Government Decree No. 40 of 2013 (II. 14.) on animal testing.

This Decree provides the framework to animal testing in order to prevent torture of and cruelty to animals. Provisions concerning the animals which may be used for testing are contained in Chapter II. General rules of testing are laid down in Chapter III. Chapter IV sets out rules regarding operational requisites of breeders, suppliers and users of laboratory animals. Chapter V provides rules on authorization of animal testing. Testing may be done only in the framework of projects. Controls and sanctions are foreseen in Article 49. Chapter VI concerns the activity of the Scientific Ethic Board on Animal Testing which is an expert body and operated by the National Food Safety Agency.
Beyond administrative procedures, the Decree incorporates the fundamental "3Rs" principle (Replacement, Reduction, and Refinement) directly into project design and evaluation. Applicants are legally obligated to demonstrate that no non-animal alternative methods exist for achieving the scientific objective, that the number of animals used is kept to the absolute minimum necessary, and that housing, care, and experimental techniques are continuously refined to minimize distress. Projects are categorized according to expected severity levels—non-recovery, mild, moderate, or severe—triggering enhanced scrutiny and mandatory retrospective assessments for higher-severity protocols or those involving non-human primates.
The Decree also establishes strict technical, environmental, and care standards that facilities must satisfy to gain registration as breeders, suppliers, or users. Establishments must maintain dedicated personnel with specified qualifications, including designated animal welfare officers, project leaders, and veterinarians responsible for monitoring animal health. Furthermore, facilities are required to set up an internal Animal Welfare Body to oversee day-to-day compliance, review local handling practices, track animal well-being, and foster an institutional culture of care prior to formal regulatory submission.
Finally, to balance scientific research with public oversight and European data transparency, the Decree establishes reporting requirements and non-technical project summaries. Approved projects must publish non-technical summaries outlining their goals, predicted harm, and expected benefits while preserving intellectual property and applicant anonymity. The National Food Chain Safety Office (Nébih) maintains registry data, oversees statistical reporting on total animal usage, and conducts periodic risk-based inspections to enforce compliance, applying sanctions or revoking permits whenever welfare standards are breached.