ID 1246 - Propolis

PL: Propolis
EN: PROPOLIS
Pdf: propolis

1. Charakterystyka żywności / składnika

The food(s)/food constituent(s) that are the subject of the health claims are propolis or flavonoids in propolis related to the following claimed effects: “respiratory health”, “antibacterial and antifungal activities”, “throat comfort”, “gut health”, “supports immune defences”, “maintenance of oral health”, “helps to maintain a normal blood circulation” and “hepatoprotective”.
Propolis, like honey and royal jelly, is a beehive product with a complex chemical composition in which more than 300 components have been identified, many of them biologically active. Propolis in natura is composed of about 30 % wax, 50 % resin and vegetable balsam, 10 % essential/aromatic oils, 5 % pollen and 5 % other substances (Burdock, 1998). Bees collect the constituents of propolis from plants in the area and use them to seal holes in their honeycombs, smooth out internal walls and cover the carcasses of dead intruders.
The chemical composition and biological properties of propolis preparations may vary according to geographical location and different plant sources, as well as the extraction procedure used (Sforcin, 2007). For example, in Russia the main plant source of propolis is Betula verrucosa Ehrh., and its purported main biologically active components are flavones and flavonols. In contrast, in Cuba and Venezuela, Clusia spp. represents the main vegetal source of propolis and the main purported active constituents are polyprenylated benzophenones (Bankova, 2005a). The references provided reported on differences in biological activity between propolis preparations from different sources. Concentrations of the purported biologically active constituents in some propolis preparations are low or undetectable in other propolis preparations (Kumazawa et al., 2004; Bankova, 2005a, 2005b). Further, the papers provided in support of the claims reported on a wide range of different propolis preparations, extracts and isolated components, and it is not clear for which type of propolis preparation/constituent the claims are made.
The fact that propolis composition is very variable creates a problem for standardisation (Marcucci, 1995). A universal chemical characterisation of propolis would be impossible (Bankova, 2005a). Because the term “propolis” is not characterised with respect to the chemical composition, the botanical source as well as the chemical composition of the specific propolis preparation should be clarified (Bankova, 2005a; Sforcin, 2007).
For IDs 1242, 1245, 1246, 1247, 1248 and 3184 the Panel notes that the references cited did not provide sufficient information for the characterisation of propolis, which is the subject of the health claims.
The Panel considers that the food/food constituent, propolis, which is the subject of the health claims in IDs 1242, 1245, 1246, 1247, 1248 and 3184, is not sufficiently characterised in relation to the claimed effects considered in this opinion.
For IDs 1244, 1644, 1645, 3526, 3527, 3798 and 3799 the claimed effects, wordings and/or conditions of use refer to (bio)flavonoids as the active constituent in propolis. Flavonoids are polyphenolic compounds which comprise a very wide group of plant secondary metabolites including flavonols, flavons, flavanones, isoflavones and flavan-3-ols with different biological activities. The conditions of use for some claims specify the amount of flavonoids required to achieve the claimed effect expressed as galangin equivalents, but also other phenolic compounds such as catechin/epicatechin or caffeic acid are used for standardisation. This specification refers to traditional spectrophotometrical measurement of total polyphenols which is based on reducing capacity. The method is not specific for flavonoids because other reducing compounds such as ascorbic acid, sugars and proteins will also be included in the quantification, thus leading to an overestimation of the actual flavonoid content. The total flavonoid content assessed with this method is not suitable for characterisation of flavonoids in foods. From the references cited, the Panel notes that the type and content of flavonoids in propolis may vary depending on the specific propolis raw material as well as the extraction and preparation methods, and that flavonoid-free propolis has been reported in the literature (Duarte et al., 2003). Differences were observed in the qualitative and quantitative values of constituents in the propolis from various geographical origins (Kumazawa et al., 2004).
For IDs 1244, 1644, 1645, 3526, 3527, 3798 and 3799 the Panel notes that the references cited did not provide sufficient information for the characterisation of flavonoids in propolis, which are the subject of the health claims.
The Panel considers that the food constituent, flavonoids in propolis, which is the subject of the health claims in IDs 1244, 1644, 1645, 3526, 3527, 3798 and 3799, is not sufficiently characterised in relation to the claimed effects considered in this opinion.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of propolis or of flavonoids in propolis and the claimed effects considered in this opinion.

Warunki i możliwe ograniczenia stosowania oświadczenia

pure /extract