On 9 October 2015, the Commission received an application from the Crop Research Institute (Czech Republic) for the approval of Saponaria officinalis L. roots as a basic substance. That application was accompanied by the information required under the second subparagraph of Article 23(3) of Regulation (EC) No 1107/2009.

The Commission asked the European Food Safety Authority (‘the Authority’) for scientific assistance. The Authority provided the Commission with a technical report on Saponaria officinalis L. roots on 19 June 20172. The Commission presented the review report3 and a draft Regulation on the non-approval of Saponaria officinalis L. roots to the Standing Committee on Plants, Animals, Food and Feed on 6 December 2017.

The documentation provided by the applicant shows that Saponaria officinalis L. roots fulfils the criteria of a foodstuff, as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council4, being used as a traditional emulsifier.

However, the technical report of the Authority identified specific concerns regarding the presence of substances of concern ( e.g. triterpenoid saponins, saporin) in extracts of Saponaria officinalis L. roots when used for plant protection purposes. Insufficient information was available to establish a safe level of intake for consumers and the consumer risk assessment could not be completed for the uses of Saponaria officinalis L. roots in cucumber, tomato and hops. Furthermore, there was insufficient information to reach a conclusion regarding the risk to non-target organisms.

No other, relevant evaluation, carried out in accordance with other Union legislation as referred to in Article 23(2) of Regulation (EC) No 1107/2009, was available.

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.

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 Saponaria officinalis L. roots as a basic substance.

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

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