CELEX: 51986PC0090
Language: en
Date: 1986-04-15
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO MATERIALS AND ARTICLES INTENDED TO COME INTO CONTACT WITH FOODSTUFFS

No C 124/10                             Official Journal of the European Communities                                       23.5.86
which the Commission has requested an opinion. When                    — to permit trade in products complying with this
seeking the opinion of the Committee, the Commission                       Directive by . . . (18 months after the notification),
may set a time limit within which such opinion shall be
                                                                       — to prohibit trade in products not complying with this
given. No vote shall be taken. However, any member of
                                                                           Directive with effect from . . . (24 months after the
the Committee may demand that his views be set down
                                                                           notification).
in the minutes.
                                                                       They shall forthwith inform the Commission thereof.
                          Article 10
                                                                       2.    Member States shall continue to put into effect the
Directive 77/94/EEC is hereby repealed.                                relevant provisions of Directive 77/94/EEC until the
                                                                       date on which the amendments are to be implemented.
                          Article 11
                                                                                                  Article 12
 1.   Member States shall amend their laws, regulations           -
and administrative provisions in such a way as:                        This Directive is addressed to the Member States.
                                                              ANNEX
             Groups of foods for particular nutritional uses for which specific provisions shall be laid down by specific
                                                              Directives
             Infant formulae
             Follow-up milk and other follow-up foods
             Baby foods
             Low-energy and energy-reduced foods
             Proposal for a Council Directive on the approximation of the laws of the Member States
                       relating to materials and articles intended to come into contact with foodstuffs
                                                        COM(86) 90 final
                                (Submitted by the Commission to the Council on 18 April 1986)
                                                          (86/C 124/07)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                              intended to come into contact with foodstuffs (*);
                                                                      whereas the number and nature of the changes that have
Having regard to the Treaty establishing the European                 had to be made to that Directive indicate the need for
Economic Community and in particular Article 100                      consolidation so as to maintain the clarity required of all
thereof,                                                              legislation;
Having regard to the proposal from the Commission,
                                                                      Whereas Directive 76/893/EEC was adopted on the
                                                                      grounds that the differences that existed at that time
Having regard to the opinion of the European Par-                     between the national laws relating to the aforesaid
liament,                                                              materials and articles impeded the free movement
                                                                      thereof, could create unequal conditions of competition
Having regard to the opinion of the Economic and                      and could thereby directly affect the establishment or
Social Committee,                                                     functioning of the common market;
Whereas on 23 November 1976 the Council adopted
Directive 76/893/EEC on the approximation of the laws
of the Member States relating to materials and articles               0) OJ No L 340, 9. 12. 1976, p. 19.
 ---pagebreak--- 23.5.86                                 Official Journal of the European Communities                              No C 124/11
Whereas those laws had to be approximated if free                  Whereas the Scientific Committee for Food, set up by
movement was to be achieved for the aforesaid materials            Commission Decision 74/234/EEC ('), should be asked
and articles, taking account primarily of human health             for its opinion before provisions liable to affect public
requirements but also, within the limits required for the          health are adopted under specific Directives;
protection of health, of economic and technological
needs;
                                                                   Whereas it is desirable that in all cases where the
                                                                   Council empowers the Commission to implement rules
Whereas the chosen method was to lay down, in the first            relating to foodstuffs, provision should be made for a
place, in a framework Directive, general principles on             procedure establishing close cooperation between the
the basis of which legal differences between certain               Member States and the Commission within the Standing
groups of materials and articles had been, and could               Committee for Foodstuffs set up by Council Decision
subsequently be, eliminated by means of specific                   69/414/EECO,
Directives; whereas this method has proved itself and
should therefore be retained;
                                                                   HAS ADOPTED THIS DIRECTIVE:
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                                   Article 1
that case, account had to be taken of possible direct
consumption by consumers; whereas the rules laid down              1.    This Directive shall apply to materials and articles
in this Directive are therefore inappropriate in such              which in their finished state are intended to come into
circumstances;                                                     contact with foodstuffs or which are in contact with
                                                                   foodstuffs and are intended for that purpose. They are
                                                                   hereinafter referred to as 'materials and articles'.
Whereas the principle underlying this Directive should
be that any material or article intended to come into              Covering or coating substances, such as the substances
contact, or which is intentionally in contact, either              covering cheese rinds, prepared meat products or fruit,
directly or indirectly with foodstuffs, must be sufficiently       which form part of foodstuffs and may be consumed
stable not to transfer substances to the foodstuffs in             together with the food, shall not be subject to this
quantities which could endanger human health or bring              Directive.
about an unacceptable change in the composition of the
foodstuffs or a deterioration in the organoleptic prop-
erties thereof;
                                                                   2.    This Directive shall apply to materials and articles
                                                                   which are in contact with water intended for human
                                                                   consumption. It shall not, however, apply to fixed public
Whereas, in order to achieve this objective, it may prove          or private water supply equipment.
necessary to lay down various types of limitations, alone
or in combination, and whereas it is appropriate to retain
in specific Directives those limitations which are most
                                                                   3.    This Directive shall not apply to antiques.
appropriate to the desired objective, having regard to the
technological characteristics peculiar to each group of
materials and articles;
                                                                                             Article 2
                                                                   Materials and articles must be manufactured in
Whereas, in order to allow the informed use of the                 compliance with good manufacturing practice so that,
materials and articles, appropriate labelling should be            under their normal or foreseeable conditions of use, they
provided for; whereas the methods used for such
                                                                   do not transfer their constituents to foodstuffs in
labelling may vary according to the user;
                                                                   quantities which could:
Whereas this Directive does not apply to the labelling of          — endanger human health,
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;                           — bring about an unacceptable change in the
                                                                       composition of the foodstuffs or a deterioration in
                                                                       the organoleptic characteristics thereof.
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 of               O OJ No L 136, 20. 5. 1974, p. 1.
these measures should be entrusted to the Commission;              O OJ No L 291, 19. 11. 1969, p. 9.
 ---pagebreak--- No C 124/12                               Official Journal of the European Communities                                   23.5.86
                           Article 3                                 the protection of human health, it shall initiate the
                                                                     procedure laid down in Article 8 with a view to adopting
1.     The groups of materials and articles listed in Annex          those amendments; the Member State which has adopted
I shall be subject to special provisions (specific                   safeguard measures may in that event retain them until
Directives).                                                         the amendments have been adopted.
2.     The specific Directives, including amendments to
existing specific Directives, shall be adopted in
accordance with the procedure laid down in Article 8.                                            Article 5
3.     They may include:                                             1.    Without prejudice to any exeptions provided for in
                                                                     the specific Directives, materials and articles not already
(a) a list of the substances the use of which is authorized          in contact with foodstuffs must, when placed on the
     to the exclusion of all others (affirmative list);              market, be accompanied by:
(b) purity standards for such substances;
(c) special conditions of use for these substances and/or            (a) — the words 'for food use',
     the materials and articles in which they are used;
(d) specific limits on the migration of constituents into                — or a specific indication as to their use, such as
     or onto foodstuffs;                                                      coffee-machine, wine bottle, soup spoon,
(e) an overall limit on the migration of constituents into
     or onto foodstuffs;                                                 — or a symbol determined in accordance with the
                                                                              procedure laid down in Article 8;
(f) if necessary, provisions aimed at protecting human
     health against any hazards which might arise
     through oral contact with these materials and
     articles;                                                       (b) where appropriate, any special conditions to be
                                                                         observed when they are being used;
(g) other rules to ensure compliance with Article 2;
(h) the basic rules necessary for checking compliance
     with the provisions referred to in points (d), (e), (f)         (c) — either the name or trade name and the address or
     and (g);                                                                 registered office,
(i) detailed rules concerning sample-taking and the
     methods of analysis required to check compliance                    — or the registered trade mark
     with the provisions referred to in points (a) to (g).
Provisions liable to affect public health shall be adopted               of the manufacturer or processor, or of a seller
after consulting the Scientific Committee for Food. They                 established within the Community.
must fulfil the criteria set out in Annex II.
                           Article 4                                 2.    The particulars listed in paragraph       1 must be
                                                                     clearly, legibly and indelibly shown:
1.     Where a Member State, as a result of new infor-
mation or of a reassessment of existing information made
since one of the specific Directives was adopted, has                (a) at the retail stage:
detailed grounds for establishing that the use of a
material or article endangers human health although it
complies with the relevant specific Directive, that                      — on the materials and articles or on the packaging,
Member State may temporarily suspend or restrict                              or
application of the provisions in question within its
territory. It shall immediately inform the other Member
States and the Commission thereof and give reasons for                   — on labels affixed to the materials and articles or
its decision.                                                                 to their packaging, or
2.     The Commission shall examine as soon as possible
the grounds given by the Member State concerned and                      — on a sign in the immediate vicinity of the
shall consult the Member States within the Standing                           materials and articles and clearly visible to pur-
Committee for Foodstuffs, and shall then deliver its                          chasers; in the case mentioned in paragraph 1 (c),
opinion fortwith and take the appropriate measures.                           however, the latter option shall be open only if
                                                                              these particulars or a label bearing them can, for
3.     If the Commission considers that amendments to                         technical reasons, be affixed to the materials and
the specific Directives are necessary in order to resolve                     articles neither at the manufacturing nor at the
the difficulties mentioned in paragraph 1 and to ensure                       marketing stage;
 ---pagebreak--- 23.5.86                                     Official Journal of the European Communities                                No C 124/13
(b) at the marketing stages other than the retail stage:                                               Article 8
     — on the accompanying documents, or                                  Where the procedure laid down in this Article is
     — on the labels or packaging, or                                     followed, the Commission will take a decision after
                                                                          consulting the Standing Committee on Foodstuffs set up
     — on the materials and articles themselves.                          under Decision 69/414/EEC, hereinafter refered to as
3.    The particulars provided for in paragraph 1 (a) and                 'the Committee'. The Committee shall discuss matters on
(b) shall be confined to materials and articles which                     which the Commission has requersted an opinion. When
comply with the criteria laid down in Article 2 and                       seeking the opinion of the Committee, the Commission
                                                                          may set a time limit within which such opinion shall be
(a) with the specific Directives;                                         given. No vote shall be taken. However, any member of
(b) in the absence of specific Directives, with               any         the Committee may demand that his views be set down
     national provisions.                                                 in the minutes.
4.    In the case of materials and articles not yet subject                                           Article 9
to a specific Directive, Member Strates may adopt
                                                                          Directive 76/893/EEC is hereby repealed.
provisions which require that such materials and articles
be accompanied by a written declaration attesting that                                                Article 10
they comply with the rules applying to them.
                                                                          1.    Member States shall amend their laws, regulations
5.    Member States shall ensure that retail trade in                     and administrative provisions so as to:
materials and articles is prohibited if the particulars                   — permit, by . . . (18 months after notification), trade in
required under paragraph 1 (a) and (b) are not given in a                     materials and articles complying with the provisions
language easily understood by purchasers, unless the                          laid down in this Directive, without prejudice to the
purchaser is informed by other means. This provision                          application of national provisions which, in the
shall not preclude such particulars appearing in several                      absence of specific Directives, shall apply to certain
languages.                                                                    groups of materials and articles;
                                                                          — prohibit, by . . . (36 months after notification), trade
                           Article 6                                          in and use of materials and articles which do not
                                                                              comply with the provisions laid down in this
The Member States shall not, for reasons relating to                          Directive.
composition, behaviour in the presence of foodstuffs or                   They shall forthwith inform the Commission thereof.
labelling, prohibit or restrict either trade in or the use of             2.    Member States shall continue to put into effect the
materials and articles complying with the provisions laid                 relevant provisions of Directive 76/893/EEC until the
down in this Directive or in the specific Directives.                     date on which the amendments are to be implemented.
                                                                                                     Article 11
                           Article 7                                      This Directive shall not apply to materials and articles
Amendments made to existing specific Directives in                        intended for export outside the Community.
order to bring them into line with this Directive shall be
                                                                                                     Article 12
adopted in accordance with the procedure laid down in
Article 8.                                                                This Directive is addressed to the Member States.
                                                                ANNEX I
                                  List of groups of materials and articles covered by specific Directives
              Plastics
              Regenerated cellulose film
              Elastomers and rubber
              Paper and board
              Ceramics
              Glass
              Metals and alloys
              Wood
 ---pagebreak--- N o C 124/14                              Official J o u r n a l of the E u r o p e a n Communities                       23.5.86
                                                                   ANNEX       II
                  General criteria to be adopted in the drafting of certain provisions laid down in specific Directives
            1. Where an approved list is established, it shall include only those substances which, under normal or
               predictable conditions of use of the material or article of which they form part, are not transferred to
               foodstuffs in quantities likely to constitute a danger to human health.
            2. All substances to be included on the list which are liable to specific migration must undergo suitable
               toxicological testing and evaluation. They must also be monitored continually and reassessed whenever
               fresh scientific data come to light.
            3. Where there is no approved list, it is advisable to identify substances for which limits should be laid
               down in order to prevent their being transferred to foodstuffs in quantities likely to constitute a danger
               to human health. The criterion set out in paragraph 2 also applies to these substances.
            4. Where a specific migration limit is laid down for a given substance, account should be taken of its
               contribution to human beings' daily intake of the substance from other sources so that the acceptable
               daily intake is not exceeded.