1988L0388 — EN — 07.02.1991 — 001.001 — 1
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►B COUNCIL DIRECTIVE
of 22 June 1988
on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs
and to source materials for their production
(88/388/EEC)
(OJ L 184, 15.7.1988, p. 61)
Amended by:
OfficialJournal
No page date
►M1 Commission Directive 91/71/EEC of 16 January 1991 L 42 25 15.2.1991
Corrected by:
►C1 Corrigendum, OJ L 345, 14.12.1988, p. 29 (88/388)
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COUNCIL DIRECTIVE
of 22 June 1988
on the approximation of the laws of the Member States relating to
flavourings for use in foodstuffs and to source materials for their
production
(88/388/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community and in particular Article 100a thereof,
Having regard to the proposalfrom the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and SocialCommittee (3),
Whereas differences between national laws relating to flavourings
hinder the free movement of foodstuffs and may create conditions ofunequal competition, thereby directly affecting the establishment orfunctioning of the common market;
Whereas the approximation of those laws is necessary if the free move-
ment of foodstuffs is to be achieved;
Whereas laws relating to flavourings for use in foodstuffs should take
account primarily of human health requirements but also, within thelimit required for the protection of health, of economic and technicalneeds;
Whereas the first step should be to lay down in a framework Directive
provisions on general purity criteria, definitions, labelling, and the prin-ciples on the basis of which legal differences may subsequently beeliminated;
Whereas, on the basis of the inventory or source materials and
substances used in the preparation of flavourings established by theCommission on the basis of Decision 88/389/EEC (
4), the Councilwil l
at a later stage adopt, under the procedure laid down in Article 100a ofthe Treaty, appropriate provisions concerning individualcategories offlavourings and source materials and any necessary measuresconcerning their use and methods of production;
Whereas on the most recent scientific and technicaladvice certain
components on vegetable or animal raw materials used in the prepara-tion of flavourings ought to be limited in foodstuffs;
Whereas specific purity criteria for given flavourings, microbiological
criteria for flavourings, methods of analysis and sampling of flavouringsand the substances listed in the Annexes in and on foodstuffs should beestablished;
Whereas, should the use in a flavouring of a substance or material
authorized on the basis of this Directive or provisions adopted at a laterstage or the presence of one of the substances listed in Annex II appearto constitute a health risk, Member States should be authorized tosuspend or limit such use, or to reduce the maximum limits provided,pending a decision at Community level;
Whereas the drawing up of the list of substances or materials authorized
as additives necessary for the storage and use of flavourings as solventsand diluents of flavouring, and as processing aids, and the establishmentof specific criteria of purity for flavourings, the procedure for taking
(1) OJ No C 144, 13. 6. 1980, p. 9, and
OJ No C 103, 24. 4. 1982, p. 7.
(2) OJ No C 66, 15. 3. 1982, p. 117 and Decision of 9 March 1988 (not yet
published in the Official Journal).
(3) OJ No C 138, 9. 6. 1981, p. 42.
(4) OJ No L 184, 15. 7. 1988, p. 67.
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samples and the methods of analysis of flavourings in or on foodstuffs
and the verification of the maximum limits laid down in the Annexesconstitute technicalimpl ementing measures; whereas in order tosimplify and expedite the procedure, the adoption of such measuresshould be entrusted to the Commission;
Whereas, it is desirable that in all cases where the Council empowers
the Commission to implement rules relating to flavourings for use infoodstuffs, provision should be made for a procedure establishing closecooperation between the Member States and the Commission within theStanding Committee for Foodstuffs set up by Decision 69/414/EEC (
1);
Whereas, without prejudice to the application of national rules which, in
the absence of specific Directives on flavouring, apply to certain groupsof flavourings, the requirements laid down in the following provisionsshall be applied in such a way as to authorize, two years after adoptionof this Directive, trade in and use of flavourings complying with theprovisions of this Directive and to prohibit, three years after the adop-tion thereof, trade in and use of flavourings which do not complytherewith,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive shall apply to ‘flavourings' used or intended for use
in or on foodstuffs to impart odour and /or taste, and to source materialsused for the production of flavourings.
2. For the purposes of this Directive:
(a) ‘flavouring' means flavouring substances, flavouring preparations,
process flavourings, smoke flavourings or mixtures thereof;
(b) ‘flavouring substance' means a defined chemical substance with
flavouring properties which is obtained:
(i) by appropriate physical processes (including distillation and
solvent extraction) or enzymatic or microbiological processesfrom materialof vegetabl e or animalorigin either in the rawstate or after processing for human consumption by traditionalfood-preparation processes (including drying, torrefaction andfermentation),
(ii) by chemicalsynthesis or isol ated by chemicalprocesses and
which is chemically identical to a substance naturally presentin materialof vegetabl e or animalorigin as described in (i),
(iii) by chemical synthesis but which is not chemically identical to
a substance naturally present in material of vegetable or animalorigin as described in (i);
(c) ‘flavouring preparation' means a product, other than the substances
defined in (b) (i), whether concentrated or not, with flavouringproperties, which is obtained by appropriate physicalprocesses(including distillation and solvent extraction) or by enzymatic ormicrobiol ogicalprocesses from materialof vegetabl e or animalorigin, either in the raw state or after processing for humanconsumption by traditionalfood-preparation processes (incl udingdrying, torrefaction and fermentation);
(d) ‘process flavouring' means a product which is obtained according to
good manufacturing practices by heating to a temperature notexceeding 180 °C for a period not exceeding 15 minutes a mixture
of ingredients, not necessarily themselves having flavouring proper-ties, of which at least one contains nitrogen (amino) and another is areducing sugar;
(e) ‘smoke flavouring' means a smoke extract used in traditional food-
stuffs smoking processes.
(1) OJ No L 291, 19. 11. 1969, p. 9.
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3. Flavourings may contain foodstuffs as well as other substances asdescribed in Article 6 (1).
Article 2
This Directive shall not apply to:
— edible substances and products intended to be consumed as such,
with or without reconstitution,
— substances which have exclusively a sweet, sour or salt taste,— materialof vegetabl e or animalorigin, having inherent fl avouring
properties, where they are not used as flavouring sources.
Article 3
Member States shall take the necessary measures to ensure that flavour-
ings may not be marketed or used if they do not comply with the ruleslaid down in this Directive.
Article 4
Member States shall take all measures necessary to ensure that:
(a) — flavourings do not contain any element or substance in a toxico-
logically dangerous quantity;
— subject to any exceptions provided for in the specific criteria of
purity referred to in Article 6 (2), third indent, they do notcontain more than 3 mg/kg of arsenic, 10 mg/kg of lead,1 mg/kg of cadmium and 1 mg/kg of mercury;
(b) the use of flavourings does not result in the presence in foodstuffs
as consumed of undesirable substances listed in Annex I in quant-ities greater than those specified therein;
(c) the use of flavourings and of other food ingredients with flavouring
properties does not result in the presence of substances listed inAnnex II in quantities greater than those specified therein.
Article 5
The Council, acting in accordance with the procedure laid down in
Article 100a of the Treaty, shall adopt:
1. Appropriate provisions concerning:
— flavouring sources composed of foodstuffs, and of herbs and
spices normally considered as foods,
— flavouring sources composed of vegetable or animal raw mate-
rials not normally considered as foods,
— flavouring substances obtained by appropriate physical processes
or by enzymatic or microbiological processes from vegetable oranimalraw material s,
— chemically synthesized or chemically isolated flavouring
substances chemically identical to flavouring substances naturallypresent in foodstuffs or in herbs and spices normally consideredas foods,
— chemically synthesized or chemically isolated flavouring
substances chemically identical to flavouring substances naturallypresent in vegetable or animal raw materials not normally consid-ered as foods,
— chemically synthesized or chemically isolated flavouring
substances other than those referred to in the fourth and fifthindents,
— source materials used for the production of smoke flavourings or
process flavourings, and the reaction conditions under which theyare prepared;
2. Any specialprovisions which may be necessary, for the protection of
public health or trade, concerning:
— the use and methods of production of flavourings, including
physicalprocesses or enzymatic or microbiol ogicalprocesses for
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the production of flavouring preparations and flavouringsubstances as referred to in Article 1 (2) (b) (i) and (c),
— the conditions for the use of the substances and materials referred
to in Article 6 (1);
3. Amendments concerning the maximum limits laid down in the
Annexes.
Article 6
The following shall be adopted in accordance with the procedure set out
in Article 10:
1. the list of substances or materials authorized in the Community as:
— additives necessary for the storage and use of flavourings,— products used for dissolving and diluting flavourings,— additives necessary for the production of flavourings (processing
aids) where such additives are not covered by other Communityprovisions;
2. where necessary:
— the methods of analysis needed to verify compliance with the
levels referred to in Article 4,
— the procedure for taking samples and the methods for qualitative
and, where appropriate, quantitative analysis of flavourings in oron foodstuffs,
— the specific criteria of purity for given flavourings;
3.— the microbiological criteria applicable to flavourings,
— the designation criteria given to the more specific names referred
to in Article 9 (1) (b);
4. the appropriate steps, to be taken by 1 July 1990 to supplement this
Directive with labelling rules for flavourings intended for sale to thefinalconsumer.
Article 7
Provisions that may have effects on public health shall be adopted only
after consulting the Scientific Committee for Food.
Article 8
1. Where, as a result of new information or of a re-assessment of
existing information made since this Directive or one of the Directivesprovided for in Article 5 was adopted, a Member State has detailedevidence:
— that the presence of one of the substances listed in the Annexes to
this Directive or the maximum levels stipulated, while complyingwith the provisions of this Directive, or
— that the use of a flavouring, while complying with the relevant
Directive or with this Directive, or
— that the presence of a substance similar to those referred to in the
Annexes
constitutes a danger to human health, that Member State may tempor-
arily suspend or restrict application of the provisions in question withinits territory. It shall immediately inform the other Member States andthe Commission thereof and give reasons for its decision.
2. The Commission shall examine as soon as possible the evidence
given by the Member State and consult the Standing Committee forFoodstuffs, and shall then deliver its opinion forthwith and take theappropriate measures, which may replace the measures referred to inparagraph 1.
3. If the Commission considers that amendments to this Directive or
to one of the Directives referred to in Article 5 are necessary in order toalleviate the difficulties mentioned in paragraph 1 and to ensure theprotection of human health, it shall initiate the procedure laid down inArticle 10, with a view to adopting these amendments; the Member
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State which has adopted safeguard measures may in that event retain
them untilthe amendments enter into force.
Article 9
1. Flavourings not intended for sale to the final consumer may not be
marketed unless their packagings or containers bear the following infor-mation, which should be easily visible, clearly legible and indelible:
(a) the name or business name and address of the manufacturer or
packer, or of a seller established within the Community;
(b) the sales description: either the word ‘flavouring' or a more specific
name or description of the flavouring.
Member States may maintain for a period of three years following
the adoption of this Directive, more specific names to designateflavourings composed of mixtures of flavouring preparations andflavouring substances.
Before this period expires, it shall be decided according to the
procedure provided for in Article 10 whether or not these namesshall be included in this Directive;
(c) either the statement ‘for foodstuffs' or a more specific reference to
the foodstuff for which the flavouring is intended;
(d) a list in descending order of weight of the categories of flavouring
substances and flavouring preparations present classified as follows:
— natural flavouring substances in the case of flavouring
substances defined in Article 1 (2) (b) (i),
— fl avouring substances identicalto naturalsubstances in the case
of flavouring substances defined in Article 1 (2) (b) (ii),
— artificial flavouring substances in the case of flavouring
substances defined in Article 1 (2) (b) (iii),
— flavouring preparations in the case of preparations defined in
Article 1 (2) (c),
— process flavourings in the case of flavourings defined in Article
1 (2) (d),
— smoke flavourings in the case of flavourings defined in Article 1
(2) (e);
(e) in the case of a mixture of flavourings with other substances or
materials referred to in the first and second indents of Article 6 (1),a list in descending order of weight in the mixture of:
— the categories of flavourings classified as in (d) of this para-
graph,
— the names of each of the other substances or materials or, where
appropriate, their ‘EEC' numbers;
(f) an indication of the maximum quantity of each component or group
of components subject to quantitative limitation in a foodstuff orappropriate information enabling the purchaser to comply with theCommunity provisions or, where there are none, nationalprovisionsapplying to that foodstuff;
(g) an indication identifying the consignment;(h) the nominalquantity expressed in units of mass or vol ume.
2. Without prejudice to paragraph 1 (d), the word ‘natural', or any
other word having substantially the same meaning, may be used onlyfor flavourings in which the flavouring component contains exclusively►
C1flavouring substances as defined in Article 1 (2) (b) (i) and/or ◄
flavouring preparations as defined in Article 1 (2) (c).
If the sales description of the flavouring contains a reference to a
foodstuff or a flavouring source, the word ‘natural', or any other wordhaving substantially the same meaning, may not be used unless theflavouring component has been isolated by appropriate physicalprocesses, enzymatic or microbiol ogicalprocesses or traditionalfood-preparation processes solely or almost solely from the foodstuff or theflavouring source concerned.
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3. By way of derogation from paragraph 1, the information required
in paragraph 1 (d), (e) and (f) may appear merely on the trade docu-ments relating to the consignment which are to be supplied with or priorto the delivery, provided the indication ‘intended for the manufacture offoodstuffs and not for retail' appears in a conspicuous part of thepackaging or container of the products in question.
4. Member States shall refrain from laying down requirements more
detailed than those contained in this Article concerning the manner inwhich the particulars provided for are to be shown.
The particulars provided for in this Article shall be given in terms easily
understood by purchasers unless other measures have been taken toensure that the purchaser is informed. This provision shall not preventsuch particulars from being indicated in various languages.
▼
M1
Article 9a
1. Flavourings intended for sale to the final consumer may not be
marketed unless their labels indicate the following obligatory informa-tion, which should be easily visible, clearly legible and indelible:
(a) either the word ‘flavouring' or a more specific name or description
of the flavouring;
(b) either the words ‘for foodstuffs' or a more specific reference to the
foodstuff for which the flavouring is intended;
(c) the date of minimum durability in conformity with Article 3 (1) No
4 and Article 9 of Council Directive 79/112/EEC (
1);
(d) where necessary, the specialconditions for storage and use;
(e) the instructions for use if omission thereof would prevent appro-
priate use of the flavouring;
(f) the net quantity expressed in units of mass or volume;
(g) the name or business name and address of the manufacturer or
packer, or of a seller established within the Community;
(h) an indication or mark identifying the batch in conformity with
CouncilDirective 89/396/EEC (2);
(i) in the case of a mixture of flavouring(s) with other substances a list
in descending order of weight in the mixture of:
— the flavouring or flavourings in question, in conformity with (a)
above;
— the names of each of the other substances or materials or, where
appropriate, their E numbers.
2. The word ‘natural', or any other word having substantially the
same meaning, may be used only for flavourings in which theflavouring component contains exclusively flavouring substances asdefined in Article 1 (2) (b) (i) and/or flavouring preparations as definedin Article 1 (2) (c). If the sales description of the flavourings contains areference to a foodstuff or a flavouring source, the word ‘natural' or anyother word having substantially the same meaning, may not be usedunless the flavouring component has been isolated by appropriate phys-icalprocesses, enzymatic or microbiol ogicalprocesses or traditionalfood-preparation processes solely or almost solely from the foodstuff orthe flavouring source concerned.
3. The particulars required in this Article shall be given in a language
easily understood by the purchaser unless other measures have beentaken to ensure that the purchaser is informed. This provision shall notprevent such particulars from being indicated in various languages.
(1) OJ No L 33, 8.2.1979, p. 1.
(2) OJ No L 186, 30.6.1989, p. 21.
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Article 10
1. Where the procedure laid down in this Article is to be followed,
the chairman shall refer the matter to the Standing Committee forFoodstuffs either on his own initiative or at the request of the repres-entative of a Member State.
2. The Commission representative shall submit to the Committee a
draft of measures to be taken. The Committee shall deliver its opinionon the draft within a time limit which the chairman may lay downaccording to the urgency of the matter. The opinion shall be deliveredby the qualified majority laid down in Article 148 (2) of the Treaty. Thechairman shall not vote.
3. (a) The Commission shall adopt the intended measures when they
are in accordance with the Committee’s opinion.
(b) Where the intended measures are not in accordance with the
opinion of the Committee, or in the absence of any opinion, theCommission shal lforthwith submit to the Councila proposalrelating to the measures to be taken. The Council shall act on aqualified majority.
If, on the expiry of three months from the date on which the
matter was referred to it, the Councilhas not adopted any meas-ures, the Commission shall adopt the proposed measures.
Article 11
1. This Directive shall also apply to flavouring intended for use in
foodstuffs, and to foodstuffs, imported into the Community.
2. This Directive shall apply neither to flavourings, nor to foodstuffs,
intended for export outside the Community.
Article 12
1. The Member States may not invoke reasons of composition or
labelling of flavourings or their behaviour in foodstuffs to prohibit,restrict, or hamper the marketing or use of flavourings which complywith this Directive and with the Directives referred to in Article 5.
2. Paragraph 1 shal lnot affect nationalprovisions which are appl ic-
able in the absence of the Directives as referred to in Article 5.
Article 13
1. Member States shall take the measures necessary to comply with
this Directive within 18 months of its adoption. They shall forthwithinform the Commission thereof. The measures taken shall:
— authorize, two years after adoption of this Directive, the marketing
and use of flavourings complying with this Directive,
— prohibit, three years after adoption of this Directive, the marketing
and use of flavourings which do not comply with this Directive.
2. Paragraph 1 shal lnot affect those nationalprovisions which, in the
absence of the Directives referred to in Article 5, apply to certaingroups of flavourings or specify the foodstuffs in or on which flavour-ings complying with the Directive may be used.
Article 14
The Directive is addressed to the Member States.
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ANNEX I
Maximum limits for certain undesirable substances present in foodstuffs as
consumed as a result of the use of flavourings
Substance Foodstuffs Beverages
3,4 benzopyrene 0,03 µg/kg 0,03 µg/kg
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ANNEX II
Maximum limits for certain substances obtained from flavourings and other food ingredients
with flavouring properties present in foodstuffs as consumed in which flavourings have been used
SubstancesFoodstuffs
mg/kgBeverages
mg/kgExceptions and/or specialrestrictions
Agaric acid (1) 20 20 100 mg/kg in alcoholic beverages and food-
stuffs containing mushrooms
Aloin (1) 0,1 0,1 50 mg/kg in alcoholic beverages
Beta asarone (1) 0,1 0,1 1 mg/kg in alcoholic beverages and season-
ings used in snack foods
Berberine (1) 0,1 0,1 10 mg/kg in alcoholic beverages
Coumarin (1) 2 2 10 mg/kg in certain types of caramelconfec-
tionery
50 mg/kg in chewing gum10 mg/kg in alcoholic beverages
Hydrocyanic acid (1) 1 1 50 mg/kg in nougat, marzipan or its substi-
tutes or similar products
1 mg/% volume of alcohol in alcoholic
beverages
5 mg/kg in canned stone fruit
Hypericine (1) 0,1 0,1 10 mg/kg in alcoholic beverages
1 mg/kg in confectionery
Pulegone (1) 25 100 250 mg/kg in mint or peppermint-flavoured
beverages
350 mg/kg in mint confectionery
Quassine (1) 5 5 10 mg/kg in confectionery in pastille form
50 mg/kg in alcoholic beverages
Safrole and isosa-frole (
1)1 1 2 mg/kg in alcoholic beverages with not more
than 25% volume of alcohol
5 mg/kg in alcoholic beverages with more
than 25% volume of alcohol
15 mg/kg in foodstuffs containing mace and
nutmeg
Santonin (1) 0,1 0,1 1 mg/kg in alcoholic beverages with more
than 25% volume of alcohol
Thuyone (alpha andbeta) (
1)0,5 0,5 5 mg/kg in alcoholic beverages with not morethan 25% volume of alcohol
10 mg/kg in alcoholic beverages with more
than 25% volume of alcohol
25 mg/kg in foodstuffs containing prepara-
tions based on sage
35 mg/kg in bitters
(1) May not be added as such to foodstuffs or to flavourings. May be present in a foodstuff either naturally or
following the addition of flavourings prepared from natural raw materials.