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Statutory Instruments of the Scottish Parliament


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SCOTTISH STATUTORY INSTRUMENTS


2004 No. 8

FOOD

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

  Made 15th January 2004 
  Laid before the Scottish Parliament 15th January 2004 
  Coming into force 6th March 2005 

The Scottish Ministers, in exercise of the powers conferred on them by sections 6(4), 16(1)(a), (e) and (f), 17(1), 26(1)(a) and (3) and 48(1) of the Food Safety Act 1990[1] and of all other powers enabling them in that behalf, having had regard in accordance with section 48(4A)[2] of that Act to relevant advice given by the Food Standards Agency and after consultation in accordance with section 48(4) and (4B)[3] of that Act, hereby make the following Regulations:

Citation, commencement and extent
     1.  - (1) These Regulations may be cited as the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (Scotland) Regulations 2004 and shall come into force on 6th March 2005.

    (2) These Regulations extend to Scotland only.

Interpretation
    
2.  - (1) In these Regulations-

    (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-

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-

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-

    (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 Part II of the Food Labelling Regulations 1996[11], processed CEREAL-BASED foods and baby foods shall be labelled with-

    (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-

    (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. Each food authority shall enforce and execute these Regulations in its area.

Offence and penalty
    
10. If any person contravenes regulation 4, that person 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. In any proceedings for an offence under these Regulations it shall be a defence for the person charged to prove-

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-

Amendment of the Tryptophan in Food (Scotland) Regulations 1990
    
13.  - (1) The Tryptophan in Food (Scotland) Regulations 1990[13] are amended in accordance with paragraph (2).

    (2) In regulation 2 (interpretation), in the definitions of "processed cereal-based food" and "baby food" for " them by Processed cereal-based Foods and Baby Foods for Infants and Young Children Regulations 1997" substitute " "processed cereal-based foods" and "baby foods" respectively in the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (Scotland) Regulations 2004".

Revocations
     14.  - (1) The Processed CEREAL-BASED Foods and Baby Foods for Infants and Young Children Regulations 1997[14], the Processed CEREAL-BASED Foods and Baby Foods for Infants and Young Children (Amendment) Regulations 1999[15] and the Processed CEREAL-BASED Foods and Baby Foods for Infants and Young Children Amendment (Scotland) Regulations 2000[16] are hereby revoked.


TOM McCABE
Authorised to sign by the Scottish Ministers

St Andrew's House, Edinburgh
15th February 2004



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


PROCESSED CEREAL-BASED FOODS




PART I

Categories of processed CEREAL-BASED foods

     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

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.

     1. Cereal content

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

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.

     2. Protein

     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 (1.5g/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.

     3. Carbohydrates

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

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

     4. Fat

     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 /100 kcal). If the fat content exceeds 0.8 g/100 kJ (3.3 g/100 kcal):

     5. Minerals

     5.1. Sodium

     5.2. Calcium

     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).

     6. Vitamins

     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:

     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.



SCHEDULE 2
Regulation 5(3) and Schedule 1, Part II, paragraph 2.4


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


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.

     1. Protein

     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:

     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:

     1.3. 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:

     1.4. 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:

     1.5 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).

     1.6. Sauces presented as an accompaniment to a meal are exempt from the requirements of paragraph 1.1 to 1.5.

     1.7. 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 paragraph 1.1 to 1.5.

     1.8. 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.

     2. Carbohydrates

The quantities of total carbohydrates present in fruit and vegetable juices and nectars, fruit-only dishes, and desserts or puddings shall not exceed:

     3. Fat

     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 (6 g/100 kcal).

     3.2. 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).

     4. Sodium

     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).

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

     5. Vitamins

Vitamin C-

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.

Vitamin A-

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.

Vitamin A shall not be added to other baby foods.

Vitamin D-

Vitamin D shall not be added to baby foods.



SCHEDULE 4
Regulations 6(1) and 8(2)


NUTRITIONAL SUBSTANCES


     1. Vitamins
Vitamin A

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

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

     2. Amino acids
L-arginine }

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

     3. Others
Choline

Choline chloride

Choline citrate

Choline bitartrate

Inositol

L-carnitine

L-carnitine hydrochloride

     4. Salts of minerals and trace elements
Calcium

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

Copper

Copper-lysine complex

Cupric carbonate

Cupric citrate

Cupric gluconate

Cupric sulphate

Zinc

Zinc acetate

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



SCHEDULE 5
Regulation 6(2) and (3)


MAXIMUM LIMITS FOR VITAMINS, MINERALS AND TRACE ELEMENTS, IF ADDED, IN PROCESSED CEREAL-BASED FOODS AND BABY FOODS




PART I

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

(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.



PART II

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 paragraphs 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.



SCHEDULE 6
Regulation 7(1) and (3)


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

Aldrin and dieldrin, expressed as dieldrin

Disulfoton (sum of disulfoton, disulfoton sulfoxide and disulfoton sulfone expressed as disulfoton)

Endrin

Fensulfothion (sum of fensulfothion, its oxygen analogue and their sulfones, expressed as fensulfothion)

Fentin, expressed as triphenyltin cation

Haloxyfop (sum of haloxyfop, its salts and esters including conjugates, expressed as haloxyfop)

Heptachlor and trans-heptachlor epoxide, expressed as heptachlor

Hexachlorobenzene

Nitrofen

Omethoate

Terbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos)



SCHEDULE 7
Regulation 7(2) and (3)


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



SCHEDULE 8
Regulation 8(3)


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



EXPLANATORY NOTE

(This note is not part of the Regulations)


These Regulations provide for the continued implementation in Scotland 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 the Processed Cereal-based Foods and Baby Foods for Infants and Young Children Regulations 1997, as amended.

These Regulations come into effect on 6th March 2005. They-

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 Commission Directive 1999/39/EC provision is made as to the analytical methods for determining levels of pesticide residues (regulation 7(5)).

These Regulations also make some minor drafting and technical changes, particularly to the provision applying certain provisions of the 1990 Act. The offence provision now relates only to a contravention of the restrictions on sale in regulation 4 (regulation 10).

A Regulatory Impact Assessment which includes a compliance cost assessment of the effect which these Regulations are likely to have on business costs, has been prepared and placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.


Notes:

[1] 1990 c.16; section 6(4) was amended by the Deregulation and Contracting Out Act 1994 (c.40), Schedule 9, paragraph 6 and by the Food Standards Act 1999 (c.28) ("the 1999 Act"), Schedule 5, paragraph 10(3); sections 16(1) and 48(1) were amended by the 1999 Act, Schedule 5, paragraph 8; section 17(1) was amended by the 1999 Act, Schedule 5, paragraphs 8 and 12; section 26(3) was amended by the 1999 Act, Schedule 6; amendments made by Schedule 5 to the 1999 Act shall be taken as pre commencement enactments for the purposes of the Scotland Act 1998 (c.46) ("the 1998 Act") by virtue of section 40(2) of the 1999 Act. The functions of the Secretary of State were transferred to the Scottish Ministers by virtue of section 53 of the 1998 Act.back

[2] Section 48(4A) was inserted by the 1999 Act, Schedule 5, paragraph 21.back

[3] Section 48(4B) was inserted by the 1999 Act, Schedule 5, paragraph 21back

[4] O.J. No. L 49, 28.2.96, p.17.back

[5] O.J. No. L 167, 12.6.98, p.23.back

[6] O.J. No. L 124, 18.5.99, p.8.back

[7] O.J. No. L 41, 14.2.03, p.33.back

[8] O.J. No. L 1, 3.1.94, p.1.back

[9] O.J. No. L 1, 3.1.94, p.571.back

[10] O.J. No. L 230, 19.8.91, p.1.back

[11] S.I. 1996/1499, amended by S.I. 1998/141, 1398 and 2424, 1999/747, 982, 1136, 1483, 1540 and 1603 and S.S.I 2000/83 and 309, 2001/38, 2002/524, 2003/145, 291, 293, 311, 527, 569 and 578.back

[12] As adopted by the EEA Joint Committee Decision No. 32/2002 (O.J. No. L 154, 13.6.2002, p.12 and EEA Supplement No. 29, p.10).back

[13] S.I. 1990/1792, amended by S.S.I. 2002/397.back

[14] S.I. 1997/2042.back

[15] S.I. 1999/275.back

[16] S.S.I. 2000/214back



ISBN 0 11062586 2


 
© Crown copyright 2004
Prepared 23 January 2004


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URL: http://www.bailii.org/scot/legis/num_reg/2004/20040008.html