Commission Regulation (EC) No 2075/2005 of  5 December 2005  laying down specific rules on official controls for  Trichinella  in meat   (Text with EEA relevance)
Date: 2005-12-05
Institutions: European Commission
Subjects: animal health, animal nutrition, food inspection, health certificate, meat processing industry, parasitology, pigmeat, research method, veterinary inspection

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COMMISSION REGULATION (EC) No 2075/2005

of 5 December 2005

laying down specific rules on official controls for Trichinella in meat

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Regulation (EC) No 854/2004 of
the
European Parliament and of the Council of 29 April laying
down specific rules for the organisation of official controls on
products of animal origin intended for human consump-
tion (1), and in particular points 9 and 10 of Article 18 thereof,

Whereas:

(1) Regulation (EC) No 853/2004 of the European Parlia-
ment and of the Council of 29 April 2004 laying down
specific hygiene rules for food of animal origin (2),
Regulations (EC) No 854/2004 and (EC) No 882/2004
of
the Council of
29 April 2004 on the official controls performed to
ensure the verification of compliance with feed and food
law, animal health and animal welfare rules (3) lay down
the health rules and requirements regarding food of
animal origin and the official controls required.

the European Parliament and of

(2)

In addition to those rules, more specific requirements
should be laid down for Trichinella. Meat of domestic
swine, wild boar, horses and other animal species may be
infested with nematodes of
the genus Trichinella.
Consumption of meat infested with Trichinella can cause
serious disease in humans. Measures should be put in
place to prevent human disease caused by the consump-
tion of meat infested with Trichinella.

(3) On 22 November 2001, the Scientific Committee on
Veterinary Measures relating to Public Health adopted an
opinion on trichinellosis, epidemiology, methods of
detection and Trichinella-free pig production. On
1 December 2004, the Scientific Panel on biological
hazards (Biohaz) of the European Food Safety Authority
adopted an opinion on the suitability and details of
freezing methods to allow human consumption of meat
infected with Trichinella or Cysticercus. On 9 and 10 March
2005, Biohaz adopted an opinion on risk assessment of a
revised inspection of slaughter animals in areas with low
prevalence of Trichinella.

(4) Council Directive 77/96/EEC of 21 December 1976 on
the examination for trichinae (trichinella spiralis) upon
importation from third countries of fresh meat derived
from domestic swine (4) was repealed by Directive 2004/
41/EC of the European Parliament and of the Council of
21 April 2004 repealing certain Directives concerning
food hygiene and health conditions for the production
and placing on the market of certain products of animal
origin intended for human consumption and amending
Council Directives 89/662/EEC and 92/118/EEC and
Council Decision 95/408/EC (5).

(5) Various laboratory methods have been approved for the
detection of Trichinella in fresh meat. The magnetic stirrer
method for pooled-sample digestion is recommended as
a reliable method for routine use. Sample size for
the sample
parasitic analysis should be increased if
cannot be collected at the predilection site and if the type
or species of animal is at higher risk of being infected.
Trichinoscopic examination fails to detect non-encapsu-
lated Trichinella species infecting domestic and sylvatic
animals and humans and is no longer suitable as a
detection method for standard use. The trichinoscopic
method should only be used under exceptional circum-
stances for the examination of a small number of animals
slaughtered per week, provided that measures are taken
by the food business operator to process the meat in
such a way that it is completely safe for consumption.
However, the method should be replaced by a more
reliable detection method within a transitional period.

(1) OJ L 139, 30.4.2004, p. 206, corrected by OJ L 226,

25.6.2004, p. 83.

(2) OJ L 139, 30.4.2004, p. 55, corrected by OJ L 226, 25.6.2004,

p. 22.

(3) OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004,

(4) OJ L 26, 31.1.1977, p. 67.
(5) OJ L 157, 30.4.2004, p. 33, corrected by OJ L 195, 2.6.2004,

p. 1.

p. 12.

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Other methods, such as serological tests, can be useful
for monitoring purposes once the tests have been
validated by a Community reference laboratory as soon
such a laboratory has been appointed by the
as
Commission. Serological
suitable for
detecting Trichinella infestation in individual animals
intended for human consumption.

tests are not

(6)

Freezing meat under specified conditions can kill any
parasites present but certain Trichinella species occurring
in game and horses are resistant when freezing is carried
out using the recommended temperature and time
combinations.

(7) Holdings should be officially recognised by the compe-
tent authority as Trichinella-free, provided specific condi-
tions are met. Fattening pigs coming from such holdings
should be exempted from inspection for Trichinella.
Categories of holdings should be officially recognised by
the competent authority as Trichinella-free, provided
specific conditions are met. Such recognition should
reduce the number of on-site inspections to be carried
out by the competent authority, but is only feasible in
Member States with a history of very low disease
prevalence.

(8) Regular monitoring of domestic swine, wild boar, horses
and foxes or other indicator animals is an important tool
for assessing changes in disease prevalence. The results of
such monitoring should be communicated in an annual
report in accordance with Directive 2003/99/EC of the
European Parliament and of the Council of 17 November
2003 on the monitoring of zoonoses and zoonotic
agents (1).

(9) Regulation (EC) No 853/2004 does not apply to wild
game or wild game meat directly supplied to the final
consumer or
retail establishments directly
supplying the final consumer. It should therefore be the
responsibility of the Member States to adopt national
measures to mitigate the risk of Trichinella-infested wild
boar meat reaching the final consumer.

to local

(10) The measures provided in this Regulation are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,

(1) OJ L 325, 12.12.2003, p. 31.

HAS ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISION

Article 1

Definition

For the purposes of this Regulation ‘Trichinella’ means any
nematode belonging to species of the genus Trichinella.

CHAPTER II

OBLIGATIONS OF COMPETENT AUTHORITIES AND OF
FOOD BUSINESS OPERATORS

Article 2

Sampling of carcases

1. Carcases of domestic swine shall be systematically
sampled in slaughterhouses as part of
the post-mortem
examination.

A sample shall be collected from each carcase and the sample
shall be examined for Trichinella, in a laboratory designated by
the competent authority, using one of the following methods
of detection:

(a)

(b)

the reference method of detection set out in Chapter I of
Annex I; or

an equivalent method of detection set out in Chapter II of
Annex I.

2.
Pending the results of the Trichinella examination and
provided full traceability is guaranteed by the food business
operator.

(a)

Such carcases may be cut up into a maximum of six parts
in a slaughterhouse or in a cutting plant on the same
premises as the slaughterhouse (the premises).

(b) By way of derogation from subparagraph (a) and
following approval by the competent authority, such
carcases may be cut up at a cutting plant attached to or
separate from the slaughterhouse provided that:

(i)

(ii)

the procedure is under supervision by the compe-
tent authority;

a carcase or the parts thereof will not have more
than one cutting plant as its destination;

(iii)

the cutting plant is situated within the territory of
the Member State; and

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(iv)

in case of a positive result all the parts will be
declared unfit for human consumption.

the Commission shall publish the list of regions
recognised as such on its website.

3. Carcases of horses, wild boar and other farmed and wild
animal species susceptible to Trichinella infestation shall be
systematically sampled in slaughterhouses or game-handling
establishments as part of the post-mortem examination.

3. Where a competent authority implements the derogation
provided for in paragraph 2, the Member State concerned shall
submit an annual report to the Commission containing the
information referred to in Chapter II(D) of Annex IV in
accordance with Article 9(1) of Directive 2003/99/EC.

Such sampling must not be carried out where the competent
authority has ascertained by risk assessment that the risk of
Trichinella infestation of a particular farmed or wild species is
negligible.

Where a Member State fails to submit that annual report or
the annual report is unsatisfactory for the purposes of this
Article, then the derogation shall cease to apply to that
Member State.

A sample shall be collected from each carcase and the sample
shall be examined in accordance with Annex I and III in a
laboratory designated by the competent authority.

Article 4

Article 3

Derogations

1. By way of derogation from Article 2(1), meat of domestic
swine that has undergone a freezing treatment in accordance
the competent
with Annex II under
authority shall be exempt from Trichinella examination.

the supervision of

2. By way of derogation from Article 2(1), carcases and meat
of domestic swine kept solely for fattening and slaughter shall
be exempt from Trichinella examination where the animals
come from:

(a)

a holding or category of holdings that has been officially
recognised by the competent authority as free from
Trichinella in accordance with the procedure set out in
Chapter II of Annex IV;

(b)

a region where the risk of Trichinella in domestic swine is
officially recognised as negligible following:

(i)

forwarding of a notification to that effect by the
Member State concerned, together with an initial
report containing the information set out
in
Chapter II(D) of Annex IV, to the Commission and
the other Member States; and

(ii)

approval of the region as a region presenting a
negligible Trichinella risk in accordance with the
following procedure:

Trichinella examination and application of health mark

1. Carcases as referred to in Article 2 or parts thereof, except
for those referred to in Article 2(2)(b), may not leave the
premises, before the result of the Trichinella examination is
found to be negative.

Similarly, other parts of an animal intended for human or
animal consumption which contain striated muscle tissue may
not leave the premises before the result of the Trichinella
examination is found to be negative.

2. Animal waste and animal by-products not intended for
human consumption and not containing striated muscle may
leave the premises before the results of
the Trichinella
examination are available.

However, the competent authority may require a Trichinella
examination or prior treatment of animal by-products to be
carried out before permitting them to leave the premises.

3. Where a procedure is in place in the slaughterhouse to
ensure that no part of carcases examined leaves the premises
until the result of the Trichinella examination is found to be
negative and the procedure is formally approved by the
competent authority, the health mark provided for in Article
5(2) of Regulation (EC) No 854/2004 may be applied before
the results of the Trichinella examination are available.

Article 5

Training

the other Member States shall have three months
from receipt of the notification referred to in (i) to
send written comments to the Commission. If the
Commission or a Member State raises no objec-
tions, the region is recognised as a region presenting
a negligible Trichinella risk and domestic swine
coming from that region shall be exempted from
examination for Trichinella at the time of slaughter;

The competent authority shall ensure that all personnel
involved in the examination of samples to detect Trichinella
shall be properly trained and participate in:

(a)

a quality control programme of the tests used to detect
Trichinella; and

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(b)

a regular assessment of the testing, recording and analysis
procedures used in the laboratory.

(a)

in the case of holdings, the requirements laid down in
Chapter I and Chapter II(A), (B) and (D) of Annex IV;

Article 6

Methods of detection

(b)

in the case of categories of holdings, the requirements
laid down in Chapter II(C) and (D) of Annex IV.

1. The methods of detection set out in Chapters I and II of
Annex I shall be used for examining samples as referred to in
Article 2:

(a) where they provide grounds for suspecting Trichinella

infestation; or

(b) when samples coming from the same holding were
previously found to be positive using the trichinoscopic
method referred to in Article 16(1).

2. All positive samples shall be forwarded to the national
reference laboratory or the Community reference laboratory
for determination of the Trichinella species involved.

Article 9

Obligation on food business operators to inform

Food business operators of holdings recognised as free from
Trichinella shall
inform the competent authority of any
requirement as laid down in Chapter I and II(B) of Annex IV
that is no longer fulfilled or of any other change that might
affect holdings' Trichinella-free status.

Article 10

Inspection of Trichinella-free holdings

Article 7

Contingency plans

The competent authority shall ensure that inspections are
carried out periodically of holdings recognised as free from
Trichinella.

The competent authorities of the Member States shall prepare
a contingency plan by 31 December 2006 outlining all action
to be taken where samples as referred to in Articles 2 and 16
test positive to Trichinella. That plan shall
include details
covering:

(a)

traceability of
containing muscle tissue;

infested carcase(s) and parts

thereof

(b) measures for dealing with infested carcase(s) and parts

thereof;

(c)

investigation of
spreading among wildlife;

the source of

infestation and any

(d)

any measures to be taken at the retail or consumer level;

(e) measures to be taken where the infested carcase cannot

be identified at the slaughterhouse;

(f)

determination of the Trichinella species involved.

Article 8

Recognition of officially Trichinella-free holdings

inspections shall be risk-based,

The frequency of
taking
account of disease history and prevalence, previous findings,
the geographical area,
susceptible wildlife, animal
husbandry practices, veterinary supervision and farmers'
compliance.

local

The competent authority shall ensure that all breeding sows
and boars coming from Trichinella-free holdings are examined
in accordance with Article 2(1).

Article 11

Monitoring programmes

The competent authority shall
implement a monitoring
programme covering domestic swine, horses and other animal
species susceptible for Trichinella coming from holdings or
categories of holdings recognised as free from Trichinella or
from regions where the risk of Trichinella in domestic swine is
recognised as negligible, in order to verify that the animals are
effectively free from Trichinella.

The frequency of testing, the number of animals to be tested
and the sampling plan shall be laid down in the monitoring
programme. To that end, meat samples shall be collected and
examined for presence of Trichinella parasites in accordance
with Chapter I or II of Annex I.

The competent authority may officially recognise holdings or
categories of holdings as free from Trichinella where the
following requirements are complied with:

The monitoring programme may include serological methods
as an additional tool once a suitable test is validated by the
Community reference laboratory.

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Article 12

(i)

any of the requirements laid down in Chapter I or II of
Annex IV is no longer fulfilled;

Withdrawal of official recognition of Trichinella-free
holdings or regions with negligible risk

(ii)

1. Where domestic swine, or other animal species suscep-
tible to Trichinella infestation,
from a holding officially
recognised as free from Trichinella test positive to Trichinella,
the competent authority shall without delay:

(a) withdraw the holding's official recognition as free from

Trichinella;

(b)

(c)

examine all domestic swine at the time of slaughter in
accordance with Article 2(1) and conduct a serological
test on all animals susceptible to Trichinella infestation on
the holding once a suitable test has been validated by the
Community reference laboratory;

trace and test all breeding animals that arrived on the
holding and, as far as possible, all those that left the
holding in at least the six months preceding the positive
finding; to that end, meat samples shall be collected and
examined for presence of Trichinella parasites using the
detection methods in Chapters I and II of Annex I; a
test may be used once a suitable test is
serological
validated by the Community reference laboratory;

(d)

investigate the spread of parasite
as far as is feasible,
infestation due to the distribution of meat from domestic
swine slaughtered in the period preceding the positive
finding;

(e)

inform the Commission and the other Member States;

(f)

initiate an epidemiological investigation to elucidate the
cause of infestation;

results or

serological
following
sampling of slaughtered swine show that the holding
or category of holdings can no longer be considered free
from Trichinella.

laboratory findings

3. When information from the monitoring programme or
the wildlife monitoring programme shows that a region can
no longer be considered a region where the risk of Trichinella
in domestic swine is recognised as negligible, the Commission
shall withdraw the region from the list and inform the other
Member States.

4.
Following withdrawal of recognition, holdings may be
recognised as officially free from Trichinella again once the
problems identified have been solved and the requirements
laid down in Chapter II(A) of Annex IV are fulfilled to the
satisfaction of the competent authority.

CHAPTER III

IMPORTS

Article 13

Import health requirements

Meat of animal species that may be carriers of Trichinella,
containing striated muscles and coming from a third country
may only be imported into the Community if it has been
examined for Trichinella in that third country before export.

(g)

increase the frequency of testing under, and the scope of
the monitoring programme provided for in Article 11;

Such examination shall be carried out in accordance with
Article 2 on the whole carcase or, failing this, on each half-
carcase, quarter, part or cut thereof.

(h)

take appropriate measures where any infested carcase
cannot be identified at the slaughterhouse, including:

Article 14

(i)

increasing the size of each meat sample collected for
testing of the suspect carcases; or

(ii)

declaring the carcases unfit for human consump-
tion; and

(iii)

taking appropriate measures for the disposal of
suspect carcases or parts thereof and those testing
positive.

Derogations from Article 13

1. Meat of domestic swine may be imported without having
undergone the examination referred to in Article 13, provided
it comes from a holding in a third country that has been
recognised by the Community as officially free from Trichinella
in accordance with Article 12 of Regulation (EC) No 854/
2004 on the basis of a request from the competent authority
of that country, accompanied by a report to the Commission
providing evidence that the requirements set out in Chapter I
of Annex IV are met.

2. The competent authority shall withdraw official recogni-
tion of holdings or categories of holdings as free from
Trichinella where:

2. Meat of domestic swine may be imported without having
undergone the examination referred to in Article 13, provided

(a)

(b)

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it has undergone a freezing treatment in accordance with
Annex II carried out under the supervision of the competent
authority in the third country.

Article 15

Documents

The health certificate accompanying imports of meat as
referred to in Article 13 shall be endorsed with a statement by
the official veterinarian to the effect that:

and wild boar in exceptional cases until 31 December 2009,
where:

(a)

single carcases as referred to in Article 2 need to be
examined individually in an establishment that does not
slaughter more than 15 domestic swine per day or 75
domestic swine per week or prepare for placing on the
market more than 10 wild boar per day; and

(b)

the detection methods set out in Chapters I and II of
Annex I are not available.

the meat has been examined in the third country of
origin in accordance with Article 13; or

2. Where the trichinoscopic method is used, the competent
authority shall ensure that:

the meat satisfies the requirements set out in Article 14
(1) or (2).

That document shall accompany the meat in the original
unless an exemption has been granted in accordance with
Article 14(4) of Regulation (EC) No 854/2004.

CHAPTER IV

TRANSITIONAL AND FINAL PROVISIONS

Article 16

Transitional provisions

1. The Member State may allow the trichinoscopic method
set out in Chapter III of Annex I to be used for domestic swine

(a)

the meat is marked with a health mark that is clearly
different from the health mark provided for in Article 5
(1)(a) of Regulation (EC) No 853/2004, and the meat is
supplied directly to the final consumer or to retail
establishments directly supplying the final consumer; and

(b)

the meat is not used for the production of products
where the production process does not kill Trichinella.

Article 17

Entry into force

This Regulation shall enter into force on the 20th day
following its publication in the Official Journal of the European
Union.

It shall apply from 1 January 2006.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 December 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

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ANNEX I

Detection methods

CHAPTER I

REFERENCE METHOD OF DETECTION

Magnetic stirrer method for pooled sample digestion

1.

Apparatus and reagents

(a)

Knife or scissors and tweezers for cutting specimens

(b)

Trays marked off into 50 squares, each of which can hold samples of approximately 2 g of meat, or other
tools giving equivalent guarantees as regards the traceability of the samples

(c) A blender with a sharp chopping blade. Where the samples are larger than 3 g, a meat mincer with
openings of 2 to 4 mm or scissors must be used. In the case of frozen meat or tongue (after removal of the
superficial layer, which cannot be digested), a meat mincer is necessary and the sample size will need to be
increased considerably

(d) Magnetic stirrers with thermostatically controlled heating plate and teflon-coated stirring rods

approximately 5 cm long

(e)

Conical glass separation funnels, capacity of at least 2 litres, preferably fitted with teflon safety plugs

(f)

Stands, rings and clamps

(g)

Sieves, mesh size 180 microns, external diameter 11 cm, with stainless steel mesh

(h)

Funnels, internal diameter not less than 12 cm, to support the sieves

(i)

(j)

Glass beakers, capacity 3 litres

Glass measuring cylinders, capacity 50 to 100 ml, or centrifuge tubes

(k) A trichinoscope with a horizontal table or a stereo-microscope, with a substage transmitted light source of

adjustable intensity

(l)

A number of 9 cm diameter petri dishes (for use with a stereo-microscope), marked on their undersides
into 10 × 10 mm square examination areas using a pointed instrument

(m) A larval counting basin (for use with a trichinoscope), made of 3 mm thick acrylic plates as follows:

(i)

the bottom of the basin to be 180 × 40 mm, marked off into squares,

(ii)

the sides to be 230 × 20 mm,

(iii)

the end to be 40 × 20 mm. The bottom and the ends must be inserted between the sides, to form
two small handles at the ends. The upper side of the bottom must be raised 7 to 9 mm from the base
of the frame formed by the sides and the ends. The components must be stuck together with glue
suitable for the material

(n) Aluminium foil

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(o)

25 % hydrochloric acid

(p)

Pepsin, strength: 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British
Pharmacopoea) and to 2 000 FIP (Fédération internationale de pharmacie)

(q)

Tap water heated to 46 to 48 oC

(r)

A balance accurate to at least 0,1 g

(s) Metal trays, capacity 10 to 15 litres, to collect the remaining digestive juice

(t)

Pipettes of different sizes (1, 10 and 25 ml) and pipette holders

(u) A thermometer accurate to 0,5 oC within the range 1 to 100 oC

(v)

Siphon for tap water.

2.

Collecting of specimens and quantity to be digested

(a)

In the case of whole carcases of domestic swine, a specimen weighing at least 1 g is to be taken from a
pillar of the diaphragm at the transition to the sinewy part. Special trichinae forceps can be used provided
an accuracy of between 1,00 and 1,15 g can be guaranteed.

In the case of breeding sows and boars, a larger sample weighing at least 2 g is to be taken from a pillar of
the diaphragm at the transition to the sinewy part.

In the absence of diaphragm pillars, a specimen of twice the size 2 g (or 4 g in the case of breeding sows
and boars) is to be taken from the rib part or the breastbone part of the diaphragm, or from the jaw
muscle, tongue or abdominal muscles.

(b)

For cuts of meat, a sample weighing at least 5 g of striated muscle, containing little fat is to be taken, where
possible from close to bones or tendons. A sample of the same size is to be collected from meat that is not
intended to be cooked thoroughly or other types of post-slaughter processing.

(c)

For frozen samples, a sample weighing at least 5 g of striated muscle tissue is to be taken for analysis.

The weight of meat specimens relates to a sample of meat that is free of all fat and fascia. Special attention
must be paid when collecting muscle samples from the tongue in order to avoid contamination with the
superficial layer of the tongue, which is indigestible and can prevent reading of the sediment.

3.

Procedure

I.

Complete pools (100 g of samples at a time)

(a)

16 ± 0,5 ml of hydrochloric acid is added to a 3 litre beaker containing 2,0 litre of tap water,
preheated to 46 to 48 oC; a stirring rod is placed in the beaker, the beaker is placed on the preheated
plate and the stirring is started.

(b)

10 ± 0,2 g of pepsin is added.

(c)

100 g of samples collected in accordance with point 2 is chopped in the blender.

(d)

(e)

The chopped meat is transferred to the 3 litre beaker containing the water, pepsin and hydrochloric
acid.

The mincing insert of the blender is immersed repeatedly in the digestion fluid in the beaker and the
blender bowl is rinsed with a small quantity of digestion fluid to remove any meat still adhering.

(f)

The beaker is covered with aluminium foil.

(g)

The magnetic stirrer must be adjusted so that it maintains a constant temperature of 44 to 46 oC
throughout the operation. During stirring, the digestion fluid must rotate at a sufficiently high speed
to create a deep whirl without splashing.

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(h)

The digestion fluid is stirred until the meat particles disappear (approximately 30 minutes). The
stirrer is then switched off and the digestion fluid is poured through the sieve into the sedimentation
funnel. Longer digestion times may be necessary (not exceeding 60 minutes) in the processing of
certain types of meat (tongue, game meat, etc.).

(i)

The digestion process is considered satisfactory if not more than 5 % of the starting sample weight
remains on the sieve.

(j)

The digestion fluid is allowed to stand in the funnel for 30 minutes.

(k) After 30 minutes, a 40 ml sample of digestion fluid is quickly run off into the measuring cylinder or

centrifuge tube.

(l)

The digestion fluids and other liquid waste are kept in a tray until reading of the results is completed.

(m) The 40 ml sample is allowed to stand for 10 minutes. 30 ml of supernatant is then carefully

withdrawn by suction to remove the upper layers and leave a volume of not more than 10 ml.

(n)

The remaining 10 ml sample of sediment is poured into a larval counting basin or petri dish.

(o)

The cylinder or centrifuge tube is rinsed with not more than 10 ml of tap water, which has to be
added to the sample in the larval counting basin or petri dish. Subsequently, the sample is examined
by trichinoscope or stereo-microscope at a 15 to 20 times magnification. Visualisation using other
techniques is allowed, provided examination of positive control samples has been shown to give an
equal or better result than traditional visualisation methods. In all cases of suspect areas or parasite-
like shapes, higher magnifications of 60 to 100 times must be used.

(p) Digests are to be examined as soon as they are ready. Under no circumstances should examination

be postponed until the following day.

Where the digests are not examined within 30 minutes of preparation, they must be clarified as
follows. The final sample of about 40 ml is poured into a measuring cylinder and allowed to stand
for 10 minutes. 30 ml of the supernatant fluid is then removed, leaving a volume of 10 ml. This
volume is made up to 40 ml with tap water. After a further settling period of 10 minutes, 30 ml of
the supernatant fluid is withdrawn by suction,
leaving a volume of no more than 10 ml for
examination in a petri dish or larval counting basin. The measuring cylinder is washed with no more
than 10 ml of tap water and these washings are added to the sample in the petri dish or the larval
counting basin for examination.

If the sediment is found to be unclear on examination, the sample is poured into a measuring
cylinder and made up to 40 ml with tap water and then the above procedure is followed. The
procedure can be repeated 2 to 4 times until the fluid is clear enough for a reliable reading.

II.

Pools of less than 100 g

Where needed, up to 15 g can be added to a total pool of 100 g and examined together with these samples
in accordance with 3(I). More than 15 g must be examined as a complete pool. For pools of up to 50 g, the
digestion fluid and the ingredients may be reduced to 1 litre of water, 8 ml of hydrochloric acid and 5 g of
pepsin.

III.

Positive or doubtful results

Where examination of a collective sample produces a positive or uncertain result, a further 20 g sample is
taken from each pig in accordance with 2(a). The 20 g samples from five pigs are pooled and examined
using the method described above. In this way samples from 20 groups of five pigs will be examined.

When Trichinella is detected in a pooled sample from five pigs, further 20 g samples are collected from the
individual pigs in the group and each is examined separately using the method described above.

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Parasite samples are to be kept in 90 % ethyl alcohol for conservation and identification at species level at
the Community or national reference laboratory.

After parasite collection, positive fluids (digestive juice, supernatant fluid, washings, etc.) are to be
decontaminated by heating to at least 60 oC.

CHAPTER II

EQUIVALENT METHODS

A. Mechanically assisted pooled sample digestion method/sedimentation technique

1.

Apparatus and reagents

(a)

Knife or scissors for cutting specimens

(b)

Trays marked off with 50 squares, each of which can hold samples of approximately 2 g of meat, or
other tools giving equivalent guarantees as regards the traceability of the samples

(c) Meat mincer or electrical blender

(d) A stomacher lab-blender 3 500 thermo model

(e)

Plastic bags suitable for the stomacher lab-blender

(f)

Conical separation funnels, capacity 2 litres, preferably fitted with teflon safety plugs

(g)

Stands, rings and clamps

(h)

Sieves, mesh size 180 microns, external diameter 11 cm, with stainless steel or brash mesh

(i)

(j)

Funnels, internal diameter not less than 12 cm, to support the sieves

100 ml glass measuring cylinders

(k) A thermometer accurate to 0,5 oC within the range 1 to 100 oC

(l)

A vibrator, e.g. an electric shaver with the head removed

(m) A relay which will switch on and off at one-minute intervals

(n) A trichinoscope with a horizontal table or a stereo-microscope, with a sub-stage transmitted light

source of adjustable intensity

(o) A larval counting basin and a number of 9 cm diameter petri dishes as in Chapter I(1)(l) and (m)

(p)

17,5 % hydrochloric acid

(q)

(r)

Pepsin, strength 1: 10 000 NF (US national formulary) corresponding to 1: 12 500 BP (British
Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie),

A number of 10 litre bins to be used for decontamination of apparatus, e.g. with formol, and for
digestive juice remaining where specimens test positive

(s)

A balance accurate to 0,1 g.

2.

Collecting of specimens and quantity to be digested

As stipulated in Chapter I(2).

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3.

Procedure

I.

Grinding

Grinding the meat samples in a meat mincer beforehand will improve the digestion quality. If an
electrical blender is used, the blender must be operated three to four times for approximately one
second each time.

II.

Digestion procedure

This procedure may involve complete pools (100 g of samples at a time) or pools of less than 100 g.

(a)

Complete pools (100 samples at a time)

(i)

The stomacher lab-blender 3 500 is fitted with a double plastic bag and the temperature
control set at 40 to 41 oC.

(ii) One and a half litres of water preheated to 40 to 41 oC is poured into the inner plastic

bag.

(iii) 25 ml of 17,5 % hydrochloric acid is added to the water in the stomacher.

(iv) 100 samples weighing approximately 1 g each (at 25 to 30 oC) taken from each

individual sample in accordance with 2 are added.

(v)

Lastly, 6 g pepsin is added. This order must be followed strictly to avoid decomposition
of the pepsin.

(vi) The stomacher is then allowed to pound the content of the bag for 25 minutes.

(vii) The plastic bag is removed from the stomacher and the digestion fluid is filtered through

the sieve into a 3 litre beaker.

(viii) The plastic bag is washed with approximately 100 ml of water, which is then used to

rinse the sieve and lastly added to the filtrate in the beaker.

(ix) Up to 15 individual samples can be added to a total pool of 100 samples and examined

together with these samples.

(b)

Smaller pools (less than 100 samples)

(i)

The stomacher lab-blender 3 500 is fitted with a double plastic bag and the temperature
control set at 40 to 41 oC.

(ii) A digestion fluid is prepared by mixing about one and a half litres of water and 25 ml of
17,5 % hydrochloric acid. 6 g of pepsin is added and the whole mixed at a temperature of
40 to 41 oC. This order must be followed strictly to avoid decomposition of the pepsin.

(iii) Of the digestion fluid, a volume corresponding to 15 ml per gram of sample is measured
(e.g. for 30 samples the volume required is 30 × 15 ml = 450 ml) and transferred to the
inner of the two plastic bags, together with the meat samples weighing approximately 1
g (at 25 to 30 oC) taken from each individual sample in accordance with 2.

(iv) Water at a temperature of approximately 41 oC is poured into the outer bag to make up a
total volume in the two bags of one and a half litres. The stomacher is then allowed to
pound the content of the bag for 25 minutes.

(v)

The plastic bag is removed from the stomacher and the digestion fluid is filtered through
the sieve into a 3 litre beaker.

(vi) The plastic bag is washed with approximately 100 ml of water (at 25 to 30 oC), which is

then used to rinse the sieve and lastly added to the filtrate in the beaker.

III.

Recovery of larvae by sedimentation

— Ice (300 to 400 g of ice flakes, scaly ice or crushed ice) is added to the digestion fluid to bring
its volume up to about 2 litres. The digestion fluid is then stirred until the ice has melted. In the

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case of smaller pools (see II(b)), the amount of ice must be reduced correspondingly.

— The chilled digestion fluid is transferred to a 2 litre separation funnel, equipped with a vibrator

in an extra clamp.

— Sedimentation is allowed to proceed for 30 minutes, during which time the sedimentation
funnel is vibrated intermittently, i.e. one minute vibration followed by a one-minute pause.

— After 30 minutes, a 60 ml sample of the sediment is quickly run off into a 100 ml measuring

cylinder (the funnel is rinsed with detergent solution after use).

— The 60 ml sample is allowed to stand for at least 10 minutes, after which time the supernatant
is withdrawn by suction to leave a volume of 15 ml, to be examined for presence of larvae.

— For suction, a disposable syringe, equipped with a plastic tube, can be used. The length of the
tube must be such that 15 ml remains in the measuring cylinder when the flanges of the
syringe rest on the cylinder's rim.

— The remaining 15 ml is poured into a larval counting basin or two petri dishes and examined

using a trichinoscope or stereo-microscope.

— The measuring cylinder is washed with 5 to 10 ml of tap water and the washings are added to

the sample.

— Digests are to be examined as soon as they are ready. Under no circumstances is examination

to be postponed until the following day.

Where the digests are unclear or they are not examined within 30 minutes of their preparation, they
must be clarified as follows:

— the final sample of 60 ml is poured into a measuring cylinder and allowed to stand for 10
minutes; 45 ml of supernatant fluid is then removed by suction and the remaining 15 ml is
made up to 45 ml with tap water,

— after a further settling period of 10 minutes, 30 ml of supernatant fluid is removed by suction
and the remaining 15 ml is poured into a petri dish or larval counting basin for examination,

— the measuring cylinder is washed with 10 ml of tap water and these washings are added to the

sample in the petri dish or the larval counting basin for examination.

IV.

Positive or doubtful results

Where the result is positive or uncertain, the provisions laid down in Chapter I(3)(III) shall apply.

B. Mechanically assisted pooled sample digestion method/‘on filter isolation’ technique

1.

Apparatus and reagents

As stipulated in Chapter II(A)(1).

Additional equipment:

(a)

1 litre Gelman funnel, complete with filter holder (diameter 45 mm);

(b)

filter discs, consisting of a circular stainless steel mesh with an aperture of 35 microns (disc diameter:
45 mm), two rubber rings 1 mm thick (external diameter: 45 mm; internal diameter: 38 mm), the
circular mesh being placed between the two rubber rings and bonded to them using a two-
component glue suitable for the two materials;

(c)

an Erlenmeyer flask, capacity 3 litres, fitted with a side tube for suction;

(d)

a filter pump;

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(e)

plastic bags, capacity at least 80 ml;

(f)

equipment for sealing the plastic bags;

(g)

rennilase, strength 1: 150 000 soxhlet units per gram.

2.

Collecting of specimens

As stipulated in Chapter I(2).

3.

Procedure

I.

Grinding

Grinding the meat samples in a meat mincer beforehand will improve the digestion quality. If an
electrical blender is used, the blender must be operated three to four times for approximately one
second each time.

II.

Digestion procedure

This procedure may involve complete pools (100 g of samples at a time) or pools of less than 100 g.

(a)

Complete pools (100 samples at a time)

See Chapter II(A)(3)(II)(a).

(b)

Smaller pools (less than 100 samples)

See Chapter II(A)(3)(II)(b).

III.

Recovery of larvae by filtration

(a)

(b)

(c)

(d)

Ice (300 to 400 g of ice flakes, scaly ice or crushed ice) is added to the digestion fluid to bring
its volume up to about 2 litres. In the case of smaller pools, the amount of ice must be reduced
correspondingly.

The digestion fluid is stirred until the ice has melted. The chilled digestion fluid is then left for
at least three minutes to let the larvae coil.

The Gelman funnel, fitted with a filter holder and filter disc, is mounted on an Erlenmeyer flask
connected to a filter pump.

The digestion fluid is poured into the Gelman funnel and filtered. Towards the end of filtration,
the digestion fluid can be helped to pass through the filter by applying suction with the filter
pump. Suction must cease before the filter becomes dry, i.e. when 2 to 5 ml of fluid is left in
the funnel.

(e) Once all the digestion fluid has been filtered, the filter disc is removed and placed in an 80 ml
capacity plastic bag, together with 15 to 20 ml of rennilase solution. The rennilase solution is
made by adding 2 g of rennilase to 100 ml of tap water.

(f)

The plastic bag is sealed twice and placed between the inner and outer bags in the stomacher.

(g)

The stomacher is allowed to pound for three minutes, e.g. while it is working on a complete or
incomplete pool.

(h) After three minutes, the plastic bag, complete with filter disc and rennilase solution, is removed
from the stomacher and opened with scissors. The liquid contents are poured into a larval
counting basin or petri dish. The bag is washed out with 5 to 10 ml of water, which is then
added to the larval counting basin for examination by trichinoscope or to the petri dish for
examination by stereo-microscope.

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(i)

Digests must be examined as soon as they are ready. Under no circumstances is examination to
be postponed until the following day.

Note:

Filter discs must never be used when not completely clean. Unclean discs must never
be allowed to dry out. Filter discs can be cleaned by leaving them in rennilase solution
overnight. Before use, they must be washed in fresh rennilase solution using the
stomacher.

IV.

Positive or doubtful results

Where the result is positive or uncertain, the provisions laid down in Chapter I(3)(III) shall apply.

C. Automatic digestion method for pooled samples of up to 35 g

1.

Apparatus and reagents

(a)

Knife or scissors for cutting specimens

(b)

Trays marked off with 50 squares, each of which can hold samples of approximately 2 g of meat, or
other tools giving equivalent guarantees as regards the traceability of the samples

(c) A Trichomatic 35® blender with filtration insert

(d) Hydrochloric acid 8,5 ± 0,5 % weight

(e)

(f)

Transparent polycarbonate membrane filters with a diameter of 50 mm and a pore size of 14
microns

Pepsin, strength 1: 10 000 NF (US National Formulary) corresponding to 1: 12 500 BP (British
Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie)

(g) A balance accurate to 0,1 g

(h)

Tweezers with a flat tip

(i)

(j)

A number of microscope slides with a side-length of at least 5 cm or a number of petri dishes at least
6 cm in diameter, marked on their undersides into 10 × 10 mm square areas using a pointed
instrument

A (stereo-)microscope with transmitted light (magnification 15 to 60 times) or a trichinoscope with
a horizontal table

(k) A bin for collection of waste liquids

(l)

A number of 10 litre bins to be used for decontamination of apparatus, e.g. with formol, and for
digestive juice remaining where specimens test positive

(m)

a thermometer accurate to 0,5 oC within the range 1 to 100 oC.

2.

Collecting of specimens

As stipulated in Chapter I(2).

3.

Procedure

I.

Digestion procedure

(a)

Place the blender with the filtration insert, connect the waste tube and place the tube so it
drains into the waste bin.

(b) When the blender is switched on, heating will start.

(c)

Before this is done, the bottom valve located below the reaction chamber must be opened and
closed.

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(d) Up to 35 samples weighing approximately 1 g each (at 25 to 30 oC) taken from each individual
sample in accordance with point 2 are then added. Ensure that larger pieces of tendons are
removed as they may clot the membrane filter.

(e)

(f)

Pour water up to the edge of a liquid chamber connected to the blender (approximately 400
ml).

Pour about 30 ml hydrochloric acid ((8,5 %) to the edge of the smaller, connected liquid
chamber.

(g)

Place a membrane filter under the coarse filter in the filter holder in the filter insert.

(h)

(i)

(j)

Lastly, add 7 g of pepsin. This order must be followed strictly to avoid decomposition of the
pepsin.

Close the lids of the reaction and liquid chambers.

Select the period of digestion. A short digestion period (5 minutes) must be set for pigs at the
normal slaughter age and a longer time (8 minutes) for other samples.

(k) When the start button on the blender is turned on, the process of dispensing and digestion
starts automatically, followed by filtration After 10 to 13 minutes the process is completed and
stops automatically.

(l)

Open the lid of the reaction chamber after checking that the chamber is empty. If there is foam
or any digestion liquid remaining in the chamber, repeat the procedure in accordance with V.

II.

Recovery of larvae

(a)

Remove the filter holder and transfer the membrane filter to a slide or Petri dish.

(b)

Examine the membrane filter using a (stereo-) microscope or a trichinoscope.

III.

Cleaning equipment

(a) Where the result is positive, fill the blender reaction chamber with boiling water until it is two-
thirds full. Ordinary tap water is poured into the connecting liquid chamber until it covers the
lower sensor. Automatic cleaning then takes place. Decontaminate the filter-holder and any
other equipment, e.g. using formol.

(b) After work is completed for the day, fill the blender liquid chamber with water and put it

through a standard cycle.

IV. Use of membrane filters

Each polycarbonate membrane filter may be used no more than five times. The filter is to be turned
between each use. In addition, the filter must be checked after each use for any damage which would
make it unsuitable for further use.

V. Method to be applied when digestion is incomplete and filtration cannot be carried out

Once the blender has been put through an automatic cycle in accordance with C(3)(I), open the lid of
the reaction chamber and check whether there is foam or any liquid remaining in the chamber. If
this is the case, proceed as follows:

(a)

close the bottom valve below the reaction chamber;

(b)

remove the filter holder and transfer the membrane filter to a slide or Petri dish;

(c)

put a new membrane filter in the filter holder and attach the filter holder;

(d)

fill the blender liquid chamber with water until the lower sensor is covered;

(e)

carry out the automatic cleaning cycle;

(f)

after the cleaning cycle has ended, open the lid of the reaction chamber and check whether any
liquid remains;

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(g)

(h)

if the chamber is empty, remove the filter holder and transfer the membrane filter to a slide or
Petri dish with tweezers;

examine the two membrane filters in accordance with C(3)(II).
If the filters cannot be
examined, repeat the entire digestion process with a longer digestion time in accordance with
C(3)(I).

VI.

Positive or doubtful results

Where the result is positive or uncertain, the provisions laid down in Chapter I(3)(III) shall apply.

CHAPTER III

TRICHINOSCOPIC EXAMINATION

1.

Apparatus

(a) An incandescent-lamp trichinoscope with 30 to 40 times and 80 to 100 times magnification or a

stereomicroscope with a substage transmitted light source of adjustable intensity

(b) A compressorium being a pressure glass consisting of two glass plates (one of which is divided into equal

fields)

(c)

Small curved scissors

(d)

Small forceps

(e) A knife for cutting specimens

(f)

Small numbered containers for storing the specimens separately

(g) A dropping pipette

(h) A glass of acetic acid and a glass of potassium hydroxide solution for brightening any calcifications and

softening dried meat.

2.

Collecting of specimens

In the case of whole carcases, several hazelnut-size samples are taken from each animal:

(a)

(b)

(c)

(d)

in domestic swine, such samples are taken from both diaphragm pillars at the transition of the sinewy
part;

in wild boar samples are taken from both diaphragm pillars at the transition of the sinewy part and in
addition from the jaw, the muscles of the lower leg, the intercostal muscles and the tongue muscles, giving
a total of six samples from each individual animal;

if certain muscles are not available for sampling, a total of four samples are taken from the muscles that
are available;

in pieces of meat, four hazelnut-size samples of striated muscle tissue containing if possible no fat, taken
from different points, are taken from each piece, where possible close to bones or tendons.

3.

Procedure

(a)

(b)

(c)

In general a compressorium is filled with 1,0 ± 0,1 g of meat, normally corresponding with 28 oat-kernel-
size pieces. If necessary, two compressoria need to be filled to examine 56 oat-kernel-size pieces.

If both diaphragm pillars are present in a domestic swine, the Trichinella inspector cuts 28 oat-kernel-size
pieces from each of the above specimens taken from a whole carcase, making 56 pieces in all.

If only one diaphragm pillar is present, 56 pieces are cut in different places, if possible from the transition
to the sinewy part.

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(d)

(e)

(f)

(g)

(h)

(i)

The samples collected from the other four muscles of wild boar are each cut into seven oat-kernel-size
pieces, giving a total of 28 additional pieces.

The Trichinella inspector then compresses the 56 (or 84) pieces between the glass plates so that normal
print can be clearly read through the slide preparation.

If the flesh of the specimens to be examined is dry and old, the preparations must be softened for 10 to 20
minutes before pressing with a mixture of one part of potassium hydroxide solution to about two parts of
water.

From each of the samples taken from pieces of meat, the Trichinella inspector cuts 14 oat-kernel-size
pieces, making 56 pieces in all.

The microscopic examination must be carried out by scanning each preparation slowly and carefully at a
magnification of 30 to 40 times.

If the trichinoscopic examination reveals suspect areas, they must be examined at the trichinoscope's most
powerful magnification (80 to 100 times).

(j) Where the result is uncertain, the examination is repeated on other specimens and slide preparations until
the information required is obtained. The trichinoscopic examination must be carried out for at least six
minutes.

(k)

(l)

The minimum time fixed for the examination does not include the time necessary for taking samples and
making the preparations.

As a general rule,
corresponding with examinations of 15 domestic swine or 10 wild boar.

the trichinoscopic examiner must not

inspect more than 840 pieces a day,

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ANNEX II

Freezing treatments

A.

Freezing method 1

(a) Meat brought in already frozen is to be kept in this condition.

(b)

(c)

The technical equipment and energy supply of the refrigeration room must be such as to ensure that the
required temperature is reached very rapidly and maintained in all parts of the room and of the meat.

Insulated packaging must be removed before freezing, except in the case of meat that is already at the
required temperature throughout when it is brought into the refrigeration room or meat so packaged that
the packaging will not prevent it from reaching the required temperature within the specified time.

(d)

Consignments in the refrigeration room must be kept separately and under lock and key.

(e)

The date and time when each consignment is brought into the refrigeration room must be recorded.

(f)

The temperature in the refrigeration room must be at least –25 oC. It must be measured using calibrated
thermo-electric instruments and recorded continuously. It may not be measured directly in the cold air
flow. The instruments must be kept under lock and key. The temperature charts must include the relevant
data from the meat inspection register on import and the date and time of commencement and
completion of freezing, and must be retained for one year after compilation.

(g) Meat of a diameter or thickness of up to 25 cm must be frozen for at least 240 consecutive hours, and
meat of a diameter or thickness of between 25 and 50 cm must be frozen for at least 480 consecutive
hours. This freezing process must not be applied to meat that is thicker or of a larger diameter. The
freezing time is calculated from the point when the temperature in the freezing room reaches that
specified in (f).

B.

Freezing method 2

The general provisions of (a) to (e) of method 1 are complied with, and the following time-temperature
combinations applied:

(a) meat of a diameter or thickness of up to 15 cm must be frozen for one of the following time-temperature

combinations:

— 20 days at –15 oC,

— 10 days at –23 oC,

— 6 days at –29 oC;

(b) meat of a diameter or thickness of between 15 cm and 50 cm must be frozen for one of the following

time-temperature combinations:

— 30 days at –15 oC,

— 20 days at –25 oC,

— 12 days at –29 oC.

The temperature in the refrigeration room must be no higher than the level of the selected inactivation
temperature. It must be measured using calibrated thermoelectric instruments and recorded continuously.
It must not be measured directly in the cold air flow. The instruments must be kept under lock and key.

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The temperature charts must include the relevant data from the meat inspection register on importation
and the date and time of commencement and completion of freezing, and must be retained for one year
after compilation.

Where freezing tunnels are used and the above procedures are not followed strictly, the food business
operator must be able to prove to the competent authority that the alternative method is effective in
killing Trichinella parasites in pigmeat.

C.

Freezing method 3

Treatment consists of commercial
combinations with temperature monitored at the centre of each cut.

freeze-drying or

freezing of meat

for

specified time-temperature

(a)

The general provisions of (a) to (e) of Method 1 are to be complied with for the following time-
temperature combinations:

— 106 hours at –18 oC,

— 82 hours at –21 oC,

— 63 hours at –23,5 oC,

— 48 hours at –26 oC,

— 35 hours at –29 oC,

— 22 hours at –32 oC,

— 8 hours at –35 oC,

— 1/2 hour at –37 oC.

(b)

The temperature is
to be measured using calibrated thermoelectric instruments and recorded
continuously. The thermometer probe is inserted in the centre of a cut of meat no smaller in size than
the thickest piece of meat to be frozen. This cut must be placed at the least favourable position in the
refrigeration room, not close to the cooling equipment or directly in the cold air flow. The instruments
must be kept under lock and key. The temperature charts must include the data numbers from the meat
inspection register on import and the date and time of commencement and completion of freezing, and
must be retained for one year after compilation.

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ANNEX III

Examination of animals other than swine

Horse meat, wild game meat and other meat that could contain Trichinella parasites must be examined in accordance
with one of the digestion methods specified in Chapter I or II of Annex I, with the following changes:

(a)

(b)

(c)

specimens weighing at least 10 g are taken from the lingual or jaw muscle of horses and from the foreleg,
tongue or diaphragm of wild boar;

in the case of horse, where those muscles are lacking, a larger-sized specimen is to be taken from a pillar of the
diaphragm at the transition to the sinewy part. The muscle must be clean of connective tissue and fat;

at least 5 g of sample is digested following the reference method of detection in Chapter I of Annex I or an
equivalent method in Chapter II. For each digest, the total weight of muscle examined must not exceed 100 g in
the case of the method in Chapter I and methods A and B in Chapter II and 35 g in the case of method C in
Chapter II;

(d) where the result is positive, a further 50 g specimen is taken for a subsequent independent examination;

(e) without prejudice to the rules on conservation of animal species, all meat of game animals other than wild boar,
such as bears, carnivorous mammals (including marine mammals) and reptiles, are to be tested by sampling 10
g of muscle at the predilection sites or larger amounts if those sites are not available. Predilection sites are:

(i)

in bear: diaphragm, masseter muscle and tongue;

(ii)

in walrus: tongue;

(iii)

in crocodiles: masseter, pterygoid and intercostal muscles;

(iv)

in birds: muscles of the head (e.g. masseter and neck muscles).

(f)

The digestion time must suffice to ensure adequate digestion of the tissue of these animals but must not exceed
60 minutes.

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ANNEX IV

Detailed conditions for Trichinella-free holdings and regions with a negligible Trichinella risk

For the purpose of this Annex,

‘controlled housing conditions in integrated production systems’ means a type of animal husbandry where swine are
kept at all times under conditions controlled by the food business operator with regard to feeding and housing.

CHAPTER I

OBLIGATIONS ON FOOD BUSINESS OPERATORS

A.

The following requirements must be met by food business operators to obtain official recognition of holdings as
free from Trichinella:

(a)

(b)

(c)

(d)

(e)

(f)

the operator must have taken all practical precautions with regard to building construction and
maintenance in order to prevent rodents, any other kind of mammals and large carnivorous birds from
having access to buildings where animals are kept;

the operator must apply a pest-control programme,
in particular for rodents, effectively to prevent
infestation of pigs. The operator must keep records of the programme to the satisfaction of the competent
authority;

the operator must ensure that all feed has been obtained from a facility that produces feed in accordance
with the principles described in Regulation (EC) No 183/2005 of the European Parliament of 12 January
2005 and of the Council laying down requirements for feed hygiene (1);

the operator must store feed intended for Trichinella susceptible species in closed silos or other containers
that are impenetrable to rodents. All other feed supplies must be heat-treated or produced and stored to
the satisfaction of the competent authority;

the operator must ensure that dead animals are collected for disposal by sanitary means within 24 hours
of death. However, dead piglets may be collected and stored on the holding in a properly closed container
pending disposal;

if a rubbish dump is located in the neighbourhood of the holding, the operator must inform the
competent authority. Subsequently, the competent authority must assess the risks involved and decide
whether the holding is to be recognised as free from Trichinella;

(g)

the operator must ensure that piglets coming onto the holding from outside and pigs purchased are born
and bred under controlled housing conditions in integrated production systems;

(h)

the operator must ensure that pigs are identified so each animal can be traced back to the holding;

(1)

OJ L 35, 8.2.2005, p. 1.

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(i)

the operator may introduce new animals, onto the holding only if they:

(i)

come from in holdings officially recognised as free from Trichinella; or

(ii)

(iii)

are accompanied by a certificate authenticated by the competent authority in the exporting country
stating that the animal comes from a holding recognised as free from Trichinella; or

are kept in isolation until the results of a serological test approved by the Community reference
laboratory prove to be negative. Serological sampling must commence only after the animals have
been on the holding for four weeks;

(j)

(k)

the operator shall ensure that no pigs intended for slaughter have had outdoor access during the entire
production period;

outdoor access during the first few weeks of life before weaning shall be permitted if all the following
conditions are met:

(i)

(ii)

no Trichinella infestations have been diagnosed in domestic animals in the country in the past 10
years;

an annual surveillance programme exists for wildlife susceptible to Trichinella. The programme shall
be risk-based and shall be conducted in an area epidemiologically related to the geographical
location of the Trichinella-free farms. The programme shall test the relevant indicator species on the
basis of previous findings. The results shall show a prevalence of Trichinella in indicator animals
below 0,5 %;

(iii) when outdoors, the animals shall be in properly fenced areas;

(iv)

(v)

the monitoring program referred to in Article 11 shall be in place and monitoring shall be more
frequent on the holdings involved;

all sows and boars kept for breeding purposes on the holding shall be systematically sampled at
slaughter for examination using the reference method of detection described in Chapter I of Annex I
or one of the equivalent methods described in Chapter II of Annex I, and

(vi)

steps shall be taken to prevent access by large carnivorous and omnivorous birds (e.g. crows, birds of
prey).

B.

Food business operators of holdings recognised as free from Trichinella shall inform the competent authority
where any of the requirements in point A is no longer fulfilled or where any other change has occurred that
might affect the Trichinella-free status of the holding.

CHAPTER II

OBLIGATIONS ON THE COMPETENT AUTHORITIES

A.

The competent authorities in Member States where Trichinella has been detected in domestic swine in the last 10
years may recognise a holding as free from Trichinella provided that:

(a)

(b)

at least two control visits are made in the 12 months preceding recognition of the holding to verify
compliance with the requirements of Chapter I(A) of Annex IV; and

all pigs sent for slaughter during the 24 months preceding recognition or a longer time period if the
competent authority decides it to be necessary have been tested to ensure to the satisfaction of the
competent authority that a sufficient number of animals from the holding have been tested using one of
the parasite detection methods described in Chapters I and II of Annex I; and

(c)

the results of the tests have been negative; and

(d)

a risk-based wildlife monitoring programme has been put in place in those areas where wildlife and
holdings applying for Trichinella-free status coexist;
the monitoring programme optimises parasite
detection by applying the most suitable indicator animal and detection technique, by sampling as wide a
number of animals and taking as large a meat sample as is feasible; parasites detected in wildlife are
identified at species level in a Community or national reference laboratory; the Community reference
laboratory can assist by preparing a standardised protocol for a wildlife monitoring programme. Historical

L 338/82

EN

Official Journal of the European Union

22.12.2005

data may be used for the fulfilment of the requirements listed in this part.

B.

The competent authorities in Member States where Trichinella has not been detected in domestic swine in the
last 10 years may recognise a holding as free from Trichinella provided that,

the requirement in part A(d) above has been fulfilled.

C.

The competent authority may decide to recognise a category of holdings as free from Trichinella where all of the
following conditions are met:

(a)

(b)

(c)

(d)

all the requirements set out in Chapter I(A) of Annex IV are met, with the exception of point (k), which
does not apply; and

no autochthonous Trichinella infestations in domestic animals have been detected in the country in the
past 10 years, during which time continuous testing has been conducted on slaughtered swine population
such as to provide at least 95 % confidence that where the prevalence of Trichinella exceeds 0,0001 %, any
infestations will be detected; and

a clear description must be available of the category of holdings, the type of farming and the type of
animals involved; and

a risk-based monitoring programme for wildlife has been established in accordance with Chapter II(A)(d)
of Annex IV.

D.

In addition to the requirements laid out in Annex IV to Directive 2003/99/EC, the initial report and the
subsequent annual reports to the Commission shall contain the following information:

(a)

(b)

the number of cases (imported and autochthonous) of Trichinella in humans, including epidemiological
data;

the results of testing for Trichinella in domestic swine not raised under controlled housing conditions in
integrated production systems; the results must include the age and sex of affected animals, the type of
management system, the type of diagnostic method used, the degree of infestation (if known), and any
relevant additional information;

(c)

the results of testing for Trichinella in breeding sows and boars; the results must include the information
mentioned under (b);

(d)

the results of testing for Trichinella in carcases of wild boar, horses, game and any indicator animals;

(e)

(f)

(g)

(h)

(i)

the results of serological tests as referred to in Article 11 once a suitable test has been validated by the
Community reference laboratory;

other cases where Trichinella is suspected, either imported or autochthonous, and all relevant laboratory
results;

details of all positive results and the Trichinella species verification by the Community or national reference
laboratory;

the data are to be submitted in the format and according to the timetable determined by EFSA for the
reporting of zoonoses.

for reports concerning Trichinella-free holdings or category of holdings: information on the number of
including
Trichinella-free holdings and summary results of
information on farmer compliance;

inspections of Trichinella-free holdings,

(j)

for reports concerning a region with negligible risk, information is to be submitted on:

(i)

the monitoring programme implemented according to Article 11, or equivalent information;

(ii)

the risk-based wildlife monitoring programmes implemented according to part A(d) above, or
equivalent information.