17.11.83 Official Journal of the European Communities NoC312/3 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive on the approximation of the laws of the Member States 
on extraction solvents used in the production of foodstuffs and food ingredients 
COM(83) 626 final 
(Submitted by the Commission to the Council on 28 October 1983) 
THE COUNCIL OF THE EUROPEAN 
COMMUNITIES, 
Having regard to the Treaty establishing the 
European Economic Community, and in particular 
Article 100 thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas differences between national laws relating to 
extraction solvents hinder the free movement of 
foodstuffs and may create unequal conditions of 
competition thereby 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 limits 
required 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 food ingredients; 
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 major part of the 
solvent residues from the foodstuff or food 
ingredient; Whereas under such conditions there may never­
theless subsist the non-intentional but technically un­
avoidable presence of residues or derivatives in the 
final foodstuff or food ingredient; 
Whereas no specific limitation need be laid down for 
substances found acceptable from the point of view of 
safety to the consumer when used under conditions of 
good manufacturing practice; whereas such residues, 
in the case of propane, butane and nitrous oxide at 
1 mg/kg; of butyl acetate, propan-2-ol and acetone 
at 5 mg/kg; and of ethyl acetate, ethanol and 
methanol at 10 mg/kg of the food or food ingredient 
represent technically unavoidable maxima attained 
only in exceptional circumstances; 
Whereas, to take account of protection of public 
health, the conditions of use of other extraction 
solvents and residues permitted in food and food 
ingredients must be established; 
Whereas other substances specified in Community 
provisions on food additives may also be authorized 
as extraction solvents; whereas, pending the adoption 
of Community rules on flavourings presently under 
discussion, Member States should not be prevented 
from authorizing, as extraction solvents for certain 
flavourings, substances used for diluting and 
dissolving such materials; 
Whereas the conditions of use of certain extraction 
solvents should be reviewed within a period of time 
on the basis of ongoing scientific and technical 
research; 
Whereas specific purity criteria for extraction solvents 
and methods of analysis and sampling of extraction 
solvents in and on foodstuffs should be established; 
Whereas in order to encourage technical progress 
Member States should not be prevented from auth­
orizing privisionally under their control the use, 
in their territory, of extraction solvents not provided 
NoC312/4 Official Journal of the European Communities 17.11.83 
for in this Directive pending a final decision at 
Community level; 
Whereas should the use of an extraction solvent 
provided for in this Directive appear to constitute a 
health risk as a result of new information, Member 
States should be able to suspend or limit such use, or 
to reduce the limits provided, pending a decision at 
Community level; 
Whereas amending the conditions of use and the 
maximum residue limits laid down in the Annex to 
take account of progress in scientific and technical 
knowledge and the establishment of sampling pro­
cedures and of the methods of analysis required for 
checking the substances listed and their purity 
standards constitute technical implementing measures; 
whereas, in order to simplify and expedite the 
procedure and facilitate their application, it is 
desirable to ensure close cooperation between the 
Member States and the Commission within the 
Standing Committee for Foodstuffs set up by Council 
Decision 69/414/EECO; 
Whereas 18 months is sufficient time for Member 
States to take the necessary measures for the free 
movement of products complying with the provisions 
of this Directive, but a longer period seems necessary 
to prohibit the use of extraction solvents which do 
not comply therewith so that processes used in the 
manufacture of foodstuffs containing residues of 
extraction solvents can be adapted to the new 
requirements laid down in this Directive, 
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. 
2. This Directive is without prejudice to specific 
legislative provisions on vitamins. 
3. For the purpose of this Directive, 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 partially or wholly removed 
but which may result in the non-intentional but 
technically unavoidable presence of residues or deri­
vatives in the foodstuff or food ingredient. 
(») OJ No L 291, 19. 11. 1969, p. 9. 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 and 
where appropriate within the maximum residue limits 
therein specified. 
Member States may not prohibit, restrict or obstruct 
the marketing of foodstuffs or their 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 authorize the use of 
other substances and materials as extraction solvents, 
nor extend the conditions of use of permitted residues 
of the extraction solvents listed in the Annex, beyond 
those specified therein. 
3. By way of derogation from paragraph 2: 
(a) dissolvents and diluents authorized by Com­
munity provisions are also authorized as extrac­
tion solvents for the production of food additives; 
(b) solvents directly or indirectly taken into account 
in Community provisions, or in their absence 
national provisions, on the specific criteria of 
purity for a particular food additive are auth­
orized as extraction solvents in the production of 
that food additive; where such solvents are 
transferred to a food or food ingredient by the 
use of the additive, the residues specified 
according to paragraphs 1 and 2 may be exceeded 
by the amount permitted by the specific criteria of 
purity in question; 
(c) until the adoption of Community provisions 
on substances used for diluting and dissolving 
flavourings Member States may, on their terri­
tory, allow the use, as solvents for the extraction 
of flavourings from natural flavouring materials, 
of substances used for diluting or dissolving 
flavourings; 
(d) foodstuffs which possess solvent properties are 
authorized as extraction solvents in the manu­
facture of foodstuffs or food ingredients. 
17.11.83 Official Journal of the European Communities NoC312/5 
4. Within five years of the notification of this 
Directive, the Commission shall re-examine the 
provisions relating to the following substances and 
shall propose any necessary amendments acting in 
accordance with the procedure laid down in Article 
100 of the Treaty: 
Butan-1-ol, 
Butan-2-ol, 
2Tmethyl-propan-2-ol, 
Propan-1-ol, 
Propan-2-ol, 
Methyl acetate, 
Butyl acetate, 
Cyclohexane, 
Dichloromethane, 
Trichloroethylene, 
Light petroleum, 
Ethylmethylketone. 
Article 3 
1. Notwithstanding Article 2, a Member State may 
authorize the use within its territory of an extraction 
solvent not included on the list in the Annex, subject 
to the condition that the authorization must be 
limited to a maximum period of three years. 
2. The Member State shall forward to the other 
Member States and to the Commission the text of any 
authorization drawn up pursuant to paragraph 1 
within two months of the date of its taking effect. 
3. Before the expiry of the three-year period 
provided for in paragraph 1, the Member State may 
submit to the Commission a request for inclusion on 
the list in the Annex of the substance or material 
given national authorization in accordance with 
paragraph 1. At the same time, it shall supply sup­
porting documents setting out the grounds on which 
it deems such inclusion justified and shall indicate the 
uses for which such substance is intended. 
Within 18 months of submission of a request, a 
decision shall be taken on the basis of information 
relating to public health and in accordance with the 
procedure laid down in Article 8 as to whether the 
substance or material in question may be included on 
the list in the Annex or whether the national author­
ization should be withdrawn. If any conditions of use 
or limits prove necessary, these shall be adopted 
under the same procedure. Notwithstanding para­
graph 1, the national authorization may remain in 
force until a decision is taken on the request. 
Should it be decided pursuant to the preceding 
subparagraph that the national authorization should 
be withdrawn, that decision shall apply to any other 
national authorization in respect of the substance in 
question. Article 4 
Member States shall take all measures to ensure that 
the substances and materials listed as extraction 
solvents in the Annex satisfy the following criteria of 
purity: 
(a) they shall not contain a toxicologically dangerous 
amount of any element or substance, in particular 
heavy metals; 
(b) subject to any exception deriving from the 
specific criteria of purity 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 criteria of purity laid 
down in accordance with Article 5. 
Article 5 
The following shall be determined in accordance with 
the procedure laid down in Article 8 : 
(a) the methods of analysis necessary to verify 
compliance with the general and specific criteria 
of purity referred to in Article 4; 
(b) the procedure for taking samples and the methods 
for qualitative and quantitative analysis of the 
extraction solvents referred to in the Annex in 
foodstuffs or food ingredients; 
(c) the specific criteria of purity for the extraction 
solvents listed in the Annex. 
Article 6 
1. Where a Member State, as a result of new infor­
mation or of a reassessment of existing information 
made since the Directive was adopted, has detailed 
grounds for establishing that the use in foodstuffs of 
any substance listed in the Annex or the level of one 
or more of the components referred to in Article 4 
contained in such substances might endanger human 
health although it complies with the provisions of 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 grounds given by the Member State 
concerned and consult the Member States within the 
Standing Committee for Foodstuffs, and shall then 
deliver its opinion forthwith and take the appropriate 
measures. 
3. If the Commission considers that amendments 
to the Directive are necessary in order to resolve the 
NoC312/6 Official Journal of the European Communities 17.11.83 
difficulties mentioned in paragraph 1 and to ensure 
the protection of human health, it shall initiate the 
procedure laid down in Article 8 with a view to 
adopting these amendments. Any Member State 
which has adopted safeguard measures may in that 
event retain them until the amendments enter into 
force in its territory. 
Article 7 
Technical amendments to the conditions of use and 
maximum residue limits laid down in the Annex 
necessary to take account of progress in scientific and 
technical knowledge on the use of the solvents therein 
specified shall be adopted in accordance with the 
procedure provided for in Article 8. 
Article 8 
1. Where the procedure laid down in this Article is 
to be followed, the matter shall be referred to the 
Standing Committee for Foodstuffs set up by 
Decision 69/414/EEC (hereinafter called 'the 
Committee') by its chairman, either on his own 
initiative or at the request of a representative of a 
Member State. 
2. The Commission representative shall submit to 
the Committee a draft of the measures to be taken. 
The Committee shall deliver its opinion on the draft 
within a period fixed by the chairman according to 
the urgency of the matter. A qualified majority of 
votes as laid down in Article 148 (2) of the Treaty 
shall be required before the Committee can deliver its 
opinion. 
The chairman shall not vote. 
3. (a) The Commission shall adopt the proposed 
measures where they are in accordance with 
the opinion of the Committee. 
(b) Where the proposed measures are not in 
accordance with the opinion of the 
Committee, or if no opinion is delivered, the 
Commission shall submit to the Council 
without delay a proposal on the measures to 
be adopted. The Council shall decide by a 
qualified majority. 
(c) If the Council has not acted within three 
months of the date on which the proposal was 
submitted, the proposed measures shall be 
adopted by the Commission. 
Article 9 
1. Member States shall take all necessary measures 
to ensure that the substances listed in the Annex and 
intended for use in foodstuffs may be marketed only if their packagings or containers bear the following 
information: 
(a) the name, and where appropriate its EEC 
number, of the substance given in the Annex; 
(b) in the case of substances listed in the Annex when 
mixed with each other, or with other substances 
or materials or with food ingredients, the name of 
each component, and where appropriate its EEC 
number, in descending order by weight;' 
(c) a clear indication that the material is of a quality 
suitable for use in the manufacture of food or 
food ingredients; 
(d) an identifying batch number; 
(e) the name or business name and address of the 
manufacturer or packager, or of a seller 
established within the Community; 
(f) the net quantity; 
(g) any special storage conditions or conditions of 
use; 
(h) an indication of the percentage of any component 
which is subject to a quantitative limitation in a 
food in the Member State in which the product 
will be sold or used or adequate information to 
enable compliance with such a limitation. Where 
the same quantitative limitation applies to 
components used singly or in combination, the 
combined percentage may be given as a single 
figure. 
2. The provisions of this Article are 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 
preparations. 
3. 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. 
Member States shall, however, ensure that the sale of 
solvents within their own territories is prohibited if 
the particulars provided 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, and it may not result in a customs 
check on imported solvents. 
17.11.83 Official Journal of the European Communities NoC312/7 
4. By way of derogation from paragraph 1, the 
information required by points (a), (b), (f) and (h) of 
that paragraph may appear on the relevant trade 
documents relating to the consignment, provided that 
the statement 'not for retail sale' appears in a 
prominent position on the packagings or container of 
the product in question. 
Article 10 
1. This Directive shall apply equally to extraction 
solvents used or intended for use in the production of 
foodstuffs or ingredients imported into the 
Community. 
2. This Directive shall not apply to extraction 
solvents, foodstuffs or ingredients intended for export 
outside the Community. 
ANNEX 
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 for which conditions of use are unspecified 
EEC No 
E290 Name 
Propane 
Butane 
Butyl acetate 
Ethyl acetate 
Methanol 
Ethanol 
Propan-2-ol 
Carbon dioxide 
Acetone 
Nitrous oxide Article 11 
Member States shall take the measures necessary to 
comply with this Directive not later than ... (*), so as 
to authorize from that date trade in and use of 
extraction solvents complying with the provisions of 
this Directive and to prohibit trade in and use of 
extraction solvents which do not comply therewith 
not later than . .. (2). They shall immediately inform 
the Commission thereof. 
Article 12 
This Directive is addressed to the Member States. 
(') 18 months after notification. 
(2) Three years after notification. 
No C 312/8 Official Journal of the European Communities 17. 11. 83 
PART II 
Extraction solvents for which conditions of use and maximum residue limits are specified 
EEC No Name 
Diethyl ether 
Iso-butane 
Light 
petroleum (') 
Cyclohexane 
Methyl acetate 
Propan-1-ol 
Butan-1-ol 
Butan-2-ol 
2-methyl-propan-
2-ol 
Ethylmethyl-
ketone Conditions of use 
(summary description of extraction) 
Preparation of flavourings from na­
tural flavouring materials 
Preparation of flavourings from na­
tural flavouring materials 
Production or fractionation of fats 
and oils and cocoa butter 
Preparation of protein products 
and defatted flours 
Preparation of defatted cereal 
germs 
Preparation of flavourings from na­
tural flavouring materials 
Fractionation of fats and oils 
Preparation of flavourings from na­
tural flavouring materials 
Decaffeination of, or removal of, 
irritants and bitterings from coffee 
and tea 
Preparation of flavourings from na­
tural flavouring materials 
Production of sugar from molasses 
Preparation of protein products 
and defatted flours 
Production of fats and oils 
Preparation of flavourings from na­
tural flavouring materials 
Preparation of protein products 
and defatted flours 
Production or fractionation of fats 
and oils 
Fractionation of fats and oils 
Decaffeination of, or removal of, 
irritants and bitterings from coffee 
and tea 
Preparation of flavourings from na­
tural flavouring materials Maximum residues in the 
extracted food or food 
ingredient 
2 mg/kg in the food 
containing the flavouring 
1 mg/kg in the food 
containing the flavouring 
5 mg/kg in the fat or oil 
or cocoa butter 
20 mg/kg in the protein 
product or flour 
5 mg/kg in the defatted 
cereal germ 
1 mg/kg in the food 
containing the flavouring 
5 mg/kg in the fat or oil 
1 mg/kg in the food 
containing the flavouring 
20 mg/kg in the coffee or 
tea 
1 mg/kg in the food 
containing the flavouring 
1 mg/kg in the sugar 
20 mg/kg in the protein 
product or flour 
5 mg/kg in the fat or oil 
1 mg/kg in the food 
containing the flavouring 
20 mg/kg in the protein 
product or flour 
5 mg/kg in the fat or oil 
5 mg/kg in the fat or oil 
20 mg/kg in the coffee or 
tea 
1 mg/kg in the food 
containing the flavouring 
(') Light petroleum means a product consisting essentially of acyclic saturated hydrocarbons containing five, six, 
seven or eight carbon atoms or mixtures thereof, distilling completely between 25 °C and 120 °C. 
17. 11. 83 Official Journal of the European Communities No C 312/9 
EEC No Name 
Dichloromethane 
Trichloroethylene 
Anhydrous solu­
tion of ammonia 
in methanol, 
ethanol, propan-
l-ol, propan-2-ol 
or butan-2-ol Conditions of use 
(summary description of extraction) 
Decaffeination of, or removal of, 
irritants and bitterings from coffee 
and tea 
Preparation of flavourings from na­
tural flavouring materials 
Production or fractionation of fats 
and oils 
Production of cocoa butter 
Decaffeination of, or removal of, 
irritants and bitterings from coffee 
and tea 
Preparation of flavourings from na­
tural flavouring materials 
Preparation of protein products 
and defatted wheat flour Maximum residues in the 
extracted food or food 
ingredient 
10 mg/kg in the coffee or 
tea 
1 mg/kg in the food 
containing the flavouring 
5 mg/kg in the fat or oil 
5 mg/kg in the cocoa 
butter 
5 mg/kg in the coffee or 
tea 
1 mg/kg in the food 
containing the flavouring 
20 mg/kg of the alcohol 
in the protein product or 
flour 
Amendment to the Amended proposal for a Council Directive on containers of liquids for 
human consumption (') 
COM(83) 638 final 
(Submitted by the Commission to the Council, pursuant to Article 149 (2) of the EEC Treaty 
on 3 November 1983) 
THE COUNCIL OF THE EUROPEAN 
COMMUNITIES, 
Having regard to the Treaty establishing the 
European Economic Community, and in particular 
Article 235 thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas the first action programme of the European 
Communities on the environment (2) recognizes the 
need for Community action relating to certain types 
of waste, including used containers; whereas the 
second action programme of the European 
Communities on the environment (3) emphasizes inter 
O OJ No C 204, 13. 8. 1981, p. 6. 
O OJ No C 112, 20. 12. 1973, p. 1. 
O OJ No C 139, 13. 6. 1977, p. 33. alia the importance of re-using or recycling the 
various materials contained in waste; 
Whereas Article 3 of Council Directive 75/442/EEC 
of 15 July 1975 on waste (4) calls for the 
implementation of measures to encourage the 
prevention, recycling and processing of waste; 
Whereas, at its meeting of 9 April 1979, when 
examining the communication from the Commission 
on the tightening-up of the Community's environ­
mental policy (5), the Council called on the 
Commission to propose appropriate measures to 
promote inter alia the standardization of containers 
of liquids for human consumption (4); 
Whereas containers of liquids for human 
consumption account for a significant proportion of 
urban waste and are a source of litter; whereas the 
cost of collecting and disposing of household waste is 
a matter of growing concern to local authorities arid 
Governments in the Member States; 
(4) OJ No L 194, 25. 7. 1975, p. 47. 
0) COM(79)144 final, 22. 3. 1979. 
(*) Document 6755/79 (ENV/73), 29. 5. 1979.