21.7.2015   

EN

Official Journal of the European Union

L 193/122

(1)

In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 26 April 2013 an application from the Institut Technique de l`Agriculture Biologique (ITAB) for the approval of Artemisia vulgaris L. as 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 (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 25 August 2014 (2). The Commission presented the review report (3) and the draft of this Regulation on the non-approval of Artemisia vulgaris L. to the Standing Committee on Plants, Animals, Food and Feed on 27 January 2015.

(3)

The documentation provided by the applicant shows that Artemisia vulgaris L. 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 (4). However, alcoholic beverages from Artemisia species are included in Part B of Annex III to Regulation (EC) No 1334/2008 of the European Parliament and of the Council (5), which sets maximum levels of certain substances, naturally present in flavourings and food ingredients with flavouring properties, in certain compound food as consumed to which flavourings and/or food ingredients with flavouring properties have been added. According to Article 6 of Regulation (EC) No 1334/2008, in the compound foods listed in that Part B, the maximum levels are not to be exceeded as a result of the use of flavourings and/or food ingredients with flavouring properties. The Artemisia species can therefore not be used as a foodstuff without qualification.

(4)

Specific concerns were identified in the Technical Report of the Authority regarding exposure to thujone, eucalyptol and camphor and the risk to operators, workers, bystanders, consumers and non-target organisms.

(5)

The Commission invited the applicant to submit its comments on the Technical Report of the Authority and on the draft review report. The applicant submitted its comments, which have been carefully examined.

(6)

However, despite the arguments put forward by the applicant, the concerns related to the substance cannot be eliminated.

(7)

Consequently, it has not been established, in the Commission review report, that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve Artemisia vulgaris L. as basic substance.

(8)

This Regulation does not prejudice the submission of a further application for the approval of Artemisia vulgaris L. as basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,