Call for technical and toxicological data on pullulan (E 1204) authorised as a food additive in the EU

EFSA-Q-number of the substance: EFSA-Q-2021-00278

• Published: 19/01/2022
• Deadline for registering interest: 19/02/2022
• Deadline for submission of data: 19/07/2022

Background

According to Regulation (EC) No 1333/2008^[1], 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^[2].

In accordance with the above regulations EFSA was requested to start the re-evaluation of pullulan (E 1204) jointly with the evaluation of a new application on the proposed extension of use of pullulan (E 1204) to several food categories^[3].

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(EU) No 257/2010, EFSA launches a public call for data in order to acquire documented information (published, unpublished or newly generated) on pullulan E 1204. 

EFSA will consider the relevance of the information provided for the risk assessment of this food additive. The submission of the requested information is without prejudice to the final opinion of the FAF 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is to offer to interested parties and/or stakeholders, the opportunity to submit documented information (published, unpublished or newly generated) relevant to the re-evaluation of pullulan (E 1204).

Deadlines for submission of data and disclosure of contact details

Interested parties and stakeholders should provide by 19/07/2022 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 (fip[at]efsa[dot]europa[dot]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 the name and address of your organisation/business to the other parties that has expressed an interest to provide the requested information. If you do not wish to make these 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 additive:

EFSA seeks data on:

1. Safety evaluation strategy and corresponding testing strategy

Following a mandate (M-2019-0199) from the European Commission, EFSA has published a Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles (EFSA SC Guidance on particle-TR)^[4]. This Guidance establishes information requirements for conventional materials which do not meet the definition of engineered nanomaterial set out in the Novel Food Regulation (EU) 2015/2283. The EFSA SC Guidance on particle-TR is applicable since its publication in August 2021, and outlines appraisal routes (e.g. solubility/dissolution rate; particle size distribution; appropriateness of safety studies) to confirm that an assessment of the fraction of small particles including nanoparticles is not needed for the food additive pullulan (E 1204), or that is already covered in the safety assessment process following the conventional sectorial guidance (i.e. the 2012 ANS Panel Guidance for submissions for food additive evaluations^[5]) and the previous EFSA AFC Panel scientific opinion^[6].

Interested parties and/or stakeholders are kindly invited to provide scientific evidence, supported by data, e.g. confirming that the food additive pullulan (E 1204) meets the solubility or the dissolution rate criteria indicated in Section 2 of the EFSA SC Guidance on particle-TR.

As indicated in the EFSA SC Guidance on particle-TR, there are complementary appraisal routes and it is sufficient to demonstrate that the food additive pullulan (E 1204) meets at least one of the Decision criteria listed in Table 1 of the EFSA SC Guidance on particle-TR. Nevertheless, interested parties and/or stakeholders may submit information on more than one appraisal route.

2. Technical data

1. Identity and characterisation of the additive, as supported by data from at least five independently produced batches of pullulan (E 1204) (as recommended in the Guidance for submission for food additive evaluations1).
2. Chemical composition of the polysaccharide pullulan used as food additive, e.g. identity and percentage of the monosaccharide units, percentage of branching points.
3. Distribution of the molecular weights within the polysaccharide pullulan used as food additive and its average molecular weight.
4. Concentration range of main components of the food additive E1204 (e.g. mono-, di- and oligosaccharides, total protein, moisture, sulphated ash). 
5. Detailed information on the manufacturing process(es) used for E 1204, including indication of starting materials, solvents used, chemical reactions and purification processes is needed. In addition, information is needed on the presence and levels in the food additive E 1204 of any impurities linked to the manufacturing process used, including information on how the absence of any potential impurities that could be present, is confirmed.
6. Analytical data on the presence of impurities, as appropriate - including toxic elements, such as arsenic, nickel, lead, mercury, cadmium, etc.- supported by certificate of analysis, together with information on lowest technologically achievable levels to adequately propose maximum limits in the current EU specifications 
7. Analytical data on microbiological specifications, and possible secondary metabolites (e.g. mycotoxins, aureobasidin A).
8. Information on the method(s) of analysis in food.
9. Information on the stability under the normal condition of storage of the food additive and its fate in food, covering the range of intended applications in food along with the conditions of food processing (e.g. high temperature, pH range).

The analyses should be performed in possibly at least 5 independently produced batches of the food additive, with appropriate analytical methods applying state of the art techniques. Specific data on the methods of analysis used should be provided. 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).

3. Information on production organism

Pullulan (E 1204) is a linear polysaccharide (glucan) consisting predominantly of repeating maltotriose units. It is produced as extracellular glucan by Aureobasidium pullulans. Aureobasidium pullulans is excluded for QPS assessment because recent taxonomic insights classified it as a filamentous fungus^[7].

Since pullulan (E 1204) is a food additive of microbial origin, the following information is sought:

1. The microbial origin of food additives produced by fermentation or cultivation, including:
   • Name of the microorganism (species and strain)
   • Taxonomic classification of the microorganism up to the strain level;
   • History of modifications of the production organism. If the organism has been subject to genetic modifications, these should be characterised;
   • Certificate of deposition of the microorganism in an internationally recognised culture collection stating the deposition number
2. Experimental data demonstrating that no living cells are present in the final product.
3. Information on the identity of residual intermediates or microbial secondary metabolites (such as aureobasidin A) in the final product.
4. Any information on possible toxigenicity or pathogenicity. 

4. Data on use and use levels

Interested parties (e.g individual food manufacturers, food manufacturer associations) are invited to submit data on use levels of pullulan (E 1204) in food and beverages for human consumption.

According to Annex II of Regulation (EC) No 1333/2008, pullulan (E 1204) is currently permitted for use in the following food categories (FC):

In order to streamline the data collection exercise, food manufacturers are invited to liaise with the relevant food manufacturer associations for the data submission. In particular, data providers shall ensure that the same data are not sent several times to EFSA: for example, sent by both the food manufacturer and also by the association to which the food manufacturer belongs. 

If an interested party has information that pullulan (E 1204) is not used in one or both of the above food categories, this information is highly relevant for EFSA. Such information will of course be cross-checked with information sent by all interested parties.

Data providers should be aware that EFSA may need to contact them once the initial submission is received. The aim would be to clarify foods not well characterised/identified or to check any possible mistakes (e.g. on MPLs) or data that seems not plausible (e.g. on reported levels, proposed dilution factors). Replies to these requests are strongly encouraged as EFSA reserves the right to discard these data if feedback is not received. Data submission of use levels of pullulan (E 1204) in food and beverages intended for human consumption should be reported in the template specifically developed for this call and published on Zenodo together with a short guide.

Business operators and other interested parties are also invited to provide any available information on ‘other uses’ (e.g. pharmaceutical excipient) other than as food additive.

5. Biological and toxicological data

1. Toxicokinetics (absorption, distribution, metabolism, excretion). 
2. Genotoxicity. 
3. Studies on subchronic and chronic toxicity and carcinogenicity. 
4. Reproductive and developmental toxicity. 
5. Special studies aimed at investigating e.g. immunotoxicity, neurotoxicity, hypersensitivity, allergy and intolerance, when relevant. 
6. Other relevant studies (e.g. human studies, including clinical and epidemiological studies and case-reports). 

Any other information relevant to the safety assessment (e.g. acute toxicity).

The requested information should follow to the extent possible, the relevant parts of the applicable guidance on submissions for food additive evaluations^[8].

Confidentiality

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 through their chosen internet-based software (submission by email is not allowed) with a 

• cover letter that should contain:
  • Reference to the specific call;
  • Reference to the substance concerned its E number and its EFSA question number;
  • The contact details^[9] (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. 

Correspondence

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

[1] Regulation (EC) No 1333/2008 on food additives, OJ L 354, 31.12.2008

[2] 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. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010R0257&from=EN

[3] https://open.efsa.europa.eu/questions/EFSA-Q-2020-00517

[4] https://doi.org/10.2903/j.efsa.2021.6769

[5] https://doi.org/10.2903/j.efsa.2012.2760

[6] https://doi.org/10.2903/j.efsa.2004.85

[7] https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6377

[8] https://doi.org/10.2903/j.efsa.2012.2760

[9] 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 (fip[at]efsa[dot]europa[dot]eu)).