Commission Implementing Regulation (EU) 2015/1375 of 10 August 2015 laying down specific rules on official controls for Trichinella in meat (codification) (Text with EEA relevance)

CHAPTER I

GENERAL PROVISION

Article 1

Definitions

For the purposes of this Regulation, the 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 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.

CHAPTER II

OBLIGATIONS OF COMPETENT AUTHORITIES AND OF FOOD BUSINESS OPERATORS

Article 2

Sampling of carcasses

Carcasses of domestic swine shall be sampled in slaughterhouses as part of the post-mortem examination as follows:

(a) all carcasses of breeding sows and boars or at least 10 % of carcasses of animals sent in for slaughter each year from each holding that is officially recognised as applying controlled housing conditions, shall be examined for Trichinella;

(b) all carcasses from holdings that are not officially recognised as applying controlled housing conditions shall be systematically examined for Trichinella.

A sample shall be collected from each carcass 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.

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

Article 3

Derogations

By way of derogation from Article 2(1), carcasses 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 one per million in that population; or

(c) the holdings applying controlled housing conditions are located in Belgium or Denmark.

Where a Member State fails to submit, in accordance with Article 9(1), second subparagraph of Directive 2003/99/EC, the data on the Trichinella examination referred to in Chapter II of Annex IV to this Regulation, the derogation, provided for in paragraph 3 of this Article, shall cease to apply to that Member State.

By way of derogation from Article 2(3) and following approval by the competent authority:

(a) carcasses may be cut up at a cutting plant attached to or separate from the slaughterhouse provided that: (i) the procedure is approved by the competent authority; (ii) a carcass or the parts thereof have not more than one cutting plant as its destination; (iii) the cutting plant is situated within the territory of the Member State; and (iv) in the case of a positive result all the parts are declared unfit for human consumption;

(b) carcasses derived from domestic swine may be cut up into more parts in a cutting plant on the same premises or attached to the slaughterhouse provided that: (i) the procedure is approved by the competent authority; (ii) cutting or boning, prior to reaching the temperature referred to in point 2(b) of Chapter V of Section I of Annex III to Regulation (EC) No 853/2004, is applied in accordance with point 4 of Chapter V of Section I of Annex III to that Regulation; (iii) in the case of a positive result all the parts are declared unfit for human consumption.

Article 4

Trichinella examination and application of health mark

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.

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.

Article 5

Training

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

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

Article 6

Methods of detection

Article 7

Contingency plans

The competent authorities of the Member States shall provide for a contingency plan outlining all action to be taken where samples as referred to in Article 2 test positive for Trichinella. That plan shall include details covering:

(a) traceability of infested carcasses and parts thereof containing muscle tissue;

(b) measures for dealing with infested carcasses and parts thereof;

(c) investigation of the source of infestation and any spread among wildlife;

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

(e) measures to be taken where infested carcasses cannot be identified at the slaughterhouse;

(f) determination of the Trichinella species involved.

Article 8

Official recognition of holdings applying controlled housing conditions

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 the Trichinella status of those holdings.

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 the audits shall be risk-based, taking account of the disease history and the 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 actually 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 the 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

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 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 carcass cannot be identified at the slaughterhouse, including: (i) increasing the size of each meat sample collected for testing of the suspect carcasses; or (ii) declaring the carcasses unfit for human consumption; (iii) taking appropriate measures for the disposal of suspect carcasses or parts thereof and those testing positive.

CHAPTER III

IMPORTS

Article 13

Import health requirements

CHAPTER IV

REPEAL AND FINAL PROVISIONS

Article 15

Repeal

Regulation (EC) No 2075/2005 is repealed.

References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VI.

Article 16

Entry into force

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

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

ANNEX I

Detection methods

CHAPTER I

REFERENCE METHOD OF DETECTION

1.The reference method of detection for the examination of samples for Trichinella, shall be ISO 18743:2015/Amd1:2023.

2.The following rules shall apply only to the examination of meat of domestic swine:

(a) In the case of whole carcasses of domestic swine other than breeding sows and boars, a specimen weighing at least 1 g shall be taken from a pillar of the diaphragm at the transition to the sinewy part. Special trichinae forceps may be used provided that an accuracy of between 1,00 and 1,15 g can be guaranteed. In the case of whole carcasses of breeding sows and boars, a larger sample weighing at least 2 g shall be taken from a pillar of the diaphragm at the transition to the sinewy part. In the absence of diaphragm pillars, a specimen of 2 g shall be taken from the rib part or the breastbone part of the diaphragm, or from the jaw muscle, tongue or abdominal muscles of domestic swine other than breeding sows and boars, and a specimen of 4 g shall be taken from the same tissues of breeding sows and boars.

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

CHAPTER II

EQUIVALENT METHODS

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

(j) 100 ml glass measuring cylinders.

(k) A thermometer accurate to 0,5 °C within the range 20 °C to 70 °C.

(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) Petri dishes of approximately 90 mm in diameter, gridded with squares of approximately 1 cm, or equivalent equipment for larval counting as in point 6.14 of the  ISO 18743:2015/Amd1:2023.

(p) 17,5 % hydrochloric acid.

(q) Pepsin with the following strength: — if powder or granular: 1:10 000 NF (US National Formulary) corresponding to 1:12 500 BP (British Pharmacopoeia) and to 2 000 FIP (Fédération internationale de pharmacie), or — if liquid: stabilised liquid pepsin with minimum 660 European Pharmacopoeia units/ml. Other pepsin activities can be used, provided the final activity in the digest fluid is equivalent to the activity of 10 g of 1:10 000 NF as stipulated in point 5.3 of the  ISO 18743:2015/Amd1:2023.

(r) 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) Calibrated scale, for weighing samples and/or pepsin (accuracy ± 0,1 g).

As stipulated in Chapter I and in point 4.2 of the ISO 18743:2015/Amd1:2023 (see also Annexes A and B thereto for further details).

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.

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 °C. (ii) One and a half litres of water preheated to 40 to 41 °C 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 °C) taken from each individual sample in accordance with point 2 are added. (v) Lastly, 6 g pepsin or 18 ml liquid 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 °C. (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 °C. 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 °C) taken from each individual sample in accordance with point 2. (iv) Water at a temperature of approximately 41 °C 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 °C), which is then used to rinse the sieve and lastly added to the filtrate in the beaker.

— 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 case of smaller pools (see Section 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 petri dish or equivalent equipment for larval counting, 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, 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 equivalent equipment for larval counting and examined using a trichinoscope or stereo-microscope.

— the measuring cylinder is washed with 10 ml of tap water and these washings are added to the sample in the petri dish or equivalent equipment for larval counting and examined using a trichinoscope or stereo-microscope.