Exiting The European Union Citation and commencement 1 These Regulations may be cited as the Transmissible Spongiform Encephalopathies and Animal By-Products (Amendment etc.) (EU Exit) Regulations 2019 and come into force on exit day. 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 2 1 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 is amended as follows. 2 In Article 3— a in paragraph 1— i in point (b), omit “in the Community”; ii in point (e)— aa for “Member State” substitute “ constituent nation ” ; bb omit from the words “it shall” to the end; iii after point (p), insert— q constituent nation: one of the following nations of the British Islands: England, Guernsey, Isle of Man, Jersey, Scotland or Wales; r OIE: the World Organisation for Animal Health. ; b after paragraph 1, insert— 1A In this Regulation, “ appropriate authority ” means: a in relation to England, the Secretary of State; b in relation to Wales, the Welsh Ministers; c in relation to Scotland, the Scottish Ministers; d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1B But the appropriate authority is the Secretary of State if consent is given by: a in relation to Wales, the Welsh Ministers; b relation to Scotland, the Scottish Ministers; c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 In Article 5— a in paragraph 1— i for the first subparagraph substitute— 1 The BSE status of countries and regions as categorised by the OIE is— a negligible risk, b controlled risk, or c undetermined risk, and, as at exit day, the BSE status for each of the constituent nations is established by Commission Decision 2007/453. ; ii omit the third subparagraph; b omit paragraphs 2 to 5; c for paragraph 6 substitute— 6 Exporting countries that are eligible for inclusion in the list of countries or regions approved for the import into Great Britain of live animals or of the products covered by this Regulation must be categorised with regard to BSE status that takes into account the criteria and potential risk factors set out in paragraph 1, and any statistical survey of the epidemiological situation regarding TSEs in the country on the basis of the use, in a screening procedure, of rapid tests. The classification criteria used by the OIE must be taken into account. Eligibility to import from a third country into Great Britain live animals or products of animal origin within scope of this Regulation under conditions determined on their established category must be established as soon as possible, once any epidemiological or other evidence which might lead to a change in BSE status has been analysed by the appropriate authorities. ; d omit paragraph (8). 4 In Article 6— a in paragraph 1, for “Each Member State” substitute “ The appropriate authority ” ; b in paragraph 2, for the words from the beginning to “Committee,” substitute “ The Secretary of State must inform the OIE ” ; c in paragraph 4— i in the first sentence, for the words from the beginning to “Commission” substitute “ The appropriate authority must, where possible, submit to their relevant ... Parliament an annual report ” ; ii omit the third sentence. 5 In Article 6a— a in paragraph 1, for “Member States may” substitute “ Appropriate authorities may confer together and with expert scientists to ” ; b in paragraph 3, omit the first sentence. 6 In Article 8— a for paragraph 1 to 2 substitute— 1 Specified risk material, referred to and listed in Annex 5 and including at least the brain, spinal cord, eyes and tonsils of bovine animals aged over 12 months, and the vertebral column of bovine animals aged over 30 months, must— a be removed and disposed of in accordance with Annex 5 and with Regulation (EC) No 1069/2009 ; b not be imported into Great Britain from any country other than a member State. 2 Tissues from animals which have undergone one of the alternative tests listed in Annex 10, which is applied under the conditions provided for in Annex 5, and in relation to which the test results are negative, are not to be regarded as specified risk material. ; b in paragraph 3, for “In Member States or regions thereof,” substitute “ In parts of Great Britain ” ; c in paragraph 4, for “the Community’s” substitute “Great Britain’s”. 6A In Article 9, in paragraph 2, omit the second subparagraph. 7 In Article 10— a in paragraph 1, for “Member States” substitute “ Appropriate authorities ” ; b omit paragraph 2. 8 In Article 11, for the first two paragraphs substitute— Any person who suspects an animal of being infected by a TSE must immediately notify the relevant competent authority. . 9 In Article 13— a in paragraph 4, omit the words from “in accordance” to the end; b omit paragraph 5. 10 Omit Article 14. 11 In Article 15(1)— a . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b in the second sentence, for “Community” substitute “ retained direct EU ” . 12 In Article 16— a . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . c in paragraph 3, in the second subparagraph, for the words from “dispatched from” to “country” substitute “ imported from a country or region ” ; d in paragraph 6, omit “into the Community”. 13 For Article 17 substitute— Article 17 Health certificates Appropriate health certificates relating to trade in the semen, embryos and ova of bovine, ovine or caprine animals, and appropriate commercial documents relating to trade in products of animal origin must be supplemented, where necessary, by a reference to the category specifying the BSE classification. . 14 For Article 18 substitute— Article 18 Supplementation of health certificates The appropriate health certificates relating to imports must be supplemented in respect of the BSE classification of any country by the specific requirements laid down in Annex 9, as soon as that classification is confirmed. . 15 Omit Article 19. 16 Omit Articles 21, 22 and 25. 17 After Article 26, omit the words from “This Regulation” to “Member States.”. 18 In Annex 2, in Chapter A, in the first paragraph, omit “Member States or third”. 19 Annex 3 is amended in accordance with paragraphs (20) to (26). 20 Chapter A is amended in accordance with paragraphs (21) to (23). 21 In Part 1 (monitoring in bovine animals)— a in point 5, for the words from “Member States” to “territory” substitute “ the appropriate authority may test other bovine animals ” ; aa in point 6.1, for “Chapter III of Section I of Annex I to Regulation (EC) No 854/2004 ” substitute “Article 18(4) of Regulation (EU) No 2017/625; b omit point 7. 22 In Part 2 (monitoring in ovine and caprine animals)— a in point 2— i in point (a)— aa for the words from the beginning to “point 4,” substitute “ The appropriate authorities shall test ” ; bb at the end insert “ within the Great Britain ” ; ii omit point (b); iii in point (c), in the words before the first indent, for “A Member State” substitute “ The Secretary of State, with the consent of the other appropriate authorities, ” ; b in point 3— i in the words before the first indent, for “Member States” substitute “ The appropriate authorities ” ; ii in Tables A and B, in the heading of column 1, omit “Member State”; iii in the footnotes to Tables A and B, omit “in the individual Member States” in both places where it occurs; c in point 6, in the words before the first indent, for “Member States” substitute “ the appropriate authority ” ; d in point 8, in the first sentence, for “Commission” substitute “ appropriate authority, which must immediately notify the other appropriate authorities ” . 23 In Part 3 (monitoring in cervids)— a omit chapter A; b for Chapter B substitute— Monitoring in cervids The appropriate authority may carry out monitoring for TSEs in cervids. . 24 Chapter B is amended in accordance with paragraphs (25) to (26). 25 In Part 1— a in the heading, for “Member States” substitute “ appropriate authorities ” ; b in Section A— i in the heading, for the words from “Member States” to the end substitute “ appropriate authorities in their annual report ” ; ii in point 2, for “Article 12(2)” substitute “ Article 12 ” ; iii in point 3, for “Article 12(1) and (2) substitute “ Article 12 ” ; iv omit point 9; c omit Section B. 26 Omit Part 2 (information to be presented in the Union summary report). 27 Annex 4 is amended in accordance with paragraphs (28) to (32). 28 In Chapter 3, in Section C, in the words before point (a), omit “for free circulation in the Union”. 29 In Chapter 4, in Section E, in point (e), omit “for free circulation in the Union”. 30 Chapter 5 is amended in accordance with paragraphs (31) to (32). 31 In Section A, for “Member States” substitute “ The appropriate authority ” . 32 In Section E— a in point 1— i in point (a), omit the words from “from the Union” to the end; ii in point (c), in the last paragraph, for “TRACES” substitute “the appropriate computerised information management system”; iii in point (d), after “TRACES”, insert “ or any replacement system in operation in Great Britain ” ; b in point 3— i in point (b)(ii)— aa in the first and second indents, omit “from the Union”; bb in the second indent, omit “in the Union”; ii in point (c), for “Union legislation”, in both places it occurs, substitute “ retained EU law ” ; iii in point (d), in the first and second paragraphs, omit “from the Union”; c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Annex 5 is amended in accordance with paragraphs (34) to (43). 34 In point 1— a in the words before point (a), for the words from “Member State” to “their” substitute “ country or a ” ; b in point (b), for “competent authority of the Member State of slaughter” substitute “ appropriate authority ” . 35 In point 2— a in the heading, for “Member States” substitute “ countries ” ; b for “Member States” substitute “ a country ” . 36 In point 4, in point 4.3, in the words before point (a), for “Member States” substitute “ the appropriate authority ” . 37 In point 5— a omit the words from “Notwithstanding” to “Article 5(2), and”; b omit “in all Member States”. 38 In point 6— a for “Member States, or regions thereof,” substitute “ parts of the United Kingdom ” ; b for the second reference to “Member States” substitute “ parts of the United Kingdom ” . 39 In point 7, for “Member States” substitute “ parts of the United Kingdom ” . 40 In point 8, in point 8.2— a in the first sentence, for “Member States may decide” substitute “ nothing in this Regulation prevents the appropriate authority from deciding ” ; b omit the third sentence. 41 In point 9, in the words before point (a), for “Member States may decide” substitute “ nothing in this Regulation prevents the appropriate authority from deciding ” . 42 In point 10— a in point 10.1— i for “Member States” substitute “ The appropriate authority ” ; ii for “another” substitute “ a ” ; b in point 10.2, for “from one” to the end, substitute “ unless prior approval has been provided by the relevant authority in the receiving country ” ; c in point 10.3, for “Community” substitute “ European Union ” . 43 In point 11— a in points 11.1 and 11.2, for “Member States” substitute “ The appropriate authority ” ; b in point 11.3(a), omit the sentence beginning “Until 30 June”. 44 Annex 7 is amended in accordance with paragraphs (45) to (54). 45 In Chapter A— a in the first paragraph, omit “in a member State”; b in the second paragraph, for “Member State” substitute “ appropriate authority ” . 46 Chapter B is amended in accordance with paragraphs (47) to (53). 47 In point 2.1, for “Member State” substitute “ appropriate authority ” . 48 In point 2.2.2— a in the words before point (a), for “Member State” substitute “ appropriate authority ” ; b in point (a)— i in the second paragraph, for the words from “territory of” to the end substitute “ Great Britain ” ; ii in the last paragraph, for “Member State” substitute “ appropriate authority ” ; c in point (b)— i in the fourth paragraph, in the words before point (i), for “Member States may decide” substitute “ nothing in this Regulation prevents the appropriate authority from deciding ” ; ii in point (i), in the first indent, for the words from “territory of” to the end substitute “ Great Britain ” ; d in point (c)— i in the last indent before point (i), for “Member State” substitute “appropriate authority”; ii in the final paragraph before point (i), for the words from “By way of derogation” to “decide” substitute “Nothing in this Regulation prevents the appropriate authority from deciding”; iii in point (i), in the first indent for “Member State” substitute “appropriate authority”; iv in point (ii), for “derogation” substitute “action”; v in point (iii)— aa for the words from “The application” to “Member State” substitute “Such action shall be limited to cases where the appropriate authority”; bb in the penultimate sentence, for “Member State” substitute “appropriate authority”; cc in the last sentence, for the words “In the case” to “the present paragraph” substitute “Where such action is taken”; e in point (d)— i in the fourth indent after the opening paragraph, for “Member State” substitute “appropriate authority”; ii in the third paragraph for “Member State” substitute “appropriate authority” in both places where it occurs; iii in the last paragraph, for “The Member States” substitute “Any appropriate authority”; 49 In point 2.3— a in point (a), for “a Member State” substitute “ the appropriate authority ” ; b in points (b) and (c), for “Member States” substitute “ the appropriate authority ” . 49A In point 3.3, in the fourth indent, for “Member State” substitute “appropriate authority”; 50 In point 3.4— a in point (b), for “Member State”, in both places it occurs, substitute “ appropriate authority ” ; b in point (c)— i in the words before the first indent, for “Member State” substitute “ appropriate authority ” ; ii in the second indent, for “territory of the same Member State” substitute “ Great Britain ” . 51 In point 4.2— a in the paragraph before the indents, for the words from “However” to “may”, substitute “Nothing in this Regulation prevents the appropriate authority from deciding that instead of the measures in points 3.2 and 3.3 the authority may decide to”; 51a In point 4.3(b)— i in the opening paragraph, for “Member State” substitute “appropriate authority”; ii in the second indent, for “territory of the same Member State” substitute “United Kingdom”; 52 In point 4.4, for “Member State” substitute “appropriate authority”. 53 In point 4.6 , for “Member State” substitute “ appropriate authority ” . 54 In Chapter C— a in Part 1— i in point 1, in the second paragraph, for “Member States” substitute “ the appropriate authority ” ; ii in point 6, omit “of the Member State”; iii in point 8— aa in the words before point (a), for “Member State” substitute “ appropriate authority ” , and omit “of the Member State”; bb in point (b), omit “determined by the Member State”; b in Part 2— i in point 3, for “Member States may decide” substitute “ Nothing in these Regulations prevents the appropriate authority from deciding ” ; ii omit point 4. c in Part 4, point (1)(b), in the second paragraph, for “Member States” substitute “ The appropriate authority ” ; d omit Part 5. 55 Annex 8 is amended in accordance with paragraphs (56) to (63). 56 Chapter A is amended in accordance with paragraphs (57) to (61). 57 In the heading, omit “intra-Union”. 58 Section A is amended in accordance with paragraphs (59) to (60). 59 In point 1— a in point 1.1— i omit “intra-Union”; ii for “Member States” substitute “ the appropriate authority ” ; b in point 1.2, in the second paragraph— i in point (c)(iv), in the first indent, for the words from “in accordance” to the end substitute “ and supervised ” ; ii in point (d), omit “from 1 January 2014”; iii in point (f)— aa omit the first paragraph; bb in the second paragraph, omit “From 1 January 2014,”; cc in the third paragraph, for “first and second paragraphs of point (f), Member States may decide” substitute “ second paragraph of point (f), nothing in this Regulation prevents the appropriate authority from deciding ” ; iv in the words before point (g), omit “from 1 January 2014”; v in points (g)(i) and (h)(i), for “Member State” substitute “ country or region ” ; c in point 1.3— i in point (c)(iv), in the first indent, for the words from “in accordance” to the end substitute “ and supervised ” ; ii in point (d), omit “from 1 January 2014”; iii in point (f)— aa omit the first paragraph; bb in the second paragraph, omit “From 1 January 2014,”; cc in the third paragraph, for “first and second paragraphs of point (f), Member States may decide” substitute “ second paragraph of point (f), nothing in this Regulation prevents the appropriate authority from deciding ” ; iv in the words before point (g), omit “from 1 January 2014”; v in points (g)(i) and (h)(i), for “Member State” substitute “ country or region ” ; d in point 1.4, in the second paragraph— i for “Member State” substitute “ appropriate authority ” ; ii for “the other Member States” substitute “ other countries ” ; 60 The following amendments are made in points 2, 3 and 4— a in the heading to point 2, for “Member States or zones of a Member State”, substitute “A constituent nation of an appropriate authority or a zone within a constituent nation”; b in point 2.1— i in the opening paragraph before (a)— aa for “a Member State” substitute “an appropriate authority”; bb for the words from “shall submit” to “in particular” substitute “must have clear and presentable evidence”; ii in (e) for “Member States” substitute “countries”; c omit point 2.2; d omit point 2.3; e in point 3.1— i in the words before point (a), for “a Member State which has” substitute “each constituent nation must have”; ii in point (a), for the words from “may” to “outlining” substitute “which outlines”; iii in the first indent, for “Member State” substitute “constituent nation”; iv omit point (b); f in point 3.2, for the opening words substitute “Within the European Union the national scrapie control programmes for the following Member States have been approved by the European Commission:”; g omit point 4. 61 In Section B— a for “United Kingdom” substitute “ appropriate authority ” ; b omit “other”. 62 In Chapter C, in the heading, omit “intra-Community”. 63 Omit Chapter D. 64 In Annex 9— a in Chapter D, in Section B, in point 2, in the words after point (b), for “Union” substitute “retained direct EU”; b in Chapter E— i in the opening paragraph, for “the Union” substitute “Great Britain”; ii after point (4), omit “In addition to the conditions set out in points 1 to 4, the animal health certificate shall attest that:”; iii in point (5), in the words before point (a) for “the Union and intended for Member States” substitute “parts of Great Britain”; iv in point (6), in the words before point (a) for “the Union and intended for a Member State” substitute “parts of Great Britain”; c in Chapter F, in points (1) and (2), for “the Union” substitute “Great Britain” in both places where it occurs; d in Chapter H, in the opening paragraph before point (1), for “the Union” substitute “Great Britain”; 65 Annex 10 is amended in accordance with paragraphs (68) to (74); 66 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 Chapter C is amended in accordance with paragraphs (69) to (74). 69 In point 1, in the second paragraph— a in the first sentence, omit “and the guidelines of the EU reference laboratory”; b in the second sentence, omit the words from “, and be processed” to the end. 70 Point 3 is amended in accordance with paragraphs (71) to (73). 71 In point 3.1— a in point (a), in the third paragraph, in the words before point (i), omit the words from “according to” to “test)”; b in point (b) in the fourth paragraph, in the words before point (i), omit the words from “according to” to “test)”; c in point (c), for the words from “which has” to the end substitute “ where they must be further tested by a two-blot method for the provisional classification of bovine TSE isolates ” . 72 In point 3.2— a in point (b), in the second paragraph, in the first sentence, for “an” substitute “ the relevant ” ; b in point (c)— i in point (i), for the words from “, listed in” to the end substitute “approved by the national reference laboratory”. ii for point (ii) substitute— ii Secondary molecular testing with additional molecular testing methods In TSE cases in which the presence of BSE cannot be excluded by the primary molecular testing referred to in point (i), the samples must be submitted to further investigation and confirmation by at least one alternative method, differing immunochemically from the original primary molecular method, depending on the volume and nature of the referred material. These additional tests will be carried out by the national reference laboratory. ; iii in point (iii)— aa in the first paragraph, omit the words from “, which will” to the end; bb omit the second paragraph. 73 In point 3.3, omit the second paragraph. 74 In point 4— a in the penultimate paragraph— i in the first sentence, omit “has been approved by the EU reference laboratory and”; ii omit the second sentence; b in the final paragraph— i in the first sentence, for the words from “after prior” to “finds that” substitute “ if ” ; ii omit the second sentence. Commission Decision 2007/453/EC establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk 3 1 Commission Decision 2007/453/EC establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk is amended as follows. 2 In Article 1— a the existing text becomes paragraph 1; b after that paragraph, insert— 2 However, the official United Kingdom BSE status for England, Northern Ireland, Scotland and Wales is categorised by reference to the website of the OIE, as amended from time to time. . 3 Omit Article 3. 4 In the Annex— a in Part A, omit— i the sub-heading “Regions of Member States”; ii the entries for Northern Ireland and Scotland; b in Part B, omit the entry for the United Kingdom; c in Part C, after “B”, insert “, other than the regions of the constituent nations of the British Islands , which have an official BSE risk status determined by their categorisation by the OIE ” . Commission Decision 2009/719/EC authorising certain Member States to revise their annual BSE monitoring programmes 4 1 Commission Decision 2009/719/EC authorising certain Member States to revise their annual BSE monitoring programmes is amended as follows. 2 For Article 1 substitute— 1 The appropriate authority may revise their annual monitoring programmes as provided for in Article 6(1b) of Regulation (EC) No 999/2001 . 2 In this Decision, “ appropriate authority ” means: a in relation to England, the Secretary of State; b in relation to Wales, the Welsh Ministers; c in relation to Scotland, the Scottish Ministers; d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 In Article 2— a in paragraph 1, in the words before point (a), for “Member States” substitute “ countries and territories ” ; b in paragraph 2— i for “Member States” substitute “ countries or territories ” ; ii for the words from “in another” to “performed” substitute “ , the age limits for testing in force in Great Britain, the Channel Islands and the Isle of Man ” . c in paragraph 3, for the words from “from 1 January” to “Annex” substitute “ the appropriate authority ” . 4 Omit Articles 3 and 4. 5 In the Annex, in the heading, for “Member States” substitute “ countries ” . 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 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Commission Regulation (EU) No 142/2011 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 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amendments to the EEA agreement 7 In Annex 1 to the EEA agreement, in Chapter 1, in Part 7.1— a in point 9b, omit point (a); b in point 9c, omit points (a) and (b). Gardiner of Kimble Parliamentary Under Secretary of State Department for Environment, Food and Rural Affairs