Additives and 'unwanted effects'

12th June 2007

In the last Food Magazine we revealed that many over-the-counter children’s medicines contain additives which are banned from food and drink for the under-threes. Here we reveal what the labels do (and don't) tell us.

In the last issue of The Food Magazine we revealed how food additives which are banned from food for the under-threes are routinely added to medicines for children of the same age. These additives are banned from food and drinks because they cannot be proved to be safe for consumption by the very young.

Before publishing our research, we contacted the Medicines and Healthcare products Regulatory Agency (MHRA) to express our concerns, but the Agency failed to respond to our questions in any detail. However, the MHRA finally rolled into action after The Food Magazine’s research made the front pages of both The Times and The Daily Telegraph on 10th March.

The MHRA made it clear it did not believe the 'under three' legislation should apply to medicines, despite our concerns, and protested that the additives used in medicines are safe. However, their response has raised even more issues, as we report here.

Warnings on labels

Many of the additives which we found require special labelling when used in medical products, as the additives may cause what the MHRA refer to as, "unwanted effects." Such additives (and any other ingredients also capable of causing an 'unwanted effect') must be listed on the outside packaging of a medical product. No specific warning needs to appear alongside the ingredient’s name.

If you know that you might react to a specific additive or ingredient (and many people will not know this) such limited labelling does at least give you a chance to avoid that ingredient.

However, we found that almost a quarter of the products we surveyed failed to list additives known to have 'unwanted effects,' on the outer packaging, in direct contravention of the guidelines. The MHRA has told The Food Magazine that the manufacturers of these products will be asked to, “submit revised labeling or justify why the guidance need not be followed for their product.”

These soft drinks contain sodium benzoate (E211), a widely used preservative which medical products warn may irritate the skin, eyes and mucosal surfaces. Like other food products, none of these drinks are required to carry any warning. 

Warnings on patient information leaflets

Additives and other ingredients which are known to cause an 'unwanted effect' should also carry a fuller warning on a patient information leaflet inside the box.

For some additives, a warning is only required if the additive is present above a certain threshold level, but for other additives, such as preservatives, the threshold level is zero. Such warnings might typically read “Maltitol may have a mild laxative effect,” or, “E123, E214, E216 & E218 may cause allergic reactions (possibly delayed).” However, our survey found that 31 out of 41 medicines failed to warn of an 'unwanted effect' for specific additives, where as other medicines did provide a warning for those additives.

When we presented this information to the MHRA it again assured us it would, “ask the authorization holders to submit revised patient leaflets or justify why guidance need not be followed for that product.”

It seems that the labelling of many medicines may be in breach of EU legislation. The MHRA, which is supposed to monitor and regulate such products, needs to keep its eye on such labelling issues. Consumers need honest information if they are to make informed choices, and at present they are not getting the facts they need.

Additive health warnings displayed on medicines (but not on food or drink)
Medicines which contain additives that can cause an 'unwanted effect' should warn consumers of the risk. However, foodstuffs which are consumed regularly and in much greater quantities, do not have to list any warning. Here we reveal the additive health warnings which medicines should give, but which you will fail to find on any foods or drinks.
Additive	Threshold	Warning
Azo colouring agents: For example, E102 (tartrazine); E110 (sunset yellow FCF); E122 (azorubine, carmoisine); E123 (amaranth); E124 (ponceau 4R red, cochineal red A); E151 (brilliant black BN, black PN).	Zero	May cause allergic reactions
E951 (aspartame)	Zero	Contains a source of phenylalanine. May be harmful for people with phenylketonuria
Benzoic acid and benzoates: for example: E210 (benzoic acid); E211 (sodium benzoate); E212 (potassium benzoate)	Zero	Mildly irritant to the skin, eyes and mucous membranes
Hydrogenated Glucose Syrup, E965 (maltitol) and E953 (isomaltitol), E965ii (maltitol liquid)	10g	May have a mild laxative effect
E421 (Mannitol)	10g	May have a mild laxative effect
E966 (Lactitol)	10g	May have a mild laxative effect
Parahydroxybenzoates and their esters. For example E214 (ethyl hydroxybenzoate); E216 (propylhydroxybenzoate); E217 (sodium propylhydroxybenzoate); E218 (methylhydroxybenzoate); E219 (sodium methylhydroxybenzoate)	Zero	May cause allergic reactions (possibly delayed)
E420 (sorbitol)	10g	May have a mild laxative effect
Sulphites including metabisulphites. For example: E220 (sulphur dioxide); E221 (sodium sulphite); E222 (sodium bisulphite); E223 (Sodium metabisulphite); E224 (Potassium metabisulphite); E228 (Potassium Bisulphite)	Zero	May rarely cause severe hypersensitivity reactions and bronchospasm (difficulty in breathing)
E967 (xylitol)	10 g	May have a laxative effect
* Information taken from European Commission Guidelines for Medicinal products for human use - excipients in the label and package leaflet of medicinal products for human use - http://www.foodcomm.org.uk/PDF%20files/EU_guidelines.pdfThe warnings listed here apply to medicines for oral consumption - different warnings may apply to medicines taken via different routes such as injection.

Sulphites: a small step forwards

Sulphites (a common type of preservative) are known to provoke asthma-like symptoms in susceptible people, but we have yet to find a food or drink product providing that information. In a very small concession to public health, legislation now forces food and drink manufacturers to declare the presence of ‘sulphur dioxide’ or ‘sulphite’ if it is present above a certain level (10mg/kg or 10mg/litre expressed as SO2).

This is all very well, but most people will have no idea if they are allergic to sulphites, and without further information they are likely to continue purchasing products that could be detrimental to their health.

Interestingly, this legislation also applies to alcoholic drinks which are exempt from normal food labelling rules and do not have to list their ingredients.

Research: Ian Tokelove