Commission Implementing Regulation (EU) 2015/2082 of 18 November 2015 concerning the non-approval of Arctium lappa L. (aerial parts) as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)

What Commission Implementing Regulation (EU) 2015/2082 of 18 November 2015 concerning the non-approval of Arctium lappa L. (aerial parts) as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance) requires

Commission Implementing Regulation (EU) 2015/2082, adopted at Brussels on 18 November 2015 and published in the Official Journal of the European Union on 19 November 2015, establishes the non-approval of Arctium lappa L. (aerial parts) as a basic substance under Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. The Regulation is binding in its entirety and directly applicable in all Member States, entering into force on the twentieth day following its publication in the Official Journal. The non-approval follows an application submitted on 3 June 2014 by the Institut Technique de l'Agriculture Biologique (ITAB), which sought approval of Arctium lappa L. as a basic substance. The European Food Safety Authority (EFSA) provided a Technical Report on 27 November 2014, identifying specific concerns regarding exposure to arctigenin, chlorogenic and caffeic acids, as a result of which the assessment of the risk to operators, workers, bystanders, consumers and non-target organisms could not be finalised. Furthermore, the documentation provided by the applicant showed that not all aerial parts of Arctium lappa L. fulfil the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002. Despite the applicant's comments being carefully examined, the concerns related to the substance could not be eliminated, and it was therefore determined that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are not satisfied. The Regulation does not prejudice the submission of a further application for approval in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

Pillar: Legal & IP Sovereignty · Authority: European Commission · Version: 1.0.0 · Last updated: 2015-11-19

Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32015R2082

SHA-256 integrity: 114656c2d091facb16c9b8e1a53bdfe38cfaca8f5dd9ecf96184f17bbe6f445c

Primary Citations — 9 traced to source

• Article 1 (Non-approval as basic substance): 'The substance Arctium lappa L. (aerial parts) is not approved as basic substance.'
• Article 2 (Entry into force): 'This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.'

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