Animal Health

The EU’s Animal Health Law

Regulation (EU) 2016/429 on transmissible animal diseases. It aims to prevent and control animal diseases that can be transmitted to other animals or humans.
The animal health law is part of a package of measures proposed by the European Commission in May 2013 to strengthen the enforcement of health and safety standards for the entire agri-food chain.
This comprehensive regulation supports the EU livestock and food production sectors and the related EU market for sustainability, competitiveness, growth and jobs. It replaces and extends existing EU rules on animal health, bringing most together into one simpler law encouraging a better focus on the key priorities in tackling disease, including:

clearer responsibilities helping farmers (livestock, fish and shellfish farms) and other stakeholders (e.g. vets) with early detection to prevent major disease outbreaks or diseases from spreading in order to limit their damage;
simplified administration for international trade in certain live animals and animal products (such as semen, ova and embryos);
a clearer legal basis and better tools for veterinary authorities to fight potentially devastating transmissible diseases, particularly for their surveillance, diagnosis and notification;
more flexibility to adjust rules to local circumstances and emerging issues such as those due to climate and social change;
reducing adverse effects on animal and human health and the environment.
It sets out requirements for:

disease prevention and preparation (e.g. biosecurity* measures) for eventual outbreaks, such as the use of diagnostic tools, vaccination and medical treatments;
the identification and registration of animals and the certification and tracing of their consignments, as well as those of certain animal products (e.g. semen, ova, embryos);
the entry of animals and animal products into the EU and movement within;
disease control and eradication, including emergency measures such as restrictions on the movement of animals, killing and vaccination.
The rules cover animal diseases in all kept animals (including pets for some), wild animals and animal products, both terrestrial and aquatic. They do not directly cover animal welfare, although the link between the health of the animals and their welfare is recognised and taken into account when considering the impact of disease.

The regulation applies from 21 April 2021. It includes, however, some transitional measures and repeals of older legislation which apply from 21 April 2016. There is also a deadline for the majority of the complementary Commission delegated and implementing acts to be adopted by 21 April 2019.

DOCUMENTS

Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (OJ L 84, 31.3.2016, pp. 1-208)

Protection of pigs

Directive 2008/120/EC — minimum standards for the protection of pigs. It seeks to lay down minimum standards for the protection of pigs.

As well as laying down standards for the protection of pigs, the directive also lays down rules with regard to painful operations in particular: castration, caudal amputation (docking), the elimination of corner teeth, etc.

Scope

Minimum standards apply to all categories of pigs kept for rearing and fattening:
piglets (from birth to weaning);
weaners (from weaning to 10 weeks old);
fatteners (more than 10 weeks old);
sows and gilts (a female pig after puberty but has not given birth);
boars (male pigs after puberty, intended for breeding) and so on.

These animals are to be raised in groups, apart from some exceptions (farrowing sows, boars). Farmers must implement measures aimed at fulfilling basic needs and preventing aggression within the group. In particular, pigs must have permanent access to a sufficient quantity of enrichment material in order to stimulate exploratory behaviour.

Sows and gilts

if necessary, pregnant sows and gilts must be treated against parasites. Tethered sows and gilts has been prohibited since 1 January 2006.
One week before farrowing, sows and gilts can be isolated. An unobstructed area must be available for natural or assisted farrowing. Boxes must be equipped with piglet protection systems.
Piglets (unweaned).Piglets cannot be weaned from the sow before they are 28 days old unless the welfare or health of the dam or the piglet would otherwise be harmed.

Weaned piglets and rearing pigs

Measures must be taken to ensure that the animals do not fight.
Pigs are to be kept in groups and must not be mixed (except before weaning or during the week following weaning, if necessary).
Aggressive animals are to be kept away from the group (as are injured animals).

Tranquilising medicaments are only to be used to facilitate mixing in exceptional conditions and after consultation with a veterinarian.

Painful operations on animals

A veterinarian or ‘carer’ trained in aspects relating to animal welfare is authorised to carry out the following:
reduction of piglets’ corner teeth;
docking of tails (before the seventh day of life or after this age if carried out by a veterinarian and under anaesthesia and with additional prolonged analgesia);
castration of males (before the seventh day of life or after this age if carried out by a veterinarian and under anaesthesia and with additional prolonged analgesia);
nose-ringing in outdoor husbandry systems.

The docking of tails or the reduction of corner teeth must not be carried out routinely but only where there is evidence that injury to sows’ teats or to other pigs’ ears or tails has occurred. Before carrying out these procedures, other measures must be taken to prevent tail biting and other vices, taking into account environment and stocking densities. For this reason, inadequate environmental conditions or management systems must be changed.

Health;Sick or injured pigs are to be placed in individual enclosures.

Feed; The directive provides for standards concerning feeding in ‘sufficient quantity’ and ‘permanent’ access to drinking water. All pigs must have access to food at the same time as other animals in the group. Animals must be fed at least once a day.

Accommodation

Standards concerning floor area are set according to the weight of the animal:
between 0.15 m2 for pigs weighing less than 10 kg and 1 m2 per animal over 110 kg;
1.64 m2 per gilt;
2.25 m2 per sow;
6 m2 for a boar (10 m2 if the boar is used for natural services).
Some accommodation standards have only applied since 1 January 2013 (for buildings constructed before 2003 or after the date of accession to the EU).
Floors must be smooth but not slippery so as to prevent injury to the animals.
The lying area must be comfortable, clean and dry.

Environment

Continuous noise as loud as 85 dB is to be avoided. Light intensity is to be at least 40 lux for 8 hours.

Inspections

EU countries must carry out inspections each year on a statistically representative sample.
The European Commission may send veterinary experts to make on-the-spot checks in the farms with the assistance of national inspectors.
Specific rules

EU countries may apply stricter rules on their own territory than those laid down in this directive. In this case, they must inform the Commission of any such measures beforehand.

Official controls regulation

Regulation (EU) 2017/625, the EU’s new legislation on the official controls of human food and animal feed, amends certain minor technical details of the directive. These changes will apply from 14 December 2019.

It has applied since 10 March 2009. The Directive 2008/120/EC is the codified version of Directive 91/630/EEC and its subsequent amendments. EU countries had to incorporate the original Directive 91/630/EEC into national law by 1994 (and its amendments by 2003).

Council Directive 2008/120/EC of 18 December 2008 laying down minimum standards for the protection of pigs (codified version) (OJ L 47, 18.2.2009, pp. 5–13)

Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on 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, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1–142)

Successive amendments to Regulation (EU) 2017/625 have been incorporated into the original document. This consolidated version is of documentary value only.

Avian influenza

Directive 2005/94/EC — EU measures to control avian influenza.It lays down measures to be taken to control avian influenza as soon as there is any suspicion of the presence of this disease.

KEY POINTS

The EU lays down measures to control avian influenza as soon as there is any suspicion of the presence of this disease.It has applied since 3 February 2006 and had to become law in the EU countries by 1 July 2007.The directive will be repealed and replaced by the EU’s new Animal Health Law Regulation (EU) 2016/429 on 21 April 2021.

EU countries are responsible for:

carrying out surveillance programmes intended to detect the virus and increase knowledge in this area;
ensuring that the presence of this disease is notified to the competent authority and that epidemiological inquiries take place in accordance with their contingency plan approved by the European Commission.

When an outbreak is suspected, the competent authority immediately opens an investigation to confirm or exclude disease by clinical examination and taking samples for laboratory examinations.

The authority places the suspect holding under official surveillance and implements a series of measures including:

counting the animals;
recording the animals that are sick, dead or likely to be infected;
isolating the holding;
prohibiting the entry and leaving of birds, bird products, feed and waste;
restricting the movement of persons and vehicles;
disinfection of the holding.

These measures are withdrawn when the suspicion of the disease is officially ruled out.

The competent authorities also carry out epidemiological investigations to identify contact holdings and possible further virus spread.

This directive provides for specific measures to be taken depending on the type of disease.

Highly pathogenic avian influenza (HPAI)

Once the presence of HPAI is confirmed, the competent authority ensures that the following measures are applied:

all poultry and other captive birds* are to be killed;
all carcasses are to be disposed of under official supervision;
poultry hatched from eggs before the application of the initial measures is to be placed under official surveillance;
meat of poultry slaughtered and eggs collected before the application of the initial measures are to be identified and disposed of;
all substances likely to be contaminated are to undergo the appropriate treatment;
manure, slurry (animal waste, together with other unusable organic matter), bedding and all materials likely to be contaminated are to be cleaned and disinfected;
any movements of animals entering and leaving the holding must take place under supervision;
the virus is to be isolated using the most appropriate laboratory procedure.

Additionally, a ‘protection zone’ of a radius of at least 3 km around the infected holding and a surrounding ‘surveillance zone’ of a radius of least 10 km around that holding must be set up. The measures applied in these zones include:

a census of the holdings;
visits by the official veterinarian;
restrictions of transport of birds, eggs, poultry meat and carcasses.
These measures remain in place until the completion of the preliminary cleaning operations at the earliest after 21 days in the protection zones and 30 days in the surveillance zone.

Low pathogenic avian influenza (LPAI)

Once the presence of LPAI is confirmed, the competent authority ensures that a series of measures are applied on the basis of the appropriate risk assessment. The measures to be taken vary depending on the criteria laid down, which include the species concerned, the number of holdings in the area in question, the location of the slaughterhouses and the biosecurity measures*. The measures to be applied are:

all poultry present on the holding and all other captive birds are either killed on the spot or depopulated by directly transporting them to the slaughterhouse following confinement and laboratory results that tested positive for disease. These operations must take place in accordance with the common minimum standards on the protection of animals at the time of slaughter or killing;
the disposal of carcasses and hatching eggs must take place under official supervision;
hatching eggs collected and poultry hatched from eggs before the application of the initial measures are placed under official surveillance;
table eggs produced on the holding before the depopulation are to be disposed of or transported to a packing centre or an establishment for the manufacture of egg products;
any material likely to be contaminated is to be disposed of;
manure, slurry, bedding, buildings and all material likely to be contaminated are to be cleaned and disinfected;
mammals of domestic species are to be prohibited from entering or leaving the holding;
the virus is to be isolated.

Additionally, specific measures are to be applied in the zone known as the ‘restricted zone’ which must be set up around the infected at a radius of at least 1 km.

The measures applied in this zone concern:

a census and tests on commercial holdings;
management of the movements of poultry, other captive birds and eggs.
These measures remain in place for a length of time that varies at the discretion of the competent authority.

Spread to other species

Following confirmation of an outbreak of avian influenza on a holding, tests are performed on other mammals kept on that holding that may be infected, specifically pigs and the authority may only authorise movement of these pigs to other holdings or to slaughterhouses provided further testing shows that the risk of virus spread is negligible.

Cleansing, disinfection and repopulation

EU countries must ensure that anything likely to have been contaminated, including holdings, slaughterhouses, vehicles and other equipment, is cleansed and disinfected. The holding may be repopulated 21 days following completion of final cleansing and disinfection.

Diagnostic procedures

A diagnostic manual adopted by Decision 2006/437/EC lays down requirements, criteria and procedures to be applied to diagnostic tests and post-mortem clinical examinations (see ‘Related documents’). These operations take place exclusively in authorised national laboratories.

Each EU country designates a reference laboratory at national level working, in cooperation with the EU reference laboratory (a new laboratory will be appointed as of 1 January 2019) which is responsible for the coordination of harmonised diagnostic procedures (e.g. by performing yearly trials) and advising the Commission and EU countries on avian influenza.

Vaccination

Depending on the disease situation and the outcome of a risk assessment, EU countries may decide to introduce emergency or preventive vaccination of poultry and captive birds under a vaccination plan that must be approved by the Commission beforehand. Farms keeping vaccinated birds must undergo strict surveillance, in particular if emergency vaccination is used. The directive includes guidelines for the application of these measures and offers the possibility of setting up vaccine banks.

Committee procedure

The Commission is assisted by the Standing Committee on Plants, Animals, Food and Feed in the management of measures related to avian influenza. Among other things, this committee may take a role in defining preventive biosecurity measures.

Fighting foot-and-mouth disease

Council Directive 2003/85/EC on EU measures for the control of foot-and-mouth disease sets out the minimum controls that should be applied if there is an outbreak of foot-and-mouth disease (FMD).It entered into force on 22 November 2003. EU countries had to incorporate it into national law by 30 June 2004.
It includes preventative measures to raise awareness and preparedness among the relevant authorities and the farming community. EU countries may take more stringent action if they wish.Regulation (EU) 2016/429 repeals Council Directive 2003/85/EC as from 21 April 2021.

KEY POINTS

Foot-and-mouth is a notifiable disease. Owners or handlers of animals and vets must report any outbreak.
When a suspected case is notified, the competent authorities must ensure:
the farm is placed under surveillance;
a census is made of all the animals and animal products present;
no animals or persons may enter or leave the premises;
entrances and exits of buildings are disinfected;
a temporary control zone may be established, banning movement of animals over a wider area;
a preventative eradication programme, involving the culling of animals, may be introduced.

When an outbreak is confirmed, the competent authorities must ensure:
all infected animals are killed on the spot;
the carcasses are buried or burned;
all buildings and vehicles used for the animals are disinfected and, if necessary, human areas and offices are as well;
all products which may have left a farm before control measures are introduced are traced and treated;
measures are taken to protect from the disease animals in laboratories, zoos and wildlife parks in the vicinity;
all animals in slaughterhouses, border inspection posts or any form of transport where a case is confirmed are immediately killed;
protection and surveillance zones are established: the first has a minimum 3-km radius, the second a minimum 10 km;
special measures apply in these zones: the sale of products originating from animals within the parameters is banned, for instance.

Restrictions applied in protection zones can be lifted 15 days after the last infected animal has been killed and disposed of. The time limit for surveillance zones is 30 days.

Special rules apply to the use, manufacture and sale of foot-and-mouth vaccines.
National authorities strictly control laboratories that handle the live FMD virus. They designate one national/central control centre.
National authorities draw up contingency plans to be implemented if an outbreak occurs. They may also carry out real-time alert exercises.

ACT

Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (OJ L 306, 22.11.2003, pp. 1-87)

The successive amendments to Directive 2003/85/EC have been incorporated into the original text. This consolidated version is of documentary value only.

Commission Decision 2007/18/EC of 22 December 2006 approving contingency plans for the control of foot-and-mouth disease pursuant to Council Directive 2003/85/EC (OJ L 7, 12.1.2007, pp. 36-37)

Council Decision 91/666/EEC of 11 December 1991 establishing Community reserves of foot-and-mouth disease vaccines (OJ L 368, 31.12.1991, pp. 21-25) See consolidated version.

Commission Decision 2001/75/EC of 18 January 2001 for safety and potency testing of foot-and-mouth disease vaccines and bluetongue vaccines (OJ L 26, 27.1.2001, pp. 38-39)

Commission Decision 2009/486/EC of 22 June 2009 on the purchase of foot-and-mouth disease virus antigens (OJ L 160, 23.6.2009, pp. 27-28)

Importing conditions and quarantine requirements for birds

Regulation (EU) No 139/2013 – conditions for imports of certain birds into the EU and related quarantine criteria.

—It specifies which birds may be imported into the EU and the conditions they must fulfil.
—It aims to ensure that certain birds do not bring diseases, such as avian influenza or Newcastle disease, with them.

It entered into force on 12 March 2013.

KEY POINTS

—Only birds from approved breeding centres in non-EU countries may be imported.
—The birds must have been bred in captivity, tested for viruses 1 to 2 weeks before being shipped and not been vaccinated against avian influenza.
—They must each have a health certificate and an individual identification number contained either on a leg-ring or in a microchip.
—Each EU country has approved quarantine centres to which the birds are transported in sealed vehicles within 9 hours of being inspected at the border.
—The birds must remain in quarantine for at least 30 days and, as a minimum precaution, must be examined at the start and end of their stay.
—During quarantine, samples of birds are tested for avian influenza and Newcastle disease.
—If a disease is confirmed, all the affected birds are killed and destroyed, the centre is cleaned and disinfected and no other birds may leave quarantine until the results of their own virus tests prove negative.
—If parrots, parakeets and cockatoos are found to be infected, they may be treated and must remain in quarantine until at least 2 months after the last case was recorded.
—National authorities must inform the European Commission within 24 hours of an outbreak of avian influenza or Newcastle disease.
—They must also file annual reports to the Commission on the number of birds imported, their mortality rate and all cases of disease discovered in quarantine.
—The legislation does not apply to poultry, pets, racing pigeons, birds for conservation programmes, zoos, circuses, amusement parks or experiments or to those imported from Andorra, Liechtenstein, Monaco, Norway, San Marino, Switzerland or the Vatican state.

ACT

Commission Implementing Regulation (EU) No 139/2013 of 7 January 2013 laying down animal health conditions for imports of certain birds into the Union and the quarantine conditions thereof (OJ L 47, 20.2.2013, pp. 1-17)