1493.pdf

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Scientific Opinion on the substantiation of health claims related to various food(s)/food constituent(s) claiming maintenance of joints (ID 1799, 1973, 2022, 2178, 2202, 2254, 2255, 2311, 2394, 2417, 2418, 2458, 2649, 2794, 2798, 3119, 3144, 3274, 3283, 3318, 3339, 3495, 3511, 3523, 3555, 3624, 3699, 3748, 3770, 3835, 3884, 3892, 3904, 3943, 3978, 4012, 4020, 4056, 4137, 4175), maintenance of bone (ID 1764, 1907, 2418, 4012, 4020, 4056, 4175) and maintenance of muscles (ID 2254, 2311) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3 European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe: Joints   bone   health claims   muscles  
ID:    3495      4175      2649      3978      3511      3119      2022      4056      1799      2417      2418      3318      3943      3884      3339      2202      1907      3283      3699      2311      1973      3523      4012      3770      2798      4137      2794      2255      2458      4020      2254      3748      3904      3835      3892      3144      2178      2394      1764      3555      3274      3624  
Produkty: Rabarbar   Symplocos racemosa   Naringina   Kurkuma   Tarczyca bajkalska   Pokrzywa zwyczajna   Jeżówka blada   Izoflawony   Hesperydyna   Bioflawonoidy z owoców cytrusowych   Czepota puszysta   Wyciąg z awokado i soi   S-Adenozylometionina   Babka lancetowata   Kadzidłowiec indyjski   Picrorhiza Kurroa   Łopian większy   Guggul   Topola osikowa   Borówki, kora sosnowa   Shilajit   Przywrotnik pospolity   Wiązówka błotna   Senes wąskolistny   Imbir lekarski   Muszkatołowiec korzenny   Siedmiopalecznik błotny   Pluskwica gałęziasta   Hakorośl rozesłana   Lukrecja gładka   Ledebouriella seseloides   Eukaliptus gałkowy   Wiśnie   Tinospora cordifolia   Wierzba pospolita   Mukopolisacharydy   Brzoza brodawkowata  

2. Znaczenie oświadczenia dla zdrowia człowieka


1.1. Utrzymanie prawidłowego stanu stawów (ID 1799, 1973, 2022, 2178, 2202, 2254, 2255, 2311, 2394, 2417, 2418, 2458, 2649, 2794, 2798, 3119, 3144, 3274, 3283, 3318, 3339, 3495, 3511, 3523, 3555, 3624, 3699, 3748, 3770, 3835, 3884, 3892, 3904, 3943, 3978, 4012, 4020, 4056, 4137, 4175)

The claimed effects are "joint health/mobility/comfort", "joints", "joint support", "helps to maintain mobility of joint during and after climacterium", "contributes to physical well-being". The Panel assumes that the target population is the general population for all claims except for ID 3144, for which the Panel assumes that the target population is post-menopausal women.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of normal joints.
The Panel considers that maintenance of normal joints is a beneficial physiological effect.

1.2. Utrzymanie prawidłowego stanu kości (ID 1764, 1907, 2418, 4012, 4020, 4056, 4175)

The claimed effects are "bone" and "bone health". The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of normal bone.
The Panel considers that maintenance of normal bone is a beneficial physiological effect.

1.3. Utrzymanie prawidłowego stanu mięśni (ID 2254, 2311)

The claimed effect is "muscle". The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the maintenance of normal muscles.
The Panel considers that maintenance of normal muscles is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka

Most of the references provided addressed food(s)/food constituent(s) other than those for which the specific claims are proposed, and/or claimed effects unrelated to the structure and/or function of joints, bone and muscles. This literature includes general reviews on the "antioxidant" or "anti- inflammatory" properties of food(s)/food constituent(s) used in certain countries in the management of medical conditions associated with acute or chronic joint damage of either inflammatory or degenerative origin (e.g. osteoarthritis, rheumatoid arthritis, psoriatic arthritis, arthritis of infectious origin). The Panel considers that no scientific conclusions can be drawn from these references for the substantiation of the claims.

2.1. Utrzymanie prawidłowego stanu stawów (ID 1799, 1973, 2022, 2178, 2202, 2254, 2255, 2311, 2394, 2417, 2418, 2458, 2649, 2794, 2798, 3119, 3144, 3274, 3283, 3318, 3339, 3495, 3511, 3523, 3555, 3624, 3699, 3748, 3770, 3835, 3884, 3892, 3904, 3943, 3978, 4012, 4020, 4056, 4137, 4175)

No human studies investigating the effects of the food(s)/food constituent(s) on the maintenance of normal joints have been provided in relation to any of the health claims evaluated in this section.
Some human intervention studies investigating the effects of the food(s)/food constituent(s) on the treatment of osteoarthrosis or (osteo)arthritis of different origin (rheumatoid arthritis, psoriatic arthritis, arthritis of infectious origin) were submitted. The Panel considers that the evidence provided does not establish that patients with osteoarthrosis or (osteo)arthritis of different origin are representative of the general population with regard to the status of joint tissues, or that results obtained in studies on subjects with osteoarthrosis or (osteo)arthritis of different origin relating to the treatment of symptoms of these diseases (e.g. erosion of articular cartilage, reduced mobility of joints) can be extrapolated to the maintenance of normal joints in the general population. Thus, for claims supported only by references to human studies on patients with osteoarthrosis or (osteo)arthritis of different origin, the Panel considers that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) and the claimed effect in the general population.
A number of in vitro studies were provided addressing the effects of different food(s)/food constituent(s) on human chondrocytes/cartilage explants and chondrocyte cell lines. Also, studies were provided on the relationship between the intake of the food(s)/food constituent(s) and the claimed effect in animal models of experimentally-induced arthritis. The Panel considers that the evidence provided in the animal and in vitro studies submitted is not sufficient to predict the occurrence of an effect of the food(s)/food constituent(s) on the maintenance of normal joints in vivo in humans. The Panel considers that while effects shown in animal and in vitro studies may be used as supportive evidence, human studies are required for substantiation of a claim. Thus, for claims supported by references to animal studies and/or in vitro studies only, the Panel considers that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) and the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this section and the maintenance of normal joints.

2.2. Utrzymanie prawidłowego stanu kości (ID 1764, 1907, 2418, 4012, 4020, 4056, 4175)

No intervention studies in humans investigating the effects of the food(s)/food constituent(s) on bone in healthy subjects have been provided in relation to any of the health claims evaluated in this section.
A number of in vitro studies were provided addressing the effects of different food(s)/food constituent(s) on human osteoblast/osteoclast cell lines. Also, studies were provided on the
relationship between the intake of the food(s)/food constituent(s) and the claimed effect in animal models of experimentally-induced osteoporosis. The Panel considers that the evidence provided in the animal and in vitro studies submitted is not sufficient to predict the occurrence of an effect of the food(s)/food constituent(s) on the maintenance of normal bone in vivo in humans. The Panel considers that while effects shown in animal and in vitro studies may be used as supportive evidence, human studies are required for substantiation of a claim. Thus, for claims supported by references to animal studies and/or in vitro studies only, the Panel considers that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) and the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this section and the maintenance of normal bone.

2.3. Utrzymanie prawidłowego stanu mięśni (ID 2254, 2311)

No studies investigating the effects of the food(s)/food constituent(s) on muscle outcomes have been provided in relation to any of the health claims evaluated in this section.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this section and the maintenance of normal muscles.

Wnioski

On the basis of the data presented, the Panel concludes that:
Maintenance of joints (ID 1799, 1973, 2022, 2178, 2202, 2254, 2255, 2311, 2394, 2417, 2418, 2458, 2649, 2794, 2798, 3119, 3144, 3274, 3283, 3318, 3339, 3495, 3511, 3523, 3555, 3624, 3699, 3748, 3770, 3835, 3884, 3892, 3904, 3943, 3978, 4012, 4020, 4056, 4137, 4175)

The claimed effects are ―joint health/mobility/comfort‖, ―joints‖, ―joint support‖, ―helps to maintain mobility of joint during and after climacterium‖, ―contributes to physical well- being‖. The target population is assumed to be the general population for all claims except for ID 3144, for which the target population is assumed to be post-menopausal women. Maintenance of normal joints is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this section and the maintenance of normal joints.

Maintenance of bone (ID 1764, 1907, 2418, 4012, 4020, 4056, 4175)

The claimed effects are ―bone‖ and ―bone health‖. The target population is assumed to be the general population. Maintenance of normal bone is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this section and the maintenance of normal bone.
Maintenance of muscles (ID 2254, 2311)
The claimed effect is ―muscle‖. The target population is assumed to be the general population. Maintenance of normal muscles is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this section and the maintenance of normal muscles.