(1)

On 15 November 2021, the Commission received an application from Concept Nature Bio (‘the applicant’) for the approval of Capsicum oleoresin as a basic substance to be used in plant protection as a mammal repellent for uses applied to seeds of wheat, maize, pea and sunflower and to crops of maize, oilseed rape, cabbage, sunflower, sugar beet, wheat and grassland via foliar spray.

(2)

On 31 March 2023, the Commission received a revised version of the application solving some requested modifications and clarifications in Section 2 ‘Identity of the substance’, Section 3 ‘Uses of the substance for plant protection’, Section 4 ‘Classification of the substance and notification of studies’.

(3)

On 11 August 2023, the Commission confirmed the validity of the application for further evaluation.

(4)

The Commission asked the European Food Safety Authority (‘the Authority’) for scientific assistance pursuant to Article 23(4) of Regulation (EC) No 1107/2009. The Authority provided the Commission with a technical report on Capsicum oleoresin on 7 August 2025 (2).

(5)

Capsicum oleoresin is available on the Union market for use as food additive (E160c), feed additive (4d11) and as riot control substance. Several relevant evaluations, carried out in accordance with other Union legislation, as referred to in Article 23(2) of Regulation (EC) No 1107/2009, were available when the Authority provided its scientific assistance (3). The Authority and the Commission have both taken the outcome of those evaluations into account.

(6)

With regard to the identity of the substance, the Authority stated that the composition of the substance is not clear and the maximum content of capsaicinoids is not specified. Moreover, when Capsicum oleoresin is used as a food additive, one of its components, capsaicin, is only allowed in concentrations of less than 250 mg/kg (< 0,025 %) in accordance with Commission Regulation (EU) No 231/2012 (4). When Capsicum oleoresin is used as food flavouring, capsaicin is not to be added as such to food, in accordance with Article 6(1) of Regulation (EC) No 1334/2008 of the European Parliament and of the Council (5).

(7)

With regard to human health, the Authority found, based on the Opinion of the Scientific Committee on Food concerning capsaicin (6), that capsaicinoids are known to be genotoxic in vivo and in vitro and adverse health effects are known to occur following their oral intake by humans. Therefore, in May 2025, the Commission mandated the Authority to issue a scientific opinion on the health risks related to the presence of capsaicin in foods (7). Furthermore, the Authority identified a data gap as regards genotoxicity assessment and could not finalise the non-dietary risk assessment, nor the consumer risk assessment because the respective toxicological reference values were not available. Consequently, the Commission concludes that it is not possible to demonstrate the fulfilment of the condition set out in Article 23(1), points (a) and (b), of Regulation (EC) No 1107/2009, that an active substance is not a substance of concern, and that it does not have an inherent capacity to cause endocrine-disrupting, neurotoxic or immunotoxic effects.

(8)

With regard to the intended uses, the Authority noted uncertainties in the application rates and the conditions of use. The Authority concluded that an exact recipe for preparation and final dilutions required for application of the substance was lacking.

(9)

Additionally, the Authority highlighted that there was insufficient toxicity data for terrestrial vertebrates, aquatic invertebrates, algae, macrophytes, non-target terrestrial plants, honey bees and non-target arthropods other than bees, and insufficient information to finalise the exposure assessment for non-target organisms.

(10)

The Commission presented its review report and a draft of this Implementing Regulation to the Standing Committee on Plants, Animals, Food and Feed on 10 December 2025 and 11 March 2026, respectively.

(11)

The Commission invited the applicant to submit its comments on the technical report of the Authority and on the Commission’s review report. The applicant submitted its comments, which have been carefully examined.

(12)

However, despite the arguments put forward by the applicant, the concerns related to the risk to consumers, operators, workers, bystanders and residents and with regard to the protection of the environment could not be eliminated.

(13)

By email of 30 April 2026, Concept Nature Bio withdrew its application for the approval of Capsicum oleoresin as basic substance. Due to the withdrawal of the application, Capsicum oleoresin should not be approved pursuant to Article 23 of Regulation (EC) No 1107/2009.

(14)

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

(15)

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