Legislative Decree no. 178 of 25 September 2026 was published in the Official Journal no. 234 of 8 October 2026.It enters into force on 23 October 2026 and implements Delegated Regulation (EU) 2022/1644 and Implementing Regulation (EU) 2022/1646.
This involves official controls on the use of pharmacologically active substances authorized as veterinary medicinal products or feed additives, and on their residues. It also covers prohibited or unauthorized substances.
Who is interested?
Farms, feed mills, slaughterhouses, and animal-origin food processing plants.It also concerns importers and operators who market products of animal origin from third countries.
The main novelties
1. The National Waste Plan (NRP) in three components.Targeted plan: risk-based sampling of animals and food produced in Italy and other Member States.
Surveillance plan: random sampling, with high-performance analytical methods.
Third-country plan : checks on imported animals and products to verify compliance with EU regulations and the principle of reciprocity. The Ministry of Health or local authorities may also order targeted checks during the marketing phase for third-country products intended directly for the final consumer.
2. “Extra-plan” activities .
The Ministry of Health, the Regions, and the Autonomous Provinces may plan additional inspections beyond the standard schedule, on specific animal categories or products. Operators may therefore be sampled even outside of the standard schedule.
3. Data governance and traceability .
The Ministry of Health is the central authority: it updates the National Research Council (PNR) annually and coordinates central and regional services.
It will be supported by a permanent working group of 13 experts, the "Residues Group", to be appointed by ministerial decree within 120 days.
Samplings, analytical results, causes of non-compliance, and corrective actions are recorded in the NSIS/RaDISAN system. Regions can establish regional veterinary surveillance units (NORV).
4. Sampling and analysis .
Samples are collected and analyzed in accordance with Regulation (EU) 2017/625, Legislative Decree 27/2021, Regulation (EU) 2021/808, and the Ministry's operational guidelines. The analyses are performed by experimental zooprophylactic institutes or, in special cases, by other laboratories designated by the Ministry.
5. Management of non-conformities .
In case of suspected or confirmed non-compliance, action must be immediate.
They serve to identify the origin and extent of the problem, establish the operator's responsibilities, ensure that they remedy the problem and prevent it from recurring.
The competent authority immediately communicates the non-compliance to the Region, the ASL of origin, the IZS (Institute for the Prevention of Viruses), and the Ministry of Health.
6. Operator protection .
In the event of a dispute, Articles 7 and 8 of Legislative Decree 27/2021 apply, i.e., counter-examination and dispute. Please note the deadlines set by those provisions: 15 days from notification of the unfavorable outcome to request a counter-examination of the documents, and 30 days to initiate the dispute before the National Institute of Health.
These terms are peremptory.
7. Regulatory coordination .
The decree amends Legislative Decree 158/2006 on the ban on hormonal substances, thyrostatics, and beta-agonists. Residue control measures are removed from that text, with the repeal of Articles 9, 11, 12, and 20 and Annexes I-IV.
What changes for companies in the agri-food supply chain?
The provisions particularly affect livestock farms, operators in the livestock supply chain, companies processing food of animal origin, and importers.While primarily concerned with the organization and implementation of official controls, the decree emphasizes the importance of rigorous management of the risks associated with the use of pharmacologically active substances.
It therefore becomes particularly important for companies:
- ensure the correct management and traceability of veterinary treatments;
- verify compliance with waiting times and maximum residue limits;
- maintain effective supplier self-control and management procedures;
- ensure the availability of necessary records and documentation during official audits;
- establish effective procedures for managing any non-conformities.
For agri-food companies, the proper management of veterinary medicinal products, residue monitoring, and effective self-monitoring systems are essential not only to ensure legislative compliance but also to strengthen product safety, supply chain reliability, and consumer trust.