implementing regulation of April 22, 2013 369/2013 approving the active substance potassium phosphonate under Regulation (EC) no 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and amending the annex to Regulation (EU) No 540/2011; Considering also that the reference product must be re-evaluated in light of a file appropriate to the prescription laid down in Regulation (EU) no 545/2011 the Commission with the data is not present at the time of temporary registration of plant protection products on the market, which took place in accordance with art. 80 of Regulation (EC) No 1107/2009, as well as to the data indicated in column ' specific provisions ' in annex to the rules of the approval of the active substance; Considered to limit the validity of the authorization to the September 30, 2023, assigned to the reference product expiration date; 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 ';

Decreta: from the date of this Decree and until September 30, 2023, the enterprise Luxembourg Pamol (Cyprous) Ltd, with registered office at 3, Demetiou Vikella, Nicosia 1061-Cyprus, it is authorized to enter the plant protection product on the market called "Century SL» with the composition and conditions indicated on the label attached to this Decree. It is without prejudice to any subsequent fulfilment and adapting the conditions for authorisation of the plant protection product, in conformity to Community measures and other conditions relating to those active substances components. The product is packaged in sizes from ml: 10-20-50-100-250-500; L 1-2-4-6-8. The product is prepared at the establishments of Foreign Enterprise: Luxembourg Industries Ltd. 27 Hamered Street-Tel-Aviv, Israel. The above mentioned product is recorded at no 16161. It is approved as an integral part of this Decree the attached label with which the product is to be marketed. This Decree will be published in the official journal of the Italian Republic and communicated to the undertaking concerned.
Rome, December 9, 2014 General Manager: Rajput