ANNEX IU.K. EXTRACTION SOLVENTS WHICH MAY BE USED DURING THE PROCESSING OF RAW MATERIALS, OF FOODSTUFFS, OF FOOD COMPONENTS OR OF FOOD INGREDIENTS
PART IU.K. Extraction solvents to be used in compliance with good manufacturing practice for all uses (1)
Name:
Propane
Butane
Ethyl acetate
Ethanol
Carbon dioxide
Acetone(2)
Nitrous oxide
PART IIU.K. Extraction solvents for which conditions of use are specified
| a 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. | ||
| b The level of n-Hexane in this solvent should not exceed 50 mg/kg. The combined use of Hexane and Ethylmethylketone is forbidden. | ||
| c [F1‘ 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. | ||
| d ‘ 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.] | ||
| Name | Conditions of use(summary description of extraction) | Maximum residue limits in the extracted foodstuff or food ingredient |
|---|---|---|
| Hexanea | 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 | |
| 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 | |
| Ethylmethylketoneb | 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 |
| [F2Dimethyl ether | Preparation of defatted animal protein products including gelatine c | 0,009 mg/kg in the defatted animal protein products including gelatine |
| Preparation of collagen d and collagen derivatives, except gelatine | 3 mg/kg in the collagen and collagen derivatives, except gelatine] | |
Textual Amendments
F1 Inserted by Commission Directive (EU) 2016/1855 of 19 October 2016 amending Directive 2009/32/EC of the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (Text with EEA relevance).
F2 Substituted by Commission Directive (EU) 2016/1855 of 19 October 2016 amending Directive 2009/32/EC of the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (Text with EEA relevance).
PART IIIU.K. Extraction solvents for which conditions of use are specified
| a The combined use of Hexane and Ethylmethylketone is forbidden. | |
| 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 |
| Hexanea | 1 mg/kg |
| Cyclohexane | 1 mg/kg |
| Methyl acetate | 1 mg/kg |
| Butan-1-ol | 1 mg/kg |
| Butan-2-ol | 1 mg/kg |
| Ethylmethylketonea | 1 mg/kg |
| Dichloromethane | 0,02 mg/kg |
| Propan-1-ol | 1 mg/kg |
| 1,1,1,2-tetrafluoroethane | 0,02 mg/kg |
| [F3Methanol | 1,5 mg/kg |
| Propan-2-ol | 1 mg/kg] |
Textual Amendments
F3 Inserted by Commission Directive 2010/59/EU of 26 August 2010 amending Directive 2009/32/EC of the European Parliament and of the Council on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (Text with EEA relevance).
ANNEX IIU.K.
PART AU.K.
Repealed Directive with list of its successive amendments
(referred to in Article 9)
| Council Directive 88/344/EEC | |
| Council Directive 92/115/EEC | |
| Directive 94/52/EC of the European Parliament and of the Council | |
| Directive 97/60/EC of the European Parliament and of the Council | |
| Regulation (EC) No 1882/2003 of the European Parliament and of the Council | Point 9 of Annex III only |
PART BU.K.
Time-limits for transposition into national law
(referred to in Article 9)
| a In accordance with Article 2(1) of Directive 92/115/EEC: Member States shall amend their laws, regulations and administrative provisions in such a way as to:
| |
| b In accordance with Article 2(1) of Directive 97/60/EC: Member States shall amend their laws, regulations and administrative provisions so as to:
| |
| Directive | Time-limit for transposition |
|---|---|
| 88/344/EEC | 13 June 1991 |
| 92/115/EEC | a.1 July 1993 |
b.1 January 1994a | |
| 94/52/EC | 7 December 1995 |
| 97/60/EC | a.27 October 1998 |
b.27 April 1999b | |
ANNEX IIIU.K.
Correlation Table
| Directive 88/344/EEC | This Directive |
|---|---|
| Article 1(1) | Article 1(1) |
| Article 1(3) | Article 1(2) |
| Article 2(1) | Article 2(1) |
| Article 2(2) | Article 2(2) |
| Article 2(3) | — |
| Article 2(4) | Article 2(3) |
| Article 3 | Article 3 |
| Article 4 | Article 4 |
| Article 5 | Article 5 |
| Article 6(1) | Article 6(1) |
| Article 6(2) | — |
| Article 6(3) | — |
| — | Article 6(2) |
| — | Article 6(3) |
| — | Article 6(4) |
| Article 7 | Article 7 |
| Article 8 | Article 8 |
| Article 9 | — |
| — | Article 9 |
| — | Article 10 |
| Article 10 | Article 11 |
| Annex | Annex I |
| — | Annex II |
| — | Annex III |
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.