The Transmissible Spongiform Encephalopathies (Wales) Regulations 2018

Made: 4 September 2018

Laid before the National Assembly for Wales: 6 September 2018

Coming into force: 1 October 2018

The Welsh Ministers have been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to measures in the veterinary and phytosanitary fields for the protection of public health.

The Welsh Ministers make these Regulations under the powers conferred by section 2(2) of, and paragraph 1A of Schedule 2 to, the European Communities Act 1972 .

The Welsh Ministers have consulted 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

Title, application and commencement

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• (1) The title of these Regulations is the Transmissible Spongiform Encephalopathies (Wales) Regulations 2018.

• (2) These Regulations apply in relation to Wales.

• (3) These Regulations come into force on 1 October 2018.

Interpretation

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• (1) In these Regulations—

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

• “BSE” (“BSE”) means bovine spongiform encephalopathy;

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

• “Commission Decision 2007/411/EC” (“Penderfyniad y Comisiwn 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 1 August 1996 for any purpose and exempting such animals from certain control and eradication measures laid down in the EU TSE Regulation;

• “compound feed” (“bwyd anifeiliaid cyfansawdd”) means a mixture of at least two feed materials, whether or not containing feed additives, for oral animal-feeding in the form of complete or complementary feed;

• “cutting plant” (“safle torri”) has the meaning given to it in paragraph 1.17 of Annex I to Regulation (EC) No 853/2004 , and is an establishment that is approved or conditionally approved as such by the Food Standards Agency under Article 148(3) of Regulation (EU) 2017/625, or operating as such under Article 4(5) of Regulation (EC) No 853/2004, pending such approval;

• “the EU TSE Regulation” (“Rheoliad TSE yr UE”) 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 programme;

• “inspector” (“arolygydd”) means an inspector appointed under regulation 13, and “veterinary inspector” (“arolygydd milfeddygol”) means a veterinary surgeon appointed by the Welsh Ministers as an inspector;

• “local authority” (“awdurdod lleol”) means in relation to an area the county council or county borough council for that area;

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

• “premises” (“mangre”) 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, another place of slaughter; andany vehicle, container or structure (moveable or otherwise);

• “Regulation (EC) No 853/2004” (“Rheoliad (EC) Rhif 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;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; andCommission 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;

• ...

• “Regulation (EC) No 1069/2009” (“Rheoliad (EC) Rhif 1069/2009”) means 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, as implemented by Commission Regulation (EU) No 142/2011 ;

• “Regulation (EU) 2017/625” (“Rheoliad (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 food and feed law, rules on animal health and welfare, plant health and plant protection products ;

• “slaughterhouse” (“lladd-dy”) has the meaning given to it in paragraph 1.16 of Annex I to Regulation (EC) No 853/2004, and is an establishment that is approved or conditionally approved as such by the Food Standards Agency under Article 148(3) of Regulation (EU) 2017/625;

• “specified risk material” (“deunydd risg penodedig”) means the tissues specified in Annex V of the EU TSE Regulation, and unless otherwise indicated, it does not include products containing or derived from those tissues;

• “third country” (“trydedd wlad”) means any country which is not a member of the European Union;

• “trained person” (“person wedi ei hyfforddi”) means any person who—has received training to take samples from dead bovine animals, andthe site operator is satisfied is competent to carry out such sampling;

• “TSE” (“TSE”) means transmissible spongiform encephalopathy;

• “the TSE requirements” (“y gofynion TSE”) means those requirements of the EU TSE Regulation set out in regulation 5 and Schedule 1.

• (2) Expressions that are not defined in these Regulations and occur in the EU TSE Regulation have the same meaning in these Regulations as they have for the purposes of the EU TSE Regulation.

• (3) References in these Regulations to Articles or Annexes are to Articles and Annexes in the EU TSE Regulation unless stated otherwise.

Appointment of competent authority

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The Welsh Ministers are the competent authority for the purposes of the EU TSE Regulation except as otherwise specified in these Regulations.

Animals intended 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 premises approved for that purpose under this regulation by the Welsh Ministers.

• (2) If a bovine, ovine or caprine animal kept in 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 — TSE Controls

The TSE Requirements

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• (1) For the purposes of Article 11, where a person has in their possession or under their control any animal suspected of being infected with a TSE that person must immediately notify the Welsh Ministers and detain the animal on the holding until it has been examined by a veterinary inspector.

• (2) Where a veterinary surgeon examines or inspects an animal and reasonably suspects the animal of being infected with TSE, the veterinary surgeon must immediately notify the Welsh Ministers of that suspicion.

• (3) Where a person examines the carcase of an animal in a laboratory and reasonably suspects the presence of a TSE, that person must immediately notify the Welsh Ministers, and retain the carcase until a veterinary inspector has authorised disposal.

• (4) The TSE requirements in Schedule 1 apply.

• (5) The occupier of a slaughterhouse must comply with the requirement to take samples or to facilitate the taking samples by an inspector resulting from the Welsh Minister's TSE monitoring requirements in Annex 3.

• (6) In accordance with Article 12, a person with animals placed under an official movement restriction must comply with—

• (a) any instructions given by an inspector and co-operate with the Welsh Ministers in delivering the TSE monitoring requirements in Annex III;

• (b) any instructions given by an inspector and co-operate with the Welsh Ministers in taking action to control and eradicate a TSE in Annex VII;

• (c) the requirements in Annex IV for the production, use of equipment, packaging, storage and transport of animal feed;

• (d) the animal feeding requirements in Annex IV;

• (e) the prohibitions concerning animal feeding in Article 7, unless the animal feed products are produced using production and manufacturing processes approved by the Welsh Ministers ;

• (f) the requirements for dealing with specified risk material in Article 8 and Annex V and Schedule 7;

• (g) the restrictions in Annex VIII and Schedule 8 concerning the placement of animals or products on the market or for export.

Application of the Schedules

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The following Schedules have effect—

• (a) Schedule 2 (TSE monitoring and approval of laboratories);

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

• (c) Schedule 4 (Control and eradication of TSE in ovine and caprine animals);

• (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 or registrations

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• (1) The Welsh 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) An approval, authorisation, licence or registration must be in writing, and must specify—

• (a) the address of the premises;

• (b) the name of the occupier; and

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

• (3) An 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) Where refusing to grant an approval, authorisation, licence or registration, or granting one subject to conditions, the Welsh Ministers must—

• (a) give reasons in writing; and

• (b) explain that the applicant has the right to make written representations to a person appointed by the Welsh Ministers.

• (5) The appeals procedure in regulation 11 then applies.

Occupier's duty

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

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

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

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

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

Suspension and amendment

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

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

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

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

• (3) A suspension or amendment—

• (a) may have immediate effect if the Welsh Ministers consider it necessary for the protection of public or animal health; and

• (b) otherwise, may have effect after the expiration of at least 21 days.

• (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; and

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

• (5) The appeals procedure in regulation 11 then applies.

• (6) If the suspension or amendment does not have immediate effect and representations are made under regulation 11, it must not have effect until the final determination of the appeal by the Welsh Ministers unless the Welsh Ministers consider that it is necessary for the protection of public or animal health for the amendment or suspension to have effect before then.

Revocations of approvals, authorisations, licences or registrations

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• (1) The Welsh Ministers may revoke an approval, authorisation, licence or registration granted under these Regulations if the Welsh Ministers 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 11 has expired or the suspension has been upheld following such appeal;

• (b) it has been previously suspended and there is further non-compliance with the EU TSE Regulation or these Regulations; or

• (c) the Welsh Ministers 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;