ethanol Circumstance: Where present in a concentration of 3% v/v or more. Requirement: To declare on the label the quantity of ethanol as % v/v. All alcohol fish and fish products (see Note 2), including: cod cod – oil halibut tuna All fish; or fish products galactose Oral galactose gluten or ingredient derived from gluten-containing grain (see Note 3) Circumstance: Where gluten or an ingredient derived from grain is present. All, than skin and mucous membrane applications Gluten hydroxybenzoic acid esters, including: ethyl hydroxybenzoate methyl hydroxybenzoate propyl hydroxybenzoate sodium ethyl hydroxybenzoate sodium methyl hydroxybenzoate sodium propyl hydroxybenzoate All hydroxybenzoates lactose (see Note 4) Oral lactose milk and milk products, including (see Note 4): casein hydrolysed milk protein nonfat dry milk whey powder whole dry milk All milk; or milk products
peanuts and peanut products, including: Arachis hypogaea arachis (peanut) oil All peanuts; or peanut products Phenylalanine All, other than skin an mucous membrane applications phenylalanine pollen Oral pollen potassium salts, including: potassium bicarbonate potassium chloride Circumstance: Where the total potassium content of the dose is greater than 39 mg (1mmol) elemental potassium per dose Requirement: To declare on the label (in mg) the quantity of elemental potassium per dose. Oral potassium propolis Oral propolis royal jelly Oral jelly saccharin, including: saccharin calcium saccharin sodium Oral saccharin sesame seeds and sesame seed products, including: sesame seed sesame oil Sesamum indicum All sesame seeds; or sesame seed products sodium salts, including: sodium bicarbonate sodium chloride Circumstance: Where the total sodium content of the maximum recommended daily dose of the formulation is greater than 120 mg of elemental sodium per dose. Requirement: To declare on the label (in mg) the quantity of elemental sodium per dose. Oral sodium
sugar alcohols, including: erythritol isomalt lactitol maltitol mannitol polydextrose sorbitol xylitol Circumstance: Where the total sugar alcohol content of the formulation exceeds 2 g per maximum recommended daily dose. Requirement: To declare on the label the quantity of sugar alcohols present per recommended maximum daily dose; and a statement 'Products containing (name of sugar alcohol) may have a laxative effect or cause diarrhoea'. Oral sugar alcohols; or name of sugar alcohol sugars – monosaccharides and disaccharides (see Note 5), including: fructose glucose honey (as a mixture of sugars) invert sugar lactose maltose sucrose Circumstance: Where the presence of sugars may have a significant glycaemic effect and the total sugar content (including lactose which requires a separate declaration) exceeds 100 mg per recommended daily dose. Oral sugars sulfites, including: (see Note 6) potassium metabisulfite sodium bisulfite sodium metabisulfite sodium sulfite sulfur dioxide All sulfites tartrazine All tartrazine
actinidain units Actinidain units actinidain (of Actinidia deliciosa and chinensis) ALU Acid lactase units Tilactase ALU/g Acid lactase unit per gram Tilactase CU Cellulase unit Cellulase CU/g Cellulase unit per gram Cellulase DUAA Alpha-amylase dextrinising unit Amylase DU/g Dextrinising unit per gram Amylase HUT Haemoglobin units on the tyrosine basis Protease HUT/g Haemoglobin unit on the tyrosine basis per gram Protease LipU Lipase Lipase LipU/g Lipase unit per gram Lipase thousand ALU Thousand Acid lactase unit Tilactase thousand ALU/g Thousand Acid lactase units per gram Tilactase thousand CU Thousand cellulase unit Cellulase thousand CU/g Thousand cellulase unit per gram Cellulase thousand DUAA Thousand alpha-amylase dextrinising unit Amylase thousand DUAA/g Thousand dextrinising unit per gram Amylase Thousand HUT Thousand haemoglobin units on the tyrosine basis Protease Thousand HUT/g Thousand haemoglobin units on the tyrosine basis per gram Protease thousand LipU Thousand lipase unit Lipase thousand LipU/g Thousand lipase units per gram Lipase USP Unit United States Pharmacopoeial Unit Caricain (of Carica papaya)