1989L0109 — EN — 20.11.2003 — 001.001 — 1
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►B COUNCILDIRECTIVE
of21December 1988
ontheapproximationofthelawsoftheMemberStatesrelatingtomaterialsandarticlesintended
tocome intocontactwithfoodstuffs
(89/109/EEC)
(OJ L 40, 11.2.1989, p. 38)
Amended by:
Official Journal
No page date
►M1Regulation (EC) No 1882/2003 of the European Parliament and of the
Council of 29 September 2003L 284 1 31.10.2003
Corrected by:
►C1Corrigendum, OJ L 347, 28.11.1989, p. 37 (89/109/EEC)
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COUNCILDIRECTIVE
of21December 1988
on the approximationof the lawsofthe Member States relating to
materialsandarticlesintendedtocomeintocontactwithfoodstuffs
(89/109/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 with the European Parliament (
1),
Having regard to the opinion of the Economic and Social
Committee (2),
Whereas Council Directive 76/893/EEC of 23 November 1976 on the
approximation of the laws of the Member States relating to materialsand articles intended to come into contact with foodstuffs(
3), as last
amended by the act of Accession of Spain and Portugal (4), has been
substantially amended on a number of occasions; whereas on makingthe new amendments to the said Directive, the opportunity should be
taken to consolidate the provisions of the existing relevant texts with
a view to ensuring legal clarity;
Whereas Directive 76/893/EEC was adopted on the grounds that the
differences that existed at that time between the national laws relatingto the aforesaid materials and articles impeded the free movement
thereof, could create unequal conditions of competition and could
thereby directly affect the establishment or functioning of the commonmarket;
Whereas those laws had to be approximated if free movement was to
be achieved for the aforesaid materials and articles, taking accountprimarily of human health requirements but also, within the limits
required for the protection of health, of economic and technological
needs;
Whereas the chosen method was to lay down, in the first place, in a
framework directive, general principles on the basis of which legaldifferences between certain groups of materials and articles had been
and could subsequently be eliminated by means of specific directives;
whereas this method has proved itself and should therefore be retained;
Whereas covering or coating substances, all or part of which form part
of foodstuffs, could not be considered to be simply in contact withthese foodstuffs; whereas, in that case, account had to be taken of
possible direct consumption by consumers; whereas the rules laid
down in this Directive are therefore inappropriate in such circum-stances;
Whereas the principle underlying this Directive should be that any
material or article intended to come into contact or which is intention-ally in contact either directly or indirectly with foodstuffs, must be
sufficiently stable not to transfer substances to the foodstuffs in quanti-
ties which could endanger human health or bring about an unacceptablechange in the composition of the foodstuffs or a deterioration in theorganoleptic properties thereof;
Whereas, in order to achieve this objective, it may prove necessary to
lay down various types of limitations, alone or in combination; whereas
it is appropriate to retain in specific directives those limitations whichare most appropriate to the desired objective, having regard to the tech-1989L0109 — EN — 20.11.2003 — 001.001 — 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 340, 9. 12. 1976, p. 19.
(4) OJ No L 302, 15. 11. 1985, p. 216.
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nological characteristics peculiar to each group of materials and arti-
cles;
Whereas, in order to allow the informed use of the materials and arti-
cles, appropriate labelling should be provided for; whereas the methodsused for such labelling may vary according to the user;
Whereas this Directive does not apply to the labelling of products
which, by reason of their behaviour in the presence of foodstuffs,
must not be designed to come into contact or be in contact with them;
Whereas the drafting of specific directives implementing the basic prin-
ciples and of amendments thereto constitute technical implementingmeasures; whereas, in order to simplify and expedite the procedure,
the adoption of these measures should be entrusted to the Commission;
Whereas the Scientific Committee for Food, set upby Commission
Decision 74/234/EEC (
1), should be asked for its opinion before provi-
sions liable to affect public health are adopted under specific
directives;
Whereas it is desirable that in all cases where the Council empowers
the Commission to implement rules relating to foodstuffs, provisionshould be made for a procedure establishing close cooperation betweenthe Member States and the Commission within the Standing Committee
on Foodstuffs set upby Council Decision 69/414/EEC (
2),
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. This Directive shall apply to materials and articles which, in their
finished state, are intended to be brought into contact with foodstuffs orwhich are brought into contact with foodstuffs and are intended for thatpurpose, hereinafter referred to as ‘materials and articles’.
Covering or coating substances, such as the substances covering cheese
rinds, prepared meat products or fruit, which form part of foodstuffs
and may be consumed together with those foodstuffs, shall not besubject to this Directive.
2. This Directive shall apply to materials and articles which are in
contact with water which is intended for human consumption. It shall
not, however, apply to fixed public or private water supply equipment.
3. This Directive shall not apply to antiques.
Article 2
Materials and articles must be manufactured in compliance with good
manufacturing practice so that, under their normal or foreseeable condi-tions of use, they do not transfer their constituents to foodstuffs inquantities which could:
— endanger human health,
— bring about an unacceptable change in the composition of the food-
stuffs or a deterioration in the organoleptic characteristics thereof.
Article 3
1. The groups of materials and articles listed in Annex I and, where
appropriate, combinations of these materials and articles shall besubject to specific directives.
2. The specific directives, including amendments to existing specific
directives, shall be adopted in accordance with the procedure laid downin Article 8.1989L0109 — EN — 20.11.2003 — 001.001 — 3
(1) OJ No L 136, 20. 5. 1974, p. 1.
(2) OJ No L 291, 19. 11. 1969, p. 9.
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3. The specific directives may include:
(a) a list of the substances the use of which is authorized to the exclu-
sion of all others (positive list);
(b) purity standards for such substances;
(c) special conditions of use for these substances and/or the materials
and articles in which they are used;
(d) specific limits on the migration of certain constituents or groups of
constituents into or onto foodstuffs;
(e) an overall limit on the migration of constituents into or onto food-
stuffs;
(f) if necessary, provisions aimed at protecting human health against
any hazards which might arise through oral contact with materialsand articles;
(g) other rules to ensure compliance with Article 2;(h) the basic rules necessary for checking compliance with the provi-
sions of points (d), (e), (f) and (g);
(i) detailed rules concerning sample taking and the methods of
analysis required to check compliance with the provisions of points
(a) to (g).
Provisions liable to affect public health shall be adopted after
consulting the Scientific Committee for Food. They must fulfill the
criteria set out in Annex II.
Article 4
1. Notwithstanding Article 3, a Member State may, where a list of
substances has been drawn up in accordance with paragraph 3 (a) ofthat Article, authorize the use within its territory of a substance not
included in the list, subject to compliance with the following condi-
tions:
(a) the authorization must be limited to a maximum period of two
years;
(b) the Member State must carry out an official check on materials and
articles manufactured from a substance of which it has authorizedthe use;
(c) materials and articles thus manufactured must bear a distinctive
indication which will be defined in the authorization.
2. The Member State shall forward to the other Member States and
to the Commission the text of any authorization drawn upp ursuant toparagraph 1 within two months of the date of its taking effect.
3. Before the expiry of the two-year period provided for in para-
graph 1 (a), the Member State may submit to the Commission arequest for the inclusion in the list referred toin Article 3 (3) (a) ofthe substance given national authorization in accordance with para-
graph 1 of this Article. At the same time, it shall supply supporting
documents setting out the grounds on which it deems such inclusionjustified and shall indicate the uses for which this substance isintended.
Within 18 months of the submission of the request, a decision shall be
taken on the basis of information relating to public health, afterconsulting the Scientific Committee for Food and in accordance withthe procedure laid down in Article 9 as to whether the substance in
question may be included in the list referred to in Article 3 (a) or
whether the national authorization should be revoked. If provisionsprove necessary pursuant to Article 3 (3) (b), (c) and (d), these shallbe adopted in accordance with the same procedure. Notwithstandingparagraph 1 (a) of this Article, the national authorization shall remainin force until a decision is taken on the request for inclusion in the list.
Should it be decided pursuant to the preceding subparagraph that the
national authorization should be revoked, this decision shall apply toany other national authorization in respect of the substance in question.1989L0109 — EN — 20.11.2003 — 001.001 — 4
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The decision may stipulate that the ban on the use of this substance
shall extend to uses other than those referred to in the request for inclu-sion in the list.
Article 5
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 theuse of a material or article endangers human health although it
complies with the relevant specific directive, that Member State may
temporarily suspend or restrict application of the provisions in questionwithin its territory. It shall immediately inform the other MemberStates and the Commission thereof and give reasons for its decision.
2. The Commission shall examine as soon as possible within the
Standing Committee on Foodstuffs the grounds adduced by theMember State referred to in paragraph 1 and shall deliver its opinionwithout delay and take the appropriate measures.
3. If the Commission considers that amendments to the specific
directives in question are necessary in order to remedy the difficulties
mentioned in paragraph 1 and to ensure the protection of human health,it shall initiate the procedure laid down in Article 9 with a view toadopting those amendments; the Member State which has adopted safe-guard measures may in that event retain them until the amendmentshave been adopted.
Article 6
1. Without prejudice to any exceptions provided for in the specific
directives, materials and articles not already in contact with foodstuffsmust, when placed on the market, be accompanied by:
(a) — the words ‘for food use’,
— or a specific indication as to their use, such as coffee-machine,
wine bottle, soupsp oon,
— or a symbol determined in accordance with the procedure laid
down in Article 9;
(b) where appropriate, any special conditions to be observed when they
are being used;
(c) — either the name or trade name and the address or registered
office,
— or the registered trade mark,
of the manufacturer or processor, or of a seller established within
the Community.
2. The particulars listed in paragraph 1 must be conspicuous, clearly
legible and indelible:
(a) at the retail stage:
— on the materials and articles or on the packaging,
— or on labels affixed to the materials and articles or to their
packaging,
— or on a notice in the immediate vicinity of the materials and
articles and clearly visible to purchasers; in the case mentioned
in paragraph 1 (c), however, the latter option shall only be open
if these particulars or a label bearing them cannot, for technicalreasons, be affixed to the said materials and articles at either themanufacturing or the marketing stage;
(b) at the marketing stages other than the retail stage:
— on the accompanying documents,
— on the labels or packaging,— or on the materials and articles themselves.
3. However, the particulars provided for ►
C1in paragraph 1
(a)◄shall not be compulsory for materials and articles which by their
nature are clearly intended to come into contact with foodstuffs.1989L0109 — EN — 20.11.2003 — 001.001 — 5
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4. The particulars provided for in paragraph 1 (a) and (b) shall be
confined to materials and articles which comply:
(a) with the criteria laid down in Article 2;
(b) with the specific directives, in the absence of such directives, with
any national provisions.
5. The specific directives shall require that such materials and arti-
cles be accompanied by a written declaration attesting that they comply
with the rules applicable to them.
In the absence of specific directives, Member States may retain
existing provisions or adopt provisions to this effect.
6. Member States shall ensure that retail trade in materials and arti-
cles is prohibited if the particulars required under paragraph 1 (a) and
(b) are not given in a language easily understood by purchasers, unlessthe purchaser is informed by other means. This provision shall notpreclude such particulars appearing in several languages.
Article 7
1. Member States shall not, for reasons relating to composition,
behaviour in the presence of foodstuffs or labelling, prohibit or restrict
either trade in or the use of materials and articles complying with this
Directive or with the specific directives.
2. Paragraph 1 shall not affect national provisions which are applic-
able in the absence of the specific directives.
Article 8
Amendments made to existing specific directives in order to bring them
into line with this Directive shall be adopted in accordance with the
procedure laid down in Article 9.
Article 9
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 10
1. Directive 76/893/EEC is hereby repealed.2. References to the Directive repealed under paragraph 1 shall be
construed as references to this Directive.
References to the Articles of the repealed Directive should be read in
accordance with the correlation table appearing in Annex III.1989L0109 — EN — 20.11.2003 — 001.001 — 6
(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).▼M1
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Article 11
1. Member States shall take all measures necessary to comply with
this Directive. They shall forthwith inform the Commission thereof.
The measures taken shall:
— permit, not later than 18 months after notification (1), trade in and
use of materials and articles complying with this Directive, withoutprejudice to the application of national provisions which, in theabsence of specific directives, apply to certain groups of materials
and articles;
— prohibit not later than 36 months after notification trade in and use
of materials and articles which do not comply with this Directive.
2. Paragraph 1 shall not affect those national provisions which, in
the absence of the specific directives, apply to certain groups of mate-rials and articles intended to come into contact with foodstuffs.
Article 12
This Directive shall not apply to materials and articles intended for
export outside the Community.
Article 13
This Directive is addressed to the Member States.1989L0109 — EN — 20.11.2003 — 001.001 — 7
(1) This Directive was notified to the Member States on 10 January 1989.
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ANNEX I
Listofgroupsofmaterials andarticles coveredbyspecific directives
Plastics, including varnish and coatings
Regenerated celluloseElastomers and rubber
Paper and board
CeramicsGlassMetals and alloys
Wood, including cork
Textile productsParaffin waxes and micro-crystalline waxes1989L0109 — EN — 20.11.2003 — 001.001 — 8
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ANNEX II
Health criteria tobeappliedinthedraftingofspecific directives
1. Where appropriate, positive lists of substances shall be established for mate-
rials and articles intended to come into contact with foodstuffs. The
acceptability of a substance for inclusion in a positive list shall be deter-
mined by considering both the quantity of the substance which is liable to
migrate into foodstuffs and the toxicity of the substance.
2. A substance shall only be included in a positive list where, under normal or
foreseeable conditions of use of any material or article of which it forms a
part, the substance is not liable to migrate into foodstuffs in a quantity likely
to constitute a danger to human health.
3. For certain materials it may be inappropriate to establish a positive list
because such a list would offer no tangible benefit in terms of safeguarding
human health. In such circumstances, any substances for which specific
migration limits need to be established in order to prevent their being trans-
ferred to foodstuffs in quantities likely to constitute a danger to health shall
be identified. The criteria set out in paragraphs 1 and 2 shall also apply to
these substances.
4. All substances shall be kept under review and reassessed whenever this is
justified by fresh scientific data or a re-evaluation of existing scientific data.
5. Where an acceptable daily intake or a tolerable daily intake is established for
a particular substance, the need to establish a specific migration limit in order
that this intake is not exceeded shall be considered. Where such a specific
migration limit is established for a substance, due regard shall be paid to
other possible sources of exposure to the substance.
6. In certain circumstances, a specific migration limit on a substance may not
be the most valid means of safeguarding human health. In such circum-
stances, the need to protect human health shall be the primary consideration
in determining what action might be appropriate.1989L0109 — EN — 20.11.2003 — 001.001 — 9
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ANNEX III
CORRELATIONTABLE
Directive 76/893/EEC Present Directive
Article 1 Article 1
Article 2 Article 2
Article 3 Article 3
Article 4 Article 4
Article 5 Article —
Article 6 Article 5Article 7 Article 6
Article 8 Article 7
Article — Article 8
Article 9 Article —
Article 10 Article 9
Article — Article 10
Article 11 Article —
Article 12 Article 12
Article 13 Article 11
Article 14 Article —
Article 15 Article 131989L0109 — EN — 20.11.2003 — 001.001 — 10