The Food for Specific Groups (Food for Special Medical Purposes for Infants, Infant Formula and Follow-on Formula) (Information and Compositional Requirements) (Amendment etc.) (England) Regulations 2020

Made: at 1.00 p.m. on 27th January 2020

Laid before Parliament: at 3.45 p.m. on 27th January 2020

Coming into force in accordance with regulation 1

The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 6(4), 16(1)(a) and (e) and (2)(b), 17(1) and (2), 26(1) and (3) and 48(1) of the Food Safety Act 1990 and now vested in him and section 2(2) of, and paragraph 1A of Schedule 2 to, the European Communities Act 1972 .

The Secretary of State is a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to measures relating to food (including drink) including the primary production of food , and food and drink intended for sale for human consumption including the presentation, packaging, labelling, marketing and advertising of such food and drink .

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Secretary of State that it is expedient for certain references to provisions of Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No. 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding to be construed as references to those provisions as amended from time to time.

It further appears to the Secretary of State that it is expedient for certain provisions of Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No. 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes to be construed as a reference to those provisions as amended from time to time.

The Secretary of State has had regard to relevant advice given by the Food Standards Agency in accordance with section 48(4A) of the Food Safety Act 1990 .

There has been open and transparent public 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 requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety , during the preparation and evaluation of these Regulations.

PART 1 — Preliminary

Citation, commencement, interpretation and application

1

• (1) These Regulations may be cited as the Food for Specific Groups (Food for Special Medical Purposes for Infants, Infant Formula and Follow-on Formula) (Information and Compositional Requirements) (Amendment etc.) (England) Regulations 2020 and come into force on 22nd February 2020, except where paragraph (2) applies.

• (2) Regulations 2 to 4 come into force on 22nd February 2022 in respect of infant formula and follow-on formula manufactured from protein hydrolysates.

• (3) In these Regulations, “the 1990 Act” means the Food Safety Act 1990.

• (4) These Regulations apply in relation to England only.

PART 2 — Infant Formula and Follow-on Formula

Interpretation of Part 2

2

• (1) In this Part—

• “Delegated Regulation 127” means Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No. 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding;

• “food authority” means—a county council;a metropolitan district council;a non-metropolitan district council;a London borough council;the Common Council of the City of London (in its capacity as a local authority);the Council of the Isles of Scilly;

• “specified EU law requirement” means any provision of Delegated Regulation 127 specified in column 1 of the table in Schedule 1, as read with the provisions specified in the corresponding entry in column 2 of that table.

• (2) Any reference to a provision of Delegated Regulation 127 is a reference to that provision as amended from time to time.

• (3) Expressions used both in this Part of these Regulations and in Delegated Regulation 127 have the same meaning in this Part as they have in Delegated Regulation 127.

Enforcement

3

Each food authority must execute and enforce this Part of these Regulations within its area.

Application of provisions of the 1990 Act

4

• (1) Section 10(1) and (2) of the 1990 Act (improvement notices) applies, with the modification (in the case of section 10(1)) specified in Part 1 of Schedule 2, for the purposes of—

• (a) enabling an improvement notice to be served on a person requiring that person to secure compliance with any specified EU law requirement; and

• (b) making a failure to comply with a notice referred to in sub-paragraph (a) an offence.

• (2) Section 32(1) to (8) of the 1990 Act (powers of entry) applies, with the modifications (in the case of section 32(1)) specified in Part 2 of Schedule 2, for the purposes of enabling an authorised officer of an enforcement authority—

• (a) to exercise a power of entry to ascertain whether food that does not comply with a specified EU law requirement is, or has been, sold;

• (b) to exercise a power of entry to ascertain whether there is any evidence of any contravention of a specified EU law requirement.

• (3) Section 35 of the 1990 Act (punishment of offences) applies, with the modifications specified in Part 3 of Schedule 2, for the purposes of specifying the punishment of an offence committed under section 10(2) as applied by paragraph (1)(b).

• (4) Section 37 of the 1990 Act (appeals) applies, with the modifications specified in Part 4 of Schedule 2, for the purpose of enabling a person to appeal a decision to serve a notice referred to in paragraph (1)(a).

• (5) Section 39 of the 1990 Act (appeals against improvement notices) applies, with the modifications (in the case of section 39(1) and (3)) specified in Part 5 of Schedule 2, for the purpose of dealing with appeals against a decision to serve a notice referred to in paragraph (1)(a).

• (6) The provisions of the 1990 Act specified in paragraph (7) (“the paragraph (7) provisions”) apply, with the modifications specified in Part 6 of Schedule 2, for the purposes of this Part of these Regulations, insofar as they relate to the provisions of the 1990 Act specified in and modified by paragraphs (1) to (5), and any reference in the paragraph (7) provisions to a section of the 1990 Act, including a reference to “any of the preceding provisions of this Part”, is to be read as a reference to such sections of the 1990 Act as applied by this Part of, and modified by Schedule 2 to, these Regulations.

• (7) The provisions of the 1990 Act are—

• (a) section 3 (presumptions that food intended for human consumption);

• (b) section 20 (offences due to fault of another person);

• (c) section 21 (defence of due diligence);

• (d) section 22 (defence of publication in the course of business);

• (e) section 29 (procurement of samples);

• (f) section 30 (analysis etc. of samples);

• (g) section 33 (obstruction etc. of officers);

• (h) section 36 (offences by bodies corporate);

• (i) section 36A (offences by Scottish partnerships);

• (j) section 44 (protection of officers acting in good faith);

• (k) section 53 (general interpretation).

Revocations, savings and transitional provisions relating to infant formula and follow-on formula

5

• (1) The instruments specified in column 1 of the table in Schedule 3 are revoked to the extent specified in column 3 of that table, subject to paragraph (2).

• (2) The instruments specified in column 1 of the table in Schedule 3 continue to have effect (so far as otherwise revoked to the extent specified in column 3 of that table)—

• (a) until 21st February 2022 in respect of infant formula and follow-on formula manufactured from protein hydrolysates;

• (b) for the purposes of paragraph (3)(b).

• (3) Infant formula and follow-on formula which does not comply with a specified EU law requirement may continue to be marketed until stocks of such food are exhausted, provided that—

• (a) it was placed on the market or labelled—

• (i) before 22nd February 2020; or

• (ii) before 22nd February 2022 in the case of infant formula and follow-on formula manufactured from protein hydrolysates; and

• (b) the conditions specified in the following provision of the Infant Formula and Follow-on Formula (England) Regulations 2007 are met—

• (i) regulation 3(1) (prohibition on the marketing of infant formula unless certain conditions are met) in the case of infant formula;

• (ii) regulation 3(2) (prohibition on the marketing of follow-on formula unless certain conditions are met) in the case of follow-on formula.

PART 3 — Amendments, revocations, saving and review

Amendment of the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016

6

Schedule 4 has effect.

Miscellaneous amendments

7

Schedule 5 has effect.

Revocations and saving relating to food for special medical purposes

8

• (1) The instruments specified in column 1 of the table in Schedule 6 are revoked to the extent specified in column 3 of that table, subject to paragraph (2).

• (2) The instruments specified in column 1 of the table in Schedule 6 continue to have effect (so far as otherwise revoked to the extent specified in column 3 of that table) for the purposes of—

• (a) regulation 8(c) of the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016 (transitional arrangements) as substituted by paragraph 3 of Schedule 4 to these Regulations; and

• (b) regulation 5(3)(b) of these Regulations.

Revocation of regulation 4 of the Food for Specific Groups (Information and Compositional Requirements) (England) (Amendment) Regulations 2017

9

Regulation 4 of the Food for Specific Groups (Information and Compositional Requirements) (England) (Amendment) Regulations 2017 (amendment of Schedule 3 to the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016) is revoked.

Review

10

• (1) The Secretary of State must from time to time—

• (a) carry out a review of the regulatory provision made by these Regulations; and

• (b) publish a report setting out the conclusions of the review.

• (2) The report must in particular—

• (a) set out the objectives intended to be achieved by the regulatory provision made by these Regulations;

• (b) assess the extent to which those objectives are achieved;

• (c) assess whether those objectives remain appropriate; and

• (d) if those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision.

• (3) The first report under this regulation must be published before 22nd February 2025.

• (4) Subsequent reports under this regulation must be published at intervals not exceeding five years.

• (5) In this regulation “regulatory provision” has the meaning given by section 32(4) of the Small Business, Enterprise and Employment Act 2015 .

SCHEDULE 1 — Specified EU law requirements

*Column 1*	*Column 2*
Specified provision of Delegated Regulation 127	Provision of Delegated Regulation 127 to be read with the specified provision of Delegated Regulation 127
Article 1(2) (placing on the market)	Article 1(1)
Article 2(1) (compositional requirements for infant formula)	Articles 1(1) and 2(3), Annex 1 and Annex 3
Article 2(2) (compositional requirements for follow-on formula)	Articles 1(1) and 2(3), Annex 2 and Annex 3
Article 2(3) (preparation of infant and follow-on formula)	Articles 1(1), 2(1) and (2)
Article 3(1) (suitability of ingredients for infant formula)	Articles 1(1) and 3(3) and paragraph 2 of Annex 1
Article 3(2) (suitability of ingredients for follow-on formula)	Articles 1(1) and 3(3) and paragraph 2 of Annex 2
Article 4(2) (active substance residue threshold)	Articles 1(1) and 4(1), (3) and (5)
Article 4(3) (derogation from active substance residue threshold)	Articles 1(1) and 4(1), (2) and (5)
Article 4(4) (requirements on pesticides)	Articles 1(1) and 4(1) and (5)
Article 5(1) (name of food not manufactured entirely from cows' or goats' milk protein)	Article 1(1) and Part A of Annex 6
Article 5(2) (name of food manufactured entirely from cows' or goats' milk protein)	Article 1(1) and Part B of Annex 6
Article 6 (specific requirements on food information)	Articles 1(1) and 7(1), (2), (3), (5), (6), (7) and (8)
Article 7(1) (specific requirements on the nutrition declaration)	Articles 1(1) and 7(4), Annex 1 and Annex 2
Article 7(3) (repetition of information included in mandatory nutrition declaration)	Article 1(1)
Article 7(4) (nutrition declaration mandatory regardless of size of packaging or container)	Articles 1(1) and 7(1), Annex 1 and Annex 2
Article 7(5) (application of Articles 31 to 35 of Regulation (EU) No. 1169/2011 )	Articles 1(1) and 7(6), (7) and (8)
Article 7(6) (expression of energy value and amounts of nutrients)	Articles 1(1) and 7(5)
The first sub-paragraph of Article 7(7) (prohibition on expressing energy value and amount of nutrients as a percentage of reference intake)	Articles 1(1) and 7(5)
Article 7(8) (presentation of particulars included in the nutrition declaration)	Article 1(1)
Article 8 (prohibition on making nutrition and health claims on infant formula)	Article 1(1)
Article 9(1) (“lactose only” statement)	Article 1(1)
The first sub-paragraph of Article 9(2) (“lactose free” statement)	Article 1(1)
The second sub-paragraph of Article 9(2), (statement that “lactose free” infant formula and follow-on formula is not suitable for infants with galactosaemia)	Article 1(1)
Article 9(3) (prohibition on references to docosahexaenoic acid where infant formula placed on the market on or after 22nd February 2025)	Article 1(1)
Article 10(1) (restriction on advertising for infant formula)	Article 1(1)
Article 10(2) (prohibition of promotional devices to induce sales of infant formula)	Article 1(1)
Article 10(3) (prohibition of provision of free or low-priced products, samples or other promotional gifts relating to infant formula to the general public, pregnant women, mothers or members of their families)	Article 1(1)
Article 10(4) (requirements for donations or low-priced sales of supplies of infant formula to institutions or organisations)	Article 1(1)
Article 11(2) (requirements on information relating to infant and young child feeding)	Article 1(1)
Article 11(3) (requirements on donations of informational or educational equipment or materials)
Article 12 (notification requirements)	Article 1(1)

SCHEDULE 2 — Modification of provisions of the 1990 Act

PART 1 — Modification of section 10 of the 1990 Act

1

Section 10 of the 1990 Act (improvement notices) applies as if, for subsection (1), there were substituted—

(1) If an authorised officer of an enforcement authority has reasonable grounds for believing that a person is failing to comply with a specified EU law requirement, the authorised officer may, by a notice served on that person (in this Act referred to as an “improvement notice”)— (a) state the officer's grounds for believing that the person is failing to comply or, as the case may be, that the food does not comply with the specified EU law requirement; (b) specify the matters which constitute the failure to comply; (c) specify the measures which, in the officer's opinion, the person must take in order to secure compliance; and (d) require the person to take those measures, or such measures that are at least equivalent to them, within such period as may be specified in the improvement notice.

PART 2 — Modification of section 32 of the 1990 Act

2

Section 32 of the 1990 Act (powers of entry) applies as if—

• (a) in subsection (1) for paragraphs (a) to (c) there were substituted—

(a) to enter any premises within the authority's area for the purpose of ascertaining whether there has been any contravention of a specified EU law requirement; (b) to enter any business premises, whether within or outside the authority's area, for the purpose of ascertaining whether there is on the premises any evidence of any contravention of a specified EU law requirement; and (c) when exercising a power of entry under this section, to exercise the associated powers in subsections (5) and (6) relating to records;

• (b) subsection (9) were omitted.

PART 3 — Modification of section 35 of the 1990 Act

3

Section 35 of the 1990 Act (punishment of offences) applies as if, before subsection (2), there were inserted—

(1B) A person guilty of an offence under section 10(2), as applied by regulation 4(1) of the 2020 Regulations, is liable on summary conviction, to a fine.

PART 4 — Modification of section 37 of the 1990 Act

4

Section 37 of the 1990 Act (appeals) applies as if—

• (a) for the heading there were substituted “ Appeals ”;

• (b) for subsection (1) there were substituted—