(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

(3)

On 13 February 2018, the company SAS EAP Group (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place dried Tenebrio molitor larva (yellow mealworm) on the Union market as a novel food. The application requested for dried Tenebrio molitor larva to be used as whole, dried insect in the form of snacks, and as a food ingredient in a number of food products, the target population being the general population. The applicant also made a request to the Commission for the protection of proprietary data submitted in the application.

(4)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 3 July 2018, asking it to provide a scientific opinion by carrying out an assessment for dried Tenebrio molitor larva as a novel food.

(5)

On 24 November 2020, the Authority adopted a scientific opinion on the safety of Tenebrio molitor larva as a novel food (3), in accordance with Article 11 of Regulation (EU) 2015/2283.

(6)

In its opinion, the Authority concluded that dried Tenebrio molitor larva is safe under the proposed uses and use levels. Therefore, the opinion of the Authority gives sufficient grounds to establish that dried Tenebrio molitor larva under the assessed conditions of use complies with Article 12(1) of Regulation (EU) 2015/2283.

(7)

In that opinion, the Authority also concluded on the basis of limited published evidence on food allergy related to insects and in particular from two studies in humans where a total of four suspect allergic reactions were attributed to dried Tenebrio molitor larva and one study in animals, that consumption of this novel food may trigger sensitisation to yellow mealworm proteins as well as to tropomyosin from other sources such as crustaceans and mites. The Authority recommended carrying out further research on the allergenicity of dried Tenebrio molitor larva. To address the Authority’s recommendation the Commission is currently exploring the ways to carry out the necessary research on the allergenicity of Tenebrio molitor larvae.

(8)

Until the data generated by the research is assessed by the Authority, and considering that, to date, only the abovementioned few allergic cases have been reported according to data available to the insect industry of dried Tenebrio molitor larva (4), the Commission considers that no specific labelling requirements concerning the potential of dried Tenebrio molitor larva to cause primary sensitization should be included in the Union list of authorised novel foods.

(9)

The Authority in its opinion also considered that the consumption of dried Tenebrio molitor larva may cause allergic reactions to persons that are allergic to crustaceans and dust mites. Furthermore, the Authority noted that additional allergens may end up in the novel food, if these allergens are present in the substrate fed to the insects. This may include allergens, listed in the Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council (5). Therefore, it is appropriate that dried Tenebrio molitor larva made available to the consumer as such and foods containing dried Tenebrio molitor larva are appropriately labelled following the requirements in accordance with Article 9 of Regulation (EU) 2015/2283 and Regulation (EU) No 1169/2011.

(10)

In its opinion, the Authority noted that its conclusion on the safety of the novel food was based on analyses of contaminants in the novel food (6), a detailed description of the drying process (7), analytical data on chitin levels (8), and data on the oxidative and microbiological status of the novel food during storage (9). It also noted that it could not have reached that conclusion without the data from the unpublished reports of the studies contained in the applicant’s file.

(11)

The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those studies and to clarify their claim to an exclusive right of reference to those studies, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

(12)

The applicant declared that they held proprietary and exclusive right of reference to analyses of contaminants in the novel food, the detailed description of the drying process, the analytical data on chitin levels, and the data on the oxidative and microbiological status of the novel food during storage, at the time they submitted the application and that therefore third parties cannot lawfully access, use or refer to those studies.

(13)

The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the specific studies on analyses of contaminants in the novel food, the detailed description of the drying process, the analytical data on chitin levels, and the data on the oxidative and microbiological status of the novel food during storage, contained in the applicant’s file, on which the Authority based its conclusion on the safety of the novel food and without which it could not have assessed the novel food, should not be used for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, only the applicant should be authorised to place dried Tenebrio molitor larva on the market within the Union during that period.

(14)

However, restricting the authorisation of dried Tenebrio molitor larva and the reference to the studies contained in the applicant’s file for the sole use of the applicant does not prevent other applicants from applying for an authorisation to place on the market the same novel food, provided that their application is based on legally obtained information supporting such authorisation.

(15)

The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(16)

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