Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (Recast) (Text with EEA relevance)
Modified by
  • Commission Directive 2010/59/EUof 26 August 2010amending 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), 32010L0059, August 27, 2010
  • Commission Directive (EU) 2016/1855of 19 October 2016amending 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), 32016L1855, October 20, 2016
  • Commission Directive (EU) 2023/175of 26 January 2023amending Directive 2009/32/EC of the European Parliament and of the Council as regards 2-methyloxolane(Text with EEA relevance), 32023L0175, January 27, 2023
Directive 2009/32/EC of the European Parliament and of the Councilof 23 April 2009on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients(Recast)(Text with EEA relevance)
Article 11.This Directive applies to extraction solvents used or intended for use in the production of foodstuffs or food ingredients.This Directive shall not apply to 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.However, the Member States shall ensure that the use of food additives, vitamins and other nutritional additives does not result in foodstuffs containing extraction solvent residue levels dangerous to human health.This Directive shall apply without prejudice to the provisions adopted under more specific Community rules.2.For the purposes of this Directive:(a)"solvent" means any substance for dissolving a foodstuff or any component thereof, including any contaminant present in or on that foodstuff;(b)"extraction solvent" means a solvent which is used in an extraction procedure during the processing of raw materials, of foodstuffs, or of components or ingredients of these 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.
Article 21.Member States shall authorise the use as extraction solvents in the manufacture of foodstuffs or food ingredients of those substances and materials listed in Annex I, under the conditions of use and where appropriate within the maximum residue limits specified in that Annex.Member States may not prohibit, restrict or obstruct the marketing of foodstuffs or food ingredients on grounds relating to the extraction solvents used or their residues if these comply with the provisions of this Directive.2.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.3.Water to which substances regulating acidity or alkalinity may have been added and other food substances which possess solvent properties are authorised as extraction solvents in the manufacture of foodstuffs or food ingredients.
Article 3Member States shall take all necessary measures to ensure that the substances and materials listed as extraction solvents in Annex I comply with the following general and specific purity criteria:(a)they shall not contain a toxicologically dangerous amount of any element or substance;(b)subject to any exceptions deriving from the specific purity criteria adopted in accordance with point (d) of Article 4, they shall not contain more than 1 mg/kg of arsenic or more than 1 mg/kg of lead;(c)they shall satisfy the specific purity criteria adopted in accordance with point (d) of Article 4.
Article 4The Commission shall adopt the following:(a)the necessary amendments to Annex I in the light of scientific and technical progress in the field of the use of solvents, their conditions of use and maximum residue limits;(b)the methods of analysis necessary to verify compliance with the general and specific purity criteria provided for in Article 3;(c)the procedure for taking samples and the methods for qualitative and quantitative analysis of the extraction solvents listed in Annex I and used in foodstuffs or food ingredients;(d)if necessary, the specific purity criteria for the extraction solvents listed in Annex I, and in particular maximum permitted limits of mercury and cadmium in the extraction solvents.The measures referred to in points (b) and (c) of the first subparagraph, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(2).The measures referred to in points (a) and (d) of the first subparagraph, designed to amend non-essential elements of this Directive, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(3).Where necessary, the measures referred to in points (a) and (d) of the first subparagraph shall be adopted in accordance with the urgency procedure referred to in Article 6(4).
Article 51.Where a Member State, as a result of new information or of a reassessment of existing information made since this Directive was adopted, has detailed grounds for establishing that the use in foodstuffs of any substance listed in Annex I or the level of one or more of the components referred to in Article 3 contained in such substances might endanger human health although it complies with the conditions laid down in this Directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory. It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision.2.The Commission shall examine as soon as possible the evidence given by the Member State concerned and consult the Committee referred to in Article 6(1), and shall then deliver its opinion forthwith and take the appropriate measures, which may replace the measures referred to in paragraph 1 of this Article.3.If the Commission considers that amendments to this Directive are necessary in order to resolve the difficulties mentioned in paragraph 1 and to ensure the protection of human health, it shall adopt those amendments.Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the urgency procedure referred to in Article 6(4).Any Member State which has adopted safeguard measures may in that event retain them until the amendments enter into force in its territory.
Article 61.The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safetyOJ L 31, 1.2.2002, p. 1..2.Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.3.Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The periods laid down in Article 5a(3)(c), (4)(b) and (4)(e) of Decision 1999/468/EC shall be set at two months, one month and two months respectively.4.Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 71.Member States shall take all necessary measures to ensure that the substances listed in Annex I and intended for use as extraction solvents in foodstuffs may not be marketed unless their packaging, containers or labels carry the following particulars in such a way as to be easily visible, clearly legible and indelible:(a)the commercial name as indicated in Annex I;(b)a clear indication that the material is of a quality suitable for use for the extraction of food or food ingredients;(c)a reference by which the batch or lot may be identified;(d)the name or business name and address of the manufacturer or packer or of a seller established within the Community;(e)the net quantity given as units of volume;(f)if necessary, the special storage conditions or conditions of use.2.By way of derogation from paragraph 1, the particulars specified in points (c), (d), (e) and (f) of that paragraph may appear only on the trade documents relating to the batch or lot which are to be supplied with or prior to the delivery.3.This Article shall be without prejudice to more precise or more extensive Community provisions regarding weights and measures or provisions applying to the classification, packaging and labelling of dangerous substances and mixtures.4.Member States shall refrain from laying down requirements more detailed than those already contained in this Article concerning the manner in which the particulars provided are to be shown.Each Member State shall, however, ensure that the sale of extraction solvents within its territory is prohibited if the particulars provided for in this Article do not appear in a language easily understood by purchasers, unless other measures have been taken to ensure that the purchaser is informed. This provision shall not prevent such particulars from being indicated in various languages.
Article 81.This Directive shall also apply to extraction solvents used or intended for use in the production of foodstuffs or food ingredients imported into the Community.2.This Directive shall not apply to extraction solvents or foodstuffs intended for export outside the Community.
Article 9Directive 88/344/EEC, as amended by the acts listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
Article 10This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 11This Directive is addressed to the Member States.
nullANNEX IEXTRACTION SOLVENTS WHICH MAY BE USED DURING THE PROCESSING OF RAW MATERIALS, OF FOODSTUFFS, OF FOOD COMPONENTS OR OF FOOD INGREDIENTSPART IExtraction solvents to be used in compliance with good manufacturing practice for all usesAn 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.Name:PropaneButaneEthyl acetateEthanolCarbon dioxideAcetoneThe use of Acetone in the refining of olive-pomace oil is forbidden.Nitrous oxidePART IIExtraction solvents for which conditions of use are specified
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.The level of n-Hexane in this solvent should not exceed 50 mg/kg. The combined use of Hexane and Ethylmethylketone is forbidden."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."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.
NameConditions of use(summary description of extraction)Maximum residue limits in the extracted foodstuff or food ingredient
HexaneProduction or fractionation of fats and oils and production of cocoa butter1 mg/kg in the fat or oil or cocoa butter
Preparation of defatted protein products and defatted flours10 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 germs5 mg/kg in the defatted cereal germs
2-methyloxolaneProduction or fractionation of fats and oils and production of cocoa butter1 mg/kg in the fat or oil or cocoa butter
Preparation of defatted protein products and defatted flours10 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 germs5 mg/kg in the defatted cereal germs
Methyl acetateDecaffeination of, or removal of irritants and bitterings from coffee and tea20 mg/kg in the coffee or tea
Production of sugar from molasses1 mg/kg in the sugar
EthylmethylketoneFractionation of fats and oils5 mg/kg in the fat or oil
Decaffeination of, or removal of irritants and bitterings from coffee and tea20 mg/kg in the coffee or tea
DichloromethaneDecaffeination of, or removal of irritants and bitterings from coffee and tea2 mg/kg in the roasted coffee and 5 mg/kg in the tea
MethanolFor all uses10 mg/kg
Propan-2-olFor all uses10 mg/kg
Dimethyl etherPreparation of defatted animal protein products including gelatine0,009 mg/kg in the defatted animal protein products including gelatine
Preparation of collagen and collagen derivatives, except gelatine3 mg/kg in the collagen and collagen derivatives, except gelatine
PART IIIExtraction solvents for which conditions of use are specified
The combined use of Hexane and Ethylmethylketone is forbidden.
NameMaximum residue limits in the foodstuff due to the use of extraction solvents in the preparation of flavourings from natural flavouring materials
Diethyl ether2 mg/kg
Hexane1 mg/kg
2-methyloxolane1 mg/kg
Cyclohexane1 mg/kg
Methyl acetate1 mg/kg
Butan-1-ol1 mg/kg
Butan-2-ol1 mg/kg
Ethylmethylketone1 mg/kg
Dichloromethane0,02 mg/kg
Propan-1-ol1 mg/kg
1,1,1,2-tetrafluoroethane0,02 mg/kg
Methanol1,5 mg/kg
Propan-2-ol1 mg/kg
PART IVSpecific purity criteria for the extraction solvents listed in Annex I
2-methyloxolane
CAS number96-47-9
AssayContent not less than 99,9 % expressed on dry basis
Purity
FuranNot more than 50 mg/kg (expressed on dry basis)
2-methylfuranNot more than 500 mg/kg (expressed on dry basis)
EthanolNot more than 450 mg/kg (expressed on dry basis)
ANNEX IIPART A
Repealed Directive with list of its successive amendments(referred to in Article 9)
Council Directive 88/344/EEC(OJ L 157, 24.6.1988, p. 28)
Council Directive 92/115/EEC(OJ L 409, 31.12.1992, p. 31)
Directive 94/52/EC of the European Parliament and of the Council(OJ L 331, 21.12.1994, p. 10)
Directive 97/60/EC of the European Parliament and of the Council(OJ L 331, 3.12.1997, p. 7)
Regulation (EC) No 1882/2003 of the European Parliament and of the Council(OJ L 284, 31.10.2003, p. 1)Point 9 of Annex III only
PART B
Time-limits for transposition into national law(referred to in Article 9)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:permit trade in products complying with this Directive at the latest by 1 July 1993,prohibit trade in products not complying with this Directive with effect from 1 January 1994."In accordance with Article 2(1) of Directive 97/60/EC:"Member States shall amend their laws, regulations and administrative provisions so as to:authorise trade in products complying with Directive 88/344/EEC, as amended by this Directive by 27 October 1998 at the latest;ban trade in products not complying with Directive 88/344/EEC, as amended by this Directive, as from 27 April 1999. However, products placed on the market or labelled before that date and not complying with Directive 88/344/EEC, as amended by this Directive, may be marketed until stocks are used up."
DirectiveTime-limit for transposition
88/344/EEC13 June 1991
92/115/EECa.1 July 1993
b.1 January 1994
94/52/EC7 December 1995
97/60/ECa.27 October 1998
b.27 April 1999
ANNEX III
Correlation Table
Directive 88/344/EECThis 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 3Article 3
Article 4Article 4
Article 5Article 5
Article 6(1)Article 6(1)
Article 6(2)—
Article 6(3)—
—Article 6(2)
—Article 6(3)
—Article 6(4)
Article 7Article 7
Article 8Article 8
Article 9—
—Article 9
—Article 10
Article 10Article 11
AnnexAnnex I
—Annex II
—Annex III
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