Regulation
Brucellosis is the generic name used for the animal and human infections caused by several species of the genus Brucella, mainly Brucella abortus, B. melitensis and B. suis. Brucellosis is a regulated disease in Europe and is listed by OIE.
EU Animal Health Law
Regulation (EU) 2016/429
[relayed from EC website] The European Parliament and the Council adopted the Regulation on transmissible animal diseases (“Animal Health Law”) in March 2016.
The Regulation was published in the Official Journal on 31 March 2016 and the full text is available here.
Overall, the single, comprehensive new animal health law will support the EU livestock sector in its quest towards competitiveness and safe and smooth EU market of animals and of their products.
Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018
Disease prevention and control rules applied to categories of listed diseases
Commission Implementing Regulation (EU) 2018/1882 of 3 December 2018 presents rules on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases (Text with EEA relevance.)
Commission Implementing Regulation (EU) 2020/2002 of 7 December 2020
Disease notification and reporting of certain listed diseases
Commission Implementing Regulation (EU) 2020/2002 of 7 December 2020 is laying down rules for the application of Regulation (EU) 2016/429 of the European Parliament and of the Council with regard to Union notification and Union reporting of listed diseases, to formats and procedures for submission and reporting of Union surveillance programmes and of eradication programmes and for application for recognition of disease-free status, and to the computerised information system (Text with EEA relevance).
Infection with Brucella abortus, B. melitensis, B. suis in bovine, ovine or caprine animals in a disease free Member State or zone:
• any primary outbreak should be notified within 24 hours
• secondary outbreaks at the latest on the first working day of each week
• Any other outbreaks of infection with Brucella abortus, B. melitensis, B. suis should be reported by 30 April every year
Commission Delegated Regulation (EU) 2020/689
Rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (Text with EEA relevance)
Commission Delegated Regulation (EU) 2020/689 describes rules for surveillance, eradication programmes, and disease-free status for certain listed and emerging diseases (Text with EEA relevance), including Brucellosis.
General passive surveillance based on notifications and investigations :
• Specific surveillance activities
• Eradication programmes
• Disease control
• Pre movement surveillance
Article 6: The cascade principle allowing a more flexible approach
a) Specific legislation and guidance which will be made available in the websites of the EURL and COM
b) OIE Manuals
c) Art 34 of OCR
• National rules. In absence of national rules, relevant methods recommended by NRL validated in accordance with international standards or
• Relevant methods validated with inter or intra laboratory methods validation studies
• In case of urgency, NRL (in absence, other designated lab) may use methods which have not been validated
Diagnostic methods for granting and maintaining disease freedom are laid down in Annexes III and VI
Legislation on official controls
Regulation (EU) 2017/625,
Official Controls Regulation (EU) 2017/625 addresses official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products (Official Controls Regulation - OCR). Main elements of regulation can be found on the following webpage: https://ec.europa.eu/food/safety/official_controls/legislation_en
World Organization for Animal Health
[relayed from www.oie.int]
The Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (Terrestrial Manual) aims to facilitate international trade in animals and animal products and to contribute to the improvement of animal health services world-wide. The principal target readership is laboratories carrying out veterinary diagnostic tests and surveillance, plus vaccine manufacturers and regulatory authorities in Member Countries. The objective is to provide internationally agreed diagnostic laboratory methods and requirements for the production and control of vaccines and other biological products.
The OIE Terrestrial Animal Health Code (the Terrestrial Code) provides standards for the improvement of animal health and welfare and veterinary public health worldwide, including through standards for safe international trade in terrestrial animals (mammals, reptiles, birds and bees) and their products. The health measures in the Terrestrial Code should be used by the Veterinary Authorities of importing and exporting countries to provide for early detection, reporting and control agents that are pathogenic to animals or humans, and to prevent their transfer via international trade in animals and animal products, while avoiding unjustified sanitary barriers to trade.
For more information, see our webpage "Web documents, Guidelines & Tools"