11.5.  77 Official  Journal  of the European  Communities No C 114/13 
Opinion  on the proposal  for a Council  Directive  on the approximation  of the laws  of 
the Member  States  relating  to materials  and  articles  containing  vinyl  chloride  monomer 
and intended  to come  into  contact  with  foodstuffs 
The text  referred  to the  Committee  has  been  published  in Official  Journal  of the 
European  Communities  No  C 16 of 21 January  1977,  page  8. 
A. LEGAL  BASIS  FOR  THE  OPINION 
On 11 January  1977  the Council  referred  the abovementioned  proposal  to the Economic 
and Social  Committee  in accordance  with  Article  100  of the  Treaty  establishing  the 
European  Economic  Community. 
B. OPINION  OF  THE  ECONOMIC  AND  SOCIAL  COMMITTEE 
The Economic  and  Social  Committee  prepared  its opinion  on the above  matter  at its 
147th  plenary  session,  held  in Brussels  on 30 and  31 March  1977. 
The full  text  of the opinion  is as follows: 
THE  ECONOMIC  AND  SOCIAL  COMMITTEE, 
Having  regard  to the Treaty  establishing  the European 
Economic  Community  and,  in particular  Article  100 
thereof, 
Having  regard  to the request  for an opinion  made  by 
the Council  of the  European  Communities  on 
11 January  1977, 
Having  regard  to the  Decision  taken  by its Bureau 
on 25  January  1977,  instructing  the  Section  for 
Protection  of the  Environment,  Public  Health  and 
Consumer  Affairs  to draw  up an opinion  and  a 
report, 
Having  regard  to the  opinion  issued  by the Section 
for Protection  of the  Environment,  Public  Health 
and Consumer  Affairs  on 8 March  1977, 
Having  regard  to the  report  submitted  by  the 
rapporteur,  Mr de Grave, 
Having  regard  to the discussions  at its 147th  plenary 
session  held  on 30 and  31 March  1977  (meeting  of 
30 March), 
HAS  ADOPTED  THE  FOLLOWING  OPINION 
by a majority,  there  being  one  vote  against  and  four 
abstentions: 
The Committee  approves  the proposal  subject  to the 
comments  set out below: 1. General  comments 
1.1. The  Committee  notes  that  this  proposal  has 
been  made  necessary  by the  fact  that  is has  been 
possible  to bring  materials  on to the market  without 
all the  effects  of vinyl  chloride  on health  being 
adequately  known.  Although  rules  based  on positive 
lists will  not  make  it possible  to eliminate  all risks 
of this  nature,  the Committee  thinks  it is right  that 
the framework  Directive  on the  approximation  of 
the laws  of the Member  States  relating  to materials 
and articles  intended  to come  into  contact  with 
foodstuffs  (1), as well  as the  preliminary  draft 
Directive  on plastics,  should  provide  for such  lists. 
1.2. The  Committee  thinks  that  the  preparatory 
work  on a Directive  on plastic  materials  and  articles 
in contact  with  foodstuffs  — a Directive  to be based 
on the principle  of sufficiently  rigorous  'positive  lists' 
— should  be speeded  up.  It would  ask  the  Com-
mission  to treat  this  question  as a matter  of priority. 
1.3. In  the meantime,  the large  number  of materials 
on the market  has forced  the Commission  to propose 
measures  now  which  are still  based  on the 'negative 
list' philosophy,  i.e. outright  bans  or restrictions  on 
products  which  have  earlier  been  found  to be 
dangerous  but  which  are  still  on the  market.  The 
Committee  would  point  out  in this  respect  that 
current  scientific  work  on other  monomers  used  in 
the plastics  industry  seems  to suggest  that  similar 
problems  may  arise  with  regard  to other  products 
whose  harmlessness  has  not  been  proven. 
Precautionary  measures  must  therefore  be taken  at 
Community  level  without  waiting  until  all scientific 
work  has  been  completed.  First  and  foremost,  the 
Committee  would  ask  the  Commission  to seek  the 
opinion  of the  Scientific  Committee  for  Foodstuffs 
about  the other  monomers  most  generally  used. 
(») OJ No L 340,  9. 12. 1976. 
No C 114/14 Official  Journal  of the  European  Communities 11.5.  77 
1.4. The  Commission's  aim  is to have  the  most 
rigorous  of the measures  already  adopted  in a number 
of Member  States  made  applicable  throughout  the 
Community.  In this  respect  it is regrettable  that 
Community  law  allows  the  Commission  to act only 
on the  basis  of Article  100  (or  on the  basis  of 
framework  Directives  issued  pursuant  thereto).  A 
Commission  initiative  is therefore  determined  not 
by a failure  of Member  States  to act but  by the prior 
existence  of at least  one  national  provision  or the 
notification  of such  a provision.  The  length  of time 
which  elapses  before  the presentation  of a Directive 
and before  its entry  into  force  is likewise  to be 
deplored. 
1.5. The  Committee  notes  that  the  proposal  does 
not cover  PVC  piping  for drinking  water,  mentioned 
explicitly  by the Scientific  Committee,  the  packaging 
of pharmaceutical  specialities,  prostheses,  medical 
equipment,  the packaging  of cosmetic  products,  floor 
and wall  coverings,  car seats,  etc.  To reduce  hazards 
resulting  from  contact  with  vinyl  chloride,  the 
Commission  needs  to get  down  straight  away  to 
exploring  all sources  of exposure  and  to preparing 
a general  programme  in this  area. 
1.6. The  Committee  notes  that  migration  is to be 
reduced  under  the  new  Directive  but  not  entirely 
eliminated.  It realizes  that  it is not  easy  to dispense 
with  products  that  have  rapidly  come  into  general 
use at the  expense  of other  packaging  materials. 
Nevertheless,  the  Committee  feels  that  exposure  to 
hazards  must  be limited  as far as possible  and  that 
consideration  should  be given  to other  complementary 
measures,  namely: 
— recourse  to,  or  promotion  of,  other  plastics 
(including  compounds)  or non-plastic  materials  — 
or at the  very  least  freedom  of choice  for 
consumers, 
— use  of a film  to prevent  migration, 
— restrictions  on certain  uses  and  a temporary  ban 
on new  uses. 
It would  seem  that  the  degree  of migration  is 
determined  less  by the  nature  of the  liquid  than  by 
the duration  of its  contact  with  the  packaging. 
Therefore,  the  Committee  wonders  whether  the  use 
of PVC  packaging  should  not  be confined  to food-
stuffs  that  do not  keep  a long  time,  and  whether 
plastic  compounds  or other  materials  should  not  be 
prescribed  for other  foodstuffs. 
1.7. The  Committee  is aware  of the  fact  that  each 
separate  packaging  must  be assessed  from  various 
angles: 
— toxicity  of the  constituents, 
— hygiene, — strength  and  ease  of use, 
— manufacturing  cost, 
— problems  of disposal  and  cost  of disposal  and 
suitability  for  reutilization  or recycling, 
— raw  material  supplies'  policy,  etc. 
The Committee  asks  the  Commission  to examine 
these  questions  as a whole,  not  just  in isolation. 
1.8. The  Committee  accepts  the  proposed  levels, 
which  are  a function  of the  state  of the  art  and 
analytical  methods;  it considers  these  levels,  however, 
to be a strictly  temporary  precautionary  measure  to 
be reviewed  later  in a wider  context  and  in the  light 
of new  scientific  and  technological  knowledge. 
Given  the  present  state  of scientific  knowledge,  the 
Committee  cannot,  however,  accept  the  principle  of 
a tolerable  level  for  a carcinogenic  substance.  The 
existence  of a 'no-effect  level'  has  never  been  proved. 
1.9. The  Committee  wonders  how  the  'polluter-
pays'  principle  can  be implemented  in the  event  of 
harm.  The  question  of  how  liability  is to be 
determined  has  not  been  settled.  The  same  applies 
to proof  of a causal  link  between  the  very  many 
different  forms  and  origins  of exposure  to vinyl 
chloride  on the  one  hand  and  possible  harm  on the 
other.  With  some  exposed  workers  the latency  period 
between  initial  exposure  to vinyl  chloride  and  the 
manifestation  of harmful  consequences  has been  more 
than  20 or even  30 years.  The  Committee  notes  that 
this question  of liability  still  remains  unresolved  and 
that,  mainly  because  of trade,  national  frontiers  may 
re-emerge. 
1.10.  As  long  as risks  continue,  the general  public 
must  be kept  properly  informed  by the  Community 
so that  consumers  can  reduce  their  exposure.  The 
Commission  should  also  give  wide  publicity  to the 
findings  of scientific  research  so as to prevent  these 
risks  from  being  underestimated  or overestimated. 
2. Specific  comments 
2.1. Article  4 
2.1.1.  The  Committee  is of the  view  that  Annex  1 
cannot  be  amended  without  first  consulting  the 
interest  groups  concerned. 
2.1.2.  The  Committee  takes  note  of the  fact  that 
the Commission  will  consult  the Advisory  Committee 
on Foodstuffs  before  adopting  any  amendments  to 
Annex  1. 
11.5.  77 Official  Journal  of the European  Communities No C 114/15 
2.2. Article  6 
2.2.1.  There  should  be a third  paragraph  stipulating 
that the  Directive  is to be applicable  for one  year 
only,  unless  extended. 
2.2.2.  The  Committee  also  urges  that  everything 
be done  to ensure  that  the  Directive  becomes 
operative  before  1 July  1978. 
2.3. Annex  I 
2.3.1.  The  Committee  finds  that,  except  where 
packages  are  sold  empty  to consumers,  two  limits 
will have  to be  complied  with  simultaneously, 
namely: 
— a limit  on the  migration  of the  monomer  into 
foodstuffs.  The  level  selected  is virtually  the same 
as the limit  of technical  detection, 
Done  at Brussels,  30 March  1977. — a limit  on the  concentration  of the  monomer  in 
the packaging.  This  limit  is about  the same  as the 
technical  limit  in manufacturing.  (It is raised 
from  1 to 5 ppm  in the case  of copolymers  not 
intended  for packaging  for liquids). 
2.3.2.  The  coexistence  of  these  two  limits 
constitutes  a safeguard  for the consumer.  The  second 
limit  offers  a good  many  firms  in the food  industry 
some  guarantee.  The  first,  however,  is indispensable, 
especially  for the checking  of imports. 
2.4. Annex  II, point  4.1. 
2.4.1.  0-1  mg should  be replaced  by 0-1 g. 
2.4.2.  The  Committee  requests  that  more 
information  be given  about  how  vinyl  chloride 
solution  is to be kept.  The  statement  that  VC 
solution  'will  keep  for  a long  time  if stored  in a 
refrigerator'  is debatable  as it stands. 
The Chairman 
of the Economic  and  Social  Committee 
Basil  de FERRANTI 
ANNEX 
to the  opinion  of the Economic  and  Social  Committee 
The following  amendment  was  rejected  during  discussions: 
Insert  a new  paragraph  in front  of 2.3.1.: 
'In view  of the  Section's  comments  under  1.8  the  permitted  quantities  laid  down  in 
Annex  I must  be radically  revised.  It must  be ensured  that  no vinyl  chloride  monomer  is 
present  or, at least,  that  the limit  is reduced  to almost  zero'. 
Reasons 
By making  this  addition,  it is possible  to bring  the Commission's  proposal  into  agreement  with 
the basic  line  taken  in the Section's  opinion. 
Voting: 
For: 1.3, against:  29, abstentions:  19.