Proposal for a Regulation of the European Parliament and of the Council on materials and articles intended to come into contact with food
Date: 2003-11-17
Institutions: European Commission
Subjects: food safety, labelling, packaging product, preparation for market, traceability

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 17.11.2003
COM(2003) 689 final

2003/0272 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on materials and articles intended to come into contact with food

(presented by the Commission)

EXPLANATORY MEMORANDUM

BACKGROUND

Council Directive 89/109/EEC 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
(Framework  Directive)  establishes  the  general  principles  applicable  to  all  food  contact
materials:

(a)

The principles of “inertness” of the materials and “purity of the food”, i.e.

– 

– 

migration  of  substances  from  the  material  or  article  into  the  food  shall  not
endanger human health,

migration  shall  not  bring  an  unacceptable  change  in  the  composition  of  the
food or deteriorate its organoleptic characteristics.

(b)

The  principle  of  “positive  labelling”,  stating  that  materials  and  articles  intended  to
come  into contact with food must be accompanied by the words ‘for food’ or  by  a
symbol determined in Directive 80/590/EEC.

Directive 89/109/EEC also lays down:

(c)

(d)

(e)

the principle of lists of authorised substances used in the manufacture of food contact
materials to the exclusion of all others (positive lists);

the  groups  of  materials  and  articles  to  be  regulated  by  implementing  measures
(specific directives);

procedures and criteria to be followed in drafting and adopting the specific directives
for  the  different  groups  of  materials  and  articles,  including  the  evaluation  of
substances  by  the  Scientific  Committee  on  Food  (SCF)  and  the  opinion  of  the
Standing Committee on Foodstuffs.

OBJECTIVES OF THE PROPOSAL

Since the adoption of Council Directive 89/109/EEC a number of new  issues have  emerged
that need to be considered in the existing legislation:

– 

– 

– 

– 

– 

important technological developments have occurred in the area of food packaging,

traceability  as  well  as  labelling  of  materials  and  articles  intended  to  come  into
contact with food need to be better ensured,

the transparency of the authorisation process should be improved  by specifying  the
various phases of the procedure,

the  Commission  must  be  given  the  possibility  to  adopt  for  the  implementing
measures not only directives, but also decisions or regulations, as the latter are more
appropriate for provisions such as positive lists,

better  enforceability  of  the  rules  must  be  ensured  through  the  establishment  of
Community and national Reference Laboratories,

2

– 

the symbol which should accompany materials and articles suitable for food contact,
and  which  has  been  determined  in  Directive  80/590/EEC,  should  be  for  reasons  of
simplicity  included  in  this  proposal.  Directive  80/590/EEC  should  be  consequently
repealed.

To this end and in the interest of clarity and efficiency, a new Regulation is proposed which
will  repeal  Directive  89/109/EEC.  This  new  Regulation  introduces  the  following  main
modifications.

1.

Legal instrument for implementing provisions

A detailed examination of the provisions of the specific implementing directives adopted so
far in the sector of food contact materials leads to the following conclusions:

– 

– 

– 

the  specific  directives  are  purely  technical  provisions,  aimed  at  implementing  the
general  principles  laid  down  in  the  Framework  Directive  in  accordance  with
previously established criteria and procedures;

they require frequent technical amendments to adapt them to the rapid technological
progress  in  the  sector  (new  materials,  analytical  methods,  technological  processes,
food conservation and processing techniques, etc.);

they  mostly  contain  simple,  repetitive  provisions  consisting  of  additions  or
amendments  to  the  lists  of  substances  authorised  for  use  (positive  lists)  or  laying
down the conditions for their use. These annual additions or amendments are always
put forward after consulting the SCF.

For these reasons, it is more appropriate to draw up regulations than directives. In fact, so far
the  Member  States  have  mostly  reproduced  verbatim  the  content  and  format  of  the
Community directives. This situation will occur even more frequently in the near future, when
amendments to existing directives or new directives on other groups of materials (paper and
board, varnishes, elastomers) are prepared.

It  should  also  be  pointed  out  that  the  use  of  regulations  as  legal  instruments  for  the
implementing  provisions  will  ensure  uniform  and  timely  application  of  the  rules  for  the
benefit both of the consumers and of the competitiveness of the industry.  For implementing
procedures,  the  proposed  Regulation  changes  from  the  compulsory  system  of  issuing
directives  to  a more  flexible  one  enabling  a  decision  about  the  legal  nature  of  the  act  to  be
adopted  –  directive,  regulation  or  decision  –  according  to  the  content.  Replacing  the  term
"directive"  by  "measure",  as  provided  in  Article  95  of  the  Treaty,  would  achieve  such
flexibility. This approach has also been requested by some Member States.

2.

Active and intelligent food contact materials and articles ("active and intelligent
materials and articles")

The  main  purpose  of  food  packaging  is  to  protect  the  food  against  physical,  biological  and
chemical  risks.  Food  packaging  materials  have  traditionally  been  developed  to  avoid
interactions  with  food  and,  in  particular,  to  minimise  the  release  of  their  components
(“migration”) into the  food.  Accordingly,  current Community  legislation asks  for  maximum
inertness  of  the  food  contact  materials  and  minimised  food  contamination.  Packaging
materials  must  not  cause  unacceptable  changes  in  the  composition  of  the  food  or  in  its
organoleptic characteristics.

3

Active materials and articles are new concepts in packaging, designed to interact with food in
order  to  maintain  or  improve  the  condition  of  the  food  during  storing  and  prolong  its  shelf
life.  Such  applications  include  oxygen  scavengers,  flavourings,  preservative  or  antioxidant
emitters, ethylene absorbers from fresh food, etc. Another innovative type of packaging called
intelligent  materials  and  articles  are  developed  to  provide  information  about  the  actual
condition of the food.

The  proposed  Regulation  provides  the  legal  framework,  which  introduces  the  possibility  to
take  into  account  these  new  technological  solutions  to  food  packaging  and  sets  some  basic
requirements for their use.

– 

– 

– 

– 

The  proposal  defines  the  active  and  intelligent  materials  and  articles  and  specifies
that the Regulation should apply to these materials and articles (Article 2).

Article 2 of Directive 89/109/EEC states that materials and articles should not bring
about  unacceptable  changes  to  the  composition  or  deteriorate  the  organoleptic
properties of the food. Active materials and articles, however, due to their intended
use  may  change  these  properties  of  the  food.  Therefore,  this  Article  has  been
modified to clarify that compositional and organoleptic changes brought to the food
by active materials and articles are allowed provided these changes comply with any
other Community legislation applicable to food (Article 4).

Labelling  requirements  are  proposed  to  inform  the  user  of  active  materials  and
articles  (food  packers)  about  the  interaction  of  these  applications  with  the  food  in
order to comply with any relevant food legislation (Article 12(1)(e)).

Since  active  and  intelligent  materials  and  articles  include  sophisticated  systems
composed  of  different  materials,  such  as  plastic,  paper,  metal,  adhesives  etc,  more
detailed rules might be needed in specific measures. For this reason, these materials
and  articles  are  added  to  the  list  of  materials  to  be  regulated  by  specific  measures
(Annex I).

3.

Authorisation procedure

Directive 89/109/EEC  lays down the  principle  of  positive lists of authorised  substances  and
the  groups  of  materials  and  articles  to  be  regulated  by  specific  measures  implementing  the
basic principles. It also sets the procedures and criteria to be followed in drafting and adopting
the implementing measures, including the evaluation of substances by the SCF.

The proposed Regulation establishes more detailed procedures for the safety assessment and
authorisation of substances to be used in the manufacture of food contact materials.

Where  a  positive  list  is  drawn  up,  the  procedure  proposed  in  the  draft  Regulation
(Articles 8-11) can be summarised as follows:

– 

– 

those interested in placing a new substance for a food contact material on the market
submit an application to the )national competent authority of a Member State;

the  national  competent  authority  informs  the  European  Food  Safety  Authority
(“Authority”)  about  the  receipt  of  an  application  and  makes  available  to  the
Authority  the  application  and  any  supplementary  information  provided  by  the
applicant;

4

– 

– 

– 

the  Authority  informs  the  Commission  and  the  other  Member  States  of  the
application and makes the application and any supplementary information submitted
by the applicant available to them;

the Authority expresses an opinion within a defined limited time, forwards it to the
Commission,  the  Member  States  and  the  applicant,  and  makes  it  public  after
adoption;

based on the opinion of the Authority, the Commission proposes a draft measure.

Confidentiality for sensitive data is provided if requested by the applicant, which is subject to
the decision of the Commission (Article 18).

4.

– 

– 

5.

Labelling

Article 6(3) of Directive 89/109/EEC states that materials and articles, which by their
nature  are  obviously  intended  to  come  into  contact  with  food,  do  not  need  to  be
labelled with the words ‘for food use’ or the symbol. However, since there are also
materials and articles of a shape or nature suggesting that they can be used for food
contact,  without  being  manufactured  for  this  purpose,  the  proposed  Regulation
replaces Article 6(3) of 89/109/EEC with the requirement that all materials or articles
suitable for food contact should be labelled by the words “suitable for food contact”
or a symbol. For simplicity, this symbol, specified by Directive 80/590/EEC, should
be integrated into the draft Regulation (Annex II) and Directive 80/590/EEC should
be repealed.

A  labelling  provision  for  active  and  intelligent  materials  and  articles  has  been
mentioned above (Article 12(1)(e)).

Traceability (Article 15)

The provisions on traceability established  in  Article 18 of Regulation (EC)  No  178/2002  of
the  European  Parliament  and  of  the  Council  laying  down  the  general  principles  and
requirements of food law, establishing the European Food Safety Authority and laying down
procedures in matters of food safety, do not apply to food contact materials and articles. It is,
therefore,  necessary  to  establish  general  requirements  to  ensure  traceability  of  all  materials
and articles in contact or intended to come into contact with food at all stages.

In  line  with  Regulation  (EC)  No  178/2002,  this  draft  Regulation  requires  all  food  contact
material businesses to have in place systems to identify at every given stage of production and
trade, their supplier(s) and to whom materials and articles are supplied, whereby at least one
step “above” and one “below” must be identifiable, unless specific provisions require further
traceability. Importers are also concerned.

Additional  provisions  for  specific  groups  of  materials  and  articles  may  be  adopted,  if
necessary, in specific measures.

6.

Safeguard measures

Emergency  measures  for  food  are  established  in  Articles  53  and  54  of  Regulation  (EC)
No 178/2002.  They  are  applicable  also  when  serious  risk  to  human  health  derives  from
migration of substances from food contact materials and articles into food. In addition to these

5

emergency measures foreseen for food by Regulation (EC) No 178/2002, a safeguard clause
specific to materials and articles as such is included in Article 16.

7.

Reference laboratories (Article 23)

In  order  to  ensure  enforceability  of  the  rules,  it  is  proposed  to  establish  a  Community
Reference  Laboratory  and  national  reference  laboratories,  in  accordance  with  Regulation  of
the European Parliament and of the Council on official feed and food controls1.

8.

New materials which may be regulated by specific measures

Further to active and intelligent materials and articles, three more groups of materials, i.e. ion-
exchange  resins,  adhesives,  printing  inks,  are  proposed  to  be  added  to  the  list  of  groups  of
materials, which may be regulated by specific measures (Annex I).

IMPACT OF THE PROPOSAL ON THE ACCEDING COUNTRIES

The proposed Regulation will have no specific impact on the acceding countries in particular,
nor will it affect the enlargement of the Union in general.

The new provisions aim at introducing more clarity and transparency to the currently existing
provisions  as 
core  principles  of
Directive 89/109/EEC remain unchanged in this proposal. The new provisions are in line with
Regulation (EC) No 178/2002 which is part of the acquis accepted by the acceding countries
under the Accession Treaty.

in  Directive  89/109/EEC.  The 

laid  down 

Notably  in  relation  to  active  and  intelligent  materials  and  articles  the  proposal  simply
establishes the legal frame for regulating these new types of packaging. The description of the
authorisation  procedure  is  introduced  for  reasons  of  transparency  and  does  not  change  the
current  practice.  Finally  the  traceability  provisions  are  aligned  with  the  requirements
established by the above mentioned Regulation (EC) No 178/2002.

Practically all acceding countries have already transposed most of the acquis on food contact
materials, including Directive 89/109/EEC or are in the process of doing so. They have been
fully informed on the principles of the above-mentioned Regulation (EC) No 178/2002 which
will be directly applicable upon accession. Further, in the context of the monitoring exercise
of  the  Commission,  DG  SANCO  is  currently  actively  co-operating  with  these  countries  to
assist  them  and  to  ensure  their  national  texts  are  fully  conform  with  EU  law,  including  the
acquis on food contact materials.

In  view  of  the  nature  of  the  changes  introduced  in  the  proposal  and  of  the  maintaining  of
exactly  the  same  policy  as  in  the  past  the  proposed  Regulation  should  not  have  cause  any
specific problems of transposition or implementation in the acceding countries, as compared
to the existing acquis.

1

Commission proposal COM(2003) 52 final. References will be added when the Regulation is adopted
by the European Parliament and the Council.

6

                                                
2003/0272 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on materials and articles intended to come into contact with food

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular
Article 95 thereof,

Having regard to the proposal from the Commission1,

Having regard to the opinion of the European Economic and Social Committee2,

Acting in accordance with the procedure laid down in Article 251 of the Treaty3,

Whereas:

(1)

(2)

(3)

Council Directive 89/109/EEC 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  foodstuffs4,  replacing  Directive  76/893/EEC,  established  general  principles  for
eliminating  the  differences  between  the  laws  of  the  Member  States  as  regards  those
materials  and  articles  and  provided  for  the  adoption  of  implementing  directives
concerning  specific  groups  of  materials  and  articles  (specific  directives).  This
approach was successful and should be continued.

The  specific  directives  adopted  under  Directive  89/109/EEC  in  general  contain
provisions which leave little room for the exercise of discretion by the Member States
in their transposition besides being subject to frequent amendments required to adapt
them  rapidly  to  technological  progress.  It  should  therefore  be  possible  for  such
measures  to  take  the  form  of  regulations  or  decisions.  At  the  same  time  it  is
appropriate to include a number of additional subjects. Directive 89/109/EEC should
therefore be replaced.

The  principle  underlying  this  Regulation  should  be  that  any  material  or  article
intended  to  come  into  contact  with  food  must  be  sufficiently  inert  to  preclude
substances  being  transferred  to  food  in  quantities  large  enough  to  endanger  human
health or  to bring about  an  unacceptable  change  in  the  composition  of  the  food  or  a
deterioration in its organoleptic properties.

1

2

3

4

OJ C
OJ C
OJ C
OJ L 40, 11.2.1989, p. 38.

7

                                                
(4)

(5)

(6)

(7)

(8)

(9)

New  types  of  materials  and  articles  designed  to  actively  maintain  or  improve  the
condition  of  the  food  (“active  food  contact  materials  and  articles”)  are  not  inert  by
their design, contrary to traditional materials and articles intended to come into contact
with  food.  Other  types  of  new  materials  and  articles  are  designed  to  monitor  the
condition  of  the  food  (“intelligent  food  contact  materials  and  articles”).  Both  these
types  of  materials and  articles may be brought  into  contact  with  food.  It  is  therefore
necessary,  for  reasons  of  clarity  and  legal  certainty,  for  active  and  intelligent  food
contact  materials  and  articles  to  be  included  in  the  scope  of  this  Regulation  and  the
main requirements for their use to be established.

Active  food  contact  materials  and  articles  are  designed  to  deliberately  incorporate
“active”  components  intended  to  be  released  into  the  food  or  to  absorb  substances
from  the  food.  They  should  be  distinguished  from  materials  and  articles  which  are
traditionally used to release their natural ingredients into specific types of food during
the process of their manufacture, such as wooden barrels.

Any material and  article intended to come into contact with food which is placed on
the  market  should  comply  with  the  requirements  of  this  Regulation.  Nevertheless,
materials and articles manufactured and placed on the market before 1 January 1980,
when the rules of Directive 76/893/EEC became applicable, and which are supplied as
antiques, should be excluded.

Covering or coating products forming  part of the  food and possibly being consumed
with it should not fall within the scope of this Regulation.

It is necessary to lay down various types of restrictions and conditions for the use of
the materials and articles covered by this Regulation and the substances used in their
manufacture. It is appropriate to establish those restrictions and conditions in specific
measures having  regard to the technological  characteristics specific  to  each group  of
materials and articles.

Pursuant  to  Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  of  the
Council  of  28  January  2002  laying  down  the  general  principles  and  requirements  of
food  law,  establishing  the  European  Food  Safety  Authority  and  laying  down
procedures  in  matters  of  food  safety5,  the  European  Food  Safety  Authority  ("the
Authority")  should  be  consulted  before  provisions  liable  to  affect  public  health  are
adopted under specific measures.

(10) When specific measures include a list of substances authorised within the Community
for use in the manufacture of materials and articles intended to come into contact with
food, those substances should undergo a safety assessment prior to their authorisation.

(11) Differences  between  national 

laws,  regulations  and  administrative  provisions
concerning  the  safety  assessment  and  the  authorisation  of  substances,  used  in  the
manufacture  of  materials  and  articles  intended  to  come  into  contact  with  food,  may
hinder  the  free  movement  of  those  materials  and  articles,  creating  conditions  of
unequal  and  unfair  competition.  An  authorisation  procedure  should  therefore  be
established  at  Community  level.  In  order  to  ensure  harmonised  safety  assessment  of
those substances, the Authority should carry out such assessments.

5

OJ  L  31,  1.2.2002,  p.  1.  Regulation  as  amended  by  Regulation  (EC)  No  1642/2003  (OJ  L  245,
29.9.2003, p. 4).

8

                                                
(12)

The  safety  assessment  of  substances  should  be  followed  by  a  risk  management
decision  as  to  whether  those  substances  should  be  entered  on  a  Community  list  of
authorised substances.

(13)

Labelling supports users in the correct use of the materials and articles. Methods used
for such labelling may vary according to the user.

(14) A  symbol  was  introduced  by  Commission  Directive  80/590/EEC  of  9  June  1980
determining the symbol that may accompany materials and articles intended to  come
into  contact  with  foodstuffs6.  It  should,  for  reasons  of  simplicity,  be  incorporated  in
this Regulation.

(15)

(16)

(17)

Traceability of materials and articles intended to come into contact with food should
be  ensured  at  all  stages.  Business  operators  should  at  least  be  able  to  identify  the
businesses from which and to which the materials and articles have been supplied.

It  is  necessary  to  establish  procedures  for  the  adoption  of  safeguard  measures  in
situations  where  a  material  or  article  is  likely  to  constitute  a  serious  risk  to  human
health.

It  is  appropriate  to  protect  the  investment  made  by  innovators  in  gathering  the
information and data supporting an application under this Regulation. In order to avoid
unnecessary repetition of studies and in particular animal testing, however, sharing of
data should be permitted provided there is agreement between the interested parties.

(18) Community and national reference laboratories should be designated to contribute to a
high  quality  and  uniformity  of  analytical  results.  This  objective  will  be  achieved
within the framework of Regulation (EC) No […] of the European Parliament and of
the Council on official feed and food controls7.

(19)

(20)

(21)

The measures necessary for the implementation of this Regulation and amendments to
Annexes I and II should be adopted in accordance with Council Decision 1999/468/EC
of 28 June 1999 laying down the procedures for the exercise of implementing powers
conferred on the Commission8.

The Member States should lay down rules on penalties applicable to infringements of
the  provisions  of  this  Regulation  and  ensure  that  they  are  implemented.  Those
penalties must be effective, proportionate and dissuasive.

Since the objectives of this Regulation cannot be sufficiently achieved by the Member
States due the differences between the national laws and provisions and can therefore
be  better  achieved  at  Community  level,  the  Community  may  adopt  measures,  in
accordance  with the principle of subsidiarity as set out in Article  5 of  the  Treaty.  In
accordance  with  the  principle  of  proportionality,  as  set  out  in  that  Article,  this
Regulation does not go beyond what is necessary in order to achieve those objectives.

6

7

8

OJ L 151, 19.6.1980, p. 21. Directive as last amended by the act of Accession of Austria, Finland and
Sweden.
Commission proposal COM(2003) 52 final. References will be added when the Regulation is adopted
by the European Parliament and the Council.
OJ L 184, 17. 7. 1999, p. 23

9

                                                
(22) Directives 80/590/EEC and 89/109/EEC should therefore be repealed,

HAVE ADOPTED THIS REGULATION:

Article 1
Subject matter and scope

1.

2.

The  pupose  of  this  Regulation  is  to  ensure  the  effective  functioning  of  the  internal
market  in  relation  to  materials  and  articles  intended  to  come  into  contact  with
foodstuffs,  whilst  providing  the  basis  for  securing  a  high  level  of  protection  of
human health and the interests of consumers.

This  Regulation  shall  apply  to  materials  and  articles  (hereinafter  referred  to  as
‘materials and  articles’), including  active and intelligent food  contact  materials  and
articles, which in their finished state:

(a)

are intended to be brought into contact with food; or

(b)

are already brought into contact with food and are intended for that purpose; or

(c)

can reasonably be expected to be brought into contact with foods or to transfer
their constituents to food.

3.

This Regulation shall not apply to:

(a) materials  and  articles  which  were  manufactured  and  placed  on  the  market

before 1 January 1980 and which are supplied as antiques;

(b)

covering  or  coating  products,  such  as  the  products  covering  cheese  rinds,
prepared  meat  products  or  fruits,  which  form  part  of  food  and  may,  be
consumed together with this food;

(c)

fixed public or private water supply equipment.

Article 2
Definitions

For  the  purposes  of  this  Regulation,  the  definitions  laid  down  in  Regulation  (EC)
No 178/2002 shall apply, with the exception of the definition of “traceability”.

The following definitions shall also apply:

(1)

(2)

“active  food  contact  materials  and  articles”  (hereinafter  referred  to  as  “active
materials and articles”) means materials and articles that are intended to  extend the
shelf-life  or  to  maintain  or  improve  the  condition  of  packaged  food.  They  are
designed  to  deliberately  incorporate  components  that  would  release  or  absorb
substances into or from the packaged food or the environment surrounding the food;

“intelligent food contact materials and articles” (hereinafter referred to as “intelligent
materials and articles”) means materials and articles which monitor the condition of
packaged food or the environment surrounding the food;

10

(3)

(4)

(5)

“business”  means  any  undertaking,  whether  for profit or not  and  whether  public  or
private,  carrying  out  any  of  the  activities  related  to  any  stage  of  manufacture,
processing and distribution of materials and articles;

“business operator” means the natural or legal persons responsible for ensuring that
the requirements of this Regulation are met within the business under their control;

“traceability” means  the ability to trace and  follow a  material  or  article  through  all
stages of manufacture, processing and distribution.

Article 3
General requirements

Materials and articles shall be manufactured in compliance with good manufacturing practice
so that, under normal or foreseeable conditions of use, they do not transfer their constituents
to food in quantities which could:

(a)

(b)

1.

2.

3.

endanger human health; or

bring about an unacceptable change in the composition of the food or a deterioration
in the organoleptic characteristics thereof.

Article 4
Special requirements for active and intelligent materials and articles

Without  prejudice  to  Article  3(a),  active  materials  and  articles  may  bring  about
changes in the composition or the organoleptic characteristics of the food only if the
changes  comply  with  the  Community  provisions  or,  in  their  absence,  with  the
national provisions applicable to food.

Active materials and articles shall not bring about changes in the composition or the
organoleptic characteristics of the food which could mislead the consumers.

Intelligent materials and articles shall not give information about the condition of the
food which could mislead the consumers.

Article 5
Specific measures for groups of materials and articles

For  the  groups  of  materials  and  articles  listed  in  Annex  I  and,  where  appropriate,
combinations of those materials and articles, specific measures may be adopted in accordance
with the procedure referred to in Article 21(2).

Those specific measures may include:

(a)

a list of the substances the use of which is authorised to the  exclusion  of  all others
(positive list);

(b)

purity standards for substances referred to in (a);

11

(c)

(d)

(e)

(f)

(g)

(h)

(i)

(j)

(k)

special  conditions  of  use  for  substances  referred  to  in  (a)  and/or  the  materials  and
articles in which they are used;

specific limits on the migration of certain constituents or groups of constituents into
or  onto  food,  taking  due  account  of  other  possible  sources  of  exposure  to  those
constituents;

an overall limit on the migration of constituents into or onto food;

provisions  aimed  at  protecting  human  health  against  hazards  arising  from  oral
contact with materials and articles;

other rules to ensure compliance with Articles 3 and 4;

basic rules for checking compliance with points (a) to (g);

rules  concerning  the  collection  of  samples  and  the  methods  of  analysis  to  check
compliance with points (a) to (g);

additional provisions for ensuring traceability of materials and articles;

provisions  requiring  that  the  Commission  establishes  and  maintains  a  publicly
available  Community  Register  (“Register”)  of  authorised  substances,  materials  or
articles.

Article 6
Role of the European Food Safety Authority

Provisions liable to affect public health shall be adopted after consulting the European Food
Safety Authority, hereinafter referred to as ‘the Authority’.

1.

2.

1.

Article 7
General requirements for placing on the market

If a list as referred to in point (a) of the second subparagraph of Article 5 is adopted,
anyone  seeking  an  authorisation  for  a  substance  not  yet  included  in  that  list  shall
submit an application in accordance with Article 8(1).

No  substance  shall  be  authorised  unless  it  has  been  adequately  and  sufficiently
demonstrated that, when used under the conditions to be set in the specific measures
the final material or article satisfies the requirements of Articles 3 and 4.

Article 8
Application for authorisation of a new substance

To  obtain  the  authorisation  referred  to  in  Article  7(1),  an  application  shall  be
submitted in accordance with the following points:

(a)

the application shall be sent to the national competent authority  of a Member
State accompanied by the following:

12

(i)

the name and address of the applicant;

(ii)

a technical dossier containing the information specified in the guidelines
for the safety assessment of a substance to be published by the Authority;

(iii) a summary of the technical dossier;

(b)

the national competent authority shall:

(i)

acknowledge receipt of the application in writing to the applicant within
14  days  of  its  receipt.  The  acknowledgement  shall  state  the  date  of
receipt of the application;

(ii)

inform without delay the Authority; and

(iii) make the application and any supplementary information supplied by the

applicant available to the Authority;

(c)

the  Authority  shall  inform  without  delay  the  other  Member  States  and  the
Commission  of  the  application  and  shall  make  the  application  and  any
supplementary information supplied by the applicant available to them.

The  Authority  shall  publish  detailed  guidance  concerning  the  preparation  and  the
submission of the application. Pending such publication, applicants shall consult the
“Guidelines  of  the  Scientific  Committee  on  Food  for  the  presentation  of  an
application for safety assessment of a substance to be used in food contact materials
prior to its authorisation”9.

Article 9
Opinion of the Authority

The  Authority  shall  give  an  opinion  within  six  months  of  the  receipt  of  a  valid
application, as to whether the substance under the intended conditions of use of the
material  or  article  in  which  it  is  used,  complies  with  the  criteria  laid  down  in
Articles 3 and 4.

The  Authority  may  extend  the  said  period.  In  such  a  case  it  shall  provide  an
explanation for the delay to the applicant, the Commission and the Member States.

The  Authority  may,  where  appropriate,  request  the  applicant  to  supplement  the
particulars  accompanying  the  application  within  a  time  limit  specified  by  the
Authority.  Where  the  Authority  requests  supplementary  information,  the  time  limit
laid down in paragraph 1 shall be suspended until such time, as that information has
been provided.  Likewise, the  time  limit  shall  be  suspended  for  the  time  allowed  to
the applicant to prepare oral or written explanations.

2.

1.

2.

3.

In order to prepare its opinion, the Authority shall:

9

http://europa.eu.int/comm/food/fs/sc/scf/out82_en.pdf

13

                                                
(a)

verify  that  the  information  and  documents  submitted  by  the  applicant  are  in
accordance with Article 8(1)(a) in which case the application shall be regarded
as  valid,  and  examine  whether  the  substance  complies  with  the  criteria  laid
down in Articles 3 and 4;

(b)

inform the applicant, the Commission and the Member States if an application
is not valid.

4.

In  the  event  of  an  opinion  in  favour  of  authorising  the  evaluated  substance,  the
opinion shall include:

(a)

the designation of the substance including its specifications;

(b) where  appropriate,  any  conditions  or  restrictions  of  use  for  the  evaluated

substance and/or the material or article;

(c)

an assessment as to whether the analytical method proposed is appropriate for
the intended control purposes.

The Authority shall forward its opinion to the Commission, the Member States and
the applicant.

The  Authority  shall  make  its  opinion  public,  after  deletion  of  any  information
identified as confidential, in accordance with Article 18.

Article 10
Community authorisation

The  Commission  shall  prepare,  where  appropriate,  a  draft  of  a  specific  measure  to
authorise  the  substance  or  substances  evaluated  by  the  Authority  and  specify  or
change the conditions of their use.

The  draft  specific  measure  shall  take  into  account  the  opinion  of  the  Authority,
relevant  provisions  of  Community  law  and  other  legitimate  factors  relevant  to  the
matter  under  consideration.  Where  the  draft  specific  measure  is  not  in  accordance
with the opinion of the Authority, the Commission shall provide an explanation for
the reasons for the differences.

The specific measure referred to in paragraph 1 shall be adopted in accordance with
the procedure referred to in Article 21(2).

After  the  authorisation  of  a  substance  in  accordance  with  this  Regulation,  any
business  operator  using  the  authorised  substance  or  materials  or  articles  containing
the  authorised  substance  shall  comply  with  any  condition  or  restriction  attached  to
such authorisation.

The  applicant  shall  immediately  inform  the  Commission  of  any  new  scientific  or
technical  information,  which  might  affect  the  safety  assessment  of  the  authorised
substance in relation to human health.  If necessary, the Authority shall then  review
the assessment.

5.

6.

1.

2.

3.

4.

5.

14

6.

1.

2.

3.

4.

5.

6.

1.

The  granting  of  an  authorisation  shall  not  affect  the  general  civil  and  criminal
liability of any business operator in respect to the authorised substance, the material
or  article  containing  the  authorised  substance,  and  the  food  that  is  in  contact  with
such a material or article.

Article 11
Modification, suspension and revocation of authorisation

The applicant may, in accordance with the procedure laid down in Article 8(1), apply
for a modification of the existing authorisation.

The application shall be accompanied by the following:

(a)

a reference to the original application;

(b)

a technical dossier containing the new information according to the guidelines
as referred to in Article 8(2);

(c)

a new complete summary of the technical dossier in a standardised form.

On its own initiative or following a request from a Member State or the Commission,
the  Authority  shall  deliver  an  opinion  on  whether  an  authorisation  is  still  in
accordance  with  this  Regulation,  in  accordance  with  the  procedure  laid  down  in
Article 9, where applicable.

The  Commission  shall  examine  the  opinion  of  the  Authority  without  delay  and
prepare a draft specific measure to be taken.

A  draft  specific  measure  modifying  an  authorisation  shall  specify  any  necessary
changes  in  the  conditions  of  use  and,  if  any,  in  the  restrictions  attached  to  that
authorisation.

A  final  specific  measure  on  the  modification,  suspension  or  revocation  of  the
authorisation  shall  be  adopted  in  accordance  with  the  procedure  referred  to  in
Article 21(2).

Article 12
Labelling

Without prejudice to the specific measures, materials and articles, which are not yet
in contact with food when placed on the market, shall be accompanied by:

(a)

the  words  “suitable  for  food  contact”,  or  a  specific  indication  as  to  their  use,
such as coffee-machine, wine bottle, soup spoon, or the symbol reproduced in
Annex II;

(b) where appropriate, special instructions to be observed for safe use;

(c)

either  the  name  or  trade  name  and  the  address  or  registered  office,  or  the
registered  trade  mark  of  the  manufacturer,  processor,  or  seller  established
within the Community;

15

(d)

(e)

adequate  labelling  or  identification  to  allow  traceability  of  the  material  or
article;

in the case of active materials and articles, instructions on the permitted use or
uses to enable the users of these materials and articles to comply with any other
relevant  Community  provisions  or,  in  their  absence,  national  provisions
applicable to food.

The  information  required  by  paragraph  1  shall  be  conspicuous,  clearly  legible  and
indelible.

At the retail stage, the information required by paragraph 1 shall be displayed on:

(a)

the materials and articles or on their packaging; or

(b)

labels affixed to the materials and articles or to their packaging; or

(c)

a  notice  in  the  immediate  vicinity  of  the  materials  and  articles  and  clearly
visible  to  purchasers;  for  the  information  referred  to  in  paragraph  1(c),
however,  this  option  shall  be  open  only  if,  for  technical  reasons,  that
information or a label bearing it cannot be affixed to the materials and articles
at either the manufacturing or the marketing stage.

At  the  marketing  stages  other  than  the  retail  stage,  the  information  required  by
paragraph 1 shall be displayed on:

(a)

the accompanying documents;

(b)

the labels or packaging; or

(c)

the materials and articles themselves.

The  information  provided  for  in  paragraph  1(a),  (b)  and  (e)  shall  be  confined  to
materials and articles which comply with:

(a)

the criteria laid down in Articles 3 and 4;

(b)

the  specific  measures  or,  in  their  absence,  with  any  national  provisions
applicable to them.

Article 13
Labelling requirements in specific measures

The specific measures referred to in Article 5 shall require that materials and articles
covered by those measures be accompanied by a written declaration stating that they
comply with the rules applicable to them.

Appropriate documentation shall be available to demonstrate such compliance. That
documentation shall be made available to the competent authorities on demand.

In the absence of specific measures, Member States may retain existing provisions or
adopt provisions to this effect.

16

2.

3.

4.

5.

1.

2.

Article 14
Language used for labelling

Retail  trade  in  materials  and  articles  shall  be  prohibited  if  the  information  required  under
Article  12(1)(a)  and  (b)  is  not  given  in  a  language  easily  understood  by  purchasers.  This
provision shall not preclude such information appearing in several languages.

Article 15
Traceability

The  traceability  of  the  materials  and  articles  shall  be  established  at  all  stages  of
manufacture, processing and distribution.

Business  operators  shall  have  in  place  systems  and  procedures  to  allow  the
identification of the businesses from which and to which the materials or articles and,
where  appropriate,  substances  or  products  used  in  their  manufacture  have  been
supplied.  That  information  shall  be  made  available  to  the  competent  authorities  on
demand.

The materials and articles which are placed on the market in the Community shall be
adequately  labelled  or  identified  to  facilitate  their  traceability  through  relevant
documentation or information.

Article 16
Safeguard measures

When a Member State, as a result of new information or a reassessment of existing
information  made  since  one  of  the  specific  measures  referred  to  in  Article  5  was
adopted,  has  detailed  grounds  for  concluding  that  the  use  of  a  material  or  article
endangers human health, although it complies with the relevant specific measures, it
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 and give
reasons for the suspension or restriction.

The  Commission  shall  examine  as  soon  as  possible,  where  appropriate  after
obtaining  an  opinion  from  the  Authority,  within  the  Committee  referred  to  in
Article 21(1) the grounds adduced by the Member State referred to in paragraph 1 of
this Article and shall deliver its opinion without delay and take appropriate measures.

If the Commission considers that amendments to the relevant specific measures are
necessary in order to remedy the difficulties referred to in paragraph 1 and to ensure
the  protection  of  human  health,  those  amendments  shall  be  adopted  in  accordance
with the procedure referred to in Article 21(2).

The Member State referred to in paragraph 1 may retain the suspension or restriction
until the amendments referred to in paragraph 3 have been adopted.

1.

2.

3.

1.

2.

3.

4.

17

1.

2.

3.

1.

2.

3.

4.

5.

6.

Article 17
Public access

The application for authorisation and supplementary information from the applicant
and opinions from the Authority, excluding confidential information, shall be made
accessible to the public.

The  Authority  shall  apply  the  principles  of  Regulation  (EC)  No 1049/2001  of  the
European  Parliament  and  of  the  Council10  mutatis  mutandis  when  handling
applications for access to documents held by the Authority.

Member States shall handle applications for access to documents received under this
Regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.

Article 18
Confidentiality

The applicant may indicate which information submitted under Article 8(1) is to be
treated as confidential because its disclosure may significantly harm his competitive
position. Verifiable justification must be given in such cases.

Information relating to the following shall not be considered confidential:

(a)

the name and address of the applicant and the chemical name of the substance;

(b)

information of direct relevance to the assessment of the safety of the substance;

(c)

the analytical method or methods.

The  Commission  shall  determine,  after  consultation  with  the  applicant,  which
information  should  be  kept  confidential  and  shall  inform  the  applicant  and  the
Authority of its decision.

The  Authority  shall  supply  the  Commission  and  the  Member  States  with  all
information in its possession on request.

The  Commission,  the  Authority  and  the  Member  States  shall  take  the  necessary
measures  to  ensure  appropriate  confidentiality  of  the  information  received  by  them
under  this  Regulation,  except  for  information  which  must  be  made  public  if
circumstances so require in order to protect human health.

If  an  applicant  withdraws  or  has  withdrawn  an  application,  the  Authority,  the
Commission and the Member States shall respect the  confidentiality of commercial
and industrial information provided, including research and development information
as well as information on which the Commission and the applicant disagree as to its
confidentiality.

10

OJ L 145, 31.5.2001, p. 43

18

                                                
Article 19
Data protection

The information in the application submitted in accordance with Article 8(1) may be used for
the benefit of another applicant, provided that the substance is the same as the one for which
the  original  application  was  submitted,  including  the  degree  of  purity  and  the  nature  of
impurities,  and  that  the  other  applicant  has  agreed  with  the  original  applicant  that  such
information may be used.

Article 20
Amendments to Annexes I and II

Amendments to Annexes I and II shall be adopted in accordance with the procedure referred
to in Article 21(2).

1.

2.

1.

2.

Article 21
Committee

The Commission shall be assisted by the Standing Committee on the Food Chain and
Animal  Health  instituted  by  Article  58(1)  of  Regulation  (EC)  No  178/2002
(hereinafter referred to as “the Committee”).

reference 

this  paragraph,  Articles  5  and  7  of
Where 
Decision 1999/468/EC  shall  apply,  having  regard  to  the  provisions  of  Article 8
thereof.

is  made 

to 

The period laid down in Article 5 (6) of Decision 1999/468/EC shall be set at three
months.

Article 22
Inspection and control measures

Member  States  shall  ensure  that  inspections  and  other  control  measures,  as
appropriate, are carried out to ensure compliance with this Regulation.

Where necessary and on the request of the Commission, the Authority shall assist in
developing  technical  guidance  on  sampling  and  testing  to  facilitate  a  co-ordinated
approach for the implementation of paragraph 1.

Article 23
Reference laboratories

A  Community  reference  laboratory  for  materials  and  articles  intended  to  come  into  contact
with  food  and  a  list  of  national  reference  laboratories  shall  be  established  as  laid  down  in
Regulation (EC) No […] [of the European Parliament and of the Council on official feed and
food controls].

19

Article 24
Penalties

The Member States shall  lay down the  rules on  penalties  applicable  to  infringements  of  the
provisions  of  this  Regulation  and  shall  take  all  measures  necessary  to  ensure  that  they  are
implemented. The penalties provided for must be effective, proportionate and dissuasive. The
Member  States  shall  notify  those  provisions  to  the  Commission  by  [insert  date  six  months
after the date of publication of this Regulation] at the latest and shall notify it without delay of
any subsequent amendment affecting them.

Article 25
Repeals

Directives 89/109/EEC and 80/590/EEC are repealed.

References to the repealed Directives shall be construed as references to this Regulation and
shall be read in accordance with the correlation table in Annex III.

Article 26
Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.

Article 15 shall apply from [2 years after the adoption of the Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, […]

For the European Parliament
The President
[…]

For the Council
The President
[…]

20

ANNEX I

List of groups of materials and articles which may be covered by specific measures

Active and intelligent materials and articles

Adhesives

Ceramics

Cork

Elastomers and rubbers

Glass

Ion-exchange resins

Metals and alloys

Paper and board

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

(10)

Plastics

(11)

Printing inks

(12)

Regenerated cellulose

(13)

Textiles

(14)

Varnishes and coatings

(15) Waxes

(16) Wood

21

ANNEX II

Symbol

22

ANNEX III

CORRELATION TABLE

Directive 89/109/EEC

This Regulation

Article 1

-

Article 2

-

Article 3

-

-

-

-

-

-

Article 4

Article 6

-

-

-

Article 5

Article 7

-

-

-

-

Article 8

Article 9

Article 1

Article 2

Article 3

Article 4

Article 5

Article 6

Article 7

Article 8

Article 9

Article 10

Article 11

-

Article 12

Article 13

Article 14

Article 15

Article 16

-

Article 17

Article 18

Article 19

Article 20

-

Article 21

23

-

-

-

Article 10

Article 11

Article 12

Article 13

Annex I

Annex II

Annex III

Article 22

Article 23

Article 24

Article 25

-

-

Article 26

Annex I

-

Annex III

Directive 80/590/EEC

This Regulation

Annex

Annex II

24

PRELIMINARY ASSESSMENT STATEMENT

1.

PROBLEM IDENTIFICATION

Directive 89/109/EEC provided the basis for the assurance of a high level of protection of
human health and of consumers’ interests in relation to materials and articles intended to
come  into  contact  with  food  whilst  ensuring  the  effective  functioning  of  the  internal
market.

Technological progress  in  the  area  of  food packaging is though  rapid and intense. New
types  of  packaging  have  been  recently  developed.  The  so-called  “active”  food  contact
materials  and  articles  have  been  designed  to  maintain  or  improve  the  condition  of  the
food and prolong its shelf life. Other new packaging applications known as “intelligent”
food contact materials and articles are used to give information about the condition of the
food.  It  is  currently  unclear  if  these  types  of  packaging  are  covered  by  national  or
Community  legislation.  The  proposal  clarifies  that  these  two  types  of  food  contact
materials and articles are covered by the Regulation and sets basic rules for their use. It
also foresees the possibility of drafting specific implementing measures for them.

Directive 89/109/EEC already sets the procedures and criteria to be followed in drafting
and  adopting  the  implementing  measures  for  the  different  groups  of  materials  and
articles,  including  the  evaluation  of  substances  by  the  Scientific  Committee  on  Food
(SCF).  Nevertheless,  it  is  necessary,  for  reasons  of  transparency,  to  establish  more
detailed procedures for the safety assessment and authorisation of substances used for the
manufacture of food contact materials.

Food  contact  materials  and  articles  need  to  be  traceable  at  all  stages  of  manufacture,
processing  and  distribution.  It  is  therefore  necessary  to  establish  general  rules  of
traceability for food contact materials, in line with similar traceability provisions for food
and feed established in Article 18 of Regulation (EC) No 178/2002.

Some additional provisions of labelling are proposed to better inform the consumers and
the users of the food contact materials.

The  present  proposal  aims  at  modifying  Directive  89/109/EEC  to  take  into  account  the
issues  mentioned  above.  It  also  integrates  for  reasons  of  simplicity  the  symbol  which
should 
in
Directive 80/590/EEC.  The  proposed  Regulation  will  therefore  replace  and  repeal
Directives 89/109/EEC and 80/590/EEC.

contact  materials 

accompany 

determined 

articles 

food 

and 

2.

OBJECTIVE OF THE PROPOSAL

The overall policy objective in terms of expected impacts is to:

– 

secure  a  high  level  of  protection  of  human  health  and  the  interests  of  the
consumer,

25

– 

– 

– 

– 

– 

– 

ensure the free movement of materials and articles intended to come into contact
with food,

take  into  account  important  technological  developments  in  the  area  of  food
packaging,

ensure better traceability as well as labelling of materials and articles intended to
come into contact with food,

improve the transparency of the authorisation process by specifying the various
phases of the procedure,

give the possibility to the Commission to adopt for the implementing measures
not  only  directives,  but  also  decisions  and  regulations,  as  the  latter  are  more
appropriate for provisions, such as positive lists,

ensure better enforceability of the rules through the establishment of Community
and national Reference Laboratories.

The  provisions  on  active  and  intelligent  food  contact  materials  and  articles  are  general
and establish the regulatory status of these packaging applications in the Community to
the benefit of the concerned industry, the consumers and the Member States.

The additional labelling requirements will ensure a more informed use of the food contact
materials and articles by the purchaser and the final consumer.

Improving  traceability  of  food  contact  materials  will  be  beneficial  for  the  consumer  in
case of a problem, and will allow a more limited withdrawal of deficient products by the
companies.

3.

POLICY OPTIONS

The basic approach suggested to reach the above-mentioned objectives is to improve and
harmonise Community legislation on materials and articled intended to come into contact
with food by introducing the proposed rules.

In  terms  of  respecting  the  subsidiarity  and  proportionality  principles  the  Framework
Directive 89/109/EEC was adopted on the grounds that differences between national laws
of  the  Member  States  impended  the  free  movement  of  these  materials  and  articles.
Directive  89/109/EEC  approximated  those  laws  to  achieve  the  free  movement  of  food
contact  materials  and  articles  whilst  protecting  consumer’s  health  and  interests.  This
Directive  also  established  a  list  of  materials  and  articles  to  be  covered  by  specific
directives. This approach was successful and should be continued.

The adoption of a Regulation instead of a Directive is justified by the technical nature of
the  act  and  will  lead  to  the  direct  application  of  the  proposed  rules  throughout  the
Community.  This  is  important  in  the  perspective  of  an  enlarged  Community  that  will

26

soon  comprise  25  Member  States  and  that  will  certainly  benefit  from  homogenous  and
directly applicable rules throughout its territory.

4.

IMPACTS – POSITIVE AND NEGATIVE

All sizes of businesses related to the manufacture, processing and trade of materials and
articles  intended  to  come  into  contact  with  food  will  be  affected  by  the  proposed
provisions. The food industry is also concerned.

The new obligations implied by this proposal are the following:

Community  authorisation  for  the  substances  used  in  the  manufacture  of  food  contact
materials is already foreseen in Directive 89/109/EEC. Thus, no new obligations arise for
business from the provisions on the authorisation procedure.

The main new obligations will be:

General obligation for applicants:

To  send  the  application  for  the  authorisation  of  a  substance  to  the  national  competent
authority of a Member State, in first place.

To  inform  the  Authority  about  new  information  which  may  influence  the  evaluation  of
the safety in the use of an authorised substance.

General  obligations  for  business  operators  responsible  for  the  manufacture,  processing,
importation, or distribution of food contact materials:

To  label  all  materials  and  articles  that  are  intended  to  come  into  contact  with  food,
including  those  for  which  this  use  is  obvious  by  their  nature  and  which  were  so  far
excluded from this obligation by Directive 89/109/EEC.

To instruct on the permitted uses of active and intelligent materials and articles, in order
to  enable  the  users  of  those  materials  and  articles  to  comply  with  relevant  legislation
applicable to food.

General obligations for all business operators:

To  comply  with  the  conditions  of  use  and  restrictions  attached  to  the  authorisation  of
substances for manufacturing food contact materials.

To  have  in  place  systems  to  identify  the  suppliers  to  their  businesses  of  materials  and
articles  and  where  appropriate  the  substances  and  products  used  for  their  manufacture.
On  request,  they  should  be  able  to  make  this  information  available  to  the  competent
authorities.

To identify to whom their products have been supplied  and, upon request, to make this
information available to the competent authorities.

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To  adequately  label  or  identify  the  materials  and  articles  placed  on  the  market  in  the
Community to allow their traceability.

In terms of economic impact the following aspects could be identified:

Already the current system requires the evaluation of substances used for the manufacture
of  food  contact  materials  before  their  authorisation.  Hence,  the  proposal  will  not
introduce major changes in this respect.

The provisions on active  and  intelligent  materials  and  articles  are  general  and  establish
the regulatory status of these materials and articles in the Community to the benefit of the
concerned industry, the consumers and the Member States.

Most of the labelling requirements already exist in Directive 89/109/EEC, and therefore
should  not  have  a  major  economic  impact.  It  should  also  be  noted  that  this  Regulation
offers different options for labelling.

The  proposed  regulation  requires  traceability  of  all  food  contact  materials  and  articles.
Since this presupposes systems enabling the identification of the products, it will involve
some  cost  for  the  businesses  manufacturing,  processing  and  distributing  food  contact
materials.  It  should  be  noted,  however,  that  most  companies  have  already  established
procedures  for  traceability  as  part  of  the  requirements  of  modern  quality  management
systems, such as ISO 9000, Good Manufacturing Practices etc. In addition, withdrawal of
deficient products is more limited when these are traceable.

No social or environmental impacts are expected by this proposal.

5.

FOLLOW-UP

A  broad  consultation  has  been  carried  out  on  a  preliminary  draft  proposal  in  several
meetings  held  with  Member  States  and  interested  parties.  Some  specific  issues,  mainly
technical  such  as  traceability  and  “active”  materials  and  articles,  were  additionally
discussed within smaller consultation groups of experts. Most of the comments received
as result of the consultations have been taken into consideration in the framework of this
proposal.

The following professional and consumers’ organisations were constantly involved in the
discussions, which led to the present proposal:

– 

– 

– 

– 

– 

APME (Association of plastics manufacturers in Europe)

BEUC (The European consumers’ organisation)

BLIC (Liaison Office of the E.U. Rubber Industry)

CEFIC-FCA (European Chemical Industry Council-Food Contact Additives)

CEI Bois (European Confederation of Woodworking Industries)

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– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

CELiège (European Cork Confederation)

CEPE  (European  Council  of  the  Paint,  Printing  Ink  and  Artists'  Colours
Industry)

CEPI (Confederation of European Paper Industries)

CERAME-UNIE (Liaison office of the European ceramic industry)

CIAA (Confederation of the food and drink industries of the EU)

CIPCEL (International Rayon and Synthetic Fibres Committee)

CITPA (International Confederation of Paper and Board Converters)

EuPC (European plastics converters confederation)

EPFMA (European Plasticized Film Manufacturers Association)

ETS (European Tissue Symposium)

EURATEX (European Apparel and Textile Organisation)

EUROCOOP (European community of consumer cooperatives)

EWF (European Wax Federation)

FABRIMETAL / SEFEL (Metal Packaging Manufacturers Association)

FEVE (European Container Glass Federation)

FEICA (Association of European Adhesives Manufacturers)

FLEXIBLE  PACKAGING  EUROPE  (The  European  Forum  for  the  Flexible
Packaging Industry)

On  the  issue  of  active  and  intelligent  materials  and  articles,  the  European  consumers’
organisation  (BEUC)  raised  concerns  in  relation  to  correct  labelling  of  these  materials
and  articles.  They  also  stressed  the  need  for  provisions  to  rule  out  that  such  systems
mislead the consumers in relation to the quality or condition of the food. Their comments
were taken into account.

The  industry  was  concerned  about  the  traceability  provisions  on  which  a  broad
consultation  was  held.  A  “Food  Contact  Materials  Industry  Liaison  Committee”  was
created  by  the  concerned  industry  to  examine  the  proposed  provisions.  Finally  the
traceability  requirements  were  generally  accepted  by  the  different  industrial  sectors.  In
addition  the  Liaison  Committee  works  proactively  on  a  volunteer  basis  for  the
preparation of guidelines for the application of the traceability rules.

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An extended assessment on this proposal is not recommended as the proposal has already
been subject to extended  consultation with  Member States  and stakeholders. No further
consultation is planned.

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