Call for technical and toxicological data on sodium carboxymethylcellulose (E 466) for uses as a food additive in foods for all population groups including infants below 16 weeks of age

EFSA-Q-number: EFSA-Q-2018-00563

• Published: 18/07/2018
• Deadline for registering interest: 26/09/2018
• Deadline for submission of data: 31/12/2019

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].

EFSA has issued a scientific opinion on the safety of sodium carboxymethylcellulose (E466) when used as food additive^[3] 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^[4]. 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^[5] 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 sodium carboxymethylcellulose (E466) 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^[5], the risk assessment to be performed will address the safety of uses of sodium carboxymethylcellulose (E466) 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 sodium carboxymethylcellulose (E466) 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 sodium carboxymethylcellulose (E466) are included in this call for data.

EFSA will consider the relevance of the information provided for the risk assessment of sodium carboxymethylcellulose (E466). 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.

Overall objective

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 sodium carboxymethylcellulose (E466) 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 (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 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 invites business operators and other interested parties (governments, interested organisations, universities, research institutions, companies) to submit information on the food additive sodium carboxymethylcellulose (E466), as appropriate. The 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 sodium carboxymethylcellulose (E466) as food additive by the EFSA ANS Panel published in 2017^[3].
• for the risk assessment of sodium carboxymethylcellulose (E466) in food for infants below 16 weeks of age in the food categories 13.1.5.1 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^[5].

A. Information regarding the follow up of the conclusions and the recommendations of the EFSA ANS Panel opinion on the safety of sodium carboxymethylcellulose (E466) as food additive^[3]

With reference to the conclusions and recommendations in the Scientific Opinion on the re-evaluation of sodium carboxymethylcellulose (E466) as a food additive by the EFSA ANS Panel published in 2017^[3] information for sodium carboxymethylcellulose (E466) 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;

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

According to the conclusions and recommendations in the Scientific opinion on the re-evaluation of sodium carboxymethylcellulose (E466) as a food additive by the EFSA ANS Panel published in 2017^[3], the generation of additional data to assess the potential health effects of sodium carboxymethylcellulose (E 466) when used as a food additive in ‘dietary foods for infants for special medical purposes and special formulae for infants’ (Food category 13.1.5.1) and in ‘dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC’ (Food category 13.1.5.2) was recommended. These requirements could be addressed as outlined in section B. 2.

3. Literature searches

Literature searches should be conducted relevant for the safety evaluation of sodium sodium carboxymethylcellulose (E466) for all uses in foods for all population groups from 02/05/2017^[6] up to the date of the data submission, as described in the Guidance for submission for food additive evaluation (see its section 5.3)^[4].

B. Information required for the risk assessment of sodium carboxymethylcellulose (E466) for uses as food additive for uses in foods for infants below 16 weeks of age

1. Technical data

For the uses of sodium carboxymethylcellulose (E466) as a food additive in foods for infants below 16 weeks (FC 13.1.5.1) EFSA seeks information on:

• the usage levels of use of sodium carboxymethylcellulose (E466) alone or in combination with other thickening agents (indication of food additive name and level of use)in the special formulae for infants below 16 weeks of age under special medical conditions (FC 13.1.5.1);
• the fate and the reaction products of sodium carboxymethylcellulose (E466) in special formulae for infants below 16 weeks of age under special medical conditions (FC 13.1.5.1);
• particular specification requirements for identity and purity of sodium carboxymethylcellulose (E466) (e.g. content of toxic elements, sodium, total glycolate, isopropanol) in special formulae for infants below 16 weeks of age under special medical conditions (FC 13.1.5.1). 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 absenceof Cronobacter (Enterobacter) sakazakii.

2. Toxicological data

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^[5] the following information on the toxicological properties of sodium carboxymethylcellulose (E466) and its adverse effects relevant for the safety of its use as a food additive in foods for special medical purposes (FSMP) for infants below 16 weeks is required. This information is also considered relevant for the risk assessment of the use of sodium carboxymethylcellulose (E 466) as a food additive in FSMP for older infants and young children considering that the studies are of appropriate duration (see part A.2.):

• a repeated dose study with direct oral administration of sodium carboxymethylcellulose (E466) to neonatal animals, which includes gross and histopathological examination of gastrointestinal tract, influence on the microbiota and a possible modification in the bioavailability of nutrients, that are normally contained in food for infants. The study shall be performed in piglets unless justification for the relevance of a study in another species is given;
• clinical data focusing on gastrointestinal effects to assess the safety of sodium carboxymethylcellulose (E466) when used in dietary foods for special medical purposes in infants below 16 weeks of age (FC 13.1.5.1);
• post-marketing surveillance reports on undesired and adverse reactions (including e.g. flatulence, gastrointestinal discomfort, changes of stool-frequencies and consistency, diarrhoea and allergic reactions), indicating the ages and other relevant data of the exposed infants and young children and the use levels in the marketed products;
• published and unpublished case reports (e.g. available nutrivigilance data) on undesired and adverse effects, including e.g. flatulence, gastrointestinal discomfort, changes of stool-frequencies and -consistency, diarrhoea and allergic reactions, associated with the oral administration of sodium carboxymethylcellulose (E466) in any form, to infants and young children.

3. Literature searches

Literature searches should be conducted relevant for the safety evaluation of sodium carboxymethylcellulose (E466) 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 evaluation (see its section 5.3)^[4].

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 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-2018-00563);
  • Reference to the substance concerned and its E number;
  • The contact details^[7] (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

Submissions should be sent to the following address:

European Food Safety Authority
FIP Unit
Via Carlo Magno 1/a
I-43126 Parma
Italy

Annex I

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: