Agriculture & Fishing

New recombinant eCG residue limit in food: what livestock farmers and veterinarians must do in 2026

E
Equipo Editorial CambiosLegales
27 Jul 2026 8 min 7 views

Key data

RegulationCommission Implementing Regulation (EU) 2026/1806 of 24 July 2026
Modified standardRegulation (EU) No 37/2010 (classification of veterinary substances and their MRLs)
Publication27 July 2026 (Official Journal of the EU)
Entry into forceNot specified in the published regulation
Regulated substanceRecombinant equine chorionic gonadotropin (recombinant eCG)
Affected partiesLivestock farmers, veterinarians, veterinary pharmaceutical industry and food control authorities
CategoryAgriculture and Fisheries
Year2026
Impact analysis reserved for subscribers
The detailed impact analysis of this regulation is available with the PRO and Business plans. Access the full content and receive personalized alerts.
From €9.99/month · Cancel anytime

If you use recombinant equine chorionic gonadotropin (recombinant eCG) in your livestock operations or prescribe it as a veterinarian, this regulation directly affects you. The Commission Implementing Regulation (EU) 2026/1806, published on 27 July 2026, amends Regulation (EU) No 37/2010 to classify this reproductive hormone and set its maximum residue limit (MRL) in food of animal origin.

Without this classification, recombinant eCG cannot receive marketing authorization as a veterinary medicinal product in the EU. With it, industry operators are obliged to ensure that residues in food produced do not exceed the set MRL, at risk of product withdrawal and administrative sanctions.

What does this regulation establish?

Regulation (EU) No 37/2010 is the European framework that classifies pharmacologically active substances used in veterinary medicine and establishes their maximum residue limits (MRLs) in food of animal origin. Until now, recombinant equine chorionic gonadotropin (recombinant eCG) did not have a specific classification in that regulation.

The new Regulation (EU) 2026/1806 introduces this classification, which has two direct consequences:

  • Enables authorization for veterinary use: Classification with an MRL is a mandatory prerequisite for recombinant eCG to be authorized as a veterinary medicinal product in any EU Member State.
  • Sets the food safety standard: Establishes the maximum level of residues of this hormone that may be present in food products of animal origin (meat, milk, eggs or other products as applicable) without posing a risk to the consumer.
AspectBefore Regulation (EU) 2026/1806After Regulation (EU) 2026/1806
Classification of recombinant eCG in Regulation (EU) No 37/2010Not classified — no MRL establishedClassified with MRL defined in food of animal origin
Possibility of veterinary authorization in the EUNot possible without prior MRLEnabled after classification
Obligations for livestock farmers and veterinariansNo specific regulatory reference for this substanceMust respect withdrawal periods and protocols adjusted to the new MRL
Residue monitoring plansParameter not includedControl authorities incorporate this parameter in their monitoring plans

Economic and operational impact

The impact is not direct cost in the form of a fee or tax, but rather operational and compliance risk. The specific effects for companies and professionals in the sector are:

  • Product withdrawal from the market: If residues of recombinant eCG in a food exceed the set MRL, the product may be withdrawn from the market by the competent authorities. This means direct loss of the affected batch and reputational damage.
  • Administrative sanctions: Non-compliance with MRLs may result in administrative sanctions for the responsible operator, the amount of which depends on the national legislation of each Member State.
  • Review of internal protocols: Livestock farmers and veterinarians must review the withdrawal periods applied after the use of recombinant eCG to ensure that residues are eliminated before slaughter or the obtaining of food products.
  • New requirements in monitoring plans: Food control authorities will incorporate recombinant eCG as an analysis parameter in their residue monitoring plans, which increases the likelihood of detection in official controls.
  • Veterinary pharmaceutical industry: Laboratories that develop or market products with recombinant eCG can now apply for marketing authorization in the EU, which opens a new regulated market.

Who does it affect?

  • Livestock farmers: Especially those engaged in animal reproduction (pigs, cattle, sheep, goats and equines) who use or may use recombinant eCG in their reproductive protocols. They must adjust withdrawal periods and document use.
  • Veterinarians: Those who prescribe or administer this hormone in livestock operations. They must know the current MRL and adapt treatment guidelines to ensure compliance before animals enter the food chain.
  • Veterinary pharmaceutical industry: Laboratories and distributors of veterinary medicines working with gonadotropins. The classification enables the application for marketing authorization for products with recombinant eCG in the EU.
  • Food control authorities: National bodies responsible for residue monitoring plans in food of animal origin. They must incorporate this new parameter in their official analysis and control protocols.
  • Meat and dairy products industry: Operators who receive animals treated with this hormone. Although not directly responsible for treatment, they may be affected if the products they receive do not comply with the MRLs.

Practical example

An intensive pig farm uses recombinant eCG to synchronize estrus in breeding sows. Until now, the responsible veterinarian applied a withdrawal period based on the technical sheet of the available analogous product, without a specific legal reference for the MRL of the recombinant version in Regulation (EU) No 37/2010.

After the entry into force of Regulation (EU) 2026/1806, the veterinarian must verify that the applied withdrawal period ensures that residues of recombinant eCG in the meat of treated animals are below the now classified MRL. If an official control by the competent authority detects that a batch of meat exceeds that limit, the operator faces withdrawal of the batch from the market and possible administrative sanctions according to applicable national legislation.

The immediate action for this farm is to review with its veterinarian the protocol for using recombinant eCG and confirm that the current withdrawal periods are sufficient to comply with the new MRL.

Do you need to monitor this and other regulations?

Check the full details in CambiosLegales

What should companies do now?

  1. Identify if you use recombinant eCG: Review whether recombinant equine chorionic gonadotropin is used in your operation or in your veterinary practice in reproductive protocols. If so, this regulation directly affects you.
  2. Review current withdrawal periods: Together with the responsible veterinarian, verify that the withdrawal periods applied after treatment with recombinant eCG are compatible with the MRL established in Regulation (EU) 2026/1806 before animals enter the food chain.
  3. Update internal use protocols: Document the changes in treatment protocols and ensure that all personnel involved are aware of the new requirements. Traceability of medicinal use is key in case of inspection.
  4. Consult with veterinary pharmaceutical suppliers: If you use products with recombinant eCG, contact the supplier laboratory to confirm that technical sheets and use recommendations are updated in accordance with the new MRL.
  5. Prepare for official controls: Food control authorities will incorporate recombinant eCG in their residue monitoring plans. Ensure that your use documentation and treatment records are in order for a possible inspection.
  6. Monitor the entry into force date: The regulation does not specify a specific entry into force date. Monitor the Official Journal of the EU and communications from national competent authorities to learn the exact deadline for mandatory application.

Frequently asked questions

What is the maximum residue limit (MRL) and why is it mandatory to set it?

The MRL is the maximum concentration of residues of a pharmacologically active substance that may be present in a food of animal origin without posing a risk to the consumer. Regulation (EU) No 37/2010 requires that any substance used in veterinary medicine has a classified MRL before it can receive marketing authorization as a veterinary medicinal product in the EU. Without that classification, the product cannot be legally marketed.

What happens if residues of recombinant eCG in my products exceed the new MRL?

According to Regulation (EU) 2026/1806, non-compliance with the MRL may result in product withdrawal from the market by food control authorities and the imposition of administrative sanctions on the responsible operator. The amount of sanctions depends on the national legislation of each Member State.

When does Regulation (EU) 2026/1806 enter into force?

The regulation was published on 27 July 2026 in the Official Journal of the EU, but the entry into force date is not specified in the published information. It is essential to consult the full text of the regulation in the Official Journal of the EU to know the exact date of application.

Does this regulation affect only recombinant eCG or also conventional eCG?

Regulation (EU) 2026/1806 specifically classifies recombinant equine chorionic gonadotropin (recombinant eCG). This is the version produced using recombinant technology, which is different from conventional eCG. If you use the conventional version, you must verify its classification in Regulation (EU) No 37/2010 separately, as this regulation does not modify it.

What should veterinary pharmaceutical laboratories do with this new classification?

The classification of recombinant eCG with its MRL in Regulation (EU) No 37/2010 enables veterinary pharmaceutical laboratories to apply for marketing authorization for veterinary medicinal products containing this substance in the EU. Before this classification, such authorization was not possible. Laboratories must now initiate or complete authorization procedures with the competent regulatory agencies.

Official source

Consult full 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_202601806



Share:
E
Equipo Editorial CambiosLegales

El equipo editorial de CambiosLegales analiza diariamente los cambios normativos que afectan a empresas y autónomos en España, ofreciendo análisis pro...

Comments

No comments yet. Be the first to comment!

Leave a comment
Activate alerts