PRODUCT SPECIFICATION – FOOD INGREDIENTS

Brenntag Benelux Documentation

1. PRODUCT IDENTIFICATION

Supplier product name Supplier product number Origin
Manufacturer

Country

Certification manufacturer:

MONOPROPYLENE GLYCOL USP 14244
Chemical synthesis
Lyondell Basel

Date of issue: 09/12/2021

Replaces: 31/07/2019

Netherlands ISO 9001

1.1 Composition

Single ingredient

Chemical name
Chemical formula
Molecular weight
1.2 Legislative information

1,2-Propanediol CH3-CHOH-CH2OH 76,09

CAS-No INTRASTAT CODE EINECS
Legal declaration

Appearance Colour Odour/taste Assay
Density
Colour Refraction index Boiling range

57-55-6 2905320000 200-338-0 E1520

2. PRODUCT INFORMATION
	Unit	Specification	Method
2.1 Physical and Chemical properties

% kg/l Pt-Co

oC oC

Clear, viscous liquid Colourless Odourless
min. 99,8

1,035 – 1,037 max. 10 1,431 – 1,432 min. 185 max. 189

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E1520 E1520

IBP DP

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BTW nr. : BE0405317567 • KvK Deerlijk no.: HRKortrijk 76927
BRENNTAG Nederland B.V. • Donker Duyvisweg 44 • NL-3316 BM DORDRECHT Tel. +31(0)78/65.44.944 • Fax +31(0)78/65.44.919 • info@brenntag.nl • www.brenntag.nl BTW nr. : NL001375945B01 • KvK Dordrecht no.: 30112931

PRODUCT SPECIFICATION – FOOD INGREDIENTS

MONOPROPYLENE GLYCOL USP

2.2 Microbiological data

See documentation Lyondell

Water
Sulphate (SO4)
Heavy Metals (as Pb) Chloride (Cl)
Arsenic (As)
Iron( Fe)
Lead (Pb)
Residue on ignition
Acidity
Oxidizing substances Reducing substances Monoethylene glycol (MEG) Diethylene glycol (DEG)

%
%
ppm
ppm
ppm
ppm
ppm
%
ml
ml Thiosulphate

ppm ppm

max. 0,2 max. 0,002 max. 5 max. 1 max. 1 max. 0,5 max. 1 max. 0,005 max. 0,05 max. 0,2 Conform max. 80 max. 80

E1520

E1520
E1520
0,1N NaOH/10 ml

2.3 Contaminants

2.3.1 Chemical contaminants

2.3.2 Physical contaminants

Foreign body control

Energy
Energy
Protein Carbohydrate :

Of which Sugars

N.A.

kJ/100g kcal/100g g/100g g/100g g/100g

1,672 0,4
0
100

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2.4 Nutritional Information (Regulation EC 1169/2011)

2.4.1 Nutritional Values

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PRODUCT SPECIFICATION – FOOD INGREDIENTS

MONOPROPYLENE GLYCOL USP

Fat :

Polyols Starches Others

Of which Saturated Mono-unsaturated Poly-unsaturated Transfatty acids Cholesterol

g/100g g/100g g/100g g/100g g/100g g/100g g/100g g/100g mg/100g mg/100g g/100g g/100g

mg/100g mg/100g mg/100g mg/100g mg/100g mg/100g

100 0
0
0

0
0
0
0
0
0
max. 0,2

max. 7 max. 0,1 max. 0,05

Direct Contamination

N
N
N
N
N
N NNN

Fiber
Water
Organic acid 2.4.2 Minerals Ash
Chlorine (Cl) Iron (Fe) Copper Phosphorus Others:

3. FOOD INTOLERANCES

3.1 Allergens (Regulation EC 1169/2011 annex II)

Y / N

Cross-Contamination (Risk)

Cereals containing gluten, namely: wheat, rye, barley, oats, spelt, kamut or their hybridised strains, and products thereof

Crustaceans and products thereof

Eggs and products thereof

Fish and products thereof

Peanuts and products thereof

Soybeans and products thereof

Milk and products thereof (including lactose)

Nuts, namely: almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans

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N N N N N N

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PRODUCT SPECIFICATION – FOOD INGREDIENTS

MONOPROPYLENE GLYCOL USP

regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoinensis (Wangenh.) K. Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia or Queensland nuts (Macadamia ternifolia), and products thereof

Celery and products thereof Mustard and products thereof

Sesame seeds and products thereof

Sulphur dioxide and sulphites ( > 10 mg/kg or 10 mg/litre SO2)

Lupin and products thereof
Molluscs and products thereof
3.1a Allergens (acc. Pharma)

Benzoic acid) BHA/BHT (E320/E321) Carnut
Cinnamon
Fructose
Gelatin
Glutamate (E620-E625) Gluten

Tartrazine (E102)
Orange yellow (E110)
Azorubine (E122)
Amaranth (E123)
Cochineal red A (E124)
Erythosine (E127)
Red 2 G (E128)
3.2 Suitability for other diets Coeliacs
Halal (Statement
Kosher

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NN N NN N NN N NNN NNN NNN

Y/N Y/N

N Parabenes N N Pulses N N Rye N N Saccharose N N Sorbic acid (E200-E203) N N Umbelliferea N N Vanillin N N Y east N

N Allures red (E129) N N Patente blue (E131) N N Indigotine (E132) N N Brilliant black BN (E151) N N Brown FK (E154) N N Chocolate brown HT (E155) N N

Y Lactose intolerant Y N Vegans Y Y Vegetarian Y

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PRODUCT SPECIFICATION – FOOD INGREDIENTS

MONOPROPYLENE GLYCOL USP

3.3 GMO Declaration (Regulations EC 1829/2003 and EC 1830/2003)

MONOPROPYLENE GLYCOL USP does not contain genetically modified organisms and is not produced using raw materials of a genetically modified origin. At no stage during production does the product comes into contact with genetically modified organisms.
MONOPROPYLENE GLYCOL USP is falling under the scope of the EC Regulation n° 1829/2003 on genetically modified food and feed and the EC Regulation n° 1830/2003 on the traceability and labeling of genetically modified organisms and the traceability of products derived from them and to modification of Directive 2001/18/EC.

3.4 Irradiation (Regulations EC 1999/2 and 1999/3)

This product was not subject to any kind of irradiation treatment

For the manufacturing of the product, no solvents are used.
This product complies with ICH guideline Q3D on residual solvents.

3.7 Regulatory information

The product complies with:

European Pharmacopeieae, USP, JP and FCC, E1520
EC Regulation 231/2012/EC on food additives listed in Annexes II and III (MONOPROPYLENE GLYCOL). EC Regulation n° 1881/2006 setting maximum levels for certain contaminants in foodstuffs.

The production plant complies with:

EC Regulation n° 852/2004 on hygienic requirements for the manufacturing of raw materials in the food industry.

3.5 BSE/TSE Declaration

The used ingredients for MONOPROPYLENE GLYCOL USP are not of animal origin. The processing equipment and the packing material which is used to manufacture, pack or fill the products into the packing units do not come into contact with any meat or meat by- product.

3.6 Residual Solvents, complies with

Brenntag Benelux Documentation

GLYCERINE VEGETABLE (E422) PHARM. KOSHER

1. PRODUCT IDENTIFICATION

Supplier product name Supplier product number Origin
Manufacturer

Country

Certification manufacturer:

GLYCERINE VEGETABLE (E422) PHARM. KOSHER 12856
Vegetable
Several

Date of issue: 25/06/2021

Replaces: 11/09/2019

Several ISO 9001

1.1 Composition

Single ingredient

Chemical name
Chemical formula
Molecular weight
1.2 Legislative information

Glycerine, glycerol C3H8O3
92,0938

CAS-No INTRASTAT CODE EINECS
Legal declaration

Appearance
Colour
Odour/taste
Assay
Water
Colour
Refractive index (20 ̊C) Rel. Density (20 ̊C) Impurity A

56-81-5 290545 200-289-5 E422

2. PRODUCT INFORMATION
	Unit	Specification	Method
2.1 Physical and Chemical properties

wt% wt% APHA D 20 kg/l %

Clear liquid Colourless Odourless min. 99,5 max. 0,5 max. 10 1,470 – 1,475 Min. 1,26 max. 0,1

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Ph.Eur.
E422, Ph.Eur.; KF Ph.Eur.; ISO2211 E422, Ph.Eur. USP

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PRODUCT SPECIFICATION – PHARMA INGREDIENTS

GLYCERINE VEGETABLE (E422) PHARM. KOSHER

Other imp. R (t) % Sum of imp. R (t) %

2.2 Microbiological data

max. 0,1 max. 0,5

max. 10 max. 10 max. 10 max. 10 max. 1 max. 1 Absent/25 g

max. 0,2 max. 10 max. 0,01 max. 10 min. 8 max. 35 max. 5 Negative max. 0,2 max. 0,1 max. 3 max. 1 max. 2 max. 1

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TVC
Yeast
Moulds Enterobacteriaceae Feacal Streptococces E-Coli

Salmonella spp.

Acidity or alkalinity Aldehydes
Sulphated ash
Chloride (Cl)
Esters
Halogenated compounds Heavy metals (as Pb) Sugar

Butanetriols

Fatty acids&esters as butaric acid

Arsenic Cadmium Lead Mercury

cfu/g cfu/g cfu/g cfu/g cfu/g cfu/g

ml NaOH 0.1 M mg/kg
%
ppm

ml HCl 0.1 M ppm
ppm

%
% mg/kg mg/kg mg/kg mg/kg

Ph.Eur. Ph.Eur. E422, Ph.Eur. Ph.Eur. Ph.Eur. E422, Ph.Eur. E422, Ph.Eur.

2.3 Contaminants

2.3.1 Chemical contaminants

2.3.2 Physical contaminants

Foreign body control Filter

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PRODUCT SPECIFICATION – PHARMA INGREDIENTS

GLYCERINE VEGETABLE (E422) PHARM. KOSHER

2.4 Nutritional Information ( Directive 90/496/EC, amended by 2003/120/EC and 2008/100/EC)

2.4.1 Nutritional Values

Energy
Energy
Protein Carbohydrate :

kJ/100g kcal/100g g/100g g/100g g/100g g/100g g/100g g/100g g/100g g/100g g/100g g/100g g/100g mg/100g g/100g g/100g

mg/100g mg/100g mg/100g mg/100g mg/100g mg/100g

0
0
0
0
0
0
0
max. 0,5 –

Fat :

Of which Sugars Polyols Starches Others

Of which Saturated Mono-unsaturated Poly-unsaturated Transfatty acids Cholesterol

Water
Organic acid 2.4.2 Minerals Sodium Calcium
Zinc
Copper Phosphorus Others:

–

Direct Contamination

3. FOOD INTOLERANCES

3.1 Allergens (Directives 2000/13/EC, 2003/89/CE 2007/68/EC)

Y / N

Cross-Contamination (Risk)

Barley N N N Beef N N N

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Brenntag NV with ISO22001 and FSSC22000 system certified by DNV GL

PRODUCT SPECIFICATION – PHARMA INGREDIENTS

GLYCERINE VEGETABLE (E422) PHARM. KOSHER

Cacao Carrot

Celery and celery products

Cereals containing gluten and products produced with these (wheat, rye, oats, spelt, barley)

Chicken

Coriander

Crustaceans and Shellfish

Eggs and egg products

Fish and fish products

Glutamate

Lupin and products thereof

Milk and milk products ( incl. Lactose)

Molluscs and products thereof

Mustard and mustard products

Nuts and nut products (almonds, hazelnuts, walnuts)

Peanuts and peanut products Pork
Sesame and sesame products Soybean and soybean products Sulphite (E221 – E228)

Sulphur dioxide ( > 10 mg/kg )

3.2 Suitability for other diets

Coeliacs
Halal
Kosher
3.3 GMO Declaration, acc. Regulations 298/2008/EC and 1830/2003/EC

N N N N N N NN N NNN N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N NNN

N N N N N N N N N N N N

N N N N N N

Y Lactose intolerant

Y Y Y

Y Vegans (not certified)

Y Vegetarian

GLYCERINE VEGETABLE (E422) PHARM. KOSHER does not contain genetically modified organisms and is not produced using raw materials of a genetically modified origin. At no stage during production does the product comes into contact with genetically modified organisms.
GLYCERINE VEGETABLE (E422) PHARM. KOSHER is falling under the scope of the EC Regulation n° 1829/2003 on genetically modified food and feed and the EC Regulation n° 1830/2003 on the traceability and labeling of genetically modified organisms and the traceability of products derived from them and to modification of Directive 2001/18/EC.

BRENNTAG N.V. • Nijverheidslaan 38 • BE-8540 DEERLIJK
Tel. +32(0)56/77.69.44 • Fax +32(0)56/77.57.11 • info@brenntag.be • www.brenntag.be

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PRODUCT SPECIFICATION – PHARMA INGREDIENTS

GLYCERINE VEGETABLE (E422) PHARM. KOSHER

3.4 Irradiation, acc. Directive 1999/2/EC and 1999/3/EC

This product was not subject to any kind of irradiation treatment

For the manufacturing of the product, no solvents are used. This product is in compliance with the Guideline CPMP/ICH/283/95 and chapter <467> of the current edition of the USP-NF for residual solvents.

3.7 Regulatory information

The product complies with:

Ph. Eur., USP, FCC, JP, E422
EC Regulation 231/2012/EC on food additives listed in Annexes II and III (GLYCERINE VEGETABLE). EC Regulation n° 1881/2006 setting maximum levels for certain contaminants in foodstuffs.

The production plant complies with:

EC Regulation n° 852/2004 on hygienic requirements for the manufacturing of raw materials in the food industry.

4. PACKAGING

Packaging description

Packaging net content

Different packagings on request

Paletisation

3.5 BSE/TSE Declaration

The used ingredients for GLYCERINE VEGETABLE (E422) PHARM. KOSHER are not of animal origin. The processing equipment and the packing material which is used to manufacture, pack or fill the products into the packing units do not come into contact with any meat or meat by- product.

3.6 Residual Solvents, complies with

Bulk / cans / drums/ IBC
– / 25 / 262 /500,1100,1250kg

Yes

5. STORAGE CONDITIONS

Storage conditions

Shelf life
(recommended re-analysis)

6. DISCLAIMER

Must be kept in a cool, dry and well ventilated environment, in closed original packaging

12 months after production, under the above mentioned conditions

The content of the Product Specification Sheet is completed to the best of our knowledge. This document does not dismiss the user of his legal obligation with respect to food safety.

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Brenntag NV with ISO22001 and FSSC22000 system certified by DNV GL