Call for scientific data on paprika extract, capsanthin, capsorubin (E 160c)

Deadline: 1 July 2011

Background
According to Article 32 of Regulation (EC) No 1333/2008[1], 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[2] of 25 March 2010.

In order to ensure an effective re-evaluation of paprika extract, capsanthin, capsorubin (E 160c), it is important that EFSA acquires from interested parties all data on genotoxicity that are needed for the ongoing safety assessment (re-evaluation of the food colour paprika extract). These data might be already existing (published or unpublished) or might need to be newly generated.

Overall objective
The purpose of this call for genotoxicity data is to offer all interested parties and stakeholders the opportunity to submit either genotoxicity data on paprika extract, capsanthin, capsorubin (E 160c) as outlined below in accordance with the Guidance on submission of food additive evaluations by the Scientific Committee on Food or a commitment to generate the sought data through new studies and provide them to EFSA.

Interested parties and stakeholders should submit the requested data on genotoxicity or provide information that they have commissioned the studies before 1 July 2011. If the necessary genotoxicity data have not been made available and genotoxicity studies have been commissioned and new genotoxicity data will be generated, EFSA will set a new deadline for the submission of these data which will be communicated to the parties commissioning the studies and published on EFSA’s website.

In case neither the necessary genotoxicity data nor a commitment to generate and provide the sought data through new studies will have been provided to EFSA by 1 July 2011, EFSA will base its evaluation of the safety of paprika extract, capsanthin, capsorubin (E 160c) when used as a food colouring substance on the information available.

Information sought
EFSA kindly asks governments, interested organisations, universities, research institutions, companies and other interested parties to submit genotoxicity data as mentioned below on paprika extract, capsanthin, capsorubin (E 160c). The request for genotoxicity data is made in accordance with the Guidance on submission of food additive evaluations by the Scientific Committee on Food[3].

-  A standard battery of in vitro tests for genotoxicity of paprika extract, capsanthin, capsorubin (E 160c). The standard test battery should include the following: (1) a test for induction of gene mutations in bacteria (Ames test; OECD Guideline 471); (2) a test for induction of gene mutations in mammalian cells (preferably the mouse lymphoma tk assay with colony sizing; OECD Guideline 476); and (3) an in vitro chromosomal aberration test (OECD Guideline 473) or an in vitro micronucleus assay (OECD Guideline 487).

-  Positive results in any of the above in vitro tests will require further assessment of genotoxicity in vivo. Any of the following tests may be conducted: (1) a rodent bone marrow or mouse peripheral blood micronucleus test (OECD Guideline 474) or a rodent bone marrow clastogenicity study (OECD Guideline 475); (2) a Comet (single cell gel electrophoresis) assay in (a) relevant tissue(s); (3) a test for gene mutations in a transgenic rodent model, e.g. using lacI, lacZ or cII as reporter gene; or (4) a rat liver Unscheduled DNA synthesis (UDS) test.

The content of capsanthin, capsorubin and particularly capsaicin in the test preparation should be clearly specified. It should also be indicated whether the material tested is in accordance with the specifications for paprika extract, capsanthin, capsorubin (E 160c) as defined in Directive 2008/128/EC[4]. The tests should be carried out according to the OECD Guideline for the Testing of Chemicals No. 474 and 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.

Process of the call for data
The above data on genotoxicity needs to be submitted electronically by 1 July 2011 at the latest.

In case genotoxicity studies have been commissioned and new genotoxicity data will be generated EFSA needs to be informed by 1 July 2011 at the latest. Based on the timeframe of the commissioned studies on genotoxicity EFSA the new deadline for submission of these data will be communicated to the parties commissioning the studies and generating the data and published on EFSA’s website.

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.

Correspondence
Please send all electronic correspondence, including enquiries to: foodadditives@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
43121 Parma
Italy

Published: 31 March 2011