Risk assessment:

Glycerin products (oleochemical

process) and Pure distilled fatty acids
from splitting

With regard to the risks for each type of vegetable oils, see relevant risk
assessment.

The risk assessment for 'Animal fat' applies to the risks associated with animal
fat.

Version: 03/07/2015
code: 332

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 Content
- Content
- Datasheet
- Flow charts
- Risk assessment

Datasheet
code Product Synonyms Definition
13.079 Glycerine, crude (from Cat.68/2013: 13.8.1 By product obtained from the oleochemical process of oil/fat splitting to obtain
the oleochemical fatty acids and sweet water, followed by concentration of the sweet water to get
process) crude glycerol.
13.080 Glycerine, refined (from Cat.68/2013: 13.8.2 Product obtained from the oleochemical process of oil/fat splitting followed by
the oleochemical concentration of sweet waters and refining by distillation or ion-exchange
process) process.
13.081 Pure distilled fatty acids Cat.68/2013: 13.6.7 Product obtained by the distillation of crude fatty acids from oil/fat splitting
from splitting potentially plus hydrogenation. By definition it consists of pure distilled fatty acids
C6-C24, aliphatic, linear, monocarboxylic, saturated and unsaturated. May
contain up to 50 ppm Nickel from hydrogenation.

Processing aids used during treatment and processing *)

Activated carbon
Hydrogen (H2)
Nickel (Ni)
Water (steam)
*) For the processing aids used in production it must be demonstrated by way of a hazards analysis that the unintentional but technically
unavoidable presence of residues of these processing aids or their derivatives in the end product has no detrimental effects on animal health,
human health or the environment and no technological effect at all on the end product. Attention should also be paid in carrying out the analysis to
the hazards of overdosage of processing aids and the presence of contaminants in the processing aids used. In the event of use as a feed additive
then the above does not apply and there should be compliance with the applicable community legislation and the compatible national legislation.

Risk assessment: Glycerin products (oleochemical process) and Pure distilled fatty acids from splitting 2/9
Version: 03/07/2015 © GMP+ International B.V.
Global
Flow chart Glycerin products and (oleochemical process) and Pure distilled fatty
acids from splitting.

Start process

1.1
1.2
Reception crude
Receptionof fats
or refined
(animal origin)*
vegetable oil*

2.
Processing

3.
Storage

4.
Transport

End process

*Animal origin products separated from Vegetal origin products

Risk assessment: Glycerin products (oleochemical process) and Pure distilled fatty acids from splitting 3/9
Version: 03/07/2015 © GMP+ International B.V.
Detail 1
Flow chart Glycerine products (oleochemical process) and Pure distilled fatty acids from
splitting.
Start Process

Vegetable oils, 1.1 Animal fat, see

1.2
see relevant risk Reception of relevant risk
Reception of fats
assessment crude or refined assessment
(Animal origin)
vegetal oil

2.1
Water
B Splitting
(steam)
(hydrolysis)

Sweet
Released
water Water
B crude fatty
(10-20% (steam)
acids
glycerol)

B Nickel
2.4
2.2 Hydrogenation
Concentration

C Hydrogen
gas

2.5
Glycerine, Distillation / Waste
A Fractioned (pitches)
crude
distillation

Pure distilled
2.3 fatty acids from
Packaging splitting*

2.6 Foreign
3.1 Packaging Filtration bodies
Storage materials

2.7
Packaging
4.1
Transport

3.2
Storage
End process
Crude glycerine

4.2
Transport
*The name shall be supplemented by the indication of the botanical or
animal origin.

End process
Pure distilled fatty acids
from splitting
Risk assessment: Glycerin products (oleochemical process) and Pure distilled fatty acids from splitting 4/9
Version: 03/07/2015 © GMP+ International B.V.
Detail 2
Flow chart Glycerine products (oleochemical process) and Pure distilled fatty acids from
splitting.

Glycerine,
crude
Water B

2.8
Distillation Volatils C
(under vacuum)

Waste
(pitches)

2.9
Active Active
Bleaching/
carbon carbon
Filtration

Foreign
bodies
Glycerine,
refined

Packaging 2.10
materials Packaging

3.3
Storage

4.3
Transport

End process
Glycerine, refined

Risk assessment: Glycerin products (oleochemical process) and Pure distilled fatty acids from splitting 5/9
Version: 03/07/2015 © GMP+ International B.V.
 Process step Hazard Risk assessment Information sources Reference in Suggestion for control measure
process
diagram
Description Category Severity Likely Standards
occurence
Reception Crop protection agents (Pesticides which
are not permitted in the EU)
Aldrin or Dieldrin chemical high low GMP+ BA1 1.1 - Establish purchasing
requirements
- Refinery
Camphechlor (toxaphene) chemical high low GMP+ BA1 1.1 - Establish purchasing
requirements
- Refinery
Chlordane chemical high low GMP+ BA1 1.1 - Establish purchasing
requirements
- Refinery
DDT chemical high low GMP+ BA1 1.1 - Establish purchasing
requirements
- Refinery
Endosulfan chemical high low GMP+ BA1 1.1 - Establish purchasing
requirements
- Refinery
Endrin chemical high low GMP+ BA1 1.1 - Establish purchasing
requirements
- Received product and/or raw
material analysis
- Refinery
HCH: Alfa-isomer chemical high low GMP+ BA1 1.1 - Establish purchasing
requirements
- Refinery
HCH: Beta-isomer chemical high low GMP+ BA1 1.1 - Establish purchasing
requirements
- Refinery
HCH: Gamma-isomer (lindane) chemical high low GMP+ BA1 1.1 - Establish purchasing
requirements
- Refinery
Heptachlor chemical high low GMP+ BA1 1.1 - Establish purchasing
requirements
- Refinery
Hexachlorobenzene (HCB) chemical high low GMP+ BA1 1.1 - Establish purchasing
requirements
- Refinery
Crop protection agents and biocides
Crop protection agents/biocides chemical high low GMP+ BA1 1.1 - Controlled use of biocides
- Refinery
Microbiological contamination
Enterobacteriaceae microbiological high low GMP+ BA1 1 - Heat treatment later in process
Salmonella microbiological high low GMP+ BA1 1 - Heat treatment later in process
Moulds and yeasts microbiological high low GMP+ BA1 1 - Entry and reception check
- Heat treatment later in process
Other undesirable substances and products

Risk assessment: Glycerin products (oleochemical process) and Pure distilled fatty acids from splitting 6/9
Version: 03/07/2015 © GMP+ International B.V.
 Process step Hazard Risk assessment Information sources Reference in Suggestion for control measure
process
diagram
Description Category Severity Likely Standards
occurence
Prohibited Animal proteins (according to chemical high low GMP+ BA1+BA3 1.2 - Entry and reception check
GMP+ BA1) - Establish purchasing
requirements
Peroxides chemical medium low 1 - Check of odour and appearance
- Product analysis (in oil)
Foreign bodies (in the product)
Glass physical high low 1 - Sieving / filtration /cleaning (later
in the process)
- Visual check on objects foreign to
the product
Wood (treated) physical high low GMP+ BA3 1 - Sieving / filtration /cleaning (later
in the process)
- Visual check on objects foreign to
the product
Plastics physical medium low GMP+ BA1 1 - Sieving / filtration /cleaning (later
in the process)
- Visual check on objects foreign to
the product
Metal particles physical high low 1 - Sieving / filtration /cleaning (later
in the process)
- Visual check on objects foreign to
the product
Packaging material: among others physical medium low GMP+ BA1+BA3 1.1 - Sieving / filtration /cleaning (later
Polyethylene in the process)
- Visual check on objects foreign to
the product
Sand, small stones physical medium low 1.1 - Sieving / filtration /cleaning (later
in the process)
- Visual check on objects foreign to
the product
Toxic substances
Dioxins and dioxin-like PCBs chemical high low GMP+ BA1+BA3 1 - Establish purchasing
requirements
- Received product and/or raw
material analysis
Non dioxin-like PCBs chemical high low 1.1 - Establish purchasing
requirements
- Received product and/or raw
material analysis
Hydrocarbons chemical high low GMP+ BA1 1.1 - Establish purchasing
requirements
- Product analysis (in oil)
Polycyclic Aromatic Hydrocarbons (PAH4) chemical high low 1.1 - Establish purchasing
requirements
- Received product and/or raw
material analysis
Heavy metals
Arsenic chemical high low GMP+ BA1 1 - Establish purchasing
requirements
- Refinery

Risk assessment: Glycerin products (oleochemical process) and Pure distilled fatty acids from splitting 7/9
Version: 03/07/2015 © GMP+ International B.V.
 Process step Hazard Risk assessment Information sources Reference in Suggestion for control measure
process
diagram
Description Category Severity Likely Standards
occurence
Cadmium chemical high low GMP+ BA1 1 - Establish purchasing
requirements
- Refinery
Mercury chemical high low GMP+ BA1 1 - Establish purchasing
requirements
- Refinery
Lead chemical high low GMP+ BA1 1 - Establish purchasing
requirements
- Refinery
Treatment / Processing Microbiological contamination
Enterobacteriaceae microbiological high low GMP+ BA1 2 - Closed production system
- Distillation temperature min.
200°C
- Finished product analysis
- High temperature and high
pressure
Salmonella microbiological high low GMP+ BA1 2 - Closed production system
- Distillation temperature min.
200°C
- Finished product analysis
- High temperature and high
pressure
Moulds and yeasts microbiological high low GMP+ BA1 2 - Closed production system
- Finished product analysis
- High temperature and high
pressure
Foreign bodies (in the product)
Glass physical high low 2 - Closed production system
- Sieving / Filtration / Cleaning
Wood (treated) physical high low GMP+ BA3 2 - Closed production system
- Sieving / Filtration / Cleaning
Plastics physical medium low GMP+ BA1 2 - Closed production system
- Sieving / Filtration / Cleaning
Metal particles physical high low 2 - Closed production system
- Sieving / Filtration / Cleaning
Toxic substances
Dioxins and dioxin-like PCBs chemical high low GMP+ BA1+BA3 2 - Closed production system
- Finished product analysis
Hydrocarbons chemical high low GMP+ BA1 2 - Closed production system
- Feed/Food grade lubricants
- Maintenance of machines and
safe fuels
Heavy metals
Arsenic chemical high low GMP+ BA1 2 - Finished product analysis
- Refinery
Cadmium chemical high low GMP+ BA1 2 - Finished product analysis
- Refinery
Mercury chemical high low GMP+ BA1 2 - Finished product analysis
- Refinery
Risk assessment: Glycerin products (oleochemical process) and Pure distilled fatty acids from splitting 8/9
Version: 03/07/2015 © GMP+ International B.V.
 Process step Hazard Risk assessment Information sources Reference in Suggestion for control measure
process
diagram
Description Category Severity Likely Standards
occurence
Lead chemical high low GMP+ BA1 2 - Finished product analysis
- Refinery
Nickel chemical high low GMP+ BA1 2 - Finished product analysis
- Refinery
Transport and Storage Microbiological contamination
Enterobacteriaceae microbiological high low GMP+ BA1 3, 4 - (Locked) closed storage
- (Locked) closed transport
Salmonella microbiological high low GMP+ BA1 3, 4 - (Locked) closed storage
- (Locked) closed transport
Moulds and yeasts microbiological high low GMP+ BA1 3, 4 - (Locked) closed storage
- (Locked) closed transport
Other undesirable substances and products
Peroxides chemical medium low 3 - Check of odour and appearance
- Product analysis (in oil)
Foreign bodies (in the product)
Glass physical high low 3, 4 - (Locked) closed storage
- (Locked) closed transport
- Packaged end products
- Prevent the introduction of objects
foreign to the product
Wood (treated) physical high low GMP+ BA3 3, 4 - (Locked) closed storage
- (Locked) closed transport
- Packaged end products
- Prevent the introduction of objects
foreign to the product
Plastics physical medium low GMP+ BA1 3, 4 - (Locked) closed storage
- (Locked) closed transport
- Packaged end products
- Prevent the introduction of objects
foreign to the product
Metal particles physical high low 3, 4 - (Locked) closed storage
- (Locked) closed transport
- Packaged end products
- Prevent the introduction of objects
foreign to the product
Toxic substances
Hydrocarbons chemical high low GMP+ BA1 3, 4 - Feed/Food grade lubricants
- Maintenance of machines and
safe fuels

Risk assessment: Glycerin products (oleochemical process) and Pure distilled fatty acids from splitting 9/9
Version: 03/07/2015 © GMP+ International B.V.