COMMISSION REGULATION (EU) No 216/2014  
of 7 March 2014  
amending Regulation (EC) No 2075/2005 laying down specific rules on official controls for  
Trichinella  in meat  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Regulation (EC) No 854/2004 of the European 
Parliament and of the Council of 29 April 2004 laying down 
specific rules for the organisation of official controls on 
products of animal origin intended for human consumption (  1 ), 
and in particular points 6, 8, 10 and 12 of Article 18 thereof,  
Whereas:  
(1) Commission Regulation (EC) No 2075/2005 of 
5 December 2005 laying down specific rules on official 
controls for  Trichinella  in meat (  2 ) lays down rules for the 
sampling of carcases of species susceptible to  Trichinella  
infection, for the determination of the status holdings 
and regions and conditions for import of meat into the 
Union. It also provides for reference methods and 
equivalent methods of detection of  Trichinella  in 
samples of carcases.  
(2) The European Food Safety Authority (EFSA) adopted on 
3 October 2011 a Scientific Opinion on the public 
health hazards to be covered by inspection of meat 
(swine) (  3 ). In that opinion EFSA identified  Trichinella  as 
a medium risk for public health related to the 
consumption of pig meat and concludes that with 
respect to inspection methods for biological hazards, a 
pork carcass safety assurance, with a range of preventive 
measures and controls applied both on-farm and at 
slaughterhouse in an integrated way is the only way to 
ensure an effective control of the main hazards.  
(3) EFSA identified certain epidemiological indicators in 
relation to  Trichinella . Depending on the purpose and 
the epidemiological situation of the country the indi ­
cators may be applied at national, regional, slaught ­
erhouse or holding level.  
(4) EFSA recognises the sporadic presence of  Trichinella  in 
the Union, mainly in free-ranging and backyard pigs. 
EFSA also identified that the type of production system 
is the single main risk factor for  Trichinella  infections. In 
addition, available data demonstrate that the risk of  
Trichinella  infection in pigs from officially recognised 
controlled housing conditions is negligible.  (5) A negligible risk status for a country or region is no 
longer recognised in an international context by the 
World Animal Health Organisation (OIE). Instead, such 
recognition is linked to compartments of one or more 
holdings applying specific controlled housing conditions.  
(6) For reasons of consistency with international standards, 
and in order to enhance a control system in accordance 
with the actual public health risks, the  Trichinella  risk 
mitigation measures, including import conditions, at 
slaughterhouses and the conditions for determination of 
the Trichinella  infection status of countries, regions or 
holdings should be adapted, rationalised and simplified.  
(7) Belgium and Denmark notified in 2011 a  Trichinella  
negligible risk for their territory in accordance with Regu ­
lation (EC) No 2075/2005. Such negligible risk status for 
a country or region is however no longer recognised. 
Nevertheless, holdings and compartments in Belgium 
and Denmark which comply with the conditions for 
controlled housing at the date of entry into force of 
this Regulation should be allowed to apply the dero ­
gation for such holdings and compartments without 
additional prerequisites such as further requirements of 
post-official recognition by the competent authority.  
(8) The EU Reference Laboratory for parasites has recom ­
mended clarifying the text of the Regulation in relation 
to the procedure of certain equivalent methods for  
Trichinella  testing.  
(9) It should be provided that the operators must ensure that 
dead animals are collected, identified and transported 
without undue delay in accordance with Articles 21 
and 22 of Regulation (EC) No 1069/2009 of the 
European Parliament and of the Council of 21 October 
2009 laying down health rules as regards animal by- 
products and derived products not intended for human 
consumption and repealing Regulation (EC) No 
1774/2002 (Animal by-products Regulation) (  4 ) and 
with Annex VIII to Commission Regulation (EU) No 
142/2011 of 25 February 2011 implementing Regu ­
lation (EC) No 1069/2009 of the European Parliament 
and of the Council laying down health rules as regards 
animal by-products and derived products not intended 
for human consumption and implementing Council 
Directive 97/78/EC as regards certain samples and 
items exempt from veterinary checks at the border 
under that Directive (  5 ).EN 8.3.2014 Official Journal of the European Union L 69/85  
( 1 ) OJ L 139, 30.4.2004, p. 206.  
( 2 ) OJ L 338, 22.12.2005, p. 60.  
( 3 ) EFSA Journal 2011; 9(10):2351[198 pp.], published 3 October 
2011.  ( 4 ) OJ L 300, 14.11.2009, p. 1.  
( 5 ) OJ L 54, 26.2.2011, p. 1.(10) The number of cases (imported and autochthonous) of  
Trichinella  in humans, including epidemiological data 
should be reported in accordance with Commission 
Decision 2000/96/EC of 22 December 1999 on the 
communicable diseases to be progressively covered by 
the Community network under Decision No 2119/98/EC 
of the European Parliament and of the Council (  1 ). 
(11) Regulation (EC) No 2075/2005 should therefore be 
amended accordingly.  
(12) The requirements provided for in this Regulation involve 
an adaptation of current practices both for food business 
operators and competent authorities. It is therefore 
appropriate to allow a delayed application of some of 
the provisions of this Regulation.  
(13) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health and 
neither the European Parliament nor the Council has 
opposed them,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation (EC) No 2075/2005 is amended as follows:  
(1) Article 1 is replaced by the following:  
‘Article 1  
Definitions  
For the purposes of this Regulation, the following defi ­
nitions shall apply:  
(1) “ Trichinella ” means any nematode belonging to the 
species of the genus  Trichinella ; 
(2) “controlled housing conditions” 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;  
(3) “compartment” means a group of holdings which apply 
controlled housing conditions. All holdings applying 
controlled housing conditions in a Member States, 
may be considered as one compartment.’;  
(2) Articles 2 and 3 are replaced by the following:  
‘Article 2  
Sampling of carcases  
1. Carcases of domestic swine shall be sampled in 
slaughterhouses as part of the post-mortem examination 
as follows:  
(a) all carcases of breeding sows and boars or at least 10 % 
of carcases of animals sent in for slaughter each year 
from each holding being officially recognised as 
applying controlled housing conditions, shall be 
examined for  Trichinella ; (b) all carcases from holdings not being officially recognised 
as applying controlled housing conditions shall be 
systematically examined for  Trichinella . 
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) the reference method of detection set out in Chapter I 
of Annex I; or  
(b) 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, 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).  
By way of derogation from the first subparagraph 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:  
(a) the procedure is under supervision by the competent 
authority;  
(b) a carcase or the parts thereof have not more than one 
cutting plant as its destination;  
(c) the cutting plant is situated within the territory of the 
Member State; and  
(d) in case of a positive result all the parts are declared unfit 
for human consumption.  
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 examin ­
ation.  
A sample shall be collected from each carcase and the 
sample shall be examined in accordance with Annexes I 
and III in a laboratory designated by the competent auth ­
ority.  
Article 3  
Derogations  
1. By way of derogation from Article 2(1), meat of 
domestic swine that has undergone a freezing treatment 
in accordance with Annex II under the supervision of the 
competent authority shall be exempt from  Trichinella  exam ­
ination.  
2. By way of derogation from Article 2(1), carcases and 
meat of not weaned domestic swine less than five weeks of 
age shall be exempt from  Trichinella  examination.EN L 69/86 Official Journal of the European Union 8.3.2014  
( 1 ) OJ L 28, 3.2.2000, p. 50.3. By way of derogation from Article 2(1), carcases and 
meat of domestic swine may be exempt from  Trichinella  
examination where the animals come from a holding or a 
compartment officially recognised as applying controlled 
housing conditions in accordance with Annex IV, if:  
(a) no autochthonous  Trichinella  infestations in domestic 
swine kept in holdings officially recognised as 
applying controlled housing conditions have been 
detected in the Member State in the past three years, 
during which time continuous testing has been 
conducted in accordance with Article 2; or  
(b) historical data on continuous testing carried out on 
slaughtered swine population provide at least 95 % 
confidence that the prevalence of  Trichinella  does not 
exceed 1 per million in that population; or  
(c) the holdings applying controlled housing conditions are 
located in Belgium or Denmark.  
4. Where a Member State implements the derogation 
provided for in paragraph 3, the Member State concerned 
shall inform the Commission and the other Member States 
at the Standing Committee of the Food Chain and Animal 
Health and submit an annual report to the Commission 
containing the information referred to in Chapter II of 
Annex IV. The Commission shall publish on its website 
the list of Member States implementing the derogation.  
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.’;  
(3) Articles 8 to 12 are replaced by the following:  
‘Article 8  
Official recognition of holdings applying controlled 
housing conditions  
1. For the purpose of this Regulation, the competent 
authority may officially recognise a holding or a 
compartment applying controlled housing conditions 
where the requirements laid down in Annex IV are 
complied with.  
2. Holdings or a compartment applying controlled 
housing conditions in Denmark or Belgium in accordance 
with Article 3, paragraph 3(c) at the date of application of 
this Regulation are considered to be officially recognised 
applying controlled housing conditions as listed in Annex 
IV to this Regulation.  
Article 9  
Obligation on food business operators to inform  
Food business operators of holdings officially recognised as 
applying controlled housing conditions shall inform the competent authority of any requirement as laid down in 
Annex IV that is no longer fulfilled or of any other 
change that might affect holdings’  Trichinella  status.  
Article 10  
Audits of holdings officially recognised as applying 
controlled housing conditions  
The competent authority shall ensure that audits are carried 
out periodically of holdings officially recognised as applying 
controlled housing conditions.  
The frequency of audits shall be risk-based, taking account 
of disease history and prevalence, previous findings, the 
geographical area, local susceptible wildlife, animal 
husbandry practices, veterinary supervision and farmers’ 
compliance.  
The competent authority shall verify that domestic swine 
coming from those holdings are examined in accordance 
with Article 2(1).  
Article 11  
Monitoring programmes  
The competent authority may implement a monitoring 
programme covering the population of domestic swine 
coming from a holding or a compartment officially 
recognised as applying controlled housing conditions, in 
order to verify that  Trichinella  is effectively absent in that 
population.  
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 monitoring programme may include serological 
methods as an additional tool once a suitable test is 
validated by the EU reference laboratory.  
Article 12  
Withdrawal of official recognition of holdings as 
applying controlled housing conditions  
1. Where the results of the audits carried out in 
accordance with Article 10 show that the requirements of 
Annex IV are no longer fulfilled, the competent authority 
shall withdraw the holdings official recognition without 
delay.  
2. Where domestic swine from a holding officially 
recognised as applying controlled housing conditions test 
positive to  Trichinella , the competent authority shall 
without delay:EN 8.3.2014 Official Journal of the European Union L 69/87(a) withdraw the holding’s official recognition;  
(b) examine all domestic swine of that holding at the time 
of slaughter;  
(c) 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 laid down in Chapters I and II of 
Annex I;  
(d) when relevant, as far as is feasible, investigate the spread 
of parasite 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) When relevant, initiate an epidemiological investigation 
to elucidate the cause of infestation;  
(g) take appropriate measures where any infested carcase 
cannot be identified at the slaughterhouse, including:  
(i) increasing the size of each meat sample collected 
for testing of the suspect carcases; or  
(ii) declaring the carcases unfit for human 
consumption;  
(iii) taking appropriate measures for the disposal of 
suspect carcases or parts thereof and those testing 
positive.  
3. Following withdrawal of recognition, holdings may be 
officially recognised again once the problems identified have 
been solved and the requirements laid down in Annex IV 
are fulfilled to the satisfaction of the competent authority.  
4. If the inspection identified a lack of compliance with 
Article 9 or positive testing in a holding of a compartment, 
the holding concerned should be removed from the 
compartment until compliance is re-established.’;  (4) Article 13 is replaced by the following:  
‘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 Union if exam ­
ination for  Trichinella  has been performed in accordance 
with Articles 2 and 3 in that third country before export.’;  
(5) Article 14 is deleted;  
(6) Article 15 is replaced by the following:  
‘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 the 
examination for  Trichinella  in the third country of origin has 
been performed in accordance with Article 13.  
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.’;  
(7) Annex I is amended in accordance with Annex I to this 
Regulation;  
(8) Annex IV is replaced by the text in Annex II to this Regu ­
lation.  
Article 2  
This Regulation shall enter into force on the twentieth day 
following that of its publication in the  Official Journal of the 
European Union . 
It shall apply from 1 June 2014.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels, 7 March 2014.  
For the Commission  
The President  
José Manuel BARROSOEN L 69/88 Official Journal of the European Union 8.3.2014ANNEX I  
Annex I to Regulation (EC) No 2075/2005 is amended as follows:  
(1) in Chapter I, point 3. Procedure, the following paragraph is added:  
‘IV. Cleaning and decontamination procedure after a positive or doubtful result  
When the examination of a collective or individual sample produces a positive or doubtful latex agglutination 
result, all material in contact with meat (blender bowl, beaker, stirring rod, temperature sensor, conical filtration 
funnel, sieve and forceps) must be carefully decontaminated by soaking for few seconds in warm water (65 to 
90 °C). Meat residues or inactivated larvae that could remain on their surface may be removed with a clean 
sponge and tap water. If required, a few drops of detergent can be added for degreasing equipment. It is then 
recommended to rinse each piece thoroughly to remove all traces of detergent.’;  
(2) Part D, of Chapter II, point 3 is replaced by the following:  
‘3. Procedure  
I. For complete pools (100 g of samples at a time)  
(a) 16 ± 0,5 ml of 25 % hydrochloric acid (0,2 % final) is added to a 3 litre beaker containing 2,0 litres 
± 200 ml of tap water, preheated to 46 to 48 °C; a stirring rod is placed in the beaker, the beaker is 
placed on the preheated plate and the stirring is started.  
(b) 10 ± 1 g of powder pepsin (or 30 ± 3 ml of liquid pepsin) is added.  
(c) 100-115 g of samples collected in accordance with point 2 are chopped in the blender, with 
150 ± 15 ml of preheated digestion buffer.  
(d) The chopped meat is transferred to the 3 litre beaker containing the water, pepsin and hydrochloric acid.  
(e) 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 °C 
throughout the operation. During stirring, the digestion fluid must rotate at a sufficiently high speed 
to create a deep whirl without splashing.  
(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 20 microns nylon mesh filter is placed on the filtration support. The conical filtration steel funnel is 
fixed to the support with the block system and the steel sieve of 180 microns mesh size is placed on the 
funnel. The vacuum pump is connected with the filtration support and with the metal or plastic tank, to 
collect the digestive fluid.  
(k) Stirring is stopped and the digestion fluid is poured into the filtration funnel through the sieve. The 
beaker is rinsed with approximately 250 ml of warm water. The rinsing liquid is poured into the 
filtration ramp after the digested fluid has been successfully filtrated.  
(l) The filtration membrane is taken with the forceps, holding it by an edge. The filtration membrane is 
folded (minimal) in four and put in the 15 ml conical tube. The choice of conical tube must be adapted 
to the pestle.EN 8.3.2014 Official Journal of the European Union L 69/89(m) The filtration membrane is pushed at the bottom of the 15 ml conical tube with the help of the pestle 
and strongly pressed by doing approximately 20 successive back and forth movements with the pestle 
which should be positioned inside the filtration membrane folding according to the manufacturer’s 
instructions.  
(n) 0,5 ± 0,01 ml of sample diluents is added into the 15 ml conical tube by pipette and the filtration 
membrane is homogenised with the pestle by doing successive low amplitude back and forth 
movements for approximately 30 seconds, avoiding abrupt movements to limit liquid splashes 
according to the manufacturer’s instructions.  
(o) Each sample, the negative control, and the positive control, are dispensed into different fields of the 
agglutination card by pipettes, according to the manufacturer’s instructions.  
(p) The latex beads are added into each field of the agglutination card by a pipette, according to the 
manufacturer’s instructions, without making them come into contact with the sample/s and controls. 
In each field, the latex beads are then gently mixed with a disposable stick until the homogeneous liquid 
covers the entire field.  
(q) The agglutination card is put on the 3D rocker and is rocked for 10 ± 1 minutes according to the 
manufacturer’s instructions.  
(r) After the time established by the manufacturer’s instructions, the rocking is stopped and the agglutination 
card is put on a plane surface and the reaction results are read immediately, according to the manu ­
facturer’s instructions. In the case of a positive sample, the beads aggregates must appear. In the case of a 
negative sample, the suspension remains homogeneous without beads aggregates.  
II. Pools of less than 100 g as set out in Chapter I(3)(II)  
For pools of less than 100 g, the procedure set out in Chapter I(3)(II) must be followed.  
III. Positive or doubtful results  
Where examination of a collective sample produces a positive or uncertain latex agglutination result, a further 
20 g sample is taken from each swine in accordance with Chapter I(2)(a). The 20 g samples from five swine 
are pooled and examined using the method described in Section I. In this way samples from 20 groups of five 
swine must be examined.  
When a positive latex agglutination is obtained from a group of five swine, further 20 g samples are collected 
from the individuals in the group and each is examined separately using the method described in Section I.  
When a positive or uncertain latex agglutination result is obtained, at least 20 g of swine muscle must be sent 
to the national reference laboratory for confirmation using one of the methods described in Chapter I.  
Parasite samples must be kept in 90 % ethyl alcohol for conservation and identification at species level at the 
EU or national reference laboratory.  
After parasite collection, positive fluids must be decontaminated by heating to at least 60 °C.  
IV. Cleaning and decontamination procedure after a positive or doubtful result.  
When the examination of a collective or individual sample produces a positive or doubtful latex agglutination 
result, all material in contact with meat (blender bowl, beaker, stirring rod, temperature sensor, conical 
filtration funnel, sieve and forceps) must be carefully decontaminated by soaking for few seconds in warm 
water (65 to 90 °C). Meat residues or inactivated larvae that could remain on their surface may be removed 
with a clean sponge and tap water. If required, a few drops of detergent can be added for degreasing 
equipment. It is then recommended to rinse each piece thoroughly to remove all traces of detergent.’EN L 69/90 Official Journal of the European Union 8.3.2014ANNEX II  
‘ANNEX IV  
CHAPTER I  
OFFICIAL RECOGNITION OF A HOLDINGS OR A COMPARTMENT AS APPLYING CONTROLLED HOUSING 
CONDITIONS  
A. The following requirements must be met by food business operators to obtain official recognition of holdings:  
(a) 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 carnivorous birds from having access to buildings where 
animals are kept;  
(b) 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;  
(c) 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 and of the Council (*);  
(d) 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;  
(e) the operator must ensure that dead animals are collected, identified and transported without undue delay in 
accordance with Articles 21 and 22 of Regulation (EC) No 1069/2009 of the European Parliament and of the 
Council (**) and with Annex VIII to Commission Regulation (EU) No 142/2011 (***);  
(f) 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 applying controlled housing conditions;  
(g) the operator must ensure that piglets coming onto the holding from outside and pigs purchased are born and bred 
under controlled housing conditions;  
(h) the operator must ensure that pigs are identified so each animal can be traced back to the holding;  
(i) the operator may introduce new animals onto the holding only if they come from holdings also officially 
recognised as applying controlled housing conditions;  
(j) none of the animals has access to outdoor facilities unless the food business operator can show by a risk analysis 
to the satisfaction of the competent authority that the time period, facilities and circumstances of outdoor access 
do not pose a danger for introduction of  Trichinella  in the holding.  
B. Food business operators of holdings officially recognised as applying controlled housing conditions shall inform the 
competent authority where any of the requirements laid down in point A is no longer fulfilled or where any other 
change has occurred that might affect the status of the holding.  
C. The competent authorities in Member States may only recognise a holding or a category of holdings provided that 
they have verified that the requirements laid down in point A are met.EN 8.3.2014 Official Journal of the European Union L 69/91CHAPTER II  
REPORTING ON  TRICHINELLA  SITUATION  
(a) The number of cases (imported and autochthonous) of  Trichinella  in humans, including epidemiological data shall be 
reported in accordance with Commission Decision 2000/96/EC (****).  
(b) The number of tests and the results of testing for  Trichinella  in domestic swine, wild boar, horses, game and any other 
susceptible animals shall be submitted in accordance with Annex IV to Directive 2003/99/EC. Data on domestic 
swine shall, at least, provide specific information related to:  
(i) tests on animals raised under controlled housing conditions;  
(ii) tests on breeding sows, boars and fattening pigs.  
___________  
(*) OJ L 35, 8.2.2005, p. 1.  
(**) OJ L 300, 14.11.2009, p. 1.  
(***) OJ L 54, 26.2.2011, p. 1.  
(****) OJ L 28, 3.2.2000, p. 50.’EN L 69/92 Official Journal of the European Union 8.3.2014