The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2002

Type Statutory-Instrument
Publication 2002-07-14
Last updated 2010-01-01
State In force
Department King's Printer of Acts of Parliament
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Made: 14th July 2002

Laid before Parliament: 15th July 2002

Coming into force in accordance with regulation 1(2) and (3)

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Title, extent and commencement

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Interpretation

2

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Restrictions on sale

3

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Verification of regulation 3(4)

4

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Notification requirement

5

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Enforcement

6

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Offences and penalties

7

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Defence in relation to exports

8

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Application of various provisions of the Act

9

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Amendment of the Tryptophan in Food Regulations 1990

10

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SCHEDULE 1 — SUBSTANCES WHICH MAY BE ADDED FOR SPECIFIC NUTRITIONAL PURPOSES IN DESIGNATED PNU FOODS

VITAMIN A: VITAMIN A:
— retinol
— retinyl acetate
— retinyl palmitate
— beta-carotene
VITAMIN D: VITAMIN D:
— cholecalciferol
— ergocalciferol
VITAMIN E: VITAMIN E:
— D-alpha-tocopherol
— DL-alpha-tocopherol
— D-alpha-tocopheryl acetate
— DL-alpha-tocopheryl acetate
— D-alpha-tocopheryl acid succinate
VITAMIN K: VITAMIN K:
— phylloquinone (phytomenadione)
VITAMIN B1: VITAMIN B1:
— thiamin hydrochloride
— thiamin mononitrate
VITAMIN B2: VITAMIN B2:
— riboflavin
— riboflavin 5'-phosphate, sodium
NIACIN: NIACIN:
— nicotinic acid
— nicotinamide
PANTOTHENIC ACID: PANTOTHENIC ACID:
— D-pantothenate, calcium
— D-pantothenate, sodium
— dexpanthenol
VITAMIN B6: VITAMIN B6:
— pyridoxine hydrochloride
— pyridoxine 5'-phosphate
— pyridoxine dipalmitate
FOLIC ACID: FOLIC ACID:
— pteroylmonoglutamic acid
VITAMIN B12: VITAMIN B12:
— cyanocobalamin
— hydroxocobalamin
BIOTIN: BIOTIN:
— D-biotin
VITAMIN C: VITAMIN C:
— L-ascorbic acid
— sodium-L-ascorbate
— calcium-L-ascorbate
— potassium-L-ascorbate
— L-ascorbyl 6–palmitate
CALCIUM: CALCIUM:
--- ---
— carbonate
— chloride
— salts of citric acid
— gluconate
— glycerophosphate
— lactate
— salts of orthophosphoric acid
— hydroxide
— oxide
MAGNESIUM: MAGNESIUM:
— acetate
— carbonate
— chloride
— salts of citric acid
— gluconate
— glycerophosphate
— salts of orthophosphoric acid
— lactate
— hydroxide
— oxide
— sulphate
IRON: IRON:
— ferrous carbonate
— ferrous citrate
— ferric ammonium citrate
— ferrous gluconate
— ferrous fumarate
— ferric sodium diphosphate
— ferrous lactate
— ferrous sulphate
— ferric diphosphate (ferric pyrophosphate)
— ferric saccharate
— elemental iron (carbonyl + electrolytic + hydrogen reduced)
COPPER: COPPER:
— cupric carbonate
— cupric citrate
— cupric gluconate
— cupric sulphate
— copper lysine complex
IODINE: IODINE:
— potassium iodide
— potassium iodate
— sodium iodide
— sodium iodate
ZINC: ZINC:
— acetate
— chloride
— citrate
— gluconate
— lactate
— oxide
— carbonate
— sulphate
MANGANESE: MANGANESE:
— carbonate
— chloride
— citrate
— gluconate
— glycerophosphate
— sulphate
SODIUM: SODIUM:
— bicarbonate
— carbonate
— chloride
— citrate
— gluconate
— lactate
— hydroxide
— salts of orthophosphoric acid
POTASSIUM: POTASSIUM:
— bicarbonate
— carbonate
— chloride
— citrate
— gluconate
— glycerophosphate
— lactate
— hydroxide
— salts of orthophosphoric acid
SELENIUM: SELENIUM:
— sodium selenate
— sodium hydrogen selentine
— sodium selenite
CHROMIUM (III) and their hexahydrates: CHROMIUM (III) and their hexahydrates:
— chloride
— sulphate
MOLYBDENUM (VI): MOLYBDENUM (VI):
— ammonium molybdate
— sodium molybdate
FLUORINE: FLUORINE:
— potassium fluoride
— sodium fluoride
For amino acids, as far as applicable, also the sodium, potassium, calcium and magnesium salts as well as their hydrochlorides may be used For amino acids, as far as applicable, also the sodium, potassium, calcium and magnesium salts as well as their hydrochlorides may be used
--- ---
— L-alanine
— L-arginine
— L-cysteine
— Cystine
— L-histidine
— L-glutamic acid
— L-glutamine
— L-isoleucine
— L-leucine
— L-lysine
— L-lysine acetate
— L-methionine
— L-ornithine
— L-phenylalanine
— L-threonine
— L-tryptophan
— L-tyrosine
— L-valine
— L-carnitine
--- ---
— L-carnitine hydrochloride
— taurine
— adenosine 5'-phosphoric acid (AMP)
--- ---
— sodium salts of AMP
— cytidine 5'-monophosphoric acid (CMP)
— sodium salts of CMP
— guanosine 5'-phosphoric acid (GMP)
— sodium salts of GMP
— insosine 5'-phosphoric acid (IMP)
— sodium salts of IMP
— uridine 5'-phosphoric acid (UMP)
— sodium salts of UMP
— choline
--- ---
— choline chloride
— choline bitartrate
— choline citrate
— inositol

SCHEDULE 2 — ADDITIONAL SUBSTANCES WHICH MAY BE ADDED FOR SPECIFIC NUTRITIONAL PURPOSES IN FOODS FOR SPECIAL MEDICAL PURPOSES

Substance Conditions of use
For amino acids, as far as applicable, also the sodium, potassium, calcium and magnesium salts as well as their hydrochlorides may be used. For amino acids, as far as applicable, also the sodium, potassium, calcium and magnesium salts as well as their hydrochlorides may be used.
L-arginine-L-aspartate
L-aspartic acid
L-citrulline
glycine
L-lysine-L-aspartate
L-lysine-L-glutamate
L-proline
L-serine
N-acetyl-L-cysteine
N-acetyl-L-methionine Shall not be used except in foods intended for persons over 1 year of age.

Signed

Signed by authority of the Secretary of State for Health

Hazel Blears — Parliamentary Under Secretary of State, — Department of Health — 2002-07-14

Explanatory note

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Footnotes

2

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 paragraphs 7 and 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(1) 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 existing Regulations made or having effect as if made by the Minister of Agriculture, Fisheries and Food (whether with others or not) under the Food Safety Act 1990.

3

OJ No. L31, 1.2.2002, p.1.

4

OJ No. L186, 30.6.89, p.27.

5

OJ No. L172, 8.7.1999, p.38.

6

OJ No. L52, 22.2.2001, p.19.

7

OJ No. L253, 21.9.2001, p.34.

8

S.I. 1990/1728, to which there is an amendment not relevant to these Regulations.

9

OJ No. L52, 22.2.2001, p.19.

10

OJ No. L253, 21.9.2001, p.34.

11

S.I. 1995/77, to which there are amendments not relevant to these Regulations.

12

S.I. 1997/2042, to which there are amendments not relevant to these Regulations.

VITAMIN A: VITAMIN A:
retinol
retinyl acetate
retinyl palmitate
beta-carotene
VITAMIN D: VITAMIN D:
cholecalciferol
ergocalciferol
VITAMIN E: VITAMIN E:
D-alpha-tocopherol
DL-alpha-tocopherol
D-alpha-tocopheryl acetate
DL-alpha-tocopheryl acetate
D-alpha-tocopheryl acid succinate
VITAMIN K: VITAMIN K:
phylloquinone (phytomenadione)
VITAMIN B1: VITAMIN B1:
thiamin hydrochloride
thiamin mononitrate
VITAMIN B2: VITAMIN B2:
riboflavin
riboflavin 5i-phosphate, sodium
NIACIN: NIACIN:
nicotinic acid
nicotinamide
PANTOTHENIC ACID: PANTOTHENIC ACID:
D-pantothenate, calcium
D-pantothenate, sodium
dexpanthenol
VITAMIN B6: VITAMIN B6:
pyridoxine hydrochloride
pyridoxine 5i-phosphate
pyridoxine dipalmitate
FOLATE: FOLATE:
pteroylmonoglutamic acid
— calcium–L–methylfolate
VITAMIN B12: VITAMIN B12:
cyanocobalamin
hydroxocobalamin
BIOTIN: BIOTIN:
D-biotin
VITAMIN C: VITAMIN C:
L-ascorbic acid
sodium-L-ascorbate
calcium-L-ascorbate
potassium-L-ascorbate
L-ascorbyl 6–palmitate
CALCIUM: CALCIUM:
--- ---
carbonate
chloride
salts of citric acid
gluconate
glycerophosphate
lactate
salts of orthophosphoric acid
hydroxide
oxide
- sulphate
MAGNESIUM: MAGNESIUM:
acetate
carbonate
chloride
salts of citric acid
gluconate
glycerophosphate
salts of orthophosphoric acid
lactate
hydroxide
oxide
sulphate
IRON: IRON:
ferrous carbonate
ferrous citrate
ferric ammonium citrate
ferrous gluconate
ferrous fumarate
ferric sodium diphosphate
ferrous lactate
ferrous sulphate
ferric diphosphate (ferric pyrophosphate)
ferric saccharate
elemental iron (carbonyl + electrolytic + hydrogen reduced)
— ferrous bisglycinate
COPPER: COPPER:
cupric carbonate
cupric citrate
cupric gluconate
cupric sulphate
copper lysine complex
IODINE: IODINE:
potassium iodide
potassium iodate
sodium iodide
sodium iodate
ZINC: ZINC:
acetate
chloride
citrate
gluconate
lactate
oxide
carbonate
sulphate
MANGANESE: MANGANESE:
carbonate
chloride
citrate
gluconate
glycerophosphate
sulphate
SODIUM: SODIUM:
bicarbonate
carbonate
chloride
citrate
gluconate
lactate
hydroxide
salts of orthophosphoric acid
POTASSIUM: POTASSIUM:
bicarbonate
carbonate
chloride
citrate
gluconate
glycerophosphate
lactate
hydroxide
salts of orthophosphoric acid
SELENIUM: SELENIUM:
sodium selenate
sodium hydrogen selentine
sodium selenite
CHROMIUM (III) and their hexahydrates: CHROMIUM (III) and their hexahydrates:
chloride
sulphate
MOLYBDENUM (VI): MOLYBDENUM (VI):
ammonium molybdate
sodium molybdate
FLUORINE: FLUORINE:
potassium fluoride
sodium fluoride
L-alanine
--- ---
L-arginine
L-cysteine
Cystine
L-histidine
L-glutamic acid
L-glutamine
L-isoleucine
L-leucine
L-lysine
L-lysine acetate
L-methionine
L-ornithine
L-phenylalanine
L-threonine
L-tryptophan
L-tyrosine
L-valine

For amino acids, as far as applicable, also the sodium, potassium, calcium and magnesium salts as well as their hydrochlorides may be used

L-carnitine
L-carnitine hydrochloride
L-arnitine-–tartrate
taurine
adenosine 5i-phosphoric acid (AMP)
--- ---
sodium salts of AMP
cytidine 5i-monophosphoric acid (CMP)
sodium salts of CMP
guanosine 5i-phosphoric acid (GMP)
sodium salts of GMP
insosine 5i-phosphoric acid (IMP)
sodium salts of IMP
uridine 5i-phosphoric acid (UMP)
sodium salts of UMP
choline
--- ---
choline chloride
choline bitartrate
choline citrate
inositol

Editorial notes

SCHEDULE 3 — SUBSTANCES WHICH MAY BE ADDED FOR SPECIFIC NUTRITIONAL PURPOSES IN DESIGNATED PNU FOODS IN ACCORDANCE WITH THE DEROGATION IN REGULATION 3(5)

Category 1. Vitamins

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Category 2. Minerals

CALCIUM:

MAGNESIUM:

IRON:

COPPER:

ZINC:

MANGANESE:

SELENIUM:

CHROMIUM:

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Category 2. Minerals

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