Extraction Solvents for Foodstuffs

L.N. 59 of 2025

FOOD SAFETY ACT

(CAP. 449)

Extraction Solvents for Foodstuffs

(Amendment) Regulations, 2025

IN EXERCISE of the powers conferred by article 10 of the Food

Safety Act, the Minister responsible for public health has made the

following regulations:-

(1) The title of these regulations is the Extraction Citation and

Solvents for Foodstuffs (Amendment) Regulations, 2025 and these scope.

regulations shall be read and construed as one with the Extraction S.L. 449.23.

Solvents for Foodstuffs Regulations, hereinafter referred to as the

"principal regulations".

(2) The scope of these regulations is to transpose Commission

Directive (EU) 2023/175 of 26 January 2023 amending Directive

2009/32/EC of the European Parliament and of the Council as regards

2-methyloxolane.

In the Maltese version only, in regulation 1 of the principal Amends

regulations the words "fi Ħwejjeġ ta’ l-Ikel" shall be substituted by the regulation

the principal

words "f’Oġġetti tal-Ikel".

regulations.

Regulation 2.1 of the principal regulations shall be Substitutes

regulation 2.1 of

substituted by the following new regulation

the principal

regulations.

" Interpret-

2.1. In these regulations, unless the context

ation.

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.".

Regulation 3.2 of the principal regulations shall be deleted.

Regulation 3.3 of the principal regulations shall be deleted.

Regulation 3.4 of the principal regulations shall be deleted.

In regulation 4.5 of the principal regulations the words "in

regulations 3.2, 3.3 or 3.4" shall be substituted by the words "in Part I,

II and III of the Schedule".

In regulation 5.1 of the principal regulations the words "in

regulations 3.2, 3.3 and 3.4" shall be substituted by the words "in Part

I, II and III of the Schedule".

In regulation 5.1.1 of the principal regulations the words

"in regulations 3.2, 3.3 and 3.4" shall be substituted by the words "in

Part I, II and III of the Schedule".

In regulation 6.1 of the principal regulations, the words "in Amends

regulations 3.2, 3.3 and 3.4" shall be substituted by the words "in Part regulation

I, II and III of the Schedule".

Immediately after regulation 6.2 of the principal Adds new

regulations there shall be added the following new Schedule

"SCHEDULE

(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 production oil or cocoa butter

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 collagen

gelatine

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)

2-methylfuran

Not more than 500 mg/kg (expressed on dry basis)

Ethanol

Not more than 450 mg/kg (expressed on dry basis)".

€0.54