1989L0107 — EN — 20.11.2003 — 002.001 — 1
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►B COUNCILDIRECTIVE
of21December 1988
on the approximation of the laws of the Member States concerning food additives authorized for
useinfoodstuffsintendedforhumanconsumption
(89/107/EEC)
(OJ L 40, 11.2.1989, p. 27)
Amended by:
Official Journal
No page date
►M1European Parliament and Council Directive 94/34/EC of 30 June 1994 L 237 1 10.9.1994
►M2Regulation (EC) No 1882/2003 of the European Parliament and of the
Council of 29 September 2003L 284 1 31.10.2003
▼B
COUNCILDIRECTIVE
of21December 1988
ontheapproximationofthelawsoftheMemberStatesconcerning
food additives authorized for use in foodstuffsintendedfor human
consumption
(89/107/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission,In cooperation withth e European Parliament (
1),
Having regard to the opinion of the Economic and Social
Committee (2),
Whereas differences between national laws relating to food additives
and the conditions for their use hinder the free movement of foodstuffs;
whereas they may create conditions of unfair competition, thereby
directly affecting the establishment or functioning of the commonmarket;
Whereas the approximation of these laws is therefore necessary;Whereas these requirements should be included in a comprehensive
directive, where neccessary drawn up in stages;
Whereas the drawing-up of lists of categories of food additives to be
covered by a directive is a matter to be decided by the Council actingunder the procedure laid down in Article 100a of the Treaty;
Whereas the use of food additives belonging to such categories should
be authorized only on the basis of agreed scientific and technologicalcriteria laid down by the Council;
Whereas in drawing up lists of additives and the conditions for their
use the Scientific Committee for Food, set up by Commission Decision
74/234/EEC (
3), should be consulted before the adoption of provisions
likely to affect public health;
Whereas it must be possible to adopt the list of authorized additives to
scientific and technical developments; whereas in that case, it may beappropriate also to have, in addition to the rules of procedure laid downby the Treaty, a system permitting the Member States to contribute, by
the adoption of temporary national measures, to the search for a
Community solution;
Whereas the determination of the criteria of purity for such food addi-
tives and the drawing-up of methods of analysis and sampling aretechnical matters to be entrusted to the Commission;
Whereas existing Community provisions on colouring matters, preser-
vatives, anti-oxidants and emulsifiers, stabilizers, thickeners andgelling agents will require amendment on the basis of this Directive;
Whereas, in all cases where the Council empowers the Commission to
implement rules relating to foodstuffs, provision should be made for a
procedure instituting close cooperation between Member States and the
Commission within the Standing Committee on Foodstuffs set up byCommission Decision 69/414/EEC (
4),1989L0107 — EN — 20.11.2003 — 002.001 — 2
(1) OJ No C 99, 13. 4. 1987, p. 65 and OJ No C 12, 16. 1. 1989.
(2) OJ No C 328, 22. 12. 1986, p. 5.
(3) OJ No L 136, 20. 5. 1974, p. 1.
(4) OJ No L 291, 19. 11. 1969, p. 9.
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HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive shall apply to food additives the various categories
of which are given in Annex I and which are used or intended to beused as ingredients during the manufacture or preparation of a food-stuff and are still present in the final product, even if in altered form,hereinafter called ‘food additives’.
2. For the purposes of this Directive ‘food additive’ means any
substance not normally consumed as a food in itself and not normallyused as a characteristic ingredient of food whether or not it has nutri-
tive value, the intentional addition of which to food for a technological
purpose in the manufacture, processing, preparation, treatment, packa-ging, transport or storage of suchfood results, or may be reasonablyexpected to result, in it or its by-products becoming directly or indir-ectly a component of suchfoods.
3. This Directive shall not apply to:
a) processing aids (
1);
b) substances used in the protection of plants and plant products in
conformity with Community rules relating to plant health;
c) flavourings for use in foodstuffs, falling within the scope of Council
Directive 88/388/EEC (2);
d) substances added to foodstuffs as nutrients (for example minerals,
trace elements or vitamins).
Article 2
1. In respect of any category of food additive listed in Annex I for
which lists have been drawn up pursuant to Article 3 (3), only thosefood additives included in suchlists may be used in th e manufactureor preparation of foodstuffs and only under the conditions of use speci-fied therein.
2. The inclusion of food additives in one of the categories in Annex
I shall be on the basis of the principal function normally associatedwith the food additive in question. However, the allocation of the addi-
tive to a particular category does not exclude the possibility of the
additive being authorized for several functions.
3. Food additives shall be included in a list on the basis of the
general criteria described in Annex II.
Article 3
1. Particular provisions in respect of the additives in the categories
given in Annex I shall be laid down in a comprehensive directive,including existing specific directives on particular categories of addi-
tives. That directive may, however, be drawn up in stages.
2. The Council shall, acting on a proposal from the Commission
under the procedure laid down in Article 100a of the Treaty, adopt:
a) a list of additives, the use of which is authorized to the exclusion of
all others;
b) the list of foodstuffs to which these additives may be added, the
conditions under which they may be added and, where appropriate,a limit on the technological purpose of their use;1989L0107 — EN — 20.11.2003 — 002.001 — 3
(1) For the purpose of this Directive, ‘processing aid’ means any substance not
consumed as a food ingredient by itself, intentionally used in the processing
of raw materials, foods or their ingredients, to fulfil a certain technological
purpose during treatment or processing and which may result in the uninten-tional but technically unavoidable presence of residues of the substance or
its derivatives in the final product, provided that these residues do not
present any health risk and do not have any technological effect on the
finished product.
(
2) OJ No L 184, 15. 7. 1988, p. 61.
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c) the rules on additives used as carrier substances and solvents,
including where necessary their purity criteria.
3. The following shall be adopted under the procedure laid down in
Article 11:
a) the criteria of purity for the additives in question;
b) where necessary, the methods of analysis needed to verify that the
criteria of purity referred to in (a) are satisfied;
c) where necessary, the procedure for taking samples and the methods
for the qualitative and quantitative analysis of food additives in andon foodstuffs;
d) other rules necessary to ensure compliance with the provisions of
Article 2.
Article 3a
1. By way of derogation from Article 3 (2) (a) and (b), the Council
shall, acting on a proposal from the Commission pursuant to the proce-
dure laid down in Article 100a of the Treaty, authorize the Member
States to maintain the prohibition on the use of certain additives inthe production of certain foodstuffs considered as traditional providedthat:
— this prohibition existed on 1 January 1992,
— the Member States concerned authorize on their territory the
production and sale of all foodstuffs not considered as traditionalwhich conform to the rules provided for in Article 3.
2. Without prejudice to Regulations (EEC) No 2081/92(
1) and
(EEC) No 2082/92 (2), before 1 July 1994, Member States shall
communicate to the Commission a list of foodstuffs which they
consider as traditional, giving their reasons in detail, together with therelevant legislative provisions prohibiting the use of certain additives insuchfoodstuffs.
Before 1 April 1995, the Commission shall submit a proposal to the
Council on the criteria to be applied for deciding whether or not a
product is traditional and on the national prohibitions which may bemaintained in conformity withth ese criteria.
The Council shall act on the proposal before 1 April 1996.3. Until such time as the Council has ruled on paragraph 2, Member
States may maintain any prohibitions which have been communicated
to the Commission pursuant to the first subparagraph of paragraph 2,
provided that they comply with the general conditions laid down inparagraph1.
Article 4
1. Where a Member State, as a result of new information or of a re-
assessment of existing information made since this Directive, or thecomprehensive directive referred to in Article 3, was adopted, hasdetailed grounds for considering that the use of additives in food,although it complies with this Directive or any list drawn up underArticle 3, endangers human health, that Member State may temporarily
suspend or restrict application of the provisions in question in its terri-
tory. It shall immediately inform the other Member States and theCommission thereof and give reasons for its decision.1989L0107 — EN — 20.11.2003 — 002.001 — 4
(1) Council Regulation (EEC) No 2081/92 of 14 July 1992 on the protection of
geographical indications and designations of origin for agricultural products
and foodstuffs (OJ No L 208, 24. 7. 1992, p. 1).
(2) Council Regulation (EEC) No 2082/92 of 14 July 1992 on certificates of
specific character for agricultural products and foodstuffs (OJ No L 208,
24. 7. 1992, p. 9).▼M1
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2. The Commission shall examine the grounds given by the Member
State referred to in paragraph 1 as soon as possible within the StandingCommittee on Foodstuffs, and shall then deliver its opinion forthwith
and take the appropriate measures.
3. If the Commission considers that amendments to this Directive or
to the comprehensive directive referred to in Article 3 are necessary inorder to resolve the difficulties mentioned in paragraph 1 and to ensurethe protection of human health, it shall initiate the procedure laid down
in Article 11, with a view to adopting those amendments; the Member
State which has adopted safeguard measures may in that event retainthem until the amendments have been adopted.
Article 5
1. In order to take account of scientific or technical developments
which have occurred since the adoption of a list in accordance with
Article 3, a Member State may provisionally authorize the marketing
and use within its territory of an additive from one of the categorieslisted in Annex I and not included in the relevant list provided thatthe following conditions are satisfied:
a) the authorization shall be limited to a maximum period of two
years;
b) the Member State shall ensure that foodstuffs containing an additive
which it has authorized are officially monitored;
c) in the authorization the Member State may require that foodstuffs
manufactured with the additive in question shall bear a special indi-
cation.
2. The Member State shall communicate to the other Member States
and to the Commission the text of any authorization decision adoptedpursuant to paragraph 1, within two months of the date on which the
decision takes effect.
3. Before the two-year period stipulated in paragraph 1 (a) has
expired, the Member State may request the Commission to include inthe list adopted in accordance with Article 3 the additive which hadbeen the subject of national authorization pursuant to paragraph 1 ofthis Article. At the same time, the Member State shall provide the
evidence which, in its view, supports such inclusion and shall indicate
how the additive is to be used. If the Commission considers thisrequest to be justified, it shall operate the procedure laid down inArticle 100a of the Treaty in order to amend the list adopted in accor-dance with Article 3. The Council shall act on a proposal from the
Commission, within 18 months from the date on which the matter was
referred to it.
4. If, within the two-year period stipulated in paragraph l, the
Commission does not submit a proposal in accordance withparagraph3, or if the Council does not act within the 18-month period stipulated
in paragraph 3, the national authorization must be cancelled. At the
same time, any authorization granted by another Member State for thesame additive must be cancelled.
5. No new authorization for the same additive may be granted unless
the scientific or technical development made since the cancellationprovided for in paragraph4 so justifies.
Article 6
Provisions that may have effect upon public health shall be adopted
after consultation withth e Scientific Committee for Food.
Article 7
1. Food additives not intended for sale to the ultimate consumer
may be marketed only if their packaging or containers bear the1989L0107 — EN — 20.11.2003 — 002.001 — 5
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following information, which must be conspicuous, clearly legible and
indelible:
(a) — for food additives sold singly or mixed witheachoth er, for
eachadditive, th e name laid down by any Community provi-
sions applying and its EEC number or, in the absence of such
provisions, a description of the additive that is sufficientlyprecise to enable it to be distinguished from additives withwhich it could be confused, in descending order of the propor-tion by weight in the total,
— when other substances or materials or food ingredients to facil-
itate storage, sale, standardization, dilution or dissolution of afood additive or food additives are incorporated in the additives,the name of the additive in accordance with the first indent andan indication of eachcomponent in descending order of th e
proportion by weight in the total;
b) — either the statement ‘for use in food’,
— or the statement ‘restricted use in food’,— or a more specific reference to its intended food use;
c) if necessary, the special conditions of storage and use;d) directions for use, if the omission thereof would preclude appro-
priate use of the additive;
e) a mark identifying the batch or lot;f) the name or business name and address of the manufacturer or
packager, or of a seller established within the Community;
g) an indication of the percentage of any component which is subject
to a quantitative limitation in a food or adequate compositional
information to enable the purchaser to comply with any Commu-
nity provisions, or in their absence national provisions, applying tothe food. Where the same quantitative limitation applies to a groupof components used singly or in combination, the combined percen-tage may be given as a single figure;
h) the net quantity;i) any other information provided for in the comprehensive Directive
referred to in Article 3.
2. By way of derogation from paragraph1, th e information required
in point (a), second indent, and points (d) to (g), may appear merely onthe documents relating to the consignment which are to be supplied
with or prior to the delivery, provided that the indication ‘intended for
the manufacture of foodstuffs and not for retail sale’ appears on aconspicuous part of the packaging or container of the product in ques-tion.
Article 8
Food additives intended for sale to the ultimate consumer may be
marketed only if their packagings or containers bear the followinginformation, which must be conspicuous, clearly legible and indelible:
a) the name under which the product is sold. This name shall be
constituted by the name laid down by any Community provisions
applying to the product in question plus its EEC number or, in the
absence of such provisions, by a description of the product that issufficiently precise to enable it to be distinguished from productswithwh ichit could be confused;
b) the information required by Article 7 (l) (a) to (f), and (h);c) the date of minimum durability within the meaning of Article 9 of
Council Directive 79/112/EEC (
1);
d) any other information provided for in the comprehensive directive
referred to in Article 3.1989L0107 — EN — 20.11.2003 — 002.001 — 6
(1) OJ No L 33, 8. 2. 1979, p. 1.
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Article 9
Articles 7 and 8 shall not affect more detailed or more extensive laws,
regulations or administrative provisions regarding weights andmeasures, or applying to the presentation, classification, packagingand labelling of dangerous substances and preparations or the transportof suchsubstances.
Article 10
Member States shall refrain from laying down requirements more
detailed than those contained in Articles 7 and 8 concerning the
manner in which the particulars provided for therein are to be shown.
The particulars provided for in Articles 7 and 8 shall appear in a
language easily understandable to purchasers unless other measures
have been taken to ensure that the purchaser is informed. This provi-
sion shall not prevent such particulars from being indicated in variouslanguages.
Article 11
1. The Commission shall be assisted by the Standing Committee on
the Food Chain and Animal Health, set up by Article 58 of Regulation(EC) No 178/2002 (
1), hereinafter referred to as ‘the Committee’.
2. Where reference is made to this Article, Articles 5 and 7 of Deci-
sion 1999/468/EC (2) shall apply, having regard to the provisions of
Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
3. The Committee shall adopt its rules of procedure.
Article 12
1. Member States shall take all measures necessary to ensure that
food additives belonging to the categories defined in Annex I may bemarketed only if they conform to the definitions and rules laid down inthis Directive and the Annexes thereto.
2. Member States may not prohibit, restrict or obstruct the
marketing of food additives, food or food ingredients on groundsrelating to food additives, if these comply with the provisions of this
Directive, the existing specific directives and the comprehensive direc-
tive referred to in Article 3.
3. Paragraph 2 shall not affect national provisions applicable in the
absence of corresponding provisions in the comprehensive directive
referred to in Article 3.
Article 13
Measures to bring existing Community directives into line withth is
Directive shall be adopted according to the procedure laid down inArticle 11.1989L0107 — EN — 20.11.2003 — 002.001 — 7
(1) OJ L 31, 1.2.2002, p. 1.
(2) Council Decision 1999/468/EC of 28 June 1999 laying down the procedures
for the exercise of implementing powers conferred on the Commission (OJ
L 184, 17.7.1999, p. 23).▼M2
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Article 14
1. Member States shall take all measures necessary to comply with
this Directive within 18 months of its notification. They shall forthwith
inform the Commission thereof. The measures taken shall:
— authorize, two years after notification of this Directive, the
marketing and use of food additives complying withth is Directive;
— prohibit, not later than three years after notification (1)of this Direc-
tive, the marketing and use of food additives which do not complywithth is Directive.
2. Paragraph1 sh all not affect existing Community provisions or
those national provisions which, in the absence of the comprehensive
directives referred to in Article 3, apply to certain groups of food addi-
tives or specify the foodstuffs in or on which food additives complyingwithth is Directive may be used.
Article 15
This Directive is addressed to the Member States.1989L0107 — EN — 20.11.2003 — 002.001 — 8
(1) This Directive was notified to the Member States on 28 December 1988.
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ANNEX I
Categoriesoffoodadditives
Colour
PreservativeAnti-oxidant
Emulsifier
Emulsifying saltThickenerGelling agent
Stabilizer (
1)
Flavour enhancerAcidAcidity regulator (
2)
Anti-caking agent
Modified starchSweetener
Raising agent
Anti-foaming agentGlazing agent (
3)
Flour treatment agent
Firming agent
HumectantSequestrant (
4)
Enzyme (4)(5)
Bulking agentPropellent gas and packaging gas1989L0107 — EN — 20.11.2003 — 002.001 — 9
(1) This category also comprises foam stabilizers.
(2) These can act as two-way acidity regulators.
(3) These substances include lubricants.
(4) Inclusion of these terms in this list is without prejudice to any future decision or
mention thereof in the labelling of foodstuffs intended for the final consumer.
(5) Only those used as additives.
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ANNEX II
General criteria fortheuseoffoodadditives
1. Food additives can be approved only provided that:
— there can be demonstrated a reasonable technological need and the
purpose cannot be achieved by other means which are economically and
technologically practicable,
— they present no hazard to the health of the consumer at the level of use
proposed, so far as can be judged on the scientific evidence available,
— they do not mislead the consumer.
2. The use of food additives may be considered only where there is evidence
that the proposed use of the additive would have demonstrable advantages
of benefit to the consumer, in other words it is necessary to establish the
case for what is commonly referred to as ‘need’. The use of food additives
should serve one or more of the purposes set out from points (a) to (d) and
only where these purposes cannot be achieved by other means which are
economically and technologically practicable and do not present a hazard to
the health of the consumer:
(a) to preserve the nutritional quality of the food: an intentional reduction in
the nutritional quality of a food would be justified only where the food
does not constitute a significant item in a normal diet or where the addi-
tive is necessary for the production of foods for groups of consumers
having special dietary needs;
(b) to provide necessary ingredients or constituents for foods manufactured
for groups of consumers having special dietary needs;
(c) to enhance the keeping quality or stability of a food or to improve its
organoleptic properties, provided that this does not so change the nature,
substance or quality of the food as to deceive the consumer;
(d) to provide aids in manufacture, processing, preparation, treatment,
packing, transport or storage of food, provided that the additive is not
used to disguise the effects of the use of faulty raw materials or of unde-
sirable (including unhygienic) practices or techniques during the course
of any of these activities.
3. To assess the possible harmful effects of a food additive or derivatives
thereof, it must be subjected to appropriate toxicological testing and evalua-
tion. The evaluation should also take into account, for example, any
cumulative, synergistic or potentiating effect of its use and the phenomenon
of human intolerance to substances foreign to the body.
4. All food additives must be kept under continuous observation and must be
re-evaluated whenever necessary in the light of changing conditions of use
and new scientific information.
5. Food additives must at all times comply withth e approved criteria of purity.
6. Approval for food additives must:
(a) specify the foodstuffs to which these additives may be added and the
conditions under which they may be added;
(b) be limited to the lowest level of use necessary to achieve the desired
effect;
(c) take into account any acceptable daily intake, or equivalent assessment,
established for the food additive and the probable daily intake of it from
all sources. Where the food additive is to be used in foods eaten by
special groups of consumers, account should be taken of the possible
daily intake of the food additive by consumers in those groups.1989L0107 — EN — 20.11.2003 — 002.001 — 10