1988L0344 — EN — 28.12.1994 — 001.001 — 1
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►B COUNCIL DIRECTIVE
of 13June 1988
on the approximation of the laws of the Member States on extraction solvents used in the
production of foodstuffs and food ingredients
(88/344/EEC)
(OJ L 157, 24.6.1988, p. 28)
Amended by:
Official Journal
No page date
►M1Council Directive 92/115/EEC of 17 December 1992 L 409 31 31.12.1992
►M2Directive 94/52/EC of the European Parliament and of the Council of 7
December 1994 L 331 10 21.12.1994
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COUNCIL DIRECTIVE
of 13June 1988
on the approximation of the laws of the Member States on extrac-
tion solvents used in the production of foodstuffs and food ingredi-
ents
(88/344/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas differences between national laws relating to extraction
solvents hinder the free movement of foodstuffs and may create condi-tions of unequal competition thereby directly affecting the establishmentor functioning of the common market;
Whereas the approximation of those laws is therefore necessary if the
free movement of foodstuffs is to be achieved;
Whereas laws relating to extraction solvents for use in foodstuffs should
take account primarily of human health requirements but also, withinthe limits required for the protection of health, of economic and tech-nical needs;
Whereas such approximation must involve the establishment of a single
list of extraction solvents for the preparation of foodstuffs or foodingredients; whereas general purity criteria should also be specified;
Whereas the use of an extraction solvent under conditions of good
manufacturing practice should result in the removal of all or the majorpart of the solvent residues from the foodstuff or food ingredient;
Whereas, under such conditions, the presence of residues or derivatives
in the final foodstuff or food ingredient may be unintentional buttechnically unavoidable;
Whereas, although in general a specific limitation is useful, it need not
be laid down for substances listed in Part I of the Annex which havebeen found acceptable from the point of view of safety to the consumerwhen used under conditions of good manufacturing practice;
Whereas to take account of protection of public health, the conditions of
use of other extraction solvents listed in Parts II and III of the Annexand residues permitted in food and food ingredients must be established;
Whereas, pending the adoption of Community rules on flavourings,
Member States should not be prevented from authorizing, as extractionsolvents for certain flavourings, substances used for diluting anddissolving such materials;
Whereas the provisions on certain extraction solvents should be
reviewed within aperiod of time on the ba sis of the ongoing scientificand technical research on the acceptability of such solvents and theconditions for their use;
(1) OJ No C 312, 17. 11. 1983, p. 3, and
OJ No C 77, 23. 3. 1985, p. 7.
(2) OJ No C 12, 14. 1. 1985, p. 152, and
OJ No C 68, 14. 3. 1988, p. 51.
(3) OJ No C 206, 6. 8. 1984, p. 7.
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Whereas specific purity criteria for extraction solvents and methods of
analysis and sampling of extraction solvents in and on foodstuffs shouldbe established;
Whereas, should the use of an extraction solvent provided for in this
Directive appear to constitute a health risk as a result of new informa-tion, Member States should be able to suspend or limit such use, or toreduce existing limits, pending adecision a t Community level;
Whereas the establishment of sampling procedures and of the methods
of analysis required for checking the substances listed and their puritystandards constitute technical implementing measures; whereas in orderto simplify and expedite these procedures and facilitate their applicationit is desirable to ensure close cooperation between the Member Statesand the Commission within the Standing Committee for Foodstuffs setup by Council Decision 69/414/EEC (
1),
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. 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 produc-
tion of food additives, vitamins and other nutritional additives, unlesssuch food additives, vitamins or nutritional additives are listed in theAnnex.
However, the Member States shall ensure that the use of food additives,
vitamins and other nutritional additives does not result in foodstuffscontaining extraction solvent residue levels dangerous to human health.
▼
M1
This Directive shall apply without prejudice to the provisions adoptedunder more specific Community rules.
▼B
3. 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 thatfoodstuff;
(b) ‘extraction solvent'means a solvent which is used in an extraction
procedure during the processing of raw materials, of foodstuffs, orof components or ingredients of these products and which isremoved but which may result in the unintentional, but technicallyunavoidable, presence of residues or derivatives in the foodstuff orfood ingredient.
Article 2
1. Member States shall authorize the use as extraction solvents in the
manufacture of foodstuffs or food ingredients of those substances andmaterials listed in the Annex, under the conditions of use and whereappropriate within the maximum residue limits therein specified.
Member States may not prohibit, restrict or obstruct the marketing of
foodstuffs or food ingredients on grounds relating to the extractionsolvents used or their residues if these comply with the provisions ofthis Directive.
2. Member States shall not authorize the use of other substances and
materials as extraction solvents, nor extend the conditions of use or
(1) OJ No L 291, 19. 11. 1969, p. 9.
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permitted residues of the extraction solvents listed in the Annex beyond
those specified therein.
3. Until the adoption of Community provisions on substances used
for diluting and dissolving flavourings Member States may, on theirterritory, allow the use, as solvents for the extraction of flavouringsfrom natural flavouring materials, of substances used for diluting ordissolving flavourings.
4. Water, to which substances regulating acidity or alkalinity may
have been added, other food substances which possess solvent proper-ties and ethanol are authorized as extraction solvents in the manufactureof foodstuffs or food ingredients.
▼
M1
▼B
Article 3
Member States shall take all measures to ensure that the substances and
materials listed as extraction solvents in the Annex satisfy the followingpurity 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
referred to in (c), they shall not contain more than 1 mg/kg ofarsenic or more than 1 mg/kg of lead;
(c) they shall satisfy the specific purity criteria determined in accord-
ance with Article 4.
Article 4
The following shall be determined in accordance with the procedure
laid down in Article 6:
(a) the methods of analysis necessary to verify compliance with the
general and specific purity criteria referred to in Article 3;
(b) the procedure for taking samples and the methods for qualitative
and quantitative analysis of the extraction solvents cited in theAnnex used in foodstuffs or food ingredients;
(c) if necessary, the specific purity criteria for the extraction solvents
listed in the Annex, and in particular maximum permitted limits ofmercury and cadmium in the extraction solvents; these criteria areto be adopted within three years from the date of adoption of thisDirective.
Article 5
1. Where a Member State, as a result of new information or of a
reassessment of existing information made since the Directive wasadopted, has detailed grounds for establishing that the use in foodstuffsof any substance listed in the Annex or the level of one or more of thecomponents referred to in Article 3 contained in such substances mightendanger human health although it complies with the conditions laiddown in this Directive, that Member State may temporarily suspend orrestrict application of the provisions in question in its territory. It shallimmediately inform the other Member States and the Commissionthereof 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 StandingCommittee for Foodstuffs, and shall then deliver its opinion forthwithand take the appropriate measures, which may replace the measuresreferred to in paragraph 1.
3. If the Commission considers that amendments to the Directive are
necessary in order to resolve the difficulties mentioned in paragraph 1and to ensure the protection of human health, it shall initiate theprocedure laid down in Article 6 with a view to adopting these amend-ments. Any Member State which has adopted safeguard measures may
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in that event retain them until the amendments enter into force in itsterritory.
Article 6
1. Where the procedure laid down in this Article is to be followed,
the chairman shall refer the matter to the Standing Committee forFoodstuffs.
2. The Commission representative shall submit to the Committee a
draft of the measures to be taken. The Committee shall deliver itsopinion on the draft within a period fixed by the chairman according tothe urgency of the matter. The opinion shall be delivered by themajority laid down in Article 148 (2) of the Treaty in the case ofdecisions which the Council is required to adopt on a proposal from theCommission. The votes of the representatives of the Member Stateswithin the Committee shall be weighted in the manner set out in thatArticle. The chairman shall not vote.
3. (a) The Commission shall adopt the intended measures when they
are in accordance with the Committee’s opinion.
(b) Where the intended measures are not in accordance with the
opinion of the Committee, or in the absence of any opinion, theCommission shall forthwith submit to the Council a proposalrelating to the measures to be taken. The Council shall act by aqualified majority.
(c) If, on the expiry of three months from the date on which the
matter was referred to it, the Council has not adopted any meas-ures, the Commission shall adopt the proposed measures.
Article 7
1. Member States shall take all the necessary measures to ensure that
the substances listed in the Annex and intended for use as extractionsolvents in foodstuffs may not be marketed unless their packaging,containers or labels carry the following information in such a way as tobe easily visible, clearly legible and indelible:
(a) the commercial name as given in the Annex;
(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 information specified
in points (c), (d), (e) and (f) of that paragraph may appear merely on thetrade documents relating to the batch or lot which are to be suppliedwith or prior to the delivery.
3. This Article is without prejudice to more precise or more exten-
sive Community provisions regarding weights and measures or provi-sions applying to the classification, packaging and labelling ofdangerous substances and preparations.
4. Member States shall refrain from laying down requirements more
detailed than those already contained in this Article concerning themanner in which the particulars provided are to be shown.
Member States shall, however, ensure that the sale of extraction
solvents within their own territories is prohibited if the particularsprovided for in this Article do not appear in a language easily under-stood by purchasers, unless other measures have been taken to ensurethat the purchaser is informed. This provision shall not prevent suchparticulars from being indicated in various languages.
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Article 8
1. This Directive shall apply equally to extraction solvents used or
intended for use in the production of foodstuffs or ingredients importedinto the Community.
2. This Directive shall not apply to extraction solvents, or foodstuffs
intended for export outside the Community.
Article 9
Member States shall take the measures necessary to comply with this
Directive within three years of its adoption, so as to authorize from thatdate trade in and use of extraction solvents complying with the provi-sions of this Directive and to prohibit trade in and use of extractionsolvents which do not comply therewith. They shall immediately informthe Commission thereof.
Article 10
This Directive is addressed to the Member States.
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NameConditions of use
(summary description of
extraction)Maximum residue limits in
the extracted foodstuff or
food ingredientANNEX
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 (1)
Name
Propane
ButaneButyl acetateEthyl acetateEthanolCarbon dioxideAcetone ►
M1(2)◄
Nitrous oxide
PART II
Extraction solvents for which conditions of use are specified
Hexane (1) Production of fractiona-
tion of fats and oils andproduction of cocoabutter5 mg/kg in the fat or oil
or cocoabutter
Preparation of proteinproducts and defattedflours10 mg/kg in the food
containing the proteinproducts and defattedflours
Preparation of defattedcereal germs5 mg/kg in the defatted
cereal germ
Defatted soya products 30 mg/kg in the soya
product as sold to thefinal consumer
Methyl acetate Decaffeination of, orremoval of irritants andbitterings from coffeeand tea20 mg/kg in the coffee
or tea
Production of sugarfrom molasses1 mg/k in the sugar
Ethylmethylketone
►M1(2)◄Fractionation of fats and
oils5 mg/k in the fat or oil
Decaffeination of, or
removal of irritants andbitterings from coffeeand tea20 mg/kg in the coffee
or tea
(1) An extraction solvent is considered as being used in compliance with good manufac-
turing practice if its use results only in the presence of residues or derivatives intechnically unavoidable quantities presenting no danger to human health.
(
2) The use of Acetone in the refining of olive-pomace oil is forbidden.
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NameConditions of use
(summary description of
extraction)Maximum residue limits in
the extracted foodstuff or
food ingredient
NameMaximum residue limits in the foodstuff due to
the use of extraction solvents in the preparation
of flavourings from natural flavouring materialsDichloromethane Decaffeination of, or
removal of irritants andbitterings from coffeeand tea►
M1 ◄
►M12 mg/kg ◄in
the roasted coffee and5 mg/kg in the tea
▼M1
Methanol For all uses 10 mg/kg
Propan-2-ol For all uses 10 mg/kg▼B
(1) Hexane means a commercial product consisting essentially of acrylic saturated hydrocar-
bons containig six carbon atoms and distilling between 64 °C and 70 °C.►M1The
combined use of Hexame and Ethylmethylketone is forbidden. ◄
▼M1
(2) The presence of n-Hexane in this solvent should not exceed 50 mg/kg. This solvent may
not be used in combination with Hexane.
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PART III
Extraction solvents for which conditions of use are specified
Diethyl ether 2 mg/kg
▼M1
▼B
Hexane►M1(1)◄ 1 mg/kg
▼M2
Cyclohexane 1 mg/kg
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Methyl acetate 1 mg/kg
Butan-1-ol 1 mg/kg
Butan-2-ol 1 mg/kg
Ethylmethylketone ►M1(1)◄ 1 mg/kg
Dichloromethane ►M1 ◄
►M10,02 mg/kg ◄
Methyl-propan-1-ol 1 mg/kg
▼M1
Propan-1-ol 1 mg/kg
▼M1
(1) The combined use of these two solvents is forbidden.