1. Charakterystyka żywności / składnika

1.1. Vitamin D (ID 215)

The food constituent that is the subject of the health claim is vitamin D. Vitamin D is a well recognised nutrient and is measurable in foods by established methods.
The Panel considers that the food constituent, vitamin D, which is the subject of the health claim, is sufficiently characterised (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009a).

1.2. Protein (ID 1398, 4704)

The food constituent that is the subject of the health claims is protein.
The Panel considers that the food constituent, protein, which is the subject of the health claims, is sufficiently characterised (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010a).

1.3. Calcium (ID 4704)

The food constituent that is the subject of the health claim is calcium. Calcium is a well recognised nutrient and is measurable in foods by established methods.
The Panel considers that the food constituent, calcium, which is the subject of the health claim, is sufficiently characterised (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009b)

1.4. Plant stanols (ID 568)

The food constituent that is the subject of the health claim is plant stanols.
The Panel considers that the food constituent, plant stanols, which is the subject of the health claim, is sufficiently characterised (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010b).

1.5. Alpha-linolenic acid (ALA) (ID 568)

The food constituent that is the subject of the health claim is “omega-3 fatty acids”.
From the proposed conditions of use and the references provided, the Panel assumes that the food constituent, which is the subject of the health claim, is alpha-linolenic acid (ALA).
The Panel considers that the food constituent, alpha-linolenic acid (ALA), which is the subject of the health claim, is sufficiently characterised (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009c).

1.6. Replacement of mixtures of saturated fatty acids (SFAs) as present in foods or diets with mixtures of polyunsaturated fatty acids (PUFAs) (ID 674, 4335)

The food constituent that is the subject of the health claims is “polyunsaturated fatty acids”.
In the context of the proposed wordings, the Panel assumes that the food constituent, which is the subject of the health claim, is saturated fatty acids (SFAs), which should be replaced by cis-polyunsaturated fatty acids (cis-PUFAs) in foods or diets in order to obtain the claimed effect.
The Panel considers that the food constituent, saturated fatty acids as present in foods or diets, and the food constituent, mixtures of cis-PUFAs, which should replace SFAs in foods, and which are the subject of the health claim, are sufficiently characterised (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011a).

1.7. Lactase (ID 1974)

The food constituent that is the subject of the health claim is lactase (beta-D-galactohydrolase).
The Panel considers that the food constituent, lactase, which is the subject of the health claim, is sufficiently characterised (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009d).

1.8. Ethanol-water extract of Caralluma fimbriata (ID 4191, 4192, 4193)

The food constituent that is the subject of the health claims is an ethanol-water extract of Caralluma fimbriata.
From the proposed conditions of use, the Panel assumes that the ethanol-water extract of Caralluma fimbriata is identical to the food/constituent (Slimaluma®) submitted under Article 13.5 of Regulation (EC) No 1924/2006 (Question No EFSA-Q-2010-00027, EFSA-Q-2010-00028, EFSA-Q-2010-00029, EFSA-Q-2010-00030, EFSA-Q-2010-00031).
The Panel considers that the food constituent, ethanol-water extract of Caralluma fimbriata, which is the subject of the health claims, is sufficiently characterised (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010c, 2010d, 2010e).

1.9. Pectins (ID 4236)

The food constituent that is the subject of the health claim is pectins.
The Panel considers that the food constituent, pectins, which is the subject of the health claim, is sufficiently characterised (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010f).

1.10. Chromium (ID 4698)

The food that is the subject of the health claim is “Saccaromyces cerevisiae-brewer’s yeast”.
From the references provided the Panel assumes that the food which is the subject of the health claim is chromium-enriched Saccharomyces cerevisiae, as a source of trivalent chromium Cr(III). Trivalent chromium is a well recognised nutrient and is measurable in foods by established methods.
The Panel considers that the food constituent, trivalent chromium, which is the subject of the health claim, is sufficiently characterised (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010g).

1.11. Choline (ID 712, 1633)

The food that is the subject of the health claims is “phospholipids (phosphatidyl choline, phosphatidyl ethanolamine, phosphatidyl inositol, lysophosphatidyl cholin)”.
Phospholipids are a major component of all cell membranes. Most phospholipids contain a diglyceride, a phosphate group, and a simple organic molecule such as choline.
From the conditions of use, the Panel assumes that the food, which is the subject of the health claim, is phosphatidylcholine, and that the food constituent responsible for the claimed effect is choline. Choline is measurable in foods by established methods.
The Panel considers that the food constituent, choline, which is the subject of the health claim, is sufficiently characterised (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011b)

2. Znaczenie oświadczenia dla zdrowia człowieka

2.1. Vitamin D and normal absorption of calcium (ID 215)

The claimed effect is “vitamin D3 enhances the calcium-absorption from the gut by inducing formation of calcium-binding proteins within the small intestinal mucosa”. The Panel assumes that the target population is the general population.
A claim on vitamin D and absorption of calcium and phosphorus and maintenance of normal blood calcium concentrations has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009a).

2.2. Protein and growth or maintenance of muscle mass (ID 1398)

The claimed effect is “contribution to the assembly of muscles”. 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 growth or maintenance of muscle mass.
A claim on protein and growth or maintenance of muscle mass has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010a).

2.3. Protein and maintenance of normal bone (ID 4704)

The claimed effect is “yogurt is a source of calcium and proteins, indispensable for bone development, mineralization, density and strength”. The Panel assumes that the target population is the general population.
A claim on protein and maintenance of normal bone has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010a).

2.4. Calcium and maintenance of normal bone (ID 4704)

The claimed effect is “yogurt is a source of calcium and proteins, indispensable for bone development, mineralization, density and strength”. The Panel assumes that the target population is the general population.
A claim on calcium and maintenance of normal bone has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009b).

2.5. Plant stanols and maintenance of normal blood cholesterol concentrations (ID 568)

The claimed effect is “cardiovascular system”. 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 blood cholesterol concentrations.
A claim on plant sterols and plant stanols and maintenance of normal blood cholesterol concentrations has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010b).

2.6. Alpha-linolenic acid (ALA) and maintenance of normal blood cholesterol concentrations (ID 568)

The claimed effect is “cardiovascular system”. 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 blood cholesterol concentrations.
A claim on ALA and maintenance of normal blood cholesterol concentrations has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009c).

2.7. Replacement of mixtures of saturated fatty acids (SFAs) as present in foods or diets with mixtures of polyunsaturated fatty acids (PUFAs) and maintenance of normal blood LDL-cholesterol concentrations (ID 674, 4335)

The claimed effect is “cardiovascular system”. 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 blood LDL-cholesterol concentrations.
A claim on the replacement of mixtures of SFAs with cis-MUFAs and/or cis-PUFAs in foods or diets and maintenance of normal blood LDL-cholesterol concentrations has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011a).

2.8. Lactase and breaking down lactose (ID 1974)

The claimed effect is “lactose digestion”. The target population is individuals whose own lactase production is insufficient for breaking down lactose.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to breaking down lactose (i.e. enzymatic hydrolysis of lactose).
A claim on lactase and breaking down lactose has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009d).

2.9. Zmniejszenie obwodu w talii (ID 4191)

The claimed effect is “helps reduce size of waist”. The Panel assumes that the target population is individuals who wish to reduce their waist circumference.

2.10. Redukcja masy ciała (ID 4192)

The claimed effect is “helps reduce body weight”. The Panel assumes that the target population is overweight individuals in the general population who wish to reduce their body weight.

2.11. Zmniejszenie apetytu (ID 4193)

The claimed effect is “helps reduce appetite”. The Panel assumes that the target population is the general population.

2.12. Pectins and maintenance of normal blood cholesterol concentrations (ID 4236)

The claimed effect is “weight management and lipid control (via fiber)”. The Panel assumes that the target population is the general population.
No references on weight management were provided in the consolidated list. In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the maintenance of normal blood cholesterol concentrations.
A claim on pectins and maintenance of normal blood cholesterol concentrations has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010f).

2.13. Chromium and maintenance of normal blood glucose concentrations (ID 4698)

The claimed effect is “sanguine 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 effect refers to the maintenance of normal blood glucose concentrations.
A claim on trivalent chromium and maintenance of normal blood glucose concentrations has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010g).

2.14. Choline and maintenance of normal liver function (ID 712, 1633)

The claimed effect is “liver health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and the clarifications provided by Member States, the Panel assumes that the claimed effects refer to the maintenance of normal liver function.
A claim on choline and maintenance of normal liver function has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011b)

3. Naukowe uzasadnienia wpływu na zdrowie człowieka -

3.1. Zmniejszenie obwodu w talii (ID 4191)

A claim on ethanol-water extract of Caralluma fimbriata and a reduction in waist circumference, if accompanied by an improvement in the adverse health effects of an excess abdominal fat, has already been assessed with an unfavourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010e), and the references cited for this claim did not provide any additional scientific data that could be used to substantiate the claim.

3.2. Redukcja masy ciała (ID 4192)

A claim on ethanol-water extract of Caralluma fimbriata and reduction of body weight, has already been assessed with an unfavourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010c), and the references cited for this claim did not provide any additional scientific data that could be used to substantiate the claim.

3.3. Zmniejszenie apetytu (ID 4193)

A claim on ethanol-water extract of Caralluma fimbriata and a reduction of appetite leading to a reduction in subsequent energy intake, has already been assessed with an unfavourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010d), and the references cited for this claim did not provide any additional scientific data that could be used to substantiate the claim.

Wnioski

On the basis of the data presented, the Panel concludes that:
The following health claims have already been assessed with a favourable outcome: vitamin D and normal absorption of calcium (ID 215); protein and growth or maintenance of muscle mass (ID 1398); protein and maintenance of normal bone (ID 4704); calcium and maintenance of normal bone (ID 4704); plant stanols and maintenance of normal blood cholesterol concentrations (ID 568); alpha-linolenic acid (ALA) and maintenance of normal blood cholesterol concentrations (ID 568); replacement of mixtures of saturated fatty acids (SFAs) as present in foods or diets with mixtures of polyunsaturated fatty acids (PUFAs) and maintenance of normal blood LDL-cholesterol concentrations (ID 674, 4335); lactase and breaking down lactose (ID 1974); pectins and maintenance of normal blood cholesterol concentrations (ID 4236); chromium and maintenance of normal blood glucose concentrations (ID 4698); choline and maintenance of normal liver function (ID 712, 1633).
The following health claims have already been assessed with an unfavourable outcome and the references cited did not provide any additional scientific data that could be used to substantiate the claims: ethanol-water extract of Caralluma fimbriata and reduction in waist circumference (ID 4191); ethanol-water extract of Caralluma fimbriata and reduction of body weight (ID 4192); ethanol-water extract of Caralluma fimbriata and reduction of appetite (ID 4193).

Oświadczenia zdrowotne

2203.pdf