Regulation 2 InterpretationI1

In these Regulations–

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

• “appropriate medical certificate” means a certificate in writing, given by a registered medical practitioner, that a person requires food to which tryptophan has been added to treat a condition from which a registered medical practitioner has diagnosed that person to be suffering;

• F1“Regulation 953/2009” means Commission Regulation (EC) No. 953/2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses;

• “dose form” 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;

• “European Pharmacopoeia” means the European Pharmacopoeia, 5th Edition (2004) published by the European Directorate for the Quality of Medicines;

• “food supplement” means any food the purpose of which is to supplement the normal diet and which–

  1. (a)

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

  2. (b)

     is sold in dose form;

• “hospital” includes a clinic, nursing home or similar institution;

• “infant formula” and “follow-on formula” have the meanings assigned to them by the Infant Formula and Follow-on Formula Regulations 1995^f1;

• “pharmacist” means a person lawfully conducting a retail pharmacy business within the meaning of section 69 of the Medicines Act 1968^f2;

• “processed cereal-based foods” and “baby foods” have the meanings assigned to them in the Processed Cereal-based Foods and Baby Foods for Infants and Young Children (Scotland) Regulations 2004^f3; and

• “tryptophan” means dextrorotatory tryptophan, laevorotatory tryptophan or racemic tryptophan, or any salt or peptide prepared from any of those forms.

In these Regulations references to adding tryptophan to 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.

The reference in regulation 5(2) to the Annex to Regulation 953/2009 is a reference to that Annex as amended from time to time.