- Published: 18/07/2018
- Deadline for registering interest: 26/09/2018
- Deadline for submission of data: 31/12/2019
According to Regulation (EC) No 1333/2008, food additives which were permitted for use in the European Union before 20 January 2009 need to be re-evaluated by the European Food Safety Authority (EFSA). The programme for this re-evaluation is defined by Regulation (EU) No 257/2010.
EFSA has issued a scientific opinion on the safety of lecithins (E 322) when used as food additive in food categories specified in Annexes II and III to Regulation (EC) No 1333/2008, exempting those for infants below 12 weeks of age. The reason was that the risk assessment approach followed until now by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in the re-evaluation of food additives does not apply to this age group. The ANS Panel has, therefore, specified in its opinion that the re-evaluation of uses for this particular age group will be performed separately.
On 31 May 2017, EFSA’s Scientific Committee (SC) published a guidance document on the risk assessment of substances present in food intended for infants below 16 weeks of age, enabling the ANS Panel to assess the safe use of lecithins (E 322) and of other food additives for the population group below that age.
Following the latest advice from the EFSA’s Scientific Committee (SC) published guidance document, the risk assessment to be performed will address the safety of uses of lecithins (E 322) in foods for infants below 16 weeks of age.
In addition, the ANS Panel identified in the conclusions and recommendations of its published opinion on lecithins (E 322) data gaps in the risk assessment, relevant for all population groups.
For the sake of efficiency, the European Commission asked EFSA to address the above lack of data (data gaps) during its risk assessment of food additives for uses in food for young infants. Therefore specific data requirements for all uses of lecithins (E 322) are included in this call for data.
EFSA will consider the relevance of the information provided for the risk assessment of lecithins (E 322). The submission of the requested information is without prejudice to the final opinion of the Panel.
According to Article 6(5) of Regulation (EU) No 257/2010 where the requested information has not been submitted to EFSA within the set deadlines, the food additive may be removed from the Union list in accordance with the procedure laid down in Article 10.3 of Regulation (EC) No 1333/2008.
The purpose of this call for data is to offer interested parties (IPs) the opportunity to submit documented information (published, unpublished or newly generated) relevant to the re-evaluation of lecithins (E 322) to be used in foods for infants below 16 weeks of age, as well as to address the data gaps that have been identified for all population groups in the already published EFSA opinion on this food additive.
Deadline for submission of data and disclosure of contact details
Interested parties and stakeholders should provide earlier or at the latest by 31/12/2019 the information described below.
Within 10 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 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.
EFSA invites business operators and other interested parties (governments, interested organisations, universities, research institutions, companies) to submit technical and toxicological data on lecithins (E 322), as appropriate. This information will be used:
- for the follow-up on issues that have been expressed in the conclusions and recommendations of the Scientific Opinion on the re-evaluation of lecithins (E 322) as a food additive by the EFSA ANS Panel published in 2017.
- for the risk assessment of lecithins (E 322) in food for infants below 16 weeks of age in the food categories 13.1.1, 184.108.40.206 and section B of part 5 of Annex III. It should be in accordance with the EFSA Guidance of the Scientific Committee on the risk assessment of substances present in food intended for infants below 16 weeks of age.
A. Information regarding the follow up of the conclusions and the recommendations of the EFSA ANS Panel opinion on the safety of lecithins (E 322) for all uses (EFSA, 2017)
With reference to the conclusions and recommendations in the Scientific Opinion on the re-evaluation of lecithins (E 322) as a food additive by the EFSA ANS Panel published in 2017 information for lecithins (E 322) is sought on:
1. Technical data
- analytical data on current levels of lead, mercury, cadmium and arsenic in commercial samples of the food additive;
- the lowest technologically achievable level for lead, mercury, cadmium, and arsenic in order to adequately define their maximum limits in the specifications
- analytical data on current levels of residual proteins in commercial samples of the food additive;
- the lowest technologically achievable level for residual proteins to reduce their content as much as possible in view of case reports on hypersensitivity reactions associated with soya and egg lecithins.
The information should be supported by data from at least five different batches and the analyses should be performed with appropriate analytical methods. EFSA seeks specific data on the methods of analysis used. These include but are not limited to e.g the principle of the method, the scope of the method (i.e. the range of sample types that the method is used for), the concentration units used to express the analytical result(s), validation of the method (in particular limit of detection (LOD) and (LOQ).
Such methods should employ state of the art techniques.
2. Toxicological data
With reference to the conclusions and recommendations in the Scientific opinion on the re-evaluation of lecithins (E 322) as a food additive by the EFSA ANS Panel published in
2017 a study with lecithins (E 322) in compliance with the current OECD TG 426 (Developmental neurotoxicity study) is required. This information is intended to clarify the relevance of the results from inadequate neurobehavioural studies. The tested lecithin should be representative of the food additive E 322 on the market and be well characterised including its content of phosphatidyl-choline. In addition the total choline (bound and free) in the diet(s) should be determined.
3. Literature searches
Literature searches should be conducted relevant for the safety evaluation of lecithins (E b322) for all uses in foods for all population groups from 23/11/2016 up to the date of the data submission, as described in the Guidance for submission for food additive evaluations (see its section 5.3).
B. Information required for the risk assessment of lecithins (E 322) for uses in foods for infants below 16 weeks of age
For the uses of lecithins (E 322) in foods for infants below 16 weeks EFSA seeks for
1. Technical data
- information on the levels of use of lecithins (E 322) in the infant formulae for infants below 16 weeks of age (FC 13.1.1) and in special formulae for infants of that age under special medical conditions (FC 220.127.116.11), as well as analytical data on the additive in these formulae and analytical data on choline in these formulae added as nutrient.
- information on the percentage of phosphatidyl choline content (mass %) in specific lecithins preparations used as food additive E 322 in the infant formulae for infants below 16 weeks of age (FC 13.1.1), as well as in special formulae for infants of that age under special medical conditions (FC 18.104.22.168);
- information on the fate and the reaction products of lecithins (E 322) in the infant formulae for infants below 16 weeks of age, as well as in special formulae for infants of that age under special medical conditions;
- information on particular specification requirements for identity and purity of lecithins (E 322) (e.g. with respect to the origin of lecithins (E 322) from soy or eggs and to levels of protein residues; content of toxic elements) when used as food additive in the infant formulae for use in infants below 16 weeks of age, as well as in special formulae for infants of that age under special medical conditions. Analytical data on impurities in the final special formulae for infants below 16 weeks of age need to be provided when no legal limit has been established. In addition, data should be provided demonstrating the absence of Cronobacter (Enterobacter) sakazakii.
2. Toxicological data
A developmental neurotoxicity study according to currentOECD TG 426 is required, as mentioned above (section A.2). In the study the concentration of metabolites of lecithins (e.g. choline) in the dams milk should be determined. Conclusions on the possible need of additional studies within the frame of the EFSA Guidance of the Scientific Committee on the risk assessment of substances present in food intended for infants below 16 weeks of age can be drawn as soon as the results of the OECD TG 426 are made available.
Furthermore, the following information on the toxicological properties of lecithins (E 322) and its adverse effects relevant for its use in formulae and foods for special medical purposes (FSMP) for infants below 16 weeks is required:
- post-marketing surveillance reports on adverse reactions, including allergic reactions, indicating the ages and other relevant data of the exposed infants and the use levels of lecithins (E 322) in the marketed products, where the infant formulae and FSMPs are already in use;
- published and unpublished case reports, e.g. available nutrivigilance data, on adverse or undesired effects, including allergic reactions, associated with the oral administration of lecithins in any form to infants.
Additional existing studies, including confidential reports, if available:
- studies on toxicokinetics (absorption, distribution, metabolism in particular related to choline production, excretion) in the neonatal and young organism compared with the adult;
- special studies aimed to identify potential effects of exposure during life stages in experimental animals of relevance to human infants e.g. extended one-generation reproductive toxicity study, repeated dose study on neonatal animals;
- special studies aimed at investigating effects on nutrient availability;
- other relevant studies (human data, including clinical and epidemiological studies).
3. Literature searches
Literature searches should be conducted relevant for the safety evaluation of lecithins (E 322) when used in foods for infants below 16 weeks of age up to the date of the data submission, as described in the Guidance for submission for food additive evaluations (see its section 5.3).
According to article 8 of 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 Regulation (EU) No 257/2010 cannot be confidential.
In application of Article 8(4) of 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-rom, DVD, etc.) with a
- cover letter that should contain:
- Reference to the specific call and the specific EFSA question number indicated (EFSA-Q-2018-00560);
- Reference to the substance concerned and its E number;
- The contact details (name of contact person, name of company/organisation, e-mail 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.
Please send all electronic correspondence, including enquiries to: fip [at] efsa.europa.eu
Submissions should be sent to the following address:
European Food Safety Authority
Via Carlo Magno 1/a
Naming convention to be used for submission of information
Please create a folder with subfolders for each section applicable, as indicated below, and name files using the E number_section identification numbers_study name abbreviation of your choice, and indicating which parts are to be considered confidential:
Section 1. Technical data
Section 2. Biological and Toxicological data
Section 3. Literature searches
 Regulation (EC) No 1333/2008 on food additives, OJ L 354, 31.12.2008
 Regulation (EU) No 257/2010, setting up a programme for the re-evaluation of approved food additives in
accordance with regulation (EC) No 1333/2008, OJ L 80, 26.03.2010.
 Re‐evaluation of lecithins (E 322) as a food additive, EFSA ANS Panel, 2017.
 Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age. EFSA Scientific Committee, 2017.
 date of last literature search reported in the EFSA ANS opinion
 The interested parties shall notify EFSA of any change in the contact details by sending an e-mail to the FIP mailbox (fip [at] efsa.europa.eu).