Vital Wheat Gluten – Product Specification

Chemical properties
Moisture max. 10 %
Ash max. 1.5 %
Protein Nx5,7(on dry basis) min. 75 %
Protein Nx6,25 (on dry basis) min. 82 %
Carbohydrate 9 %
Sugar 1.9 %
Dietary Fibre 2.6 %
Sodium 10 mg
PH-Range 5.0 – 7.0
Water binding min. 150 %
Solubility Insoluble
Specific gravity 500 – 550 Kg/m3
Energy 1595kJ/100g 381kcal/100g
Sieve analysis 1% > 200 µm

Microbiological properties
Total Plate Count max. 10.000 cfu/g
Yeast and Moulds max. 500 cfu/g
E. coli max. 10 cfu/g
Salmonella absent in 25 gram
Fat max. 1.5 %
Saturated fatty acid 0.3 %
Trans fatty acid N/A

Physical Properties
Appearance Creamy light yellow powder
Taste and odour Neutral, bland and free from objectionable odours

Packaging
25 kg multiwall paper bags
50 lbs multiwall paper bags
1 metric ton big bags

Royal Ingredients Group BV

Noorderstraat 1C Tel: +31 (0)72-5208080
1823 CS Alkmaar E-mail: [email protected]
The Netherlands Web: www.royal-ingredients.com

The information given is based on laboratory and field experience. It is set in good faith and for guidance only.
Royal Ingredients Group holds the right of changing the product specification. Users should conduct their own
tests to determine the suitability of our product for their particular purpose.
To whom it may concern,

Nutritional Declaration

Vital Wheat Gluten

HS Code No. 1109.0000.00

Herewith we declare in accordance with the regulation of FD and BfR that our Vital Wheat Gluten is of
food grade quality.

We hereby certify our product vital wheat gluten being produced directly from wheat and without use
of any by-products or merchandise according to Commission Regulation (EEC) No. 1855/92 of
07.07.1992, as required in Commission Regulation (EEC) No. 1722/93 of 30.06.1993, General Food Law
EG Vo Nr. 178/2002.

Composition mg Vitamins µg Minerals Mg Amino acids (mg) Trace elements µg

Water 5994 A 0 Na: 0 ILE 3240 Fe 54
Protein 81000 D 0 K 8 LEU 5508 Zn 43
Fat 4000 E 100 Ca 1 LYS 1134 Cu 8
Carbohydrates 7000 K 10 Mg 1 MET 1296 Mn 54
Dietary fiber 1000 B1 10 P 7 CYS 1539
Alcohol 0 B2 3 S 6 PHE 4050
Cholesterol 0 Niac 70 Cl 3 TYR 2835
Linols 1754 Panth 16 THR 1944
Linolens 118 B6 10 TRP 810
Purin-N 110 Biot 1 VAL 3321
Fols 10 ARG 2349
B12 0 HIS 1620

Period of validity: 01.01.2018 - 31.12.2018

Royal Ingredients Group BV

Noorderstraat 1C Tel: +31 (0)72-5208080
1823 CS Alkmaar E-mail: [email protected]
The Netherlands Web: www.royal-ingredients.com

The information given is based on laboratory and field experience. It is set in good faith and for guidance only.
Royal Ingredients Group holds the right of changing the product specification. Users should conduct their own
tests to determine the suitability of our product for their particular purpose.
Alkmaar, 2 January 2018

Vital Wheat Gluten – Safety Data Sheet

1. Chemical product and company identification

Royal Ingredients Group BV

Noorderstraat 1C
1823 CS Alkmaar
Tel: +31 (0)72 520 8080
Fax: +31 (0)70 520 8862
E-mail: [email protected]
Chemical name
Vital Wheat Gluten

2. Composition and information in ingredients

Composition
Chemical name: Vital Wheat Gluten
Cas #: 93384-22-6
EC-no (EINECS/ELINCS): 297-233-5

3. Hazards identification

Classification
This substance is not classified as dangerous.

4. First aid measures

After inhalation
Provide fresh air.
After contact with skin
Rinse with water.
After contact with eyes
Rinse with water if necessary seek medical advice.
After ingestion
Rinse mouth thoroughly with water.

Royal Ingredients Group BV

Noorderstraat 1C Tel: +31 (0)72-5208080
1823 CS Alkmaar E-mail: [email protected]
The Netherlands Web: www.royal-ingredients.com

The information given is based on laboratory and field experience. It is set in good faith and for guidance only.
Royal Ingredients Group holds the right of changing the product specification. Users should conduct their own
tests to determine the suitability of our product for their particular purpose.
 5. Fire and explosion data

Suitable extinguishing media

All about, water gives slippery floors.
Extinguishing media which must not be used for safety reasons
All extinguishing agents available
Special exposure hazards arising from substance or preparation itself, combustion products,
resulting gases
Carbon dioxide (CO2). Carbon monoxide.

Special protective equipment for fire-fighters

In case of fire: wear self-contained breathing apparatus.

6. Accidental Release measures

Personal precautions
Avoid skin and eye contact.

Environmental precautions
Do not empty into drains or the aquatic environment.

Methods for cleaning up/taking up

Take up dust free, small rests rinse with water.

7. Handling and storage

Advice on safe handling

Avoid generation of dust.
Advice on protection against fire and explosion
Explosive dust-air mixtures may form. Dust explosive category: ST1. Avoid dust deposits.
Further information on handling
Use explosion-protected machinery, apparatus, suction equipment, appliances etc.
Requirements for storage room and vessels
Keep cool and dry in closed bags.
Further information on storage conditions
Storage temperature of 15 °C up to 25 °C. Relative room humidity up to 65%.

8. Exposure controls and personal protection

Occupational exposure controls

Care for good ventilation/absorption at work.
Protective and hygiene measures
No dangerous substance, however pay attention for universally precaution in handling with chemicals.
Respiratory protection
Under dusting conditions: breathing mask filter P1
Hand protection
Wear protective gloves
Eye protection
Under dusting conditions: eye protection

Royal Ingredients Group BV

Noorderstraat 1C Tel: +31 (0)72-5208080
1823 CS Alkmaar E-mail: [email protected]
The Netherlands Web: www.royal-ingredients.com

The information given is based on laboratory and field experience. It is set in good faith and for guidance only.
Royal Ingredients Group holds the right of changing the product specification. Users should conduct their own
tests to determine the suitability of our product for their particular purpose.
 9. Physical and chemical properties

General information
Physical state: Powder
Colour: Creamy
Odour: Neutral
Important health, safety and environmental information
Dust explosion category: ST1
Lower explosion limits: 30 g/m3
Water solubility: insoluble
Ignition temperature: 480 °C
Bulk density ca. 500 – 550 kg/m3
PH value 6 – 7 ( 10% suspension)
Dangerous reaction Dust explosion due to incorrect handling

10. Stability and reactivity data

Conditions to avoid
humidity and heat

Hazardous decomposition products

Does not decompose by proper application.

11. Toxicological information

Toxicological test
No toxic reaction known

12. Ecological information

Persistence and degradability

Easily biodegradable

13. Disposal considerations

Waste disposal number of waste from residue/unused products

020399
WASTES FROM AGRICULTURE, HORTICULTURE, AQUACULTURE, FORESTRY, HUNTING AND FISHING,
FOOD PREPARATION AND PROCESSING; wastes from fruit, vegetables, cereals, edible oils, cocoa,
coffee, tea and tobacco preparation and processing; conserve production; yeast and yeast extract
production, molasses preparation and fermentation; wastes not otherwise specified.

Waste disposal number of used products

020399
WASTES FROM AGRICULTURE, HORTICULTURE, AQUACULTURE, FORESTRY, HUNTING AND FISHING,
FOOD PREPARATION AND PROCESSING; wastes from fruit, vegetables, cereals, edible oils, cocoa,
coffee, tea and tobacco preparation and processing; conserve production; yeast and yeast extract
production, molasses preparation and fermentation; wastes not otherwise specified.
Contaminated packaging
Waste disposal according to official state regulations.

Royal Ingredients Group BV

Noorderstraat 1C Tel: +31 (0)72-5208080
1823 CS Alkmaar E-mail: [email protected]
The Netherlands Web: www.royal-ingredients.com

The information given is based on laboratory and field experience. It is set in good faith and for guidance only.
Royal Ingredients Group holds the right of changing the product specification. Users should conduct their own
tests to determine the suitability of our product for their particular purpose.
 14. Transport information

Land transport (ADR/RID)

Not a hazardous material with respect to these transportation regulations. Keep separated from food.
Inland waterways transport
Not a hazardous material with respect to these transportation regulations. Keep separated from food.
Marine transport
Not a hazardous material with respect to these transportation regulations. Keep separated from food.

Air transport
Not a hazardous material with respect to these transportation regulations. Keep separated from food.

15. Other regulatory information

National regulatory information

Water contaminating class: 1 – slightly water contaminating. A classification is not necessary at
application according to LFGB.

16. Other information

Royal Ingredients Group BV

Noorderstraat 1C Tel: +31 (0)72-5208080
1823 CS Alkmaar E-mail: [email protected]
The Netherlands Web: www.royal-ingredients.com

The information given is based on laboratory and field experience. It is set in good faith and for guidance only.
Royal Ingredients Group holds the right of changing the product specification. Users should conduct their own
tests to determine the suitability of our product for their particular purpose.
Alkmaar, 2 January 2018

Allergen Statement
Vital Wheat Gluten

Ingredient
Vital Wheat Gluten
Yes No
1
Cereals container gluten and products thereof X
Crustaceans and products thereof X
Eggs and products thereof X
Fish and products thereof X
Peanuts and products thereof X
Soybeans and products thereof X
Milk and products thereof X
Nuts and products thereof X
Celery and products thereof X
Mustard and products thereof X
Sesame and products thereof X
Sulphur dioxide and sulphites expressed as SO2 X
Lupins and products thereof X
Molluscs and products thereof X

Royal Ingredients Group B.V.

Quality department

Royal Ingredients Group BV

Noorderstraat 1C Tel: +31 (0)72-5208080
1823 CS Alkmaar E-mail: [email protected]
The Netherlands Web: www.royal-ingredients.com

The information given is based on laboratory and field experience. It is set in good faith and for guidance only.
Royal Ingredients Group holds the right of changing the product specification. Users should conduct their own
tests to determine the suitability of our product for their particular purpose.
To whom it may concern

Alkmaar, 02 January 2017

Royal Ingredients Group

GRAS statement

We herewith declare that the product: Vital Wheat Gluten under brand name Royal Lion
is generally recognized as safe.

Trust to have informed you sufficiently.

Royal Ingredients Group BV Tel: +31 (0)72-5208080

Noorderstraat 1 Fax: +31 (0)72-5208862
1823 CS Alkmaar E-mail: [email protected]
The Netherlands Web: www.royal-ingredients.com

The information given is based on laboratory and field experience. It is set in good faith and for
guidance only. Royal Ingredients Group holds the right of changing the product specification. Users
should conduct their own tests to determine the suitability of our product for their particular
purpose.
Alkmaar, 2 January 2018

To whom it may concern,

GMP Statement
Vital Wheat Gluten

Our Vital Wheat Gluten products are produced using applicable Good Manufacturing Practices (GMP).

The Food Safety Management System used by us is independently certified as meeting the
requirements of ISO22000 (HACCP), The FSMS reflects activities associated with both product
manufacturing and distribution.

Royal Ingredients Group B.V.

Quality department

Royal Ingredients Group BV

Noorderstraat 1C Tel: +31 (0)72-5208080
1823 CS Alkmaar E-mail: [email protected]
The Netherlands Web: www.royal-ingredients.com

The information given is based on laboratory and field experience. It is set in good faith and for guidance only.
Royal Ingredients Group holds the right of changing the product specification. Users should conduct their own
tests to determine the suitability of our product for their particular purpose.
Alkmaar, 2 January 2018

To whom it may concern,

Manufacturer’s declaration
Vital Wheat Gluten & Organic Vital Wheat Gluten

We herewith declare that above mentioned products are manufactured in compliance with:

· General Legislation: (EC) No 178/2002

· Hygiene of foodstuffs: (EC) No 852/2004
· Food contamination:
- (EC) No 1881/2006, max. levels for contaminants in food (e.g. nitrates, mycotoxins, heavy
metals and dioxins)
- (EC) No 396/2005, residues of pesticide
· Genetically modified organisms (GMOs)
- Regulation (EC) No 1829/2003 and Regulation (EC) No 1830/2003 on the authorization,
traceability and labelling of genetically modified food and feed are not applicable.

We herewith certify that our vital wheat gluten & organic vital wheat gluten:

· Are produced without of using glyphosate.

Royal Ingredients Group B.V.

Quality department

Royal Ingredients Group BV

Noorderstraat 1C Tel: +31 (0)72-5208080
1823 CS Alkmaar E-mail: [email protected]
The Netherlands Web: www.royal-ingredients.com

The information given is based on laboratory and field experience. It is set in good faith and for guidance only.
Royal Ingredients Group holds the right of changing the product specification. Users should conduct their own
tests to determine the suitability of our product for their particular purpose.
QM-Manual TITEL DATE

3.0 Starchplant 3.2.2.3 Vital Wheat Gluten !!!!"#!"

Frischwasser
flour Condensate EDA storage
C-silo

15 12
1
mixing water magnet
flour silo (MW) 12000 Gauss
tank
Neutralisation with Na2CO3 3

screw 2 LP from SDA 110

conveyor Bagging unit/ 14
transport
MW
Scales
process water
(PW) tank
3
kneader 1
SSE 300
DA 100
4
3a

kneader 2 magnet
5000 Gauss
C-starch starage tank
3b
MW LP to C-Starch tank 13
Rest grinding sifter

10
slurry tank Drytec
1+2
5
4

11 gas burner:
PW natural gas
heat exchanger

11

gas burner:
natural gas
8 9 13 heat exchanger

7 gluten gluten B 2000

Tricanter collective press vetterpress
(three-phase LP to EDA curved screen wascher 1 wascher 2
separation

6
MP to Gluten
PW-process water
9
MW-mixing water
Condensate
vetterpress FW-fresh water
EDA
sifter LP- "light" liquid phase
separation bran MP- "liquid" phase
sifter
separation bran HP-"heavy" liquid phase
to starchline
to bran washer

Overworked Vers.

0!.0".201# 9
 TITEL
QM-Manual DATE
3.0 Starchplant 3.2.2.3 Vital Wheat Gluten
!.1.201"

Gluten

15 17

C-Silo
gluten Silo gluten

Transport

16

18

Rüter Sifter

All-Metal- 19
Separator
20

Combi Silo

Starch

23 22 Transport
receiver receiver
21
tank tank

22a

Packing station 24
Paper bags
Metaldetection

23a

Big Bags
Packing station

25 Storage end product

Transport

26

Overworked Vers.

0!.0#.201" 9
QM-manual 3.2.2.4 Wheat Gluten

CCP,
hazard analysis CP,
No process step hazard potential management of control documents
PRP,
Cat. P C R statement of risk oPRP

1 flour storage pest infestation M g g 1 Plausibility "g": PRP !"#$%&'()*+&"#,"%-#'."'&.&*./#*"./0&%

The retention time in the silo are very short. By
the constantproduct flow no pest can accumulat.
Consequence "g":
The flour silo is used as buffering. The product
is processed immediately. The retention time is
not more than one hour.

2 neutralisation with pH-value of mixing water C g m 2 Plausibility "g": CP 1 !'&123)'"+#*.'#3"#,".-&"+3&)*/*1" 3.1.3

sodium carbonate The control of the pH-value happens function of the automat 3.1.4.1
automatically. Limit and warning values are !"456+#*.'#3 3.1.4.1a
given. The total loss of pH control is unlikely !"'&123)'"+#*.'#3"#,".-&"45"%&*%#' 3.1.2a Pkt. F, G
and is indicated by a warning signal. !"'&123)'"+3&)*/*1
Consequence "m":
It could be coming to a temporary increase of
the pH value in the product by a failure of the
pH control. There is no health risk in the end
product since most of soda is dissolves.
3 mixing water and foreign bodies, product P g g 1 Plausibility "g": PRP !"'&123)'"+3&)*/*1
process water tank residues No entry of foreign bodies from outside, closing
system.
Consequence "g":
The influence on the consumer is low due to the
following product processes.
3a recovery microbiological M g g 1 Plausibility "g": PRP !"'&123)'"+3&)*/*1 3.1.2a Pkt. F, G
DA 100/SSE 300 contamination Short retention time. No formation of death !"789 3.1.2b
areas. No entry of foreign bodies from the
outside, closing system.
Consequence "g":
Through following product process is a direct
effect unimportant to the consumer.

1 !.".#$"%; Vers.: 10
QM-manual 3.2.2.4 Wheat Gluten

CCP,
hazard analysis CP,
No process step hazard potential management of control documents
PRP,
Cat. P C R statement of risk oPRP

3b impeller type mixer foreign bodies, product P g g 1 Plausibility "g": PRP !"'&123)'"+3&)*/*1
remainders Short retention time. No formation of death
areas. No entry of foreign bodies from the
outside, closing system.
Consequence "g":
Through following product process is a direct
effect unimportant to the consumer.
4 dough production product remainders M g g 1 Plausibility "g": PRP !"'&123)'"+3&)*/*1
Short retention time. No formation of death !"789
areas. No entry of foreign bodies from the
outside, closing system.
Consequence "g":
Through following product process is a direct
effect unimportant to the consumer.
P g g 1 Plausibility "g":
The fraction of the machine elements not
happen according to experience.
Consequence "g":
Through following product process is a direct
effect impossible to the consumer.
5 slurry tank foreign bodies, product P g g 1 Plausibility "g": PRP !"'&123)'"+3&)*/*1
remainders Short retention time. No formation of death
areas. No entry of foreign bodies from the
outside, closing system.
Consequence "g":
Through following product process is a direct
effect unimportant to the consumer.

2 !.".#$"%; Vers.: 10
QM-manual 3.2.2.4 Wheat Gluten

CCP,
hazard analysis CP,
No process step hazard potential management of control documents
PRP,
Cat. P C R statement of risk oPRP

6 separation product remainders MP g g 1 Plausibility "g": PRP !"'&123)'"+3&)*/*1

decanter Short retention time. No formation of death
areas. No entry of foreign bodies from the
outside, closing system.
Consequence "g":
Through following product process is a direct
effect unimportant to the consumer.
7 dewatering foreign bodies, product P m g 2 Plausibility "m": PRP !"'&123)'"+3&)*/*1 3.1.3
curved screen residues Open process, thus entry from foreign bodies. 3.1.2a Pkt. F
Consequence "g":
The influence on the consumer is low due to the
following product processes.
8 washing foreign bodies, product P m g 2 Plausibility "m": PRP !"'&123)'"+3&)*/*1
Glutenwasher 1+2 residues Open process, thus entry from foreign bodies.
Consequence "g":
The influence on the consumer is low due to the
following product processes.
lubrication C g m 2 Plausibility "g": CP 2 !"2%&"#,"1'&)%&",#'".-&",##:"/*:2%.'; 1,7
gluten press The lubrication of the gluten press takes place !"'&3&)%&"%4&+/,/+)./#*<%2443/&'
fully automatic. By defects in the lubrication it !"&*.';"/*".-&"0)/*.&*)*+&"%+-&:23&
can come in rare cases to a carry over into the
product.
Consequence "m":
With bad maintenance to the lubrication, grease
can arrive into the process and contaminate thus
the product.
9 dewatering product remainders MP g g 1 Plausibility "g": PRP !"'&123)'"+3&)*/*1
press Short retention time. No formation of death
areas. No entry of foreign bodies from the
outside, closing system.
Consequence "g":
Through following product process is a direct
effect unimportant to the consumer.

3 !.".#$"%; Vers.: 10
QM-manual 3.2.2.4 Wheat Gluten

CCP,
hazard analysis CP,
No process step hazard potential management of control documents
PRP,
Cat. P C R statement of risk oPRP

10+ drying combustion residue C g m 2 Plausibility "g": CP 3 !"1)%"$2'*&'"0)/*.&*)*+& 3.1.4.3

11 gas burner By the use of synthetic filter materials, the !"'&4)/'"1)%"$2'*&' 3.1.4.3a
likelihood of breakage of the filter material is 3.1.4.3b
low. By clogged filters the production capacity
of the plant is disturbed, making it easy to
recognize.
Consequence "m":
With poor maintenance of the filter minimal
amounts of particles can contaminate the
product. By subsequent separator a major part
of the particles can be retained.
The disturbance of health is considered to be
minimal because of the possible share of
pollution experience has shown to be negligible.

12 magnet metal, machine abrasion P h g 3 Plausibility "h": oPRP1 !"+#*.'#3")*:"+3&)*/*1"#,".-&"0)1*&.% 3.1.4.5

Metal can come by repair and machine abrasion
into the product.
Consequence "g":
The process is protected by three magnets.
There is little chance that more than one magnet
fails at the same time. The magnets are
routinely checked and cleaned.
13 rest grinding metal, machine abrasion P g g 1 Plausibility "g": PRP
sifter Short retention time. No formation of death
areas. No entry of foreign bodies from the
outside, closing system.
Consequent "g":
Through following product process is a direct
effect on the consumer unimportant.

4 !.".#$"%; Vers.: 10
QM-manual 3.2.2.4 Wheat Gluten

CCP,
hazard analysis CP,
No process step hazard potential management of control documents
PRP,
Cat. P C R statement of risk oPRP

14 Scale metal, machine abrasion P g g 1 Plausibility "g": PRP

Short retention time. No formation of death
areas. No entry of foreign bodies from the
outside, closing system.
Consequent "g":
Through following product process is a direct
effect on the consumer unimportant.
15 storage product remainders MP g g 1 Plausibility "g": PRP !"%/3#"+3&)*/*1"132.&* 3.1.3.7
Silo C/ Gluten Short retention time. No formation of dead
space. No entry of foreign bodies from outside,
closing system.
Consequence "g":
The influence on the consumer is low due to the
following product processes.
16 to load in bulk impurities, P g g 1 Plausibility "g": PRP !"/*%.'2+./#*",#'".-&"%.)'+-"3#):/*1 3.1.4.6
by truck foreign bodies Dry storage. Short retention time. No entry of !"73&)*/*1"+&'./,/=).& GMP B 4.1
foreign bodies from the outside. 7.0
Consequence "g":
By upstream production processes have a direct
impact on the consumer is low.
17 storage product remainders MP g g 1 Plausibility "g": PRP !"%/3#"+3&)*/*1"132.&* 3.1.3.7
Gluten Short retention time. No formation of dead
space. No entry of foreign bodies from outside,
closing system.
Consequence "g":
The influence on the consumer is low due to the
following product processes.

5 !.".#$"%; Vers.: 10
QM-manual 3.2.2.4 Wheat Gluten

CCP,
hazard analysis CP,
No process step hazard potential management of control documents
PRP,
Cat. P C R statement of risk oPRP

18 control sifting impurities, P m g 2 Plausibility "m": oPRP 2 !">)/3;"%+'&&*"+#*.'#3"#* 3.1.4.4

bagging machine foreign bodies By the foregoing manufacturing steps, the risk Integrity of the screens
of contamination in the product is low. At break
sifter impurities can remain in the product, but
by downstream purification process they are
retained.
Consequence "g":
Daily checks schows that only grain product
and no product-foreign contaminants are
present.
On the basis of experience, the health
impairment is assessed as low.
19 All-Metal- product remainders P g g 1 Plausibility "g": PRP "!".&%./*1"#,",2*+./#*)3/.;
Separator By the foregoing manufacturing steps, the risk
of contamination in the product is low.
Consequence "g":
The process is protected by metal detector.
By a further metal detector has a direct impact
on the consumer is low.
20 storage silo product remainders MP g g 1 Plausibility "g": PRP !"%/3#"+3&)*/*1" 3.1.3.6
gluten Short retention time. No formation of death
areas. No entry of foreign bodies from the
outside, closing system.
Consequence "g":
Through previous product process is a direct
effect unimportant to the consumer.
21 transport impurities, P g g 1 Plausibility "g": PRP !"(/%2&3"+#*.'#3"#,".-&".'2+= GMP B 4.1
foreign bodies By the foregoing manufacturing steps, the risk !"+#*.'#3"+3&)*/*1"+&'./,/+).&% 3.1.4.6
of contamination in the product is low. !"+#*.'#3".')*%4#'."%&?2&*+&"#,"1##:%"
Consequence "g": transported
The impairment of health is assessed as minimal
as possible the share of pollution experience has
shown to be negligible.

6 !.".#$"%; Vers.: 10
QM-manual 3.2.2.4 Wheat Gluten

CCP,
hazard analysis CP,
No process step hazard potential management of control documents
PRP,
Cat. P C R statement of risk oPRP

22 receiver tank product remainders P g g 1 Plausibility "g": PRP !".)*="+3&)*/*1" 3.1.3.6

Short retention time. No formation of death
areas. No entry of foreign bodies from the
outside, closing system.
Consequence "g":
By the previous production process have a
direct impact on the finished product is low.
22a bagging machine migration of chemical C g g 1 Plausibility "g": PRP !"7&'./,/+).&"#,"*#*6#$@&+./#* N:\Büro\-
paper bags substance from paper or Employment of food safe paper bags and Spezifikationen -
printing ink into the printing ink. \Zertifikate\
product Consequence "g": Papiersäcke\Mon
Certificate of non-objection from the supplier. di_neu
23 receiver tank krosscontamination P h g 3 Plausibility "h": PRP !"+3&)*/*1"'2*%"
The Plausibility of product contamination is
taking place very high. By cleaning runs by
product changing the risk is reduced to
acceptable level.
Consequence "g":
The effect is considered to be very low, since
both products meet the food standard. When
insufficient cleaning, the contaminating amount
of product is very low.
23a bagging machine migration of chemical C g g 1 Plausibility "g": PRP !"7&'./,/+).&"#,"*#*6#$@&+./#* N:\Büro\-
big bags substance from big bags Employment of food safe big bags and printing Spezifikationen -
into the product ink. \Zertifikate\
Consequence "g": Papiersäcke\Mon
Certificate of non-objection from the supplier. di_neu

7 !.".#$"%; Vers.: 10
QM-manual 3.2.2.4 Wheat Gluten

CCP,
hazard analysis CP,
No process step hazard potential management of control documents
PRP,
Cat. P C R statement of risk oPRP

24 metal detector foreign bodies p g g 1 Plausibility "g": oPRPs 3 !"7-&+="#,"0&.)3":&.&=.#' 3.4

By the foregoing manufacturing steps, the risk
of contamination in the product is low.
Consequence "g":
The impairment of health is considered very
minimal, as the functionality of the device is
ensured by daily inspection and testing services.
The bags featured are taken out of the process.
When equipment fails, the bags are up to the
last successful test as "locked" and are
examined for possible contamination.
25 storage end- impurities, P g g 1 Plausibility "g": PRP !"+3&)*/*1"43)* 3.1.3.2
products foreign bodies Regular cleaning of the warehouse, physical !"+#*.'#3")*:"%&'(/+&"#,".-&"&3&+.'/+)3" 3.1.3.5
paletts/big bags separation from the production areas. flytraps 3.1.2a Pkt. F, I
Consequence "g":
Paper bags are palletized and wrapped in foil.
Big Bags are closed.
26 transport impurities, P g g 1 Plausibility "g": PRP !"(/%2&3"+#*.'#3"#,".-&".'2+= GMP B 4.1
foreign bodies By the preceding production steps a minor !"+#*.'#3"+3&)*/*1"+&'./,/+).&% 7.0
hazard of the pollution exists. !"+#*.'#3".')*%4#'."%&?2&*+&"#,"1##:%"
Consequence "g": transported
Keep clearly marked as "Locked", Lock the
delivery and to clarify the seriousness of the
contamination.
The impairment of health is assessed as minimal
as possible the share of pollution experience has
shown to be negligible.
Abbreviation: Cat. = Categorie, P = Plausibility, C = Consequence, R = Risk, M P C = (Mikro)biologic Physikal Chemical, g = minor, m = medium, h = major

8 !.".#$"%; Vers.: 10
QM-Manual 3.2.2.5 Monitoring plan (CP; CCP; oPRP)

control point sampling testing

process-step measure in the
after risk risk control point objectcheck target who where how often who where how to do how often records case of
analysis deviation

!"):@2%.&0&*."
2 pH-measure-
pH value to control-ling pH pH value shift in front of shift in front of shift of pH value
mixing water 6,5 ± 0.3 1x per shift ment after AA 1x per shift
high or to low control unit mixing water leader kneader 1 leader kneader 1 journal !"+)3/$')./#*"#,"
CP 1 3.1.4.1
pH control unit

!"+#*.'#3"A"
8 lubrication lubrication regular cycle lubrication regular cycle lubrication acc.
use of grease use of grease
lubrication residues of points points fixed in points visuel control + fixed in maintenance to maintenance
for food for food fitter fitter
glutenpress lubrication press above press above mainten-ance press above lubrication mainten-ance schedule schedule
industrie industrie
CP 2 gluten washer gluten washer schedule gluten washer schedule !"'&4)/'"
glutenpress

!"'&4)/'"1)%"
11
combustion monitoring of control maintenance service staff maintenance burner
drying standardized gas burner monthly gas burner visual control annual
residue the gas burner flame-property staff gas burner schedule !"1)%"$2'*&'"
CP 3
maintenance

oPPR, CCP control point control testing

processstep oPRP =with "acceptance measure in the
object
after risk risk control point criteria" who where how often who where how to do how often records case of
check
analysis CCP =with measurably limits deviation

12 Magnet !"B&4)/'")*:"
magnet shift Checklist
Magnet Metal, abrasion Magnet control + cleaning L13 1x per day lab staff Lab WI 3.1.4.5 1x per day cleaning of the
inspection leader Lab report
oPRP 1 L21 magnet

!C::"4'#:2+."
18
foreign bodies, control Rüter- shift Rüter-sifter specially silo
Gluten sifter foreign bodies Integrity of the screens 1x per day lab staff Lab WI 3.1.4.4 1 x per day Lab report
pollution Sifter leader L21 Check and
oPRP 2
repair Sifter

!"92."4'#:2+."
Regular into an extra
24
inspection of shift band-conveyor Checklist metal storage space
Metal detector Fe, non Fe, SS positily Test 100% sorting out of Testbag 1x per day area manager bagging unit WI 3.4 1 x per day
the Metatall- leader L22 detector !"D&.)3"
oPRP 3
detector detector control
and repair