The Trade in Animals and Related Products (Amendment and Legislative Functions) and Animal Health (Miscellaneous Amendments) (Wales) (EU Exit) Regulations 2022

Modifications to Directive 64/432

9.—(1) Directive 64/432 is modified as follows.

(2) Article 1 is to be read as if for that Article there were substituted—

“Articles 2, 9, 10 and 14 of, and Annexes A, D and E to, this Directive apply so far as necessary for the purposes of giving effect to provisions which contain references to them in Directives 88/407, 89/556, 90/429, 92/65 and 2009/156, and Regulation (EU) No 206/2010. The provisions of this Directive, to which such reference is made, have effect for those purposes without prejudice to—

(a) Directive 88/407;

(b) Directive 90/429;

(c) Directive 2002/99;

(d) the Official Controls Regulation;

(e) Regulation (EC) No 1760/2000;

(f) Regulation (EC) No 1/2005;

(g) Regulation (EC) No 1069/2009;

(h) Regulation (EU) No 652/2014 of the European Parliament and of the Council laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material(1);

(i) the Foot-and-Mouth Disease Orders;

(j) the Pigs (Records, Identification and Movement) (Wales) Order 2011(2);

(k) the Diseases of Swine Regulations 2014(3), so far as they relate to the control of swine vesicular disease.”

(3) Article 2 is to be read as if—

(a) paragraph 1 were omitted;

(b) in paragraph 2—

(i) in the words before point (a), “In addition” were omitted;

(ii) in point (a), in the definition of “herd”, for “Article 2(b) of Directive 92/102/EEC” there were substituted “article 2 of the Pigs (Records, Identification and Movement) (Wales) Order 2011 as regards swine, and Article 2 of Regulation (EC) No 1760/2000 as regards bovine animals”;

(iii) in point (e), in the definition of “officially tuberculosis-free Member State or region of a Member State”, for “Member State”, in each place where it occurs, there were substituted “country”;

(iv) in point (g), in the definition of “officially brucellosis-free region”, for “Member State” there were substituted “country”;

(v) in point (h), in the definition of “officially brucellosis-free Member State”, for “Member State”, in both places where it occurs, there were substituted “country”;

(vi) in point (k), in the definition of “officially enzootic-bovine-leukosis free Member State or region”, for “Member State”, in both places where it occurs, there were substituted “country”;

(vii) point (l) were omitted;

(viii) in point (m), in the definition of “approved veterinarian”, for “Article 14(3)(B)” there were substituted “Article 14”;

(ix) in point (o), in the definition of “assembly centre”—

(aa) for “trade” there were substituted “importation into Wales”;

(bb) for “for trading purposes” there were substituted “for the purposes of export by the third country of export”;

(cc) for “Article 11” there were substituted “Part 5 of Annex 1 to Regulation (EU) No 206/2010”;

(x) in point (p), in the definition of “region”—

(aa) for “Member State’s” there were substituted “country’s”;

(bb) the words from “and includes at least one” to the end of point (p) were omitted;

(xi) point (q) were omitted.

(4) Article 9 is to be read as if—

(a) in paragraph 1—

(i) for “A Member State which has” there were substituted “The appropriate authority may, by regulations or in accordance with a procedure set out by the appropriate authority by regulations, set out”;

(ii) for “its territory may submit the said programme to the Commission” there were substituted “Wales”;

(iii) in the first indent, for “the Member State” there were substituted “Wales”;

(iv) in the fifth indent, “the results of which must be supplied at least annually to the Commission,” were omitted;

(b) for paragraph 2 there were substituted—

“(2) The appropriate authority may, in accordance with a procedure set out by the appropriate authority by regulations, set out the additional guarantees, general or limited, which may be required for importation into Wales.”;

(c) paragraph 3 were omitted.

(5) Article 10 is to be read as if—

(a) in paragraph 1, for the words from “Where a Member State” to “appropriate supporting documentation, setting out in particular” there were substituted “The matters referred to in paragraph 2 are”;

(b) for paragraph 2 there were substituted—

“(2) The appropriate authority may, in accordance with a procedure set out by the appropriate authority by regulations, set out additional guarantees, general or limited, that are required where it considers that Wales or part of Wales is free from one of the diseases listed in Annex E(2), taking into account the matters specified in paragraph 1.”;

(c) paragraph 3 were omitted.

(6) Article 14 is to be read as if for that Article there were substituted—

“14.   The approved veterinarians must be under the control of the competent authority and must comply with the following requirements. They must—

(a) meet the conditions for pursuing the veterinary profession;

(b) have no financial interest or family connections with the owner of or person responsible for the holding;

(c) possess particular knowledge in the field of animal health as it applies to animals of the species concerned. This means that they must—

(i) regularly update their knowledge, especially as regards the relevant health regulations,

(ii) meet the requirements laid down by the competent authority to ensure the proper functioning of any surveillance network,

(iii) provide the owner of or person responsible for the holding with information and assistance in order that all steps are taken to ensure that the holding’s animal health status is maintained, particularly on the basis of programmes agreed with the competent authority,

(iv) ensure compliance with the requirements concerning—

(aa) the identification and health certification of the animals of the herd, the animals introduced and those imported;

(bb) compulsory reporting of infectious animal diseases and any other risk factor for animal health or welfare, and for human health;

(cc) establishing as far as possible the cause of death of animals and where they are to be consigned;

(dd) the hygiene conditions of the herd and of the livestock production units.

If the proper functioning of any system of surveillance networks so requires, each country may limit the veterinarians’ responsibility to a specific number of holdings or to a specific geographical area.

The competent authority must draw up lists of approved veterinarians and of the approved holdings participating in any surveillance network. If the competent authority finds that a participant in the network no longer fulfils the conditions set out above, it must suspend or withdraw approval, without prejudice to any penalties that may be applied.”

(7) Article 16 is to be read as if for that Article there were substituted—

“16.   The appropriate authority may by regulations—

(a) modify Annex A and Chapter 1 of Annex D, in particular with regard to their adaptation to technological and scientific developments;

(b) modify Annexes B, C, E and Chapter 2 of Annex D; or

(c) amend the modifications made to any Annex to this Directive by Part 5 of the TARP (ALF) (Wales) (EU Exit) Regulations 2022.”

(8) Annex A is to be read as if—

(a) in Section 1—

(i) in paragraph 1(c), in the second subparagraph, the words from “; except in a Member State” to the end of that subparagraph were omitted;

(ii) in paragraph 2(c)—

(aa) in the second subparagraph, for “Member State”, in each place where it occurs, there were substituted “country”;

(bb) in the third subparagraph, for “Member State” there were substituted “country”;

(iii) in paragraph 3A(d)—

(aa) “in a Member State” were omitted;

(bb) for “enter into intra-Community trade” there were substituted “be traded”;

(iv) in paragraph 4, for the words from “in accordance with Article 8,” to “procedure laid down in Article 17” there were substituted “in relation to the occurrence of bovine tuberculosis in the relevant country, the appropriate authority may, in accordance with a procedure set out by the appropriate authority by regulations, declare a country or part of a country to be officially tuberculosis-free”;

(v) in paragraph 4(b), for “Community legislation” there were substituted “legislation in force in Wales ”;

(vi) in paragraph 5—

(aa) for “Member State”, in each place where it occurs, there were substituted “country”;

(bb) for “Commission” there were substituted “appropriate authority”;

(cc) for “in accordance with the procedure laid down in Article 17” there were substituted “in accordance with a procedure set out by the appropriate authority by regulations”;

(b) in Section 2—

(i) in paragraph 1(d), for “in accordance with the procedure at Article 17” there were substituted “by the appropriate authority, in accordance with a procedure set out by the appropriate authority by regulations”;

(ii) in paragraph 2(a), in the second subparagraph, for “Member State”, in each place where it occurs, there were substituted “country”;

(iii) in paragraph 2(b), in the first subparagraph, for “in accordance with the procedure at Article 17” there were substituted “by the appropriate authority, in accordance with a procedure set out by the appropriate authority by regulations”;

(iv) in paragraph 2(b), in the second subparagraph—

(aa) for “Member States”, in both places where it occurs, there were substituted “countries”;

(bb) for “Member State” there were substituted “country”;

(v) in paragraph 2(c), in the second subparagraph, for “under the procedure set out in Article 17” there were substituted “by the appropriate authority, in accordance with a procedure set out by the appropriate authority by regulations”;

(vi) in paragraph 3A, in the third subparagraph, in point (b), for “under the procedure set out in Article 17” there were substituted “by the appropriate authority, in accordance with a procedure set out by the appropriate authority by regulations”;

(vii) in paragraph 4(i), in the third indent, for “procedure laid down in Article 17” there were substituted “Veterinary Medicines Regulations 2013(4)”;

(viii) in paragraph 6A, in the second subparagraph, for “under the procedure set out in Article 17” there were substituted “by the appropriate authority, in accordance with a procedure set out by the appropriate authority by regulations”;

(ix) in paragraph 7, in the words before point (a)—

(aa) for “Member State”, in both places where it occurs, there were substituted “country”;

(bb) for “according to the procedure laid down in Article 17” there were substituted “by the appropriate authority, in accordance with a procedure set out by the appropriate authority by regulations”;

(x) in paragraph 7(a)—

(aa) for “Member State”, in the first two places where it occurs, there were substituted “country”;

(bb) the words from “provided that the central competent authority” to the end were omitted;

(xi) in paragraph 7(b), for “Community legislation” there were substituted “legislation in force in Wales”;

(xii) in paragraph 8, in the words before point (a), for “Member State”, in both places where it occurs, there were substituted “country”;

(xiii) in paragraph 9—

(aa) for “Member State”, in each place where it occurs, there were substituted “country”;

(bb) for “Commission”, in both places where it occurs, there were substituted “appropriate authority”;

(cc) for “according to the procedure laid down in Article 17 propose that the status be suspended or revoked” there were substituted “in accordance with a procedure set out by the appropriate authority by regulations revoke or suspend the status”;

(xiv) in paragraph 10, for “under the procedure laid down in Article 17” there were substituted “by the appropriate authority, in accordance with a procedure set out by the appropriate authority by regulations”.

(9) Annex B is to be read as if—

(a) in point 1, in the fourth subparagraph, for “Fourth Edition, 2000, Chapter 2.3.3 (bovine tuberculosis)” there were substituted “2021 edition(5), Chapter on bovine tuberculosis”;

(b) in point 2.1.4.5, for “4^th Edition 2002” there were substituted “in the 10th edition, 2022(6),”;

(c) in point 2.2.5.3.4—

(i) for “Community legislation” there were substituted “legislation in force in Wales”;

(ii) for “entered into intra-Community trade” there were substituted “allowed to be traded”;

(d) in point 2.2.5.3.5, for “Member States” there were substituted “the appropriate authority”;

(e) in point 3—

(i) for “Member States” there were substituted “the appropriate authority”;

(ii) for “4^th Edition, 2000, Chapter 2.3.3 (bovine tuberculosis)” there were substituted “2021 edition, Chapter on bovine tuberculosis”;

(f) in point 4—

(i) in the title, “State” were omitted;

(ii) in point 4.1—

(aa) “State” were omitted;

(bb) for “Article 6a” there were substituted “Article 100 of the Official Controls Regulation”;

(cc) “respectively in their respective Member States” were omitted.

(10) Annex C is to be read as if—

(a) in point 1, in the fourth subparagraph, for “Sixth Edition, 2008, Chapter 2.4.3 (bovine brucellosis), Chapter 2.7.2 (caprine and ovine brucellosis) and Chapter 2.8.5 (porcine brucellosis)” there were substituted “2021 edition, in the relevant Chapters on brucellosis”;

(b) in point 2.1.5—

(i) for “Community” there were substituted “WOAH”;

(ii) for “Veterinary Laboratories Agency (VLA), Weybridge” there were substituted “Animal and Plant Health Agency, Weybridge laboratory”;

(c) in point 2.1.6, “in each Member State” were omitted;

(d) in point 2.2.1—

(i) for “Chapter 1.1.4” there were substituted “the Chapter on bovine brucellosis”;

(ii) for “Sixth Edition, 2008” there were substituted “2021 edition,”;

(e) in point 2.2.3.3, “in accordance with Article 6(1)” were omitted;

(f) in point 2.7.1—

(i) for “Chapter 2.4.3 (bovine brucellosis)” there were substituted “in the Chapter on bovine brucellosis”;

(ii) for “Sixth Edition, 2008” there were substituted “2021 edition,”;

(g) in point 3.1.1(a), for “intra-Community trade” there were substituted “importation into Wales”;

(h) in point 3.1.2—

(i) for “Section C1 of Chapter 2.4.3” there were substituted “the relevant section of the Chapter on bovine brucellosis”;

(ii) for “Sixth Edition, 2008” there were substituted “2021 edition,”;

(i) in point 3.2.1, in the first paragraph, for “intra-Community trade” there were substituted “importation into Wales”;

(j) in point 3.2.2—

(i) for “Section B(2) of Chapter 2.4.3” there were substituted “the relevant section of the Chapter on bovine brucellosis”;

(ii) for “Sixth Edition, 2008” there were substituted “2021 edition,”;

(k) in point 4.1—

(i) in the words before point (a), for “Article 6a” there were substituted “Article 100 of the Official Controls Regulation”;

(ii) in point (a), “in the Member State” were omitted;

(iii) in point (d), “in the Member State” were omitted;

(iv) in point (e), for “Community” there were substituted “relevant”.

(11) Annex D is to be read as if—

(a) in Chapter 1—

(i) in the title, “, Member States and Regions” were omitted;

(ii) in Section A, in point (iii), for “Member State” there were substituted “country”;

(iii) in Section B, in point (iv), for “Directive 72/462/EEC” there were substituted “Directive 2004/68”;

(iv) in Section E, for the words before point (a) there were substituted “On the basis of information supplied in relation to the occurrence of enzootic-bovine-leukosis in the relevant country, the appropriate authority may declare a country, or part of a country, to be officially enzootic-bovine-leukosis-free in accordance with a procedure set out by the appropriate authority by regulations, if—”;

(v) in Section E, in point (b), for “Member State”, in each place where it occurs, there were substituted “country”;

(vi) in Section F, in the words before point (a) for “Member State”, in both places where it occurs, there were substituted “country”;

(vii) in Section F, in point (a), for “Member State” there were substituted “country”;

(viii) in Section F, in point (b)—

(aa) for “Member State” there were substituted “country”;

(bb) for “Commission” there were substituted “appropriate authority”;

(ix) in Section F, in point (d)—

(aa) for “Member State”, in both places where it occurs, there were substituted “country”;

(bb) for “in accordance with the procedure laid down in Article 17” there were substituted “by the appropriate authority, in accordance with a procedure set out by the appropriate authority by regulations”;

(x) in Section G—

(aa) for “Member State”, in each place where it occurs, there were substituted “country”;

(bb) for “in accordance with the procedure in Article 17”, in both places where it occurs, there were substituted “by the appropriate authority, in accordance with a procedure set out by the appropriate authority by regulations”;

(b) in Chapter 2—

(i) in the second paragraph, for the words from “, which shall be the official EU standard” to the end of that paragraph there were substituted “to be supplied by a WOAH reference laboratory for enzootic-bovine-leukosis”;

(ii) in Section A, in point 2—

(aa) “State” were omitted;

(bb) for “Article 6a” there were substituted “Article 100 of the Official Controls Regulation”;

(iii) in Section A, in point 3—

(aa) “State” were omitted;

(bb) for “Article 6a” there were substituted “Article 100 of the Official Controls Regulation”;

(iv) in Section C, in point 3(b), “in accordance with Article 6(2)(c)” were omitted.

(1)

EUR 2014/652, amended by S.I. 2018/1410 and 2020/1388.

(2)

S.I. 2011/2830 (W. 303), amended by S.I. 2018/632 (W. 118) and 2019/92 (W. 24).

(3)

S.I. 2014/1894, amended by S.I. 2018/1410.

(4)

S.I. 2013/2033, amended by S.I. 2014/599, 2018/761, 2019/676, 865 and 1488, 2020/44, 353, 1461 and 1631.

(5)

The Manual of Standards for Diagnostic Tests and Vaccines for Terrestrial Animals 2021 is freely accessible online (https://www.woah.org/en/what-we-do/standards/codes-and-manuals/#ui-id-2) or available to order in hard copy from the WOAH online bookshop (at https://www.woah.org/en/ebookshop/). The WOAH’s address is 12, rue de Prony, 75017 Paris, France. A hard copy is also available to view on request from the Virology Department at the offices of the Animal and Plant Health Agency, Weybridge, Woodham Lane, New Haw, Addlestone, Surrey, KT15 3NB.

(6)

The European Pharmacopoeia is set of legally binding reference standards for the quality control of medicines adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia. It is available online or in print version for a subscription fee (see https://www.edqm.eu/en/european-pharmacopoeia for links to the subscription services).