No C 299/14 Official  Journal  of the European  Communities 18.12.  76 
in Article  33  (6)  and  (7)  might,  depending  on 
requirements,  be printed  on the containers  and  outer 
packages  of medicinal  products  or on the descriptive 
insert  which  it is compulsory  to pack  with  such 
products. 
This  is necessary  above  all where  one  is dealing  with 
medicinal  products  which  may  be administered  to a 
variety  of animals,  in which  case  waiting  periods  are 
liable  to differ  considerably. 
A provision  to this  effect  should,  therefore,  be added 
to Article  39. 
1.9. Article  41 
It is unfortunate  that  the proposal  does  not  contain 
any measure  to coordinate  (a) the  instructions  for 
using  the products  in question,  or (b) the conditions 
under  which  such  products  are supplied  to the public. 
This  situation  should  be  remedied  as soon  as 
possible. 
1.10.  Article  43 (2) 
The Committee  considers  that  15 years,  as proposed 
by the  Commission,  is too  long.  It would  be more 
realistic  to set a period  of 10 years. 2. Proposal  for  a Council  Directive  on  the 
approximation  of the  laws  of Member  States 
relating  to analytical,  pharmaco-toxicological  and 
clinical  standards  and  protocols  in respect  of the 
testing  of veterinary  medicinal  products 
2.1. Article  2 
The Committee  stresses  that  the  amendment 
procedure  proposed  here  is purely  administrative  in 
character  and  does  not  provide  for  the compulsory 
consultation  of experts. 
There  is a risk  of  'technical  progress'  being 
interpreted  too widely. 
This  difficult  concept  could  be  defined  by  the 
Standing  Committee  for Medicinal  Products  itself  in 
the course  of its work.  The  Committee  feels  that 
technical  progress  should  be assessed  in the light  of 
its direct  and  indirect  benefits  to public  health. 
The Standing  Committee  will  have  to discuss 
scientific  matters  which  will  have  an effect  on the 
authorization  of products  and  their  manufacture.  The 
Standing  Committee  should  therefore  engage  in close 
consultations  with  the  appropriate  trade  and 
professional  bodies. 
Done  at Brussels,  28 October  1976. 
The Chairman 
of the Economic  and  Social  Committee 
Basil  de FERRANTI 
Opinion  on the proposal  for a Council  Directive  on the harmonization  of provisions  laid 
down  by law,  regulation  or administrative  action  relating  to customs  debt 
The text  referred  to the  Committee  has  been  published  in Official  Journal  of the 
European  Communities  No  C 128  of 10 June  1976,  page  48. 
A. LEGAL  BASIS  FOR  THE  OPINION 
On 28 April  1976,  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. 
18. 12. 76 Official  Journal  of the European  Communities No C 299/15 
B. OPINION  OF THE  ECONOMIC  AND  SOCIAL  COMMITTEE 
The Economic  and  Social  Committee  prepared  its opinion  on the above  matter  at its 
142nd  plenary  session,  held  in Brussels  on 27 and  28 October  1976. 
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  made  by the Council  of 
the European  Communities  on 28 April  1976  for an 
opinion, 
Having  regard  to the decision  taken  by its bureau  on 
27 April  1976,  instructing  the  Section  for  Industry, 
Commerce,  Crafts  and  Services  to prepare  the 
Committee's  work  on the matter, 
Having  regard  to the opinion  adopted  by the Section 
for Industry,  Commerce,  Crafts  and  Services  on 6 
October  1976, 
Having  regard  to the  oral  report  made  by the 
rapporteur,  Mr.  Marvier, 
Having  regard  to the discussions  at its 142nd  plenary 
session  held  on 27 and  28 October  1976  (meeting  of 
28 October), 
HAS  ADOPTED  THE  FOLLOWING  OPINION 
by a unanimous  vote: 
The Committee  approves  the proposed  Directive,  but 
would  make  the following  comments. 
1. General  comments 
1.1. The  Committee  considers  it normal  for  the 
Commission  to try  and  establish  a Community 
doctrine  on questions  of principle  such  as customs 
debt,  after  having  first  sought  to align  customs 
systems  and  procedures. 
1.2. While  it may  seem  surprising  that  a Directive 
has been  chosen  as the legal  instrument  in this  case,  it 
should  be noted  that  the proposal  contains  a number 
of specific  provisions  that  in fact  give  it the nature  of 
a Regulation.  Furthermore,  the choice  of a Directive 
seems  appropriate  in that  the  text  of the  proposal 
cannot  — and  for  good  reason  — regulate  the 
controversies  arising  out  of the  principles  it lays down  because  systems  of penalties  are  still  totally 
national  in character. 
1.3 The  proposed  Directive  merely  defines  the 
extent  of the  liability  vis-a-vis  the  authorities  of a 
person  liable  to pay  duties  and  the moment  when  this 
liability  comes  into  effect,  without  laying  down  who 
is liable  to pay  duties.  It is therefore  only  a small  but 
important  step  forward  along  the road  towards  a full 
Community  customs  system  covering  not  only  rates 
of duty  and  procedures  but also  the principles  behind 
such  a system  and  the  consequences  of applying 
them. 
1.4 Finally,  one  may  say  that  it would  be of the 
greatest  interest  and  avoid  all kinds  of difficulties  if 
identical  rules  were  drawn  up rapidly  for defining  the 
fiscal  debt  on goods  and,  in particular,  VAT,  because 
distortions  between  rules  on customs  duties  and  rules 
on VAT  charged  on the  same  consignments  are  a 
source  of difficulties  for both  businessmen  and  the 
authorities. 
2. Specific  comments 
2.1. Article  1 (2) (d) 
2.1.1.  This  defines  entry  in the  accounts  as 'the 
official  act by which  the amount  of the ... duties  to 
be recovered  ... is duly  determined'.  Now,  liability  for 
payment  of duties  dates  from  when  the  said  duities 
are entered  in the  accounts  (Article  7). Since  the 
procedures  of the  official  act referred  to vary  from 
one country  to another,  this  definition  is tantamount 
to saying  that  the date  of entry  in the accounts  also 
varies  from  country  to country. 
2.2. Article  3 (d) 
2.2.1.  The  use  of goods  for  purposes  other  than 
those  for  which  total  or partial  relief  from  import 
duties  was  provided  should  be the only  criterion  used 
for establishing  the  time  of creation  of a customs 
debt.  The  two  subparagraphs  of Article  3 (d) could 
therefore  be combined  and  simplified. 
No C 299/16 Official  Journal  of the European  Communities 18.12.  76 
2.3. Article  4 
2.3.1.  The  reference  to 'unforeseen  circumstances 
or force  majeure'  at the  end  of this  Article  does  not 
strictly  cover  the case  of accidents.  Now,  more  often 
than  not,  the destruction  of duty-free  goods  is due  to 
accidents  en route.  It would  be a good  idea  to 
expressly  mention  accidents  (see,  for  instance, 
Article  41 of the  revised  TIR  Convention,  Geneva, 
November  1975,  which  in a similar  case  referred  to 
accidents  as an exonerating  circumstance). 
2.4. Article  7 
2.4.1.  Bearing  in mind  what  has  been  said  on 
Article  1 (definition  of entry  in the accounts),  it must 
be clear  that  this  Article  refers  to  national 
procedures.  Now  the  wording  of this  Article,  which 
in fact  refers  people  to the  Directive  on deferred 
payment,  could  lead  to the  authorities  having  to 
grant  time  limits  for payment  on a case-by-case  basis 
to businesses  using  consolidated  procedures  (also 
known  as  simplified  or 'domiciled'  procedures). 
These  procedures  give  satisfaction  to both  businessmen 
and the  authorities  and  they  should  therefore  be kept.  The  following  could  be inserted  at the beginning 
of Article  7: 
'Without  prejudice  to the  special  provisions 
applicable  to  consolidated  or  simplified 
procedures  or to the time  limits  for payment.  ..' 
2.5. Article  8 
2.5.1.  Paragraph  1 (b) 
2.5.1.1.  Once  again,  settlement  by  prescription 
refers  to national  provisions. 
2.5.2.  Paragraph  2 (a) (iii) 
2.5.2.1.  The  same  applies  as  for  Article  4. 
Reference  should  be made  to accidents. 
2.5.3.  Paragraph  2 (b) (i) 
2.5.3.1.  This  should  include  rules  corresponding  to 
those  in paragraph  2 (a),  to cover  withdrawal  of a 
declaration  by the declarant  upon  authorization. 
Done  at Brussels,  28 October  1976. 
The Chairman 
of the Economic  and  Social  Committee 
Basil  de FERRANTI 
Opinion  on the  proposal  for  a Council  Directive  on the  limitation  of noise  emission 
from  subsonic  aircraft 
The text  referred  to the  Committee  has  been  published  in Official  Journal  of the 
European  Communities  No  C 126  of 9 June  1976,  page  2. 
A. LEGAL  BASIS  FOR  THE  OPINION 
On 6 May  1976,  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.