No C 124/10 Official Journal of the European Communities 23.5.86 
which the Commission has requested an opinion. When 
seeking the opinion of the Committee, the Commission 
may set a time limit within which such opinion shall be 
given. No vote shall be taken. However, any member of 
the Committee may demand that his views be set down 
in the minutes. 
Article 10 
Directive 77/94/EEC is hereby repealed. 
Article 11 
1. Member States shall amend their laws, regulations -
and administrative provisions in such a way as: 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community and in particular Article 100 
thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European Par­
liament, 
Having regard to the opinion of the Economic and 
Social Committee, 
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 — to permit trade in products complying with this 
Directive by ... (18 months after the notification), 
— to prohibit trade in products not complying with this 
Directive with effect from ... (24 months after the 
notification). 
They shall forthwith inform the Commission thereof. 
2. Member States shall continue to put into effect the 
relevant provisions of Directive 77/94/EEC until the 
date on which the amendments are to be implemented. 
Article 12 
This Directive is addressed to the Member States. 
intended to come into contact with foodstuffs (*); 
whereas the number and nature of the changes that have 
had to be made to that Directive indicate the need for 
consolidation so as to maintain the clarity required of all 
legislation; 
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 the establishment or 
functioning of the common market; 
0) OJ No L 340, 9. 12. 1976, p. 19. 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) 
23.5.86 Official Journal of the European Communities No C 124/11 
Whereas those laws had to be approximated if free 
movement was to be achieved for the aforesaid materials 
and articles, taking account primarily 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 legal differences 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 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 are therefore 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, either 
directly 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 or a deterioration in the organoleptic prop­
erties thereof; 
Whereas, in order to achieve this objective, it may prove 
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 
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 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 principles and of amendments thereto constitute 
technical implementing measures; 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 up by 
Commission Decision 74/234/EEC ('), 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 be made for a 
procedure establishing close cooperation between the 
Member States and the Commission within the Standing 
Committee for Foodstuffs set up by Council Decision 
69/414/EECO, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
1. This Directive shall apply to materials and articles 
which in their finished state are intended to come into 
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'. 
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 the food, shall not be subject to this 
Directive. 
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 
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 conditions of use, they 
do not transfer their constituents to foodstuffs in 
quantities which could: 
— endanger human health, 
— bring about an unacceptable change in the 
composition of the foodstuffs or a deterioration in 
the organoleptic characteristics thereof. 
O OJ No L 136, 20. 5. 1974, p. 1. 
O OJ No L 291, 19. 11. 1969, p. 9. 
No C 124/12 Official Journal of the European Communities 23.5.86 
Article 3 
1. The groups of materials and articles listed in Annex 
I shall be subject to special provisions (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. They may include: 
(a) a list of the substances the use of which is authorized 
to the exclusion of all others (affirmative 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 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 these materials and 
articles; 
(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) 
and (g); 
(i) detailed rules concerning sample-taking and the 
methods of analysis required to check compliance 
with the provisions referred to in points (a) to (g). 
Provisions liable to affect public health shall be adopted 
after consulting the Scientific Committee for Food. They 
must fulfil the criteria set out in Annex II. 
Article 4 
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 
detailed grounds for establishing that the use 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 question within its 
territory. It shall immediately inform the other Member 
States and the Commission thereof and give reasons for 
its decision. 
2. The Commission shall examine as soon as possible 
the grounds given by the Member State concerned and 
shall consult the Member States within the Standing 
Committee for Foodstuffs, and shall then deliver its 
opinion fortwith and take the appropriate measures. 
3. If the Commission considers that amendments to 
the specific Directives are necessary in order to resolve 
the difficulties mentioned in paragraph 1 and to ensure the protection of human health, it shall initiate the 
procedure laid down in Article 8 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 5 
1. Without prejudice to any exeptions 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 8; 
(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 
clearly, legibly and indelibly shown: 
(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 sign in the immediate vicinity of the 
materials and articles and clearly visible to pur­
chasers; in the case mentioned in paragraph 1 (c), 
however, the latter option shall be open only if 
these particulars or a label bearing them can, for 
technical reasons, be affixed to the materials and 
articles neither at the manufacturing nor at the 
marketing stage; 
23.5.86 Official Journal of the European Communities No C 124/13 
(b) at the marketing stages other than the retail stage: 
— on the accompanying documents, or 
— on the labels or packaging, or 
— on the materials and articles themselves. 
3. The particulars provided for in paragraph 1 (a) and 
(b) shall be confined to materials and articles which 
comply with the criteria laid down in Article 2 and 
(a) with the specific Directives; 
(b) in the absence of specific Directives, with any 
national provisions. 
4. In the case of materials and articles not yet subject 
to a specific Directive, Member Strates may adopt 
provisions which require that such materials and articles 
be accompanied by a written declaration attesting that 
they comply with the rules applying to them. 
5. Member States shall ensure that retail trade in 
materials and articles is prohibited if the particulars 
required under paragraph 1 (a) and (b) are not given 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. 
Article 6 
The 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 the provisions laid 
down in this Directive or in the specific Directives. 
Article 7 
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 8. Article 8 
Where the procedure laid down in this Article is 
followed, the Commission will take a decision after 
consulting the Standing Committee on Foodstuffs set up 
under Decision 69/414/EEC, hereinafter refered to as 
'the Committee'. The Committee shall discuss matters on 
which the Commission has requersted an opinion. When 
seeking the opinion of the Committee, the Commission 
may set a time limit within which such opinion shall be 
given. No vote shall be taken. However, any member of 
the Committee may demand that his views be set down 
in the minutes. 
Article 9 
Directive 76/893/EEC is hereby repealed. 
Article 10 
1. Member States shall amend their laws, regulations 
and administrative provisions so as to: 
— permit, by ... (18 months after notification), trade in 
materials and articles complying with the provisions 
laid down in this Directive, without prejudice to the 
application of national provisions which, in the 
absence of specific Directives, shall apply to certain 
groups of materials and articles; 
— prohibit, by . . . (36 months after notification), trade 
in and use of materials and articles which do not 
comply with the provisions laid down in this 
Directive. 
They shall forthwith inform the Commission thereof. 
2. Member States shall continue to put into effect the 
relevant provisions of Directive 76/893/EEC until the 
date on which the amendments are to be implemented. 
Article 11 
This Directive shall not apply to materials and articles 
intended for export outside the Community. 
Article 12 
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 
No C 124/14 Official Journal of the European 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.