Choose the experimental features you want to try

This document is an excerpt from the EUR-Lex website

Document 32025R1782

Commission Implementing Regulation (EU) 2025/1782 of 9 September 2025 concerning the authorisation of a preparation of chromium chelate of DL-methionine as a feed additive for salmonids (holder of authorisation: Zinpro Animal Nutrition Europe, Inc.)

C/2025/5967

OJ L, 2025/1782, 10.9.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/1782/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

Legal status of the document In force

ELI: http://data.europa.eu/eli/reg_impl/2025/1782/oj

European flag

Official Journal
of the European Union

EN

L series


2025/1782

10.9.2025

COMMISSION IMPLEMENTING REGULATION (EU) 2025/1782

of 9 September 2025

concerning the authorisation of a preparation of chromium chelate of DL-methionine as a feed additive for salmonids (holder of authorisation: Zinpro Animal Nutrition Europe, Inc.)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of chromium chelate of DL-methionine (‘the preparation’). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)

The application concerns the authorisation of the preparation as a feed additive for salmonids, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 February 2025 (2) that, under the proposed conditions of use, the preparation is safe for the target species, consumers and the environment. It also concluded that the preparation is not a skin or eye irritant but is considered a skin and respiratory sensitiser, while inhalation and dermal exposure are considered a risk. The Authority further concluded that the preparation may have the potential to be efficacious in improving the performance of salmonids, despite noting that one study showed a worse feed-to-gain ratio compared to the control when fed to salmons at the highest proposed use level. It did not consider that there is a need for specific requirements of post-market monitoring.

(5)

The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning another application for the authorisation of the same additive and verified by the Authority in its opinion of 30 January 2020 (3) are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005 (4), an evaluation report of the Reference Laboratory is therefore not required.

(6)

In view of the above, the Commission considers that the preparation of chromium chelate of DL-methionine satisfies the conditions as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 9 September 2025.

For the Commission

The President

Ursula VON DER LEYEN


(1)   OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

(2)   EFSA Journal 2025;23:e9310, https://doi.org/10.2903/j.efsa.2025.9310.

(3)   EFSA Journal 2020;18(2):6026, https://doi.org/10.2903/j.efsa.2020.6026.

(4)  Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/2005/378/oj).


ANNEX

Identification number of the feed additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg additive/kg of complete feedingstuff with a moisture content of 12 %

Category: zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)

4d30

Zinpro Animal Nutrition Europe, Inc

Chromium chelate of DL-methionine

Additive composition

Preparation of:

Chromium chelate of DL-methionine: 1,8 to 2,2 % (≥ 1 000  mg Cr(III)/kg additive)

Iron coloured microtracer coated with tartrazine and shellac: 270 particles /g additive

Impurities:

Nickel ≤ 1,33 mg/kg additive

Solid form.

Characterisation of the active substance

Chromium chelate of DL-methionine:

[CH3S(CH2)2CH(NH2)COO]3Cr(III)

chromium-DL-2-amino-4-(methylthio)butanoic acid

Analytical method  (1)

For the determination of total chromium in the feed additive: Inductively coupled plasma coupled with mass spectrometry (ICP-MS)

For the determination of methionine in the feed additive: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS)

For proving the chelated structure of the feed additive: Mid-infrared (IR) spectrometry together with the determination of total chromium and methionine in the feed additive

For the determination of inclusion rate of the microtracer into the feed additive preparation: Enumeration of colour coated particles of the microtracer

For the determination of total chromium in premixtures: Inductively coupled plasma coupled to atomic emission spectrometry (ICP-AES)

For the determination of added chromium / chromium chelate of DL-methionine in premixtures and compound feed: Enumeration of colour coated particles of the microtracer present at fixed mass ratio in the feed additive preparation

Salmonids

200

600

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.

30 September 2035


(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en


ELI: http://data.europa.eu/eli/reg_impl/2025/1782/oj

ISSN 1977-0677 (electronic edition)


Top