According to Article 32 of Regulation (EC) No 1333/2008 , all food additives permitted before 20 January 2009 should be subject to a new risk assessment by the European Food Safety Authority (EFSA). The programme for the re-evaluation of approved food additives has been set up by Commission Regulation (EU) No 257/2010.
In order to ensure an effective re-evaluation of Patent Blue V (E 131) and to meet the deadline of December 2010 set in the Commission Regulation (EU) No 257/2010, it is important that EFSA acquires from interested parties all required data (published, unpublished or newly generated).
The purpose of this call for data is to offer all interested parties and stakeholders the opportunity to submit the data on Patent Blue V (E 131) as identified by the ANS Panel and outlined below in accordance with the Guidance on submission of food additive evaluations by the Scientific Committee on Food .
EFSA kindly asks governments, interested organisations, universities, research institutions, companies and other interested parties to submit the following information and data on Patent Blue V (E 131).
1. Genotoxicity data for Patent Blue V (E 131) including the following.
- A test for induction of gene mutations in bacteria.
- A test for induction of gene mutations in mammalian cells in vitro (preferably the mouse lymphoma TK assay).
- A test for induction of chromosomal aberrations in mammalian cells in vitro.
Interested parties should refer to the Guidance on Submission of Food Additive Evaluations by the Scientific Committee on Food for details and should note that evidence for genotoxicity from in vitro studies requires subsequent in vivo genotoxicity studies.
2. The full study report of the 13-week study on dogs by the Institut Français de recherches et Essais Biologiques (IFREB, 1978) .
3. Data on the metabolism on Patent Blue V (E 131) and on the metabolites that could be formed from Patent Blue V.
Process of the call for data
The above information needs to be submitted electronically by 15 October 2010 at the latest.
The interested parties are invited to contact EFSA for further clarification if required.
Confidentiality and unpublished data
Specific issues relating to confidentiality of the data provided should be discussed between the owners and EFSA. In application of Article 8.4 of Regulation 257/2010, following a proposal from EFSA, the Commission will decide after consulting the interested business operator and/or the other interested parties which information may remain confidential and shall notify EFSA and the Member States accordingly.
All electronic correspondence, including enquiries, should be sent to:
foodadditives [at] efsa.europa.eu
Hard copies can also be sent to the address below:
ANS Unit, Food Additives
European Food Safety Authority
Largo N. Palli 5/A
 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives
 Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives.
 Guidance on submission of food additive evaluations by the Scientific Committee on Food, 2001.
 IFREB 1978, Essai toxicologique de 3 mois par incorporation dans le régime chez le chien Beagle. Institut Français de recherches et Essais Biologiques Colourant E 131 (Blue Patent V). IFREB Report No. 806216 (unpublished). The studies were performed for the REC colours groups.