EXTRACTION SOLVENTS FOR FOODSTUFFS REGULATIONS

SUBSIDIARY LEGISLATION 449.23

EXTRACTION SOLVENTS FOR FOODSTUFFS

REGULATIONS

27th April, 1999

LEGAL NOTICE 25 of 1999, as amended by Legal Notices 405 of 2011,

373 of 2018 and 59 of 2025.

1 The title of these regulations is Extraction Solvents for

Foodstuffs Regulations.

(regulations 4.5, 5.1, 5.1.1 and 6.1)

Extraction Solvents which may be Used during the Processing

of Raw Materials, Foodstuffs, Food Components or Food Ingredients

PART I

Extraction solvents to be used in compliance with good manufacturing

practice for all uses (*)

Propane

Butane

Ethyl acetate

Ethanol

Acetone (**)

Nitrous oxide

Carbon

(*) An extraction solvent is considered as being used in 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.

(**) The use of Acetone in the refining of olive-pomace oil is

forbidden.

PART II

Extraction solvents for which conditions of use are specified

Name

Conditions of use (summary

Maximum residue

description of extraction)

limits in the

extracted foodstuff

or food ingredient

Hexane (*)

Production or fractionation of 1 mg/kg in the fat or

fats and oils and production of oil or cocoa butter

cocoa butter

Preparation of defatted protein 10 mg/kg in the food

products and defatted flours

containing the

defatted protein

products and

defatted flours

30 mg/kg in the

defatted soya

products as sold to

the final consumer

Preparation of defatted cereal

5 mg/kg in the

germs

defatted cereal

germs

2-methyloxolane

Production or fractionation of 1 mg/kg in the fat or

fats and oils and the

oil or cocoa butter

production of cocoa butter

Preparation of defatted protein 10 mg/kg in the food

products and defatted flours

containing the

defatted protein

products and the

defatted flours

30 mg/kg in the

defatted soya

products as sold to

the final consumer

Preparation of defatted cereal

5 mg/kg in the

germs

defatted cereal

germs

Methyl acetate

Decaffeination of, or removal

20 mg/kg in the

of irritants and bitterings from

coffee or tea

coffee and tea

Production of sugar from

1 mg/kg in the sugar

molasses

Ethylmethylketone Fractionation of fats and oils 5 mg/kg in the fat or

(**)

oil

Decaffeination of, or removal

20 mg/kg in the

of irritants and bitterings from

coffee or tea

coffee and tea

Dichloromethane

Decaffeination of, or removal

2 mg/kg in the

of irritants and bitterings from roasted coffee and 5

coffee and tea

mg/kg in the tea

Methanol

For all uses

10 mg/kg

Propan-2-ol

For all uses

10 mg/kg

Dimethyl Ether

Preparation of defatted animal

0,009 mg/kg in the

protein products, including

defatted animal

gelatine

protein products,

including gelatine

Preparation of collagen and

3 mg/kg in the

collagen derivatives, except

collagen and

gelatine

collagen derivatives,

except gelatine

(*) The combined use of Hexane and Ethylmethylketone is forbidden.

(**) The level of n-Hexane in this solvent shall not exceed 50 mg/kg.

This solvent may not be used in combination with Hexane.

PART III

Extraction solvents for which conditions of use are specified

Name

Maximum residue limits

in the foodstuff due to the use of

extraction

solvents

in

the

preparation of flavourings from

natural flavouring materials

Diethyl ether

2 mg/kg

Hexane (*)

1 mg/kg

2-methyloxolane

1 mg/kg

Cyclohexane

1 mg/kg

Methyl acetate

1 mg/kg

Butan-1-ol

1 mg/kg

Butan-2-ol

1 mg/kg

Ethylmethylketone (*)

1 mg/kg

Dichloromethane

0,02 mg/kg

Propan-1-ol

1 mg/kg

1,1,1,2-tetrafluoroethane

0,02 mg/kg

Methanol

1.5 mg/kg

Propan-2-ol

1 mg/kg

(*) The combined use of Hexane and Ethylmethylketone is forbidden.

PART IV

Specific purity criteria for the extraction solvents

2-methyloxolane

CAS number

96-47-9

Assay

Content not less than 99,9% expressed on dry

basis

Purity

Furan

Not more than 50 mg/kg (expressed on dry

basis)

EXTRACTION SOLVENTS FOR FOODSTUFFS

2-

Not more than 500 mg/kg (expressed on dry

methylfuran

basis)

Ethanol

Not more than 450 mg/kg (expressed on dry

basis)

1 In these regulations, unless the context otherwise requires

"collagen" means the protein-based product derived from

animal bones, hides, skins and tendons manufactured in

accordance with the relevant requirements of Regulation (EC)

No 853/2004 of the European Parliament and of the Council of

29 April 2004 laying down specific hygiene rules for food of

animal origin;

"extraction solvent" means a solvent which is used in an

extraction procedure during the processing of raw materials,

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;

"gelatine" means natural, soluble protein, gelling or non-

gelling, obtained by the partial hydrolysis of collagen produced

from bones, hides and skins, tendons and sinews of animals, in

accordance with the relevant requirements of Regulation (EC)

No 853/2004 of the European Parliament and of the Council of

29 April 2004 laying down specific hygiene rules for food of

animal origin;

"hexane" means a commercial product consisting

essentially of acyclic saturated hydrocarbons containing six

carbon atoms and distilling between 64 °C and 70 °C;

"solvent" means any substance for dissolving a foodstuff

or any component thereof, including any contaminant present

in, or on that foodstuff.

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

Repealed by Legal Notice 59 of 2025.

3.3

Repealed by Legal Notice 59 of 2025.

3.4

Repealed by Legal Notice 59 of 2025.

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.

1 These regulations shall apply to extraction solvents used or

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 Part I, II and III of the Schedule

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.

1 The substances listed in Part I, II and III of the Schedule and

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 Part I, II

and III of the Schedule;

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

particulars from being additionally indicated in other languages.

1 The substances and materials listed as extraction solvents

in Part I, II and III of the Schedule 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.

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.