Authorisation Of The Plant Protection Product ' Etravon Pro».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-23&atto.codiceRedazionale=15A01111&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 in particular art. 80, paragraph 5 and 6 on "transitional measures"; Visto l'art. 58, Regulation (EC) no 1107/2009, concerning the placing on the market and use of adjuvants; Visto l'art. 81, paragraph 3 of Regulation (EC) No 1107/2009 derogating from the provisions of art. 58, paragraph 1; 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, regarding "Division of powers" and art. 119, regarding "authorizations"; Having regard to law no 172 on November 13, 2009 "establishment 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, no. 44 concerning "regulation on the reorganization of collective bodies and other bodies active in the Ministry of health, in accordance with art. 2, paragraph 4, of law November 4, 2010, # 183 "; 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, regarding "the Directorate-General 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, regarding "regulation for the simplification of the procedures for authorising the production, placing on the market and sales of plant protection products and related processing", as amended; Having regard to the Legislative Decree March 14, 2003, n. 65, on "implementation of directives 1999/45/EC and 2001/60/EC relating to the classification, packaging and labelling of dangerous preparations, and its subsequent amendments; Having regard to the Legislative Decree of August 14, 2012, n. 150 on "implementing directive 2009/128/EC establishing a framework for Community action to achieve a sustainable use of pesticides; Having regard to the Ministerial Decree January 22, 2014 on "Adoption of the national action plan for the sustainable use of plant protection products on the market, in accordance with art. 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 on October 15, 2014, by the company Cheminova Agro Italy Srl, with registered office in Bergamo, via F.lli Bronzetti, 32/28, intended to obtain the authorisation of the additive called Etravon Pro, containing the active substance alchiletere sulfate, sodium salt of auxiliary material product equal to the reference product called Wetting Plus, recorded at # 2191 with D.D. on April 12, 1976 , and edited successively by decrees whose last on October 22, 2013, on behalf of the company Scam SpA; Noted that technical and administrative verification of the Office has confirmed the existence of the requirements for the application of art. 16 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 Wetting Plus, recorded at # 2191;
exist legitimate agreement between the company Cheminova Agro Italy Srl and the undertaking which owns the reference product; Detected so it's not requested the opinion of the Advisory Committee on pesticides, under art. Legislative Decree 20 March 17, 1995, # 194; Considered to limit the validity of the authorization to the December 31, 2015, expiration date assigned to the reference product, without prejudice to the obligations and adjustments made to the procedure for renewal of registration of the reference product that will be conducted on the basis of National Guideline, and at any other Community provisions relating to the active substance adjuvant component for the product in question; 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 December 31, 2015, the company Cheminova Agro Italy Srl, with registered office in Bergamo, via F.lli Bronzetti, 32/28, are authorized to place on the market the adjuvant called ETRAVON PRO, with the composition and conditions indicated on the label attached to this Decree. It is done also save any fulfillment and adapting the conditions for authorisation of the plant protection product, in conformity to Community measures and additional provisions concerning the adjuvant component. The product is packaged in sizes 0.5 L-1-5-10-20. The product is prepared at commercial establishments: Scam Srl-Modena;
Althaller Italy Srl-s. Colombano al Lambro (MI). The above mentioned product is recorded at # 16194. The label attached to this Decree, by which the plant protection product must be placed on the market, it is equivalent to that proposed by the undertaking which owns the reference product, suitable for grading the conditions laid down in reg. 1272/2008, according to the press release of the Ministry of health of January 14, 2014. This Decree will be published in the official journal of the Italian Republic and communicated to the undertaking concerned. The abovementioned product data are available in the "database" of the area dedicated to plant protection products of the portal http://www.salute.gov.it/Rome, December 9, 2014 General Manager: Rajput