Call for data for Talc E 553b

Deadline for registering interest: 30 August 2026 
Deadline for submission of data: 31 July 2027

Background

According to Regulation (EC) No 1333/2008¹, 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). Only food additives that are included in the Union list, in particular in Annex II to that Regulation, may be placed on the market and used in foods under the conditions of use specified therein. Moreover, food additives shall comply with the specifications as referred to in Article 14 of that Regulation and laid down in Commission Regulation (EU) No 231/2012².

Talc (E 553b) is authorised for use as a food additive in the EU and, since it was permitted before 20 January 2009, it belongs to the group of food additives which are subject to a new risk assessment by the European Food Safety Authority (EFSA), according to Commission Regulation (EU) No 257/2010³, and in line with the provisions of Regulation (EC) No 1333/2008.

In August 2018, EFSA⁴ completed the re-evaluation of talc (E 553b) as a food additive together with other silicates (E 552, E 553a(i), E 553a(ii)) and concluded that the safety of talc and the other silicates, when used as food additives, could not be assessed. Consequently, the European Commission requested⁵ business operators to submit data addressing the issues identified by EFSA during the re-evaluation.

In particular, the call for data requested: 

• Data on particle size and particle size distribution for talc (E 553b) and other silicates (E 552, E 553a(i), E 553a(ii));
• Data on current levels - as well as the lowest achievable levels - for lead, mercury, arsenic, aluminium, nickel, fluoride and crystalline silica (alpha-quartz) in E 552, E 553a(i), E 553a(ii) and E 553b, in order to adequately define their maximum limits in their specifications;
• Toxicological data: Toxicological studies as recommended for a Tier 1 approach according to the EFSA “Guidance for submission for food additive evaluations” (EFSA ANS Panel, 2012), should be conducted with adequately characterised materials(s). In case of read-across from one substance to the other(s), the relevance of the data obtained with one food additive should be demonstrated for the other food additives under consideration by means of a reasoned justification.

In October 2020, business operators submitted the data in reply to the call issued by the European Commission. In accordance with Article 29(1)(a) of Regulation (EC) No 178/2002, the European Commission requests the European Food Safety Authority (EFSA) to provide an updated scientific opinion on the safety of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) used as food additives.

In 2021, In August 2021, two new EFSA guidance documents⁶, clarifying the approach for the assessment of nanomaterials in the food and feed chain and setting down data and information requirements for regulated food and feed products were published. These horizontal guidance documents are relevant for the assessment of E 553b and also the other silicates, (calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and as food additives.

In July 2025, ECHA Risk Assessment Committee (RAC)⁷ published an opinion on talc, proposing a harmonized classification for talc as follows: “Carcinogen category 1B (H350 – May cause cancer)” and as “STOT RE 1 (H372 – Causes damage to organs through prolonged or repeated exposure, by inhalation).”

The carcinogenic effects after inhalation or genital/perineal exposure in the lungs and ovaries respectively, were considered. In addition, “RAC concludes that no specific route of exposure can be designated in accordance with the CLP criteria, due to inadequacy or lack of data conclusively demonstrating the lack of carcinogenicity via other routes (such as oral or dermal).”

A recent IARC monograph⁸ has classified talc as probably carcinogenic to humans (Group 2A; IARC 2025), based on limited evidence that exposure to talc causes cancer of the ovary in humans, sufficient evidence for cancer in experimental animals and strong evidence that talc exhibits key characteristics of carcinogens. Concerning genotoxicity, few studies were available, mainly negative findings were reported, but notably most of the studies were conducted before the implementation of GLP, and had limited design protocols thus, they did not appropriately address the evidence of genotoxicity-associated endpoints (IARC, 2025).

In July 2026, the European Commission (EC) amended the mandate⁹ sent to EFSA in 2021 to take into considerations in the safety assessment both the two horizontal EFSA guidance documents on the approach and data requirements for the assessment of nanomaterials in the food and feed chain. In addition, the EC requested EFSA to consider the data and conclusion from RAC opinion in line with the principles of 'One substance – one assessment' set in Regulation (EU) 2025/2457¹⁰ Finally, the EC requested to prepare first scientific opinion on the food additive talc (E 553b), followed later by another scientific opinion on the remaining food additives originally belonging to the group of silicates: calcium silicate (E 552), magnesium silicate (E 553a(i)) and magnesium trisilicate (E 553a(ii)).

Therefore, in accordance with amended mandate, EFSA launches the present public call for data in order to acquire documented information (published and/or unpublished) on talc (E 553b).

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 interested parties (e.g. food business operators, national food authorities, research institutions, academia) and/or other stakeholders, the opportunity to submit additional data (published, unpublished and/or newly generated) relevant to the safety assessment of Talc E 553b (EFSA-Q-2021-00560).

Talc (E 553B)

Based on data submitted to EFSA (EFSA-Q-2021-00560), talc (E 553b) used as food additive is a nanostructured, non‑coated and non‑functionalised material composed of plate-like particles made of thin multilayers, exhibiting a highly polydisperse size distribution with lateral dimensions ranging from the nanometre to the micrometre scales.

Talc is practically insoluble in water (European Pharmacopoeia 6.0¹¹). Therefore, taking into account the size distribution of the material and its insolubility in water, in line with the EFSA Guidance on Particle – Technical Requirements (EFSA Scientific Committee, 2021¹²), E 553b requires risk assessment at the nanoscale following the EFSA Guidance on Nano – Risk Assessment (EFSA Scientific Committee, 2021¹³), to complement the conventional risk assessment conducted according to the applicable sectoral guidance.

Information/data sought

A preliminary evaluation by the Food Additives and Flavourings Panel Working Group on “Food Additives Re-evaluation and Follow-up” assessed whether the available data on talc (E 553b) used as food additive meet current standards or whether additional information is needed to progress the safety assessment.

This preliminary evaluation identified the need for data complementary to those already available and further data generation.

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

1. GENOTOXICITY

A bacterial reverse mutation test (Ames test), according to OECD TG 471 (OECD, 2020), and an in vitro mammalian cell micronucleus test, according to OECD TG 487 (OECD, 2023) have been submitted by the interested business operators (IBOs) in October 2020. 

As recommended by the EFSA Guidance on Nano – Risk Assessment (EFSA Scientific Committee, 2021), taking into account the presence of a fraction of small particles including nanoparticles in talc, the bacterial reverse mutation (Ames) test is not considered suitable for evaluating mutagenicity of such materials, as bacterial cells show limited or no uptake of nanoparticles because their cell walls prevent them from being internalised. In order to have a complete in vitro genotoxicity dataset, covering all three genetic endpoints, i.e., gene mutations, structural chromosomal aberrations (CAs) (clastogenicity) and numerical CAs (aneuploidy), the following study is required:

An in vitro gene mutation assay in mammalian cells performed according to principles of the EFSA Guidance on Nano – Risk Assessment (EFSA Scientific Committee, 2021). 

Either the in vitro mammalian cell gene mutation test using the Hprt and xprt genes (OECD TG 476) or the in vitro mammalian cell gene mutation test using the Thymidine Kinase Gene (OECD TG 490) are appropriate.

While performing the test, cellular uptake of the small particles including nanoparticles should be demonstrated, which is in particular relevant in the case of negative results. Information on characterisation of the dispersion state and stability of the test item should also be provided.

2. ADME AND TOXICITY TESTING

According to the “Guidance on the scientific data requirements for an application for authorisation of a food additive submitted under Regulation (EC) No 1331/2008¹⁴, for food additives that do not raise a concern for genotoxicity, toxicity testing necessary for the safety evaluation depends on the outcome of absorption/uptake of the material.

The data obtained with radiolabelled talc in several experimental animals (Philipps et al., 1978¹⁵; Wehner et al., 1977¹⁶, as described in the re-evaluation opinion of E 553b (EFSA ANS Panel, 2018¹⁷), suggest low absorption. However, it is not clear whether the urinary radioactivity was due to the absorption of radiolabeled talc particles, solubilized radioactive talc or other factors (e.g., exchange of 3H-label used in the study). Therefore, the available data does not allow the exclusion of absorption of talc particles.

Taking into account the currently available evidence, the following study is required:

In vivo ADME study to determine whether talc particles are absorbed and become systemically available following oral exposure. The presence of particles should be investigated in tissues which may be involved in the absorption process such as Peyer’s patches in the small intestine; liver and spleen tissues should be also analysed to investigate the absorption of talc particles. The potential for accumulation should be investigated after repeated exposure by using two, sufficiently separate time points (e.g. at 14 and 90 days).

When designing the study, three dose levels (plus a control group) are also recommended to gain insight into non-linear kinetic processes. When urine is sampled, care should be taken to avoid contamination of urine with unabsorbed talc from faeces.

Appropriate sensitive analytical methods (e.g. using radioactively labelled talc) should be used for the detection of talc particles and the quantitative determination of talc concentrations in the tissues. In view of the nature of talc, it should be taken into account that background concentrations of Mg and Si can limit the reliability of the results obtained by methods based on elemental analysis.

The EFSA Guidance on Nano – Risk Assessment (EFSA Scientific Committee, 2021) and the draft OECD Guidance on Toxicokinetics to accommodate Testing of (Nano)particles¹⁸ may be consulted to design the appropriate study protocol.

In case ADME study in vivo would not provide conclusive evidence of absence of absorption or systemic availability of talc particles, carcinogenicity via oral route would need to be addressed in the light of the ECHA RAC opinion on harmonised classification of talc as carcinogen category 1B. In case an in vivo follow-up of the in vitro genotoxicity test would be required, the possibility to conduct the in vivo genotoxicity study in combination with the in vivo ADME study should be considered.

Considerations on test material for which data are to be provided 

Talc as food additive, E 553b, exhibits a highly polydisperse size distribution with lateral dimensions ranging from the nanometre to the micrometre scales. E 553b with different percentage of small particles including nanoparticles is present on the market. 

E 553b containing the highest percentage of particles below 250nm in the fraction of 500nm particles should be considered as the worst case. The test material should also be representative of both lamellar and microcrystalline talc intended to be used as food additive. Justification of the selection of the test material is required.

Due to the high polydispersity in size of E 553b containing particles with large lateral dimensions, and for practical reasons (for example due to difficulty to achieve stable dispersions in aqueous media, or to demonstrate cellular uptake), it could be appropriate to specifically investigate only the fraction of small particles including nanoparticles, by removing the larger sized particles before the in vitro genotoxicity testing.

Isolation of the small particles including nanoparticles can, for example, be achieved by removing largersized particles by sieving and gravitational or centrifugal sedimentation (or a combination thereof). If such an approach is applied, a detailed physicochemical characterization of the isolated fraction and confirmation that this material is similar in terms of size distribution to the fraction of the small particles including nanoparticles contained in the original material (E 553b) is mandatory.

Full characterisation of the test material is required and should include the parameters for material characterisation as specified in section 5.1.2 and summarized in Table 1A of the EFSA Guidance on Nano-Risk Assessment¹⁹. The particle size distribution including the size distribution of the lateral
dimensions, analysed using quantitative electron microscopy need to be reported following the practical instructions for reporting the results of electron microscopy analysis of nanomaterials or materials
possibly containing a fraction of small particles including nanoparticles (Annex C – Guidance on Particle - Technical Requirements²⁰). 

Specific considerations on data to be provided

The genotoxicity, ADME and toxicity studies should be designed in accordance with the recommendations for nano-specific issues described in the EFSA Guidance on Nano – Risk Assessment (EFSA Scientific Committee, 2021). 

For the purposes of risk assessment, testing of nano-sized material should be conducted in a well-dispersed form. The Guidance on Particle-TR (EFSA Scientific Committee, 2021²¹) provides a generic dispersion protocol for conventional materials containing a fraction of small particles, which may be used and adapted to the specific characteristics of the material under investigation. Sections 5.1.1 and 5.1.2 describe dispersion and characterisation in a test medium. As a general principle, dispersions should be reproducible and stable during exposure throughout the duration of the test.

Confirmation of exposure of cells and/or tissues to the nanoparticles should be provided, as this would increase the reliability of the results. 

Dose selection should take into account concentration-dependent agglomeration behaviour and its potential impact on the relationship between the administered dose and the effective exposure.

Where relevant, dose–response relationships should be interpreted in the context of the degree of agglomeration in the dispersion medium and the corresponding internal concentrations determined in the ADME study, particularly where differences in degree of agglomeration of the dispersion between administered doses may influence absorption and, consequently, internal exposure. 

For non-particulate materials, in the absence of adverse effects, histopathological examination is generally performed in the control and highest dose groups. However, considering the potential for atypical dose–response relationships associated with small particles, including nanoparticles, examination of at least the lowest and highest dose groups is recommended. Furthermore, histopathological examination of the mid-dose group could facilitate a more robust interpretation of dose–response relationships. 

DEADLINES FOR SUBMISSION OF DATA AND DISCLOSURE OF CONTACT DETAILS

Interested parties and stakeholders should provide by 31 July 2027 the information described
below. 

Within 6 weeks from the publication of this call, please communicate in writing by e-mail to: RAL [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. Please use “Call for data for Talc E 553b (EFSA-Q-2021-00560)” in the subject of your email when writing to RAL [at] efsa.europa.eu (RAL[at]efsa[dot]europa[dot]eu). 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 based on 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 have expressed an interest in providing the requested information. If you do not wish to make your contact details available, clearly indicate it in your first communication.

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 they 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/DATA

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: Call for data for Talc E 553b (EFSA-Q-2021-00560)
  • The contact details²² (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.

EFSA may 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

Once internet-based software chosen please kindly send the link and login to RAL [at] efsa.europa.eu (RAL[at]efsa[dot]europa[dot]eu). If a password is needed, kindly send it to the same email address in a separate email. Please always use a reference to this call in the heading of your email: Call for data for Talc E 553b (EFSA-Q 2021- 00560).

¹ Regulation (EC) No 1333/2008 on food additives, OJ L 354, 31.12.2008
² OJ L 83, 22.3.2012, p. 1.
³ OJ L 80, 26.3.2010, p. 19
⁴ Re-evaluation of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5375
⁵ Call for scientific and technical data on the permitted food additives
⁶ Scientific Committee Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles; SC Guidance on Particle-TR; Scientific Committee Guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health; SC Guidance on Nano-RA
⁷https://echa.europa.eu/documents/10162/c809b923-6241-b3e2-4902-543593b64f0d
⁸ IARC (2025). Talc. IARC Monogr Identif Carcinog Hazards Hum. 136:1–488. Advance publication. IARC Working Group on the Identification of Carcinogenic Hazards to Humans. Talc and acrylonitrile, Vol 136. Lyon: International Agency for Research on Cancer, 2025. | Series: IARC monographs on the identification of carcinogenic hazards to humans, ISSN 1017-1606; v. 136. ISBN 9789283245339 (pbk.), ISBN 9789283202936 (ebook). https://publications.iarc.who.int/646
⁹Open EFSA: M-2022-00020 Amended mandate EFSA silicates-talc https://open.efsa.europa.eu/study-inventory/EFSA-Q2021-00560/2/147f00f2-ac72-4b81-9e3a-dfcf0bcab1ec
¹⁰ Regulation (EU) 2025/2457 of the European Parliament and of the Council of 26 November 2025 amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 as regards the reattribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals.
¹²EFSA Guidance on Particle – Technical Requirements
¹³ EFSA Guidance on Nano – Risk Assessment
¹⁴ Guidance on the scientific data requirements for an application for authorisation of a food additive submitted under Regulation (EC) No 1331/2008 https://doi.org/10.2903/j.efsa.2026.9778
¹⁵ Phillips JC, Young PJ, Hardy K and Gangolli SD, 1978. Studies on the absorption and disposition of 3H-labelled talc in the rat, mouse, guinea-pig and rabbit. Food and Cosmetics Toxicology, 16, 161–164
¹⁶ Wehner AP, Tanner TM and Buschbom RL, 1977. Absorption of ingested talc by hamsters. Food and Cosmetics Toxicology, 15, 453–456. 
¹⁷ Re-evaluation of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate(E 553a(ii)) and talc (E 553b) https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5375
¹⁸draft OECD Guidance on Toxicokinetics to accommodate Testing of (Nano)particles
¹⁹EFSA Guidance on Nano – Risk Assessment
²⁰Annex C – Guidance on Particle - Technical Requirements
²¹EFSA Guidance on Particle – Technical Requirements
²² The interested parties shall notify EFSA of any change in the contact details by sending an e-mail to the RAL mailbox (RAL [at] efsa.europa.eu)