Call for scientific data on selected food additives permitted in the EU- Extended deadline: 1 September 2014 (batch A), 1 November 2014 (batch B)

Background

According to Article 32 of Regulation (EC) No 1333/2008[i], all food additives permitted in the EU 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[ii].

In accordance with the above regulations EFSA started a systematic re-evaluation of authorised food additives and is preparing to issue scientific opinions on these food additives, according to the indicated priorities. 

However, in order to ensure an effective re-evaluation of the selected food additives it is important that EFSA acquires from interested parties all relevant data. Therefore, in accordance to article 6(3) of the regulation (EU) No 257/2010, the EFSA launches a public call for data for particular food additives in order to retrieve available documented information (published, unpublished or newly generated). These data will be considered for the EFSA Opinions on the food additives which are expected to be issued in the 2014-2015 time frame.

The food additives referred to are as follows (full list in Annex I):

• (E120) cochineal, carminic acid, carmines
• (E140ii) chlorophyllins
• (E141) copper complexes of chlorophylls, chlorophyllins
• (E160b) annatto, bixin, norbixin
• (E160c) paprika extract, capsanthin, capsorubin
• (E174) silver
• (E175) gold
• (E210-213) benzoic acid and benzoates
• (E220-228) sulphur dioxide and sulphites
• (E304ii) ascorbyl stearate
• (E311-312) gallates
• (E315-316) erythorbates
• (E444) sucrose acetate isobutyrate
• (E445) glycerol ester of wood rosin
• (E475) polyglycerol esters of fatty acids
• (E483) stearyl tartrate
• (E491-495) sorbitan esters

Overall objective

The purpose of this call for data is to offer interested business operators and/or other interested parties the opportunity to submit for the above mentioned food additives any available documented information (published, unpublished or newly generated) relevant to metabolism and toxicokinetics and toxicological data (details below).

Deadline for submission of data

Interested business operators and/or other interested parties should provide by 1 September 2014 or by 1 November 2014 the information available, according to the priority reported in Annex I.

Information sought

EFSA kindly asks national food authorities, research institutions, academia, food business operators and other interested parties to submit the following data for the above mentioned food additives:

Metabolism and toxicokinetics (absorption, distribution, metabolism, excretion)

• metabolism and pharmacokinetic studies

Toxicological data

• genotoxicity
• acute oral toxicity, short-term and subchronic toxicity, chronic toxicity and carcinogenicity
• reproductive and developmental toxicity
• special studies aimed at investigating immunotoxicity, hypersensitivity, neurotoxicity, endocrine activity, allergy and intolerance
• any other information relevant to the safety assessment

Response to the call of interest

Interested business operators and/or other interested parties are kindly invited to communicate to EFSA within 4 weeks from the launch of the call their interest to provide data for selected food additive/s. At the end of the period, EFSA intends to make publicly available the list of interested parties having expressed their interest in order to facilitate interactions among them and possibly coordination in the data submission. In case a party involved would object to the publication of its contact details, that shall be mentioned on the occasion of the first communication of interest to EFSA.  In the contrary case, the communication of interest shall be considered as a permission for EFSA to include the details of the party concerned in a list to be published in the EFSA website.

Please send all electronic communications to: fip [at] efsa.europa.eu

Response to the call of interest(266.91 KB)

Process of the call for data

Interested business operators and/or other interested parties should submit the information electronically to EFSA on a physical media (e.g. CD, DVD, etc.), with a cover letter stating clearly in the subject the food additive or group of food additives to which it refers.

All information should be submitted by 1 September 2014 or by 1 November 2014 at the latest, according to the priority reported in Annex I.

The cover letter should also contain the contact details (name of contact person, name of company, email address and telephone number) of the person responsible for the data submission and, as applicable, the list of interested business operators represented. The letter should also specify the rights of the provider on the data submitted (especially the right to disclose them to third parties). In case the submitter does not have the rights for these data, the contact details of the respective data owner(s) should also be provided in order to enable EFSA to seek their approval directly.

Interested business operators and/or other 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.

Possibility for EFSA to use the data for the safety assessment of the same substance under other legal or regulatory frameworks.

In line with Union policy objectives on animal welfare and testing on vertebrates, EFSA aims at avoiding  the duplication of testing on vertebrates, and at achieving an optimal use of the relevant financial and human resources by the private sector. Therefore, in anticipation of cases where EFSA may be interested in using or reusing relevant information or data (i.e. technical, toxicological data) for the evaluation of the same substance under a different legal or regulatory framework from the one mentioned above, or for the evaluation of another substance under the same or different legal framework above, please indicate explicitly in writing whether by participating to the voluntary submission or relevant data or information you also give EFSA the permission to use and/or reuse these data for another EFSA safety assessment, and/or for a data sharing exercise with third country or international bodies.

Contact details

Submissions should be sent to the following address:

Food Ingredients and Packaging Unit - Food Additives
European Food Safety Authority
Via Carlo Magno 1/a
43126 Parma
Italy

Please send all electronic correspondence to:  fip [at] efsa.europa.eu

Annex I

The full list of food additives is as follows