REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT - Cooperation between administrations for enforcement of internal market law - a progress report
Date: 1996-01-29
Institutions: European Commission
Subjects: EU legal system, administrative cooperation, application of EU law, exchange of information, single market

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels,  29.01.1996 
COM(96) 20 final 

REPORT  FROM THE COMMISSION  TO THE COUNCIL 
AND THE EUROPEAN  PARLIAMENT 

Cooperation  between  administrations 

for  enforcement  of  internal  market  law 

-  a progress  report -

Contents 

- 

/)  _ 

I. 

II. 

III. 

IV. 

Introduction 

Notification  of  contact  points 

Table  1: Notifications  of  contact  points  for  each area, by  Member  State 

Programme  of  discussions 

Improvements  to  existing  arrangements 

Annex  Enforcement  cooperation  in  specific  areas  of  Internal  Market  legislation 

Table 2:  Karolus  exchanges  ranked  by priority  area 

1  o^ 

2 

3 

4 

6 

8 
52 

I  - Introduction 

-1  -CL  -

1. 
This  report  provides  a  survey  of  progress  made  to  ensure  that  the  enforcement  of 
Community  law on the  internal market was more consistent  by promoting cooperation  and mutual 
assistance  between  administrations  in the  different  Member  States.  This  is  an  objective  which 
responds  to  needs  expressed  by  business,  consumers,  Member  States'  governments  and  EC 
institutions.  It was announced in the Commission's Strategic Programme for the Internal Market1. 

The  Commission  set  out  a  framework  for  enforcement  cooperation  in  its  Communication  of 
16 February  1994  on  the  development  of  administrative  cooperation  in  the  implementation  and 
enforcement of Community legislation in the internal market2. The Council consequently adopted a 
Resolution3  on  16  June  1994  on  the  same  topic.  The  Economic  and  Social  Committee  also 
emphasized  the  same  point4  and  most  recently  the  French  Council  Presidency  made  it  a  major 
focus,  linking  the  question  of  enforcement  especially  with  the  levels  of  penalties  for  non 
compliance  with  Community  rules.  Following  the  Commission's  communication  on  the  role  of 
internal  market  legislation5,  the  Council  adopted  a 
penalties  in  implementing  Community 
Resolution  on  29 June  1995,  setting  out  a  common  approach  to  this  issue6.  This  Resolution 
stressed  that  "... administrative  cooperation  must  be  strengthened,  where  necessary,  in  those 
sectors  where  it  is  under-developed  and  must  in any  event  satisfy  the  requirements  of  effective 
uniform implementation of Community rules". 

The  Council resolution of  16 June  1994  had called, among others, for three  specific actions 

2. 
in this regard: 

i) 

ii) 

the Member States were called upon to notify to the Commission by 31 December  1994 
a  list  of  contact  points  for  enforcement  purposes  in each  of  eighteen  priority  areas  of 
Internal  Market  legislation,  together  with  essential  information  on  their  enforcement 
structures for these areas; 

the  Commission  was  called  upon  to  pursue  the  programme  of  discussions  with  the 
Member  States  it was already conducting in sectoral committees and working groups to 
find out what  kind of cooperation was  required  in each  area  of legislation  considered a 
priority; 

iii)  the  Commission  was  called  upon,  on  the  basis  of  these  discussions,  to  propose 
improvements  to existing  arrangements,  including any extensions  to  support  measures 
for  administrative  cooperation,  such  as  seminars,  training  and  exchange  programmes 
for  enforcement  officials  and  the  publication  of  interpretative  guides.  This  was  also to 
include, where necessary, adjustments to legislation. 

.„ 

The following chapters report on progress under each of these headings. 

1 

2 

3 

4 

5 

6 

Commission  communication  to  the  Council  of  22  December  1 9 93  "Making  the  most  of  the  Internal  M a r k e t" 
Programme,  (COM(93)  6 32  final) 

:  Strategic 

COM(94)  29  final  of  1 6 . 2 . 1 9 94 

Council  Resolution  of  16  June  1 9 94  on 
enforcement  of  Community  legislation  in  the  internal  market,  OJ  C  1 7 9,  1 . 7 . 1 9 9 4,  p.  1 

the  development  of  administrative  cooperation 

in 

the 

implementation  and 

Economic  and  Social  Committee  Opinion  on  the  annual  report  on  the 
3 1 . 1 2 . 1 9 9 4,  p. 1 4,  in  recommendation  2  :  "implementation  and  control  ....  must  be  supervised  rigorously." 

functioning  of 

the 

internal  market,  OJ  C  3 9 3, 

C o m m u n i c a t i on  f r om  the  Commission  to  the  Council  and  the  European  Parliament  on  the  role  of  penalties  in  implementing 
C o m m u n i ty  internal  market  legislation,  COM(95)  162  final,  3 . 5 . 1 9 95 

Council  Resolution  of  29  June  1 9 95  on  the  role  of  penalties 
OJ  C  1 8 8,  2 2 . 7 . 1 9 9 5,  p.1 

in  implementing  Community 

internal  market 

legislation, 

- 2-

II  -  Notification  of  contact  points 

3. 
All Member  States  have now notified contact  points for  most of the priority  areas  identified  in 
the June  1994 Resolution. Some legislation already  included requirements for enforcement  contact 
points  to  be  notified  to  the  Commission,  for  example  Directive  93/99  on  the  control  of  foodstuffs 
and  Directive  89/48  on the  recognition  of diplomas. The  Commission  did  not  set  out to  replace  or 
duplicate  these  pre-existing  systems,  but  rather  to  confirm  that  they  were  functioning  correctly. 
The  purpose  of  such  contact  points  is to  place  officials  responsible  for  enforcing  internal  market 
legislation 
is  decentralized, 
communications  may  have  to  pass  through  a  central  coordinator  at  national  level.  However,  it  is 
noteworthy  that  notifications  have  been  made  for  some  regional  authorities,  such  as  individual 
German Lander. 

touch  with  one  another.  Where  control  or  surveillance 

in 

The  data  concerning  contact  points  generally  includes  the  designation  of  the  administrative 
4. 
unit  directly  involved  in  the  Member  State's  administration  (or  the  Commission)  and  a  direct  fax 
number.  Most  include  a  named  person  and  give  his  or  her  direct  telephone  number.  Some 
notifications  also  include  the  languages  which  the  contact  points  can  speak  or  read  and  their 
electronic  mail  (E-mail)  addresses.  In  some  cases  an  official  in  the  Member  State's  Permanent 
Representation  in Brussels  is given as a contact  point. All the contact  points  have  been  placed on 
a database, from which print-outs or information diskettes are distributed to those concerned. 

Table  1 indicates,  for  each  area  of  legislation,  which  Member  States  had  notified  contact  points 
when  this  communication  was  finalized  (27.11.95).  Where  there  are  sub-areas  within  an  area  of 
legislation, the table  indicates whether  full or  partial  notification  was  received  of  contact  points  for 
each  sub-area.  The  latter  case  is  indicated  by  a  letter  "P"  in  a  shaded  square.  A  black  square 
shows  that  no  notification  has  been  received. The  database  also  contains  data  on  contact  points 
for three areas which were notified to the Commission separately from this exercise, those of dual-
use  goods,  drug  precursors  and  recognition  of  diplomas  (listed  under  freedom  of  establishment); 
notifications for all three areas are complete for all Member States. 

The table  shows  that  in this  exercise  only  one  Member  State  has failed to  notify  contact  points  in 
more  than  one  or  two  areas.  Greece  has  not  yet  notified  contact  points  in  four  of  the  eighteen 
areas listed in the Council Resolution, and has only made partial notifications  in others. 

National  contact  points  for  broadcasting  have  not  yet  been  notified  in  two  Member  States.  The 
Commission  especially  requested  a  detailed  breakdown  of  contact  points  in  the  transport  area, 
and  only  seven  of  the  Member  States  have  made  this  full  notification  (Spain  notified  a  single 
contact  point for the whole transport field). In this table only two of the areas from the Annex to the 
Council  Resolution  of  16  June  1994  are  shown  with  their  breakdown  into  sub-areas,  those  of 
"foodstuffs,  animal  and  plant  health  and  veterinary  medicines"  and  "taxation".  The  sub-area  with 
the least notifications  is direct taxation. 

5.  Many of the contact  points notified appear to be officials  principally  concerned with  legislation 
or  policy  rather  than  control  of  marketing  of  a product  or service  or the  enforcement  of  legislation 
on the ground. The Commission  considers that  links  between  policy  coordinators  and their  market 
control colleagues will need to be ensured for information on enforcement to pass quickly from  one 
Member  State to  another.  Similarly,  some  of the  areas  referred to  in the  Council  Resolution  of  16 
June  1994  are  very  broad.  A  single  contact  point  on  technical  harmonization  directives,  for 
instance,  would  need  to  cover  several  distinct  areas  of  legislation,  from  medicines  to  toys.  The 
extent  to  which  the  contact  points  notified  are  actually  used  will  give  an  indication  of  how 
appropriate they are. 

Table  1 - Notifications  of  contact  points  for  each area, bv  Member  State  as at  27.11.95 

MEMBER  STATE: 

B  DK 

D 

1.  Technical harmonization: directives 

to remove barriers to trade 

F 

IRL 

1 

L 

NL 

A 

P 

FIN 

S 

UK 

E 
EL 
1111 

• 

III 

mm 

I 

l il • 

l l ll • 

N 

ill! 

•N 

mm 

2.  Public  procurement 

3.  Firearms 

4.  Dual use goods 

5.  General Product Safety  Directive 

6.  Telecommunications 

7.  Foodstuffs, animal and plant health, 

veterinary  medicines 

a) foodstuffs 

b) veterinary  controls 

c) phytosanitary  controls 

d) veterinary  medicines 

8.  Notification of technical regulations -

Directive 83/189 

9.  Customs and Excise 

10.  Taxation 

a) direct taxation 

b) indirect taxation 

11.  Drug  precursors 

12.  Cultural goods 

13.  Right of establishment 

14.  Company  law 

15.  Insurance, banking, securities 

16.  Intellectual property 

17.  Broadcasting 

18.  Transport 

• 

P 

P 

l 

III 

11111 

1111 

111! 

(P  =  partial  notification  for  area;  black  square  =  not  notified  yet;  all others  notified) 

It  is  important  to  mention  that  the  Commission  has  undertaken  to  apply  the  principles  of  data 
protection  laid  down  by  Directive  95/46/EC7.  Consequently  access  to  the  personal  information 
provided will  be strictly  limited to those  Commission  services  and those  parts  of  Member  States' 
administrations  which  are  directly  involved  in the  particular  enforcement  co-operation  exercise in 
question. Contact persons will be provided with full information about this and about the purposes 
for which their  details  are  used. They  will  be  informed  and their  consent  obtained  in advance of 
their data being distributed to any other specific bodies. 

Little  information  on  enforcement  structures  and  procedures  has  been  received,  although  the 
Council Resolution called upon Member States to supply such information. 

6. 
Looking to the future, other steps could also be taken by the Member  States to ensure that 
the  system  of  contact  points  now  in  place  can  be  used  more  effectively,  for  instance  by 
establishing contact  points to give private individuals and business (especially  small and medium-

Directive  95/46/EC  of  the  European  Parliament  and of  the  Council  of  24  October  1995  on the  protection  of  individuals  with 
regard to  the  processing  of  personal  data  and on the  free  movement  of  such data, OJ  L 2 8 1,  23.11.95  p.  31 

-4 

sized  enterprises  -  SMEs)  an  interface  with  the  authorities  of  each  Member  State,  in  order  to 
enable them to draw  attention to  barriers to free  movement  or trade.  Examples  are the  UK  Single 
Market  Compliance  Unit  and the  Danish  Trade  Barriers  Committee. A  recent  Council  Resolution8 
called  for  the  establishment  of  such  contact  points  for  enterprises,  in  particular  SMEs,  and 
another9  invited  the  Commission  to  send  the  Council  a  report  of  their  findings.  So  far  very  few 
Member States have implemented this political commitment. 

Member  States  will  not  be  seen  to  be  doing  their  best  to  eliminate  barriers  to  trade  and  the  free 
movement  of persons  as long as such contact  points  are not  made available to  address  problems 
in the internal market with as little bureaucracy  as possible. 

Ill - Programme of  discussions 

7. 
Discussions  on enforcement  cooperation were held during  1994 and  1995 in all the  eighteen 
areas  of  legislation  listed in the Annex  to the  Council  Resolution  of  16 June  1994 (see the Annex 
to this Communication), except for broadcasting. 

The objectives of the discussions have been fourfold: 

• 

• 

to identify the need for mutual assistance  in each sector or area of activities  (information 
requirements and the means of satisfying them); 

to determine  how far these needs have already been satisfied; 

•  where  necessary,  to  encourage  participants  in  the  discussions  to  introduce  or  extend 

enforcement  cooperation; 

•  where this  has  not  been  done  already,  to  compile  lists  of  contact  points  in the  Member 

States. 

A detailed examination of enforcement  cooperation in these sectors is given in the Annex. 

These  issues  have been raised in meetings of committees  and working  groups  organized 
8. 
by  the  Commission  and  involving  representatives  of  the  Member  States'  administrations  with 
responsibilities  in the  area  concerned.  In parallel, the Advisory  Committee  for  Coordination  in the 
Internal  Market  Field  (IMAC)10  has  been  kept  informed  of  progress,  particularly  on  the  contact 
point issue. 

The specialist committees or other bodies consulted fall into three categories: 

• 

• 

those  whose  sole  purpose  is  to  ensure  enforcement  cooperation,  (e.g.,  the  Standing 
Committee for Administrative Cooperation in the field of Indirect Taxation - SCAC) 

those  with  a  regulatory  or  advisory  role,  but  which  spend  part  of  their  time  on 
enforcement cooperation  (e.g., the Standing Veterinary  Committee)  and 

8 

9 

Council  Resolution  of  10 October  1994  on giving  full  scope to  the  dynamism  and  innovatory  potential  of  small  and  medium-
sized  enterprises,  including  the  craft  sector  and  micro-enterprises,  in  a competitive  economy,  OJ  C 294,  22.10.1994  -  last 
dash of  section  III,  p.7 

Council  Resolution  of  21  November  1994  on  the  strengthening  of  the  competitiveness  of  Community  industry,  OJ  C  343, 
6.12.1994  - paragraph  III.4.,  p.4 

1^  Commission  Decision  93/72/EEC  of  23  December  1992  on the  setting-up  of  an Advisory  Committee  for  coordination  in  the 

Internal  Market  field,  OJ  L 26,  3.2.1993,  p.  18 

• 

those which deal with policy issues rather than enforcement,  but which may  provisionally 
act  as  a channel  of  information  between  national  enforcement  authorities,  and  between 
them and the Commission  (e.g., the Advisory Committee for Public  Procurement). 

The Commission  is concerned that the cooperation described in the Annex, which in a few areas is 
only indirectly  connected with enforcement  of the rules in the field, should become  more centred in 
enforcement  issues. 

One  means  of  communication  which  is  already  used  in several  areas  was  given  special  attention 
in  the  discussions,  namely  electronic  data  networks,  and  the  lessons  learnt  from  those  which 
already exist should be applied to future projects. 

IMAC has been kept informed and was consulted about this progress  report. 

9. 
A  number  of  areas  not  mentioned  in the  Council  Resolution  of  16 June  1994 are  covered  in 
the Annex to this  report,  namely  social policy,  public administration  and competition  policy, as they 
underpin  the  operation  of the  Single  Market.  There  are  also final  sections  on Telematic  Networks 
between Administrations  and the Karolus exchange programme11. 

10.  While  needs  vary  according  to  the  area  of  Community  activity  in  question,  some  common 
points can be made on the discussions so far. 

Firstly,  the  extent  of  enforcement  cooperation  in  place  varies  considerably  between  the  priority 
areas of Community  legislation. These may be broadly divided into four categories: 

1. 

2. 

3. 

4. 

those where cooperation between administrations  is already strong: 
these  include  customs,  VAT,  veterinary  and  plant  health  controls,  banking,  insur 
ance  and  securities  (and,  in  addition  to  the  priority  sectors,  social  security  for 
migrant workers); 

those  where  new  arrangements  for  enforcement  cooperation  have  recently  been 
introduced and where surveillance of these systems is necessary: 
these  include pharmaceutical  products, foodstuffs  and dual use goods; 

those where cooperation exists, but to a variable extent: 
these  include  firearms,  cultural  goods,  product  safety,  legal  metrology,  transport 
and telecommunications. 

those  where  the  Commission  believes  that  cooperation  between  administrations  for  the 
enforcement  of Community  legislation still needs to be firmly established: 
these  include  some  of  the  "New  Approach"  directives  (especially  those  which  have 
very  recently  entered  into  force),  public  procurement,  the  "Television  without 
frontiers" directive and the Data Protection  Directive. 

11.  The  needs for further  cooperation  are also very different  from  area to area. They  range from 
exchange  of  specific  numerical  information  (as  in taxation, customs  and statistical  cooperation)  to 
a  need to  understand  procedures  for  placing  products  or services  on the  market  in other  Member 
States. 

In  technical  areas,  such  as  medicinal  products  or  terminal  equipment,  information  needs  to  be 
exchanged on testing techniques  and the characteristics  of the products or services in question. 

11 

Council  Decision  92/481/EEC  of  22  September  1 9 92  on  the  adoption  of  an  action  plan  for  the  exchange  b e t w e en  Member 
State  administrations  of  national  officials  w ho  are  engaged  in  the  implementation  of  Community 
achieve  the  internal  market,  OJ  L  2 8 6,  1 . 1 0 . 1 9 9 2,  p.  65 

legislation  required  to 

-6 

Other  needs  frequently  expressed  include  the  translation  of  information,  guidance  in  interpreting 
the  legislation,  the  drawing  up  of  procedural  rules  for  information  exchanges,  and,  above  all, 
coordinated training of enforcement authorities. 

Another  need which  has  become  apparent  in some  areas, such as customs,  drug  precursors  and 
arms, is clarification of the relationship between measures taken under the  EC Treaty and those to 
which inter-governmental  cooperation under Title VI TEU applies. 

12.  Officials  in the Member States and the Commission were eager to have the contact  points  in 
their  sectors  at  their  disposal.  Those  who  dealt  with  enquiries  from  firms  sometimes  needed 
contacts  in other  sectors, to  reduce the time taken to  resolve  problems.  The Trade  department  of 
one  Member  State  had  to  contact  the  authorities  of  another  country  through  its  embassy,  for 
instance,  to  enable  beer  to  be  marketed  in that  Member  State  without  having  to  be tested  again; 
direct  contact  with  the  foodstuffs  enforcement  authorities  would  have  solved  this  problem  more 
quickly. 

13.  Members  of  the  committees  and  groups  consulted  generally  looked  to  the  Commission  to 
provide  coordination,  and  in  many  cases  funding  for  cooperation,  as  in  the  establishment  of 
electronic  data  networks. Exceptions to this were banking supervisory  authorities, which  cooperate 
under  a  series  of  bilateral  memoranda  of  understanding,  direct  taxation  authorities,  which 
cooperate  under  Directive  77/799/EEC  and  the  bilateral  tax  conventions  and  to  some  extent 
telecommunications  control authorities. 

14.  Sectors  where  cooperation  was  either  developing  or  already  well  developed  were  generally 
aware  of  the  need  for  joint  training  of  enforcement  officials.  Those  who  had  experience  of  the 
KAROLUS  exchange  programme  had generally found it very  useful, but the  benefits  had not  been 
spread  widely  enough.  It was  often  felt  that  those  who  would  benefit  most  from  the  exchange  of 
experience  had  no  time  to  go  on  extended  exchanges.  And  there  was  also  limited  capacity  for 
administrations  to  act  as  host.  These  factors  may  have  resulted  in  the  target  numbers  of 
exchanges  not  being  reached.  Drawing  from  the  experience  of  other  programmes,  such  as 
MATTHAEUS  for  customs  officials,  a  desire  was  expressed  in  a  number  of  sectors  for  shorter 
exchanges  or visits  and for joint  seminars  and similar training activities,  in addition to  conventional 
exchanges. 

IV  -  Improvements  to  existing  arrangements 

15.  Conclusions  at  this  early  stage  must  be  tentative.  However,  further  action  is  needed  to 
ensure  that  the  objective  of  even  enforcement  of  Community  law  across  the  Union  is  achieved. 
The Commission would particularly  recommend the following steps: 

Contact  points 

• 

• 

• 

Member  States  should complete  notification  of contact  points for the eighteen  areas  listed in 
the Annex to the Resolution of 16 June  1994 as soon as possible. 

They  should  also  provide  sufficient 
procedures. 

information  on  their  enforcement  structures  and 

Member  States  should  ensure  that  the  lists  of  contact  points  are  kept  up to  date  and  notify 
the Commission of any changes. 

• 

• 

• 

The Commission will investigate the use of on-line versions of these lists. 

The  Commission  will,  during  1996,  extend  its  monitoring  of the  work  of the  contact  points 
notified in this exercise to find out how many times they communicate, how useful the results 
of this cooperation are and how cooperation could be improved, and will report to the IMAC. 

The  Member  States  should  as  soon  as  possible  implement  the  Council  Resolution  of 
10 October  1994  by  establishing  contact  points  for  the  public,  especially  for  small  and 
medium-sized enterprises, in order that the system of inter-administration contact points now 
in place can yield its full benefits. 

More facilities for joint training 

• 

• 

The Commission will examine the possibility of modifying the Karolus exchange programme, 
in particular to include specific training sessions on similar lines to the present  MATTHAEUS 
and  MATTHAEUS-Tax  seminars.  The  accent  would  be  on joint  training  between  different 
States' officials and greater flexibility in exchanges. 

The  Commission  and  the  Member  States  should  also  encourage  more  short-term  mutual 
joint visits or joint  inspections such as those currently  carried out in the GLP  and foodstuffs 
areas,  in addition to  exchanges  and training  sessions,  as these  are  needed  to  provide the 
cross-Community perspective which helps officials to enforce the rules evenly. 

Basis for cooperation 

• 

Finally, where appropriate and in consultation with the Member States, the Commission will, 
by the end of 1996, endeavour to draw up ground rules for enforcement cooperation in each 
sector or area  of legislation, dealing, for instance, with the  precise type of information to be 
exchanged and at what stage in the enforcement process. Only such "tailor-made" solutions, 
respecting  the  specificities  of  each  sector,  can  create  the  confidence  required  between 
administrations. Rules of the game, to be followed by all parties involved, have been found to 
be  particularly  necessary  for the  "New Approach" directives.  If  in specific sectors  it proves 
impossible  to  achieve  satisfactory  enforcement  of the  rules  in any  other  way,  for  example 
under  Article  5  of the  Treaty,  the  Commission  will  consider  proposing  legislation  imposing 
such rules for cooperation. 

The  Commission  calls  upon  the  Council  and  Parliament  to  take  note  of  the  above 
recommendations. 

8-

Annex 
Enforcement  cooperation in specific areas 
of  Internal Market  legislation 

Contents 

Parti 

Priority  areas  identified  in the  Council  Resolution  of  16 June  1994 

1.  Technical  harmonization:  directives  on  the  elimination  of  barriers  to  trade 

2.  Public  procurement 

3.  Firearms 

4.  Dual  use  goods 

5.  General  product  safety  Directive 

6.  Telecommunications 

7.  Foodstuffs,  animal  and  plant  health,  veterinary  medicines 

8.  Notification  of  technical  regulations 

9.  Customs 

10.  Taxation 

1 1.  Drug  precursors 

12.  Cultural  goods 

13.  Right  of  establishment 

14.  Company  law 

15.  Insurance,  banking,  securities 

16.  Intellectual  property 

17.  Broadcasting 

18.  Transport 

Part  II  Other  areas 

19.  Social  policy 

20.  Public  administration 

2 1.  Competition 

22.  Telematic  networks  between  administrations  (TNA  /  IDA) 

23.  The  Karolus  exchange  programme 

9 

16 

18 

19 

20 

21 

22 

26 

27 

29 

31 

33 

34 

35 

37 

41 

42 

43 

44 

46 

47 

49 

51 

The  description  of enforcement  cooperation  in each  of the  areas  of  legislation  concerned  is  divided 
into  a  maximum  of five  sections: 

1°  -Introduction; 

2 °-  Existing  mechanisms  for  enforcement  cooperation; 

3°  -Needs  for  cooperation; 

4°  -Impediments  to  cooperation; 

5°  -Next  steps. 

(2) 

9-

Part  I 

Priority  areas  identified  in the  Council  Resolution  of  16  June  1994 

1. 

Technical  harmonization:  directives  on  the  elimination  of  barriers  to  trade 

This sector has been broken down into the following sub-areas: 

A -  New Approach: Toys, Machines, Personal protective equipment,  Electromagnetic  compatibility, 

Gas appliances, Pressure equipment, Medical devices, Metrology  and Explosives 

B -  Pharmaceutical  products 

C - Good Laboratory  Practice (GLP) 

Conformity  testing  and  market  supervision  in  relation  to  these  directives  is  one  of  the  areas  for 
which the  Karolus  programme  of exchanges  between  enforcement  officials  is  available.  For  more 
details see section 23 on the Karolus programme. 

1  A  —  New  Approach:  Toys,  Machines,  Personal  protective  equipment 

(PPE), 
Electromagnetic  compatibility  (EMC),  Gas  appliances,  Pressure  equipment, 
Medical  devices.  Metrology  and  Explosives 

1° 

Introduction 

The  application  of  these  directives  is  only  now  becoming  mandatory.  They  have  also  been 
amended  by  Directive  93/68/EEC12, which  imposes  CE marking for the different  products  covered 
and  entered  into  force  on  1 January  1995. A  transitional  period  lasts  until  1 January  1997,  after 
which such marking will be compulsory  in each sector (as it is currently for toys). Thus  cooperation 
on enforcement  is only now starting to develop. 

2° 

Existing mechanisms for enforcement  cooperation 

• 

Toys  Directive13: application since 1.1.90. 
Contacts  between  the  Commission  and  the  Member States  occur  mainly  when  safeguard 
measures are reported by national supervisory  authorities, before notifications are passed on 
to the other Member States. These consultations  are case by case and generally  bilateral. In 
order  to  acquire  further  information  on  implementation  of  Directive  88/378/EEC  in  each 
country  and  to  permit  an  exchange  of  views  on  a  number  of  problems  in  interpreting  and 
implementing  it,  the  Commission  organized  in  1995  a  number  of  bilateral  meetings  with 
national  supervisory  authorities  and  a  meeting  between  the  Member States'  supervisory 
authorities.  The  discussions  showed  that  exchanges  of  information  were  necessary  as  a 
matter of urgency  both for supervisory  authorities and for the bodies notified. 

12  OJ  L 220,  31.8.1993,  p.  1 
13  Council  Directive  88/378/EEC  of  3  May  1988  on  the  approximation  of  the  laws  of  the  Member  States  concerning  the 

safety  of  toys,  OJ  L 187,  16.07.1988,  p.  1 

10-

Machines  Directive14:  application  since  1.1.93,  mandatory  since  1.1.95,  (safety  components 
and machinery for lifting or moving persons15: 1.1.97): 
Discussions  are  taking  place  on  the  type  of  information  to  be  exchanged  and  means  for 
exchanging  it  (work  is  in  progress  on  developing  forms  adapted  to  the  essential  require 
ments of the Directive); 

The  Committee  established  under  the  Directive  is  working  on  common  interpretations  and 
has  reached  agreement  on  particular  issues,  such  as what  parts of technical files are to be 
submitted and when, and clarification of the types of machinery excluded from the Directive. 
The PPE Directive16 (application  1.7.92, mandatory since 1.7.95) 
Work so far has mainly focused on interpretation problems and certification issues. 
Electromagnetic  compatibility  (EMC)  Directive17  (application  1.1.92,  mandatory  1.1.96)  and 
the Low Voltage  Directive18 (LVD, application 21.8.74, DK 21.12.79). 
The  LVD  is  a fully  "New  Approach"  Directive  by  virtue  of the  Council  Decisions  concerning 
the  modules  for  the  various  phases  of  the  conformity  assessment  procedures19  and  of 
Directive  93/68/EEC  on  CE  marking.12  EMC  is  the  only  case  where  Member  States  are 
required  to  notify  competent  authorities  for the  implementation  of a  New Approach Directive 
to the Commission. 

Discussions  have  been  heid twice  for the  LVD and  3 times for the  EMC  Directive on needs 
and  information  to  be exchanged.  Meetings  of national enforcement  officials have examined 
the  enforcement  systems  of  different  Member  States  and  have  set  out  to  define  the form 
which cooperation should take. These have addressed the definition of 

(a) 

lists  of contact  points,  responsible both for  application of the  Directives and for market 
surveillance; 

(b) 

the content  and type of information to be exchanged between these authorities; and 

the means to be used for developing these contacts: fax, IDA networks, etc. 

(c) 
Gas  appliances20  and  Pressure  vessels21:  application  1.1.92  and  1.1.90,  mandatory  from 
1.1.96 and  1.7.92 respectively. Work is going on concerning  interpretation issues. Guides for 
industry  and  regulators  are  under  preparation  -  a  guide  has  been  published  for  the  gas 
sector,  in particular  listing pre-market contact points. 
Medical  Devices:  application:  Active  Implantable22  1.1.93;  Medical  Devices23:  1.1.95;  man 
datory  from  1  1.95  and  14.6.98  (in certain  cases  1.7.2004)  respectively.  On 28  March  1995, 

Council  Directive  89/392/EEC  of  14  June  1 9 89  on  the  approximation  of  the  laws  of  the  Member  States  relating  to 
machinery,  OJ  L  1 8 3.  2 9 . 6 . 1 9 3 9,  p.  3 

Council  Directives  91,368/EFC  of  20  June  1991  and  93/44/EEC  of  14  June  1 9 93  amending  Directive  89/392/EEC  on  the 
approximation  of 
the  Member  States  relating  to  machinery,  OJs  L  1 9 8,  2 2 . 7 . 1 9 9 1,  p.  16  and  L  1 7 5, 
1 9 . 7 . 1 9 9 3,  p.  12 

laws  of 

the 

Council  Directive  89/686/EEC  of  21  December  1 9 89  on  the  approximation  of  the  laws  of  the  Member  States  relating  to  the 
design  of  personal  protective  equipment,  OJ  L  3 9 9,  3 0 . 1 2 . 1 9 8 9,  p.  1 8 

Council  Directive  89/336/EF.C  of  3  May  1 9 89  on  the  approximation  of  the 
electromagnetic  compatibility,  OJ  L  139,  2 3 . 5 . 1 9 8 9,  p.  19 

laws  of  the  Member  States  relating  to 

Council  Directive  73/23/EEC  of  19  February  1973  on  the  harmonization  of  the  laws  of  the  Member  States  relating  to  electrical 
equipment  designed  for  use  within  certain  voltage  limits,  OJ  L 77,  26.3.1973,  p.29 

Council  Decision  90/683/EEC  of  >3 December  1990  concerning  the  modules  for the  various  phases  of the  conformity  assessment 
procedures  which  are  intenîieri  to  be  used  in  the  technical  harmonization  directives,  OJ  L 380,  31.12.1990,  p.  13,  as  amended  by 
Decision  93/46S/EEC  of  22  July  1993,  OJ  L  220,  30.8.1993,  p.  23 

Council  Directive  90/296/EEC  of  29  June  1 9 90  on  the  approximation  of  the  laws  of  the  Member  States  relating  to 
appliances  burning  gaseous  fuels,  OJ  L  1 9 6,  2 6 . 7 . 9 0,  p.  1  5 

Council  Directive  H//404/EFC  of  25  June  1987  on  the  harmonization  of  the  laws  of  the  Member  States  relating  to  simple 
pressure  vessels,  0 

I.  2 2 0.  8.8.1  9 8 7,  p  4 8,  as  amended  by  Directive  90/488/EEC,  OJ  L 2 7 0,  2 . 1 0 . 1 9 9 0,  p.  25 

Council  Directive  90/385/EEC  of  20  Ju<m  1 9 90  on  the  approximation  of  the  laws  of  the  Member  States  relating  to  active 
implantable  m a d i as  ^  luiprr.ont,  OJ  L  1 8 3,  2 0 . 7 . 1 9 9 0,  p.  17 

14 

15 

16 

17 

18 

19 

2^ 

21 

22 

11 

• 

• 

during  the  Competent  Authorities/Member  States  experts'  meeting,  a  draft  document  and 
form for  information exchange under the rapid alert system was presented to Member  States 
by the Commission for comments. 
Legal  Metrology:  Directive  90/384/EEC24  applies  1.1.93  and  has  been  mandatory  since 
1.1.95.  A  feasibility  study  is  in  progress  on  a  database  to  allow  exchange  of  information 
between notified bodies and with market surveillance  authorities. 
Explosives25  (application  1.1.95,  obligatory  from  1.1.2003):  cooperation  is  required  for 
enforcement  of the part of the  Directive  relating to the transfer of explosives.  In this case, the 
agreement  of  various  competent  authorities  is  required.  Cooperation  takes  place  via  the 
committee and also on a case by case basis. 

In these  "New Approach" areas there has only  been a limited experience  so far.  However,  a num 
ber of exchanges  between officials  in these areas have occurred under the KAROLUS  programme 
and more are planned for 1996. 

Apart  from  one  seminar  at  Union  level  that  has  been  organized  for  PPE  and  one  for  Machines, 
knowledge  is mainly  based on seminars  organized  by individual  Member  States, contacts  through 
attendance at committee meetings and bilateral exchanges during visits and/or missions. 

3°  Needs 

A  need  for  common  interpretations  of  the  terms  used  in  these  Directives  is  being  met  through 
"guides". 

The guides to the  Machinery  and EMC  Directives were  published  in  1993, that for  gas  appliances 
in  February  1995.  Information  packs  containing  guidelines  on  pressure  vessels  and  medical 
devices are also issued on request. 

A  guide  to  the  implementation  of  the  Toys  Directive  will  be  drawn  up  by  the  Commission  in 
consultation  with  national  authorities.  This  guide  will  shed  light  on the  limits  on the  definition  of  a 
toy  as  given  in the  Directive,  the  kinds  of  compliance  tests  to  be  applied  to  certain  toys  and  the 
interpretation of compliance tests. 

These  activities  also take  account  of the  results of the  ongoing  coordination with and  between the 
notified  bodies  in  each  area.  It  should  be  noted,  however,  that  interpreting  legislation  is  strictly 
speaking a matter for the Court of Justice. 

The  needs  for  improvement  are  not  substantially  new  -  reference  should  be  made  to  the 
conclusions on administrative cooperation in "The Single Market in 1994"26. 

4° 

Impediments 

No  systematic  inventory  has  been  made  of  material  difficulties,  lack  of  resources  or  communi 
cations  infrastructure.  Experts  in  the  Commission  working  groups  are  not  necessarily  contact 
points  and are even  not working  in the  relevant  Ministries that would  be in charge  of  enforcement 
at  national  level.  Efforts  so far  have  concentrated  on enhancing  bilateral  and  multilateral  contacts 

23  Council  Directive  93/42/EEC  of  14  June  1993  concerning  medical  devices,  OJ  L  169,  12.7.1993,  p 1 
24  Council  Directive  90/384/EEC  of  20  June  1990  on  the  harmonization  of  the  laws  of  the  Member  States  relating  to  non-

automatic  weighing  instruments,  OJ  L  189,  20.7.1990,  p T 

25  Council  Directive  93/15/EEC  of  5 April  1993  on  the  harmonization  of  the  provisions  relating  to  the  placing  on  the  market  and 

supervision of explosives for civil uses OJ L 121,  15.5.1993 p. 20 

26  COM  (95)238  final,  15  June  1995,  para.  123 

12-

at  a  personal  level, which  will  at  a  later  stage  enable  the  administrations  involved  to  assess  the 
right technical means to put in place. 

The  fact  that  there  appear  to  be  doubts  in  some  quarters  about  the  effective  implementation  of 
Community  rules  by  all  Member  States  and  about  the  existence  of  a  common  will  to  improve 
cooperation  indicates  that the  "rules  of the  game" still  have to  be defined  and  must  be applied  by 
all Member States. 

1  B  —  Pharmaceutical  Products 

1° 

Introduction 

Over  the  last  thirty  years,  EC  pharmaceutical  legislation  has  progressively  covered  all  industrially 
produced  medicinal  products for  human and animal  use. Specific  rules apply to  particular types  of 
medicines,  such  as  vaccines,  blood  products  and  radiopharmaceuticals,  with  harmonized  quality, 
safety and efficacy  requirements. 

In June  1993, the  Council  adopted  three  Directives27  and  a  Regulation28 which  together  form  the 
legal  basis  of  the  new  European  system  for  the  authorization  of  medicinal  products.  This  system 
became  operational  in  1995 when  the  European Agency  for  the  Evaluation  of  Medicinal  Products 
(EMEA) opened its doors in London. 

Two marketing authorization  procedures are now available: 

• 

• 

a centralized  procedure  leading to  a single  marketing  authorization  valid throughout  the EU. 
This  procedure  is  compulsory  for  medicinal  products  derived  from  biotechnology  and 
available at the request of companies for other innovative new products; 

and  a  decentralized  procedure  based  upon  the  principle  of  mutual  recognition  of  national 
authorizations.  The  purpose  of  the  decentralized  procedure  is  to  permit  the  extension  of  a 
marketing  authorization  granted  by  one  Member  State to  one  or  more  of the  other  Member 
the  national 
States  by  means  of  recognition  of  the  original  authorization.  Should 
authorization  not  be  recognized  by  other  Member  States,  and  after  exhaustion  of  all 
possibilities  for  the  resolution  of  the  issues  directly  by  the  Member  States  concerned,  the 
dispute will be submitted to binding Community arbitration; 

2° 

Existing mechanisms for enforcement  cooperation 

A  number  of  committees  and  working  parties  have  been  set  up  since  1975  to  deal  with  various 
questions  relating to pharmaceutical  harmonization, administrative collaboration, alert systems  and 
advice to the Commission. 

• 

The  Pharmaceutical  Committee  was  set  up  by  Council  Decision  75/320/EEC  to  examine 
any  question  relating  to  the  preparation  and  application  of  pharmaceutical  legislation.  It 
consists  of senior  representatives  from the  Member  States'  administrations  who  are  experts 

27  Council  Directives  93/39/EEC  of  14  June  1993  amending  Directives  65/65/EEC,  75/318/EEC  and  75/319/EEC  in  respect  of 
medicinal  products,  93/40/EEC  of  14 June  1993  amending  Directives  81/851/EEC  and  81/852/EEC  on  the  approximation  of  the 
laws  of  the  Member  States  relating  to  veterinary  medicinal  products  and  93/41/EEC  of  14  June  1993  repealing  Directive 
87/22/EEC  on  the  approximation  of  national  measures  relating  to  the  placing  on  the  market  of  high-technology  medicinal 
products, particularly those derived from biotechnology, OJ L 214, 24.8.1993, pp. 22, 31 and 40 

28  Council  Regulation  (EEC)  No 2309/93  of 22 July  1993  laying down  Community  procedures  for  the  authorization  and  supervision 
of  medicinal  products  for  human  and  veterinary  use  and  establishing  a  European  Agency  for  the  Evaluation  of  Medicinal 
Products, OJ L 214, 24.8.1993, p. 1 

-13 

in  public  health  matters.  Questions  of  interpretation  and  enforcement  of  EC  pharmaceutical 
legislation are examined jointly within this Committee. 

• 

Two  scientific  Committees,  the  Committee  for  Proprietary  Medicinal  Products  (CPMP)  and 
the  Committee  for  Veterinary  Medicinal  Products  (CVMP)  set  up  by  Council  Directives 
75/319/EEC  and  81/851/EEC,  have  been  created  to  facilitate  the  adoption  of  common 
positions on marketing authorizations  of medicinal products  These two committees  and their 
various  working  parties  have  been  used  as  a corner-stone  for  the  creation  of  the  European 
Agency  for  the  Evaluation  of  Medicinal  Products  (EMEA).  Each  Committee  has  two 
members from each Member State and both are assisted by a European iist of  1600 experts. 

The  EMEA  was  conceived  as  an  interface  of  coordination  and  cooperation  of  national  scientific 
resources, whether  human, intellectual  or material.  Its  role  is that  of  a catalyst  for  the  deployment 
of  resources,  in  particular  through  the  establishment  of  networks  of  European  resources  of 
national  origin.  The  national  competent  authorities  remain  the  pillar  of  the  new  European 
registration  system.  They  will  continue 
inspecting 
manufacturers  of  medicinal  products  and  performing  pharmacovigiiance  activities  on  behalf  of 
the EU. 

for  example 

their  duties, 

to  perform 

A telematic  network  is currently  being set up between the  European Commission, the  EMEA and 
the  national  authorities.  Its  purpose  is  to  ensure  fast  and  secure  transmission  of  data  such  as 
assessment  reports and pharmacovigiiance alerts. 

Regarding  industrial  manufacture  of  medicinal  products,  a  system  of  national  authorizations 
and  supervision  has  been  developed  since  1975  based  on  the  principle  of  genuine  mutual 
recognition  with  appropriate  procedures  for  administrative  collaboration  on  inspection  matters, 
including an alert system on quality defects. 

With  regard  to  pharmaceutical  inspections,  harmonization  of  Good  Manufacturing  Practice 
continues  in  the  Working  Party  on  Inspection  and  Control  of  Medicinal  Products  set  up  by  the 
Commission. 

Pharmaceutical  supervision  officials  have  taken  part  in the  KAROLUS  programme  of  exchanges 
of officials  between national administrations  (see section 23 below). 

3°  Needs 

Making  a  success  of  the  new  European  system  for  medicines  is  a  challenge  which  can  only  be 
achieved  if Member  States  are fully  committed  and provide the system with experts  of the  highest 
scientific quality. 

Knowledge  of  other  national  systems  also  needs  to  penetrate  beyond  the  level  of  officials  who 
attend the  committees  and working  parties.  No Community  programme  except  KAROLUS  covers 
training of the officials closest to the terrain and national resources are scarce. 

Detailed  information  on  technical  criteria  and  administrative  procedures  for  national  approval  are 
needed  by  those  responsible  for  approvals  (who  are  also,  generally  speaking,  responsible  for 
market  control). There  needs to  be mutual  confidence  in the efficacy  with which  these  procedures 
are applied in practice. 

4°  Next steps 

The Working Party oh Inspection and Control of Medicinal  Products  has suggested that these two-
month exchanges  under the Karolus programme should be supplemented  by workshops,  seminars 
and  the  like  to  increase  mutual  knowledge  on  the  processing  of  applications  and  market 

14 

supervision, analogous to those available under the MATTHAEUS  programme. This Working  Party 
has  repeatedly  suggested  that  the  KAROLUS  programme  could  be  used  to  build  up  mutual 
confidence  through  joint 
inspections  and  training  sessions,  and  that  the  duration  of  the 
"exchanges"  should  be  adapted  to  what  it  saw  as  the  actual  needs  in  this  area  (i.e.  1-2  weeks 
rather than two months). 

1  C  —  Good  Laboratory  Practice  (GLP) 

1° 

Introduction 

Laboratory  tests  are  required  prior to the  putting on the  market  of  industrial  chemicals,  pesticides, 
foodstuffs,  animal  feedingstuffs,  cosmetics  and  pharmaceutical  products,  and  EC  legislation 
covers GLP in these areas29. 

The aim  is  mutual  recognition  of test  results, avoidance  of  repeat  testing, thus facilitating  the  free 
circulation of these products at lower marketing costs. 

Compliance  with  the  internationally  agreed  GLP  standard  should  guarantee  that  test  data  are 
accepted by the authorities of all Member States. 

2° 

Existing mechanisms for enforcement  cooperation 

Informal  meetings  take  place  with  the  national  monitoring  authorities,  workshops  have  been 
organized  to  familiarize  participants  with  other  Member  States'  systems,  databases  concerning 
inspections,  administrative  infrastructures  and  national  legislation  are  annually  updated  by  the 
Commission  and  distributed  in  hard  copy  form.  Information  exchanges  also  take  place  within  an 
OECD framework. 

The  latest  development  is  the  establishment  of  a  system  of  Mutual  Joint  Visits  (MJVs).This 
programme  is a voluntary  scheme consisting of a series of informal visits of one week at most by a 
team  of  3  observers.  These  are  inspectors  from  national  GLP  monitoring  authorities  of  other 
Member States. The Commission coordinates  but does not physically  participate  in the visits. 

The  goal  is  not  to  criticize  Member  States  when  lack  of  conformity  with  the  GLP  standards  is 
found,  but  to  help  them  to  adopt  the  same  approach  as  other  Member  States.  The  result  is 
openness and transparency,  leading to mutual understanding and more confidence. 

3°  Needs 

A  certain  lack  of  mutual  confidence  in  each  others  compliance  monitoring  systems  needs  to  be 
overcome.  The  Member  States'  GLP  inspectorates  are  fully  aware  that  information  exchange  is 
the keystone for mutual confidence. 

Two main fields of information exchange can be identified: 

(a) 

29 

that  concerning  application  and  interpretation  of  the  texts,  which  takes  place  at  meetings, 
workshops,  databases  and within  the  OECD, and  mainly  aims  at  overcoming  problems  due 
to real or presumed differences  in application and interpretation of legal texts, and 

e.g.  Council  Directive  87/18/EEC  of  22  December  1986  relating  to  the  application  of  the  principles  of  good  laboratory 
practice  and  the  verification  of  their  applications  for  tests  on  chemical  substances;  OJ  L  15,  17.1.1987,  p.29;  Council 
Directive  88/320/EEC  of  9.6.1988  on  the  inspection  and  verification  of  good  laboratory  practice,  OJ  L  145,  11.6.1988, 
p.35;  Council  Decision  89/569/EEC  of  28  July  1989  on  the  acceptance  by  the  EEC of  an  OECD  decision/recommendation 
on  compliance  with  principles  of  good  laboratory  practice,  OJ  L 315,  28.10.1989,  p.  1. 

-15 

(b) 

that  related  to  compliance  surveillance.  The  MJV  programme  enables  delegations  to 
compare the  real functioning  of  national  mechanisms.  This  is a far-reaching  form  of  infor 
mation exchange as well as a mechanism for circumventing formalistic approaches. 

4° 

Impediments 

No  major  obstacles  are  expected,  so  long  as  the  system  functions  on  a  voluntary  and  rather 
informal basis. 

2. 

Public  procurement 

16-

1 ° 

Existing mechanisms for enforcement  cooperation 

Administration cooperation with the Member States currently  has two aspects: 

• 

• 

meetings  of  an  advisory  committee  bringing  together  representatives  of  the  administrations 
in  charge  of  public  procurement,  to  study  proposals  for  amendments  to  the  existing  direc 
tives, to look into questions  of their  interpretation  and any difficulties  in their  implementation, 
or any other matter concerning enforcement of Community  law on public procurement.  There 
is  also  an  Advisory  Committee  on  the  Opening-up  of  Public  Procurement,  composed  of 
independent  experts  whose  business  and  industrial  experience  and  whose  competence 
regarding  public  procurement  at  Community  level  are  widely  recognized,  whose  task  is  to 
contribute to discussion on the various problems concerning public  procurement; 

package  meetings  with  each  Member  State  to  examine,  with  the  various  national  admini 
strations  or  authorities  concerned,  cases  in  dispute  which  come  to  the  Commission's 
attention, either through complaints or after investigations of its own. 

A significant  number  of exchange visits  between officials from the Member states to study  aspects 
of public procurement  policy and practice are being arranged under the Karolus  Programme.  Sixty-
six  such  exchanges  had  been  approved  by  the  mid-November  1995,  and  forty-two  of  these  had 
been completed. 

2°  Needs 

The  directives30  require  specific  information  for  tender  notices,  contract  award  notices,  periodic 
information  notices  and  notices  on the  existence  of  a qualification  system  to  be  printed  and  pub 
lished  in  the  Official  Journal.  Provision  of  on-line  access  to  public  procurement  opportunities 
through Tenders  Electronic  Daily  (TED)  has been available since  1986. More than 500 notices  are 
currently  being published each day. 

Under the directives  Member  states  are required to  provide  regular  statistical  reports  on  contracts 
awarded  by contracting  entities. The Commission  is encouraging the development  of  technologies 
and services required for information management and electronic tendering. 

Under the  Remedies  Directives31 the Commission  needs to know how complaints  are dealt with at 
a national  level, as do the other  Member  States, in order for them to  have confidence  in the  equal 
treatment  of  their  firms,  but  for  the  moment  all  the  Member  States  are  reluctant  to  provide  such 
information. 

The  two  Consultative  Committees  on  Public  Procurement  both  consider  questions  of  interpre 
tation. The  adoption  of  interpretative  texts  approved  by these  committees  could  help  in  arriving  at 
common interpretations  of the texts. 

30 

31 

such  as  Directives  9 3 / 3 6,  9 3 / 37  and  9 2 / 50  coordinating  procedures  for  the  award  of  public  supply,  w o r ks  and  service 
contracts  respectively,  OJ  L  1 9 9,  9 . 8 . 1 9 9 3,  pp.  1  and  5 4;  OJ  L  2 0 9,  2 4 . 7 . 1 9 9 2,  p.  1 

Directive  89/665/EEC  of  29  December  1 9 89  on  the  coordination  of  the  laws,  regulations  and  administrative  provisions 
relating  to  the  application  of  review  procedures  to  the  award  of  public  supply  contracts,  OJ  L  3 9 5,  3 0 . 1 2 . 1 9 8 9,  p.  3 3; 
Directive  92/13/EEC  of  25  February  1 9 92  coordinating  the  l a w s,  regulations  and  administrative  provisions  relating  to  t he 
application  of  C o m m u n i ty  rules  on  the  procurement  procedures  of  entities  operating  in  the  w a t e r,  energy,  transport  and 
telecommunications  sectors,  OJ  L  7 6,  2 3 . 3 . 1 9 9 2,  p.  14 

(3) 

3°  Next steps 

17 

The  Commission  is  reflecting  on  the  possibility  of  developing  proposals  for  a  common  training 
programme  (to  be  conducted  by  the  Commission,  Member  States  and  business)  to  disseminate 
knowledge  of the  public  procurement  regime to  all those  involved  in public  procurement  activities. 
It would hope for early action by the Council on such proposals. 

The development  of  information technology  may  bring appreciable  benefits  in public  procurement. 
Transparency  in  public  purchasing  is  a  key  factor  in  ensuring  that  public  purchasing  procedures 
are  able  to  provide  the  best  cost/benefit  ratio.  The  Commission  has  begun  the  pilot  phase  of  a 
project  called  SIMAP  (Système  d'Information  sur  les  Marchés  Publics),  the  aim  of  which  is  to 
compile  electronically  all  information  concerning  procurement  by  contracting  entities  in  the  Com 
munity  and  to  disseminate  them,  electronically  to  all  potential  suppliers.  If  the  project  is  to  be 
effective,  the  collaboration  of  all  those  concerned  is  necessary,  including  of  course  the  Member 
States. 

In addition,  in order to ensure  that  public  procurement  rules  are complied with  in the  case  of  pro 
jects  financed  by  Community  funds,  there  has  since  1988  been  a  sharing  of  tasks  between  the 
Commission  and  the  Member  States,  based  on  the  principle  of  subsidiarity:  the  Member  States 
have to  check whether  such  projects  are carried  out  in compliance  with  public  procurement  rules. 
Unfortunately,  most  Member  States  have  not  allocated the  necessary  resources  for  this.  In  order 
to  develop  this  approach,  the  Commission  might  propose  that  the  Member  States  set  up  inde 
pendent  national  authorities to ensure that  public  procurement  rules  are complied with  in the  case 
of  projects  financed  by  Community  funds.  Details  of their  operation would  be  left  to the  discretion 
of  the  Member  States,  provided  that  there  was  a  guarantee  of  their  being  independent  of  the 
contracting  entities  and  given the  necessary  resources.  If such  authorities  are  set  up, they  will  of 
course have to be cooperation among them and between them and the Commission. 

A  further  possible  action  would  be  for  the  central  governments  in  the  Member  States  and  the 
(largely  local  or  regional)  contracting  entities  to  use  such  independent  structures  for  coordinating 
enforcement  of the rules on all public procurement to which Community  law applies. 

The Commission  recommends that this question be examined with the Member States. 

18 

Firearms 

1° 

Introduction 

Council  Directive  91/477/EEC  of  18  June  1991  on  control  of  the  acquisition  and  possession  of 
weapons32  is  the  main  accompanying  measure  for  discontinuing  checks  on  goods  at  internal 
frontiers  in the  case  of weapons.  It  harmonizes  aspects  of  legislation  on firearms  and  lays  down 
the formalities for movement  in the Community. 

2° 

Existing mechanisms for enforcement  cooperation 

The Directive provides for the Member States to inform each other on transfers of firearms  and the 
acquisition and possession of firearms  by non-residents. 

It  provides  for  the  Member  States  to  set  up,  by  1 January  1993,  networks  for  exchange  of  infor 
mation  in order to  comply with these  obligations. They  are to  inform  other  Member  States  and the 
Commission of the national authorities  responsible for sending and receiving this information. 

The information exchange networks have been set up and are operating well. 

3°  Needs 

Some  Member  States  feel  the  absence  of  a  structure  (for  example,  a  committee)  which  would 
enable  representatives  of  national  authorities  to  hold  multilateral  meetings  from  time  to  time  and 
discuss practical problems posed by the implementation of the Directive. 

4° 

Impediments 

In November  1995, the Directive had still not been transposed by Austria, Finland or Sweden. 

32  OJ  L 256,  13.9.1991,  p.  51 

19 

4.  Dual  Use  Goods 

1° 

Introduction 

The  system  of  export  controls  on  dual-use  goods  consists  of  two  pillars:  Council  Decision 
N° 94/942/CFSP  on the joint  action adopted by the Council on the basis of article J.3 of the Treaty 
on  European  Union  and  Council  Regulation  (EC)  N°  3381/94  of  19  December  1994  setting  up a 
Community  regime for the  control  of exports  of dual-use goods33. The  system  applies from  1 July 
1995. 

The  Regulation  stipulates  the  need  for  administrative  cooperation.  A  list  of  contacts  has  been 
established and national licence forms are drafted on the basis of a model form. 

2° 

Existing mechanisms for enforcement  cooperation 

The  Coordination  Group  on  Export  Controls  of  dual-use  goods  meets  regularly  to  discuss 
administrative  cooperation  in  this  area.  This  Group  has  assisted  the  Commission  in  drawing  up 
detailed procedures for administrative cooperation between Member States. 

Five  exchanges  between  export  control  enforcement  officials  have  been  approved  under  the 
KAROLUS  programme.  A  seminar  was  organized  in  1994  as  part  of  the  MATTHAEUS 
programme, for customs cooperation in the dual-use area. 

3°  Needs 

Various  provisions  of the  Regulation  require close cooperation  between the authorities  of  Member 
States,  both  those  responsible  for  licensing  and  those  responsible  for  customs  (which  in 
Community terminology  includes post-exit controls), in particular: 

a) 

b) 

c) 

Licences  issued  by  an  authority  in  one  Member  State  must  be  recognizable  by  the 
authorities in another Member State which has to enforce them. 

The  licensing  authorities  of  the  Member  State  in  which  the  exporter  is  established  must 
consult  the  licensing  authorities  of the  Member  State  in which the good  is or will  be located. 
No format has been foreseen. 

The  effectiveness  of  post-exit  control  measures  can  be  increased  by  cooperation  between 
administrations. 

d)  Member  States  may  ask  for  an  export  licence  for  exports  from  their  territory  for  dual-use 
goods  not  listed  in  Annex  1  of  the  Council  Decision  on  the  Joint  Action.  Transparency  of 
these  measures  is  in the  interest  of all Member  States, and exchange  of  information  on the 
authorizations foreseen in the Regulation could prove useful. 

The Commission  services will provide explanatory  notes on provisions of the  Regulation that  could 
give rise to divergent  interpretations. 

All Member  States already  had a well functioning export  control system  before the entry  into force 
of the  Community  system.  However  differing  experiences  of  different  administrations  with  certain 
categories of goods need to be remedied by a sharing of information. 

An  electronic  data  exchange  infrastructure  could  facilitate  the  efficient  and  effective  implemen 
tation  of the  Community  system  of  export  controls,  but  Member  States  want  to  assess  at  a  later 
stage whether such an infrastructure  is needed. 

33  OJ  L 367,  31.12.1994,  p.  1 

20 

5.  General  Product  Safety 

1° 

Introduction 

Cooperation  on  enforcement  of  the  rules  in the  sector  of  product  safety  is  based  on  the  various 
mechanisms  provided by Directive 92/59/EEC on General Product Safety. 

2° 

Existing mechanisms for enforcement  cooperation 

Directive  92/59/EEC  This  Directive  established  an  "Emergency  Committee",  consisting  of 
representatives from the Member  States and the Commission services.  In this Committee  matters 
related to enforcement cooperation are discussed. 

The  Commission  regularly  submits  working  documents  to  the  members  of  the  Committee  with  a 
view to obtaining  convergent  practice  in the application  of the various  mechanisms  provided for  in 
the Directive. 

3°  Needs 

In  July  1994  a  questionnaire  was  submitted  to  the  members  of  the  Emergency  Committee 
established  under the  General  Product  Safety  Directive, with  a view to  identifying  needs  in  terms 
of  enforcement  cooperation  in  this  sector.  Only  a  minority  of  Member  States  have  provided  the 
Commission with detailed answers to date. 

4° 

Impediments 

A  few  Member  States  have  expressed  their  concerns  as  to  their  lack  of  resources  and  of 
communications  infrastructure.  Lack  of  training  for  inspectors  was  specifically  mentioned  in  the 
context  of  obtaining  as  homogeneous  an  approach  as  possible  in  the  framework  of  the  Internal 
Market. 

5°  Next steps 

A feasibility  study  on the computerization of the rapid information exchange system  provided for  in 
the  General  Product  Safety  Directive  has  recently  been  completed  in  the  framework  of  the  IDA 
Programme.  Depending  on  the  credits  available,  a  pilot  project  with  some  Member  States  could 
start in the second quarter  in  1996 and, if the results are positive, the project  could be extended to 
all Member States. 

Consideration  should  be given to  Community  support for  country-specific  training  programmes  for 
product safety enforcement  officers. 

-21 

6. 

Telecommunications 

1 ° 

Existing mechanisms for enforcement  cooperation 

Commission  Directive  90/388/EEC  provides  that  all  Member  States  should  have  a  national 
regulatory  authority  for  telecommunications,  separate  from  the  Telecoms  Operators.  So  far  as 
cooperation  on  enforcement  of  EU  legislation  is  concerned,  two  committees  are  the  most 
important  fora  for  exchange  of  information,  the  Committee  for  Approvals  of  Terminal  Equipment 
(ACTE)34  and  the  Open  Network  Provision  (ONP)  Committee  in  the  area  of  networks  and 
services35.  (These are committees  of Member States chaired by the Commission, which can act in 
both an advisory  and a regulatory  capacity.) 

Cooperation  on  Telecoms  issues  also  takes  place  through  the  International  Telecommunications 
Union  of  the  United  Nations,  and  at  the  European  level  through  the  European  Conference  on 
Posts and Telecommunications  (CEPT). 

The  ACTE  is  the  chief  forum  for  enforcement  cooperation  between  Member  States  regarding 
terminal equipment. 

There  is  intense  activity  in the  area  of seminars,  conferences  and consultancy  studies  at  national 
and  European  levels - run both  by the Commission  and commercial  companies  - in which  officials 
are  involved. Cooperation  also takes  place through the Association  of  Designated  Laboratories  of 
the  Notified  Bodies, dealing with practical questions  concerning the  performance  of procedures  for 
certifying compliance  of terminal  equipment. 

2°  Needs 

Liberalization  of the telecommunications  sector  means that  many  of the tasks  previously  handled 
by administrations  are nodled on a commercial basis by the telecommunications  operators. 

Coordination  between  administrations  in  Member  States  is  still  needed  on  licensing  of  tele 
communications  services, frequency  allocation and numbering. 

The electronic  mail system  between  representatives  of the  Member States  and between them  and 
the Commission should be completed. This would be useful for the exchange of routine  Committee 
documents  and for keeping track of enforcement of the legislation. 

The need is strongly felt for guidelines to be drawn up on the application  of ONP  principles. This is 
important  in view  of  progress  in discussions  on the  future  of  ONP, and  especially  with  respect  to 
future directives  in this area (for example those on voice telephony  and interconnection). 

3° 

Impediments 

Some  national  regulatory  authorities  for  telecommunications,  particularly  in  the  smaller  Member 
States, suffer  from  lack of  resources. The specialist  nature  of telecommunications  means that  it is 
sometimes difficult for them to find staff with the necessary  knowledge and experience. 

4°  Next steps 

34  Council  Directive  91/263/EEC  of  29  April  1991  on  the  approximation  of  the  laws  of  the  Member  States  concerning 
telecommunications  terminal  equipment,  including the  mutual  recognition  of  their  conformity,  OJ  L  128,  23.5.91,  p.  1 
35  Council  Directive  90/387/EEC  of  28  June  1990  on  the  establishment  of  the  internal  market  for  telecommunications 

services  through  the  implementation  of  open  network  provision, OJ  L  192,  24.7.90,  p.  1 

22 

Day-to-day  exchange  of information would be helped if all administrations  had easy  access to E-
mail systems for document distribution. 

23 

7. 

Foodstuffs,  animal  and  plant  health,  veterinary  medicines 

These are four distinct areas, which are therefore treated separately: 

7  A  —  Foodstuffs 

1° 

Introduction 

In the foodstuffs  sector,  a form of administrative  cooperation was embarked  upon in  1984 with the 
setting-up  of  a  network  of  contract  points  for  reporting  cases  of  serious  danger  concerning  food 
stuffs  and  exchanging  the  necessary  information  for  dealing  with  the  serious  dangers  to  health 
which  the  system  was  able to  identify.  These  arrangements  were  institutionalized  in the  Directive 
on general product  safety36. 

2° 

Existing mechanisms for enforcement  cooperation 

Directive  89/397/EEC  on the  official  control  of foodstuffs  set  up further  instruments  of  administra 
tive cooperation: 

• 

• 

since  1993  figures  concerning  the  results  of  national  programmes  of  official  controls  on 
foodstuffs  have been sent to the Commission annually; 
the  Commission  makes  an  annual  recommendation  concerning  a  coordinated  Community 
programme of official  inspections of foodstuffs. 

Under  Directive  93/99/EEC,  a  formal  system  of  administrative  cooperation  has  been  set  up.  It 
came  into  effect  on  1 May  1995.  National  inspection  services  give  each  other  assistance  in their 
task  of  supervising  whether  foodstuffs  are  in  compliance  with  the  rules  governing  them.  Each 
Member  State  designates  a  single  liaison  body  which  transmits  requests  for  assistance  to  other 
bodies and ensures that requests for assistance from other Member States are replied to. 

The  equivalence  and  effectiveness  of  national  food  control  systems  are  evaluated  by  specific 
officials designated by the Commission. 

Directive  93/5/EEC  lays  down  procedures  for  scientific  cooperation  between the  Commission  and 
the Member States to be followed from June  1993 onwards. 

• 

• 

Among the specific actions carried out using these various tools for cooperation are: 
• 

the work  on increasing transparency  carried out by the Commission/Member  States Working 
Party  on  the  Official  Control  of  Foodstuffs  through  summarizing  the  results  of  the  annual 
inspection programmes of the Member States. 
the  execution  of  the  first  coordinated  Community  programme  of  inspections  in  1995,  which 
demonstrated the advantages of certain inspection measures  being carried out for the  single 
market as a whole 
the  beginning  of  missions  to  assess  the  effectiveness  and  equivalence  of  the  Member 
States'  national  systems,  which  are  carried  out  in  cooperation  between  the  Member  States 
and  the  Commission.  The  first  missions  (United  Kingdom,  Italy  and  the  Netherlands)  took 
place  in  1995.  Clearly  the  effects  of  these  assessment  missions  will  assume  their  full  pro 
portions  over  the  long  term,  in  particular  when  all  the  Member  States  have  been  visited. 
However  it already  appears  that these  steps to  create  contacts with  the  practical  realities  of 
foodstuffs  control have had very beneficial effects; 

36  Council  Directive  92/59/EEC  of  29  June  1 9 92  on  general  product  safety,  OJ  L  2 2 8,  1 1 . 8 . 1 9 9 2,  p.  2 4. 

24 

• 

the  execution  of the  programme  of scientific  collaboration  between the  Commission  and the 
Member  States  at  their  research  institutes,  which  in  1995  covered  topics  such  as  aromas, 
microbiological criteria, the assessment of food consumption and various  contaminants. 

Finally, the Standing  Foodstuffs  Committee  plays an important  role in achieving consensus on how 
the legislation  is to be implemented as do exchanges of officials  under the Karolus  programme. 

3°  Needs 

Needs  for  the  exchange  of  information  between  Member  States  and  the  Commission  and  for 
scientific cooperation are broadly covered by existing food legislation. 

As  regards  official  inspection,  discussion  in the  Commission/Member  States  working  group  have 
shown  up the  need for  a vade  mecum or guidelines  on how the  national  results  of  official  inspec 
tion  are to  be communicated  to the  Commission. This  should  be adopted  by the  end  of  1995  and 
should  make  national figures  on  official  inspection  of foodstuffs  more transparent  and  more  com 
parable. 

4° 

Impediments to cooperation 

Two problems arise here: 

• 

• 

ensuring  that  the  results  of  the  national  and  Community  annual  inspection  programmes 
reported are as comparable as possible; 

ensuring  rapid  statistical  processing  at  Community  level  so  as  to  provide  a  synthesis  of 
figures received. 

In  a  system  like  scientific  cooperation,  where  the  scientific  and  technical  resources  are  concen 
trated  in  the  Member  States,  experience  shows  a  balance  is  necessary  between  devolving 
responsibilities  to  the  Member  States  and  coordination  at  Community  level,  based  on  a  precise 
definition of the tasks involved. 

5°  Next steps 

High-performance  tools  for  information  exchange  should  be  put  in  place,  including  for  the  trans 
mission  and  processing  of the  large  number  of  statistics  involved. A  study  has  been  planned  for 
1996 to decide on the most suitable system. 

Concrete experience  in current administrative cooperation also shows that it would in certain cases 
be  useful  to  have  Community  facilities  for  training  inspection  officials.  The  Karolus  programme 
should  be  continued  but  might  in  some  cases  be  redirected  to  include  not  only  exchanges  of 
officials  but also training seminars or exchanges of experience. 

As  regards  scientific  cooperation, Community  incentives should  be retained, especially  as  regards 
defraying  the  administrative  costs  generated  by  cooperation  work,  the  scientific  work  involved 
being financed by the Member States. 

7  B  —  Veterinary  Controls 

1° 

Introduction 

The  veterinary  sector  has  well  developed  arrangements  for  enforcement  cooperation,  reflecting 
the  lengthy  experience  of  legislation  at  Community  level.  In  1989  the  Council  adopted  Council 

(4) 

- 2 5-

Directive  89/608/EEC37,  setting  out  provisions  on  assistance  between  authorities  and  the  com 
munication  of  such  information.  This  Directive  places  a  strong  emphasis  on  the  role  of  the 
Standing Committees  (see II). 

2° 

Existing mechanisms for enforcement  cooperation 

The  main  area through which  enforcement  cooperation  takes  place  is the  regular  meetings  of the 
Standing Veterinary  Committee  (established  in  1968) and the Standing Committee  on Zootechnics 
(Regulatory  Committees).  During  1994  there  were  31  meetings,  with  a  total  of  69  days,  of  the 
Standing  Veterinary  Committee  and  one  meeting  of  the  Standing  Committee  on  Zootechnics.  In 
addition, the Member  States and the Commission services also meet regularly  in expert,  scientific, 
technical and working groups organized by the Commission to examine particular issues. 

A system for the  notification  of animal diseases to the  Commission  and other  Member  States was 
established  by Council Directive 82/894/EEC38, with information transmitted electronically within 24 
hours.  A  computerized  system  (ANIMO)  for  the  notification  of  animal  movements  has  also  been 
established39,  with  the  Member  State  of  dispatch  providing  the  Member  State  of  destination  with 
advance  notice  of the  arrival  of  animals,  and  now  connects  more than  2,000  local  units  in the  12 
Member  States  and  some  125,000  messages  transmitted  during  the  second  half  of  1994.  The 
ANIMO system will be implemented  in Austria, Finland and Sweden during 1995. 

Work  is  underway  to  develop  a  further  electronic  information  system  connecting  all  the  border 
inspection  points  in the Community, the SHIFT system40 to ensure close and effective  cooperation 
between  the  Community's  external  border  posts  and  ensure  effective  implementation  of  the 
Community's  import  requirements. 

Commission  officials  from  the  Office  of  Veterinary  and  Phytosanitary  Inspection  and  Control 
(OICVP)  regularly  carry  out  missions  in the  Member  States  to  ensure  the  uniform  application  of 
Community  law. These  missions, which are carried out  in cooperation with the  competent  national 
authorities,  provide  a  useful  opportunity  for  exchanging  information  and  discussing  practical 
problems.  In 1994 there were  142 missions focusing on animal health, fraud, poultry,  residues  and 
border inspection posts. 

A  programme  of  exchanges  of veterinary  officers  between  the  Member  States  has  been  in  place 
for  some  time,  based  on Article  34  of  Council  Decision  90/424/EEC41.  In  1994  these  exchanges 
focused  on veterinary  officers  responsible  for work  in border  inspection  posts,  and  31  exchanges 
took place involving all 12 Member States. 

Conferences  and seminars are organized both by the Member States and the Commission. 

37 

38 

39 

40 

41 

Council  Directive  89/608/EEC  of  21  November  1 9 89  on  mutual  assistance  b e t w e en  the  administrative  authorities  of  the 
Member  States  and  cooperation  b e t w e en  the  latter  and  the  Commission  to  ensure  the  correct  application  of  legislation  on 
veterinary  and  zootechnical  matters,  OJ  L  3 5 1,  2 . 1 2 . 1 9 8 9,  p.  3 4.  Last  amended  by  the  A ct  concerning  the  conditions  for 
the  Accession  of  Austria,  Finland  and  Sweden  and  adjustments  to  the  Treaties  on  w h i ch  the  EU  is  f o u n d e d,  OJ  C  2 4 1, 
2 9 . 8 . 1 9 9 4,  p.  2 1. 

Council  Directive  82/894/EEC  of  21  December  1 9 82  on  the  notification  of  animal  diseases  w i t h in  the  C o m m u n i t y,  OJ  L 
3 7 8,  3 1 . 1 2 . 1 9 8 2,  p.  5 8.  Last  modified  by  the  A ct  concerning  the  conditions  for  the  Accession  of  Austria,  Finland  and 
Sweden  and  adjustments  to  the  Treaties  on  w h i ch  the  EU  is  founded,  OJ  C  2 4 1,  2 9 . 8 . 1 9 9 4,  p.  2 1. 

Established  in  accordance  w i th  Article  20  of  Council  Directive  90/425/EEC  of  26  June  1 9 90  concerning  veterinary  and 
zootechnical  checks  applicable 
the 
establishment  of  the  internal  market,  OJ  N°  L  2 2 4,  1 8 . 8 . 1 9 9 0,  p.  2 9.  Last  amended  by  the  A ct  concerning  the  conditions 
for  the  Accession  of  Austria,  Finland  and  Sweden  and  adjustments  to  the  Treaties  on  w h i ch  the  EU  is  f o u n d e d,  OJ  C  2 4 1, 
2 9 . 8 . 1 9 9 4,  p.  2 1. 

live  animals  and  products  w i th  a  v i ew 

intra-Community 

in  certain 

trade 

to 

in 

Council  Decision  92/438/EEC  of  13  July  1 9 92  on  computerization  of  veterinary 
(SHIFT  project), 
amending  Directives  9 0 / 6 7 5 / E E C,  91/496/EEC,  91/628/EEC  and  Decision  90/424/EEC,  and  repealing  Decision  8 8 / 1 9 2 / E E C, 
OJ  L  2 4 3,  2 5 . 8 . 1 9 9 2,  p.  2 7.  Last  amended  by  the  A ct  concerning  the  conditions  for  the  Accession  of  Austria,  Finland  and 
S w e d en  and  adjustments  to  the  Treaties  on  w h i ch  the  EU  is  founded,  OJ  C  2 4 1,  2 9 . 8 . 1 9 9 4,  p.  2 1. 

import  procedures 

Council  Decision  90/424/EEC  of  26  June  1 9 90  on  expenditure  in  the  veterinary  field,  OJ  L  2 2 4,  1 8 . 8 . 1 9 9 0,  p.  1 9.  Last 
amended  by  Decision  93/70/EEC  of  21  December  1 9 9 2,  OJ  L  2 5,  2 . 2 . 1 9 9 3,  p.  3 4. 

26-

7C  — 

Phytosanitary  and  other 
nutrition 

legislation  relating  to  crop  products  and  animal 

1° 

Existing mechanisms for enforcement  cooperation 

A well developed framework  of enforcement  cooperation  in the  areas  of  plant  health, seeds,  plant 
breeders'  rights, animal nutrition, pesticide  residues, plant  protection  products  and organic  farming 
has existed for  some time  in the form  of the  regulatory  committees  which  covers  these  sectors  of 
activity42.  Some of these  committees  have existed since the  mid  1960s and others, as in the  case 
of plant health and plant breeders' rights, since 1977 and 1994 respectively. 

Apart  from  their  legislative  functions,  these  committees,  particularly  through  their  numerous 
dependent  committees  of experts  and working groups, ensure  regular  and intensive  exchanges  of 
information.  Fast  information  exchange  is essential  in many  cases, for  example  where  a  Member 
State has intercepted a plant or plant product originating  in a third country  or in the  EU which does 
not fulfil the  EU legislative  requirements. This  is usually  achieved through direct  contacts  between 
the  Member  States  and  the  Commission.  This  is  supplemented  by  the  EUROPHYT  system,  an 
electronic  mailing system between Member States for information exchange. 

Specific  cooperation  exercises  include  the  organizing  of  technical  workshops  and  exchanges  of 
officials  between  Member  States  under the  KAROLUS  programme  (twelve  had been approved  by 
mid-November  1995). The  Plant  Health  Inspectorate  organizes  seminars  and training  courses  for 
Member  States  on  plant  health  inspection  and  also  participates  itself  in  national  training  courses. 
Furthermore,  the  Community  has  arranged  for  Member  States  to  cooperate  in  exchanging  avail 
able scientific  information  and for the  performance  of research  projects  in the field  of  plant health. 
In the  pesticides  area, a seminar  covering  all  Member  States was  held  in  1994 and, under  a new 
pilot  project,  monthly  meetings  of the  Member  States are being held to discuss  specific  aspects  of 
implementation. 

The  committees  also  ensure  that  there  is  a common  interpretation  and  application  of  Community 
legislation  in  these  highly  technical  fields  through  discussion  and  exchanges  of  practical  experi 
ence.  In some  areas there  is a specific  legislative  requirement  to  ensure  a uniform  approach.  For 
example,  in  the  seeds  area,  the  carrying  out  of  Community  comparative  trials  is  designed  to 
ensure harmonized technical  methods of seed certification. Also, if necessary, the Commission will 
assist  in  interpretation  of  difficult  pieces  of  legislation  by  issuing,  for  example,  'interpretative 
notes',. 

2°  Next steps 

Areas of cooperation which might  be improved are those relating to the exchange of officials  under 
the  KAROLUS  programme  (experience  has  shown  a  reluctance  on  the  part  of  some  Member 
States  to  accept  officials  due to  a lack  of time)  and the  development  of the  use  of  electronic  mail 
transfer  between Member States. 

7  D  —  Veterinary  Medicines 

See section  1 B above under Pharmaceutical  products 

42 

That  is  the  Standing  Committee  for  Seeds  and  Propagating  Material  for  Agriculture,  Horticulture  and  Forestry;  Standing 
Committee  for  Plant  Health;  Standing  Committee  for  Animal  Feedingstuffs;  Standing  Committee  for  Propagating  Materials 
and  Plants  of  Fruit  Genera  and  Species;  Standing  Committee  for  Propagating  Material  and  Ornamental  Plants;  Standing 
Committee  on  Plant  Variety  Rights  and  the  Standing  Committee  for  Organic  Farming. 

- 2 7-

8.  Notification  of  technical  Regulations  -  Directive  8 3 / 1 89 

1° 

Introduction 

This  Directive43  provides  for  notification  to  the  Commission  of  national  draft  standards  and 
technical regulations which may give rise to technical barriers within the Internal Market. This gives 
the  other  Member  States  and  the  Commission  the  opportunity  to  react  to  the  draft  regulations 
concerned, which may  not be brought  into effect  until after a standstill period. It is an example of a 
formalized  system  of  information  exchange  in  which  all  communications  pass  through  the 
Commission. 

2° 

Existing mechanisms for enforcement  cooperation 

The  Committee  for  Standards  and  Technical  Regulations,  which  oversees  application  of  the 
Directive, also brings together the Notifying Authorities which appoint the Notified Bodies under the 
New Approach  directives.  Until the  recent  meeting  in July  1995  (see section  1.a)(i) above),  it was 
also the only body in which issues relating to the application of the Toys Directive were discussed. 

Electronic  mail  is  used  for  summary  notifications  and  for  associated  messages.  A  project  to 
increase  the  use  of  E-mail and to establish  appropriate  databases  is at the feasibility  study  stage 
under the IDA programme  (see section 22). 

3° 

Needs 

To be determined  by the study. 

43  Council  Directive  83/189/EEC  of  28  March  1983  laying  down  a  procedure  for  the  provision  of  information  in  the  field  of 
technical  standards  and  regulations,  OJ  L  109,  26.4.83,  p.  8;  amended  by  Directives  88/182/EEC,  OJ  L  8 1,  26.3.1988, 
p.  75,  and  94/10/EC,  OJ  L  100,  19.4.1994,  p.  30 

2 8-

9. 

Customs 

1° 

Introduction 

Customs  is an  area where  administrative  cooperation was  implemented  very  quickly.  As  early  as 
1968  the  Commission  was  trying  to  harmonize  legislation,  mainly  through  directives.  Directives 
have  been  progressively  replaced  by  sectoral  regulations,  which  are  more  binding  and  more 
effective  in achieving legislative harmonization. It became clear,  however, that this inconsistency  in 
the  legal form  of the  texts  was  far  from  making them  easier  to  implement.  The  Commission  thus 
undertook  to  bring the existing  rules together  in a customs  code, which came  into effect  when  the 
single  market was completed. Customs administrations  and economic  operators  now  have to  deal 
with  legislation  which  is  accessible,  precise  and  consistent.  This  is  an  indispensable  condition  for 
the operation of the single  market. 

2° 

Existing  mechanisms:  the  "Customs 2000"  programme,  a  new  challenge  for  customs 
in the European  Union 

If a single  market without  internal frontiers  is to function  properly,  any  customs  checks  carried  out 
in it must be uniform across the various Member States. 

The Commission  has thus  proposed a number  of projects  in preparation for customs work  into the 
next century,  on a basis of partnership with the Member  States. The aim in each case  is to  enable 
customs  to  watch  and  control  the  Community's  external  frontier,  putting  existing  legislation  on  a 
firmer  footing  by  developing  consistent  practices.  These  measures  all  depend  on  administrative 
cooperation of a very active kind. 

The measures  under way  include the following: 

(a) 

adoption of new working  methods 

Efforts  are  afoot  at the Commission to spread the  use of  risk  analysis techniques, whereby  physi 
cal  or  documentary  inspections  can  be targeted,  by  working  out  in  conjunction  with  the  Member 
States  guidelines  enabling  them  to  become  aware  of  all  the  methods  at  present  in  use  in  the 
Union. 

Similar efforts will be devoted to audit techniques, the aim of which is to permit thorough  inspection 
of the accounts  and management  of enterprises,  including those with establishments  in more than 
one country. 

(b) 

customs  penalties 

In  partnership  with  the  Member  States  the  Commission  is  looking  into  this  field,  with  the  aim  of 
avoiding any distortions of competition which economic operators might be liable to. 

(c) 

evaluation of results 

Monitoring  visits  are  being  paid  to  Member  States,  by joint  teams  of  national  officials  from  other 
Member  States  and  Commission  staff.  They  enable  national  officials  to  acquaint  themselves 
directly with the working  methods of other customs administrations. The aim is to ensure the wider 
adoption of those practices which are identified as most effective. 

- 2 9-

(d) 

training 

A  specific  training  programme  for  officials  from  the  Member  States  (the  Matthaeus  programme) 
was  set  up  by  Council  Decision  in  199144.  It  provides  for  exchanges  of  customs  officials  from  the 
Member States and seminars  on specific customs  legislation topics.  It also aims to develop  shared 
training material. 

(e) 

information technology 

The  Commission  and the  Member States  support  the  idea  of a global  strategy  to  guide the  future 
development  of  information  technology  in  customs  procedures.  It will  be  based  on  using  existing 
systems and developing links between them. It also aims to use businesses' computer systems. 

3° 

Impediments 

There  is currently  an  institutional  obstacle  to these  measures, whose  aim  is the  consistent  imple 
mentation of uniform  legislation. Most customs cooperation  is a matter of Community  competence, 
but  unharmonized  fields,  such  as  weapons,  drugs  and  nuclear  military  material,  are  covered  by 
Title VI  of  the  Maastricht Treaty  (Article K. 1(8)).  This  means  that  there  are  difficulties  in  the 
interface between these provisions and Community  law. 

4°  Next steps 

The  Commission  will  be  carrying  on  with  the  programme  begun  in  1994,  in  order  to  put  it  on  a 
firmer footing  and give  it  more  concrete form. The  measures  described  above  could  be  expanded 
and developed. The  main  aim  is that  customs  administrations  should get to. know  each  other  and 
work  together  spontaneously  and  naturally,  with the  aim  of ensuring  greater  equality  of  treatment 
between operators, through inspection being carried out in a consistent  manner. 

44  Council  Decision  91/341/EEC  of  20  June  1991,  OJ  No  L  187,  13.7.1991,  p.  41 

- 3 0-

10  Taxation 

10  A  —  Direct  Taxation 

1° 

Introduction 

Directive  77/799/EEC  on  mutual  assistance  in the  field  of  direct  and  indirect  taxation  provides  a 
framework  under  which  Member  States  provide  mutual  assistance  so  as  to  combat  international 
tax evasion and avoidance.  It is largely concerned with exchange of information. 

2° 

Existing mechanisms for enforcement  cooperation 

An  on-going  programme  of meetings  between direct tax  officials  of Member  States to  improve the 
quantity  and quality  of  information  exchange  under the  Directive was  begun  in  1993. The  working 
group  concerned  achieved  its  first  results  in  1994  when  common  guidelines  on  the  conduct  of 
exchange  of  information  involving  specific  requests  were  agreed.  The  group  also  established  a 
code  of  practice  on  the  "turnaround"  times  that  Member  States  should  aim  to  meet  when 
responding  to  requests  received.  By  pooling  simple  statistics  on  how  far  agreed  standards  are 
met, the group will monitor progress, and review them as necessary  in the future. 

3°  Needs 

To increase and improve the use made of the existing  instruments 

4° 

Impediments 

Different  levels of tax and bank secrecy in different  Member States. 

5°  Next steps 

The  working  group  will  examine  how  equivalent  improvements  might  be  achieved  in  the  field  of 
exchange of information involving "automatic" or "spontaneous" means. 

10  B  —  Indirect  Taxation 

1° 

Introduction 

The  abolition  of  border  formalities  on  1 January  1993  placed  a  premium  on  enforcement  coop 
eration  between  national  tax  control  authorities.  The  VAT  Information  Exchange  System  (VIES) 
was thus set up between them through  Regulation  218/92. Similarly,  Directive  92/12 established a 
Committee  on  Excise and a System  of Exchange  of Excise  Data  (SEED)  Certain VAT data  is now 
stored and transmitted electronically  between Member States, and excise data by diskette. 

The Regulation  also provided for the establishment  of a network of Central  Liaison Offices  and the 
Standing  Committee  on  Administrative  Cooperation  (SCAC),  which  is  also  foreseen  in  Directive 
77/799  on  mutual  assistance  in the field  of direct  and  indirect  taxation. The  Commission  runs  the 
telematic network, maintains and distributes a directory  of the Offices  and manages the SCAC and 
the  Excise  Committee.  It  provides  a  framework  for  future  development  of  cooperation  in 

31 

partnership with the Member  States  in the light of shared experience  and a common  perception of 
one another's needs. 

2° 

Existing mechanisms for enforcement  cooperation 

Council  Decision  93/588  set  up the  Matthaeus-Tax  programme,  which  provides  for  exchanges  of 
indirect  tax  officials  between  administrations  and the  holding  of training  seminars  for  enforcement 
and  training  officials.  Up to  100  officials  are  exchanged  each  year  and  10  or  more  seminars  are 
held.  The  decision  also  provides  for  common  training  programmes  to  be  implemented  in  each 
Member State. 

For VAT  control  purposes, the  administrations  need to  be able to  identify  traders  who  are  making 
intra-Community  acquisitions  to  ensure  that  they  are  correctly  accounting  for  the  tax.  Data  from 
quarterly  statements  by  traders  is  exchanged  between  administrations  through  the  VIES  for  this 
purpose.  The  VIES  also  enables  VAT  identification  numbers  to  be  checked  across  internal 
borders,  whilst  for  excise  duties,  the  SEED  fulfils  the  same  function.  Further  information  can  be 
requested, under both Regulation 218/92 and Directive 77/799. More than  1 400 such requests for 
further  information  were  handled  during  1994.  For  excise,  similar  data  is  exchanged  under  the 
movement verification system established in accordance with Article  19(6) of Directive 92/12/EEC. 

The  VAT  Committee  provided  for  in  Article  29  of  the  6th  VAT  Directive  and  the  Committee  on 
Excise  duties  mentioned  above  ensure  the  common  interpretation  of  Community  Law  on  indirect 
taxation.  Valuable  input  is  provided  by the Advisory  Committee  on  Customs  Matters  and  Indirect 
Taxation and a number of ad hoc bodies. 

The  Commission  distributes  a  guide  on  VAT  arrangements  in  each  Member  State,  recently 
updated to  include the  new  Member  States.  It has  also  initiated  and financed  experiments  on the 
coordinated  control  by  several  Member  States  of  multinational  enterprises  and  other  enterprises 
operating in intra-Community trade. 

3° 

Impediments 

These  are  few,  thanks  partly  to  the  Central  Liaison  Offices.  The  Commission, the  SCAC  and  the 
Committee  on  Excise  duties  keep  watch  on  those  still  caused  by  differences  in  legislation  and 
methods. 

4°  Next steps 

The  Commission  proposes  to  build  on  the  already  high  level  of  enforcement  cooperation  in  this 
sector  and,  in  addition  to  its  work  on  the  exchange  of  information,  is  seeking  to  improve  mutual 
assistance  in the recovery  of tax debts  by examining the use of existing Community  arrangements 
and reviewing the adequacy of the legislation. 

The  adequacy  of  existing  messaging  systems  will  also  be  reviewed,  for  example  the  present 
exchange  of excise data from  national databases  by means of diskettes will be replaced by an on 
line  system.  The  Commission  will  argue  for  adequate  budget  to  finance  this,  the  VIES  and  the 
Matthaeus-Tax  programme. 

32-

1 1.  Drug  Precursors 

1° 

Introduction 

Regulation  3677/90  as amended was adopted to implement Article  12 of the  1988 UN  Convention 
against  Illicit  Drugs  Traffic,  to  which  the  Community  has  become  a  Contracting  Party.  The 
amendments  introduced  by  Reg. 900/92  reflect the  results  of the G7  Chemical Action  Task  Force 
(CATF) established  by the  1990 Houston Summit,  in the work of which the Commission  and seven 
Member States participated. 

2° 

Existing mechanisms for enforcement  cooperation 

Information  exchange  takes  place  via  the  SCENT  E-mail  network  which  operates  on  some  300 
terminals  in all  Member  States. The  network  is open to  all authorities  competent  under  the  above 
Regulation. Administrations  not yet connected are being served via fax or telex. 

(a)  Exchanges  between Member States' officials 

Exchanges  between enforcement  officials are planned in 1995 under the Matthaeus  (customs)  and 
Karolus  (other  branches)  programmes.  In  addition,  1-month traineeships  at  the  Commission  will 
soon  be  offered  to  Member  States'  officials  (quite  a  number  of  applications  have  already  been 
received). 

(b)  Training  programmes: 

Annual seminars  have been held since  1994, partially financed under the Matthaeus  programme; it 
is  suggested  that  more  specialized  events  be  conducted,  each  aimed  at  a  specific  group  of 
officials  (investigators, licensing officials, etc.). 

(c)  Other 

The  smooth  implementation  of  the  rules  is  monitored  at  the  periodic  meetings  of  the  Drugs 
Precursors  Committee.  Cases  of  diversion  established  or  suspected  have  to  be  reported  to  the 
Commission  as  well  as  other  elements  that  concern  gaps  or  shortcomings  in  the  provisions. 
Instances  of  divergent  implementation  are  examined  by  the  Committee  with  a  view  to  finding  a 
to 
solution  shared  by  all  delegations.  Committee  rulings  are  established  and  circulated 
administrations  as "Agreed Opinions". 

In  addition  to  contacts  through  the  Committee,  officials  from  the  Member  States  regularly 
participate  as  trainers  in  external  programmes  in  favour  of  third  countries  (e.g.  a  precursors 
training  programme  under  PHARE;  seminars  for  CIS,  Middle  Eastern,  ASEAN  etc.  countries) 
which offer continuous opportunities for contact and feedback. 

3°  Needs 

Competent  authorities  have to consult  each other with  regard to  all  relevant  aspects  of the  matter 
(issue  of  licences,  export  authorizations  and  in  particular,  anti-fraud  cooperation).  Regulation 
3677/90  refers  to  the  application,  mutatis  mutandis,  of  Reg.  1468/81,  as  an  established  tool  of 
administrative  cooperation  in the field of customs  and agriculture.  The  Commission  depends  on a 
continuous  information  flow  to  fulfil  its  role  as  coordinator  in  anti-fraud  matters,  reporting  to 
international organizations  such as the United Nations. 

4° 

Impediments 

33-

Certain difficulties  may stem from a lack of coordination with other areas managing similar forms of 
export  controls  (chemical  weapons  etc.),  and the  sharp  contrast  between  drugs  precursors  being 
involving 
subject  to  Community  procedures  and  the  remaining  field  of  drugs  cooperation 
cooperation  under Title VI of the Treaty on European Union. 

5°  Next steps 

Maintaining  the  current  resource  and  action  level  would  certainly  help  to  ensure  a  continuous 
growth  in  the  efficiency  of  cooperation  in this  field.  It  would  be  desirable  if  the  Commission  and 
Member  States  could  overcome  pragmatically- the  unproductive  gap  between  activities  based  on 
the EC Treaty  and those under Title VI TEU. 

« 

34 

1 2.  Cultural  Goods 

1° 

Introduction 

The Community  has adopted two main instruments in the field of protecting cultural goods, in order 
to  do  away  with  checks  on  goods  at  internal  frontiers:  the  Regulation  on  the  export  of  cultural 
goods45 and the Return Directive46. 

2° 

Existing mechanisms for enforcement  cooperation 

There  can  be  no  question  of  any  return  arrangements  without  cooperation  between  the  Member 
States (for instance, to find but where unlawfully  removed goods now are and who is in  possession 
of them). The  Directive thus  provides for the cooperation which  is indispensable  if the  mechanism 
for return is to operate  properly. 

Powers  regarding the  protection  of cultural goods  are  spread  among  many  different  authorities  in 
each  Member  State,  so  the  Directive  lays  down  that  each  country  is  to  designate  one  or  more 
central  authorities  (depending  on  the  particular  structures  of  the  Member  State,  which  may  be a 
federal one) to carry out the functions covered by the Directive. 

These  central  authorities  serve  mainly  as  contact  points.  They  cooperate  with  each  other  and 
facilitate consultation among the competent authorities of the Member States. 

The  Directive  lays down that  Member  States  are to  inform the  Commission  of the  central authori 
ties they designate and that the Commission is to publish a list of them in the Official Journal. 

The  Regulation  also  provides  that  there  is to  be  cooperation  between  the  authorities  responsible 
for controls on cultural goods being exported and the central authorities  referred to here. 

3°  Needs 

The "general" cooperation  on protection of national treasures  envisaged  by the  Council  and falling 
within the  competence  of the  Member  States  has  not  so far  been  embarked  upon. The  Council's 
working  group  on  drugs  and  organized  crime  has  started  its  examination  of  initiatives  in  police 
cooperation against illegal traffic  in works of art. 

4° 

Impediments 

Nine  Member  States  were  to  have  transposed  the  Directive  by  15  December  1993,  Belgium, 
Germany  and the  Netherlands  by  15 March  1994, and Austria,  Finland and Sweden  by  1 January 
1995. 

By  October  1995,  it  had  been  transposed  only  by  Denmark,  Spain,  France,  Ireland;  the  Nether 
lands,  Finland,  Sweden  and  the  United  Kingdom.  Of  these  eight,  only  Finland,  Ireland,  Sweden 
and the United Kingdom had informed the Commission of their central authorities. 

5°  Next steps 

Those  Member  States  which  have  not  yet  done  so  should  transpose  the  Directive  as  soon  as 
possible  and  let  the  Commission  know  who  their  central  authorities  are,  indicating  whether  they 
are the  same  contact  points  notified  under  either  the  Regulation  or  the  Council  Resolution  of  16 
June  1994 on administrative cooperation. 

45  Council  Regulation  (EEC)  No  3911/92  of  9  December  1992  on  the  export  of  cultural  goods,  OJ  No  L 395,  31.12.1992,  p. 

1 

46  Council  Directive  93/7/EEC  of  1 5  March  1993  on  the  return  of  cultural  objects  unlawfully  removed  from  the  territory  of  a 

Member  State,  OJ  No  L 74,  27.3.1993,  p.  29 

35 

13.  Freedom of  Establishment 

Recognition  of  diplomas 

1° 

Introduction 

In the  recognition  of  diplomas,  there  are  already  several  examples  of  administrative  cooperation 
playing a very  important  role in the proper implementation of the Directives. 

2° 

Existing mechanisms for enforcement  cooperation 

The Committee  of Senior Officials  on Public  Health, set up in  1975, is made up of Member States' 
senior  officials  with  direct  responsibility  for  public  health.  Its job  is to  discuss  and where  possible 
solve problems arising in the implementation  of the  Directives concerning doctors, dentists,  nurses 
and midwives. 

Ad hoc working  parties  have  been set  up by the Commission to cover the  Directives  on  architects 
and  veterinarians.  Like  the  Pharmaceutical Committee,  whose  scope  was  extended  to  include 
pharmacists  by Directives 85/432 and 85/433, they do the same work  as the Committee  on  Public 
Health in their own specific areas. 

Directives 89/48/EEC  and 92/51/EEC on a general system for the recognition of diplomas  also set 
up  a  system  of  administrative  cooperation  between  the  Member States  and  the  Commission. 
Under  them,  each  Member State  has  to  appoint  a  coordinator  for  recognition  of  diplomas.  The 
coordinators  meet  five  times  a  year  with  the  Commission,  to  discuss  problems  in  implementing 
in  uniform 
these  Directives.  Their  discussions  provide  guidance 
interpretation  of  the  Directives  as  regards  certain  more  sensitive  areas.  Contacts  between 
coordinators  and between them and Commission officials  have enabled many specific  problems to 
be resolved. The group  has also helped in drawing up the vade mecum to the general system  and 
the user's guide, intended for the use of private citizens. 

the  Member States 

for 

3°  Next steps 

Improving  cooperation  involves above all constant efforts to build mutual confidence  in daily work. 
This will be continued in the committees and groups mentioned above (and the seven others which 
also include expert members from the universities and the professions). 

Efforts  will  continue  to  develop  the  use  of  electronic  mail,  where  this  is justified,  and  to  improve 
statistics. 

1 4.  Company  Law 

36 

In  general,  for  problems  in  the  company  law  areas  the  partners  of  the  Commission  are  the 
representatives  of  the  ministries  of  Justice.  As  far  as  the  accounting  area  is  concerned,  the 
partners come from the ministries of Justice or the economics or finance ministries. 

14  A  —  Accounting 

1° 

Introduction 

With  the  adoption  of  the  Fourth  Directive  in  1978  a  "Contact  Committee  for  the  Accounting 
Directive " was set up. This Committee  is composed of representatives  of the  Member States  and 
of the Commission. The chairman is a representative of the Commission. 

2° 

Existing mechanisms for enforcement  cooperation 

The functions of the Committee are: 

• 

• 

to  facilitate  harmonized  application  of  the  Accounting  Directives  through  regular  meetings 
dealing in particular with practical problems arising in connection with its application; 

to advise the Commission, if necessary, on additions or amendments to these Directives. 

The Committee  is convened  (normally twice a year)  by the chairman  either  on his own  initiative or 
at  the  request  of  one  of  its  members.  The  points  of  the  agenda  are  largely  influenced  by  the 
representatives  of the Member States. 

The outcome of discussions  on accounting  problems are laid down in the  meeting  report.  In 1990, 
a brochure summarizing some of the conclusions was published by the Commission. 

There  is agreement  that the  Contact  Committee  is the  appropriate  body to  "play  a  leading  role  in 
the  practical  organization  of  cooperation  between  the  competent  administrations  of  the  Member 
States  and  the  Commission  departments,  primarily  in  the  framework  of  existing  bodies  and 
committees", as called for in the Resolution. 

As  the  accounting  rules  are  very  much  influenced  by  national  standard  setting  bodies,  an 
Accounting  Advisory  Forum,  representing  the  main  parties  involved  in accounting  in the  EU, was 
set  up. This  body  advises  the  Commission  on technical  accounting  matters  and  possible  ways  to 
facilitate further harmonization. 

14  B  —  European  Economic  Interest  Grouping  (EEIG) 

1° 

Introduction 

A  Contact  Committee  was  set  up  under  the  Regulation  on  the  European  Economic  Interest 
Grouping47 adopted on 25 July  1985. 

47  Council  Regulation  (EEC)  No  2137/85  of  25  July  1985  on the  European  Economic  Interest  Grouping,  OJ  L  199,  31.7.1985, 

P-1 

37-

2° 

Existing mechanisms s for enforcement  cooperation 

The  functions  of  the  Committee  are to  facilitate  the  application  of  the  Regulation  through  regular 
consultation  dealing  in  particular  with  practical  problems  arising  in  connection  with  its  application 
and to advise the Commission, if necessary, on additions or amendments to the Regulation. 

3°  Next steps 

It  is  hoped  that  the  Contact  Committee  may  act  as  a  means  of  collating  information  on  EElGs 
registered  in individual  Member States, which would assist  in the maintenance  by the  Commission 
of a database of existing EElGs. 

38 

1 5. 

Insurance,  Banks,  Securities 

15  A  —  Insurance  Sector 

1° 

Introduction 

In  the  insurance  sector,  administrative  cooperation  has  always  been  considered  necessary  to 
ensure  the  proper  enforcement  of  EEC  legislation  throughout  the  Community.  EEC  Insurance 
Directives  already  lay  down  close  cooperation  among  the  competent  insurance  supervisory 
authorities.  The whole  system  of the  "European  passport"  is  built  on  such  cooperation.  Coopera 
tion  is  also  required  between  Member  States  and the Commission  in order  to  ensure  the  correct 
implementation of these  Directives. 

2° 

Existing mechanisms for enforcement  cooperation 

Two fora  carry  out the  enforcement  cooperation  in the  insurance  sector:  the  Conference  of  Insur 
ance Supervisory Authorities  (of the Member States of the EU) and the Insurance Committee. 

The Conference was set up in 1957 by Member States. The Commission  has observer status. The 
Conference  discusses  problems  relating  to  insurance  supervision  {i.e.  solvency  of  insurance 
undertakings).  The  Conference  has  also  laid  down  protocols  for  collaboration  between  the  com 
petent authorities to facilitate the practical implementation of the insurance directives. 

The  Insurance Committee  (IC), was created by Directive 91/675/EEC. Apart from  its role of assist 
ing the Commission  in the use of its implementing  powers, the  Insurance Committee  may  examine 
any  particular  question  pertaining  to  the  insurance  sector  as  well  as  the  application  of  the 
insurance  directives.  A  number  of  questions  concerning  insurance  problems  have  already  been 
discussed  by the  IC (insurance  groups,  border  lines  between  social  security  and  insurance,  inter 
pretation of insurance directives, etc.) 

An  ad  hoc  Interpretation  Group  was  created  in  1994  to  examine  interpretative  questions  arising 
from  EU  legislation  on  insurance.  The  group,  composed  of  representatives  of  Member  Sates' 
supervisory  authorities,  is  chaired  by  the  Commission.  The  Interpretation  Group  reports  to  the 
Insurance  Committee, which  may  convene to discuss the  interpretation  to  be given to  a  particular 
provision of EEC legislation. Two meetings have taken place in 1995. 

The  Insurance  Committee,  under  its  "comitology"  powers,  may  also  take  decisions  to  clarify  the 
definition of the insurance directives. 

The  KAROLUS  programme  provides  an  opportunity  for the  exchange  of  officials  of  national  com 
petent authorities. The first conclusion of these exchanges appears to be positive. 

3°  Needs 

Cooperation  between  Member  States  and  Member  States  and  the  Commission  is  essential  to 
ensure  the  smooth  application  of  the  "single  licence"  system  and  the  home  country  supervisory 
regime in the  Community. 

The Third  Insurance Directives also provide for on-the-spot verification by the Home Member  State 
of  the  branch  of  an  insurance  undertaking.  The  competent  authorities  of  the  Host  Member  State 
must  cooperate with the  Home Member  State to facilitate this verification of the branch. They  may 
also take part in this verification exercise. 

39 

Interpretative  Communications  could be used to make clear the Commission's  position  on particu 
lar  and  sensitive  points.  This  is the  case  in the  management  and  custodian  activities  of  pension 
funds.  A  Communication  on  the  management  of  assets  held  by  pension  funds  as  well  as  the 
investment  of these assets was published by the Commission in December  1994. 

4°  Next steps 

Besides  participation  by  national  officials  in  Karolus,  the  participation  by  Commission  officials  in 
specific  training  programmes  on  insurance  and financial  services  aspects  would  be  useful. Train 
ing periods with supervisors and in insurance companies are also seen as necessary to enable the 
Commission to carry out its tasks. 

The  Commission  has started  discussions  with  Member  States  to  set  up  a  pilot  programme  for  an 
electronic  network  to  enable  the  exchange  of  messages  and  information  on  the  supervision  of 
insurance  undertakings  between  Member  States'  competent  authorities  (EDENIS  Electronic  data 
exchange  network  in  insurance).  This  network  could  ease  cooperation  between  competent 
authorities.  The  objective  Was  to  make  the  system  operative  during  the  second  half  of  1995. 
Unfortunately,  budgetary  constraints  have meant that it has been postponed for the time being. 

However,  it  is felt  that  some  kind  of  electronic  network  will  be  necessary  to  improve  enforcement 
cooperation,  make  the  exchange  of  information  between  administrations  easier  and  quicker  and 
make for a more efficient  supervision of the insurance industry  in the internal market. 

15  B  —  Banks 

1° 

Introduction 

The  second  Banking  Directive,  89/646/EEC  of  15  December  1989,  has  been  in  force  since  1 
January  1993.  Among  its  provisions  this  directive  introduced  a  single  "passport"  or  licence  for 
credit  institutions,  which  is  recognized  throughout  the  Union  and  is  backed  up  by  innovative 
machinery  for  notification  and  cooperation,  being  based  on  supervision  by  the  authorities  of  the 
country  of  registration  for  overall  solvency  and  by the  host  country  for  liquidity  of  branches  on  its 
territory. 

2° 

Existing mechanisms for enforcement  cooperation 

There  has  been  cooperation  with  the  Member  States  in  the  banking  field,  at  institutional  level, 
since  1979, when  the  Banking  Advisory  Committee  was  set  up  by  the  first  coordinating  directive 
(77/780/EEC).  Another  form  of  cooperation  takes  place  in  the  Contact  Group  of  the  banking 
supervisory  authorities  of the  Member  States, which was  not set  up by a Community  directive  but 
whose  existence  was  recognized  by Community  instruments,  and  in which the  Commission's  par 
ticipates.  The  Central  Bank  Governors  of  the  European  Community  hold  cooperation  meetings 
without  the  Commission  in the  Subcommittee  on  Banking  Supervision  of the  European  Monetary 
Institute. 

These  various  bodies  examine  the  problems  in the  single  banking  market  with  a view  to  working 
out solutions that can be the subject of national measures, or to recommending to the  Commission 
solutions which require new proposals for Council or Commission directives  in accordance with the 
new committee  procedures. 

40 

The  Commission  has  also  received  many  bilateral  memoranda  of  understanding,  which  the 
majority  of Member  States  have concluded with a view to  implementing  the  new  procedures  intro 
duced by the second Directive. 

The  Commission  has  set  up the  Working  Party  on  the  Implementation  of  the  Banking  Directives 
(WPIBD), whose  purpose  is to  examine  and, as  appropriate,  resolve  all the  problems  of  interpre 
tation  which  the  Member  States  encounter  when  applying  the  directives.  If  the  Working  Party 
agrees  on  a  common  interpretation,  the  Commission  undertakes  to  publish  it.  If  there  is  no 
agreement,  the  problem  is  referred to the  Banking Advisory  Committee  (BAC), which  delivers  an 
opinion.  If  the  Committee  reaches  agreement  the  Commission  publishes  the  interpretation;  if  it 
does  not, the  Commission  has the  right to draw the  conclusions  necessary.  The  Commission  has 
published  a draft  communication  on the  concepts  of freedom  to  provide  services  and the  interest 
of  the  general  good,  interpretation  of  which  has  been  under  discussion  in  the  WPIBD  and  the 
BAC48. 

3°  Needs 

The  home  and  host  countries  need  to  exchange  prudential  and  other  information,  especially  if 
there is doubt as to whether the institution still complies with the criteria for authorization. 

4°  Next steps 

A  recently  adopted  Council  Directive49 extends  the  arrangements  for the  exchange  of  information 
between  supervisory  authorities  belonging to different  categories  and requires  external  auditors  to 
notify the supervisory  authorities  of any  circumstances  likely to  undermine the  stability  of the  insti 
tutions whose accounts they audit. 

In the  light  of  contributions  received  in response  to  its draft  communication  mentioned  above, the 
Commission  will  consider  publication  of  an  interpretative  communication  enabling  economic 
operators  and the  Member  States to determine the stance that the  Commission  would  be likely  to 
adopt on these questions  in the event of a particular problem being brought to its attention. 

15  C  —  Securities 

1° 

Introduction 

Many  directives  already  adopted  in the securities  markets field, for  example  the  1979 directive  on 
stock  exchange  listing  conditions,  provide  for  cooperation  between  the  competent  authorities  in 
different  Member  States,  notably  as  regards  the  exchange  of  information.  Such  information 
exchanges are covered by a professional secrecy obligation. 

In addition  Member  States  supervisors  meet  at  biannual  meetings  organized  by  the  Commission 
(High  Level  Securities  Supervisors  Committee)  and on an informal  ad hoc  basis without  Commis 
sion  participation.  Furthermore,  the  Commission  has  adopted  a  proposal  for  a  Directive  on  the 

48  OJ  C 291,4.11.1995,  p.  7. 
49  European  Parliament  and  Council  Directive  95/26/EC  of  29  June  1995  amending  Directives  77/780/EEC  and  89/646/EEC  in 
insurance,  Directives 
the  field  of  credit  institutions,  Directives  73/239/EEC  and  92/49/EEC 
79/267/EEC  and  92/96/EEC  in the  field  of  life  assurance,  Directive  93/22/EEC  in the  field  of  investment  firms  and  Directive 
85/611/EEC  in  the  field  of  undertakings  for  collective  investment  in  transferable  securities  (Ucits),  with  a  view  to 
reinforcing  prudential  supervision,  OJ  L  168,  18.7.1995,  p.  7 

in  the  field  of  non-life 

-41 

setting  up of the  Securities  Committee50,  which  would  replace  the  High  Level  Securities  Supervi 
sors Committee. 

2° 

Existing mechanisms for enforcement  cooperation 

In  the  securities  markets  field  cooperation  is  being  given  practical  effect  by  the  drawing  up  of 
mutual  cooperation  agreements  ("Memoranda  of  understanding)  between  supervisors  whose 
countries  have  significant  amounts  of  trading  volume  between  them.  These  agreements  were 
initially  entered  into  between  some  European  Supervisors  and  US  and  Japanese  regulators,  but 
are now becoming  more common as regards contacts within Europe. 

3°  Needs 

As  securities  trading  is essentially  an  international  activity,  the  more  so  as  information  technology 
permits  greater  ease  of  communication,  effective  regulation  of  market  participants  depends  cru 
cially  on  cooperation  between  supervisors  in  the  enforcement  of  their  respective  national  rules. 
This  is  particularly  evident  in the  case  of  insider  trading, where  an  insider  can  use the  securities 
market  of  another  country  to  carry  out  an  illegal  trade  in the  hope  of  non-detection  by  the  home 
country  supervisors. The Commission  does  not  play an active  part  in this exchange  of  information 
between supervisors, because the Commission has no direct supervisory  role to play. 

Following  the  adoption  in  1993  of  the  Investment  Services  and  Capital  Adequacy  directives  the 
Commission  has convened  a certain  number  of informal  interpretation  meetings  on both  directives 
in  order  to  discuss  particular  problems  encountered  by  Member  States  in  the  course  of  the 
implementation  process. 

4°  Next steps 

The  Commission  should  monitor  how  effectively  the  cooperation  provisions  of  the  securities 
markets  directives  are  working  in  practice,  particularly  when  there  is  a  sharing  of  supervisory 
responsibility  between  home  and  host  Member  State  supervisors  and the  Directive  setting  up the 
Securities Committee should be adopted as soon as possible. 

50  COM  (95)  360  final  of  1 7 July  1995 

- 4 2-

1 6. 

Intellectual  Property 

1° 

Introduction 

Practical  implementation  of  Community  legislation  corlcerning  industrial  property  is  a  matter  for 
Member  States'  patent  offices,  most  of which  are independent of any national ministry. They deal 
with  patents,  trade  marks,  designs  and  models  generally,  and  also  any  utility  models.  A  high 
degree  of  coordination  between  the  policies  of  Member States,  through  the  European  Patent 
Office in Munich and the Office for Harmonization in the Internal Market in Alicante. 

2° 

Existing mechanisms for implementation  cooperation 

As  regards  patents, the  meetings  of the Administrative  Council and of Heads of delegation  at the 
European  Patent  Office  (Munich)  provide the  opportunity for regular exchanges of views between 
representatives  of the  Commission  and of the  Member States, including as regards developments 
in  national  legislation. The  same  meetings  also  enable  ratification of the  Luxembourg Convention 
on  the  Community  patent  to  be  monitored.  The  European  Patent  Office  also  provides  the 
secretariat  for  a  special  body  responsible  for  setting  up  the  Community  patent,  called  the 
Community  Patent  Interim Committee. 

A meeting  of  national experts  organized  by the Commission  in January  1995 allowed a discussion 
of  a  number  of  problems  in the  interpretation  of  Regulation 1768/92  concerning the  creation  of a 
supplementary  protection  certificate for  medicinal products, on which joint guidelines were worked 
out. 

As  regards  trade  marks,  since  the  adoption  of  Regulation 40/94  on the  Community  trade  mark, 
meetings of the Administrative  Council of the Office for Harmonization in the Internal Market (trade 
marks,  designs  and  models)  have  been  providing 
for  meetings  with 
Member  States' officials. These meetings discuss matters concerning the setting-up of the Alicante 
office and also monitor certain aspects of national trade marks. 

the  opportunity 

There  is  appropriate  coordination  for  meetings  of  the  governing  bodies  of the  World  Intellectual 
Property  Organization  (WIPO)  in  September  each  year  and  of  expert  committees  looking  at 
specific  aspects of  intellectual  property.  Thanks  to such coordination, the  Presidency  is frequently 
able to speak for all  15 Member States. 

As  regards  copyright  and neighbouring  rights, there are contacts in the Council's Working Party of 
Intellectual  Property Attachés, where positions are coordinated for meetings at WIPO. Discussions 
within  the  Council  of  Europe  and  UNESCO  on  copyright  matters  also  provide the  opportunity for 
many  meetings  between Commission and Member State representatives. 

3°  Next steps 

The  Commission  plans  to  continue  and  if  necessary  step  up  its  contacts  with  Member States' 
experts. 

4 3-

1 7.  Broadcasting 

1° 

Introduction 

All  the  Member States  have  reported  their* national  measures  transposing  Directive  89/552.  The 
Commission  has  decided  to  initiate  infringement  procedures  against  most  of  them.  The  national 
legislation  of  the  new  Member  States  is  currently  being  scrutinized.  Most  of  the  problems 
(mistaken interpretation, ambiguous drafting)  seem to be nearing solution. The points at issue vary 
greatly  from  one  Member  State  to  another  and  a strengthened  coordination  procedure  is  unlikely 
to provide a solution for them. 

2° 

Existing  mechanisms 

To  monitor this  Directive, there  is an ad hoc group of  representatives  of Member States  set  up by 
the  Commission,  to  discuss  problems  of  interpretation  or  implementation  encountered  by  the 
Member States. This group  has been very  useful in facilitating  implementation  of the  Directive  and 
will  continue  to  play  this  role  both  in  monitoring  implementation  of  the  present  Directive  and 
implementing the new one when it is adopted. 

3°  Needs 

Some Member States  have said that it would be useful to have a formal working group  (composed 
of  regulatory  bodies)  with  the  dual  task  of  formulating  a joint  approach  to  problems  concerning 
public  morality  (pornography,  violence,  collaboration  in  the  viewing  of  films  etc.  and  ensuring 
regular  exchange  of  information  on  broadcasting  bodies  in  order  to  avoid  gaps  or  overlaps 
between the competence of Member States. 

4°  Next steps 

The  Council,  at  its  meeting  held  on  20  November  1995 for  the  purpose  of  revising  the  Directive, 
arrived at a political agreement,  part of which involved the establishment  of a contact committee. 

44-

1 8.  Transport 

1° 

Existing mechanisms 

In  transport,  and  particularly 
the 
Member States  or  between  them  and  the  Commission  is  expressly  provided  for  in  some 
regulations and directives. 

in  road  and  air  transport,  cooperation  either  between 

The  cooperation  networks  thus  set  up  are  still  far  from  being  effective  in  all  areas,  but  some  of 
them  are operating fairly well, for example,  international  passenger  bus transport,  road  passenger 
and goods cabotage, crisis measures  in road transport of goods, taxation of road transport,  mutual 
recognition  of  boatmasters'  certificates  (inland  waterways),  access  for  Community  air  carriers  to 
intra-Community  air routes. Ad hoc meetings are organized for this purpose. 

Other  networks  have  been  provided  for  in  the  legislation  but  are  not  operating  well.  In  certain 
areas no such networks are provided for. 

Under  the  Karolus  programme,  a  number  of  exchanges  have  taken  place  between  national 
officials  responsible for  inspection work  in the  implementation  of legislation  concerning  road trans 
port and in the field of shipping,. 

- 4 5-

Part II 
Other  areas 

1 9.  Social  Policy 

19  A—  Social  Security  for  Migrant  Workers 

1° 

Introduction 

In accordance with the provisions  of Articles 48 - 51 of the Treaty  on free  movement  for workers, 
Council  Regulation  1408/7151  lays down  provisions  for  the  coordination  of  national  social  security 
schemes.  Detailed  provisions  on  the  implementation  of  Regulation  (EEC)  1408/71,  including  the 
institutions  responsible, are laid down in Regulation 574/72 of 21 March  1972. 

2° 

Existing mechanisms for enforcement  cooperation 

An  "Administrative  Commission  on Social  Security  for  Migrant  Workers"  is  set  up  by  virtue  of  the 
provisions  of  Regulation  1408/7. This Administrative  Commission, made  up of  Member  State  rep 
resentatives  has  a  number  of tasks  including  dealing  "with  all  administrative  questions  and  ques 
tions  of interpretation  arising from the provisions  of the  Regulation." In.cases where  administrative 
problems  arise  due  to  lack  of  enforcement  of  the  provisions  of  the  Regulation,  the  subjects  are 
discussed  in  the  Administrative  Commission  and  solutions  are  found.  The  Secretariat  of  the 
Administrative  Commission  is  often  contacted  by  individuals  claiming  that  social  security  institu 
tions  have  failed  to  recognize  their  entitlement  to  benefits  under  the  provisions  of  Regulation 
1408/71.  Solutions  are  found  in  collaboration  with  representatives  of  the  Member  States  in  the 
Administrative Commission. 

Within the Community,  there are thousands  of social security  institutions  implementing  Regulation 
1408/71.  The Administrative  Commission  has  elaborated  a  number  of  model  forms  that  structure 
the flow of information between institutions  in the Member States. 

In  1991, the  Administrative  Commission  set  up  the  TESS  Working  Party  (Telematics  for  Social 
Security)  which  implements  the  TESS  Programme:  Development  of  Telematic  Services  for  the 
Coordination  of European  Social Security  Schemes. The TESS Working  Party  analyses the  needs 
of  the  social  security  institutions  in  terms  of  exchange  of  information  and  defines  appropriate 
solutions for improvement  and modernization. 

Once  it  has  dealt  with  a  question  of  interpretation  of  Regulation  (EEC)  1408/71  or  574/72,  the 
Administrative  Commission  formalizes  its  findings  in  Decisions  or  Recommendations  which  are 
published in the Official Journal. 

Within  the  TESS  framework  a glossary  of  "Social  Security  Terms"  is  being  developed  to  support 
the future telematic exchange of information. 

The Secretariat  of the Administrative  Commission  within the  Commission  organizes  regular  semi 
nars  on  various  subjects  relating  to  the  implementation  of  Regulation  1408/71.  in  1994  a  guide 
was  published,  describing  the  functioning  of  the  Regulation  in  a  language  which  is  easily  acces 
sible for the general public and introducing the social security schemes  in the Member States. 

51 

Regulation  (EEC)  No  1 4 0 8 / 71  of  the  Council  of  14  June  1971  on  the  application  of  social  security  schemes  to  employed 
persons,  to  self-employed  persons  and  to  members  of  their  families  moving  w i t h in  the  Community,  OJ  L  1 4 9,  5 . 7 . 7 1,  p.2 

46-

19  B  —  Labour  Inspection 

1° 

Introduction 

Since  1982,  on the  initiative  of the  Commission,  a Committee  of  Senior  Labour  Inspectors  (SLIC) 
has held regular  meetings with the aim  of  improving  cooperation  between  Member  States  and the 
Commission  and  of encouraging  the effective  and consistent  enforcement  of  European  legislation 
in the  Member  States.  The  Committee  consists  of two  high-ranking  representatives  of  the  labour 
inspectorates  in each of the Member States. 

From the  start  SLIC  has  been  both  a forum  of  close  collaboration  between  national  experts  from 
the  Member  States  and  the  Commission  to  exchange  information  and  a  network  of  relevant  offi 
cials to assist the achievement  of effective enforcement  of Community  social legislation. 

By decision  of the  Commission  on  12 July  1995, the  SLIC was  established  as  an official  Commit 
tee. 

2° 

Existing mechanisms for enforcement  cooperation 

The  SLIC  has established  a network  of  national  correspondents  - labour  inspection  - for the  rapid 
exchange  of  information.  This  network  is  being  used to  exchange  information  about  enforcement 
of  Community  law  on  the  internal  market  and,  among  others,  the  enforcement  of  the  Machinery 
Directive. 

The  SLIC  has  defined  common  principles  of  labour  inspection  in the  field  of  health  and  safety  at 
work  and  is fostering  the  development  of  methods  of  assessing  national  systems  of  inspection  in 
relation to these principles (the first  pilot evaluation  is now being carried out in the  Netherlands). 

One of the main activities of the SLIC is the exchange of inspectors  between Member States. 

Over  the  years,  nearly  100  inspectors  have  visited  another  European  country  to  study  a  topic  of 
particular  interest  to their  own country.  Through this  activity  mutual  knowledge  about  enforcement 
experiences  is being promoted. 

Two  "European  Sessions"  to  exchange  information  on  methods  of  inspection  in  specific  sectors, 
involving  inspectors  from four  different  Member  States,  have  been  completed  since the  beginning 
of  1990s, in the construction  and agricultural  sectors  respectively.  . A third will  be launched  at the 
next plenary  meeting of SLIC. The sector will be the car industry and its subcontractors. 

One of the documents  resulting from the work of SLIC is a training module for labour inspectors  on 
the  EU and  health  and  safety  at work.  This  training  module  has  been  used  as the  basic  material 
for training  programmes for labour inspectors  in all Member  States 

3°  Needs 

The  necessary  human  and  budgetary  resources  should  be  made  available  to  promote  the  further 
work of the Committee  as expressed  in its three-year  programme. 

4° 

Impediments 

It  is  very  important  that  the  necessary  communication  resources,  such  as  interpretation  and 
translation,  should  be  provided  to  support  the  work  of  the  SLIC  in  its  task  towards  effective  and 
consistent enforcement  of Community  health and safety legislation. 

4 7-

2 0.  Public  Administration 

1° 

Introduction 

Although  under  the  Treaties  public  administration  is  not  a  matter  of  Union  competence,  the 
progress  of  the  building  of  Europe,  especially  in  the  internal  market  field,  requires  ever  closer 
cooperation  between  administrations.  Meetings  of Civil Service  Heads - 24 in all so far - have thus 
become the forum for discussing  problems of common interest, with implications for the  building of 
Europe. 

2° 

Existing  mechanisms 

At the Nancy  Ministerial Conference  in February  1995, the Civil Service  Heads were given the task 
of  seeking  overall,  balanced  solutions  to  remove  the  obstacles  in  the  way  of  opening  up  public 
service  employment  to  Community  nationals  and improving  coordination  in the training  of  national 
officials  in  European  matters.  At  their  most  recent  meeting  in  Paris  in  early  May  1995,  the  Civil 
Service  Heads decided to: 

• 

• 

set  up two  working  groups,  one to  examine  access to  public  service  employment,  the  other 
to  deal with  pension  regimes  for  officials.  They  should  present  their  conclusions  in  the  first 
half of 1996; 

organize  two  meetings  of  national  schools  and  institutes  of  administration,  in  June  and 
October  1995. 

Within the  limits  of their  powers, which vary  greatly  from  one  country  to  another,  the  Civil  Service 
Heads  also  help  in  supporting  the  programmes  for  exchanges  of  national  officials,  including  the 
Karolus  Programme. 

3° 

Needs 

in 

Recurrent  problems 
typically  concern 
information - its  real-time  flow  between  Community,  national,  regional  and/or  local  administra 
tions,  and  between  administrations  in  different  countries - and  the  training  of  national,  regional 
and local officials  in European matters. 

the  development  of  administrative  cooperation 

These  matters  are  of  particular  concern  to  regional  and  local  administrations,  especially  as  the 
Maastricht Treaty  gives  greater  prominence  to  the  regional  dimension  in  the  building  of  Europe. 
The  associations  of  "préfets"  are  aware  of  what  is  at  stake  and  have  spontaneously  taken  the 
initiative  of  calling  together  "préfets"  and  their  equivalents  in the  other  countries  of  the  Union  to 
size up the problem and begin tackling it. 

48 

2 1.  Competition 

1° 

Introduction 

There  has  from  the  outset  been  cooperation  with  national  competition  authorities  in the  antitrust 
field  (see  Regulation  17/62, the first  regulation  implementing Articles  85 and 86 of the  EC  Treaty) 
and  on  mergers  (see  Regulation  4064/89).  Procedures  in  these  fields  have  to  be  carried  on  "in 
close and constant liaison" with those authorities. 

The  Directorate-General  for  Competition  is seeking to  reinforce  implementation  of Articles  85  and 
86  by  national  authorities.  The  ways  and  means  of  achieving  this  were  covered  in  a  report  and 
conclusions  approved  by  the  heads  of  cooperation  departments  in  September  1994.  It  is  envis 
aged that the Commission will be asked to adopt, before the end of this year,  a communication  on 
cooperation with those authorities. 

This communication will match the existing one on cooperation with national courts  in applying the 
same articles, published in February  199352. 

2° 

Existing mechanisms for enforcement  cooperation 

Exchanges  of  officials  are taking  place  between  Member  States'  competition  authorities  (Bundes-
kartellamt,  Office  of  Fair  Trading,  etc.).  The  Commission  also  has  national  experts  from  these 
authorities detached to it. 

Checks on undertakings  suspected of infringing competition rules are carried out jointly  by  officials 
from the Commission and from national competition authorities52. 

In addition to receiving detached  national experts, which enables them to get to know its aims  and 
methods, DG IV also receives national officials for short periods of training. 

Seminars  and workshops take  place frequently,  and the heads of the  Member  States'  competition 
departments  meet  periodically.  Meetings  of  national  experts  are  organized  on  all  draft  legislation 
and para-legal texts (communications) which concern the single market. 

Discussions  are  also  under  way  on  decentralized  enforcement  of  Articles  85  and  86.  A  recent 
conference, the  European  Competition  Forum, was the first  one to  be open  not  only to  represen 
tatives  of  national  authorities  but  also  to  members  of  the  judiciary  specializing  in  competition 
matters. 

3°  Needs 

Expanding the  decentralized  implementation  of Articles  85  and  86 will  require  new  procedures  to 
be developed, and some work  has already  been carried out on this. These  procedures  should  not 
require  amendments  to  the  legislation.  The  growing  extent  to  which  Community  law  is  to  be 
implemented  by  national  authorities  -  and this  is something  which  is to  be encouraged  -  requires 
the  Commission  to  be kept  informed  quickly  and fully, the  legislation  does  not  at  present  provide 
for this. Computerized exchange of information could speed up the collection of information. There 
is  a  project  called  Fourcom  (DG  IV  Communication),  financed  by  the  IDA  programme,  with  one 
pilot application to be launched this year. 

- 4 9-

Uniform interpretation  of Community  competition  law, especially Articles  85  and  86,  requires that 
only  cases  of  obvious  infringement  whose  effects  are  restricted  largely  to  one  Member  State 
should  be  dealt  with  by  national  authorities.  This  excludes  concerted  practices  which  fall  under 
Article 85(1) but might be exempt under Article 85(3)52. 

52  As  regards  mergers,  the  question  does  not  arise.  Above  the  thresholds  laid  down  in  Regulation  4064/89,  the  Community 
basically  has  sole  competence.  Up  to  these  thresholds,  it  is  the  Member  States  alone  which  are  responsible.  The 
Commission  also  has  exclusive  competence  in  implementing  the  provisions  of  the  ECSC Treaty  (Articles  65  and  66) 
concerning  competition. 

- 5 0-

2 2.  Telematic  Networks  between  Administrations  (TNA  /  IDA) 

1° 

Introduction 

By  1982,  well  before  the  Internal  Market  Programme  was  launched,  the  Council  had  already 
adopted decisions  on establishing computer  links between the Community  institutions  and those of 
the  Member  States. The initial focus was on customs  and agricultural  cooperation, with  a study53, 
which  led to the  CADDIA  programme  (Cooperation  in Automation  of  Data  and  Documentation  for 
Imports/Exports  and  Agriculture)54.  The  Council  also  decided  to  set  up  a  Community  inter-
institutional  integrated  information  system  (INSIS)  which  would  "make  it  possible  to  use  new 
information  between  the  administrations  of  the 
electronic  technologies 
Community 
the 
Commission's  own electronic  mail (E-mail)  backbone. 

the  Member  States"55,  and  which, 

inter  alia,  provided 

for  exchanges  of 

institutions  and 

In the context  of the  1992 programme  it became clear that these  links had to  be developed to the 
full to  enable  the  Internal  Market  to  be  managed  effectively.  The third  and fourth  R&D  framework 
programmes  both  included  studies  into  telematics  networks  between  administrations.  The 
European  Nervous  System  (ENS)  programme  is  part  of  a  specific  research  and  development 
programme  implementing  these56.  For  the  development  of  projects  beyond  the  pre-competitive 
stage  into fully  operational  systems with the  specific  aim of furthering  management  of the  Internal 
Market,  the  Commission  proposed  in  1993  both  guidelines  and  a  multiannual  Community 
programme  to  support  the  implementation  of  trans-European  networks  for  interchange  of  data 
between  administrations  (IDA)57.  A  single  Council  Decision,  on the  multiannual  programme  only, 
was adopted on 6 November  199558. This provides funding for projects, some of which are already 
running. 

2° 

Existing cooperation  using telematic  networks 

The CADDIA  programme  has assisted the development  of the Customs  Information  System  (CIS) 
and the  SHIFT  system  (see  sections  7(a)  and  9  above  on veterinary  controls  and  customs).  The 
SIMAP  project,  under  IDA,  should  result  in  electronic  tendering  becoming  available  for  Europe-
wide  public  procurement  (section  2  above).  The  Social  Security  Network  (SOSENET)  has  been 
transferred  from  ENS  to  IDA  as  it  becomes  operational.  Members  of  a  number  of  committees, 
including  the  Internal  Market  Advisory  Committee,  have  already  received  IDA  funding  for 

" 

5 

55 

56 

57 

58 

7 7 / 61 9/EEC:  Council  Decision  of  27  September  1 9 77  instituting  a  study  of  informatic  systems  for  the  processing  of  data 
on 
financial  control  of  agricultural  market  organizations,  OJ  L  2 5 5, 
6 . 1 0 . 1 9 7 7,  p.  32 

imports/exports  and  on 

the  management  and 

Council  Decision  No  82/607/EEC  of  28  July  1 9 82  concerning  the  coordination  of  the  actions  of  the  Member  States  and  the 
Commission  related  to  activities  preparatory  to  a  long-term  programme  for  the  use  of  telematics  for  C o m m u n i ty 
information 
systems  concerned  w i th  imports/exports  and  the  management  and  financial  control  of  agricultural  market  organizations,  OJ 
L  2 4 7,  2 3 . 8 . 1 9 8 2,  p.25;  Council  Decision  No  85/214/EEC  of  26  March  1 9 85  concerning  the  coordination  of  the  activities 
the  use  of 
of 
telematics  for  C o m m u n i ty  information  systems  concerned  w i th  imports/exports  and  the  management  and  financial  control 
of  agricultural  market  organizations,  OJ  L  9 6,  3 . 4 . 1 9 8 5,  p.  3 5. 

the  Member  States  and  the  Commission  related  to 

implementation  of  a  long-term  programme 

the 

for 

Council  Decision  No  82/869/EEC  of  13  December  1 9 82  relating  to  the  coordination  of  the  activities  of  the  Member  States 
and  C o m m u n i ty  institutions  w i th  a  v i ew  to  assessing  the  need  for,  and  preparing  proposals  for  setting  up,  a  C o m m u n i ty 
inter-institutional  information  system  OJ  L  3 6 8,  2 8 . 1 2 . 8 2,  p.  40 

Council  Decision  91/353/EEC  of  7  June  1991  adopting  a  specific  programme  of  research  and  technological  development  in 
the  field  of  telematic  systems  in  areas  of  general  interest  ( 1 9 90  to  1 9 9 4 ),  OJ  L  1 9 2,  1 6 . 7 . 1 9 9 1,  p.  1 8;  Council  Decision 
9 4 / 8 01 /EC  of  23  November  1 9 94  adopting  a  specific  programme  for  research  and  technological  development, 
including 
demonstration  in  the  field  of  telematics  applications  of  c o m m on  interest  ( 1 9 94  to  1 9 9 8 ),  OJ  L  3 3 4,  2 2 . 1 2 . 1 9 9 4,  p.  1 

COM(93)  69  final,  1 2 . 0 3 . 1 9 9 3,  OJ  C  1 0 5,  1 6 . 4 . 1 9 9 3,  pp.  10  and  12 

Council  Decision  95/468/EC  of  6  November  1995  on  a  Community  contribution  for  telematic  interchange  of  data  between 
administrations  in  the  Community  (IDA),  OJ  L 2 6 9,  11.11.1995,  p.  23 

-51 

improvements  to  their  E-mail  communications  with  the  Commission  (and  among  their  members) 
through  the  "E-mail  for  committees"  project.  These  are  a  few  examples  of  the  actions  funded 
through the different  programmes. 

3°/4°/5° 

Needs, Impediments, Next steps 

The  user-needs  that  flow  from  cooperation  between  national  administrations  and  between  them 
and  the  Commission  should  be  the  driving  force  and  motivation  for  the  TNA  actions  of  the 
Community  (Commission  and the Member States). Such actions should be fully  integrated  into the 
policy  of  the  administrations  and  in  the  Community  legislation  of  the  sectors  concerned.  These 
user-needs  should  determine  where  the  operational  networks  are  needed,  what  is  the  use 
provided by these networks and what is the quality of service required. 

Numerous  discussions  have  taken  place  with  the  Member  States  on  how  to  tailor  the 
Communities'  TNA  contribution  in terms  of  scope, financing  and  management.  The  IDA  Decision 
should be implemented  and all the  budget allocated to it released without further delay,  in order to 
give  the  existing  projects  the  support  they  require.  Further  projects  should  be  introduced  in 
accordance with the needs of administrations as mentioned above. 

This programme  provides essential support for cooperation in many of the areas mentioned  in this 
report, and needs to be expanded to enable other sectors to benefit from  modern  communications 
between  administrations.  Without  sufficient  funding, there  is a risk that  even  some  of the  projects 
already started will have to be abandoned. 

2 3.  The  KAROLUS  Exchange  Programme 

52 

1° 

Introduction 

The  Karolus  Programme  was  initiated  in  1993,  for  five  years59.  It  provides  for  exchanges  of 
officials  between Member States' administrations  in the internal market field.  It enables  participants 
to  work  with  their  counterparts  in  another  Member State  for  some  two  months.  The  aim  is  to 
harmonize interpretation of Community  legislation and implement it consistently. 

2° 

Progress 

Of  280 applications  accepted  by  14 November  1995,  193 had  led to  exchanges  being  carried  out 
by the  same  date, together  with  introduction  and assessment  seminars.  Participants  said that  the 
exchanges  had  led  to  a  better  understanding  among  officials  from  the  different  Member  States 
working  in the  same  area,  a fruitful  exchange  of  experience  and the  establishment  of  network  of 
contacts which would allow effective  and concrete cooperation. 

Among  the  areas  considered  to  be  priority  ones,  public  procurement,  foodstuffs,  product 
conformity  assessment,  market  supervision  and  pharmaceutical  products  accounted  for  most 
exchanges.  All  12  Member  States  (1993-1994)  participated  in  that  they  both  sent  and  received 
participants.  Most  of  those  taking  part  came  from  national  administrations,  with  local  ones 
nonetheless  being  well  represented,  more  especially  in the  case  of  Spain  (autonomous  commu 
nities)  and  Germany  (Lander).  The  leading  host  countries  are  France  and  the  United Kingdom, 
while the main ones of origin are Italy, Spain, the United Kingdom, Germany  and Greece. The new 
Member States are beginning to take an active part. 

3°  Results so far 

The  number  of  participants  is  much  lower than was  expected, at  no  more than  one third  or  so  of 
the  Programme's  potential.  There  are  several  reasons  for  this:  language  difficulties,  50% 
contribution  by the  Member State  of  origin to  subsistence  expenses,  lack  of encouragement  from 
administrations and difficulties experienced in taking two months  off. 

It  is  now  for  the  Commission  to  assess  the  Karolus  Programme,  by the  end  of  March  1996.  The 
assessment  will  look  at  the  Programme's  operation  and  its  contribution  to  the  process  of 
administrative  cooperation  between Member State administrations  and its results.  It will serve as a 
basis for thinking about the future development  of the Programme. 

4°  Next steps 

Depending  on  the  results  of  this  assessment,  amendments  to  the  Council  Decision  might  be 
proposed,  such  as  including  seminars  and  short  visits  in  the  Programme.  However,  two-month 
exchanges  have  proved their value and there should  be a campaign to  make potential  candidates 
more aware of them, in close collaboration with the Member States. 

59  Council  Decision  92/481/EEC  of  22  September  1992,  OJ  L 286,  1.10.1992,  p.  65 

53 

Table  2: 

Karolus  exchanges 

ranked  by  priority  area 

(period  1.1.93  -  1 4 . 1 1 . 9 5,  total  2 80  approved,  193  completed) 

FN 

CON 

CPR 

CRT 

EXC 

EXP 

FOO 

FRM 

PHA 

PLA 

PPR 

RTR 

STR 

STA 

TRW 

NF 

•  10 

Key 

FIN  Banking,  insurance,  stock  exchanges 

CON  Conformity  testing  and  market  supervision 

CPR  Consumer  protection 

CPT  Competition 

EXC  Export  controls  on  cultural  goods 

EXP  Export  controls  on  certain  dual-use  goods  and  technologies 

FOO  Foodstuffs 

FRM  Free  movement  of  persons 

PHA  Pharmaceutical  products 

PLA  Animal  and  plant  health  controls 

PPR  Public  procurement 

RTR  Road  Transport 

STR  Sea  transport 

STA  Statistical  programmes 

TRW  Transfer  of  waste 

INF  Directive  83/189/EEC  -  exchange  of  information 

ISSN 0254-1475 

COM(96) 20  final 

DOCUMENTS 

EN 

10 

Catalogue number  : CB-CO-96-021-EN-C 

ISBN 92-77-99657-9 

Office for Official Publications of the European Communities 

L-2985 Luxembourg