No general deadline is defined for step 2 as step 2 will take place at different points in time following the selection by EFSA of the relevant data.
Deadline for informing EFSA about additional documents/data, which may become available after the deadline defined for step 1 of this call for data: 31 December 2012
The Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) has been asked by the European Commission to re-evaluate all currently permitted food additives in the EU and issue related scientific opinions. Article 32 of Regulation (EC) No 1333/2008 specifies that all food additives permitted before 20 January 2009 should be subject to a new risk assessment by EFSA. A new Regulation setting the re-evaluation programme in accordance with Regulation (EC) No 1333/2008 will be adopted by the European Commission in 2010. This Regulation will specify the priorities and the deadlines for the re-evaluation.
After the food colours, which are currently being re-evaluated, another group of food additives to be re-evaluated is comprised of the emulsifiers, stabilisers and gelling agents (see table in Annex).
In preparation for their re-evaluation, existing information on the permitted emulsifiers, stabilisers and gelling agents needs to be collected, collated and summarised. Evaluation of the technical requirements and use of food additives is outside the remit of EFSA and will be undertaken by the European Commission and EU Member States.
The purpose of this call for data is to offer interested parties the opportunity to submit any available documented information, published or unpublished, relevant to the specific areas indicated below.
These submissions will be done in a 2-step process and should be as comprehensive as possible:
- Step 1: Registration of the contact details of the interested party and description of the information available
The interested parties need to register their contact details and provide a list of documents/data available for a given group of food additives (as defined by EFSA). This information needs to be submitted electronically, using the excel file template defined by EFSA, to the following e-mail address: foodadditives [at] efsa.europa.eu
Please provide one excel file per defined group of food additives (the groups are predefined by EFSA as shown in the Annex and can be selected in the excel file from a drop-down menu). Therefore, if an interested party wants to submit information related to different groups of food additives, several excel files should be provided.
N.B.: some groups can consist of only one food additive and the deadline of the call for data applies only to 'step 1'
- Step 2: Submission to EFSA of the data selected by EFSA
Following the screening of all submissions received, EFSA will request hard and/or electronic copies of selected documents only.
Timely receipt of such information is important in ensuring that appropriate science-based evaluations will be taken into account for the re-evaluation of these food additives. Therefore the submission of the selected data should take place within 20 working days following EFSA’s request.
N.B.: Interested parties can inform EFSA about additional documents/data, which may become available after the deadline defined for step 1 of this call for data, before 31.12.2012 at the latest. This information needs to be submitted electronically, to the e-mail address: foodadditives [at] efsa.europa.eu.
During the re-evaluation process, EFSA may request additional information considered to be relevant for the re-evaluation of a particular food additives or group of food additives by a new call for data.
EFSA kindly ask governments, interested organisations, universities, research institutions, companies and other EFSA stakeholders to submit information on the food additives under consideration relevant to the specific areas indicated below.
- Safety in use (including the scientific data not previously reviewed in the scientific opinions by the SCF and JECFA, as well as the original study reports evaluated by the SCF and JECFA; safety in use should be understood in the widest possible sense and the relevance of any biological data should be considered);
- Specifications presently in use, including purity and, when relevant, particle size;
- Production methods;
- Analytical methods available for determination in food;
- Present use and use patterns (i.e. which food categories and subcategories, proportion of foods within categories/subcategories in which it is used, actual use levels (typical and maximum use levels), especially for those uses which are only limited by quantum satis);
Confidentiality and unpublished data
Specific issues relating to confidentiality of unpublished data should be discussed between the owners of the data and EFSA and the Commission shall decide on a proposal from EFSA which information may remain confidential.
All correspondence should be sent only electronically to: foodadditives [at] efsa.europa.eu
 In the case of invertase, in view of the deadline for the re-evaluation of this enzyme foreseen in the forthcoming Commission Regulation setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives, the deadline for informing EFSA about additional documents/data, which may become available after the deadline defined for step 1 of this call for data is set to 31.12.2013.
 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives.
 Any personal data is processed pursuant to Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000, on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data.
Personal data will be collected in an internal EFSA database and concern contact references and affiliation information of representatives of organisations submitting information relevant to the safety of the food additives under consideration in this call.
The Head of the Unit for Food additives and nutrient sources added to food (ANS Unit) is identified as the controller of the personal data processing.
Applicants are able to modify at any time personal data submitted in EFSA’s internal database by contacting directly the ANS Unit (foodadditives [at] efsa.europa.eu). Personal data contained in this system are only accessible by the authorised users of the ANS Unit and the IT Unit of EFSA.
Personal data will be erased from the system as soon as these are no longer relevant for the purpose of this call. Concerning the processing of personal data, applicants have the right to have recourse at any time to the European Data Protection Supervisor.