AHW(13)3740:1
The new EU Regulation on Animal Health
(Animal Health Law)
COPA-COGECA / IE Presidency Conference "The new package for
Healthier Animals and Plants for a safer food chain"
6-7 May, 2013
Alberto Laddomada, Barbara Logar
Unit G2 – Animal health
Directorate-General for Health and Consumers
European Commission, Brussels
This presentation does not necessarily represent the views of the European Commission
Health and
Consumers
Contents
• Animal Health Law: what it is all about?
• Main new elements & specific changes
• Timetable
Health and
Consumers
ANIMAL HEALTH LAW:
Why a new law and what is it
all about?
Health and
Consumers
Animal Health Strategy (2007-2013)
"Prevention is better than cure"
Action plan of the New Animal Health Strategy
Underlying principles: Partnership and Communication
Pillar 1
Defining Priorities
Health and
Consumers
Pillar 2
Pillar 3
Pillar 4
A Modern Legal
Framework
Prevention and
Controls
Science, Innovation &
Research
The EU Animal Health Law
• The main instrument to implement the objectives of the
Animal Health Strategy (2007-2013)
• More risk based, proactive, preventive behaviour
• Horizontal principles and rules for transmissible
diseases
• Simplify existing rules:
• Numerically
• In substance
• Align with Lisbon Treaty
• Fit for decades to come
• No revolution, but evolution
Health and
Consumers
The Animal Health Law (AHL)
• From a fragmented legislation of ca. 40 Directives and
Regulations
• To a single and robust legal framework for animal health
• Laying down the overarching principles for:
• Disease prevention (disease awareness, registration,
traceability, biosecurity)
• Disease control and eradication
• Intra-EU movements and entry into the EU of animals and
animal products
• Emergency measures
• Supplementing rules needed to ensure complete
implementation
• Detailed provisions of the current Directives and Regulations
included in delegated and implementing acts
Health and
Consumers
ANIMAL
LAW
ANIMALHEALTH
HEALTH LAW
GENERAL RULES:
GENERAL
PRINCIPLES
Responsibilities,
biosecurity,
disease categorization and
prioritization, notification, surveillance, disease freedom
TERRESTRIAL ANIMALS•Disease control AQUATIC ANIMALS
BASIC RULES:
•Entry into EU
•Emergency measures BASIC RULES:
•MOVEMENTS
•MOVEMENTS
TERRESTR.
ANIMALS
•IMPORT
AQUATIC ANIMALS
REQUIREMENTS
•DISEASE CONTROL
• EU movements
• EU movements
OTHER ANIMALS
•IMPORT
REQUIREMENTS
•DISEASE CONTROL
• EU movements
Delegated/ implementing
DISEASE
CONTROL
MOVEMENTS:
ENTRY into EU:
Animals &
Products
Animals &
Products
Health and
Consumers
Opportunities of the AHL
• Horizontal principles and rules contributing to
better overall husbandry
• Better response to new threats
• Less administrative burdens/costs, where
involved risks permit so
• Facilitated movements and trade
• Flexibility for disease prevention and control
measures proportionate to the risks
Health and
Consumers
What is out of Animal Health Law?
• Not in scope:
•
•
•
•
•
•
•
Welfare of animals
Pathologies of individual animals
Veterinary checks, controls
EU veterinary expenditure
Feed, medicated feed
Veterinary medicines
Veterinary education
• In scope but specific rules remain in place:
• ABPs
• TSE rules
• Certain zoonoses (e.g. Salmonella)
Health and
Consumers
Single package
• Four legal proposals:
•
•
•
•
Animal Health Law
Plant Health Law
Plant Reproductive Material
Official Controls
• Additional proposal:
• Expenditure in food chain, animal health and
welfare, plant health and plant reproductive
material
Health and
Consumers
10
Animal Health Law:
NEW ELEMENTS AND
SPECIFIC CHANGES
Health and
Consumers
AHL – New elements
• The main instrument to implement the objectives of
Animal Health Strategy (2007-2013) "Prevention is
better than cure"
• The scope:
• Transmissible diseases
• Kept and wild animals (not only production animals)
and their products
• Terrestrial, aquatic and other animals
• Responsibilities of keepers, operators, veterinarians,
competent authorities, etc.
• Risk based approach: Categorization/prioritisation of
diseases for EU intervention
• Improved response to emerging diseases
Health and
Consumers
AHL – New elements
• More prevention:
• Biosecurity at farms, in transport, assembly, at
borders
• Enhanced surveillance, disease notification and
reporting
• Clearer policy for the use of vaccines and in
relation to disease control & diagnosis also some
other veterinary medicines
• Easier and safer trade:
• Enhanced convergence with international
standards on animal health (OIE)
• Compartmentalisation
• Requirements for export
• Added flexibility
Health and
Consumers
AHL – Added flexibility
• More flexibility to adjust to:
• Climate changes and emerging risks
• International standards and scientific developments
• Different sizes and types of establishments, types of
animal production
• Local circumstances (registration, approval, etc.)
• Systems providing equal guarantees (for animal
movements, traceability, etc.)
• Objectives:
• Better response to new threats and adjustment to local
circumstances
• Reduce administrative burdens/costs, where involved
risks permit so
Health and
Consumers
Union intervention for transmissible
animal diseases
• Disease listing and categorization:
• listing of diseases requiring EU intervention
• which measures to be applied for which diseases
• Clusters of rules for listed diseases (categories of
diseases)
• Disease notification, surveillance
• Measures in "trade" – movements within and between Member
States and entry into the Union
• Eradication (compulsory or voluntary) & disease freedom
• Disease control measures
• Response to emerging diseases
Health and
Consumers
Categorisation and prioritisation
• Study with OIE and the disease
categorisation and prioritisation tool
• Available on SANCO web
• Dynamic and transparent:
• Criteria for categorisation and prioritisation
in AHL
• Lists and tables in Commission acts
Health and
Consumers
Union intervention: Disease control
measures
• Union measures for listed diseases in animals
• Most serious diseases: control measures &
preparedness (i.e. contingency plans, vaccination,
vaccine banks)
• Serious diseases: compulsory or voluntary eradication
• Some national measures for
• Listed diseases (beyond EU minimum measures)
• Non-listed diseases (no interference with Internal
market)
• Tools for Union measures for emerging diseases
• Coordination by the Commission
Health and
Consumers
Union intervention: Antimicrobial
resistant pathogens
• AMR pathogens are considered as "disease
agents"
• Following the outcome of disease categorisation /
prioritisation
• Different disease preventive and control measures
may be applied (notification, surveillance,
eradication, disease control measures, movement
control, etc.)
Health and
Consumers
Union intervention for different
species and wild animals
• Kept animals:
• Animal health requirements mainly apply to
certain animal species (bovines, sheep & goats,
pigs, horses..)
• Other species and other animals: basic
requirements apply & possibility to lay down rules
(bees, amphibians, etc.)
• Special rules for certain categories (pet animals,
zoos, circuses, contained establishments, etc.)
• Wild animals:
• Possibility to lay down rules (surveillance,
eradication, disease control, movements)
Health and
Consumers
Animal health requirements for
movements
• Certain basic requirements apply for all
movements
• Majority apply for movements between MSs
• Animal species presenting risk for spreading
diseases
• Operations presenting risk
• Differences between terrestrial and aquatic
• Terrestrial: specific requirements for movements
between MSs
• Aquatic: specific requirements for movements
between zones and compartments
Health and
Consumers
General animal health requirements
for movements
• General (non-disease specific) requirements:
•
•
•
•
Registration or approval of establishments
Record keeping and registers
Identification and registration
Other preventive measures to be respected for
moving animals and products:
•
•
•
•
Measures to prevent spreading diseases
Disease prevention in transport
Prohibition of change of intended use (aquatic animals)
Preventive measures related to movement for export from
the Union
Health and
Consumers
Disease specific animal health
requirements for movements
• For listed diseases:
• Categorised for "trade" / "entry into the EU"
measures
•
•
Mainly diseases subject to control measures, compulsory and
voluntary eradication
Also diseases under EU notification & reporting and surveillance,
if relevant
• For emerging diseases:
•
Measures based on the COM decision
• For-non listed diseases:
•
•
No EU disease specific measures for movements of terrestrial
animals
Exemption possible for movements of aquatic animals (approved
by the COM decision)
Health and
Consumers
More on movements: flexible
approach
• Species specific:
• Specific animal health requirements for
movements between MS or zones for some
species
• Animal health certificates for some species
• Self-declaration or flexibility for other species
• Different possibilities for certain categories of
animals and specific situations
• More flexibility on certification:
• For low risk movements
• Recognition of surveillance & biosecurity systems
(incl. animal health visits)
Health and
Consumers
Animal health requirements for entry
into the Union
• Requirements as stringent as those within the
Union
• Entry allowed from countries & territories that are
on the list
• Zones and compartments
• Establishments (where relevant)
• Further animal health requirements:
• Disease related requirements (delegated acts)
• Animal health certificate
• Presentation to the border control
Health and
Consumers
AHL: When?
• AHL proposal adopted by the Commission
• Discussions in the Council and the EP will start
• Envisaged period for adoption of delegated and
implementing acts: 36 months
Health and
Consumers
In conclusion
• Animal health Regulation builds upon the good
•
experiences of the existing legal framework
Provides:
• Solid ground for healthier animals and humans
• Clearer and better understood framework for
operators, citizens and non-EU countries
• Provides new elements for more:
• Competitive and sustainable livestock and
aquaculture sectors
• Confident consumers
Health and
Consumers