(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 (2) has established a Union list of novel foods.

(3)

Commission Implementing Regulation (EU) 2021/2029 (3) authorised the placing on the Union market of 3-Fucosyllactose obtained by microbial fermentation using the genetically modified strain K12 MG1655 of Escherichia coli (‘E. coli’) as a novel food under Regulation (EU) 2015/2283.

(4)

On 17 March 2020, the company Chr. Hansen A/S (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place 3-fucosyllactose (‘3-FL’) obtained by microbial fermentation using one genetically modified strain of E. coli BL21(DE3), on the Union market as a novel food. The applicant requested for 3-fucosyllactose to be used in infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (4), processed cereal-based food for infants and young children and baby food for infants and young children as defined in Regulation (EU) No 609/2013, foods for infants and young children for special medical purposes as defined in Regulation (EU) No 609/2013, foods for special medical purposes as defined in Regulation (EU) No 609/2013 excluding foods for infants and young children, in milk-based drinks and similar products intended for young children, and in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5) intended for the general population. Subsequently, on 17 June 2022, the applicant modified the initial request in the application on the use of 3-FL in food supplements to exclude infants and young children. The applicant also proposed that food supplements containing 3-FL should not be used if other foods with added 3-fucosyllactose are consumed the same day.

(5)

On 17 March 2020, 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, the mass spectrometry (‘MS’), nuclear magnetic resonance (‘NMR’) spectroscopy and high-performance anion-exchange chromatography with pulsed amperometric detection (‘HPAEC-PAD’) method validation and the results for the determination of the identity of 3-FL and carbohydrate by-products (6); a description of the genetically modified 3-FL production strain (7); a certificate of deposition of the genetically modified 3-FL production strain (8); real time quantitative polymerase chain reaction (‘qPCR’) system and method validation reports for the genetically modified 3-FL production strain (9); a bacterial reverse mutation test with 3-FL (10); an in vitro mammalian cell micronucleus test with 3-FL (11); a 7-day dose range finding oral toxicity study in rats with 3-FL (12); and, a 90-day oral toxicity study in rats with 3-FL (13).

(6)

On 23 September 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of 3-Fucosyllactose obtained by microbial fermentation using a genetically modified production strain derived from the host strain E. coli BL21(DE3), as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283.

(7)

On 29 April 2022, the Authority adopted its scientific opinion on the ‘Safety of 3-fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3) as a novel food pursuant to Regulation (EU) 2015/2283’ (14) in accordance with Article 11 of Regulation (EU) 2015/2283.

(8)

In its scientific opinion, the Authority concluded that 3-FL is safe under the proposed conditions of use for the proposed target populations. Therefore, that scientific opinion gives sufficient grounds to establish that 3-FL, when used in infant formula and follow-on formula as defined in Regulation (EU) No 609/2013, processed cereal-based food for infants and young children and baby food for infants and young children as defined in Regulation (EU) No 609/2013, foods for infants and young children for special medical purposes as defined in Regulation (EU) No 609/2013, foods for special medical purposes as defined in Regulation (EU) No 609/2013 excluding foods for infants and young children, in milk-based drinks and similar products intended for young children, and in food supplements as defined in Directive 2002/46/EC, complies with the authorisation requirements of Article 12(1) of Regulation (EU) 2015/2283.

(9)

In its scientific opinion, the Authority considered that it could not have reached its conclusions on the safety of the 3-FL without the scientific studies and data on the MS, NMR and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL and of the carbohydrate by-products present in the novel food; the description of the genetically modified 3-FL production strain; the certificate of deposition of the genetically modified 3-fucosyllactose production strain; the qPCR system and method validation report for the genetically modified 3-FL production strain; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 7-day dose range finding oral toxicity study in rats with 3-FL; and, the 90-day oral toxicity study in rats with 3-FL.

(10)

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.

(11)

The applicant declared that they held proprietary and exclusive rights of reference to the scientific studies and data on MS, NMR and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL and of the carbohydrate by-products present in the novel food; the description of the genetically modified 3-FL production strain; the certificate of deposition of the genetically modified 3-FL production strain; the qPCR system and method validation report for the genetically modified 3-FL production strain; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 7-day dose range finding oral toxicity study in rats with 3-FL; and, the 90-day oral toxicity study in rats with 3-FL, 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.

(12)

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 on MS, NMR and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL and of the carbohydrate by-products present in the novel food; the description of the genetically modified 3-FL production strain; the certificate of deposition of the genetically modified 3-FL production strain; the qPCR system and method validation report for the genetically modified 3-FL production strain; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 7-day dose range finding oral toxicity study in the rat with 3-FL; and, the 90-day oral toxicity study in the rat with 3-FL, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place 3-fucosyllactose produced with a derivative strain of E. coli BL21(DE3) on the market within the Union during a period of five years from the entry into force of this Regulation.

(13)

However, restricting the authorisation of 3-FL produced with a derivative strain of E. coli BL21(DE3) 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.

(14)

In line with the conditions of use of food supplements containing 3-FL as proposed by the applicant and assessed by the Authority, it is necessary to inform consumers with an appropriate label that food supplements containing 3-FL should not be consumed by infants and children under 3 years of age and should not be used if other foods with added 3-FL are consumed the same day.

(15)

It is appropriate that the inclusion of 3-FL produced with a derivative strain of E. coli BL21(DE3) 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.

(16)

3-FL produced with a derivative strain of E. coli BL21(DE3) 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,

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.

(2)

In accordance with Article 7(1) of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Pediococcus acidilactici CNCM I-4622. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)

The application concerns the authorisation of a preparation of Pediococcus acidilactici CNCM I-4622 as a feed additive for all animal species, to be classified in the additive category ‘technological additives’ and in the functional groups ‘acidity regulators’ and ‘hygiene condition enhancers’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 29 June 2022 (2) that, under the proposed conditions of use, the preparation of Pediococcus acidilactici CNCM I-4622 does not have adverse effects on animal health, consumer safety or the environment. It also concluded that it is considered a respiratory sensitiser, but not irritant to eyes/skin or a skin sensitiser. The Authority further concluded that the preparation showed a potential to reduce the pH and the growth of coliforms in liquid feeds. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The assessment of the preparation of Pediococcus acidilactici CNCM I-4622 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised. The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

(6)

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

(1)

The use of the bitter orange extract as a feed additive was authorised for certain animal species by Commission Implementing Regulation (EU) 2022/652 (2).

(2)

Bitter orange extract is known to contain 10 to 20 % neohesperidin, as detailed in the column ‘Composition, chemical formula, description, analytical method’ in the Annex to Implementing Regulation (EU) 2022/652.

(3)

An incorrect presumption of a relationship between neohesperidin, identified with CAS number 13241-33-3, and neohesperidin dihydrochalcone, identified with CAS number 20702-77-6, which has a similar name, but is a distinct substance, resulted in point 3 of the column ‘Other provisions’ in the Annex to Implementing Regulation (EU) 2022/652, which mistakenly provides for the exclusion of the use of bitter orange extract in combination with neohesperidin dihydrochalcone.

(4)

Theopinion of the European Food Safety Authority of 23 June 2021 on the safety of bitter orange extract (3) does not mention any risk as regards the use of bitter orange extract in combination with neohesperidin dihydrochalcone.

(5)

It is therefore necessary to correct the Annex to Implementing Regulation (EU) 2022/652 by deleting point 3 of the column ‘Other provisions’ in that Annex. For the sake of clarity, it is appropriate to replace the whole Annex to that Implementing Regulation.

(6)

In the interest of preventing disruptions to the placing of the feed additive in the market due to the error in Implementing Regulation (EU) 2022/652, this Regulation should enter into force as a matter of urgency.

(7)

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

(1)

As stated in the proposal for a regulation of the European Parliament and of the Council, establishing an Instrument for providing support to Ukraine for 2023 (macro-financial assistance+) (1) and in the proposal for a regulation of the European Parliament and the Council amending Regulation (EU, Euratom) 2018/1046 as regards the establishment of a diversified funding strategy as a general borrowing method (2), the funding needs for the Union’s support to Ukraine require mobilisation and disbursement in a cost-effective and financially sound manner, integrating all funding needs including those for NextGenerationEU (‘NGEU’). Funding should therefore be organised using a single funding method in order to allow different policy needs of the Union to be met concurrently, ensuring parallel financing of all Union programmes relying on borrowing.

(2)

Article 13(2) of Commission Implementing Decision of 14 April 2021 establishing the necessary arrangements for the administration of the borrowing operations under Council Decision (EU, Euratom) 2020/2053 and for the lending operations related to loans granted in accordance with Article 15 of Regulation (EU) 2021/241 of the European Parliament and of the Council (3) provides that a dedicated account is maintained with the European Central Bank (ECB) for prudential cash holdings. Following the establishment of a single funding method ensuring parallel financing of all Union programmes that rely on borrowing, the dedicated account maintained with the ECB is also to be used in the context of this single funding method for the purposes of prudential cash holdings related to the Instrument for providing support to Ukraine for 2023 (macro-financial assistance+).

(3)

The Governing Council has decided that it is appropriate that the dedicated account maintained with the ECB, which is currently used for prudential holdings related to NGEU and which will be extended to be used also for prudential holdings related to the Instrument for providing support to Ukraine for 2023 (macro-financial assistance+), continues to be remunerated on the basis of the rules and provisions laid down in Decision (EU) 2019/1743 of the European Central Bank (ECB/2019/31) (4) and Decision (EU) 2022/1521 of the European Central Bank (ECB/2022/30) (5).

(4)

Decision (EU) 2022/1521 (ECB/2022/30) will remain in force until 30 April 2023. Until that date, pursuant to Article 3 of that Decision, in the event of a conflict between it and, inter alia, Article 2 of Decision (EU) 2019/1743 (ECB/2019/31), Decision (EU) 2022/1521 (ECB/2022/30) prevails. Therefore, Decision (EU) 2019/1743 (ECB/2019/31) and Decision (EU) 2022/1521 (ECB/2022/30) are to be read in conjunction.

(5)

In light of the current situation in Ukraine, this Decision should enter into force and apply as a matter of urgency.

(6)

Therefore, Decision (EU) 2019/1743 (ECB/2019/31) and Decision (EU) 2022/1521 (ECB/2022/30) should be amended accordingly,