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)    The novel food isomalto-oligosaccharide was authorised under certain conditions of use by the UK competent authority .
(4)    The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 therefore includes isomalto-oligosaccharide as an authorised novel food.
(5)    On 26 March 2021, the company BioNeutra North America Inc. (‘the applicant’) submitted an application for the existing conditions of use, for extension of the conditions of use and new specifications for the novel food isomalto-oligosaccharide in accordance with Article 10(1) of Regulation (EU) 2015/2283. In addition to the existing authorised conditions of use the applicant requested for isomalto-oligosaccharide to be used in ice cream and other dairy desserts, instant coffee and tea, table-top sweeteners, cakes, muffins and pies, pastries, breakfast cereals, condiments/relishes, gravies and sauces, gelatines, puddings, fruit pie fillings, jams and jellies, yoghurts, milk based drinks, snack foods, sweet sauces, toppings and syrups, as well as in food supplements, as defined in Directive 2002/46/EC of the  European Parliament and of the Council , for the general population above 10 years of age. 
(6)    The applicant asked for an authorisation of the existing authorised conditions of use. However, the Commission notes that those conditions of use are already authorised and are applicable to all food business operators, including the applicant therefore, this authorisation should be limited to the new conditions of use only.
(7)    With regard to the conditions of use of the novel food in food supplements, the applicant initially proposed the maximum intake level of 30g/day but subsequently agreed to reduce it to 10 g/day as the substance is a source of glucose. The applicant also proposed an additional condition of use that food supplements containing isomalto-oligosaccharide should not be consumed if other foods with added isomalto-oligosaccharide are consumed on the same day.  
(8)    On 26 March 2021, the applicant also made a request to the Commission for the protection of proprietary scientific studies and data, namely, the compositional analyses data and an expert opinion on those data , the product batch data , the request of the applicant to the competent authorities of the United Kingdom in accordance with Article 4 of Regulation (EC) 258/97 of the European Parliament and of the Council  to place isomalto-oligosaccharide on the market as a novel food ingredient , the certificates of analyses , the descriptions of the analytical methods , the laboratory accreditation certificates , the isomalto-oligosaccharide intake assessment reports , a stability study , a double-blind, randomised, placebo controlled study to investigate the effects of isomalto-oligosaccharide in healthy adults , and a randomised, triple-blind placebo-controlled parallel study to evaluate the safety and tolerability of isomalto-oligosaccharide on a healthy adult population , submitted in support of the application.
(9)    In accordance with Article 10(3) of Regulation (EU) 2015/2283, on 7 December 2021, the Commission requested the European Food Safety Authority (ʽthe Authorityʼ) to carry out an assessment of the proposed new conditions of use and additional specifications for isomalto-oligosaccharide as a novel food.
(10)    On 14 December 2023, the Authority adopted its scientific opinion on the ‘extension of use of isomalto-oligosaccharide as a novel food pursuant to Regulation (EU) 2015/2283’ , in accordance with Article 11 of Regulation (EU) 2015/2283.
(11)    In its scientific opinion, the Authority concluded that isomalto-oligosaccharide is safe under the proposed new conditions of use and for the proposed target populations.  In its opinion, the Authority also considered that the proposed microbiological parameters should be added to the specifications of this novel food as a mean to reinforce its safety. It is therefore appropriate that the specifications of isomalto-oligosaccharide for the proposed new conditions of use include microbiological parameters.
(12)    The scientific opinion of the Authority gives sufficient grounds to establish that isomalto-oligosaccharide, when used under the new conditions of use fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283
(13)    In its scientific opinion, the Authority noted that its conclusion on the safety of the novel food under the new conditions of use and on the additional specifications was based on scientific studies and data from the compositional analyses data and the expert opinion on those data; the product batch data, the request of the applicant to the competent authorities of the United Kingdom in accordance with Article 4 of Regulation (EC) 258/97 to place isomalto-oligosaccharide on the market as a novel food ingredient, the certificates of analyses, the descriptions of the analytical methods, the laboratory accreditation certificates,, the isomalto-oligosaccharide intake assessment reports, the stability study, the double-blind, randomised, placebo- controlled study to investigate the effects of isomalto-oligosaccharide in healthy adults, and the randomised, triple-blind, placebo-controlled, parallel study to evaluate the safety and tolerability of isomalto-oligosaccharide on a healthy adult population, contained in the applicant’s file, without which it could not have assessed the novel food and reached its conclusion.
(14)    The Commission requested the applicant to further clarify the justification provided with regard to its proprietary claim over those scientific studies and data, and to clarify its claim to an exclusive right of reference to them in accordance with Article 26(2), point (b) of Regulation (EU) 2015/2283.
(15)    The applicant declared that, at the time of submission of the application, it held proprietary and exclusive rights of reference to the scientific studies and data, namely, the compositional analyses data and expert opinion on those data, the product batch data, the request of the applicant to the competent authorities of the United Kingdom in accordance with Article 4 of Regulation (EC) 258/97 to place isomalto-oligosaccharide on the market as a novel food ingredient, the certificates of analyses, the descriptions of the analytical methods; the laboratory accreditation certificates,  the isomalto-oligosaccharide intake assessment reports, the stability study, the double-blind, randomised, placebo-controlled study to investigate the effects of isomalto-oligosaccharide in healthy adults, and the randomised, triple-blind, placebo-controlled, parallel study to evaluate the safety and tolerability of isomalto-oligosaccharide on a healthy adult population, under national law and that third parties cannot lawfully access, use or refer to those data and studies.
(16)    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 scientific studies and data submitted in support of the application, namely, the compositional analyses data and expert opinion on those data;  the product batch data; the request of the applicant to the competent authorities of the United Kingdom in accordance with Article 4 of Regulation (EC) 258/97 to place isomalto-oligosaccharide on the market as a novel food ingredient; the certificates of analyses; the descriptions of the analytical methods; the laboratory accreditation certificates;  the isomalto-oligosaccharide intake assessment reports;  the stability study; the double-blind, randomised, placebo controlled study to investigate the effects of isomalto-oligosaccharide in healthy adults; and the randomised, triple-blind, placebo-controlled, parallel study to evaluate the safety and tolerability of isomalto-oligosaccharide on a healthy adult population, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place its isomalto-oligosaccharide on the market within the Union during a period of 5 years from the entry into force of this Regulation.
(17)    However, restricting the authorisation of isomalto-oligosaccharide and the reference to the scientific studies and data contained in the applicant’s file to 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. 
(18)    It is appropriate that the inclusion of isomalto-oligosaccharide produced by the applicant as a novel food in the Union list of novel foods contains also the information referred to in Article 9(3) of Regulation (EU) 2015/2283.
(19)    In line with the conditions of use of food supplements containing isomalto-oligosaccharide, it is necessary to inform consumers by appropriate labelling that food supplements containing isomalto-oligosaccharide should only be consumed by the general population over 10 years of age. It is also appropriate to inform the consumers that the novel food is a source of glucose. In addition, the Authority’s opinion concluded that the cumulative intake of isomalto-oligosaccharide that would result from the already authorised uses and the proposed extended uses, including food supplements does not pose a safety concern. Taking into account the Authority’s opinion, the Commission considers that requiring a label informing consumers that food supplements containing isomalto-oligosaccharide should not be used if other foods with added isomalto-oligosaccharide are consumed on the same day, as proposed by the applicant, is not necessary.
(20)    The applicant has proposed the use of isomalto-oligosaccharide in jams and jellies. Council Directive 2001/113/EC  defines products relating to fruit jams, jellies and marmalades and sweetened chestnut purée intended for human consumption. This Directive lays down specific provisions regarding the designation and compositional requirements of the products within its scope. Only certain designations relating to fruit jams, jellies and marmalades and sweetened chestnut purée and only certain ingredients and substances authorised by this Directive may be used. While the Union list of novel foods applies without prejudice to other provisions laid down in sector specific legislation, to ensure clarity and regulatory consistency, it is appropriate that the conditions of use of this novel food should reflect the restrictions imposed by the provisions of Directive 2001/113/EC.
(21)    The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(22)    The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,