Scientific Opinion on the substantiation of health claims related to
L-phenylalanine and increased alertness (ID 708, 1629), enhancement of
mood (ID 657), pain relief (ID 657) and improvement of memory (ID 658)
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:
L-phenylalanine
alertness
health claims
memory
mood
pain
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is phenylalanine.
L-phenylalanine is an essential amino acid and can be measured in food by established methods. It occurs naturally in foods, particularly protein-rich foods such as meat, fish and dairy products as a constituent of the proteins.
The Panel considers that the food constituent, L-phenylalanine, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Zwiększenie czujności (ID 708, 1629)
The claimed effect is “mental health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claim refers to alertness which is a well defined construct and can be measured by validated psychometric cognitive tests.
The Panel considers that increased alertness might be a beneficial physiological effect.
2.2. Poprawa nastroju (ID 657)
The claimed effect is “increase activity of endorfins”. 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 effect refers to mood enhancement.
Enhancement of mood is measurable by established methods.
The Panel considers that enhancement of mood might be a beneficial physiological effect.
2.3. Uśmierzanie bólu (ID 657)
The claimed effect is “increase activity of endorfins”. 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 effect refers to pain relief.
Pain relief is measurable by established methods.
The Panel considers that pain relief is a beneficial physiological effect.
2.4. Poprawa pamięci (ID 658)
The claimed effect is “supports memory”. The Panel assumes that the target population is the general population.
The Panel considers that improvement of memory is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
3.1. Zwiększenie czujności (ID 708, 1629)
A total of 29 references were provided to substantiate the claimed effect, including seven textbooks, seven narrative reviews and four unclassified references which included a newsletter and a monograph. The Panel notes that these references did not provide any scientific data that could be used to substantiate the claimed effect.
The remaining 11 references described ten human studies and one animal study. Six of the human studies considered outcomes related to depression symptoms rather than alertness, three did not address the food constituent that is the subject of the claim, and the remaining reference described a study on patients with schizophrenia. No evidence was presented to show that findings from patients with schizophrenia can be extrapolated to the general population. The animal study investigated the oxidation of tryptophan to 5-hydroxytryptophan (5-HTP). 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 L-phenylalanine and increased alertness.
3.2. Poprawa nastroju (ID 657)
A total of four references were provided to substantiate the claimed effect, including one narrative review, two human studies and one animal study.
The Panel notes that the narrative review (Russell and McCarty, 2000) and the animal study (Halpern and Dong, 1986) reported on outcomes associated with pain relief rather than mood. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The two human studies were on DL-phenylalanine effects on the treatment of patients with depression. The Fischer et al. (1975) study was an uncontrolled therapeutic study on patients with endogenous depression who had previously undergone unsuccessful treatment with common anti- depressant drugs. The Beckman et al. (1977) study was an uncontrolled therapeutic study on depressed patients. The Panel notes 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 L-phenylalanine and enhancement of mood.
3.3. Uśmierzanie bólu (ID 657)
A total of four references were provided to substantiate the claimed effect, including one narrative review, two human studies and one animal study.
The Panel notes that the two human studies (Fischer et al., 1975; Beckman et al., 1977) investigated the effect of DL-phenylalanine on the treatment of patients with depression rather than pain relief. The Panel considers that no conclusions could be drawn from these references for the scientific substantiation of the claimed effect.
The Panel notes that the narrative review (Russell and McCarty, 2000) did not provide primary scientific data that could be used to substantiate the claimed effect. The animal study of Halpern and Dong (1986) showed that D-phenylalanine had no significant effect in a primate acute pain model.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of L-phenylalanine and pain relief.
3.4. Poprawa pamięci (ID 658)
A total of four references were provided to substantiate the claimed effect, including one narrative review, two human studies and one animal study.
The Panel notes that these references (Fischer et al., 1975; Beckman et al., 1977; Russell and McCarty, 2000; Halpern and Dong, 1986) did not address endpoints relevant to the claimed effect (e.g. pain relief, depression symptoms). The Panel considers that no conclusions could 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 L-phenylalanine and improvement of memory.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, L-phenylalanine, which is the subject of the health claims, is sufficiently characterised.
Increased alertness (ID 708, 1629)
The claimed effect is “mental health”. The target population is assumed to be the general population. Increased alertness might be a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of L-phenylalanine and increased alertness.
Enhancement of mood (ID 657)
The claimed effect is “increase activity of endorfins”. The target population is assumed to be the general population. Enhancement of mood might be a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of L-phenylalanine and enhancement of mood.
Pain relief (ID 657)
The claimed effect is “increase activity of endorfins”. The target population is assumed to be the general population. Pain relief is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of L-phenylalanine and pain relief.
Improvement of memory (ID 658)
The claimed effect is “supports memory”. The target population is assumed to be the general population. Improvement of memory is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of L-phenylalanine and improvement of memory.
