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EFSA pronounces on glycaemic carbohydrates, Buglossoides oil

3 Mar 2015

Following applications from Dextro Energy, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of health claims related to glycaemic carbohydrates and maintenance of normal brain function. The scope of the applications was proposed to fall under health claims based on newly developed scientific […]

Following applications from Dextro Energy, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of health claims related to glycaemic carbohydrates and maintenance of normal brain function.

The scope of the applications was proposed to fall under health claims based on newly developed scientific evidence.

The applicant proposed “glucose”, “glycaemic carbohydrates” and “dextrose tablets” as the food constituents that are the subject of the health claims. The main constituent of “dextrose tablets” is dextrose, i.e. glucose monohydrate.

Glucose (i.e. dextrose) is one of the main glycaemic carbohydrates in the diet. The Panel considered that the food constituent, glycaemic carbohydrates, which is the subject of the health claims, is sufficiently characterised in relation to the claimed effect.

The claimed effect proposed by the applicant is “contributes to the maintenance of normal brain function”. The target population proposed by the applicant is the general population. The Panel considered that maintenance of normal brain function is a beneficial physiological effect.

A claim on glycaemic carbohydrates and maintenance of normal brain function has already been assessed by the Panel with a favourable outcome.

The panel was also asked to deliver a scientific opinion on refined Buglossoides oil as a novel food ingredient (NFI). Refined Buglossoides oil is a triglyceride oil, in which the polyunsaturated fatty acids (PUFAs) alpha-linolenic acid (ALA, 44 %), stearidonic acid (SDA, 20 %) and linoleic acid (13 %) are the main fatty acids (FAs), with smaller amounts of oleic acid, gamma-linolenic acid (GLA) and saturated FAs. With the exceptions of SDA and GLA, the main FAs present are widely present in common foods. The NFI is produced from seeds of Buglossoides arvensis using processes conventionally used for edible oil production.

With the exceptions of SDA and protein, the content specifications of refined Buglossoides oil are similar to those of refined Echium oil, which has previously been authorised in the EU as an NFI.

The NFI is intended to be used in a range of foods and in food supplements to provide approximately 200 mg of SDA per day.

Upon digestion, FAs are used primarily as an energy source. ALA and SDA can be elongated and desaturated to produce eicosapentaenoic acid. In human studies using various sources of SDA (750–4 200 mg/day for 3–16 weeks), no increase or small increases in SDA levels were observed in the membranes of blood cells or in total plasma.

Taking into account the composition of the oil and the proposed conditions of use, the Panel considered that consumption of the NFI is not nutritionally disadvantageous.

The microbiological information provided does not give rise to any safety concerns.

The proposed specifications for pyrrolizidine alkaloids and erucic acid, which are undesirable substances, do not give rise to concern in view of the proposed conditions of use. The Panel noted that the available information does not raise concerns as regards other undesirable substances in the NFI.

Three animal feeding studies were carried out with the NFI. No adverse effects were seen in these studies. The Panel noted that these studies were not designed for toxicity testing. A number of animal studies were conducted using SDA- and/or GLA-containing oils from other sources or diets supplemented with SDA ethyl esters. No adverse effects were seen in any of these studies. The Panel noted that most studies were not designed for toxicity testing. The Panel also noted that a number of the animal studies provided were carried out in rodents. The Panel noted that desaturation and elongation of PUFAs are more pronounced in rodents than in humans and therefore extrapolation of results from studies in rodents to humans requires caution. Overall, the Panel considered that the available animal studies provide only limited information on the safety of the NFI.

Human studies that investigated different plant oils or fatty acid ethyl esters as sources of SDA, GLA and ALA found no adverse effects with up to 4 200 mg SDA/day for 12 weeks, up to 1 700 mg GLA/day for 28 days and 9 100 mg ALA/day for four weeks.

The Panel considered that the likelihood of adverse allergic reactions to the NFI is low.

The Panel concluded that the NFI is safe under the proposed uses and use levels.