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2016/429

EU Animal Health Law explained

  • Animal health

Summary

Background information on the EU Animal Health Law on transmissible animal diseases, which amends and repeals certain Acts in the area of animal health.

Overview of the EU Animal Health Law on transmissible animal diseases

Regulation (EU) 2016/429 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (Animal Health Law)

Update

Background information on the EU Animal Health Law on transmissible animal diseases, which amends and repeals certain Acts in the area of animal health.

Background

The Animal Health Law (Regulation EU/2016/429) is one of the umbrella acts of the EU legislative framework for food production, along with the General Food Law (EC/178/2002), the Official Controls Regulation (EU/2017/625) and the Plant Health Law (EU/2016/2031).

It is part of the EU’s “One Health” approach, which considers that human, animal and plant health are interlinked and can have a significant impact on society. It takes an overarching approach across sectors, placing an emphasis on disease prevention, including biosecurity, surveillance and traceability.

The Animal Health Law repealed and replaced 38 pieces of legislation (listed in Art. 270).

Impacted Products

animals (terrestrial and aquatic), germinal products, animal by-products, food of animal origin

What is changing?

Diseases transmissible to animals and/or humans

The Animal Health Law deals with animal diseases that can be passed on to animals or to humans.

It establishes principles and rules for the prevention and control of such diseases in animals kept by humans (including farm animals, fish and aquaculture), wild animals, and animal products.

The basis of the Regulation is that “prevention is better than cure”.

Scope

The Animal Health Law applies to live animals (terrestrial, aquatic, wild), germinal products, animal by-products, and products of animal origin produced in the EU and exported from third countries to the EU. It covers facilities, means of transport and equipment that may be involved in spreading diseases.

Structure and content

The structure of the Animal Health Law is presented in Figure 1.

In particular, it lays down:

  • Definitions (Art. 2)
  • Criteria to determine animal diseases of concern for the EU and animal species subject to regulatory measures (Arts. 5.3, 7)
  • A new list of diseases relevant for EU intervention based on those criteria (Art. 5, Annex II)
  • Prioritisation and categorisation of diseases (Arts. 6–9)
  • Requirements for competent authorities regarding early detection systems, notification and reporting of diseases, surveillance, eradication programmes, and disease-free status (Arts. 9, 18–52)
  • Basic responsibilities of animal keepers and veterinarians in respect of health, biosecurity measures, early detection and prevention of animal diseases, surveillance (Art. 24) and animal health visits (Arts. 10–17, 53–83)
  • Obligation on operators for registration/ approval by their competent authorities (Arts. 84–101; for aquaculture Arts. 172–185)
  • Obligation on operators for notification of (possible) animal diseases to their competent authority (Art. 18) and subsequent actions by competent authorities (Arts. 19–23, 53)
  • Obligation on operators for record keeping (Arts. 102–107; for aquaculture Arts. 186–190)
  • Traceability requirements for kept terrestrial animals and germinal products (Arts. 108–123)
  • Obligations on farms for animal health visits by veterinarians (Arts. 25–27)
  • Movements within the EU (Arts. 108–171, 191–226)
  • Animals and their products not covered by the definition of terrestrial and aquatic animals (Arts. 227–228).

Specific requirements for exports from third countries to the EU

These are set out in Part V (Arts. 229–242), in particular:

  • List of third countries (or geographical areas) that can export to the EU based on defined criteria (Arts. 230–234); the list is set out in Regulation (EU) 2021/404
  • Animals and goods can only be imported from establishments approved by third country authorities (Art. 233); see the European Commission’s Non-EU country establishments database
  • Animal health requirements in third countries must be at least as stringent as the EU legislation (Arts. 234–236); if not, third countries must offer equivalent guarantees to the animal health requirements for registration, approval, traceability and movement (detailed in Delegated Regulation (EU) 2020/692)
  • Animal health certificates (see EU official health certificates for exports to the EU – explained), declarations, other documents to accompany consignments (Arts. 237, 238)
  • Requirements for other goods such as disease agents, plant material, means of transport, equipment, packaging materials, transport of water, feed and fodder (Arts. 240–242).

Importantly, requirements are based on risk. In the cases where risks are considered low, the Regulation foresees some derogations (exceptions) to certain requirements (e.g. for transhipment, research, cultural events, from/to confined establishments, or when there is a risk-mitigating treatment).

Texts relevant to third countries

The Animal Health Law is supplemented in particular by:

  • Delegated Regulation (EU) 2020/692 (rules for entry into the EU of consignments of animals, germinal products and products of animal origin)
  • Implementing Regulation (EU) 2021/404 (lists of third countries, territories or zones from which the entry into the Union of animals, germinal products and products of animal origin is permitted)
  • Implementing Regulation (EU) 2018/1882 (disease prevention and control rules, and list of species and groups of species posing a risk of spread; this Regulation describes disease categories A–E).

Why?

Trading conditions have evolved since the adoption of the first animal health rules at EU level. The volume of trade in animals, germinal products and products of animal origin has increased significantly, both within the EU and with third countries. During the same period, EU animal health policies and rules have helped eradicate certain diseases, and have prevented or controlled others.

But on several occasions, emerging diseases have posed new challenges for EU animal health status, trade, and the local economy in areas affected by those diseases. As a result, it was necessary to review and consolidate the EU animal health requirements.

Timeline

Date of publication: 31 March 2016

Date of entry into application: 21 April 2021

Evaluation report: no later than 22 April 2026

What are the major implications for exporting countries?

Compliance with the EU animal health requirements is necessary for a third country to be approved to export to the EU. The specific requirements for third countries exporting to the EU are described in Animal health requirements for third countries exporting to the EU – explained.

Resources

Online resources from the European Commission:

Sources

Regulation (EU) 2016/429

Tables & Figures

AG00113_Figure1_27-01_page-0001

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