General Quality Statement

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Allergen information for ISOMALT (all types including galenIQ™)

This document summarizes information relevant for isomalt (all types including galenIQ™)
produced and marketed by BENEO-Palatinit on substances considered as allergens in various
regions of the world.1 In particular (but not exclusively) covered are allergens listed in Regulation
(EU) No 1169/2011 "on the provision of food information to consumers...", in Section 201(qq) [21.
U.S.C. 321] of the [USA] Food, Drug & Cosmetic Act as well as in Resolucao RDC No 26 (Brazilian
allergen regulation 2015). It further contains (non-exhaustive) information on substances
sometimes been associated with intolerances.2

Description of the production process

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.

1 "True" allergic reactions are caused by adverse immune reaction to usually harmless food proteins.
2 For information on dietary (in)tolerances of isomalt as polyols, we refer to our nutritional service.
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Risk assessment for advisory or precautionary labelling

Apart from mandatory allergen labelling 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). Both references use
principles of the VITAL (Voluntary Incidental Trace Allergen Labelling) concept, namely threshold
or "Eliciting Doses" (ED) doses of the allergens. ED doses are defined as those doses that are
likely to elicit an allergic reaction in a certain percentage of the population, i.e. the VITAL 3.0
concepts identified so-called ED01 and ED05 for major food allergens to produce a response in 1 %
or 5 % of the allergic populations.

The threshold concept for allergens is scientifically overall accepted, however, the specific values
and implementation into food control applications vary between countries. In this document, the
guidance for German food control authorities was taken, who transferred threshold doses into
reference concentrations in mg/kg food and assumes that 100 g of the food are consumed. This is
a conservative approach for individual ingredients such as gluten, because rarely 100 g of an
ingredient are eaten at one occasion.

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 appreciable 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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The result of the risk assessment and its basis are listed in the annexed table. When a theoretical
chance of presence in the supply chain is not fully excluded, a quantitative risk estimate is given.
For information, when available the reference concentration in mg/kg protein is listed that is used
as action values for official food control in Germany. When it is exceeded, the consumption of 100
g of the food is associated with the risk for allergic reactions - for lower levels in food, German food
control authorities would not enforce an allergen labelling, provided the allergen is not an
ingredient. In other words, an exceeding of the reference concentration in final consumer products
justifies a consideration of a "may contain [allergen]" labelling.

The outcome of the risk assessment do not suggest a precautionary "may contain
[allergen]" claim for ISOMALT under the conditions defined in the Annex.

The warranties regarding the exclusion of cross contamination refer to final product in its original
intact packaging or the unloaded, sealed truck.

Dr. Gunhild Kozianowski

Corporate Product Safety/Specifications Management
BENEO GmbH

References

77. Arbeitstagung des ALTS. Conclusions of the meeting of June 20-22, 2016.
Allergen Bureau (2019) Summary of the 2019 VITAL Scientific Expert Panel Recommendations.
BfR (2020) "VITAL 3.0": Neue und aktualisierte Vorschläge für Referenzdosen von Lebensmittelallergien.
Comité Scientifique de l'Agence fédérale poru la Sécurité de la Chaîne alimentaire. AVIS 24-2017. Doses de
réfèrence pour les allergènes repris á l'annexe II du Règlement (UE) n° 1169/2011 du 25 octobre 2011.
SciCom 2017/01.
Waiblinger HU, Schulze G (2018) Action Levels for Food Allergens: An Approach for Official Food Control in
Germany. J AOAC Int. 10, 17-22.

This statement is valid on the date of issue. Its legally binding character automatically expires after 3 years.
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Annex
Result of the allergen risk assessment for ISOMALT in view of advisory or preventive allergen labelling

Allergen Used as Potentially present in the Risk of cross conta- Rationale for cross contact Reference value
(with the condition/exceptions of Regulation ingredient on raw material, handled mination of ISOMALT assessment3, 4 may cause allergic reac-
(EU) No 1169/2011 or fully refined the processing loose in production- in original intact tion when 100 g food are
oils/carbohydrates) line relevant areas until packaging or bulk consumed;
(Y/N) packaging or allowed transport3, 4 Waiblinger and Schulze,
preload for bulk3 (Y/N) 2018
(Y/N)
Cereals containing gluten and products N N N cross-contact unlikely 100 mg/kg
thereof; i.e.
Wheat N N N cross-contact unlikely 100 mg/kg
Rye N N N cross-contact unlikely 100 mg/kg
Barley N N N cross-contact unlikely 100 mg/kg
Oats N N N cross-contact unlikely 100 mg/kg
Spelt N N N cross-contact unlikely 100 mg/kg
Kamut N N N cross-contact unlikely 100 mg/kg
Crustaceans and products thereof N N N cross-contact unlikely
Eggs and products thereof N N N cross-contact unlikely 0.66 mg/kg
Fish and products thereof N N N cross-contact unlikely
Peanuts and products thereof; N N N cross-contact unlikely 8 mg/kg
Soybeans and products thereof N N N cross-contact unlikely 25 mg/kg
Milk and products thereof (incl. lactose) N N N cross-contact unlikely 2.8 mg/kg
Nuts, i.e. N N N cross-contact unlikely

3 In originally sealed packaging or unloaded, sealed carrier within the responsibility of BENEO-Palatinit; does not cover bulk transport by customer;
unless column one explicitly refers to another chemical identity (e.g. sulphite, glutamate, carbohydrates), "risk" refers to a protein contamination/crosscontact, only.
4 For the purpose of compliance testing: a complaint is justified, when allergens are found in a sample of an integer delivery by a validated method for proteins above the
indicated condition in the risk or rationale column - resp. the limit of quantification when no conditional is mentioned. By derogation, for sulphite and lactose resp. validated
methods are applicable, for latex a CS2 concentration above 0.05 mg/kg justifies a complaint; for natural constituents/traces and royal jelly/pollen (no chemical identity),
complaints cannot be accepted.
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Allergen
(with the condition/exceptions of Regulation
(EU) No 1169/2011 or fully refined
oils/carbohydrates)
Almonds (Amygdalus communis L.)
Hazelnuts (Corylus avellana)
Walnuts (Juglans regia) and heartnuts
Cashews (Anacardium occidentale)
Pecan (Carya illinoiesis (Wangenh.) K.
Koch) and other hickory nuts
Brazil nuts (Bertholletia excelsa)
Pistachio nuts (Pistacia vera)
Macadamia / Queensland nuts (Maca-
damia ternifolia)
Celery and products thereof
Mustard and products thereof
Sesame seeds and products thereof
Sulphur dioxide and sulphites (E220- E228)
resulting in concentrations of more than
10 mg/kg or 10 mg/litre in the final product,
expressed as SO2
Lupin and products thereof
Molluscs and products thereof
Cocoa
Glutamate (i.e. added E620 – E625)
Glucose
Fructose
Used as Potentially present in the Risk of cross conta- Rationale for cross contact Reference value
ingredient on raw material, handled mination of ISOMALT assessment3, 4 may cause allergic reac-
the processing loose in production- in original intact tion when 100 g food are
line relevant areas until packaging or bulk consumed;
(Y/N) packaging or allowed transport3, 4 Waiblinger and Schulze,
preload for bulk3 (Y/N) 2018
(Y/N)
N N N cross-contact unlikely
N N N cross-contact unlikely 6.4 mg/kg
N N N cross-contact unlikely
N N N cross-contact unlikely 106 mg/kg
cross-contact unlikely
N N N
N N N cross-contact unlikely
N N N cross-contact unlikely
cross-contact unlikely
N N N
N N N cross-contact unlikely
N N N cross-contact unlikely 1.9 mg/kg
N N N cross-contact unlikely 11.8 mg/kg
N Y N supply chain
(< 10 mg/kg)
N N N cross-contact unlikely 100 mg/kg
N N N cross-contact unlikely
N N N cross-contact unlikely
N glutamate is natural con- glutamate is natural no glutamate added
stituent of cells constituent of cells traces within the microbial
specifications (constituent)
N (bound) glucose is natural constituent of ISOMALT;
residual traces from sucrose hydrolysis no glucose, fructose or
sucrose added as ingredients
glucose is natural constituent of fructans
residual sugars in acc. with
N residual fructose as by product from sucrose Product Sheets
hydrolysis
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Allergen Used as Potentially present in the Risk of cross conta- Rationale for cross contact Reference value
(with the condition/exceptions of Regulation ingredient on raw material, handled mination of ISOMALT assessment3, 4 may cause allergic reac-
(EU) No 1169/2011 or fully refined the processing loose in production- in original intact tion when 100 g food are
oils/carbohydrates) line relevant areas until packaging or bulk consumed;
(Y/N) packaging or allowed transport3, 4 Waiblinger and Schulze,
preload for bulk3 (Y/N) 2018
(Y/N)
Sucrose Y (raw material) Y (residual traces)
Chicken meat N N N cross-contact unlikely
Coriander N N N cross-contact unlikely
Corn/maize N N N cross-contact unlikely
Buckwheat N N N cross-contact unlikely
Legumes N N N cross-contact unlikely
Beef incl. gelatine N N N cross-contact unlikely
Pork incl. gelatine N N N cross-contact unlikely
Carrot N N N cross-contact unlikely
Chestnut N N N cross-contact unlikely
Coconut N N N cross-contact unlikely
Pine nut/Pinoli N N N cross-contact unlikely
Beech nut N N N cross-contact unlikely
Butter nut N N N cross-contact unlikely
Chinquapin N N N cross-contact unlikely
Ginkgo nut N N N cross-contact unlikely
Pili nut N N N cross-contact unlikely
Sheanut N N N cross-contact unlikely
Lychee nut N N N cross-contact unlikely
Cinnamon N N N cross-contact unlikely
Onion N N N cross-contact unlikely
Apple N N N cross-contact unlikely
Banana N N N cross-contact unlikely
Citrus fruits (all types) N N N cross-contact unlikely
Kiwi N N N cross-contact unlikely
Yams N N N cross-contact unlikely
Tomato N N N cross-contact unlikely
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Allergen Used as Potentially present in the Risk of cross conta- Rationale for cross contact Reference value
(with the condition/exceptions of Regulation ingredient on raw material, handled mination of ISOMALT assessment3, 4 may cause allergic reac-
(EU) No 1169/2011 or fully refined the processing loose in production- in original intact tion when 100 g food are
oils/carbohydrates) line relevant areas until packaging or bulk consumed;
(Y/N) packaging or allowed transport3, 4 Waiblinger and Schulze,
preload for bulk3 (Y/N) 2018
(Y/N)
Peach N N N cross-contact unlikely
Mango N N N cross-contact unlikely
Cotton N N N cross-contact unlikely
Poppy N N N cross-contact unlikely
Sunflower N N N cross-contact unlikely
Latex N N N (≤0.05 mg/kg as CS2) no contact with latex material
Yeast N Y Y within the microbial
specifications (constituent)
Hydrolysed vegetable protein N N N cross-contact unlikely
Royal jelly, bee pollen, propolis N N N cross-contact unlikely
Mushrooms N N N cross-contact unlikely