Following an application from Vifor Ltd, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Equazen eye q® and improving reading ability.
The scope of the application was proposed to fall under a health claim referring to children’s development and health. The application included a request for the protection of proprietary data.
The food that is the subject of the health claim is Equazen eye q®, a combination of the n-3 polyunsaturated fatty acids (PUFAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and the n-6 PUFA gamma-linolenic acid (GLA), at a weight ratio of 9:3:1 (EPA:DHA:GLA). EPA and DHA are derived from natural or highly concentrated fish oils, whereas GLA is derived from evening primrose seed oil. EPA, DHA and GLA are well-recognised nutrients, which can be measured in foods by established methods. The Panel considers that Equazen eye q®, a combination of EPA, DHA and GLA (at a weight ratio of 9:3:1), is sufficiently characterised.
The claimed effect proposed by the applicant is ‘improvement in reading ability’. The target population proposed by the applicant is healthy children from 3 to 13 years of age. The Panel considers that improving reading ability is a beneficial physiological effect.
The applicant provided four human intervention studies that investigated the effect of Equazen eye q® on reading ability in children.
The Panel considers that no conclusions can be drawn for the scientific substantiation of the claim from three of the provided studies, owing to different reasons (i.e. uncontrolled design, lack of testing for multiplicity of outcomes, interaction between intervention and schools on reading ability not addressed in the statistical analysis).
In the fourth study, which was a double-blind, placebo-controlled parallel intervention, children were randomised to consume Equazen eye q® or placebo for 20 school weeks. Reading ability in children was measured using the Wide Range Achievement Test: Fourth Edition. This study does not show an effect of Equazen eye q® consumed daily over a period of 20 school weeks, on reading ability in children aged 3–13 years.
The Panel notes that, in the absence of evidence for an effect of Equazen eye q® on reading ability in children, studies on potential mechanisms by which Equazen eye q® could exert the claimed effect cannot be used in supporting the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Equazen eye q®, a combination of EPA, DHA and GLA (at a weight ratio of 9:3:1), and improving reading ability in children.