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Scientific Opinion on the substantiation of a health claim related to EffEXT™ and “helps to support joint function by maintaining low levels of plasma C-reactive protein” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

EFSA Journal 2012;10(9):2889 [6 pp.]. doi:10.2903/j.efsa.2012.2889
  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 Contact nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: Competent Authority of Belgium following an application by Nutrilinks Sarl Question number: EFSA-Q-2012-00386 Adopted: 13 September 2012 Published: 27 September 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Following an application from Nutrilinks Sarl, 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 (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to EffEXT™ and “helps to support joint function by maintaining low levels of plasma C‑reactive protein”. The Panel considers that EffEXT™, which is standardised pure krill oil, is sufficiently characterised. The claimed effect is “helps to support joint function by maintaining low levels of plasma C-reactive protein”. The Panel notes that the claim refers to a reduction of inflammation indicated by a lowered concentration of plasma C-reactive protein. Whether or not reduction of inflammatory markers is considered beneficial depends on the context in which a claim is made. In the context of the study provided, the Panel notes that the claim refers to diseases such as osteoarthritis or rheumatoid arthritis, in which a reduction of inflammation would be a therapeutic target for the treatment of the disease. The Panel considers that the reduction of inflammation in the context of diseases such as osteoarthritis or rheumatoid arthritis is a therapeutic target for the treatment of the disease and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

© European Food Safety Authority, 2012

Summary

Following an application from Nutrilinks Sarl, 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 (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to EffEXT™ and “helps to support joint function by maintaining low levels of plasma C-reactive protein”.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.

The food that is the subject of the health claim is EffEXT™, which is standardised pure krill oil. The Panel considers that EffEXT™ is sufficiently characterised.
The claimed effect is “helps to support joint function by maintaining low levels of plasma C-reactive protein”. The target population as proposed by the applicant is adults presenting with sensitive joints.

The Panel notes that the claim refers to a reduction of inflammation indicated by a lowered concentration of plasma C-reactive protein. Whether or not reduction of inflammatory markers is considered beneficial depends on the context in which a claim is made. In the context of the study provided by the applicant, the Panel notes that the claim refers to diseases such as osteoarthritis or rheumatoid arthritis, in which a reduction of inflammation would be a therapeutic target for the treatment of the disease.

The Panel considers that the reduction of inflammation in the context of diseases such as osteoarthritis or rheumatoid arthritis is a therapeutic target for the treatment of the disease and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

Keywords

EffEXT™, krill oil, joints, inflammation, health claims