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

Statutory Instruments

2002 No. 1817

FOOD, ENGLAND

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

Made

14th July 2002

Laid before Parliament

15th July 2002

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

The Secretary of State, in exercise of the powers conferred by sections 16(1)(f), 17(1), 26(3) and 48(1) of the Food Safety Act 1990M1 and now vested in himM2 , 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 CouncilM3 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 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.

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

Title, extent and commencement E+W

1.—(1) These Regulations may be cited as the Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) Regulations 2002 and extend to England only.

(2) Regulations 1, 5 and 10, and regulations 2 and 6 to 9 in so far as they relate to regulation 5, come into force on 5th August 2002.

(3) The remainder of these Regulations comes into force—

(a) on 5th August 2002 in relation to an L-tryptophan food; and

(b) in any other case on 1st April 2004.

Interpretation E+W

2.—(1) In these Regulations—

• “the Act” means the Food Safety Act 1990;

• “designated PNU food” means any PNU food other than infant formulae, follow-on formulae, processed cereal-based foods and baby foods intended for infants and young children;

• “Directive 89/398” means Council Directive 89/398/EEC M4 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses, as amended by Directive 1999/41/EC of the European Parliament and of the Council M5 ;

• “Directive 2001/15” means Commission Directive 2001/15/EC M6 (as corrected M7 ) on substances that may be added for specific nutritional purposes in foods for particular nutritional uses [F1 , as amended by Commission Directive 2004/5/EC [F2 and Commission Directive 2006/34/EC] and as read with Commission Directive 2004/6/EC derogating from Directive 2001/15/EC to postpone the application of the prohibition of trade to certain products];

• “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);

• “L-tryptophan food” means any designated PNU food being a food to which L-tryptophan, or any of its sodium, potassium, calcium or magnesium salts or its hydrochloride, has been added for a specific nutritional purpose;

• “PNU food” means a food for a particular nutritional use which—

  (a)

  owing to its special composition or process of manufacture, is clearly distinguishable from food intended for normal consumption, and

  (b)

  is sold in such a way as to indicate its suitability for its claimed particular nutritional purpose;

• “particular nutritional use” means the fulfilment of the particular nutritional requirements of—

  (a)

  certain categories of persons whose digestive processes are, or whose metabolism is, disturbed, or

  (b)

  certain categories of person whose physiological condition renders them able to obtain a special benefit from the controlled consumption of any substance in food, or

  (c)

  infants or young children in good health; and

• “sell” includes possess for sale and offer, expose or advertise for sale.

(2) Other expressions used both in these Regulations and in Directive 89/398 or 2001/15 have the same meaning in these Regulations as they have in the Directive concerned.

Textual Amendments

F1 Words in reg. 2(1) inserted (31.3.2004) by The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2004 (S.I. 2004/649), regs. 1(2), 3

F2 Words in reg. 2(1) inserted (31.12.2006) by The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2006 (S.I. 2006/3116), regs. 1(2), 3

Marginal Citations

M4 OJ No. L186, 30.6.89, p.27.

M5 OJ No. L172, 8.7.1999, p.38.

M6 OJ No. L52, 22.2.2001, p.19.

M7 OJ No. L253, 21.9.2001, p.34.

Restrictions on sale E+W

3.— [F3 (1) Subject to paragraph (5), no person shall sell any designated PNU food being a food to which a substance falling within one of the categories mentioned in paragraph (2) has been added for a specific nutritional purpose unless —

(a) that substance is listed under that category —

(i) in the case of any food for special medical purposes, in Schedule 1 or 2; and

(ii) in any other case, in Schedule 1;

(b) that substance complies with the relevant purity criteria referred to in paragraph (3); and

(c) in the case of a substance listed in Schedule 2, the conditions of use (if any) set out in that Schedule relating to that substance are met.]

(2) For the purposes of paragraph (1), the categories are—

(a) vitamins,

(b) minerals,

(c) amino acids,

(d) carnitine and taurine,

(e) nucleotides, and

(f) choline and inositol.

(3) The relevant purity criteria for the purposes of paragraph (1)(b) are—

(a) the purity criteria, if any, specified by Community legislation for the use of the substance in question in the manufacture of food for purposes other than those covered by Directive 2001/15, or

(b) in the absence of such purity criteria, generally acceptable purity criteria for the substance in question recommended by international bodies.

(4) No person shall sell any designated PNU food in the manufacture of which any substance has been used for a specific nutritional purpose unless that food—

(a) is safe when used in accordance with the manufacturer’s instructions (if any); and

(b) fulfils the particular nutritional requirements of the persons for whom it is intended,

as established by generally accepted scientific data.

[F4 (5) The restrictions in paragraph (1) shall not apply until 1st January 2007 in the case of a substance falling within one of the categories mentioned in paragraph (2) and listed under that category in Schedule 3 if —

(a) the European Food Safety Authority has not given an unfavourable opinion in respect of the use of that substance in the manufacture of any designated PNU food; and

(b) that substance was used in the manufacture of a food for a particular nutritional use which was on sale in the European Community on 11th February 2004.]

Textual Amendments

F3 Reg. 3(1) substituted (31.3.2004) by The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2004 (S.I. 2004/649), regs. 1(2), 4(a)

F4 Reg. 3(5) inserted (31.3.2004) by The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2004 (S.I. 2004/649), regs. 1(2), 4(b)

Verification of regulation 3(4) E+W

4.  The manufacturer or, as the case may be, the importer of a designated PNU food in the manufacture of which a substance has been used for a specific nutritional purpose shall supply to the Food Standards Agency on request—

(a) a copy of the scientific work and data establishing that the use of that substance in the manufacture of that food results in a food which meets the criteria in regulation 3(4), or

(b) if such work and data are contained in a publication which is readily available, a reference to that publication.

Notification requirement E+W

5.—(1) Subject to paragraph (2), the manufacturer or, where appropriate, the importer of any notifiable food shall not sell any such food unless at least 3 months before placing food of that particular type on the market in England for the first time he notified the Food Standards Agency in writing by forwarding to it a model of the label to be used for that food and details of the composition of the food.

(2) Paragraph (1) shall not apply if the manufacturer or, where appropriate, the importer has already notified the Food Standards Agency before placing food of that particular type on the market elsewhere in the United Kingdom for the first time in accordance with an equivalent provision having effect there.

(3) In this regulation “notifiable food” means any L-tryptophan food which is—

(a) intended for use in energy-restricted diets for weight reduction;

(b) intended to meet the expenditure of intense muscular effort, especially for sportsmen; or

(c) for persons suffering from carbohydrate-metabolism disorders (diabetes).

Enforcement E+W

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

Offences and penalties E+W

7.  If any person—

(a) contravenes regulation 3(1) or (4), or

(b) without reasonable excuse contravenes regulation 4 or 5(1),

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 E+W

F5 8.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F5 Reg. 8 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

9.  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 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).

Amendment of the Tryptophan in Food Regulations 1990 E+W

F6 10.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F6 Reg. 10 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

Hazel Blears

Parliamentary Under Secretary of State,

Department of Health

Regulation 3(1)(a)

SCHEDULE 1 E+W SUBSTANCES WHICH MAY BE ADDED FOR SPECIFIC NUTRITIONAL PURPOSES IN DESIGNATED PNU FOODS

 

Category 1. Vitamins

VITAMIN A:
	retinol
	retinyl acetate
	retinyl palmitate
	beta-carotene
VITAMIN D:
	cholecalciferol
	ergocalciferol
VITAMIN E:
	D-alpha-tocopherol
	DL-alpha-tocopherol
	D-alpha-tocopheryl acetate
	DL-alpha-tocopheryl acetate
	D-alpha-tocopheryl acid succinate
VITAMIN K:
	phylloquinone (phytomenadione)
VITAMIN B1:
	thiamin hydrochloride
	thiamin mononitrate
VITAMIN B2:
	riboflavin
	riboflavin 5i-phosphate, sodium
NIACIN:
	nicotinic acid
	nicotinamide
PANTOTHENIC ACID:
	D-pantothenate, calcium
	D-pantothenate, sodium
	dexpanthenol
VITAMIN B6:
	pyridoxine hydrochloride
	pyridoxine 5i-phosphate
	pyridoxine dipalmitate
[F7 FOLATE]:
	pteroylmonoglutamic acid
	[F7 — calcium–L–methylfolate]
VITAMIN B12:
	cyanocobalamin
	hydroxocobalamin
BIOTIN:
	D-biotin
VITAMIN C:
	L-ascorbic acid
	sodium-L-ascorbate
	calcium-L-ascorbate
	potassium-L-ascorbate
	L-ascorbyl 6–palmitate

Category 2. Minerals

CALCIUM:
	carbonate
	chloride
	salts of citric acid
	gluconate
	glycerophosphate
	lactate
	salts of orthophosphoric acid
	hydroxide
	oxide
	[F8 - sulphate]
MAGNESIUM:
	acetate
	carbonate
	chloride
	salts of citric acid
	gluconate
	glycerophosphate
	salts of orthophosphoric acid
	lactate
	hydroxide
	oxide
	sulphate
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)
	[F9 — ferrous bisglycinate]
COPPER:
	cupric carbonate
	cupric citrate
	cupric gluconate
	cupric sulphate
	copper lysine complex
IODINE:
	potassium iodide
	potassium iodate
	sodium iodide
	sodium iodate
ZINC:
	acetate
	chloride
	citrate
	gluconate
	lactate
	oxide
	carbonate
	sulphate
MANGANESE:
	carbonate
	chloride
	citrate
	gluconate
	glycerophosphate
	sulphate
SODIUM:
	bicarbonate
	carbonate
	chloride
	citrate
	gluconate
	lactate
	hydroxide
	salts of orthophosphoric acid
POTASSIUM:
	bicarbonate
	carbonate
	chloride
	citrate
	gluconate
	glycerophosphate
	lactate
	hydroxide
	salts of orthophosphoric acid
SELENIUM:
	sodium selenate
	sodium hydrogen selentine
	sodium selenite
CHROMIUM (III) and their hexahydrates:
	chloride
	sulphate
MOLYBDENUM (VI):
	ammonium molybdate
	sodium molybdate
FLUORINE:
	potassium fluoride
	sodium fluoride

Category 3. Amino acids

	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

Textual Amendments

F7 Words in Sch. 1 substituted (31.12.2006) by The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2006 (S.I. 2006/3116), regs. 1(2), 4(a)

F8 Sch. 1 entry inserted (31.3.2004) by The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2004 (S.I. 2004/649), regs. 1(2), 5(a)

F9 Words in Sch. 1 inserted (31.12.2006) by The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2006 (S.I. 2006/3116), regs. 1(2), 4(b)

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

Category 4. Carnitine and taurine

	L-carnitine
	L-carnitine hydrochloride
	[F10 L-arnitine-–tartrate]
	taurine

Category 5. Nucleotides

	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

Category 6. Choline and inositol

	choline
	choline chloride
	choline bitartrate
	choline citrate
	inositol

Textual Amendments

F10 Sch. 1 entry inserted (31.3.2004) by The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2004 (S.I. 2004/649), regs. 1(2), 5(b)

Regulation 3(1)(a)

[F11 SCHEDULE 2 E+W ADDITIONAL SUBSTANCES WHICH MAY BE ADDED FOR SPECIFIC NUTRITIONAL PURPOSES IN FOODS FOR SPECIAL MEDICAL PURPOSES

Textual Amendments

F11 Sch. 2 substituted (31.3.2004) by The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2004 (S.I. 2004/649), regs. 1(2), Sch. 1

[F12 Category 2. Minerals

magnesium L–aspartate]

Textual Amendments

F12 Words in Sch. 2 inserted (31.12.2006) by The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2006 (S.I. 2006/3116), regs. 1(2), 5

Category 3. Amino acids

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.]
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.

Regulation 3(5)

[F13 SCHEDULE 3 E+W SUBSTANCES WHICH MAY BE ADDED FOR SPECIFIC NUTRITIONAL PURPOSES IN DESIGNATED PNU FOODS IN ACCORDANCE WITH THE DEROGATION IN REGULATION 3(5)

Textual Amendments

F13 Sch. 3 inserted (31.3.2004) by The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (England) (Amendment) Regulations 2004 (S.I. 2004/649), regs. 1(2), Sch. 2

Category 1. Vitamins E+W

VITAMIN E:

• D–alpha tocopheryl polyethylene glycol 1000 succinate

Category 2. Minerals E+W

BORON:

• boric acid

• sodium borate

CALCIUM:

• amino acid chelate

• pidolate

MAGNESIUM:

• amino acid chelate

• pidolate

IRON:

• ferrous hydroxide

• ferrous pidolate

• amino acid chelate

COPPER:

• amino acid chelate

ZINC:

• amino acid chelate

MANGANESE:

• amino acid chelate

SELENIUM:

• enriched yeast

CHROMIUM:

• amino acid chelate]

Explanatory Note

(This note is not part of the Regulations)

1.  These Regulations implement in England Commission Directive 2001/15/EC on substances that may be added for specific nutritional purposes in foods for particular nutritional uses. E+W

2.  These Regulations concern food for most particular nutritional uses (definition of “designated PNU food” in regulation 2(1) which excludes infant formulae, follow-on formulae, processed cereal-based foods and baby foods intended for infants and young children) where there has been added to that food for a specific nutritional purpose a substance falling within one of the following categories: vitamins; minerals; amino acids; carnitine and taurine; nucleotides; choline and inositol. The Regulations prohibit the sale of such food unless the substance is listed under the relevant category in Schedule 1 or, in the case of foods for special medical purposes, is listed under the relevant category in either Schedule 1 or 2. Relevant purity criteria must be met for the substance. (Regulation 3(1) to (3)). E+W

3.  The Regulations also impose general restrictions on the sale of designated PNU foods in the manufacture of which any substances have been used for specific nutritional purposes (regulation 3(4)); and require the manufacturer or importer to supply the Food Standards Agency with information on request to verify that those restrictions are met (regulation 4). The Regulations prohibit the sale by the manufacturer or importer of certain designated PNU foods to which L-tryptophan has been added for a specific nutritional purpose, unless prior notification has been given to the Food Standards Agency before the first marketing of food of that particular type (regulation 5). E+W

4.  The Regulations make provision as to responsibilities for enforcement (regulation 6); create offences and penalties (regulation 7) and apply certain provisions of the Food Safety Act 1990 (regulation 9). The Regulations 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 8). E+W

5.  The Regulations also disapply the prohibitions in the Tryptophan in Food Regulations 1990 (in their application to England) in so far as they conflict with Directive 2001/15/EC, Article 5 of Commission Directive 91/321/EEC (OJ No. L175, 4.7.91, p.35) on infant formulae and follow-on formulae and Article 5 of Commission Directive 96/5/EC (OJ No. L49, 28.2.96, p.17) on processed cereal-based foods and baby foods for infants and young children (regulation 10). E+W

6.  A regulatory impact assessment 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 2001/15/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