# L_2009111EN.01003101.xml

| 5.5.2009 | EN | Official Journal of the European Union | L 111/31 |
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5.5.2009

EN

Official Journal of the European Union

L 111/31

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COMMISSION DECISION

of 28 April 2009

authorising the placing on the market of lycopene from Blakeslea trispora as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2009) 3039)

(Only the Spanish text is authentic)

(2009/365/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 30 August 2007 the company Vitatene made a request to the competent authorities of the United Kingdom to place lycopene from Blakeslea trispora on the market as a novel food ingredient; on 17 October 2007 the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that, in the light of other pending applications concerning lycopene, an additional assessment is required in order to assure that an authorisation for use of the different lycopenes as novel food ingredients is granted under the same terms. |
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(1)

On 30 August 2007 the company Vitatene made a request to the competent authorities of the United Kingdom to place lycopene from Blakeslea trispora on the market as a novel food ingredient; on 17 October 2007 the competent food assessment body of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that, in the light of other pending applications concerning lycopene, an additional assessment is required in order to assure that an authorisation for use of the different lycopenes as novel food ingredients is granted under the same terms.

| (2) | The Commission forwarded the initial assessment report to all Member States on 11 February 2008. |
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(2)

The Commission forwarded the initial assessment report to all Member States on 11 February 2008.

| (3) | The European Food Safety Authority was consulted and issued its opinion on 4 December 2008. |
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(3)

The European Food Safety Authority was consulted and issued its opinion on 4 December 2008.

| (4) | In its opinion EFSA came to the conclusion, because lycopene may undergo oxidative changes, it needs to be formulated as suspensions in edible oils, directly compressible or water dispersible powders. Sufficient antioxidative protection has to be ascertained. |
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(4)

In its opinion EFSA came to the conclusion, because lycopene may undergo oxidative changes, it needs to be formulated as suspensions in edible oils, directly compressible or water dispersible powders. Sufficient antioxidative protection has to be ascertained.

| (5) | EFSA also concluded that the consumption of lycopene by the average user will stay below the acceptable daily intake (ADI), but that some users of lycopene may exceed the ADI. Therefore, it also appears appropriate to collect intake data for a number of years following the authorisation in order to review this authorisation in the light of any further information on the safety of lycopene and its consumption. Particular attention should be given to the collection of data regarding levels of lycopene in breakfast cereals. However, this requirement under the present Decision, applies to the use of lycopene as a novel food ingredient and not to the use of lycopene as a food colour, that falls within the scope of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (2). |
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(5)

EFSA also concluded that the consumption of lycopene by the average user will stay below the acceptable daily intake (ADI), but that some users of lycopene may exceed the ADI. Therefore, it also appears appropriate to collect intake data for a number of years following the authorisation in order to review this authorisation in the light of any further information on the safety of lycopene and its consumption. Particular attention should be given to the collection of data regarding levels of lycopene in breakfast cereals. However, this requirement under the present Decision, applies to the use of lycopene as a novel food ingredient and not to the use of lycopene as a food colour, that falls within the scope of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (2).

| (6) | On the basis of the scientific assessment, it is established that the lycopene from Blakeslea trispora complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97. |
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(6)

On the basis of the scientific assessment, it is established that the lycopene from Blakeslea trispora complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

| (7) | The company Vitatene agreed that Commission Decision 2006/721/EC (3) will be repealed. |
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(7)

The company Vitatene agreed that Commission Decision 2006/721/EC (3) will be repealed.

| (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

Lycopene from Blakeslea trispora (hereinafter referred to as the product), as specified in Annex I, may be placed on the market in the Community as a novel food ingredient to be used in the foods listed in Annex II.

Article 2

The designation of the novel food ingredient authorised by this Decision on the labelling of the foodstuff containing it shall be ‘lycopene’.

Article 3

The company Vitatene shall establish a monitoring programme accompanying the marketing of the product. This programme shall encompass information about use levels of lycopene in foods as specified in Annex III.

The data collected shall be made available to the Commission and Member States. In the light of new information and a report of EFSA, at the latest in the year 2014 the use of lycopene as an ingredient in foods shall be reviewed.

Article 4

Decision 2006/721/EC is herewith repealed.

Article 5

This Decision is addressed to Vitatene SAU, Avda. Antibióticos 59-61, 24009 León, Spain.

Done at Brussels, 28 April 2009.

For the Commission

Androulla VASSILIOU

Member of the Commission

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

1

(2)  
  OJ L 40, 11.2.1989, p. 27.

2

(3)  
  OJ L 296, 26.10.2006, p. 13.

3

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ANNEX I

Specifications of lycopene from Blakeslea trispora

DESCRIPTION

The purified lycopene from Blakeslea trispora consists of ≥ 95 % lycopene and ≤ 5 % other carotenoids. It is presented either as a powder in a suitable matrix or an oily dispersion. The colour is dark red or red-violet. Antioxidative protection has to be assured.

SPECIFICATION

| Chemical name | : | Lycopene |
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| CAS number | : | 502-65-8 (all trans-lycopene) |
| Chemical formula | : | C40H56 |
| Chemical formula | : | |
| Formula weight | : | 536,85 |

Chemical name

:

Lycopene

CAS number

:

502-65-8 (all trans-lycopene)

Chemical formula

:

C40H56

Chemical formula

:

Image 1

Formula weight

:

536,85

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ANNEX II

List of foods to which lycopene from Blakeslea trispora may be added

| Food category | Maximum content of lycopene |
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| Fruit/vegetable juice-based drinks (including concentrates) | 2,5 mg/100 g |
| Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen | 2,5 mg/100 g |
| Foods intended for use in energy-restricted diets for weight reduction | 8 mg/meal replacement |
| Breakfast cereals | 5 mg/100 g |
| Fats and dressings | 10 mg/100 g |
| Soups other than tomato soups | 1 mg/100 g |
| Bread (including crispy breads) | 3 mg/100 g |
| Dietary foods for special medical purposes | In accordance with the particular nutritional requirements |
| Food supplements | 15 mg per daily dose as recommended by the manufacturer |

Food category

Maximum content of lycopene

Fruit/vegetable juice-based drinks (including concentrates)

2,5 mg/100 g

Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

2,5 mg/100 g

Foods intended for use in energy-restricted diets for weight reduction

8 mg/meal replacement

Breakfast cereals

5 mg/100 g

Fats and dressings

10 mg/100 g

Soups other than tomato soups

1 mg/100 g

Bread (including crispy breads)

3 mg/100 g

Dietary foods for special medical purposes

In accordance with the particular nutritional requirements

Food supplements

15 mg per daily dose as recommended by the manufacturer

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ANNEX III

Post-launch monitoring of lycopene from Blakeslea trispora

INFORMATION TO BE COLLECTED

Quantities of lycopene from Blakeslea trispora provided by Vitatene to their customers for the production of final food products to be placed on the market in the European Union.

Results of data base searches on product launches of foods with added lycopene from Blakeslea trispora, including fortification levels and portion sizes per launched food by Member State.

REPORTING OF THE INFORMATION

The information above shall be reported to the European Commission annually for the years 2009 to 2012. For the first time on 31 October 2010 for the reporting period 1 July 2009 to 30 June 2010; and then with the same yearly reporting period for the following two years.

ADDITIONAL INFORMATION

Where appropriate and available to Vitatene also the same information on intakes of lycopene used as food colour should be reported.

Where available, Vitatene shall provide new scientific information for a reconsideration of the maximum safe intake levels of lycopene.

ASSESSMENT OF INTAKE LEVELS OF LYCOPENE

Based on the collected and reported information above, Vitatene shall carry out an updated intake assessment.

REVIEW

The Commission shall consult EFSA in 2013 to review the information provided by industry.

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