NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk and reduction of the loss of vision: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), Dominique Turck, Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Anders Sjödin, Martin Stern, Daniel Tomé, Henk Van Loveren, Marco VincetiPeter Willatts, Ambroise Martin, Sean (J. J.). Strain, Alfonso Siani

Research output: Contribution to journalArticle

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Abstract

Following an application from Newtricious R&D B.V., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, 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 NWT-02 and a reduction of the loss of vision. The food proposed by the applicant as the subject of the health claim is NWT-02. NWT-02 is standardised by its content in lutein (≥ 1.10 mg), zeaxanthin (≥ 0.20 mg) and docosahexaenoic acid (DHA) (≥ 170 mg). The Panel considers that the food/constituent that is the subject of the health claim, NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, is sufficiently characterised. The claimed effect proposed by the applicant is ‘reduces loss of vision’. The target population proposed by the applicant is ‘healthy adults over 50 years of age’. The Panel considers that a reduction of the loss of vision is a beneficial physiological effect. The applicant provided two human intervention studies for the scientific substantiation of the claim. The Panel considers that the only study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of NWT-02 on vision. The Panel concludes that a cause and effect relationship has not been established between the consumption of NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, and a reduction of the loss of vision.

Original languageEnglish
Article numbere05139
Pages (from-to)1-12
Number of pages12
JournalEFSA Journal
Volume16
Issue number1
Early online date18 Jan 2018
DOIs
Publication statusPublished - Jan 2018

Fingerprint

Lutein
health claims
Egg Yolk
Docosahexaenoic Acids
zeaxanthin
docosahexaenoic acid
lutein
egg yolk
Health
Food
Dietetics
Health Services Needs and Demand
dietetics
hypersensitivity
Netherlands
Hypersensitivity
Zeaxanthins
nutrition

Keywords

  • health claim
  • NWT-02
  • vision
  • vision acuity

Cite this

EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), Turck, D., Bresson, J. L., Burlingame, B., Dean, T., Fairweather-Tait, S., ... Siani, A. (2018). NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk and reduction of the loss of vision: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal, 16(1), 1-12. [e05139]. https://doi.org/10.2903/j.efsa.2018.5139
EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel) ; Turck, Dominique ; Bresson, Jean Louis ; Burlingame, Barbara ; Dean, Tara ; Fairweather-Tait, Susan ; Heinonen, Marina ; Hirsch-Ernst, Karen Ildico ; Mangelsdorf, Inge ; McArdle, Harry J. ; Naska, Androniki ; Neuhäuser-Berthold, Monika ; Nowicka, Grażyna ; Pentieva, Kristina ; Sanz, Yolanda ; Sjödin, Anders ; Stern, Martin ; Tomé, Daniel ; Van Loveren, Henk ; Vinceti, Marco ; Willatts, Peter ; Martin, Ambroise ; Strain, Sean (J. J.). ; Siani, Alfonso. / NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk and reduction of the loss of vision : evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. In: EFSA Journal. 2018 ; Vol. 16, No. 1. pp. 1-12.
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abstract = "Following an application from Newtricious R&D B.V., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, 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 NWT-02 and a reduction of the loss of vision. The food proposed by the applicant as the subject of the health claim is NWT-02. NWT-02 is standardised by its content in lutein (≥ 1.10 mg), zeaxanthin (≥ 0.20 mg) and docosahexaenoic acid (DHA) (≥ 170 mg). The Panel considers that the food/constituent that is the subject of the health claim, NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, is sufficiently characterised. The claimed effect proposed by the applicant is ‘reduces loss of vision’. The target population proposed by the applicant is ‘healthy adults over 50 years of age’. The Panel considers that a reduction of the loss of vision is a beneficial physiological effect. The applicant provided two human intervention studies for the scientific substantiation of the claim. The Panel considers that the only study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of NWT-02 on vision. The Panel concludes that a cause and effect relationship has not been established between the consumption of NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, and a reduction of the loss of vision.",
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EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), Turck, D, Bresson, JL, Burlingame, B, Dean, T, Fairweather-Tait, S, Heinonen, M, Hirsch-Ernst, KI, Mangelsdorf, I, McArdle, HJ, Naska, A, Neuhäuser-Berthold, M, Nowicka, G, Pentieva, K, Sanz, Y, Sjödin, A, Stern, M, Tomé, D, Van Loveren, H, Vinceti, M, Willatts, P, Martin, A, Strain, SJJ & Siani, A 2018, 'NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk and reduction of the loss of vision: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006', EFSA Journal, vol. 16, no. 1, e05139, pp. 1-12. https://doi.org/10.2903/j.efsa.2018.5139

NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk and reduction of the loss of vision : evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. / EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel); Turck, Dominique; Bresson, Jean Louis; Burlingame, Barbara; Dean, Tara; Fairweather-Tait, Susan; Heinonen, Marina; Hirsch-Ernst, Karen Ildico; Mangelsdorf, Inge; McArdle, Harry J.; Naska, Androniki; Neuhäuser-Berthold, Monika; Nowicka, Grażyna; Pentieva, Kristina; Sanz, Yolanda; Sjödin, Anders; Stern, Martin; Tomé, Daniel; Van Loveren, Henk; Vinceti, Marco; Willatts, Peter; Martin, Ambroise; Strain, Sean (J. J.).; Siani, Alfonso.

In: EFSA Journal, Vol. 16, No. 1, e05139, 01.2018, p. 1-12.

Research output: Contribution to journalArticle

TY - JOUR

T1 - NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk and reduction of the loss of vision

T2 - evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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AU - Turck, Dominique

AU - Bresson, Jean Louis

AU - Burlingame, Barbara

AU - Dean, Tara

AU - Fairweather-Tait, Susan

AU - Heinonen, Marina

AU - Hirsch-Ernst, Karen Ildico

AU - Mangelsdorf, Inge

AU - McArdle, Harry J.

AU - Naska, Androniki

AU - Neuhäuser-Berthold, Monika

AU - Nowicka, Grażyna

AU - Pentieva, Kristina

AU - Sanz, Yolanda

AU - Sjödin, Anders

AU - Stern, Martin

AU - Tomé, Daniel

AU - Van Loveren, Henk

AU - Vinceti, Marco

AU - Willatts, Peter

AU - Martin, Ambroise

AU - Strain, Sean (J. J.).

AU - Siani, Alfonso

PY - 2018/1

Y1 - 2018/1

N2 - Following an application from Newtricious R&D B.V., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, 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 NWT-02 and a reduction of the loss of vision. The food proposed by the applicant as the subject of the health claim is NWT-02. NWT-02 is standardised by its content in lutein (≥ 1.10 mg), zeaxanthin (≥ 0.20 mg) and docosahexaenoic acid (DHA) (≥ 170 mg). The Panel considers that the food/constituent that is the subject of the health claim, NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, is sufficiently characterised. The claimed effect proposed by the applicant is ‘reduces loss of vision’. The target population proposed by the applicant is ‘healthy adults over 50 years of age’. The Panel considers that a reduction of the loss of vision is a beneficial physiological effect. The applicant provided two human intervention studies for the scientific substantiation of the claim. The Panel considers that the only study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of NWT-02 on vision. The Panel concludes that a cause and effect relationship has not been established between the consumption of NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, and a reduction of the loss of vision.

AB - Following an application from Newtricious R&D B.V., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, 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 NWT-02 and a reduction of the loss of vision. The food proposed by the applicant as the subject of the health claim is NWT-02. NWT-02 is standardised by its content in lutein (≥ 1.10 mg), zeaxanthin (≥ 0.20 mg) and docosahexaenoic acid (DHA) (≥ 170 mg). The Panel considers that the food/constituent that is the subject of the health claim, NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, is sufficiently characterised. The claimed effect proposed by the applicant is ‘reduces loss of vision’. The target population proposed by the applicant is ‘healthy adults over 50 years of age’. The Panel considers that a reduction of the loss of vision is a beneficial physiological effect. The applicant provided two human intervention studies for the scientific substantiation of the claim. The Panel considers that the only study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of NWT-02 on vision. The Panel concludes that a cause and effect relationship has not been established between the consumption of NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, and a reduction of the loss of vision.

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EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), Turck D, Bresson JL, Burlingame B, Dean T, Fairweather-Tait S et al. NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk and reduction of the loss of vision: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal. 2018 Jan;16(1):1-12. e05139. https://doi.org/10.2903/j.efsa.2018.5139