1.1. Wpływ na wzrost i utrzymanie masy mięśniowej (ID 858, 1536, 1540, 4038, 4712)

The claimed effects are “guard against symptoms of fatigue of skeleton muscle cells”, “increasing strength”, “strength and energy”, and “muscle development”. 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 growth or maintenance of muscle mass by decreasing muscle breakdown, increasing muscle synthesis or both. Failure to increase muscle mass during growth and development, and the loss of muscle mass at any age will reduce muscle strength and power.
The Panel considers that growth or maintenance of muscle mass is a beneficial physiological effect.

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.

1.3. Utrzymanie prawidłowego stanu kości (ID 1860, 4501, 4672)

The claimed effects are “bone”, “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 bone.
The Panel considers that maintenance of normal bone is a beneficial physiological effect.

1.4. Udział w prawidłowym pozyskiwaniu energii w procesach metabolicznych (ID 1381, 1613)

The claimed effects are “energy metabolism” and “muscles/energy”. 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 energy-yielding metabolism.
The Panel considers that contribution to normal energy-yielding metabolism is a beneficial physiological effect.

1.5. Zwiększenie wydolności fizycznej (ID 472, 543, 1403, 1538, 1539, 3127)

The claimed effects are “endurance, enhanced carbohydrate delivery to muscle”, “endurance performance and increases carbohydrate availability”, “muscles/increase in performance”, “enhancing training volume and intensity”, “increasing exercise thresholds”, and “adaptogen, supports energy level, invigoration of the body, supports immune system”. The Panel assumes that the target population is adults performing endurance exercise.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to an increase in endurance performance. Endurance performance relates to the ability to complete certain tasks with higher intensity, faster, or with a higher power output when performing long-term exercise.
The Panel considers that an increase in endurance performance is a beneficial physiological effect.

1.6. Wzrost wytrzymałości podczas kolejnych ćwiczeń fizycznych po dużym wysiłku (ID 462, 1437, 1438)

The claimed effects are “recovery, glycogen restoration through ingested carbohydrate, muscle tissue building from the amino acids obtained from protein, muscle lipid reloading by consuming the right amount of dietary fat”, “carbohydrate and lipid metabolism”, and “carbohydrate metabolism”. The Panel assumes that the target population is adults performing endurance exercise.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to an increase in endurance performance during the subsequent exercise bout after strenuous exercise. Endurance performance relates to the ability to complete certain tasks with higher intensity, faster, or with a higher power output when performing long-term exercise.
The Panel considers that an increase in endurance performance during the subsequent exercise bout after strenuous exercise is a beneficial physiological effect.

1.7. Wzrost wytrzymałości podczas intensywnych i powtarzających się ćwiczeń beztlenowych (anaerobowych) (ID 1543)

The claimed effect is “enhancing anaerobic working capacity”. The Panel assumes that the target population is individuals performing sports which require intense and repeated exercise bouts.
In the context of the proposed wordings and references provided, the Panel assumes that the claimed effect refers to the increase in exercise performance, which in the present context refers to performing repeated exercise bouts with higher intensity, faster or with a higher power output.
The Panel considers that an increase in performance during intense and repeated anaerobic exercise bouts is a beneficial physiological effect.

1.8. Wzrost wytrzymałości (ID 1537, 1538)

The claimed effects are “increasing work capacity”, and “enhancing training volume and intensity”. The Panel assumes that the target population is adults performing endurance exercise.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to an increase in endurance capacity. Endurance capacity refers to the exercise time to self-reported fatigue when exercising at a constant workload or speed, generally at intensity <80 % maximum O2 consumption.
The Panel considers that an increase in endurance capacity is a beneficial physiological effect.

1.9. Udział w prawidłowym metabolizmie białek (ID 406)

The claimed effect is “formation and activation of protein”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effect refers to protein metabolism.
The Panel considers that the contribution to normal protein metabolism is a beneficial physiological effect.

2.1. Wpływ na wzrost i utrzymanie masy mięśniowej (ID 858, 1536, 1540, 4038, 4712)

The references provided in relation to these claims included textbooks, narrative reviews or monographs which did not provide any original data for the scientific substantiation of the claims and human intervention studies on the effects of food constituents other than the specific combination of food constituents which is the subject of some claims (ID 1536, 1540, 4712). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
No human studies which investigated the effects of the food(s)/food constituent(s)/combination of food constituents on the growth or maintenance of muscle mass were provided in relation to any of the claims evaluated in this section.
Two references addressed the effects of the food(s)/food constituent(s) on muscle contractility, on the generation of free radicals and on lipid peroxidation in skeletal muscle in vitro using muscle biopsies and electrical stimulation. 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 growth or maintenance of muscle mass 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)/combination of food constituents, which are the subject of the claims evaluated in this section, and growth or maintenance of muscle mass.

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.

2.3. Utrzymanie prawidłowego stanu kości (ID 1860, 4501, 4672)

The references provided in relation to these claims were textbooks, narrative reviews and monographs which did not provide any original data for the scientific substantiation of the claims or reported on health outcomes (e.g. treatment of osteoarthritis) unrelated to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
No human studies which investigated the effects of the food(s)/food constituent(s) on the maintenance of normal bone were provided in relation to any of the 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) which are the subject of the claims evaluated in this section and maintenance of normal bone.

2.4. Udział w prawidłowym pozyskiwaniu energii w procesach metabolicznych (ID 1381, 1613)

The references provided in relation to these claims were monographs and narrative reviews which did not provide any original data for the scientific substantiation of the claims or addressed health outcomes (e.g. daily activity in a murine model of chronic fatigue syndrome, treatment of fibromyalgia) unrelated to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
No human studies which investigated the effects of the food(s)/food constituent(s) on contribution to normal energy-yielding metabolism were provided in relation to any of the 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), which are the subject of the claims evaluated in this section, and contribution to normal energy-yielding metabolism.

2.5. Zwiększenie wydolności fizycznej (ID 472, 543, 1403, 1538, 1539, 3127)

The references provided in relation to these claims were monographs and narrative reviews which did not provide any original data for the scientific substantiation of the claims or addressed health outcomes (e.g. antioxidant activity, immune parameters, blood flow) unrelated to the claimed effect, studies which assessed the effects of food constituents other than the food constituent(s) or the specific combinations which are the subject of the claims on measures of endurance performance, and/or investigated health outcomes (e.g. rate of exogenous carbohydrate oxidation, muscle strength) other than endurance performance. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
No human studies which investigated the effects of the food(s)/food constituent(s)/combination of food constituents on measures of performance during endurance exercise were provided in relation to any of the 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)/combination of food constituents which are the subject of the claims evaluated in this section and increase in endurance performance.

2.6. Wzrost wytrzymałości podczas kolejnych ćwiczeń fizycznych po dużym wysiłku (ID 462, 1437, 1438)

The references provided in relation to these claims included narrative reviews or studies which addressed the effects of food(s)/food constituent(s) other than the food constituent(s) or the specific combination of food constituents which are the subject of the claims, and/or investigated health outcomes (e.g. gastric emptying rate, blood glucose concentration, serum insulin concentration) unrelated to the claimed effect. The references also included one study on the specific combination of the food constituents which is the subject of the claim on health outcomes (e.g. muscle glycogen stores) other than endurance performance. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
No human studies which investigated the effects of the food(s)/food constituent(s)/combination of food constituents on an increase in endurance performance during the subsequent exercise bout after strenuous exercise were provided in relation to any of the 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)/combination of food constituents which are the subject of the claims evaluated in this section and increase in endurance performance during the subsequent exercise bout after strenuous exercise.

2.7. Wzrost wytrzymałości podczas intensywnych i powtarzających się ćwiczeń beztlenowych (anaerobowych) (ID 1543)

The references provided for the scientific substantiation of this claim included a number of human intervention studies which investigated the effect of food constituents other than the specific combination of food constituents which is the subject of the claim, and/or assessed health outcomes (e.g. muscle strength, endurance capacity) unrelated to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Among the references provided was a human intervention study in which participants were randomised to receive the specific combination of food constituents which is the subject of the claim or a “placebo” matched with the intervention, except for one constituent (Kreider et al., 1998). The Panel notes that the placebo used in this study does not allow conclusions to be drawn on an effect of the specific combination of food constituents which is the subject of the claim. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claim.
No human studies which investigated the effects of the specific combination of food constituents on an increase in performance during intense and repeated anaerobic exercise bouts were provided in relation to the claim evaluated in this section.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the combination of food constituents which is the subject of the claim evaluated in this section and increase in performance during intense and repeated anaerobic exercise bouts.

2.8. Wzrost wytrzymałości (ID 1537, 1538)

The references provided for the scientific substantiation of this claim included a number of human intervention studies which investigated the effect of food constituent(s) other than the specific
combination of food constituents which is the subject of the claims. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
No human studies which investigated the effects of the specific combination of food constituents on an increase in endurance capacity were provided in relation to any of the claims evaluated in this section.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the combination of food constituents which is the subject of the claims evaluated in this section and increase in endurance capacity.

2.9. Udział w prawidłowym metabolizmie białek (ID 406)

The reference provided in relation to this claim was a pharmacy leaflet which did not provide any original data for the scientific substantiation of the claim. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claim.
No human studies which investigated the effects of the food on contribution to normal protein metabolism were provided in relation to the claim evaluated in this section.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food which is the subject of the claim evaluated in this section and contribution to normal protein metabolism.