![]() ![]() No 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. Furthermore, there was not sufficient information available regarding environmental exposure and the risks to non-target organisms. did not allow the Authority to finalise a non-dietary exposure risk assessment and the assessment of the risk to consumers. Moreover, the available information on the fermented extract from leaves of Symphytum officinale L. is not to be considered as a substance of concern as provided for by Article 23(1)(a) of Regulation (EC) No 1107/2009. Consequently, it was not possible to conclude that the fermented extract from leaves of Symphytum officinale L. The Authority also indicated that comfrey is known to contain genotoxic and carcinogenic components, and information on the concentration of genotoxic and carcinogenic compounds in the fermented extract from leaves of Symphytum officinale L. The Authority concluded that the specification of the fermented extract from leaves of Symphytum officinale L. (comfrey) was insufficient to demonstrate that it 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 ( 3). The information provided by the applicant on the fermented extract from leaves of Symphytum officinale L. Based on that technical report and the documentation provided by the applicant, it is appropriate to define the scope of the application as covering the active substance ‘fermented extract from leaves of Symphytum officinale L. The Authority provided the Commission with a technical report on ‘comfrey steeping’ on 28 November 2019 ( 2). The Commission asked the European Food Safety Authority (‘the Authority’) for scientific assistance. That application was accompanied by the information required under the second subparagraph of Article 23(3) of Regulation (EC) No 1107/2009. On 22 January 2015, the Commission received an application from the company Greenprotech for the approval of ‘comfrey steeping’ as a basic substance to be used as an insect repellent and plant elicitor in fruit trees, grass and vegetables. Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) in conjunction with Article 23(5) thereof, Having regard to the Treaty on the Functioning of the European Union, (comfrey) 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 COMMISSION IMPLEMENTING REGULATION (EU) 2021/809Ĭoncerning the non-approval of fermented extract from leaves of Symphytum officinale L.
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