CELEX: 51980PC0286
Language: en
Date: 1980-05-22
Title: Proposal for a Council Directive on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production

13.6. 80                          Official Journal of the European Communities                               N o C 144/9
              Proposal for a Council Directive on the approximation of the laws of the Member States
                relating to flavourings for use in foodstuffs and to source materials for their production
                              (Submitted by the Commission to the Council on 28 May 1980)
THE COUNCIL OF THE EUROPEAN                                      Whereas on the most recent scientific and technical
COMMUNITIES,                                                     advice certain components of natural flavouring
                                                                 materials and natural flavouring preparations ought
                                                                 to be limited in foodstuffs;
Having regard to the Treaty establishing the
European Economic Community and in particular
Article 100 thereof,
                                                                 Whereas specific purity criteria for flavourings and
                                                                 substances and materials used in their production, and
Having regard to the proposal from the Commission,
                                                                 methods of analysis and sampling of flavourings in
                                                                 and on foodstuffs should be established;
Having regard to the opinion of the European
Parliament,
                                                                 Whereas, in order to encourage technical progress,
                                                                 Member States should be allowed to permit provi-
Having regard to the opinion of the Economic and
                                                                 sionally in their territory, under official control, the
Social Committee,
                                                                 use of flavourings not provided for in one of the
                                                                 specific Directives, pending a final decision at
Whereas differences between national laws relating to            Community level;
flavourings hinder the free movement of foodstuffs
and may create conditions of unequal competition,
thereby affecting the establishment or functioning of
the common market;                                               Whereas, should the use in a flavouring of a
                                                                 substance or material provided for in one of the
                                                                 specific Directives or the presence of one of the sub-
Whereas the approximation of those laws is necessary             stances listed in Annex II appear to constitute a
if the free movement of foodstuffs is to be achieved;            health risk, Member States should be authorized to
                                                                 suspend or limit such use, or to reduce the limits
                                                                 provided, pending a decision at Community level;
Whereas laws relating to flavourings for use in
foodstuffs should take account primarily of human
health requirements but also, within the limit required
for the protection of health, of economic and                    Whereas the updating of the list of flavourings and
technical needs;                                                 substances and materials authorized in their manu-
                                                                 facture and the establishment of sampling procedures
                                                                 and of the methods of analysis required for checking
Whereas the first step should be to lay down in a                not only the substances listed, their purity standards
framework Directive provisions on general purity                 and conditions of use but also the limits which have
criteria, definitions, labelling, and the principles on          been laid down in Annex II constitute technical
the basis of which legal differences may subsequently            implementing measures; whereas in order to simplify
be eliminated.                                                   and expedite the procedure, the adoption of such
                                                                 measures should be entrusted to the Commission;
Whereas at a later stage specific Directives relating to
 individual categories of flavourings and source
 materials from which they are derived should be                 Whereas, it is desirable that for all cases where the
 adopted, listing the flavourings which are to be auth-          Council empowers the Commission to implement
orized by the Member States for the treatment of                  rules relating to flavourings for use in foodstuffs,
foodstuffs and indicating any special conditions of               provision should be made for a procedure establishing
manufacture or limitations on use that might be                   close cooperation between the Member States and the
 necessary;                                                       Commission within the Standing Committee for
 ---pagebreak---  N o C 144/10                           Official Journal of the European Communities                             13.6. 80
 Foodstuffs set up by Council Decision 69/414/                       — 'natural' when isolated by appropriate physical
 EEC (');                                                                processes    (including distillation,    solvent
                                                                         extraction) or trditional food preparation
                                                                         processes (including drying, torrefaction and
Whereas, without prejudice to the application of
                                                                         fermentation)     from    natural flavouring
national provisions which in the absence of specific
                                                                         materials or foodstuffs and when the
Directives on flavourings shall apply to certain groups
                                                                         composition of the flavouring component of
of flavourings, the requirements laid down in the
                                                                         the preparation is substantially the same as in
following provisions should be applied in such a way
                                                                         the natural flavouring material or foodstuff,
as to authorize, two years after notification of this
Directive, trade in and use of flavourings complying                 — 'artificial' when obtained by other than appro-
with the provisions of this Directive and to prohibit,                   priate physical processes or other than
three years after the notification thereof, trade in and                 traditional food preparation processes from
use of flavourings which do not comply therewith,                        natural flavouring materials or foodstuffs, or
                                                                         when not exclusively derived from natural
                                                                         flavouring materials or foodstuffs;
                                                                (d) 'natural flavouring material' means material of
                                                                     vegetable or animal origin, inherently having
HAS ADOPTED THIS DIRECTIVE:
                                                                     flavouring properties and used for its flavouring
                                                                     properties either as such or processed for human
                                                                     consumption by traditional food preparation
                         Article 1                                   processes (including drying, torrefaction and
                                                                     fermentation).
1.     This Directive shall apply to flavouring agents,
hereinafter called 'flavourings' used or intended for
use in or on foodstuffs to impart odour or taste, and
to natural flavouring materials and other source                                         Article 2
materials used for the production of flavourings.
                                                                This Directive shall not apply to
2.     For the purposes of this Directive:
                                                                — substances and products intended to be consumed
(a) 'flavouring' means flavouring substance, flavour-               as such, with or without reconstitution,
     ing preparation or their mixtures;
                                                                — natural flavouring materials, except as is provided
(b) 'flavouring substance' means a defined chemical                 for in Articles 4 and 5,
     substance with flavouring properties and is:
                                                                — substances and products which have exclusively a
     — 'natural' when isolated from natural flavour-                sweet, sour or salt taste,
         ing materials, natural flavouring preparations
                                                                — protein hydrolysates obtained by the autolysis or
         or    foodstuffs by       appropriate     physical
                                                                    hydrolysis of protein rich foods, or food proteins,
         processes, (including distillation, solvent
                                                                    without the addition of other substances.
         extraction),
     — 'nature-identical' when obtained by chemical
         synthesis, or isolated by chemical processes
         and chemically identical to a substance
                                                                                         Article 3
         occuring naturally in natural flavouring
         materials, natural flavouring preparations or
         foodstuffs,                                            Member States shall take all measures necessary to
                                                                ensure that flavourings and, insofar as this Directive
     — 'artificial' when not chemically identical to a          applies, natural flavouring materials may be marketed
         substance occuring naturally in natural                or used only if they comply with the rules laid down
         flavouring    materials,     natural    flavouring     in this Directive.
         preparations or foodstuffs;
(c) 'flavouring preparation' means a product or
     mixture, concentrated or not with flavouring
                                                                                         Article 4
     properties and is:
                                                                1.     Member States shall take all measures necessary
                                                                to ensure that
                                                                (a) flavourings satisfy the general purity criteria listed
 (') OJ No L 291, 19. 11. 1969, p. 9.                                in Annex I,
 ---pagebreak--- 13.6. 80                           Official Journal of the European Communities                            N o C 144/11
(b) the use of natural flavouring materials a n d / o r        — the methods of analysis needed to verify
     natural flavouring preparations may not result in               compliance with the general and specific purity
     the presence in food as consumed of any                         criteria referred to in Article 4 (1) (a) and this
     substance listed in Annex II in a quantity greater              Article;
     than therein specified. These substances must not
     be added as such, being present exclusively from           — the methods of analysis needed to verify
                                                                     compliance with the limits referred to in Article
     the use of such natural flavouring materials or
                                                                     4(l)(b);
     natural flavouring preparations.
                                                                — the procedure for taking samples and the methods
2.      Annex II shall be completed as soon as possible              for qualitative and quantitative analysis of
on the basis of the list drawn up under the provisions               flavourings in or on foodstuffs;
of Article 5 (1) (c).
                                                                — the     specific criteria of purity for the substances
                                                                     and   materials referred to in Article 5 (1) (a) and
                                                                     (b), and where necessary Article 5 (1) (c) and (d)
                           Article 5                                 and  2 (a).
 1.     The Council shall, under the procedure                                            Article 7
provided for in Article 100 of the Treaty adopt by
means of specific Directives special provisions
                                                                1.     Notwithstanding Article 5, a Member State may,
applicable to groups of flavourings (e.g. special
                                                               where a list of substances or materials has been drawn
conditions governing their use which may be
                                                                up in accordance with paragraph 1 (a) to (d) of that
necessary and methods used in their production).
                                                               Article, authorize the use within its territory of a
These specific Directives shall include lists bf subs-
                                                                substance or material not included in such list, subject
tances or materials the use of which is authorized to
                                                                to the following conditions:
the exclusion of all others of:
                                                                (a) the authorization must be limited to a maximum
(a) artificial flavouring substances;
                                                                     period of three years;
(b) nature-identical flavouring substances;
                                                                (b) flavourings manufactured using the substance or
(c) source materials for the production of natural                   material must bear a distinctive indication which
      flavouring preparations and natural flavouring                 will be defined on the authorization.
      substances;
                                                                2.     The Member State shall forward to tile other
(d) source materials for the production of artificial
                                                                Member States and to the Commission the text of any
      flavouring preparations;
                                                                authorization drawn up pursuant to paragraph 1
                                                                within two months of the date of its entry into force.
2.      The Council, under the procedure provided for
in Article 100 of the Treaty, shall:
                                                                3.     Before the expiry of the three year period
 (a) adopt lists of substances or materials the use of          provided for in paragraph 1, the Member State may
      which is authorized to the exclusion of all others        submit to the Commission a request to authorize the
      of;                                                       inclusion of the substance or material referred to in
                                                                paragraph 1 in a list as referred to in Article 5 (1) (a)
      — additives necessary for the production and              to (d). At the same tiipe, it shall supply supporting
          storage of flavourings,                                documents setting out the grounds on which it deems
      — products used for dissolving and            diluting     such authorization justified and shall indicate the uses
          flavourings,                                           for which such substance or material is intended.
      — processing aids (e.g. extraction solvents)               Within 18 months of the submission of this request, a
           necessary for the production of flavourings;          decision shall be taken on the basis of information
                                                                 relating to public health, and in accordance with the
  (b) specifiy the conditions for the use of the sub-            procedure laid down in Article 11 as to whether the
       stances and materials referred to in paragraph            substance or material in question may be included in
       2(a).                                                     the list as referred to in Article 5 (1) (a) to (d) or
                                                                 whether the authorization should be revoked. If any
                                                                  special provisions prove necessary pursuant to the
                                                                  provisions of Article 5 (1), these too shall be adopted
                           Article 6                              under     the    same     procedure.   Notwithstanding
                                                                  paragraph 1 (a), the national authorization shall
 The procedure laid down in Article 11 shall be used              remain in force until a decision is taken on the
  to determine:                                                   request.
 ---pagebreak--- No C 144/12                           Official Journal of the European Communities                             13. 6. 80
Should the authorization be revoked by the Member                                      Article 10
State, this decision to revoke shall apply to any other
temporary authorization granted in respect of the              1.   Without prejudice to any exception provided for
substance or material in question. Such decision may          in the specific Directives, flavourings may be
stipulate that the ban on the use of the substance or         marketed only if their packagings or containers bear
material in question shall extend to uses other than          the following information:
those referred to in the first sub-paragraph.
                                                              (a) the name or business name and address of the
                                                                   manufacturer or packager, or of a seller
                                                                   established within the Community;
                        Article 8                             (b) either the word 'flavouring' or a more specific
                                                                  name or description of the flavouring;
Without prejudice to Article 7 (3), amendments to the
technical Annexes of the specific Directives referred         (c) either the statement 'for foodstuffs' or a more
to in Article 5 (1), to the lists referred to in Article          specific reference to its intended food use;
5 (2), and to the Annexes to this Directive, necessary
to take account of progress in scientific and technical       (d) in the case of mixtures of flavourings a list of the
knowledge shall be adopted in accordance with the                 categories of flavourings present in accordance
procedure provided for in Article 11.                             with the definitions given in Article 1 (2) in order
                                                                  of proportion by weight which each category
                                                                  bears to the total;
                                                              (e) in the case of flavourings containing other sub-
                        Article 9                                 stances or materials in accordance with the first
                                                                  and second indents of Article 5 (2)
1.    Where a Member State, as a result of new infor-
mation or of a reassessment of existing information               — the name of any such substances or material
made since this Directive or one of the specific                       or where appropriate its 'E' number,
Directives laid down in Article 5 was adopted has
detailed grounds for establishing                                 — the percentage of such substance or material,
— that the presence of one of the substances listed in                 where this requirement is laid down in
    the Annexes to this Directive or the maximum                       provisions relating to other categories of
    level which may be present, although it complies                   additives;
    with the provisions of this Directive,
                                                              (f) an indication of the maximum amount present of
— that the use of a flavouring although it complies               any substance listed in Annex II, and instructions
    with the relevant specific Directive,                         for use where the absence of such instructions
endangers human health, that Member State may                     would make it impossible for the user to comply
temporarily suspend or restrict application of the                with the special conditions of use stipulated in
provisions in question in its territory. It shall                 Article 4 (1) (b);
immediately inform the other Member States and the
Commission thereof and give reasons for its decision.         (g) in the case/ of pre-packaged flavourings, the net
                                                                  quantity; Article 8 of Council Directive
2.    The Commission shall examine as soon as                     79/112/EEC of 19 December 1978 on the
possible the grounds given by the Member State                    approximation of the laws of the Member States
within the Standing Committee for Foodstuffs, and                 relating to the labelling, presentation and
shall then deliver its opinion forthwith and take the             advertising of foodstuffs for sale to the ultimate
appropriate measures.                                             consumer (') shall apply by analogy.
 3.   If the Commission considers that amendments
to this Directive or a specific Directive are necessary       2.    The word 'natural', or any word having sub-
in order to resolve the difficulties mentioned in             stantially the same meaning, may only be used for
paragraph 1 and to ensure the protection of human             flavourings, the flavouring component of which
health, it shall initiate the procedure laid down             contains exclusively natural flavouring preparations.
in Article 11, with a view to adopting these
amendments; the Member State which has adopted
safeguard measures may in that event retain them
until the amendments enter into force.                        (') OJ No L 33, 8. 12. 1979, p. 1.
 ---pagebreak--- 13.6. 80                          Official Journal of the European Communities                             N o C 144/13
3.    Any reference to the type of flavour shall be                (b) Where the measures envisaged are not in
accompanied by the word 'reproduced' where the                          accordance with the         Opinion     of   the
flavouring contains nature-identical flavouring sub-                    Committee, or if no Opinion is delivered, the
stances, this indication being replaced by 'artificial' if              Commission shall without delay submit to the
one or more artificial flavouring substances is present.                Council a proposal on the measures to be
                                                                        taken. The Council shall act by a qualified
                                                                        majority.
4.    The details referred to in paragraph 1 (b) and
(c) and paragraph 3 shall appear on one of the main                (c) If within three months of the proposal being
surfaces of the packaging or container and in the                       submitted to it the Council has not acted, the
same field of vision.                                                   proposed measures shall be adopted by the
                                                                        Commission.
5.     By derogation from the provisions of this
Article, where flavourings are not intended for retail
sale, the information required in paragraph 1 (a), (d),                                 Article 12
(e), (f) and (g) may figure on the relevant trade
documents.                                                     1.     Without prejudice to Article 14, Member States
                                                              shall adopt all the measures necessary to ensure that
                                                              trade in flavourings referred to in Article 1 which
6.    Member States shall refrain from laying down            comply with the definitions and rules laid down in
requirements more detailed than those already                 this Directive or in the Directives referred to in
contained in this Article, concerning the manner in           Article 5(1) and (2) cannot be impeded by the
which the particulars provided for are to be shown.           application of non-harmonized national provisions
                                                              governing the composition, manufacturing specifi-
The Member States shall, however, ensure that the             cations, packaging or labelling of those products.
sale of flavourings within their own territories is
prohibited if the particulars provided in this Article do
                                                              2.      Paragraph 1 shall not be applicable to non-
not appear in a language easily undertstood by
                                                               harmonized provisions justified on grounds of:
purchaser, unless other measures have been taken to
ensure that the purchaser is informed. This provision
shall not prevent such particulars from being                 — protection of public health;
indicated in various languages.
                                                              — prevention of frauds unless such provisions are
                                                                    liable to impede the application of the definitions
                                                                    and rules laid down by this Directive;
                          Article 11
                                                              — protection of industrial and commercial property,
                                                                    indications of source, registered designation and
1.    Where the procedure laid down in this Article is              prevention of unfair competition.
to be followed, the matter shall be referred to the
Standing Committee for Foodstuffs set up by
Decision 6 9 / 4 1 4 / E E C (hereinafter called 'the
Committee') by its Chairman, either on his own
initiative or at the request of a representative of a                                   Article 13
Member State.
                                                               1.     This Directive shall apply to flavourings
                                                               intended for use in foodstuffs, and to foodstuffs,
 2.    The representative of the Commission shall              imported into the Community.
 submit to the Committee a draft of the measures to
 be taken. The Comittee shall give its opinion on that
 draft within a time limit set by the Chairman having           2.     This Directive shall apply neither to flavourings,
 regard to the urgency of the matter. Opinions shall be         nor to foodstuffs, intended for export outside the
 delivered by a majority of 41 votes, the votes of the          Community.
 Member States being weighted as provided in Article
 148 (2) of the Treaty. The Chairman shall not vote.
                                                                                        Article 14
 3. (a) Where the measures envisaged are in
         accordance with the Opinion              of   the      Within 18 months of the notification of this Directive,
         Committee, the Commission shall adopt them.            Member States shall take the measures necessary to
 ---pagebreak--- N o C 144/14                           Official Journal of the European Communities                              13. 6. 80
comply with this Directive and shall forthwith inform               — prohibit, three years after notification of this
the Commission thereof. The measures taken shall:                       Directive, trade in and use of flavourings which
                                                                        do not comply with the provisions laid down in
— authorize, two years after notification of this                       this Directive.
    Directive, trade in and use of flavourings,
    complying with the provisions laid down in this
    Directive, without prejudice to the application of
    national provisions, which in the absence of the                                           Article 15
    Directives referred to in Article 5(1) and (2) shall
    apply to certain groups of flavourings;                         This Directive is addressed to the Member States.
                                                           ANNEX     I
             Flavourings shall not contain a toxicologically dangerous amount of any element.
             Subject to any exception deriving from the criteria of purity referred to in Article 6:
             — they shall not contain more than 0-5 mg/kg cadmium, more than 0 - 5 mg/kg mercury, more
                 than 2 mg/kg arsenic or more than 5 mg/kg lead;
             — they shall not contain more than 50 mg/kg of copper and zinc taken together of which the zinc
                 content must not exceed 25 mg/kg;
 ---pagebreak--- 13.6. 80                           Official Journal of the European Communities                                N o C 144/15
                                                         ANNEX II
         Maximum limits for certain substances having biological activity present in food as consumed as a
                 result of the use of natural flavouring materials and/or natural flavouring preparations
                                      Food         Beverages
                Substance                                                           Exceptions
                                      mg/kg         mg/kg
         Beta asarone                 0-1            01           1 mg/kg in alcoholic beverages and sea-
                                                                  sonings used in snack foods
         Coumarin                      2             2            10 mg/kg in certain types of caramel confec-
                                                                  tionery
                                                                  50 mg/kg in chewing gum
                                                                  10 mg/kg in alcoholic beverages
         Hydrocyanic acid              1              1           25 mg/kg in confectionery
                                                                  50 mg/kg in marzipan or its substitutes
                                                                  1 mg/kg per 1 % volume alcohol in alcoholic
                                                                  beverages
                                                                  5 mg/kg in stone fruit juices
         Safrole and                   1              1           2 mg/kg in alcoholic beverages less than 25 %
         iso-safrole                                              volume alcohol
                                                                  5 mg/kg in alcoholic beverages above 25 %
                                                                  volume alcohol
                                                                   15 mg/kg in foods containing mace and nut-
                                                                  meg
         Thujone (alpha and            0-5           0-5          5 mg/kg in alcoholic beverages less than 25 %
         beta)                                                    volume alcohol
                                                                  10 mg/kg in alcoholic beverages above 25 %
                                                                  volume alcohol
                                                                  50 mg/kg in foods containing sage
                                                                   100 mg/kg in sage stuffings
                                                                  35 mg/kg in bitters