The Animal By-Products (Scotland) Regulations 2003

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"the Community Regulation" 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[2] as amended by and as read with-

(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 [3];

(b) Regulation (EC) 811/2003[4];

(c) Regulation (EC) 813/2003[5];

(d) Commission Decision 2003/320/EC on transitional measures under Regulation (EC) No. 1774/2002 of the European Parliament and of the Council as regards the use in feed of used cooking oil[6];

(e) Commission Decision 2003/321/EC on transitional measures under Regulation (EC) No. 1774/2002 of the European Parliament and of the Council as regards the processing standards for mammalian blood[7];

(f) 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[8]; and

(g) Commission Decision 2003/327/EC on transitional measures under Regulation (EC) No. 1774/2002 of the European Parliament and of the Council as regards the low capacity incineration or co-incineration plants which do not incinerate or co-incinerate specified risk material or carcases containing them[9];

"inspector" means-

(a) a person appointed as such for the purposes of these Regulations by the Scottish Ministers; and

(b) a person appointed as such for the purposes of these Regulations by a local authority in relation to its enforcement responsibilities under these Regulations;

"local authority" means a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994[10];

"Regulation (EC) 811/2003" means 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[11];

"Regulation (EC) 813/2003" means 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[12]; and

"poultry" includes birds of all species including wild birds.

    (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 comprise the animal by-products set out in Articles 4, 5 and 6 respectively of the Community Regulation.

    (3) Unless the context otherwise requires, any reference in these Regulations-

(a) to a numbered regulation is a reference to the regulation so numbered in these Regulations;

(b) to a numbered paragraph is a reference to the paragraph so numbered in the regulation, Schedule or part of a Schedule in which that reference occurs; and

(c) to a numbered Schedule is a reference to the Schedule to these Regulations so numbered.

    (4) Any person appointed by the Scottish Ministers or a local authority to be an inspector for the purposes of the Animal Health Act 1981[13] or the Animal By-Products Order 1999[14] shall be deemed to have been appointed by the Scottish Ministers or that authority to be an inspector for the purposes of these Regulations.

    (5) Other than in relation to the issuing of an approval, authorisation, registration, notice or instructions in accordance with regulation 3, any reference in these Regulations to anything done in writing or produced in written form includes a reference to an electronic communication, as defined in the Electronic Communications Act 2000[15], which has been recorded and is consequently capable of being reproduced.

Approvals etc.
     3. Any approval, authorisation, registration, notice or instructions 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.

    (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 be allowed access to such material during the secondary or subsequent phase of composting.

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

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

    (8) 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.

Restrictions on use
     10. Subject to regulation 12(1), any person who fails to comply with Article 22(1) of the Community Regulation shall 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 that is intended to be used for grazing or cropping for feedingstuffs following the application or deposit of organic fertilisers and soil improvers within a period of-

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

(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,

shall be guilty of an offence.

Intra-species recycling of fish
     12.  - (1) Notwithstanding regulation 10, it shall 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 I to, Regulation (EC) 811/2003[16].

    (2) The Scottish Ministers shall be the competent authority for the purposes of Article 5 of Regulation (EC) 811/2003.

(a) checking intermediate plants in accordance with Articles 10(2)(d) and 10(3)(d) of the Community Regulation;

(b) checking storage plants in accordance with Article 11(2)(b) of that Regulation;

(c) validating and checking Category 1 and Category 2 processing plants in accordance with Articles 13(2)(c) and 13(2)(e) of that Regulation, supervising Category 1, 2 and 3 plants in accordance with Annex V, Chapter IV, paragraph 1 to that Regulation, and validating those plants in accordance with Annex V, Chapter V, paragraph 1 to that Regulation;

(d) authorising the temporary use of a Category 2 processing plant for the processing of Category 1 material in accordance with Annex VI, Chapter 1, paragraph 2 to that Regulation;

(e) checking oleochemical plants in accordance with Article 14(2)(d) of that Regulation and the person to whom records shall be produced in accordance with Article 14(2)(c) of that Regulation;

(f) checking biogas plants and composting plants in accordance with Article 15(2)(c) of that Regulation;

(g) validating and checking Category 3 processing plants in accordance with Article 17(2)(c) and 17(2)(e) of that Regulation;

(h) authorising the temporary use of a Category 3 processing plant for the processing of Category 1 or Category 2 material in accordance with Annex VII, Chapter 1, paragraph 2 to that Regulation, or the use of a Category 2 processing plant as a collection centre in accordance with Annex IX, paragraph 3 to that Regulation;

(i) receiving records relating to a petfood or technical plant which must be produced in accordance with Article 18(2)(a)(iv) of that Regulation;

(j) recognising laboratories for the purposes of analysing samples from petfood and technical plants in accordance with Article 18(2)(a)(iii) of that Regulation, receiving information under Article 18(2)(a)(v) of that Regulation, and checking petfood plants and technical plants in accordance with Article 18(2)(b) of that Regulation;

(k) carrying out inspection and supervision in accordance with Article 26 of that Regulation;

(l) giving instructions for the purposes of Annex II, Chapter II, paragraph 4 to that Regulation[17];

(m) the presentation of commercial documents under Annex II, Chapter V to that Regulation;

(n) authorising a representative point in the combustion chamber of an incinerator in accordance with Annex IV, Chapter II, paragraph 3 to that Regulation, and inspecting them in accordance with Annex IV, Chapter VII, paragraph 8 to that Regulation[18]; and

(o) authorising specific requirements in accordance with Annex VI, Chapter II, Part C, paragraphs 14 and 15 to that Regulation[19].

Approval of premises
     14.  - (1) No person shall 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; or

(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 the Community Regulation and these Regulations.

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

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


(i) any conditions of approval; and

(ii) the requirements of the Community Regulation and these Regulations; and



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

    (3) The operator of a high capacity incineration plant shall dispose of the ash in accordance with Annex IV, Chapter VII, paragraph 4 to 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 shall be guilty of an offence.

Biogas and composting plants
     15.  - (1) The provisions of Part 1 of Schedule 1 shall 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-

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

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

    (3) Any person who fails to comply with this regulation shall be 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) 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 at 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 shall be guilty of an offence.

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

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

Sampling at processing plants
     18.  - (1) If a processing plant is processing Category 1 or 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 shall 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 under regulation 21 to test it for Clostridium perfringens.

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

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

(b) send the sample to a laboratory approved under regulation 21 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 shall-

(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 under regulation 21 to test it for Salmonella and Enterobacteriaceae.

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

Sampling at biogas and composting plants
     19.  - (1) In the case of biogas and composting plants, the operator shall, at intervals specified in the approval, take a representative sample of material that has been treated to the time temperature parameters specified in Part 2 of Schedule 1 or in 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 under regulation 21 to carry out those tests.

    (2) No person shall 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 shall-

(a) immediately notify the Scottish Ministers, 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-


(i) it has been re-treated under the supervision of the Scottish Ministers and resampled and re-tested by the Scottish Ministers, and the re-testing has shown that the re-treated digestion residue or compost complies with the standards in the Community Regulation; or

(ii) it is consigned for processing or incineration at an approved processing plant or incinerator or (in the case of catering waste) it is consigned to landfill; and



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

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

Laboratories
     21.  - (1) The Scottish Ministers shall approve laboratories under this regulation to carry out one or more of the tests referred to in this regulation if they are 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 Scottish Ministers may require the laboratory to successfully undertake any quality control tests as they reasonably think fit.

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

    (4) A test for Clostridium perfringens shall 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 perfringens) or equivalent[20].

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

(a) ISO 6579/2002 (BS-EN 12824:1998) (Detection of Salmonella) or equivalent[21]; or

(b) NMKL 71: 1993 or equivalent[22].

    (6) A test for Enterobacteriaceae shall 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 equivalent[23].

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

(a) the tests fail to establish that the material is free from Clostridium perfringens;

(b) the tests fail to establish that the material is free from Salmonella; or

(c) the material successfully passes the test for Enterobacteriaceae in paragraph 5 of Part 3 of Schedule 2,

and failure to so notify shall be an offence.

    (8) The operator of a laboratory approved under this regulation shall in relation to processed material notify the Scottish Ministers immediately after the last day of each month of the number, type and results of tests carried out during that month, and failure to do so shall be an offence.

    (9) Reprocessing in accordance with Article 25(2)(c) and (d) of the Community Regulation shall be carried out under the supervision of the Scottish Ministers.

    (10) If the sample has been sent to the approved laboratory from premises outside Scotland, the requirements in this regulation to notify the Scottish Ministers shall be construed as a requirement to notify the competent authority for the premises from which the sample was sent.

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

Collection centres
     27.  - (1) For the purposes of Article 23(2) of the Community Regulation, no person shall operate a collection centre, as defined in Annex I to 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 approved premises shall ensure that-

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


(i) the conditions of the authorisation; and

(ii) the requirements of the Community Regulation and these Regulations; and



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

    (3) Any person who fails to comply with any provision of this regulation shall 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.

Remote areas
     29.  - (1) For the purposes of Article 24(1)(b) of the Community Regulation 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 Regulation (EC) 811/2003) where they originate in the remote areas specified in Schedule 3, provided that this is done in accordance with Part C of Annex II to Regulation (EC) 811/2003[24].

    (2) The Scottish Ministers shall be the competent authority for the purposes of Article 7 of, and Part C of Annex II to, Regulation (EC) 811/2003.

Burning or burial in the event of a disease outbreak
     30.  - (1) For the purposes of Article 24(1)(c) of the Community Regulation, if there is an outbreak of a 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 Regulation (EC) 811/2003) if the animal by-product is transported, and buried or burnt, in accordance with-

(a) a notice given by the Scottish Ministers 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, Regulation (EC) 811/2003.

    (2) The Scottish Ministers shall be the competent authority for the purposes of Article 6 of, and Part B of Annex II to, Regulation (EC) 811/2003.

Burning and burial of bees and apiculture products
     31. In accordance with Article 8 of 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 shall be 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 shall 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 1 of Schedule 1; and

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

and failure to do so shall be an offence.

Records for approved laboratories
     38. The operator of a laboratory approved under regulation 21 shall 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 shall be 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 poultry are kept shall record-

(a) the date on which 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 are allowed access to the land, whichever is the sooner,

and failure to do so shall be an offence.

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

Suspension, amendment or revocation of approvals, authorisations and registrations
     41.  - (1) The Scottish Ministers, by notice in writing served on the operator, shall-

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

(b) suspend or amend an approval or authorisation if they are 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) shall have immediate effect if the Scottish Ministers consider that this is necessary for the protection of public or animal health; or

(b) otherwise shall not have effect for a period of at least 21 days following the date of service of the notice.

    (3) The notice shall-

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

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

(c) explain the rights of the operator of the premises to make written representations to the Scottish Ministers 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 Scottish Ministers.

    (4) Where there is a review under regulation 42, the suspension or amendment shall cease to have effect until the final determination by the Scottish Ministers in accordance with that review, unless the Scottish Ministers reasonably consider 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 giving the reasons why this is reasonably considered necessary.

    (5) The Scottish Ministers may by notice in writing served on the operator revoke an approval if they are 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-

(a) following a review in accordance with regulation 42 which upholds a suspension; or

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

    (6) Where an authorisation of premises has been revoked under this regulation, the Scottish Ministers may remove the entry in the register relating to those premises from the register maintained under regulation 26(4).

Review
     42.  - (1) An applicant or operator on whom a notice is served under regulations 40 or 41 may within the period of 21 days beginning with the date on which the notice is served-

(a) make written representations to the Scottish Ministers; and

(b) give notice of whether or not that person wishes to appear before and be heard by an independent person appointed by the Scottish Ministers.

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

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

(b) the person so appointed shall not, except with the consent of the applicant or operator, be an officer or servant of the Scottish Ministers;

(c) if the applicant or operator so requests, the hearing shall be in public; and

(d) if the applicant or operator so requests, the Scottish Ministers shall furnish the appellant with a copy of the report of the person so appointed.

    (3) The independent person shall conduct the hearing in such form and manner as that person considers fit and thereafter shall report to the Scottish Ministers as to the findings of fact of that person and the recommendation of that person as to how to determine the review.

    (4) The Scottish Ministers, having had regard to the written representations and the report (if any), shall determine the outcome of the review and shall give to the applicant or operator written notification of their final determination and the reasons for it.

    (5) The Scottish Ministers shall be responsible for meeting the reasonable fees and expenses of the independent person in relation to the review except where the Scottish Ministers-

(a) confirm the notice served under regulations 40 or 41; and

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

    (6) Where the Scottish Ministers are 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, they shall give notice to the applicant or operator of the full amount or the proportion which they are satisfied the applicant or operator should bear.

    (7) The applicant, operator and the Scottish Ministers shall each be responsible for their own costs incurred in relation to the review.

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, 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
     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, 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
     45.  - (1) Any notice served under these Regulations shall 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 shall be guilty of an offence.

Powers of entry
     46.  - (1) An inspector shall, on producing, if so required, some duly authenticated document showing the authority of that inspector, have a right at all reasonable hours, to enter 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 provide 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 thing for identification purposes;

(g) be accompanied by-


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

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

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

    (4) If an inspector enters any unoccupied premises, that inspector shall leave them as effectively secured against unauthorised entry as they were before entry.

    (5) For the purposes of this regulation, 'premises' includes any vehicle or container.

Obstruction, reasonable assistance and information
     47.  - (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 purpose of carrying out the functions of that person under these Regulations;

(c) furnishes to any person acting in the execution of these Regulations any information which is known to be false or misleading in a material particular; or

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

shall be guilty of an offence.

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

Penalties and offences by bodies corporate
     48.  - (1) A person guilty of an offence under these Regulations shall be liable-

(a) on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three 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 an offence under these Regulations committed by a body corporate or a partnership is proved to have been committed with the consent or connivance of, or to have been attributable to any neglect on the part of any director, manager, secretary or similar officer of the body corporate, or any person who was purporting to act in any such capacity (or in the case of a partnership, a partner or a person who was purporting to act as such), that officer or person as well as the body corporate or the partnership, as the case may be, shall be guilty of that offence and shall be liable to be proceeded against and punished accordingly.

    (3) Where the affairs of a body corporate are managed by its members, the provisions of paragraph (2) shall apply in relation to the acts and defaults of a member in connection with the members' functions of management as if the member were a director of the body corporate.

Enforcement
     49.  - (1) These Regulations shall be enforced by the Scottish Ministers in relation to-

(a) premises which are licensed under the Fresh Meat (Hygiene and Inspection) Regulations 1995[25];

(b) premises which are licensed under the Poultry Meat, Farmed Game Bird Meat and Rabbit Meat (Hygiene and Inspection) Regulations 1995[26];

(c) premises which are licensed under the Wild Game Meat (Hygiene and Inspection) Regulations 1995[27];

(d) combined premises as defined in the Meat Products (Hygiene) Regulations 1994[28]; and

(e) combined premises as defined in the Minced Meat and Meat Preparations (Hygiene) Regulations 1995[29].

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

    (3) The Scottish Ministers 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 Scottish Ministers and not by the local authority.

Transitional provisions
     50.  - (1) Schedule 4 shall have effect.

    (2) Part 1 of Schedule 4 (intra-species recycling ban for fish) shall cease to have effect on 1st January 2004.

    (3) Part 2 of Schedule 4 (collection, transport and disposal of former foodstuffs of animal origin) shall cease to have effect on 1st January 2006.

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

    (5) Part 4 of Schedule 4 (mammalian blood) shall cease to have effect on 1st January 2005.

    (6) Part 5 of Schedule 4 (oleochemical plants using rendered fats from Category 2 and 3 materials) shall cease to have effect on 1st November 2005.

    (7) Part 6 of Schedule 4 (low capacity incineration or co-incineration plants which do not incinerate or co-incinerate specified risk materials or carcases containing them) shall cease to have effect on 1st January 2005.

Amendments
     51.  - (1) The TSE (Scotland) Regulations 2002[30] are amended in accordance with the provisions of Part 1 of Schedule 5.

    (2) The consequential amendments set out in Part 2 of Schedule 5 shall have effect.

Revocations
     52. The Orders and Regulations specified in the first column of Schedule 6 are revoked to the extent specified in the corresponding entry in the third column of that Schedule.


ROSS FINNIE
A member of the Scottish Executive

St Andrew's House, Edinburgh
4th September 2003

(a) stab inoculated into motility nitrate medium[32]; and

(b) inoculated into either lactose gelatin medium[33] or charcoal gelatin discs[34], and incubated anaerobically at 37°C±1°C for 20 hours±2 hours.

EXAMINATION OF SUBCULTURES


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 between 2°C and 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 to 24 hours, the medium chilled for a further one hour at between 2°C and 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-

(a) Clostridium perfringens no more than seven days old at the time of use;

(b) Escherichia coli NCTC 10418[35] or equivalent not more than seven days old at the time of use; and

(c) rendered animal protein which is free of Clostridium perfringens.

     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)[36] 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.

(a) on to a blood agar plate;

(b) on to a MacConkey agar plate[40]; and

(c) into biochemical media suitable for the identification of Salmonella.

These media shall be incubated at 37°C overnight.

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

Day 5
     8. 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 and a subculture sent to a veterinary laboratory nominated in writing by the Scottish Ministers for this purpose 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
     1. 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 1
     2. 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)[41] and incubated at 37°C for 18 hours.

Day 2
     3. The incubated BPW/L/G shall be added to Selenite Cystine Trimethylamine-N-Oxide Dulcitol (SC/T/D)[42] and Lysine Decarboxylase Glucose (LD/G)[43] 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 3
     4. 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 4
     5. The plates shall be examined and a minimum of 3 colonies from each plate showing suspicion of Salmonella growth shall be subcultured-

(a) on to a blood agar plate;

(b) on to a MacConkey agar plate; and

(c) into biochemical media suitable for the identification of Salmonella.

These media shall be incubated at 37°C overnight.

Day 5
     6. 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, a subculture shall be sent to a veterinary laboratory nominated in writing by the Scottish Ministers for this purpose for further typing.

The sample provisionally fails if either-

(a) any arithmetic mean is above 30[45]; or

(b) three or more arithmetic means are above 10,

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-

(a) Escherichia coli NCTC 10418 no more than seven days old at time of use; and

(b) processed animal protein or compost or digestive residue which is free of Enterobacteriaceae.

     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.

(a) originates exclusively in restaurants, catering facilities and kitchens, including central kitchens and household kitchens; and

(b) is intended for the production of animal feed.

Approvals
     3.  - (1) The Scottish Ministers shall approve-

(a) collectors of used cooking oil if they are satisfied that the collector will comply with the requirements of this Part; and

(b) operators of premises on which used cooking oil is treated or mixed with other oils if they are satisfied that the premises and operation comply with the requirements of this Part.

    (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 shall specify-

(a) the name of the operator and the address of the approved premises;

(b) in the case of treatment premises, the parts of the premises in which used cooking oil may be received and treated; and

(c) the expiry date, which shall be no later than 31st October 2004.

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

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

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

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

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

     7. Used cooking oil shall be-

(a) collected by an approved collector;

(b) treated by an approved operator on approved treatment premises; and

(c) mixed with other oils by an approved operator on approved blending premises.

Collection and transportation of used cooking oil
     8.  - (1) Used cooking oil shall 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 shall 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, shall be cleaned, washed and disinfected after each use.

    (4) Vehicles or containers which carry any material which could contaminate the used cooking oil shall 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 approved premises shall 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 shall ensure that each batch of used cooking oil is tested to ensure compliance with the standards in paragraph 16. A batch shall be no greater than 30 tonnes.

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

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

    (2) Animals and unauthorised persons shall not have access to the premises.

    (3) The premises shall 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 shall have adequate lavatories and washing facilities for staff.

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

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

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

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

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

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

    (3) They shall in particular-

(a) identify and control the critical control points in the premises;

(b) establish and implement methods for monitoring and checking such critical control points;

(c) keep records of such checks for at least two years; and

(d) ensure the traceability of each batch received and despatched.

     13.  - (1) The operator of approved blending premises shall 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 shall-

(a) establish the causes of failures of compliance;

(b) ensure that the oil is not despatched for use in feedingstuffs;

(c) instigate appropriate decontamination and cleaning procedures; and

(d) where used cooking oil has already been despatched for use in feedingstuffs, or incorporated into feedingstuffs, take all necessary measures to ensure that feedingstuffs containing the oil are not fed to livestock.

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

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

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

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

    (3) Used cooking oil intended for use in animal feed shall 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 shall be established and documented for all parts of the premises.

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

    (6) Inspection schedules and results shall be recorded.

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

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

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

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

Specification for used cooking oil for use in animal feed
     16. Used cooking oil shall meet the following minimum standards before use in animal feed:-

(a) Physical contamination:


(i) moisture and impurities: <3%; and

(ii) impurities: <0.15 %;



(b) Presence of mineral oil: absence;

(c) Presence of oxidised fatty acids: >88% Elutable Fatty acid content;

(d) Presence of pesticide residues: complies with Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed[49];

(e) Presence of PCBs: <100ppb for the 7 main congeners[50];

(f) Presence of Salmonella: absence; and

(g) Presence of animal fat-



(i) Pentadecanoic acid (C15): <0.2%;

(ii) Cis-9-hexadecanoic acid (C16:1): <2%;

(iii) Heptadecanoic acid (C17): <0.4%;

(iv) Cis-9-heptadecanoic acid (C17:1): <0.3%; and

(v) Fatty acids with a chain length of 20 carbon atoms or more (C20+): < 5%.

Commercial documents
     17.  - (1) A written commercial document or a printout of an electronic document shall accompany the consignment of used cooking oil during transportation.

    (2) The producer, receiver and carrier shall each retain a copy of a written commercial document or, for electronic information, a printout of that information.

    (3) Commercial documents shall contain the following information:-

(a) the address of the premises from which the used cooking oil was taken;

(b) the date on which the used cooking oil was taken from the premises;

(c) the quality and description of the used cooking oil;

(d) the quantity of the used cooking oil;

(e) the name and the address of the carrier;

(f) the destination of the used cooking oil; and

(g) a unique reference number that links the collector and the container or vehicle to the premises from which the used cooking oil was taken.

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

    (2) For used cooking oil which is suitable for use in animal feed, the records shall 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 shall 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 Scottish Ministers shall maintain a list of the names and addresses of approved-

(a) collectors of used cooking oil;

(b) operators of treatment premises; and

(c) operators of blending premises.

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

    (3) The Scottish Ministers shall make this list publicly available.

(a) animal by-products are handled and stored safely and incinerated or co-incinerated without undue delay in such a way that they are reduced to dry ash;

(b) the dry ash is disposed of properly and records are kept of the quantity and description of the animal by-products incinerated and the date of incineration;

(c) the dry ash is not removed from the combustion chamber unless combustion is complete; and

(d) transportation and intermediate storage of the dry ash takes place in a closed container to prevent dispersal in the environment and the dry ash is disposed of safely,

and failure to do so shall 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 shall be an offence.

" "ABPR approved", in relation to premises, means approved under article 40 of the Animal By-Products (Scotland) Regulations 2003[55], and "ABPR approval" shall be construed accordingly;".

     3. At the end of regulation 13 (mammalian meat and bone meal for use in fertilisers on agricultural land), there is inserted-

    " (7) In this regulation mammalian meat and bone meal does not include any compost or digestion residues resulting from the treatment of animal by-products in a composting or biogas plant in accordance with the Animal By-Products (Scotland) Regulations 2003.".

     4. In regulations 16(2)(b), 17(3)(a) and (b) and 20(1)(c), for "ABPO approved" or "ABPO approval", there is respectively substituted "ABPR approved" or "ABPR approval" as the case may be.