1993D0342 — EN — 01.07.1994 — 001.001 — 1
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►B ►M1 COMMISSION DECISION
of 12 May 1993
laying down the criteria for classifying third countries with regard to avian influenza and
Newcastle disease in relation to imports of live poultry and hatching eggs ◄
(OJ L 137, 8.6.1993, p. 24)
Amended by:
Official Journal
No page date
►M1Commission Decision 94/438/EC of 7 June 1994 L 181 35 15.7.1994
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COMMISSION DECISION
of 12 May 1993
laying down the criteria for classifying third countries with regard
to avian influenza and Newcastle disease in relation to imports of
live poultry and hatching eggs
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THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community,
Having regard to Council Directive 90/539/EEC of 15 October 1990 on
animal health conditions governing intra-Community trade in andimports from third countries of poultry and hatching eggs (
1), as last
amended by Directive 92/65/EEC (2), and in particular Article 22 (2)
thereof,
Having regard to Council Directive 91/494/EEC of 26 June 1991 on
animal health conditions governing intra-Community trade in andimports from third countries of fresh poultrymeat (
3), as last amended by
Directive 92/116/EEC (4), and in particular Article 10 (2) thereof,
Whereas poultry, hatching eggs and poultry meat coming from third
countries must be free from avian influenza and Newcastle disease;whereas it is necessary to establish the criteria for classifying thirdcountries accordingly;
Whereas the criteria for third countries have to be established taking
into account the provisions regarding Member States as laid down inCouncil Directives 92/40/EEC (
5) and 92/66/EEC (6);
Whereas the measures provided for in this Decision are in accordance
with the opinion of the Standing Veterinary Committee,
HAS ADOPTED THIS DECISION:
Article 1
Forthe pur pose of this Decision:
(a)‘Avian influenza' means infection as defined in ChapterI of Annex
A;
(b)‘Newcastle disease' means infection as defined in ChapterII of
Annex A;
(c)‘Recognized vaccine' means any vaccine against Newcastle disease
complying with the criteria laid down in Annex B;
(d)‘Emergency vaccination' means vaccination used as a means of
controlling the disease following one or more outbreaks and carriedout:
(i) against avian influenza using any vaccine;
(ii) against Newcastle disease using non-recognized vaccines;
(e)‘Sanitary slaughter policy' means the application, in the event of
outbreaks of avian influenza or Newcastle disease, of the measuresprovided for in Annex C;
(1) OJ No L 303, 31. 10. 1990, p. 6.
(2) OJ No L 268, 14. 9. 1992, p. 54.
(3) OJ No L 268, 24. 9. 1991, p. 35.
(4) OJ No L 62, 15. 3. 1993, p. 1.
(5) OJ No L 167, 22. 6. 1992, p. 1.
(6) OJ No L 260, 5. 9. 1992, p. 1.
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(f) ‘Part of the territory' means a part of a third country of sufficient
size, which is well defined geographically or administratively,taking into account the epizootiological situation.
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Article 2
A third country is classified as free from avian influenza and Newcastle
disease if it fulfils the following general criteria:
(a) it must have a general animal-health structure allowing adequate
monitoring of poultry flocks;
(b) it must have legislation which makes avian influenza and Newcastle
disease notifiable diseases forall species of poultr y and forall bir dskept in captivity;
(c) it must undertake to examine closely any suspicion of those
diseases;
(d) if there is suspicion, it must submit samples of each avian influenza
virus or paramyxovirus found to specific laboratory testing inaccordance with the procedure set out in Annex A;
(e) it must have at its disposal laboratory capacity in its own official
laboratories or have arrangements with other national laboratoriesforr apid testing;
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(f) it must send a list of these laboratories, as well as a description of
the methods used fordiagnosis and pathotyping of avian influenzaand Newcastle disease to the Commission and allow checking ofthem by experts from the Community;
(g) for each primary outbreak it must send virusisolates to the EC
reference laboratory in Weybridge (Addlestone, United Kingdom);
(h) it must notify to the Commission, within 24 hours after confirma-
tion, of initial outbreaks in each previously free part of its territory;
i) it must send to the Commission, at least monthly in the event of
subsequent outbreaks in the same part of the territory, a report onthe disease situation;
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(j) in cases where vaccination against avian influenza and/or Newcastle
disease is not forbidden, it must officially control the production,testing and distribution for the vaccines;
(k) it must communicate to the Commission the characteristics of each
strain used for the production of vaccines against avian influenza orNewcastle disease.
Article 3
1. Without prejudice to the general criteria laid down in Article 2, a
third country is classified as free from avian influenza if:
(a) no outbreaks of that disease have occurred in poultry on its territory
forat least 36 months; and
(b) no vaccinations against avian influenza viruses of the same sub-
types as those for which highly pathogenic viruses are known toexist (currently H5 and H7 subtypes) have been carried out for atleast 12 months.
2. Where a sanitary slaughter policy is practised to control the
disease and without prejudice to the provision of paragraph 1 (b) theperiod of 36 months referred to in paragraph 1 (a) is reduced to:
(a) 6 months if no emergency vaccination has been carried out;
(b) 12 months if emergency vaccination has been carried out, provided
that a further 12-month period has elapsed after the official termina-tion of such emergency vaccination.
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Article 4
1. Without prejudice to the general criteria laid down in Article 2, a
third country is classified as free from Newcastle disease for the firsttime if:
(a) no outbreaks of that disease have occurred in poultry on its territory
forat least 36 months; and
(b) no vaccinations against Newcastle disease using non-recognized
vaccines have been carried out for at least 12 months.
2. Where a sanitary slaughter policy is practised to control the
disease and without prejudice to the provision of paragraph 1 (b) theperiod of 36 months referred to in paragraph 1 (a) is reduced to:
(a) 6 months if no emergency vaccination has been carried out;
(b) 12 months if emergency vaccination has been carried out, provided
that a further 12-month period has elapsed after the official termina-tion forsuch emer gency vaccination.
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4. By way of derogation from paragraphs 1 (b) and 2 (b) a thirdcountry is classified as free from Newcastle disease if it allows the useof vaccines against the disease, which, although complying with thegeneral criteria set out in Annex B for the vaccines, do not fulfil thespecific criteria thereof.
In such cases the third country concerned will be authorized to send live
poultry and hatching eggs ►
M1 ◄to the Community if
the additional guarantees laid down in Annex E ►M1 ◄
F to this Decision are included in the accompanying animal healthcertificate.
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Article 4a
The provisions of Article 22 (1) of Directive 90/539/EEC and of
Articles 3 and 4 of this Decision apply mutatis mutandis to parts of the
territory which comply with the requirements laid down therein,provided that satisfactory guarantees have been given as to:
— movement restrictions vis-à-vis other parts of the territory which are
not free from avian influenza and/or Newcastle disease,
— serological screening when necessary,— otherpossible measur es.
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Article 5
This Decision shall apply from 1 October 1993.
Article 6
This Decision is addressed to the Member States.
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Days afterinoculation (numberof bir ds)
Clinical Signs
12345678910Total ScoreANNEX A
DEFINITIONS OF ‘AVIAN INFLUENZA'AND ‘NEWCASTLE DISEASE'
CHAPTER I
Avian influenza
‘Avian influenza' means an infection of poultry caused by any influenza A virus
which has an intravenous pathogenicity index (IVPI) in six-week-old chickensgr eaterthan 1,2 orany infection with influenza A vir us of H5 orH7 sub-type forwhich nucleotide sequencing has demonstrated the presence of multiple basicamino acids at the cleavage site of the haemagglutinin.
The IVPI has to be determined according to the following method:
Intravenous pathogenicity index (IVPI)
1. Infective allantoic fluid from the lowest passage level available, preferably
from the initial isolation without any selection, is diluted 10
1in sterile isotonic
saline.
2. 0,1 ml diluted virus is injected intravenously into each of 10 six-week-old
chickens (specific pathogen free birds should be used).
3. Birds are examined at 24 hour intervals for 10 days.4. At each observation each bird is recorded normal (O), sick (1), severely sick
(2) ordead (3).
5. Record results and calculate index as shown in this example:
Normal 102000000001 2×0 = 0
Sick 04200000006×1 = 6
Severely sick (*) 02220000006×2 = 1 2
Dead 02681010101010107 6×3 = 228
Total = 246
Index = mean score per bird per observation =246
100= 2,46
(*) This has to be a subjective clinical judgement but normally this would involve birds
showing more than one of the following signs: respiratory involvement, depression,diarrhoea, cyanosis of exposed skin or wattles, oedema of face and/or head, nervoussigns.
CHAPTER II
Newcastle disease
‘Newcastle disease' means an infection of poultry caused by any avian strain of
the paramyxovirus 1 with an intracerebral pathogenicity index (ICPI) inone-day-old chicks greater than 0,7.
The ICPI has to be determined according to the following method:
Intracerebral pathogenicity index text (ICPI)
1. Infective freshly harvested allantoic fluid (HA titre must be greater than 2
4)i s
diluted 1:10 in sterile isotonic saline (antibiotics must not be used).
2. 0,05 ml of the diluted virus is injected intracerebrally into each 10
one-day-old chicks (i.e. 24 - 40 hours after hatching). The chicks should behatched from eggs obtained from a specific pathogen-free flock.
3. The birds are examined at intervals of 24 hours for eight days.4. At each observation each bird is scored : 0 = normal; 1 = sick ; 2 = dead.
5. The index is calculated as shown in the following example:
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Days afterinoculation (numberof bir ds)
Clinical signs
12345678Total Score
Normal 1040000001 4×0 = 0
Sick 0610400002 0×1 =2 0
Dead 0006101010104 6×2 =9 2
Total = 112
Index = is a mean score per bird of observation =246
100= 2,46
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ANNEX B
CRITERIA FOR RECOGNISED VACCINES
1.General criteria
A. Vaccines have to be registered by the competent authorities of the third
country concerned before being allowed to be distributed and used. Forthis registration the competent authorities have to rely on a complete filecontaining data about efficacy and innocuity; forimpor ted vaccines thecompetent authorities can rely on data checked by the competent authori-ties of the country where the vaccine is produced, as far as these checkshave been carried out in conformity with internationally accepted stan-dards.
B. Furthermore importation or production and distribution of the vaccines
have to be controlled by the competent authorities of the third countryconcerned.
C. Before distribution is allowed, each batch of vaccines has to be tested on
innocuity, in particular regarding attenuation or inactivation and absenceof undesired contaminating agents, and on efficacy on behalf of thecompetent authorities.
2.Specific criteria
A. Live attenuated Newcastle disease vaccines shall be prepared from a
Newcastle disease virus strain for which the master seed has been testedand shown to have an intracerebral pathogenicity index (ICPI) of:
either
(i) less than 0,4 if not less than 10
7EID50are administered to each bird
in the ICPI test;
or
(ii) less than 0,5 if not less than 108EID50are administered to each bird
in the ICPI test.
B. Inactivated Newcastle disease vaccines shall be prepared form a
Newcastle disease virus strain with an intracerebral pathogenicity index(ICPI) in one-day-old chicks of less than 0,7 if not less than 10
8EID50are
administered to each bird in the ICPI test.
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ANNEX C
MINIMAL MEASURES TO BE TAKEN WHEN SANITARY
SLAUGHTER IS PRACTISED TO ELIMINATE OUTBREAKS OF
AVIAN INFLUENZA OR NEWCASTLE DISEASE
1. In case of suspicion the holding concerned shall be placed under official
supervision. This shall in particular mean that:
(a) all necessary samples shall be taken without delay and sent to a labora-
tory approved by the competent authorities for diagnosis;
(b) a record shall be made of all categories of poultry kept on the holding
showing number of dead and diseased animals; this record shall be keptup-to-date and should be checked at each official visit;
(c) all poultr y shall be kept isolated and, wheneverpossible, in theirliving
quarters;
(d) no poultr y is allowed to enterorto leave the holding;
(e) all movements of persons, vehicles, materials etc. onto and from the
holding shall be subject to official authorization;
(f) table eggs can leave the holding afteradequate disinfection orcan be sent
directly to an installation where they receive an adequate heat treatment;
(g) appropriate means of disinfection have to be used at the entrances of
buildings housing poultry and of the holding itself;
(h) an epizootiological inquiry has to be carried out to discover the source of
infection and its possible spread;
(i) possibly infected contact premises, i. e. these known from the inquiry
meant in point (g) have to be put also underofficial sur veillance.
2. As soon as the presence of the disease is officially confirmed on a holding,
the following measures shall be taken in addition of those mentioned underpoint 1:
(a) all poultry on the holding shall be killed on the spot without any delay;
their carcasses and eggs shall be destroyed; these operations have to becarried out in a way which minimizes the risk of spreading disease;
(b) any substance orwaste liable to be contaminated shall be destr oyed or
treated in a way to ensure destruction of any virus present;
(c) the meat of poultry slaughtered during the presumed incubation period
should be traced and destroyed;
(d) hatching eggs laid during the presumed incubation period should be
traced and destroyed; poultry which hatched from such eggs shall beplaced underofficial sur veillance;
(e) after carrying out killing and destruction operations the premises shall be
thoroughly cleansed and desinfected;
(f) no poultry shall be reintroduced onto the holding until at least 21 days
afterthe end of the disinfection oper ations.
3. The operations mentioned in point 2 may be restricted to parts of holdings
which form an epizootiological unit as far as the necessary guarantees exist toavoid spread of the disease to the non-infected units of the holding.
4. Around confirmed outbreaks of disease a protection zone with a minimum
radius of 3 km and a surveillance zone with a minimum radius of 10 km shallbe implemented. In these zones stand-still measures and controlled move-ments of poultry shall be in force until at least 21 days after the end of thedisinfection operations on the infected holding. Before lifting the measures inthese zones the authorities shall carry out the necessary inquiries andsampling of the poultry holdings to confirm that disease is no longer presentin the region concerned.
5. The operations mentioned in this Annex have to be carried out by or under the
supervision of the official veterinary authorities.
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ANNEX E
ADDITIONAL GUARANTEES TO BE INCLUDED IN THE ANIMAL
HEALTH CERTIFICATE FOR IMPORT OF LIVE POULTRY ORHATCHING EGGS INTO THE COMMUNITY FROM THIRD COUN-
TRIES WHERE ARTICLE 4 (4) OF DECISION 93/342/EEC APPLIES
Although the use of vaccines against Newcastle disease which do not fulfil the
specific criteria of Annex B, heading 2 of Decision 93/342/EEC is not prohibitedin … (*), the:
— live poultry (**),
— breeding poultry from which the hatching eggs (**) day-old chicks (**) are
derived:
(a) have not been vaccinated forat least 12 months with such vaccines;
and
(b) originate from a flock which has undergone, no earlier than 14 days
preceding consignment or collecting of hatching eggs, on the basis of arandom sample of cloacal swabs of at least 60 birds of each flock concerned,a virus isolation test for Newcastle disease, carried out in an official labora-tory, in which no avian paramyxoviruses with an Intracerebral PathogenicityIndex (ICPI) of more than 0,4 have been found;
and
(c) have not been in contact during the last 60 days before consignment or
collecting of hatching eggs, with poultry which do not fulfil the guaranteesmentioned respectively under (a) and (b);
and
(d) have been isolated under official surveillance on the holding of origin during
the 14-day period mentioned in (b);
and
when it concerns export of day-old chicks, the hatching eggs from which they
hatched have not been in contact in the hatchery or during transport with eggs orpoultry which do not fulfil the abovementioned guarantees.
(*) Name of the country of origin.
(**) Delete where not applicable.