Scientific Opinion on the substantiation of health claims related to various
food(s)/food constituent(s) claiming biotransformation of xenobiotic
substances (ID 1378, 2388, 2401, 3900, 3942, 4039, 4510, 4513, 4544, 4628,
4639), “elimination”, “cleansing” and “purification” (ID 1347, 4024, 4442,
4457), elimination of heavy metals (ID 1887, 3156), and maintenance of
normal bowel function (ID 4039) 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:
Xenobiotic substances
biotransformation
bowel function
health claims
heavy metals
Produkty:
Liść aloesu, korzeń bzu hebd, owoc bzu czarnego, liść mniszka lekarskiego
Klinoptilolit
Wodorosty
Korzeń łopianu, liść pokrzywy, ziele mniszka
Ziele powoju polnego, liść babki lancetowatej, owoc jałowca, ziele mniszka, ziele szałwi, liść i kwat głogu jednoszyjkowego, ziele dziurawca
Liściokwiat garbnikowy
Ziele fiołka trójbarwnego, korzeń cykorii podróżnik, korzeń łopianu większego, liść brzozy brodawkowatej, owoc jałowca pospolitego, owoce bzu czarnego, liście jesionu wyniosłego
Pędy psianki słodkogórz, ziele dymnicy lekarskiej, kora wiązu pospolitego, korzeń łopianu większego, korzeń szczwiu, sarsaparilla
Buraki
Aloes zwyczajny
Jukka
Listownica
Nostrzyk lekarski
Ocet jabłkowy (proszek)
Guggul
Parmelia perlata
Andrographis paniculata
2. Znaczenie oświadczenia dla zdrowia człowieka
1.1. Przemiany substancji ksenobiotycznych (oczyszczanie organizmu, detoksykacja) (ID 1378, 2388, 2401, 3900, 3942, 4039, 4510, 4513, 4544, 4628, 4639)
The claimed effects are “purification”, “purifying/detoxifying”, “urinary elimination”, “depurative, detoxificant”, “detoxification”, “blood health”, “supports the natural mechanism for body's purification”, “elimination and detox”, and “favours toxin elimination”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and/or the clarifications provided by Member States, the Panel assumes that the claimed effect relates to the biotransformation of xenobiotic substances.
Enzymatic biotransformation reactions of xenobiotic substances after absorption involve Phase I and Phase II biotransformation reactions, which usually work together in a sequential manner to convert xenobiotics into more readily excretable metabolites (Yu, 2005; Buhler and Williams, 1988). Phase I biotransformation reactions include oxidation, reduction, and hydrolysis, while Phase II biotransformation consists essentially of conjugation reactions (Yu, 2005). Whereas biotransformation reactions normally result in detoxification, some chemicals may also be enzymatically converted to highly reactive, electrophilic metabolites which may induce cytotoxic, teratogenic, mutagenic or carcinogenic effects through reaction with various cellular constituents (Buhler and Williams, 1988).
The Panel notes that from the proposed wordings or the clarifications provided by Member States it could not be established which xenobiotic substance or which biotransformation reaction related to the elimination of xenobiotic substances is the target for the claim.
In the absence of such information, 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.
1.2. Eliminacja, wydalanie, oczyszczanie (ID 1347, 4024, 4442, 4457)
The claimed effects are “elimination”, “cleansing” and “purification”. The Panel assumes that the target population is the general population.
“Elimination”, “cleansing” and “purification” are not sufficiently defined. No clarifications have been provided by Member States and no more details were contained in the proposed wording.
The Panel considers that the claimed effects are general and non-specific and do not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
1.3. Usuwanie metali ciężkich (ID 1887, 3156)
The claimed effects are “helps eliminate toxins/heavy metals from the body” and “might support detoxication processes”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect is related to the elimination of heavy metals.
The Panel considers that elimination of heavy metals is a beneficial physiological effect.
1.4. Utrzymanie prawidłowego funkcjonowania jelit (ID 4039)
The claimed effect is “elimination and detox”. The Panel assumes that the target population is the general population.
In the context of the clarification provided by Member States, the Panel assumes that the claimed effect is related to aspects of “laxative action”. Changes in bowel function within the normal range e.g. reduced transit time, increased frequency of bowel movements or bulk of stools might be interpreted as improvement of bowel function.
The Panel considers that maintenance of normal bowel function might be a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
2.1. Usuwanie metali ciężkich (ID 1887, 3156)
No human studies that contained data which could be used to substantiate the claim were cited in the references provided.
The references provided comprised some animal studies and human studies which were not related to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
One reference was an animal study on the reduction of blood lead concentrations. One was an in vitro study which investigated the removal of copper and nickel from solution. The Panel considers that while effects shown in animal and in vitro studies may be used as supportive evidence, human studies are required for the substantiation of a claim, and that the evidence provided in animal and in vitro studies alone is not sufficient to predict the occurrence of an effect of the consumption of the food(s)/food constituent(s) on the elimination of heavy metals in humans.
One reference was a textbook, describing a study which examined the reduction of cadmium, copper, chromium, nickel and lead in children. The information provided regarding the study design, methodology and statistical analyses given in this textbook was insufficient for a complete scientific evaluation and the original reference cited in the textbook was not available to the Panel, even after having made all reasonable efforts to retrieve it. 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 consumption of the food(s)/food constituent(s) which are the subject of the health claim and elimination of heavy metals.
2.2. Utrzymanie prawidłowego funkcjonowania jelit (ID 4039)
The references provided included some textbooks in which the claimed effect was mentioned. The remaining references were animal or in vitro studies which were not related to the claimed effect. 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 consumption of the food/food constituent which is the subject of the health claim and maintenance of normal bowel function.
Wnioski
On the basis of the data presented, the Panel concludes that:
Biotransformation of xenobiotic substances (ID 1378, 2388, 2401, 3900, 3942, 4039, 4510, 4513,
4544, 4628, 4639)
The claimed effects are “purification”, “purifying/detoxifying”, “urinary elimination”, “depurative, detoxificant”, “detoxification”, “blood health”, “supports the natural mechanism for body’s purification”, “elimination and detox”, and “favors toxin elimination”. The target population is assumed to be the general population. In the context of the proposed wordings and/or the clarifications provided by Member States, it is assumed that the claimed effect relates to the biotransformation of xenobiotic substances. From the proposed wordings or the
clarifications provided by Member States it could not be established which xenobiotic substance or which biotransformation reaction related to the elimination of xenobiotic substances is the target for the claim.
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.
“Elimination”, “cleansing” and “purification” (ID 1347, 4024, 4442, 4457)
The claimed effects are “elimination”, “cleansing” and “purification”. The target population is assumed to be the general population. The claimed effects, “elimination”, “cleansing” and “purification” are not sufficiently defined. No clarifications have been provided by Member States and no more details were contained in the proposed wording.
The claimed effects are general and non-specific and do not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
Elimination of heavy metals (ID 1887, 3156)
The claimed effects are “helps eliminate toxins/heavy metals from the body” and “might support detoxication processes”. The target population is assumed to be the general population. Elimination of heavy metals is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of the foods(s)/food constituent(s) which are the subject of the health claim and elimination of heavy metals.
Maintenance of normal bowel function (ID 4039)
The claimed effect is “elimination and detox”. The target population is assumed to be the general population. Maintenance of normal bowel function might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of the food/food constituent which is the subject of the health claim and maintenance of normal bowel function.
