EFSA   Panel   on   Dietetic   Products,   Nutrition   and   Allergies   (NDA); Scientific Opinion on the substantiation of a health claim related to EffEXT™ and maintenance of normal joint mobility pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Inge Tetens; EFSA Publication

doi:10.2903/j.efsa.2012.3002

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Eff_EXT™ and maintenance of normal joint mobility pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Inge Tetens, EFSA Publication

1 Citationer (Scopus)

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 maintenance of normal joint mobility. The Panel considers that EffEXT™, which is standardised pure krill oil, is sufficiently characterised. The claimed effect proposed by the applicant is “contributes to support joint flexibility”. The Panel considers that maintenance of normal joint mobility is a beneficial physiological effect. The applicant identified one human intervention study as being pertinent to the health claim. The Panel notes that chronic inflammation was an inclusion criterion of the study, that a significant number of the patients recruited were reported to have confirmed diagnosis of osteoarthritis, rheumatoid arthritis, or of both cardiovascular disease and osteoarthritis, and that the WOMAC osteoarthritis questionnaire was administered only to patients with arthritic disease (osteoarthritis or rheumatoid arthritis). The Panel also notes that no evidence which could justify the extrapolation of the results, obtained in patients with joint diseases characterised by chronic inflammation, to the target population, subjects without chronic joint diseases, was provided by the applicant. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of EffEXT™ and maintenance of normal joint mobility.
© European Food Safety Authority, 2012

Originalsprog	Engelsk

Forlag	European Food Safety Authority
DOI	https://doi.org/10.2903/j.efsa.2012.3002
Status	Udgivet - 2012
Udgivet eksternt	Ja

Emneord

EffEXT™
Krill oil
Joints
Osteoarthritis
Chronic inflammation
Health claims

Adgang til dokumentet

10.2903/j.efsa.2012.3002

Citationsformater

Tetens, I., & Publication, EFSA. (2012). EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Eff_EXT™ and maintenance of normal joint mobility pursuant to Article 13(5) of Regulation (EC) No 1924/2006. European Food Safety Authority. https://doi.org/10.2903/j.efsa.2012.3002

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to Eff_EXT™ and maintenance of normal joint mobility pursuant to Article 13(5) of Regulation (EC) No 1924/2006. / Tetens, Inge; Publication, EFSA.

European Food Safety Authority, 2012.

Publikation: Bog/antologi/afhandling/rapport › Rapport › Forskning › peer review

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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{\texttrademark} and maintenance of normal joint mobility. The Panel considers that EffEXT{\texttrademark}, which is standardised pure krill oil, is sufficiently characterised. The claimed effect proposed by the applicant is “contributes to support joint flexibility”. The Panel considers that maintenance of normal joint mobility is a beneficial physiological effect. The applicant identified one human intervention study as being pertinent to the health claim. The Panel notes that chronic inflammation was an inclusion criterion of the study, that a significant number of the patients recruited were reported to have confirmed diagnosis of osteoarthritis, rheumatoid arthritis, or of both cardiovascular disease and osteoarthritis, and that the WOMAC osteoarthritis questionnaire was administered only to patients with arthritic disease (osteoarthritis or rheumatoid arthritis). The Panel also notes that no evidence which could justify the extrapolation of the results, obtained in patients with joint diseases characterised by chronic inflammation, to the target population, subjects without chronic joint diseases, was provided by the applicant. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of EffEXT{\texttrademark} and maintenance of normal joint mobility.{\textcopyright} European Food Safety Authority, 2012",

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N2 - 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 maintenance of normal joint mobility. The Panel considers that EffEXT™, which is standardised pure krill oil, is sufficiently characterised. The claimed effect proposed by the applicant is “contributes to support joint flexibility”. The Panel considers that maintenance of normal joint mobility is a beneficial physiological effect. The applicant identified one human intervention study as being pertinent to the health claim. The Panel notes that chronic inflammation was an inclusion criterion of the study, that a significant number of the patients recruited were reported to have confirmed diagnosis of osteoarthritis, rheumatoid arthritis, or of both cardiovascular disease and osteoarthritis, and that the WOMAC osteoarthritis questionnaire was administered only to patients with arthritic disease (osteoarthritis or rheumatoid arthritis). The Panel also notes that no evidence which could justify the extrapolation of the results, obtained in patients with joint diseases characterised by chronic inflammation, to the target population, subjects without chronic joint diseases, was provided by the applicant. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of EffEXT™ and maintenance of normal joint mobility.© European Food Safety Authority, 2012

AB - 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 maintenance of normal joint mobility. The Panel considers that EffEXT™, which is standardised pure krill oil, is sufficiently characterised. The claimed effect proposed by the applicant is “contributes to support joint flexibility”. The Panel considers that maintenance of normal joint mobility is a beneficial physiological effect. The applicant identified one human intervention study as being pertinent to the health claim. The Panel notes that chronic inflammation was an inclusion criterion of the study, that a significant number of the patients recruited were reported to have confirmed diagnosis of osteoarthritis, rheumatoid arthritis, or of both cardiovascular disease and osteoarthritis, and that the WOMAC osteoarthritis questionnaire was administered only to patients with arthritic disease (osteoarthritis or rheumatoid arthritis). The Panel also notes that no evidence which could justify the extrapolation of the results, obtained in patients with joint diseases characterised by chronic inflammation, to the target population, subjects without chronic joint diseases, was provided by the applicant. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of EffEXT™ and maintenance of normal joint mobility.© European Food Safety Authority, 2012

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