CELEX: 51983PC0626
Language: en
Date: 1983-10-26
Title: 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

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