Godkjenning av delvis avfettet pulver av hussiriss (Acheta domesticus) som ny mat

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Kommisjonens gjennomføringsforordning (EU) 2023/5 av 3. januar 2023 om tillatelse til å bringe delvis avfettet pulver av Acheta domesticus i omsetning som et nytt næringsmiddel, og om endring av Kommisjonens gjennomføringsforordning (EU) 2017/2470

Commission Implementing Regulation (EU) 2023/5 of 3 January 2023 authorising the placing on the market of Acheta domesticus (house cricket) partially defatted powder as a novel food and amending Implementing Regulation (EU) 2017/2470

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Kommisjonsforordning publisert i EU-tidende 4.1.2023

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BAKGRUNN (fra kommisjonsforordningen)

(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 has established a Union list of authorised novel foods.

(3) On 24 July 2019, the company Cricket One Co. Ltd (‘the applicant’) submitted an application to the Commission for an authorisation in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place Acheta domesticus (house cricket) partially defatted powder on the Union market as a novel food. The application requested for partially defatted powder obtained from whole Acheta domesticus (house cricket) to be used in multigrain bread and rolls, crackers and breadsticks, cereal bars, dry pre-mixes for baked products, biscuits, dry stuffed and non-stuffed pasta-based products, sauces, processed potato products, legume- and vegetable- based dishes, pizza, pasta-based products, whey powder, meat analogues, soups and soup concentrates or powders, maize flour-based snacks, beer-like beverages, chocolate confectionary, nuts and oilseeds, snacks other than chips, and meat preparations, intended for the general population.

(4) On 24 July 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; results of proximate analyses; analytical data on contaminants; results of the stability studies; analytical data on microbiological parameters; and, results of the protein digestibility studies.

(5) On 8 July 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of Acheta domesticus (house cricket) partially defatted powder as a novel food.

(6) On 23 March 2022, the Authority adopted its scientific opinion on the ‘Safety of partially defatted whole Acheta domesticus (house cricket) powder 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 Acheta domesticus (house cricket) partially defatted powder is safe under the proposed conditions of use and use levels. Therefore, that scientific opinion gives sufficient grounds to establish that Acheta domesticus (house cricket) partially defatted powder when used in multigrain bread and rolls, crackers and breadsticks, cereal bars, dry pre-mixes for baked products, biscuits, dry stuffed and non-stuffed pasta-based products, sauces, processed potato products, legume- and vegetable- based dishes, pizza, pasta-based products, whey powder, meat analogues, soups and soup concentrates or powders, maize flour-based snacks, beer-like beverages, chocolate confectionary, nuts and oilseeds, snacks other than chips, and meat preparations, 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) On the basis of limited published evidence on food allergy related to insects in general, which equivocally linked the consumption of Acheta domesticus to a number of anaphylaxis events and, on the basis of evidence demonstrating that Acheta domesticus contains a number of potentially allergenic proteins, the Authority concluded in the opinion that consumption of this novel food may trigger sensitisation to Acheta domesticus proteins. The Authority recommended carrying out further research on the allergenicity of Acheta domesticus.

(9) 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 Acheta domesticus. Until the data generated by the research is assessed by the Authority, and considering that, to date, evidence directly linking the consumption of Acheta domesticus to cases of primary sensitisation and allergies is inconclusive, the Commission considers that no specific labelling requirements concerning the potential of Acheta domesticus to cause primary sensitization should be included in the Union list of authorised novel foods.

(10) The Authority also considered in its opinion that the consumption of Acheta domesticus (house cricket) partially defatted powder may cause allergic reactions in persons that are allergic to crustaceans, molluscs and dust mites. Furthermore, the Authority noted that additional allergens may end up in the novel food, if those allergens are present in the substrate fed to insects. Therefore, it is appropriate that foods containing Acheta domesticus (house cricket) partially defatted powder are appropriately labelled in accordance with Article 9 of Regulation (EU) 2015/2283.

(11) In its scientific opinion, the Authority also noted that its conclusion on the safety of the Acheta domesticus (house cricket) partially defatted powder was based on the scientific studies and data on the detailed description of the production process; the results of proximate analyses; the analytical data on contaminants; the results of the stability studies; the analytical data on microbiological parameters; and, the results of the protein digestibility studies, without which it could not have assessed the novel food and reached its conclusion.

(12) 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)(b) of Regulation (EU) 2015/2283.

(13) 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; the results of proximate analyses; the analytical data on contaminants; the results of the stability studies; the analytical data on microbiological parameters; and, the results of the protein digestibility studies, 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.

(14) 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; the results of proximate analyses;, the analytical data on contaminants; the results of the stability studies; the analytical data on microbiological parameters; and, the results of the protein digestibility studies, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place Acheta domesticus (house cricket) partially defatted powder on the market within the Union during a period of 5 years from the entry into force of this Regulation.

(15) However, restricting the authorisation of Acheta domesticus (house cricket) partially defatted powder 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.

(16) Acheta domesticus (house cricket) partially defatted powder 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.

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

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03.01.2023
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