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

Regulation 2(1)

SCHEDULE 1 E+W Specified EU law requirements

Commencement Information

I1 Sch. 1 in force at 22.2.2020, see reg. 1(1)

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
M1 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)

Marginal Citations

M1 Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, etc. (O.J. No. L 304, 22.11.2011, p. 18).

Regulation 4

SCHEDULE 2 E+W Modification of provisions of the 1990 Act

PART 1 E+W 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— E+W

“(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.”.

Commencement Information

I2 Sch. 2 para. 1 in force at 22.2.2020, see reg. 1(1)

PART 2 E+W Modification of section 32 of the 1990 Act

2.  Section 32 of the 1990 Act M2 (powers of entry) applies as if— E+W

(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.

Commencement Information

I3 Sch. 2 para. 2 in force at 22.2.2020, see reg. 1(1)

Marginal Citations

M2 Section 32(5) and (6) was amended by section 70 of, and paragraph 18 of Schedule 2 to, the Criminal Justice and Police Act 2001 (c. 16).

PART 3 E+W 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— E+W

“(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.”.

Commencement Information

I4 Sch. 2 para. 3 in force at 22.2.2020, see reg. 1(1)

PART 4 E+W Modification of section 37 of the 1990 Act

4.  Section 37 of the 1990 Act (appeals) applies as if— E+W

(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 M3 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 ”.

Commencement Information

I5 Sch. 2 para. 4 in force at 22.2.2020, see reg. 1(1)

Marginal Citations

M3 S.I. 2009/1976, amended by S.I. 2010/43, 2653, 2011/651, 2012/500, 2013/477, 2014/2128, 2015/2059, 2017/1168, 2018/1053 and 2019/925.

PART 5 E+W Modification of section 39 of the 1990 Act

5.  Section 39 of the 1990 Act (appeals against improvement notices) applies as if— E+W

(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.

Commencement Information

I6 Sch. 2 para. 5 in force at 22.2.2020, see reg. 1(1)

PART 6 E+W Further modifications of provisions of the 1990 Act

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 ”. E+W

Commencement Information

I7 Sch. 2 para. 6 in force at 22.2.2020, see reg. 1(1)

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 ”. E+W

Commencement Information

I8 Sch. 2 para. 7 in force at 22.2.2020, see reg. 1(1)

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 ”. E+W

Commencement Information

I9 Sch. 2 para. 8 in force at 22.2.2020, see reg. 1(1)

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 ”. E+W

Commencement Information

I10 Sch. 2 para. 9 in force at 22.2.2020, see reg. 1(1)

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 ”. E+W

Commencement Information

I11 Sch. 2 para. 10 in force at 22.2.2020, see reg. 1(1)

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

(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 ”.

Commencement Information

I12 Sch. 2 para. 11 in force at 22.2.2020, see reg. 1(1)

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 ”. E+W

Commencement Information

I13 Sch. 2 para. 12 in force at 22.2.2020, see reg. 1(1)

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 ”. E+W

Commencement Information

I14 Sch. 2 para. 13 in force at 22.2.2020, see reg. 1(1)

14.  Section 36A of the 1990 Act M4 (offences by Scottish partnerships) applies as if, for “this Act”, there were substituted “ the 2020 Regulations ”. E+W

Commencement Information

I15 Sch. 2 para. 14 in force at 22.2.2020, see reg. 1(1)

Marginal Citations

M4 Section 36A was inserted by section 40(1) of, and paragraph 16 of Schedule 5 to, the 1999 Act.

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 ”. E+W

Commencement Information

I16 Sch. 2 para. 15 in force at 22.2.2020, see reg. 1(1)

16.  Section 53 of the 1990 Act (general interpretation) applies as if— E+W

(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;”.

Commencement Information

I17 Sch. 2 para. 16 in force at 22.2.2020, see reg. 1(1)

Regulation 5(1)

SCHEDULE 3 E+W Revocations relating to Infant Formula and Follow-on Formula

Commencement Information

I18 Sch. 3 in force at 22.2.2020, see reg. 1(1)

Column 1	Column 2	Column 3
Instrument	Reference	Extent of revocation
Infant Formula and Follow-on Formula (England) Regulations 2007	S.I. 2007/3521	The whole of the Regulations, except regulation 30
Infant Formula and Follow-on Formula (England) (Amendment) Regulations 2008	S.I. 2008/2445	Regulation 2
Transfer of Functions (Food) Regulations 2011	S.I. 2011/3012	Regulation 5
Infant Formula and Follow-on Formula (England) (Amendment) Regulations 2013	S.I. 2013/3243	The whole of the Regulations
Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016	S.I. 2016/688	Schedule 3, paragraph 4
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	S.I. 2020/43	Schedule 5, paragraph 4

Regulation 6

SCHEDULE 4 E+W Amendment of the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016

Interpretation E+W

1.  In this Schedule, “ the 2016 Regulations” means the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016 M5 .

Commencement Information

I19 Sch. 4 para. 1 in force at 22.2.2020, see reg. 1(1)

Marginal Citations

M5 S.I. 2016/688, amended by S.I. 2017/62 and 2019/44.

Amendment of regulation 2 of the 2016 Regulations E+W

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

Commencement Information

I20 Sch. 4 para. 2 in force at 22.2.2020, see reg. 1(1)

Amendment of regulation 8 of the 2016 Regulations E+W

3.  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 M6 (restrictions on sale) are met.”.

Commencement Information

I21 Sch. 4 para. 3 in force at 22.2.2020, see reg. 1(1)

Marginal Citations

M6 S.I. 2000/845, the relevant amending instrument is S.I. 2011/3012.

Amendment of Schedule 1 to the 2016 Regulations E+W

4.  In Schedule 1 to the 2016 Regulations M7 (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—

“Specified provision of the Delegated Regulation	Provisions to be read with the specified provision of the Delegated Regulation
Article 2(2) (requirement for the formulation of food to be based on sound medical and nutritional principles)	Article 1
The first sub-paragraph of article 2(3) (requirement for food for special medical purposes developed to satisfy the nutritional requirements of infants to comply with the compositional requirements in Part A of Annex 1)	Articles 1 and 2(4) and Part A of Annex 1
The second-sub paragraph of article 2(3) (requirement for food other than that developed to satisfy the nutritional requirements of infants to comply with the compositional requirements in Part B of Annex 1)	Articles 1 and 2(4) and Part B of Annex 1
Article 3(2) (requirement relating to residue threshold for certain active substances where food for special medical purposes is developed to satisfy the nutritional requirements of infants and young children)	Articles 1 and 3(1), (3) and (5) and Annex 2
Article 3(3) (maximum residue levels for substances listed in Annex 2)	Articles 1 and 3(1), (2) and (5) and Annex 2
Article 3(4) (prohibition on the use of plant protection products)	Articles 1 and 3(1) and (5) and Annex 3
Article 4 (name of the food)	Article 1 and Annex 4
Article 5(1) (requirement for food for special medical purposes to comply with Regulation (EU) No. 1169/2011 unless otherwise specified)	Articles 1 and 5(2)
Article 5(2) (additional mandatory particulars relating to food information)	Articles 1 and 5(1) and (3)
Article 5(3) (application of articles 13(2) and (3) of Regulation (EU) No. 1169/2011 to additional mandatory particulars)	Articles 1 and 5(1) and (2)
Article 6 (specific requirements on the nutrition declaration)	Article 1 and Annex 1
Article 7 (nutrition and health claims)	Article 1
Article 8(1) (requirement for mandatory particulars to appear in a language easily understood by consumers)	Article 1
The first sub-paragraph of article 8(2) (prohibition of pictures of infants or certain other pictures or text)	Article 1
Article 8(3) (requirements relating to labelling, presentation and advertising)	Article 1
The first sub-paragraph of article 8(4) (restriction on publication)	Article 1 and the third sub-paragraph of article 8(4)
Article 8(5) (prohibition on use of promotional devices to induce sales)	Article 1
Article 8(6) (prohibition on providing free or low-priced products, samples or other promotional gifts)	Article 1
Article 9 (notification)	Article 1”

Commencement Information

I22 Sch. 4 para. 4 in force at 22.2.2020, see reg. 1(1)

Marginal Citations

M7 The table in Schedule 1 was substituted by S.I. 2019/44.

Regulation 7

SCHEDULE 5 E+W Miscellaneous Amendments

Amendment of the Foods Intended for Use in Energy Restricted Diets for Weight Reduction Regulations 1997 E+W

1.—(1) The Foods Intended for Use in Energy Restricted Diets for Weight Reduction Regulations 1997 M8 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 ”.

Commencement Information

I23 Sch. 5 para. 1 in force at 22.2.2020, see reg. 1(1)

Marginal Citations

M8 S.I. 1997/2182, the relevant amending instrument is S.I. 2016/688.

Amendment of the Medical Food (England) Regulations 2000 E+W

F1 2.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Sch. 5 para. 2 revoked (22.2.2020) by 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 (S.I. 2020/43), reg. 1(1), Sch. 6 (with reg. 8(2))

Amendment of the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003 E+W

3.—(1) The Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003 M9 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 ”.

Commencement Information

I24 Sch. 5 para. 3 in force at 22.2.2020, see reg. 1(1)

Marginal Citations

M9 S.I. 2003/3207, the relevant amending instrument is S.I. 2016/688.

Amendment of the Infant Formula and Follow-on Formula (England) Regulations 2007 E+W

F2 4.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F2 Sch. 5 para. 4 revoked (22.2.2020) by 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 (S.I. 2020/43), reg. 1(1), Sch. 3 (with reg. 5(2)) (as amended by S.I. 2021/168, reg. 2(3))

Amendment of the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2009 E+W

5.—(1) The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2009 M10 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 ”.

Commencement Information

I25 Sch. 5 para. 5 in force at 22.2.2020, see reg. 1(1)

Marginal Citations

M10 S.I. 2009/3051, the relevant amending instrument is S.I. 2016/688.

Regulation 8

SCHEDULE 6 E+W Revocations relating to food for special medical purposes

Commencement Information

I26 Sch. 6 in force at 22.2.2020, see reg. 1(1)

Column 1	Column 2	Column 3
Instrument	Reference	Extent of revocation
Medical Food (England) Regulations 2000	S.I. 2000/845	The whole of the Regulations
Infant Formula and Follow-on Formula (England) Regulations 2007	S.I. 2007/3521	Regulation 30
Infant Formula and Follow-on Formula (England) (Amendment) Regulations 2008	S.I. 2008/2445	Regulation 3
Transfer of Functions (Food) Regulations 2011	S.I. 2011/3012	Regulation 2
Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016	S.I. 2016/688	In Part 2 of Schedule 3, paragraph 2
Food for Specific Groups (Information and Compositional Requirements) (Amendment) (England) Regulations 2019	S.I. 2019/44	Regulation 5
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	S.I. 2020/ 43	Schedule 5, paragraph 2