(Utkast) Kommisjonens gjennomføringsforordning om avslag på godkjenning av paprikaekstrakt (capsantin, capsorubin E 160 c) som basisstoff i samsvar med europaparlaments- og rådsforordning (EF) nr. 1107/2009 om markedsføring av plantevernmidler
(Draft) Commission Implementing Regulation concerning the non-approval of paprika extract (capsanthin, capsorubin E 160 c) 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
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 12.10.2017
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(1) In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 19 June 2015 an application from Group Peyraud Nature for the approval of Capsicum spice as a basic substance. That application was accompanied by the information required under the second subparagraph of Article 23(3).
(2) The Commission asked the European Food Safety Authority ('the Authority') for scientific assistance. The Authority provided the Commission with a Technical Report on the substance concerned on 10 October 2016 . The Commission presented the review report and the draft of this Regulation on the non-approval of paprika extract (capsanthin, capsorubin E 160 c) to the Standing Committee on Plants, Animals, Food and Feed on 24 January 2017 and finalised them for the meeting of that Committee on 6 October 2017.
(3) During the consultation organised by the Authority, the applicant agreed to modify the basic substance name to paprika extract (capsanthin, capsorubin E 160 c).
(4) The documentation provided by the applicant shows that paprika extract (capsanthin, capsorubin E 160 c) fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council and is not predominantly used for plant protection pruposes.
(5) Specific concerns were identified, in the Technical Report of the Authority, regarding exposure to its component capsaicin and the non-availability of exposure estimates for paprika extract (capsanthin, capsorubin E 160 c), specifically through pesticide use and, as a result, the assessment of the risk to operators, workers, bystanders and non-target organisms could not be finalised.
(6) The Commission invited the applicant to submit its comments on the draft review report. The applicant submitted its comments, which have been carefully examined.
(7) However, despite the arguments put forward by the applicant, the concerns related to the substance cannot be eliminated.
(8) Consequently, as laid down in the Commission review report, it has not been established that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve paprika extract (capsanthin, capsorubin E 160 c) as a basic substance.
(9) This Regulation does not prejudice the submission of a further application for the approval of paprika extract (capsanthin, capsorubin E 160 c) as a basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Landbruks- og matdepartementet