ID 1513 -
Hydrolizat kolagenu
PL: Hydrolizat kolagenu
EN: Collagen hydrolysate
Pdf: various food(s)/food constituent(s) not supported by pertinent human data
1.2. Utrzymanie prawidłowego stanu stawów (ID 659, 678, 696, 1513, 1627, 1855, 1981, 2126, 2514, 4501, 4672, 4718)
The claimed effects are “joints”, “soigne l'ostéoarthrose”, “joint health”, “articulations”, “muscles and joint health”, “shows anti-inflammatory properties”, “bones and joints health”, and “health of bones and joints, as a structural component of the cartilage”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, clarifications from Member States and references provided for the substantiation of these claims, 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.
2.2. Utrzymanie prawidłowego stanu stawów (ID 659, 678, 696, 1513, 1627, 1855, 1981, 2126, 2514, 4501, 4672, 4718)
The references provided in relation to these claims included textbooks, narrative reviews and monographs which did not provide any original data for the scientific substantiation of the claims. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
Some human intervention studies, which investigated 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 and related 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.
No human studies which investigated the effects of the food(s)/food constituent(s) on the maintenance of normal joints were provided in relation to any of the claims evaluated in this section.
A number of in vitro studies were provided which addressed the effects of different food(s)/food constituent(s) on human chondrocytes/cartilage explants, chondrocyte cell lines and expression of cell surface molecules. Studies on the relationship between the intake of the food(s)/food constituent(s) and the claimed effect in animal models of experimentally-induced arthritis were also provided.
The Panel considers that evidence provided in in vitro studies is not sufficient to predict the occurrence of an effect of the consumption of the food(s)/food constituent(s) on the maintenance of normal joints in vivo in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s), which are the subject of the claims evaluated in this section, and maintenance of normal joints.
Warunki i możliwe ograniczenia stosowania oświadczenia
10g per day (Type I collagen with an average Molecular Weight of up to 3.500 Dalton)