BAKGRUNN (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 20 November 2020, the company Evergrain LLC (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) on the Union market as a novel food. The applicant requested for partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) to be used in a number of foods intended for the general population.
 

(4)    On 20 November 2020, the applicant also made a request to the Commission for the protection of proprietary data, namely, report on the protein quality of the novel food , information on the inactivation of the enzyme in the novel food , information on the absence of toxigenic potential in the enzyme preparation , information on the absence of mycotoxins and other secondary metabolites produced by Aspergillus niger in the enzyme preparation , compositional data (certificates of analyses of the novel food batches)  and the stability study report .
 

(5)    On 10 June 2021, the Commission requested the European Food Safety Authority (ʽthe Authorityʼ) to carry out an assessment of partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) as a novel food.
 

(6)    On 24 May 2023, the Authority adopted its scientific opinion on the ‘Safety of partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) 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 the novel food, partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa), is safe under the proposed conditions of use. Therefore, that scientific opinion gives sufficient grounds to establish that partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa), when used under the proposed conditions of use fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.  
 

(8)    In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the report on the protein quality of the novel food, information on the inactivation of the enzyme in the novel food, information on the absence of mycotoxins and other secondary metabolites produced by Aspergillus niger in the enzyme preparation, compositional data (certificates of analyses of the novel food batches) and the stability study report without which it could not have assessed the novel food and reached its conclusion.
 

(9)    The Commission requested the applicant to further clarify the justification provided with regard to its proprietary claim over those data and studies 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.
 

(10)    The applicant declared that it held proprietary and exclusive rights of reference to the report on the protein quality of the novel food, information on the inactivation of the enzyme in the novel food, information on the absence of mycotoxins and other secondary metabolites produced by Aspergillus niger in the enzyme preparation, compositional data (certificates of analyses of the novel food batches) and the stability study report, at the time it submitted the application, and that third parties cannot lawfully access, use or refer to those data. 
 

(11)    The Commission assessed all the information provided by the applicant and considered that it has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the report on the protein quality of the novel food, information on the inactivation of the enzyme in the novel food, information on the absence of mycotoxins and other secondary metabolites produced by Aspergillus niger in the enzyme preparation, compositional data (certificates of analyses of the novel food batches) and the stability study report should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) on the market within the Union during a period of five years from the entry into force of this Regulation.
 

(12)    However, restricting the authorisation of partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) and the reference to the data contained in the applicant’s file for its sole use 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.
 

(13)    As the source of the novel food comes from barley (Hordeum vulgare), which is listed in Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council  as one of a number of substances or products which may cause allergies or intolerances, foods containing the novel food should be appropriately labelled following the requirements laid down in Article 21 of that Regulation.
 

(14)    It is appropriate that the inclusion of partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283. 
 

(15)    Partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) 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.
 

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