(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 (2) establishing a Union list of authorised novel foods was adopted.

(3)

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

(4)

On 4 May 2016, the company Longlive Europe Food Division Ltd (‘the Applicant’) submitted a request to the competent authority of Hungary to place xylo-oligosaccharides on the Union market as a novel food ingredient within the meaning of point (e) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council (3). The application requests for xylo-oligosaccharides to be used in a number of food categories, namely, bakery and dairy products, fruit spreads, chocolate confectionery and soy-drinks for the general population.

(5)

Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, and for which the final decision has not been taken before 1 January 2018, shall be treated as an application submitted under Regulation (EU) 2015/2283.

(6)

While the request for placing xylo-oligosaccharides on the market as a novel food within the Union was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

(7)

On 18 July 2016, the competent authority of Hungary issued its initial assessment report. In that report, it concluded that xylo-oligosaccharides meets the criteria for a novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.

(8)

On 12 June 2017, the Commission forwarded the initial assessment report to the other Member States. Reasoned objections were raised by other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97 with regard to the specifications, stability, anticipated daily intake and toxicological studies.

(9)

In view of the objections raised by the other Member States, the Commission consulted the European Food Safety Authority (‘the Authority’) on 6 September 2017, asking it to carry out an additional assessment for xylo-oligosaccharides as a novel food ingredient in accordance with Regulation (EC) No 258/97.

(10)

On 27 June 2018, the Authority adopted the ‘Scientific Opinion on the safety of xylo-oligosaccharides as a novel food pursuant to Regulation (EU) 2015/2283’ (4). This opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

(11)

That opinion gives sufficient grounds to establish that xylo-oligosaccharides in the proposed uses and use levels when used as an ingredient in bakery and dairy products, fruit spreads, chocolates and soy-drinks, complies with Article 12(1) of Regulation (EU) 2015/2283.

(12)

Regulation (EU) No 1308/2013 of the European Parliament and of the Council (5) lays down requirements for milk and milk products which apply to xylo-oligosaccharides when used as an ingredient in milk products. Pursuant to point 2 of Part III of Annex VII to that Regulation, xylo-oligosaccharides cannot be used in milk products to replace, in whole or in part, any milk constituent. The use of xylo-oligosaccharides as a novel food in milk products should therefore be limited accordingly.

(13)

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

(1)

Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use.

(2)

Commission Implementing Regulation (EU) No 872/2012 (3) adopted the list of flavouring substances and introduced that list it in Part A of Annex I to Regulation (EC) No 1334/2008.

(3)

That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State or by an interested party.

(4)

The Union list of flavourings and source materials contains a number of substances for which the European Food Safety Authority (the ‘Authority’) has requested additional scientific data to be provided for completion of the evaluation before specific deadlines established in Part A of Annex I to Regulation (EC) No 1334/2008.

(5)

In the case of the following three substances: p-mentha-1,4(8)-dien-3-one (FL No 07.127), 2-aminoacetophenone (FL No 11.008), and 4-acetyl-2,5-dimethylfuran-3(2H)-one (FL No 13.175), the persons responsible for placing them on the market have withdrawn the application.

(6)

Therefore, the substances p-mentha-1,4(8)-dien-3-one (FL No 07.127), 2-aminoacetophenone (FL No 11.008), and 4-acetyl-2,5-dimethylfuran-3(2H)-one (FL No 13.175) should be removed from the Union list.

(7)

Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended accordingly.

(8)

Due to technical reasons, transitional periods should be laid down to cover food to which any of the three flavouring substances have been added, which has been placed on the market or dispatched from third countries for the Union, before the entry into force of this Regulation

(9)

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

(1)

Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (the commodities). It provides that the commodities are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto.

(2)

Regulation (EC) No 798/2008 provides that consignments of commodities may only be imported into and transit through the Union if they comply with certain conditions, including the specific conditions set out in column 6 of the table in Part 1 of Annex I thereto, and where appropriate, the ‘closing date’ and ‘opening date’ set out in columns 6A and 6B of that table. The closing date indicates the date from which consignments of commodities produced in a third country, territory, zone or compartment are no longer authorised for import into or transit through the Union, while the opening date indicates the date from which consignments of commodities produced in a third country, territory, zone or compartment are again authorised for import into or transit through the Union.

(3)

The entries in columns 6A and 6B are kept in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 to prevent the import into and transit through the Union of consignments of commodities produced in the restricted zones outside the Union during the period when the import into and transit through the Union of such consignments was not authorised in accordance with the rules laid down in that Regulation.

(4)

The entry for Canada in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 includes zones of that third country which, following the confirmation of HPAI, have applied stamping out, cleaning and disinfection and have been re-authorised for imports into and transit through the Union of certain poultry commodities with an opening date of more than two years ago. The entry for Canada should therefore be amended accordingly.

(5)

The entry for the United States in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 includes zones of that third country which, following the confirmation of HPAI, have applied stamping out, cleaning and disinfection and have been re-authorised for imports into and transit through the Union of certain poultry commodities with an opening date of more than two years ago. The entry for the United States should therefore be amended accordingly.

(6)

Regulation (EC) No 798/2008 also lays down the conditions for a third country, territory, zone or compartment to be considered as free from HPAI.

(7)

Russia is listed in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country from which imports into and transit through the Union of certain poultry commodities are authorised from the whole of its territory.

(8)

On 17 November 2016, Russia confirmed the presence of HPAI of subtype H5N8 in a poultry holding on its territory. Since November 2016, Russia has confirmed several outbreaks of HPAI in poultry holdings on its territory. Due to those confirmed outbreaks since November 2016 Russia cannot be considered as free from that disease and the veterinary authorities of Russia are not in a position to certify consignments of meat of poultry for human consumption intended for import into or transit through the Union.

(9)

The veterinary authorities of Russia have submitted information to the Commission on the outbreaks of HPAI and have confirmed that since 17 November 2016 they have suspended issuing veterinary certificates for consignments of meat of poultry for human consumption intended for import into or transit through the Union.

(10)

Therefore, no consignments of such products originating in Russia have been introduced into the Union since that date. For reasons of clarity and legal certainty, it is appropriate to document this situation and introduce in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 the relevant closing date. This also ensures that, where Russia regains freedom from HPAI and an opening date is established, consignments of such products produced after the closing date and before that opening date will not be eligible for introduction into the Union.

(11)

The entry for Russia in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 should therefore be amended to take account of the epidemiological situation in that third country since November 2016 and indicate the closing date from which that third country cannot be considered as free from HPAI

(12)

Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

(13)

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

(1)

In accordance with the procedure laid down in Article 21(5) of the 11th EDF Financial Regulation, the Commission is to present a proposal by 10 October 2018 specifying: (a) the amount of the third instalment of the contribution for 2018; and (b) a revised annual amount of the contribution for 2018, in cases where the amount deviates from actual needs.

(2)

In accordance with Article 52 of the 11th EDF Financial Regulation, the European Investment Bank (EIB) sent to the Commission its updated estimates of commitments and payments under the instruments it manages.

(3)

Article 22(1) of the 11th EDF Financial Regulation provides that calls for contributions first use up the amounts provided for in previous European Development Funds (EDFs). Therefore, a call for funds under the 11th EDF should be made for funds called by the Commission.

(4)

On 9 July 2018, the Council adopted Decision (EU) 2018/965 (3), setting the annual amount of the Member States' EDF contributions for 2018 at EUR 4 250 000 000 for the Commission and at EUR 250 000 000 for the EIB,