Revoking Marketing Authorisations Of Prodottifitosanitari Containing The Active Substance Amisulbrom Approved Conregolamento (Eu) 193/2014 In Accordance With Regulation (Ec) No 1107/2009, Why You Don't Have On Presentation ...

Original Language Title: Revoca delle autorizzazioni all'immissione in commercio dei prodottifitosanitari contenenti la sostanza attiva amisulbrom approvata conregolamento (UE) n. 193/2014 in conformita' al regolamento (CE) n.1107/2009, perche' non supportate dalla presentazio...

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-20&atto.codiceRedazionale=15A02914&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

The GENERAL MANAGER for hygiene and food safety and nutrition having regard to act November 13, 2009 # 172 on "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 Council of Ministers in February 11, 2014, # 59 on "organisational regulations of the Ministry of health", and in particular art. 19 on "transitional and final provisions"; Having regard to law No 283, April 30, 1962 concerning "editing articles 242, 243, 247, 250 and 262 of the consolidated text of the health laws, approved by Royal Decree July 27, 1934, n. 1265: hygienic Discipline of production and sale of foodstuffs and beverages ", as amended, and in particular article 6; 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", August 6, 2008, converted with amendments by law No. 133, as amended, and in particular articles 115 containing "Division of powers" and article 119 on "Permissions"; 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 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 article 2, paragraph 4, of law November 4, 2010, # 183"; Having regard to the Decree of the President of the Republic April 23, 2001, # 290 on "regulation for the simplification of procedures for authorization for the production, marketing and sale of pesticides and related adjuvants", 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 review; 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 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 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 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, as amended; Given that the press release of October 2, 2011, published in the Official Gazette No. 246 of October 21, 2011, informed that with the entry into force of Regulation (EC) no 1107/2009 active substances were approved by means of regulations published in the official journal of the European Union; Considering that it was attached to the above statement a summary table update object accessible on the website of this Ministry to the address www.salute.gov.it, in order to ensure maximum disclosure of those Community regulations approval or non-approval of active substances, specifying the modalities and time-limits within which enterprises must submit the necessary documents to reviewing plant protection products; Considered the press release of March 2, 2015 that changed the method of disposal of stocks stipulated by circular of September 7, 2010; Having regard to Council Regulation (EU) No. 193/2014 of the Committee which approved the active substance amisulbrom in conformity with Regulation (EC) No 1107/2009 and amended the annex to Regulation (EU) No 540/2011 to include the active substance itself; Considered that, on the basis of the indications given in the above table, the marketing authorisation holders had to submit, within the time shown on the above table, a dossier satisfying the requirements of Regulation (EU) No. 545/2011 and "part B" of the specific provisions of the annex to Regulation (EU) No. 193/2014, for adaptation in the light of the uniform principles laid down in article 29, paragraph 6, of Regulation (EC) No 1107/2009; Considering that the holders of the authorisations of plant protection products, as an alternative to the presentation of the dossier, may prove to be able to still access via a letter of access to the file of the notifier for the purposes of Community approval of the active substance master amisulbrom; Given that the outcome of the necessary administrative checks it turns out that for holders of marketing authorisations and use of plant protection products set out in the annex to this decree did not submit a dossier satisfying the requirements of the Regulation (EU) no 545/2011; Deemed it necessary to proceed to revoke permissions to the entries on the market and use of plant protection products set out in the annex to this Decree, containing the active substance amisulbrom;

Decrees: The authorisation and use of plant protection products containing the active substance shall be revoked with effect from 1 St April amisulbrom 2015. The withdrawal of these products set out in the annex is due to failure to submit a dossier satisfying the requirements of the Regulation (EU) no 545/2011 as indicated in the summary report, available on the website of this Ministry to the address www.salute.gov.it marketing and sales, the quantities produced up to the date of withdrawal is allowed for 6 months from the date of withdrawal therefore until September 30, 2015, while 6 months allowed for further usage and therefore until March 31, 2016. The holders of the authorisations of plant protection products set out in annex of this Decree are required to take every initiative to inform retailers and users of plant protection products on the same successful withdrawal and respect for deadlines for the disposal of its inventory. This Decree will be published in the official journal of the Italian Republic and notified administratively to the undertakings concerned.
Roma, March 30, 2015 Director General: Rajput