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"B COUNCIL DIRECTIVE
of 21 December 1988
on the approximation of the laws of the Member States relating to materials and articles intended to come
into contact with foodstuffs
(89/109/EEC)
(OJ L 40 , 11.2.1989, p. 38)
Corrected by:
"C1 Corrigendum, OJ L 347 , 28.11.1989, p. 37 (89/109)1989L0109 — EN — 10.01.1989 — 000.001 — 1
COUNCIL DIRECTIVE
of 21 December 1988
on the approximation of the laws of the Member States relating to
materials and articles intended to come into contact with foodstuffs
(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 materials andarticles 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 making the new amendments to the
said Directive, the opportunity should be taken to consolidate the provisionsof 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 relating to
the aforesaid materials and articles impeded the free movement thereof, could
create unequal conditions of competition and could thereby directly affect theestablishment or functioning of the common market;
Whereas those laws had to be approximated if free movement was to be
achieved for the aforesaid materials and articles, taking account primarily ofhuman 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 legal differences
between certain groups of materials and articles had been and couldsubsequently be eliminated by means of specific directives; whereas thismethod 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 with these
foodstuffs; whereas, in that case, account had to be taken of possible direct
consumption by consumers; whereas the rules laid down in this Directive aretherefore inappropriate in such circumstances;
Whereas the principle underlying this Directive should be that any material or
article intended to come into contact or which is intentionally in contact eitherdirectly or indirectly with foodstuffs, must be sufficiently stable not to transfer
substances to the foodstuffs in quantities which could endanger human health
or bring about an unacceptable change in the composition of the foodstuffs ora deterioration in the organoleptic 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 isappropriate to retain in specific directives those limitations which are most
appropriate to the desired objective, having regard to the technological
characteristics peculiar to each group of materials and articles;
Whereas, in order to allow the informed use of the materials and articles,
appropriate labelling should be provided for; whereas the methods used forsuch 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 designedto come into contact or be in contact with them;!B
(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. 216.1989L0109 — EN — 10.01.1989 — 000.001 — 2
Whereas the drafting of specific directives implementing the basic principles
and of amendments thereto constitute technical implementing measures;whereas, in order to simplify and expedite the procedure, the adoption ofthese measures should be entrusted to the Commission;
Whereas the Scientific Committee for Food, set up by Commission Decision
74/234/EEC (
1), should be asked for its opinion before provisions 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, provision should bemade for a procedure establishing close cooperation between the MemberStates and the Commission within the Standing Committee on Foodstuffs set
up by 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 or whichare brought into contact with foodstuffs and are intended for that purpose,
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 be subject 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 conditionsof use, they do not transfer their constituents to foodstuffs in quantities whichcould:
— endanger human health,
— bring about an unacceptable change in the composition of the foodstuffs
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 be subject to
specific directives.
2. The specific directives, including amendments to existing specific
directives, shall be adopted in accordance with the procedure laid down in
Article 8.
3. The specific directives may include:(a) a list of the substances the use of which is authorized to the exclusion 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 foodstuffs;
(f) if necessary, provisions aimed at protecting human health against any
hazards which might arise through oral contact with materials andarticles;!B
(1) OJ No L 136, 20. 5. 1974, p. 1.
(2) OJ No L 291, 19. 11. 1969, p. 9.1989L0109 — EN — 10.01.1989 — 000.001 — 3
(g) other rules to ensure compliance with Article 2;
(h) the basic rules necessary for checking compliance with the provisions 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 AnnexII.
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) of that
Article, authorize the use within its territory of a substance not included in the
list, subject to compliance with the following conditions:
(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 authorized theuse;
(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 up pursuant to paragraph 1
within two months of the date of its taking effect.
3. Before the expiry of the two-year period provided for in paragraph 1 (a),
the Member State may submit to the Commission a request for the inclusionin the list referred toin Article 3 (3) (a) of the substance given nationalauthorization in accordance with paragraph 1 of this Article. At the same
time, it shall supply supporting documents setting out the grounds on which it
deems such inclusion justified and shall indicate the uses for which thissubstance is intended.
Within 18 months of the submission of the request, a decision shall be taken
on the basis of information relating to public health, after consulting the
Scientific Committee for Food and in accordance with the procedure laid
down in Article 9 as to whether the substance in question may be included inthe list referred to in Article 3 (a) or whether the national authorization shouldbe revoked. If provisions prove necessary pursuant to Article 3 (3) (b), (c) and
(d), these shall be adopted in accordance with the same procedure.
Notwithstanding paragraph 1 (a) of this Article, the national authorizationshall remain in 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 to any other national
authorization in respect of the substance in question. The decision maystipulate that the ban on the use of this substance shall extend to uses other
than those referred to in the request for inclusion 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 specific directives
was adopted, has detailed grounds for establishing that the use of a material orarticle endangers human health although it complies with the relevant specific
directive, that Member State may temporarily suspend or restrict application
of the provisions in question within its territory. It shall immediately informthe other Member States and the Commission thereof and give reasons for itsdecision.
2. The Commission shall examine as soon as possible within the Standing
Committee on Foodstuffs the grounds adduced by the Member State referred
to in paragraph 1 and shall deliver its opinion without delay and take theappropriate measures.!B1989L0109 — EN — 10.01.1989 — 000.001 — 4
3. If the Commission considers that amendments to the specific directives in
question are necessary in order to remedy the difficulties mentioned inparagraph 1 and to ensure the protection of human health, it shall initiate theprocedure laid down in Article 9 with a view to adopting those amendments;
the Member State which has adopted safeguard measures may in that event
retain them until the amendments have been adopted.
Article 6
1. Without prejudice to any exceptions provided for in the specific
directives, materials and articles not already in contact with foodstuffs must,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, soup spoon,
— 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 paragraph1 (c), however, the latter option shall only be open if these particulars
or a label bearing them cannot, for technical reasons, be affixed to
the said materials and articles at either the manufacturing or themarketing 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) 3shall
not be compulsory for materials and articles which by their nature are clearly
intended to come into contact with foodstuffs.
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 articles be
accompanied by a written declaration attesting that they comply with the rulesapplicable 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 articles is
prohibited if the particulars required under paragraph 1 (a) and (b) are notgiven in a language easily understood by purchasers, unless the purchaser is
informed by other means. This provision shall not preclude such particulars
appearing in several languages.!B1989L0109 — EN — 10.01.1989 — 000.001 — 5
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 applicable 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 laiddown in Article 9.
Article 9
1. Where the procedure laid down in this Article is to be followed, the
chairman shall refer the matter to the Standing Committee on Foodstuffseither on his own initiative or at the request of the representative 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 opinion on the draftwithin a time limit which the chairman may lay down according to theurgency of the matter. The opinion shall be delivered by the qualified majority
laid down in Article 148 (2) of the Treaty. The chairman 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, the Commission
shall forthwith submit to the Council a proposal relating to themeasures to be taken. The Council shall act on a qualified majority.
If, on the expiry of three months from the date on which the matter
was referred to it, the Council has not adopted any measures, theCommission shall adopt the proposed measures and apply them
immediately.
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.
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, without prejudice tothe application of national provisions which, in the absence of specificdirectives, 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 materials and
articles intended to come into contact with foodstuffs.!B
(1) This Directive was notified to the Member States on 10 January 1989.1989L0109 — EN — 10.01.1989 — 000.001 — 6
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.!B1989L0109 — EN — 10.01.1989 — 000.001 — 7
ANNEX I
List of groups of materials and articles covered by specific directives
Plastics, including varnish and coatings
Regenerated cellulose
Elastomers and rubber
Paper and boardCeramics
Glass
Metals and alloysWood, including cork
Textile products
Paraffin waxes and micro-crystalline waxes!
B1989L0109 — EN — 10.01.1989 — 000.001 — 8
ANNEX II
Health criteria to be applied in the drafting of specific directives
1. Where appropriate, positive lists of substances shall be established for materials
and articles intended to come into contact with foodstuffs. The acceptability of asubstance for inclusion in a positive list shall be determined by considering boththe 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 transferred tofoodstuffs 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 thatthis intake is not exceeded shall be considered. Where such a specific migrationlimit is established for a substance, due regard shall be paid to other possiblesources 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 circumstances, theneed to protect human health shall be the primary consideration in determiningwhat action might be appropriate.!
B1989L0109 — EN — 10.01.1989 — 000.001 — 9
ANNEX III
CORRELATION TABLE
Directive 76/893/EEC Present Directive
Article 1 Article 1
Article 2 Article 2
Article 3 Article 3Article 4 Article 4
Article 5 Article —
Article 6 Article 5Article 7 Article 6
Article 8 Article 7
Article — Article 8Article 9 Article —
Article 10 Article 9
Article — Article 10Article 11 Article —
Article 12 Article 12
Article 13 Article 11Article 14 Article —Article 15 Article 13!
B1989L0109 — EN — 10.01.1989 — 000.001 — 10