Safety of a feed additive consisting of chromium propionate (KemTRACE™ Chromium) for all growing poultry species (KEMIN EUROPA N.V.)

TL;DR

This study evaluates the safety of chromium propionate as a feed additive for growing poultry species.

Contribution

The study confirms the safety of chromium propionate for chickens and turkeys but cannot confirm it for other poultry species.

Findings

Chromium propionate is safe for chickens and turkeys at 0.2–0.4 mg Cr/kg feed.

No new data support safety for other poultry species like ducks or geese.

The FEEDAP Panel cannot conclude safety for minor poultry species.

Abstract

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of a feed additive consisting of chromium propionate (KemTRACE™ Chromium) intended for use as a zootechnical additive (functional group: other zootechnical additives) for all growing poultry species. The safety and efficacy of chromium propionate has been assessed previously by the Panel, and it was concluded that the additive is considered safe for chickens for fattening and chickens reared for laying/breeding and for turkeys for fattening and reared for reproduction at the proposed use level of 0.2–0.4 mg Cr/kg complete feed, but the conclusion was not extrapolated to other growing species. No additional data have been submitted in the current application that would support the safety for poultry species other than chickens or turkeys. The FEEDAP Panel cannot conclude on the safety of the additive for minor poultry for fattening or reared for reproduction.

Tables

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

Full text

INTRODUCTION

1

Background and Terms of Reference as provided by the requestor

1.1

Regulation (EC) No 1831/2003 establishes the rules governing the Union 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.

On 27.11.2024, 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, (1) the Panel could not conclude on the safety for the groundwater of the microtracer with the proposed conditions of use.
• – 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.) (2), 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 (applications number FEED‐2025‐34730 and FEED‐2025‐34733 respectively).1

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 micro‐tracer 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.

Additional information

1.2

The additive KemTRACE^™^ Chromium 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) and the safety of an associated microtracer (EFSA FEEDAP Panel, 2025b).

DATA AND METHODOLOGIES

2

Data

2.1

The present assessment is based on data submitted by the applicant in the form of supplementary information2 to a previous application on the same product.3 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‐2025‐00200.

The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA or other expert bodies, peer‐reviewed scientific papers, other scientific reports and experts' (elicitation) knowledge, to deliver the present output.

Methodologies

2.2

The approach followed by the FEEDAP Panel to assess the safety and efficacy of chromium propionate (KemTRACE^™^ Chromium) is in line with the principles laid down in Regulation (EC) No 429/20084 and the relevant guidance documents: Guidance on the assessment of the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017).

ASSESSMENT

3

The additive chromium propionate (trade name: KemTRACE^™^ Chromium) is intended to be used as a zootechnical feed additive (functional group: other zootechnical additives; claim: improvement of growth parameters and carcass traits) for all growing poultry species.

The feed additive under assessment has been fully characterised in previous opinions (EFSA FEEDAP Panel, 2021, 2025a, 2025b). In those opinions, the FEEDAP Panel also concluded that the use of the additive at the proposed conditions of use is safe for the consumers. The Panel considered that the additive is corrosive to the eyes, but it is not a skin irritant nor a skin sensitiser. Although the Panel considered that the use of the additive is safe for the environment, it could not conclude on the safety of the microtracer for the groundwater compartment. The Panel concluded that the additive has the potential to be efficacious as a zootechnical additive in the target species under application. The Panel also concluded that the additive is safe for chickens for fattening and chickens reared for laying/breeding, turkeys for fattening and turkeys reared for reproduction, but could not conclude on the safety for other (or minor) poultry species for fattening and reared for laying/breeding.

The applicant provided arguments to support the safety for (minor) poultry species for fattening and reared for laying/breeding, which are assessed below. The additional information regarding the safety of the microtracer for the environment will be assessed in a separate opinion.5

Safety for the target species

3.1

The safety of the chromium propionate for the target species has been previously assessed by the FEEDAP Panel (EFSA FEEDAP Panel, 2021, 2025a, 2025b). Based on the studies in chickens for fattening and in turkeys for fattening, the Panel concluded that the additive is safe at the proposed conditions of use (maximum level of 0.4 mg Cr/kg complete feed) in chickens for fattening and reared for laying/reproduction and turkeys for fattening and reared for reproduction. None of the previous studies either with chickens for fattening or with turkeys for fattening allowed to establish a margin of safety. Consequently, the FEEDAP Panel could not conclude on the safety of the additive for minor poultry for fattening or reared for laying/reproduction.

The applicant provided a calculation of the maximum safe concentration in feed, based on a 90‐day repeat dose oral toxicity study in rats6 already assessed in a previous opinion (EFSA FEEDAP Panel, 2021), following the methodology described in the guidance on the safety for the target species (EFSA FEEDAP Panel, 2017). Based on the applicant's calculations, the safe level for feed for chickens for fattening and turkeys for fattening would be 56 and 75 mg additive/kg feed, respectively, which would be far above the maximum recommended use level of the additive in feed (4 mg additive/kg complete feed, which corresponds to 0.4 mg Cr/kg complete feed). According to the applicant, this would allow to conclude on the safety of chromium propionate for minor poultry for fattening or reared for laying/breeding at the proposed conditions of use.

In the tolerance studies in chickens for fattening and turkeys for fattening previously evaluated, adverse effects were observed at the overdose concentrations not allowing to identify any margin of safety. The concentrations that led to adverse effects were well below the levels calculated to be safe from the 90‐day dose oral toxicity study in rats. Therefore, the FEEDAP Panel does not consider it appropriate using the no observed adverse effect level (NOAEL) derived from the 90‐day dose oral toxicity study in rats to derive a safe concentration for minor poultry for fattening or reared for laying/breeding.

Considering this, and in the absence of an adequate margin of safety in chickens and turkeys, the FEEDAP Panel reiterates its position and cannot conclude on the safety of the additive for minor poultry for fattening or reared for reproduction.

CONCLUSIONS

4

The FEEDAP Panel reiterates its conclusion that the additive KemTrace^™^ Chromium is safe for chickens for fattening, chickens reared for laying/breeding, turkeys for fattening and turkeys reared for breeding at the maximum proposed supplementation level of 0.4 mg Cr/kg complete feed, but cannot conclude on the safety for other growing (minor) poultry species.ABBREVIATIONSEURLEuropean Union Reference LaboratoryFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal FeedNOAELno observed adverse effect level

REQUESTOR

European Commission

QUESTION NUMBER(S)

EFSA‐Q‐2025‐00200

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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, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona, Ilen Röhe and Katerina Theodoridou.