Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the renewal of bentonite as a technological feed additive in the functional groups of anticaking agents for all animal species and of substances for reduction of the contamination of feed by mycotoxins for pigs, poultry and ruminants. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for the target species, consumers and the environment under the authorised conditions of use. Regarding user safety, the Panel concludes that bentonite is not irritant to skin but mildly irritant to eyes and is a skin and respiratory sensitiser. Exposure of users by any route is considered a risk and should be minimised. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
Keywords: anticaking agents, bentonite, safety, substances for reduction of the contamination of feed by mycotoxins, technological additives
1. INTRODUCTION
1.1. Background and Terms of Reference
Regulation (EC) No 1831/2003 1 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 14(1) of that Regulation lays down that an application for renewal shall be sent to the Commission at the latest one year before the expiry date of the authorisation.
The European Commission received a request from BASF SE 2 for the renewal of the authorisation of the additive consisting of bentonite, when used as a feed additive for all animal species (category: technological; functional group: anticaking agents) and for poultry, pigs and ruminants (category: technological; functional group: substances for reduction of the contamination of feed by mycotoxins).
According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the application to the European Food Safety Authority (EFSA) as an application under Article 14(1) (renewal of the authorisation). The dossier was received on 28 November 2022 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2022‐00829. The particulars and documents in support of the application were considered valid by EFSA as of 05 July 2023.
According to Article 8 of Regulation (EC) No 1831/2003, EFSA, after verifying the particulars and documents submitted by the applicant, shall undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of the feed additive consisting of bentonite, when used under the proposed conditions of use (see Section 3.1.3).
1.2. Additional information
The additive under assessment, bentonite (dioctahedral montmorillonite) is currently authorised as a technological feed additive for reduction of the contamination of feed by mycotoxins for ruminants, poultry and pigs (1m558) and as a binder, an anticaking agent and a substance for control of radionuclide contamination for all animal species (1m558i). 3
EFSA issued several opinions on safety and efficacy of this product, when used in feed for all animal species (EFSA FEEDAP Panel, 2011a, 2011b, 2012, 2013, 2017, 2025a) and for ruminants, poultry and pigs (EFSA FEEDAP Panel, 2025b).
2. DATA AND METHODOLOGIES
2.1. Data
The present assessment is based on data submitted by the applicant in the form of a technical dossier 4 in support of the authorisation request for the use of bentonite (dioctahedral montmorillonite) as a feed additive.
In accordance with Article 38 of the Regulation (EC) No 178/2002 5 and taking into account the protection of confidential information and of personal data in accordance with Articles 39 to 39e of the same Regulation, and of the Decision of EFSA's Executive Director laying down practical arrangements concerning transparency and confidentiality, 6 a non‐confidential version of the dossier has been published on Open.EFSA.
According to Article 32c(2) of Regulation (EC) No 178/2002 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre‐submission phase and public consultations, EFSA carried out a public consultation on the non‐confidential version of the technical dossier from 23 February to 15 March 2024 for which no comments were received.
The confidential version of the technical dossier was subject to a target consultation of the interested Member States from 5 July to 7 October 2023 for which the received comments were considered for the assessment.
The European Union Reference Laboratory (EURL) considered that the conclusions and recommendations reached in the previous assessment regarding the methods used for the control of bentonite in animal feed are valid and applicable for the current application. 7
2.2. Methodologies
The approach followed by the FEEDAP Panel to assess the safety of bentonite is in line with the principles laid down in Regulation (EC) No 429/2008 8 and the relevant guidance documents: Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2021).
3. ASSESSMENT
Bentonite is currently authorised as a technological additive under different functional groups (binders, anticaking agents, substances for reduction of the contamination of feed by mycotoxins and substances for control of radionuclide contamination). The present application regards the renewal of the authorisation of its use as anticaking agent in feed for all animal species and as substance for reduction of the contamination of feed by mycotoxins (aflatoxin B1) for ruminants, poultry and pigs.
3.1. Characterisation
3.1.1. Characterisation of the additive
The current authorisation sets different specifications for the additive depending on the functional group. As regards the additive to be used as anticaking agent, bentonite is specified to contain ≥ 50% of smectite, while for the additive to be used as substance for reduction of the contamination of feed by mycotoxins the specifications are ≥ 70% of smectite (dioctaedral montmorillonite), ≤ 10% of opal and feldspar, ≤ 4% of quartz and calcite and an aflatoxin B1 binding capacity above 90%.
The applicant states that no modifications to the manufacturing process or composition of the additive have been introduced since the original authorisation. 9
The data provided by the applicant on the mineralogical and chemical composition, 10 aflatoxin B1‐binding capacity 11 and relevant impurities 12 of the additive are reported in Table 1. Data on other impurities, 13 physical properties 14 and stability 15 of the additive are reported in Appendix A.
TABLE 1.
Data on the mineralogical and chemical composition and impurities of the additive. The data presented are average values and (range) for batch‐to‐batch variation, and ranges for all other parameters. The number of batches analysed per parameter, or group of parameters are indicated in [].
| Specifications as anticaking agent 1 | |
| Smectite (%) | ≥ 50 |
| Specifications as substances for the reduction of the contamination of feed by mycotoxins 2 | |
| Smectite (%) | ≥ 70 |
| Opal and feldspar (%) | < 10 |
| Quartz and calcite (%) | < 4 |
| Aflatoxin B1‐binding capacity (%) | > 90 |
| Mineralogical analysis (XRD) (%) | [5] |
| Smectite | 89.2 |
| (88.2–90.3) | |
| Quartz | 2.8 |
| (2.1–3.8) | |
| Feldspar | 4.0 |
| (3.4–4.8) | |
| Calcite | 3.4 |
| (2.6–4.0) | |
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| Elemental analysis (XRF) (expressed as % oxide) 3 | [5] |
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| Aflatoxin B 1 ‐binding capacity (%) | 97.0 |
| (96.3–97.4) | |
| [5] | |
| Impurities | [3] |
| Crystalline silica (%) | 0.01–0.04 |
| Nickel (mg/kg) | 6.0–6.7 |
Abbreviations: XRD, X‐ray diffraction; XRF, X‐ray fluorescence.
Specifications set in Regulation (EU) No 1060/2013.
Specifications set in Regulation (EU) No 1060/2013.
Other elements, such as Mn3O4, Na2O, P2O5, V2O5, Cr2O3, SrO, ZrO2, BaO, NiO, CuO, ZnO, PbO, HfO2, SO3 were present at levels equal or below 0.02%.
The data provided showed that all the analysed batches complied with the specifications set in the authorising regulation with regards to the content of smectite for both uses. In addition, the levels of opal, felspar, quartz and calcite comply also with the levels set in the authorising regulation 16 for its use as substance for the reduction of the contamination of feed by mycotoxins, as does the aflatoxin B1 binding capacity. The FEEDAP Panel considers that the microbial contamination and the amounts of the detected impurities do not raise safety concerns, with the exception of nickel, which is addressed in the user safety section (see Section 3.2.4).
The particle size of the additive was characterised in one production batch using a transmission electron microscopy (TEM). 17 Based on the data, the presence of small particles, including nanoparticles, cannot be excluded.
3.1.2. Interference of the additive with the analysis of mycotoxins in feed
The capacity of the additive to interfere with the analytical determination of mycotoxins in feed was studied in four different feeds (all based on the broiler feed basic mixture), each tested with three batches of the additive and contaminated with aflatoxin B1 (AfB1). 18 The mycotoxin was introduced at the final concentration of 4.5 μg/kg in the absence or presence of 2 g bentonite per kg of feed. The presence of the additive in the feed did not significantly influence the recovery of AfB1 when compared to the control. Based on these results, bentonite does not interfere with analysis of AfB1 in the studied feed.
3.1.3. Conditions of use
The additive is currently authorised for use in feed for ruminants, poultry and pigs as a substance for reduction of the contamination of feed by mycotoxins (aflatoxin B1) and as an anticaking agent in feed for all animal species, in both cases with a maximum content of 20,000 mg/kg of complete feedingstuff.
Under other provisions, it is stated:
-
–Indicate in the instructions for use:
-
–‘The simultaneous oral use with macrolides shall be avoided’;
-
–for poultry: ‘The simultaneous use with robenidine shall be avoided’.
-
–
-
–
For poultry: the simultaneous use with coccidiostats other than robenidine is contraindicated with level of bentonite above 5000 mg/kg of complete feed.
-
–
The total amount of bentonite must not exceed the permitted maximum level in complete feedingstuff of 20,000 mg/kg of complete feedingstuff.
-
–
For safety: breathing protection, glasses and gloves shall be used during handling.
The authorisation as substances for reduction of the contamination of feed by mycotoxins, in addition, lists the following:
-
–
The use of the additive is allowed in feedingstuffs complying with the European Union legislation on undesirable substances in animal feed.
The applicant did not request any change in the current conditions of the authorisation. 19
3.2. Safety
The safety of bentonite for the target species, consumers, users and the environment was evaluated in previous opinions (EFSA FEEDAP Panel, 2011a, 2012, 2013, 2017, 2025a, 2025b).
In its previous opinion (EFSA FEEDAP Panel, 2017), the FEEDAP Panel concluded that bentonite is safe for all animal species, the consumers and the environment when used at a maximum level of 20,000 mg/kg complete feed. The FEEDAP Panel also concluded that bentonite is not a skin irritant nor a skin sensitiser but might be mildly irritant to the eye and, owing to its silica content, the additive is a hazard by inhalation for the users.
The applicant states that no incidents or safety issues have been documented or reported since the previous authorisation. 20
The applicant provided new data on the genotoxic potential of the additive (Section 3.2.1) and a literature search on the safety of bentonite for the target animals, consumers, users and the environment (Section 3.2.2).
3.2.1. Genotoxicity studies
The test item used in the genotoxicity studies showed compliance with the specifications of both functional groups. 21
3.2.1.1. Bacterial reverse mutation test
In order to investigate the potential of bentonite to induce gene mutations in bacteria, an Ames test was performed in Salmonella Typhimurium strains TA1535, TA1537, TA98, TA100 and in Escherichia coli strain WP2uvrA(pKM101), both in the presence and absence of metabolic activation. 22 The study was performed according to the OECD Test Guideline (TG) 471 and was claimed to be compliant with the principles of Good Laboratory Practice (GLP). The test item was insoluble in water. Five concentrations of a suspension obtained in NaCl 0.15 M from bentonite (range from 50 to 5000 μg/plate) were tested in two independent experiments applying the plate incorporation and pre‐incubation methods. No toxicity was observed in any experimental condition. Precipitate, not interfering with the analysis, was observed at the two highest concentrations tested (1500 and 5000 μg/plate) in all the experimental conditions. No significant changes in the number of revertant colonies were induced by the test item compared to the vehicle controls at any concentration and with any tester strain. Therefore, the FEEDAP Panel concludes that the soluble part of the test item, if any does not induce gene mutations in bacterial cells under the experimental conditions employed in this study.
3.2.1.2. In vitro mammalian micronucleus test
To evaluate the potential of bentonite to induce chromosomal damage, an in vitro micronucleus assay was performed in Chinese Hamster Ovary (CHO) cells according to the OECD TG 487, in a study claimed to be compliant with the principles of GLP. 23 The test item was insoluble in water and a suspension was obtained in NaCl 0.15 M by continuous stirring. Based on the results of a preliminary cytotoxicity test, three concentrations of the suspension were selected for the analysis of the frequency of micronuclei applying a short treatment (4 h + a recovery period 1.5–2 times the cell cycle) in the absence (51.2, 89.6, 128 μg/mL) and presence (128, 224, 320 μg/mL) of metabolic activation and a continuous treatment (1.5–2 times the cell cycle) (35.84, 51.2, 89.6 μg/mL) in the absence of metabolic activation. No cytotoxicity was observed after treatment with the test item, as measured by the relative increase in cell count. No increase in the frequency of micronuclei was observed in treated cultures compared to vehicle control cultures at any concentration and in any experimental condition. Therefore, the FEEDAP Panel concludes that the soluble part of the test item, if any, does not induce structural and numerical chromosome aberrations under the experimental conditions employed in the study.
3.2.1.3. Conclusions on genotoxicity
Based on the results of the available studies, the FEEDAP Panel concludes that the additive under assessment does not raise concern for genotoxicity.
3.2.2. Extensive literature search
The applicant performed a literature search to provide evidence that the additive remains safe under the approved conditions for the target species, consumers, users and the environment. 24 The search covered the period 2011–2025 and was conducted using four cumulative databases (LIVIVO, NCBI, Ovid and Toxinfo). The search protocol properly described the search terms and the inclusion and exclusion criteria applied for the screening process. A total of 308 publications were retrieved, of which 108 were considered relevant. Additional complementary searches were performed, which resulted in the addition of seven relevant publications. The FEEDAP Panel reviewed the publications retrieved in the search and concluded that none of them identified new information that would lead to reconsider its previous conclusions.
3.2.3. Safety for the target species, consumer and environment
A total of 115 publications were retrieved and considered eligible by the applicant for the safety for the target species. No relevant papers were identified regarding the safety for the consumers or the environment.
The FEEDAP Panel thoroughly evaluated each of these studies. Most papers examined bentonites of various origins, primarily with the aim of assessing their efficacy as mycotoxin binders. In these studies bentonite was typically administered at levels within the currently authorised use limits, either alone or in combination with other feed additives. Overall, the papers reviewed did not report any adverse effects associated with bentonite supplementation up to the authorised use level on the performance or health parameters of the target animals. The only studies that documented adverse effects at levels within the authorised range and the level of mycotoxins within the legal limits/recommendations are outlined below.
Khatoon et al. (2016) observed a reduction in body weight, an increase in the relative weight of the liver and kidney, and a decreased weight of the bursa in chickens for fattening that were fed a diet containing 20,000 mg/kg of an unspecified bentonite sourced from Pakistan. However, it is not clear how the test item was added to the diet and therefore whether this effect was due to a potential nutritional imbalance of the diet. Majewska et al. (2011) showed an adverse effect on the feed‐to‐gain ratio of the chickens for fattening, when the diets were supplemented with 0.1% of a product containing bentonite, compared with a control group, the diets of both groups containing levels of mycotoxins (ochratoxin A and DON) within the recommendations. However, it is worth noting that the composition of the test item used in the study, including the bentonite content, was not specified. Additionally, García‐Pérez et al. (2013) reported a reduction in feed intake in shrimp diets supplemented with up to 5000 mg/kg bentonite; however, performance parameters remained unaffected.
Previous opinions issued by the Panel highlighted the potential for bentonite to interact with coccidiostats and other medicinal substances, a consideration reflected in the specific provisions of the additive's authorisation. The literature search further identified three publications documenting bentonite's binding effects toward tylosin and doxycycline (De Baere et al., 2018; De Mil et al., 2015; Devreese et al., 2012), thereby corroborating earlier observations regarding such interactions.
The Panel notes that in most of the papers no adverse effects were observed by the supplementation with bentonite at levels within the authorised range or above. Based on all the data provided, the Panel concludes that, in light of the current knowledge, there is no novel information that would contradict the previous conclusions.
Therefore, considering the above and the fact that the manufacturing of the additive, specifications and conditions of use have not been modified, the FEEDAP Panel concludes that bentonite remains safe for the target species, the consumer and the environment under the current conditions of authorisation.
3.2.4. Safety for the user
In its previous opinion (EFSA FEEDAP Panel, 2017), the FEEDAP Panel concluded that bentonite is not a skin irritant nor a skin sensitiser but might be mildly irritant to the eye and, owing to its silica content, the additive is a hazard by inhalation for the users.
The FEEDAP Panel notes that the additive contains nickel (see Section 3.1.1). The Directive (EU) 2022/431 25 set an occupational exposure limit (OEL) of 0.01 and 0.05 mg/m3 for both respirable and inhalable fraction, respectively as nickel meets the criteria for classification as carcinogenic (category 1A).
The FEEDAP Panel also notes that the additive contains crystalline silica (see Section Error! Reference source not found.). Inhalation of silica is known to be hazardous and is associated with increased risk of lung cancer and the industrial disease, silicosis. The Directive (EU) 2017/2398 26 set an OEL of 0.1 mg/m3 of air for respirable crystalline silica dust.
No new safety studies conducted with the additive under assessment were submitted and none of the papers identified in the literature search provided new information relevant to the safety for the user.
Therefore, the FEEDAP Panel reiterates its previous conclusions that bentonite is not irritant to skin but mildly irritant to eyes. Due to the presence of nickel the additive should be considered as a skin and respiratory sensitiser. Exposure of users by any route is considered a risk and should be minimised.
3.3. Efficacy
The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
4. CONCLUSIONS
The applicant has provided evidence that the additive currently on the market complies with the existing conditions of its authorisation as anticaking agent and as substance for reduction of the contamination of feed by mycotoxins.
The Panel concludes that bentonite remains safe for the target species, consumers and the environment under the authorised conditions of use.
Regarding user safety, the additive is not irritant to the skin but is mildly irritant to the eyes and should be considered a skin and respiratory sensitiser. Exposure of users by any route is considered a risk and should be minimised.
There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation.
5. RECOMMENDATIONS
The Panel considers that the provision ‘The simultaneous oral use with macrolides shall be avoided’ should be extended also to tetracyclines, and to all bentonites currently authorised.
The Panel also recommends setting individual limits for opal, feldspar, calcite and quartz in the authorisation for its use as substance for reduction of the contamination of feed by mycotoxin, to avoid ambiguity.
ABBREVIATIONS
- AfB1
aflatoxin B1
- CFU
colony forming unit
- CHO
Chinese Hamster Ovary
- CV
coefficient of variation
- DM
dry matter
- DON
deoxynivalenol
- EURL
European Union Reference Laboratory
- FEEDAP
EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
- GLP
Good Laboratory Practice
- nDL‐PCBs
non‐dioxin‐like PCBs
- OECD
Organisation for Economic Co‐operation and Development
- OEL
occupational exposure limit
- PCBs
polychlorinated biphenyls
- PCDD/Fs
polychlorinated dibenzo‐p‐dioxins and dibenzofurans
- TEM
transmission electron microscopy
- TEQ
toxic equivalent
- TG
Test Guideline
- WHO
World Health Organization
- XRD
X‐ray diffraction
- XRF
X‐ray fluorescence
REQUESTOR
European Commission
QUESTION NUMBER
EFSA‐Q‐2022‐00829
COPYRIGHT FOR NON‐EFSA CONTENT
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PANEL MEMBERS
Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Giovanna Martelli, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona and Katerina Theodoridou.
LEGAL NOTICE
The published scientific output implements EFSA's decision on the confidentiality requests submitted on specific information items. Information items awarded confidential status by EFSA and included in the relevant scientific output have been withheld from public disclosure by redaction.
ACKNOWLEDGEMENTS
The Panel wishes to thank the following for the support provided to this scientific output (in alphabetical order of the last name): Gabriele Aquilina, Natalia Alija‐Novo.
APPENDIX A. Impurities and physicochemical and technological properties
The data provided by the applicant on other impurities, physical properties and stability of the additive are reported in Table A1.
TABLE A1.
Data on the other impurities and physicochemical and technological properties of the additive. The data presented are ranges for all parameters. The number of batches analysed per parameter or group of parameters are indicated in [].
| Impurities | [3] |
| Lead (mg/kg) | 10.8–11.2 |
| Mercury (mg/kg) | < 0.02 |
| Cadmium (mg/kg) | < 0.2 |
| Arsenic (mg/kg) | 1.5–1.9 |
| Fluorine (mg/kg) | 39.0–42.0 |
| Dioxins and furans (upper bound) 1 | |
| PCDD/Fs (ng WHO2005‐TEQ/kg) | < 0.17 |
| PCDD/Fs + PCBs (ng WHO2005‐TEQ/kg) | 0.1 |
| nDL‐PCBs (μg/kg) | 2.6–3.2 |
| Mycotoxins (μg/kg) | |
| Aflatoxins B1 | < 3 |
| Deoxynivalenol | < 500 |
| Zearalenone | < 50 |
| Ochratoxin A | < 5 |
| Fumonisins B1 + B2 | < 200 |
| Microbial contamination | |
| Salmonella spp. (per 25 g) | Not detected |
| Escherichia coli (CFU/g) | < 1 |
| Physical properties | [3] |
| Form | Solid |
| Bulk density (kg/m3) | 550–750 |
| Dusting potential (Stauber Heubach) (mg/m3) | 7075–7775 |
| Particle size distribution (laser diffraction) (% of particles below, v/v) | |
| 100 μm | 58.0–72.0 |
| 50 μm | 35.0–41.0 |
| 10 μm | 8.0–8.1 |
| Stability (% recovery) | |
| Shelf‐life | |
| Ambient conditions – 60 months | 101.3–103.1 a |
| [5] | |
| Homogeneity (coefficient of variation, %) | |
| Chickens for fattening, mash feed | 1.1 |
| [1] | |
Abbreviations: CFU, colony forming unit; nDL‐PCBs, non‐dioxin‐like PCBs; PCBs, polychlorinated biphenyls; PCDDs, polychlorinated dibenzo‐p‐dioxins; PCDFs, polychlorinated dibenzofurans; TEQ, toxic equivalent factors for dioxins, furans and dioxin‐like PCBs established by WHO in 2005 (Van den Berg et al., 2006); WHO, World Health Organization.
Upper bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification. Values are expressed per kg of additive with 88% dry matter content.
<: means below the limit of quantification.
% of retention in terms of aflatoxin B1 capacity.
EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Villa, R. E. , Azimonti, G. , Bonos, E. , Christensen, H. , Durjava, M. , Dusemund, B. , Gehring, R. , Glandorf, B. , Kouba, M. , López‐Alonso, M. , Marcon, F. , Martelli, G. , Nebbia, C. , Pechová, A. , Prieto‐Maradona, M. , Theodoridou, K. , Dulak‐Lis, M. , Galobart, J. , … Valeri, P. (2026). Assessment of the feed additive consisting of bentonite (dioctahedral montmorillonite) as an anticaking agent for all animal species and as a substance for reduction of the contamination of feed by mycotoxins for pigs, poultry and ruminants for the renewal of its authorisation (BASF SE). EFSA Journal, 24(7), e10245. 10.2903/j.efsa.2026.10245
Adopted: 30 June 2026
Correspondence: Ask a Question
The declarations of interest of all scientific experts active in EFSA's work are available at https://open.efsa.europa.eu/experts.
Notes
Regulation (EC) No 1831/2003 of the European Parliament and of the council of 22 September 2003 on the additives for use in animal nutrition. OJ L 268, 18.10.2003, p. 29.
BASF SE, Carl‐Bosch‐Str. 38, Ludwigshafen – 67056, Germany.
Commission Implementing Regulation (EU) No 1060/2013 of 29 October 2013 concerning the authorisation of bentonite as a feed additive for all animal species. OJ L 289, 31.10.2013, p. 33.
Dossier reference: FEED‐2022‐10171.
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, 1.2.2002, pp. 1–48.
Decision available at: https://www.efsa.europa.eu/en/corporate‐pubs/transparency‐regulation‐practical‐arrangements.
Evaluation report available on the EU Science Hub: https://joint‐research‐centre.ec.europa.eu/reports‐and‐technical‐documentation/fad‐2016‐0051_en.
Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives. OJ L 133, 22.5.2008, p. 1.
FEED‐2022‐10171_Bentonite_BASF Response_MAR 2026.
Mineralogical and chemical composition: Annex_2.1._2_XRPD_XRF.
Annex_2.1._4_BCAfB1.
Relevant impurities: Annex_2.1._12_Resp_SiO2, Annex_2.1._5_Impurities_1_Nickel, Annex_2.1._6_Impurities_2_Nickel, Annex_2.1._7_Impurities_3_Nickel.
Other impurities: Annex_2.1._5_Impurities_1, Annex_2.1._6_Impurities_2, Annex_2.1._7_Impurities_3.
Physical properties: Annex_2.1._11_Dusting potential, Annex_2.1._8_Particle size 1, Annex_2.1._9_Particle size 2, Annex_2.1._10_Particle size 3.
Stabilty: Annex_2.4._1_Novasil Plus shelf life, Annex_2.4._2_Homogeneity.
The Panel notes that the specifications for opal, feldspar, calcite and quartz are considered to refer to individual values.
Annex_I_R‐20230123‐00093‐TEMV2_signed.
Annex_2.4._3_Interference.
Section_2_Conditions of use.
3.1_Target animal safety.
Analysed values: smectite: 84%; opal: traces; feldspar: 7%; quartz: 2%; calcite: 1%; aflatoxin B1‐binding capacity: 92.7%.
Annex_V‐1_Final report AMES‐PH‐24‐0339_signed.
Annex_V‐2_Final report MNS‐PH‐24‐0339_signed.
Annex_IV‐1_ELS.
DIRECTIVE (EU) 2022/431 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2022 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. OJ L 88/2, 16.3.2022, 14 pp.
Directive (EU) 2017/2398 of the European Parliament and of the Council of 12 December 2017 amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work. OJ L 345, 27.12.2017, 8 pp.
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