Call for scientific data on miscellaneous food additives permitted in the EU and belonging to several functional classes

Échéance: 9 décembre 2010

Modified on 16 June 2010[1], [2]

Background

According to Article 32 of Regulation (EC) No 1333/2008[2], all food additives permitted before 20 January 2009 should be subject to a new risk assessment by 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an effective re-evaluation, it is important that EFSA acquires from the interested parties all data (published or unpublished) relevant to the re-evaluation of the selected miscellaneous food additives. These data will be considered for the EFSA opinions/statements on the food additives to be re-evaluated in the coming years in accordance with the priorities and deadlines set in the Regulation[3].

The miscellaneous food additives to be re-evaluated (see tables in Annex) have been selected in line with the priorities defined by the Commission Regulation (EU) 257/2010, and based on their technological function, can be grouped as follows:

1. Preservatives and antioxidants
2. Flavour enhancers
3. Acidity regulators
4. Emulsifiers, stabilisers, gelling agents and anti-caking agents.

In preparation for their re-evaluation and in the absence of new application dossiers, existing information on the selected miscellaneous food additives needs to be collected, collated and summarised.

Overall objective

The purpose of this call for data is to offer all interested parties and stakeholders the opportunity to submit any available documented information, published or unpublished, relevant to the specific areas indicated below.

Information sought

EFSA kindly ask governments, interested organisations, universities, research institutions, companies and other interested parties to submit information on food additives relevant to the specific areas indicated below.

• Present use patterns (intake, actual use levels (typical and maximum) and exceptions to these levels), and, if available, corresponding exposure assessments;
• Purity of miscellaneous additives presently in use, including particle size and particle size distribution when relevant;
• Production methods;
• Analytical methods available for determination in food;
• Toxicokinetics and toxicity (subchronic toxicity, genotoxicity, chronic toxicity and carcinogenicity, reproduction and developmental toxicity, allergenicity etc.) and any information relevant to their safety assessment.

N.B.: EFSA is interested to receive all the original study reports previously evaluated by the SCF and JECFA as well as scientific papers and original study reports not previously considered in SCF and JECFA evaluations.

Process of the call for data

The submissions of data 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 available information
  The interested parties should provide EFSA with a description of available information (i.e. documents, type of data, reports etc) for each particular food additive or given group of food additives (as predefined by EFSA, shown in the Annex) as well as their contact details (name of contact person, name of company, email address and telephone number). This inventory of available data should, as far as possible, be made according to the structure of the currently applicable guidance document on food additives (SCF 2001 Guidance on submissions for food additive evaluations[4]).
  
  This information needs to be submitted electronically to the following e-mail address foodadditives@efsa.europa.eu, stating clearly in the subject line the food additive or group of food additives it refers to.

• Step 2[5] : Submission to EFSA of the data selected by EFSA
  Following the receipt and screening of all submissions, EFSA will request hard and/or electronic copies of selected documents only. Timely receipt of such information is important in ensuring a comprehensive science-based evaluation will be undertaken for the re-evaluation of these additives. Therefore the submission of the selected data should take place within 20 working days following EFSA’s request. However, please note that this request by EFSA will not necessarily take place immediately after the receipt of the description of the available information (done during step 1) and will usually be made after consultation with the information holder.

N.B.: In case additional documents/data would become available after the deadline defined for the step 1 of this call for data, the interested parties will be able to inform EFSA before 31.12.2012 at the latest. This information needs to be submitted electronically, to the e-mail address: foodadditives@efsa.europa.eu

Confidentiality and unpublished data

Specific issues relating to confidentiality of the data provided should be discussed between the owners and EFSA. In application of the 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.

Contact details

All electronic correspondence, including enquiries, should be sent 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

Publié: 9 juin 2010