The Processed Cereal-based Foods and Baby Foods for Infants and Young Children (Wales) Regulations 2004

Made: 10th February 2004

Coming into force: 6th March 2005

The National Assembly for Wales, in exercise of the powers conferred by sections 6(4), 16(1)(a), (e) and (f), 17(1), 26(1) and (3) and 48(1) of the Food Safety Act 1990 and now vested in it , having had regard in accordance with section 48(4A) of that Act to relevant advice given by the Food Standards Agency and after consultation both as required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety and in accordance with section 48(4) and (4B) of that Act, makes the following Regulations:

Title, application and commencement

1

These Regulations may be cited as the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (Wales) Regulations 2004; they apply in relation to Wales only and come into force on 6th March 2005.

Interpretation

2

• (1) In these Regulations —

• “the Act” (“y Ddeddf”) means the Food Safety Act 1990;

• “baby foods” (“bwyd babanod”) 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;

• “the Directive” (“y Gyfarwyddeb”) means Commission Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and young children;

• ...

• “food authority” (“awdurdod bwyd”) has the same meaning as in section 5(1A) and (3) of the Act sofar as subsection 3 can apply to Wales;

• “infants” (“babanod”) means children under the age of twelve months;

• “pesticide residue” (“gweddill plaleiddiad”) means the residue in processed cereal-based foods or baby foods of a plant protection product 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” (“bwydydd proses sydd wedi'u seilio ar rawn”) 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” (“gwerthu”) includes possess for sale and offer, expose or advertise for sale , and “sold” (“cael ei werthu”) is to be construed accordingly; and

• “young children” (“plant ifanc”) 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.

Exemption

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

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

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

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

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

8

• (1) Without prejudice to the generality of 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.

Enforcement

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

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.

Defence in relation to exports

11

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

Application of various provisions of the Act

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

13

• (1) The Processed Cereal-based Foods and Baby Foods for Infants and Young Children Regulations 1997 and the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (Amendment) Regulations 1999 are revoked in relation to Wales.

• (2) The Processed Cereal-based Foods and Baby Foods for Infants and Young Children (Amendment) (Wales) Regulations 2001 are revoked.

Amendment

14

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

SCHEDULE 1 — PROCESSED CEREAL-BASED FOODS

PART I

1

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

2

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

3

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

4

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

PART II

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

Cereal content

1

Processed cereal-based foods are prepared primarily from one or more milled cereals and/or starchy root products.

Protein

2

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).

2.2

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).

2.3

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).

2.4

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

3

3.1

If sucrose, fructose, glucose, glucose syrups or honey are added to products mentioned in paragraphs 1 and 4 of Part I:

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

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

3.2

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

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

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

Fat

4

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).

4.2

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

5

Sodium

5.1

• sodium salts may only be added to processed cereal-based foods for technological purposes,

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

Calcium

5.2

5.2.1

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).

5.2.2

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

6

6.1

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

6.2

For products mentioned in paragraph 2 of Part I:

• The following limits apply:

• Per 100 kJPer 100 kcalMinimumMaximumMinimumMaximum (1) RE = all trans retinol equivalents (2) In the form of cholecalciferol, of which 10 μg = 400 i.u. of Vitamin D Vitamin A (μg RE)[^f01000]144360180Vitamin D (μg)[^f01001]0.250.7513

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

SCHEDULE 2 — 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

SCHEDULE 3 — 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

1

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:

• 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,

• 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,

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

1.2

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: