Scientific Opinion on the substantiation of a health claim related to “slowly digestible starch in starch-containing foods” and “reduction of post-prandial glycaemic responses” pursuant to Article 13(5) of Regulation (EC) No 1924/2006
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen
Acknowledgment
The Panel wishes to thank the members of the Working Group on Claims for the preparatory work on this scientific opinion: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen
Possible conflict of interest
One member of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests
Contact
nda@efsa.europa.eu
Following an application from Kraft Foods Europe, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the EFSA Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to “slowly digestible starch in starch-containing foods” and “reduction of post-prandial glycaemic responses”. The food constituent, “slowly digestible starch (SDS)”, as defined by the applicant in applying an appropriate method (such as the method developed by Englyst et al. (1996; 1999)), which is the subject of the health claim, and the comparator food constituent, “rapidly digestible starch (RDS)”, as defined by the applicant, are sufficiently characterised in relation to the claimed effect. The claimed effect, reduction of post-prandial glycaemic responses (as long as post-prandial insulinaemic responses are not disproportionally increased), may be a beneficial physiological effect. The studies provided consistently showed that consumption of 40-50 % of digestible starch as “SDS” in cereal products containing about 55-70 % of available carbohydrates as starch and 30-45 % as sugars in the context of a meal providing at least 60 E% of available carbohydrates induced significantly lower post-prandial glycaemic responses (without leading to disproportionally increased post-prandial insulinaemic responses) than the consumption of all digestible starch as “RDS” in cereal products with a similar content of available carbohydrates, starch and sugars. Cereal products, however, providing around 30 % of digestible starch as “SDS” and containing around 70 % of available carbohydrates as starch and 30 % as sugars did not show such an effect. A cause and effect relationship has been established between the consumption of “SDS”, as compared to the consumption of “RDS”, in cereal products and reduced post-prandial glycaemic responses (without disproportionally increased post-prandial insulinaemic responses).
© European Food Safety Authority, 2011
Following an application from Kraft Foods Europe, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to “slowly digestible starch in starch-containing foods” and “reduction of post-prandial glycaemic responses”.
The scope of the application was proposed to fall under a health claim referring to a health claim based on newly developed scientific evidence and/or a health claim including a request for the protection of proprietary data.
The food constituent that is the subject of the health claim is “slowly digestible starch (SDS)” as compared to “rapidly digestible starch (RDS)” in starch-containing foods. The Panel considers that the food constituent, “SDS”, as defined by the applicant in applying an appropriate method (such as the method developed by Englyst et al. (1996; 1999)), which is the subject of the health claim, and the comparator food constituent, “RDS”, as defined by the applicant, are sufficiently characterised in relation to the claimed effect.
The claimed effect proposed by the applicant relates to the reduction of post-prandial glycaemic responses. The target population proposed for the claim is the general population. The Panel considers that reduction of post-prandial glycaemic responses (as long as post-prandial insulinaemic responses are not disproportionally increased) may be a beneficial physiological effect.
The applicant provided five human intervention studies (four claimed as proprietary by the applicant) for the scientific substantiation of the claim. In these studies, the effect of consuming cereal products high in “SDS” compared to consuming cereal products low in “SDS” and high in “RDS” on post-prandial blood glucose and insulin responses was investigated.
The Panel notes that the studies provided consistently showed that consumption of 40-50 % of digestible starch as “SDS” in cereal products containing about 55-70 % of available carbohydrates as starch and 30-45 % as sugars in the context of a meal providing at least 60 E% of available carbohydrates induced significantly lower post-prandial glycaemic responses (without leading to disproportionally increased post-prandial insulinaemic responses) than the consumption of all digestible starch as “RDS” in cereal products with a similar content of available carbohydrates, starch and sugars. Cereal products, however, providing around 30 % of digestible starch as “SDS” and containing around 70 % of available carbohydrates as starch and 30 % as sugars did not show such an effect. The Panel also notes that a reduction in the sugar content in these cereal products is expected to have a similar effect on post-prandial glycaemic responses.
The Panel concludes that a cause and effect relationship has been established between the consumption of “SDS”, as compared to the consumption of “RDS”, in cereal products and reduced post-prandial glycaemic responses (without disproportionally increased post-prandial insulinaemic responses).
The Panel could have reached the conclusion that the rate of starch digestibility assessed in vitro in cereal products has an effect on post-prandial glycaemic responses in vivo in humans without the data marked as proprietary by the applicant. However, the four unpublished studies claimed as proprietary by the applicant were required to establish conditions of use for this specific claim.
The Panel considers that the following wording reflects the scientific evidence: “Consumption of cereal products high in slowly digestible starch raises blood glucose concentrations less after a meal than cereal products low in slowly digestible starch”.
The Panel considers that, in order to bear the claim, cereal products should contain at least 55 % of available carbohydrates as starch of which at least 40 % should be “SDS”. The target population is individuals who wish to reduce their post-prandial blood glucose responses.
Slowly, rapidly, digestible starch, post-prandial, glucose, responses, health claim
