PART 4AMENDMENT OF EU REGULATIONS

Amendment of Regulation (EU) No 609/2013I119

1

Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 is amended as follows.

2

In Article 1 (subject matter), in paragraph 2, for “Union” substitute “ F1Great Britain ”.

3

In Article 2 (definitions), after paragraph (h) insert—

i

‘F1Great Britain list’ means the list set out in the Annex.

4

In Article 3 (interpretation decisions)—

a

for the first paragraph, substitute “ The appropriate authority may make regulations specifying: ”;

b

omit the final paragraph.

5

In Article 4 (placing on the market), omit paragraph 3.

6

In Article 6 (general provisions), for “Union law” in each place where those words appear substitute “ retained EU law ”.

7

Omit Articles 7 and 8.

8

In Article 9 (general compositional and information requirements), in paragraph 4, for “Article 1 of Regulation (EC) No 258/97” substitute “ Regulation (EU) 2015/2283 ”.

9

In Article 11 (specific compositional and information requirements)—

a

in paragraph 1—

i

omit the words from “Subject to the general requirements” to “article 10, and”;

ii

for the words from “the Commission” to “Article 18” substitute “ and having regard to such scientific opinion as an appropriate authority considers appropriate, the appropriate authority may make regulations ”;

iii

in sub-paragraph (b) omit the words from “The specific requirements” in the second place they appear to the end of that sub-paragraph;

iv

in sub-paragraph (d) omit the words from “and on the basis” until the end of that sub-paragraph;

v

omit the words “Those delegated acts shall be adopted by 20 July 2015.”.

b

omit paragraph 2.

10

Omit Articles 12 and 13.

11

In Article 14 (technical guidelines)—

a

for “The Commission” substitute “ The Secretary of State, the Scottish Ministers F3and the Welsh Ministers ”;

b

for “SMEs” substitute “ small or medium sized enterprises as defined in the Annex to Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises ”;

c

after “Chapter III”, insert—

, as it applies in their territory. For the purposes of this Article, the Annex to Commission Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises M1 is to be read as if—

a

in Article 2—

i

in paragraph 1, for “EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million” there were substituted “ £44,000,000, and/or an annual balance sheet total not exceeding £38,000,000 ”;

ii

in paragraph 2, for “EUR 10 million” there were substituted “ £8,800,000 ”;

iii

in paragraph 3, for “EUR 2 million” there were substituted “ £1,750,000 ”;

b

in Article 3—

i

in paragraph 2(a), for “EUR 1 250 000” there were substituted “ £1,100,000 ”;

ii

in paragraph 2(d), for “EUR 10 million” there were substituted “ £8,800,000 ”;

iii

in paragraph 5, for “by national or Community rules” there were substituted “ under the law of F2Great Britain (or any part of it) ”;

c

in Article 5, in paragraph (b), for “national law” there were substituted “the law of F2Great Britain (or any part of it).

12

In the heading to Chapter III, substitute “ F1Great Britain list ”.

13

In Article 15—

a

for “Union list” in the heading and in each place where those words appear substitute “ F1Great Britain list ”;

b

in paragraphs 4 and 5, for “Union law” substitute “ retained EU law and any other legislation applying in any part of F2Great Britain ”;

c

in paragraph 5, omit “Member States may maintain national rules setting stricter purity criteria.”;

d

in paragraph 6, for the words from “the Commission” to “Article 18” substitute “ an appropriate authority may make regulations in relation to the categories of substances listed in paragraph 1 of this Article ”.

14

In Article 16 (updating the union list)—

a

for “Union list” in the heading and in each place where those words appear, substitute “ F1Great Britain list ”;

b

in paragraph 1—

i

omit the words from “Subject to the general requirements” to “article 11, and”;

ii

for the words from “the Commission” to “Article 18 to” substitute “ the appropriate authority may by regulations ”;

c

omit paragraph 2.

15

After Article 16, in Chapter IV (procedural provisions) insert—

Article 16ARegulations

1

Any power to make regulations under this Regulation may be exercised by the Secretary of State for the whole or part of F2Great Britain if consent is given by—

a

for regulations applying in relation to Scotland, the Scottish Ministers;

b

for regulations applying in relation to Wales, the Welsh Ministers;

F4c

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2

Regulations made under this Regulation may–

a

contain consequential, incidental, supplementary, transitional or saving provision (including provision amending, repealing or revoking enactments);

b

make different provision for different purposes.

3

In this Regulation–

  • “appropriate authority” means:

    1. a

      for regulations applying in relation to England, the Secretary of State;

    2. b

      for regulations applying in relation to Scotland, the Scottish Ministers;

    3. c

      for regulations applying in relation to Wales, the Welsh Ministers;

    4. d

      F5...

  • “enactment” includes any enactment of the types specified in the definition of ‘enactment’ in section 20(1) of the European Union (Withdrawal) Act 2018.

Article 16BRegulations: Secretary of State

1

Any power of the Secretary of State to make regulations under this Regulation is exercisable by statutory instrument.

2

A statutory instrument containing regulations made under this Regulation is subject to annulment in pursuance of a resolution of either House of Parliament.

Article 16CRegulations: The Scottish Ministers

1

For regulations made by the Scottish Ministers, see section 27 of the Interpretation and Legislative Reform (Scotland) Act 2010.

2

Regulations made by the Scottish Ministers under this Regulation are subject to the negative procedure (see section 28 of the Interpretation and Legislative Reform (Scotland) Act 2010).

Article 16DRegulations: The Welsh Ministers

1

Any power of the Welsh Ministers to make regulations under this Regulation is exercisable by statutory instrument.

2

A statutory instrument containing regulations made under this Regulation by the Welsh Ministers is subject to annulment in pursuance of a resolution of the National Assembly for Wales.

Article 16ERegulations: Northern Ireland

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16

Omit Articles 17 to 20.

17

In Article 21—

a

in paragraph 1, omit the second sentence;

b

after paragraph 2, insert—

3

In this Article, any reference to compliance with a provision of the Directive is to be read as a reference to complying with that provision as would be required if the provision formed part of domestic law.

18

Omit Article 22.

19

In the heading to the Annex, for “Union list” substitute “ F1Great Britain list ”.