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
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.
