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FDA Approves Chromium DL-Methionine Chelate as Nutritional Additive in Cattle Feed

A final FDA order amends animal feed additive regulations to permit chromium DL-methionine chelate in cattle feed, with objections due by September 18, 2026.

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The Food and Drug Administration has issued a final order amending 21 CFR Part 573 to provide for the safe use of chromium DL-methionine chelate as a nutritional source of chromium in cattle feed. The order is effective August 19, 2026, and was prompted by a food additive petition filed by Zinpro Corp., located at 10400 Viking Dr., Suite 240, Eden Prairie, MN 55344.

Background and Petition History

FDA announced the filing of the underlying food additive petition — designated FAP 2300, submitted by Zinpro Corp. — in a Federal Register document published September 22, 2017. The petition originally proposed amending the regulations to permit "chromium DL-methionine" as a nutritional source of chromium in cattle feed. During its review, the agency determined that a different name better describes the substance; the final order accordingly renames it "chromium DL-methionine chelate" to ensure consistency with the regulation for chromium propionate at 21 CFR 573.304 and to reflect the additive's composition as a chelate.

What the Rule Does

The final order adds a new section, 21 CFR 573.302, to Subpart B of Part 573. Under the prescribed conditions, chromium DL-methionine chelate may be safely used as a nutritional source of chromium in cattle feed. The additive is manufactured by the reaction of a chromium salt with excess DL-methionine, at an appropriate stoichiometric ratio, to produce a chelate — tris (DL-methioninato) chromium (III) hydrochloride — with the empirical formula Cr[(CH₃S(CH₂)₂CH(NH₂)COO)₃]·HCl. The regulation limits its addition to complete feed for cattle at a level not to exceed 0.5 milligrams of chromium from chromium DL-methionine chelate per kilogram of feed.

Agency Conclusions and Regulatory Classification

FDA states that the data establishes the safety and utility of chromium DL-methionine chelate as a nutritional source of chromium in cattle feed. The agency characterizes this final order as expected to result in expanded production options and designates it an E.O. 14192 deregulatory action. On environmental review, FDA determined the action is categorically excluded under 21 CFR 25.32(r), which applies to substances that occur naturally in the environment when the action does not significantly alter the concentration or distribution of the substance, its metabolites, or degradation products. The agency explains that chromium DL-methionine chelate completely dissociates into chromium and DL-methionine — both naturally occurring compounds — and that excretion of these compounds into the environment by cattle is not expected to significantly alter their concentration or distribution. The agency states it is not aware of any extraordinary circumstances, and therefore neither an environmental assessment nor an environmental impact statement is required.

What to Watch

Parties adversely affected by one or more provisions of the regulation may file electronic or written objections, which must be submitted by September 18, 2026. Each objection must be separately numbered, must specify with particularity the provision objected to and the grounds, and must explicitly state whether a hearing is requested on that provision. Parties that do not request a hearing for a particular objection waive the right to a hearing on that objection. Objections requesting a hearing must include a detailed description and analysis of the specific factual information the objecting party intends to present. Per 21 CFR 571.1(h), the petition and documents FDA considered and relied upon in reaching its approval decision will be made available for public disclosure, with materials not available for public disclosure deleted.

Related

Sources

16 cited

Every hard fact above is grounded in and cited to a primary source record.

  1. FDA issued a final order amending 21 CFR Part 573 to provide for the safe use of chromium DL-methionine chelate as a nutritional source of chromium in cattle feed.

    federalregister.gov

  2. The order is effective August 19, 2026.

    federalregister.gov

  3. The order was prompted by a food additive petition filed by Zinpro Corp.

    federalregister.gov

  4. Zinpro Corp. is located at 10400 Viking Dr., Suite 240, Eden Prairie, MN 55344.

    federalregister.gov

  5. FDA announced the filing of food additive petition FAP 2300 in a Federal Register document published September 22, 2017 (82 FR 44367).

    federalregister.gov

  6. The petition originally proposed amending the regulations to permit 'chromium DL-methionine' as a nutritional source of chromium in cattle feed.

    federalregister.gov

  7. The agency renamed the additive from 'chromium DL-methionine' to 'chromium DL-methionine chelate' to ensure consistency with the regulation for chromium propionate at 21 CFR 573.304 and to reflect the additive's composition as a chelate.

    federalregister.gov

  8. The final order adds a new section, 21 CFR 573.302, to Subpart B of Part 573.

    federalregister.gov

  9. The additive is manufactured by the reaction of a chromium salt with excess DL-methionine, at an appropriate stoichiometric ratio, to produce a chelate — tris (DL-methioninato) chromium (III) hydrochloride.

    federalregister.gov

  10. The regulation limits addition of the additive to complete feed for cattle at a level not to exceed 0.5 milligrams of chromium from chromium DL-methionine chelate per kilogram of feed.

    federalregister.gov

  11. FDA characterizes the final order as expected to result in expanded production options and designates it an E.O. 14192 deregulatory action.

    federalregister.gov

  12. FDA determined the action is categorically excluded under 21 CFR 25.32(r), which applies to substances that occur naturally in the environment when the action does not significantly alter the concentration or distribution of the substance, its metabolites, or degradation products.

    federalregister.gov

  13. FDA explains that chromium DL-methionine chelate completely dissociates into chromium and DL-methionine, both of which are naturally occurring compounds.

    federalregister.gov

  14. FDA states that excretion of these compounds into the environment by cattle is not expected to significantly alter their concentration or distribution.

    federalregister.gov

  15. Electronic or written objections must be submitted by September 18, 2026.

    federalregister.gov

  16. Per 21 CFR 571.1(h), the petition and documents FDA considered and relied upon in reaching its approval decision will be made available for public disclosure.

    federalregister.gov

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