Commission Regulation (EC) No 41/2009 stipulates that a product may bear the term ‘gluten-free’ if the gluten content does not exceed 20 mg/kg in the food as sold to the final consumer.
Foodstuffs for people intolerant to gluten, containing wheat, rye, barley, oats or their crossbred varieties and especially processed to reduce gluten, must not contain a level of gluten exceeding 100 mg/kg. These must be labelled ‘very low gluten’.
Scientific consultancy firm RSSL has developed a quantitative risk assessment toolkit for manufacturers that provides documented evidence in support of labelling statements.
Simon Flanagan, food safety consultant at RSSL said: "Many of the procedures applicable to safe handling of allergenic ingredients are equally applicable to handling of ingredients containing gluten.”
“Since risk assessment forms the basis of the most practical and useful approach to allergen management, the same applies to gluten management," he said.
RSSL stressed that processing could affect how easy it can be to extract and detect gluten in finished products meaning laboratory results need careful interpretation.
"It is absolutely essential that any laboratory validate its methods for testing for gluten to avoid the risk of false positive or false negative results," said Flanagan.
RSSL said that even the recommended method of analysis approved by the Codex Committee on Methodology, Sampling and Analysis (CCMAS), the R5-sandwich ELISA (Mendez method), was not fool proof.
“Occasional analytical problems arise from heated or hydrolysed products,” it said.
Flanagan said that complying with the new regulation would be “fairly easy for most food manufacturers and suppliers of non-pre-packed foods provided they observe the basic, best-practice principles in ingredient handling and laboratory analysis”.
The regulation is directly applicable in all EU member states.
In the US, the Food and Drug Administration (FDA) plans similar regulations. In 2007, it proposed that only food containing below 20mg per kg (20ppm) of gluten could be labelled as gluten-free.
In August last year it opened up its proposal for comment and the legislation has yet to be finalised.