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

• Citation: S.I. 2020/43
• Sections: 35

Section 1 Citation, commencement, interpretation and application

(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.

Section 2 Interpretation of Part 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.

Section 3 Enforcement

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

Section 4 Application of provisions of the 1990 Act

(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).

Section 5 Revocations, savings and transitional provisions relating to infant formula and follow-on formula

(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.

Section 6 Amendment of the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016

Schedule 4 has effect.

Section 7 Miscellaneous amendments

Schedule 5 has effect.

Section 8 Revocations and saving relating to food for special medical purposes

(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.

Section 9 Revocation of regulation 4 of the Food for Specific Groups (Information and Compositional Requirements) (England) (Amendment) Regulations 2017

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.

Section 10 Review

(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 .

Section 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.

Section 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.

Section 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.

Section 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—

(1) Any person who is aggrieved by a decision of an authorised officer of an enforcement authority to serve an improvement notice under section 10(1), as applied and modified by regulation 4(1) of, and Part 1 of Schedule 2 to, the 2020 Regulations, may appeal to the First-tier Tribunal.

(c) subsection (2) were omitted;

(d) for subsection (3) there were substituted—

(3) The appeals procedure under the Tribunal Procedure (First-tier Tribunal) (General Regulatory Chamber) Rules 2009 applies to appeals made under subsection (1).

(e) subsection (4) were omitted;

(f) for subsection (5) there were substituted—

(5) The notice of appeal period under rule 22 of the Tribunal Procedure (First-tier Tribunal) (General Regulatory Chamber) Rules 2009 applies to appeals made under subsection (1).

(g) in subsection (6)—

(i) for “subsection (3) or (4)” there were substituted “ subsection (1) ” ; and

(ii) in paragraph (a), for “a magistrates' court or to the sheriff” there were substituted “ the First-tier Tribunal ” .

Section 5

Section 39 of the 1990 Act (appeals against improvement notices) applies as if—

(a) for subsection (1) there were substituted—

(1) On an appeal against an improvement notice served under section 10(1), as applied and modified by regulation 4(1) of, and Part 1 of Schedule 2 to, the 2020 Regulations, the First-tier Tribunal may either cancel or affirm the notice and, if it affirms it, it may do so either in its original form or with such modifications as the First-tier Tribunal may in the circumstances think fit.

(b) in subsection (3), “for want of prosecution” were omitted.

Section 6

Section 3 of the 1990 Act (presumptions that food intended for human consumption) applies as if, in subsection (1), for “this Act” there were substituted “ the 2020 Regulations ” .

Section 7

Section 20 of the 1990 Act (offences due to fault of another person) applies as if, for “any of the preceding provisions of this Part”, there were substituted “ the 2020 Regulations ” .

Section 8

Section 21 of the 1990 Act (defence of due diligence) applies as if, in subsection (1), for “any of the preceding provisions of this Part”, there were substituted “ the 2020 Regulations ” .

Section 9

Section 22 of the 1990 Act (defence of publication in the course of business) applies as if, for “any of the preceding provisions of this Part”, there were substituted “ the 2020 Regulations ” .

Section 10

Section 29 of the 1990 Act (procurement of samples) applies as if, in paragraph (b)(ii), after “under section 32 below”, there were inserted “ , including under section 32 as applied and modified by regulation 4(2) of, and Part 2 of Schedule 2 to, the 2020 Regulations ” .

Section 11

Section 30 of the 1990 Act (analysis etc. of samples) applies as if—

(a) in subsection (1), after “under section 29 above”, there were inserted “ , including under section 29 as applied and modified by regulation 4(6) of, and Part 6 of Schedule 2 to, the 2020 Regulations ” ; and

(b) in subsection (8), for “this Act” there were substituted “ the 2020 Regulations ” .

Section 12

Section 33 of the 1990 Act (obstruction etc. of officers) applies as if, in subsection (1), for “this Act” (in each place where it occurs) there were substituted “ the 2020 Regulations ” .

Section 13

Section 36 of the 1990 Act (offences by bodies corporate) applies as if, in subsection (1), for “this Act” there were substituted “ the 2020 Regulations ” .

Section 14

Section 36A of the 1990 Act (offences by Scottish partnerships) applies as if, for “this Act”, there were substituted “ the 2020 Regulations ” .

Section 15

Section 44 of the 1990 Act (protection of officers acting in good faith) applies as if, for “this Act”, in each place where those words appear, there were substituted “ the 2020 Regulations ” .

Section 16

Section 53 of the 1990 Act (general interpretation) applies as if—

(a) after the definition of “the 1956 Act” there were inserted—

“ the 2020 Regulations ” means 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;

(b) after the definition of “slaughterhouse” there were inserted—

“ specified EU law requirement ” has the meaning given in regulation 2(1) of the 2020 Regulations;

Section 1 Interpretation

In this Schedule, “ the 2016 Regulations ” means the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016 .

Section 2 Amendment of regulation 2 of the 2016 Regulations

In regulation 2 of the 2016 Regulations (interpretation), omit paragraph (6).

Section 3 Amendment of regulation 8 of the 2016 Regulations

For regulation 8 of the 2016 Regulations (transitional arrangements) substitute—

Transitional arrangements

(8) Food for special medical purposes that does not comply with any specified provision of the Delegated Regulation specified in Schedule 1 may continue to be marketed until stocks of such food are exhausted provided that—

(a) it complies with the provisions of the EU Regulation specified in Schedule 1;

(b) it was placed on the market or labelled—

(i) before 22nd February 2019; or

(ii) before 22nd February 2020 in the case of food for special medical purposes developed to satisfy the nutritional requirements of infants; and

(c) the requirements specified in regulation 3(1) and (2) of the Medical Food (England) Regulations 2000 (restrictions on sale) are met.

Section 4 Amendment of Schedule 1 to the 2016 Regulations

In Schedule 1 to the 2016 Regulations (specified EU Requirements)—

(a) in the part of the table relating to the EU Regulation, in the entry relating to “Article 15(1) (Union list)”, in column 2, for “Articles 1(1)(c), 4(1) and the Annex insofar as it applies to food for special medical purposes” substitute “ Articles 1(1)(a) and (c) and 4(1) and the Annex insofar as it applies to infant formula, follow-on formula and food for special medical purposes ” ;

(b) for the part of the table relating to the Delegated Regulation substitute—

Section 1 Amendment of the Foods Intended for Use in Energy Restricted Diets for Weight Reduction Regulations 1997

(1) The Foods Intended for Use in Energy Restricted Diets for Weight Reduction Regulations 1997 are amended as follows.

(2) In Schedule 3 (modification of the improvement notice provisions of the Act)—

(a) In Part 1, in paragraph 1, in the modification of section 10(1) of the 1990 Act (improvement notices) in paragraph (a) for “state the officer's grounds for suspecting” substitute “ state the officer's grounds for believing ” ;

(b) in Part 5, in paragraph 10, in the modification of section 39(1) of the 1990 Act (appeals against improvement notices) for “either cancel of affirm the notice” substitute “ either cancel or affirm the notice ” .

Section 2 Amendment of the Medical Food (England) Regulations 2000

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

Section 3 Amendment of the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003

(1) The Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003 are amended as follows.

(2) In Schedule 9 (modification of the improvement notice provisions of the Act)—

(a) in Part 1, in paragraph 1, in the modification of section 10(1) of the 1990 Act (improvement notices)—

(i) omit “in England”;

(ii) in paragraph (a) for “state the officer's grounds for suspecting” substitute “ state the officer's grounds for believing ” ;

(b) in Part 5, in paragraph 10, in the modification of section 39(1) of the 1990 Act (appeals against improvement notices) for “either cancel of affirm the notice” substitute “ either cancel or affirm the notice ” .

Section 4 Amendment of the Infant Formula and Follow-on Formula (England) Regulations 2007

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

Section 5 Amendment of the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2009

(1) The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2009 are amended as follows.

(2) In regulation 3A(1) (application of the improvement notice provisions of the Act) for “Part 1 of the Schedule” substitute “ Part 1 of Schedule 2 ” .

(3) In Schedule 2 (modification of the improvement notice provisions of the Act)—

(a) in Part 1, in paragraph 1, in the modification of section 10(1) of the 1990 Act (improvement notices)—

(i) omit “in England”;

(ii) in paragraph (a) for “state the officer's grounds for suspecting” substitute “ state the officer's grounds for believing ” ;

(b) in Part 5, in paragraph 10, in the modification of section 39(1) of the 1990 Act (appeals against improvement notices) for “either cancel of affirm the notice” substitute “ either cancel or affirm the notice ” .