In February 2012 the European Food Safety Authority (EFSA) launched a second public call for scientific data on the food additive shellac (E 904)1. The call for data was launched due to the limit outcome of a previous public call for data launched in November 2009 on miscellaneous waxes permitted as food additives in the EU2 .
The second public call for data ended in June 2012 and limited toxicological data on shellac (E 904) were provided which would not enable EFSA to conclude on the safety of its use as a food additive. However, interested parties have provided information to EFSA that they are willing to commission new studies to generate the missing data needed for the risk assessment.
In order to ensure an effective re-evaluation of shellac (E 904), it is important that EFSA acquires from interested parties commitment to commission the studies listed below which are deemed needed for the re-evaluation of shellac (E 904).
The purpose of this call for data is to offer all interested parties and stakeholders the opportunity to provide commitment to commission new studies as outlined in more detail below.
Interested parties and stakeholders should provide by 1 December 2012 information that they have commissioned the relevant studies with supporting evidence as well as the detailed protocols and timelines of the studies. Based on the commissioned studies EFSA will set a final 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 no commitment to generate the sought data through new studies would have been provided to EFSA by 1 December 2012, EFSA will base its re-evaluation of shellac (E 904) on the information available at that date.
EFSA kindly asks governments, interested organisations, universities, research institutions, companies and other interested parties to submit the data as mentioned below on shellac (E 904) and with reference to the 2001 guidance of the Scientific Committee on Food on submissions for food additive evaluations4.
In the absence of evidence from the ADME studies (unfeasible, due to the fact that shellac is a complex mixture of chemicals and that no specific marker compound has been identified that could be used to this end) the ANS Panel have concluded that it cannot be assumed that absorption of shellac (E 904) is negligible and therefore the following studies should be commissioned:
- a sub-chronic 90-day repeated toxicity in rats in accordance with the OECD Test Guideline 4083 , limited to dose-range finding.
- for the endpoint genotoxicity an in vitro micronucleus test.
- a combined chronic toxicity/carcinogenicity study in rats following the OECD Test Guideline 4534 as specified in the previous public call for data.
- a two-generation reproductive toxicity study in rats in accordance with OECD Test Guideline 4165 , is considered acceptable provided that it is accompanied by the prenatal developmental toxicity study (OECD Test Guideline 4146), as specified in the previous public call for data.
The content of shellac (E 904) in the test preparation should be clearly specified. It should also be indicated whether the material tested is in accordance with the specifications for shellac (E 904) as defined in Directive 2008/84/EC7. The tests should be carried out according to the principles of Good Laboratory Practice (GLP) described in Directives 2004/9/EC8 and 2004/10/EC9 and accompanied by a statement of GLP compliance.
Process of the call for data
The information that case studies have been commissioned and new data will be generated needs to be submitted to EFSA electronically by 1 December 2012 at the latest.
Based on the timeframe of the commissioned studies the new deadline for submission of these data will be communicated by EFSA 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 on the basis of the justifications provided by the data owners. 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:
FIP Unit, Food Additives
European Food Safety Authority
Via Carlo Magno 1/a