Regulation 5 Exceptions from prohibitions

(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^f1.

(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.

Annotations

Footnotes

f1: European Pharmacopoeia 5th Edition, Volume II (2004) Pub. European Directorate for the Quality of Medicines, at pages 2636 to 2638.