Isomalt fine powder (Isomalt PF)

Raw material for the production process of ISOMALT resp. the pharmaceutical excipient galenIQ™ is food-grade sucrose. Sucrose is refined and not considered as a source of allergen introduction. During processing, sucrose is contacted with an immobilized biocatalyst and enzymatically converted into the disaccharide isomaltulose. Residual sucrose is removed either by enzymatic hydrolysis or crystallisation. Isomaltulose is subsequently hydrogenated to the compound polyol ISOMALT. In the whole production process, several refining steps such as filtration and ion exchange are built in. No allergens are used as direct processing aids in the production process of ISOMALT and galenIQ™. Enzyme preparations are thoroughly rinsed before placing them in operation. ISOMALT is a polyol that consists virtually only of carbohydrates in its dry matter. Contents of other nutrients (fat, protein) are below their detection limits. As a result, ISOMALT (all types incl. galenIQ) does not prompt a mandatory allergen labelling as ingredient in acc. with the above mentioned regulations in the European Union, the United States or Brazil. Apart from mandatory allergen obligations, BENEO's responsible department for product safety carried out a risk assessment for allergen cross contacts in order to enable our customers a risk-based decision in favour or against the use of an advisory labelling or precautionary labelling "may contain [allergen]". Quantitative guidance for such a risk assessment is available from the Belgium Comité Scientifique de l'Agence fédérale pour la Sécurité de la Chaîne alimentaire (SciCom 2017/01, AVIS 214-2017) as well as the Official Food Control in Germany (ALTS meeting decisions, 20-22.06.2016 and Waiblinger & Schulze (2018).3 The latter transfers threshold doses into reference concentrations in mg/kg food and assumes that 100 g of the food are consumed. The risk assessment for ISOMALT considered the likelihood of the presence of an allergen in the supply chain from the raw material, the impact of the processing to the packaging of ISOMALT or as allowed preload in trucks for bulk when the transport is organized by BENEO-Palatinit in accordance with the agreed transport conditions: The raw material crystalline sucrose is highly refined without an appriable risk for an allergen introduction into the production process for ISOMALT. Direct processing aids are no food allergens either; any traces from earlier steps would be removed during the refining steps as described above. The risk for a cross-contact with other substances, introduction via packing line or transportation was estimated as well - essentially based on plausibility consideration. No allergenic pre-loads are allowed as part of the contract conditions agreed for transports organized by BENEO-Palatinit.

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