Annex I - EXTRACTION SOLVENTS WHICH MAY BE USED DURING THE PROCESSING OF RAW MATERIALS, OF FOODSTUFFS, OF FOOD COMPONENTS OR OF FOOD INGREDIENTS

EXTRACTION SOLVENTS WHICH MAY BE USED DURING THE PROCESSING OF RAW MATERIALS, OF FOODSTUFFS, OF FOOD COMPONENTS OR OF FOOD INGREDIENTS

PART I

Extraction solvents to be used in compliance with good manufacturing practice for all uses (2)

Name:

Propane

Butane

Ethyl acetate

Ethanol

Carbon dioxide

Acetone (3)

Nitrous oxide

PART II

Extraction solvents for which conditions of use are specified

Name | Conditions of use (summary description of extraction) | Maximum residue limits in the extracted foodstuff or food ingredient

Hexane (¹) | Production or fractionation of fats and oils and production of cocoa butter | 1 mg/kg in the fat or oil or cocoa butter

Preparation of defatted protein products and defatted flours | 10 mg/kg in the food 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 germs | 5 mg/kg in the defatted cereal germs

▼M3

2-methyloxolane | Production or fractionation of fats and oils and production of cocoa butter | 1 mg/kg in the fat or oil or cocoa butter

Preparation of defatted protein products and defatted flours | 10 mg/kg in the food 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 germs | 5 mg/kg in the defatted cereal germs

▼B

Methyl acetate | Decaffeination of, or removal of irritants and bitterings from coffee and tea | 20 mg/kg in the coffee or tea

Production of sugar from molasses | 1 mg/kg in the sugar

Ethylmethylketone (²) | Fractionation of fats and oils | 5 mg/kg in the fat or oil

Decaffeination of, or removal of irritants and bitterings from coffee and tea | 20 mg/kg in the coffee or tea

Dichloromethane | Decaffeination of, or removal of irritants and bitterings from coffee and tea | 2 mg/kg in the roasted coffee and 5 mg/kg in the tea

Methanol | For all uses | 10 mg/kg

Propan-2-ol | For all uses | 10 mg/kg

▼M2

Dimethyl ether | Preparation of defatted animal protein products including gelatine (³) | 0,009 mg/kg in the defatted animal protein products including gelatine

Preparation of collagen (⁴) and collagen derivatives, except gelatine | 3 mg/kg in the collagen and collagen derivatives, except gelatine

▼B

(^{1}) Hexane means a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64 °C and 70 °C. The combined use of Hexane and Ethylmethylketone is forbidden. (^{2}) The level of n-Hexane in this solvent should not exceed 50 mg/kg. The combined use of Hexane and Ethylmethylketone is forbidden. ►M2 (^{3}) ‘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. (^{4}) ‘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. ◄

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) | 1 mg/kg

▼M3

2-methyloxolane | 1 mg/kg

▼B

Cyclohexane | 1 mg/kg

Methyl acetate | 1 mg/kg

Butan-1-ol | 1 mg/kg

Butan-2-ol | 1 mg/kg

Ethylmethylketone (¹) | 1 mg/kg

Dichloromethane | 0,02 mg/kg

Propan-1-ol | 1 mg/kg

1,1,1,2-tetrafluoroethane | 0,02 mg/kg

▼M1

Methanol | 1,5 mg/kg

Propan-2-ol | 1 mg/kg

▼B

(¹) The combined use of Hexane and Ethylmethylketone is forbidden.

PART IV

Specific purity criteria for the extraction solvents listed in Annex I

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)