Updated List of EFSA NDA Panel Opinions

EFSA NDA Opinions

Recent News:

EFSA has published an updated briefing document aimed at Member States and the European Commission on Article 13.1 claims. It describes the procedures EFSA follows for the evaluation of Article 13.1 claims, including the use of uniform scientific criteria for substantiation of claims and for the characterisation of foods.

A Community Register of Claims has been established and is available at:

http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/index_en.htm

It currently lists positive and negative opinions for Article 13.5 and 14 (disease risk reduction) claims, with Article 13.1 claims to be eventually added.

Approved


Calcium + Vitamin D3 chewing tablets and bone loss - Scientific substantiation of a health claim related to Calcium plus Vitamin D3 chewing tablets and reduction of the risk of osteoporotic fractures by reducing bone loss pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Published: 7 August 2009 Adopted: 2 July 2009

Lycopene-whey complex (bioavailable lycopene) and risk of atherosclerotic plaques Scientific substantiation of a health claim related to Lycopene-whey complex (bioavailable lycopene) and reduction of the risk of atherosclerotic plaques pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Published: 3 August 2009 Adopted: 2 July 2009

Plant Stanols and Plant Sterols and Blood LDL-Cholesterol - Scientific Opinion of the Panel on Dietetic Products Nutrition and Allergies on a request from the European Commission and a similar request from France in relation to the authorization procedure for health claims on plant stanols and plant sterols and lowering/reducing blood LDL-cholesterol pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Published: 31 July 2009 Adopted: 30 June 2009


Water-soluble tomato concentrate (WSTC I and II) and platelet aggregation - Water-soluble tomato concentrate (WSTC I and II) and platelet aggregation [1]

Published: 28 May 2009 Adopted: 15 May 2009

Lipil® and visual development - Scientific substantiation of a health claim related to Lipil® and visual development pursuant to Article14 of Regulation (EC) No 1924/2006[1]

Published: 23 March 2009 Adopted: 13 March 2009

Enfamil® Premium and visual development - Scientific substantiation of a health claim related to Enfamil® Premium and visual development pursuant to Article14 of Regulation (EC) No 1924/2006[1]

Published: 23 March 2009 Adopted: 13 March 2009

DHA and ARA and visual development - Scientific substantiation of a health claim related to docosahexaenoic acid (DHA) and arachidonic acid (ARA) and visual development pursuant to Article14 of Regulation (EC) No 1924/2006[1]

Published: 13 February 2009 Adopted: 22 January 2009

Safety of ‘Lipid extract from Euphausia superba' as a novel food ingredient Safety of ‘Lipid extract from Euphausia superba' as a novel food ingredient [1]

Published: 13 February 2009 Adopted: 22 January 2009

Animal protein and bone growth - Scientific substantiation of a health claim related to animal protein and bone growth pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 14 November 2008 Adopted: 31 October 2008

Plant stanol esters and blood cholesterol - Scientific substantiation of a health claim related to plant stanol esters and lower/reduced blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 31 October 2008 Adopted: 2 October 2008

Calcium and bone growth - Scientific substantiation of a health claim related to calcium and bone growth pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 22 October 2008 Adopted: 2 October 2008

Calcium and vitamin D and bone strength - Scientific substantiation of a health claim related to calcium and vitamin D and bone strength pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 22 October 2008 Adopted: 2 October 2008

Vitamin D and bone growth - Scientific substantiation of a health claim related to vitamin D and bone growth pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 22 October 2008 Adopted: 2 October 2008

Plant Sterols and Blood Cholesterol - Scientific substantiation of a health claim related to plant sterols and lower/reduced blood cholesterol and reduced risk of (coronary) heart disease pursuant to Article 14 of Regulation (EC) No 1924/2006[1]

Published: 21 August 2008 Adopted: 11 July 2008

Not Approved

Substantiation of a health claim related to Catalgine® bouffées de chaleur and contributes to the reduction in the number of hot flushes pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Published: 20 January 2010

Substantiation of a health claim related to a combination of bifidobacteria (Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum) and decreasing potentially pathogenic intestinal microorganisms pursuant to Article 14 of Regulation (EC) No 1924/2006

Published: 21 December 2009

Substantiation of a health claim related to a Uroval® and urinary tract infection pursuant to Article 14 of Regulation (EC) No 1924/2006

Published: 21 December 2009

Scientific Opinion on the substantiation of a health claim related to OPC Premium and the reduction of blood cholesterol pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Published: 23 October 2009 Adopted: 15 October 2009

Regulat® and “the immune system” - Scientific substantiation of a health claim related to Regulat® and “enhancement/modulation/improvement/regulation of the activity of the immune system” pursuant to Article 13(5) of Regulation (EC) No 1924/2006 [1]

Published: 17 July 2009 Adopted: 2 July 2009


Gum Periobalance(TM) tablets and chewing gum and oral health - Scientific substantiation of a health claim related to Gum Periobalance™ tablets and chewing gum and oral health pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Published: 16 July 2009 Adopted: 2 July 2009

BimunoTM and help to maintain a healthy gastro-intestinal function - Scientific substantiation of a health claim related to BimunoTM and help to maintain a healthy gastro-intestinal function pursuant to Article 13(5) of Regulation (EC) No 1924/2006[1]

Published: 7 July 2009 Adopted: 15 May 2009

BimunoTM and support of the immune system - Scientific substantiation of a health claim related to BimunoTM and support of the immune system pursuant to Article 13(5) of Regulation (EC)[1]

Published: 7 July 2009 Adopted: 15 May 2009

BimunoTM and reduction of the bad bacteria that can cause travellers’ diarrhoea - Scientific substantiation of a health claim related to BimunoTM and reduction of the bad bacteria that can cause travellers’ diarrhoea pursuant to Article 14 of Regulation (EC) No 1924/2006[1]

Published: 7 July 2009 Adopted: 15 May 2009


Natural Push-Up® Tablets and Capsules and female breast-enhancement process - Scientific substantiation of a health claim related to a Natural Push-Up® Tablets and Capsules, and imitating the female breast-enhancement process pursuant to Article 13(5) of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 4 June 2009 Adopted: 15 May 2009

DHA and support of the visual development of the unborn child and breastfed infant - Scientific substantiation of a health claim related to DHA and support of the visual development of the unborn child and breastfed infant pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Published: 15 April 2009 Adopted: 13 March 2009

DHA and support of the cognitive development of the unborn child and breastfed infant - Scientific substantiation of a health claim related to DHA and support of the cognitive development of the unborn child and breastfed infant pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Published: 15 April 2009 Adopted: 13 March 2009

Lactobacillus plantarum 299v (DSM 9843) and improve iron absorption

- Scientific substantiation of a health claim related to Lactobacillus plantarum 299v (DSM 9843) and improve iron absorption pursuant to Article 13(5) of Regulation (EC) No 1924/2006 [1]

Published: 6 April 2009 Adopted: 13 March 2009

ALA and contribution to brain development - Scientific substantiation of a health claim related to ALA and contribution to brain development pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Published: 3 April 2009 Adopted: 13 March 2009

DHA and ARA and brain development - Scientific substantiation of a health claim related to docosahexaenoic acid (DHA) and arachidonic acid (ARA) and brain development pursuant to Article14 of Regulation (EC) No 1924/2006[1]

Published: 23 March 2009 Adopted: 13 March 2009

Enfamil® Premium and brain development - Scientific substantiation of a health claim related to Enfamil® Premium and brain development pursuant to Article14 of Regulation (EC) No 1924/2006[1]

Published: 23 March 2009 Adopted: 13 March 2009

Lipil® and brain development - Scientific substantiation of a health claim related to Lipil® and brain development pursuant to Article14 of Regulation (EC) No 1924/2006[1]

Published: 23 March 2009 Adopted: 13 March 2009

Follow-on formulae with bioactive constituents and intestinal ailments - Scientific substantiation of a health claim related to “Follow-on formulae with fixed combination of short-chain galacto-oligosaccharides (GOS), acidified milk, nucleotides and beta-palmitate” and intestinal ailments pursuant to Article 14 of Regulation (EC) No 1924/2006[1]

Published: 13 March 2009 Adopted: 22 January 2009

Algatrium® and antioxidant response - Scientific substantiation of a health claim related to Algatrium® and antioxidant response Article 13(5) of Regulation (EC) No 1924/2006[1]

Published: 13 March 2009 Adopted: 22 January 2009

Melgaço mineral water and reduction of glycaemia - Scientific substantiation of a health claim related to Melgaço® mineral water and reduction of glycaemia pursuant to Article 14 of Regulation (EC) No 1924/2006[1]

Published: 13 February 2009 Adopted: 22 January 2009

Kinder Chocolate® and growth - Scientific substantiation of a health claim related to Kinder Chocolate® and growth pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Published: 13 February 2009 Adopted: 22 January 2009

Ocean Spray Cranberry Products® and urinary tract infection in women - Scientific substantiation of a health claim related to Ocean Spray Cranberry Products® and urinary tract infection in women pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Published: 13 February 2009 Adopted: 22 January 2009

Dairy fresh cheese and bone growth - Scientific substantiation of a health claim related to dairy fresh cheese and bone growth pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 15 January 2009 Adopted: 4 December 2008

Black tea from Camellia sinensis and helps to focus attention - Scientific substantiation of a health claim related to black tea from Camellia sinensis and helps to focus attention, pursuant to Article 13(5) of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 22 December 2008 Adopted: 4 December 2008

Mumomega® and central nervous system development - Scientific substantiation of a health claim related to Mumomega® and central nervous system development pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 19 December 2008 Adopted: 4 December 2008

Efalex® and coordination - Scientific substantiation of a health claim related to Efalex® and coordination pursuant to Article14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 19 December 2008 Adopted: 4 December 2008

Milk product, rich in fibre and protein, and reduction of the sense of hunger[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 19 December 2008 Adopted: 4 December 2008

Eye q® and concentration - Scientific substantiation of a health claim related to Eye q® and concentration pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 19 December 2008 Adopted: 4 December 2008

Efalex® and brain development and function - Scientific substantiation of a health claim related to Efalex® and brain development and function pursuant to Article14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 19 December 2008 Adopted: 4 December 2008

Efalex® and concentration - Scientific substantiation of a health claim related to Efalex® and concentration pursuant to Article14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 19 December 2008 Adopted: 4 December 2008

Efalex® and eye development and function - Scientific substantiation of a health claim related to Efalex® and eye development and function pursuant to Article14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 19 December 2008 Adopted: 4 December 2008

Eye q baby® and central nervous system development - Scientific substantiation of a health claim related to Eye q baby® and central nervous system development pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 19 December 2008 Adopted: 4 December 2008

Eye q® and brain functions - Scientific substantiation of a health claim related to Eye q® and brain functions pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 19 December 2008 Adopted: 4 December 2008

Dairy product enriched with milk peptide and magnesium and help to moderate signs of anxiety in mildly stress-sensitive adult[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 19 December 2008 Adopted: 4 December 2008

Efalex® and learning ability - Scientific substantiation of a health claim related to Efalex® and learning ability pursuant to Article14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 19 December 2008 Adopted: 4 December 2008

LACTORAL and improvement of the general immunity - Scientific substantiation of a health claim related to LACTORAL (a combination of three probiotic strains: Lactobacillus plantarum, Lactobacillus rhamnosus, Bifidobacterium longum) and improvement of the general immunity pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 10 December 2008 Adopted: 28 October 2008

LACTORAL and normal functioning of the alimentary tract - Scientific substantiation of a health claim related to LACTORAL (a combination of three probiotic strains: Lactobacillus plantarum, Lactobacillus rhamnosus, Bifidobacterium longum) and normal functioning of the alimentary tract pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 10 December 2008 Adopted: 28 October 2008

LACTORAL and living probiotic bacteria - Scientific substantiation of a health claim related to LACTORAL (a combination of three probiotic strains: Lactobacillus plantarum, Lactobacillus rhamnosus, Bifidobacterium longum) and living probiotic bacteria, pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 10 December 2008 Adopted: 28 October 2008

LACTORAL and maintenance of natural intestinal microflora during travel - Scientific substantiation of a health claim related to LACTORAL (a combination of three probiotic strains: Lactobacillus plantarum, Lactobacillus rhamnosus, Bifidobacterium longum) and maintenance of natural intestinal microflora during travel, pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 10 December 2008 Adopted: 28 October 2008

LACTORAL and building of the natural intestinal barrier - Scientific substantiation of a health claim related to LACTORAL (a combination of three probiotic strains: Lactobacillus plantarum, Lactobacillus rhamnosus, Bifidobacterium longum) and building of the natural intestinal barrier pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 10 December 2008 Adopted: 28 October 2008

Xylitol chewing gum/pastilles and reduction of the risk of tooth decay - Scientific substantiation of a health claim related to xylitol chewing gum/pastilles and reduction the risk of tooth decay pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 14 November 2008 Adopted: 30 October 2008

LGG® MAX and gastro-intestinal discomfort - Scientific substantiation of a health claim related to LGG® MAX and reduction of gastro-intestinal discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 14 November 2008 Adopted: 30 October 2008

I omega kids®/Pufan 3 kids® and learning ability - Scientific substantiation of a health claim related to I omega kids®/Pufan 3 kids® and learning ability pursuant to Article14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 31 October 2008 Adopted: 24 October 2008

I omega kids®/Pufan 3 kids® and thinking capacity - Scientific substantiation of a health claim related to I omega kids®/Pufan 3 kids® and thinking capacity pursuant to Article14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 31 October 2008 Adopted: 24 October 2008

I omega kids®/Pufan 3 kids® and concentration - Scientific substantiation of a health claim related to I omega kids®/Pufan 3 kids® and concentration pursuant to Article14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 31 October 2008 Adopted: 24 October 2008

I omega kids®/Pufan 3 kids® and mental development - Scientific substantiation of a health claim related to I omega kids®/Pufan 3 kids® and mental development pursuant to Article14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 31 October 2008 Adopted: 24 October 2008

I omega kids®/Pufan 3 kids® and vision - Scientific substantiation of a health claim related to I omega kids®/Pufan 3 kids® and vision pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 22 October 2008 Adopted: 2 October 2008

I omega kids®/Pufan 3 kids® and calming - Scientific substantiation of a health claim related to I omega kids®/Pufan 3 kids® and calming pursuant to Article14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 22 October 2008 Adopted: 2 October 2008

SI omega kids®/Pufan 3 kids® and serenity - Scientific substantiation of a health claim related to I omega kids®/Pufan 3 kids® and serenity pursuant to Article14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 22 October 2008 Adopted: 2 October 2008

Regulat®.pro.kid BRAIN and mental and cognitive development of children - Scientific substantiation of a health claim related to regulat®.pro.kid BRAIN and mental and cognitive developments of children pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 22 October 2008 Adopted: 2 October 2008

Evolus® and reduce arterial stiffness - Scientific substantiation of a health claim related to Lactobacillus helveticus fermented Evolus® low-fat milk products and reduction of arterial stiffness pursuant to Article 14 of the Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 22 October 2008 Adopted: 2 October 2008

DHA and ARA and development of brain and eyes - Scientific substantiation of a health claim related to Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) and support of the neural development of the brain and eyes pursuant to Article 14 of Regulation (EC) No 1924/2006 [1]

Published: 25 September 2008 Adopted: 8 September 2008

regulat®.pro.kid IMMUN and immune system of children - Scientific substantiation of a health claim related to regulat®.pro.kid IMMUN and immune system of children during growth pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 21 August 2008 Adopted: 11 July 2008

ALA and LA and growth and development of children - Scientific substantiation of a health claim related to α-linolenic acid and linoleic acid and growth and development of children pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 21 August 2008 Adopted: 11 July 2008

Femarelle® and bone mineral density - Scientific substantiation of a health claim related to “Femarelle®” and “induces bone formation and increases bone mineral density reducing the risk for osteoporosis and other bone disorders” pursuant to Article 14 of the Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 21 August 2008 Adopted: 4 August 2008

Elancyl Global Silhouette® and regulation of body composition - Scientific substantiation of a health claim related to Elancyl Global Silhouette® and “regulation of body composition in people with light to moderate overweight” pursuant to Article 13(5) of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 21 August 2008 Adopted: 12 August 2008

NeOpuntia® and blood lipid parameters - Scientific substantiation of a health claim related to NeOpuntia® and improvement of blood lipid parameters associated with cardiovascular risk, especially HDL-cholesterol, pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 21 August 2008 Adopted: 13 August 2008

Dairy and dental health - Scientific substantiation of a health claim pursuant related to dairy products (milk and cheese) and dental health to Article 14 of Regulation (EC)[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 21 August 2008 Adopted: 12 August 2008

Dairy foods and healthy body weight - Scientific substantiation of a health claim related to dairy foods and healthy body weight pursuant to Article 14 of Regulation (EC) No 1924/2006[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

Published: 21 August 2008 Adopted: 8 August 2008

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