Made | 19th August 2005 | ||
Laid before Parliament | 24th August 2005 | ||
Coming into force | 28th September 2005 |
1. | Title, extent and commencement |
2. | Interpretation |
3. | Approvals, etc. |
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 |
9. | Restrictions on feeding catering waste and other animal by-products |
10. | Intra-species recycling |
11. | Access to catering waste and other animal by-products |
12. | Pasture land |
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 |
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 |
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. | Remote areas |
30. | Burial in the event of a disease outbreak |
31. | Burning and burial of bees and apiculture products |
32. | Records |
33. | Records for consigning, transporting or receiving animal by-products |
34. | Records for burying or burning of animal by-products |
35. | Records for disposal or use on premises |
36. | Delivery records to be kept by operators of biogas and composting plants |
37. | Treatment records for biogas and composting plants |
38. | Records for approved laboratories |
39. | Records to be kept for consignments of compost or digestion residue |
40. | Grant of approvals, etc. |
41. | Suspension, amendment and revocation of approvals, etc. |
42. | Representations to an appointed person |
43. | Notice requiring the disposal of animal by-products or catering waste |
44. | Cleansing and disinfection |
45. | Compliance with notices |
46. | Powers of entry |
47. | Obstruction |
48. | Penalties |
49. | Enforcement |
50. | Transitional measures: technical products |
51. | Transitional measures: photographic products from gelatine |
52. | Transitional measures: milk |
53. | Transitional measures with expiry dates |
54. | Repeals and revocation |
SCHEDULE 1— | Additional requirements for biogas and composting plants |
SCHEDULE 2— | Ruminant derived fluid |
SCHEDULE 3— | Testing Methods |
SCHEDULE 4— | Transitional Measures |
(2) Category 1 material, Category 2 material and Category 3 material comprise the animal by-products set out in Articles 4, 5 and 6 respectively of the Community Regulation, and other expressions defined in the Community Regulation have the same meaning in these Regulations.
Approvals, etc.
3.
Any approval, authorisation, registration, instruction, notice or recognition issued under these Regulations or the Community Regulation must be in writing, and may be made subject to such conditions as are necessary to—
Intra-species recycling
10.
—(1) It is an offence to contravene Article 22(1)(a) of the Community Regulation (which prohibits intra-species re-cycling).
(2) Notwithstanding paragraph (1), it is not an offence to feed fish with processed animal protein derived from the bodies or parts of bodies of fish if this is done in accordance with Articles 2 to 4 of, and Annex I to, Commission Regulation (EC) No. 811/2003.
(3) The Secretary of State is the competent authority for the purposes of Article 5 of Commission Regulation (EC) No. 811/2003.
Access to catering waste and other animal by-products
11.
This regulation applies in relation to—
(b) other animal by-products that have not been processed or treated in accordance with the Community Regulation and these Regulations.
(2) Any person who brings any catering waste or other animal by-product (other than milk, colostrum, manure or digestive tract content) on to any premises where any livestock is kept is guilty of an offence.
(3) Paragraph (2) does not apply if the occupier of the premises and the person in control of the by-products ensure that livestock do not have access to the by-products, and if the animal by-products are—
(c) intended for feeding to animals on the premises in accordance with Article 23(2) of the Community Regulation as applied by regulation 26(3) of these Regulations.
(4) Any person who is in possession of the carcase or part of a carcase of any livestock that has not been slaughtered for human consumption must, pending consignment or disposal in accordance with the Community Regulation and these Regulations, ensure that it is held in such a way that animals and birds (including wild animals and birds) do not have access to it, and failure to do so is an offence.
(5) It is an offence for any person to allow livestock to have access to any catering waste or other animal by-product except—
(6) It is an offence for any person to allow any animal to have access to material derived from catering waste or other animal by-product in a biogas or composting plant, except that it is not an offence for wild birds to have access to the material during the secondary or subsequent phase of composting.
(7) In this regulation "livestock" means all farmed animals, and any other ruminant animals, pigs and birds (other than wild birds).
Pasture land
12.
—(1) It is an offence to contravene Article 22(1)(c) of the Community Regulation (application of material to pasture land).
(2) For the purposes of paragraph (1), pasture land is land that is intended to be used for grazing or cropping for feedingstuffs following the application or deposit of organic fertilisers and soil improvers (other than manure or digestive tract content) within the following periods—
(3) Any person who—
is guilty of an offence.
(2) She is also the competent authority for—
(3) The use of the processes described in Annexes I to V to Commission Regulation (EC) No. 92/2005 is authorised in accordance with Articles 1 and 2 of that Regulation and the Secretary of State is the competent authority for the purposes of ensuring that Article 5(3) of that Regulation is complied with.
Approval of premises
14.
—(1) No person may operate any—
for the storage, processing, treatment, disposal or use of animal by-products or processed products unless —
are approved for that purpose in accordance with the Community Regulation and these Regulations.
(2) The operator of approved premises must ensure that—
(b) any person employed by him, and any person permitted to enter the premises, complies with those conditions and requirements.
(3) The operator of a high capacity incineration or co-incineration plant that incinerates or co-incinerates material referred to in Article 4(1)(b) of the Community Regulation 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; but for the avoidance of doubt, this provision does not apply in relation to the incineration or co-incineration of a product derived from material referred to in Article 4(1)(b) of the Community Regulation that has already been processed or treated in accordance with the Community Regulation.
(4) Any person who fails to comply with any provision of this regulation is guilty of an offence.
Biogas and composting plants
15.
—(1) The provisions of Part I of Schedule 1 to these Regulations apply in a biogas and composting plant used for treating any 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) of and Annex VI, Chapter II, paragraph 14 to the Community Regulation—
(3) Any operator who fails to comply with this regulation is guilty of an offence.
Composting catering waste on the premises on which it originates
16.
In accordance with Article 6(2)(g) of, and Annex VI, Chapter II, paragraph 14 to 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 —
Processing and intermediate plants' own checks
17.
—(1) Any person who fails to comply with Article 25(1) of the Community Regulation is guilty of an offence.
(2) Any person who fails to comply with Article 25(2) of the Community Regulation is guilty of an offence.
(3) The operator must record the action taken in accordance with Article 25(2) of the Community Regulation as soon as is reasonably practicable , and failure to do so is an offence.
(4) Schedule 2 (ruminant derived fluid) has effect in relation to fluid arising from the processing of ruminant animal by-products.
Sampling at processing plants
18.
—(1) If a processing plant is processing Category 1 or Category 2 material and processed proteinaceous material is to be sent to landfill (or, in the case of Category 2 material, is applied to land or sent to a biogas or composting plant) the operator must, once every week—
(2) If a processing plant is processing Category 3 material and the processed proteinaceous material is intended for use in feedingstuffs the operator must, on each day that the material is consigned from the premises—
(3) If a processing plant is processing Category 3 material and the processed proteinaceous material is not intended for use in feedingstuffs the operator must, once every week —
(4) Any person who fails to comply with any provision of this regulation is 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) 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—
(c) record the action taken in accordance with this regulation.
(3) Any person who fails to comply with any provision of this regulation is guilty of an offence.
Samples sent to laboratories
20.
—(1) Whenever an operator sends a sample to a laboratory in accordance with this Part, he must send with the sample the following information in writing—
(2) No person shall tamper with a sample taken under these Regulations with intent to affect the result of the test.
(3) The operator shall keep a record of all results of laboratory tests.
(4) Any person who fails to comply with paragraphs (1) or (3) or who contravenes paragraph (2) is guilty of an offence.
Laboratories
21.
—(1) The Secretary of State shall approve laboratories under this regulation to carry out one or more of the tests in this regulation if she is satisfied that they have the necessary facilities, personnel and operating procedures to do so.
(2) In deciding whether to grant or continue an approval, the Secretary of State may require the laboratory to successfully undertake any quality control tests as she 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 is an offence.
(4) A test for Clostridium perfingens must be carried out in accordance with the method in Part I of Schedule 3 or (if specified in the approval) with a method which conforms with ISO 7937/1997 (BS-EN 13401:1999) (Enumeration of Clostridium perfingens) or equivalent[17].
(5) A test for Salmonella must be carried out in accordance with one of the methods in Part II of Schedule 3 or (if specified in the approval) with a method that conforms with—
(6) A test for Enterobacteriaceae must be carried out in accordance with the method in Part III of Schedule 3 or (if specified in the approval) with a method which conforms with ISO 7402/1993 (BS 5763: Part 10: 1993) (Enumeration of Enterobacteriaceae) or equivalent[20].
(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 Secretary of State and the operator of the premises if—
and failure to do so is an offence.
(8) The operator of a laboratory approved under this regulation must in relation to processed material notify the Secretary of State on the last day of each month of the number, type and results of tests carried out in that month, and failure to do so is an offence.
(9) If the sample has been sent to the approved laboratory from premises outside England, the requirements in this regulation to notify the Secretary of State shall be construed as a requirement to notify the competent authority for the premises from which the sample was sent.
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 has his attention drawn to the requirements of regulation 12 (provisions relating to pasture land) and any person who fails to do so is guilty of an offence.
(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 Secretary of State shall maintain a register of premises authorised 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.
(5) The register in the previous paragraph shall contain the following information—
(6) In this regulation and in the following regulation "zoo" means premises either licensed under the Zoo Licensing Act 1981[21] or premises in relation to which the Secretary of State has granted a dispensation under section 14 of that Act.
(7) Any person who uses animal by-products for any of the purposes in this regulation other than in accordance with an authorisation is 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 for the purposes of feeding animal by-products to—
unless the premises and the operator of the premises are authorised.
(2) No person may operate any premises on which animal by-products are collected and treated for feeding to zoo or circus animals on other premises unless the premises on which the by-products are collected and treated and the operator of those premises are authorised.
(3) Operators of premises authorised under this regulation must maintain and operate the premises in accordance with—
(4) They must also ensure that any person employed on, or invited on to, the premises complies with those conditions and requirements.
(5) Any person who fails to comply with any provision of this regulation is 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.
Remote areas
29.
—(1) Only the Isles of Scilly and Lundy Island are remote areas for the purposes of Article 24(1)(b) of the Community Regulation and accordingly the animal by-products referred to in that sub-paragraph and originating in those areas may be disposed of by burning or burial on site provided that this is done in accordance with Part C of Annex II to Commission Regulation (EC) No. 811/2003[22].
(2) The Secretary of State is the competent authority for the purposes of Article 7 of, and Part C of Annex II to, Commission Regulation (EC) No. 811/2003.
Burial in the event of a disease outbreak
30.
—(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, on site burning or burial (as defined in Part A of Annex II to Commission Regulation (EC) No. 811/2003) of animal by-products is not an offence if the animal by-product is transported, and buried or burnt, in accordance with—
(2) The Secretary of State is 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
31.
In accordance with Article 8 of Commission Regulation (EC) 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.
and failure to do so is an offence.
Treatment records for biogas and composting plants
37.
The operator of a biogas or composting plant treating catering waste or other animal by-products must record—
and failure to do so is an offence.
Records for approved laboratories
38.
The operator of a laboratory approved under regulation 21 must, as soon as is reasonably practicable, record—
and failure to do so is an offence.
Records to be kept for consignments of compost or digestion residue
39.
—(1) Subject to paragraph (2), the occupier of premises on which ruminant animals, pigs or birds are kept must, as soon as is reasonably practicable, record—
and failure to do so is an offence.
(2) The requirement in paragraph (1) to make records does not apply in the case of any supply of compost or digestion residue for use at any premises used only as a dwelling.
(3) If the Secretary of State refuses to grant an approval, authorisation or registration, or grants it subject to a condition she shall by notice in writing served on the applicant —
(4) During validation of premises for the purposes of granting an approval, authorisation or registration, the Secretary of State may direct in writing how the processed or treated material must be disposed of, and failure to comply with this direction is an offence.
Suspension, amendment and revocation of approvals, etc.
41.
—(1) The Secretary of State, by notice served on the operator—
(2) A suspension or amendment under paragraph 1(b)—
(3) The notice shall—
(4) If the notice does not have immediate effect, and representations are made under regulation 42, an amendment or suspension shall not have effect until the final determination by the Secretary of State in accordance with the following regulation unless the Secretary of State decides that it is necessary for the protection of public or animal health for the amendment or suspension to have immediate effect and gives notice to the operator.
(5) The Secretary of State may by notice revoke an approval, authorisation or registration if, following representations made under regulation 42, if any, in accordance with the following regulation, which upholds a suspension, she is satisfied, taking into account all the circumstances of the case, that the premises will not be operated in accordance with these Regulations and the Community Regulation.
Representations to an appointed person
42.
—(1) A person may make written representations concerning a refusal, suspension or amendment under regulations 40 or 41 within 21 days of notification of the decision to a person appointed for the purpose by the Secretary of State.
(2) The appointed person shall report in writing to the Secretary of State.
(3) The Secretary of State shall give to the appellant written notification of her final determination and the reasons for it.
Notice requiring the disposal of animal by-products or catering waste
43.
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, he may —
Cleansing and disinfection
44.
—(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, he 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—
Compliance with notices
45.
—(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 is guilty of an offence.
Powers of entry
46.
—(1) An inspector shall, on producing, if so required, some duly authenticated document showing his authority, have a right at all reasonable hours, to enter any land or premises (including any domestic premises if they are being used for any purpose in connection with the Community Regulation or these Regulations) for the purpose of ensuring that the Community Regulation and these Regulations are being complied with; and in this regulation "premises" includes any vehicle or container.
(2) An inspector may—
(3) Any person who defaces, obliterates or removes any mark applied under paragraph (2) is guilty of an offence.
(4) If an inspector enters any unoccupied premises he shall leave them as effectively secured against unauthorised entry as he found them.
Obstruction
47.
Any person is guilty of an offence if he—
Penalties
48.
—(1) A person guilty of an offence under these Regulation is liable—
(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—
he, as well as the body corporate, is guilty of the offence and 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
49.
—(1) These Regulations shall be enforced by the Secretary of State in relation to—
(2) From 1st January 2006 (when the Regulations in paragraph (1) will be revoked in England by the coming into force of the Food Hygiene (England) Regulations 2005[28]), they shall be enforced by the Secretary of State in any slaughterhouses, game handling establishments, and cutting plants placing fresh meat on the market where the Food Standards Agency enforces those Regulations.
(3) Other than as specified in paragraphs (1) and (2) these Regulations shall be enforced by the local authority.
(4) The Secretary of State 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 shall be discharged by the Secretary of State and not by the local authority.
Transitional measures: technical products
50.
—(1) Notwithstanding regulations 4 and 5, the placing on the market of the types of Category 1 and 2 material referred to in Article 1 of Commission Regulation (EC) No. 878/2004 for consignment to a dedicated technical plant approved in accordance with Article 18 of the Community Regulation is authorised in accordance with Article 2 of that Regulation.
(2) It is an offence to fail to comply with Article 4(1) of Commission Regulation (EC) No. 878/2004 (placing on the market) or Article 5 of that Regulation (collection and transportation).
Transitional measures: photographic products from gelatine
51.
—(1) Notwithstanding regulation 4, in accordance with Article 1 of Commission Decision 2004/407/EC, the use of gelatine is authorised for the manufacture of photographic products if it has been—
(2) The manufacture of photographic products must be carried out in the photographic factory listed in Annex I to that Decision, and in accordance with an approval granted for the purpose by the Secretary of State.
(3) The Secretary of State shall immediately suspend the approval if the conditions of this regulation are not complied with.
(4) No person shall—
(5) The operator of the approved photographic factory shall ensure that any surpluses or residues of and other waste derived from the photographic gelatine are—
(6) The operator of the approved photographic factory shall keep records for at least two years detailing the purchases and uses of photographic gelatine, as well as the disposal of residues and surplus material.
(7) An inspector may serve a notice on any person in possession or control of any material to which this regulation applies and which has not been transported, used or disposed of in accordance with this regulation, requiring him to dispose of the material as specified in the notice.
(8) Failure to comply with any provision of this regulation or a notice served under it is an offence.
Transitional measures: milk
52.
The collection, transportation, processing, use and storage of milk, milk-based products and milk-derived products is authorised in accordance with Article 1 of Commission Regulation (EC) No. 79/2005, and the Secretary of State is the competent authority for the purposes of issuing registrations and authorisations in accordance with that Regulation.
Transitional measures with expiry dates
53.
—(1) Schedule 4 (transitional measures) shall have effect.
(2) Part I of Schedule 4 (transitional measures on the collection, transportation and disposal of former foodstuffs) shall cease to have effect on 1st January 2006.
(3) Part II of Schedule 4 (oleochemical plants using rendered fats from Category 2 and 3 materials) shall cease to have effect on 1st November 2005.
Repeals and revocation
54.
—(1) The following are repealed in so far as they have effect in England—
(2) The Rendering (Fluid Treatment) (England) Order 2001[34] and the Animal By-Products Regulations 2003[35] are revoked.
Ben Bradshaw
Parliamentary Under Secretary of State Department for Environment, Food and Rural Affairs
19th August 2005
(2) The clean area shall 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 shall be laid so that liquid cannot seep into the clean area from the other areas.
(3) The reception area shall be easy to clean and disinfect and shall have an enclosed and lockable place or container to receive and store the untreated animal by-products.
2.
The animal by-products shall be unloaded in the reception area and either—
3.
The plant shall 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 shall be cleaned in the dedicated area 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.
System | Composting in a closed reactor | Composting in a closed reactor | Composting in housed windrows |
Maximum particle size | 40cm | 6cm | 40cm |
Minimum temperature | 60°C | 70°C | 60°C |
Minimum time spent at the minimum temperature | 2 days | 1 hour | 8 days (during which the windrow shall be turned at least 3 times at no less than 2 days intervals) |
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 |
Biogas plants
4.
The approval for a biogas plant shall specify one of the methods in the table and in addition require that either —
(b) treat the fluid arising from the processing on the processing premises in such a way that the treated fluid has—
(3) This paragraph does not apply in relation to blood that has not been mixed with any other ruminant material.
Measurement of treated fluid
2.
—(1) In order to ensure that the treated fluid complies with the levels in paragraph 1(1)(b) an operator who treats fluid in accordance with that paragraph shall as a minimum carry out the following measurements.
(2) He shall continuously monitor the level of suspended solids in the treated fluid or alternatively measure it three times a day.
(3) Once a week he shall measure the level of suspended solids in the treated fluid by a method that conforms with "Suspended Settleable and Total Dissolved Solids in Waters and Effluents[38]".
(4) Once a week he shall measure the biochemical oxygen demand of the treated fluid by a method which conforms with the "5 day Biochemical Oxygen Demand (BOD5)[39]".
(5) If any of these measurements demonstrates that the treated fluid does not comply with the levels in paragraph 1(1)(b) the operator shall ensure that he only discharges the treated fluid in accordance with paragraph 1(1)(a) until further tests show that the treatment system is achieving the required levels.
(6) It is an offence to fail to comply with any provision of this paragraph.
Records
3.
—(1) Any person who processes any ruminant animal by-products shall, as soon as is reasonably practicable, record the dates and results of the measurements taken in accordance with paragraph 2.
(2) For all fluid discharged or consigned from the processing premises he shall, as soon as is reasonably practicable, record—
(3) It is an offence to fail to comply with any provision of this paragraph.
Records of consignment
4.
—(1) Any person who consigns any fluid arising from the processing of ruminant animal by-products (whether or not he processed the by-products himself) from any premises shall, as soon as is reasonably practicable, record—
(2) He shall give a copy to the person who transports the fluid.
(3) The transporter shall keep his copy of the record with the consignment until the fluid is discharged or disposed of.
(4) The consignor shall keep a copy of the record for at least two years, and the transporter shall keep it for at least two years.
(5) It is an offence to fail to comply with any provision of this paragraph.
and incubated anaerobically at 37°C±1°C for 20 hours±2 hours.
Motility
10.
The motility nitrate medium shall 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 shall 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 shall 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) should be discounted. If no red colour is formed within 15 minutes, a small amount of zinc dust shall 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 shall be examined for the presence of small gas bubbles in the medium.
13.
The lactose gelatin medium shall be examined for colour. A yellow colour indicates fermentation of lactose.
14.
The lactose gelatin medium shall 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 shall 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 shall 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 shall be considered to be Clostridium perfringens.
Control Tests
16.
Control tests shall be carried out each day that a test is initiated using—
17.
10 gram portions of the rendered animal protein shall be placed aseptically in each of two sterile containers containing 90 ml Buffered Peptone Water (BPW)[45] and mixed thoroughly until the samples are evenly suspended.
18.
One colony of Clostridium perfringens shall be placed in 10 ml BPW and mixed to form an even suspension. 0.1 ml of the suspension shall be added to the suspension in the preceding paragraph. This shall 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 shall be invalid and shall be repeated.
These media shall be incubated at 37°C overnight.
7.
The reincubated RV both shall be plated out as described in paragraph 4.
Day five
8.
On day five the incubated composite media or equivalent shall be examined and the findings recorded, discarding cultures which are obviously not Salmonella. Slide serological tests shall 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 shall be typed by slide serology. If requested in writing by the Secretary of State, the operator of the laboratory shall send a subculture 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 shall be examined and further action taken as in paragraph 6 and 8.
B. ELECTRICAL CONDUCTANCE METHOD
10.
Tests shall 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 shall be stored in a refrigerator until required. If the sample has been refrigerated it shall be stored at room temperature for at least four hours before the test is started.
Day one
11.
On day one tests shall be carried out in duplicate using two 25 gram portions of each sample submitted for testing. Each 25 gram sample shall be placed aseptically in a sterile container containing 225 ml Buffered Peptone Water/Lysine/Glucose (BPW/L/G)[50] and incubated at 37°C for 18 hours.
Day two
12.
On day two the incubated BPW/L/G shall be added to Selenite Cystine Trimethylamine-N-Oxide Dulcitol (SC/T/D)[51] and Lysine Decarboxylase Glucose (LD/G)[52] 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 shall be added and for cells or wells containing 5 ml or less medium 0.1 ml of the BPW/L/G shall be added. Cells or wells shall 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 shall be kept at 37°C.
Day three
13.
On day three, at the end of the 24 hour period, the information recorded by the conductance measuring equipment shall 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 shall 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 shall 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 shall be 0.5 cm - 1.0 cm. The plates shall be incubated at 37°C overnight.
Day four
14.
On day four the plates shall be examined and a minimum of 3 colonies from each plate showing suspicion of Salmonella growth shall be subcultured -
These media shall be incubated at 37°C overnight.
Day five
15.
On day five the incubated composite media or equivalent shall be examined and the findings recorded, discarding cultures which are obviously not Salmonella. Slide serological tests shall 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 shall be typed by slide serology. If requested in writing by the Secretary of State, the operator of the laboratory shall send a subculture to a Regional Veterinary Laboratory of the Veterinary Laboratories Agency of the Department for Environment, Food and Rural Affairs for further typing.
in which case the following procedure shall be followed to establish whether or not the colonies are Enterobacteriaceae.
6.
After counting the colonies, characteristic colonies shall be taken at random from the agar plates, the number being at least the square root of the colonies counted. The colonies shall 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 shall be performed on each of the five subcultured colonies. Colonies which are oxidase-negative and glucose fermentation-positive shall be considered to be Enterobacteriaceae.
8.
If not all of the colonies prove to be Enterobacteriaceae, the total count in paragraph 5 shall be reduced in proportion prior to establishing whether or not the sample should fail.
Controls
9.
Control tests shall be carried out each day that a test is initiated using -
10.
A 10 gram portion of the rendered animal protein shall 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 shall be placed in 10 ml BPW and mixed to form an even suspension. 0.1 ml of the suspension shall 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 shall be invalid and shall be repeated.
Provision in England for the administration and enforcement of measures in the Community Regulation in relation to import, export and trade between member States is made by separate instruments.
The Regulations provide as follows.
It is a specific offence to categorise, collect, transport, dispose, store, process or use, category 1, category 2 or category 3 material other than in accordance with the Community Regulation (regulations 4, 5 and 6). A mixture of mammalian and non-mammalian by-products are to be treated as mammalian by-products (regulation 7).
It is a specific offence to collect, transport, identify or store animal by-products other than in accordance with the Community Regulation (regulation 8).
Regulations 9 and 10 enforce the restrictions on the feeding of catering waste and processed animal protein in Article 22 of the Community Regulation. Additionally regulation 9 prohibits the feeding to farmed animals of other unprocessed animal by-products.
Regulation 11 restricts access to catering waste and other animal by-products.
Regulation 12 enforces the restrictions in Article 22 of the Community Regulation on the application of organic fertiliser to pasture land.
Regulations 13 to 15 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 does 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 the placing on the market of various products derived from 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 permits burial and burning in remote areas, which are defined as Lundy Island and the Isles of Scilly. Regulations 30 and 31 provide for burial or burning in the event of a disease outbreak and for burning and burial of bees and apiculture products.
Regulations 32 to 39 provide for record keeping.
Regulations 40 to 42 provide for applications for approvals, authorisations and registrations, their suspension or revocation and for representations against a notice to amend, suspend or revoke them.
Under Regulations 43 to 45 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 shall be complied with at the expense of the person on whom the notice is served.
Regulations 46 and 47 provide powers of entry and an offence of obstructing an inspector.
The Regulations are enforced by the local authority except in specified premises (regulation 49).
Regulations 50 to 52 provide for transitional measures for technical products, photographic products from gelatine and milk (which do not have an expiry date).
Schedule 1 makes provision for biogas and composting plants.
Schedule 2 makes provision for the disposal of fluid from rendering ruminant animal by-products.
Schedule 3 provides for testing methods.
Schedule 4 contains transitional provisions relating to the disposal of former foodstuffs and to oloechemical plants (which do have an expiry date).
Breach of the Regulations is an offence punishable on summary conviction to a fine up to the statutory maximum or three months imprisonment. On indictment the penalty is an unlimited fine or two years imprisonment (regulation 48)
A Regulatory Impact Assessment has been prepared and placed in the library of each House of Parliament. Copies can be obtained from BSE Division of the Department for Environment, Food and Rural Affairs, 1A Page Street, London, SW1P 4PQ.
[3] OJ No. L273, 10.10.2002, p.1.back
[4] OJ No. L117, 13.5.2003, p. 1.back
[5] OJ No. L117, 13.5.2003, p. 14.back
[6] OJ No. L117, 13.5.2003, p. 22.back
[7] OJ No. L117, 13.5.2003, p. 42.back
[8] OJ No. L 151,30.4.2004, p. 11 as corrected by a Corrigendum published in the Official Journal at OJ No. L208, 10.6.2004, p. 9 and as further corrected by a Corrigendum published in the Official Journal at OJ No. L 396, 31.12.2004, p. 63.back
[9] OJ No. L112, 19.4.2004, p. 1.back
[10] OJ No. L162, 30.4.2004, p. 62.back
[11] OJ No. L16, 20.1.2005, p. 46.back
[12] OJ No. L19, 21.1.2005, p. 27.back
[13] OJ No. L19, 21.1.2005, p. 34.back
[14] S.I. 1994/867 to which there are amendments not relevant to these Regulations.back
[15] Chapter VII was added to Annex IV by Commission Regulation (EC) No. 808/2003.back
[16] This paragraph was added by Commission Regulation (EC) No. 808/2003.back
[17] Published by the British Standards Institute, British Standards House, 389 Chiswick High Road, London W4 4AL.back
[18] Published by the British Standards Institute; see above.back
[19] Published by the British Standards Institute; see above.back
[20] Published by the British Standards Institute; see above.back
[22] OJ No. L117, 13.5.2003, p. 14.back
[23] S. I. 1995/539 as amended by S.I. 1995/731, 1995/1763, 1995/2148, 1995/2200, 1995/3124, 1995/3189, 1996/1148, 1996/2235, 1997/1729, 1997/2074,. 2000/225, 2000/656, 2000/2215, 2001/1512, 2001/1739, 2001/1771, 2001/2601, 2001/3451, 2002/118 and 2002/889.back
[24] S.I. 1995/540 as amended by S.I.. 1995/1763, 1995/2148, 1995/2200, 1995/3205, 1997/1729, 2000/225,. 2000/656,. 2000/2215, 2001/3399, 2002/889 and 2005/209.back
[25] S.I. 1995/2148 as amended by S.I. 1995/3205 and 2000/656.back
[26] S.I. 1994/3082 as amended by S.I. 1995/539, 1995/1763, 1995/2200, 1995/3205,. 1996/1499, 1999/683,. 2000/225, 2000/656, 2000/790, 2000/2215, 2001/1512, 2001/1771, 2001/2601 and 2002/118.back
[27] S.I. 1995/3205 as amended by S.I. 1996/3124, S. I. 2000/225, S. I. 2000/656, 2000/2215, 2001/1512, 2001/1739, 2001/1771, 2001/2601, 2001/3451 and 2002/118.back
[29] ()OJ No. L 332, 28.12.2000, p. 91.back
[30] ()OJ No. L 182, 16.7.1999, p. 1; Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).back
[31] ()OJ No. L 30, 6.2.1993, p. 1; Regulation as last amended by Commission Regulation (EC) No 2557/2001 (L 349, 31.12.2001, p. 1).back
[38] This is set out in the series "Methods for the Examination of Waters and Associated Materials" available on the Environment Agency internet web-page (http://www.environment-agency.gov.uk/nls) but previously published by HMSO as ISBN 011751957X.back
[39] This is set out in the series "Methods for the Examination of Waters and Associated Materials" available on the Environment Agency internet web-page (http://www.environment-agency.gov.uk/nls) but previously published by HMSO as ISBN 0117522120.back
[40] Shahidi-Ferguson agar- See Shahidi, S. A. and Ferguson, A. R. (1971) Applied Microbiology 21:500-506.American Society for Microbiology, 1913 1 St N.W., Washington DC 20006, USA.back
[41] Motility nitrate medium-See Hauschild AHW, Gilbert RJ, Harmon SM, O'Keefe MF, Vahlefeld R, (1997) ICMSF Methods Study VIII, Canadian Journal of Microbiology 23, 884-892. National Research Council of Canada, Ottawa ON K1A oR6, Canadaback
[42] Lactose gelatin medium- See Hauschild AHW, Gilbert RJ, Harmon SM, O'Keefe MF, Vahlefield R, (1997) ICMSF Methods Study VIII, Canadian Journal of Microbiology 23, 884-892.back
[43] Charcoal gelatin discs-See Mackie and McCartney, (1996) Practical Medical Microbiology 14, 509. Churchill Livingstone, Robert Stevenson House, 1-3 Baxter's Place, Leith Walk, Edinburgh EH1 3AF.back
[44] The National Collection of Type Cultures, Central Public Health Laboratory, 61 Colindale Ave, London NW9 5HT.back
[45] Buffered Peptone Water – See Edel, W. and Kampelmacher, E.H. (1973) Bulletin of World Health Organisation, 48: 167-174, World Health Organisation Distribution and Sales, CH-1211, Geneva 27, Switzerland (ISSN 0042-9686).back
[46] Rappaports Vassiliadis Broth—See Vassiliadis P, Pateraki E, Papaiconomou N, Papadkis J A, and Trichopoulos D (1976) Annales de Microbiologie (Institut Pasteur) 127B: 195-200. Elsevier, 23 rue Linois, 75724 Paris, Cedex 15, France.back
[47] Brilliant Green Agar—See Edel W and Kampelmacher E H (1969) Bulletin of World Health Organisation 41:297-306, World Health Organisation Distribution and Sales, CH-1211, Geneva 27, Switzerland (ISSN 0042-9686).back
[48] Xylose Lisene Deoxycholate Agar—See Taylor W I, (1965) American Journal of Clinical Pathology, 44:471-475, Lippincott and Raven, 227E Washington Street, Philadelphia PA 19106, USA.back
[49] MacConkey agar—See (1963) International Standards for Drinking Water, World Health Distribution and Sales, CH-1211, Geneva 27, Switzerland.back
[50] Buffered Peptone Water/Lysine/Glucose—See Ogden I D (1988) International Journal of Food Microbiology 7:287-297, Elsevier Science BV, PO Box 211, 1000 AE, Amsterdam, Netherlands (ISSN 0168-1695).back
[51] Selenite Cystine Trimethylamine-N-Oxide Dulcitol—See Easter, M C and Gibson, D M, (1985) Journal of Hygiene 94:245-262, Cambridge University Press, Cambridge.back
[52] Lysine Decarboxylase Glucose—See Ogden I D (1988) International Journal of Food Microbiology 7:287-297, Elsevier Science BV, PO Box 211, 1000 AE, Amsterdam, Netherlands (ISSN 0168-1695).back
[53] Violet Red Bile Glucose Agar—See Mossell D A A, Eelderink I, Koopmans M, van Rossem F (1978) Laboratory Practice 27 No. 12 1049-1050; Emap Maclaren, PO Box 109, Maclaren House, 19 Scarbrook Road, Croydon CR9 1QH.back
[54] An arithmetic mean of 30 is equivalent to 3x10² colony forming units per gram of original sample.back
[55] This Part of the Schedule enforces 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, OJ No. L117, 13.5.2003, p. 22.back
[56] This Part of the Schedule implements Commission Decision 2003/326/EC on transitional measures under Regulation (EC) No. 1774/2002 of the European Parliament and of the Council as regards the separation of Category 2 and Category 3 oleochemical plants, OJ No. L117, 13.5.2003, p. 42.back
[57] OJ No. L117, 13.5.2003, p. 1.back
[58] OJ No. L117, 13.5.2003, p. 14.back
[59] OJ No. L117, 13.5.2003, p. 22.back
[60] OJ No. L117, 13.5.2003, p. 42.back
[61] OJ No. L 151,30.4.2004, p. 11 as corrected by a Corrigendum published in the Official Journal at OJ No. L208, 10.6.2004, p. 9 and as further corrected by a Corrigendum published in the Official Journal at OJ No. L 396, 31.12.2004, p. 63.back
[62] OJ No. L112, 19.4.2004, p.1.back
[63] OJ No. L162, 30.4.2004, p. 62.back
[64] OJ No. L16, 20.1.2005, p. 46.back
[65] OJ No. L19, 21.1.2005, p. 27.back
[66] OJ No. L19, 21.1.2005, p. 34.back