Scientific Opinion on the substantiation of a health claim related to eicosapentanoic acid (EPA) and “reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with ADHD-like symptoms”

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Article
EFSA Journal 2013;11(4):3161 [10 pp.].
doi
10.2903/j.efsa.2013.3161
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
Panel Members
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen
Acknowledgement

The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Hildegard Przyrembel, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Sean (J.J.) Strain, Inge Tetens, Hendrik Van Loveren, Hans Verhagen and Peter Willatts for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
Competent Authority of Belgium following an application by Minami Nutrition Health BVBA
Question Number
EFSA-Q-2012-00573
Adopted
21 March 2013
Published
8 April 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (169.34 KB)169.34 KB
Abstract

Following an application from Minami Nutrition Health BVBA, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, 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 eicosapentaenoic acid (EPA) and “reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with attention deficit hyperactivity disorder (ADHD)-like symptoms”. The food constituent, EPA, which is the subject of the health claim, is sufficiently characterised. The claimed effect proposed by the applicant is “reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with ADHD-like symptoms. These children are also characterised by less hyperactivity and/or coexisting oppositional behaviour”. Upon a request by EFSA for clarification, the applicant indicated that the disease was ADHD, which is classified as such in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), that the risk factor for the disease was an elevated AA/EPA ratio in blood, and that the target population for the claim was children with diagnosis of ADHD. The Panel considers that the evidence provided does not establish that reducing the AA/EPA ratio reduces the risk of ADHD in children, and considers that the target population is a diseased population (i.e. children with ADHD). The Panel concludes that the claimed effect relates to the treatment of a disease, and that therefore the health claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

Summary

Following an application from Minami Nutrition Health BVBA, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, 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 eicosapentaenoic acid (EPA) and “reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with ADHD-like symptoms”. The scope of the application was proposed to fall under a health claim referring to disease risk reduction.

The Panel considers that the food constituent, EPA, which is the subject of the health claim, is sufficiently characterised.

The claimed effect proposed by the applicant is “reduces the AA/EPA ratio in blood. A high AA/EPA level is a risk factor in the development of attention difficulties in children with attention deficit hyperactivity disorder (ADHD)-like symptoms. These children are also characterised by less hyperactivity and/or coexisting oppositional behaviour”. The target population proposed by the applicant is “children 5-13 years of age with ADHD-like symptoms and low blood levels of omega-3 fatty acids”.

Upon a request by EFSA for clarification in relation to the proposed claimed effect, the validity of the risk factor proposed for the disease, and the target population, the applicant indicated that the disease was ADHD, which is classified as such in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), that the risk factor for the disease was an elevated AA/EPA ratio in blood, and that the target population for the claim was children with diagnosis of ADHD.

No evidence was provided by the applicant to substantiate that the AA/EPA ratio plays a role in the development of ADHD, that the AA/EPA ratio can predict the incidence of ADHD, or that lowering the AA/EPA ratio can lower the risk of ADHD.

The Panel considers that the evidence provided does not establish that reducing the AA/EPA ratio reduces the risk of ADHD in children.

The Panel notes that the target population for the claim is a diseased population (i.e. children with ADHD).

The Panel concludes that the claimed effect relates to the treatment of a disease, and that therefore the health claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

Keywords
Eicosapentaenoic acid, EPA, arachidonic acid, AA/EPA ratio, attention deficit hyperactivity disorder, ADHD, health claims
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Number of Pages
10