Key data
| Regulation | Commission Implementing Regulation (EU) 2026/2087 |
|---|---|
| Publication | September 21, 2026 |
| Entry into force | Not specified in available data |
| Affected parties | Feed manufacturers, feed additive producers and farmers in the EU |
| Category | Agriculture and Fisheries |
| Authorized additive | L-isoleucine produced with Corynebacterium glutamicum CCTCC M 2022764 |
| Type of additive | Zootechnical additive (essential amino acid) |
| Species | All animal species |
| Safety assessment | EFSA (animals, consumers and environment) |
Feed manufacturers and animal additive producers in the EU have had a new authorized ingredient available in their formulations since September 21, 2026: L-isoleucine produced by fermentation with the bacterial strain Corynebacterium glutamicum CCTCC M 2022764. Commission Implementing Regulation (EU) 2026/2087 formalizes this authorization and establishes the conditions that sector operators must comply with to use it legally.
L-isoleucine is an essential amino acid that cannot be synthesized in the animal organism and must be provided through diet. Its incorporation in feed improves the nutritional profile and feed conversion efficiency, which has a direct impact on livestock production costs. The key point here is not just that the additive is available, but that its use without complying with the regulation's conditions constitutes a breach of European feed additive regulations.
What does this regulation establish?
Regulation 2026/2087 formally authorizes L-isoleucine obtained by fermentation with Corynebacterium glutamicum CCTCC M 2022764 as a zootechnical additive in feed intended for all animal species. The key points it regulates are:
- Conditions of use: Operators must respect the specific conditions of use established in the regulation for each application.
- Maximum doses: The regulation sets maximum doses that cannot be exceeded in feed formulation.
- Labeling: Products incorporating this additive must comply with the labeling requirements defined in the standard.
- Technical documentation: Companies producing and distributing this additive must update their records and technical documentation in accordance with the new authorization.
- Safety assessment: The EFSA previously evaluated the safety of the additive for animals, human consumers and the environment, giving the green light for its use.
The strain used, Corynebacterium glutamicum CCTCC M 2022764, is a specific bacterium whose precise identification is relevant: the authorization is exclusive to this specific producer microorganism, not to any L-isoleucine production process.
Economic and operational impact
The authorization of this new additive has a dual reading for the sector:
Business opportunity: Feed manufacturers can now expand their catalog of formulations with an additional essential amino acid, improving the nutritional efficiency of their products. Better feed conversion translates directly into lower feeding costs per kilogram of weight gain for the farmer, which can be a relevant commercial argument.
Compliance obligation: The use of this additive is not free. It involves a specific operational burden:
- Updating product records with the competent authorities.
- Review and adaptation of technical documentation for feed incorporating L-isoleucine with this strain.
- Adjustment of product labeling to the regulation's requirements.
- Verification that the doses used do not exceed the authorized maximums.
For additive producers already manufacturing L-isoleucine with this specific strain, the authorization opens the European market in a legal and structured way. For those not yet producing it, it represents a signal of potential demand from the livestock sector.
Who does it affect?
- Compound feed manufacturers wishing to incorporate L-isoleucine (strain CCTCC M 2022764) in their formulations for any animal species.
- Producers and distributors of feed additives that market or intend to market this amino acid in the European market.
- EU farmers of all species (cattle, pigs, poultry, aquaculture, etc.) who purchase feed incorporating this additive and must verify regulatory compliance of their suppliers.
- Quality and regulatory managers in animal nutrition companies who must update technical documentation and product registration records.
- Advisors and consultants in the agricultural sector who support their clients in complying with European feed additive regulations.
Practical example
A pig feed manufacturer currently using L-isoleucine from another source in its formulations decides to incorporate the variant produced with Corynebacterium glutamicum CCTCC M 2022764, now authorized by Regulation 2026/2087.
To do so legally, this manufacturer must:
- Verify that the additive supplier certifies that the L-isoleucine comes specifically from the strain CCTCC M 2022764 (any strain of Corynebacterium glutamicum will not do).
- Check that the dose incorporated in the formula does not exceed the maximums established in the regulation for pigs.
- Update the feed labeling to reflect the presence of the additive in accordance with the standard's requirements.
- Update the product's technical documentation with the competent authority of its Member State.
If the manufacturer omits any of these steps and markets the feed without complying with the regulation's conditions, it operates outside the European legal framework for feed additives, with the administrative consequences that entails.
What should companies do now?
- Review the complete regulation to understand the exact conditions of use, maximum doses and labeling requirements applicable to each animal species.
- Verify the supplier's strain: Confirm that any L-isoleucine incorporated in formulations comes specifically from Corynebacterium glutamicum CCTCC M 2022764, as the authorization is strain-specific.
- Update technical documentation for all feed incorporating this additive, including technical sheets and registration files.
- Adapt product labeling to the requirements established in Regulation 2026/2087.
- Inform the quality and regulatory team about the new authorization so it is integrated into raw material control and formulation procedures.
- Communicate with farmer clients (if applicable) that feed incorporating this additive complies with the new European authorization, providing the regulation as documentary support.
Frequently asked questions
What exactly is the L-isoleucine authorized by Regulation 2026/2087?
It is an essential amino acid produced by fermentation with the bacterial strain Corynebacterium glutamicum CCTCC M 2022764. Its use as a zootechnical additive in feed for all animal species is authorized by this regulation, provided that the conditions of use, maximum doses and labeling requirements established by the standard are respected.
For which animal species is this L-isoleucine authorized?
Regulation 2026/2087 authorizes its use in feed intended for all animal species, without restriction by species. This includes, among others, cattle, pigs, poultry and aquaculture.
What documentation must feed manufacturers update?
Manufacturers and distributors of this additive must update their records and technical documentation in accordance with the new authorization. This includes technical sheets for the additive, product registration files with the competent authority and labeling of feed incorporating it.
Who evaluated the safety of this additive before its authorization?
The EFSA (European Food Safety Authority) previously evaluated the safety of L-isoleucine produced with this strain for animals, human consumers and the environment, issuing a favorable opinion that served as the basis for authorization by the European Commission.
Is the authorization valid for any L-isoleucine or only for that produced with that specific strain?
The authorization is strain-specific: it only covers L-isoleucine produced with Corynebacterium glutamicum CCTCC M 2022764. It is not extensible to L-isoleucine obtained by other processes or with other bacterial strains. Manufacturers must verify this information with their supplier before incorporating the additive.
Official source
Consult complete regulation at official source
Notice: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=CELEX:32026R2087
