The Transmissible Spongiform Encephalopathies (Scotland) Regulations 2010

Made: 5th May 2010

Laid before the Scottish Parliament: 6th May 2010

Coming into force: 28th May 2010

The Scottish Ministers make the following Regulations in exercise of the powers conferred by section 2(2) of, and paragraph 1A of Schedule 2 to, the European Communities Act 1972 and all other powers enabling them to do so.

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Scottish Ministers that it is expedient for references to the EU instruments referred to in Schedule 1 to be construed as references to those instruments as amended from time to time.

The Scottish Ministers have carried out consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety .

PART 1 — General provisions

Citation, commencement and extent

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• (1) These Regulations may be cited as the Transmissible Spongiform Encephalopathies (Scotland) Regulations 2010 and come into force on 28th May 2010.

• (2) These Regulations extend to Scotland only.

Interpretation

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• (1) In these Regulations—

• “approved research premises” means premises approved for research purposes by the Scottish Ministers;

• “bovine animal” includes bison and buffalo (including water buffalo);

• “BSE” means bovine spongiform encephalopathy;

• “bulk” means not enclosed or wrapped in packaging;

• “cattle passport” has the same meaning as in the Cattle Identification (Scotland) Regulations 2007 ;

• “Commission Decision 2007/411/EC” means Commission Decision 2007/411/EC prohibiting the placing on the market of products derived from bovine animals born or reared within the United Kingdom before 1st August 1996 for any purpose and exempting such animals from certain control and eradication measures laid down in Regulation (EC) No. 999/2001 and repealing Decision 2005/598/EC;

• “cutting plant” (except in Schedule 7, paragraph 9(3)(b)(iii)) has the meaning given to it in paragraph 1(17) of Annex 1 to Regulation (EC) No. 853/2004 , and is an establishment that is—approved or conditionally approved as such by the Food Standards Scotland under Article 148 of Regulation (EU) 2017/625 ; oroperating as such under Article 4(5) of Regulation (EC) No. 853/2004, pending such approval;

• “EU TSE Regulation” means Regulation (EC) No. 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies , as read with—Commission Decision 2007/411/EC;Commission Decision 2007/453/EC establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk ; andCommission Decision 2009/719/EC authorising certain Member States to revise their annual BSE monitoring programmes ;

• “inspector” means an inspector appointed under regulation 12, and “veterinary inspector” means a veterinary surgeon appointed by the Scottish Ministers as an inspector;

• “local authority” means a council constituted under section 2 of the Local Government etc. (Scotland) Act 1994 ;

• “offal” has the meaning given to it in point 1.11 of Annex I to Regulation (EC) No. 853/2004 (definitions);

• “premises” includes—domestic premises if they are being used for any purpose in connection with the EU TSE Regulation or these Regulations;land and outbuildings;a slaughterhouse;a cutting plant;a place that is, for the purposes of point 4.1(a) of Annex V to the EU TSE Regulation (removal of specified risk material), an other place of slaughter; andany vehicle, container or structure (moveable or otherwise);

• ...

• “Regulation (EC) No. 853/2004” means Regulation (EC) No. 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin, as read with—Directive 2004/41/EC of the European Parliament and of the Council repealing certain directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC;Commission Regulation (EC) No. 1688/2005 implementing Regulation (EC) No. 853/2004 of the European Parliament and of the Council as regards special guarantees concerning salmonella for consignments to Finland and Sweden of certain meat and eggs , as last amended by Commission Implementing Regulation (EU) No 1223/2011;Commission Regulation (EC) No. 2074/2005 laying down implementing measures for certain products under Regulation (EC) No. 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No. 854/2004 of the European Parliament and of the Council and Regulation (EC) No. 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No. 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No. 853/2004 and (EC) No. 854/2004 , as last amended by Commission Regulation (EU) 2017/1980;...

• “Regulation (EU) 2017/625” means Regulation (EU) 2017/625 of the European Parliament and of the Council on official controls and other official activities performed to ensure the application of feed and food law, rules on animal health and welfare, plant health and plant protection products

• “Regulation (EC) No1069/2009” means Regulation (EC) No1069/2009 of the European Parliament and of the Council laying down health rules concerning animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) , as last amended by Regulation (EU) No 2017/625;

• “Regulation (EU) No 142/2011” means Commission Regulation (EU) No142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by‑products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive ...;

• “slaughterhouse” has the meaning given to it in point 1.16 of Annex I to Regulation (EC) No. 853/2004 (definitions), and is an establishment that is—approved or conditionally approved as such by the Food Standards Scotland under Article 148 of Regulation (EU) 2017/625; oroperating as such under Article 4(5) of Regulation (EC) No. 853/2004 (registration and approval of establishments) pending such approval;

• “suspect animal” means an animal suspected of having a TSE;

• “TSE” means transmissible spongiform encephalopathy; and

• “TSE susceptible” means capable of having a TSE.

• (2) Expressions defined in the EU TSE Regulation and not defined in these Regulations have the same meaning in these Regulations as they have for the purposes of the EU TSE 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 , which has been recorded and is consequently capable of being reproduced.

• (4) References in these Regulations to the EU instruments identified in Schedule 1 are references to those instruments as amended from time to time.

Appointment of competent authority

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The Scottish Ministers are the competent authority for the purposes of the EU TSE Regulation except in relation to paragraphs 1 to 18 of Schedule 7 and paragraphs 1, 3 and 4 of Schedule 8 where the Food Standards Scotland are the competent authority.

Exception for research

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• (1) The provisions of Schedules 2 to 8 do not apply in relation to animals kept for the purposes of research in approved research premises.

• (2) If a bovine animal, sheep or goat kept in approved research premises or its progeny dies or is killed, the occupier must dispose of it as a Category 1 animal by-product in accordance with Regulation (EC) No. 1069/2009 and failure to do so is an offence.

PART 2 — Introduction of Schedules

The Schedules

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The following Schedules have effect—

• (a) Schedule 2 (TSE monitoring);

• (b) Schedule 3 (control and eradication of TSE in bovine animals);

• (c) Schedule 4 (control and eradication of TSE in sheep and goats);

• (d) Schedule 5 (control and eradication of TSE in animals that are not bovine, ovine or caprine);

• (e) Schedule 6 (feedingstuffs);

• (f) Schedule 7 (specified risk material, mechanically separated meat and slaughtering techniques); and

• (g) Schedule 8 (restrictions on placing on the market and export).

PART 3 — Administration and enforcement

Approvals, authorisations, licences and registrations

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• (1) The Scottish Ministers must grant an approval, authorisation, licence or registration under these Regulations if they are satisfied that the provisions of the EU TSE Regulation and these Regulations will be complied with.

• (2) Any approval, authorisation, licence or registration must be in writing, and specify—

• (a) the address of the premises;

• (b) the name of the occupier; and

• (c) the purpose for which it is granted.

• (3) Any approval, authorisation, licence or registration may be made subject to such conditions as are necessary to—

• (a) ensure that the provisions of the EU TSE Regulation and these Regulations will be complied with; or

• (b) protect public or animal health.

• (4) If the Scottish Ministers refuse to grant an approval, authorisation, licence or registration, or grant one subject to conditions—

• (a) they must—

• (i) give their reasons in writing; and

• (ii) explain the right of the applicant to make written representations to a person appointed by the Scottish Ministers; and

• (b) the appeals procedure in regulation 10 applies in relation to any decision of the Scottish Ministers under this regulation.

Occupier's duty

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The occupier of any premises approved, authorised, licensed or registered under these Regulations commits an offence if that occupier does not ensure that—

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

• (i) any condition of the approval, authorisation, licence or registration; and

• (ii) the requirements of the EU TSE Regulation and these Regulations; and

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

Suspension and amendment

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• (1) The Scottish Ministers may suspend or amend any approval, authorisation, licence or registration granted under these Regulations if—

• (a) any of the conditions under which it was granted is not being complied with; or

• (b) they are satisfied that the provisions of the EU TSE Regulation or these Regulations are not being complied with.

• (2) The Scottish Ministers may amend an approval, authorisation, licence or registration granted under these Regulations if the Scottish Ministers consider it necessary in the light of technical or scientific developments.

• (3) A suspension or amendment—

• (a) has immediate effect if the Scottish Ministers consider it necessary for the protection of public or animal health; or

• (b) otherwise, does not have effect for at least 21 days from notification of the suspension or amendment.

• (4) Notification of the suspension or amendment must—

• (a) be in writing;

• (b) state when the suspension or amendment comes into effect;

• (c) give the reasons for the suspension or amendment; and

• (d) explain the right of the person who has been notified to make written representations to a person appointed by the Scottish Ministers.

• (5) The appeals procedure in regulation 10 applies in relation to any decision of the Scottish Ministers under this regulation.

• (6) If the suspension or amendment does not have immediate effect and representations are made under regulation 10, the suspension or amendment does not have effect until the final determination of the appeal by the Scottish Ministers unless at any point they consider that it is necessary for the protection of public or animal health for the suspension or amendment to have effect before then.

Revocation of approvals, authorisations, licences and registrations

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• (1) The Scottish Ministers may revoke any approval, authorisation, licence or registration granted under these Regulations if they are satisfied that the premises will not be operated in accordance with the EU TSE Regulation or these Regulations and if—

• (a) it is currently suspended and the period for appeal under regulation 10 has expired or they have upheld the suspension following such appeal;

• (b) they have previously suspended it and there is further non�??compliance with the EU TSE Regulation or these Regulations; or

• (c) they are satisfied that the occupier no longer uses the premises for the purpose for which it was granted.

• (2) Notification of the revocation must—

• (a) be in writing;

• (b) state when the revocation comes into effect;

• (c) give the reasons for the revocation; and

• (d) explain that the person who has been notified has the right to make written representations to a person appointed by the Scottish Ministers.

• (3) If the Scottish Ministers make a revocation under paragraph (1)(b) or (c) the appeals procedure in regulation 10 applies but the revocation remains in force during that appeals procedure.

Appeals procedure

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• (1) Where this regulation applies, a person may make written representations to a person appointed for the purpose by the Scottish Ministers concerning any decision of the Scottish Ministers within 21 days of notification of the decision to that person.

• (2) The Scottish Ministers may also make written representations to the appointed person concerning the decision.

• (3) The appointed person must then report in writing to the Scottish Ministers.

• (4) The Scottish Ministers must give to the appellant written notification of the Scottish Ministers' final determination and the reasons for it.

Valuations

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• (1) This regulation applies when a valuation is to be obtained under these Regulations.

• (2) The owner and the Scottish Ministers may agree a valuation.

• (3) If the owner and the Scottish Ministers cannot agree a valuation, they may jointly appoint a valuer.

• (4) If the owner and the Scottish Ministers cannot agree who to appoint as valuer, the President of the Institute of Auctioneers and Appraisers in Scotland will nominate a valuer, and both the owner and the Scottish Ministers must accept the nomination.

• (5) The valuer will carry out the valuation and submit it and any other relevant information and documentation to the Scottish Ministers, and submit a copy to the owner.

• (6) The owner and a representative of the Scottish Ministers each have the right to be present at the valuation.

• (7) The valuation is binding on the owner and the Scottish Ministers.

• (8) In this regulation, “owner” means the owner of the animal or product in question.

Appointment of inspectors

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• (1) Except as specified in paragraph (2), the Scottish Ministers or the local authority may appoint inspectors for the purposes of enforcing these Regulations.