Monitoring report

22020n-MSS-WAS, page 1/6

Functional Fiber MONITORING 2021

Products: Orafti®powders and liquids
Functional fibers from BENEO-Orafti are regularly monitored for verification of compliance with their
specifications as well as other trace compounds that are relevant for food (e.g. Regulation (EC) No
1881/2006 "setting maximum levels for certain contaminants in foodstuffs" and Regulation (EC) No
396/2005 "on maximum residue levels of pesticides in or on food and feed of plant and animal origin ".

This monitoring report is released once a year, taking into account all products produced in both
production sites, Chile and Belgium. For cost saving reasons it was decided to gather all external and
internal analyses for the samples in one run, end of December, to release the report the following
year.

The following results were obtained. Details on samples and methods are given in annex 1. The
functional fibers to which the results are applicable are listed in annex 2:

Parameter Target Number of Limit of Max result

samples Quantification
Inorganic impurities
Arsenic, total max 0.03 mg/kg 19 0.004 mg/kg 0.012 mg/kg
Arsenic inorganic max 0.03 mg/kg 19 0.0040 mg/kg 0.0098 mg/kg
Lead max 0.02 mg/kg 19 0.0060 mg/kg 0.0077 mg/kg
Cadmium max 0.01 mg/kg 17 0.0010 mg/kg 0.0094 mg/kg
Mercury max 0.01 mg/kg 19 0.0005 mg/kg 0.0027 mg/kg
Sulphur dioxide max 10 mg/kg 19 1 mg/kg 6 mg/kg
Ash (sulphated) max 0.2 g/100g d.m. 20 0.2 g/100g d.m <0.2 g/100g d.m
Mycotoxins
Aflatoxin B1, B2, G1, G2 max 0.1 µg/kg, each 19 0.1 µg/kg <0.1 µg/kg
Ochratoxin A max 0.5 µg/kg 19 0.1 µg/kg <0.1 µg/kg
Zearalenone max 15 µg/kg 19 15 µg/kg <15 µg/kg
Deoxynivalenol max 100 µg/kg 19 20 µg/kg <20 µg/kg
Pesticides
(about 690 active MRLs acc. to 18 typically 0.005- <LOQ
substances analyzed) Regulation 0.05 mg/kg
2016/127/EC

All monitoring results are within the specifications and/or applicable legal limits. BENEO-Orafti is
certified by the food safety management system FSSC 22000 which also includes an HACCP study.
The HACCP study concludes that trace compounds are adequately addressed and under control. The
results above verify this conclusion.
Monitoring report

22020n-MSS-WAS, page 2/6

Microbiological parameters

Orafti®fructans marketed by BENEO-Orafti are produced in accordance with applicable food hygiene
criteria in compliance with Regulation (EC) No 852/2004 "on food hygiene". Powdered and liquid
Orafti®fructans have a water activity aw of not more than <0.4 (powders) resp. <0.85 (liquids) and pH
values between 4 and 7; foodborne pathogens are therefore not able to grow. Several microbiological
parameters are batch-wise analyzed. Beyond that, regular monitoring analyses are carried out on
further food-borne pathogens.

The document summarizes the monitoring results for the production of 2021 on foodborne pathogens
and hygiene indicators for Orafti®fructans of both production sites. Details on samples, methods and
laboratories are given in annex 1. The list of products to which the report is applicable are listed in
annex 2.

Parameter Sample size/Unit No of Results 2021

samples
Bacillus cereus cfu/ 0.1 g 20 <1
Salmonella 375 g 20 not detected
Coagulase-positive 1g 20 not detected
staphylococci
Sulfite-reducing anaerobes cfu/g 20 <1
(Clostridia)
Listeria monocytogenes 25 g 20 not detected

The production sites of BENEO-Orafti have implemented HACCP concepts and a monitoring program
for the listed microbes. The monitoring reports shall demonstrate the effectiveness of preventive
measures to ensure safety and quality in all batches delivered.
Monitoring report

22020n-MSS-WAS, page 3/6

ANNEX 1: Analytical details

Laboratory Chemical impurities Accreditation/Method used

Sciensano (Coda)
Centrum voor Onderzoek in Diergeneeskunde BELAC
en Agrochemie
Leuvensesteenweg 17
B-3080 Tervuren Belgium
Method of Analyses
Heavy metals /metals ICP-OES, AMA 254, ICP-MS

Südzucker Central Laboratory Tienen ISO 9001, Internal supervision

Aandorenstraat 1
B-3300 Tienen Belgium

Method of Analyses
Sulphur dioxide HPIC
Ash (sulphated) ICUMSA GS3/4/7/8-11 adapted

Primoris (Fytolab) Belgium CVBA BELAC

Technologiepark 2/3,
B-9052 Zwijnaarde - Gent Belgium
Method of Analyses
Mycotoxins LC-MS/MS, LC-UV

Eurofins Sofia GmbH DAkkS D-PL-19579-02-00

Rudower Chaussee 29
D-12489 Berlin Germany

Method of Analyses
Pesticides LFGB and internal; LC-MS/MS, GC-MS/(MS)
incl Quaternary ammonium compounds LC-MS/MS
(DDAC, BAC)
Monitoring report

22020n-MSS-WAS, page 4/6

Batch Code Laboratory Parameters Samp Test report No Test report

ling date
date
LFWLG19XXX
LCPCT19XXX SZ Tie Sulphur dioxide 2021
Ash (sulphated)
PETLK1ALK1
YAPKJ1AKJ1
RRSEW1CEW1
RHTLV1ALV1
RBPHV1AHV1
HRSGE1DGE1
LBALY19BX1
SFDHP19BX1
LFWLG19xxx
LCALL19BX1
PEFET1DET1
YAADJ1BDJ1
RTBDB1CDB1
RRDNR1BNR1
RGENM0FDR1
ROARD1BRD1
RHNFF1BFF1

Same batches Sciensano Arsenic, total 2021 F21FD02015 25/01/2022

as above Arsenic, inorganic F21FD02014 25/01/2022
Lead
Cadmium
Mercury

Same batches Primoris Aflatoxins 2021 21/078919-21-22-23-25- Dec/2021

as above Ochratoxin A 27
Zearalenone 21/003709 Jan/2022
Deoxynivalenol 21/078930_078932 Dec/2021
21/078934-078941 Dec/2021

Same batches
as above Eurofins Sofia Pesticides and 2021 AR-21-SF-006086 Jan/2022
Quaternary AR-21-SF-000488 Jan/2022
ammonium AR-21-SF-098276-80 Dec/2021
compounds AR-21-SF-097067-69 Dec/2021
AR-21-SF-098281-84 Dec/2021
Monitoring report

22020n-MSS-WAS, page 5/6

Laboratory Microbiological parameters

Normec Foodcontrol BELAC

Honderdweg 13 FPS Economy, S.M.E.s, Self-employed and
B-9230 Wetteren Energy
Belgium General Direction Quality and Safety
Lab accreditation No 080-TEST
ISO 17025

Parameters/Method of analyses
Salmonella spp. ISO 6579
Bacillus cereus ISO 7932
Coagulase-positive staphylococci ISO 6888
Sulfite-reducing anaerobes ("Clostridia") ISO 15213
Listeria species ISO 11290

Batch code Laboratory Parameters Sampling Test report No Test

(method) date report
date
LBALY19BX1 2021 2112-16814 23/12/2021
SFDHP19BX1 2112-16815 23/12/2021
LFWLG19xxx 2112-17108 21/01/2022
LCALL19BX1 2112-16816 27/12/2021
PEFET1DET1 Salmonella 2112-18340 10/02/2022
YAADJ1BDJ1 2112-16818 17/03/2022
RTBDB1CDB1 Bacillus cereus 2112-16819 17/03/2022
RRDNR1BNR1 2112-16820 17/03/2022
RGENM0FDR1 Coagulase-positive 2112-16821 17/03/2022
ROARD1BRD1 Staphylococci 2112-16822 17/03/2022
Normec
HRBNH1CNH1 2112-16825 17/03/2022
Food control
RHNFF1BFF1 Listeria 2112-16826 17/03/2022
monocytogenes
LFWLG19XXX 2112-14678 20/12/2021
LCPCT19XXX Sulfite-reducing 2112-14679 13/01/2022
YAPKJ1AKJ1 anaerobes 2021 2112-14681 10/01/2022
PETLK1ALK1 2112-14680 13/01/2022
HPSFZ1CFZ1 2112-14683 10/01/2022
RRSEW1CEW1 2112-14682 10/01/2022
RHTLV1ALV1 2112-14684 23/12/2021
RBPHV1AHV1 2112-14685 23/12/2021
Monitoring report

22020n-MSS-WAS, page 6/6

ANNEX 2 – Functional fibers for which this statement applies

1. Orafti®L85
2. Orafti®scL85AM
3. Orafti®L90/92
4. Orafti®L95
5. Orafti®P95
6. Orafti®Synergy1
7. Orafti®GR
8. Orafti®ST
9. Orafti®ST-Gel
10. Orafti®FTX
11. Orafti®HSI
12. Orafti®LGI

AUTHORIZATION

18/05/2022 Monique Steegmans Sophie Lepair Monica Pena

Central Analytics, Head Head of Quality Head of Quality
of Tienen Laboratory Control, Oreye Control, Pemuco

18/05/2022 Wim Antheunis

Head of Central
Microbiology, Tienen lab