2265.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to spermidine and contribution to normal hair growth (ID 1705) 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: Spermidine   hair growth   health claims  
ID:    1705  
Produkty: Spermidyna  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is spermidine.
Spermidine (N-(3-aminopropyl)butane-1,4-diamine) is a polyamine which is present in nearly all eukaryotic cells. Under physiological conditions, polyamines are totally protonated and behave as natural polycations. The cellular content of these amines is closely regulated and they are synthesised by a highly regulated pathway from ornithine after decarboxylation (Agostinelli et al., 2010; Morgan, 1999; Pegg, 2009).
The Panel considers that the food, spermidine, which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “skin and annexes health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and references provided, the Panel assumes that the claimed effect refers to contribution to normal hair growth.
The Panel considers that contribution to normal hair growth is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Wpływ na prawidłowy wzrost włosów

Two references were provided for the scientific substantiation of the claim. One was a review and one an unpublished confidential statistical report both reporting on the same double-blind, randomised parallel trial on the effect of spermidine on the hair growth cycle and hair loss (No authors listed, 2004, unpublished; Rinaldi et al., 2002). The hair growth cycle was evaluated by a trichogram to assess the percentage of hair in the telogen and anagen phases, whereas hair loss was evaluated by wash and hair pull tests. The Panel notes that these references did not provide sufficient information for a full scientific evaluation (e.g. on the recruitment and randomisation of subjects and on the
methodology used for measurement of relevant outcomes). The Panel also notes that the evidence provided in these references did not establish that the outcome measures used in the study were appropriate measures of hair growth. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of spermidine and contribution to normal hair growth.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food, spermidine, which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “skin and annexes health”. The target population is assumed to be the general population. In the context of the proposed wordings, it is assumed that the claimed effect refers to contribution to normal hair growth. Contribution to normal hair growth is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of spermidine and contribution to normal hair growth.