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Commission Directive 2008/128/EC sets out the specific purity criteria concerning colours for use in foodstuffs, which colours are mentioned in European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs.
Under Article 30(4) of Regulation (EC) No 1333/2008 specifications of the food additives covered under paragraphs 1 to 3 of that Article (which include also additives authorised under Directive 94/36/EC) shall be adopted, in accordance with Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings, at the moment those food additives are entered in the Annexes in accordance with those paragraphs.
Since the lists have not yet been drawn up, and in order to ensure that the modification of the Annexes to Directive 94/36/EC pursuant to Article 31 of Regulation (EC) No 1333/2008 is effective and that additives so authorised comply with safe conditions of use, Directive 2008/128/EC should therefore be amended.
The European Food Safety Authority (hereinafter ‘the Authority’) has assessed the information on the safety in use of lycopene as a food colour from all sources in its opinion of 30 January 2008. The sources that were considered were the following: (a) E160d Lycopene obtained by solvent extraction of the natural strains of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent, (b) synthetic lycopene and (c) lycopene from Blakeslea trispora.
Current legislation lays down specifications only for lycopene of red tomatoes and needs to be modified respectively by including the other two sources. Specifications of lycopene extracted from red tomatoes need also to be updated. Dichloromethane does not need to be listed in the list of the extraction solvents, as it is not used any more for lycopene of red tomatoes, according to the information received from stakeholders. Maximum limit for lead needs to be lowered due to safety reasons, and the reference on heavy metals is too generic and not relevant any more. In addition the reference on natural strains needs to be updated according to Regulation (EC) No 1829/2003 of the European Parliament and of the Council.
Dichloromethane (methylene chloride) is being reported to be used for manufacturing ready-to-sale formulations of lycopene, mentioned also in the Authority's opinion on Safety of ‘Lycopene Cold Water Dispersible Products from Blakeslea trispora’ of 4 December 2008. Similar products are produced also from synthetic lycopene, as mentioned in the Authority's opinion on safety of Synthetic Lycopene of 10 April 2008. As the Authority evaluated this specific use, it is necessary to authorise this use by the same residual levels that were considered during the evaluation.
It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius drafted by the Joint Expert Committee on Food Additives (JECFA). In particular, the specific purity criteria need to be adapted to reflect the limits for individual heavy metals of interest, where appropriate.
Comments are to reach the Technical Regulations Division within the Regulatory Affairs Directorate, in writing or via email by Friday 19th August 2011
Should any further information be required kindly contact the Technical Regulations Division of the Regulatory Affairs Directorate within the Malta Competition and Consumer Affairs Authority, using the following contact details:
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