Professional Documents
Culture Documents
in the EU
(1) Cultivation of soya (beans)
Characters between brackets refer to those on the following sheets
Refining outside EU
Soya (beans)
Production of refined
(2) Drying at primary production soya (bean) oil
(D) Transport by
OUTSIDE EU
ocean going (D) Transport by
vessel ocean going vessel
INSIDE EU
(5) Modification inside EU
(4) Refining
Hydrogenated soy oil products (5.1) Hydrogenation
Production of
(5.2) Interesterification
refined soya Interesterified soy oil products
(bean) oil (B) Transport (C) Storage
09SAF058 Rev6
Food
Risk assessment of the chain of soya (bean) oil products
Pesticide residues above C The countries of export of soya (beans) EC Regulation No. 396/2005 Regulation EC No 882/2004
the EU MRL, i.e. residues of (USA, Brazil, Argentina and Paraguay) prohibits putting into allows for the processing of
herbicides, insecticides, work with positive lists for the use of circulation commodities that non-compliant agricultural
fungicides or rodenticides pesticides during cultivation which, for do not comply with the MRLs commodities into compliant
above the EU MRL. some substances, may conflict with set in the annexes. EC food or feed products under
European pesticide residue legislation. Regulation No. 178/2006 the control of the authorities.
Regular monitoring of pesticides on soya establishes Annex I that lists
(beans) shows that residue levels remain the food and feed products for
within legal limits. which pesticide residue limits
apply. Regulation 149/2008
establishes Annexes II, III and
IV that sets the MRLs for the
products listed in Annex I.
Non-EU-authorised GMOs B Different pace of approval of new GMOs This is an issue of legal
between EU and third countries from compliance, rather than one of
which oilseeds are imported. Risk of food safety.
traces of non-EU-authorised GMOs
ending up in EU imported oilseeds.
Phytotoxins C Soya (beans) may contain weeds (only Visual inspection of soya
relevant for protein products). (beans) is recommended.
Contaminants caused by
drying
Hydraulic oils or lubricants C low high 3 Hydraulic oils, lubricants and thermal FEDIOL code of practice for Critical lubrication/fluid points
from equipment and/or heating fluids may contain toxic the management of mineral in the plants are identified and
thermal heating fluids (THF) compounds. oil hydrocarbons presence in clear procedures for the
from equipment vegetable oils and fats correct management of the
intended for food uses (ref lubrication/fluid systems are in
14COD 341). place to prevent/minimize
leakages/contact.
In all critical lubrication points,
only food grade lubricants are
used (i.e. lubricants suitable
for incidental contact with
food or lubricants for direct
food contact).
Equipment in the production
chain requires proper
lubrication to operate at
optimum performance and
reliability. In specific cases
where no food grade lubricant
with high quality could meet
the particular lubrication
requirements of an
equipment, a technical
solution should be found to
avoid leakage/contact.
Contaminants in water such C low high 2 Water is used in the crushing and refining Regulation 852/2004/EC is
as Perfluorooctane process. addressing water use.
sulfonate (PFOS) and
perfluorooctanoic acid
(PFOA)
Cleaning agents and boiler C medium medium 3 Cleaning agents and steam (using boiler Cleaning agents used in the
chemicals chemicals) come into contact with the production system should be
product. flushed. Cleaning agents and
boiler chemicals must be
suitable for use in the food
industry.
Toxins from pest control C low high 3 Poisoned grain from open boxes could A pest control programme
materials end up in the food chain. must be applied that is
suitable for use in the food
chain.
Toxic compounds from C low high 3 Industrial hexane may contain toxic Directive 2009/32 and its Food grade hexane must be
hexane such as benzene compounds. amendments sets purity used. An extraction solvent is
criteria for the use of hexane considered as being used in
during the crush of oilseeds. compliance with good
manufacturing practice if its
use results only in the
presence of residues or
derivatives in technically
unavoidable quantities
presenting no danger to
human health.
Foreign material such as P medium medium 3 Foreign material may be present. A system should be in place
glass, wood, metals, etc. that removes foreign material.
Contaminants from filter C low high 3 The crude oil can potentially wash FEDIOL Code of Practice and Use of filter aids that are
aids contaminants out of the filter aid. quality assurance agreement suitable for the food industry.
on the purchase and use
conditions of fresh bleaching Monitoring, establishment of
earth and filter aids for quality and safety criteria for
vegetable oils and fats the purchase of filter aids.
refineries and integrated
plants (Ref. 16COD137)
Mineral oils from a failing C medium medium 3 Low-medium viscosity mineral oil is used FEDIOL code of practice for Mineral oil of the recovery
recovery system for hexane recovery. It is in the interest of the management of mineral system must be suitable for
the crusher to recover as much hexane as oil hydrocarbons presence in incidental contact with food.
possible, and to thus maintain the vegetable oils and fats The prerequisite programme
recovery system well and thus to avoid intended for food uses (Ref should assure that the
that a possible contamination of the 14COD341). contamination of product with
mineral oil is washed out and carried to non-food grade oils is avoided
the vegetable oil by hexane. and that the risk of
contamination of the product
with is minimised. The
prerequisite programme could
involve recording of the
quantities used.
Pesticide residues above C low medium 2 . The level of a pesticide residue EC Regulation No.
the EU MRL, i.e. residues of exceeding the legal limit doesn’t 396/2005 sets limits for
herbicides, insecticides, necessarily mean a food safety issue. residues of pesticides. This
fungicides or rodenticides regulation allows using a
above the EU MRL. processing/concentration
factor for pesticides into
processed products, providing
food safety is assured. The
FEDIOL position on MRLs in
vegetable oils and fats
(11SAF181) concludes that
based on the average oil
content in soybeans, ranging
from 18-20%, a processing
factor of 5 should be used to
establish the MRL for fat
soluble pesticide residues in
soybean oil.
4. Refining
LEGISLATION, INDUSTRY
RISK
HAZARD CAT. CHANCE SERIOUSNESS JUSTIFICATION STANDARDS AND/OR CONTROL MEASURE REMARKS
CLASS.
CONTRACT TERMS
Contaminants in processing C low high 3 Processing aids come into contact with the Processing aids that directly
aids (such mercury in product. come into contact with the oil
caustic soda) must be for food use or of
food grade quality.
Dioxin and dioxin-like PCBs C low high 3 A potential source of dioxin contamination EC Regulation No. Source fresh bleaching earth Dioxin partly evaporates
for the oil is drying of soybeans and 1881/2006, and its from suppliers that fulfil the during distillation.
bleaching earth. However, the dosage amendment Commission FEDIOL specifications on
level of bleaching earth during refining is Regulation No 1259/2011, for fresh bleaching earth
only 1-3%. vegetable fats and oils sets a (16COD137).
dioxin limit of 0.75 ng/kg
(WHO-PCDD/F-TEQ) and
one for the sum of dioxin and
dioxin-like PCBs of 1.25
ng/kg (WHO-PCDD/F-PCB-
TEQ). The non-dioxin like
PCBs are specified as well.
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
(16COD137).
Pesticide residues above C low medium 2 The level of a pesticide residue exceeding EC Regulation No.396/2005 Refining of the crude oil
the EU MRL, i.e. residues of the legal limit doesn’t necessarily mean a sets limits for residues of is a control measure for
herbicides, insecticides, food safety issue. pesticides. This regulation regulatory compliance.
fungicides or rodenticides allows using a Regulation (EC)
above the EU MRL. processing/concentration 882/2004 allows for the
factor for pesticides into processing of non-
processed products, compliant agricultural
providing food safety is commodities into
assured. compliant food or feed
products under the
control of the authorities.
Adventitious presence of C low high 3 Potential cross contamination. Allergic Regulation 1169/2011 Prerequisite programme to This risk is only relevant
allergens from for example reactions may occur at very low levels. requires the mandatory prevent cross contamination. when different types of
peanuts, and products labelling of ingredients known oils are processed.
thereof to trigger allergies or
intolerances.
PAHs C low high 3 BaP may be found in crude soya (bean) oil EC Regulation No. Use of active carbon to verify Occurrence depends on
due to bad drying practices. BaP is an 1881/2006 sets a maximum compliance with EU origin of beans.
indicator for PAHs. limit at 2.0 μg/kg limit for BaP legislation.
and at 10 μg/kg for the sum
of four PAH in oils and fats
intended for direct human
consumption or use as an
ingredient in foods (excluding
cocoa butter and coconut oil).
Glycidyl esters (GE) C Medium High 4 Glycidyl esters can arise in refined oils FEDIOL Review of mitigation Implementation of mitigation See the dedicated
and fats during the refining process. measures on MCPD esters measures tailor-made to the FEDIOL webpage on 2,
and glycidyl esters (Ref refinery and commodity at 3 MCPD- and GE.
15SAF108). stake throughout the refining
Commission Reg (EU) process. FEDIOL members
2018/290 amending committed to a max level of
Regulation (EC) 1881/2006. GE of 1 mg/kg in the oils and
A Codex Alimentarius Code fats that they put on the
of Practice is under market for food as of
construction. September 2017.
3-MCPD esters C medium high 4 3-MCPD esters are substances formed FEDIOL Review of mitigation Implementation of mitigation See the dedicated
during the refining process. measures on MCPD esters measures tailor-made to the FEDIOL webpage on 2,
and glycidyl esters (Ref refinery and commodity at 3 MCPD- and GE.
15SAF108) stake throughout the refining
A Codex Alimentarius Code process.
of Practice is under
construction.
Lead C Very low High 2 Lead has poor oil solubility. EC Regulation 1881/2006
limits lead in fats and oil to
0.1 mg/kg wet weight.
5. Modification (general)
LEGISLATION, INDUSTRY
RISK
HAZARD CAT. CHANCE SERIOUSNESS JUSTIFICATION STANDARDS AND/OR CONTROL MEASURE REMARKS
CLASS.
CONTRACT TERMS
Foreign materials such as P medium medium 3 Foreign materials may be present. Filter before loading.
glass, metals, etc.
Contaminants in processing C low high 3 Processing aids come into contact with the Processing aids that directly
aids such as heavy metals product. come into contact with the oil
must be for food use or of
food grade quality.
5.1 Hydrogenation
LEGISLATION, INDUSTRY
RISK
HAZARD CAT. CHANCE SERIOUSNESS JUSTIFICATION STANDARDS AND/OR CONTROL MEASURE REMARKS
CLASS.
CONTRACT TERMS
Traces of nickel remaining C medium medium 3 Nickel used as a catalyst may be Proper post-refining or post- France has a legal limit
in the hydrogenated incompletely removed after filtration. bleaching. of nickel in oil for food of
product after filtration. 0.2 ppm.
Foreign materials such as P medum medium 3 Foreign bodies may be present. FEDIOL Code of working Filter before loading.
glass, wood, metals, etc practice for bulk road and
tank container transport of A quality plan should require
fats and oils for direct food the loading of tank cars with
use refined oils under a roof.
Misuse of additives C low Medium 2 Misuse or overdosing of additives may Regulation (EC) 1333/2008
occur.
Adventitious presence of C low high 3 Potential cross contamination. Allergic Regulation EU No 1169/2011 Prerequisite programme to This risk is only
allergens (from soy lecithin, reactions may occur at very low levels. requires the mandatory prevent cross contamination. applicable when
peanuts, nuts, sesame labelling of ingredients known different types of oils
seeds and products thereof) to trigger allergies or are processed and / or
intolerances. additives are used.
A. Transport of soya bean oil and derived products for food application by
tank car, rail tank, barge or coaster (excluding ocean going vessel).
RISK LEGISLATION, INDUSTRY STANDARDS
HAZARD CAT. CHANCE SERIOUSNESS JUSTIFICATION CONTROL MEASURE REMARKS
CLASS. AND/OR CONTRACT TERMS
Microbiological growth B Low High 3 Residual water in a tank can make Control drying after cleaning.
pathogens grow.
Contamination by previous
cargo
- Tank cars, rail tanks and C Tank cars and barges may have been Tank cars and barges that are
barges outside of the EU used for non-food compatible products not dedicated to the transport
such as petrochemicals. of foodstuff should have
undergone a validated
cleaning procedure.
- Tank cars, tank containers, C low high 3 Transport of vegetable oils for food The Food Hygiene Regulation EC No. Make sure a means of
rail tanks and barges following application is by means of transport 852/2004 requires the transport of liquid transport is marked “for
EU standards for the transport that are dedicated to food stuffs. food stuffs by tank cars, rail tanks and foodstuffs only”.
of food stuffs barges to be dedicated to that of food
stuffs.
Contamination by cleaning
agents
- Residues of detergents C medium medium 3 Increased risk at cleaning stations that Oils for processing: Apply good practices for
used to clean tank cars, rail clean both food and chemical tanks on FEDIOL Code of Practice for the cleaning of tanks
tanks and barges used for the one site. transport in bulk of oils and fats into or
transport of chemicals within the European Union (Ref .
14COD152 chapter A).
- Residues of detergents used C medium medium 3 Increased risk in case coaster is not FEDIOL Code of Practice for the FOSFA certificate of
to clean tank coasters used dedicated to foodstuff. This can be the transport in bulk of oils and fats into or compliance, cleanliness and
for the transport of chemicals case with the transport of crude within the European Union (Ref suitability of Ship’s tanks
vegetable oils and fats by coaster 014COD152 chapter B) (including issued by a FOSFA Member
(previous cargo to be on EU list of FOSFA operational procedures). Superintendent.
Acceptable Previous Cargoes in case FOSFA combined Masters
of stainless steel tank). Coasters that certificate signed by the
are carrying refined vegetable oils and Captain/First Officer or an
fats are dedicated to the transport of equivalent statement signed
food stuffs and are cleaned with water. by the ship’s owner or
In these cases the risk of contamination authorised agent, applicable
with residues of detergents is low. before any loading or cargo
transfer.
Heating or cooling fluids
from equipment
- Tank cars C low medium 2 Stainless steel tanks are used which Oils for processing: Use of thermal heating fluids
are heated with cooling water from the FEDIOL Code of Practice for the in direct heating systems is
motor through a system of double walls transport in bulk of oils and fats into or forbidden.
(and not coils). within the European Union (14COD152
chapter A).
- Rail tanks, tank barges C low high 3 Toxic thermal heating fluids may still be FEDIOL Code of Practice for the Heating coils of rail tanks The use of hot water or steam
used. However, due to the relatively transport in bulk of oils and fats into or must be of stainless steel. heating is recommended.
low heating temperatures applied within the European Union (14COD152 Thermal heating fluids in
during transport, the chance of leakage chapter A). direct heating systems is
of thermal heating fluids into the forbidden. The transporter of
product is low. the oil must provide for
documentation on possible
net losses of thermal heating
fluids and analyse accordingly
if necessary.
- Tank coasters C low high 3 Toxic thermal heating fluids may still be FEDIOL Code of Practice for the If thermal heating fluids have
used. However, due to the relatively transport in bulk of oils and fats into or been used, the transporter of
low heating temperatures applied within the European Union (14COD152 the oil must provide for
during transport, the chance of leakage chapter B) (including FOSFA operational documentation on possible
of thermal heating fluids into the procedures). net losses and analyse
product is low. accordingly if necessary.
Foreign material such as P medium medium 3 Oils for direct use: A quality plan should require
glass, wood, metals, etc. FEDIOL Code of working practice for the loading of tank cars with
bulk road and tank container transport of refined oils under a roof.
fats and oils for direct food use (Ref
07COD138).
Contamination due to C low high 3 This risk classification applies to terminals that Terminals in the EU that Food or feed dedication of
lack of segregation store both chemicals and vegetable oils. Less store oils and fats for food storage tanks. Otherwise,
(contamination from risk is involved when the tank terminal applies application are obliged to storage tanks must at least
previous cargoes, use of the EU list of acceptable previous cargoes apply HACCP (Regulation adhere to the EU rules on
incorrect joining, shared during sea transport to the storage of vegetable EC No. 852/2004) previous cargoes that have been
equipment) oils. Least risk is involved when the vegetable set up for sea transport in
oils are stored in tanks that are dedicated to the Regulation EU No 579/2014.
storage of foodstuffs.
Contamination by C low high 3 This risk classification applies to terminals that Cleaning agents must be suitable
cleaning agents store both chemicals and vegetable oils. They for use in the food industry.
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.
Solvent from coating C low high 3 Solvents from virgin coatings migrating to the oil, Do proper analyses on maiden oil
which may end up in the fatty acid distillates storage before accepting and
during refining monitor refining
Misuse of additives C low medium 2 Additives allowed for food oil applied to oil going
to feed –or vice versa- for which use they may
not have been approved.
LEGISLATION, INDUSTRY
SERIOUSNES RISK
HAZARD CAT. CHANCE JUSTIFICATION STANDARDS AND/OR CONTROL MEASURE REMARKS
S CLASS.
CONTRACT TERMS
Transport contamination
- Contamination by previous C medium medium 3 Bulk vegetable oils and fats Regulation 579/2014 (Derogation to FOSFA certificate of compliance,
cargoes present in tanks or imported into the EU undergo EC Regulation No. 852/2004) cleanliness and suitability of Ship’s
pipes refining before they are delivered for requires that previous loads have to tanks issued by a FOSFA Member
food application. Ocean going be checked. Superintendent. FOSFA combined
vessels carrying these oils and fats Masters certificate signed by the
into the EU must have as the FOSFA contracts oblige the seller to Captain/First Officer or an equivalent
immediate previous cargo a product inform the buyer what the three statement signed by the ship’s owner
that is either a foodstuff or a product preceding cargoes have been during or authorised agent, applicable
appearing on the EU list of accepted the sea transport of oils and fats. before any loading or cargo transfer.
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 (Ref
014COD152 chapter B) (including
FOSFA operational procedures).