ID 1818 - Laktaza

PL: Laktaza
EN: Lactase enzyme
Pdf:

Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is “lactase enzyme”.
The intestinal enzyme lactase hydrolyses the mammalian milk sugar lactose into galactose and glucose. Externally administered enzymes with lactose-splitting activity are bacterial or yeast derived beta-glucosidases. These enzymes have different lactose splitting activities and optimal conditions for use. For greater lactose splitting efficacy, milk can be incubated with lactase before milk consumption. The amount of active enzyme needed for the alleviation of symptoms in lactose intolerant individuals depends on the mode of administration, the amount of intended milk intake and the lactose sensitivity of the individual.
The references provided identified lactase enzyme (beta-galactosidase) preparations from fungal sources, e.g. Aspergillus oryzae and Kluyveromyces lactis. This opinion applies also to other sources presenting standardised lactase (Food Chemicals Codex, (FCC)).
The Panel considers that the food constituent, lactase enzyme, which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “digestion”. The target population is individuals whose own lactase enzyme production is insufficient for breaking down lactose.
“Digestion” is not sufficiently defined. In the context of the proposed wording, the Panel assumes that the claimed effect relates to breaking down lactose (i.e. hydrolyse lactose).
Lactose maldigestion is a common condition characterised by intestinal lactase deficiency. In Europe, around 5% - 22% of the population have primary lactose maldigestion but are usually able to tolerate small amounts of lactose. Lactose maldigestion is an inherited deficiency present in the majority of the world's population, and is most prevalent in Asian, African, Hispanic and Indian populations. Recently discovered genetic polymorphisms may be used as first stage screening tests for adult type hypolactasia. Individuals who show an abnormal breath hydrogen excretion test, the standard test for diagnosis of lactose maldigestion, can often tolerate up to 12g of lactose (around 240 mL of cows milk). However, some individuals may react to lower amounts with intestinal symptoms. These include bloating, abdominal pain, nausea, diarrhoea, cramps and distension. Improvement of lactose digestion may be of interest in lactose intolerant subjects. The alleviation of lactose intolerance symptoms may be a health benefit conferred by externally administered lactase enzymes which hydrolyse lactose.
The Panel considers that breaking down lactose may be beneficial to the health of individuals with symptomatic lactose maldigestion.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Trawienie laktozy

The references provided consist of small scale clinical studies with different enzyme preparations and activities in different lactase-deficient populations.
Of the submitted references, one was a review, three references related to management of lactose intolerance/treatment approaches of lactose maldigestion (Savaiano and Kotz, 1989; Montalto at al., 2006; Swagerty et al., 2002) and another evaluated the impact of lactose intolerance on quantitative bone parameters (Segal et al., 2003). The Panel notes that these references do not address the relationship between the consumption of lactase enzyme and the claimed effect and therefore considers that no scientific conclusions can be drawn from these references for the substantiation of the claimed effect.
The references evaluating the effect of lactase preparations which are pertinent to the claimed effect are given below:
Reference Study design Study
Population
Hydrogen
excretion
Clinical
symptoms
Enzyme
activity / amount
Source of
enzyme
Biller et
al., 1987
Open
challenged
16;
3-16 years
USA
reduced reduced 125 – 375 mg Asp. oryzae
DiPalma
& Collins,
1989
Open
challenged
10;
adults mean
43.5 years,
USA
reduced reduced 250 – 500 mg
~4000 FCC Asp. oryzae
Barillas &
Solomons,
1987
Open
challenged
27 school
children,
2.5-6 years,
Guatemala
reduced Not
assessed ~6500 FCC
Asp oryzae;
Kluyveromyces
lactis
Lami et
al., 1988
Open
challenged
52;
20-65 years,
Italy
reduced
38 – 75%
symptom
free
325 FCC / drop
(+pre incubation)
~2600 FCC
Kluyveromyces
lactis
Reference Study design Study
Population
Hydrogen
excretion
Clinical
symptoms
Enzyme
activity / amount
Source of
enzyme
Montalto
et al.,
2005
Crossover
double-blind
placebo
controlled
study
30;
18-65 years,
Italy
reduced
75 - 90%
symptom
free
~6500 –
7800 FCC
Kluyveromyces
lactis
Rask
Pedersen
et al.,
1982
Double blind,
crossover
11;
20-67 years,
Denmark
reduced Non-
significant
~4200 FCC
(3205 U)
Kluyveromyces
lactis
Moskovitz
et al.,
1987
Open
challenged
16 lactose
intolerant
adults, USA
reduced 5/9
reduced
~ 4000 FCC
(250/500 mg
Lactase)
Asp. oryzae
Ramirez
et al.,
1994
Randomised
placebo-
controlled
10 lactose
intolerant
volunteers,
USA
reduced reduced
6600 – 9900
FCC; 500 mg
Lactase
(~ 6600 FCC)
Asp. oryzae;
Kluyveromyces
lactis
NB: the definition of enzyme activity units has differed in publications. To provide comparative activity information, units have been converted to FCC using a conversion factor 1.3 from neutral units. Effects
are listed after administration of the active enzyme preparation.
Assuming a fully active enzyme preparation, the intended dose of 4500 FCC (Food Chemicals Codex) units has been shown to reduce H2 exhalation and clinical symptoms in small scale clinical studies. Enzyme activity is defined by the amount of substrate that a unit of specific enzyme will break down per unit of time according to the United States Pharmacopoeia (USP) and the Food Chemicals Codex (FCC). Doses used in the studies range from: 2600-9900 FCC.
The results presented are derived from studies with small sample sizes and some also had a weak design. However, the Panel notes the known mechanism of action and the biological plausibility of the effect.
The Panel concludes that a cause and effect relationship has been established between the consumption of lactase enzyme and breaking down lactose in individuals with symptomatic lactose maldigestion.

4. Uwagi do zaproponowanego brzmienia oświadczenia

The Panel considers that the following wording reflects the scientific evidence: “Lactase enzyme contributes to breaking down lactose”.

5. Warunki i możliwe ograniczenia stosowania oświadczenia

The Panel considers that consumers should be made aware that lactase enzyme, which is the subject of health claim, is intended for individuals with lactose (milk sugar) maldigestion and with associated clinical symptoms, i.e. individuals with symptomatic lactose intolerance.
The recommended dose is 4500 FCC (Food Chemicals Codex) units with each lactose containing meal. The Panel considers that the dose may have to be adjusted to individual needs for lactase supplementation and consumption lactose containing products.

Warunki i możliwe ograniczenia stosowania oświadczenia

Food supplement with 4500 FCC units of lactase in the daily dose.