(fra kommisjonsforordningen)

(1)    Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods 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  has established a Union list of novel foods.
(3)    On 16 March 2019, the company Nutri’Earth (‘the applicant’) submitted an application to the Commission for an authorisation in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place UV-treated powder of whole Tenebrio molitor larvae (yellow mealworm) on the Union market as a novel food. The applicant requested for UV-treated powder obtained from whole Tenebrio molitor larvae to be used in bread and rolls, cakes, pasta-based products, processed potato products, cheese and cheese products and fruit and vegetable compotes, intended for the general population. 
(4)    On 16 March 2019, the applicant also made a request to the Commission for the protection of proprietary scientific studies and data submitted in support of the application, namely, a detailed description of the production process  and the detailed results of the composition analyses .
(5)    On 17 May 2022, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of UV-treated powder of whole Tenebrio molitor larvae as a novel food.
(6)    On 28 March 2023, the Authority adopted its scientific opinion on the ‘Safety of UV-treated powder of whole yellow mealworm (Tenebrio molitor larvae) as a novel food pursuant to Regulation (EU) 2015/2283’  in accordance with Article 11 of Regulation (EU) 2015/2283.
(7)    In its scientific opinion, the Authority concluded that UV-treated powder of whole Tenebrio molitor larvae is safe under the proposed conditions of use and at the proposed use levels. Therefore, that scientific opinion gives sufficient grounds to establish that UV-treated powder of whole Tenebrio molitor larvae, when used in bread and rolls, cakes, pasta-based products, processed potato products, cheese and cheese products and fruit and vegetable compotes, intended for the general population, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.
(8)    In that opinion, the Authority also noted that although the UV treatment of the powder obtained from whole Tenebrio molitor larvae enhances its vitamin D3 content, the novel food is not a significant dietary contributor of vitamin D3. Nevertheless, taking into consideration that foods containing the novel food may end up containing an amount of vitamin D that is considered significant under Point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011 of the European Parliament and of the Council , the Commission considers that it is appropriate to inform consumers about that fact. In such cases the designation of the novel food shall be accompanied by the statement ‘contains vitamin D produced by UV-treatment’ and the nutrition declaration shall contain the amount of vitamin D.
(9)    On the basis of limited published evidence of food allergies linked to the consumption of Tenebrio molitor larvae and evidence demonstrating that members of the phylum Arthropoda to which Tenebrio molitor belongs, contain a number of potentially allergenic proteins, the Authority concluded in its opinion that consumption of the novel food may also trigger sensitisation to Tenebrio molitor larvae proteins. The Authority therefore recommended to carry out further research on the allergenicity of Tenebrio molitor larvae. 
(10)    In order 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. Until the data of that research is assessed by the Authority, and considering that, to date, evidence directly linking the consumption of Tenebrio molitor larvae to cases of primary sensitisation and allergies is limited, the Commission considers that no specific labelling requirements concerning the potential  of UV-treated powder obtained from whole Tenebrio molitor larvae to cause primary sensitization should be included in the conditions of use of the novel food.
(11)    The Authority also considered in its opinion that the consumption of UV-treated powder obtained from whole Tenebrio molitor larvae may cause allergic reactions in persons that are allergic to crustaceans and dust mites. Furthermore, the Authority noted that additional allergens might end up in the novel food, if those allergens are present in the substrate fed to insects. Therefore, it is appropriate that foods containing UV-treated powder obtained from whole Tenebrio molitor larvae are appropriately labelled in accordance with Article 9 of Regulation (EU) 2015/2283.
(12)    In its scientific opinion, the Authority also noted that its conclusion on the safety of the UV-treated powder obtained from whole Tenebrio molitor larvae was based on the scientific studies and data on the detailed description of the production process and the detailed results of the composition analyses, without which it could not have assessed the novel food and reached its conclusion. 
(13)    The Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over those scientific studies and data, and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2), point (b), of Regulation (EU) 2015/2283.
(14)    The applicant declared that they held proprietary and exclusive rights of reference to the scientific studies and data on the detailed description of the production process and the detailed results of the composition analyses, under national law at the time they submitted the application and that third parties cannot lawfully access, use or refer to those data and studies.
(15)    The Commission assessed all the information provided by the applicant and considered that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the scientific studies and data on the detailed description of the production process and the detailed results of the composition analyses should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place UV-treated powder obtained from whole Tenebrio molitor larvae on the market within the Union during a period of five years from the entry into force of this Regulation.
(16)    However, restricting the authorisation of UV-treated powder obtained from whole Tenebrio molitor larvae and the reference to the scientific studies and data contained in the applicant’s file for the sole use by them does not prevent subsequent 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 an authorisation.
(17)    UV-treated powder obtained from whole Tenebrio molitor larvae should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly. 
(18)    The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,