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 of 25 March 2010.
In order to ensure an effective re-evaluation of Patent Blue V (E 131), EFSA published a call for scientific data on Patent Blue V (E 131) on 6 June 2011 with a deadline on 1 September 2011 to provide either the sought data or a commitment to generate and provide the sought data through new studies.
Following this call an interested party informed EFSA that a genotoxicity study had been commissioned to address EFSA’s request and that its results should be available by the end of February 2012. No other contribution was received.
The information sought consists in genotoxicity data as mentioned below on Patent Blue V (E 131). The request for genotoxicity data is made in accordance with the Guidance on submission of food additive evaluations by the Scientific Committee on Food and considering the Draft Scientific Opinion on Genotoxicity Testing Strategies applicable in food and feed safety assessment which was recently endorsed by the Scientific Committee for public consultation.
- Further assessment of genotoxicity in vivo. Any of the following tests may be conducted: (1) an in vivo Comet assay with oral administration and analysis of at least liver, gastrointestinal and blood cells; (2) a transgenic rodent assay (draft OECD TG) with oral administration.
- In case of positive results showing genotoxic effects in vivo, Interested parties and stakeholders might consider to test a product with a purity higher to that mentioned in the current EU specification (“Content not less than 85% total colouring matters, calculated as the sodium salt”) on a battery of genotoxicity tests as described in the Draft Scientific Opinion on Genotoxicity Testing Strategies. In case of absence of genotoxicity interested parties and stakeholders are invited to propose new criteria for purity which might be considered when the current specification is revised.
The content of Patent Blue V (E 131) in the test preparation should be clearly specified. It should also be indicated whether the material tested is in accordance with the specifications for Patent Blue V (E 131) as defined in Directive 2008/128/EC. The tests should be carried out according to the principles of Good Laboratory Practice (GLP) described in Directives 2004/9/EC and 2004/10/EC and accompanied by a statement of GLP compliance.
Deadline for the submission of data
The above data on genotoxicity needs to be submitted electronically by 29 February 2012 at the latest.
Should the sought genotoxicity data not be provided to EFSA by 29 February 2012, EFSA will base its evaluation of the safety of Patent Blue V (E 131) when used as a food colouring substance, on the information available.
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.
Please send all electronic correspondence, including enquiries to: foodadditives [at] efsa.europa.eu
Hard copies can also be sent to the address below:
Food Ingredients & Packaging Unit, Food Additives
European Food Safety Authority
Via Carlo Magno 1/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.
 Call for scientific data on Patent Blue V (E 131) . Published on 6th June 2011.
 Genotoxicity testing strategies applicable to food and feed safety assessment, EFSA 2011 .
 (no OECD TG at present; internationally agreed protocols available, e.g. see: http://cometassay.com)
 OEDC Guideline for the testing of chemicals. Draft proposal for a new guideline. Transgenic rodent gene mutation assays. December 2010.
 Commission Directive 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs. OJ L 6, 10.1.2009, p.20