2009/355/EC: Commission Decision of 28 April 2009 authorising the placing on the market of lycopene oleoresin from tomatoes as novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2009) 3036)

• CELEX: Regulation (EC) No 258/97
• Articles: 7

Article 1

Lycopene oleoresin from tomatoes, hereinafter called 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 oleoresin from tomatoes’.

Article 3

The company LycoRed 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 accordance with the periodicity established in Annex III.

In the light of new information and a report of EFSA, at the latest in the year 2014 the use of lycopene oleoresin from tomatoes as an ingredient to foods shall be reviewed.

Article 4

This Decision is addressed to LycoRed Ltd, Hebron Rd, Industrial Zone, Beer Sheva 84102, Israel.

Schedules & Appendices

ANNEX I

ANNEX I

Specifications of lycopene oleoresin from tomatoes

DESCRIPTION

Lycopene oleoresin from tomatoes is obtained by solvent extraction of ripe tomatoes Lycopersicon esculentum ) with subsequent removal of the solvent. It is a red to dark brown viscous, clear liquid.

COMPOSITION

Total lycopene

5 to 15 %

Thereof trans-lycopene

90 – 95 %

Total carotenoids (calculated as lycopene)

6,5 – 16,5 %

Other carotenoids

1,75  %

(Phytoene/phytofluene/β-carotene)

(0,5 to 0,75/0,4 to 0,65/0,2 to 0,35 %)

Total tocopherols

1,5 to 3,0 %

Unsaponifiable matter

13 to 20 %

Total fatty acids

60 to 75 %

Water (Karl Fischer)

Not more than 0,5 %

ANNEX II

ANNEX II

List of foods to which ‘lycopene oleoresin from tomatoes’ may be added

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 & 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

ANNEX III

ANNEX III

Post launch monitoring of lycopene oleoresin from tomatoes

INFORMATION TO BE COLLECTED

Quantities of lycopene oleoresin from tomatoes expressed as lycopene provided by LycoRed 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, 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 LycoRed also the same information on intakes of lycopene used as food colour or ingredient to food supplements should be reported.

Where available, LycoRed 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, LycoRed shall carry out an updated intake assessment.

REVIEW

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