16 December 2010
Flow chart of the production chain of palm oil and palm kernel oil products
for food application in the EU
(1) Cultivation of palm fruits
Transport to the oil mill
Palm fruits
(2) Production of crude oil
Processing of fruit bunches
Drying and processing of
palm kernels
Palm kernels
Storage and transport
Crude oil (A) Transport Storage
(D) Transport by
ocean going vessel
(3) Refining
Refined oil products
(B) Transport
EU FOOD
INDUSTRY
(4) Modification
(4.1) Fractionation
(4.2) Hydrogenation
(4.3) Interesterification
Fractionated oil products
Hydrogenated oil products
Interesterified oil products
Refining
Production of RBD oil
Fractionation
(5) Loading of
refined products
(B) Transport
RBD oil
RBD oil
RBD fractions
(C) Storage
OUTSIDE EU
INSIDE EU
Characters between brackets refer to those on the following sheets
(C) Storage
09SAF056 Rev6
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
1. Cultivation of palm fruits*
HAZARD CAT. CHANCE
SERIOUSNESS
*
RISK
CLASS.
PRP or CCP
JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Pesticide residues above
the MRL, i.e. residues of
herbicides, insecticides,
fungicides or rodenticides
above the MRL.
C The countries of export of
palm oil (Indonesia, Malaysia
and others) work with positive
lists for the use of pesticides
during cultivation which, for
some substances, may
conflict with European
pesticide residue legislation.
Hitherto no residues of
pesticides have been
detected in palm and palm
kernel oil.
EC Regulation No. 396/2005
prohibits putting into
circulation commodities that
do not comply with the MRLs
set in the annexes. EC
Regulation 459/2010 amends
the annexes II, III and IV
listing all pesticide MRLs by
products.
* Assessment of risks outside the EU is out of the scope of this document. See the methodology document paragraph 2.3 for more information.
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
2. Production of crude oil*
HAZARD CAT. CHANCE SERIOUSNESS
RISK
CLASS.
PRP or CCP JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Boiler chemicals C Increased risk at plants
without good manufacturing
practices.
Steam (using boiler chemicals) that
directly comes into contact with the
product must be suitable for use in the
food industry.
Recycling of contaminated
fat from fat traps in effluent
water.
C Effluent water may be
chemically contaminated.
Fat from fat traps in effluent water must
not be recycled for food application.
Hydraulic oil or lubricants
from equipment
C Hydraulic oils and lubricants
may contain toxic
compounds.
The prerequisite programme should
assure that the contamination of the
product with non-food grade hydraulic oils
or lubricants is avoided and that the risk of
contamination of the product with food
grade hydraulic oils and lubricants is
minimised. The prerequisite programme
could involve recording of the quantities
used.
Foreign bodies P Foreign bodies may be
present.
A system should be in place that removes
any foreign material.
PAHs
(only for palm kernels)
C BaP may be found in crude
palm kernel oil due to bad
drying practices.
JECFA (Joint FAO/WHO Expert
Committee on Food Additives)
recommends replacing direct drying by
indirect drying. In case of direct heating,
Good Manufacturing Practices recommend
not to use waste products as a fuel for
direct drying. Temperature and time
should be controlled to avoid PAH
formation. The equipment has to be kept
clean and well maintained.
EC Regulation No. 1881/2006 sets a 2.0
g/kg limit for BaP in oils and fats intended
for direct human consumption or use as an
ingredient in foods.
* Assessment of risks outside the EU is out of the scope of this document. See the methodology document paragraph 2.3 for more information.
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
Utilities: palm and palm kernel oil refining and processing.
HAZARD CAT. CHANCE SERIOUSNESS
RISK
CLASS.
PRP or CCP JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Hydraulic oils or lubricants
from equipment
C low high 3 PRP Hydraulic oils and lubricants may contain
toxic compounds.
The prerequisite programme
should assure that the
contamination of product with
non-food grade hydraulic oils
or lubricants is avoided and
that the risk of contamination
of the product with food grade
hydraulic oils and lubricants is
minimised. The prerequisite
programme could involve
recording of the quantities
used.
Quality of water
C low high 3 PRP Water is used in the crushing and refining
process.
Apply water of suitable
quality.
Cleaning agents and boiler
chemicals
C medium medium 3 PRP Cleaning agents and steam (using boiler
chemicals) come into contact with the
product.
Cleaning agents used in the
production system should be
flushed. Cleaning agents and
boiler chemicals must be
suitable for use in the food
industry.
Thermal heating fluids
(THF) from equipment
C medium high 4 CCP THF may still be used by non-FEDIOL
members.
According to the FEDIOL
Code of Practice on the
Heating of Edible Oils during
Processing, the use of THF is
not allowed*.
Use hot water or steam
heating. Otherwise, a control
measure should assure that
the contamination of product
with thermal heating fluids is
avoided.
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
3. Refining
HAZARD CAT. CHANCE SERIOUSNESS
RISK
CLASS.
PRP or CCP JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Processing aids C medium medium 3 PRP Processing aids come into
contact with the product.
Processing aids that directly come into
contact with the oil must be of food
grade quality or for food use.
Dioxin from bleaching earth C low high 3 PRP A potential source of dioxin
contamination during refining is
bleaching earth. Nevertheless,
the dosage level of bleaching
earth during refining is only 1-
3%.
EC Regulation No. 1881/2006, for
vegetable fats and oils sets a dioxin
limit of 0.75 ng/kg (WHO-PCDD/F-
TEQ) and one for the sum of dioxin
and dioxin-like PCBs of 1,5 ng/kg
(WHO-PCDD/F-PCB-TEQ).
FEDIOL has developed a Code of
Practice on the purchase conditions
of fresh bleaching earth for oil
refining, which includes a maximum
limit for dioxin and dioxin-like PCBs
of 1,5 ng/kg (WHO-PCDD/F-PCB-
TEQ) as upperbound value.
Source fresh bleaching earth
from suppliers that fulfil the
FEDIOL specifications on fresh
bleaching earth.
Pesticide residues above
the MRL, i.e. residues of
herbicides, insecticides,
fungicides or rodenticides
above the MRL.
C very low medium 1 Hitherto no residues of pesticides
have been detected in palm or
palm kernel oil.
EC Regulation No. 396/2005 sets
limits for residues of pesticides. This
regulation allows to use a transfer
factor for authorised pesticides into
processed products, providing food
safety is assured. EC Regulation
No. 459/2010 amends the annexes
II, III and IV listing all pesticide
MRLs by products.
Microbiological
contamination
B low medium 2 Moisture content (i.e. water
activity) in refined oils is too low
for bacteria to grow.
Adventitious presence of
allergens (from lecithin,
peanuts, nuts, sesame
seeds and products thereof)
C low high 3 PRP Potential cross contamination.
Allergic reactions may occur at
very low levels.
Directive 2000/13/EC as amended
by Directive 2003/89/EC requires
the mandatory labelling of
ingredients known to trigger
allergies or intolerances.
FEDIOL Code of Practice on the
Prerequisite programme to
prevent cross contamination.
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
production and labelling of certain
oils in connection with allergy.
PAHs
(only for palm kernel oil)
C medium high 4 CCP BaP levels may be found in
crude palm kernel oil .due to bad
drying practices. BaP is an
indicator for PAHs.
EC Regulation No. 1881/2006 sets
a 2.0 g/kg limit for BaP in oils and
fats intended for direct human
consumption or use as an ingredient
in foods.
Use of active carbon to verify
compliance with EU legislation.
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
4. Modification (general)
HAZARD CAT. CHANCE SERIOUSNESS
RISK
CLASS.
PRP or CCP JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Foreign materials P medium medium 3 PRP Foreign materials may be
present.
Filter before loading.
Processing aids C medium medium 3 PRP Processing aids come into
contact with the product.
Processing aids that directly
come into contact with the oil
must be for food use or of
food grade quality.
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
4.1 Fractionation (dry or wet)
HAZARD CAT. CHANCE SERIOUSNESS
RISK
CLASS.
PRP or CCP JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Contaminantion of the
stearin
P/C/B low high 3 PRP Open stearin collection tank. High-care zone and filtering.
Toxic compounds from
solvent
C low high 3 PRP Solvents are used for wet
fractionation. Probable use of
solvents that are not of food-
grade quality.
Directive 2009/32 sets purity
criteria for the use of solvents
for food production.
Use of solvents suitable for
use in the food industry
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
4.2 Hydrogenation
HAZARD CAT. CHANCE SERIOUSNESS
RISK
CLASS.
PRP or CCP JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Contamination with high
nickel levels
C medium medium 3 PRP Nickel used as a catalyst may
be incompletely removed after
filtration.
Proper post-refining or post-
bleaching.
France has a legal limit of
nickel in oil for food of 0.2
ppm and Denmark of 10 ppm
for oil for feed.
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
4.3 Interesterification
HAZARD CAT. CHANCE SERIOUSNESS
RISK
CLASS.
PRP or CCP JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR CONTRACT
TERMS
CONTROL MEASURE REMARKS
No hazards in addition to those listed
under 5. Modification (general)
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
5. Loading of refined products
HAZARD CAT. CHANCE SERIOUSNESS
RISK
CLASS.
PRP or CCP JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Foreign matter
P low high 3 PRP Foreign bodies may be
present.
FEDIOL Code of working
practice for bulk road and tank
container transport of fats and
oils for direct food use.
Filter before loading.
A quality plan should require
the loading of tank cars with
refined oils under a roof.
Microbiological
contamination
B low medium 2 Moisture content (i.e. water
activity) in refined oils is too
low for bacteria to grow.
Misuse of additives
C low medium 2 Misuse or overdosing of
additives may occur.
Directive 89/107/EEC.
Adventitious presence of
allergens (from lecithin,
peanuts, nuts, sesame
seeds and products thereof)
C low high 3 PRP Potential cross contamination.
Allergic reactions may occur
at very low levels.
Directive 2000/13/EC as
amended by Directive
2003/89/EC requires the
mandatory labelling of
ingredients known to trigger
allergies or intolerances.
FEDIOL Code of Practice on
the Production and Labelling
of certain oils in connection
with allergy.
Prerequisite programme to
prevent cross contamination.
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
A. Transport outside EU*
HAZARD CAT. CHANCE SERIOUSNESS
RISK
CLASS.
PRP or CCP JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Microorganisms B Due to residual water in a tank.
Contamination by previous
cargo
C Tank cars and barges may have been
used for non-food grade approved
products such as petrochemicals.
Tank cars and barges that are not
dedicated to the transport of foodstuff
should have undergone a proper
cleaning procedure.
Contamination by cleaning
agents
C Increased risk at cleaning stations that
clean both food and chemical tanks at
one site.
In Indonesia and Malaysia few cleaning
stations exist. However, those that
exist may have limited facilities and
may also be used for cleaning non-food
tank cars. Used cleaning water may be
re-used.
Cleaning agents must be suitable for
use in the food industry.
Heating or cooling fluids
from equipment
- Tank cars C The tanks are heated with cooling
water from the motor through a system
of double walls (and not internal coils).
Use of tank cars that use coils for heat
transfer should be banned. Instead
tanks that are equipped with double
walls have to be used.
- Barges C Toxic thermal heating fluids may still be
used. However, due to the relatively
low heating temperatures applied
during transport, the chance of leakage
of thermal heating fluids into the
product is low.
If thermal heating fluids have been
used, the transporter of the oil must
provide for documentation on possible
net losses and analyse accordingly if
necessary.
The use of hot water or steam heating
is recommended.
Adulteration C/P/B Adulteration can cause harm. FEDIOL Code of Practice on
Sampling and Analysis of all
imported crude vegetable oils
in bulk by ship into the EU.
Proper sealing system should be
applied.
* Assessment of risks in this part of the chain is out of the scope of this document. See the methodology document paragraph 2.3 for more information.
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
B. Transport inside EU
HAZARD CAT. CHANCE SERIOUSNESS
RISK
CLASS.
PRP or CCP JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Microorganisms B Low high 3 PRP Residual water in a tank can make
microorganisms grow.
Control drying process after
cleaning.
Contamination by previous
cargo
- Tank cars, rail tanks and
barges
C Low high 3 PRP Transport of oils is foodstuff dedicated. EC Regulation No. 852/2004
implies the transport of liquid
food stuffs by tank cars, rail
tanks and barges to be
dedicated.
FEDIOL code of working
practice for bulk road and tank
container transport of fats and
oils for direct food use.
Check previous cargoes via
FEDIOL practical guide to
previous cargo(es) for means of
transport and tank lining.
- Tank coasters C low high 3 PRP Tank coasters carrying oils and fats
during short sea voyages in the EU must
have as an absolute minimum as the
immediate previous cargoes a product
that is either a foodstuff or a product
appearing on the EU list of accepted
immediate cargoes of Directive 96/3/EC.
FEDIOL Code of Practice for
the transport in bulk of oils and
fats into or within the European
Union.
Check previous cargoes via
FEDIOL practical guide to
previous cargo(es) for means of
transport and tank lining.
Contamination by cleaning
agents
- Tank cars, rail tanks and
barges
C medium medium 3 PRP Increased risk at cleaning stations that
clean both food and chemical tanks on
one site.
FEDIOL Code of Practice for
the transport in bulk of oils and
fats into or within the European
Union.
FEDIOL code of working
practice for bulk road and tank
container transport of fats and
oils for direct food use.
Include safeguards to preclude
contamination of the food grade
cargo tanks and equipment by
steam, water and cleaning
agents used in the cleaning of
non-food grade cargo tanks.
FEDIOL code of working
practice for bulk road and tank
container transport of fats and
oils for direct food use includes
good practices for cleaning of
tanks.
- Tank coasters C medium medium 3 PRP Increased risk in case coaster is not
dedicated to foodstuff.
Selected cleaning stations must
have an implemented HACCP-
system. Demand a signed
cleaning certificate before
loading.
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
B. Transport inside EU (continued)
HAZARD CAT. CHANCE SERIOUSNESS
RISK
CLASS.
PRP or CCP JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Heating or cooling fluids
from equipment
- Tank cars C low high 3 PRP Stainless steel tanks are used which
are heated with cooling water from the
motor through a system of double walls
(and not coils).
FEDIOL Code of Practice for
the transport in bulk of oils
and fats into or within the
European Union.
- Rail tanks, tank barges and
coasters
C low high 3 PRP Toxic thermal heating fluids may still be
used. However, due to the relatively
low heating temperatures applied
during transport, the chance of leakage
of thermal heating fluids into the
product is low.
FEDIOL code of working
practice for bulk road and tank
container transport of fats and
oils for direct food use.
Heating coils of rail tanks
must be of stainless steel
(FEDIOL).
If thermal heating fluids have
been used, the transporter of
the oil must provide for
documentation on possible
nett losses and analyse
accordingly if necessary.
Foreign bodies P low high 3 PRP FEDIOL code of working
practice for bulk road and tank
container transport of fats and
oils for direct food use.
A quality plan should require
the loading of tank cars with
refined oils under a roof.
FEDIOL code of working
practice for bulk road and tank
container transport of fats and
oils for direct food use
includes good practices for
loading and unloading.
Adulteration C/P/B low high 3 PRP Adulteration can cause harm. FEDIOL code of working
practice for bulk road and tank
container transport of fats and
oils for direct food use.
Application of minimum
mandatory requirements in
FEDIOL code of working
practice for bulk road and tank
container transport of fats and
oils for direct food use.
Sealing of tanks where
possible.
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
C. Storage
HAZARD CAT. CHANCE SERIOUSNESS
RISK
CLASS.
PRP or CCP JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Contamination due to lack of
segregation (contamination
from previous cargoes, use of
incorrect joining, shared
equipment)
C low high 3 PRP This risk classification applies to
terminals that store both
chemicals and vegetable oils.
Less risk is involved when the
tank terminal applies the EU list
of acceptable previous cargoes
during sea transport to the
storage of vegetable oils. Least
risk is involved when the
vegetable oils are stored in
tanks that are dedicated to the
storage of foodstuffs.
Terminals in the EU that store
oils and fats for food application
are obliged to apply HACCP
(EC Regulation No. 852/2004).
Food or feed dedication of
storage tanks. Otherwise,
storage tanks must at least
adhere to the EU rules on
previous cargoes that have
been set up for sea transport in
Directive 96/3/EC.
Contamination by cleaning
agents
C low high 3 PRP This risk classification applies to
terminals that store both
chemicals and vegetable oils.
They may abstain from using
cleaning agents that are
suitable for use in the food
industry. For tank terminals in
the EU that apply HACCP and
that keep the storage of
vegetable oils and chemicals
separated, the chance of using
the wrong cleaning agents is
very low.
Cleaning agents must be
suitable for use in the food
industry.
Solvent from coating C low high 3 PRP Solvents from virgin coatings
migrating to the oil, which may
end up in the fatty acid
distillates during refining
Use stainless steel tanks or in
case of use of tanks with virgin
coating, do not feed the FAD
Misuse of additives C low high 3 PRP Additives allowed for food oil
applied to oil going to feed or
vice versa- for which use they
may not have been approved.
Agree on clear specifications as
regards use of additives
Misuse of additives
Thermal heating fluids from
equipment
C low high 3 PRP Toxic thermal heating fluids may
still be used. However, due to
the relatively low heating
temperatures applied during
storage, the chance of leakage
of thermal heating fluids into the
product is low.
If thermal heating fluids have
been used, the storage
company must provide for
documentation on net losses
and analyse accordingly, if
necessary.
The use of water and steam
heating is recommended.
16 December 2010 09SAF056rev6
Food
Risk assessment of the chain of palm and palm kernel oil products
D. Transport by ocean going vessel
HAZARD CAT. CHANCE SERIOUSNESS
RISK
CLASS.
PRP or CCP JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR CONTRACT
TERMS
CONTROL MEASURE REMARKS
Transport contamination
- Contamination by previous
cargoes present in tanks or
pipes
C medium medium 3 PRP Ocean going vessels carrying oils
and fats for edible use into the EU
must have as an absolute minimum
that the immediate previous cargoes
is a product that is either a foodstuff
or a product appearing on the EU
list of accepted immediate cargoes
of Directive 96/3/EC.
Directive 96/3/EC (Derogation to EC
Regulation No. 852/2004) requires
that previous loads have to be
checked.
FOSFA contracts oblige the seller to
inform the buyer what the three
preceding cargoes have been during
the sea transport of oils and fats.
FEDIOL Code of Practice for the
transport in bulk of oils and fats into
or within the European Union.
Before loading, FOSFA
recognised superintendents
need to check whether tanks
are sufficiently cleaned.
Before unloading, FOSFA
recognised superintendents
need to check the ships
logbook on compliance with
previous cargo lists.
The use of dedicated pipe
lines at loading and
unloading.
- Contamination by cleaning
agents
C low high 3 PRP Usually maritime business sticks to
good practice.
Check ship log-book.
Solvent from coating C low high 3 PRP Solvents from virgin coatings
migrating to the oil, which may end
up in the fatty acid distillates during
refining
Use stainless steel tanks or in
case of use of tanks with
virgin coating, do not feed the
FAD
Thermal heating fluids
(THF) from equipment
C low high 3 PRP Toxic thermal heating fluids may still
be used. However, due to the
relatively low heating temperatures
applied during transport, the chance
of leakage of thermal heating fluids
into the product is low.
If thermal heating fluids have
been used, the transporter of
the oil must provide for
documentation on possible
net losses and analyse
accordingly if necessary.
The use of water and steam
heating is recommended.
Hydraulic oils from portable
pumps
C low high 3 PRP Hydraulic oils from portable pumps
may be toxic.
The use of portable pumps
with clear separation of
hydraulic motor from pump. If
not, hydraulic oils of food
grade quality must be used.
Hydraulic motors that are
directly linked to the pump
allow for unwanted leakages
of hydraulic oil into the
vegetable oil in case of seal
failure.