Scientific Opinion on the substantiation of health claims related to
pantothenic acid and mental performance (ID 58), reduction of tiredness
and fatigue (ID 63), adrenal function (ID 204) and maintenance of normal
skin (ID 2878) 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:
Pantothenic acid
adrenal function
fatigue
health claims
mental
skin
tiredness
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is pantothenic acid which is a well recognised nutrient and is measurable in foods by established methods.
Pantothenic acid occurs naturally in foods and is authorised for addition to foods (Annex I of Regulation (EC) No 1925/20066 and Annex I of Directive 2002/46/EC7). This evaluation applies to pantothenic acid naturally present in foods and to those forms authorised for addition to foods (Annex II of Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).
The Panel considers that the food constituent, pantothenic acid, which is the subject of the health claims is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Zdolności umysłowe (ID 58)
The claimed effect is “the role of vitamins and minerals in mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning)”. The Panel assumes that the target population is the general population.
A claim on pantothenic acid and normal mental performance has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009).
2.2. Zmniejszenie zmęczenia (ID 63)
The claimed effect is “vitamin/mineral supplementation to reduce fatigue and tiredness in situations of inadequate micronutrient status”. The Panel assumes that the target population is the general population.
The Panel considers that reduction of tiredness and fatigue is a beneficial physiological effect.
2.3. Funkcjonowanie nadnerczy (ID 204)
The claimed effect is “adrenal function”. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined, no clarifications were provided by Member States and no further details were contained in the proposed wording which could be used to define the claimed effect.
The Panel considers that the claimed effect is general and non-specific and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
2.4. Utrzymanie prawidłowego stanu skóry (ID 2878)
The claimed effect is “skin care”. The Panel assumes that the target population is the general population.
A claim on pantothenic acid and maintenance of normal skin has already been assessed with an unfavourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009) and the references cited for this claim did not provide any additional scientific data that could be used to substantiate the claim.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
Pantothenic acid is required for the synthesis of coenzyme A (CoA), a cofactor and acyl group carrier for many enzymatic processes and for the synthesis of the prosthetic group of the acyl carrier protein (ACP), a component of the fatty acid synthesis complex. Most tissues transport pantothenic acid into cells for the synthesis of CoA (IoM, 1998). The evidence for the essentiality of pantothenic acid consists of its well known role in cellular biochemistry.
Deficiency symptoms have only been observed in experimental settings such as giving a pantothenic acid metabolic antagonist and not in dietary studies. Deficiency symptoms included irritability, restlessness, fatigue, apathy, malaise, sleep disturbances, numbness and muscle cramps (IoM, 1998).
3.1. Zmniejszenie zmęczenia (ID 63)
Deficiency symptoms of pantothenic acid in experimental settings include fatigue (IoM, 1998).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of pantothenic acid and reduction of tiredness and fatigue. However, the evidence provided does not establish that inadequate intake of pantothenic acid leading to tiredness and fatigue occurs in the general EU population.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Zmniejszenie zmęczenia (ID 63)
The Panel considers that the following wording reflects the scientific evidence: “Pantothenic acid can contribute to the reduction of tiredness and fatigue”.
Wnioski
On the basis of the data available, the Panel concludes that:
The food constituent, pantothenic acid, which is the subject of the health claims is sufficiently characterised.
Mental performance (ID 58)
The claimed effect is “the role of vitamins and minerals in mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning)”. The target population is assumed to be the general population.
A claim on pantothenic acid and normal mental performance has already been assessed with a favourable outcome.
Reduction of tiredness and fatigue (ID 63)
The claimed effect is “vitamin/mineral supplementation to reduce fatigue and tiredness in situations of inadequate micronutrient status”. The target population is assumed to be the general population. Reduction of tiredness and fatigue is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of pantothenic acid and reduction of tiredness and fatigue.
The evidence provided does not establish that inadequate intake of pantothenic acid leading to tiredness and fatigue occurs in the general EU population.
The following wording reflects the scientific evidence: “Pantothenic acid can contribute to the reduction of tiredness and fatigue”.
Adrenal function (ID 204)
The claimed effect is “adrenal function”. The target population is assumed to be the general population. The claimed effect is not sufficiently defined, no clarifications were provided by Member States and no further details were contained in the proposed wording which could be used to define the claimed effect.
The claimed effect is general and non-specific and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
Maintenance of normal skin (ID 2878)
The claimed effect is “skin care”. The target population is assumed to be the general population.
A claim on pantothenic acid and maintenance of normal skin has already been assessed with an unfavourable outcome and the references cited for this claim did not provide any additional scientific data that could be used to substantiate the claim.
Conditions and possible restrictions of use
In order to bear the claims a food should be at least a source of pantothenic acid 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.
