1988L0344 — EN — 23.12.1997 — 002.002 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of13June1988
ontheapproximationofthelawsoftheMemberStatesonextractionsolventsusedintheproduc-
tionoffoodstuffsandfoodingredients
(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 1994L 331 10 21.12.1994
►M3Directive 97/60/EC of the European Parliament and of the Council of 27
October 1997L 331 7 3.12.1997
Corrected by:
►C1Corrigendum, OJ L 32, 5.2.2004, p. 34 (88/344/EEC)
▼B
COUNCILDIRECTIVE
of13June1988
on the approximation of the laws of the Member States on extrac-
tion solvents used in the production of foodstuffs and food
ingredients
(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),
Whereasdifferencesbetween national lawsrelating to extraction
solvents hinder the free movement of foodstuffs and may create condi-tionsof unequal competition thereby directly affecting the
establishment or 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,within the limitsrequired for the protection of health, of economic
and technical 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 but tech-nically 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 consumer
when used under conditions of good manufacturing practice;
Whereasto take account of protection of public health, the conditions
of use of other extraction solvents listed in Parts II and III of theAnnex and residues permitted in food and food ingredients must beestablished;
Whereas, pending the adoption of Community rules on flavourings,
Member Statess hould not be prevented from authorizing, asextraction
solvents for certain flavourings, substances used for diluting and dissol-
ving such materials;
Whereas the provisions on certain extraction solvents should be
reviewed within a period of time on the basis of the ongoing scientificand technical research on the acceptability of such solvents and theconditionsfor their us e;1988L0344 — EN — 23.12.1997 — 002.002 — 2
(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.
▼B
Whereas specific purity criteria for extraction solvents and methods of
analysis and sampling of extraction solvents in and on foodstuffsshould be 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 a decision at 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 applica-
tion it is desirable to ensure close cooperation between the Member
Statesand the Commis s ion within the Standing Committee for Food-stuffs set up 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 addi-
tives, vitamins and other nutritional additives does not result infoodstuffs containing extraction solvent residue levels dangerous tohuman health.
This Directive shall apply without prejudice to the provisions adopted
under more specific Community rules.
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 onthat foodstuff;
(b) ‘extraction solvent’ means a solvent which is used in an extraction
procedure during the processing of raw materials, of foodstuffs, orof componentsor ingredientsof thes e productsand which isremoved but which may result in the unintentional, but technicallyunavoidable, presence of residues or derivatives in the foodstuff or
food ingredient.
Article 2
1. Member States shall authorize the use as extraction solvents in
the manufacture of foodstuffs or food ingredients of those substances
and materials listed in the Annex, under the conditions of use andwhere appropriate 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 extraction
solvents used or their residues if these comply with the provisions of
thisDirective.
2. Member States shall not authorize the use of other substances and
materials as extraction solvents, nor extend the conditions of use or1988L0344 — EN — 23.12.1997 — 002.002 — 3
(1) OJ No L 291, 19. 11. 1969, p. 9.▼M1
▼B
▼B
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 their
territory, allow the use, as solvents for the extraction of flavourings
from natural flavouring materials, of substances used for diluting ordissolving flavourings.
4. Water, to which substances regulating acidity or alkalinity may
have been added, and other food substances which possess solventproperties are authorised as extraction solvents in the manufacture of
foodstuffs or food ingredients.
Article 3
Member States shall take all measures to ensure that the substances and
materials listed as extraction solvents in the Annex satisfy thefollowing 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
referred to in (c), 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 determined in accor-
dance with Article 4.
Article 4
The following shall be determined in accordance with the procedure
laid down in Article 6:
(a) The necessary amendments to the Annex in the light of scientific
and technical progress in the field of the use of solvents, their
conditions of use and maximum residue limits;
►
M3(b)◄the methods of analysis necessary to verify compliance
with the general and specific purity criteria referred to in Article 3;
►M3(c)◄the procedure for taking samples and the methods for
qualitative and quantitative analysis of the extraction solvents citedin the Annex used in foodstuffs or food ingredients;
►
M3(d)◄if necessary, the specific purity criteria for the extrac-
tion solvents listed in the Annex, and in particular maximum
permitted limitsof mercury and cadmium in the extraction
solvents; these criteria are to be adopted within three years fromthe date of adoption of thisDirective.
Article 5
1. Where a Member State, asa res ult 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 might
endanger human health although it complieswith the conditionslaid
down 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 Standing1988L0344 — EN — 23.12.1997 — 002.002 — 4
▼C1
▼M1
▼B
▼M3
▼B
▼B
Committee for Foodstuffs, and shall then deliver its opinion forthwith
and 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 the proce-dure laid down in Article 6 with a view to adopting these amendments.Any Member State which has adopted safeguard measures may in that
event retain them until the amendmentsenter into force in itsterritory.
Article 6
1. Where the procedure laid down in thisArticle isto 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 accordingto the urgency of the matter. The opinion shall be delivered by themajority laid down in Article 148 (2) of the Treaty in the case of deci-
sions which the Council is required to adopt on a proposal from the
Commission. 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'sopinion.
(b) Where the intended measures are not in accordance with the
opinion of the Committee, or in the absence of any opinion,
the Commission shall forthwith submit to the Council a proposal
relating to the measures to be taken. The Council shall act by aqualified majority.
(c) If, on the expiry of three monthsfrom the date on which the
matter wasreferred to it, the Council hasnot adopted anymeasures, 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 extrac-
tion solvents in foodstuffs may not be marketed unless their packaging,containersor labelscarry the following information in s uch a way astobe easily visible, clearly legible and indelible:
(a) the commercial name asgiven 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 asunitsof 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
the trade documentsrelating to the batch or lot which are to besupplied with or prior to the delivery.
3. ThisArticle iswithout prejudice to more precis e or more exten-
sive Community provisions regarding weights and measures or
provisions applying to the classification, packaging and labelling of
dangerous substances and preparations.
4. Member Statess hall refrain from laying down requirementsmore
detailed than those already contained in this Article concerning themanner in which the particularsprovided are to be s hown.1988L0344 — EN — 23.12.1997 — 002.002 — 5
▼B
Member States shall, however, ensure that the sale of extraction
solvents within their own territories is prohibited if the particularsprovided for in thisArticle do not appear in a language eas ily under-
stood by purchasers, unless other measures have been taken to ensure
that the purchaser is informed. This provision shall not prevent suchparticularsfrom being indicated in variouslanguages .
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 yearsof itsadoption, s o asto authorize from
that date trade in and use of extraction solvents complying with theprovisions of this Directive and to prohibit trade in and use of extrac-tion solvents which do not comply therewith. They shall immediatelyinform the Commission thereof.
Article 10
This Directive is addressed to the Member States.1988L0344 — EN — 23.12.1997 — 002.002 — 6
▼B
ANNEX
EXTRACTION SOLVENTS WHICH MAY BE USEDD URING THE
PROCESSING OF RAW MATERIALS, OF FOODSTUFFS, OF FOOD
COMPONENTSOROFFOODINGREDIENTS
PART I
Extractionsolventstobeusedincompliancewithgoodmanufacturingprac-
tice foralluses (1)
Name
Propane
Butane
Ethyl acetate
Ethanol
Carbon dioxide
Acetone►M1(2)◄
Nitrousoxide
PART II
Extractionsolventsforwhichconditionsofusearespecified
NameConditionsof us e
(summary description of
extraction)Maximum residue limits in
the extracted foodstuff or
food ingredient
Hexane (1) Production or fractio-
nation of fatsand oils
and production of
cocoa butter1 mg/kg in the fat or oil
or cocoa butter
Preparation of defatted
protein productsand
defatted flours10 mg/kg in the food
containing the defatted
protein productsand 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 acetate Decaffeination of, or
removal of irritants
and bitteringsfrom
coffee and tea20 mg/kg in the coffee
or tea
Production of sugar
from molasses1 mg/k in the sugar1988L0344 — EN — 23.12.1997 — 002.002 — 7
(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 quantitiespres enting no danger to human health.
(
2) The use of Acetone in the refining of olive-pomace oil is forbidden.▼M3
▼B
▼M3
▼B
▼B
NameConditionsof us e
(summary description of
extraction)Maximum residue limits in
the extracted foodstuff or
food ingredient
Ethylmethylketone
►M1(2)◄Fractionation of fats
and oils5 mg/k in the fat or oil
Decaffeination of, or
removal of irritants
and bitteringsfrom
coffee and tea20 mg/kg in the coffee
or tea
Dichloromethane Decaffeination of, or
removal of irritants
and bitteringsfrom
coffee and tea►M1 ◄
►M12 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
(1) Hexane means a commercial product consisting essentially of acrylic saturated hydro-
carbons containig six carbon atoms and distilling between 64 ºC and 70 ºC. ►M1The
combined use of Hexame and Ethylmethylketone is forbidden. ◄
(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.
PART III
Extractionsolventsforwhichconditionsofusearespecified
NameMaximum residue limits in the foodstuff
due to the use of extraction solvents in the
preparation of flavouringsfrom natural
flavouring materials
Diethyl ether 2 mg/kg
Hexane►M1(1)◄ 1 mg/kg
Cyclohexane 1 mg/kgMethyl 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 ◄
Propan-1-ol 1 mg/kg
1,1,1,2-tetrafluoroethane 0,02 mg/kg
(1) The combined use of these two solvents is forbidden.1988L0344 — EN — 23.12.1997 — 002.002 — 8
▼M1
▼B
▼M1
▼B
▼M1
▼B
▼M2
▼B
▼M3
▼M1
▼M3
▼M1