EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
SANCO/11157/2012 Rev. 1 
(POOL/G4/2012/11157/11157R1-EN.doc) […](2013) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EC) No  2075/2005 laying down specific rules on official controls 
for Trichinella  in meat  
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
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 conditio ns for import of meat into 
the Union. It also provides for reference me thods 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 resp ect 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 epidemiol ogical situation of the country the 
indicators may be applied at national, regional, slaughterhouse or holding level.  
(4) EFSA recognises the sp oradic presence of Trichinella  in the Union, mainly in free-
ranging and backyard pigs. EFSA also identifi ed that the type of production system is 
the single main risk factor for Trichinella  infections. In addi tion, available data 
demonstrate that the risk of Trichinella  infection in pigs from officially recognised 
controlled housing cond itions is negligible. 
(5) A negligible risk status for a country or region is no longe r recognised in an 
international context by the World Animal H ealth Organisation (OIE). Instead, such 
recognition is linked to compartments of one or more holdings applying specific 
controlled housing conditions.  
                                                 
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.  
EN 3   EN (6) For reasons of consistency with internati onal standards, and in order to enhance a 
control system in accordance with th e actual public health risks, the Trichinella  risk 
mitigation measures, including import c onditions, 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 Regulation (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 derogation for such holdings  and compartments without additional 
prerequisites such as further requirem ents of post-official recognition by the 
competent authority. 
(8) The EU Reference Laboratory for parasites ha s recommended to clarify the text of the 
Regulation in relation to the procedur e 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 de lay in accordance with Articles 21 and 22 
of Regulation (EC) No 1069/2009 of 21 Oc tober 2009 laying down health rules as 
regards animal by-products and derived produc ts not intended for human consumption 
and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation)
4 and 
with Annex VIII to Commission Regul ation (EU) No 142/2011 implementing 
Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying 
down health rules as regards animal by-pr oducts 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 Directive5. 
(10) The number of cases (impor ted 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 of the 
European Parliament and of the Council6. 
(11) Regulation (EC) No 2075/2005 should therefore be amended accordingly. 
(12) The requirements provided for in this Regul ation involve an adaptation of current 
practices both for food busine ss operators and competent aut horities. It is therefore 
appropriate to allow a delayed applicatio n of some of the provisions of this 
Regulation. 
(13) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Anim al Health and neither the European 
Parliament nor the Council has opposed them, 
                                                 
4 OJ L 300, 14.11.2009, p. 1. 
5 OJ L 54, 26.2.2011, p. 1. 
6 OJ L 28, 3.2.2000, p. 50.  
EN 4   EN 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, th e following definitions 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 c ontrolled by the food business operator 
with regard to feeding and housing. 
(3) 'compartment' means a group of hol dings which apply controlled housing 
conditions. All holdings appl ying controlled housing c onditions 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 sa mpled in slaughterhouses as part of the 
post-mortem examination as follows: 
(a) all carcases of breeding sows and bo ars or at least 10% of carcases of 
animals sent in for slaughter each year from each holding being officially recognised as applying controlled ho using 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 fo llowing methods of detection: 
(a) the reference method of detection se t 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 bus iness 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 supervis ion by the competent authority;  
EN 5   EN (b) a carcase or the parts thereof have not more than one cutting plant as its 
destination; 
(c) the cutting plant is situ ated 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 estab lishments as part of the post-mortem 
examination. 
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 authority. 
Article 3 
Derogations 
1. By way of derogation from Article 2( 1), meat of domestic swine that has 
undergone a freezing treatment in acco rdance with Annex II under the 
supervision of the competent authority shall be exempt from Trichinella  
examination. 
2. By way of derogation from Article 2( 1), carcases and meat of not weaned 
domestic swine less than 5 weeks of age shall be exempt from Trichinella  
examination. 
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 rec ognised 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 3 years, during which time continuous testing has been conduc ted in accordance with Article 2; 
or  
(b) historical data on continuous test ing carried out on slaughtered swine 
population provide at leas t 95 % confidence that the prevalence of 
Trichinella  does not exceed 1 per milli on in that population; or 
(c) the holdings applying controlled housing conditions are located in 
Belgium or Denmark. 
4. Where a Member State implements the de rogation provided for in paragraph 3, 
the Member State concerned shall inform the Commission and the other Member States at the Standing Comm ittee 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 lis t of Member States implementing the derogation. 
Where a Member State fails to submit that  annual report or th e annual report is 
unsatisfactory for the purposes of this Article, then the derogation shall cease 
to apply to that Member State."  
EN 6   EN (3) Articles 8 to 12 are replaced by the following: 
"Article 8 
Official recognition of holdings app lying controlled housing conditions  
1. For the purpose of this Regulation, th e competent authority may officially 
recognise a holding or a compartment ap plying controlled housing conditions 
where the requirements laid down in Annex IV are complied with. 
2. Holdings or a compartment applying controlled housing c onditions 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 of this 
Regulation. 
Article 9 
Obligation on food business operators to inform 
Food business operators of holdings official ly recognised as a pplying controlled 
housing conditions shall inform the competen t 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 recognise d 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-b ased, taking account of disease history and 
prevalence, previous findings, the geograp hical 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 implemen t a monitoring programme covering the 
population of domestic swine coming from a holding or a compartment officially 
recognised as applying controlled housi ng conditions, in order to verify that 
Trichinella  is effectively abse nt in that population. 
The frequency of testing, the number of an imals to be tested and the sampling plan 
shall be laid down in the monitoring program me. 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 sero logical methods as an additional tool 
once a suitable test is validated  by the EU refere nce 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 holding s official recognition without delay.  
EN 7   EN 2. Where domestic swine from a holding officially recognised as applying 
controlled housing conditions test positive to Trichinella , the competent 
authority shall without delay: 
(a) withdraw the holding's official recognition; (b) examine all domestic swine of th at holding at the time of slaughter; 
(c) trace and test all breeding animals th at arrived on the holding and, as far 
as possible, all those that left th e holding in at leas t 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 distributio n 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 epidemio logical investigation to elucidate the 
cause of infestation; 
(g) take appropriate measures wher e 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 th e disposal of suspect carcases or 
parts thereof and thos e 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 sa tisfaction of the competent authority. 
4. If the inspection identified a lack of compliance with Article 9 or positive 
testing in a holding of a compartmen t, 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 ma y only be imported into the Union if 
examination for Trichinella  has been performed in accordance with Articles 2 and 3 
in that third country before export." 
(5) Article 14 is deleted.  
EN 8   EN (6) Article 15 is replaced by the following: 
"Article 15 
Documents  
The health certificate accompa nying imports of meat as re ferred 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 or igin 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 Regulation. 
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,  
 For the Commission 
 The President  José Manuel BARROSO  
EN 9   EN ANNEX I  
Annex I is amended as follows: 
(1) In Chapter I, the following paragraph is added: 
"IV. Cleaning and decontamination proce dure 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 se nsor, conical filtration funnel, sieve 
and forceps) must be carefully decontaminated by soaking for few seconds in warm water (65°C to 90°C). Meat resi dues or inactivated larvae that could 
remain on their surface may be removed w ith 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 l iters +/- 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 15 0 ml +/-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 blende r is immersed repeatedly in the 
digestion fluid in the beaker and th e 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 mu st rotate at a sufficiently high 
speed to create a deep whirl without splashing. 
(h) The digestion fluid is stirred until the meat pa rticles disappear 
(approximately 30 minutes). The stir rer is then switched off and the 
digestion fluid is poured through th e 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 consider ed satisfactory if not more than 
5 % of the starting sample weight remains on the sieve.  
EN 10   EN (j) The 20 microns nylon mesh filter is placed on the filtration support. 
The conical filtration st eel 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 dige stion fluid is poured into the 
filtration funnel through the sieve. The beaker is rinsed with approximately 250 ml of warm wate r. 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 fo lded in four minimum and put it 
in the 15 ml conical tube. The c hoice of conical tube must be 
adapted to the pestle. 
(m) The filtration membrane is pushed at the bottom of the 15 ml 
conical tube with the help of th e pestle and strongly pressed by 
doing approximately 20 successive back and forth movements with the pestle which should be po sitioned inside the filtration 
membrane folding according to th e manufacturer's instructions. 
(n) '0.5 ml ± 0.01 ml of sample diluen ts is added into the 15 ml conical 
tube by pipette and the filtration membrane is homogenized with the pestle by doing successive lo w 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 e ach field of the agglutination card 
by a pipette, according to the manuf acturer'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 liqui d covers the entire field. 
(q) The agglutination card is put on the 3D rocker and is rocked for 
10 +/- 1 minutes according to th e manufacturer's instructions. 
(r) After the time established by the manufacturer's instructions, the 
rocking is stopped and the agglu tination card is put on a plane 
surface and the reaction results are read immediately, according to 
the manufacturer'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 proce dure set out in Chapter I(3)(II) 
must be followed.  
EN 11   EN 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 Chapte r 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 a gglutination result is obtained, at 
least 20g 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 pr ocedure after a positive or doubtful 
result. 
When the examination of a collectiv e or individual sample produces a 
positive or doubtful latex agglutination re sult, all material in contact with 
meat (blender bowl, beaker, stirri ng rod, temperature sensor, conical 
filtration funnel, sieve and forceps) mu st be carefully decontaminated by 
soaking for few seconds in warm wate r (65 ° to 90 °C). Meat residues or 
inactivated larvae that could rema in on their surface may be removed 
with a clean sponge and tap water. If required, a few dr ops of detergent 
can be added for degreasing equipment.  It is then recommended to rinse 
each piece thoroughly to remove all traces of detergent."  
EN 12   EN ANNEX II  
"ANNEX IV  
CHAPTER I:  
OFFICIAL RECOGNITION OF A HOLDING S OR A COMPARTMENT AS APPLYING 
CONTROLLED HOUSING CONDITIONS 
A. The following requirements must be met by f ood business operators to obtain official 
recognition of holdings: 
(a) the operator must have taken all practi cal 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 prin ciples described in Regulation (EC) 
No 183/2005 of the European Pa rliament and of the Council
i; 
(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 Eur opean Parliament and of the Council
ii 
and with Annex VIII to Commi ssion Regulation (EU) No 142/2011iii. 
(f) if a rubbish dump is located in th e neighbourhood of the holding, the operator 
must inform the competent authority. Subsequently, the co mpetent authority 
must assess the risks involved and d ecide whether the holding is to be 
recognised as applying cont rolled housing conditions; 
(g) the operator must ensure that piglet s 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 animal s, onto the holding only if they come 
from holdings also officially rec ognised as applying controlled housing 
conditions; 
(j) none of the animals has access to out door 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 offici ally recognised as applying controlled 
housing conditions shall inform the competent authority where any of the requirements laid down in point A is no l onger fulfilled or where any other change 
has occurred that might aff ect the status of the holding.  
EN 13   EN 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.  
CHAPTER II 
REPORTING ON TRICHINELLA  SITUATION 
(a) The number of cases (im ported 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
iv. Data on domestic swine shall, 
at least, provide specific information related to: 
(i) tests on animals raised unde r controlled housing conditions; 
(ii) tests on breeding sows, boars and fattening pigs. _________________ 
i OJ L 35, 8.2.2005, p. 1. 
ii OJ L 300, 14.11.2009, p. 1. 
iii OJ L 54, 26.2.2011, p. 1. iv OJ L 325, 12.12.2003, p. 31."