What are extraction solvents and what are they used for?
Extraction solvents are solvents used in an extraction procedure during the processing of raw materials, of foodstuffs, or of components or ingredients of these products and which are removed but which may result in the unintentional, but technically unavoidable, presence of residues or derivatives in the foodstuff or food ingredient.
Solvent means any substance for dissolving a foodstuff or any component thereof, including any contaminant present in or on that foodstuff.
The EU Rules on extraction solvents for use in foodstuffs should take account primarily human health requirements but also, within the limits required for the protection of health, economic and technical needs.
Directive 2009/32/EC on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients applies to extraction solvents used or intended for use in the production of foodstuffs or food ingredients either in the EU or imported into the EU.
This Directive shall not apply to:
- extraction solvents or foodstuffs intended for export outside the EU
- extraction solvents used in the production of food additives, vitamins and other nutritional additives, unless such food additives, vitamins or nutritional additives are listed in Annex I (of the Directive).
Member States shall not authorise the use of other substances and materials as extraction solvents, nor extend the conditions of use or permitted residues of the extraction solvents listed in Annex I beyond those specified therein.
How to submit an application for an amendment of Directive 2009/32/EC?
For requests for amendments to Directive 2009/32/EC it is recommended to follow the requirements set in Regulation (EU) No 234/2011 and the information within the practical guidance for applicants at our Common Authorisation Procedure page.
It is essential that the technological need is well explained, including the reason for setting a maximum residual level at a certain level. It should also be clearly demonstrated that the (new) extraction solvent (use) would not be of safety concern.