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EFSA: Opinion of the scientific panel on dietetic products, nutrition and allergies related to the safety of alpha-cyclodextrin

Adopted date: 06/07/2007

© EFSA.EUROPA.eu - Pubblicata il 05.09.07

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A request has been submitted under the Novel Food Regulation (EC) No. 258/97 for the placing of α-cyclodextrin (α-CD) on the market as a novel food ingredient to be added as dietary fibre to a variety of foods. The applicant intends to add the ingredient to bakery products, beverages, ready-to-eat breakfast cereals and other grain products, yoghurts and other dairy products, snacks, soups and sweets. Alpha-cyclodextrin is a non-reducing cyclic saccaharide consisting of six α-1,4-linked glucopyranosyl units. It is manufactured by the enzyme action of an α-cyclodextrin glucosyltransferase (α-CGTase) on food grade liquefied starch. During the production process 1-decanol is added to form an insoluble complex with the α-CD and the α-CD is obtained as a white crystalline powder following steam distillation to liberate the 1-decanol. A specification has been provided in which the content of α-CD is > 98 %. Ingested α-CD is resistant to the action of digestive enzymes and is not hydrolysed to a significant extent during small intestine passage.

A very small fraction of the α-CD (< 1 %) is absorbed and excreted with the urine. About 99 % reaches the larger intestine where the α-CD ring is readily opened by microbial enzymes.

The resulting linear malto-oligosaccharides are then further hydrolysed and fermented to absorbable and metabolisable short-chain fatty acids. Overall the metabolic fate of ingested α-CD resembles that of other non-digestible but fermentable carbohydrates such as resistant starch or inulin. Anticipated daily intake levels for consumers aged 2-5 years, 6-12 years, 13-19 years and 20 years and over in the US have been provided by the applicant on the basis that users will regularly consume all the categories of food that contain α-CD at the maximum level. The mean value for users of all age groups combined is 10.7 g/person/day (0.20 g/kg bw/day) and 18.8 g/person/day (0.42 g/kg bw/day) at the 90th percentile.

In its consideration of the safety of α-CD, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) calculated for European consumers a total intake of 65 g/person/day from both additive and ingredient use. An intake assessment provided by Food Standards Australia New Zealand to JECFA is 16 g and 37 g/person/day at the mean and 95th percentile respectively. The calculations made by JECFA were based on Food Balance Sheets, whereas the US and Australian/New Zealand estimates were based on individual food consumption data.

Two human studies using both single and repeated dosing with α-CD showed that α-CD at the applied dose levels - 25 g at the single dose and 15 g per 2,200 kcal for repeat dosing - is well tolerated and does not affect markers of carbohydrate and fat metabolism. Concerns that cyclodextrins might impair the bioavailability of vitamins and minerals are unwarranted.

In 28- and 90- day feeding studies there were no signs of toxicity in rats and dogs. At very high doses (20 % of the diet corresponding to 13.9 g/kg bw/day in rats and 10.4 g/kg bw/day in dogs) caecal enlargement was observed most likely due to the high concentration of an osmotically active substance in the large intestine. Studies of embryotoxicity and teratogenicity in mice, rats and rabbits fed diets containing α-CD at levels up to 20 % did not indicate any adverse effects. Alpha-cyclodextrin showed no effects in assays for genotoxicity in vitro and in vivo and was demonstrated not to be an irritant or sensitizer after dermal application. The Panel considers that the margin between the maximum intake of α-CD for dogs that shows no signs of toxicity and the maximum estimated daily intake (EDI) for humans is sufficient. On the basis of all the information reviewed the Panel concluded that there are no safety concerns for the proposed use levels and anticipated consumption.

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