EXTRACTION SOLVENTS FOR FOODSTUFFS ġ S.L.231.41 1
SUBSIDIARY LEGISLATION 231.41
EXTRACTION SOLVENTS FOR FOODSTUFFS 
REGULATIONS
27th April, 1999
Legal Notice 25 of 1999.
Title.
Foodstuffs Regulations.
Interpretation.
unless the context otherwise requires -
"solvent" means any substance for dissolving a foodstuff or any
component thereof, including any contaminant present in or on that
foodstuff; and
"extraction solvent" means a solvent which is used in an
extraction procedure during the processing of raw materials, of
foodstuffs, or of components or ingredients of such products and
which is removed but which may result in the unintentional but
technically unavoidable presence of residues or derivatives in the
foodstuff or food ingredient.
Permitted list of 
extraction solvents.
3.1 Only the substances and materials permitted by these
regulations may be used as extraction solvents in the processing of
raw materials, foodstuffs, food components or food ingredients and
only under the specified conditions of use and within the maximum
residue limits, if any.
3.2 The following extraction solvents are permitted for all
uses, in accordance with good manufacturing practice provided that
any resulting residues or derivatives are present only in technically
unavoidable quantities presenting no danger to human health:
Propane Acetone *
Butane Nitrous oxide
Ethyl acetate Carbon.
Ethanol
3.3 The following extraction solvents may be used only under
the specified conditions of use:
*The use of acetone in the refining of olive pomace oil is prohibited.
Name/condition of use (summary 
description of extraction)
Maximum residue limits in extracted 
foodstuff or food ingredient
Hexane 2
(A commercial product consisting
essentially of acyclic saturated
hydrocarbons containing 6 carbon
atoms and distilling between 64°C
and 70°C)
2 ġ S.L.231.41 EXTRACTION SOLVENTS FOR FOODSTUFFS
3.4 The following extraction solvents may be used only under
the specified of use:
Production or fractionation of fats
and oils and production of cocoa
butter
1 mg/kg in fat or oil or cocoa
butter
Preparation of defatted protein
products and defatted flours
10 mg/kg in the food containing
the defatted proton products and
defatted flours
30 mg/kg in the defatted soya
products as sold to final consumer
Preparation of defatted cereal germs 5 mg/kg in defatted cereal genes
Methyle acetate
Decaffeination of, or removal of
irritants and bitterings from coffee
and tea
20 mg/kg in coffee or tea
Production of sugar from molasses 1 mg/kg in sugar
Ethyl methyl ketone 3
Fractionation of fats and oils 5 mg/kg in fat or oil
Decaffeination of, or removal of
irritants and bitterings from coffee
and tea
20 mg/kg in coffee or tea
Dichloromethane
Decaffeination of, or removal of
irritants and bitterings from coffee
and tea
2 mg/kg in roasted coffee, 5 mg/
kg in tea
Methanol
All uses 10 mg/kg
Propan-2 ol
All uses 10 mg/kg
2 The combined use of hexane and ethyl methyl ketone is prohibited.
Name Maximum residue limits in 
foodstuffs due to use of 
extraction solvents in 
preparation of flavourings from 
natural flavouring materials
Diethyl ether 2 mg/kg
Hexane 3 1 mg/kg
Cyclohexane 1 mg/kg
Methyl acetate 1 mg/kg
Butan-1-ol 1 mg/kg
Butan-2-ol 1 mg/kg
Ethyl methyl ketone 3 1 mg/kg
Dichloromethane 0.02 mg/kg
Propan-1-ol 1 mg/kg
1, 1, 1, 2-tetrafluoroethane 0.02 mg/kg
3 The presence of n-hexane in this solvent should not exceed 50 mg/kg. This solvent may not
be used in combination with hexane.
Name/condition of use (summary 
description of extraction)
Maximum residue limits in extracted 
foodstuff or food ingredient
EXTRACTION SOLVENTS FOR FOODSTUFFS ġ S.L.231.41 3
Additional 
authorisations.
3.5 The use as solvents for the extraction of flavourings from
natural flavouring materials of substances used for diluting or
dissolving flavourings is allowed.
3.6 Water, to which substances regulating acidity or alkalinity
may have been added, other foodstuffs with solvent properties and
ethanol are authorised as extraction solvents in the manufacture of
foodstuffs or food ingredients.
Applicability.
intended for use in the production of foodstuffs or food ingredients.
4.2 These regulations shall apply without prejudice to
provisions adopted under more specific regulations.
4.3 These regulations shall apply equally to foodstuffs or food
ingredients imported into Malta, in the production of which
extraction solvents have been used.
4.4 These regulations shall not apply to extraction solvents or
to foodstuffs intended for export from Malta.
4.5 These regulations shall not apply to extraction solvents
used in the production of food additives, vitamins and other
nutrients unless these are listed in regulations 3.2, 3.3 or 3.4 and
provided that the use of food additives, vitamins and other nutrients
does not result in foodstuffs containing extraction solvent residue
levels which are dangerous to human health.
Labelling.
which are intended for use as extraction solvents in foodstuffs may
only be marketed if their packaging, labels or containers carry the
following information which must be clearly visible, legible and
indelible:
5.1.1 the commercial name of the substance as listed in
regulations 3.2, 3.3 and 3.4;
5.1.2 a clear indication that the material is of a quality suitable
for use for the extraction of food or food ingredients;
5.1.3 an identifying batch or lot reference;
5.1.4 the name or business name and address of the
manufacturer, packer or of a seller established in Malta;
5.1.5 the net quantity, in units of volume;
5.1.6 if necessary, any special storage conditions or conditions
of use.
5.2 The information specified in regulations 5.1.3, 5.1.4, 5.1.5
and 5.1.6 may appear only on the trade documents relating to the
batch or lot which are to be supplied with or prior to the delivery.
5.3 The provisions laid down in this regulation shall apply
without prejudice to more precise or more extensive provisions
regarding weights and measures or provisions applying to the
classification, packing and labelling of dangerous substances and
preparations.
5.4 The particulars provided for in this regulation shall appear
in Maltese, English or Italian. This provision shall not prevent such
4 ġ S.L.231.41 EXTRACTION SOLVENTS FOR FOODSTUFFS
particulars from being additionally indicated in other languages.
Purity criteria. 6.1 The substances and materials listed as extraction solvents
in regulations 3.2, 3.3 and 3.4 shall not contain a toxicologically
dangerous amount of any element or substance and, unless specific
purity criteria determine otherwise, shall not contain more than 1
mg/kg of arsenic or more than 1 mg/kg of lead.
Danger to health. 6.2 The Superintendent of Public Health may temporarily
suspend or restrict the use of any extraction solvent if there are
detailed grounds for establishing that the use in any foodstuff of the
substance or the level of one or more of the solvent’s components
might endanger human health.
