Abstract
An assessment of the safety and efficacy of a feed additive consisting of chromium propionate (KemTRACE™ Chromium) was issued on 18 March 2021. Due to difficulties in implementing the proposed method for the official control of added organic chromium in premixtures and feed, the additive needed incorporating a tracer in the composition of a premix. The European Commission asked EFSA to issue a new opinion on the safety and efficacy of Cr propionate (KemTRACE™ Chromium) as a feed additive for all growing poultry species, including the newly submitted information by the applicant that involves the use of the microtracer. In the FEEDAP Panel opinion on the safety of the microtracer issued on 15 January 2025, no conclusion could be made on the environmental safety of the microtracer for the groundwater compartment. Following the request from the applicant and its acceptance by the European Commission, as indicated in its letter to EFSA of 12 January 2026, the scope of the current assessment has been modified to consider a change in the additive under assessment and a reduction of the target species. Therefore, EFSA delivers an assessment of the safety and efficacy of the additive consisting of Cr propionate (KemTRACE chromium 0.4% MT) for chickens for fattening, chickens reared for laying/reproduction, turkeys for fattening and turkeys reared for reproduction. The use of KemTRACE Chromium 0.4% MT (containing a microtracer) at the proposed conditions of use is safe for the target species, consumers and the environment. The additive is considered irritant to the eyes and a dermal and respiratory sensitiser. Exposure of users by any route is considered a risk. KemTRACE Chromium 0.4% MT has the potential to be efficacious as a zootechnical additive in chickens for fattening, chickens reared for laying/reproduction, turkeys for fattening and turkeys reared for reproduction at the supplementation level of 0.4 mg Cr/kg feed.
Keywords: digestibility enhancers, environment, groundwater, microtracer, safety, zootechnical additives
1. INTRODUCTION
1.1. Background and Terms of Reference as provided by the requestor
Regulation (EC) No 1831/2003 1 establishes the rules governing the Community authorisation of additives for use in animal nutrition; in particular, Article 9 defines the terms of the authorisation by the Commission.
The applicant is seeking a Union authorisation of the feed additive described in Table 1.
TABLE 1.
Description of the additive in the application SANTE‐0076‐2019/FAD‐2019‐0076 and FEED‐2022‐6191.
| Category of additive | Zootechnical additives |
|---|---|
| Functional group of additive | Other zootechnical additives |
| Description | Chromium propionate |
| Target animal category | All growing poultry species (poultry for fattening, reared for breeding and reared for laying) |
| Applicant | Kemin Europa N.V. |
| Type of request | New opinion – Request for scientific opinion pursuant to Article 29(1)(a) of Regulation (EC) No 178/2002 |
On 27 November 2024, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted two opinions on a feed additive consisting of Chromium propionate as a zootechnical additive. Both opinions are related to the initial application SANTE‐0076‐2019/FAD‐2019‐0076 of 19.11.2019, which was later partially duplicated by the application FEED‐2022‐6191 of 17.05.2022:
-
–
In the follow‐up opinion linked to the initial application SANTE‐0076‐2019/FAD‐2019‐0076, on the safety of the use of a microtracer with the feed additive consisting of chromium propionate (KemTRACE™ Chromium) for all growing poultry species, 2 the Panel could not conclude on the safety for the groundwater of the microtracer with the proposed conditions of use.
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–
In the opinion linked to the subsequent application FEED‐2022‐6191, on the safety and efficacy of a feed additive consisting of chromium propionate (KemTRACE™ Chromium) for all growing poultry species (Kemin Europa N.V.), 3 the Panel could not conclude on the safety of the additive for growing minor poultry species.
The European Commission gave the possibility to the applicant to submit supplementary information and data to complete the assessment and to allow a revision of the conclusions of both EFSA's opinions.
The new supplementary information and data have been transmitted by the applicant using the E‐Submission Food Chain Platform (application number FEED‐2025‐34,730 and FEED‐2025‐34,733, respectively). 4
In view of the above and in accordance with Article 29(1)(a) of Regulation (EC) No 178/2002, the European Commission requests EFSA to deliver a new scientific opinion on a feed additive consisting of Chromium propionate as a zootechnical additive for all growing poultry and on the microtracer to be included in the composition of the premix, under the conditions of Regulation (EC) No 1831/2003, based on the supplementary information and data submitted by the applicant.
On 24 November 2025, Kemin Europa N.V. requested in writing the partial withdrawal of their application as regards minor growing poultry species, asking the Commission to proceed with the authorisation of the additive for chickens for fattening, chickens reared for laying/reproduction, turkeys for fattening and turkeys reared for reproduction. The Commission accepted this request.
On 15 December 2025, Kemin Europa N.V. informed the Commission in writing of their intention to modify their application, making KemTRACE Chromium 0.4%, a solid preparation including the microtracer, as the additive instead of the liquid preparation (KemTRACE™ Chromium).
On 12 January 2026, the European Commission requested EFSA to take these adjustments into consideration in the context of the present assessment.
1.2. Interpretation of the Terms of Reference
The original mandate from the European Commission aimed at requesting EFSA to assess the new data to support the safety of the additive for all growing poultry species and the safety of the microtracer for the groundwater compartment.
Following the request from the applicant and its acceptance by the European Commission, as indicated in its letter to EFSA of 12 January 2026, the scope of the current assessment has been modified to consider a change in the additive under assessment and a reduction of the target species. Therefore, EFSA will deliver an assessment of the safety and efficacy of the additive consisting of chromium propionate (KemTRACE chromium 0.4% MT) for chickens for fattening, chickens reared for laying/reproduction, turkeys for fattening and turkeys reared for reproduction.
1.3. Additional information
The additive KemTRACE Chromium 0.4% MT is a preparation containing chromium propionate and is currently not authorised as a feed additive in the European Union.
The FEEDAP Panel assessed the safety and efficacy of chromium propionate as a zootechnical additive for all growing poultry species (EFSA FEEDAP Panel, 2021, 2025a, 2025b), and the safety of an associated microtracer (EFSA FEEDAP Panel, 2025c).
2. DATA AND METHODOLOGIES
2.1. Data
The present assessment is based on data submitted by the applicant in the form of supplementary information 5 to a previous application on the same product. 6 The dossier was received on 12 March 2025 and the general information and supporting documentation are available on Open.EFSA at https://open.efsa.europa.eu/questions/EFSA‐Q‐2025‐00199.
In accordance with Article 38 of the Regulation (EC) No 178/2002 7 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, 8 a non‐confidential version of the dossier has been published on Open.EFSA.
The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA, to deliver the present output.
The European Union Reference Laboratory (EURL) delivered an addendum to the original report to recommend a method of analysis for the quantification of chromium propionate in feed based on the enumeration of the particles of a microtracer. 9
2.2. Methodologies
The approach followed by the FEEDAP Panel to assess the safety of the feed additive consisting of chromium propionate (KemTRACE Chromium 0.4% MT) is in line with the principles laid down in Regulation (EC) No 429/2008 10 and the relevant guidance documents: Guidance on the Assessment of the Safety of feed additives for the target species (EFSA FEEDAP Panel, 2017) and Guidance on the assessment of the safety of feed additives for the environment (EFSA FEEDAP Panel, 2019).
3. ASSESSMENT
The additive chromium propionate (trade name: KemTRACE Chromium 0.4% MT) is intended to be used as a zootechnical feed additive (functional group: other zootechnical additives; improvement of growth parameters and carcass traits) for chickens for fattening, chickens reared for laying/reproduction, turkeys for fattening and turkeys reared for reproduction. Unless otherwise indicated, chromium in the opinion refers to chromium (III).
In the original application, the applicant requested the authorisation of a liquid feed additive containing chromium propionate 29%–32%, equivalent to ≥ 7% organic chromium (trade name: KemTRACE™ Chromium). The FEEDAP Panel fully characterised the product in its opinion in 2021. Subsequently, due to some limitations of the method of analysis of the liquid preparation in compound feed, the applicant proposed the use of the additive in a solid premixture in which a microtracer was added to allow for the quantification of organic Cr in premixtures of feed. This premixture, identified as KemTRACE Chromium 0.4%, was the subject of two opinions of the Panel (EFSA FEEDAP Panel, 2025a, 2025b). Overall, in those three opinions, the Panel concluded that the additive KemTRACE™ Chromium is safe for chickens for fattening and chickens reared for laying/breeding, turkeys for fattening and turkeys reared for reproduction, for the consumer and the environment, but could not conclude on the safety for other minor poultry species for fattening and reared for laying/breeding. The Panel also concluded that the use of the microtracer in the premixture KemTRACE Chromium 0.4% was safe for the same target species, consumers and raised some concerns for the users. Regarding the environment, the use of the microtracer was considered safe for the terrestrial compartment, but the Panel could not conclude on the safety of the colourants for the groundwater.
In the present submission, the applicant withdrew the application for minor poultry species and changed the subject of the request of the authorisation by considering the previously so‐called solid premixture KemTRACE Chromium 0.4% as the additive under assessment, with the trade name KemTRACE Chromium 0.4% MT, and modifying the composition of the microtracer (reduction of the concentration of the dyes).
The applicant provided data on the characterisation of the additive, of the new microtracer and on the safety of the microtracer for the environment.
3.1. Characterisation
3.1.1. Characterisation of the additive
KemTRACE Chromium 0.4% MT is specified to contain organic chromium 0.4% and 500 particles of microtracer/g additive.
The additive consists of ■■■■■ of liquid chromium propionate, ■■■■■ special Microtracer FS‐Green Lake and ■■■■■ of calcium carbonate. The liquid chromium proprionate corresponds to the former additive KemTRACE Chromium, which was characterised in the previous opinions (EFSA FEEDAP Panel, 2021, 2025a, 2025b). The Panel notes that the additive KemTRACE Chromium 0.4% MT corresponds to the premixture KemTRACE Chromium 0.4% described in the previous opinion (EFSA FEEDAP Panel 2025a), with the only difference being the different composition of the microtracer used.
The data provided by the applicant on the batch‐to‐batch variation 11 and impurities 12 of the additive are reported in Table 2.
TABLE 2.
Data on the batch‐to‐batch variation, impurities and physicochemical and technological properties of premixture KemTRACE Chromium 0.4% MT. 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 is indicated in [].
| Specifications | |
| Organic chromium (%) | 0.4 |
| Microtracer FS‐Green Lake (number of particles/g) | 500 |
| Batch to batch variation | |
| Organic chromium (%) 1 | 0.43 (0.41–0.45) [6] |
| Microtracer FS‐Green Lake (number of particles/g) 2 | 562 (532–589) [1] |
| Impurities | [3] |
| Chromium VI (mg/kg) | < 0.1 |
| Lead (mg/kg) | 0.89–0.92 |
| Mercury (mg/kg) | < 0.01 |
| Cadmium (mg/kg) | 0.12–0.13 |
| Arsenic (mg/kg) | 0.37–0.51 |
| Fluorine (mg/kg) | 42–64 |
| Dioxins and furans (upper bound) 3 | [3] |
| PCDD/Fs (ng WHO2005‐TEQ/kg) | 0.05 |
| PCDD/Fs + PCBs (ng WHO2005‐TEQ/kg) | 0.2 |
| nDL‐PCBs (μg/kg) | – |
| Physical properties | |
| Physical state | Solid |
Abbreviations: PCBs, polychlorinated biphenyls; PCDDs, polychlorinated dibenzo‐p‐dioxins; PCDFs, polychlorinated dibenzofurans; TEQ, toxic equivalent factors for dioxins, furans and dioxin‐like PCBs established by the WHO in 2005 (Van den Berg et al., 2006); WHO, World Health Organization.
Selective extraction with acetonitrile (ACN):H20 followed by ICP‐AES quantification.
One batch of microtracer tested in five different premixtures. From each premixture, 10 subsamples of about 0.2 g tested for the number of particles.
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.
<: below the limit of quantification of the analytical method.
–: not analysed.
The data provided showed compliance with the specifications set by the applicant. The Panel considers that the levels of impurities reported are of no concern.
To address the concerns raised on the safety of the microtracer for groundwater in the previous opinion (EFSA FEEDAP Panel, 2025c), the applicant proposed to use a different microtracer (Special Microtracer FS‐Green) with a reduced content of the dyes. The composition of the original microtracer and the new alternative proposed are given in Table 3. Compared with the concentrations of the original microtracer, 13 the reduction of concentration of the dyes in comparison to the new microtracer 14 is 77 and 87% for Brilliant Blue and Tartrazine, respectively.
TABLE 3.
Composition of the original microtracer and the new proposed microtracer (%).
| Component | Original (%) | New (%) |
|---|---|---|
| Stainless steel grit | > 91 | > 95 |
| Brilliant Blue | 0.25–0.70 | 0.10–0.16 |
| Tartrazine | 0.6–1.5 | 0.13–0.19 |
| Shellac | 1–4 | 1–4 |
Compliance with the specifications of the new microtracer was confirmed by analytical data from three batches, in which shellac ranged 1.4%–1.6%, Brilliant Blue pure dye ranged 0.14%–0.15% and Tartrazine pure dye ranged 0.14%–0.16%.
No other information was provided with regard to the physical and technological properties of the additive other than a study on the homogeneous distribution in feed. The Panel considers that the data on stability assessed in 2021 would also apply to the current application.
To support the capacity of the newly proposed microtracer to homogeneously distribute in feed, three samples of the additive, each of them prepared with a different batch of the microtracer, were mixed in a feed for chickens for fattening made of wheat, soybean meal and maize, subsequently pelleted. 15 A total of 10 subsamples were analysed for each feed form. The particles were counted (colour spots) by naked eye and by a computer‐assisted system. Results of mixing uniformity were expressed as probability (p) of the Poisson distribution. p values > 25% were considered indicative of an excellent mixing uniformity. In all cases, p values were > 25%, except one sample of pelleted feed, that had a p value of 23% and was considered still a good mix.
3.1.2. Conditions of use
The additive is intended to be used in feed for chickens for fattening, chickens reared for laying/reproduction, turkeys for fattening and turkeys reared for reproduction, to provide a minimum of 0.2 mg and a maximum of 0.4 mg organic Cr/kg complete feed. The supplementation level of 0.2 and 0.4 mg Cr/kg feed would correspond to 0.5 and 1 mg microtracer per kg feed, respectively.
3.2. Safety
The FEEDAP Panel assessed the safety of the liquid preparation of chromium propionate (KemTRACE Chromium) in previous opinions and concluded that its use in feed for chickens for fattening, chickens reared for laying/reproduction, turkeys for fattening and reared for reproduction is safe up to the maximum use level of 0.4 mg Cr/kg complete feed (EFSA FEEDAP Panel, 2021, 2025a). In the same opinions, the Panel concluded that the use of the additive KemTRACE Chromium is safe for the consumers and the environment and raised concerns for user safety due to the corrosiveness for the eyes.
The safety of the microtracer FS‐Green Lake used to formulate the premixture KemTRACE Chromium 0.4% was also assessed in a previous opinion (EFSA FEEDAP Panel, 2025c). In that opinion, the Panel concluded that the use of the microtracer was safe for the target species, the consumer and the terrestrial compartment of the environment but raised concerns for user safety (dermal and respiratory sensitiser) and, for the colouring dyes, the groundwater compartment.
Taking into account that the additive under assessment KemTRACE Chromium 0.4% MT corresponds to the premixture KemTRACE Chromium 0.4% described in the 2025 opinions, with the only difference being the reduced amount of dyes in the microtracer, the Panel considers that the previous conclusions regarding target species, consumer, user and the terrestrial compartment of the environment apply to the present assessment.
Therefore, the Panel concludes that the use of additive KemTRACE Chromium 0.4% MT at the proposed conditions of use is safe for the target species, the consumer and the terrestrial compartment of the environment. The additive should be considered irritant to the eyes, and a dermal and respiratory sensitiser. Exposure of users by any route is considered a risk.
The safety of the microtracer for the groundwater compartment is considered below.
3.3. Safety of the microtracer for the groundwater
The use of the new microtracer at 1 mg/kg feed would correspond to the addition of 0.76 mg iron/kg feed, 0.19 mg chromium/kg feed, 0.0016 mg Brilliant Blue FCF/kg feed, 0.0019 mg Tartrazine/kg feed and 0.04 mg shellac/kg feed. 16
The predicted environmental concentration in groundwater (PECgw) of the colouring dyes in Phase I was calculated according to the methodology described in the Guidance on the assessment of the safety of the additive for the environment (EFSA FEEDAP Panel, 2019), using the parameters described in Table 4. 17
TABLE 4.
Parameters used in the calculations of predicted environmental concentrations of the two dyes.
| Parameter | Brilliant blue | Tartrazine |
|---|---|---|
| Molar mass (g/mol) | 749.9 (neutral acid) | 534.4 |
| Vapour pressure [Pa] * | 2.03 × 10−36 | 4.07 × 10−17 |
| Water solubility (mg/L) * | 30,000 | 1,000,000 |
| Koc (L/kg) ** | 0 | 0 |
| DT50 (d) ** | 1000 | 1000 |
Calculated with EPISuite.
Default value considered a worst‐case scenario.
Turkeys for fattening are considered the worst‐case scenario for growing poultry. The PECgw for the dyes of the microtracer when the additive is used in turkeys for fattening were calculated to be 0.05 and 0.06 μg/L for Brilliant Blue FCF and Tartrazine, respectively. These values are below the trigger value of 0.1 μg/L for groundwater. Therefore, no substantial safety concerns are expected for the groundwater from the use of the microtracer according to the conditions of use.
3.4. Efficacy of KemTRACE Chromium 0.4% MT
In its opinion of 2021, the FEEDAP Panel concluded that KemTRACE™ Chromium has the potential to be efficacious as a zootechnical additive in poultry species for fattening and reared for laying/breeding at the supplementation level of 0.4 mg Cr/kg feed.
The additive under assessment (KemTRACE Chromium 0.4% MT) consists of ■■■■■ of the liquid KemTRACE™ Chromium with a microtracer and a carrier. As the composition in terms of active substance and the conditions of use have not changed, the FEEDAP Panel considers that the previous conclusions on the efficacy of the liquid KemTRACE™ Chromium are applicable to the additive under assessment.
4. CONCLUSIONS
The use of the additive KemTRACE Chromium 0.4% MT (containing a microtracer) at the proposed conditions of use is safe for the target species, consumers and the environment. The additive is considered an irritant to the eyes and a dermal and respiratory sensitiser. Exposure of users by any route is considered a risk.
KemTRACE Chromium 0.4% MT has the potential to be efficacious as a zootechnical additive in chickens for fattening, chickens reared for laying/reproduction, turkeys for fattening and turkeys reared for reproduction at the supplementation level of 0.4 mg Cr/kg feed.
ABBREVIATIONS
- DM
dry matter
- EURL
European Union Reference Laboratory
- FEEDAP
EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
- LOD
limit of detection
- LOQ
limit of quantification
- Log Kow
logarithm of octanol‐water partition coefficient
- OECD
Organisation for Economic Co‐operation and Development
REQUESTOR
European Commission
QUESTION NUMBER
EFSA‐Q‐2025‐00199
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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): Lydia Alarcón Asensio and Maria Vittoria Vettori and the experts of the Environment working group of the FEEDAP Panel.
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. , Anguita, M. , Galobart, J. , Innocenti, M. L. , & Tarrés‐Call, J. (2026). Safety of the feed additive consisting of chromium propionate (KemTRACE Chromium 0.4% MT) for chickens for fattening, chickens reared for laying/reproduction, turkeys for fattening and turkeys reared for reproduction (Kemin Europa N.V.). EFSA Journal, 24(7), e10248. 10.2903/j.efsa.2026.10248
Adopted: 1 July 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.
Available online: https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2025.9149.
Available online: https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9148.
The E‐Submission Food Chain Platform, available online: https://webgate.ec.europa.eu/esfc.
Dossier reference: FEED‐2025‐34,730 or EFSA‐Q‐2025‐00199.
Dossier reference: FAD‐2019‐0076, FEED‐2022‐6191 or EFSA‐Q‐2023‐00166.
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, p. 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/eurl‐fa‐eurl‐feed‐additives/eurl‐fa‐authorisation/eurl‐fa‐evaluation‐reports_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.
Annex RFI Feb26_1 Report Organic Cr, RFI Feb 2026 FEED‐2025‐34,730, and Annex RFI feb26 10 CoA 5 batches KemTRACE Chromium 0.4% MT.
Annex RFI Feb26 3 CoA Heavy metalsFluorine 3 batches; Annex RFI Feb26 7 CoA Dioxins PCBs 3 batches, Annex RFI Feb 26 9 Report Hexavalent Cr.
Annex SI III 2 PDS Initial Microtracer.
Annex RFI May 25 1 CoAs Batch‐to‐batch variation.
Annex RFI May 25_2 Report Special Microtracer.
Annex RFI May 25 1 CoAs Batch‐to‐batch variation.
Annex RFI May 25_3_Report ERA Aug 25.
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