Agriculture & Fishing

Amendment to EU Regulation on Medicated Feed: What Changes for Manufacturers and Livestock Farmers in 2026

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Equipo Editorial CambiosLegales
25 Aug 2026 6 min 15 views

Key data

RegulationAmendment to Regulation (EU) 2019/4 of the European Parliament and of the Council, of 11 December 2018, on the manufacture, placing on the market and use of medicated feed for animals
Publication25 August 2026
Entry into forceNot specified in the published text
Affected partiesManufacturers and distributors of medicated feed, livestock farmers and veterinarians in the EU
CategoryAgriculture and Fisheries
Repealed regulationCouncil Directive 90/167/CEE
Modified regulationRegulation (EC) 183/2005 on feed hygiene
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If your company manufactures, distributes or uses medicated feed in the European market, there is a regulatory correction you cannot ignore. The amendment to Regulation (EU) 2019/4—the regulation that has governed the entire chain of medicated feed for animals in the EU since 2019—was published on 25 August 2026 in the Official Journal of the European Union.

This type of amendment is not a minor formality. It corrects the current legal text with official status, which means that previous versions of the regulation become outdated. If your internal procedures, technical sheets or contracts are based on the original text without the corrections, your company may be operating outside the regulation without knowing it.

What does this regulation establish?

Regulation (EU) 2019/4 is the reference regulation in the EU for everything related to medicated feed for animals. When it came into force, it repealed Council Directive 90/167/CEE—which had regulated the sector for nearly three decades—and amended Regulation (EC) 183/2005 on feed hygiene.

The regulation covers three major areas:

  • Manufacture: requirements for establishments producing medicated feed, including conditions for facilities, equipment and personnel.
  • Placing on the market: conditions for market placement, labelling and traceability of products.
  • Use: rules for veterinary prescription, administration to animals and waste management.

The amendment published in August 2026 corrects errors or omissions detected in the original text. Although the exact content of the corrections must be verified in the official text, these may affect key definitions, specific technical requirements or administrative procedures applicable to any of the three areas above.

Regulatory frameworkStatus
Directive 90/167/CEERepealed by Regulation (EU) 2019/4
Regulation (EC) 183/2005 (feed hygiene)Amended by Regulation (EU) 2019/4
Regulation (EU) 2019/4Current regulation, now amended by the August 2026 amendment

Economic and operational impact

Amendments to European regulations have a direct operational impact that companies often underestimate. These are the main practical consequences:

  • Review of technical documentation: any internal procedure, product sheet or manufacturing manual that cites or reproduces articles of Regulation (EU) 2019/4 must be updated with the corrected text.
  • Risk of non-compliance: operating with procedures based on the original text—without the corrections—may result in observations or sanctions in the event of inspection by the competent authorities.
  • Contracts and commercial agreements: if contracts with suppliers or customers refer to specific articles of the regulation, it may be necessary to review whether the corrections affect the agreed obligations.
  • Veterinary prescription: if the corrections affect prescription or administration procedures, veterinarians will need to update their protocols.

Who does it affect?

  • Manufacturers of medicated feed: companies that produce feed with incorporated medicines for administration to animals.
  • Distributors and marketers: operators that place these products on the market in any EU Member State.
  • Livestock farms: farms and operations that use medicated feed prescribed by a veterinarian.
  • Veterinarians: professionals who prescribe and supervise the use of medicated feed.
  • Technical advisors and agricultural consultants: who must keep their regulatory knowledge up to date to properly advise their clients.

Practical example

Imagine a medicated feed manufacturing company authorized to operate in several EU countries. Its manufacturing and quality control procedures are documented with explicit references to Regulation (EU) 2019/4. Following the publication of the amendment on 25 August 2026, one of the articles regulating labelling requirements or prescription periods is corrected.

If the company does not update its internal procedures with the corrected text and an inspection by the competent authority detects that it is operating according to the original (now outdated) text, it may receive a non-compliance observation that forces it to halt the commercialization of the product until the deviation is remedied. The cost of a halt—even temporary—in terms of retained batches, document review and possible sanctions can be far greater than the effort of proactively reviewing the corrected text.

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What should companies do now?

  1. Download and read the amendment text: access the official version published in the Official Journal of the EU on 25 August 2026 and identify exactly which articles or annexes have been corrected.
  2. Compare with the original text of Regulation (EU) 2019/4: locate the differences between the original text (published on 7 January 2019 in OJ L 4) and the corrected text.
  3. Review internal documentation: update manufacturing procedures, technical sheets, quality manuals and any document that references the corrected articles.
  4. Inform the technical and veterinary team: ensure that personnel responsible for manufacturing, quality control and prescription are aware of the changes and act in accordance with the corrected text.
  5. Review contracts with third parties: if there are commercial agreements that reference specific articles of the regulation, assess whether the corrections affect the contractual obligations.
  6. Document the update process: in the event of an inspection, being able to demonstrate that the company has reviewed and adapted its procedures following the publication of the amendment is a guarantee of diligence.

Frequently asked questions

What exactly does the amendment to Regulation (EU) 2019/4 correct?

The amendment published on 25 August 2026 corrects errors or omissions present in the original text of Regulation (EU) 2019/4. According to available information, the corrections may affect technical requirements, definitions or procedures applicable to the manufacture, placing on the market or use of medicated feed for animals. To know the exact details of each correction, it is necessary to consult the text published in the Official Journal of the EU.

When does this amendment come into force?

The date of entry into force has not been specified in the published information. European amendments are usually applicable immediately from their publication in the Official Journal, but it is essential to verify the official text published on 25 August 2026 to confirm the exact date of application.

What is the difference between Regulation (EU) 2019/4 and the Directive 90/167/CEE it repealed?

Directive 90/167/CEE was the regulation that governed medicated feed for animals in Europe for nearly three decades. Regulation (EU) 2019/4 completely repealed it and established a more modern and harmonized framework, directly applicable in all Member States without the need for national transposition. In addition, it amended Regulation (EC) 183/2005 on feed hygiene to integrate both regulations.

What happens if my company does not update its procedures following the amendment?

Operating with procedures based on the original text of Regulation (EU) 2019/4, without incorporating the corrections of the amendment, may result in non-compliance situations detectable in inspections by the competent authorities. This may involve observations, remediation requirements or, in serious cases, suspension of activity until the situation is regularized.

Where can I consult the official corrected text of Regulation (EU) 2019/4?

The official text of the amendment is available in the Official Journal of the European Union, published on 25 August 2026. You can access it directly through the EUR-Lex portal at the official URL of this regulation.

Official source

Consult complete regulation in 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_202690711



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