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 shall 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 shall 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.