# L_2012327EN.01004601.xml

| 27.11.2012 | EN | Official Journal of the European Union | L 327/46 |
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27.11.2012

EN

Official Journal of the European Union

L 327/46

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COMMISSION IMPLEMENTING DECISION

of 22 November 2012

authorising the placing on the market of bovine lactoferrin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (Morinaga)

(notified under document C(2012) 8390)

(Only the English text is authentic)

(2012/725/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,

Whereas:

| (1) | On 2 March 2011 the company Morinaga Milk Industry Co. Ltd made a request to the competent authorities of Ireland to place bovine lactoferrin on the market as novel food ingredient. Bovine lactoferrin is an iron binding protein from milk to be added to foods. |
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(1)

On 2 March 2011 the company Morinaga Milk Industry Co. Ltd made a request to the competent authorities of Ireland to place bovine lactoferrin on the market as novel food ingredient. Bovine lactoferrin is an iron binding protein from milk to be added to foods.

| (2) | On 22 June 2011 the competent food assessment body of Ireland issued its initial assessment report. In this report they recommended that instead of carrying out an initial assessment an additional assessment was required, because another application concerning bovine lactoferrin was already referred to EFSA. |
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(2)

On 22 June 2011 the competent food assessment body of Ireland issued its initial assessment report. In this report they recommended that instead of carrying out an initial assessment an additional assessment was required, because another application concerning bovine lactoferrin was already referred to EFSA.

| (3) | The Commission forwarded the initial assessment report to all Member States on 20 July 2011. |
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(3)

The Commission forwarded the initial assessment report to all Member States on 20 July 2011.

| (4) | The European Food Safety Authority (EFSA) was consulted on 22 August 2011. |
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(4)

The European Food Safety Authority (EFSA) was consulted on 22 August 2011.

| (5) | On 28 June 2012 in their ‘Scientific opinion on bovine lactoferrin’ (2) EFSA came to the conclusion that bovine lactoferrin is safe under the proposed uses and use levels. |
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(5)

On 28 June 2012 in their ‘Scientific opinion on bovine lactoferrin’ (2) EFSA came to the conclusion that bovine lactoferrin is safe under the proposed uses and use levels.

| (6) | On 27 April 2012 in another ‘Scientific opinion on bovine lactoferrin’ (3) EFSA already came to the conclusion that lactoferrin was safe under the proposed uses and use levels. Therefore it appears appropriate to authorise the same uses for both applications. |
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(6)

On 27 April 2012 in another ‘Scientific opinion on bovine lactoferrin’ (3) EFSA already came to the conclusion that lactoferrin was safe under the proposed uses and use levels. Therefore it appears appropriate to authorise the same uses for both applications.

| (7) | Bovine lactoferrin complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97. |
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(7)

Bovine lactoferrin complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

| (8) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(8)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Bovine lactoferrin as specified in Annex I may be placed on the market as a novel food ingredient for the uses defined and at the maximum levels established in Annex II, and without prejudice to the provisions of Regulation (EC) No 1925/2006 of the European Parliament and of the Council (4) and Directive 2009/39/EC of the European Parliament and of the Council (5).

Article 2

The designation of bovine lactoferrin authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cow’s milk’.

Article 3

This Decision is addressed to Morinaga Milk Industry Co., Ltd, 33-1, Shiba 3-chome, Minato-ku, Tokyo 108-8384, Japan.

Done at Brussels, 22 November 2012.

For the Commission

Maroš ŠEFČOVIČ

Vice-President

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(1)  
  OJ L 43, 14.2.1997, p. 1.

1

(2)  
  EFSA Journal 2012; 10(7): 2811.

2

EFSA Journal

(3)  
  EFSA Journal 2012; 10(5): 2701.

3

EFSA Journal

(4)  
  OJ L 404, 30.12.2006, p. 26.

4

(5)  
  OJ L 124, 20.5.2009, p. 21.

5

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ANNEX I

SPECIFICATIONS OF BOVINE LACTOFERRIN

Definition

Bovine lactoferrin (bLF) is a protein that occurs naturally in cow’s milk. It is an iron-binding glycoprotein of approximately 77 kDa and consists of a single polypeptide chain of 689 amino acids.

bLF is isolated from skimmed milk via ion exchange and subsequent ultra-filtration steps. Finally it is dried by spraying and large particles are sieved out.

Description: Virtually odorless, light pinkish powder

Physical-chemical properties of bovine lactoferrin

| Moisture | less than 4,5 % |
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| Ash | less than 1,5 % |
| Arsenic | less than 2 mg/kg |
| Iron | less than 350 mg/kg |
| Protein | more than 93,0 % |
| of which bovine lactoferrin | more than 95,0 % |
| of which other proteins | less than 5,0 % |
| pH (2 % solution, 20 °C) | 5,2 to 7,2 |
| Solubility (2 % solution, 20 °C) | complete |

Moisture

less than 4,5 %

Ash

less than 1,5 %

Arsenic

less than 2 mg/kg

Iron

less than 350 mg/kg

Protein

more than 93,0 %

of which bovine lactoferrin

more than 95,0 %

of which other proteins

less than 5,0 %

pH (2 % solution, 20 °C)

5,2 to 7,2

Solubility (2 % solution, 20 °C)

complete

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ANNEX II

USES OF BOVINE LACTOFERRIN (bLF)

| Food category | Maximum use levels of bLF |
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| Infant formulae and follow on formulae (ready to drink) | 100 mg/100 ml |
| Foods on dairy basis intended for young children (ready to eat/drink) | 200 mg/100 g |
| Processed cereal food (solid) | 670 mg/100 g |
| Foods for special medical purposes | Depending on the needs of the individual up to 3 g/day |
| Beverages based on milk | 200 mg/100 g |
| Powdered drink mixes based on milk (ready to drink) | 330 mg/100 g |
| Beverages based on fermented milk (including yoghurt drinks) | 50 mg/100 g |
| Non-alcoholic drinks | 120 mg/100 g |
| Products based on yoghurt | 80 mg/100 g |
| Products based on cheese | 2 000  mg/100 g |
| Ice cream | 130 mg/100 g |
| Cakes and pastries | 1 000  mg/100 g |
| Candies | 750 mg/100 g |
| Chewing gum | 3 000  mg/100 g |

Food category

Maximum use levels of bLF

Infant formulae and follow on formulae (ready to drink)

100 mg/100 ml

Foods on dairy basis intended for young children (ready to eat/drink)

200 mg/100 g

Processed cereal food (solid)

670 mg/100 g

Foods for special medical purposes

Depending on the needs of the individual up to 3 g/day

Beverages based on milk

200 mg/100 g

Powdered drink mixes based on milk (ready to drink)

330 mg/100 g

Beverages based on fermented milk (including yoghurt drinks)

50 mg/100 g

Non-alcoholic drinks

120 mg/100 g

Products based on yoghurt

80 mg/100 g

Products based on cheese

2 000  mg/100 g

Ice cream

130 mg/100 g

Cakes and pastries

1 000  mg/100 g

Candies

750 mg/100 g

Chewing gum

3 000  mg/100 g

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