The Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003

Statutory Instruments

2003 No. 3207

FOOD, ENGLAND

The Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003

Made

8th December 2003

Laid before Parliament

22nd December 2003

Coming into force

6th March 2005

The Secretary of State, in exercise of the powers conferred by sections 16(1)(a), (e) and (f), 17(1), 26(1)(a) and (3) and 48(1) of the Food Safety Act 1990 M1 and now vested in him M2 , having had regard in accordance with section 48(4A) of that Act to relevant advice given by the Food Standards Agency and after consultation as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council M3 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 and in accordance with section 48(4) and (4B) of that Act, makes the following Regulations:

Marginal Citations

M1 1990 c. 16.

M2 Functions formerly exercisable by “the Ministers” (being, in relation to England and Wales and acting jointly, the Minister of Agriculture, Fisheries and Food and the Secretaries of State respectively concerned with health in England and food and health in Wales and, in relation to Scotland, the Secretary of State) are now exercisable in relation to England by the Secretary of State pursuant to paragraph 8 of Schedule 5 to the Food Standards Act 1999 (1999 c. 28), and paragraphs 12 and 21 of that Schedule amend respectively sections 17 and 48 of the 1990 Act. Functions of “the Ministers” so far as exercisable in relation to Wales were transferred to the National Assembly for Wales by the National Assembly for Wales (Transfer of Functions) Order 1999 (S.I. 1999/672), as read with section 40(3) of the 1999 Act, and those functions so far as exercisable in relation to Scotland were transferred to the Scottish Ministers by section 53 of the Scotland Act 1998 (1998 c. 46), as read with section 40(2) of the 1999 Act. Regulation 13(4) of S.I. 2000/656 expressly authorises the Secretary of State to amend or revoke existing Regulations made or having effect as if made by the Minister of Agriculture, Fisheries and Food (whether with others or not) under the 1990 Act.

M3 OJ No. L31, 1.2.2002, p.1.

Title, application and commencement E+W

1.  These Regulations may be cited as the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003; they apply in relation to England only and come into force on 6th March 2005.

Interpretation E+W

2.—(1) In these Regulations—

“the Act” means the Food Safety Act 1990;

“baby foods” means foods for particular nutritional use fulfilling the particular requirements of infants and young children in good health and intended for use by infants while they are being weaned, and by young children as a supplement to their diet or for their progressive adaptation to ordinary food, but excludes processed cereal-based foods;

[F1 “the Directive” means Commission Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and young children;]

“EEA Agreement” means the Agreement on the European Economic Area M4 signed at Oporto on 2nd May 1992 as adjusted by the Protocol M5 signed at Brussels on 17th March 1993;

“EEA State” means a State which is a Contracting Party to the EEA Agreement;

“food authority” does not include—

(a)

the council of a district of a non-metropolitan county except where the county functions have been transferred to that council pursuant to a structural change; or

(b)

the appropriate Treasurer referred to in section 5(1)(c) of the Act (which deals with the Inner Temple and the Middle Temple);

“infants” means children under the age of twelve months;

“pesticide residue” [F2 which has the same meaning as in Article 2 (1) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, and “residue” shall be read in accordance with Article 3(1) of that Regulation], including its metabolites and products resulting from its degradation or reaction;

“processed cereal-based foods” means foods for particular nutritional use within the categories specified in Part I of Schedule 1 fulfilling the particular requirements of infants and young children in good health and intended for use by infants while they are being weaned, and by young children as a supplement to their diet or for their progressive adaptation to ordinary food;

“sell” includes possess for sale and offer, expose or advertise for sale [F3 , and “sold” is to be construed accordingly]; and

“young children” means children aged between one and three years.

(2) Other expressions used in these Regulations and in the Directive have the same meaning in these Regulations as they have in the Directive.

(3) Where any Schedule contains any note, the provisions of that Schedule shall be interpreted and applied in accordance with such note.

Textual Amendments

F1 Words in reg. 2(1) substituted (15.10.2007) by The Food for Particular Nutritional Uses (Miscellaneous Amendments) (England) Regulations 2007 (S.I. 2007/2591), regs. 1, 6(2)

F2 Words in reg. 2 substituted (24.9.2011) by The Plant Protection Products Regulations 2011 (S.I. 2011/2131), reg. 1(1), Sch. 4 (with reg. 29)

F3 Words in reg. 2(1) inserted (20.7.2016) by The Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016 (S.I. 2016/688), reg. 1(3), Sch. 3 para. 3(a)

Marginal Citations

M4 OJ No. L1, 3.1.94, p.1.

M5 OJ No. L1, 3.1.94, p.571.

Exemption E+W

3.  These Regulations shall not apply to any baby food which is a milk intended for young children.

Restrictions on the sale of processed cereal-based foods and baby foods E+W

4.  No person shall sell any processed cereal-based food or baby food unless—

(a) it complies with the requirements of regulations 5 to 7 as to manufacture and composition; and

(b) it is labelled in accordance with regulation 8.

General requirements as to manufacture and composition E+W

5.—(1) No processed cereal-based food or baby food shall be manufactured from any ingredient other than those whose suitability for particular nutritional use by infants and young children has been established by generally accepted scientific data.

(2) No processed cereal-based food or baby food shall contain any substance in such quantity as to endanger the health of infants or young children.

(3) The composition of a processed cereal-based food shall comply with the criteria specified in Part II of Schedule 1 as read with Schedule 2.

(4) The composition of a baby food shall comply with the criteria specified in Schedule 3.

Added nutritional substances and nutrients E+W

6.—(1) In the manufacture of any processed cereal-based food or baby food, no nutritional substance shall be added other than a nutritional substance specified in Schedule 4.

(2) No processed cereal-based food or baby food shall contain any added nutrient specified in column 1 of Part I of Schedule 5 in an amount exceeding the maximum limit specified opposite that nutrient in column 2 of that Part.

(3) No processed cereal-based food or baby food specified in column 1 of Part II of Schedule 5 shall contain any added nutrient specified opposite that food in column 2 of that Part in an amount exceeding the maximum limit specified opposite that food in column 3 of that Part.

Pesticide residues E+W

7.—(1) No processed cereal-based food or baby food shall contain—

(a) any pesticide residue of a pesticide specified in Schedule 6; or

(b) any omethoate, where it is a metabolite of a pesticide not specified in Schedule 6, or any product resulting from degradation or reaction of that metabolite,

at a level exceeding 0.003 mg/kg.

(2) No processed cereal-based food or baby food shall contain any pesticide residue of a pesticide specified in column 1 of Schedule 7 at a level exceeding that specified in column 2 of that Schedule in relation to that pesticide.

(3) No processed cereal-based food or baby food shall contain any pesticide residue of any individual pesticide which is not specified in Schedule 6 or column 1 of Schedule 7 at a level exceeding 0.01 mg/kg.

(4) The levels referred to in paragraphs (1) to (3) apply to the processed cereal-based food or baby food—

(a) manufactured as ready for consumption, or

(b) if it is not so manufactured, as reconstituted according to its manufacturer’s instructions.

(5) Analytical methods for determining levels of pesticide residues for the purposes of this regulation shall be generally acceptable standardised methods.

Labelling E+W

8.—(1) Without prejudice to the generality of [F4 Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers], processed cereal-based foods and baby foods shall be labelled with the following particulars—

(a) a statement as to the appropriate age (which shall be not less than four months) from which the food may be used, regard being had to its composition, texture or other particular properties;

(b) information as to the presence or absence of gluten if the age stated pursuant to sub-paragraph (a) is less than six months;

(c) the available energy value expressed in kJ and kcal, and the protein, carbohydrate and fat content, expressed in numerical form, per 100 g or 100 ml of the food as sold and, where appropriate, per specified quantity of the food as proposed for consumption;

(d) the average quantity, expressed in numerical form, per 100 g or 100 ml of the food as sold and, where appropriate, per specified quantity of the food as proposed for consumption, of each mineral substance and of each vitamin in respect of which a maximum or a minimum compositional requirement is specified in—

(i) Part II of Schedule 1 in the case of processed cereal-based foods; and

(ii) Schedule 3 in the case of baby foods; and

(e) if preparation of the food is necessary, appropriate instructions for preparation and a statement as to the importance of following those instructions.

(2) Subject to paragraph (1)(d), no processed cereal-based food or baby food shall be labelled with the average quantity of any nutrient specified in Schedule 4 unless—

(a) that average quantity is expressed in numerical form, per 100 g or 100 ml of the food as sold and, where appropriate, per specified quantity of the food as proposed for consumption; and

(b) in the case of a mineral substance or vitamin, it is a mineral substance or vitamin other than one referred to in paragraph (1)(d).

(3) Where, pursuant to paragraph (1)(d) or paragraph (2), any processed cereal-based food or baby food is labelled with the average quantity, per 100 g or 100 ml of the food as sold and, where appropriate, per specified quantity of the food as proposed for consumption, of any vitamin or mineral which is specified in column 1 of Schedule 8, the labelling of the food shall not express that average quantity as a percentage of the reference value specified in column 2 of Schedule 8 in relation to that vitamin or mineral unless the quantity present is equal to 15 per cent or more of the reference value.

Textual Amendments

F4 Words in reg. 8(1) substituted (13.12.2014) by The Food Information Regulations 2014 (S.I. 2014/1855), reg. 1(5)-(8), Sch. 7 para. 39

Enforcement E+W

9.—(1) Except where paragraph (2) applies, each food authority shall enforce and execute these Regulations in its area.

(2) Each port health authority shall enforce and execute these Regulations in its district in relation to imported food.

Offence and penalty E+W

10.  If any person contravenes regulation 4 he shall be guilty of an offence and liable on summary conviction to a fine not exceeding level 5 on the standard scale.

[F5 Application of the improvement notice provisions of the Act E+W

10A.— (1) Section 10(1) and (2) of the Act (improvement notices) applies, with the modification (in the case of section 10(1)) specified in Part 1 of Schedule 9, for the purposes of—

(a) enabling an improvement notice to be served on a person requiring the person to secure compliance with any of the requirements specified in regulation 4; and

(b) making the failure to comply with a notice referred to in subparagraph (a) an offence.

(2) Section 32(1) to (8) of the Act (powers of entry) applies, with the modifications (in the case of section 32(1)) specified in Part 2 of Schedule 9, 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 one or more of the requirements specified in regulation 4 is, or has been, sold; and

(b) to exercise a power of entry to ascertain whether there is any evidence of any contravention of regulation 4.

(3) Section 35 of the Act applies, with the modifications specified in Part 3 of Schedule 9, for the purpose of specifying the punishment of an offence committed under paragraph (1)(b).

(4) Section 37(1) and (6) of the Act (appeals) applies, with the modifications specified in Part 4 of Schedule 9, for the purpose of enabling a decision to serve a notice referred to in paragraph (1)(a) to be appealed.

(5) Section 39 of the Act (appeals against improvement notices) applies, with the modifications (in the case of section 39(1) and (3)) specified in Part 5 of Schedule 9, for the purpose of dealing with appeals against a decision to serve a notice referred to in paragraph (1)(a).]

Textual Amendments

F5 Reg. 10A inserted (20.7.2016) by The Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016 (S.I. 2016/688), reg. 1(3), Sch. 3 para. 3(b)

Defence in relation to exports E+W

F6 11.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F6 Reg. 11 revoked (1.1.2006) by The Official Feed and Food Controls (England) Regulations 2005 (S.I. 2005/2626), reg. 1(b), Sch. 6 Pt. 2

Application of various provisions of the Act E+W

12.  The following provisions of the Act shall apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act or Part thereof shall be construed as a reference to these Regulations—

(a) section 2 (extended meaning of “sale” etc.);

(b) section 3 (presumptions that food is intended for human consumption);

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

(d) section 21 (defence of due diligence) as it applies for the purposes of section 8, 14 or 15;

(e) section 22 (defence of publication in the course of a business);

(f) section 30(8) (which relates to documentary evidence);

(g) section 33(1) (obstruction etc. of officers);

(h) section 33(2), with the modification that the reference to “any such requirement as is mentioned in subsection (1)(b) above” shall be deemed to be a reference to any such requirement as is mentioned in that subsection as applied by paragraph (g) above;

(i) section 35(1) (punishment of offences) in so far as it relates to offences under section 33(1) as applied by paragraph (g) above;

(j) section 35(2) and (3) in so far as it relates to offences under section 33(2) as applied by paragraph (h) above;

(k) section 36 (offences by bodies corporate); and

(l) section 44 (protection of officers acting in good faith).

Revocations E+W

13.—(1) The Processed Cereal-based Foods and Baby Foods for Infants and Young Children Regulations 1997 M6 and the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (Amendment) Regulations 1999 M7 are revoked in relation to England.

(2) The Processed Cereal-based Foods and Baby Foods for Infants and Young Children (Amendment) (England) Regulations 2000 M8 are revoked.

Marginal Citations

M6 S.I. 1997/2042.

M7 S.I. 1999/275.

M8 S.I. 2000/1510.

Amendment E+W

F7 14.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F7 Reg. 14 revoked (11.11.2005) by The Tryptophan in Food (England) Regulations 2005 (S.I. 2005/2630), regs. 1, 10(2)

Signed by authority of the Secretary of State for Health

Melanie Johnson

Parliamentary Under Secretary of State,

Department of Health

Regulations 2(1), 5(3) and 8(1)(d)

SCHEDULE 1 E+W PROCESSED CEREAL-BASED FOODS

PART I E+W Categories of processed cereal-based foods

1.  Simple cereals which are or have to be reconstituted with milk or other appropriate nutritious liquids. E+W

2.  Cereals with an added high protein food which are or have to be reconstituted with water or other protein-free liquid. E+W

3.  Pastas which are to be used after cooking in boiling water or other appropriate liquids. E+W

4.  Rusks and biscuits which are to be used either directly or, after pulverisation, with the addition of water, milk or other suitable liquids. E+W

PART II E+W Essential composition of processed cereal-based foods

The requirements concerning nutrients refer to the products ready for use, marketed as such or reconstituted as instructed by the manufacturer.

Cereal content E+W

1.—(1) Processed cereal-based foods are prepared primarily from one or more milled cereals and/or starchy root products. E+W

(2) The amount of cereal and/or starchy root shall not be less than 25 per cent of the final mixture on a dry weight for weight basis.

Protein E+W

2.—(1) For products mentioned in paragraphs 2 and 4 of Part I, the protein content shall not exceed 1.3 g / 100 kJ (5.5 g / 100 kcal). E+W

(2) For products mentioned in paragraph 2 of Part I, the added protein shall not be less than 0.48 g / 100 kJ (2 g / 100 kcal).

(3) For biscuits mentioned in paragraph 4 of Part I made with the addition of a high protein food, and presented as such, the added protein shall not be less than 0.36 g / 100 kJ (1.5 g / 100 kcal).

(4) The chemical index of the added protein shall be equal to at least 80 per cent of that of the reference protein (casein as defined in Schedule 2), or the protein efficiency ratio (PER) of the protein in the mixture shall be equal to at least 70 per cent of that of the reference protein. In all cases, the addition of amino acids is permitted solely for the purpose of improving the nutritional value of the protein mixture, and only in the proportions necessary for that purpose.

Carbohydrates E+W

3.—(1) If sucrose, fructose, glucose, glucose syrups or honey are added to products mentioned in paragraphs 1 and 4 of Part I— E+W

(a) the amount of added carbohydrates from these sources shall not exceed 1.8 g / 100 kJ (7.5 g / 100 kcal);

(b) the amount of added fructose shall not exceed 0.9 g / 100 kJ (3.75 g / 100 kcal).

(2) If sucrose, fructose, glucose syrups or honey are added to products mentioned in paragraph 2 of Part I—

(a) the amount of added carbohydrates from these sources shall not exceed 1.2 g / 100 kJ (5 g / 100 kcal);

(b) the amount of added fructose shall not exceed 0.6 g / 100 kJ (2.5 g / 100 kcal).

Fat E+W

4.—(1) For products mentioned in paragraphs 1 and 4 of Part I, the fat content shall not exceed 0.8 g / 100 kJ (3.3 g / 100 kcal). E+W

(2) For products mentioned in paragraph 2 of Part I, the fat content shall not exceed 1.1 g / 100 kJ (4.5 g / 100 kcal). If the fat content exceeds 0.8 g / 100 kJ (3.3 g / 100 kcal)—

(a) the amount of lauric acid shall not exceed 15 per cent of the total fat content;

(b) the amount of myristic acid shall not exceed 15 per cent of the total fat content;

(c) the amount of linoleic acid (in the form of glycerides = linoleates) shall not be less than 70 mg / 100 kJ (300 mg / 100 kcal) and shall not exceed 285 mg / 100 kJ (1200 mg / 100 kcal).

Minerals E+W

5.—(1) Sodium E+W

(i) Sodium salts may only be added to processed cereal-based foods for technological purposes.

(ii) The sodium content of processed cereal-based foods shall not exceed 25 mg /100 kJ (100 mg / 100 kcal).

(2) Calcium

(i) For products mentioned in paragraph 2 of Part I, the amount of calcium shall not be less than 20 mg / 100 kJ (80 mg / 100 kcal).

(ii) For products mentioned in paragraph 4 of Part I manufactured with the addition of milk (milk biscuits) and presented as such, the amount of calcium shall not be less than 12 mg / 100 kJ (50 mg / 100 kcal).

Vitamins E+W

6.—(1) For processed cereal-based foods the amount of thiamin shall not be less than 25 μg / 100 kJ (100 μg / 100 kcal). E+W

(2) For products mentioned in paragraph 2 of Part I:

	Per 100 kJ		Per 100 kcal
	Minimum	Maximum	Minimum	Maximum
Vitamin A (μg RE)(1)	14	43	60	180
Vitamin D (μg)(2)	0.25	0.75	1	3

(1) RE = all trans retinol equivalents

(2) In the form of cholecalciferol, of which 10 μg = 400 i.u. of Vitamin D

These limits are also applicable if vitamins A and D are added to other processed cereal-based foods.

Regulation 5(3) and Schedule 1, Part II, paragraph 2.4

SCHEDULE 2 E+W AMINO ACID COMPOSITION OF CASEIN

Amino acid	(g per 100 g of protein)
Arginine	3.7
Cystine	0.3
Histidine	2.9
Isoleucine	5.4
Leucine	9.5
Lysine	8.1
Methionine	2.8
Phenylalanine	5.2
Threonine	4.7
Tryptophan	1.6
Tyrosine	5.8
Valine	6.7

Regulations 5(4) and 8(1)(d)

SCHEDULE 3 E+W ESSENTIAL COMPOSITION OF BABY FOODS

The requirements concerning nutrients refer to the products ready for use, marketed as such or reconstituted as instructed by the manufacturer.

Protein E+W

1.—(1) If meat, poultry, fish, offal or other traditional source of protein are the only ingredients mentioned in the name of the product, then— E+W

(a) the named meat, poultry, fish, offal or other traditional protein source, in total, shall constitute not less than 40 per cent by weight of the total product;

(b) each named meat, poultry, fish, offal or other traditional source of protein shall constitute not less than 25 per cent, by weight, of total named protein sources;

(c) the total protein from the named sources shall not be less than 1.7 g / 100 kJ (7 g / 100 kcal).

(2) If meat, poultry, fish, offal or other traditional source of protein, singularly or in combination, are mentioned first in the name of the product, whether or not the product is presented as a meal, then—

(a) the named poultry, fish, offal or other traditional protein source, in total, shall constitute not less than 10 per cent by weight of the total product;

(b) each named meat, poultry, fish, offal or other traditional source of protein shall constitute not less than 25 per cent by weight, of total named protein sources;

(c) the protein from the named sources shall not be less than 1 g / 100 kJ (4 g / 100 kcal).

(3) If meat, poultry, fish, offal or other traditional source of protein, singularly or in combination are mentioned, but not first, in the name of the product, whether or not the product is presented as a meal, then—

(a) the named meat, poultry, fish, offal or other traditional protein source, in total, shall constitute not less than 8 per cent by weight of the total product;

(b) each named meat, poultry, fish, offal or other traditional source of protein shall constitute not less than 25 per cent, by weight, of total named protein sources;

(c) the total protein from the named sources shall not be less than 0.5 g / 100 kJ (2.2 g / 100 kcal);

(d) the total protein in the product from all sources shall not be less than 0.7 g / 100 kJ (3 g / 100 kcal).

(4) If cheese is mentioned together with other ingredients in the name of a savoury product, whether or not the product is presented as a meal, then—

(a) the protein from the dairy sources shall not be less than 0.5 g / 100 kJ (2.2 g / 100 kcal);

(b) the total protein in the product from all sources shall not be less than 0.7 g / 100 kJ (3 g / 100 kcal).

(5) If the product is designated on the label as a meal, but does not mention meat, poultry, fish, offal or other traditional source of protein in the name of the product, the total protein in the product from all sources shall not be less than 0.7 g / 100 kJ (3 g /100 kcal).

(6) Sauces presented as an accompaniment to a meal are exempt from the requirements of sub-paragraphs (1) to (5).

(7) Sweet dishes that mention dairy products as the first or only ingredient in the name shall contain not less than 2.2 g dairy protein / 100 kcal. All other sweet dishes are exempt from the requirements in sub-paragraphs (1) to (5).

(8) The addition of amino acids is permitted solely for the purpose of improving the nutritional value of the protein present, and only in the proportions necessary for that purpose.

Carbohydrates E+W

2.  The quantities of total carbohydrates present in fruit and vegetable juices and nectars, fruit-only dishes, and desserts or puddings shall not exceed— E+W

(a) 10 g / 100 ml for vegetable juices and drinks based on them;

(b) 15 g / 100 ml for fruit juices and nectars and drinks based on them;

(c) 20 g / 100 g for fruit-only dishes;

(d) 25 g / 100 g for desserts and puddings;

(e) 5 g / 100 g for other non-milk-based drinks.

Fat E+W

3.—(1) For products referred to in paragraph 1(1) if meat or cheese are the only ingredients or are mentioned first in the name of a product, the total fat in the product from all sources shall not exceed 1.4 g / 100 kJ (6g / 100 kcal). E+W

(2) For all other products the total fat in the product from all sources shall not exceed 1.1 g / 100 kJ (4.5 g / 100 kcal).

Sodium E+W

4.—(1) The final sodium content in the product shall be either not more than 48 mg / 100 kJ (200 mg / 100 kcal) or not more than 200 mg per 100 g. However if cheese is the only ingredient mentioned in the name of the product, the final sodium content in the product shall not be more than 70 mg / 100 kJ (300 mg / 100 kcal). E+W

(2) Sodium salts may not be added to products based on fruit, nor to desserts or puddings except for technological purposes.

Vitamins E+W

5.—(1) Vitamin C— E+W

In a fruit juice, nectar, or vegetable juice the final content of vitamin C in the product shall be either not less than 6 mg / 100 kJ (25 mg / 100 kcal) or not less than 25 mg per 100 g.

(2) Vitamin A—

(i) In vegetable juices, the final content of vitamin A in the product shall be not less than 25 μg RE/100 kJ (100 μg RE/100 kcal) and, for the purposes of this paragraph, RE = all trans retinol equivalents.

(ii) Vitamin A shall not be added to other baby foods.

(3) Vitamin D—

Vitamin D shall not be added to baby foods.

Regulations 6(1) and 8(2)

SCHEDULE 4 E+W NUTRITIONAL SUBSTANCES

Vitamins E+W

1.  Vitamin A E+W

Retinol

Retinyl acetate

Retinyl palmitate

Beta-carotene

Vitamin D

Vitamin D₂ (= ergocalciferol)

Vitamin D₃ (= cholecalciferol)

Vitamin B1

Thiamin hydrochloride

Thiamin mononitrate

Vitamin B2

Riboflavin

Riboflavin-5’-phosphate, sodium

Niacin

Nicotinamide

Nicotinic acid

Vitamin B6

Pyridoxine hydrochloride

Pyridoxine-5-phosphate

Pyridoxine dipalmitate

Pantothenic acid

D-pantothenate, calcium

D-pantothenate, sodium

Dexpanthenol

Folate

Folic acid

[F8 Calcium-L-methylfolate]

Vitamin B12

Cyanocobalamin

Hydroxocobalamin

Biotin

D-biotin

Vitamin C

L-ascorbic acid

Sodium L-ascorbate

Calcium L-ascorbate

6-palmityl-L-ascorbic acid (ascorbyl palmitate)

Potassium ascorbate

Vitamin K

Phylloquinone (phytomenadione)

Vitamin E

D-alpha tocopherol

DL-alpha tocopherol

D-alpha tocopherol acetate

DL-alpha tocopherol acetate

Textual Amendments

F8 Word in Sch. 4 para. 1 inserted (10.2.2023) by The Food Supplements and Food for Specific Groups (Miscellaneous Amendments) Regulations 2023 (S.I. 2023/28), regs. 1(2), 2(2)(a) (as amended by S.I. 2023/131, regs. 1(3), 2)

Amino acids E+W

2.  L-arginine} E+W

L-cystine}

L-histidine} and their hydrochlorides

L-isoleucine}

L-leucine}

L-lysine}

L-cysteine}

L-methionine

L-phenylalanine

L-threonine

L-tryptophan

L-tyrosine

L-valine

Others E+W

3.  Choline E+W

Choline chloride

Choline citrate

Choline bitartrate

Inositol

L-carnitine

L-carnitine hydrochloride

Salts of minerals and trace elements E+W

4.  Calcium E+W

Calcium carbonate

Calcium chloride

Calcium salts of citric acid

Calcium gluconate

Calcium glycerophosphate

Calcium lactate

Calcium oxide

Calcium hydroxide

Calcium salts of orthophosphoric acid

Magnesium

Magnesium carbonate

Magnesium chloride

Magnesium salts of citric acid

Magnesium gluconate

Magnesium oxide

Magnesium hydroxide

Magnesium salts of orthophosphoric acid

Magnesium sulphate

Magnesium lactate

Magnesium glycerophosphate

Potassium

Potassium chloride

Potassium salts of citric acid

Potassium gluconate

Potassium lactate

Potassium glycerophosphate

Iron

Ferrous citrate

Ferric ammonium citrate

Ferrous gluconate

Ferrous lactate

Ferrous sulphate

Ferrous fumarate

Ferric diphosphate (ferric pyrophosphate)

Elemental iron (carbonyl + electrolytic + hydrogen-reduced)

Ferric saccharate

Sodium ferric diphosphate

Ferrous carbonate

[F9 Ferrous bisglycinate]

Copper

Copper-lysine complex

Cupric carbonate

Cupric citrate

Cupric gluconate

Cupric sulphate

Zinc

Zinc acetate

[F10 Zinc chloride]

Zinc citrate

Zinc lactate

Zinc sulphate

Zinc oxide

Zinc gluconate

Manganese

Manganese carbonate

Manganese chloride

Manganese citrate

Manganese gluconate

Manganese sulphate

Manganese glycerophosphate

Iodine

Sodium iodide

Potassium iodide

Potassium iodate

Sodium iodate

Textual Amendments

F9 Words in Sch. 4 para. 4 inserted (10.2.2023) by The Food Supplements and Food for Specific Groups (Miscellaneous Amendments) Regulations 2023 (S.I. 2023/28), regs. 1(2), 2(2)(b)(i) (as amended by S.I. 2023/131, regs. 1(3), 2)

F10 Words in Sch. 4 para. 4 inserted (10.2.2023) by The Food Supplements and Food for Specific Groups (Miscellaneous Amendments) Regulations 2023 (S.I. 2023/28), regs. 1(2), 2(2)(b)(ii) (as amended by S.I. 2023/131, regs. 1(3), 2)

Regulation 6(2) and (3)

SCHEDULE 5 E+W MAXIMUM LIMITS FOR VITAMINS, MINERALS AND TRACE ELEMENTS, IF ADDED, IN PROCESSED CEREAL-BASED FOODS AND BABY FOODS

PART I E+W General

Column 1	Column 2
Nutrient	Maximum limit per 100 kcal(1)
Vitamin E	3 mg α-TE
Riboflavin	0.4 mg
Niacin	4.5 mg NE
Vitamin B6	0.35 mg
Folic acid	50 μg
Vitamin B12	0.35 μg
Pantothenic acid	1.5 mg
Biotin	10 μg
Potassium	160 mg (of the food as sold)
Magnesium	40 mg
Iron	3 mg
Zinc	2 mg
Copper	40 μg
Iodine	35 μg
Manganese	0.6 mg

PART II E+W Specified foods

Column 1	Column 2	Column 3
Food	Nutrient	Maximum limit per 100 kcal(1)
1.  Vegetable juices which are baby foods	Vitamin A	180 μg RE(2)
2.  Food fortified with iron	Vitamin C	25 mg
3.  Fruit-based dishes, fruit juices, nectars or vegetable juices	Vitamin C	125 mg
4.  Food other than that within entry number 2 or 3 above	Vitamin C	12.5 mg
5.  Processed cereal-based food	Thiamin	0.5 mg
6.  Baby food	Thiamin	0.25 mg
7.  Food within paragraph 1 or 2 of Part I of Schedule 1	Calcium	180 mg (of the food as sold)
8.  Food within paragraph 4 of Part I of Schedule 1	Calcium	100 mg (of the food as sold)
9.  Food other than that within entry number 7 or 8 above	Calcium	80 mg (of the food as sold)

(1) Unless otherwise stated in column 2 of Part I or column 3 of Part II, the maximum limits specified in those columns apply to food ready for use, whether marketed as such or reconstituted as instructed by the manufacturer.

(2) RE = all trans retinol equivalents.

Regulation 7(1) and (3)

SCHEDULE 6 E+W PESTICIDES WHOSE RESIDUES MUST NOT BE PRESENT IN PROCESSED CEREAL-BASED FOODS OR BABY FOODS AT A LEVEL EXCEEDING 0.003 mg/kg

Chemical name E+W

Regulation 7(2) and (3)

SCHEDULE 7 E+W SPECIFIC MAXIMUM RESIDUE LEVELS OF CERTAIN PESTICIDES IN PROCESSED CEREAL-BASED FOODS OR BABY FOODS

Column 1	Column 2
Chemical name of the substance	Maximum residue level (mg/kg)
Cadusafos	0.006
Demeton-S-methyl/demeton-S-methyl sulfone/oxydemeton-methyl (individually or combined, expressed as demeton-S-methyl)	0.006
Ethoprophos	0.008
Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil)	0.004
Propineb/propylenethiourea (sum of propineb and propylenethiourea)	0.006

Regulation 8(3)

SCHEDULE 8 E+W REFERENCE VALUES FOR NUTRITION LABELLING FOR FOODS INTENDED FOR INFANTS AND YOUNG CHILDREN

Column 1	Column 2
Nutrient	Labelling reference value
Vitamin A	(μg) 400
Vitamin D	(μg) 10
Vitamin C	(mg) 25
Thiamin	(mg) 0.5
Riboflavin	(mg) 0.8
Niacin equivalents	(mg) 9
Vitamin B6	(mg) 0.7
Folate	(μg) 100
Vitamin B12	(μg) 0.7
Calcium	(mg) 400
Iron	(mg) 6
Zinc	(mg) 4
Iodine	(μg) 70
Selenium	(μg) 10
Copper	(mg) 0.4

[F11 SCHEDULE 9 E+W Modification of the improvement notice provisions of the Act

Textual Amendments

F11 Sch. 9 inserted (20.7.2016) by The Food for Specific Groups (Information and Compositional Requirements) (England) Regulations 2016 (S.I. 2016/688), reg. 1(3), Sch. 3 para. 3(c) (as amended (1.3.2017) by The Food for Specific Groups (Information and Compositional Requirements) (England) (Amendment) Regulations 2017 (S.I. 2017/62), regs. 1(3), 4)

PART 1 E+W Modification of section 10(1)

1.   For section 10(1) (improvement notices) substitute— E+W

“(1) If an authorised officer of an enforcement authority F12 ... has reasonable grounds for believing that a person is failing to comply with regulation 4 of the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003, the authorised officer may, by a notice served on that person (in this Act referred to as an “improvement notice”)—

(a) [F13 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 relevant provision;

(b) specify the matters which constitute the failure to so 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 notice.”.

Textual Amendments

F12 Words in Sch. 9 Pt. 1 para. 1 omitted (22.2.2020) by virtue of 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. 5 para. 3(2)(a)(i)

F13 Words in Sch. 9 Pt. 1 para. 1 substituted (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. 5 para. 3(2)(a)(ii)

PART 2 E+W Modification of section 32(1)

2.   For paragraphs (a) to (c) of section 32(1) (powers of entry) substitute— E+W

“(a) to enter any premises within the authority's area for the purpose of ascertaining whether there has been any contravention of regulation 4 of the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003; and

(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 that regulation;”.

3.   Section 32(9) does not apply. E+W

PART 3 E+W Modification of section 35 (punishment of offences)

4.   In section 35, after subsection (1A), insert— E+W

“(1B) A person guilty of an offence under section 10(2), as applied by regulation 10A(1) of the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003, is liable, on summary conviction, to a fine.”.

PART 4 E+W Modification of section 37(1) and (6)

5.   For section 37(1) (appeals) substitute— E+W

“(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 10A(1) of, and Part 1 of Schedule 9 to, the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003, may apply to the First-tier Tribunal”.

6.   Section 37(2) does not apply. E+W

7.   For section 37(3) substitute— E+W

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

8.   For section 37(5) substitute– E+W

“(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)”.

9.   In section 37(6)— E+W

(a) for “(3) or (4)” substitute “ (1) ”, and

(b) in paragraph (a), for “magistrates' court or to the sheriff” substitute “ the First-tier Tribunal ”.

PART 5 E+W Modification of section 39(1) and (3)

10.   For section 39(1) (appeals against improvement notices) substitute— E+W

“(1) On an appeal against an improvement notice served under section 10(1), as applied and modified by regulation 10A(1) of, and Part 1 of Schedule 9 to, the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (England) Regulations 2003, the First-tier Tribunal may [F14 either cancel or affirm the notice] and, if it affirms it, may do so either in its original form or with such modifications as the First-tier Tribunal may in the circumstances think fit.”.

Textual Amendments

F14 Words in Sch. 9 Pt. 5 para. 10 substituted (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. 5 para. 3(2)(b)

11.   in section 39(3), omit “for want of prosecution”.] E+W

Explanatory Note

(This note is not part of the Regulations)

1.  These Regulations provide for the continued implementation in England of Commission Directive 96/5/EC on processed cereal-based foods and baby foods for infants and young children, as amended by Commission Directives 1998/36/EC and 1999/39/EC and now as further amended by Commission Directive 2003/13/EC. These Regulations revoke and replace in relation to England the Processed Cereal-based Foods and Baby Foods for Infants and Young Children Regulations 1997, as amended. E+W

2.  These Regulations come into force on 6th March 2005. They— E+W

(a) prohibit the sale of processed cereal-based foods and baby foods for infants and young children unless they comply with the manufacturing and compositional requirements in regulations 5 to 7 and the labelling requirements in regulation 8 (regulation 4);

(b) exempt from their application any baby food which is a milk intended for young children (regulation 3);

(c) specify the enforcement authorities (regulation 9);

(d) create an offence and prescribe a penalty (regulation 10);

(e) provide a defence in relation to exports in accordance with Articles 2 and 3 of Council Directive 89/397/EEC (OJ No. L186, 30.6.89, p.23) on the official control of foodstuffs (regulation 11);

(f) apply certain provisions of the Food Safety Act 1990 (regulation 12); and

(g) contain a revocation provision (regulation 13) and make a consequential amendment (regulation 14).

3.  In implementation of Directive 2003/13/EC these Regulations prohibit the sale of processed cereal-based foods and baby foods for infants and young children if those foods contain pesticide residues above certain levels. Different levels are set depending on the pesticide in question (regulation 7 and Schedules 6 and 7). In implementation of the final sentence of Article 6(2) of Directive 96/5/EC as substituted by Directive 1999/39/EC, provision is made as to analytical methods (regulation 7(5)). E+W

4.  These Regulations also make some minor, drafting and technical changes, particularly to the provision applying certain provisions of the 1990 Act (regulation 12). Port health authorities now have a role in enforcement (regulation 9). The offence provision now relates only to a contravention of the restrictions on sale in regulation 4 (regulation 10). E+W

5.  A full regulatory impact assessment of the effect that this instrument will have on the costs of business has been prepared and placed in the Library of each House of Parliament together with a Transposition Note setting out how the main elements of Directive 2003/13/EC are transposed in these Regulations. Copies may be obtained from the Food Labelling and Standards Division of the Food Standards Agency, Aviation House, 125 Kingsway, London WC2B 6NH. E+W