Tillatelse til endring av spesifikasjonene for lipidekstrakt fra antarktisk krill som ny matingrediens

Tittel

(Utkast) Kommisjonens gjennomføringsforordning om tillatelse til endring av spesifikasjoner for lipidekstrakt fra antarktisk krill (Euphausia superba) som en ny næringsmiddelingrediens i henhold til europaparlaments- og rådsforordning (EU) 2015/2283, og om endring av gjennomføringsforordning (EU) 2017/2470

(Draft) Commission Implementing Regulation authorising the change of specifications of the novel food ingredient lipid extract from Antarctic Krill (Euphasia superba) under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Implementing Regulation (EU) 2017/2470

Siste nytt

Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 11.12.2018

Nærmere omtale

BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)

(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 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) Commission Decision (EU) 2009/752/EC authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council , the placing on the market of lipid extract from Antarctic Krill (Euphausia superba) as a novel food ingredient to be used in certain foods and foodstuffs. In that Decision, the maximum level of phospholipids was established at 50%.

(5) Commission Implementing Decision (EU) 2016/598 authorised, in accordance with Regulation (EC) No 258/97, an extension of use of lipid extract from Antarctic Krill (Euphausia superba) as a novel food ingredient to be used in food supplements. In that Decision, the minimum level of phospholipid was established at 35%.

(6) The novel food 'Antarctic Krill oil rich in phospholipids from Euphausia superba' was authorised to be used in certain food categories by the Finnish competent authorities . The minimum level of phospholipids was established at 60%.

(7) The conditions of use for both 'Antarctic Krill oil from Euphausia superba' and 'Antarctic Krill oil rich in phospholipids from Euphausia superba' are identical and are based on the maximum levels of combined eicosapentaenoic acid and docosahexaenoic acid. However, they differ in the phospholipid content, which is established at a range of 35% to 50% for 'Antarctic Krill oil from Euphausia superba' and a minimum of 60% for 'Antarctic Krill oil rich in phospholipids from Euphausia superba'. Therefore, the current authorisations do not cover the range of phospholipids in 'Antarctic Krill oil from Euphausia superba' between 50% and 60%.

(8) On 29 August 2018, the company Aker BioMarine A/S (‘the Applicant’) made a request to the Commission to change the specifications of the novel food Antarctic Krill oil from Euphausia superba within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The applicant requested to increase the maximum phospholipid content from 50% to less than 60% thereby covering the range in the phospholipid concentration, which is not currently authorised.

(9) The Commission considers that a safety evaluation of the current application by the European Food Safety Authority in accordance with Article 10(3) is not necessary on the basis of the fact that if certain levels of a given novel food component have been assessed and determined to be safe, then lower levels of the same component would also be safe. The authorised maximum levels of combined eicosapentaenoic acid and docosahexaenoic acid for both 'Antarctic Krill oil from Euphausia superba' and 'Antarctic Krill oil rich in phospholipids from Euphausia superba' under Commission Implementing Regulation (EU) 2017/2470 are the same. The proposed change in the phospholipid levels in the specification of the 'Antarctic Krill oil from Euphausia superba' does not change the safety considerations that supported its authorisation and the authorisation of the 'Antarctic Krill oil rich in phospholipids from Euphausia superba' which concluded that phospholipid levels above and below 60% are both safe.

(10) The proposed change to the specifications in the phospholipid content will address the gap in phospholipid content between 'Antarctic Krill oil from Euphausia superba' and 'Antarctic Krill oil rich in phospholipids from Euphausia superba'. Therefore, it is appropriate to amend the specifications of the novel food Antarctic Krill oil from Euphausia superba at the proposed level for phospholipids.

(11) The information provided in the application gives sufficient grounds to establish that the proposed changes to the specifications of the novel food 'Antarctic Krill oil from Euphausia superba' comply with Article 12(2) of Regulation (EU) 2015/2283.

(12) Implementing Regulation (EU) 2017/2470 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

Nøkkelinformasjon
eu-flagg

EU

Kommisjonens framlegg
Dato
07.12.2018
norge-flagg

Norge

Ansvarlig departement
Helse- og omsorgsdepartementet