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STATUTORY INSTRUMENTS

2003 No. 2756 (W.267)
ANIMALS, WALES
ANIMAL HEALTH
The Animal By-Products (Wales) Regulations 2003

	Made	29th October 2003
	Coming into force	31st October 2003

ARRANGEMENT OF REGULATIONS

PART 1
Introduction

1.	Title, application and commencement

2.	Interpretation

3.	Approvals etc.

PART 2
Collection, transportation, storage, handling, processing and disposal of animal by-products

4.	Category 1 material

5.	Category 2 material

6.	Category 3 material

7.	Mixing mammalian and non-mammalian by-products

8.	Collection, transportation and storage

PART 3
Restrictions on access to animal by-products and their use

9.	Access to animal by-products

10.	Restrictions on use

11.	Pasture land

12.	Intra-species recycling of fish

PART 4
Approved premises and competent authorities

13.	The competent authority

14.	Approval of premises

15.	Biogas and composting plants

16.	Composting catering waste on the premises on which it originates

17.	Processing and intermediate plants own checks

18.	Sampling at processing plants

19.	Sampling at biogas and composting plants

20.	Samples sent to laboratories

21.	Laboratories

PART 5
Placing animal by-products and processed products on the market

22.	Placing on the market of processed animal protein and other processed products that could be used as feed material

23.	Placing on the market of petfood, dogchews and technical products

24.	Placing on the market of compost or digestion residues for use on agricultural land

PART 6
Derogations

25.	Competent authority for Chapter V of the Community Regulation

26.	Derogations regarding the use of animal by-products

27.	Collection centres

28.	Burial of pet animals

29.	Burial in the event of a disease outbreak

30.	Burning and burial of bees and apiculture products

PART 7
Records

31.

Records

32.	Records for consigning, transporting or receiving animal by-products

33.	Records for burying or burning of animal by-products

34.	Records for disposal or use on premises

35.	Delivery records to be kept by operators of approved biogas and composting plants

36.	Treatment records for biogas and composting plants

37.	Records for approved laboratories

38.	Records to be kept for consignments of compost or digestion residue

PART 8
Administration and enforcement

39.	Grant of approvals

40.	Suspension, amendment or revocation of approvals and registrations

41.

Appeals

42.	Notice requiring the disposal of animal by-products or catering waste

43.	Cleansing and disinfection

44.	Compliance with notices

45.	Powers of entry

46.	Obstruction

47.

Penalties

48.	Enforcement

49.	Service of notices and other documents

50.	Transitional provisions

51.	Amendments and Revocations

SCHEDULE 1

Additional requirements for biogas and composting plants

SCHEDULE 2

Testing Methods

SCHEDULE 3

Transitional Measures

SCHEDULE 4

Amendments

The National Assembly for Wales being designated[1] for the purposes of section 2(2) of the European Communities Act 1972[2] in relation to measures in the veterinary fields for the protection of public health, in exercise of the powers conferred on it by that section, makes the following Regulations -

PART 1
Introduction
Title, application and commencement
1. These Regulations may be cited as the Animal By-Products (Wales) Regulations 2003; they apply in relation to Wales and come into force on 31 October 2003.

Interpretation
2. - (1) In these Regulations -

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"the Community Regulation" ("Rheoliad y Cyngor") means Regulation (EC) No. 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption[

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(2) Expressions defined in the Community Regulation have the same meaning in these Regulations, and Category 1 material, Category 2 material and Category 3 material comprises the animal by-products set out in Articles 4, 5 and 6 respectively of the Community Regulation.

Approvals etc.
3. Any approval, authorisation, registration, instructions or notice issued under these Regulations or the Community Regulation shall be in writing, and may be made subject to such conditions as are necessary to -

(a) ensure that the provisions of the Community Regulation and these Regulations are complied with; and

(b) protect public and animal health.

(3) Subject to paragraph (4), no person shall bring any animal by-product (other than milk, colostrum, manure or digestive tract content) on to any premises where any farmed animal, or any other ruminant animal, pig or poultry, is kept, unless it has been -

(4) Paragraph (3) shall not apply to -

    (5) No person shall allow any animals to have access to material in a biogas or composting plant, except in the case of wild birds which may have access to such material during the secondary or subsequent phase of composting.

    (6) In this regulation "animal by-product" includes catering waste of all kinds, including catering waste to which the Community Regulation does not apply because of Article 1.2(e) of that Regulation.

    (7) This regulation does not prohibit feeding animal by-products to animals under Article 23(2) of the Community Regulation as enforced by regulation 26(3) of these Regulations.

    (8) Any person who fails to comply with any provision of this regulation will be guilty of an offence.

Restrictions on use
     10. Subject to regulation 12(1), any person who fails to comply with Article 22(1) of the Community Regulation will be guilty of an offence.

Pasture land
     11. - (1) For the purposes of Article 22(1)(c) of the Community Regulation, pasture land is land which is intended to be used for grazing or cropping for feedingstuffs following the application or deposit of organic fertilisers and soil improvers within the following periods -

(a) two months in the case of pigs; and

(b) three weeks in the case of other farmed animals.

(2) Any person who -

(a) uses pasture land for grazing within the period specified in paragraph (1); or

(b) feeds to pigs or other farmed animals within that period anything cropped from pasture land during that period;

will be guilty of an offence.

Intra-species recycling of fish
     12. - (1) Notwithstanding regulation 10, it will not be an offence under these Regulations to feed fish with processed animal protein derived from the bodies or parts of bodies of fish (other than farmed fish of the same species) if this is done in accordance with Articles 2 to 4 of, and Annex 1 to, Commission Regulation (EC) No. 811/2003.

    (2) The National Assembly will be the competent authority for the purposes of Article 5 of Commission Regulation (EC) No. 811/2003.

    (3) In accordance with Article 10 of Commission Regulation (EC) No. 811/2003 this regulation will not apply until 1 January 2004.

PART 4
Approved premises and competent authorities
The competent authority
13. - (1) The National Assembly will be the competent authority for the purposes of granting approvals under Chapter III and Chapter IV of the Community Regulation, the Annexes that Regulation and these Regulations.

(2) The National Assembly will also be the competent authority for -

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Approval of premises
14. - (1) No person may operate any -

(a) category 1,2 or 3 intermediate plant;

(b) storage plant;

(c) incineration or co-incineration plant;

(d) category 1 or category 2 processing plant;

(e) category 2 or category 3 oleochemical plant;

(f) biogas or composting plant;

(g) category 3 processing plant;

(h) petfood or technical plant;

for the storage, processing, treatment, disposal or use of animal by-products, unless the premises, the operator of the premises and any equipment are approved for that purpose in accordance with these Regulations and the Community Regulation.

(2) The operator of approved premises must ensure that -

(a) the premises are maintained and operated in accordance with -

(b) any person employed by the operator, and any person permitted to enter the premises, complies with these conditions and requirements.

    (3) The operator of a high capacity incineration plant must dispose of the ash in accordance with Annex IV, Chapter VII, paragraph 4 of the Community Regulation in the same way as the operator of a low capacity incineration plant.

    (4) Any person who fails to comply with any provision of this regulation will be guilty of an offence.

Biogas and composting plants
     15. - (1) The provisions of Part I of Schedule 1 to these Regulations will apply in a biogas and composting plant used for treating animal by-products (including catering waste) in addition to the requirements of paragraphs 1 to 11 of Annex VI, Chapter II to the Community Regulation.

    (2) In accordance with Article 6.2(g) and Annex VI, Chapter II, paragraph 14 of the Community Regulation -

(a) catering waste may be treated in a biogas or composting plant either in accordance with Annex VI, Chapter II, paragraphs 12 or 13 of the Community Regulation or in accordance with Part II of Schedule 1 to these Regulations; and

(b) any other animal by-product treated in a biogas or composting plant must be treated in accordance with Annex VI, Chapter II, paragraphs 12 or 13 of the Community Regulation.

(3) Any person who fails to comply with any provision of this regulation will be guilty of an offence.

Composting catering waste on the premises on which it originates
16. In accordance with Article 6.2(g) and Annex VI, Chapter II, paragraph 14 of the Community Regulation, the provisions of that Chapter and of regulation 14(1)(f) above do not apply to the composting of Category 3 catering waste on the premises on which it originates provided that -

(a) the decomposed material is only applied to land at those premises,

(b) no ruminant animals or pigs are kept at the premises, and

(c) if poultry is kept on the premises the material is composted in a secure container which prevents the poultry having access to it during decomposition.

Processing and intermediate plants own checks
     17. - (1) Any person who fails to comply with Article 25(1) of the Community Regulation will be guilty of an offence.

    (2) Any person who fails to comply with Article 25(2) of the Community Regulation will be guilty of an offence.

    (3) The operator must record the action taken in accordance with Article 25(2) of the Community Regulation, and failure to do so will be an offence.

Sampling at processing plants
     18. - (1) If a processing plant is processing Category 1 or Category 2 material, and the processed material is to be sent to landfill (or, in the case of Category 2 material, a biogas or composting plant) the operator must, not less than once every week -

(a) take from the outlet of the cooker in which the material is processed a sample of at least 50 grams of processed material; and

(b) send the sample to a laboratory approved to test it for Clostridium perfingens.

(2) In the case of Category 3 processing plants, where the processed material is intended for use in feedingstuffs, the operator must -

(a) take a representative sample of the material on each day that the material is consigned from the premises; and

(b) send the sample to a laboratory approved to test it for Salmonella and Enterobacteriaceae.

(3) In the case of Category 3 processing plants, where the processed material is not intended for use in feedingstuffs, the operator must -

(a) take a sample, not less than once every week of the material that is consigned from the premises; and

(b) send the sample to a laboratory approved to test it for Salmonella and Enterobacteriaceae.

    (4) Any person who fails to comply with any provision of this regulation will be guilty of an offence.

Sampling at biogas and composting plants
     19. - (1) In the case of biogas and composting plants, the operator must, at intervals specified in the approval, take a representative sample of material that has been treated to the time temperature parameters specified in Part II of Schedule 1 to these Regulations or the Community Regulation and send it for testing for Salmonella and Enterobacteriaceae (or, in the case of material derived from catering waste, Salmonella only) in a laboratory approved to carry out those tests.

    (2) No person may consign any material from a biogas or composting plant until the results of the test are received from the laboratory.

    (3) In the event of tests establishing that treated material does not comply with the limits in Annex VI, Chapter II, paragraph 15 to the Community Regulation, the operator must -

(a) immediately notify the National Assembly giving full details of the failure, the nature of the sample and the batch from which it was derived;

(b) ensure that no digestion residue or compost suspected or known to be contaminated is moved from the premises unless -

(c) record the action taken in accordance with this regulation.

(4) Any person who fails to comply with any provision of this regulation will be guilty of an offence.

Samples sent to laboratories
20. - (1) Whenever an operator sends a sample to a laboratory in accordance with this Part, the operator must send with the sample the following information in writing -

(a) the name and address of the premises at which the sample was taken;

(b) the date on which the sample was taken; and

(c) the description and identity of the sample.

    (2) It will be an offence for any person to tamper with a sample taken under these Regulations with intent to affect the result of the test.

    (3) The operator must keep a record of all results of laboratory tests.

    (4) Any person who fails to comply with any provision of this regulation will be guilty of an offence.

Laboratories
     21. - (1) The National Assembly may approve laboratories under this regulation to carry out one or more of the tests in this regulation if it is satisfied that those laboratories have the necessary facilities, personnel and operating procedures to do so.

    (2) In deciding whether to grant or continue an approval, the National Assembly may require the laboratory to successfully undertake any quality control tests as the National Assembly reasonably thinks fit.

    (3) The operator of a laboratory approved under this regulation carrying out tests for the purposes of these Regulations or the Community Regulation must do so in accordance with the following provisions, and failure to do so will be on offence.

    (4) A test for Clostridium perfingens must be carried out in accordance with the method in Schedule 2, or (if specified in the approval) with a method which conforms with ISO 7937/1997 (BS-EN 13401:1999) (Enumeration of Clostridium perfingens) or an equivalent method[13].

    (5) A test for salmonella must be carried out in accordance with the method in Schedule 2, or (if specified in the approval) with a method which conforms with -

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(6) A test for Enterobacteriaceae must be carried out in accordance with the method in Schedule 2, or (if specified in the approval) with a method which conforms with ISO 7402/1993 (BS 5763: Part 10: 1993) (Enumeration of Enterobacteriaceae) or an equivalent method[16].

(7) Where tests are carried out for the detection of any of the following, the operator of a laboratory approved under this regulation must immediately notify the National Assembly and the operator of the premises if -

Clostridium perfringens

Enterobacteriaceae

and failure to do so will be an offence.

    (8) The operator of a laboratory approved under this regulation must in relation to processed material notify the National Assembly on the first day of each month of the number, type and results of tests carried out during the month before, and failure to do so will be an offence.

    (9) Reprocessing in accordance with Article 25(2)(c) and (d) of the Community Regulation must be carried out under the supervision of the National Assembly.

    (10) If the sample has been sent to the approved laboratory from premises outside Wales, the requirement in paragraph (7) to notify the National Assembly shall be construed as a requirement to notify the competent authority for the premises from which the sample was sent.

PART 5
Placing animal by-products and processed products on the market
Placing on the market of processed animal protein and other processed products that could be used as feed material
     22. Any person who places on the market processed animal protein or other processed products that could be used as feed material which do not meet the requirements of Article 19 of the Community Regulation will be guilty of an offence.

Placing on the market of petfood, dogchews and technical products
     23. - (1) Any person who places on the market petfood, dogchews, technical products (other than fat derivatives produced from Category 2 material) or those animal by-products referred to in Annex VIII to the Community Regulation, which do not meet the requirements of Article 20(1) of that Regulation will be guilty of an offence.

    (2) Any person who places on the market fat derivatives produced from Category 2 material which do not meet the requirements of Article 20(3) of the Community Regulation will be guilty of an offence.

Placing on the market of compost or digestion residues for use on agricultural land
     24. Any person who places on the market compost or digestion residues for use on agricultural land must ensure that it is labelled or accompanied by documentation in such a way that the recipient's attention is drawn to the requirements of regulation 11 (provisions relating to pasture land) and any person who fails to do so will be guilty of an offence.

PART 6
Derogations
Competent authority for Chapter V of the Community Regulation
     25. The National Assembly will be the competent authority for the purposes of Chapter V of the Community Regulation.

Derogations regarding the use of animal by products
     26. - (1) The use of animal by-products for diagnostic, educational or research purposes is permitted if it is in accordance with an authorisation.

    (2) The use of animal by-products for taxidermy is permitted if -

(3) The feeding of animal by-products specified in Article 23(2)(b) of the Community Regulation to -

is permitted if it is in accordance with an authorisation

(4) The National Assembly is to maintain a register of premises used for the feeding of such animal by-products to zoo or circus animals, dogs from recognised kennels or recognised packs of hounds and maggots for fishing bait containing the following information -

(5) Any person who uses animal by-products for any of the purposes in this regulation other than in accordance with an authorisation will be guilty of an offence.

Collection centres
27. - (1) For the purposes of Article 23(2) of the Community Regulation, no person may operate a collection centre as defined in Annex 1 of the Community Regulation, for the purposes of feeding animal by-products to -

(a) dogs from recognised kennels or recognised packs of hounds; or

(b) maggots for fishing bait;

unless the premises and the operator of the premises are authorised.

(2) The operator of the authorised premises must -

(a) ensure that the premises are maintained and operated in accordance with -

(b) ensure that any person employed by the operator, and any person invited to the premises complies with these conditions and requirements.

    (3) Any person who fails to comply with any provision of this regulation will be guilty of an offence.

Burial of pet animals
     28. In accordance with Article 24(1)(a) of the Community Regulation, dead pet animals may be buried.

Burial in the event of a disease outbreak
     29. - (1) In accordance with Article 24(1)(c) of the Community Regulation, if there is an outbreak of disease mentioned in List A of the International Office of Epizootic Diseases, it shall not be an offence under these Regulations for animal by-products to be disposed of as waste by burning or burial on site (as defined in Part A of Annex II to Commission Regulation (EC) No. 811/2003) if the animal by-product is transported, and buried or burnt, in accordance with -

(a) a notice given by the National Assembly under Article 24(1)(c) authorising disposal in accordance with that provision; and

(b) the provisions of Article 6 of and Part B of Annex II to Commission Regulation (EC) No. 811/2003.

(2) The National Assembly will be the competent authority for the purposes of Article 6 of and Part B of Annex II to Commission Regulation (EC) No. 811/2003.

Burning and burial of bees and apiculture products
30. In accordance with Article 8 of Commission Regulation (EC) No. 811/2003, bees and Category 2 apiculture products may be disposed of by burial or burning on site if this is done in accordance with that Article.

PART 7
Records
Records
     31. Any record required to be kept under these Regulations may be in written or electronic form and must be kept for at least two years.

Records for consigning, transporting or receiving animal by-products
     32. Any person who fails to comply with Article 9(1) of the Community Regulation will be guilty of an offence.

Records for burying or burning of animal by-products
     33. Any person who fails to comply with Article 9 of Commission Regulation (EC) No. 811/2003 will be guilty of an offence.

Records for disposal or use on premises
     34. - (1) Subject to paragraph (2), an operator of any premises who disposes or uses any animal by-product (other than manure or material excluded from the Community Regulation by Article 1(2) of that Regulation), or processed product on the premises must make on disposal or use a record of each disposal or use showing the date on which the animal by product was disposed of or used and the quantity and description of the material disposed of or used, and failure to do so will be an offence.

    (2) The requirement in paragraph (1) shall not apply to disposal on the premises by feeding of animal by-products or processed products to reptiles and birds of prey other than zoo or circus animals.

Delivery records to be kept by operators of approved biogas and composting plants
     35. - (1) The operator of any biogas or composting plant receiving catering waste must record -

and failure to do so will be an offence.

Treatment records for biogas and composting plants
36. The operator of a biogas or composting plant treating catering waste or other animal by-products must record -

(a) the dates on which the material is treated;

(b) a description of the material treated;

(c) the quantity of material treated;

(d) the result of all checks carried out at the critical points identified under paragraph 4 of Part I of Schedule 1; and

(e) sufficient information to show that the material has been treated to the required parameters;

and failure to do so will be an offence.

Records for approved laboratories
37. The operator of a laboratory approved under regulation 21 must record -

(a) the name and address of the premises at which the sample was taken;

(b) the date on which the sample was taken;

(c) the description and identity of the sample;

(d) the date on which the sample was received at the laboratory;

(e) the date on which the sample was tested at the laboratory; and

(f) the result of the test;

and failure to do so will be an offence.

Records to be kept for consignments of compost or digestion residue
38. - (1) Subject to paragraph (2), the occupier of premises on which ruminant animals, pigs or poultry are kept must record -

(a) the date on which the compost or digestion residue is brought on to those premises;

(b) the quantity and description of the compost or digestion residue;

(c) the land to which the compost or digestion residue is applied;

(d) the date of such application; and

(e) the date on which the land is first cropped or the date on which ruminant animals, pigs or poultry were allowed access to the land, whichever is the sooner;

and failure to do so will be an offence.

(2) The requirement in paragraph (1) to keep records will not apply in the case of any supply of compost or digestion residue for use at any premises used only as a dwelling.

PART 8
Administration and enforcement
Grants of approvals
39. - (1) The National Assembly may grant an approval under these Regulations if it is satisfied that the requirements of the Community Regulation and these Regulations will be complied with.

(2) An approval must specify -

(3) If the National Assembly refuses to grant the approval, or approves it subject to a condition, it must by notice in writing served on the applicant -

Suspension, amendment or revocation of approvals, authorisations and registrations
40. - (1) The National Assembly, by notice in writing served on the operator -

(a) must suspend an approval, authorisation or registration if it is satisfied that any of the conditions under which the approval, authorisation or registration was granted are not fulfilled; and

(b) may suspend or amend an approval, authorisation or registration if it is satisfied that the provisions of the Community Regulation or these Regulations are not being complied with.

(2) A suspension or amendment under paragraph (1) -

(a) must have immediate effect if the National Assembly considers that this is necessary for the protection of public or animal health;

(b) otherwise it will have effect on the date stated in the notice which shall not be less than 21 days following service of the notice.

(3) The notice must -

(a) specify the date on which it takes effect;

(b) give the reasons for the suspension or amendment (and, in a case under sub-paragraph (2)(a), the reasons why immediate suspension or amendment is considered necessary); and

(c) explain the right of the operator of the premises to make written representations to the National Assembly within a period of 21 days beginning with the date on which the notice is served and to be heard by an independent person appointed by the National Assembly.

(4) Where there is an appeal under regulation 41, the amendment or suspension will not have effect until the final determination by the National Assembly in accordance with the following regulation, unless the National Assembly reasonably considers that it is necessary for the protection of public or animal health for the amendment or suspension to have effect from an earlier date, which must be specified in a notice in writing to the operator.

(5) The National Assembly by notice in writing may revoke an approval or registration if it is satisfied, taking into account all the circumstances of the case, that the premises will not be operated in accordance with the Community Regulation and these Regulations -

(a) following an appeal in accordance with the following regulation which upholds a suspension; or

(b) after a period of 21 days following service of the notice of amendment or suspension where there has been no such review.

Appeals
41. - (1) An applicant or operator on whom a notice is served under regulation 39 or 40 may within 21 days beginning with the day on which the notice is served -

(a) provide written representations to the National Assembly; and

(b) provide notice of whether or not they wish to appear before an independent person appointed by the National Assembly.

(2) Where an applicant or operator gives notice of their wish to appear before and be heard by an independent person -

(a) the National Assembly must appoint an independent person to hear representations and specify a time limit within which representations must be made;

(b) the appointed person must not, except with the consent of the applicant or operator, be an officer of the National Assembly;

(c) if the applicant or operator so requests the hearing must be in public;

(d) if the applicant or operator so requests, the National Assembly must provide them with a copy of the report of the appointed person.

    (3) The independent person must report to the National Assembly.

    (4) The National Assembly must give to the applicant or operator written notification of its final determination and the reasons for it.

    (5) The National Assembly will be responsible for meeting the reasonable fees and expenses of the independent person in relation to the appeal except -

(a) where it confirms the notice served under regulation 39 or 40; and

(b) it is satisfied it is reasonable in all the circumstances for the applicant or operator to bear some or all of the expense.

    (6) Where the National Assembly is satisfied that it is reasonable in all the circumstances for the applicant or operator to bear some or all of the reasonable fees and expenses of the independent person, it must give notice to the applicant or operator of the proportion which it is satisfied the applicant or operator should bear.

    (7) The applicant, operator and the National Assembly will each be responsible for their own costs incurred in relation to the appeal.

Notice requiring the disposal of animal by-products or catering waste
     42. If an inspector considers it necessary for animal or public health purposes or if any provision of these Regulations or the Community Regulation is not being complied with, the inspector may -

(a) serve a notice on any person in possession or control of any animal by product requiring that person to dispose of it as may be specified in the notice, or

(b) serve a notice on the occupier of any premises prohibiting animal by-products being brought on to the premises, or only permitting this in a way specified in the notice.

Cleansing and disinfection
43. - (1) If an inspector reasonably suspects that any vehicle, container or premises to which these Regulations or the Community Regulation apply constitutes an animal or public health risk, the inspector may serve a notice on the person in charge of the vehicle or container, or on the occupier of the premises, requiring the vehicle, container or premises to be cleansed and disinfected.

(2) The notice may -

(a) specify the method of cleansing and disinfection;

(b) specify the method of disposal of any material remaining in the vehicle, container or premises; and

(c) prohibit the movement of any animal by-product into the vehicle or container or on to the premises until such time as the required cleansing and disinfection has been satisfactorily completed.

Compliance with notices
     44. - (1) Any notice served under these Regulations must be complied with at the expense of the person on whom the notice is served, and if it is not complied with, an inspector may arrange for it to be complied with at the expense of that person.

    (2) Any person on whom a notice is served who contravenes or fails to comply with the provisions of that notice will be guilty of an offence.

Powers of entry
     45. - (1) An inspector, on producing, if so required, some duly authenticated document showing the authority of the inspector, may enter at all reasonable hours any premises (excluding any premises used only as a dwelling) for the purpose of administering and enforcing these Regulations and the Community Regulation.

    (2) An inspector may -

(a) seize any animal by-products and dispose of them as necessary;

(b) carry out any inquiries, examinations and tests;

(c) take any samples;

(d) have access to, and inspect and copy any records (in whatever form they are held) kept under these Regulations or the Community Regulation, or remove such records to enable them to be copied;

(e) have access to, inspect and check the operation of, any computer and any associated apparatus or material which is or has been in use in connection with the records; and for this purpose may require any person having charge of, or otherwise concerned with the operation of, the computer, apparatus or material to afford the inspector such assistance as the inspector may reasonably require and, where a record is kept by means of a computer, may require the records to be produced in a form in which they may be taken away;

(f) mark any animal, animal by-product or other thing for identification purposes; and

(g) take with him or her -

(3) Any person who defaces, obliterates or removes any mark applied under paragraph (2) will be guilty of an offence.

(4) If a justice of the peace, on sworn information in writing, is satisfied that there is a reasonable ground for an inspector to enter any premises (excluding premises used only as a dwelling) for any purpose mentioned in this regulation and either -

(a) admission to the premises has been refused, or a refusal is expected, and that notice of the intention to apply for a warrant has been given to the occupier; or

(b) an application for admission, or the giving of such a notice, would defeat the object of the entry, or that the case is one of urgency, or that the premises are unoccupied or the occupier is absent,

the justice of the peace may issue a warrant authorising an inspector to enter the premises for that purpose if need be by reasonable force.

(5) Every warrant issued under this regulation will continue in force for a period of one month.

(6) An inspector entering any premises by virtue of this regulation, or of a warrant issued under it may be accompanied by -

(a) such other persons as the inspector considers necessary; and

(b) any representative of the European Commission acting for the purpose of the Community Regulation.

    (7) If an inspector enters any unoccupied premises the inspector shall leave them as effectively secured against unauthorised entry as the inspector found them.

    (8) In this regulation "premises" includes any vehicle or container.

Obstruction
     46. - (1) Any person who -

(a) intentionally obstructs any person acting in the execution of these Regulations,

(b) without reasonable cause, fails to give to any person acting in the execution of these Regulations any assistance or information which that person may reasonably require for the performance of the functions of that person under these Regulations,

(c) furnishes to any person acting in the execution of these Regulations any information which that person so furnishing knows to be false or misleading; or

(d) fails to produce a record when required to do so to any person acting in the execution of these Regulations;

will be guilty of an offence.

(2) Nothing in paragraph (1)(b) may be construed as requiring any person to answer any question or give any information if to do so might incriminate that person.

Penalties
47. - (1) A person guilty of an offence under these Regulations will be liable -

(a) on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding six months or both; or

(b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or both.

(2) Where a body corporate is guilty of an offence under these Regulations, and that offence is proved to have been committed with the consent or connivance of, or to have been attributable to any neglect on the part of -

(a) any director, manager, secretary or other similar person of the body corporate, or

(b) any person who was purporting to act in any such capacity,

that person, as well as the body corporate, will be guilty of the offence and will be liable to be proceeded against and punished accordingly.

(3) For the purposes of paragraph (2) above, "director", in relation to a body corporate whose affairs are managed by its members, means a member of the body corporate.

Enforcement
48. - (1) These Regulations are to be enforced by the National Assembly in relation to -

(a) premises which are licensed under the Fresh Meat (Hygiene and Inspection) Regulations 1995[

    (2) Other than as specified in paragraph (1) these Regulations are to be enforced by the local authority.

    (3) The National Assembly may direct, in relation to cases of a particular description or any particular case, that an enforcement duty imposed on a local authority under this regulation is to be discharged by the National Assembly and not by the local authority.

Service of notices and other documents
     49. - (1) Any notice or other document to be served under or in relation to these Regulations may be served either -

(a) by delivering it to the person on whom it is to be served; or

(b) by leaving it, or sending it by post to that person at the usual or last known address of that person; or

(c) in the case of an incorporated body, by delivering it to that body's secretary or clerk at their registered or principal office, or by sending it by post to that person at that office.

(2) Where a notice or other document is to be given or served on the owner, proprietor, operator or occupier of any premises and it is not practicable after reasonable enquiry to ascertain the name and address of the person to or on whom it should be given or served, or the premises are unoccupied, the document may be given or served by addressing it to the person concerned by the description of "owner", "proprietor", "operator" or "occupier" of the premises (naming them) and -

(a) by delivering it to some person on the premises; or

(b) if there is no person on the premises to whom it can be delivered, by affixing it, or a copy of it, to some conspicuous part of the premises.

Transitional provisions
     50. - (1) Schedule 3 (transitional measures) will have effect.

    (2) Part I of Schedule 3 (intra-species recycling of fish) shall cease to have effect on 1st January 2004.

    (3) Part II of Schedule 3 (collection, transportation and disposal of former foodstuffs) shall cease to have effect on 1st January 2006.

    (4) Part III of Schedule 3 (used cooking oil in animal feed) will cease to have effect on 1st November 2004.

    (5) Part IV of Schedule 3 (mammalian blood) will cease to have effect on 1st January 2005.

    (6) Part V of Schedule 3 (oleochemical plants using rendered fats from Category 2 and 3 materials) will cease to have effect on 1st November 2005.

    (7) Part VI of Schedule 3 (low capacity incineration or co-incineration plants which do not incinerate or co-incinerate specified risk materials or carcases containing them) will cease to have effect on 1st January 2005.

Amendments and Revocations
     51. - (1) The TSE (Wales) Regulations 2002 are amended in accordance with Schedule 4.

    (2) In so far as they apply to Wales, the Animal By-Products Order 1999[22] and the Animal By-Products (Amendment) (Wales) Order 2001[23] are revoked.

Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998[24]

D. Elis-Thomas
The Presiding Officer of the National Assembly

29th October 2003

SCHEDULE 1Regulation 15

Additional requirements for biogas and composting plants

PART 1
Premises
1. - (1) There must be -

    (2) The clean area must be, adequately separated from the reception area and the area in which vehicles and containers are cleansed and disinfected so as to prevent contamination of the treated material. Floors must be laid so that liquid cannot seep into the clean area from the other areas.

    (3) The reception area must be easy to clean and disinfect and must have an enclosed and lockable place or container to receive and store the untreated animal by-products.

     2. The animal by-products must be unloaded in the reception area and either -

3. The plant must be operated in such a way that -

4. The operator shall identify, control and monitor suitable critical points in the operation of the plant to demonstrate that -

5. Containers, receptacles and vehicles used for transporting untreated animal by-products must be cleaned in the dedicated are before they leave the premises and before any treated material is loaded. In the case of vehicles transporting only untreated catering waste and not subsequently transporting treated material, only the wheels of the vehicle need be cleaned.

PART II
Treatment systems and parameters for catering waste
1. Unless an approval specifically permits a different system, catering waste must be treated by one of the systems specified in the table below. The system must ensure that the material is treated to the following parameters:

Composting

System	Composting in a closed reactor	Composting in a closed reactor	Composting in housed windrows
Maximum Particle size	40cm	6cm	40cm
Minimum Temp-erature	60°C	70°C	60°C
Minimum Time spent at the minimum Temp-erature	2 days	1 hour	8 days (during which the windrow must be turned at least 3 times at no less than 2 days intervals)

The time temperature requirements will be achieved as part of the composting process

Biogas

System	Biogas in a closed reactor	Biogas in a closed reactor
Maximum Particle size	5cm	6cm
Minimum Temperature	57°C	70°C
Minimum time spent at the minimum temperature	5 hours	1 hour

2. The approval must normally specify one of the methods in the table, but the National Assembly may approve a different system if it is satisfied that it achieves the same reduction in pathogens as those methods (including any additional conditions imposed on those methods) in which case the approval must fully describe the whole system.

Composting plants
3. If the approval for a composting plant specifies one of the methods in the table, it must in addition have as a condition either that -

Biogas plants
4. The approval of a biogas plant must specify one of the methods in the table and in addition require that either -

SCHEDULE 2Regulation 21

Testing Methods

PART I
METHOD FOR THE ISOLATION OF CLOSTRIDIUM PERFRINGENS
Time of testing
     1. Tests must be begun on receipt of the sample or on the first working day which allows this method to be completed. If the test is not begun on the day of receipt the sample must be stored in a refrigerator at between 2°C and 8°C until required. If the sample has been refrigerated it must be removed from the refrigerator and stored at room temperature for at least one hour before the test is started.

Samples
     2. Tests must be carried out using two 10 gram portions of each sample submitted for testing. Each 10 gram sample must be placed aseptically in a sterile container containing 90 ml Clostridium perfringens diluent consisting of 0.1% peptone and 0.8% sodium chloride at a pH of 7 and mixed thoroughly until the sample is evenly suspended.

Inoculations
     3. For each portion of the sample 1 ml of solution must be transferred to a sterile 90 mm petri dish (in duplicate), to which 15 ml of Shahidi - Ferguson agar (SF agar)[25] at a temperature of 47°C±1°C must be added and immediately gently mixed by swirling the dish with 5 clockwise and 5 anticlockwise circular movements.

     4. Once the agar has set, each agar plate must be overlaid with a further 10 ml SF agar at a temperature of 47°C±1°C. Once the overlay has set and with the plate lids uppermost the plates must be incubated anaerobically at 37°C±1°C for 20 hours±2 hours.

Samples with colonies of Clostridium perfringens
     5. After incubation each set of duplicate plates must be examined for colonies characteristic of Clostridium perfringens (black). The sample provisionally fails if any colonies characteristic of Clostridium perfringens are present, in which case the following procedure must be followed to establish whether or not the colonies are Clostridium perfringens.

     6. In the case of each plate, 10 characteristic colonies of Clostridium perfringens must be subcultured on to a further SF agar plate. If there are less than 10 colonies on the plate, all characteristic colonies must be subcultured on to the further plate. The plates must be incubated anaerobically at 37°C±1°C for 20 hours±2 hours.

     7. If the surface area of the plates is overgrown and it is not possible to select well isolated characteristic colonies, 10 suspect colonies must be subcultured on to duplicate SF agar plates and incubated anaerobically at 37°C±1°C for 20 hours±2 hours.

     8. One characteristic colony from each plate must be subcultured on to SF agar and incubated anaerobically at 37°C±1°C for 20 hours±2 hours.

Subcultured colonies
     9. After incubation each plate must be examined for colonies characteristic of Clostridium perfringens. All colonies characteristic of Clostridium perfringens must be -

26

27

28

and incubated anaerobically at 37°C±1°C for 20 hours±2 hours.

Examination of subcultures

Motility
     10. The motility nitrate medium must be examined for the type of growth along the stab line. If there is evidence of diffuse growth out into the medium away from the stab line, the bacteria must be considered to be motile.

Reduction of nitrate to nitrite
     11. After examination of the motility nitrate medium, 0.2 ml to 0.5 ml of nitrite detection reagent must be added to it. The formation of a red colour confirms that the bacteria have reduced nitrate to nitrite. Cultures that show a faint reaction (i.e. a pink colour) must be discounted. If no red colour is formed within 15 minutes, a small amount of zinc dust must be added and the plate allowed to stand for 15 minutes. If a red colour is formed after the addition of zinc dust no reduction of nitrate to nitrite has taken place.

Production of gas and acid from lactose and liquefaction of gelatin
     12. The lactose gelatin medium must be examined for the presence of small gas bubbles in the medium.

     13. The lactose gelatin medium must be examined for colour. A yellow colour indicates fermentation of lactose.

     14. The lactose gelatin medium must be chilled for one hour at 2 - 8°C and then checked to see if the gelatin has liquefied. If the medium has solidified it must be re-incubated anaerobically for a further 18 - 24 hours, the medium chilled for a further one hour at 2 - 8°C and again checked to see if the gelatin has liquefied.

     15. The presence of Clostridium perfringens must be determined on the basis of the results from paragraphs 10 to 14. Bacteria which produce black colonies on SF agar, are non-motile, reduce nitrate to nitrite, produce gas and acid from lactose and liquefy gelatin within 48 hours must be considered to be Clostridium perfringens.

Control Tests
     16. Control tests must be carried out each day that a test is initiated using -

Clostridium perfringens

Escherichia coli

29

Clostridium perfringens.

     17. 10 gram portions of the rendered animal protein must be placed aseptically in each of two sterile containers containing 90 ml Buffered Peprone Water (BPW)[30] and mixed thoroughly until the samples are evenly suspended.

     18. One colony of Clostridium perfringens must be placed in 10 ml BPW and mixed to form an even suspension. 0.1 ml of the suspension must be added to the suspension in the preceding paragraph. This must be repeated for Escherichia coli.

     19. These are then treated and examined in the same way as test samples. If no typical colonies are formed then that day's testing must be invalid and must be repeated.

PART II
METHODS FOR THE ISOLATION OF SALMONELLA
A. BACTERIOLOGICAL METHOD
     1. Tests must be begun on receipt of the sample or on the first working day which allows this method to be completed. If the test is not begun on the day of receipt the sample must be stored in a refrigerator until required. If the sample has been refrigerated it must be removed from the refrigerator and stored at room temperature for at least four hours before the test is started.

Day 1
     2. Tests must be carried out in duplicate using two 25 gram portions of each sample submitted for testing. Each 25 gram sample must be placed aseptically in a sterile container containing 225 ml Buffered Peptone Water (BPW) and incubated at 37°C±1 °C for 18 hours±2 hours.

Day 2
     3. 0.1 ml from the jar of incubated BPW must be inoculated into 10 ml Rappaports Vassiliadis broth (RV broth)[31] and incubated at 41.5°C±0.5°C for 24 hours±3 hours.

Day 3
     4. The RV broth must be plated out on to two 90 millimetre plates of Brilliant Green Agar (BGA)[32] or on to one 90 millimetre plate of BGA and one 90 millimetre plate of Xylose Lysine Deoxycholate Agar (XLD)[33] using a 2.5 mm diameter loop. The plates must be inoculated with a droplet taken from the edge of the surface of the fluid by drawing the loop over the whole of one plate in a zig zag pattern and continuing to the second plate without recharging the loop. The space between the loop streaks must be 0.5 cm - 1.0 cm. The plates must be incubated at 37°C ±2°C for 24 ± 3 hours.

     5. The residual RV broth must be reincubated at 41.5°C±0.5°C for a further 24 hours.

Day 4
     6. The plates must be examined and a minimum of 3 colonies from each plate showing suspicion of Salmonella growth must be subcultured -

34

These media must be incubated at 37°C overnight.

     7. The reincubated RV broth must be plated out as described in paragraph 4.

Day 5
     8. The incubated composite media or equivalent must be examined and the findings recorded, discarding cultures which are obviously not Salmonella. Slide serological tests must be performed using Salmonella polyvalent "O" and polyvalent "H" (phase 1 and 2) agglutinating sera on selected suspect colonies collected from the blood agar or MacConkey plates. If reactions occur with one or both sera, the colonies must be typed by slide serology and a subculture sent to a Regional Veterinary Laboratory of the Veterinary Laboratories Agency of the Department for Environment, Food and Rural Affairs for further typing.

     9. The plates referred to in paragraph 7 must be examined and further action taken as in paragraph 6 and 8.

B. ELECTRICAL CONDUCTANCE METHOD
     1. Tests must be begun on receipt of the sample or on the first working day which allows the following method to be completed. If the test is not begun on the day of receipt the sample must be stored in a refrigerator until required. If the sample has been refrigerated it must be stored at room temperature for at least four hours before the test is started.

Day 1
     2. Tests must be carried out in duplicate using two 25 gram portions of each sample submitted for testing. Each 25 gram sample must be placed aseptically in a sterile container containing 225 ml Buffered Peptone Water/Lysine/Glucose (BPW/L/G)[35] and incubated at 37°C for 18 hours.

Day 2
     3. The incubated BPW/L/G must be added to Selenite Cystine Trimethylamine-N-Oxide Dulcitol (SC/T/D)[36] and Lysine Decarboxylase Glucose (LD/G)[37] media in electrical conductance cells or wells. For cells or wells containing more than 5 ml medium 0.2 ml of the BPW/L/G must be added and for cells or wells containing 5 ml or less medium 0.1 ml of the BPW/L/G must be added. Cells or wells must be connected to appropriate electrical conductance measuring equipment set to monitor and record changes in electrical conductance at 6 minute intervals over a 24 hour period. The temperature of cells and wells must be kept at 37°C.

Day 3
     4. At the end of the 24 hour period, the information recorded by the conductance measuring equipment must be analysed and interpreted using criteria defined by the manufacturers of the equipment. Where a well or cell is provisionally identified as being positive for Salmonella, the result must be confirmed by subculturing the contents of the well or cell on to two 90 millimetre plates of BGA or on to one 90 millimetre plate of BGA and one 90 millimetre plate of Xylose Lysine Deoxycholate Agar (XLD) using a 2.5 mm diameter loop. The plates must be inoculated with a droplet taken from the edge of the surface of the fluid by drawing the loop over the whole of one plate in a zig zag pattern and continuing to the second plate without recharging the loop. The space between the loop streaks must be 0.5 cm - 1.0 cm. The plates must be incubated at 37°C overnight.

Day 4
     5. The plates must be examined and a minimum of 3 colonies from each plate showing suspicion of Salmonella growth must be subcultured -

These media must be incubated at 37°C overnight.

Day 5
6. The incubated composite media or equivalent must be examined and the findings recorded, discarding cultures which are obviously not Salmonella. Slide serological tests must be performed using Salmonella polyvalent "O" and polyvalent "H" (phase 1 and 2) agglutinating sera on selected suspect colonies collected from the blood agar or MacConkey plates. If reactions occur with one or both sera, a subculture must be sent to a Regional Veterinary Laboratory of the Veterinary Laboratories Agency of the Department for Environment, Food and Rural Affairs for further typing.

PART III
METHOD FOR THE ISOLATION OF ENTEROBACTERIACEAE
     1. Tests must be begun on receipt of the sample or on the first working day which allows this method to be completed. If the test is not begun on the day of receipt the sample must be stored in a refrigerator until required at between 2°C and 8°C. If the sample has been refrigerated it must be removed from the refrigerator and stored at room temperature for at least one hour before the test is started.

Samples
     2. Tests must be carried out using five 10 gram portions of each sample submitted for testing. Each 10 gram sample must be placed aseptically in a sterile container containing 90 ml Buffered Peptone Water and mixed thoroughly until the sample is evenly suspended.

Inoculations
     3. For each portion of the sample 1 ml of solution must be transferred to a sterile 90 mm petri dish (in duplicate). The plates must be labelled to identify the portion of sample they were taken from. 15 ml of Violet Red Bile Glucose Agar (VRBGA)[38] at a temperature of 47°C±2°C must be added to each petri dish and immediately gently mixed by swirling the dish with five clockwise and five anticlockwise circular movements.

     4. Once the agar has set, each agar plate must be overlaid with a further 10 ml VRBGA at a temperature of 47°C±2°C. Once the overlay has set, the plates must be inverted and incubated aerobically at 37°C±1°C for 20 hours±2 hours.

Samples with colonies of Enterobacteriaceae
     5. After incubation each set of duplicate plates must be examined for colonies characteristic of Enterobacteriaceae (purple colonies 1 - 2 mm in diameter). All characteristic colonies on each plate must be counted and the arithmetic mean of the duplicate plates taken.

The sample provisionally fails if either -

39

in which case the following procedure must be followed to establish whether or not the colonies are Enterobacteriaceae.

     6. After counting the colonies, characteristic colonies must be taken at random from the agar plates, the number being at least the square root of the colonies counted. The colonies must be subcultured onto a blood agar plate and incubated aerobically at 37°C±1°C for 20 hours±2 hours.

Examination of subcultures
     7. An oxidase test and a glucose fermentation test must be performed on each of the five subcultured colonies. Colonies which are oxidase-negative and glucose fermentation-positive must be considered to be Enterobacteriaceae.

     8. If not all of the colonies prove to be Enterobacteriaceae, the total count in paragraph 5 must be reduced in proportion prior to establishing whether or not the sample should fail.

Controls
     9. Control tests must be carried out each day that a test is initiated using -

Escherichia coli

Enterobacteriaceae

     10. A 10 gram portion of the rendered animal protein must be placed aseptically in a sterile container containing 90 ml BPW and mixed thoroughly until the sample is evenly suspended.

     11. One colony of Escherichia coli must be placed in 10 ml BPW and mixed to form an even suspension. 0.1 ml of the suspension must be added to the suspension in the preceding paragraph.

     12. This is then treated and examined in the same way as test samples. If no typical colonies are formed then that day's testing must be invalid and must be repeated.

SCHEDULE 3regulation 50

Transitional Measures

PART I
INTRA-SPECIES RECYCLING BAN FOR FISH[40]
     1. In accordance with Article 1 of Commission Regulation (EC) No. 811/2003 implementing Regulation (EC) No. 1774/2002 of the European Parliament and of the Council as regards the intra-species recycling ban for fish, the burial and burning of animal by-products and certain transitional measures, the prohibition on the feeding of fish with processed animal protein derived from the bodies or parts of bodies of fish of the same species in Article 22(1)(a) of the Community Regulation shall not apply.

PART II
COLLECTION, TRANSPORTATION AND DISPOSAL OF FORMER FOODSTUFFS[41]
     1. - (1) The National Assembly will be the competent authority for granting approvals under Commission Regulation (EC) No. 813/2003 on transitional measures under Regulation (EC) No. 1774/2002 of the European Parliament and of the Council as regards the collection, transport and disposal of former foodstuffs.

    (2) Instructions, for the purposes of Article 3(3) of that Regulation, of the competent authority may be issued by an inspector.

     2. For the purposes of Article 1(1) of Commission Regulation (EC) No. 813/2003, by way of derogation from Article 6(2)(f) and Article 7 of the Community Regulation, former foodstuffs which have not been mixed with any other animal by-products (other than Category 3 catering waste) may be collected, transported and disposed of or treated in the same way as catering waste.

     3. Where former foodstuffs are mixed with Category 1 or Category 2 material any person in possession or control of the material must ensure that it is disposed of in accordance with Article 1(2) of Commission Regulation (EC) No. 813/2003; and any person who fails to do so will be guilty of an offence.

     4. Where former foodstuffs are sent for disposal in an approved landfill site, any person in possession or control of the material must comply with Article 1(3) of Commission Regulation (EC) No. 813/2003 and any person who fails to do so will be guilty of an offence.

     5. Any person who fails to comply with any instructions given by an inspector under Article 3(3) of Commission Regulation (EC) No. 813/2003 will be guilty of an offence.

     6. In this Part "former foodstuffs" does not include waste from the production of products which are intended to be cooked before they are eaten.

PART III
USKED COOKING OIL IN ANIMAL FEED[42]
Scope
     1. Notwithstanding the prohibition on feeding farmed animals with catering waste or feed materials containing or derived from catering waste used cooking oil may be used for the production of animal feed if it has been collected, treated and blended in accordance with this Part.

     2. This Part is confined to used cooking oil which -

Approvals
3. - (1) The National Assembly may approve -

(2) The approval shall only be granted if the collector or operator was collecting, treating or blending used cooking oils on 1st November 2002.

4. The approval must specify -

     5. - (1) Approval must be suspended immediately if the conditions under which it was granted are no longer fulfilled.

    (2) Once suspended, the approval may only be reinstated subject to fulfilment of the requirements of the Community Regulation in their entirety.

General obligations
     6. - (1) Used cooking oil must be collected, transported, stored, handled, treated, and used in accordance with this Part.

    (2) Any person who fails to comply with paragraph (1) will be guilty of an offence.

    (3) Any used cooking oil which does not comply with the provisions of this Part must be disposed of as directed by notice by an inspector.

     7. Used cooking oil must be -

Collection and transportation of used cooking oil
     8. - (1) Used cooking oil must be collected and transported in lidded containers or leak proof vehicles and identified in such a way that the contents, even after mixing, are traceable to all the premises of origin.

    (2) Collectors must take all necessary measures to ensure that the used cooking oil collected is free from contamination by harmful substances.

    (3) Reusable containers, and all reusable items of equipment or appliances that come into contact with used cooking oil, must be cleaned, washed and disinfected after each use.

    (4) Vehicles or containers which carry any material which could contaminate the used cooking oil must be thoroughly cleansed and disinfected before they are used to carry used cooking oil.

Approved premises and the operation of blending premises
     9. The operator of an approved premises must ensure that the premises comply with, and are operated in accordance with, the provisions of this Part.

     10. - (1) Before mixing with other oil operators of blending premises must ensure that each batch of used cooking oil is tested to ensure compliance with the standards in paragraph 16 of this Part. A batch must be no greater than 30 tonnes.

    (2) Collectors and operators of approved premises must ensure that used cooking oil that does not comply with the standards in paragraph 16 of this Part is not used for animal feed.

Approved premises
     11. - (1) Approved premises must be constructed in such a way that they are easy to clean and disinfect.

    (2) Unauthorised persons and animals must not have access to the premises.

    (3) The premises must have adequate facilities for cleaning and disinfecting the containers or receptacles in which used cooking oil is received and, where appropriate, the vehicles in which it is transported.

    (4) The premises must have adequate lavatories and washing facilities for staff.

    (5) The premises must have a covered space, clearly marked, to receive used cooking oil.

    (6) Where appropriate, the premises must have a separate storage area for any used cooking oil that is not suitable for use in animal feed.

    (7) Tanks must be sealed with vents located and screened in a manner that prevents entry by contaminants or pests.

    (8) Pipework must be sealed when not in use.

Operators'own-checks
     12. - (1) Operators of approved premises must adopt all measures necessary to comply with the requirements of this Part.

    (2) They must put in place, implement and maintain a procedure developed in accordance with the principles of the system of hazard analysis and critical control points (HACCP).

    (3) They must in particular -

13. - (1) The operator of approved blending premises must carry out checks and take samples for the purposes of checking compliance with the standards in paragraph 16.

(2) Where the results of a check or a test show that the used cooking oil does not comply with the provisions of this Part, the operator must -

     14. - (1) The operator must record the results of the checks and tests.

    (2) The operator must keep a sample of each consignment of used cooking oil despatched from the premises for at least six months from the date of despatch.

Hygiene requirements in approved premises
     15. - (1) Containers, receptacles and, where appropriate, vehicles used for transporting used cooking oil must be cleaned in a designated area.

    (2) Preventive measures against birds, rodents, insects or other vermin must be taken systematically.

    (3) Used cooking oil intended for use in animal feed must not be stored in the same area as used cooking oil which is not suitable for use in animal feed or products which may pose a risk to animal or human health.

    (4) Cleaning procedures must be established and documented for all parts of the premises.

    (5) Hygiene control must include regular inspections of the environment and equipment.

    (6) Inspection schedules and results must be recorded.

    (7) Installations and equipment must be kept in a good state of repair.

    (8) Measuring equipment must be calibrated at least once a year.

    (9) Tanks and pipes must be cleaned internally at least once a year or when there is build-up of water and physical contaminants.

    (10) Treated used cooking oil must be handled and stored in such a way as to preclude contamination.

Specification for used cooking oil for use in animal feed
     16. - (1) Used cooking oil must meet the following minimum standards before use in animal feed.

    (2) Physical contamination:

    (3) Presence of mineral oil: absence.

    (4) Presence of oxidised fatty acids: >88% Elutable Fatty acid content.

    (5) Presence of pesticide residues complies with Directive 2002/32/EC[43] of the European Parliament and the Council on undesirable substances in animal feed.

    (6) Presence of PCBs: <100ppb for the 7 main congeners[44].

    (7) Presence of Salmonella: absence.

    (8) Presence of animal fat:

Commercial documents
     17. - (1) Commercial documents may be in written or electronic form.

    (2) A written commercial document or a printout of an electronic document must accompany the consignment of used cooking oil during transportation.

    (3) The producer, receiver and carrier must each retain a copy of a written commercial document or, for electronic information, a record of that information.

    (4) Commercial documents must contain the following information -

Records
     18. - (1) Any person consigning, transporting or receiving used cooking oil must keep a record containing the information specified in the commercial document.

    (2) For used cooking oil which is sutable for use in animal feed, the records must in addition provide for full traceability of the oil from the premises of origin to its incorporation into animal feed.

    (3) For used cooking oil which is not suitable for use in animal feed, the person consigning the oil for disposal must in addition keep a record showing the method and place of disposal and the date the oil was consigned for disposal.

List of premises
     19. - (1) The National Assembly shall maintain a list of the names and addresses of approved:

(2) Each collector and operator of approved premises must be assigned an official identification number.

(3) The National Assembly will make this list publicly available.

PART IV
MAMMALIAN BLOOD[45]
General
     1. By way of derogation from Annex VII, Chapter 11, paragraph 1 of the Community Regulation, mammalian blood may be processed in accordance with this Part.

     2. The National Assembly may approve the use of processing methods 2 to 5 or 7 of Annex V of the Community Regulation for the processing of mammalian blood.

     3. - (1) Approval must be suspended immediately if the conditions under which it was granted are not fulfilled.

    (2) Once suspended, the approval may only be reinstated subject to fulfilment of the requirements of the Community Regulation in their entirety.

    (3) Any material not processed in accordance with this Part or the Community Regulation must be disposed of as instructed by an inspector.

     4. The approval may only be granted if the operator was processing at these premises, using that equipment and using those methods on 1st November 2002.

     5. All other relevant provisions of the Community Regulation must be complied with.

PART V
OLEOCHEMICAL PLANTS USING RENDERED FATS FROM CATEGORY 2 AND CATEGORY 3 MATERIALS[46]
General obligations
     1. By way of derogation from article 14 of the Community Regulation, the National Assembly may approve the use of oleochemical plants to process rendered fats derived from both Category 2 and Category 3 material providing they comply with the following conditions.

     2. - (1) Approval must be suspended immediately if the conditions under which it was granted are not fulfilled.

    (2) Once suspended, the approval may only be reinstated subject to fulfilment of the requirements of the Community Regulation in their entirety.

    (3) Any material not processed in accordance with this Part or the Community Regulation must be disposed of as instructed by an inspector.

     3. The approval may only be granted to premises and facilities that operated in that way on 1st November 2002.

Specific requirements
     4. - (1) Only rendered fats derived from Category 2 and Category 3 materials may be used.

    (2) Rendered fats derived from Category 2 materials must be processed in accordance with the standards in Chapter III of Annex VI of the Community Regulation.

    (3) Additional processes such as distillation, filtration and processing with absorbents must be used to further improve the safety of the tallow derivatives.

PART VI
LOW CAPACITY INCINERATION OR CO-INCINERATION PLANTS WHICH DO NOT INCINERATE OR CO-INCINERATE SPECIFIED RISK MATERIALS OR CARCASES CONTAINING THEM[47]
General obligations
     1. By way of derogation from Article 12(3) of the Community Regulation, the National Assembly may approve the use of low capacity incineration or co-incineration plants which do not meet the requirements laid down in Annex IV to the Community Regulation if they are operated in accordance with this Part.

     2. - (1) Approval must be suspended immediately if the conditions under which it was granted are not fulfilled.

    (2) Once suspended, the approval may only be reinstated subject to fulfilment of the requirements of the Community Regulation in their entirety, including Annex IV.

    (3) Any material not incinerated in accordance with this Part or the Community Regulation must be disposed of as instructed by an inspector.

     3. The approval may only be granted to incinerators that were in operation on 1st November 2002.

Specific requirements
     4. The operator shall take all necessary measures to ensure that -

and failure to do so will be an offence.

5. In the case of a breakdown or malfunction, the operator must reduce or close down operations as soon as practicable until normal operations can be resumed and failure to do so will be an offence.

SCHEDULE 4Regulation 51

Amendments

Amendments to the TSE (Wales) Regulations 2002
     1. The TSE (Wales) Regulations 2002[48] are amended in accordance with this Schedule.

     2. Regulations 33(4), 34(2),52, 54, 56(1)(a), 56(2)(b), 56(4)(c) and (d), 63 to 68, 69(1), (3), (4) and (5) and Schedule 6 are revoked.

     3. At the end of the regulation 13 there shall be added -

4. After regulation 34 there shall be inserted -

Mixing specified risk material with other animal material

34A.

5. For regulation 40 there is substituted the following regulation -

40.

6. For Schedule 5 (Application of Part IV of the Regulations to scheme animals) there shall be substituted the following Schedule -

SCHEDULE 5
APPLICATION OF PART IV OF THE REGULATIONS TO SCHEME ANIMALS

PROVISION OF THE REGULATIONS	EXTENT TO WHICH THE PROVISON APPLIES TO SCHEME ANIMALS
Regulation 33(3)	Not applicable
Regulation 33(4)	Subject to the modification that from the point at which specified risk material derived from a scheme animal is removed from the slaughterhouse, it may come into contact with any other animal material from such an animal
Regulation 34	Not applicable
Regulation 39(3)(b)	Not applicable
Regulation 57	Not applicable

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations make provision in Wales for the administration and enforcement of Regulation (EC) No. 1774/2002 of the European Parliament and of the Council of 3rd October 2002 laying down health rules concerning animal by-products not intended for human consumption (OJ No. L273, 10.10.2002, p.1) ("the Community Regulation"). They revoke the Animal By-Products Order 1999, S.I. 1999/646, and the Animal By-Products (Amendment) (Wales) Order 2001, S.I. 2001/1735 (W.122).

They also make provision for the enforcement of the following measures, which amend the Community Regulation and make provision for transitional arrangements -

(a) Commission Regulation (EC) No. 808/2003 amending Regulation (EC) No. 1774/2002 of the European Parliament and of the Council laying down health rules concerning animal by-products not intended for human consumption[

Provision in Wales for the administration and enforcement of measures in the Community Regulation in relation to export and trade between Member States is intended to be made by a separate instrument.

The Community Regulation categorises material comprising or containing animal by-products to which these Regulations apply as -

category 1 material where the by-products

category 2 material where the by-products

category 3 material where the by-products derive from animals which are fit for human consumption in accordance with Community legislation and are

The Regulations provide as follows:

Regulation 10 enforces the restrictions on use of animal by-products in Article 22 of the Community Regulation. This includes intra-species re-cycling, feeding catering waste to farm animals and the application of organic fertilisers on pasture land. Regulation 11 defines pasture land. Regulation 12 permits the intra-species re-cycling of fish after 1 January 2004. Until then it is permitted by a transitional measure in Part VI of Schedule 4.

Regulations 13 to 16 provide for the approval of premises for the different types of treatment of animal by-products. Regulation 16 provides that composting on premises where the composted material originated do not need approval if the conditions of that regulation are complied with.

Regulations 17 to 21 provide for checks at plants, sampling and approved laboratories.

Regulations 22 to 24 regulate placing on the market of various processed animal by-products.

Regulations 25 to 27 provide derogations relating to the use of animal by-products for taxidermy and feeding certain specified animals. Regulation 28 permits the burial of pet animals.

Regulation 29 and 30 provide for burial or burning in the event of a disease outbreak or for burning and burial of bees and apiculture products.

Regulations 31 to 38 provide for record keeping.

Regulations 39 to 41 provide for applications for approvals, the suspension or revocation of approvals and an appeal against a notice to amend, suspend or revoke an approval.

Under regulations 42 to 44 an inspector can serve a notice requiring the disposal of animal by-product or catering waste and requiring cleansing and disinfection of any vehicle, container or premises. Any notice served under these Regulations must be complied with at the expense of the person on whom the notice is served.

Regulations 45 and 46 provide powers of entry and an offence of obstructing an inspector.

Schedule 1 makes provision for biogas and composting plants, and Schedule 2 provides for testing methods.

Schedule 3 contains transitional provisions relating to intra-species re-cycling of fish, disposal of former foodstuffs, used cooking oils in animal feed, disposal of mammalian blood, oloechemical plants and low capacity incinerators.

Breach of the Regulations is an offence punishable on summary conviction to a fine up to the statutory maximum or six months imprisonment. On indictment the penalty is an unlimited fine or two years imprisonment (regulation 48).

The Regulations are enforced by the local authority except in specified premises (regulation 49).

A Regulatory appraisal has been prepared and is available from the Animal Health Division, National Assembly for Wales, Cathays Park, Cardiff CF10 3NQ.