2009/348/EC: Commission Decision of 23 April 2009 authorising the placing on the market of lycopene 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) 2975)

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

Article 1

Synthetic lycopene (hereinafter 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 BASF 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 to foods shall be reviewed.

Article 4

This Decision is addressed to BASF AG, 67056 Ludwigshafen, Germany.

Schedules & Appendices

ANNEX I

ANNEX I

Specifications of synthetic lycopene

DESCRIPTION

Synthetic lycopene is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other carotenoids used in food. Synthetic lycopene consists of ≥ 96 % lycopene and minor quantities of other related carotenoid components. Lycopene 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

CAS number

:

502-65-8 (all trans lycopene)

Chemical formula

:

C 40 H 56

Structural formula

:

Formula weight

:

536,85

ANNEX II

ANNEX II

List of foods to which synthetic lycopene 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/per 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

ANNEX III

ANNEX III

Post-launch monitoring of synthetic lycopene

INFORMATION TO BE COLLECTED

Quantities of synthetic lycopene provided by BASF to their customers for the production of final food products to be placed on the market in the European Union.

Results of database 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 BASF also the same information on intakes of lycopene used as food colour should be reported.

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

REVIEW

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