1989L0398 — EN — 20.11.2003 — 003.001 — 1
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►B COUNCILDIRECTIVE
of3May1989
on the approximation of the laws of the Member States relating to foodstuffs intended for parti-
cularnutritionaluses
(89/398/EEC)
(OJ L 186, 30.6.1989, p. 27)
Amended by:
Official Journal
No page date
►M1Directive 96/84/EC of the European Parliament and of the Council of 19
December 1996L 48 20 19.2.1997
►M2Directive 1999/41/EC of the European Parliament and of the Council of
7 June 1999L 172 38 8.7.1999
►M3Regulation (EC) No 1882/2003 of the European Parliament and of the
Council of 29 September 2003L 284 1 31.10.2003
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COUNCILDIRECTIVE
of3May1989
on the approximationof the lawsofthe Member States relating to
foodstuffsintendedforparticularnutritionaluses
(89/398/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 (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social
Committee (3),
Whereas Council Directive 77/94/EEC of 21 December 1976 on the
approximation of the laws of the Member States relating to foodstuffsfor particular nutritional uses(
4), as last amended by Directive 85/7/
EEC (5), has been amended on a number of occasions; whereas, on the
occasion of new amendments, the said Directive should, for reasons ofclarity, be redrafted;
Whereas the adoption of Directive 77/94/EEC was justified by the fact
that the differences between national laws relating to foodstuffs for
particular nutritional uses impeded their free movement, may havecreated unequal conditions of competion, and thus had a direct impacton the establishment and functioning of the common market;
Whereas the approximation of national laws presupposed, in an initial
stage, the drawing-upof a common definition, the determination of
measures enabling the consumer to be protected against fraud
concerning the nature of these products and the adoption of rules tobe complied with in labelling the products in question;
Whereas the products covered by this Directive are foodstuffs the
composition and preparation of which must be specially designed tomeet the particular nutritional requirements of the persons for whom
they are mainly intended; whereas it may be necessary, therefore, to
provide for derogations to the general or specific provisions applicableto foodstuffs in order to achieve the specific nutritional objective;
Whereas, although foodstuffs intended for particular nutritional uses
which are the subject of specific provisions can be efficiently moni-tored on the basis of the general rules for monitoring all types offoodstuffs, this is not always the case for those foodstuffs in respect
of which no such specific provisions exist;
Whereas for the latter the usual means available to the monitoring
bodies might not in certain cases enable them to check whether a food-stuff actually has the particular nutritional properties attributed to it;whereas it is necessary therefore to provide that, where necessary, theperson responsible for placing that foodstuff on the market should
assist the monitoring body in carrying out its activities;
Whereas the current state of development of Community rules on addi-
tives means that it is not possible, in the framework of this Directive,to adopt provisions on the use of additives in foodstuffs intended forparticular nutritional uses if they do not belong to one of the groupsmentioned in Annex I; whereas this question should therefore be re-examined in due course;1989L0398 — EN — 20.11.2003 — 003.001 — 2
(1) OJ No C 124, 23. 5. 1986, p. 7, and OJ No C 161, 19. 6. 1987, p. 12.
(2) OJ No C 99, 13. 4. 1987, p. 54, and OJ No C 120, 16. 5. 1989.
(3) OJ No C 328, 22. 12. 1986, p. 9.
(4) OJ No L 26, 31. 1. 1977, p. 55.
(5) OJ No L 2, 3. 1. 1985, p. 22.
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Whereas the drawing-up of specific Directives implementing the basic
principles of Community rules and amendments thereto are imple-menting measures of a technical nature; whereas their adoption should
be entrusted to the Commission in order to simplify and expedite the
procedure;
Whereas in all cases where the Council empowers the Commission to
implement rules relating to foodstuffs intended for human consump-tion, provision should be made for a procedure establishing close
cooperation between the Member States and the Commission within
the Standing Committee for Foodstuffs, set upby Decision 69/414/EEC (
1);
Whereas this Directive does not affect the time limits within which the
Member States must comply with Directive 77/94/EEC,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive concerns foodstuffs for particular nutritional uses.
2. (a) Foodstuffs for particular nutritional uses are foodstuffs which,
owing to their special composition or manufacturing process,are clearly distinguishable from foodstuffs for normal consump-tion, which are suitable for their claimed nutritional purposesand which are marketed in such a way as to indicate such suit-ability.
(b) A particular nutritional use must fulfil the particular nutritional
requirements:
(i) of certain categories of persons whose digestive processes
or metabolism are disturbed; or
(ii) of certain categories of persons who are in a special physio-
logical condition and who are therefore able to obtainspecial benefit from controlled consumption of certainsubstances in foodstuffs; or
(iii) of infants or young children in good health.
Article 2
1. The products referred to in Article 1 (2) (b) (i) and (ii) may be
characterized as ‘dietetic’ or ‘dietary’.
2. In the labelling, presentation and advertising of foodstuffs for
normal consumption the following shall be prohibited:
(a) the use of the adjectives ‘dietetic’ or ‘dietary’ either alone or in
conjunction with other words, to designate these foodstuffs;
(b) all other markings or any presentation likely to give the impression
that one of the products referred to in Article 1 is involved.
3. However, in accordance with provisions to be adopted according
to the procedure provided for in Article 13, it shall be possible forfoodstuffs for normal consumption which are suitable for a particularnutritional use to indicate such suitability.
The aforesaid provisions may lay down the arrangements for indicating
this suitability.
Article 3
1. The nature or composition of the products referred to in Article 1
must be such that the products are appropriate for the particular nutri-tional use intended.
2. The products referred to in Article 1 must also comply with any
mandatory provisions applicable to foodstuffs for normal consumption,1989L0398 — EN — 20.11.2003 — 003.001 — 3
(1) OJ No L 291, 19. 11. 1969, p. 9.
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save as regards changes made to them to ensure their conformity with
the definitions given in Article 1.
Article 4
1. The specific provisions applicable to the groups of foods for
particular nutritional uses appearing in Annex I shall be laid down bymeans of specific Directives.
Such specific Directives may cover in particular:
(a) essential requirements as to the nature or composition of the
products;
(b) provisions regarding the quality of raw materials;
(c) hygiene requirements;
(d) permitted changes within the meaning of Article 3 (2);
(e) a list of additives;
(f) provisions regarding labelling, presentation and advertising;
(g) sampling procedures and methods of analysis necessary for
checking compliance with the requirements of the specific Direc-tives.
Such specific Directives shall be adopted:— in the case of point (e), by the Council acting in accordance
with the procedure laid down in Article 100a,
— in the case of the other points, in accordance with the procedure
laid down in Article 13.
Provisions likely to have an effect on public health shall be adopted
after consultation of the Scientific Committee for Food, set upby
Decision 74/234/EEC (
1).
1a. To enable foodstuff intended for particular nutritional uses and
resulting from scientific and technological progress to be placed on
the market rapidly, the Commission may, after consulting the ScientificCommittee for Food and in accordance with the procedure laid down inArticle 13, authorize for a two-year period the placing on the market offoodstuffs which do not comply with the rules as to composition laid
down by the specific directives referred to in Annex I.
If necessary, the Commission may add in the authorization decision
labelling rules relating to the change in composition.
2. A list of substances with specific nutritional purposes such as
vitamins, mineral salts, amino acids and other substances intended to
be added to foodstuffs intended for particular nutritional uses, together
with the purity criteria applicable to them, and, where appropriate, theconditions under which they should be used, shall be adopted in accor-dance with the procedure laid down in Article 13.
Article 4a
Rules for the use of terms concerning
— the reduction or absence of sodium or salt (sodium chloride, table
salt) content,
— the absence of gluten,
which may be used to describe the products referred to in Article 1,
shall be adopted in accordance with the procedure laid down in Article13.1989L0398 — EN — 20.11.2003 — 003.001 — 4
(1) OJ No L 136, 20. 5. 1974, p. 1.▼M1
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Article 4b
Before 8 July 2002, the Commission shall, after consulting the Scien-
tific Committee for Food, present to the European Parliament and tothe Council a report on the desirability of special provisions for foodsfor persons suffering from carbohydrate-metabolism discorders(diabetes).
In the light of the conclusions of this report, the Commission shall
either, in accordance with the procedure laid down in Article 13,proceed with the preparation of the special provisions concerned orshall present, in accordance with the procedure laid down in Article95 of the Treaty, any appropriate proposals for amendments to this
Directive.
Article 5
Conditions under which reference may be made in labelling, presenta-
tion and advertising to a diet or to a category of persons for which aproduct referred to in Article 1 is intended may be adopted in accor-dance with the procedure laid down in Article 13.
Article 6
1. The labelling and the labelling methods used, the presentation and
the advertising of the products referred to in Article 1 must not attri-bute properties for the prevention, treatment or cure of human diseaseto such products or imply such properties.
Derogations from the first subparagraph may be provided for in accor-
dance with the procedure laid down in Article 13 in exceptional andclearly defined cases. Derogations may be continued until that proce-dure has been completed.
2. Paragraph 1 shall not prevent the dissemination of any useful
information or recommendations exclusively intended for personshaving qualifications in medicine, nutrition or pharmacy.
Article 7
1. Council Directive 79/112/EEC of 18 December 1978 on the
approximation of the laws of the Member States relating to the label-ling, presentation and advertising of foodstuffs (
1), as last amended by
Directive 89/395/EEC (2), shall apply to the products referred to in
Article 1, under the conditions set out below.
2. The designation under which a product is sold shall be accompa-
nied by an indication of its particular nutritional characteristics;however, in the case of the products referred to in Article 1 (2) (b)(iii), this reference shall be replaced by a reference to the purpose for
which they are intended.
3. The labelling of products for which no specific Directive has been
adopted in accordance with Article 4 must also include:
(a) the particular elements of the qualitative and quantitative composi-
tion or the special manufacturing process which gives the product
its particular nutritional characteristics;
(b) the available energy value expressed in kilojoules and kilocalories
and the carbohydrate, protein and fat content per 100 grams or 100millilitres of the product as marketed and, where appropriate, perspecified quantity of the product as proposed for consumption.
If, however, the energy value is less than 50 kilojoules (12 kilocalories)
per 100 grams or 100 millilitres of the product as marketed, these parti-culars may be replaced either by the words ‘energy value less than 501989L0398 — EN — 20.11.2003 — 003.001 — 5
(1) OJ No L 33, 8. 2. 1979, p. 1.
(2) OJ No L 186, 30. 6. 1989, p. 17.▼B
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kilojoules (12 kilocalories) per 100 grams’ or by the words ‘energy
value less than 50 kilojoules (12 kilocalories) per 100 millilitres’.
4. The particular labelling requirements for those products for which
a specific Directive has been adopted shall be laid down in that Direc-
tive.
Article 8
1. The products referred to in Article 1 shall only be allowed on the
retail market in pre-packaged form, and the packaging shall completelycover the products.
2. Member States may, however, permit derogations from these
provisions for purposes of the retail trade provided that the product isaccompanied by the particulars provided for in Article 7 at the time
when it is put on sale.
Article 9
To permit efficient official monitoring of foodstuffs intended for a
particular nutritional use which do not belong to one of the groupslisted in Annex I the following specific provisions shall apply:
1. When a product as referred to above is placed on the market for the
first time the manufacturer or, where a product is manufactured in athird State, the importer, shall notify the competent authority of the
Member State where the product is being marketed by forwarding it
a model of the label used for the product.
2. Where the same product is subsequently placed on the market in
another Member State the manufacturer or, where appropriate, the
importer, shall provide the competent authority of that Member
State with the same information, together with an indication of therecipient of the first notification.
3. Where necessary, the competent authority shall be empowered to
require the manufacturer or, where appropriate, the importer, to
produce the scientific work and the data establishing the product'scompliance with Article 1 (2) together with the informationprovided for in Article 7 (3) (a). If such work is contained in areadily available publication, a mere reference to this publicationshall suffice.
4. Member States shall communicate to the Commission the identity of
the competent authorities within the meaning of this Article and anyother useful information on them.
The Commission shall publish this information in the Official
Journal of the European Communities .
Detailed rules for implementing this paragraph may be adopted in
accordance with the procedure laid down in Article 13.
5. Before 8 July 2002 and every three years thereafter, the Commission
shall send the European Parliament and the Council a report on theimplementation of this Article.
Article 10
1. Member States shall not, for reasons related to their composition,
manufacturing specifications, presentation or labelling, prohibit or
restrict trade in products referred to in Article 1 which comply with
this Directive and where appropriate, with Directives adopted in imple-mentation of this Directive.
2. Paragraph 1 shall not affect national provisions which are applic-
able in the absence of Directives adopted in implementation of thisDirective.1989L0398 — EN — 20.11.2003 — 003.001 — 6
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Article 11
1. Where a Member State has detailed grounds for establishing that
a foodstuff intended for a particular nutritional use which does notbelong to one of the groups listed in Annex I does not comply withArticle 1 (2) or endangers human health, albeit freely circulating in
one or more Member States, that Member State may temporarily
suspend or restrict trade in that product within its territory. It shallimmediately inform the Commission and the other Member Statesthereof and give reasons for its decision.
2. The Commission shall examine as soon as possible the grounds
adduced by the Member State concerned, consult the Member Stateswithin the Standing Committee for Foodstuffs, and shall then deliverits opinion without delay and take appropriate measures.
3. If the Commission considers that the national measure must be
dispensed with or modified, it shall initiate the procedure laid down inArticle 13 for the adoption of appropriate measures.
Article 12
1. Where a Member State, as a result of new information or of a
reassessment of existing information made since one of the specificDirectives was adopted, has detailed grounds for establishing that afoodstuff intended for particular nutritional uses endangers humanhealth although it complies with the relevant specific Directive, thatMember State may temporarily suspend or restrict application of the
provisions in question within its territory. It shall immediately inform
the other Member States and the Commission thereof and give reasonsfor its Decision.
2. The Commission shall examine as soon as possible the grounds
adduced by the Member State concerned and shall consult the MemberStates within the Standing Committee for Foodstuffs, and shall thendeliver its opinion without delay and take appropriate measures.
3. If the Commission considers that amendments to this Directive or
to the specific Directives are necessary in order to remedy the difficul-ties mentioned in paragraph 1 and to ensure the protection of humanhealth, it shall initiate the procedure laid down in Article 13 with a
view to adopting those amendments. The Member State which has
adopted safeguard measures may in that event retain them until theamendments have been adopted.
Article 13
1. The Commission shall be assisted by the Standing Committee on
the Food Chain and Animal Health, set upby 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 14
Directive 77/94/EEC is hereby repealed.1989L0398 — EN — 20.11.2003 — 003.001 — 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).▼M3
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References to the repealed Directive shall be construed as references to
this Directive and are to be read in accordance with the correlationtable set out in Annex II.
Article 15
1. Member States shall amend their laws, regulations and adminis-
trative provisions in such a way as:
— to permit trade in products complying with this Directive not later
than 16 May 1990,
— to prohibit trade in products not complying with this Directive with
effect from 16 May 1991.
They shall forthwith inform the Commission thereof.2. Paragraph 1 shall not affect those national provisions which in the
absence of the Directives referred to in Article 4 apply to certaingroups of foodstuffs intended for particular nutritional uses.
Article 16
This Directive is addressed to the Member States.1989L0398 — EN — 20.11.2003 — 003.001 — 8
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ANNEX I
— Groups of foodstuffs for particular nutritional uses for which specific provi-
sions will be laid down by specific Directives: (1)
1. Infant formulae and follow-on formulae
2. Processed cereal-based foods and baby foods for infants and young chil-
dren
3. Food intended for use in energy-restricted diets for weight reduction4. Dietary foods for special medical purposes5. Foods intended to meet the expenditure of intense muscular effort, espe-
cially for sportsmen;
— Groups of foodstuffs for particular nutritional uses for which specific provi-
sions will be laid down by a specific Directive (
1), dependant on the outcome
of the procedure described in Article 4b:
6. Foods for persons suffering from carbohydrate-metabolism disorders
(diabetes).1989L0398 — EN — 20.11.2003 — 003.001 — 9
(1) It is understod that products already on the market when Directive is adopted will not
be affected by it.
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ANNEX II
CORRELATIONTABLE
Directive 77/94/EEC ThisDirective
Article 1 (1) Article 1 (1)
Article 1 (2) Article 2 (2)
Article 1 (3) —
Article 2 (1) Article 3 (1)
Article 2 (2) first subparagraph Article 2 (1)
Article 2 (2) second subparagraph —Article 2 (3) Article 2 (2)
Article 2 (4) Article 2 (3)
Article 3 Article 3 (2)
— Article 4
Article 4 (1) Article 6 (1)
Article 4 (2) Article 5
Article 4 (3) Article 6 (2)
Article 5 (1) Article 7 (1)
Article 5 (2) point (a) Article 7 (2)
Article 5 (2) points (b) and (c) Article 7 (3) points (a) and (b)
Article 5 (2) point (d) —
Article 5 (2) point (e) Article 7 (4)
Article 5 (3) —
Article 6 Article 8
— Article 9
Article 7 (1) Article 10 (1)
— Article 10 (2)
Article 7 (2) —
Article 8 —
— Article 11
— Article 12Article 9 Article 13
Article 10 —
Article 11 —
— Article 14
Article 12 Article 15
Article 13 Article 16
— Annex I1989L0398 — EN — 20.11.2003 — 003.001 — 10