This Statutory Instrument has been published in sub stitution of the S.I. 2019/788 which did not 
reflect the version approved by Parliament and has been removed from legislation.gov.uk. These 
Regulations are being issued free of charge to all known recipients of that Statutory Instrument. 
S T A T U T O R Y  I N S T R U M E N T S  
2019 No. 865 
EXITING THE EUROPEAN UNION 
AGRICULTURE 
FOOD 
INTELLECTUAL PROPERTY 
MEDICINES 
TRIBUNALS AND INQUIRIES 
The Food and Drink, Veterinary Medicines and Residu es 
(Amendment etc.) (EU Exit) Regulations 2019 
Made - - - - 11th April 2019 
Coming into force in accordance with regulation 1 
CONTENTS 
PART 1 
Introductory 
 
1. Citation and commencement 
 
PART 2 
Amendment of subordinate legislation relating to fo od and drink 
 
2. The Spirit Drinks Regulations 2008 
3. The Tribunal Procedure (First-tier Tribunal) (Ge neral Regulatory Chamber) Rules 
2009 
4. The Wine Regulations 2011 
5. The Quality Schemes (Agricultural Products and F oodstuffs) Regulations 2018 
  2PART 3 
Amendment and revocation of retained direct EU legi slation relating to food and drink 
 
6. Commission Regulation (EC) No 2870/2000 
7. Regulation (EU) No 1151/2012 of the European Par liament and of the Council 
8. Commission Implementing Regulation (EU) No 716/2 013 
9. Regulation (EU) No 251/2014 of the European Parl iament and of the Council 
10. Commission Delegated Regulation (EU) No 664/201 4 
11. Commission Delegated Regulation (EU) No 665/201 4 
12. Commission Implementing Regulation (EU) No 668/ 2014 
13. Commission Delegated Regulation (EU) 2018/273 
14. Commission Implementing Regulation (EU) 2018/27 4 
15. Annex 2 to the EEA Agreement 
16. Revocations 
 
PART 4 
Amendment of subordinate legislation relating to ve terinary medicines 
 
17. The Veterinary Medicines Regulations 2013 
 
PART 5 
Amendment of retained direct EU legislation relatin g to veterinary medicines and residues 
 
18. Regulation (EC) No 470/2009 of the European Par liament and of the Council 
 
 SCHEDULE 1 — Regulation (EU) No 1151/2012 of the E uropean Parliament and 
of the Council: new provisions 
 PART 1 — Article 3: new definitions 
 PART 2 — Article 28: new Article 
 PART 3 — New Article 52a 
 PART 4 — New Title 5A 
 PART 5 — New Article 56 
 PART 6 — New Annex 3 
 SCHEDULE 2 — Commission Implementing Regulation (E U) No 716/2013: new 
Annexes 1 to 5 
 SCHEDULE 3 — Regulation (EU) No 251/2014 of the Eu ropean Parliament and 
of the Council: new provisions 
 PART 1 — Article 2(1): new definitions 
 PART 2 — Article 24: new paragraph 3 
 PART 3 — New Articles 25a to 25d 
 PART 4 — New Article 33 
 PART 5 — Annex 1, point (5): new subparagraph 
 PART 6 — New Annex 4 
 SCHEDULE 4 — Commission Delegated Regulation (EU) No 664/2014, Article 6: 
new paragraphs 3a to 3d and 4 to 4l 
 SCHEDULE 5 — Commission Implementing Regulation (E U) No 668/2014, 
Article 14:  new paragraphs 3, 3a, 3b and 4  3 SCHEDULE 6 — Commission Delegated Regulation (EU) 2018/273, Annex 7, 
Parts 1 and 2: new Parts 
 SCHEDULE 7 — Revocations 
 SCHEDULE 8 — The Veterinary Medicines Regulations 2013: new provisions 
 PART 1 — New Schedule 1A 
 PART 2 — Schedule 7, paragraph 15: new table 
 SCHEDULE 9 — Regulation (EC) No 470/2009 of the Eu ropean Parliament and 
of the Council: new provisions 
 PART 1 — New Article 8 
 PART 2 — New Article 9 
 PART 3 — Article 10(1): new paragraphs 
 PART 4 — New Article 14A 
The Secretary of State makes these Regulations in e xercise of the powers conferred by section 8 
of, and paragraph 1 of Schedule 4 and paragraph 21 of Schedule 7 to, the European Union 
(Withdrawal) Act 2018( a). 
In accordance with paragraphs 1(1) and 12(1) of Sch edule 7 to that Act, a draft of this instrument 
has been laid before Parliament and approved by a r esolution of each House of Parliament. 
In accordance with paragraph 3(1) of Schedule 4 to that Act, the Treasury have consented to the 
making of regulations 17 and 18(2), Schedule 8 and Part 1 of Schedule 9. 
In relation to Parts 2 and 3 of, and Schedules 1 to  7 to, this instrument, there has been 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 requ irements of food law, establishing the 
European Food Safety Authority and laying down proc edures in matters of food safety( b). 
PART 1 
Introductory 
Citation and commencement 
1. —(1) These Regulations may be cited as the Food and  Drink, Veterinary Medicines and 
Residues (Amendment etc.) (EU Exit) Regulations 201 9. 
(2)  These Regulations come into force on the later of e xit day or the day after the day on which 
they are made. 
PART 2 
Amendment of subordinate legislation relating to fo od and drink 
The Spirit Drinks Regulations 2008 
2. —(1) The Spirit Drinks Regulations 2008( c) are amended as follows. 
(2)  In regulation 10— 
                                                                                                                                            
(a) 2018 c. 16. 
(b) OJ No L 31, 1.2.2002, p. 1, to which there are am endments not relevant to these Regulations. 
(c) S.I. 2008/3206, to which there are amendments not  relevant to these Regulations.  4(a)  for paragraph (2) substitute— 
“(2) The authorised officer may take with them such  other person as they consider 
necessary.”; 
(b)  omit paragraph (14). 
The Tribunal Procedure (First-tier Tribunal) (Gener al Regulatory Chamber) Rules 2009 
3. —(1) The Tribunal Procedure (First-tier Tribunal) ( General Regulatory Chamber) Rules 
2009( a) are amended as follows. 
(2)  In rule 1(3), insert in the appropriate alphabetica l places— 
““agricultural product or foodstuff decision” means  a decision of the Secretary of State 
specified in the first column of the table in Annex  3 to Regulation (EU) No 1151/2012 
of the European Parliament and of the Council on qu ality schemes for agricultural 
products and foodstuffs;” 
““aromatised wine decision” means a decision of the  Secretary of State specified in 
column 1 of the table in Annex 4 to Regulation (EU)  No 251/2014 of the European 
Parliament and of the Council on the definition, de scription, presentation, labelling and 
the protection of geographical indications of aroma tised wine products;”. 
(3)  In rule 22(6), after sub-paragraph (g), insert— 
“(h) in an appeal against an agricultural product o r foodstuff decision, within 28 days of 
the date on which the decision was published; 
(i) in an appeal against an aromatised wine decisio n, within 28 days of the date on 
which the decision was published.”. 
The Wine Regulations 2011 
4. —(1) The Wine Regulations 2011( b) are amended as follows. 
(2)  In regulation 4— 
(a)  in paragraph (1) omit “, and acts as the Member Sta te for,”; 
(b)  in paragraph (2)(a)(i) omit “or Member State”. 
(3)  For regulation 8(4) substitute— 
“(4) An authorised officer entering any premises by  virtue of this regulation or regulation 
9 may be accompanied by such other person as the of ficer considers necessary.”. 
The Quality Schemes (Agricultural Products and Food stuffs) Regulations 2018 
5. —(1) The Quality Schemes (Agricultural Products and  Foodstuffs) Regulations 2018( c) are 
amended as follows. 
(2)  For regulation 3(2) substitute— 
“(2) The Secretary of State is responsible for exer cising the functions of the designated 
authority for the purposes of Articles 13(3), 24(2) , 34 and 38.”. 
(3)  Omit regulation 5(1). 
(4)  For regulation 10(8) substitute— 
“(8) An authorised officer may be accompanied by su ch other persons as the authorised 
officer considers necessary.”. 
(5)  Omit regulation 21. 
                                                                                                                                            
(a) S.I. 2009/1976; relevant amending instruments are  S.I. 2010/43, 2653, 2012/500, 2017/1168, 2018/1053 . 
(b) S.I. 2011/2936, amended by S.I. 2013/3235, there are other amending instruments but none is relevant . 
(c) S.I. 2018/1275.  5PART 3 
Amendment and revocation of retained direct EU legi slation relating to food and 
drink 
Commission Regulation (EC) No 2870/2000 
6. —(1) Commission Regulation (EC) No 2870/2000 laying  down Community reference 
methods for the analysis of spirits drinks is amend ed as follows. 
(2)  In Article 3— 
(a)  in the words before point (a)— 
(i)  omit “Community”; 
(ii)  after “down” insert “in retained EU law”; 
(b)  in point (a), for “the Annex to Directive 85/591/EE C” substitute “Annex 3 to Regulation 
(EC) No 882/2004 of the European Parliament and of the Council”; 
(c)  in point (d), in the first indent— 
(i)  at the beginning insert “in relation to an official  control,”; 
(ii)  for “Member State concerned” substitute “appropriat e authority, by administrative 
decision, on a case by case basis”; 
(d)  after the existing paragraph insert— 
“In this Article ‘the appropriate authority’ means:  
(a) in relation to England, the Secretary of State;  
(b) in relation to Northern Ireland, the Department  of Agriculture, Environment and Rural 
Affairs; 
(c) in relation to Scotland, the Scottish Ministers ; 
(d) in relation to Wales, the Welsh Ministers.”. 
(3)  In Article 4, after point (c) insert— 
“(d) ‘Regulation 110/2008’: means Regulation (EC) N o 110/2008 of the European 
Parliament and of the Council.”. 
(4)  After Article 5 omit the words from “This Regulatio n” to “Member States.”. 
(5)  In the Annex— 
(a)  in Part 3(1) (general remarks relating to the deter mination of volatile substances and 
methanol of spirit drinks)— 
(i)  in point 1, in the words before point 1, for “Regul ation (EEC) No 1576/89” 
substitute “Regulation 110/2008”; 
(ii)  in point 2, in the second subparagraph, for “Regula tion (EEC) No 1576/89” 
substitute “Regulation 110/2008”; 
(b)  in Part 6 (determination of glycyrrhizic acid using  high performance liquid 
chromatography), in point 1, for “Regulation (EEC) No 1576/89” substitute “Regulation 
110/2008”; 
(c)  in Part 7 (high-performance liquid chromatography m ethod for verifying the presence of 
chalcones in pastis), in point 1, in the second sub paragraph, for “Regulation (EEC) No 
1576/89” substitute “Regulation 110/2008”. 
Regulation (EU) No 1151/2012 of the European Parlia ment and of the Council 
7. —(1) Regulation (EU) No 1151/2012 of the European P arliament and of the Council on 
quality schemes for agricultural products and foods tuffs is amended as follows. 
(2)  In Article 1—  6(a)  at the end of point (b) insert “and”; 
(b)  at the end of point (c) omit “and”; 
(c)  omit point (d). 
(3)  In Article 2— 
(a)  in paragraph 1, in the second subparagraph, for the  words from “Commission” to “Article 
56,” substitute “Secretary of State may make regula tions”; 
(b)  in paragraph 2, for “Annex XIb to Regulation (EC) N o 1234/2007” substitute “Part 2 of 
Annex 7 to Regulation 1308/2013”; 
(c)  in paragraph 3— 
(i)  for “Union provisions” substitute “provisions in re tained EU law”; 
(ii)  for “the single common organisation of the markets,  and” substitute “provisions in, 
or under, Regulation 1308/2013 and provisions relat ing”; 
(d)  omit paragraph 4. 
(4)  In Article 3— 
(a)  in point (6), for “Union” substitute “United Kingdo m”; 
(b)  after point (8) insert the points in Part 1 of Sche dule 1. 
(5)  In Article 4(b), for “Union” substitute “United Kin gdom”. 
(6)  In Article 5(4)— 
(a)  in the first subparagraph, for the words from “Comm ission” to “Article 56,” substitute 
“Secretary of State may make regulations”; 
(b)  in the second subparagraph, for the words from “Com mission” to “Article 56,” substitute 
“Secretary of State may make regulations”. 
(7)  In Article 7— 
(a)  in paragraph 1(e) omit the words from “, taking int o account” to the end of that point; 
(b)  in paragraph 2— 
(i)  in the first subparagraph, for the words from “Comm ission” to “Article 56,” 
substitute “Secretary of State may make regulations ”; 
(ii)  in the second subparagraph— 
(aa)  for “Commission may adopt implementing acts” substi tute “Secretary of State 
may make regulations”; 
(bb)  omit the second sentence. 
(8)  In Article 8— 
(a)  in paragraph 1, in the words before point (a), for “49(2) or (5)” substitute “49”; 
(b)  omit paragraph 2. 
(9)  Omit Article 9. 
(10)  In Article 10— 
(a)  in paragraph 1, in the words before point (a), for “Commission” substitute “Secretary of 
State”; 
(b)  in paragraph 2, for “Union” substitute “United King dom”. 
(11)  In Article 11— 
(a)  for paragraph 1, for the words from “Commission” to  “maintaining” substitute “Secretary 
of State must establish and maintain”; 
(b)  in paragraph 2, for “Union”, in both places it occu rs, substitute “United Kingdom”; 
(c)  in paragraph 3— 
(i)  for “Commission may adopt implementing acts” substi tute “Secretary of State may 
make regulations”;  7(ii)  omit the second sentence; 
(d)  in paragraph 4, for “Commission” substitute “Secret ary of State”. 
(12)  In Article 12— 
(a)  in paragraph 2 omit “Union”; 
(b)  in paragraph 4, for “Member State” substitute “Unit ed Kingdom or third country, as 
relevant, in which that geographical area of origin  is located”; 
(c)  in paragraph 5, for the words from “Directive 2000/ 13/EC” to “Directive 2008/95/EC” 
substitute “Regulation (EU) No 1169/2011 of the Eur opean Parliament and of the Council 
on the provision of food information to consumers, the collective geographical marks 
registered under the Trade Marks Act 1994( a)”; 
(d)  in paragraph 6 omit “Union”; 
(e)  in paragraph 7— 
(i)  in the first subparagraph— 
(aa)  for the words from “Commission” to “Article 56,” su bstitute “Secretary of 
State may make regulations”; 
(bb)  omit “Union”; 
(ii)  in the second subparagraph— 
(aa)  for “Commission may adopt implementing acts” substi tute “Secretary of State 
may make regulations”; 
(bb)  omit “Union”; 
(cc)  omit the second sentence. 
(13)  In Article 13(3)— 
(a)  in the first subparagraph— 
(i)  for “Member States” substitute “The designated auth ority”; 
(ii)  for “that Member State” substitute “the United King dom”; 
(b)  omit the second subparagraph. 
(14)  In Article 14(1)— 
(a)  in the first subparagraph, for “Commission” substit ute “Secretary of State”; 
(b)  in the third subparagraph, for “Directive 2008/95/E C” substitute “the Trade Marks Act 
1994”. 
(15)  In Article 15— 
(a)  in paragraph 1— 
(i)  in the first subparagraph, in the words before poin t (a)— 
(aa)  for the words from “Commission” to “five years” sub stitute “Secretary of 
State may, by regulations, make provision for a tra nsitional period of up to 
five years to apply”; 
(bb)  omit “originating in a Member State or a third coun try”; 
(cc)  for “on condition” substitute “if the Secretary of State is satisfied”; 
(dd)  omit “Article 49(3) or”; 
(ii)  omit the second subparagraph; 
(b)  in paragraph 2— 
(i)  in the first subparagraph— 
                                                                                                                                            
(a) 1994 c. 26.  8(aa)  in the words before point (a), for the words from “ the Commission” to 
“shown” substitute “an application may be made to t he Secretary of State to 
extend the transitional period mentioned in paragra ph 1 to 15 years in duly 
justified cases and the Secretary of State may, by regulations, make provision 
for such a transitional provision if the Secretary of State is satisfied”; 
(bb)  in point (a), for “Commission” substitute “Secretar y of State”; 
(ii)  omit the second subparagraph; 
(c)  in paragraph 4— 
(i)  in the first subparagraph— 
(aa)  for the words from “a Member State may” to “10 year s” substitute “nothing in 
this Regulation prevents the Secretary of State fro m using any power the 
Secretary of State has to make regulations to provi de for a transitional period 
of up to 10 years to apply”; 
(bb)  for “Commission” substitute “Secretary of State”; 
(cc)  omit “to the authorities of the Member State”; 
(dd)  omit “national”; 
(ee)  for “49(3)” substitute “51”; 
(ii)  in the third subparagraph, for “dossier referred to  in Article 8(2)” substitute 
“submitted under Article 8(1)”. 
(16)  In Article 16— 
(a)  in paragraph 1— 
(i)  for the words from the beginning to “entered in”, i n the second place it occurs, 
substitute “The Secretary of State must enter the n ames of established protected 
designations of origin and established protected ge ographical indications on”; 
(ii)  after “such registrations” insert “under EU Regulat ion 1151/2012( a)”; 
(b)  in paragraph 2, for the words from “Commission” to “Article 56,” substitute “Secretary of 
State may make regulations; 
(c)  in paragraph 3— 
(i)  at the beginning insert “In relation to established  protected designations of origin and 
established protected geographical indications,”; 
(ii)  after “Regulation (EC) No 510/2006” insert “, as th at Regulation had effect in the 
United Kingdom immediately before it was repealed b y EU Regulation 1151/2012,”; 
(d)  after paragraph 3 insert— 
“4. In paragraph 1, in relation to an established p rotected designation of origin and an 
established protected geographical indication, ‘cor responding specifications’ means the 
product specification for the relevant designation of origin or geographical indication as the 
specification stood immediately before exit day.”. 
(17)  In Article 18— 
(a)  in paragraph 3 omit “Member State or in a third”; 
(b)  in paragraph 4, for “Union legislation” substitute “retained EU law”; 
(c)  in paragraph 5, for the words from “Commission” to “Article 56,” substitute “Secretary of 
State may make regulations”. 
(18)  In Article 19— 
(a)  in paragraph 1(a) omit “, in the appropriate langua ge versions”; 
(b)  in paragraph 2— 
                                                                                                                                            
(a) OJ No. L 343, 14.12.2012, p. 1, to which there ar e amendments not relevant to these Regulations.  9(i)  in the first subparagraph, for the words from “Comm ission” to “Article 56,” 
substitute “Secretary of State may make regulations ”; 
(ii)  in the second subparagraph— 
(aa)  for “Commission may adopt implementing acts” substi tute “Secretary of State 
may make regulations”; 
(bb)  omit the second sentence. 
(19)  In Article 20— 
(a)  in paragraph 1, in the words before point (a), for “49(2) or (5)” substitute “49”; 
(b)  omit paragraph 2. 
(20)  In Article 21— 
(a)  in paragraph 1, in the words before point (a), for “Commission” substitute “Secretary of 
State”; 
(b)  in paragraph 2, for “Union” substitute “United King dom”. 
(21)  In Article 22— 
(a)  in paragraph 1, for the words from “Commission” to “maintaining” substitute “Secretary 
of State must establish and maintain”; 
(b)  in paragraph 2— 
(i)  for “Commission may adopt implementing acts” substi tute “Secretary of State may 
make regulations”; 
(ii)  omit the second sentence. 
(22)  In Article 23— 
(a)  in paragraph 2 omit “Union”; 
(b)  in paragraph 4— 
(i)  in the first subparagraph— 
(aa)  for the words from “Commission” to “Article 56,” su bstitute “Secretary of 
State may make regulations”; 
(bb)  omit “Union”; 
(ii)  in the second subparagraph— 
(aa)  for “Commission may adopt implementing acts” substi tute “Secretary of State 
may make regulations”; 
(bb)  omit “Union”; 
(cc)  omit the words from “, including” to the end. 
(23)  In Article 24— 
(a)  in paragraph 2— 
(i)  for “Member States” substitute “The designated auth ority”; 
(ii)  for “at national level” substitute “in the United K ingdom”; 
(b)  in paragraph 3— 
(i)  for “Commission may adopt implementing acts” substi tute “Secretary of State may 
make regulations”; 
(ii)  omit the second sentence. 
(24)  In Article 25— 
(a)  in paragraph 1— 
(i)  for the words from the beginning to “entered in” su bstitute “The Secretary of State 
must enter the names of established protected tradi tional specialities guaranteed on”; 
(ii)  after “such registrations” insert “under EU Regulat ion 1151/2012 as it had effect in 
the United Kingdom immediately before exit day”;  10 (b)  omit paragraph 2; 
(c)  in paragraph 3— 
(i)  for the words from “Commission” to “Article 56,” su bstitute “Secretary of State may 
make regulations”; 
(ii)  at the end insert “relating to the entries to be ma de on the register referred to in 
Article 22 under paragraph 1”; 
(d)  after paragraph 3 insert— 
“4. In paragraph 1, in relation to an established p rotected traditional speciality 
guaranteed, ‘corresponding specifications’ means th e product specification for the 
traditional speciality guaranteed as the specificat ion stood immediately before exit day.”. 
(25)  Omit Article 26. 
(26)  In Article 27, for “internal market” substitute “Un ited Kingdom”. 
(27)  For Article 28 substitute the Article in Part 2 of Schedule 1. 
(28)  In Article 29— 
(a)  in paragraph 1(c), for “European” substitute “Unite d Kingdom”; 
(b)  in paragraph 4, for the words from “Commission” to “Article 56,” substitute “Secretary of 
State may make regulations”; 
(c)  in paragraph 5— 
(i)  for “Commission may adopt implementing acts” substi tute “Secretary of State may 
make regulations”; 
(ii)  omit the second sentence; 
(d)  in paragraph 6— 
(i)  for “adopting delegated and implementing acts” subs titute “making regulations”; 
(ii)  for “Commission” substitute “Secretary of State”. 
(29)  In Article 30— 
(a)  in paragraph 1, for the words from “Commission” to “Article 56,” substitute “Secretary of 
State may make regulations”; 
(b)  in paragraph 2, for the words from “Commission” to “Article 56,” substitute “Secretary of 
State may make regulations”. 
(30)  In Article 31— 
(a)  in paragraph 2— 
(i)  for “Union” substitute “United Kingdom”; 
(ii)  for “Article 18(1) of Regulation (EC) No 1257/1999” , in the first place it occurs, 
substitute “Article 32 of Regulation (EU) No 1305/2 013 of the European Parliament 
and of the Council on support for rural development  by the European Agricultural 
Fund for Rural Development (EAFRD)”; 
(iii)  for “Article 18(1) of Regulation (EC) No 1257/1999” , in the second place it occurs, 
substitute “Article 32 of Regulation (EU) No 1305/2 013 of the European Parliament 
and of the Council”; 
(b)  in paragraph 3— 
(i)  for the words from “Commission”, in the first place  it occurs, to “Article 56,” 
substitute “Secretary of State may make regulations ”; 
(ii)  for the words from “Commission”, in the second plac e it occurs, to “delegated act” 
substitute “Secretary of State may make regulations ”; 
(c)  in paragraph 4, for the words from “Commission” to “Article 56,” substitute “Secretary of 
State may make regulations”. 
(31)  Omit Article 32.  11 (32)  In Article 33(2)— 
(a)  for “Commission may adopt implementing acts” substi tute “Secretary of State may make 
regulations”; 
(b)  omit the second sentence. 
(33)  In Article 34, for “Member States” substitute “The designated authority”. 
(34)  In Article 36— 
(a)  for the heading substitute— 
“Official controls ”; 
(b)  in paragraph 1 omit the first subparagraph; 
(c)  in paragraph 2 omit “referred to in paragraph 1”. 
(35)  In Article 37— 
(a)  in paragraph 1— 
(i)  in the first subparagraph— 
(aa)  in the words before point (a), for “Union” substitu te “United Kingdom”; 
(bb)  in point (a), for the words from the beginning to “ Regulation” substitute “the 
competent authority”; 
(ii)  in the second subparagraph, for “Member States” sub stitute “Secretary of State”; 
(b)  in paragraph 3— 
(i)  in the first subparagraph, for “Member States” subs titute “The Secretary of State”; 
(ii)  in the second subparagraph, for “Commission” substi tute “the Secretary of State”; 
(iii)  after the second subparagraph insert— 
“The Secretary of State may make the information sp ecified in the first and second 
subparagraphs public, and update that information p eriodically, in such manner as appears 
appropriate to the Secretary of State from time to time.”; 
(c)  omit paragraph 4. 
(36)  In Article 38— 
(a)  omit the first paragraph; 
(b)  in the second paragraph— 
(i)  for “Member States”, in the first place it occurs, substitute “The designated 
authority”; 
(ii)  for “Member States”, in the second place it occurs,  substitute “that authority”. 
(37)  In Article 39(3), in both points (a) and (b), for “ Union” substitute “United Kingdom”. 
(38)  In Article 40(1), for “Member States” substitute “T he Secretary of State”. 
(39)  In Article 41— 
(a)  in paragraph 1, for “Union” substitute “United King dom”; 
(b)  for paragraph 2(b) substitute— 
“(b) any relevant enactment.”; 
(c)  in paragraph 3, for the words from “Commission” to “Article 56,” substitute “Secretary of 
State may make regulations”. 
(40)  In Article 42(2), for the words from “Commission” t o “Article 56,” substitute “Secretary of 
State may make regulations”. 
(41)  In Article 43— 
(a)  for “Union rules or to those of Member States” subs titute “retained EU law and any other 
enactments”;  12 (b)  for “those rules” substitute “such law and those en actments”. 
(42)  In Article 44— 
(a)  omit paragraph 2; 
(b)  in paragraph 3— 
(i)  for “Commission shall adopt implementing acts” subs titute “Secretary of State may 
make regulations”; 
(ii)  omit the second sentence. 
(43)  In Article 45— 
(a)  in paragraph 1— 
(i)  in the words before point (a), for “Regulation (EC)  No 1234/2007” substitute 
“Regulation 1308/2013”; 
(ii)  in point (a), for the words from “competent authori ties” to “other competent” 
substitute “the competent authority or any designat ed”; 
(b)  in paragraph 2— 
(i)  for “Member States”, in the first place it occurs, substitute “The Secretary of State”; 
(ii)  for “on their territories” substitute “in the Unite d Kingdom”; 
(iii)  for the second and third sentences substitute— 
“The Secretary of State must publish the names and addresses of the groups referred to in 
Article 3(2) in such manner as appears appropriate to the Secretary of State from time to 
time.”. 
(44)  In Article 46— 
(a)  in paragraph 1, for “Member States” substitute “The  Secretary of State”; 
(b)  in paragraph 3, for “Member States” substitute “The  Secretary of State”. 
(45)  Omit Article 47. 
(46)  In Article 49— 
(a)  in paragraph 1, in the first subparagraph— 
(i)  after “Article 48” insert “may be submitted to the Secretary of State”. They”; 
(ii)  for “different Member States or third countries” su bstitute “the United Kingdom and 
a third country, or from more than one country, as relevant,”; 
(b)  omit paragraphs 2 to 4; 
(c)  in paragraph 5, for “Commission,” substitute “Secre tary of State”; 
(d)  in paragraph 6, for “Commission” substitute “Secret ary of State”; 
(e)  in paragraph 7— 
(i)  omit the first subparagraph; 
(ii)  in the second subparagraph— 
(aa)  for “Commission may adopt implementing acts” substi tute “Secretary of State 
may make regulations”; 
(bb)  omit the second sentence. 
(47)  In Article 50— 
(a)  in the heading, for “ Commission ” substitute “ Secretary of State ”; 
(b)  in paragraph 1— 
(i)  in the first subparagraph— 
(aa)  for “Commission”, in both places it occurs, substit ute “Secretary of State”; 
(bb)  for “that it receives” substitute “received”; 
(ii)  in the second subparagraph—  13 (aa)  for “Commission” substitute “Secretary of State”; 
(bb)  after “public” insert “, in such manner as appears appropriate to the Secretary 
of State from time to time,”; 
(cc)  for “it” substitute “the Secretary of State”; 
(c)  in paragraph 2— 
(i)  in the words before point (a)— 
(aa)  for “Commission” substitute “Secretary of State”; 
(bb)  for “it” substitute “the Secretary of State”; 
(cc)  for “the Official Journal of the European Union ” substitute “such manner as 
appears appropriate to the Secretary of State from time to time”; 
(ii)  in point (a) omit “the reference to the publication  of the”. 
(48)  In Article 51— 
(a)  in paragraph 1— 
(i)  in the first subparagraph— 
(aa)  for “in the Official Journal of the European Union ” substitute “of the 
documents published by virtue of Article 50(2)”; 
(bb)  omit “of a Member State or”; 
(cc)  omit “and established in a third country”; 
(dd)  for “Commission” substitute “Secretary of State”; 
(ii)  omit the second subparagraph; 
(iii)  in the last subparagraph, for “Commission” substitu te “Secretary of State”; 
(b)  in paragraph 2, for “Commission”, in both places it  occurs, substitute “Secretary of 
State”; 
(c)  in paragraph 3, in the first, second and third subp aragraphs, for “Commission”, in each 
place it occurs, substitute “Secretary of State”; 
(d)  in paragraph 4, for “Commission” substitute “Secret ary of State”; 
(e)  in paragraph 5, for “Commission” substitute “Secret ary of State”; 
(f)  in paragraph 6— 
(i)  in the first subparagraph, for the words from “Comm ission” to “Article 56,” 
substitute “Secretary of State may make regulations ”; 
(ii)  in the second subparagraph— 
(aa)  for “Commission may adopt implementing acts” substi tute “Secretary of State 
may make regulations”; 
(bb)  omit the second sentence. 
(49)  In Article 52— 
(a)  in paragraph 1— 
(i)  for “Commission”, in both places it occurs, substit ute “Secretary of State”; 
(ii)  for “it shall adopt implementing acts rejecting” su bstitute “the Secretary of State 
must reject”; 
(iii)  omit the second sentence; 
(b)  in paragraph 2— 
(i)  for “Commission” substitute “Secretary of State”; 
(ii)  for the words from “it shall” to “registering” subs titute “the Secretary of State must 
register”; 
(c)  in paragraph 3—  14 (i)  in the words before point (a)— 
(aa)  for “Commission” substitute “Secretary of State”; 
(bb)  for “it” substitute “the Secretary of State”; 
(ii)  in point (a) omit the words from “by means” to “sub stantial”; 
(iii)  in point (b), for the words from “adopt” to the end  substitute “decide whether to 
register the name”; 
(d)  for paragraph 4 substitute— 
“4. After making a decision under this Article, the  Secretary of State must publish in 
such manner as appears appropriate to the Secretary  of State from time to time: 
(a) a notice informing the applicant and the public  of the decision made in relation to the 
application, and 
(b) where the application is approved, a copy of th e approved product specification.”; 
(e)  after paragraph 4 insert— 
“5. An implementing act to which paragraph 6 applie s is revoked. 
6. This paragraph applies to an implementing act ad opted by the European Commission 
under Article 52 of EU Regulation 1151/2012 and inc orporated into domestic law by 
section 3 of the European Union (Withdrawal) Act 20 18.”. 
(50)  After Article 52 insert the Article in Part 3 of Sc hedule 1. 
(51)  In Article 53— 
(a)  in paragraph 2, in the second subparagraph— 
(i)  for “Commission”, in both places it occurs, substit ute “Secretary of State”; 
(ii)  for “the Official Journal of the European Union ” substitute “such manner as appears 
appropriate to the Secretary of State from time to time”; 
(b)  in paragraph 3— 
(i)  in the first subparagraph, for the words from “Comm ission” to “Article 56,” 
substitute “Secretary of State may make regulations ”; 
(ii)  in the second subparagraph— 
(aa)  for “Commission may adopt implementing acts” substi tute “Secretary of State 
may make regulations”; 
(bb)  omit the second sentence; 
(c)  after paragraph 3 insert— 
“4. An implementing act to which paragraph 5 applie s is revoked. 
5. This paragraph applies to an implementing act re lating to an amendment to a product 
specification adopted by the European Commission pu rsuant to Article 53 of EU 
Regulation 1151/2012 and incorporated into domestic  law by section 3 of the EUWA.”. 
(52)  In Article 54— 
(a)  in paragraph 1— 
(i)  in the first subparagraph, in the words before poin t (a)— 
(aa)  for “Commission” substitute “Secretary of State”; 
(bb)  for “its” substitute “the Secretary of State’s”; 
(cc)  omit “adopt implementing acts to”; 
(ii)  in the second subparagraph, for “Commission” substi tute “Secretary of State”; 
(iii)  omit the third subparagraph; 
(b)  in paragraph 2—  15 (i)  in the first subparagraph, for the words from “Comm ission” to “Article 56” 
substitute “Secretary of State may make regulations ”; 
(ii)  in the second subparagraph— 
(aa)  for “Commission may adopt implementing acts” substi tute “Secretary of State 
may make regulations”; 
(bb)  omit the second sentence. 
(c)  after paragraph 2 insert— 
“3. An implementing act to which paragraph 4 applie s is revoked. 
4. This paragraph applies to an implementing act ad opted by the European Commission 
under Article 54 of EU Regulation 1151/2012 and inc orporated into domestic law by 
section 3 of the EUWA.”. 
(53)  After Title 5 insert the Title in Part 4 of Schedul e 1. 
(54)  In Title 6 omit Chapter 1. 
(55)  For Article 56 substitute the Article in Part 5 of Schedule 1. 
(56)  Omit Article 57. 
(57)  In Article 58(1) omit the second subparagraph. 
(58)  In Article 59 omit the second paragraph. 
(59)  After Article 59 omit the words from “This Regulati on” to “Member States.”. 
(60)  After Annex 2 insert the Annex in Part 6 of Schedul e 1. 
Commission Implementing Regulation (EU) No 716/2013  
8. —(1) Commission Implementing Regulation (EU) No 716 /2013 laying down rules for the 
application of Regulation (EC) No 110/2008 of the E uropean Parliament and of the Council on the 
definition, description, presentation, labelling an d the protection of geographical indications of 
spirit drinks is amended as follows. 
(2)  In Article 2, after point (d) insert— 
“(e) ‘third country’ means any country, other than the United Kingdom, and includes: 
 (i) the Bailiwick of Guernsey; 
 (ii) the Bailiwick of Jersey; 
 (iii) the Isle of Man.”. 
(3)  Article 7 is amended in accordance with paragraphs (4) and (5). 
(4)  In paragraph 1— 
(a)  omit the first subparagraph; 
(b)  in the second subparagraph, in the words before poi nt (a), for “Commission” substitute 
“Secretary of State”; 
(c)  in the third subparagraph— 
(i)  in the words before point (a)— 
(aa)  for “at least one Member State” substitute “the Uni ted Kingdom”; 
(bb)  for “Commission by one of the Member States” substi tute “Secretary of State 
by private entities from the United Kingdom”; 
(ii)  in point (b), for “each of the Member States or” su bstitute “the”. 
(5)  In paragraph 2— 
(a)  omit “Member States or the”; 
(b)  omit “from the third country in question”; 
(c)  for “Commission”, in both places it occurs, substit ute “Secretary of State”.  16 (6)  In Article 8— 
(a)  in paragraph 1, for “Commission” substitute “Secret ary of State”; 
(b)  in paragraph 2, in the words before point (a)— 
(i)  for “Member State or” substitute “Secretary of Stat e must send”; 
(ii)  for the words from “from the third country” to “rec eive” substitute “as the case may 
be”. 
(7)  Omit Articles 8a and 9. 
(8)  In Article 11(2), for “Commission”, in both places it occurs, substitute “Secretary of State”. 
(9)  In Article 15— 
(a)  in paragraph 1— 
(i)  for “Commission” substitute “Secretary of State”; 
(ii)  omit “the Member State,”; 
(iii)  omit “from the third country in question”; 
(b)  in paragraph 2, for “Commission” substitute “Secret ary of State”; 
(c)  in paragraph 3— 
(i)  for “Commission” substitute “Secretary of State”; 
(ii)  for “it” substitute “the Secretary of State”; 
(d)  in paragraph 4, for “Commission”, in both places it  occurs, substitute “Secretary of 
State”. 
(10)  In Article 18(1), for “Commission”, in both places it occurs, substitute “Secretary of State”. 
(11)  In Article 19— 
(a)  in paragraph 2, for “from the Member State or” subs titute “, where relevant, from”; 
(b)  in paragraph 3— 
(i)  in the first subparagraph, for “Commission”, in bot h places it occurs, substitute 
“Secretary of State”; 
(ii)  in the second subparagraph— 
(aa)  for “Commission” substitute “Secretary of State”; 
(bb)  omit “the Member State,”; 
(cc)  omit “from the third country,”. 
(12)  In Article 20— 
(a)  in paragraph 1— 
(i)  for “Commission” substitute “Secretary of State”; 
(ii)  for “it” substitute “the Secretary of State”; 
(iii)  omit “the Member State or”; 
(iv)  omit “from the third country,”; 
(b)  in paragraph 2— 
(i)  for “Commission” substitute “Secretary of State”; 
(ii)  omit “Member State,”; 
(iii)  omit “from the third country in question”; 
(c)  in paragraph 4— 
(i)  in the first subparagraph— 
(aa)  for “Commission” substitute “Secretary of State”; 
(bb)  for “it may suspend”, in the second place it occurs , substitute “the Secretary of 
State may suspend”;  17 (cc)  for “It” substitute “The Secretary of State”; 
(ii)  in the second subparagraph, for “Commission” substi tute “Secretary of State”. 
(13)  After Article 23 omit the words from “This Regulati on” to “Member States.”. 
(14)  For Annexes 1 to 5 substitute the Annexes in Schedu le 2. 
(15)  Omit Annex 6. 
Regulation (EU) No 251/2014 of the European Parliam ent and of the Council 
9. —(1) Regulation (EU) No 251/2014 of the European Pa rliament and of the Council on the 
definition, description, presentation, labelling an d the protection of geographical indications of 
aromatised wine products is amended as follows. 
(2)  In Article 1(3)— 
(a)  for “Union”, in both places it occurs, substitute “ United Kingdom”; 
(b)  for “Member States” substitute “United Kingdom”. 
(3)  In Article 2— 
(a)  renumber the unnumbered paragraph as paragraph 1; 
(b)  in paragraph 1 as renumbered, after point (3), inse rt the points (new definitions) in Part 1 
of Schedule 3; 
(c)  after paragraph 1 as renumbered insert— 
“2. In this Regulation, a reference to a competent authority is to be interpreted, as 
regards the United Kingdom, as a reference to: 
(1) in relation to England, Northern Ireland and Wa les, the Secretary of State, 
(2) in relation to Scotland, the Scottish Ministers .”. 
(4)  In Article 5— 
(a)  in paragraph 1, for “Union” substitute “United King dom”; 
(b)  in paragraph 5 omit “Without prejudice to Article 2 6,”. 
(5)  In Article 7 omit “Member State or third”. 
(6)  Omit Article 9. 
(7)  In Article 10— 
(a)  in paragraph 2(f)— 
(i)  omit the words from “laid down” to “indication”; 
(ii)  for “Union”, in the second place it occurs, substit ute “retained EU”; 
(b)  after paragraph 2 insert— 
“3. In paragraph 2(f), ‘applicable requirements’ me ans: 
(a) requirements laid down in law relating to the u se of the geographical indication in the 
country in which the relevant geographical area is located, including, where the 
geographical area is located in, or partly within, the United Kingdom, requirements 
contained in any enactment, and 
(b) where they must be complied with in the country  in which the relevant geographical 
area is located, requirements laid down by an organ isation that manages the protected 
geographical indication.”. 
(8)  In Article 11(2), for “Commission” substitute “Secr etary of State”. 
(9)  Omit Article 13. 
(10)  Before Article 14 insert—  18 “Article 13a 
Application for protection relating to a geographic al area in the United Kingdom”; 
An application for the protection of a geographical  indication for an aromatised wine 
product originating in the United Kingdom must be s ubmitted to the Secretary of State.”. 
(11)  In Article 14— 
(a)  in the heading, for “Commission” substitute “Secret ary of State”; 
(b)  in paragraph 1, for “Commission” substitute “Secret ary of State”; 
(c)  in paragraph 2— 
(i)  for “Commission” substitute “Secretary of State”; 
(ii)  for “referred to in Article 13(5)” substitute “subm itted to the Secretary of State”; 
(d)  in paragraph 3— 
(i)  for “Commission” substitute “Secretary of State”; 
(ii)  for the words from “it shall” to the end substitute  “the Secretary of State must 
publish the product specification referred to in Ar ticle 10(1)(c), and the single 
document referred to in Article 10(1)(d), in such m anner as appears appropriate to 
the Secretary of State from time to time”; 
(e)  in paragraph 4— 
(i)  for “Commission” substitute “Secretary of State”; 
(ii)  for the words from “it” to “decide to” substitute “ the Secretary of State must”; 
(iii)  omit the second sentence. 
(12)  In Article 15, in the first paragraph— 
(a)  for the words from “Member State or” to “protection  or in” substitute “natural or legal 
person with a legitimate interest, or the authoriti es of ”; 
(b)  for “Commission” substitute “Secretary of State”. 
(13)  In Article 16— 
(a)  for “Commission”, in both places it occurs, substit ute “Secretary of State”; 
(b)  omit “, by means of implementing acts,”; 
(c)  for “Union law” substitute “retained EU law by gran ting the application”; 
(d)  omit the second sentence; 
(e)  after the existing paragraph insert— 
“After making a decision under the first paragraph,  the Secretary of State must publish in 
such manner as appears appropriate to the Secretary  of State from time to time: 
(a) a notice informing the applicant and the public  of the decision made in relation to the 
application, and 
(b) where the application is approved, a copy of th e approved product specification.”. 
(14)  In Article 18(1)— 
(a)  in the second subparagraph, for “Union” substitute “United Kingdom”; 
(b)  in the third subparagraph— 
(i)  in point (a), for “Union” substitute “United Kingdo m”; 
(ii)  for point (b) substitute “any relevant enactment or  retained direct EU legislation”. 
(15)  In Article 19— 
(a)  in paragraph 1, in the first subparagraph, for “Com mission” substitute “Secretary of 
State”; 
(b)  in paragraph 2, in the first subparagraph—  19 (i)  for the words from “, if that possibility” to “Unio n” substitute “in the United 
Kingdom”; 
(ii)  for “Commission” substitute “Secretary of State”; 
(iii)  for the words from “Directive” to the end substitut e “Trade Marks Act 1994”. 
(16)  In Article 20— 
(a)  in paragraph 3, for “Union” substitute “United King dom”; 
(b)  omit paragraph 4. 
(17)  In Article 21— 
(a)  in the first paragraph, for the words from “Commiss ion” to “Article 34(2),” substitute 
“Secretary of State must”; 
(b)  in the second paragraph, for “Union”, in both place s it occurs, substitute “United 
Kingdom”; 
(c)  after the second paragraph insert— 
“Any entry placed on the register by the Secretary of State, and any amendment of such an 
entry, or cancellation of such entry, takes effect immediately after the expiry of 20 days 
beginning with the day on which that entry, amendme nt or cancellation is made.”. 
(18)  Omit Article 22. 
(19)  In Article 23(1)— 
(a)  in the words before point (a), for “Union” substitu te “United Kingdom”; 
(b)  in point (a) omit “or authorities referred to in Ar ticle 22”. 
(20)  In Article 24— 
(a)  in paragraph 1, after “may apply” insert “to the Se cretary of State”; 
(b)  in paragraph 2— 
(i)  for “13” substitute “14”; 
(ii)  for “Commission shall, by means of implementing act s,” substitute “Secretary of 
State may”; 
(iii)  omit the words from “and in the case” to the end; 
(c)  after paragraph 2 insert the paragraph in Part 2 of  Schedule 3. 
(21)  In Article 25— 
(a)  in the first paragraph— 
(i)  for “Commission may, on its” substitute “Secretary of State may, on the Secretary of 
State’s”; 
(ii)  omit “a Member State, of”; 
(iii)  omit “, by means of implementing acts,”; 
(iv)  omit the second sentence; 
(b)  in the second paragraph, for “13” substitute “14”. 
(22)  After Article 25 insert the Articles in Part 3 of S chedule 3. 
(23)  Omit Articles 26 and 27. 
(24)  In Article 28— 
(a)  for the heading substitute— 
“Power to make regulations ”; 
(b)  in paragraph 1, in the words before point (a), for the words from “Commission” to 
“Article 33” substitute “Secretary of State may mak e regulations”;  20 (c)  in paragraph 2, for the words from “Commission” to “Article 33” substitute “Secretary of 
State may make regulations”; 
(d)  in paragraph 3— 
(i)  in the words before point (a), for the words from “ Commission” to “Article 33” 
substitute “Secretary of State may make regulations ”; 
(ii)  in point (c), for “Commission” substitute “Secretar y of State”; 
(e)  in paragraph 4, for the words from “Commission” to “Article 33” substitute “Secretary of 
State may make regulations”. 
(25)  In Article 29— 
(a)  for the heading substitute— 
“Further power to make regulations ”; 
(b)  in paragraph 1— 
(i)  in the first subparagraph— 
(aa)  in the words before point (a), for the words from “ Commission” to 
“measures” substitute “Secretary of State may make regulations”; 
(bb)  in point (d), for “Member States” substitute “autho rities specified in those 
regulations”; 
(ii)  omit the second subparagraph; 
(c)  in paragraph 2— 
(i)  in the first subparagraph, for the words from “Comm ission” to “adopt” substitute 
“Secretary of State may, by regulations, make provi sion for”; 
(ii)  omit the second subparagraph. 
(26)  In Article 30, for the words from “Commission” to “ decide to” substitute “Secretary of 
State must”. 
(27)  In Article 31— 
(a)  omit paragraph 1; 
(b)  in paragraph 2— 
(i)  omit the second subparagraph; 
(ii)  insert as the last subparagraphs— 
“The Secretary of State may make regulations concer ning the administrative and physical 
checks to be conducted with regard to the respect o f obligations resulting from the 
application of Chapter 3 of this Regulation.”. 
(28)  In Article 32— 
(a)  in paragraph 1, for “Member States and the Commissi on” substitute “The authorities 
specified in paragraph 4”; 
(b)  after paragraph 3 insert— 
“4. The specified authorities are: 
(a) in relation to England, the Secretary of State;  
(b) in relation to Northern Ireland, the Department  of Agriculture, Environment and Rural 
Affairs; 
(c) in relation to Scotland, the Scottish Ministers ; 
(d) in relation to Wales, the Welsh Ministers.”. 
(29)  For Article 33 substitute the Article in Part 4 of Schedule 3. 
(30)  Omit Article 34. 
(31)  In Article 36—  21 (a)  omit paragraph 1; 
(b)  in paragraph 2— 
(i)  for “have been” substitute “were”; 
(ii)  after “Regulation (EEC) No 1601/91( a)” insert “as it had effect in the United 
Kingdom immediately”; 
(c)  in paragraph 3— 
(i)  for “have been” substitute “were”; 
(ii)  after “Regulation (EEC) No 1601/91” insert “, as th at Regulation had effect in the 
United Kingdom immediately before it was repealed,” . 
(32)  In Article 37 omit the second paragraph. 
(33)  After Article 37 omit the words from “This Regulati on” to “Member States.”. 
(34)  In Annex 1, in point (5)— 
(a)  in the second subparagraph, for the words from “Dir ective 2009/54/EC” to “Directive 
98/83/EC” substitute “any relevant water quality le gislation”; 
(b)  after the third subparagraph insert the subparagrap h in Part 5 of Schedule 3. 
(35)  In Annex 2— 
(a)  in Part A, in point (5) omit the second and third p aragraphs; 
(b)  in Part B— 
(i)  in point (3), in the second paragraph— 
(aa)  for “other Member States” substitute “another count ry”; 
(bb)  for “Member State” substitute “country”; 
(ii)  in point (4), in the second paragraph— 
(aa)  for “other Member States” substitute “another count ry”; 
(bb)  for “Member State” substitute “country”; 
(iii)  in point (13), in the second paragraph— 
(aa)  for “other Member States” substitute “another count ry”; 
(bb)  for “Member States” substitute “country”. 
(36)  After Annex 3 insert the Annex in Part 6 of Schedul e 3. 
Commission Delegated Regulation (EU) No 664/2014 
10. —(1) Commission Delegated Regulation (EU) No 664/20 14 supplementing Regulation (EU) 
No 1151/2012 of the European Parliament and of the Council with regard to the establishment of 
the Union symbols for protected designations of ori gin, protected geographical indications and 
traditional specialities guaranteed and with regard  to certain rules on sourcing, certain procedural 
rules and certain additional transitional rules is amended as follows. 
(2)  Before Article 1 insert— 
“Article A1 
Definition of ‘third country’ 
In this Regulation ‘third country’ means any countr y, other than the United Kingdom, and 
includes: 
(a) the Bailiwick of Guernsey; 
(b) the Bailiwick of Jersey; 
                                                                                                                                            
(a) OJ No. L 149, 14.6.1991, p. 1, as last amended be fore its repeal by Regulation (EC) No 1334/2008 of the European 
Parliament and of the Council (OJ No. L 354, 31.12. 2008, p. 34) and repealed by Regulation (EU) No 251 /2014 of the 
European Parliament and of the Council (OJ No. L 84 , 20.3.2014, p. 14).   22 (c) the Isle of Man.”. 
(3)  Omit Article 4. 
(4)  In Article 5— 
(a)  at the beginning insert “In the case of an applicat ion to which Article 49(5) of Regulation 
(EU) No 1151/2012 applies,”; 
(b)  omit “of the Member State or”; 
(c)  for “Commission” substitute “Secretary of State”; 
(d)  omit “of a Member State or”. 
(5)  Article 6 is amended in accordance with paragraphs (6) to (9). 
(6)  In paragraph 1, in both the third and fourth subpar agraphs, for “Commission” substitute 
“Secretary of State”. 
(7)  In paragraph 2— 
(a)  in the first subparagraph— 
(i)  in the first sentence, for the words from “authorit ies” to “relates to” substitute 
“Secretary of State”; 
(ii)  in the second sentence, for the words from “authori ties” to “established” substitute 
“Secretary of State”; 
(iii)  in the third sentence— 
(aa)  after “a product specification” insert “concerning products originating in the 
United Kingdom”; 
(bb)  for “Member State” substitute “Secretary of State”;  
(iv)  for the fourth sentence substitute— 
“Applications for a minor amendment to a product sp ecification concerning products 
originating in the United Kingdom must be submitted  by a group having a legitimate 
interest.”; 
(v)  in the fifth sentence, for “Commission” substitute “Secretary of State”; 
(b)  in both the third and fourth subparagraphs, for “Co mmission” substitute “Secretary of 
State”; 
(c)  for the fifth subparagraph substitute— 
“After making a decision in relation to an applicat ion under this paragraph, the Secretary of 
State must publish in such manner as appears approp riate to the Secretary of State: 
(a) a notice informing the applicant and the public  of the decision made under this 
paragraph in relation to the application, and 
(b) where the application is approved, a copy of th e amended product specification.”; 
(d)  after the fifth subparagraph insert— 
“The publication obligations imposed on the Secreta ry of State by the previous 
subparagraph also apply in the case of an applicati on that is tacitly approved by virtue of 
the third subparagraph.”. 
(8)  In paragraph 3— 
(a)  in the first subparagraph— 
(i)  at the beginning insert— 
“This paragraph applies to a temporary amendment to  a product specification concerning 
the production of products originating in a third c ountry.”; 
(ii)  after “public authorities” insert “in a third count ry”; 
(iii)  at the end insert “in a third country”;  23 (b)  omit the second subparagraph. 
(9)  After paragraph 3 insert the paragraphs in Schedule  4. 
(10)  Omit Article 7(2). 
(11)  Omit Articles 8 and 9. 
(12)  In Article 10 omit the second paragraph. 
(13)  After Article 10 omit the words from “This Regulati on” to “Member States.”. 
Commission Delegated Regulation (EU) No 665/2014 
11. —(1) Commission Delegated Regulation (EU) No 665/20 14 supplementing Regulation (EU) 
No 1151/2012 of the European Parliament and of the Council with regard to conditions of use of 
the optional quality term ‘mountain product’ is ame nded as follows. 
(2)  Omit Article 6(2). 
(3)  After Article 7 omit the words from “This Regulatio n” to “Member States.”. 
Commission Implementing Regulation (EU) No 668/2014  
12. —(1) Commission Implementing Regulation (EU) No 668 /2014 laying down rules for the 
application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on 
quality schemes for agricultural products and foods tuffs is amended as follows. 
(2)  Before Article 1 insert— 
“Article A1 
Definition of ‘third country’ 
In this Regulation ‘third country’ means any countr y, other than the United Kingdom, and 
includes: 
(a) the Bailiwick of Guernsey; 
(b) the Bailiwick of Jersey; 
(c) the Isle of Man.” . 
(3)  Omit Article 1(2). 
(4)  In Article 6— 
(a)  in paragraph 1 omit the second subparagraph; 
(b)  in paragraph 3, for “Commission”, in both places it  occurs, substitute “Secretary of 
State”. 
(5)  In Article 8— 
(a)  for the words from “as referred to” to “Member Stat es concerned” substitute “by more 
than one group referred to in the first subparagrap h of Article 49(1) of Regulation (EU) 
No 1151/2012 relating to a trans-border geographica l area, or the name of a traditional 
speciality guaranteed, must be submitted to the Sec retary of State by one of the applicant 
groups or through the authorities of the relevant t hird country concerned or by the 
authorities of one of the third countries concerned  (where there is more than one of 
them)”; 
(b)  for “Member States and third” substitute “the”. 
(6)  In Article 9(3), for “Commission” substitute “Secre tary of State”. 
(7)  In Article 10— 
(a)  in paragraph 1, in the first subparagraph, for the words from “The reference” to “lead to 
the” substitute “The application must be accompanie d by”; 
(b)  in paragraph 2—  24 (i)  in the second subparagraph, for the words from “The  reference” to “lead to the” 
substitute “It must also be accompanied by an”; 
(ii)  in the third subparagraph— 
(aa)  omit the first and second sentences; 
(bb)  omit “the fifth subparagraph of”; 
(cc)  for the words from “the reference” to the end subst itute “the updated product 
specification”; 
(iii)  in the fourth subparagraph omit the second sentence ; 
(c)  in paragraph 3, for “Commission” substitute “Secret ary of State”; 
(d)  in paragraph 4, for “Commission”, in both places it  occurs, substitute “Secretary of 
State”. 
(8)  In Article 11(1) omit the second subparagraph. 
(9)  In Article 12— 
(a)  for “Commission” substitute “Secretary of State”; 
(b)  for “10, 11, and 15” substitute “10 and 11”. 
(10)  In Article 13(3) omit “Union”. 
(11)  In Article 14— 
(a)  in paragraph 1— 
(i)  in the words before point (a)— 
(aa)  for the words from the beginning to “registering” s ubstitute “Following a 
decision by the Secretary of State to approve an ap plication to register”; 
(bb)  for “Commission” substitute “Secretary of State”; 
(cc)  at the end insert “and attach a copy of the product  specification relating to the 
designation of origin or geographical indication to  the register”; 
(ii)  for point (c) substitute— 
“(c) the date of the Secretary of State’s decision; ”; 
(b)  after paragraph 1 insert— 
“1a. The entries in the register, and the provision s in the product specification attached to 
the register, relating to a designation of origin o r geographical indication take effect 
immediately after the expiry of 20 days beginning w ith the day on which the entries are 
made in, and the copy of the product specification is attached to, the register, or, if a copy 
of the product specification is attached to the reg ister at a later date, immediately after the 
expiry of 20 days beginning with the day on which t he copy of the product specification is 
attached to the register.”; 
(c)  in paragraph 2— 
(i)  in the words before point (a)— 
(aa)  for the words from the beginning to “registering” s ubstitute “Following a 
decision by the Secretary of State to approve an ap plication to register”; 
(bb)  for “Commission” substitute “Secretary of State”; 
(cc)  at the end insert “and attach a copy of the product  specification relating to the 
traditional speciality guaranteed to the register”;  
(ii)  for point (c) substitute— 
“(c) the date of the Secretary of State’s decision; ”; 
(iii)  omit point (f); 
(d)  after paragraph 2 insert—  25 “2a. The entries in the register, and the provision s in the product specification attached to 
the register, relating to a traditional speciality guaranteed take effect immediately after the 
expiry of 20 days beginning with the day on which t he entries are made in, and the copy of 
the product specification is attached to, the regis ter, or, if a copy of the product 
specification is attached to the register at a late r date, immediately after the expiry of 20 
days beginning with the day on which a copy of the product specification is attached to the 
register.”; 
(e)  for paragraphs 3 and 4 substitute the paragraphs in  Schedule 5. 
(12)  Omit Article 15. 
(13)  In Article 16 omit the second, third and fourth par agraphs. 
(14)  After Article 16 omit the words from “This Regulati on” to “Member States.”. 
(15)  In Annex 1— 
(a)  for “EU No: [for EU use only]” substitute “UK No: [ for official use only]”; 
(b)  in the heading of paragraph 2, for “ Member State ” substitute “ United Kingdom ”; 
(c)  at the end for the words from “Reference to publica tion” to the end substitute— 
“Product specification 
[attach copy]”. 
(16)  In Annex 2— 
(a)  for “EU No: [for EU use only]” substitute “UK No: [ for official use only]”; 
(b)  for “Member State” substitute “United Kingdom”. 
(17)  In Annex 3— 
(a)  in paragraph 1, for “ Official Journal (OJ ) publication” substitute “the single document 
(where relevant) or product specification published  under Article 50(2) of Regulation 
(EU) No 1151/2012”; 
(b)  in paragraph 2— 
(i)  for “ Official Journal (OJ ) publication” substitute “in connection with the p ublication 
of the single document (where relevant) and product  specification relating to the 
application published under Article 50(2) of Regula tion (EU) No 1151/2012”; 
(ii)  for “Date of OJ  publication” substitute “Date of publication”; 
(c)  in paragraph 3, for “ national ” substitute “ third country ”; 
(d)  in paragraph 5, in the second subparagraph, after “ authorities” insert “of a third country”. 
(18)  In Annex 4— 
(a)  in paragraph 1, for “ Official Journal (OJ)  publication” substitute “the notice relating to 
the application published under Article 50(2) of Re gulation (EU) No 1151/2012”; 
(b)  in paragraph 2— 
(i)  in the heading, for “ Official Journal (OJ)  publication ” substitute “ the notice 
relating to the application published under Article  50(2) of Regulation (EU) No 
1151/2012 ”; 
(ii)  for “Date of OJ  publication” substitute “Date of publication”. 
(19)  In Annex 5— 
(a)  for “EU No: [for EU use only]” substitute “UK No: [ for official use only]”; 
(b)  in paragraph 2, in the heading, for “ Member State ” substitute “ United Kingdom ”. 
(20)  In Annex 6— 
(a)  for “EU No: [for EU use only]” substitute “UK No: [ for official use only]”; 
(b)  in paragraph 2, in the heading, for “ Member State ” substitute “ United Kingdom ”. 
(21)  In Annex 7— 
(a)  for “EU No: [for EU use only]” substitute “UK No: [ for official use only]”;  26 (b)  in paragraph 2, in the heading, for “ Member State ” substitute “ United Kingdom ”; 
(c)  in paragraph 6, for points (a) and (b) substitute “ [insert the proposed updated product 
specification]”. 
(22)  In Annex 8— 
(a)  for “EU No: [for EU use only]” substitute “UK No: [ for official use only]”; 
(b)  in paragraph 1, in the heading, omit “ Member State or ”. 
(23)  In Annex 9— 
(a)  for “EU No: [for EU use only]” substitute “UK No: [ for official use only]”; 
(b)  in paragraph 2, in the heading, for “ Member State ” substitute “ United Kingdom ”. 
Commission Delegated Regulation (EU) 2018/273 
13. —(1) Commission Delegated Regulation (EU) 2018/273 supplementing Regulation (EU) No 
1308/2013 of the European Parliament and of the Cou ncil as regards the scheme of authorisations 
for vine plantings, the vineyard register, accompan ying documents and certification, the inward 
and outward register, compulsory declarations, noti fications and publication of notified 
information, and supplementing Regulation (EU) No 1 306/2013 of the European Parliament and 
of the Council as regards the relevant checks and p enalties is amended as follows. 
(2)  In Article 1— 
(a)  in the words before point (a), for the words from “ Regulations” to “respectively,” 
substitute “Regulation (EU) No 1308/2013”; 
(b)  omit points (a), (b) and (e); 
(c)  in point (f) omit “and the analytical databank of i sotopic data”. 
(3)  In Article 2— 
(a)  in paragraph 1— 
(i)  in point (a)— 
(aa)  for the words from “Union territory” to “the Europe an Union,” substitute 
“United Kingdom”; 
(bb)  omit the words from “or for graft” to the end; 
(ii)  omit points (c) and (d); 
(iii)  after point (k) insert— 
“(l) ‘third country’ means any country, other than the United Kingdom, and includes: 
 (i) the Bailiwick of Guernsey; 
 (ii) the Bailiwick of Jersey; 
 (iii) the Isle of Man.”; 
(b)  in paragraph 2, for “IV to VIII” substitute “4, 5, 7 and 8”; 
(c)  in paragraph 3 omit the second subparagraph. 
(4)  Omit Chapters 2 and 3. 
(5)  In Article 8(3), for “Member States” substitute “Th e Food Standards Agency, in relation to 
operators operating in England, Northern Ireland or  Wales, and Food Standards Scotland, in 
relation to operators operating in Scotland,”. 
(6)  In Article 9(1)— 
(a)  in point (a), for the words from “territory” to the  end substitute “United Kingdom”; 
(b)  in point (d), for the words from “territory” to the  end substitute “United Kingdom”; 
(c)  in point (e), in the words before point (i), for “t erritory of a Member State” substitute 
“United Kingdom”. 
(7)  In Article 14—  27 (a)  in paragraph 1— 
(i)  in the first subparagraph— 
(aa)  in point (a), in the words before point (i), for “U nion” substitute “United 
Kingdom”; 
(bb)  in point (b), in the words before point (i), for “U nion” substitute “United 
Kingdom”; 
(cc)  in point (c)(v), for the words from “not listed” to  the end substitute “that do 
not fall within point (a) or (b) of the second subp aragraph of Article 81(2) of 
Regulation (EU) No 1308/2013”; 
(ii)  omit the second subparagraph; 
(b)  omit paragraph 2. 
(8)  In Article 15— 
(a)  in the heading, for “Union” substitute “United King dom”; 
(b)  in paragraph 1— 
(i)  in the first subparagraph, in the words before poin t (a), for “Union” substitute 
“United Kingdom”; 
(ii)  in the second subparagraph omit “of the Member Stat es”. 
(9)  In Article 17(1), in the first subparagraph, for th e words from “the Union” to “thereto” 
substitute “retained EU law”. 
(10)  In Article 20(2)— 
(a)  in point (a)— 
(i)  for “Union law” substitute “retained EU law”; 
(ii)  for “Union” substitute “United Kingdom”; 
(b)  in point (c)— 
(i)  for “Union legislation” substitute “retained EU law ”; 
(ii)  for “Union” substitute “United Kingdom”. 
(11)  In Article 22(1), in the fourth subparagraph, for “ Union customs office” substitute “customs 
office in the United Kingdom”. 
(12)  In Article 24, in the first paragraph, in the words  before point (a), for “Union”, in both 
places it occurs, substitute “United Kingdom”. 
(13)  In Article 25(2)— 
(a)  for “Union legislation” substitute “retained EU law ”; 
(b)  for “Union” substitute “United Kingdom”. 
(14)  In Article 26(1), for “Union” substitute “United Ki ngdom”. 
(15)  In Article 27— 
(a)  in paragraph 2, for “Union” substitute “United King dom”; 
(b)  in paragraph 3— 
(i)  for “of the Member State” substitute “in a case”; 
(ii)  after “free circulation” insert “in the United King dom”. 
(16)  Omit Article 28(2). 
(17)  Omit Article 30. 
(18)  Omit Chapter 6. 
(19)  In Article 36(2) omit the second subparagraph. 
(20)  Omit Article 39. 
(21)  Omit Articles 43, 44 and 46.  28 (22)  In Article 47(1) omit “of a Member State”. 
(23)  Omit Articles 49 and 50. 
(24)  In Article 51— 
(a)  in the heading, for “the information notified” subs titute “information”; 
(b)  in paragraph 1— 
(i)  in the words before point (a), for “Commission” sub stitute “Secretary of State”; 
(ii)  in point (d), for “Commission and the Member States ” substitute “United Kingdom”. 
(25)  After Article 56 omit the words from “This Regulati on” to “Member States.”. 
(26)  Omit Annexes 1 to 4. 
(27)  Annex 5 is amended in accordance with paragraphs (2 8) to (31). 
(28)  In Section A— 
(a)  in the fourth paragraph— 
(i)  for “the Member States” substitute “the Secretary o f State, by administrative 
decision,”; 
(ii)  at the end insert— 
“The Secretary of State must publish such informati on in such manner as considered 
appropriate by the Secretary of State from time to time.”; 
(b)  after the fourth paragraph insert— 
“The Secretary of State may not make a decision con cerning the order and specific details 
concerning the layout of the entries on the documen ts referred to in Article 10 in relation to 
the use of such documents in Northern Ireland, Scot land or Wales without the consent of: 
(a) in relation to Northern Ireland, the Department  of Agriculture, Environment and Rural 
Affairs; 
(b) in relation to Scotland, the Scottish Ministers ; 
(c) in relation to Wales, the Welsh Ministers.”; 
(c)  in the table— 
(i)  in the sixth row (competent authorities at place of  dispatch), in the column numbered 
1— 
(aa)  omit the words from “in the case” to “Member State or”; 
(bb)  for “Union” substitute “United Kingdom”; 
(ii)  in the twentieth row (date of dispatch etc.), in th e column numbered 1, omit the 
words from “and, where” to the end”. 
(29)  In Section B, in paragraph 2.1— 
(a)  in point (a), for “Union rules” substitute “rules i n retained EU law”; 
(b)  in point (d), in the words before point (i), for “U nion provisions” substitute “provisions in 
retained EU law”; 
(c)  in point (e) (ii), in the wording relating to the u se of the figure “12” (other operations), 
omit the words from “Examples” to “C III(b)(2)”. 
(30)  In Section C, in note 1, for “Symbol of Member Stat e” substitute “The symbol ‘UK’”. 
(31)  In Section D, for the indications in that Section s ubstitute “In English: Exported: Export 
declaration No … of [date]”. 
(32)  In Annex 7— 
(a)  for Parts 1 and 2 substitute the Parts in Schedule 6; 
(b)  in Part 3, in Section C— 
(i)  in the instruction relating to Box 2, for “EU” subs titute “United Kingdom”;  29 (ii)  in the instruction relating to Box 4, in the first indent, for “EU” substitute “United 
Kingdom”. 
Commission Implementing Regulation (EU) 2018/274 
14. —(1) Commission Implementing Regulation (EU) 2018/2 74 laying down rules for the 
application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council as 
regards the scheme of authorisations for vine plant ings, certification, the inward and outward 
register, compulsory declarations and notifications , and of Regulation (EU) No 1306/2013 of the 
European Parliament and of the Council as regards t he relevant checks is amended as follows. 
(2)  In Article 1— 
(a)  in the words before point (a), for the words from “ Regulations” to “respectively” 
substitute “Regulation (EU) No 1308/2013”; 
(b)  omit points (a), (e) and (f). 
(3)  Omit Chapter 2. 
(4)  In Article 12— 
(a)  in paragraph 1— 
(i)  omit the second subparagraph; 
(ii)  in the last subparagraph— 
(aa)  at the beginning insert “In relation to wine produc ed in the United Kingdom,”; 
(bb)  for “Member State in which the wine is produced” su bstitute “United 
Kingdom”; 
(cc)  for “different Member States” substitute “the Unite d Kingdom and a third 
country”; 
(dd)  for “by any of the Member States” substitute “in th e United Kingdom or in the 
relevant third country”; 
(b)  in paragraph 2, in the second subparagraph, omit “,  save where Member States decide 
otherwise”; 
(c)  after paragraph 3 insert— 
“4. In this Article ‘third country’ means any count ry, other than the United Kingdom, 
and includes: 
(a) the Bailiwick of Guernsey; 
(b) the Bailiwick of Jersey; 
(c) the Isle of Man.”. 
(5)  In Article 13(2)— 
(a)  in the first subparagraph, in point (c), after “com petent authorities” insert “, by 
administrative decision, following an application m ade by an operator”; 
(b)  omit the second subparagraph. 
(6)  In Article 14—- 
(a)  in paragraph 1(a)(iii), for the words from “of the classification” to “1308/2013” substitute 
“to the wine grape variety (which must be a wine gr ape variety that complies with point 
(a) or (b) of Article 81(2) of Regulation (EU) No 1 308/2013)”; 
(b)  in paragraph 2, for “Union legislation” substitute “retained EU law”. 
(7)  In Article 15(1)— 
(a)  in point (a), for “under Union or national” substit ute “by”; 
(b)  in point (d) omit “Union or national”. 
(8)  In Article 16(1)(b)(v) omit “Union or national”.  30 (9)  Omit Chapters 5 and 6. 
(10)  Omit Articles 33 and 34. 
(11)  In Article 35 omit paragraphs 2 and 4. 
(12)  After Article 37 omit the words from “This Regulati on” to “Member States.”. 
(13)  Omit Annexes 1 to 4. 
Annex 2 to the EEA Agreement 
15.  In Annex 2 to the EEA Agreement, in Chapter 27, om it points 8, 9, 9a, 9b and 9ba. 
Revocations 
16.  The retained direct EU legislation listed in Sched ule 7 is revoked. 
PART 4 
Amendment of subordinate legislation relating to ve terinary medicines 
The Veterinary Medicines Regulations 2013 
17. —(1) The Veterinary Medicines Regulations 2013( a) are amended as follows. 
(2)  In regulation 4, after paragraph (3) insert— 
“(4) Schedule 1A (converted EU marketing authorisat ions) has effect.”. 
(3)  After Schedule 1 insert the Schedule in Part 1 of S chedule 8. 
(4)  In Schedule 7— 
(a)  in paragraph 1— 
(i)  omit the definition of “national application”; 
(ii)  in the definition of “simultaneous application” omi t the text after sub-paragraph (b); 
(b)  in paragraph 7— 
(i)  for the heading substitute “Application for a marke ting authorisation for a 
pharmaceutical veterinary medicinal product”; 
(ii)  in sub-paragraph (a), for “a national application” substitute “an application”; 
(iii)  omit sub-paragraphs (b) and (c); 
(iv)  in the table— 
(aa)  in the heading, in the second column omit “national ”; 
(bb)  in the heading, in the third column omit “national” ; 
(cc)  for the heading for the fourth column (including th e heading which straddles 
the fourth and fifth columns) substitute “Pharmacol ogically equivalent 
application”; 
(dd)  omit the fifth and sixth columns; 
(c)  omit paragraph 8; 
(d)  in paragraph 9— 
(i)  in sub-paragraph (1)— 
(aa)  for “a national application” substitute “an applica tion”; 
(bb)  omit the words from “a decentralised” to “another m ember State”; 
                                                                                                                                            
(a) S.I. 2013/2033, amended by S.I. 2014/599, 2018/76 1.  31 (ii)  in the table— 
(aa)  in the heading, in the second column omit “National ”; 
(bb)  omit the third column; 
(e)  omit paragraph 10; 
(f)  in paragraph 11— 
(i)  for the heading substitute “Application for a marke ting authorisation based on 
informed consent”; 
(ii)  for “fees” substitute “fee”; 
(iii)  for the text from “are in accordance” to the end (i ncluding the table) substitute “is 
£945 per application.”; 
(g)  in paragraph 15, for the table substitute the table  in Part 2 of Schedule 8; 
(h)  omit paragraph 16; 
(i)  in paragraph 17— 
(i)  in the heading omit the words from “dealt with” to the end; 
(ii)  in the table— 
(aa)  omit the heading for the second column; 
(bb)  omit the third and fourth columns; 
(j)  in paragraph 18— 
(i)  for sub-paragraph (2) substitute— 
“(2) The fees for a worksharing application are spe cified in the following table.”; 
(ii)  omit sub-paragraphs (3) to (5); 
(iii)  in the table— 
(aa)  omit the heading for the second column; 
(bb)  omit the third, fourth, fifth, sixth, seventh and e ighth columns; 
(k)  omit paragraphs 19 and 20; 
(l)  in paragraph 21 omit the words from “in the case” t o the end; 
(m)  in paragraph 22, in the heading omit “national”; 
(n)  omit paragraph 23; 
(o)  in paragraph 24, in the first column of the table o mit “or in another member State”; 
(p)  in paragraph 48— 
(i)  in sub-paragraph (1), for the words from “£345” to the end substitute “£815”; 
(ii)  omit sub-paragraph (3); 
(q)  in paragraph 49(1)— 
(i)  omit sub-paragraph (a); 
(ii)  in sub-paragraph (b), for “a third” substitute “ano ther”. 
PART 5 
Amendment of retained direct EU legislation relatin g to veterinary medicines and 
residues 
Regulation (EC) No 470/2009 of the European Parliam ent and of the Council 
18. —(1) Regulation (EC) No 470/2009 of the European Pa rliament and of the Council laying 
down Community procedures for the establishment of residue limits of pharmacologically active 
substances in foodstuffs of animal origin is amende d as follows.  32 (2)  For Article 8 substitute the Article in Part 1 of S chedule 9. 
(3)  For Article 9 substitute the Article in Part 2 of S chedule 9. 
(4)  In Article 10— 
(a)  for paragraph 1 substitute the paragraphs in Part 3  of Schedule 9; 
(b)  in paragraph 2— 
(i)  in the first subparagraph— 
(aa)  for “Commission” substitute “Secretary of State”; 
(bb)  for “paragraph 1” substitute “paragraphs 1 and 1A”;  
(cc)  after “Article 14” insert “, subject to the consent  requirement in Article 83B of 
Regulation (EU) 528/2012 (treating this Article as a provision of that 
Regulation for the purposes of construing Article 8 3B(1))”; 
(dd)  omit the second sentence; 
(ii)  in the second subparagraph, for “Article 10(2) of D irective 98/8/EC” substitute 
“Article 19(7) of Regulation (EU) No 528/2012”; 
(c)  omit paragraph 3. 
(5)  In Article 14— 
(a)  for paragraph 1 substitute— 
“1. The appropriate authority (or, as regards Artic le 10(2), the Secretary of State) must 
classify pharmacologically active substances in acc ordance with this Article.”; 
(b)  in paragraph 3, for the words after “human health” to the end substitute “, and when 
laying down a limit regard may be had to any intern ational decisions in respect of that 
substance.”; 
(c)  in paragraph 5 omit the words from “, pursuant to” to “as appropriate,”; 
(d)  in paragraph 6 omit the words from “, pursuant to” to “as appropriate,”. 
(6)  After Article 14 insert the Article in Part 4 of Sc hedule 9. 
 
 
 
 
 
 
 
 David Rutley  
 Parliamentary Under Secretary of State 
11th April 2019 Department for Environment, Food an d Rural Affairs 
 
 
We consent 
 
 Craig Whittaker  
 Mike Freer  
11th April 2019 Two of the Lords Commissioners of H er Majesty’s Treasury  33  SCHEDULE 1 Regulation 7(4)(b), (27), (50), 
 (53), (55) and (60) 
Regulation (EU) No 1151/2012 of the European Parlia ment and of the 
Council: new provisions 
PART 1 
Article 3: new definitions 
“(9) ‘the EUWA’ means the European Union (Withdrawa l) Act 2018; 
(10) ‘EU Regulation 1151/2012’ means Regulation (EU ) No 1151/2012 of the European 
Parliament and of the Council on quality schemes fo r agricultural products and foodstuffs 
as it had effect in EU law immediately before exit day; 
(11) ‘Regulation 1308/2013’ means Regulation (EU) N o 1308/2013 of the European 
Parliament and of the Council establishing a common  organisation of the markets in 
agricultural products; 
(12) ‘Regulation 664/2014’ means Commission Delegat ed Regulation (EU) No 664/2014 
supplementing Regulation (EU) No 1151/2012 of the E uropean Parliament and of the 
Council with regard to the establishment of the Uni on symbols for protected designations of 
origin, protected geographical indications and trad itional specialities guaranteed and with 
regard to certain rules on sourcing, certain proced ural rules and certain additional 
transitional rules; 
(13) ‘the Quality Schemes Regulations’ means the Qu ality Schemes (Agricultural 
Products and Foodstuffs) Regulations 2018; 
(14) ‘the competent authority’, in relation to the United Kingdom, means the person 
specified in regulation 3(1) of the Quality Schemes  Regulations; 
(15) ‘the designated authority’ means: 
(a) unless point (b) or (c) applies, the person spe cified in regulation 3(2) of the Quality 
Schemes Regulations as the person responsible for c arrying out the relevant function; 
(b) in a case where an official control has been de legated to a control body in accordance 
with Article 39, the control body to which the func tion has been delegated; 
(c) in a case where an enforcement authority has be en appointed to carry out the function 
under regulation 6 of the Quality Schemes Regulatio ns, the appointed enforcement 
authority; 
(16) ‘domestic law’ means the means the law of Engl and and Wales, Scotland and 
Northern Ireland; 
(17) ‘enactment’ includes: 
(a) enactments of the type specified in paragraphs (a) to (f) of the definition of 
“enactment” in section 20(1) of the EUWA, and 
(b) except in Article 28, retained direct EU legisl ation; 
(18) ‘established protected designation of origin’ means a designation of origin shown as 
a United Kingdom registered designation of origin o n the register maintained by the 
European Commission pursuant to Article 11 of EU Re gulation 1151/2012 as that register 
stood immediately before exit day; 
(19) ‘established protected geographical indication ’ means a geographical indication 
shown as a registered United Kingdom geographical i ndication on the register maintained 
by the European Commission pursuant to Article 11 o f EU Regulation 1151/2012 as that 
register stood immediately before exit day; 
(20) ‘established protected traditional speciality guaranteed’ means a traditional speciality 
guaranteed shown as a registered United Kingdom tra ditional speciality guaranteed on the  34 register maintained by the European Commission purs uant to Article 22 of EU Regulation 
1151/2012 as that register stood immediately before  exit day; 
(21) ‘FTT’ means the First-tier Tribunal; 
(22) ‘third country’ means any country, other than the United Kingdom, and includes: 
(a) the Bailiwick of Guernsey; 
(b) the Bailiwick of Jersey; 
(c) the Isle of Man.” 
PART 2 
Article 28: new Article 
“Article 28 
Existing enactments 
1. Nothing in this Regulation prevents the maintena nce of enactments on optional 
quality terms that are not covered by this Regulati on and are in force immediately before 
exit day, provided that they comply with retained E U law. 
2. In paragraph 1, ‘maintenance’ includes repeal an d replacement, and revocation and 
replacement, without, in both cases, any substantiv e modification.” 
PART 3 
New Article 52a 
“Article 52a 
Applications pending on exit day 
1. An application made under EU Regulation 1151/201 2 before exit day to which 
paragraph 2 applies is deemed to be an application made under Article 49(1) of this 
Regulation for which scrutiny under Article 50(1) o f this Regulation has not been 
commenced. Unless requested not to do so in writing  by the applicant who submitted the 
application, the Secretary of State must scrutinise  the application under Article 50(1) of this 
Regulation. The six month period specified in Artic le 50(1) starts from the day on which 
exit day falls. 
2. This paragraph applies to an application submitt ed to the Secretary of State on or 
after 1st January 2019 or the Secretary of State or  the Department for Environment Food 
and Rural Affairs before that date: 
(a) to register: 
 (i) a name of a geographical area in, or partly in , the United Kingdom as a 
designation of origin, 
 (ii) a name of a geographical area in, or partly i n, the United Kingdom as a 
geographical indication, or 
 (iii) a name as a traditional speciality guarantee d, and 
(b) that has not been scrutinised under Article 49( 2) of EU Regulation 1151/2012 before 
exit day or has been subject to scrutiny under Arti cle 49(2) before exit day but for 
which no decision has been taken as to whether it m eets the relevant conditions of EU 
Regulation 1151/2012 or is justified. 
3. An application made under EU Regulation 1151/201 2 before exit day to which 
paragraph 4 applies is deemed to be an application made under Article 49(1) of this 
Regulation that has been found by the Secretary of State, for the purpose of Article 50(2), to  35 fulfil the conditions laid down in this Regulation but for which the documents specified in 
Article 50(2) have not been published. 
In the case of an application to register the name of a designation of origin or geographical 
indication, the Secretary of State must, unless req uested not to do so in writing by the 
applicant who submitted the application, publish th e single document and product 
specification submitted with the application made u nder EU Regulation 1151/2012 as soon 
as reasonably practicable after exit day. 
In the case of an application to register the name of a traditional speciality guaranteed, the 
Secretary of State must, unless requested not to do  so in writing by the applicant who 
submitted the application, publish the product spec ification submitted with the application 
made under EU Regulation 1151/2012 as soon as reaso nably practicable after exit day. 
The publication of the documents specified in the s econd or third subparagraph by the 
Secretary of State initiates the opposition procedu re to which Article 51 of this Regulation 
applies in relation to the application. 
4. This paragraph applies to an application submitt ed to the Secretary of State on or 
after 1st January 2019 or the Secretary of State or  the Department for Environment Food 
and Rural Affairs before that date: 
(a) to register: 
 (i) the name of a geographical area in, or partly in, the United Kingdom as a 
designation of origin, 
 (ii) the name of a geographical area in, or partly  in, the United Kingdom as a 
geographical indication, or 
 (iii) a name as a traditional speciality guarantee d, and 
(b) that has been scrutinised under Article 49(2) o f EU Regulation 1151/2012 and been 
found by the Secretary of State to meet the conditi ons of, and to be justified under, EU 
Regulation 1151/2012 before exit day but for which the Commission has not adopted 
an implementing act under Article 52 of EU Regulati on 1151/2012 before exit day.” 
PART 4 
New Title 5A 
“TITLE 5A 
APPEALS 
Article 54a 
Appeals: general 
1. An appeal may be made to the FTT against a decis ion of the Secretary of State 
specified in the first column of the table in Annex  3. 
2. Such an appeal may be made: 
(a) in all cases, by a person specified in the corr esponding entry in the second column of 
the table in Annex 3; 
(b) in the case of a decision affecting an applicat ion submitted by the authorities of a third 
country, the authorities of that third country. 
3. In determining such an appeal the FTT: 
(a) must consider the decision appealed against afr esh, and 
(b) may take into account evidence that was not ava ilable to the Secretary of State.  36 4. The FTT may: 
(a) dismiss the appeal, or 
(b) if it allows the appeal, exercise any power spe cified in the corresponding entry in the 
third column of the table in Annex 3. 
5. The Secretary of State may consider a decision s pecified in the first column of the 
table in Annex 3 afresh if evidence becomes availab le to the Secretary of State after making 
the original decision that was not available to the  Secretary of State at the time of the 
original decision. 
6. Paragraph 5 applies even though an appeal has be en made to the FTT in respect of 
the original decision. 
7. Where the Secretary of State decides to consider  an original decision afresh in a case 
where an appeal has been made to the FTT in respect  of that decision, the appeal to the FTT 
is suspended until such time as the Secretary of St ate has made a fresh decision in relation 
to the matter. 
8. If the Secretary of State makes the same decisio n again, the appeal to the FTT 
restarts. If the Secretary of State makes a differe nt decision, the appeal to the FTT ceases 
unless the FTT directs otherwise. 
Article 54b  
Appeals: applications to register designations of o rigin, geographical indications and 
traditional specialities guaranteed 
1. Where an appeal is made to the FTT relating to a  decision to approve an application 
to register a designation of origin, geographical i ndication or traditional speciality 
guaranteed, and the Secretary of State has made an entry in the relevant register pursuant to 
Article 52 relating to that registration, the entry  in the register is to be maintained but is in 
suspense and must be marked to indicate that it is in suspense until the FTT has determined 
the appeal and any necessary consequent action or d ecision has been taken by the Secretary 
of State. 
2. Where an appeal is made to the FTT relating to a  decision to approve an application 
to register a designation of origin, geographical i ndication or traditional speciality 
guaranteed, and the Secretary of State has not made  an entry in the register, the Secretary of 
State must not make an entry in the register until the FTT has determined the appeal and 
any necessary consequent action or decision has bee n taken by the Secretary of State. 
Article 54c 
Appeals: applications to amend product specificatio ns 
1. Paragraph 2 applies where an appeal is made to t he FTT relating to a decision by the 
Secretary of State to approve an application of the  type specified in Article 53(2) to amend 
a product specification relating to a protected des ignation of origin, protected geographical 
indication or traditional speciality guaranteed and  the Secretary of State has not updated the 
entry in the relevant register relating to it pursu ant to Article 14(3) of Commission 
Implementing Regulation (EU) 668/2014 by replacing the copy of the product specification 
attached to the relevant register with the amended version of the product specification. 
2. Until the FTT has determined the appeal and any necessary consequent action or 
decision has been taken by the Secretary of State, the existing copy of the product 
specification attached to the entry in the relevant  register relating to the protected 
designation of origin, protected geographical indic ation or traditional speciality guaranteed 
applies without amendment but the entry in the rele vant register must be marked to indicate 
that an appeal relating to the amendment of the pro duct specification is pending. 
3. Paragraph 4 applies where an appeal is made to t he FTT relating to a decision by the 
Secretary of State to approve an application of the  type specified in Article 53(2) in relation  37 to the amendment of a product specification relatin g to a protected designation of origin, 
protected geographical indication or traditional sp eciality guaranteed and the Secretary of 
State has updated the entry in the relevant registe r relating to the protected designation of 
origin, protected geographical indication or tradit ional speciality guaranteed by replacing 
the copy of the product specification with the appr oved amended version. 
4. Until the FTT has determined the appeal and any necessary consequent action or 
decision has been taken by the Secretary of State, the previous copy of the product 
specification attached to the entry in the relevant  register is to be restored but the entry in 
the relevant register must be marked to indicate th at an appeal relating to the amendment of 
the product specification is pending. 
5. Paragraph 6 applies where an appeal is made to t he FTT relating to a decision by the 
Secretary of State to reject an application of the type specified in Article 53(2) to amend a 
product specification relating to a protected desig nation of origin, protected geographical 
indication or traditional speciality guaranteed. 
6. Until the FTT has determined the appeal and any necessary consequent action or 
decision has been taken by the Secretary of State, the existing copy of the product 
specification attached to the entry in the relevant  register is to be maintained but the entry in 
the register must be marked to indicate that an app eal relating to an application to amend 
the product specification is pending. 
7. Paragraph 8 applies where an appeal is made to t he FTT relating to a decision by the 
Secretary of State to approve an application of the  type specified in Article 6(4) and (4)(a) 
of Regulation 664/2014 to amend a product specifica tion relating to a protected designation 
of origin, protected geographical indication or tra ditional speciality guaranteed on a 
temporary basis and the Secretary of State has not included an entry in the relevant register 
relating to the temporary amendment of the product specification pursuant to Article 14(3b) 
of Commission Implementing Regulation (EU) 668/2014 . 
8. Until the FTT has determined the appeal and any necessary consequent action or 
decision has been taken by the Secretary of State, the existing copy of the product 
specification attached to the entry in the relevant  register applies without amendment but 
the entry in the register must be marked to indicat e that an appeal relating to the temporary 
amendment of the product specification is pending. 
9. Paragraph 10 applies where an appeal is made to the FTT relating to a decision by 
the Secretary of State to approve an application of  the type specified in Article 6(4) of 
Regulation 664/2014 in relation to the temporary am endment of a product specification 
relating to a protected designation of origin, prot ected geographical indication or traditional 
speciality guaranteed and the Secretary of State ha s updated the entry in the relevant 
register by including an entry relating to the temp orary amendment of the product 
specification. 
10. Until the FTT has determined the appeal and any  necessary consequent action or 
decision has been taken by the Secretary of State, the copy of the product specification 
attached to the entry in the relevant register appl ies and the entry in the relevant register 
relating to the temporary amendment must be marked to indicate that an appeal relating to 
the temporary amendment of the product specificatio n is pending. 
11. Paragraph 12 applies where an appeal is made to  the FTT relating to a decision by 
the Secretary of State to reject an application of the type specified in Article 6(4) and (4)(a) 
of Regulation 664/2014 to amend a product specifica tion relating to a protected designation 
of origin, protected geographical indication or tra ditional speciality guaranteed on a 
temporary basis. 
12. Until the FTT has determined the appeal and any  necessary consequent action or 
decision has been taken by the Secretary of State, the copy of the product specification 
attached to the entry in the relevant register appl ies but the entry in the register must be  38 marked to indicate that an appeal relating to an ap plication to amend the product 
specification on a temporary basis is pending. 
Article 54d 
Appeals: applications to cancel registered designat ions of origin, geographical 
indications and traditional specialities guaranteed  
1. Paragraph 2 applies where an appeal is made to t he FTT relating to a decision of the 
Secretary of State to cancel the registration of a protected designation of origin, protected 
geographical indication or traditional speciality g uaranteed under Article 54 and the 
Secretary of State has not removed the entry in the  relevant register. 
2. Until the FTT has determined the appeal and any necessary consequent action or 
decision has been taken by the Secretary of State, the entry in the relevant register is to be 
maintained but must be marked to indicate that an a ppeal relating to its cancellation is 
pending. 
3. Paragraph 4 applies where an appeal has been mad e to the FTT relating to a decision 
of the Secretary of State to cancel the registratio n of a protected designation of origin, 
protected geographical indication or traditional sp eciality guaranteed and the Secretary of 
State has removed the entry in the relevant registe r. 
4. Until the FTT has determined the appeal and any necessary consequent action or 
decision has been taken by the Secretary of State, the entry in the register must be restored 
but must be marked to indicate that an appeal relat ing to its cancellation is pending. 
5. Paragraph 6 applies where an appeal has been mad e to the FTT relating to a decision 
of the Secretary of State not to cancel the registr ation of a protected designation of origin, 
protected geographical indication or traditional sp eciality guaranteed. 
6. Until the FTT has determined the appeal and any necessary consequent action or 
decision has been taken by the Secretary of State, the entry in the relevant register relating 
to the protected designation of origin, protected g eographical indication or traditional 
speciality guaranteed must be marked to indicate th at an appeal relating to the cancellation 
of the entry is pending.” 
PART 5 
New Article 56 
“Article 56 
Regulations 
1. Any power to make regulations conferred on the S ecretary of State by this 
Regulation is exercisable by statutory instrument. 
2. Such regulations may: 
(a) contain supplementary, incidental, consequentia l, transitional or saving provision 
(including provision amending, repealing or revokin g enactments); 
(b) make different provision for different purposes . 
3. Except as specified in paragraph 4, a statutory instrument containing regulations 
under this Regulation is subject to annulment in pu rsuance of a resolution of either House 
of Parliament. 
4. A statutory instrument containing regulations ma de under the second subparagraph 
of Article 2(1) or Article 18(5), 30(1) or 41(3) ma y not be made unless a draft of the 
instrument has been laid before, and approved by a resolution of, each House of Parliament.  39 5. Before making any regulations under this Regulat ion, the Secretary of State must 
consult: 
(a) such bodies or persons as appear to the Secreta ry of State to be representative of the 
interests likely to be substantially affected by th e regulations; 
(b) such other bodies or persons as the Secretary o f State may consider appropriate.” 
PART 6 
New Annex 3 
“ANNEX 3  
APPEALS 
 
Decision Persons who may appeal 
against the decision FTT powers 
Decision of the Secretary of 
State to approve an application 
made under Article 49 to 
register a designation of 
origin, geographical indication 
or traditional speciality 
guaranteed The persons are: 
(a) a person who submitted a 
reasoned statement of 
opposition under Article 51(2); 
(b) a person marketing a 
product that is, or may be, 
affected by the registration of 
the designation of origin, 
geographical indication or 
traditional speciality 
guaranteed. Power to: 
(a) quash the decision and 
direct the Secretary of State to 
reject the application and (if 
appropriate) restore the 
register; 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
of the application and (if 
appropriate) to restore the 
register in the meantime. 
Decision of the Secretary of 
State to reject an application 
made under Article 49 to 
register a designation of 
origin, geographical indication 
or traditional speciality 
guaranteed The persons are: 
(a) the person who submitted 
the application to register the 
designation of origin, 
geographical indication or 
traditional speciality 
guaranteed; 
(b) a person marketing a 
product that is, or may be, 
affected by the decision not to 
register the designation of 
origin, geographical indication 
or traditional speciality 
guaranteed. Power to: 
(a) quash the decision and 
direct the Secretary of State to 
approve the application and 
register the designation of 
origin, geographical indication 
or traditional speciality 
guaranteed; 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
of the application. 
Decision of the Secretary of 
State to approve an application 
made under Article 53 to make 
an amendment to a product 
specification relating to a 
protected designation of 
origin, protected geographical 
indication or protected 
traditional speciality 
guaranteed The persons are: 
(a) a person who submitted a 
reasoned statement of 
opposition under Article 51(2), 
as read with the first 
subparagraph of Article 53(2), 
in relation to the application; 
(b) a person marketing a 
product that is, or may be, 
affected by the amendment of 
the product specification. Power to: 
(a) quash the decision and 
direct the Secretary of State to 
reject the application and (if 
appropriate) restore the 
register; 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
of the application and (if 
appropriate) to restore the 
register in the meantime.  40 Decision Persons who may appeal 
against the decision FTT powers 
Decision of the Secretary of 
State to reject an application 
made under Article 53 to make 
an amendment to a product 
specification relating to a 
protected designation of 
origin, protected geographical 
indication or protected 
traditional speciality 
guaranteed The persons are: 
(a) the person who submitted 
the application to amend the 
product specification; 
(b) a person marketing a 
product that is, or may be, 
affected by the decision not to 
approve the application to 
amend the product 
specification. Power to: 
(a) quash the decision and 
direct the Secretary of State to 
approve the application and 
attach a copy of the amended 
product specification to the 
register; 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
of the application. 
Decision of the Secretary of 
State under Article 54 to 
cancel the registration of a 
protected designation of 
origin, protected geographical 
indication or protected 
traditional speciality 
guaranteed on the Secretary of 
State’s initiative The persons are: 
(a) a person who submitted a 
reasoned statement of 
opposition under Article 51(2) 
as read with Article 7(1) and 
(4) of Regulation 664/2014; 
(b) a person marketing a 
product that is, or may be, 
affected by the cancellation of 
the registration of the 
protected designation of 
origin, protected geographical 
indication or protected 
traditional speciality 
guaranteed. Power to: 
(a) quash the decision and 
direct the Secretary of State (if 
appropriate) to restore the 
register; 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
relating to the cancellation and 
(if appropriate) to restore the 
register in the meantime. 
Decision of the Secretary of 
State to approve an application 
made under Article 54 to 
cancel the registration of a 
protected designation of 
origin, protected geographical 
indication or protected 
traditional speciality 
guaranteed The persons are: 
(a) a person who submitted a 
reasoned statement of 
opposition under Article 51(2) 
as read with Article 7(1) and 
(4) of Regulation 664/2014; 
(b) a person marketing a 
product that is, or may be, 
affected by the cancellation of 
the registration of the 
protected designation of 
origin, protected geographical 
indication or protected 
traditional speciality 
guaranteed. Power to: 
(a) quash the decision and 
direct the Secretary of State to 
(if appropriate) restore the 
register, or 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
of the application and (if 
appropriate) to rectify the 
register in the meantime. 
Decision of the Secretary of 
State to reject an application 
made under Article 54 to 
cancel the registration of a 
protected designation of 
origin, protected geographical 
indication or protected 
traditional speciality 
guaranteed The persons are: 
(a) the person who submitted 
the application to cancel the 
registration of the protected 
designation of origin, 
protected geographical 
indication or protected 
traditional speciality 
guaranteed; 
(b) a person marketing a 
product that is, or may be, 
affected by the decision not to 
cancel the registration the Power to: 
(a) quash the decision and 
direct the Secretary of State to 
cancel the registration; 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
of the application.”  41 Decision Persons who may appeal 
against the decision FTT powers 
protected designation of 
origin, protected geographical 
indication or protected 
traditional speciality 
guaranteed. 
 SCHEDULE 2 Regulation 8(14) 
Commission Implementing Regulation (EU) No 716/2013 : new Annexes 
1 to 5 
“ANNEX 1  
APPLICATION TO REGISTER A GEOGRAPHICAL INDICATION 
 
Date of receipt (DD/MM/YYYY) … 
[for official use ] 
Number of pages (including this page) … 
File number … 
[for official use ] 
Geographical indication to be registered … 
 
Category of the spirit drink 
Applicant 
Name of legal or natural person … 
Full address (street number and name, town/city and  postal code, country) … 
Legal status, size and composition ( in the case of legal persons ) … 
Nationality … 
Tel., e-mail 
Intermediary (if applicable) 
Third-country authority 
Name(s) of intermediary(ies) … 
Full address(es) (street number and name, town/city  and postal code, country) … 
Tel., e-mail … 
Proof of protection in third country … 
 
Technical file  42 Number of pages … 
Name(s) of signatory(ies) … 
Signature(s) … 
ANNEX 2 
TECHNICAL FILE 
Date of receipt (DD/MM/YYYY) … 
[for official use ] 
Number of pages (including this page) … 
File number … 
[for official use ] 
Geographical indication to be registered … 
 
Category of the spirit drink 
Description of the spirit drink 
— Physical, chemical and/or organoleptic characteri stics 
— Specific characteristics (compared to spirit drin ks of the same category) 
Geographical area concerned 
 
Method for obtaining the spirit drink 
Link with the geographical environment or origin 
— Details of the geographical area or origin releva nt to the link 
— Specific characteristics of the spirit drink attr ibutable to the geographical area 
National/regional provisions 
 
Applicant 
— Third Country or legal/natural person … 
— Full address (street number and name, town/city a nd postal code, country) … 
— Legal status (in the case of legal persons) … 
Supplement to the geographical indication 
 
Specific labelling rules  43 ANNEX 3 
OBJECTION TO A GEOGRAPHICAL INDICATION 
Date of receipt (DD/MM/YYYY) … 
[for official use ] 
Number of pages (including this page) … 
File number … 
[for official use ] 
Objector 
Name of legal or natural person … 
Full address (street number and name, town/city and  postal code, country) … 
Nationality … 
Tel., e-mail … 
Intermediary (if applicable)  
Third-country authority (optional) 
Name(s) of intermediary(ies) … 
Full address(es) (street number and name, town/city  and postal code, country) … 
Objected geographical indication … 
 
Prior rights 
Registered geographical indication (*) 
National geographical indication (*) 
[(*) delete as appropriate ] 
Name … 
Registration number … 
Date of registration (DD/MM/YYYY) … 
Trademark 
Sign … 
List of products and services … 
Registration number … 
Date of registration … 
Country of origin … 
Reputation/renown (*) … 
[(*) delete as appropriate ]  44 Grounds for objection 
Name of signatory … 
Signature … 
ANNEX 4 
APPLICATION TO CANCEL A GEOGRAPHICAL INDICATION 
 
Date of receipt (DD/MM/YYYY) … 
[for official use ] 
Number of pages (including this page) … 
Author of request of cancellation … 
File number … 
[for official use ] 
Name of legal or natural person … 
Full address ( street number and name, town/city and postal code, country ) … 
Nationality … 
Tel., e-mail … 
Contested geographical indication … 
 
Legitimate interest of the author of the request … 
Statement by the third country (where relevant)… 
 
Grounds for cancellation 
 
Name of signatory … 
Signature … 
ANNEX 5 
APPLICATION TO AMEND THE TECHNICAL FILE OF A GEOGRA PHICAL 
INDICATION 
 
Date of receipt (DD/MM/YYYY) … 
[for official use ] 
Number of pages (including this page) … 
File number … 
[for official use ]  45 Intermediary (if applicable)  
Third-country authority (optional) 
Name(s) of intermediary(ies) … 
Full address(es) (street number and name, town/city  and postal code, country) … 
Tel., e-mail … 
Name of the geographical indication 
 
Specification heading affected by the amendment 
 
Protected name (*) 
Description of product (*) 
Geographical area (*) 
Link (*) 
Names and addresses of control authorities (*) 
Other (*) 
[(*) delete as appropriate] 
Amendment 
Amendment to the product specification not entailin g an amendment of the main 
specifications (*) 
Amendment to the product specification entailing an  amendment to the main specifications 
(*) 
[(*)  delete as appropriate ] 
Explanation of the amendment … 
 
Amended main specifications 
[on separate sheet ] 
 
 
Name of signatory … 
Signature …”  46  SCHEDULE 3 Regulation 9(3)(b), (20)(c), (22),  
(29), (34)(b) and (36) 
Regulation (EU) No 251/2014 of the European Parliam ent and of the 
Council: new provisions 
PART 1 
Article 2(1): new definitions 
“(4) ‘constituent nation’ means England, Northern I reland, Scotland or Wales; 
(5) ‘country’, in relation to the United Kingdom, m eans the United Kingdom as a whole 
and does not mean any of the individual constituent  nations forming part of the United 
Kingdom; 
(6) ‘enactment’ includes enactments of the type spe cified in paragraphs (a) to (f) of the 
definition of ‘enactment’ in section 20(1) of the E uropean Union (Withdrawal) Act 2018 
but does not include enactments of the type specifi ed in paragraphs (g) and (h) of that 
definition; 
(7) ‘FTT’ means the First-tier Tribunal; 
(8) ‘register’ means the register established and m aintained by the Secretary of State 
pursuant to Article 21; 
(9) ‘third country’ means any country, other than t he United Kingdom, and includes: 
(a) the Bailiwick of Guernsey; 
(b) the Bailiwick of Jersey; 
(c) the Isle of Man.” 
PART 2 
Article 24: new paragraph 3 
“3. In a case where the proposed amendment is only minor and the Secretary of State 
decides not to follow the procedure laid down in Ar ticles 14(2) and 15, the Secretary of 
State, after making a decision in relation to the a pplication, must publish in such manner as 
appears appropriate to the Secretary of State from time to time: 
(a) a notice informing the applicant and the public  of the decision made in relation to the 
application, and 
(b) where the application is approved, a copy of th e single document and product 
specification for the geographical indication incor porating the approved amendment.” 
PART 3 
New Articles 25a to 25d 
“Article 25a 
Appeals: general 
1. An appeal may be made to the FTT against a decis ion of the Secretary of State 
specified in the first column of the table in Annex  4. 
2. Such an appeal may be made: 
(a) in all cases, by a person specified in the corr esponding entry in the second column of 
the table in Annex 4;  47 (b) in the case of a decision affecting an applicat ion submitted by the authorities of a third 
country, the authorities of that third country. 
3. In determining such an appeal, the FTT: 
(a) must consider the decision appealed against afr esh, and 
(b) may take into account evidence that was not ava ilable to the Secretary of State. 
4. The FTT may: 
(a) dismiss the appeal, or 
(b) if it allows the appeal, exercise any power spe cified in the corresponding entry in the 
third column of the table in Annex 4. 
5. The Secretary of State may consider a decision s pecified in the first column of the 
table in Annex 4 afresh if evidence becomes availab le to the Secretary of State after making 
the original decision that was not available to the  Secretary of State at the time of the 
original decision. 
6. Paragraph 5 applies even though an appeal has be en made to the FTT in respect of 
the original decision. 
7. Where the Secretary of State decides to consider  an original decision afresh in a case 
where an appeal has been made to the FTT in respect  of that decision, the appeal to the FTT 
is suspended until such time as the Secretary of St ate has made a fresh decision in relation 
to the matter. 
8. If the Secretary of State makes the same decisio n again, the appeal to the FTT 
restarts. If the Secretary of State makes a differe nt decision, the appeal to the FTT ceases 
unless the FTT directs otherwise. 
Article 25b 
Appeals: applications to register geographical indi cations 
1. Where an appeal is made to the FTT relating to a  decision to approve an application 
to register a geographical indication and the Secre tary of State has made an entry in the 
register relating to that geographical indication, the entry in the register is to be maintained 
but is in suspense and must be marked to indicate t hat it is in suspense until the FTT has 
determined the appeal and any necessary consequent action or decision has been taken by 
the Secretary of State. 
2. Where an appeal is made to the FTT relating to a  decision to approve an application 
to register a geographical indication and the Secre tary of State has not made an entry in the 
register relating to that geographical indication, the Secretary of State must not make an 
entry in the register until the FTT has determined the appeal and any necessary consequent 
action or decision has been taken by the Secretary of State. 
Article 25c 
Appeals: applications to amend product specificatio ns 
1. Paragraph 2 applies where an appeal is made to t he FTT relating to a decision by the 
Secretary of State to approve an application made u nder Article 24 to amend a product 
specification for a geographical indication and the  Secretary of State has not updated the 
entry in the register relating to the indication to  incorporate the approved amendment. 
2. Until the FTT has determined the appeal and any necessary consequent action or 
decision has been taken by the Secretary of State, the existing entry in the register relating 
to the geographical indication is to be maintained but must be marked to indicate that an 
appeal relating to the amendment of the product spe cification is pending. 
3. Paragraph 4 applies where an appeal is made to t he FTT relating to a decision by the 
Secretary of State to approve an application made u nder Article 24 in relation to the  48 amendment of a product specification for a geograph ical indication and the Secretary of 
State has updated the entry in the register relatin g to the geographical indication to 
incorporate the approved amendment. 
4. Until the FTT has determined the appeal and any necessary consequent action or 
decision has been taken by the Secretary of State, the previous entry in the register for the 
protected geographical indication is to be restored  but the entry in the register must be 
marked to indicate that an appeal relating to the a mendment of the product specification is 
pending. 
5. Paragraph 6 applies where an appeal is made to t he FTT relating to a decision by the 
Secretary of State to reject an application made un der Article 24 to amend a product 
specification for a protected geographical indicati on. 
6. Until the FTT has determined the appeal and any necessary consequent action or 
decision has been taken by the Secretary of State, the existing entry in the register is to be 
maintained but the entry in the register must be ma rked to indicate that an appeal relating to 
an application to amend the specification is pendin g. 
Article 25d 
Appeals: applications to cancel geographical indica tions 
1. Paragraph 2 applies where an appeal is made to t he FTT relating to a decision of the 
Secretary of State to cancel the registration of a protected geographical indication under 
Article 25 and the Secretary of State has not remov ed the entry in the register relating to the 
geographical indication. 
2. Until the FTT has determined the appeal and any necessary consequent action or 
decision has been taken by the Secretary of State, the entry in the register for the 
geographical indication is to be maintained but mus t be marked to indicate that an appeal 
relating to its cancellation is pending. 
3. Paragraph 4 applies where an appeal has been mad e to the FTT relating to a decision 
of the Secretary of State to cancel the registratio n of a protected geographical indication and 
the Secretary of State has removed the entry in the  register for the geographical indication. 
4. Until the FTT has determined the appeal and any necessary consequent action or 
decision has been taken by the Secretary of State, the entry in the register must be restored 
but must be marked to indicate that an appeal relat ing to its cancellation is pending. 
5. Paragraph 6 applies where an appeal has been mad e to the FTT relating to a decision 
of the Secretary of State not to cancel the registr ation of a protected geographical 
indication. 
6. Until the FTT has determined the appeal and any necessary consequent action or 
decision has been taken by the Secretary of State, the entry in the register relating to the 
protected geographical indication must be marked to  indicate that an appeal relating to the 
cancellation of the entry is pending.” 
PART 4 
New Article 33 
“Article 33 
Provisions relating to regulations 
1. Any power to make regulations conferred on the S ecretary of State by this 
Regulation is exercisable by statutory instrument. 
2. Such regulations may:  49 (a) contain supplementary, incidental, consequentia l, transitional or saving provision 
(including provision amending, repealing or revokin g enactments and retained direct 
EU legislation); 
(b) make different provision for different purposes . 
3. Except as specified in paragraph 4, a statutory instrument containing regulations 
under this Regulation is subject to annulment in pu rsuance of a resolution of either House 
of Parliament. 
4. A statutory instrument containing regulations un der Article 28 may not be made 
unless a draft of the instrument has been laid befo re, and approved by a resolution of, each 
House of Parliament.” 
PART 5 
Annex 1, point (5): new subparagraph 
“In this point, ‘relevant water quality legislation ’ means: 
(a) in relation to aromatised wine products markete d in England: 
 (i) the Natural Mineral Water, Spring Water and Bo ttled Drinking Water (England) 
Regulations 2007( a); 
 (ii) the Water Supply (Water Quality) Regulations 2016( b); 
 (iii) the Private Water Supplies (England) Regulat ions 2016( c); 
(b) in relation to aromatised wine products markete d in Northern Ireland: 
 (i) the Natural Mineral Water, Spring Water and Bo ttled Drinking Water (Northern 
Ireland) Regulations 2015( d); 
 (ii) the Private Water Supplies Regulations (North ern Ireland) 2017( e); 
 (iii) the Water Supply (Water Quality) Regulations  (Northern Ireland) 2017( f); 
(c) in relation to aromatised wine products markete d in Scotland: 
 (i) the Natural Mineral Water, Spring Water and Bo ttled Drinking Water (Scotland) 
(No. 2) Regulations 2007( g); 
 (ii) the Public Water Supplies (Scotland) Regulati ons 2014( h); 
 (iii) the Water Intended for Human Consumption (Pr ivate Supplies) (Scotland) 
Regulations 2017( i); 
(d) in relation to aromatised wine products markete d in Wales: 
 (i) the Natural Mineral Water, Spring Water and Bo ttled Drinking Water (Wales) 
Regulations 2015( j); 
 (ii) the Private Water Supplies (Wales) Regulation s 2017( k); 
 (iii) the Water Supply (Water Quality) Regulations  2018( l).” 
                                                                                                                                            
(a) S.I. 2007/2785, amended by S.I. 2009/1598, 2010/4 33, 2011/451, 1043, 2014/1855, 2018/352. 
(b) S.I. 2016/614, amended by S.I. 2017/506, 2018/706 . 
(c) S.I. 2016/618, amended by S.I. 2017/506, 2018/707 . 
(d) S.R. 2015 No 365, amended by S.R. 2017 No 201. 
(e) S.R. 2017 No. 211. 
(f) S.R. 2017 No. 212. 
(g) S.S.I. 2007/483, amended by S.S.I. 2009/273, 2010 /89, 127, 2011/94, 2014/312, 2015/100, 363, 2017/28 7. 
(h) S.S.I. 2014/364; relevant amending instruments ar e S.S.I. 2015/346, 2017/281. 
(i) S.S.I. 2017/282, amended by S.S.I. 2017/321. 
(j) S.I. 2015/1867 (W. 274), amended by S.I. 2017/935 . 
(k) S.I. 2017/1041 (W. 270). 
(l) S.I. 2018/647 (W. 121).  50 PART 6 
New Annex 4 
“ANNEX 4 
APPEALS 
 
Decision Persons who may appeal 
against the decision FTT powers 
Decision of the Secretary of 
State to approve an application 
made under Article 11 or 13a 
to register a geographical 
indication  The persons are: 
(a) a person who lodged a duly 
substantiated statement of 
opposition under Article 15; 
(b) a person marketing a 
product that is, or may be, 
affected by the registration of 
the geographical indication. Power to: 
(a) quash the decision and (if 
appropriate) direct the 
Secretary of State to reject the 
application and (if appropriate) 
restore the register; 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
of the application and (if 
appropriate) to restore the 
register in the meantime. 
Decision of the Secretary of 
State to reject an application 
made under Article 11 or 13a 
to register a geographical 
indication The persons are: 
(a) the person who submitted 
the application to register the 
geographical indication; 
(b) a person marketing a 
product that is, or may be, 
affected by the decision not to 
register the geographical 
indication. Power to: 
(a) quash the decision and 
direct the Secretary of State to 
register the geographical 
indication; 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
of the application. 
Decision of the Secretary of 
State to approve an application 
made under Article 24 to 
amend a product specification 
for a protected geographical 
indication The persons are: 
(a) in relation to the approval 
of an application to which the 
first sentence of Article 24(2) 
applies, a person who lodged a 
duly substantiated statement of 
opposition under Article 15 as 
read with Article 24(2); 
(b) in relation to the approval 
of any application under 
Article 24(2), a person 
marketing a product that is, or 
may be, affected by the 
amendment of the product 
specification. Power to: 
(a) quash the decision and 
direct the Secretary of State to 
reject the application and (if 
appropriate) restore the 
register; 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
of the application and (if 
appropriate) to restore the 
register in the meantime. 
Decision of the Secretary of 
State to reject an application 
made under Article 24 to 
amend a product specification 
for a protected geographical 
indication  The persons are: 
(a) the person who submitted 
the application to amend the 
product specification; 
(b) a person marketing a 
product that is, or may be, 
affected by the decision to 
reject the application to amend 
the product specification. Power to: 
(a) quash the decision and 
direct the Secretary of State to 
approve the application and 
update the register; 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
of the application.  51 Decision Persons who may appeal 
against the decision FTT powers 
Decision of the Secretary of 
State under Article 25 to 
cancel the registration of a 
protected geographical 
indication on the Secretary of 
State’s initiative The persons are: 
(a) a person who lodged a duly 
substantiated statement of 
opposition under Article 15 as 
read with the second paragraph 
of Article 25; 
(b) a person marketing a 
product that is, or may be, 
affected by the cancellation of 
the registration of the 
protected geographical 
indication. Power to: 
(a) quash the decision and (if 
appropriate) direct the 
Secretary of State to restore 
the register; 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
relating to the cancellation of 
the registration and (if 
appropriate) to restore the 
register in the meantime. 
Decision of the Secretary of 
State to approve an application 
made under Article 25 to 
cancel the registration of a 
protected geographical 
indication The persons are: 
(a) a person who lodged a duly 
substantiated statement of 
opposition under Article 15 as 
read with the second paragraph 
of Article 25; 
(b) a person marketing a 
product that is, or may be, 
affected by the cancellation of 
the registration of the 
protected geographical 
indication. Power to: 
(a) quash the decision and 
direct the Secretary of State to 
reject the application and (if 
appropriate) restore the 
register; 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
of the application and (if 
appropriate) to restore the 
register in the meantime. 
Decision of the Secretary of 
State to reject an application 
made under Article 25 to 
cancel the registration of a 
protected geographical 
indication The persons are: 
(a) the person who submitted 
the application to cancel the 
registration of the protected 
geographical indication; 
(b) a person marketing a 
product that is, or may be, 
affected by the decision not to 
cancel the registration of the 
protected geographical 
indication. Power to: 
(a) quash the decision and 
direct the Secretary of State to 
cancel the registration; 
(b) remit the matter to the 
Secretary of State with a 
direction to repeat the scrutiny 
of the application.” 
 SCHEDULE 4 Regulation 10(9) 
Commission Delegated Regulation (EU) No 664/2014, A rticle 6: new 
paragraphs 3a to 3d and 4 to 4l 
“3a. Temporary amendments concerning products origi nating in third countries must be 
communicated to the Secretary of State before the e nd of the period of two weeks 
beginning with the day after the first day on which  the amendments apply in the relevant 
third country. 
3b. The temporary amendments must be communicated t o the Secretary of State by a 
group having a legitimate interest or by the author ities of the relevant third country. 
3c. The communication must be accompanied by: 
(a) the reasons for the amendments, and  52 (b) as appropriate, evidence of the relevant sanita ry and phytosanitary measures or a copy 
of a document issued by the authorities of the rele vant third country recognising the 
natural disaster or adverse weather conditions. 
3d. The Secretary of State must make the temporary amendments public in such manner 
as appears appropriate to the Secretary of State fr om time to time. 
4. Paragraphs 4a to 4l apply to an application for a temporary amendment to a product 
specification for a protected designation of origin , protected geographical indication or 
traditional speciality guaranteed (‘the temporary a mendments application’) concerning the 
production of products originating in the United Ki ngdom where it is impossible or difficult 
to comply with a requirement in a product specifica tion in relation to the production of a 
product in the United Kingdom: 
(a) because of the imposition of an obligatory sani tary or phytosanitary measure in the 
United Kingdom by a public authority, including the  Secretary of State, or 
(b) for reasons linked to a natural disaster or adv erse weather conditions recognised by a 
public authority, including the Secretary of State.  
4a. The temporary amendments application may be mad e to the Secretary of State. 
4b. The procedure laid down in Articles 49 to 52 of  Regulation (EU) No 1151/2012 does 
not apply to the temporary amendments application. 
4c. The temporary amendments application may be mad e by a group having a legitimate 
interest in the relevant protected designation of o rigin, protected geographical indication or 
traditional speciality guaranteed. If the applicati on is not made by the group that submitted 
the application to register the relevant protected designation of origin, protected 
geographical indication or traditional speciality g uaranteed (‘the original applicant group’), 
the Secretary of State must give the original appli cant group the opportunity to make 
comments on the application if that group still exi sts. 
4d. The temporary amendments application must: 
(a) describe the amendment applied for, 
(b) be accompanied by a copy of the product specifi cation annotated in a way to show the 
proposed temporary amendment, 
(c) compare, for each amendment— 
 (i) the original product specification against the  proposed amended product 
specification, and 
 (ii) where relevant, the original single document against the proposed amended single 
document, 
(d) provide a summary of the reasons why an amendme nt is required, explaining how the 
circumstances specified in point (a) or (b) of para graph 4 affect the production of 
products to which the protected designation of orig in, protected geographical 
indication or traditional speciality guaranteed app lies, 
(e) be accompanied, as the case may be, by: 
 (i) evidence of the sanitary or phytosanitary meas ure or a reference to that measure 
that will enable the Secretary of State to identify  the measure, and obtain a copy of 
it, easily, or 
 (ii) a copy of a document issued by the relevant p ublic authority recognising the 
natural disaster or adverse weather conditions or a  reference to that document that 
will enable the Secretary of State to identify the document, and obtain a copy of it, 
easily, 
(f) provide an estimate, where this is possible, of  the period during which it is anticipated 
that the temporary amendment will need to apply, an d  53 (g) be self-sufficient and contain all amendments t o the product specification, and, where 
relevant, to the single document, for which approva l is sought. 
4e. A temporary amendments application that does no t comply with paragraph 4d is not 
admissible. The Secretary of State must inform the applicant if the application is 
inadmissible as soon as reasonably practicable afte r receiving the application. 
4f. The Secretary of State may approve a temporary amendments application if the 
Secretary of State considers that a temporary amend ment to the product specification is 
appropriate. 
4g. Where a temporary amendments application is app roved, the Secretary of State must 
specify the period for which the temporary amendmen t is approved.  
4h. That period may be specified by reference to a set period of time or may be specified 
by reference to the a period expiring on the happen ing of an event specified in the decision. 
The Secretary of State, in deciding the period, mus t take into account the conditions 
prevailing at the time the decision to approve the application is taken and the period for 
which the Secretary of State anticipates that those  conditions will continue.  
4i. The Secretary of State may extend the temporary  amendment on one or more 
occasions if the Secretary of State considers it is  appropriate to do so having regard to the 
conditions prevailing at the time that decision is made. 
4j. After making a decision in relation to a tempor ary amendments application, the 
Secretary of State must publish in such manner as a ppears appropriate to the Secretary of 
State: 
(a) a notice informing the applicant and the public  of the decision made in relation to the 
application, and 
(b) where the application is approved, details of t he temporary amendments made to the 
product specification and the period during which t hose temporary amendments apply. 
4k. Where a temporary amendments application is app roved and the period during which 
such temporary amendments are to apply is extended,  the Secretary of State must, on each 
occasion the period is extended, publish in such ma nner as appears appropriate to the 
Secretary of State a notice informing the applicant  and the public of the extension of the 
period. 
4l. In this paragraph ‘public authority’ has the me aning given in section 20(1) of the 
European Union (Withdrawal) Act 2018.” 
 SCHEDULE 5 Regulation 12(11)(e) 
Commission Implementing Regulation (EU) No 668/2014 , Article 14:  
new paragraphs 3, 3a, 3b and 4 
“3. Where the Secretary of State approves an amendm ent to a product specification and 
the change in the product specification affects oth er information recorded in the relevant 
register, the Secretary of State must delete the or iginal data, record the new data in the 
register and attach a copy of the approved amended product specification to the register. 
The new data, and the provisions in the approved am ended product specification, take 
effect immediately after the expiry of 20 days begi nning with the day on which the new 
data is recorded in the register and the copy of th e amended product specification is 
attached to the register or, if a copy of the amend ed product specification is attached to the 
register at a later date, immediately after the exp iry of 20 days beginning with the day on 
which the copy of the amended product specification  is attached to the register.  54 Where the Secretary of State approves an amendment to a product specification and the 
change in the product specification does not affect  other information recorded in the 
relevant register, the Secretary of State must repl ace the copy of the product specification 
attached to the entry in the register with a copy o f the approved amended product 
specification. The provisions in the approved amend ed product specification take effect 
immediately after the expiry of 20 days beginning w ith the day on which the copy of the 
approved amended product specification is attached to the register. 
3a. Where the Secretary of State receives a communi cation of the type referred to in 
Article 6(3a) of Delegated Regulation (EU) No 664/2 014 relating to a temporary 
amendment of a product specification concerning the  production of a product originating in 
a third country, the Secretary of State must includ e an entry in the relevant register relating 
to the temporary amendment of the product specifica tion. The temporary amendment takes 
effect from the time that entry is made. From that time the provisions of the product 
specification attached to the register apply as rea d with those temporary amendments until 
the entry relating to the temporary amendment is re moved from the register. 
3b. Where the Secretary of State approves an applic ation to amend a product 
specification to which Article 6(4) of Delegated Re gulation (EU) No 664/2014 applies (an 
application for a temporary amendment to a product specification concerning the 
production of products originating in the United Ki ngdom), the Secretary of State must 
include an entry in the relevant register relating to the temporary amendment of the product 
specification. The temporary amendment takes effect  from the time that entry is made. 
From that time the provisions of the product specif ication attached to the register apply as 
read with those temporary amendments until the entr y relating to the temporary amendment 
is removed from the register. 
4. Where the Secretary of State makes a decision to  cancel a protected designation of 
origin, protected geographical indication or tradit ional speciality guaranteed pursuant to 
Article 54 of Regulation (EU) No 1151/2012, the Sec retary of State must delete the name 
from the register concerned. The cancellation takes  effect from the day after the day on 
which the entry is deleted from the register.” 
 SCHEDULE 6 Regulation 13(32)(a) 
Commission Delegated Regulation (EU) 2018/273, Anne x 7, Parts 1 and 
2: new Parts 
“PART 1 
Specimen of the VI-1 document referred to in Articl e 22 
 
 
1. Exporter (name and address)  
THIRD COUNTRY OF ISSUE: 
 
  VI 1 Serial No 
   
DOCUMENT FOR THE IMPORT OF WINE, 
GRAPE JUICE OR GRAPE MUST INTO 
THE UNITED KINGDOM 
 
2. Consignee (name and address) 3. Customs stamps ( for official use only) 
  55  
 
 
4. Means of transport and transport details 
  
5. Place of unloading (if different from 2) 
 
 
6. Description of the imported product 
 
 
  
7. Quantity in l/hl/kg (1) 
 
 
 
8. Number of containers 
 
 
 
9. CERTIFICATE 
 
The product described above (2)   is/  is not intended for direct human consumption, comp lies 
with the United Kingdom definitions or categories o f grapevine products and has been product 
using oenological practices (2)   recommended and published by the OIV/  authorised by the 
United Kingdom. 
 
Full name and address of the competent body: 
 
 
 Place and date: 
Stamp: 
 
 
 Signature, name and title of the official: 
 
 
 
10. ANALYSIS REPORT (describing the analytical char acteristics of the product described 
above) 
 
FOR GRAPE MUST AND GRAPE JUICE 
— Density: 
 
FOR WINE AND GRAPE MUST STILL IN FERMENTATION 
 
— Total alcoholic strength: — Actual alcoholic stre ngth: 
 
FOR ALL PRODUCTS 
 
— Total dry extract: — Total sulphur dioxide 
— Total acidity: — Volatile acidity: — Citric acidi ty: 
 
Full name and address of the designated body or dep artment (laboratory) 
 
 
 
 
 
  56  
 
 
Stamp:   
Place and date: 
 
  
Signature, name and title of official: 
 
 
 
(1)  Delete as appropriate. 
(2)   Put an ‘X’ in the appropriate box.  
 
Attribution (entry into free circulation and issue of extracts)  
 
 
Quantity  
11.  
No and date of the 
customs document 
of release into free 
circulation and of 
the extract  
12.  
Full name and 
address of 
consignee 
(extract)  
13.  
Stamp of the 
competent authority 
 
Available 
       
 
Attributed 
       
 
Available 
       
 
Attributed 
       
 
Available 
       
 
Attributed 
       
 
Available 
       
 
Attributed 
       
14. Other remarks 
 
  57  
PART 2 
Specimen of the VI-2 document referred to in Articl e 22 
 
 
UNITED KINGDOM  
 
1. Consignor (name and address) 
 
  
VI 2  
Serial No 
 EXTRACT OF A DOCUMENT FOR THE 
IMPORT OF WINE, GRAPE JUICE OR 
GRAPE MUST INTO THE UNITED 
KINGDOM 
 
2. Consignee (name and address) 
 
 
  
 
 
3. Extract VI 1 document 
 
  
4. Extract of VI 2 extract 
No No 
 
Issued by (name of third country): 
 
  
Stamped by (full name and address of the 
customs office within the United Kingdom): 
 
On: 
 
 On: 
5. Description of the imported product  
6. Quantity in l/hl/kg (1)  
 
 
7. Number of containers 
 
 
8. CONSIGNOR’S DECLARATION (2)  
The VI 1 document referred to in box 3  /The extract referred to in box 4  was completed in 
respect of the product described above and comprise s: 
 a CERTIFICATE to the effect that the product descr ibed above  is/  is not intended for 
direct human consumption, complies with the United Kingdom definitions or categories of 
grapevine products and has been product using oenol ogical practices (2)  recommended and 
published by the OIV/  authorised by the United Kingdom. 
 an ANALYSIS REPORT showing that the product has th e following analytical characteristics: 
 
FOR GRAPE MUST AND GRAPE JUICE 
— Density: 
  58  
 
 
FOR WINE AND GRAPE MUST STILL IN FERMENTATION  
 
— Total alcoholic strength: 
  
— Actual alcoholic strength: 
 
 
FOR ALL PRODUCTS 
 
— Total dry extract: — Total sulphur dioxide: 
   
— Total acidity: 
 — Volatile acidity: — Citric acidity: 
 
 
 an ENDORSEMENT (2)  from the competent authority certifying that: 
 
— the wine covered by this document is certified as  having been produced in the wine-growing 
region and was given the geographical indication sh own in box 5 in accordance with the 
provisions of the country of origin. 
 
— the alcohol added to this wine is certified as be ing wine alcohol. 
 
 
9. CUSTOMS 
   
Declaration certified as true 
Place and date: 
 
 Stamp: Full name and address of the 
customs office concerned: 
 
Signature: 
 
 
 
   
 
(1)  Delete as appropriate. 
(2)  Put an ‘X’ in the appropriate box. 
  59  
Attribution (entry into free circulation and issue of extracts)  
 
 
Quantity   
10.  
No and date of the 
customs document 
of release into free 
circulation and of 
the extract  
11.  
Full name and 
address of 
consignee 
(extract)  
12.  
Stamp of the 
competent 
authority 
 
 
Available 
       
 
Attributed 
       
 
Available 
       
 
Attributed 
       
 
Available 
       
 
Attributed 
       
 
Available 
       
 
Attributed 
       
 
13. Other remarks” 
 
 
 
 
 SCHEDULE 7 Regulation 16 
Revocations 
1.  Council Decision 94/184/EC concerning the conclusi on of an Agreement between the 
European Community and Australia on trade in wine. 
2.  Council Decision 97/361/EC concerning the conclusi on of an Agreement between the 
European Community and the United Mexican States on  the mutual recognition and protection of 
designations for spirit drinks. 
3.  Commission Decision 2000/192/EC concerning the con clusion of an Agreement amending 
the Agreement between the European Community and Au stralia on trade in wine. 
4.  Commission Decision 2001/339/EC concerning an Exch ange of Letters amending point B of 
the Annex to the Agreement between the European Com munity and the Republic of Bulgaria on 
the reciprocal protection and control of wine names .  60 5.  Commission Decision 2001/581/EC concerning the con clusion of an Agreement amending 
the Agreement between the European Community and Au stralia on trade in wine. 
6.  Council Decision 2001/916/EC on the conclusion of an Additional Protocol adjusting the 
trade aspects of the Stabilisation and Association Agreement between the European Communities 
and their Member States, of the one part, and the f ormer Yugoslav Republic of Macedonia, of the 
other part, to take account of the outcome of the n egotiations between the parties on reciprocal 
preferential concessions for certain wines, the rec iprocal recognition, protection and control of 
wine names and the reciprocal recognition, protecti on and control of designations for spirits and 
aromatised drinks. 
7.  Council Decision 2001/917/EC on the conclusion of an Additional Protocol adjusting the 
trade aspects of the Interim Agreement between the European Community, of the one part, and the 
former Yugoslav Republic of Macedonia, of the other  part, to take account of the outcome of the 
negotiations between the parties on reciprocal pref erential concessions for certain wines, the 
reciprocal recognition, protection and control of w ine names and the reciprocal recognition, 
protection and control of designations for spirits and aromatised drinks. 
8.  Council Decision 2001/918/EC on the conclusion of an Additional Protocol adjusting the 
trade aspects of the Stabilisation and Association Agreement between the European Communities 
and their Member States, of the one part, and the R epublic of Croatia, of the other part, to take 
account of the outcome of the negotiations between the parties on reciprocal preferential 
concessions for certain wines, the reciprocal recog nition, protection and control of wine names 
and the reciprocal recognition, protection and cont rol of designations for spirits and aromatised 
drinks. 
9.  Council Decision 2001/919/EC on the conclusion of an Additional Protocol adjusting the 
trade aspects of the Interim Agreement between the European Community, of the one part, and the 
Republic of Croatia, of the other part, to take acc ount of the outcome of the negotiations between 
the parties on reciprocal preferential concessions for certain wines, the reciprocal recognition, 
protection and control of wine names and the recipr ocal recognition, protection and control of 
designations for spirits and aromatised drinks. 
10.  Council Decision 2001/920/EC on the conclusion of an Additional Protocol adjusting the 
trade aspects of the Europe Agreement establishing an association between the European 
Communities and their Member States, acting within the framework of the European Union, of the 
one part, and the Republic of Slovenia, of the othe r part, to take account of the outcome of the 
negotiations between the parties on reciprocal pref erential concessions for certain wines, the 
reciprocal recognition, protection and control of w ine names and the reciprocal recognition, 
protection and control of designations for spirits and aromatised drinks. 
11.  Council Decision 2002/51/EC on the conclusion of a n Agreement between the European 
Community and the Republic of South Africa on trade  in wine. 
12.  Council Decision 2002/53/EC concerning the provisi onal application of the Agreement 
between the European Community and the Republic of South Africa on trade in wine. 
13.  Council Decision 2002/55/EC on the conclusion of a n Agreement in the form of an 
Exchange of Letters between the European Community and the Republic of South Africa on trade 
in wine. 
14.  Commission Decision 2002/650/EC concerning the con clusion of an Agreement amending 
the Agreement between the European Community and Au stralia on trade in wine. 
15.  Commission Decision 2003/898/EC concerning the con clusion of an agreement amending 
the Agreement between the European Community and Au stralia on trade in wine. 
16.  Council Decision 2004/91/EC on the conclusion of t he agreement between the European 
Community and Canada on trade in wines and spirit d rinks.  61 17.  Commission Decision 2004/387/EC on the conclusion of an Agreement in the form of an 
Exchange of Letters between the European Community and the United Mexican States concerning 
amendments to Annex I to the Agreement between the European Community and the United 
Mexican States on the mutual recognition and protec tion of designations for spirit drinks, taking 
into account the enlargement. 
18.  Commission Decision 2004/483/EC on the conclusion of an Agreement in the form of an 
exchange of letters between the European Community and the United Mexican States concerning 
amendments to Annex I of the Agreement between the European Community and the United 
Mexican States on the mutual recognition and protec tion of designations for spirit drinks, taking 
into account the enlargement. 
19.  Commission Decision 2004/785/EC on the conclusion of an Agreement in the form of an 
exchange of letters between the European Community and the United Mexican States concerning 
amendments to Annex II of the Agreement between the  European Community and the United 
Mexican States on the mutual recognition and protec tion of designations for spirit drinks. 
20.  Council Decision 2005/798/EC concerning the conclu sion of an Agreement in the form of an 
Exchange of Letters between the European Community and the United States of America on 
matters related to trade in wine. 
21.  Council Decision 2006/136/EC on the conclusion of an Agreement in the form of an 
Exchange of Letters between the European Community and the Republic of Chile concerning 
amendments to the Agreement on Trade in Wines annex ed to the Agreement establishing an 
Association between the European Community and its Member States, of the one part, and the 
Republic of Chile, of the other part. 
22.  Council Decision 2006/232/EC on the conclusion of the Agreement between the European 
Community and the United States of America on trade  in wine. 
23.  Commission Decision 2006/567/EC on the conclusion of an Agreement in the form of an 
Exchange of Letters between the European Community and the Republic of Chile concerning 
amendments to Appendices I, II, III and IV of the A greement on Trade in Wines annexed to the 
Association Agreement between the European Communit y and its Member States, of the one part, 
and the Republic of Chile, of the other part. 
24.  Commission Decision 2006/569/EC on the conclusion of an Agreement in the form of an 
Exchange of Letters between the European Community and the Republic of Chile concerning 
amendments to Appendix VI of the Agreement on Trade  in Wines annexed to the Association 
Agreement between the European Community and its Me mber States, of the one part, and the 
Republic of Chile, of the other part. 
25.  Commission Regulation (EC) No 555/2008 laying down  detailed rules for implementing 
Council Regulation (EC) No 479/2008 on the common o rganisation of the market in wine as 
regards support programmes, trade with third countr ies, production potential and on controls in the 
wine sector. 
26.  Council Decision 2009/49/EC on the conclusion of t he Agreement between the European 
Community and Australia on trade in wine. 
27.  Commission Decision 2009/104/EC on the conclusion of an Agreement in the form of an 
Exchange of Letters between the European Community and the Republic of Chile concerning 
amendments to Appendix V of the Agreement on Trade in Wines annexed to the Association 
Agreement between the European Community and its Me mber States, of the one part, and the 
Republic of Chile, of the other part. 
28.  Council Decision 2011/51/EU on the signing of the Agreement between the European Union 
and the Swiss Confederation on the protection of de signations of origin and geographical 
indications for agricultural products and foodstuff s, amending the Agreement between the 
European Community and the Swiss Confederation on t rade in agricultural products.  62 29.  Council Decision 2011/620/EU on the signing, on be half of the Union, of the Agreement 
between the European Union and Georgia on protectio n of geographical indications of agricultural 
products and foodstuffs. 
30.  Council Decision 2011/738/EU on the conclusion of the Agreement between the European 
Union and the Swiss Confederation on the protection  of designations of origin and geographical 
indications for agricultural products and foodstuff s, amending the Agreement between the 
European Community and the Swiss Confederation on t rade in agricultural products. 
31.  Commission Implementing Decision 2011/751/EU on th e notification of a proposal for 
amendment to the Annexes to the EC-US Agreement on trade in wine. 
32.  Council Decision 2012/164/EU on the conclusion of the Agreement between the European 
Union and Georgia on protection of geographical ind ications of agricultural products and 
foodstuffs. 
33.  Commission Implementing Decision 2012/275/EU on th e inclusion of vine varieties in 
Appendix IV of the Protocol on wine labelling as re ferred to in Article 8(2) of the EC-US 
Agreement on trade in wine. 
34.  Council Decision 2012/292/EU on the signing, on be half of the Union, of the Agreement 
between the European Union and the Republic of Mold ova on the protection of geographical 
indications of agricultural products and foodstuffs . 
35.  Council Decision 2012/533/EU on the position to be  taken by the European Union within the 
Joint Committee set up by Article 11 of the Agreeme nt between the European Union and Georgia 
on protection of geographical indications of agricu ltural products and foodstuffs, as regards the 
adoption of the rules of procedure of the Joint Com mittee. 
36.  Council Decision 2013/7/EU on the conclusion of th e Agreement between the European 
Union and the Republic of Moldova on the protection  of geographical indications of agricultural 
products and foodstuffs. 
37.  Council Decision 2013/482/EU on the position to be  taken by the European Union within the 
Joint Committee set up by Article 11 of the Agreeme nt between the European Union and the 
Republic of Moldova on protection of geographical i ndications of agricultural products and 
foodstuffs, as regards the adoption of the rules of  procedure of the Joint Committee. 
38.  Council Decision 2014/429/EU on the position to be  adopted on behalf of the European 
Union within the Association Council set up by the Agreement establishing an Association 
between the European Union and its Member States, o n the one hand, and Central America, on the 
other, as regards the adoption of a decision by the  Association Council on the inclusion in Annex 
XVIII of the respective geographical indications pr otected in the territory of the parties. 
39.  Commission Delegated Regulation (EU) 2016/1149 sup plementing Regulation (EU) No 
1308/2013 of the European Parliament and of the Cou ncil as regards the national support 
programmes in the wine sector. 
40.  Commission Implementing Regulation (EU) 2016/1150 laying down rules for the 
application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council as 
regards the national support programmes in the wine  sector. 
41.  Council Decision (EU) 2016/2136 on the signing, on  behalf of the European Union, of the 
Agreement between the European Union and Iceland on  the protection of geographical indications 
for agricultural products and foodstuffs. 
42.  Council Decision (EU) 2017/1912 on the conclusion of the Agreement between the 
European Union and Iceland on the protection of geo graphical indications for agricultural 
products and foodstuffs.  63  SCHEDULE 8 Regulation 17(3) and (4)(g) 
The Veterinary Medicines Regulations 2013: new prov isions 
PART 1 
New Schedule 1A 
 “SCHEDULE 1A Regulation 4(4) 
Converted EU marketing authorisations 
1.  In this Schedule— 
“converted EU marketing authorisation” means an EU marketing authorisation to 
which paragraph 2 applies; 
“EU marketing authorisation” means a marketing auth orisation for a veterinary 
medicinal product granted by the European Commissio n in accordance with Title 3 of 
Regulation (EC) No 726/2004 of the European Parliam ent and of the Council laying 
down Community procedures for the authorisation and  supervision of medicinal 
products for human and veterinary use and establish ing a European Medicines 
Agency( a). 
2.  This paragraph applies to an EU marketing authoris ation which— 
(a) was granted before exit day, and 
(b) remains in force immediately before exit day. 
3.  A converted EU marketing authorisation has effect on and after exit day for the 
purposes of these regulations as if it were a marke ting authorisation granted by the 
Secretary of State under these Regulations on the d ate it was originally granted— 
(a) on the terms which were in force immediately be fore exit day, 
(b) with the benefit of any periods of data marketi ng exclusivity from which the holder 
benefited immediately before exit day, and 
(c) subject to any suspension or post-authorisation  obligations which were in force 
immediately before exit day. 
4.  Without prejudice to the generality of paragraph 3 — 
(a) the holder of a converted EU marketing authoris ation is subject to the annual fee as 
set out in paragraph 26 of Schedule 7; 
(b) a converted EU marketing authorisation is to be  treated as having been granted in 
accordance with regulation 4(3) and Schedule 1 for the purposes of Regulation 
(EC) No 469/2009.” 
                                                                                                                                            
(a) OJ No L 136, 30.4.2004, p 1, as last amended by R egulation (EU) No 1027/2012 (OJ No L 316, 14.11.201 2, p 38).  64 PART 2 
Schedule 7, paragraph 15: new table 
“Parallel imports 
Application Fee (£) 
Application where the imported product is 
identical to the UK authorised product 2,130 
Application where the imported product is 
therapeutically similar to the UK authorised 
product (can only be applied to imported 
products for non-food producing species) 4,710” 
 SCHEDULE 9 Regulation 18(2), (3), 
(4)(a) and (6) 
Regulation (EC) No 470/2009 of the European Parliam ent and of the 
Council: new provisions 
PART 1 
New Article 8 
“Article 8 
Application for a maximum residue limit 
1. An application under these Regulations for a new  or amended maximum residue 
limit for a substance intended for use in a veterin ary medicinal product must be made to the 
appropriate authority. 
2. An application must include all necessary admini strative information, and all 
scientific documentation necessary for demonstratin g the safety of the substance. 
3. The applicant must pay to the appropriate author ity the application fee, which is— 
(a) for a new maximum residue limit in respect of a  substance, £62,300; 
(b) for an amended maximum residue limit in respect  of a substance, £18,850. 
4. The appropriate authority must ensure that where  a valid application is received, the 
substance is classified under Article 14 within 210  days. 
5. For the purposes of paragraph 4 an application i s valid when both the requirements 
in paragraphs 2 and 3 have been complied with. 
6. As soon as practicable after the substance is cl assified under Article 14, the 
appropriate authority must publish— 
(a) a notice setting out the classification; 
(b) the assessment report that has been prepared, w ith any commercially confidential or 
personal information deleted. 
7. If the appropriate authority classifies a substa nce under Article 14(2)(b) or (d), it 
must notify the applicant accordingly, and the appl icant may appeal to the Veterinary 
Products Committee under regulation 29 of the Veter inary Medicines Regulations 2013.  65 8. For the purposes of paragraph 7, regulations 29 and 30 of the Veterinary Medicines 
Regulations 2013 are to be read as if references to  the Secretary of State were references to 
the appropriate authority.” 
PART 2 
New Article 9 
“Article 9 
Further power for appropriate authority to classify  substances 
1. The appropriate authority may classify a substan ce intended for use in a veterinary 
medicinal product which is to be administered to fo od-producing animals under Article 14 
without an application having been made under these  Regulations. 
2. The power in paragraph 1 includes power to class ify a substance which has 
previously been classified under Article 14.” 
PART 3 
Article 10(1): new paragraphs 
“1. An application for the classification of a phar macologically active substance 
intended to be used in a biocidal product used in a nimal husbandry pursuant to Article 
19(7) of Regulation (EU) 528/2012 of the European P arliament and of the Council 
concerning the making available on the market and u se of biocidal products must be made 
under Article 8, notwithstanding that it is not a s ubstance intended for use in a veterinary 
medicinal product to be administered to food-produc ing animals. 
1A. The power to classify a substance under Article  9 may be exercised in respect of a 
pharmacologically active substance intended to be u sed in a biocidal product used in animal 
husbandry, notwithstanding that it is not a substan ce intended for use in a veterinary 
medicinal product to be administered to food-produc ing animals, where the Secretary of 
State considers it appropriate to do so for the pur poses of Article 19(1)(e) of Regulation 
(EU) 528/2012. 
1B. Where proposals are made for the classification  of a substance under Article 9 in the 
circumstances described in paragraph 1A by a devolv ed authority, the Secretary of State 
must have regard to such proposals when exercising functions under that paragraph. 
1C. In this Article, “devolved authority” has the m eaning given in section 20(1) of the 
European Union (Withdrawal) Act 2018.” 
PART 4 
New Article 14A 
“Article 14A 
MRL register 
1. The appropriate authority must maintain a regist er (“the MRL register”) in 
accordance with this Article. 
2. The MRL register must contain— 
(a) a list of substances which have been classified  under Article 14; 
(b) in respect of each such substance—  66  (i) any maximum residue limit or other matter esta blished under paragraph 2 of 
Article 14; 
 (ii) any conditions or restrictions included in th e classification pursuant to paragraph 7 
of Article 14. 
3. The MRL register must be kept up to date. 
4. The MRL register must contain a search facility.  
5. The appropriate authority must make the MRL regi ster available for inspection by 
the public on a website maintained by the appropria te authority.” 
 
EXPLANATORY NOTE 
(This note is not part of the Regulations) 
These Regulations are made in exercise of the power s conferred by the European Union 
(Withdrawal) Act 2018 (c. 16) (in particular under section 8(2)(a), (b), (c), (d), (e) and (g)) in 
order to address failures of retained EU law to ope rate effectively and other deficiencies arising 
from the withdrawal of the United Kingdom from the European Union. 
These Regulations make amendments to legislation re lating to— 
(a)  aromatised wine; 
(b)  the quality scheme for agricultural products and fo odstuffs; 
(c)  spirit drinks; 
(d)  wine; 
(e)  veterinary medicines; 
(f)  residues. 
Part 2 amends subordinate legislation and Part 3 am ends and revokes retained direct EU 
legislation as regards the subjects in paragraphs ( a) to (d). Part 4 amends subordinate legislation as  
regards the subject in paragraph (e) and Part 5 ame nds retained direct EU legislation as regards the 
subjects in paragraphs (e) and (f). 
An impact assessment has not been produced for this  instrument as no, or no significant, impact 
on the private or voluntary sector is foreseen. 
  
  
© Crown copyright 2019 
Printed and published in the UK by The Stationery O ffice Limited under the authority and superintenden ce of Jeff James, 
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UK201904111030   04/2019   19585 
http://www.legislation.gov.uk/id/uksi/2019/865