Call for technical data on salts of fatty acids (E470a,b) and related food additives authorised in the EU - Extended deadline: 30 September 2016

Deadline
30 September 2016
Document (151.24 KB)

Background

Regulation (EC) No 1333/20081 of the European Parliament and of the Council on food additives requires the European Commission to set up a programme for the re-evaluation, by the European Food Safety Authority (EFSA), of the safety of food additives which were permitted in the European Union before 20 January 2009. In consultation with EFSA, the European Commission adopted a re-evaluation programme for the risk assessment of those additives, set up in Commission Regulation (EU) No 257/20102 to be carried out by EFSA.

In accordance with the above regulations EFSA started a systematic re-evaluation of authorised food additives and is issuing scientific opinions on these food additives, according to the priorities indicated in the Commission Regulation (EU) No 257/2010.

In order to ensure an effective re-evaluation, it is important that EFSA retrieves from interested parties all relevant data for the re-evaluation of the selected food additives. Therefore, in accordance to article 6(3) of the regulation (EU) No 257/2010 EFSA launches a public call for data in order to acquire documented information (published, unpublished or newly generated) on the specifications and manufacturing processes of salts of fatty acids (E470a,b) and related food additives authorised in the EU.

EFSA will consider the relevance of the information provided for the risk assessment of these food additives. The submission of the requested information is without prejudice to the final opinion of the ANS Panel.

Overall objective

The purpose of this call for data is to offer to interested parties and/or stakeholders the opportunity to submit documented information (published, unpublished or newly generated) relevant to the re-evaluation of salts of fatty acids (E470a,b) and related food additives authorised in the EU.

Deadline for submission of data and disclosure of contact details

Interested parties and stakeholders should provide by 30/09/2016 the information described below.

Within 4 weeks from the publication of this call, please communicate in writing by e-mail to: fip [at] efsa.europa.eu, your availability to submit the requested information by the timeline specified above or any proposal for a new deadline providing justified reasons. Depending on the replies received the final deadline will be communicated to you through e-mail and by updating the current call.

In accordance with Article 6(4) of the Commission Regulation (EU) No 257/2010 the information not submitted within the final deadline will only exceptionally be considered and EFSA can finalise its opinions on the basis of the information already provided.

In order to facilitate the collaboration of all interested parties to provide the data needed, we are seeking your consent to disclose your personal data (name, e-mail address and telephone number) to the other parties that has expressed an interest to provide the requested information. If you do not wish to make your contact details available, clearly indicate it in your first communication.

Information sought

EFSA kindly invites business operators and other interested parties (governments, interested organisations, universities, research institutions, companies) to submit information on the following food additives:

Additive

E number

Sodium, potassium and calcium salt of fatty acids

E 470a

Magnesium salt of fatty acids

E 470b

Mono- and diglycerides of fatty acids

E 471

Acetic acid esters of mono- and diglycerides of fatty acids

E 472a

Lactic acid esters of mono- and diglycerides of fatty acids

E 472b

Citric acid esters of mono- and diglycerides of fatty acids

E 472c

Tartaric acid esters of mono- and diglycerides of fatty acids

E 472d

Mono and diacetyltartaric acid esters of mono- and diglycerides of fatty acids

E 472e

Mixed acetic and tartaric acid esters of mono- and diglycerides of fatty acids

E 472f

Polyglycerol esters of fatty acids

E 475

Propane-1,2-diol esters of fatty acids

E 477

Thermally oxidized soya bean oil interacted with mono- and diglycerides of fatty acids

E 479b

 

Each of the above food additives can be manufactured using different sources of fatty acids and as a consequence, EFSA seeks for the following data:

  • Information on manufacturing processes for the food additive listed above including information on the sources used.
  • Information on the chemical identity of each individual fatty acid including their percentage in the sources used for each food additive listed above.

Confidentiality

According to article 8 of Commission Regulation (EU) No 257/2010 setting up a re-evaluation programme of approved food additives, confidential treatment may be given to information the disclosure of which might significantly harm the competitive position of business operators or other interested parties.

Therefore, the business operators and/or the interested parties should indicate which information wish to be treated as confidential and provide verifiable justification supporting this request. Note that the information described in article 8(2) of the Commission Regulation (EU) No 257/2010 cannot be confidential.

In application of Article 8(4) Commission Regulation (EU) 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.

Submission of information

Interested business operators and/or interested parties should submit the information to EFSA in electronic form (e.g. CD, DVD, etc.) with a

  • cover letter that should contain:

    • Reference to the specific call and the specific EFSA question number indicated (EFSA-Q-2016-00073);
    • Reference to the substance concerned and its E-number;
    • The contact detail (name of contact person, name of company/organisation, email address and telephone number) of the person responsible for the data submission and, if applicable, the list of interested business operators and/or interested parties represented and their contact details;
  • statement of the submitter that they hold all the necessary rights to grant EFSA permission to use and, where appropriate, to disclose the submitted information, data, document, paper or study for the purposes better defined in this call. In case the submitter does not enjoy the necessary rights for these data or studies, they should share the contact details of the respective owner(s) of data and/or of the relevant intellectual property right, so that EFSA may seek their approval directly.
  • separate folders with the confidential and with the non-confidential parts.

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

In case future mutual interests arise in exchanging any relevant information (i.e. technical or toxicological data) with the Joint WHO – FAO Expert Committee on Food Additives (JECFA) for the re-evaluation of food additives, we would appreciate your written consent for data sharing between EFSA and JECFA on this additive.

Note that EFSA may use or re-use relevant information or data (i.e. technical, toxicological data) for the evaluation of the same or another substance under the same or a different legal or regulatory framework from the one mentioned above.

Correspondence

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

Submissions should be sent to the following address:

FIP Unit, Food Additives
European Food Safety Authority
Via Carlo Magno 1/a
43126 Parma

Published
19 January 2016