(1)

In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 18 May 2015 an application from Ets Christian Callegari for the approval of clayed charcoal as a basic substance. That application was accompanied by the information required by 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 6 July 2016 (2). The Commission presented the review report (3) and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 7 October 2016 and finalised them for the meeting of that Committee on 24 January 2017.

(3)

The documentation provided by the applicant shows that clayed charcoal does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects, nor is it a substance of concern. Moreover, it is not placed on the market as a plant protection product, nor is it predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water. Consequently, it is to be considered as a basic substance. Clayed charcoal is a mixture of charcoal, as defined in Commission Regulation (EU) No 231/2012 (4), and bentonite, as specified in Commission Implementing Regulation (EU) No 1060/2013 (5), in the form of granules.

(4)

It has appeared from the examinations made that clayed charcoal may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve clayed charcoal as a basic substance.

(5)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions for the approval which are detailed in Annex I to this Regulation.

(6)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (6) should be amended accordingly.

(7)

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