Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies

• (a) information on the annual BSE monitoring system in place during the previous six-year period within the territory of the Member State, including detailed documentation proving compliance with the epidemiological criteria set out in point 7.2;

• (b) information on the bovine identification and traceability system, as referred to in point (b) of the third subparagraph of Article 6(1b), in place during the previous six-year period within the territory of the Member State, including a detailed description of the functioning of the computerised database as referred to in Article 5 of Regulation (EC) No 1760/2000 of the European Parliament and of the Council (²⁹);

• (c) information on prohibitions concerning animal feeding during the previous six-year period within the territory of the Member State, including a detailed description of the enforcement of the feed ban for farmed animals, as referred to in point (c) of the third subparagraph of Article 6(1b), including the sampling plan and the number and type of infringements found and the follow-up results;

• (d) a detailed description of the proposed revised BSE monitoring programme that includes the geographical area in which the programme is to be implemented and a description of subpopulations of bovine animals to be covered by the BSE revised monitoring programme, including indications of the age limits and the sample sizes for testing;

• (e) the result of a comprehensive risk analysis showing that the revised BSE monitoring programme will ensure the protection of human and animal health. This risk analysis shall include a birth cohort analysis or other relevant studies aiming to demonstrate that the TSE risk reducing measures, including the feeding prohibitions as referred to in point (c) of the third subparagraph of Article 6(1b), have been implemented in an efficient way.

7.2.   Epidemiological criteria

Applications for revision of a BSE monitoring programme may only be accepted if the Member State concerned can demonstrate that, in addition to the requirements laid down in points (a), (b) and (c) of the third subparagraph of Article 6(1b), the following epidemiological criteria are met within its territory:

• (a) for a period of at least six consecutive years following the date of implementation of the Community BSE testing scheme as referred to in point (b) of the third subparagraph of Article 6(1b): either
• (i) the average decrease of the annual BSE incidence rate observed within the adult bovine animal population (over 24 months of age) was superior to 20 %, and the total number of BSE affected cattle born after the implementation of the Community total feed ban for farmed animals, as referred to in point (c) of the third subparagraph of Article 6(1b), did not exceed 5 % of the total number of confirmed BSE cases; or
• (ii) the annual observed BSE incidence rate within the adult bovine animal population (over 24 months of age) remained consistently less than 1/100 000 ; or
• (iii) as a further option for a Member State with an adult bovine animal population (over 24 months of age) of less than 1 000 000 animals, the cumulated number of confirmed BSE cases remained under five;

• (b) following the six-year period referred to in point (a), there is no evidence that the BSE epidemiological situation is deteriorating.

II.   MONITORING IN OVINE AND CAPRINE ANIMALS

1. General

Monitoring in ovine and caprine animals shall be carried out in accordance with the laboratory methods laid down in Annex X, Chapter C, point 3.2(b).

2. Monitoring in ovine and caprine animals slaughtered for human consumption

• (a)Member States in which the population of ewes and ewe lambs put to the ram exceeds 750 000 animals shall test, in accordance with the sampling rules set out in point 4, a minimum annual sample of 10 000 ovine animals slaughtered for human consumption;

• (b)Member States in which the population of goats which have already kidded and goats mated exceeds 750 000 animals shall test, in accordance with the sampling rules set out in point 4, a minimum annual sample of 10 000 caprine animals slaughtered for human consumption;

• (c)A Member State may choose to replace a maximum of:

• — 50 % of its minimum sample size of ovine and caprine animals slaughtered for human consumption set out in points (a) and (b) by testing dead ovine or caprine animals over the age of 18 months at the ratio of one to one and in addition to the minimum sample size set out in point 3;

• — 10 % of its minimum sample size set out in points (a) and (b) by testing ovine or caprine animals killed in the framework of a disease eradication campaign over the age of 18 months at the ratio of one to one.

3. Monitoring in ovine and caprine animals not slaughtered for human consumption

Member States shall test, in accordance with the sampling rules set out in point 4 and the minimum sample sizes indicated in Table A and Table B, ovine and caprine animals which have died or been killed, but which were not:

• — killed in the framework of a disease eradication campaign, or

• — slaughtered for human consumption.

Table A

Member State population of ewes and ewe lambs put to the ram	Minimum sample size of dead ovine animals 5
> 750 000	10 000
100 000 -750 000	1 500
40 000 -100 000	100 % up to 500
< 40 000	100 % up to 100

Minimum sample sizes are set to take account of the size of the ovine populations in the individual Member States and are intended to provide achievable targets.

Table B

Member State population of goats which have already kidded and goats mated	Minimum sample size of dead caprine animals 6
> 750 000	10 000
250 000 -750 000	1 500
40 000 -250 000	100 % up to 500
< 40 000	100 % up to 100

Minimum sample sizes are set to take account of the size of the caprine population in the individual Member States and are intended to provide achievable targets.

4. Sampling rules applicable to the animals referred to in points 2 and 3

The animals shall be over 18 months of age or have more than two permanent incisors erupted through the gum.

The age of the animals shall be estimated on the basis of dentition, obvious signs of maturity, or any other reliable information.

The sample selection shall be designed with a view to avoid the over-representation of any group as regards the origin, age, breed, production type or any other characteristic.

The sampling shall be representative for each region and season. Multiple sampling in the same flock shall be avoided, wherever possible. Member States shall aim their monitoring programmes to achieve, wherever possible, that in successive sampling years all officially registered holdings with more than 100 animals and where TSE cases have never been detected are subject to TSE testing.

The Member States shall put in place a system to check, on a targeted or other basis, that animals are not being diverted from sampling.

However, Member States may decide to exclude from the sampling remote areas with a low animal density, where no collection of dead animals is organised. Member States making use of this derogation shall inform the Commission thereof, and shall submit a list of those remote areas where the derogation applies. The derogation shall not cover more than 10 % of the ovine and caprine population in the Member State concerned.

5. Monitoring in holdings under TSE control and eradication measures

Animals over 18 months of age which are killed for destruction in accordance with Annex VII, Chapter B, Part 2, point 2.2.1. and point 2.2.2.(b) or (c), shall be tested for the presence of TSE in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.(b), based on the selection of a simple random sample, in accordance with the sample size set out in the following table.

Number of animals over 18 months of age killed for destruction in the herd or flock	Minimum sample size
70 or less	All eligible animals
80	68
90	73
100	78
120	86
140	92
160	97
180	101
200	105
250	112
300	117
350	121
400	124
450	127
500 or more	150

6. Monitoring in other animals

In addition to the monitoring programmes set out in points 2, 3 and 4, Member States may on a voluntary basis carry out monitoring in other animals, in particular:

• — animals used for dairy production,

• — animals originating from countries with indigenous TSEs,

• — animals which have consumed potentially contaminated feedingstuffs,

• — animals born or derived from TSE infected dams.

7. Measures following testing of ovine and caprine animals

• 7.1.Where an ovine or caprine animal slaughtered for human consumption has been selected for TSE testing in accordance with point 2, its carcase shall not be marked with the health marking provided for in Section I, Chapter III of Annex I to Regulation (EC) No 854/2004 until a negative result to the rapid test has been obtained.

• 7.2.Member States may derogate from point 7.1. where a system approved by the competent authority is in place in the slaughterhouse ensuring that all parts of an animal can be traced and that no parts of the animals tested bearing the health mark can leave the slaughterhouse until a negative result to the rapid test has been obtained.

• 7.3.All parts of the body of a tested animal, including the hide, shall be retained under official control until a negative result has been obtained to the rapid test, unless they are disposed of in accordance with Article 12(a) or (b) of Regulation (EC) No 1069/2009, or unless its fats are processed in accordance with Regulation (EU) No 142/2011 and used in accordance with Article 12(e) of Regulation (EC) No 1069/2009 or used for the manufacture of derived products referred to in Article 36 of that Regulation.

• 7.4.All parts of the body of an animal found positive to the rapid test, including the hide, shall be directly disposed of in accordance with Article 12(a) or (b) of Regulation (EC) No 1069/2009, apart from the material to be retained in conjunction with the records provided for in Chapter B, Part III of this Annex, and apart from rendered fats derived from such a body provided that these rendered fats are processed in accordance with Regulation (EU) No 142/2011 and used in accordance with Article 12(e) of Regulation (EC) No 1069/2009 or used for the manufacture of derived products referred to in Article 36 of that Regulation.

8. Genotyping

• 8.1. The prion protein genotype for the codons 136, 154 and 171 shall be determined for each positive TSE case in sheep. TSE cases found in sheep of genotypes which encode alanine (A) on both alleles at codon 136, arginine (R) on both alleles at codon 154 and arginine (R) on both alleles at codon 171 shall immediately be reported to the Commission. Where the positive TSE case is an atypical scrapie case the prion protein genotype for the codon 141 shall also be determined.

• 8.2. The prion protein genotype for the codons 146 and 222 shall be determined for each positive TSE case in goats. TSE cases found in goats of genotypes which encode serine (S) or aspartic acid (D) on at least one allele at codon 146 and/or lysine (K) on at least one allele at codon 222, shall immediately be reported to the Commission.

III.   MONITORING IN CERVIDS

A. Three-year monitoring programme for chronic wasting disease (CWD)

1. General

• 1.1.The Member States which have a wild and/or farmed and/or semi-domesticated population of moose and/or reindeer (Estonia, Finland, Latvia, Lithuania, Poland and Sweden) shall carry out a three-year monitoring programme for CWD in cervids, from 1 January 2018 to 31 December 2020. The TSE tests performed for the purpose of this monitoring programme shall take place between 1 January 2018 and 31 December 2020, however, the collection of samples for the purpose of the monitoring programme may, however, start in 2017.

• 1.2.The three-year CWD monitoring programme shall cover the following cervid species:

• — Eurasian tundra reindeer (Rangifer tarandus tarandus);

• — Finnish forest reindeer (Rangifer tarandus fennicus);

• — Moose (Alces alces);

• — Roe deer (Capreolus capreolus);

• — White-tailed deer (Odocoileus virginianus);

• — Red deer (Cervus elaphus).

• 1.3.By way of derogation from point 1.2, a Member State may, based on a documented risk assessment submitted to the European Commission, select for the three-year CWD monitoring programme a subset of the species listed in that point.

2. Sampling design

• 2.1.The Member States referred to in point 1.1 shall identify Primary Sampling Units (PSU), which shall cover all territories in which cervid populations are present, using at least the following elements:

• (a) for farmed and captive cervids, each farm and each facility in which cervids are kept in an enclosed territory shall be considered as a PSU.

• (b) for wild and semi-domesticated cervids, PSU shall be defined geographically based on the following criteria:
• (i) the areas in which wild and semi-domesticated animals of a species covered by the monitoring programme gather in at least a certain period of the year;
• (ii) if no gathering takes place for a species, the areas delimited by natural or artificial barriers in which animals of the species covered by the monitoring programme are present;
• (iii) the areas in which animals of the species covered by the monitoring programme are hunted and areas connected to other relevant activities related to the species covered by the monitoring programme.

• 2.2.The Member States referred to in point 1.1 shall select farmed, captive, wild and semi-domesticated cervids for TSE testing using the following two-stage sampling approach:

• (a) in the first stage, those Member States shall:
• (i) for farmed and captive cervids:
• — select, on a random basis ensuring geographical representativeness, and if relevant taking into account relevant risk factors identified in a documented risk assessment carried out by the Member State, 100 PSU to be covered over the three-year period of the monitoring programme, or
• — if the Member State was unable to identify 100 PSU for farmed and captive cervids, select all PSU identified.
• (ii) For wild and semi-domesticated cervids:
• — select, on a random basis ensuring geographical representativeness, and if relevant taking into account relevant risk factors identified in a documented risk assessment carried out by the Member State, 100 PSU to be covered over the three-year period of the monitoring programme, or
• — if the Member State was unable to identify 100 PSU for wild and semi-domesticated cervids, select all PSU identified.

• (b) in the second stage:
• (i) for farmed and captive cervids:
• — a Member State having selected 100 PSU shall, within every selected PSU, sample all animals belonging to the target groups listed under point 2.4.(a) over the three-year period until a target of 30 animals tested per PSU is reached. If however certain PSU are not be able to reach the target of 30 animals tested over the three-year period due to the limited size of their cervid population, the sampling of animals belonging to the target groups listed under point 2.4.(a) may continue in larger PSU even after having reached the target of 30 animals tested, with the objective of reaching a total number of up to 3 000 farmed and captive cervids, where possible, tested at national level over the three-year period of the monitoring programme;
• — a Member State having identified fewer than 100 PSU shall, within every PSU, sample all animals belonging to the target groups listed under point 2.4.(a) over the three-year period, with the objective of approaching a total number of up to 3 000 farmed and captive cervids, where possible, tested at national level over the three-year period of the monitoring programme.
• (ii) for wild and semi-domesticated cervids:
• — a Member State having selected 100 PSU shall, within every selected PSU, sample all animals belonging to the target groups listed under point 2.4.(b), over the three-year period until a target of 30 animals tested per PSU is reached, with the objective of reaching up to 3 000 wild and semi-domesticated cervids tested at national level over the three-year period;
• — a Member State having identified fewer than 100 PSU shall, within every PSU, sample all animals belonging to the target groups listed under point 2.4.(b) over the three-year period, with the objective of approaching a total number of 3 000 wild and semi-domesticated cervids tested at national level over the three-year period of the monitoring programme.

• 2.3.All cervids selected must be over 12 months of age. The age shall be estimated on the basis of dentition, obvious signs of maturity, or any other reliable information.

• 2.4.The cervids must be selected from the following target groups:

• (a) for farmed and captive cervids:
• (i) fallen/culled farmed or captive cervids, defined as farmed or captive cervids found dead on the enclosed territory in which they are kept, during transport or at slaughterhouse, as well as farmed or captive cervids killed for health/age reasons;
• (ii) clinical/sick farmed or captive cervids, defined as farmed or captive cervids showing abnormal behavioural signs and/or locomotor disturbances and/or as being generally in poor condition;
• (iii) slaughtered farmed cervids which have been declared unfit for human consumption;
• (iv) slaughtered farmed cervids considered fit for human consumption if a Member State identifies fewer than 3 000 farmed and captive cervids from the groups (i) to (iii).

• (b) for wild and semi-domesticated cervids:
• (i) fallen/culled wild or semi-domesticated cervids, defined as cervids found dead in the wild as well as semi-domesticated cervids found dead or killed for health/age reasons;
• (ii) road- or predator-injured or killed cervids, defined as wild or semi-domesticated cervids hit by road vehicles, by trains or attacked by predators;
• (iii) clinical/sick wild and semi-domesticated cervids, defined as wild and semi-domesticated cervids which are observed as showing abnormal behavioural signs and/or locomotor disturbances and/or as being generally in poor health condition;
• (iv) wild hunted cervids and slaughtered semi-domesticated cervids which have been declared unfit for human consumption;
• (v) hunted wild game and slaughtered semi-domesticated cervids considered fit for human consumption if a Member State identifies fewer than 3 000 wild and semi-domesticated cervids from the groups (i) to (iv).

• 2.5.In case of a positive finding of TSE in a cervid, the number of samples from cervids collected in the zone where the positive TSE case was found must be increased, based on an assessment carried out by the Member State concerned.

3. Sampling and laboratory testing

• 3.1.For each cervid selected in accordance with point 2, a sample of obex shall be collected and tested for TSEs.

• In addition, where feasible, a sample of one of the following tissues shall be collected in the following order of preference:

• (a) retropharyngeal lymph nodes;

• (b) tonsils;

• (c) other head lymph nodes.

• For rapid testing a hemisection of obex shall be submitted in a fresh or frozen state. The remaining hemisection should be fixed. When collected, lymph nodes and tonsils should be fixed.

• A portion of fresh tissue from each sample type shall be kept frozen until a negative result is obtained, in case bioassay is required.

• 3.2.Until the publication of guidelines on TSE testing in cervids of the EU Reference Laboratory for TSE, the following laboratory method shall be used for the purpose of the CWD monitoring programme:

• (a) rapid tests: Rapid tests as referred to in point 4 of Chapter C of Annex X used for TSE detection in obex of bovine or small ruminant animals are considered suitable for TSE detection in obex of cervids. Rapid tests as referred to in point 4 of Chapter C of Annex X used for TSE detection in the lymph nodes of bovine or small ruminant animals are considered suitable for TSE detection in lymph nodes of cervids. Member States may also use immunohistochemistry for screening purposes for which purpose they shall satisfy a proficiency test organised by the EU Reference Laboratory for TSE.

• (b) confirmatory tests: When the result of the rapid test is inconclusive or positive, the sample shall be subjected to confirmatory examinations using at least one of the following methods and protocols as laid down in the latest edition of the Manual for diagnostic tests and vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE):
• — the immunohistochemical (IHC) method;
• — Western blot. Where a Member State is unable to confirm a positive rapid test result, it shall send adequate tissue to the EU Reference laboratory for confirmation.

• (c) isolate characterisation: In the case of positive findings of TSE, further isolate characterisation should be undertaken, in consultation with the EU Reference Laboratory for TSE.

• 3.3.The prion protein genotype shall be determined for each positive finding of TSE in cervids.

• In addition, for each cervid tested and found negative for TSE, either:

• — the prion protein genotype of the animal tested and found negative for TSE is determined, or

• — a sample of a tissue, which may be the obex, shall be kept frozen until at least 31 December 2021, to allow for genotyping if so decided.

B. Other monitoring in cervids

Member States shall carry out additional monitoring for TSEs in cervids based on a risk assessment which may take into account the detection of a TSE in cervids in the same or neighbouring regions.

Member States other than those mentioned under point 1.1 of Part A may on a voluntary basis carry out monitoring for TSEs in cervids.

After the end of the three-year monitoring programme referred to in Part A, the Member States mentioned under point 1.1 may on a voluntary basis carry out monitoring for TSEs in cervids.

IV.   MONITORING IN OTHER ANIMAL SPECIES

Member States may on a voluntary basis carry out monitoring for TSE in animal species other than bovine, ovine, caprine and cervid animals.

CHAPTER B

REPORTING AND RECORDING REQUIREMENTS

I. REQUIREMENTS ON MEMBER STATES

A. Information to be presented by Member States in their annual report as provided for in Article 6(4)

• 1.The number of suspected cases placed under official movement restrictions in accordance with Article 12(1), per animal species.

• 2.The number of suspected cases subject to laboratory examination in accordance with Article 12(2), per animal species, including the results of the rapid and confirmatory tests (number of positives and negatives) and, with regard to bovine animals, the age distribution of all tested animals. The age distribution should be grouped as follows: ‘below 24 months’, distribution per 12 months between 24 and 155 months, and ‘above 155 months’ of age.

• 3.The number of flocks where suspected cases in ovine and caprine animals have been reported and investigated pursuant to Article 12(1) and (2).

• 4.The number of bovine animals tested within each subpopulation referred to in Chapter A, Part I, points 2.1, 2.2, 3.1 and 5. The method of the sample selection, the results of the rapid and confirmatory tests and the age distribution of the tested animals grouped as set out in point 2 shall be provided.

• 5.The number of ovine and caprine animals and flocks tested within each subpopulation referred to in Chapter A, Part II, points 2, 3, 5 and 6 together with the method for sample selection and the results of the rapid and confirmatory tests.

• 6.The geographical distribution, including the country of origin if not the same as the reporting country, of positive cases of BSE and scrapie. The year, and where possible the month of birth shall be given for each TSE case in bovine, ovine and caprine animals. TSE cases which have been considered atypical shall be indicated. For scrapie cases, the results of the primary and secondary molecular testing, referred to in Annex X, Chapter C, point 3.2(c), shall be reported, where appropriate.

• 7.In animals other than bovine, ovine and caprine animals, as well as in cervids other than those covered by the three-year CWD monitoring programme referred to in Part III.A of Chapter A of this Annex, the number of samples and confirmed TSE cases per species.

• 8.The genotype, and, where possible, the breed, of each ovine and caprine animal found positive to TSE and sampled in accordance with Chapter A, Part II, point 8.

• 9.For Member States covered by the three-year CWD monitoring programme referred to in Part III.A of Chapter A of this Annex, the annual report for the years 2018, 2019 and 2020 shall include:

• (a) The number of cervid samples submitted for testing, by target group according to the following criteria:
• — primary Sampling Unit (PSU) identifier,
• — species,
• — management system: farmed, captive, wild or semi-domesticated,
• — target group,
• — sex,

• (b) The results of the rapid and confirmatory tests (number of positives and negatives) and, where applicable, of further isolate characterisation investigations, the tissue sampled and the rapid test and confirmatory technique used.

• (c) The geographical location, including the country of origin if not the same as the reporting Member State, of positive cases of TSE.

• (d) The genotype and species of each cervid found positive for TSE.

• (e) Where tested, the genotype of cervids tested and found negative for TSE.

B. Reporting periods

The compilation of reports containing the information referred to in Section A and submitted to the Commission (which shall send it to the European Food Safety Authority) on a monthly basis in the electronic format agreed between the Member States, the Commission and the European Food Safety Authority or, with regard to the information referred to in point 8 on a quarterly basis, may constitute the annual report as required by Article 6(4), provided that the information is updated whenever additional information becomes available.

II.   INFORMATION TO BE PRESENTED IN THE UNION SUMMARY REPORT

The Union summary shall be presented in a tabled format covering at least the information referred to in Part I.A for each Member State.

From 1 January 2016, the European Food Safety Authority shall analyse the information referred to in Part I and publish by the end of November a summary report on the trends and sources of Transmissible Spongiform Encephalopathies in the Union.

III.   RECORDS

• 1.The competent authority shall keep, for 7 years, records of the information referred to in Part I.A.

• 2.The investigating laboratory shall keep, for 7 years, all records of testing, in particular laboratory workbooks and, where appropriate, paraffin blocks and photographs of western blots.

ANNEX IV

ANIMAL FEEDING

CHAPTER I

Extensions of the prohibition provided for in Article 7(1)

In accordance with Article 7(2), the prohibition provided for in Article 7(1) shall be extended to the feeding:

• (a) to ruminants of dicalcium phosphate and tricalcium phosphate of animal origin and compound feed containing these products;

• (b) to non-ruminant farmed animals, other than fur animals, of:
• (i) processed animal protein;
• (ii) blood products;
• (iii) hydrolysed protein of animal origin;
• (iv) dicalcium phosphate and tricalcium phosphate of animal origin;
• (v) feed containing the products listed in points (i) to (iv).

CHAPTER II

Derogations from the prohibitions provided for in Article 7(1) and in Chapter I

In accordance with the first subparagraph of Article 7(3), the prohibitions provided for in Article 7(1) and in Chapter I shall not apply to the feeding to:

• (a) ruminants of:
• (i) milk, milk-based products, milk-derived products, colostrum and colostrum products;
• (ii) eggs and egg products;
• (iii) collagen and gelatine derived from non-ruminants;
• (iv) hydrolysed proteins derived from:
• — parts of non-ruminants, or
• — ruminant hides and skins;
• (v) compound feed containing the products listed in points (i) to (iv) above;

• (b) non-ruminant farmed animals of the following feed materials and compound feed:
• (i) hydrolysed proteins derived from parts of non-ruminants or from ruminant hides and skins;
• (ii) fishmeal and compound feed containing fishmeal which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section A of Chapter IV;
• (iii) dicalcium phosphate and tricalcium phosphate of animal origin and compound feed containing such phosphates which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section B of Chapter IV;
• (iv) blood products derived from non-ruminants and compound feed containing such blood products which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section C of Chapter IV;

• (c) aquaculture animals of the following feed materials and compound feed:
• (i) processed animal protein derived from non-ruminants, other than fishmeal and other than processed animal protein derived from farmed insects, and compound feed containing such processed animal protein, which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section D of Chapter IV;
• (ii) processed animal protein derived from farmed insects, and compound feed containing such processed animal protein, which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Section F of Chapter IV;

• (d) unweaned ruminants of milk replacers containing fishmeal and which are produced, placed on the market and used in accordance with specific conditions laid down in Section E of Chapter IV;

• (e) farmed animals of feed materials of plant origin and compound feed containing such feed materials contaminated with insignificant amount of bone spicules derived from unauthorised animal species. Member States may only use this derogation if they have carried out a risk assessment beforehand which has confirmed there is a negligible risk for animal health. That risk assessment must take into account at least the following:
• (i) the level of the contamination;
• (ii) the nature and the source of the contamination;
• (iii) the intended use of the contaminated feed;

• (f) poultry of the following feed materials and compound feed:
• (i) processed animal protein derived from porcine animals and compound feed containing such processed animal protein, which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Chapter IV, Section G;
• (ii) processed animal protein derived from farmed insects, and compound feed containing such processed animal protein, which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Chapter IV, Section F;

• (g) porcine animals of the following feed materials and compound feed:
• (i) processed animal protein derived from poultry and compound feed containing such processed animal protein, which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Chapter IV, Section H;
• (ii) processed animal protein derived from farmed insects, and compound feed containing such processed animal protein, which are produced, placed on the market and used in accordance with the general conditions laid down in Chapter III and the specific conditions laid down in Chapter IV, Section F.

CHAPTER III

General conditions for the application of certain derogations provided for in Chapter II

SECTION A

Transport and storage of feed materials and compound feed intended to be used for feeding non-ruminant farmed animals

• 1.The following products intended to be used for feeding non-ruminant farmed animals shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively, for the transport or storage of feed intended for ruminants:

• (a) bulk processed animal protein derived from non-ruminants, including fishmeal, processed animal protein derived from farmed insects, processed animal protein derived from porcine animals and processed animal protein derived from poultry;

• (b) bulk dicalcium and tricalcium phosphate of animal origin;

• (c) bulk blood products derived from non-ruminants;

• (d) bulk compound feed containing the feed materials listed in (a), (b) and (c).

• Records detailing the type of products that were transported or stored in a storage plant shall be kept available to the competent authority for a period of at least two years.

• 2.By way of derogation from point 1, vehicles, containers and storage facilities which have been previously used for the transport or storage of the products listed in that point, may be subsequently used for the transport or storage of feed intended for ruminants provided that they are cleaned beforehand in order to avoid cross-contamination, in accordance with a documented procedure which has been given prior authorisation by the competent authority.

• Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years.

• 3.Storage plants storing in accordance with point 2 feed materials and compound feed listed in point 1 shall be authorised by the competent authority based on verification of their compliance with the requirements listed in point 2.

• 4.Bulk processed animal protein derived from porcine animals, and bulk compound feed containing such processed animal protein, shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively, for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture animals and poultry.

• 5.By way of derogation from point 4, vehicles, containers and storage facilities which have been previously used for the transport or storage of bulk processed animal protein derived from porcine animals and bulk compound feed containing such processed animal protein may be subsequently used for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture animals and poultry provided that they are cleaned beforehand in order to avoid cross-contamination, in accordance with a documented procedure which has been given prior authorisation by the competent authority.

• Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years.

• 6.Bulk processed animal protein derived from poultry, and bulk compound feed containing such processed animal protein, shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively, for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture and porcine animals.

• 7.By way of derogation from point 6, vehicles, containers and storage facilities which have been previously used for the transport or storage of bulk processed animal protein derived from poultry and bulk compound feed containing such processed animal protein may be subsequently used for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture animals and porcine animals provided that they are cleaned beforehand in order to avoid cross-contamination, in accordance with a documented procedure which has been given prior authorisation by the competent authority.

• Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years.

• 8.Bulk processed animal protein derived from farmed insects, and bulk compound feed containing such processed animal protein, shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively, for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture, poultry and porcine animals.

• 9.By way of derogation from point 8, vehicles, containers and storage facilities which have been previously used for the transport or storage of bulk processed animal protein derived from farmed insects and bulk compound feed containing such processed animal protein may be subsequently used for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture animals, poultry and porcine animals provided that they are cleaned beforehand in order to avoid cross-contamination, in accordance with a documented procedure which has been given prior authorisation by the competent authority.

• Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years.

• 10.Bulk processed animal protein derived from non-ruminants, excluding fishmeal and processed animal protein derived from poultry, porcine animals and farmed insects, and bulk compound feed containing such processed animal protein, shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively, for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture animals.

• 11.By way of derogation from point 10, vehicles, containers and storage facilities which have been previously used for the transport or storage of the products referred to in that point may be subsequently used for the transport or storage of feed intended for non-ruminant farmed animals other than aquaculture animals provided that they are cleaned beforehand in order to avoid cross-contamination, in accordance with a documented procedure which has been given prior authorisation by the competent authority.

• Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years.

SECTION B

Production of compound feed intended to be used for feeding non-ruminant farmed animals

• 1.Compound feed intended to be used for feeding non-ruminant farmed animals and which contain the following feed materials, shall be produced in establishments which do not produce compound feed for ruminants, and which are authorised by the competent authority:

• (a) fishmeal;

• (b) dicalcium and tricalcium phosphate of animal origin;

• (c) blood products derived from non-ruminants.

• 2.By way of derogation from point 1, the production of compound feed for ruminants, in establishments which also produce compound feed for non-ruminant farmed animals which contains the products listed in that point, may be authorised by the competent authority, following an on-site inspection by it, subject to compliance with the following conditions:

• (a) compound feed intended for ruminants must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for non-ruminants are manufactured and kept;

• (b) records detailing the purchases and uses of the products listed in point 1 and the sales of compound feed containing those products must be kept available to the competent authority for a period of at least five years;

• (c) regular sampling and analysis of the compound feed intended for ruminants must be carried out in order to verify the absence of unauthorised constituents of animal origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Commission Regulation (EC) No 152/2009 (³⁰); the frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on hazard analysis and critical control points (HACCP) principles; the results of such sampling and analysis shall be kept available to the competent authority for a period of at least five years.

• 3.By way of derogation from point 1, a specific authorisation for the production of complete feed from compound feed containing the products listed in that point, shall not be required for home compounders subject to their compliance with the following conditions:

• (a) they must be registered by the competent authority as producing complete feed from compound feed containing the products listed in point 1;

• (b) they must keep only non-ruminant animals;

• (c) any compound feed containing fishmeal used in the production of the complete feed must contain less than 50 % crude protein;

• (d) any compound feed containing dicalcium and tricalcium phosphate of animal origin used in the production of the complete feed must contain less than 10 % total phosphorus;

• (e) any compound feed containing blood products derived from non-ruminants used in the production of the complete feed must contain less than 50 % crude protein.

SECTION C

Import of feed materials and compound feed intended to be used for feeding non-ruminant farmed animals other than fur animals

Before release for free circulation in the Union, importers shall ensure that each of the consignment of the following feed materials and compound feed, which are intended to be used for the feeding of non-ruminant farmed animals, other than fur animals, in accordance with Chapter II of this Annex, is analysed in accordance with the methods of analysis for the determination of constituents of animal origin for the control of feed set out Annex VI to Regulation (EC) No 152/2009 in order to verify the absence of unauthorised constituents of animal origin:

• (a) processed animal protein derived from non-ruminants, including fishmeal, processed animal protein derived from farmed insects, processed animal protein derived from porcine animals and processed animal protein derived from poultry;

• (b) blood products derived from non-ruminants;

• (c) compound feed containing the feed materials listed in (a) and (b).

SECTION D

Use and storage on farms of feed intended to be used for feeding non-ruminant farmed animals

• 1.The use and storage of the following feed shall be prohibited on farms keeping farmed animal species for which such feed is not intended:

• (a) processed animal protein derived from non-ruminants, including fishmeal, processed animal protein derived from farmed insects, processed animal protein derived from porcine animals and processed animal protein derived from poultry;

• (b) dicalcium and tricalcium phosphate of animal origin;

• (c) blood products derived from non-ruminants;

• (d) compound feed containing the feed materials listed in (a) to (c).

• 2.By way of derogation from point 1, the competent authority may authorise the use and storage of compound feed referred to in point 1(d) in farms keeping farmed animal species for which the compound feed is not intended provided that on-farm measures are implemented to prevent such compound feed being fed to an animal species for which it is not intended.

CHAPTER IV

Specific conditions for the application of derogations provided for in Chapter II

SECTION A

Specific conditions applicable to the production and the use of fishmeal and compound feed containing fishmeal intended to be used for feeding non-ruminant farmed animals other than fur animals

The following specific conditions shall apply to the production and use of fishmeal and compound feed containing fishmeal intended to be used for the feeding of non-ruminant farmed animals other than fur animals:

• (a) the fishmeal must be produced in processing plants dedicated exclusively to the production of products derived from:
• (i) aquatic animals, except sea mammals;
• (ii) farmed aquatic invertebrates other than those that fall within the definition of ‘aquatic animals’ provided for in Article 3(1)(e) of Directive 2006/88/EC; or
• (iii) starfish of the species Asterias rubens which are harvested in a production area as defined in Annex I point 2.5 of Regulation (EC) No 853/2004 and classified accordingly;

• (b) The words ‘fishmeal — shall not be used in feed for ruminants except unweaned ruminants’ shall be clearly indicated on the accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, as well as on the label of fishmeal; The words ‘contains fishmeal — shall not be fed to ruminants’ shall be clearly indicated on the label of compound feed containing fishmeal intended for non-ruminant farmed animals other than fur animals.

SECTION B

Specific conditions applicable to the use of dicalcium phosphate and tricalcium phosphate of animal origin and compound feed containing such phosphates intended to be used for feeding non-ruminant farmed animals other than fur animals

• (a) The words ‘di-/tricalcium phosphate of animal origin — shall not be used in feed for ruminants’ shall be clearly indicated on the accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, as well as on the label of dicalcium/tricalcium phosphate of animal origin;

• (b) The words ‘contains dicalcium/tricalcium phosphate of animal origin — shall not be fed to ruminants’ shall be clearly indicated on the label of compound feed containing dicalcium/tricalcium phosphate of animal origin.

SECTION C

Specific conditions applicable to the production and use of blood products derived from non-ruminants and compound feed containing those products intended to be used for feeding non-ruminant farmed animals other than fur animals

The following specific conditions shall apply to the production and use of blood products derived from non-ruminants and to compound feed containing such blood products, intended to be used for the feeding of non-ruminant farmed animals other than fur animals:

• (a) The blood intended to be used for the production of blood products shall be derived from slaughterhouses which do not slaughter ruminants and which are registered by the competent authority as not slaughtering ruminants. By way of derogation from that specific condition, the competent authority may authorise the slaughter of ruminants in a slaughterhouse producing non-ruminant blood intended for the production of blood products for use in feed for non-ruminant farmed animals. That authorisation may be granted only where the competent authority is satisfied, following an inspection, concerning the effectiveness of measures aimed to prevent cross-contamination between ruminant and non-ruminant blood. Those measures shall include the following minimum requirements:
• (i) the slaughtering of non-ruminants must be carried out in lines that are physically separate from lines used for the slaughtering of ruminants;
• (ii) the collection, storage, transport and packaging facilities for blood of non-ruminant origin must be kept separate from those used for blood of ruminant origin;
• (iii) a regular sampling and analysis of blood of non-ruminant origin must be carried out to detect the presence of ruminant proteins. The method of analysis used must be scientifically validated for that purpose. The frequency of sampling and analysis must be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles.

• (b) The blood intended to be used for the production of blood products for non-ruminants shall be transported to a processing plant in vehicles and containers dedicated exclusively for the transport of non-ruminant blood. By way of derogation from that specific condition, vehicles and containers which have been previously used for the transport of blood derived from ruminants may be used for the transport of non-ruminant blood provided that they have been thoroughly cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented trace of such use shall be kept available to the competent authority for a period of at least two years.

• (c) The blood products shall be produced in processing plants exclusively processing non-ruminant blood, and registered by the competent authority as processing exclusively non-ruminant blood. By way of derogation from that specific condition, the competent authority may authorise the production of blood products for use in feed for non-ruminant farmed animals in processing plants processing ruminant blood. That authorisation may be granted only where the competent authority is satisfied, following an inspection, concerning the effectiveness of measures aimed to prevent cross-contamination. Those measures shall include the following minimum requirements:
• (i) the production of non-ruminant blood products must be carried out in a closed system that is kept physically separated from that used for the production of ruminant blood products;
• (ii) the collection, storage, transport and packaging facilities for bulk raw material and bulk finished products of non-ruminant origin must be kept separate from those for bulk raw material and bulk finished of ruminant origin;
• (iii) an ongoing reconciliation process between the incoming blood respectively derived from ruminants and non-ruminants and the corresponding blood products must be applied;
• (iv) a regular sampling and analysis of blood products of non ruminant origin must be carried out to verify the absence of cross-contamination with blood products of ruminant origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on hazard analysis and critical control points (HACCP) principles; the results of such sampling and analysis shall be kept available to the competent authority for a period of at least five years.

• (d) The words ‘non-ruminant blood products — shall not be used in feed for ruminants’ shall be clearly indicated on the accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, as well as on the label of blood products derived from non-ruminants. The words ‘contains non-ruminant blood products — shall not be fed to ruminants’ shall be clearly indicated on the label of compound feed containing blood products derived from non-ruminants.

SECTION D

Specific conditions applicable to the production and use of processed animal protein derived from non-ruminants, other than fishmeal and other than processed animal protein derived from farmed insects, and compound feed containing such protein, intended to be used for feeding aquaculture animals

The following specific conditions shall apply to the production and use of processed animal protein derived from non-ruminants, other than fishmeal and other than processed animal protein derived from farmed insects, and compound feed containing such protein, intended to be used for feeding aquaculture animals:

• (a) The animal by-products intended to be used for the production of processed animal protein referred to in this Section shall come from one or more of the following:
• (i) slaughterhouses approved in accordance with Article 4 of Regulation (EC) No 853/2004 which do not slaughter ruminants and which are registered by the competent authority as not slaughtering ruminants;
• (ii) cutting plants approved in accordance with Article 4 of Regulation (EC) No 853/2004 which do not bone or cut up ruminant meat and which are registered by the competent authority as not boning or cutting up ruminant meat;
• (iii) other establishments than those referred to in point (i) or (ii), registered or approved in accordance with Article 4 of Regulation (EC) No 853/2004, which do not handle ruminant products and which are registered by the competent authority as not handling ruminant products;
• (iv) approved establishments referred to in Article 24(1), points (h) and (i) of Regulation (EC) No 1069/2009 which are registered by the competent authority as handling or storing only non-ruminant animal by-products coming from establishments referred to in points (i), (ii) and (iii). By way of derogation from points (i), (ii) and (iii) of the first paragraph, the competent authority may authorise the slaughter of ruminants and the handling of ruminant products in the establishments referred to in points (i), (ii) and (iii) of the first paragraph producing non-ruminant animal by-products intended for the production of processed animal protein referred to in this Section. That authorisation may be granted only where the competent authority is satisfied, following an on-site inspection, of the effectiveness of measures aimed to prevent cross-contamination between ruminant and non-ruminant by-products. Those measures shall include the following minimum requirements:
• (1) the slaughtering of non-ruminants must be carried out in lines that are physically separate from those used for the slaughtering of ruminants;
• (2) non-ruminant products must be handled on production lines that are physically separate from those used for the handling of ruminant products;
• (3) the collection, storage, transport and packaging facilities for animal by-products of non-ruminant origin must be kept separate from those for animal by-products of ruminant origin;
• (4) a regular sampling and analysis of animal by-products of non-ruminant origin must be carried out to detect the presence of ruminant proteins. The method of analysis used must be scientifically validated for that purpose. The frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles.

• (b) The animal by-products of non-ruminant origin intended to be used for the production of processed animal protein referred to in this Section shall be transported to a processing plant in vehicles and containers which are not used for the transport of animal by-products of ruminant origin. By way of derogation from that specific condition, they may be transported in vehicles and containers which have been previously used for the transport of animal by-products derived from ruminants, provided that those vehicles and containers have been cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented trace of such use shall be kept available to the competent authority for a period of at least two years.

• (c) The processed animal protein referred to in this Section shall be produced in processing plants that are dedicated exclusively to processing non-ruminant animal by-products sourced from slaughterhouses, cutting plants or other establishments referred to in point (a). Those processing plants shall be registered by the competent authority as processing exclusively non-ruminant animal by-products. By way of derogation from that specific condition, the competent authority may authorise the production of processed animal protein referred to in this Section in processing plants processing ruminant animal by-products. That authorisation may be granted only where the competent authority is satisfied, following an inspection, concerning the effectiveness of the measures aimed to prevent cross-contamination between processed animal protein of ruminant origin and processed animal protein of non-ruminant origin. Those preventive measures shall include the following minimum requirements:
• (i) the production of processed animal protein derived from ruminants must be carried out in a closed system that is physically separated from that used for the production of the processed animal protein referred to in this Section;
• (ii) the keeping of animal by-products derived from ruminants during storage and transport in facilities that are physically separated from those for animal by-products derived from non-ruminants;
• (iii) the keeping of processed animal protein derived from ruminants during storage and packaging in facilities that are physically separated from those used for finished products derived from non-ruminants;
• (iv) regular sampling and analysis of the processed animal protein referred to in this Section must be carried out to verify the absence of cross-contamination with ruminant processed animal protein using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on hazard analysis and critical control points (HACCP) principles; the results of such sampling and analysis shall be kept available to the competent authority for a period of at least five years.

• (d) Compound feed containing processed animal protein referred to in this Section shall be produced in establishments authorised for that purpose by the competent authority and which are dedicated exclusively to the production of feed for aquaculture animals. By way of derogation from that specific condition:
• (i) the production of compound feed, containing processed animal protein referred to in this Section, for aquaculture animals in establishments which also produce compound feed intended for other farmed animals, other than fur animals, may be authorised by the competent authority, following an on-site inspection, subject to compliance with the following conditions:
• — compound feed destined for ruminants must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for non-ruminant animals are manufactured and kept;
• — compound feed destined for aquaculture animals must be manufactured and kept, during storage, transport and packaging, in facilities that are physically separate from those facilities where compound feed for other non-ruminant animals are manufactured and kept;
• — records detailing the purchases and uses of processed animal protein referred to in this Section and the sales of compound feed containing such protein must be kept available to the competent authority for a period of at least five years;
• — regular sampling and analysis of the compound feed destined for farmed animals other than aquaculture animals in order to verify the absence of unauthorised constituents of animal origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of such sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles; the results must be kept available to the competent authority for a period of at least five years;
• (ii) a specific authorisation for the production of complete feed from compound feed containing processed animal protein referred to in this Section shall not be required for home compounders that comply with the following conditions:
• — they are registered by the competent authority as producing complete feed from compound feed containing processed animal protein derived from non-ruminants, other than fishmeal and other than processed animal protein derived from farmed insects,
• — they keep only aquaculture animals, and
• — the compound feed containing processed animal protein referred to in this Section used in their production contains less than 50 % crude protein.

• (e) The accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, of processed animal protein referred to in this Section and the label thereof shall be clearly marked with the following words: ‘non-ruminant processed animal protein — shall not be used in feed for farmed animals except aquaculture and fur animals’. The following words shall be clearly indicated on the label of compound feed containing processed animal protein referred to in this Section: ‘contains non-ruminant processed animal protein — shall not be fed to farmed animals except aquaculture and fur animals’.

SECTION E

Specific conditions applicable to the production, placing on the market and use of milk replacers containing fishmeal for the feeding of unweaned ruminants

The following specific conditions shall apply to the production, placing on the market and use of milk replacers containing fishmeal in the feeding of unweaned farmed animals of the ruminant species:

• (a) the fishmeal used in milk replacers shall be produced in processing plants dedicated exclusively to the production of products derived from:
• (i) aquatic animals, except sea mammals;
• (ii) farmed aquatic invertebrates other than those that fall within the definition of ‘aquatic animals’ provided for in Article 3(1)(e) of Directive 2006/88/EC; or
• (iii) starfish of the species Asterias rubens which are harvested in a production area as defined in Annex I point 2.5 of Regulation (EC) No 853/2004 and classified accordingly. The fishmeal used in milk replacers shall comply with general conditions laid set out in Chapter III.

• (b) the words ‘fishmeal — shall not be used in feed for ruminants except unweaned ruminants’ shall be clearly indicated on the accompanying commercial document or health certificate referred to in Article 21(2) of Regulation (EC) No 1069/2009, as appropriate, as well as the label of fishmeal intended to be used in milk replacers;

• (c) the use of fishmeal for unweaned farmed animals of the ruminant species shall only be authorised for the production of milk replacers, distributed in dry form and administered after dilution in a given quantity of liquid, intended for the feeding of unweaned ruminants as a supplement to, or substitute for, post-colostral milk before weaning is complete;

• (d) milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species shall be produced in establishments which do not produce other compound feed for ruminants and which are authorised for this purpose by the competent authority. By way of derogation from that special condition, the production of other compound feed for ruminants in establishments which also produce milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species may be authorised by the competent authority, following an on-site inspection, subject to compliance with the following conditions:
• (i) other compound feed destined for ruminants must be kept in facilities that are physically separate from those used for bulk fishmeal and bulk milk replacers containing fishmeal during storage, transport and packaging;
• (ii) other compound feed destined for ruminants must be manufactured in facilities that are physically separate from facilities where milk replacers containing fishmeal are manufactured;
• (iii) records detailing the purchases and uses of fishmeal and the sales of milk replacers containing fishmeal must be kept available to the competent authority for a period of at least five years;
• (iv) regular sampling and analysis of the other compound feed destined for ruminants must be carried out in order to verify the absence of unauthorised constituents of animal origin using the methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009; the frequency of such sampling and analysis shall be determined on the basis of a risk assessment carried out by the operator as part of its procedures based on the HACCP principles; the results must be kept available to the competent authority for a period of at least five years;

• (e) before release for free circulation in the Union, importers shall ensure that each consignment of imported milk replacers containing fishmeal is analysed in accordance with methods of analysis for the determination of constituents of animal origin for the control of feed set out in Annex VI to Regulation (EC) No 152/2009 in order to verify the absence of unauthorised constituents of animal origin;

• (f) The label of milk replacers containing fishmeal, intended for unweaned farmed animals of the ruminant species, must be clearly marked with the words ‘contains fishmeal — shall not be fed to ruminants except unweaned ruminants’;

• (g) bulk milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species shall be transported in vehicles and containers and stored in storage facilities which are not used, respectively for the transport or storage of other feed intended for ruminants. By way of derogation from that special condition, vehicles, containers and storage facilities which will be subsequently used for the transport or storage of other bulk feed intended for ruminants may be used for the transport or storage of bulk milk replacers containing fishmeal intended for unweaned farmed animals of the ruminant species provided that they have been cleaned beforehand in order to avoid cross-contamination in accordance with a documented procedure which has been given prior authorisation by the competent authority. Whenever such a procedure is used, a documented record of such use shall be kept available to the competent authority for a period of at least two years;

• (h) on farms where ruminants are kept, on-farm measures shall be in place to prevent milk replacers containing fishmeal being fed to other ruminants than unweaned ruminants. The competent authority shall establish a list of farms where milk replacers containing fishmeal are used through a system of prior notification by the farm or another system thereby ensuring compliance with this specific condition.

SECTION F

Specific conditions applicable to the production and use of processed animal protein derived from farmed insects and compound feed containing such protein intended to be used for feeding aquaculture animals, poultry and porcine animals

The following specific conditions shall apply to the production and use of processed animal protein derived from farmed insects and compound feed containing such processed animal protein intended to be used for feeding aquaculture animals, poultry and porcine animals: