Standards Development

Scope

This standard applies to extractables of propolis derived from raw propolis from Apis mellifera bees, that may be offered as liquid or solid propolis extracts. This standard applies to propolis extracts where propolis is the only ingredient. Propolis extracts shall be safe for animal and human consumption. This standard establishes the requirements for authenticity, quality, analytical methods and bioactivity. Further, the standard describes storage and transportation conditions, and packing mark requirements.

Purpose

Propolis is a resinous, balsamic mixture of natural, plant-derived substances collected by worker bees (Apis mellifera) from newly formed buds and plant exudates and resins. Bees enhance this mixture with secretions from their salivary and wax glands, utilizing it to protect the hive (ISO 24381:2023). To optimize the use of propolis for human and animal health, it is essential to remove beeswax and foreign matter from raw propolis (Galeotti et al. 2018; Özkök et al. 2021). Appropriate solvents and process facilitate the extraction and purification of bioactive components from propolis.

Various propolis extracts are derived from different raw materials (e.g., Populus spp., Baccharis dracunculifolia, Dalbergia ecastophillum, Symphonia globulífera, Clusia and others) (ISO 24381:2023). The extraction solvent and process, even when using the same type of propolis raw material, yield different extracts by extracting bioactives to varying degrees based on their polarity (Bankova, 2005). Alcoholic and hydroalcoholic extracts are the most studied and commercialized globally (Berretta et al. 2023a). However, the low solubility and bioavailability of these extracts, along with the presence of ethanol, have driven the development of new technologies that aim to provide alternative formulations with comparable composition, effectiveness, and safety (Berretta et al. 2023b). This variability in propolis extracts available in the market presents significant challenges for analytical and quality control laboratories in ensuring authenticity and quality.

This proposal is not intended to be restrictive regarding extraction solvents and processes but aims to define the minimum criteria and requirements for propolis extracts to be considered authentic, safe, and of high quality for human and animal consumption. Given the increasing international demand for propolis extracts and the increasing presence of fraudulent market practices (Zhang et al. 2011; Zhang et al. 2015), it is crucial to establish an international standard to ensure minimum authenticity and quality requirements. This proposal outlines terms and definitions, quality requirements, test methods, transportation and storage conditions, and packaging and labelling for propolis extracts.