The Tryptophan in Food (Wales) Regulations 2005

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"Directive 2001/15/EC" ("Cyfarwyddeb 2001/15/EC") means Commission Directive 2001/15/EC[4] on substances that may be added for specific nutritional purposes in foods for particular nutritional uses, as amended by Commission Directive 2004/5/EC[5];

"dose form" ("ffurf dogn") means a form such as capsules, pastilles, tablets, pills, and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids or powders designed to be taken in measured small unit quantities;

"follow-on formula" ("fformiwla ddilynol") means a food intended for particular nutritional use by infants in good health who are aged over four months and constituting the principal liquid element in a progressively diversified diet;

"food authority" ("awdurdod bwyd") has the same meaning as in section 5(1A) and (3)(a) and (b) of the Food Safety Act 1990;

"food supplement" ("ategolyn bwyd") means any food the purpose of which is to supplement the normal diet and which—

(a) is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination; and

(b) is sold in dose form;

"hospital" ("ysbyty") includes a clinic, nursing home or similar institution;

"infant" ("baban") means a child under the age of twelve months;

"infant formula" ("fformiwla fabanod") means a food intended for particular nutritional use by infants in good health during the first four to six months of life and satisfying by itself the nutritional requirements of such infants;

"pharmacist" ("fferyllydd") means a person lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968[6];

"port health authority" ("awdurdod iechyd porthladd") means in relation to any port health district constituted by order under section 2(3) of the Public Health (Control of Disease) Act 1984(a), a port health authority for that district constituted by order under section 2(4) of that Act.

"processed cereal-based food" ("bwyd proses sydd wedi'i seilio ar rawn") and "baby food" ("bwyd babanod") have the same meaning as in the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (Wales) Regulations 2004[7];

"tryptophan" ("tryptoffan") means dextrorotatory tryptophan, laevorotatory tryptophan or racemic tryptophan, or any salt or peptide prepared from any of those forms.

    (2) In these Regulations references to adding tryptophan to food—

(a) do not include cases where food which contains only tryptophan occurring naturally in it is added to any other such food or to food which contains no tryptophan;

(b) but otherwise include cases where food to which tryptophan has been added is added to any other food,

and references in regulations 4 and 5 to food containing tryptophan do not include cases where that tryptophan only occurs naturally in the food or an ingredient of the food.

Presumption
     3. Where any requirements of these Regulations are contravened in respect of any food and that food is part of a batch, lot or consignment of food of the same class or description, it is presumed, until the contrary is proved, that all of the food in that batch, lot or consignment fails to comply with those requirements.

Prohibitions
     4. Subject to regulation 5, no person may—

(a) add tryptophan to food;

(b) sell, or offer for sale, food containing tryptophan

(c) expose for sale food containing tryptophan.

Exceptions from prohibitions
     5. —(1) Food containing tryptophan may be sold or offered for sale—

(a) by a pharmacist; or

(b) in the course of the activities of a hospital,

to a person in respect of whom there is an appropriate medical certificate or to someone acting on that person's behalf, and—

(i) any person may add tryptophan to food intended for sale in those circumstances; and

(ii) any person may sell, or offer for sale, food containing tryptophan for the purposes of its being sold in those circumstances.

    (2) Regulation 4 does not apply in respect of—

(a) laevorotatory tryptophan added to any infant formula or follow-on formula;

(b) laevorotatory tryptophan added to any processed cereal-based food or baby food; or

(c) laevorotatory tryptophan, its sodium, potassium, calcium or magnesium salts or its hydrochloride, added in compliance with Directive 2001/15/EC to any food for a particular nutritional use referred to in the Annex to that Directive,

if that added substance complies with the purity criteria specified for that substance in the European Pharmacopoeia[8].

    (3) Regulation 4 does not apply in respect of laevorotatory tryptophan added to any food supplement if—

(a) the laevorotatory tryptophan complies with the purity criteria specified for that substance in the European Pharmacopoeia; and

(b) the recommended daily dose for that food supplement does not exceed 220 mg.

Offences and penalty
     6. —(1) Subject to paragraph (2), a person who contravenes regulation 4 is guilty of an offence and will be liable on summary conviction to a fine not exceeding level 5 on the standard scale.

    (2) A pharmacist or a person acting in the course of the activities of a hospital who contravenes regulation 4(b) by reason only that a document purporting to be the appropriate medical certificate is not genuine does not commit an offence if, having exercised all due diligence, that person has reasonable cause to believe that the document was an appropriate medical certificate.

Enforcement
     7. —(1) Subject to paragraph (2), each food authority must enforce and execute the provisions of these Regulations in its area.

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

Application of various provisions of the Act
     8. The following provisions of the Act apply for the purposes of these Regulations with the modification that any reference in those provisions to the Act or Part of it must be construed as a reference to these Regulations—

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

(b) section 3 (presumptions that food 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 14 or 15;

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

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

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

(h) section 35(1) (punishment of offences)[9] in so far as it relates to offences under section 33(1) as applied by paragraph (f) above;

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

(j) section 36 (offences by bodies corporate);

(k) section 36A (offences by Scottish partnerships)[10]; and

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

Condemnation of food
     9. Where any food is certified by a food analyst as being food which it is an offence under these Regulations to sell, that food may be treated for the purposes of section 9 of the Act (under which food may be seized and destroyed on the order of a justice of the peace)[11] as failing to comply with food safety requirements.

Revocations
     10. —(1) The Tryptophan in Food Regulations 1990[12] are revoked in relation to Wales.

    (2) Regulation 10 of the Food for Particular Nutrition Use (Addition of Substances for Specific Nutritional Purposes)(Wales) Regulations 2002[13] and regulation 14 of the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (Wales) Regulations 2004[14] are revoked.



Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998[15].


D. Elis-Thomas
The Presiding Officer of the National Assembly

8 November 2005

     4. The Regulations also—

(a) continue to provide for offences and a penalty (regulation 6);

(b) make provision as to enforcement (regulation 7);

(c) apply various provisions of the Food Safety Act 1990 (regulations 8 and 9) and include a presumption as regards food which contravenes the Regulations in certain circumstances (regulation 3);

(d) make revocations (regulation 10).

     5. The Regulations were notified in draft to the European Commission in accordance with Article 8 of Directive 98/34/EC of the European Parliament and of the Council (OJ No. L204, 21.7.98, p.37) laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services, as amended by Directive 98/48/EC of the European Parliament and of the Council (OJ No. L217, 5.8.98, p.18).

     6. The European Pharmacopoeia may be obtained from The Stationery Office (customer services telephone number 0870 600 5522; email: customer .services@tso.co.uk).

     7. A full Regulatory appraisal of the effect that these Regulations will have on the costs of business has been prepared and placed in the library of the National Assembly for Wales. Copies may be obtained from the Food Standards Agency, 11th Floor, Southgate House, Wood Street, Cardiff CF10 1EW.

[2] Functions of the Secretary of State under the Food Safety Act 1990, 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. 1996/672).back

[3] OJ No. L31, 1.2.2002, p.1. That Regulation was last amended by Regulation (EC) No. 1642/2003 of the European Parliament and of the Council (OJ No. L245, 29.9.2003, p.4)back

[4] OJ No. L52, 22.2.2001, p.19, as corrected by a Corrigendum (OJ No. L253, 21.9.2001, p.34).back

[5] OJ No. L14, 21.1.2004, p.19.back

[6] 1968 c.67, section 69 was amended by the Pharmacists (Fitness to Practise) Act 1997 (1997 c.19), Schedule, paragraph 5, from a date to be appointed.back

[7] S.I. 2004/314 (W.32).back

[8] European Pharmacopoeia 5th Edition, Volume II (2004) Pub. European Directorate for the Quality of Medicines, at pages 2636 to 2638.back

[9] Section 35(1) is amended by the Criminal Justice Act 2003 (2003 c.44), Schedule 26, paragraph 42, from a date to be appointed.back

[10] Section 36A was inserted by the Food Standards Act 1999 (1999 c.28), Schedule 5, paragraph 16.back

[11] Section 9 and section 8 were amended by S.I. 2004/3279.back

[12] S.I. 1990/1728, amended by S.I. 1990/2486, 2002/2939 (W.280), 2004/314 (W.32).back

[13] S.I. 2002/2939 (W.280) to which there is an amendment not relevant to these Regulations.back

[14] S.I. 2004/314 (W.32).back

[15] 1998 c.38.back