Key data
| Regulation | Commission Implementing Regulation (EU) 2026/2115, of 23 September 2026 |
|---|---|
| Publication | 24 September 2026 |
| Entry into force | Not specified in the regulation |
| Affected parties | Feed manufacturers, livestock farmers and animal nutrition companies in the EU |
| Category | Agriculture and Fisheries |
| Repealed regulation | Commission Implementing Regulation (EU) 2015/2307 |
| Authorized substances | Menadione sodium bisulfite (vitamin K3) and menadione nicotinamide bisulfite (vitamin K3) |
| Animal species | All animal species |
If you manufacture feed, distribute additives for animal nutrition or are a livestock farmer who purchases compound feed, this regulation directly affects you. The Commission Implementing Regulation (EU) 2026/2115, published on 24 September 2026, renews the authorization of vitamin K3 as an additive in feed for all animal species and expressly repeals Commission Implementing Regulation (EU) 2015/2307, which has been regulating these substances for over a decade.
The change is not a simple administrative extension: it involves new authorization conditions that require reviewing product records and labeling. Anyone who fails to do so in time risks having their products withdrawn from the market.
What does this regulation establish?
Regulation 2026/2115 renews the authorization of two specific forms of vitamin K3 for use as additives in feed intended for all animal species:
| Authorized substance | Common name | Authorized species | Previous regulation |
|---|---|---|---|
| Menadione sodium bisulfite | Vitamin K3 | All animal species | Reg. (EU) 2015/2307 (repealed) |
| Menadione nicotinamide bisulfite | Vitamin K3 | All animal species | Reg. (EU) 2015/2307 (repealed) |
The basis for the renewal is the safety and efficacy assessment carried out by the EFSA (European Food Safety Authority), which has concluded that the use of these substances presents no risks to:
- Animal health
- Human health
- The environment
The key difference from the previous situation is that the Regulation (EU) 2015/2307 is expressly repealed. This means that any reference to that regulation in records, technical sheets or labeling ceases to have legal validity. Products must be covered by the new regulation and comply with the authorization conditions it establishes.
Economic and operational impact
The direct economic impact of this regulation is not new fees or quantified economic sanctions in the text, but it does generate real operational costs for companies in the sector:
- Review and update of product records: All feed containing menadione sodium bisulfite or menadione nicotinamide bisulfite must be updated to reference the new regulation instead of the repealed 2015/2307.
- Labeling redesign: Labels that cite Regulation 2015/2307 as the legal basis for authorization must be modified. This involves redesign costs, printing and possible management of already-printed packaging stock.
- Risk of market withdrawal: Non-compliance with the requirements established in the new regulation may result in the withdrawal of affected products from the market, with the consequent economic impact on sales, logistics and reputation.
- Review of supplier contracts: Additive distributors must verify that their suppliers have updated the documentation of the substances supplied.
In comparative terms, the previous regulation (2015/2307) had been in force for more than 10 years. The sector has operated under that framework for a decade, so documentary and labeling adaptation may affect a significant volume of product references in circulation.
Who does it affect?
- Compound feed manufacturers that include vitamin K3 (in either of its two authorized forms) in their formulation.
- Manufacturers and distributors of feed additives that market menadione sodium bisulfite or menadione nicotinamide bisulfite.
- Livestock farmers and agricultural operations that purchase feed with these additives: they must verify that the products they purchase comply with the new regulation.
- Animal nutrition companies operating in any EU Member State, given that the regulation applies directly throughout the Union.
- Quality and regulatory affairs managers of companies in the sector, who must manage the documentary transition.
Practical example
A poultry feed manufacturer that produces compound feed enriched with menadione sodium bisulfite (vitamin K3) currently has its technical sheets and labels referencing Commission Implementing Regulation (EU) 2015/2307 as the legal basis for authorization of the additive.
With the entry into force of Regulation 2026/2115, that manufacturer must:
- Update the technical documentation of all affected feed to cite the new regulation.
- Redesign labels that mention 2015/2307 as the reference regulation.
- Manage the stock of labels already printed with the old reference, deciding whether to exhaust them in a transitional period or withdraw them.
- Communicate the change to its livestock farmer customers so they update their records on additive use.
If it does not act, its products could be considered non-compliant in an inspection, with risk of market withdrawal.
What should companies do now?
- Identify all affected products: Review the complete catalog of feed and additives containing menadione sodium bisulfite or menadione nicotinamide bisulfite.
- Update records and technical documentation: Replace all references to Regulation (EU) 2015/2307 with the new Commission Implementing Regulation (EU) 2026/2115 in technical sheets, specifications and regulatory documentation.
- Review and redesign labeling: Adapt the labels of affected products to reflect the new legal basis for authorization.
- Verify the supply chain: Confirm with additive suppliers that the documentation of the substances supplied is already updated in accordance with the new regulation.
- Consult a specialized regulatory advisor: Given that the entry into force date is not specified in the published regulation, it is essential to obtain advice on applicable adaptation periods and the specific authorization conditions established in the full text of the regulation.
Risk of non-compliance: The regulation itself establishes that non-compliance with the requirements may result in the withdrawal of affected products from the market.
Frequently asked questions
What specific substances does Regulation (EU) 2026/2115 regulate?
The regulation regulates two forms of vitamin K3 as additives in feed: menadione sodium bisulfite and menadione nicotinamide bisulfite. Both are authorized for use in feed intended for all animal species.
What regulation does Regulation 2026/2115 repeal and what are the implications?
It expressly repeals Commission Implementing Regulation (EU) 2015/2307, which has been in force since 2015. Any reference to that regulation in records, technical sheets or labeling ceases to have legal validity. Manufacturers must update all their documentation to cite the new regulation.
What happens if a feed manufacturer does not update its labeling?
The regulation itself establishes that non-compliance with the requirements may result in the withdrawal of affected products from the market. This implies direct economic losses in sales and withdrawal logistics costs, in addition to reputational impact.
When does Regulation (EU) 2026/2115 enter into force?
The regulation was published on 24 September 2026, but the entry into force date is not specified in the published data. It is essential to consult the full text of the regulation in the EU Official Journal to know the exact application period.
Does this regulation affect only feed manufacturers or also livestock farmers?
It affects the entire chain: feed manufacturers (who must update records and labeling), additive distributors (who must ensure their documentation is updated) and livestock farmers (who must verify that the feed they purchase complies with the new regulation). The regulation applies directly in all EU Member States.
Official source
Consult complete regulation at official source
Disclaimer: 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=OJ:L_202602115