LegalizeCommission 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.)
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| Image omitted; see official source | Official Journal of the European Union | EN L series |
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| 2025/1782 | 10.9.2025 |
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 [^ntr1-L_202501782EN.000101-E0001], 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 [^ntr2-L_202501782EN.000101-E0002] 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 [^ntr3-L_202501782EN.000101-E0003] are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005 [^ntr4-L_202501782EN.000101-E0004], 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
[^ntr1-L_202501782EN.000101-E0001]: OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
[^ntr2-L_202501782EN.000101-E0002]: EFSA Journal 2025;23:e9310, https://doi.org/10.2903/j.efsa.2025.9310.
[^ntr3-L_202501782EN.000101-E0003]: EFSA Journal 2020;18(2):6026, https://doi.org/10.2903/j.efsa.2020.6026.
[^ntr4-L_202501782EN.000101-E0004]: 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 | mg additive/kg of complete feedingstuff with a moisture content of 12 % | mg additive/kg of complete feedingstuff with a moisture content of 12 % | Other provisions | End of period of authorisation |
| Category: zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) | Category: zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) | Category: zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) | Category: zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) | Category: zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) | Category: zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) | Category: zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) | Category: zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) | Category: zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) | 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 [^ntr1-L_202501782EN.000301-E0001] — 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 |
[^ntr1-L_202501782EN.000301-E0001]: 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)
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