Scientific Opinion on the substantiation of health claims related to
selenium and maintenance of normal hair (ID 281), maintenance of normal
nails (ID 281), protection against heavy metals (ID 383), maintenance of
normal joints (ID 409), maintenance of normal thyroid function (ID 410,
1292), protection of DNA, proteins and lipids from oxidative damage
(ID 410, 1292), and maintenance of the normal function of the immune
system (ID 1750) 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:
Selenium
hair
health claims
heavy metals
immune system
joints
minerals
nails
thyroid
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is selenium, which is a well recognised nutrient and is measurable in foods by established methods.
Selenium occurs naturally in foods and is authorised for addition to foods and for use in food supplements (Annex I of the Regulation (EC) No 1925/20066 and Annex I of Directive 2002/46/EC7). This evaluation applies to selenium naturally present in foods and to those forms authorised for addition to foods and for use in food supplements (Annex II of the Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).
The Panel considers that the food constituent, selenium, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Utrzymanie prawidłowego stanu włosów (ID 281)
The claimed effect is “hair and nail formation”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal hair is a beneficial physiological effect.
2.2. Utrzymanie prawidłowego stanu paznokci (ID 281)
The claimed effect is “hair and nail formation”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal nails is a beneficial physiological effect.
2.3. Ochrona przed metalami ciężkimi (ID 383)
The claimed effect is “detoxification”. The Panel assumes that the target population is the general population.
In the context of the wording provided, the Panel assumes that the claimed effect is related to the protection against heavy metals.
The Panel considers that protection against heavy metals is a beneficial physiological effect.
2.4. Utrzymanie prawidłowego stanu stawów (ID 409)
The claimed effect is “joint function”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal joints is a beneficial physiological effect.
2.5. Utrzymanie prawidłowego funkcjonowania tarczycy (ID 410, 1292)
The claimed effects are “key function within metabolism (e.g. GSH-peroxidase)”, “antioxidant to prevent oxidative stress”, “proper thyroid function” and “maintenance of cellular redox status”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effects are related to thyroid function.
A claim on selenium and normal thyroid function has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009).
2.6. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 410, 1292)
The claimed effects are “key function within metabolism (e.g. GSH-peroxidase)”, “antioxidant to prevent oxidative stress”, “proper thyroid function” and “maintenance of cellular redox status”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effects are related to the protection of DNA, proteins and lipids from oxidative damage.
A claim on selenium and protection of DNA, proteins and lipids from oxidative damage has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009).
2.7. Utrzymanie prawidłowego funkcjonowania układu odpornościowego (ID 1750)
The claimed effect is “natural defences/immune system”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect is related to the normal function of the immune system.
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A claim on selenium and normal function of the immune system has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009).
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
Selenium is an essential trace element. Twenty-five selenoprotein genes have been identified in the human genome (Kryukov et al., 2003). Selenoproteins have a number of functions, comprising various catalytic roles (glutathione peroxidases, thioredoxin reductases, and iodothyronine deiodinases), structural roles, and storage and transport activities. Selenium is present in foods mainly as selenomethionine and selenocysteine. It is absorbed efficiently by the intestine over a wide range of concentrations and across a variety of different molecular forms (Bates, 2005).
3.1. Utrzymanie prawidłowego stanu włosów (ID 281)
Deficiency in selenium has been shown to result in various disorders including impairment of hair (Biesalski et al., 1995; Sunde, 2006). Clinical manifestations such as white nail beds, pseudoalbinism, alopecia and thin hair have been observed in particular in patients receiving total parenteral nutrition lacking selenium. Administration of selenium was able to restore these deficiency symptoms (Abrams et al., 1992; Kanekura et al., 2005; Masumoto et al., 2007; Vinton et al., 1987).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of selenium and maintenance of normal hair. However, the evidence provided does not establish that inadequate intake of selenium leading to impaired maintenance of normal hair occurs in the general EU population.
3.2. Utrzymanie prawidłowego stanu paznokci (ID 281)
Deficiency in selenium has been shown to result in various disorders including impairment of nails (Biesalski et al., 1995; Sunde, 2006). Clinical manifestations such as white nail beds, pseudoalbinism, alopecia and thin hair have been observed in particular in patients receiving total parenteral nutrition lacking selenium. Administration of selenium was able to restore these deficiency symptoms (Abrams et al., 1992; Kanekura et al., 2005; Masumoto et al., 2007; Vinton et al., 1987).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of selenium and maintenance of normal nails However, the evidence provided does not establish that inadequate intake of selenium leading to impaired maintenance of normal nails occurs in the general EU population.
3.3. Ochrona przed metalami ciężkimi (ID 383)
One reference was provided for the scientific substantiation of the claim which was a textbook in which the claimed effect was mentioned. No further evidence was provided in support of the claim. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of selenium and protection against heavy metals.
3.4. Utrzymanie prawidłowego stanu stawów (ID 409)
A total of 15 references were provided for the scientific substantiation of the claim. Ten human studies assessed plasma selenium concentrations in patients with rheumatoid arthritis, (juvenile) chronic polyarthritis, psoriatic arthritis, or in patients with elevated C-reactive protein, lung cancer or
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adult T-cell leukaemia. Five human intervention studies have been provided which were carried out in patients with rheumatoid arthritis or chronic polyarthritis. The Panel considers that the evidence provided does not establish that patients with arthritis of different origin are representative of the general population with regard to the status of joint tissue, or that results obtained in studies on subjects with arthritis of different origin relating to the treatment of symptoms of these diseases can be extrapolated to the maintenance of normal joints in the general population.
The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of selenium and maintenance of normal joints.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Utrzymanie prawidłowego stanu włosów (ID 281)
The Panel considers that the following wording reflects the scientific evidence: “Selenium contributes to the maintenance of normal hair”.
4.2. Utrzymanie prawidłowego stanu paznokci (ID 281)
The Panel considers that the following wording reflects the scientific evidence: “Selenium contributes to the maintenance of normal nails”.
5. Warunki i możliwe ograniczenia stosowania oświadczenia
The Panel considers that in order to bear the claims a food should be at least a source of selenium as per Annex to Regulation (EC) No 1924/2006. Such amounts can be easily consumed as part of a balanced diet. The target population is the general population. Tolerable Upper Intake Levels (ULs) have been established for adults, pregnant and lactating woman, children and adolescents (SCF, 2000).
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, selenium, which is the subject of the health claims is sufficiently characterised.
Maintenance of normal hair (ID 281)
The claimed effect is “hair and nail formation”. The target population is assumed to be the general population. Maintenance of normal hair is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of selenium and maintenance of normal hair.
The evidence provided does not establish that inadequate intake of selenium leading to impaired maintenance of normal hair occurs in the general EU population.
The following wording reflects the scientific evidence: “Selenium contributes to the maintenance of normal hair”.
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Maintenance of normal nails (ID 281)
The claimed effect is “hair and nail formation”. The target population is assumed to be the general population. Maintenance of normal nails is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of selenium and maintenance of normal nails.
The evidence provided does not establish that inadequate intake of selenium leading to impaired maintenance of normal nails occurs in the general EU population.
The following wording reflects the scientific evidence: “Selenium contributes to the maintenance of normal nails”.
Protection against heavy metals (ID 383)
The claimed effect is “detoxification”. The target population is assumed to be the general population. Protection against heavy metals is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of selenium and protection against heavy metals.
Maintenance of normal joints (ID 409)
The claimed effect is “joint function”. The target population is assumed to be the general population. Maintenance of normal joints is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of selenium and maintenance of normal joints.
Maintenance of normal thyroid function (ID 410, 1292)
The claimed effects are “key function within metabolism (e.g. GSH-peroxidase)”, “antioxidant to prevent oxidative stress”, “proper thyroid function”, and “maintenance of cellular redox status. The target population is assumed to be the general population.
A claim on selenium and normal thyroid function has already been assessed with a favourable outcome.
Protection of DNA, proteins and lipids from oxidative damage (ID 410, 1292)
The claimed effects are “key function within metabolism (e.g. GSH-peroxidase)”, “antioxidant to prevent oxidative stress”, “proper thyroid function”, and “maintenance of cellular redox status”. The target population is assumed to be the general population.
A claim on selenium and protection of DNA, proteins and lipids from oxidative damage has already been assessed with a favourable outcome.
Maintenance of the normal function of the immune system (ID 1750)
The claimed effect is “natural defences/immune system”. The target population is assumed to be the general population.
A claim on selenium and normal function of the immune system has already been assessed with a favourable outcome.
Conditions and possible restrictions of use
In order to bear the claims a food should be at least a source of selenium as per Annex to Regulation (EC) No 1924/2006. Such amounts can be easily consumed as part of a balanced diet. The target population is the general population.
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