SCHEDULE 1Specified 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 |
M1Article 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 2Modification of provisions of the 1990 Act
PART 1Modification of section 10 of the 1990 Act
1.
“(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 2Modification of section 32 of the 1990 Act
2.
Section 32 of the 1990 Act M2 (powers of entry) applies as if—
(a)
“(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 3Modification of section 35 of the 1990 Act
3.
“(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 4Modification 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)
“(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)
“(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)
“(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
”
.
PART 5Modification of section 39 of the 1990 Act
5.
Section 39 of the 1990 Act (appeals against improvement notices) applies as if—
(a)
“(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.
PART 6Further 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
”
.
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
”
.
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
”
.
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
”
.
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
”
.
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
”
.
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
”
.
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
”
.
14.
Section 36A of the 1990 Act M4 (offences by Scottish partnerships) applies as if, for “this Act”, there were substituted “
the 2020 Regulations
”
.
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
”
.
16.
Section 53 of the 1990 Act (general interpretation) applies as if—
(a)
““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)
““specified EU law requirement” has the meaning given in regulation 2(1) of the 2020 Regulations;”.
SCHEDULE 3Revocations relating to Infant Formula and Follow-on Formula
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 |
SCHEDULE 4Amendment of the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016
Interpretation
1.
In this Schedule, “the 2016 Regulations” means the Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016 M5.
Amendment of regulation 2 of the 2016 Regulations
2.
In regulation 2 of the 2016 Regulations (interpretation), omit paragraph (6).
Amendment of regulation 8 of the 2016 Regulations
3.
“Transitional arrangements8.
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.”.
Amendment of Schedule 1 to the 2016 Regulations
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)
“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”
SCHEDULE 5Miscellaneous Amendments
Amendment of the Foods Intended for Use in Energy Restricted Diets for Weight Reduction Regulations 1997
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
”
.
Amendment of the Medical Food (England) Regulations 2000
F12.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003
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
”
.
Amendment of the Infant Formula and Follow-on Formula (England) Regulations 2007
F24.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Amendment of the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2009
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
”
.
SCHEDULE 6Revocations relating to food for special medical purposes
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 |