2019 No. 860

Exiting The European Union

Food

The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019

Made10th April 2019

Coming into force in accordance with regulation 1

The Secretary of State makes these Regulations in exercise of the powers conferred by section 8(1) of the European Union (Withdrawal) Act 2018 M1.

In accordance with paragraph (1) of Schedule 7 to that Act, a draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament.

As required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety there has been open and transparent public consultation during the preparation of these Regulations.

Annotations:

Marginal Citations

2018 c. 16.

PART 1Introduction

Citation and commencementI11

These Regulations may be cited as the Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 and come into force on the later of exit day or the day after the day on which they are made.

PART 2Amendment of subordinate legislation

Amendment of the Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013I1592

The Food Additives, Flavourings, Enzymes and Extraction Solvents (England) Regulations 2013 M2 are amended as follows.

I2F253

In regulation 10(b), for “the European Union” substitute “ Great Britain ”.

I34

In regulation 14(1)(d) for “territory of the EU” substitute “ United Kingdom ”.

I45

Omit regulation 15.

I56

In Schedule 1—

a

in Table 1 in the entry for Article 26.1 in the second column for “Commission” substitute “ Authority ”;

b

in Table 2—

i

in the entry for Article 21.1 (as read with Article 22) in the second column for “a language easily understandable to purchasers” substitute “ English, or in English and Welsh ”;

ii

entry for Article 26.2 in the second column for “Commission” substitute “ Authority ”.

I67

In Schedule 2 in Table 1—

a

in the entry for Article 10 in the second column for “Union” substitute “ domestic ”;

b

in the entry for Article 19.2 in the second column for “Commission” substitute “ Authority ”;

c

in the entry for Article 19.3 in the second column for “Commission” substitute “ Authority ”.

I78

In Schedule 3 in Table 1 in the entry for Article 9.5 in the second column for “Commission” substitute “ Authority ”.

I89

In Schedule 4 in Table 1—

a

in the entry for Article 4 in the second column for “Union” substitute “ domestic ”;

b

in the entry for Article 14.1 in the second column for “Commission” substitute “ Authority ”;

c

in the entry for Article 14.2 in the second column for “Commission” substitute “ Authority ”.

PART 3Amendment of retained direct EU legislation

Amendment of Regulation (EC) No. 2065/2003 of the European Parliament and of the Council on smoke flavourings used or intended for use in or on foodsI16010

Regulation (EC) No. 2065/2003 of the European Parliament and of the Council on smoke flavourings used or intended for use in or on foods is amended as follows.

I911

In Article 1—

a

in paragraph 1 omit “internal”;

b

in paragraph 2—

i

in point (a) omit “Community”;

ii

for point (b) substitute—

b
a procedure for the establishment of a list of authorised primary smoke condensates and primary tar fractions and their conditions of use in or on foods.

I1012

In Article 3 at the end insert—

5
“Authority” means—
a
as regards F21England and Wales , the Food Standards Agency;
b
as regards Scotland, Food Standards F22Scotland
6
“prescribe”, means prescribe by regulations;
7
“appropriate authority” means—
a
in relation to England, the Secretary of State;
b
in relation to Wales, the Welsh Ministers;
c
in relation to Scotland, the Scottish Ministers;
F23d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8
“Regulation 1321/2013” means Commission Implementing Regulation (EU) No. 1321/2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings;
F249
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

I1113

In Article 5(3)—

a

for “Community legislation” substitute “ retained EU law ”;

b

omit the second sentence.

I1214

In the heading to Article 6 omit “Community”.

I1315

In Article 6—

a

in paragraph 1—

i

omit “in the Community”;

ii

omit “in accordance with the procedure referred to in Article 19(2)”;

b

for paragraph 3 substitute—

3
“Following the establishment of the list referred to in paragraph 1, the appropriate authority may prescribe the addition of primary products to that list.

I1416

In Article 7(2)—

a

in point (a) for “competent authority of a Member State” substitute “ appropriate authority ”;

b

for point (b) substitute—

b
The appropriate authority must acknowledge receipt of the application in writing to the applicant within 14 days of its receipt. The acknowledgement must state the date of receipt of the application;

F34c

for point (c) substitute—

c
The appropriate authority must inform the Authority of the application without delay and make the application and any supporting information supplied by the applicant available to the Authority.

I1517

In Article 8—

a

in paragraph 1 in the third sentence omit “, the Commission and the Member States”;

b

in paragraph 3 in point (b) omit “the Commission and the Member States”;

c

in paragraph 5 for “Commission, the Member States” substitute “ appropriate authority ”.

I1618

In the heading to Article 9 omit “Community”.

I1719

In Article 9—

a

for paragraphs 1 and 2 substitute—

1
Within three months of receiving the opinion of the Authority, the appropriate authority must take the decision whether to include a primary product in the list referred to in Article 6(1), taking account of the opinion of the Authority, the requirements of Article 4(1), any relevant provisions of retained EU law and other legitimate factors relevant to the matter under consideration. The appropriate authority must inform the applicant of its decision without delay. Where the decision is not in accordance with the opinion of the Authority, the appropriate authority must provide an explanation for the differences to the Authority and to the applicant.
2
Where the appropriate authority decides to include a primary product in the list referred to in Article 6(1) it must prescribe the addition of that product to the list together with the details referred to in Article 6(2) and amend Regulation 1321/2013.

b

in paragraph 3 omit “throughout the Community”;

c

in paragraph 5 for “Commission” substitute “ Authority ”.

I1820

Omit Article 10.

I1921

In Article 11—

a

in paragraph 2 omit “On its own initiative or following a request from a Member State or the Commission,”;

b

for paragraph 3 substitute—

3
The appropriate authority must examine the opinion of the Authority without delay and take the decision whether to modify the entry for that authorisation.

c

for paragraph 4 substitute—

4
Where the appropriate authority decides to modify the entry for that authorisation it must prescribe the modification of the entry for that product on the list and amend Regulation 1321/2013.

d

omit paragraph 5;

e

in paragraph 6 for “Commission” substitute “ Authority ”.

I2022

In Article 12—

a

in paragraph 1 for “Commission” substitute “ Authority ”;

b

in paragraph 2(b) after “Authority” insert “ , or provided to the European Food Safety Authority, if provided before F35IP completion day, ”;

c

in paragraph 4—

i

for “Commission” substitute “ Authority ”;

ii

omit “and the Member States”.

I2123

In Article 13 (4) for “Community legislation” substitute “ retained EU law ”.

I2224

Omit Article 14.

I2325

In Article 15—

a

in paragraph 2—

i

for “Commission” substitute “ Authority ”;

ii

omit “and the Authority”;

b

in paragraph 4, for “Commission and the Member States” substitute “ appropriate authority ”;

c

in paragraph 5 for “Commission, the Authority and the Member States” substitute “ appropriate authority and the Authority ”;

d

in paragraph 6—

i

for “the Commission and the Member States” substitute “ and the appropriate authority ”;

ii

for “Commission” substitute “ Authority ”.

I2426

In Article 17—

a

in paragraph 1 for “Member States” substitute “ The Authority ”;

b

in paragraph 2 for “Commission” substitute “ appropriate authority ”;

F36c

for paragraph 3 substitute—

3
The appropriate authority may, taking account of available scientific evidence, supplement this Regulation by prescribing quality criteria for validated analytical methods referred to in point 4 of Annex 2, including substances to be measured.

I25F3727

The appropriate authority may, following a request to the Authority for scientific and/or technical assistance, prescribe amendments to—

a

the Annexes; and

b

the list referred to in Article 6(1).

I26F3828

Omit Articles 18a and 19.

I2729

Insert a new Article 19A—

Article 19ARegulations and devolved powers
1
Any power to make regulations under this Regulation—
a
so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;
b
so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument;
F1c
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
Any power to make regulations under this Regulation includes power—
a
to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business);
b
to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.
3
F2Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution—
a
in the case of England, of either House of Parliament;
b
in the case of Wales, of F3Senedd Cymru;
c
in the case of Scotland, of the Scottish Parliament;
F4d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
In this Regulation, any power—
a
of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;
b
of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;
c
of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only;
F5d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

I2830

After Article 21 omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

I2931

In Annex 1 in paragraph 1 for “Community legislation” substitute “ retained EU law ”.

I3032

In Annex 1 in paragraph 2, in the opening words, for “Community legislation” substitute “ retained EU law ”.

I3133

In Annex 2 in point 6 for “Scientific Committee on Food given in its report on smoke flavourings of 25 June 1993 or its latest update” substitute “ Authority ”.

Amendment of Commission Regulation (EC) No. 627/2006 implementing Regulation (EC) No. 2065/2003 of the European Parliament and of the Council as regards quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke productsI16134

Commission Regulation (EC) No. 627/2006 implementing Regulation (EC) No. 2065/2003 of the European Parliament and of the Council as regards quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products is amended as follows.

I3235

After Article 2 omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

Amendment of Regulation (EC) No. 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavouringsI16236

Regulation (EC) No. 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings is amended as follows.

I3337

In Article 1—

a

in paragraph 1 omit “within the Community”;

b

in paragraph 2 omit “in the Community”;

c

in paragraph 3 for “Community” substitute “ domestic ”.

I3438

In the heading to Article 2 for “Community” substitute “ domestic ”.

I3539

In Article 2—

a

in paragraph 1

i

omit “Community” the first time it occurs;

ii

for “Community” substitute “ domestic ” the second time it occurs;

iii

for the second sentence substitute “ The domestic list is to be updated by the appropriate authority. ”;

iv

omit the third sentence;

b

in paragraph 2 for “Community” substitute “ domestic ” each place it occurs;

c

after paragraph 2 add—

3
“Authority” means—
a
as regards F31England and Wales, the Food Standards Agency;
b
as regards Scotland, Food Standards Scotland;
4
“prescribe”, means prescribe by regulations;
5
“appropriate authority” means—
a
in relation to England, the Secretary of State;
b
in relation to Wales, the Welsh Ministers;
c
in relation to Scotland, the Scottish Ministers;
F32d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
“Regulation 234/2011” means Commission Implementing Regulation (EU) No. 234/2011 implementing Regulation (EC) No. 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings;
F337
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

I3640

In Article 3—

a

in paragraph 1—

i

for “Community” substitute “ domestic ”;

ii

for “Commission” substitute “ Authority ” the first time it occurs;

iii

omit “by a Member State or”;

iv

for “the implementing measures referred to in Article 9(1)(a) (hereinafter referred to as the applicant)” substitute “ Regulation 234/2011 ”;

v

for “Commission” substitute “ appropriate authority ” the second time it occurs;

b

in paragraph 2—

i

for “Commission” substitute “ appropriate authority ” both places it occurs;

ii

for “European Food Safety Authority (hereinafter referred to as the Authority)” substitute “ Authority ”;

c

for paragraph 3 substitute—

3
The common procedure is to end with the appropriate authority prescribing the update, in accordance with Article 7.

d

in paragraph 4 in the first subparagraph—

i

for “Commission” substitute “ appropriate authority ”;

ii

omit “the views of Member States”;

iii

for “Community” substitute “ retained EU ”;

e

in paragraph 4 in the second subparagraph—

i

for “Commission” substitute “ appropriate authority ”;

ii

omit “and the Member States”.

I3741

In Article 4—

a

in paragraph 1—

i

in the opening words, for “Community” substitute “ domestic ”;

ii

in the opening words, for “Commission” substitute “ appropriate authority ”;

iii

omit “The application shall be made available to the Member States by the Commission.”;

b

omit paragraph 2.

I3842

In Article 5(2) for “Commission, the Member States” substitute “ appropriate authority ”.

I3943

In Article 6—

a

in paragraph 1 omit “and shall inform the Commission” to the end of the paragraph;

b

in paragraph 3 omit “and to the Commission”;

c

omit paragraph 4.

I4044

In the heading to Article 7 for “Community” substitute “ domestic ”.

I4145

In Article 7—

a

for paragraph 1 substitute—

1
Within nine months of receiving the opinion of the Authority, the appropriate authority must take the decision whether to update the domestic list taking into account the opinion of the Authority, any relevant provisions of retained EU law and any other legitimate factors relevant to the matter under consideration.
In those cases where the Authority has not given an opinion, the nine month period starts from the date the appropriate authority receives a valid application.

b

omit paragraph 2;

c

for paragraph 3 substitute—

3
Where the decision is not in accordance with the opinion of the Authority, the appropriate authority must explain the reasons for its decision.

d

in paragraph 4 for “shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3)” substitute “ may be prescribed by the appropriate authority after seeking advice from the Authority ”;

e

in paragraph 5—

i

for “Community” substitute “ domestic ” in both places it occurs;

ii

for “shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(4)” substitute “ may be prescribed by the appropriate authority after seeking advice from the Authority ”;

f

omit paragraph 6.

I4246

In Article 8—

a

in paragraph 1—

i

in the first sentence for “Commission” substitute “ Authority ”;

ii

omit the third sentence;

b

in paragraph 2 for “Commission” substitute “ Authority ”.

I4347

In Article 9—

a

in the opening words of paragraph 1—

i

omit “In accordance with the regulatory procedure referred to in Article 14(2), within a period of no longer than 24 months from the adoption of each sectoral food law,”;

ii

for “shall be adopted by the Commission” substitute “ may be prescribed by the appropriate authority after seeking advice from the Authority ”;

b

omit paragraph 2.

I4448

In Article 10—

a

for “Commission” substitute “ Authority ” in both places it occurs;

b

omit “or, where applicable, at the Authority's request”;

c

omit “and the Member States”.

I4549

In Article 11 for “shall ensure the transparency of its activities in accordance with Article 38 of Regulation (EC) No 178/2002. In particular, it shall” substitute “ must ”.

I4650

In Article 12—

a

in paragraph 3—

i

for “Commission” substitute “ Authority ”:

ii

omit “and the Member States”;

b

in paragraph 4 for “Commission's” substitute “Authority's”;

c

omit paragraph 5;

d

in paragraph 6—

i

for “Commission, the Authority and the Member States” substitute “ appropriate authority and the Authority ”;

ii

for “Commission” substitute “ Authority ”;

e

in paragraph 7 for “Commission, the Authority and the Member States” substitute “ appropriate authority and the Authority ”.

I4751

Omit Articles 13 and 14.

I4852

Insert a new Article 14A—

Article 14ARegulations and devolved powers
1
Any power to make regulations under this Regulation—
a
so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;
b
so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument;
F26c
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
Any power to make regulations under this Regulation includes power—
a
to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business);
b
to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.
3
F27Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution—
a
in the case of England, of either House of Parliament;
b
in the case of Wales, of F28Senedd Cymru;
c
in the case of Scotland, of the Scottish Parliament;
F29d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
In this Regulation, any power—
a
of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;
b
of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;
c
of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only;
F30d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

I4953

Omit Article 15.

I5054

After Article 16 omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

Amendment of Regulation (EC) No. 1332/2008 of the European Parliament and of the Council on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No. 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No. 258/97I16355

Regulation (EC) No. 1332/2008 of the European Parliament and of the Council on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No. 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No. 258/97 is amended as follows.

I5156

In Article 1—

a

in the first paragraph omit “internal”;

b

in the second paragraph at point (a) for “Community” substitute “ domestic ”.

I5257

In Article 2(3) omit “Community”.

I5358

In Article 3(2) at the end insert—

c
“Authority” means—
i
as regards F39England and Wales, the Food Standards Agency;
ii
as regards Scotland, Food Standards Scotland;

I5459

In the heading to Chapter 2 for “Community” substitute “ Domestic ”.

I5560

In the heading to Article 4 for “Community” substitute “ Domestic ”.

I5661

In Article 4 for “Community” substitute “ domestic ”.

I5762

In the heading to Article 6 for “Community” substitute “ domestic ”.

I5863

In Article 6 for “Community” substitute “ domestic ”.

I5964

In the heading to Article 7 for “Community” substitute “ domestic ”.

I6065

In Article 7 for “Community” substitute “ domestic ” in each place it occurs.

I6166

In Article 8 for “Community” substitute “ domestic ” in both places it occurs.

I6267

Omit Article 9.

I6368

In Article 10

a

in paragraph 1 in the last sentence for “a language easily understandable to purchasers” substitute “ English, or in English and Welsh ”;

b

omit paragraph 2.

I6469

In Article 11(1)(g) for “Community” substitute “ retained EU ”.

I6570

In Article 14—

a

in paragraph 1 for “Commission” substitute “ Authority ”;

b

in paragraph 2—

i

for “European Food Safety Authority (hereinafter referred to as the Authority)” substitute “ Authority ”;

ii

for “Commission” substitute “ Authority ”;

c

in paragraph 3—

i

in the first sentence for “Commission” substitute “ Authority ”.

ii

omit the second sentence.

I6671

Omit Article 15.

I6772

Insert a new Article 15A—

Article 15ARegulations and devolved powers
1
Any power to make regulations under this Regulation—
a
so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;
b
so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument;
F6c
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
Any power to make regulations under this Regulation includes power—
a
to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business);
b
to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.
3
F7Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution—
a
in the case of England, of either House of Parliament;
b
in the case of Wales, of F8Senedd Cymru;
c
in the case of Scotland, of the Scottish Parliament;
F9d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
In this Regulation, any power—
a
of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;
b
of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;
c
of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only;
F10d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

I6873

Omit Article 16.

I6974

In the heading to Article 17 for “Community” substitute “ domestic ”.

I7075

In Article 17—

a

in paragraph 1 for “Community” substitute “ domestic ”;

b

in paragraph 2—

i

in the first subparagraph for “Community” substitute “ domestic ”;

ii

for the second subparagraph substitute—

The deadline for submitting such applications is to be prescribed by the appropriate authority.

c

in paragraph 3—

i

in the first subparagraph—

aa

for “Commission” substitute “ Authority ”;

bb

for “Community” substitute “ domestic ”;

ii

in the second subparagraph for “Commission” substitute “ appropriate authority ”;

d

in paragraph 4—

i

in the first subparagraph—

aa

for “Community” substitute “ domestic ”;

bb

for “Commission” substitute “ appropriate authority ”;

ii

in the second subparagraph at point (b)—

aa

for “Commission” substitute “ appropriate authority ”;

bb

for “Community” substitute “ domestic ”;

e

in paragraph 5 for “shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3)” substitute “ are to be prescribed by the appropriate authority ”.

I7176

In Article 18 for “Community” substitute “ domestic ”.

I7277

In Article 24 in the second paragraph—

i

for “Community” substitute “ domestic ”;

ii

omit “in the Member States”.

I7378

After Article 24 omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

Amendment of Regulation (EC) No. 1333/2008 of the European Parliament and of the Council on food additivesI16479

Regulation (EC) No. 1333/2008 of the European Parliament and of the Council on food additives is amended as follows.

I7480

In Article 1—

a

in the first paragraph omit “internal”;

b

in the second paragraph for “Community” substitute “ domestic ”.

I7581

In Article 2—

a

in paragraph 2(b) for “Community rules” substitute “ retained EU law ”;

b

in paragraph 3 for “Community” substitute “ domestic ”;

c

in paragraph 4, in the opening words, for “Community rules” substitute “ retained EU law ”.

I7682

At the end of Article 3 insert—

i
“Authority” means—
i
as regards F40England and Wales, the Food Standards Agency;
ii
as regards Scotland, Food Standards Scotland;

I7783

In the heading to Chapter 2 for “Community” substitute “ Domestic ”.

I7884

In the heading to Article 4 for “Community” substitute “ Domestic ”.

I7985

In Article 4 for “Community” substitute “ domestic ” both places it occurs.

I8086

In the heading to Article 6 for “Community” substitute “ Domestic ”.

I8187

In Article 6 for “Community” substitute “ domestic ” in each place it occurs.

I8288

In Article 7 for “Community” substitute “ domestic ”.

I8389

In Article 8 for “Community” substitute “ domestic ”.

I8490

In Article 9(2) for “shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(3)” substitute “ are to be prescribed by the appropriate authority ”.

I8591

In the heading to Article 10 for “Community” substitute “ domestic ”.

I8692

In Article 10 for “Community” substitute “ domestic ” in each place it occurs.

I8793

In the heading to Article 12 for “Community” substitute “ domestic ”.

I8894

In Article 12 for “Community” substitute “ domestic ” both places it occurs.

I8995

In Article 13 for “Community” substitute “ domestic ” both places it occurs.

I9096

In Article 14 for “Community” substitute “ domestic ”.

I9197

Omit Article 19.

I9298

Omit Article 20.

I9399

In Article 21—

a

in paragraph 1 in the last sentence for “a language easily understandable to purchasers” substitute “ English, or in English and Welsh ”;

b

omit paragraph 2.

I94100

In Article 22(1)(g) for “Community” substitute “ retained EU ”.

I95101

In Article 23(4) omit the second sentence.

I96102

In Article 24(3)—

a

after “measures” insert “ prescribed by the appropriate authority ”;

b

omit “in accordance with the regulatory procedure with scrutiny referred to in Article 28(4)”.

I97103

In Article 26—

a

in paragraph 1 for “Commission” substitute “ Authority ”;

b

in paragraph 2—

i

for “Commission” substitute “ Authority ”;

ii

omit the second sentence.

I98104

Omit Articles 27 and 28.

I99105

Insert a new Article 28A—

Article 28ARegulations and devolved powers
1
Any power to make regulations under this Regulation—
a
so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;
b
so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument;
F11c
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
Any power to make regulations under this Regulation includes power—
a
to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business);
b
to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.
3
F12Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution—
a
in the case of England, of either House of Parliament;
b
in the case of Wales, of F13Senedd Cymru;
c
in the case of Scotland, of the Scottish Parliament;
F14d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
In this Regulation, any power—
a
of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;
b
of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;
c
of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only;
F15d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

I100106

Omit Article 29.

I101107

Omit Article 30(5).

I102108

In Article 31 in the first paragraph—

a

for “Community” substitute “ domestic ”;

b

for “Annexes to Directives 94/35/EC, 94/36/EC and 95/2/EC” substitute “ existing lists ”;

c

for “shall be adopted by the Commission in accordance with the regulatory procedure with scrutiny referred to in Article 28(4)” substitute “ are to be prescribed by the appropriate authority ”.

I103109

Omit Article 32.

I104110

In Article 34 in the last paragraph for “Community” substitute “ domestic ”.

I105111

After Article 35 omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

I106112

In the heading to Annex 2 for “Union” substitute “ Domestic ”.

I107113

In Annex 2—

a

in Part A, paragraph 1 for “Union” substitute “ domestic ”.

b

in Part E point 04.1.1—

i

in the entry for E172 omit “the Union legislation and/or national”;

ii

in the entry for E464 omit “the Union legislation and/or national”.

I108114

In the heading to Annex 3 for “Union” substitute “ Domestic ”.

I109115

Omit Annex 4.

Amendment to Regulation (EC) No. 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No. 1601/91, Regulations (EC) No. 2232/96 and (EC) No. 110/2008 and Directive 2000/13/ECI165116

Regulation (EC) No. 1334/2008 of the European Parliament and of the Council on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No. 1601/91, Regulations (EC) No. 2232/96 and (EC) No. 110/2008 and Directive 2000/13/EC is amended as follows.

I110117

In Article 1—

a

in the first paragraph omit “internal”;

b

in the second paragraph for “Community” substitute “ domestic ” in both places it occurs.

I111118

At the end of Article 3(2)(k) add—

l
“Authority” means—
i
as regards F41England and Wales, the Food Standards Agency;
ii
as regards Scotland, Food Standards Scotland.

I112119

For Article 6(3) substitute—

3
Detailed rules for the implementation of paragraph 2 may be prescribed by the appropriate authority.

I113120

In Article 8(2)—

a

for “Commission, a Member State” substitute “ appropriate authority ”;

b

for “Commission shall adopt” substitute “ appropriate authority is to prescribe ”;

c

omit “in accordance with the regulatory procedure with scrutiny referred to in Article 21(3)”;

d

omit the final sentence.

I114121

In the heading to Chapter 3 for “Community” substitute “ Domestic ”.

I115122

In the heading to Article 10 for “Community” substitute “ Domestic ”.

I116123

In Article 10 for “Community” substitute “ domestic ”.

I117124

In the heading to Article 11 for “Community” substitute “ Domestic ”.

I118125

In Article 11 for “Community” substitute “ domestic ” in each place it occurs.

I119126

In Article 12 for “Community” substitute “ domestic ” in both places it occurs.

I120127

Omit Article 13.

I121128

In Article 14—

a

in paragraph 1 in the last sentence for “a language easily understandable to purchasers” substitute “ English, or in English and Welsh ”;

b

omit paragraph 2.

I122129

In Article 15(1)(g) for “Community” substitute “ retained EU ”.

I123130

In Article 19—

a

in paragraph 1—

i

for “Commission” substitute “ Authority ”;

ii

for “Community” substitute “ United Kingdom ”;

iii

omit the second subparagraph;

b

in paragraph 2 for “Commission” substitute “ Authority ”;

c

in paragraph 3 for “Commission” substitute “ Authority ”;

d

omit paragraph 4.

I124131

Omit Articles 20 and 21.

I125132

Insert a new Article 21A—

Article 21ARegulations and devolved powers
1
Any power to make regulations under this Regulation—
a
so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;
b
so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument;
F16c
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
Any power to make regulations under this Regulation includes power—
a
to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business);
b
to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.
3
F17Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution—
a
in the case of England, of either House of Parliament;
b
in the case of Wales, of F18Senedd Cymru;
c
in the case of Scotland, of the Scottish Parliament;
F19d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
In this Regulation, any power—
a
of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;
b
of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;
c
of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only;
F20d
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

I126133

In Article 22—

a

In the first paragraph for “adopted in accordance with the regulatory procedure with scrutiny referred to in Article 21(3)” substitute “ prescribed by the appropriate authority ”;

b

omit the second paragraph.

I127134

Omit Article 23.

I128135

Omit Article 25.

I129136

After Article 30 omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

I130137

In the heading to Annex 1 and in the heading to Part A of Annex 1 for “Union” substitute “ domestic ”.

I131138

In Annex 1, Part A, Section 1, in the paragraph that begins with the words “Column 8 (Footnotes):” for “Union” substitute “ domestic ”.

Amendment to Regulation (EU) No. 234/2011 implementing Regulation (EC) No. 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavouringsI166139

Regulation (EU) No. 234/2011 implementing Regulation (EC) No. 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings is amended as follows.

I132140

In Article 3—

a

in paragraph 1—

i

in the first sentence for “Commission” substitute “ appropriate authority ”;

ii

for the second sentence substitute “ The applicant must take into account any practical guidance on the submission of applications made available by the Authority. ”;

b

omit paragraph 2.

I133141

In Article 4—

a

in point (g) for “the Union legislation” substitute “ retained EU law ”;

b

in point (i) for “the Union legislation” substitute “ retained EU law ”.

I134142

In Article 5—

a

in paragraph 3 omit “(The EFSA Journal)”;

b

in paragraph 7 in the second subparagraph for “Union” substitute “ United Kingdom ”.

I135143

in Article 6(1)(g) for “Union” substitute “ domestic ”.

I136144

In Article 7(2)(f) for “Union” substitute “ domestic ”.

I137145

In Article 9(2)(f) omit “as described in the Authority's guidance document on food enzymes”.

I138146

In Article 10(1)(e) for “Union” substitute “ domestic ”.

I139147

In Article 12—

a

in paragraph 1 for “Commission” substitute “ Authority ”;

b

in paragraph 2 for “Commission shall, where necessary, request the Authority” substitute “ Authority is ”;

c

in paragraph 3—

i

in the first subparagraph—

aa

omit the first sentence;

bb

in the second sentence for “Authority's letter is received by the Commission” substitute “ application is received by the Authority ”;

ii

in the second subparagraph for “Union” substitute “ domestic ”;

d

in paragraph 4—

i

for “Union” substitute “ domestic ”;

ii

for “Commission” substitute “ Authority ” in both places it occurs;

e

in paragraph 5 in the second sentence—

i

for “Commission” substitute “ Authority ”;

ii

omit “the Member States and the Authority”.

I140148

In Article 13(1)(c) omit “European”.

I141149

Omit Article 13(2).

I142150

After Article 14 omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

I143151

In the Annex in the Model Letter accompanying an application for Food Additives—

a

for “European Commission Directorate General Directorate Unit” substitute “ appropriate authority ”;

b

for “in the European Union” substitute “ in the United Kingdom ”;

c

for “EU list” substitute “ domestic list ”.

I144152

In the Annex in the Model Letter accompanying an application for Food Enzymes—

a

for “European Commission Directorate General Directorate Unit” substitute “ appropriate authority ”;

b

for “in the European Union” substitute “ in the United Kingdom ”;

c

for “EU list” substitute “ domestic list ”.

I145153

In the Annex in the Model Letter accompanying an application for Flavourings—

a

for “European Commission Directorate General Directorate Unit” substitute “ appropriate authority ”;

b

for “in the European Union” substitute “ in the United Kingdom ”;

c

for “EU list” substitute “ domestic list ”.

Amendment to Commission Regulation (EU) No. 231/2012 laying down specifications for food additives listed in Annexes 2 and 3 to Regulation (EC) No. 1333/2008 of the European Parliament and of the CouncilI167154

Commission Regulation (EU) No. 231/2012 laying down specifications for food additives listed in Annexes 2 and 3 to Regulation (EC) No. 1333/2008 of the European Parliament and of the Council is amended as follows.

I146155

After Article 4 omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

Amendment to Commission Implementing Regulation (EU) No. 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No. 2232/96 of the European Parliament and of the Council introducing it in Annex 1 to Regulation (EC) No. 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No.1565/2000 and Commission Decision 1999/217/ECI168156

Commission Implementing Regulation (EU) No. 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No. 2232/96 of the European Parliament and of the Council introducing it in Annex 1 to Regulation (EC) No. 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No.1565/2000 and Commission Decision 1999/217/EC is amended as follows.

I147157

In Article 1—

a

in point (a) for “Union” substitute “ domestic ”;

b

in point (b) —

i

in the first sentence omit “at Union level”;

ii

in the second sentence for “Union” substitute “ domestic ”;

c

in point (c) —

i

in the first sentence omit “at Union level”;

ii

in the second sentence for “Union” substitute “ domestic ”.

I148158

In Article 4 for “Union” substitute “ domestic ”.

I149159

In Article 5 for “Union” substitute “ domestic ”.

I150160

Omit Article 6(2).

I151161

In Article 7 omit the second sentence.

I152162

Omit Article 9.

I153163

After Article 10 omit the words “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

Amendment to Commission Regulation (EU) No. 873/2012 on transitional measures concerning the Union list of flavourings and source materials set out in Annex 1 to Regulation (EC) No. 1334/2008 of the European Parliament and of the CouncilI169164

Commission Regulation (EU) No. 873/2012 on transitional measures concerning the Union list of flavourings and source materials set out in Annex 1 to Regulation (EC) No. 1334/2008 of the European Parliament and of the Council is amended as follows.

I154165

After Article 6 omit the words “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

Amendment to Commission Implementing Regulation (EU) No. 1321/2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavouringsI170166

Commission Implementing Regulation (EU) No. 1321/2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings is amended as follows.

I155167

In Article 1 omit “in the Union”.

I156168

After Article 2 omit the following words “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

I157169

In the heading to the Annex for “Union” substitute “ domestic ”.

PART 4Revocation of retained direct EU legislation

Revocation of Commission Regulation (EU) No. 257/2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No. 1333/2008 of the European Parliament and of the Council on food additivesI158170

Commission Regulation (EU) No.257/2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No. 1333/2008 of the European Parliament and of the Council on food additives is revoked.

Signed by authority of the Secretary of State for Health and Social Care.

Seema Kennedy Parliamentary Under-Secretary of State, Department of Health and Social Care

(This note is not part of the Regulations)

These Regulations are made in exercise of the powers conferred by section 8(1) of the European Union (Withdrawal) Act 2018 (c. 16) in order to address failures of retained EU law to operate effectively and other deficiencies arising from the withdrawal of the United Kingdom from the European Union. In particular, the Regulations address the deficiency specified in section 8(2)(b) of that Act, namely the conferral of functions by retained EU law on, or in relation to, EU entities which no longer have functions in that respect under EU law in relation to the United Kingdom.

These Regulations make amendments to legislation relating to food additives. Part 2 amends subordinate legislation in England. Part 3 amends retained direct EU legislation for the whole of the United Kingdom, and Part 4 revokes certain retained direct EU legislation for the whole of the United Kingdom.

An impact assessment has not been produced for this instrument as no, or no significant, impact on the public, private or voluntary sector is foreseen.