# L_2019023EN.01000401.xml

| 25.1.2019 | EN | Official Journal of the European Union | L 23/4 |
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25.1.2019

EN

Official Journal of the European Union

L 23/4

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/108

of 24 January 2019

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

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,

Whereas:

| (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. |
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(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. |
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(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. |
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(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 2009/752/EC (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), 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 %. |
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(4)

Commission Decision 2009/752/EC (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), 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 (5) 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 %. |
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(5)

Commission Implementing Decision (EU) 2016/598 (5) 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 ingredient ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’ was authorised to be used in certain food categories by the Finnish competent authorities (6). The minimum level of phospholipids was established at 60 %. |
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(6)

The novel food ingredient ‘Antarctic Krill oil rich in phospholipids from Euphausia superba’ was authorised to be used in certain food categories by the Finnish competent authorities (6). 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 %. |
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(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. |
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(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) of Regulation (EU) 2015/2283 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 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. |
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(9)

The Commission considers that a safety evaluation of the current application by the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 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 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. |
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(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 ingredient ‘Antarctic Krill oil from Euphausia superba’ comply with Article 12(2) of Regulation (EU) 2015/2283. |
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(11)

The information provided in the application gives sufficient grounds to establish that the proposed changes to the specifications of the novel food ingredient ‘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. |
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(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, |
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(13)

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

HAS ADOPTED THIS REGULATION:

Article 1

The entry in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 referring to the novel food ‘Antarctic Krill oil from Euphausia superba’ shall be amended as specified in the Annex to this Regulation.

Article 2

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 24 January 2019.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 327, 11.12.2015, p. 1.

1

(2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

2

(3)  Commission Decision 2009/752/EC of 12 October 2009 authorising the placing on the market of a lipid extract from Antarctic Krill Euphausia superba as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 268, 13.10.2009, p. 33).

3

Euphausia superba

(4)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

4

(5)  Commission Implementing Decision (EU) 2016/598 of 14 April 2016 authorising an extension of use of lipid extract from Antarctic Krill (Euphausia superba) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 103, 19.4.2016, p. 34).

5

Euphausia superba

(6)  Letter of 13 May 2015 (https://ec.europa.eu/food/sites/food/files/safety/docs/novel-food_authorisation_2015_auth-letter_krill-oil_en.pdf)

6

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ANNEX

The entry for ‘Antarctic Krill oil from Euphausia superba
  ’ in Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470 is replaced by the following:

| Authorised Novel Food | Specifications |
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| ‘Antarctic Krill oil from

  Euphausia superba | Description/Definition:

  To produce lipid extract from Antarctic Krill (Euphausia superba) deep-frozen crushed krill or dried krill meal is subjected to lipid extraction with an approved extraction solvent (under Directive 2009/32/EC). Proteins and krill material are removed from the lipid extract by filtration. The extraction solvents and residual water are removed by evaporation.
  Saponification value: ≤ 230 mg KOH/g
  Peroxide value (PV): ≤ 3 meq O2/kg oil
  Oxidative stability: All food products containing Antarctic Krill oil from Euphausia superba should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC).
  Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activity at 25 °C
  Phospholipids: ≥ 35 % to < 60 %
  Trans-fatty acids: ≤ 1 %
  EPA (eicosapentaenoic acid): ≥ 9 %
  DHA (docosahexaenoic acid): ≥ 5 %’ |

Authorised Novel Food

Specifications

‘Antarctic Krill oil from

  Euphausia superba

Description/Definition:

To produce lipid extract from Antarctic Krill (Euphausia superba) deep-frozen crushed krill or dried krill meal is subjected to lipid extraction with an approved extraction solvent (under Directive 2009/32/EC). Proteins and krill material are removed from the lipid extract by filtration. The extraction solvents and residual water are removed by evaporation.

Saponification value: ≤ 230 mg KOH/g

Peroxide value (PV): ≤ 3 meq O2/kg oil

Oxidative stability: All food products containing Antarctic Krill oil from Euphausia superba should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC).

Moisture and volatiles: ≤ 3 % or 0,6 expressed as water activity at 25 °C

Phospholipids: ≥ 35 % to < 60 %

Trans-fatty acids: ≤ 1 %

EPA (eicosapentaenoic acid): ≥ 9 %

DHA (docosahexaenoic acid): ≥ 5 %’

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