Proposal for a Council Decision on the conclusion of bilateral Agreements laying down a procedure for the provision of information in the field of technical regulations and of rules on information society services between the European Community and the Republic of Bulgaria, the European Community and Romania
Date: 2006-10-05
Institutions: European Commission
Subjects: Bulgaria, Romania, access to information, agreement (EU), exchange of information, technical regulations

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.10.2006 
COM(2006) 573 final 

2006/0179 (ACC) 

Proposal for a 

COUNCIL DECISION 

on the conclusion of bilateral Agreements laying down a procedure for the provision of 
information in the field of technical regulations and of rules on information society 
services between the European Community and the Republic of Bulgaria, the European 
Community and Romania 

(presented by the Commission) 

EN 

   EN 

 
 
 
  
EXPLANATORY MEMORANDUM 

1. CONTEXT OF THE PROPOSAL 

Prior to the 2004 enlargement of the EU and on the basis of the negotiating directives adopted 
by the Council on 21.10.2002, the Commission negotiated bilateral Agreements laying down 
a procedure for the provision of information in the field of technical regulations and of rules 
on information society services between the European Community and ten former candidate 
countries (the Republic of Cyprus, the Czech Republic, the Republic of Estonia, the Republic 
of  Hungary,  the  Republic  of  Latvia,  the  Republic  of  Lithuania,  the  Republic  of  Malta,  the 
Republic of Poland, the Slovak Republic and the Republic of Slovenia). This resulted in the 
adoption  of  two  Council  Decisions  on  the  conclusion  of  bilateral  Agreements  with  the 
Republic  of  Cyprus  and  the  Republic  of  Hungary  (Council  Decision  2004/299/EC  of  24 
November  2003)1  and  with  the  other  eight  former  candidate  countries  (Council  Decision 
2004/330/EC  of  22  September  2003)2and  the  subsequent  conclusion  of  Agreements  with 
several former candidate countries prior to 1 May 2004.  

The  negotiating  mandate  adopted  in  2002  also  covered  the  Republic  of  Bulgaria  and 
Romania, with whom the Commission has negotiated identical bilateral Agreements. 

The text of these two Agreements and their Annexes is exactly the same as those previously 
negotiated with the former candidate countries prior to 1 May 2004. 

A  proposal  for  a  Council  Decision  is  attached.  The  proposal  concerns  the  adoption  and 
signature of the two bilateral Agreements. Consequently, it foresees that the Council approves 
these bilateral Agreements.  

Signature is required by each of the two candidate countries for the adoption of its bilateral 
Agreement.  It  is  accordingly  proposed  that  the  President  of  the  Council  be  authorised  to 
designate the persons empowered to sign the Agreements on behalf of the Community.  

The Commission therefore proposes that the Council adopt the attached Decision. 

The  text  of  these  two  Agreements  and  their  Annexes  are  attached  to  this  proposal  and  the 
following provides an assessment of the Agreements in the light of the negotiating directives 
approved by the Council.  

2. LEGAL ELEMENTS OF THE PROPOSAL 

2.1. Summary of the proposed agreements 

The Agreements provide for the participation of the above mentioned two candidate countries 
level  by  
in 

the  notification  procedure,  which  was 

introduced  at  Community 

1 
2 

OJ L098, 02/04/2004, P.0030 
OJ L 117, 22/04/2004, P.0001 

EN 

2 

   EN 

 
                                                 
Directive  83/189/CEE  (amended  several  times,  then  codified  by  Directive  98/34/EC,  and 
subsequently amended by Directive 98/48/EC)3. 

Both  bilateral  Agreements  contain  exactly  the  same  articles.  In  accordance  with  the 
negotiating mandate, the scope of the Agreements is exactly the same as that provided for in 
Directive  98/34/EC,  as  amended  by  Directive  98/48/EC.  Furthermore,  the  definition  of 
technical regulations and rules on information society services is identical with the definitions 
contained in Article 1 of Directive 98/34/EC, as amended by Directive 98/48/EC.  

As  regards  the  system  of  exchange  of  information,  in  accordance  with  the  negotiating 
mandate,  the  Community  is  responsible  for  communicating  to  the  countries  concerned  the 
draft  technical  regulations  and  draft  rules  on  information  society  services  notified  to  the 
Commission  by  the  Member  States  in  application  of  Directive  98/34/EC,  as  amended  by 
Directive 98/48/EC.  

Each of the two candidate countries with which a bilateral Agreement has been drawn up is 
responsible  for  communicating  to  the  Community  its  draft  technical  regulations  and  draft 
rules on information society services.  

In accordance with the negotiating directives, the three-month standstill period provided for in 
Directive  98/34/EC,  as  amended  by  Directive  98/48/EC,  has  been  included  in  each 
Agreement.  During  this  three-month  standstill  period  the  Community  has  the  right  to  make 
comments on the drafts notified by each of the two candidate countries with whom a bilateral 
Agreement has been drawn up; and each of the two candidate countries has the right to make 
comments on the drafts thus notified by the Member States. 

Finally,  as  stated  in  the  negotiating  directives,  the  two  candidate  countries  have  to  submit 
information in one of the official Community languages. 

2.2 Explanation article-by-article 

The Agreement 

An  article-by-article  assessment  follows  (given  that  the  articles  are  the  same  in  all 
agreements, the description given below applies to both bilateral Agreements): 

Preamble.  This  sets  out  the  basic  objective  of  the  Agreement,  that  is  to  extend  the 
notification procedure to the candidate country concerned.  

Article  1:  Definitions.  This  is  self-explanatory.  The  definitions  are  exactly  the  same  as  the 
ones used in Directive 98/34/EC, as amended by Directive 98/48/EC. 

3 

Directive  98/34/EC  of  the  European  Parliament  and  of  the  Council  of  22  June  1998  laying  down  a 
procedure for the provision of information in the field of technical standards and regulations, OJ L 204 
of 21.7.1998. Its scope has been extended to information society services by Directive 98/48/EC of the 
European Parliament and of the Council of 20 July 1998 amending Directive 98/34/EC laying down a 
procedure for the provision of information in the field of technical standards and regulations, OJ L 217 
of 5.8.1998. The new title of this act is: Directive of the European Parliament and of the Council laying 
down  a  procedure  for  the  provision  of  information  in  the  field  of  technical  standards  and  regulations 
and of rules on Information Society services. 

EN 

3 

   EN 

 
                                                 
Article  2:  Exception  from  scope.  Like 
in  Directive  98/34/EC,  as  amended  by  
Directive 98/48/EC, it is foreseen that measures taken by the Member States or the candidate 
country concerned for the protection of persons (and in particular workers), when products are 
used,  do  not  fall  under  the  scope  of  the  Agreement.  However,  it  is  specified  that  if  such 
measures affect the products, then notification is required. 

Article 3: System of exchange of information. This article stipulates that the Community is 
responsible for transmitting the notifications of the Member States to the candidate countries 
concerned.  In  the  same  way,  the  notifications  of  the  candidate  country  concerned  are  to  be 
transmitted  to  the  Community.  In  accordance  with  Directive  98/34/EC,  as  amended  by 
Directive  98/48/EC,  where  a  technical  regulation  simply  transposes  the  full  text  of  an 
international or a European standard, it is not necessary to send the text of that standard, given 
that these texts are easily available to the Commission. In this case, it is sufficient to transmit 
the exact reference of the standard concerned. 

Article 4: Language of transmission. It is specified that the draft technical regulations have 
to  be  submitted  in  a  full  translation  into  one  of  the  official  languages  of  the  European 
Community. 

Article 5: Basic texts and risk analysis. As foreseen in Directive 98/34/EC, as amended by 
Directive 98/48/EC, basic texts have also to be submitted where this is necessary in order to 
assess  the  implications  of  the  draft  technical  regulations  notified.  Furthermore,  in  certain 
cases risk evaluations, where these are available, have to be transmitted.  

Article  6:  Notification  in  case  of  significant  changes.  This  Article  provides  that  a  new 
notification has to be made if the Member States or the candidate country concerned modify 
their  previously  notified  drafts.  The  definitions  of  what  constitutes  a  significant  change  are 
identical with the ones of Directive 98/34/EC, as amended by Directive 98/48/EC. 

Article  7:  Further  information.  This  stipulates  that  each  contracting  party  has  the  right  to 
ask for further information on the notified drafts where this is considered necessary for their 
evaluation.  

Article 8: Comments. It is specified that each contracting party may make comments on the 
drafts notified by the other contracting party.  

Article 9: Standstill period. A uniform standstill period of three months applies to the drafts 
notified by each contracting party. No extension of this standstill period is possible. 

Article  10:  Urgency  procedure.  This  Article  stipulates  that  where  urgent  reasons  are 
invoked  the  three-month  standstill  period  shall  not  apply.  The  definition  of  urgency  of  this 
Article is identical with the one of Directive 98/34/EC, as amended by Directive 98/48/EC.  

Article  11:  Final  text  and  administrative  arrangements  for  transmission.  It  is  foreseen 
that the final text has also to be transmitted. This is because for some notifications, it is useful 
to  be  able  to  compare  the  notified  text  with  the  finally  adopted  one.  The  same  article  also 
refers to Annex III of the Agreement (see below) which lays down some general rules as to 
the administrative arrangements for communication of information under the Agreement.  

Article 12: Exceptions to notification obligation. This Article stipulates the cases in which 
in  
notification 

required.  These  exceptions  are 

identical 

is  not 

listed 

those 

to 

EN 

4 

   EN 

 
Directive  98/34/EC,  as  amended  by  Directive  98/48/EC.  With  regard  to  international 
agreements concluded by the candidate country concerned, it is foreseen that it does not have 
to notify those laws, regulations and administrative provisions arising out of the obligations of 
an  international  agreement  that  applies  in  the  candidate  country  and  in  the  entire  European 
Community.  The  reason  for  this  is  that  the  same  provisions  will  apply  in  the  candidate 
country and in the European Community, as the candidate country and all the Member States 
have transposed the international agreement.  

On  the  other  hand,  if  the  candidate  country  adopts  laws,  regulations  or  administrative 
provisions arising out of an international agreement that applies in the candidate country and a 
third  country,  or  that  applies  in  the  candidate  country  and  only  a  part  of  the  European 
Community,  then  notification  is  required,  given  that  in  these  two  cases,  the  provisions  may 
create  barriers  to  trade,  as  these  two  types  of  international  agreement  do  not  apply  in  the 
whole territory of the two contracting parties. 

Article  13:  Confidentiality.  Information  provided  under  the  bilateral  Agreement  is  in 
principle  not  confidential,  however  each  contracting  party  has  the  possibility  to  ask  for 
confidentiality.  

Article  14:  Management  of  the  Agreement.  For  the  management  of  the  Agreement,  it  is 
foreseen  that  on  the  one  hand,  regular  consultations  shall  take  place  between  experts  of  the 
European  Community  and  the  candidate  country  concerned  and  on  the  other,  candidate 
countries shall participate in the Standing Committee established under  Directive  98/34/EC, 
as amended by Directive 98/48/EC.  

Article  15:  Territorial  clause.  This  is  a  standard  provision  defining  the  geographical 
application of the Agreement. 

Article 16: Entry into force. This is a standard provision that provides the arrangement for 
the entry into force. 

Article  17:  Expiry.  It  is  self-explanatory  that  the  Agreement  will  expire  on  the  date  of 
accession of the candidate country. 

Article 18: Languages of the Agreement. This is a standard provision that the Agreement is 
drawn up in all Community languages and the language of the candidate country.  

The Annexes to the Agreement 

There follows an assessment of the content of the annexes. 

Annex  I:  Information  society  services.  This  Annex  provides  a  further  clarification  of  the 
concept of information society services, as defined in point 2 of Article 1 of the Agreement. 
The  Annex  is  identical  with  Annex  V  of  Directive  98/34/EC,  as  amended  by  Directive 
98/48/EC  and  provides  an  indicative  list  of  services  which  fall  outside  the  definition  of 
information society services. 

Annex  II:  Financial  services.  This  Annex  gives  an  indicative  list  of  the  financial  services 
which  are  excluded  from  the  scope  of  the  Agreement  (see  Article  1,  point  5,  third 
subparagraph  of  the  Agreement).  The  Annex  is  identical  with  Annex  VI  of  Directive 
98/34/EC, as amended by Directive 98/48/EC. 

EN 

5 

   EN 

 
Annex  III:  Administrative  procedure  for  transmission  of  information.  This  Annex  lays 
down  some  general  rules  as  to  the  administrative  arrangements  for  communication  of 
information under the Agreement. These arrangements are in principle identical with the ones 
currently in force with the EFTA countries signatory to the EEA Agreement. 

EN 

6 

   EN 

 
2006/0179 (ACC) 

Proposal for a 

COUNCIL DECISION 

on the conclusion of bilateral Agreements laying down a procedure for the provision of 
information in the field of technical regulations and of rules on information society 
services between the European Community and the Republic of Bulgaria, the European 
Community and Romania 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular  
Article 133 in conjunction with the first sentence of the first subparagraph of Article 300(2),  

Having regard to the proposal from the Commission4, 

Whereas the bilateral Agreements laying down a procedure for the provision of information in 
the  field  of  technical  regulations  and  of  rules  on  information  society  services  between  the 
European Community and the Republic of Bulgaria, the European Community and Romania 
have been negotiated and should be approved; 

HAS DECIDED AS FOLLOWS: 

Article 1 

The  bilateral  Agreements  laying  down  a  procedure  for  the  provision  of  information  in  the 
field  of  technical  regulations  and  of  rules  on  information  society  services  between  the 
European Community and the Republic of Bulgaria, the European Community and Romania, 
are hereby approved on behalf of the European Community. The text of the Agreements and 
the Annexes are attached to this Decision. 

4 

OJ C […], […], p. […] 

EN 

7 

   EN 

 
                                                 
Article 2 

The President of the Council is hereby authorised to designate the persons empowered to sign 
the Agreements in order to bind the Community and to transmit, on behalf of the Community, 
the note provided for in Article 16 of the Agreements (5). 

Done at Brussels,  

For the Council 

The President 

5 

The date of entry into force of the Agreements will be published in the Official Journal of the European 
Union by the Secretariat of the Council. 

EN 

8 

   EN 

 
 
 
 
 
                                                 
AGREEMENT 

laying down a procedure for the provision of information in the field of technical 
regulations and of rules on information society services between the European 
Community and the Republic of Bulgaria 

THE EUROPEAN COMMUNITY, 

on the one hand, and 

THE REPUBLIC OF BULGARIA, 

on the other hand, 

The above being hereinafter referred to as the Contracting Parties, 

HAVING  REGARD  to  the  Europe  Agreement  establishing  an  Association  between  the 
European  Communities  and  their  Member  States,  of  the  one  part,  and  the  Republic  of 
Bulgaria, of the other part6, and in particular to the aims set out in Article 1, 

HAVING  REGARD  to  the  information  procedure  on  technical  regulations  and  rules  on 
information society services applied within the European Community7, 

CONSIDERING the commitment of the Republic of Bulgaria and the European Community 
to promote harmonious economic relations between the Contracting Parties, 

CONSIDERING  the  ongoing  cooperation  between  the  European  Community  and  the 
Republic of Bulgaria in the field of technical barriers to trade and the common understanding 
reached  within  the  framework  of  that  cooperation  to  extend  this  information  procedure  on 
technical  regulations  and  rules  on  information  society  services  applied  in  the  European 
Community to the Republic of Bulgaria, 

HAVE AGREED AS FOLLOWS: 

For the purpose of this Agreement, the following definitions apply: 

Article 1 

1. 

2. 

6 
7 

“product”:  any  industrially  manufactured  product  and  any  agricultural  product, 
including fish products; 

“service”:  any  Information  Society  service,  that  is  to  say,  any  service  normally 
provided  for  remuneration,  at  a  distance,  by  electronic  means  and  at  the  individual 
request of a recipient of services. 

For the purposes of this definition: 

OJ L 358, 31.12.1994, p.3 
Directive  98/34/EC  (OJ  L  204,  21.7.1998,  p.  37),  as  amended  by  Directive  98/48/EC  (OJ  L  217, 
5.8.1998, p. 18) 

EN 

9 

   EN 

 
                                                 
– 

– 

– 

“at  a  distance”:  means  that  the  service  is  provided  without  the  parties  being 
simultaneously present, 

“by electronic means”: means that the service is sent initially and received at 
its destination by means of electronic equipment for the processing (including 
digital  compression)  and  storage  of  data,  and  entirely  transmitted,  conveyed 
and received by wire, by radio, by optical means or by  other  electromagnetic 
means, 

“at the individual request of a recipient of services”: means that the service is 
provided through the transmission of data on individual request. 

An indicative list of services not covered by this definition is set out in Annex I. 

This Agreement shall not apply to: 

– 

– 

radio broadcasting services, 

television broadcasting services covered by point (a) of Article 1 of Directive 
89/552/EEC8. 

“technical  specification”:  a specification contained in a document  which lays down 
the characteristics required of a product such as levels of quality, performance, safety 
or  dimensions,  including  the  requirements  applicable  to  the  product  as  regards  the 
name  under  which  the  product  is  sold,  terminology,  symbols,  testing  and  test 
methods, packaging, marking or labelling and conformity assessment procedures. 

The  term  “technical  specification”  also  covers  production  methods  and  processes 
used  in  respect  of  agricultural  products  as  referred  to  Article  38(1)  of  the  Treaty 
establishing  the  European  Community,  products  intended  for  human  and  animal 
consumption,  and  medicinal  products  as  defined  in  Article  1  of  Directive 
2001/83/EC9, as well as production methods and processes relating to other products, 
where these have an effect on their characteristics. 

“other requirements”: a requirement, other than a technical specification, imposed on 
a product for the purpose of protecting, in particular, consumers or the environment, 
and  which  affects  its  life  cycle  after  it  has  been  placed  on  the  market,  such  as 
conditions  of  use,  recycling,  reuse  or  disposal,  where  such  conditions  can 
significantly influence the composition or nature of the product or its marketing; 

“rule  on  services”:  requirement  of  a  general  nature  relating  to  the  taking-up  and 
pursuit  of  service  activities  within  the  meaning  of  point  2,  in  particular  provisions 
concerning the service provider, the services and the recipient of services, excluding 
any rules which are not specifically aimed at the services defined in that point. 

This  Agreement  shall  not  apply  to  rules  relating  to  matters  which  are  covered  by 
European Community legislation in the field of telecommunications services, defined 

OJ L 298, 17.10.1989, p. 23. Directive as last amended by Directive 97/36/EC (OJ L 202, 30.7.1997, p. 
1). 
OJ L 311, 28.11.2001, p. 67. 

3. 

4. 

5. 

8 

9 

EN 

10 

   EN 

 
                                                 
as  “services  whose  provision  consists  wholly  or  partly  in  the  transmission  and 
routing of signals on a telecommunications network by means of telecommunications 
processes, with the exception of radio broadcasting and television”10. 

This  Agreement  shall  not  apply  to  rules  relating  to  matters  which  are  covered  by 
European  Community  legislation  in  the  field  of  financial  services,  as  listed  non-
exhaustively in Annex II to this Agreement. 

With the exception of Article 11, this Agreement shall not apply to rules enacted by 
or for regulated markets within the meaning of Directive 2004/39/EC11 or by or for 
other  markets  or  bodies  carrying  out  clearing  or  settlement  functions  for  those 
markets. 

For the purposes of this definition: 

– 

– 

a  rule  shall  be  considered  to  be  specifically  aimed  at  Information  Society 
services where, having regard to its statement of reasons and its operative part, 
the  specific  aim  and  object  of  all  or  some  of  its  individual  provisions  is  to 
regulate such services in an explicit and targeted manner, 

a rule shall not be considered to be specifically aimed at Information Society 
services if it affects such services only in an implicit or incidental manner. 

6. 

“technical  regulation”:  technical  specifications  and  other  requirements  or  rules  on 
services, including the relevant administrative provisions, the observance of which is 
compulsory,  de  jure  or  de  facto,  in  the  case  of  marketing,  provision  of  a  service, 
establishment  of  a  service  operator  or  use  in  one  of  the  Member  States  of  the 
European  Community  or  a  major  part  thereof,  or  in  the  Republic  of  Bulgaria  or  a 
major  part  thereof,  as  well  as  laws,  regulations  or  administrative  provisions  of  the 
Member States of the European Community or of the Republic  of Bulgaria,  except 
those provided for in Article 12, prohibiting the manufacture, importation, marketing 
or use of a product or prohibiting the provision or use of a service, or establishment 
as a service provider. 

De facto technical regulations include: 

– 

laws,  regulations  or  administrative  provisions  of  a  Member  State  of  the 
European  Community  or  the  Republic  of  Bulgaria  which  refer  either  to 
technical  specifications  or  to  other  requirements  or  to  rules  on  services,  or  to 
professional  codes  or  codes  of  practice  which  in  turn  refer  to  technical 
specifications or to other requirements or to rules on services, compliance with 
which  confers  a  presumption  of  conformity  with  the  obligations  imposed  by 
the aforementioned laws, regulations or administrative provisions, 

10 

11 

This definition arises by virtue of Directive 98/48/EC which makes reference to Directive 90/387/EEC 
on the establishment of the internal market for telecommunications services through the implementation 
of  open  network  provision  (OJ  L  192,  24.7.1990,  p.  1).  The  latter  directive  has  been  repealed  by 
Directive 2002/21/EC on a common regulatory framework for electronic communications networks and 
services (OJ L 108, 24.04.2002, p.3) However, the definition of ‘telecommunications services’ found in 
Directive 90/387/EEC should be retained for the purposes of Directive 98/48/EC. .  
OJ L 145, 30.4.2004, p.1 

EN 

11 

   EN 

 
                                                 
– 

– 

voluntary  agreements  to  which  a  public  authority  is  a  contracting  party  and 
which  provide,  in  the  general  interest,  for  compliance  with  technical 
specifications  or  other  requirements  or  rules  on  services,  excluding  public 
procurement tender specifications, 

technical  specifications  or  other  requirements  or  rules  on  services  which  are 
linked to fiscal or financial measures affecting the consumption of products or 
services by encouraging compliance with such technical specifications or other 
technical  specifications  or  other 
requirements  or 
requirements or rules on services linked to national social security systems are 
not included. 

rules  on  services; 

This  comprises  technical  regulations  imposed  by  the  authorities  designated  by  the 
Member States and appearing on a list drawn up by the Commission of the European 
Community12  (thereinafter  called  ‘the  Commission’)  in  the  framework  of  the 
Committee referred to in Article 5 of Directive 98/34/EC. The Republic of Bulgaria 
shall draw up such a list and forward it to the Commission the first day of the first 
month following entry into force of this Agreement. 

The same procedure shall be used for amending this list. 

7. 

“draft technical regulation”: the text of a technical specification or other requirement 
or of a rule on services, including administrative provisions, formulated with the aim 
of  enacting  it  or  of  ultimately  having  it  enacted  as  a  technical  regulation,  the  text 
being at a stage of preparation at which substantial amendments can still be made. 

Article 2 

This  Agreement  shall  not  apply  to  those  measures  Member  States  consider  necessary  under 
the  Treaty  establishing  the  European  Community  or  the  Republic  of  Bulgaria  considers 
necessary: 

– 

for the protection of persons, in particular workers, when products are used, provided 
that such measures do not affect the products. 

Article 3 

1. 
Subject to Article 12, the European Community shall notify the Republic of Bulgaria 
of  the  draft  technical  regulations  notified  to  it  by  its  Member  States.  Where  these  technical 
regulations  merely  transpose  the  full  text  of  an  international  or  European  standard, 
information  regarding  the  relevant  standard  shall  suffice.  It  shall  also  let  the  Republic  of 
Bulgaria  have  a  statement  of  the  grounds  which  make  the  enactment  of  such  a  technical 
regulation necessary, where these have not already been made clear in the draft. 

Subject  to  Article  12,  the  Republic  of  Bulgaria  shall  likewise  notify  the  European 
2. 
Community  of  its  draft  technical  regulations.  Where  these  technical  regulations  merely 
transpose  the  full  text  of  an  international  or  European  standard,  information  regarding  the 

12 

OJ C 23, 27.1.2000, p. 3. 

EN 

12 

   EN 

 
                                                 
relevant standard shall suffice. It shall also let the European Community have a statement of 
the grounds which make the enactment of such a technical regulation necessary, where these 
have not already been made clear in the draft. 

Article 4 

A  full  text  of  the  draft  technical  regulation  notified  shall  be  made  available  in  the  original 
language  as  well  as  in  a  full  translation  into  one  of  the  official  languages  of  the  European 
Community. 

Article 5 

1. 
Where appropriate, and unless it has already been sent with a prior communication, a 
full text in the original language of the basic legislative or regulatory provisions principally 
and directly concerned shall also be simultaneously communicated, should knowledge of such 
text be necessary in order to assess the implications of the draft technical regulation notified.  

2. 
Where,  in  particular,  the  draft  seeks  to  limit  the  marketing  or  use  of  a  chemical 
substance,  preparation  or  product  on  grounds  of  public  health  or  of  the  protection  of 
consumers  or  the  environment,  Member  States  and  the  Republic  of  Bulgaria  shall  also 
forward  either  a  summary  or  the  references  of  all  relevant  data  relating  to  the  substance, 
preparation  or  product  concerned  and  to  known  and  available  substitutes,  where  such 
information  may  be  available,  and  communicate  the  anticipated  effects  of  the  measure  on 
public  health  and  the  protection  of  the  consumer  and  the  environment,  together  with  an 
analysis of the risk carried out as appropriate in accordance with the general principles for the 
risk evaluation of chemical substances as referred to in Article 10(4) of Regulation (EEC) No. 
793/9313 in the case of an existing substance or in Article 3(2) of Directive 67/548/EEC14, in 
the case of a new substance. 

Article 6 

The Member States and the Republic of Bulgaria shall communicate the draft again under the 
above conditions if they make changes to the draft that have the effect of significantly altering 
its  scope,  shortening  the  timetable  originally  envisaged  for  implementation,  adding 
specifications  or  requirements,  or  making  the  latter  more  restrictive.  Transmission  of  these 
communications shall take place in accordance with the provisions set out in Article 3. 

Each  Contracting  Party  may  ask  for  further  information  on  a  draft  technical  regulation 
notified in accordance with this Agreement. 

Article 7 

13 

14 

Council  Regulation  (EEC)  No.  793/93  of  23  March  1993  on  the  evaluation  and  control  of  the  
risks of existing substances (OJ L 84, 5.4.1993, p.1). 
Council  Directive  67/548/EEC  of  27  June  1967  on  the  approximation  of  the  laws,  regulations  and 
administrative provisions relating to the classification, packaging and labelling of dangerous substances 
(OJ L 196, 16.8.1967, p. 1). Directive, as amended by Directive 92/32/EEC (OJ L 154, 5.6.1992, p. 1) 
and subsequent directives 

EN 

13 

   EN 

 
                                                 
Article 8 

1. 
The  European  Community  and  the  Republic  of  Bulgaria  may  make  comments  upon 
the drafts communicated. The comments of the Republic of Bulgaria shall be forwarded to the 
Commission  and  the  comments  of  the  European  Community  shall  be  forwarded  by  the 
Commission to the Republic of Bulgaria. 

The  Member  States  and  the  Republic  of  Bulgaria  shall  take  such  comments  into 

2. 
account as far as possible in the subsequent preparation of the technical regulation. 

3. 
With respect to the technical specifications or other requirements or rules on services 
referred  to  in  the  third  indent  of  the  second  subparagraph  of  point  6  of  Article  1,  the 
comments of the Contracting Parties may concern only aspects which may hinder trade or, in 
respect of rules on services, the free movement of services or the freedom of establishment of 
service operators and not the fiscal or financial aspects of the measure.  

The Commission shall, when a six-month standstill is invoked according to the rules 

4. 
set out in Directive 98/34/EC, inform the Republic of Bulgaria thereof. 

Article 9 

The competent authorities of the Member States and the Republic of Bulgaria shall postpone 
the adoption of draft technical regulations notified for three months from the date of receipt 
by the Commission of the text of the draft regulation. 

Article 10 

The standstill period referred to in Article 9 shall not apply in those cases where: 

– 

– 

for urgent reasons, occasioned by serious and unforeseeable circumstances relating to 
the protection of public health or safety, the protection of animals or the preservation 
of plants and, for rules on services, also for public policy, notably the protection of 
minors,  the  competent  authorities  are  obliged  to  prepare  technical  regulations  in  a 
very  short  space  of  time  in  order  to  enact  and  introduce  them  immediately  without 
any consultations being possible or 

for urgent reasons occasioned by serious circumstances relating to the protection of 
the  security  and  the  integrity  of  the  financial  system,  notably  the  protection  of 
depositors,  investors  and  insured  persons,  the  competent  authorities  are  obliged  to 
enact and implement rules on financial services immediately. 

The reasons which warrant the urgency of the measures taken shall be given. The justification 
for  urgent  measures  shall  be  detailed  and  clearly  explained  with  particular  emphasis  on  the 
unpredictability  and  the  seriousness  of  the  danger  confronting  the  concerned  authorities  as 
well as the absolute necessity for immediate action to remedy it. 

EN 

14 

   EN 

 
Article 11 

The  final  text  in  the  original  language  of  the  technical  regulation  shall  also  be 

1. 
communicated. 

The administrative arrangements for the above mentioned notifications are detailed in 

2. 
Annex III, which forms an integral part of this Agreement. 

Article 12 

1. 
Articles  3  to  10  shall  not  apply  to  those  laws,  regulations  and  administrative 
provisions  of  the  Member  States  and  the  Republic  of  Bulgaria  or  voluntary  agreements  by 
means of which Member States or the Republic of Bulgaria: 

– 

– 

– 

– 

– 

– 

– 

comply  as  far  as  the  Member  States  are  concerned  with  binding  European 
Community acts which result in the adoption of technical specifications or rules on 
services, and as far as the Republic of Bulgaria is concerned transpose into national 
law  European  Community  acts  which  result  in  the  adoption  of  technical 
specifications or rules on services, 

fulfil  as  far  as  the  Member  States  are  concerned  the  obligations  arising  out  of 
international  agreements  which  result  in  the  adoption  of  common  technical 
specifications or rules on services in the European Community, 

fulfil  as  far  as  the  Republic  of  Bulgaria  is  concerned  the  obligations  arising  out  of 
international  agreements  which  result  in  the  adoption  of  common  technical 
specifications  or  rules  on  services  in  the  Republic  of  Bulgaria  and  the  European 
Community, 

make use of safeguard clauses provided for in binding European Community acts, 

apply Article 12(1) of Directive 2001/95/EC15, 

restrict  themselves  to  implementing  a  judgement  of  the  Court  of  Justice  of  the 
European Communities, 

restrict themselves to amending a technical regulation within the meaning of point 6 
of Article 1, in accordance with a Commission request, with a view to removing an 
obstacle to trade or, in the case of rules on services, to the free movement of services 
or the freedom of establishment of service operators. 

Articles 9 and 10 shall not apply to the laws, regulations and administrative provisions 
2. 
of the Member States and of the Republic of Bulgaria prohibiting manufacture insofar as they 
do not impede the free movement of products. 

Article 9 and 10 shall not apply to the technical specifications or other requirements or 
3. 
the rules on services referred to in the third indent of the second subparagraph of point 6 of 
Article 1.  

15 

Directive 2001/95/EC of 3 December 2001 on general product safety (OJ L 011, 15.01.2002, p.4). 

EN 

15 

   EN 

 
                                                 
Article 13 

Information supplied under this Agreement shall be considered as confidential upon request. 
However, both the European Community and the Republic of Bulgaria may, provided that the 
necessary  precautions  are  taken,  consult  for  an  expert  opinion  natural  or  legal  persons, 
including persons in the private sector. 

Article 14 

1. 
The  Contracting  Parties  shall,  within  the  framework  of  the  established  cooperation 
between  experts  of  the  European  Community  and  the  Republic  of  Bulgaria  in  the  field  of 
technical  barriers  to  trade,  hold  regular  consultations  both  to  ensure  the  satisfactory 
functioning  of  the  procedure  laid  down  in  this  Agreement  and  to  exchange  views  on  the 
comments which have been submitted by any Contracting Party concerning a draft technical 
regulation notified in accordance with this Agreement. Furthermore, by common consent, the 
Contracting  Parties  may  hold  additional  ad  hoc  meetings  to  deal  with  specific  cases  of 
particular interest to any Contracting Party. 

the  Republic  of  Bulgaria  shall  appoint  an  expert  to  represent  it  in  meetings  of  the 
2. 
Committee  established  under  article  5  of  Directive  98/34/EC,  part  ‘information  society 
services’  and  ‘technical  regulations’.  The  expert  must  be  a  member  of  the  government 
services of the Republic of Bulgaria. The expert shall not be entitled to vote.  

3. 
The Commission shall, in good time, inform the expert of the dates of the meetings, 
and  of  the  items  on  the  agenda  of  the  Committee.  The  Commission  shall  forward  relevant 
information to the expert. 

4. 
On  the  initiative  of  its  chairman,  the  Committee  may  meet  without  the  expert 
representing  the  Republic  of  Bulgaria  being  present.  In  that  case  the  Republic  of  Bulgaria 
shall be informed. 

Article 15 

This  Agreement  shall  apply,  on  the  one  hand,  to  the  territories  in  which  the  Treaty 
establishing the European Community is applied and under the conditions laid down in that 
Treaty and, on the other hand, to the territory of the Republic of Bulgaria.  

Article 16 

This Agreement shall enter into force on the first day of the second month following the date 
on  which  the  Contracting  Parties  have  exchanged  Notes  confirming  the  completion  of  their 
respective procedures for the entry into force of this Agreement. 

This  Agreement  shall  expire  on  the  date  of  accession  of  the  Republic  of  Bulgaria  to  the 
European Union. 

Article 17 

EN 

16 

   EN 

 
Article 18 

This Agreement is drawn up in two originals in the Bulgarian, Czech, Danish, Dutch, English, 
Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, 
Polish, Portuguese, Slovene, Slovak, Spanish and Swedish languages, each text being equally 
authentic. 

EN 

17 

   EN 

 
ANNEX I 

Indicative list of services not covered by the second subparagraph of point 2 of Article 1 

1. 

Services not provided "at a distance" 

Services provided in the physical presence of the provider and the recipient, even if 
they involve the use of electronic devices: 

(a)  medical  examinations  or  treatment  at  a  doctor's  surgery  using  electronic 

equipment where the patient is physically present; 

(b) 

consultation of an electronic catalogue in a shop with the customer on site;  

(c) 

(d) 

plane  ticket  reservation  at  a  travel  agency  in  the  physical  presence  of  the 
customer by means of a network of computers;  

electronic  games  made  available  in  a  video-arcade  where  the  customer  is 
physically present. 

2. 

Services not provided "by electronic means" 

– 

Services having material content even though provided via electronic devices: 

(a) 

automatic cash or ticket dispensing machines (banknotes, rail tickets);  

(b) 

access  to  road  networks,  car  parks,  etc.,  charging  for  use,  even  if  there 
are  electronic  devices  at  the  entrance/exit  controlling  access  and/or 
ensuring correct payment is made. 

– 

– 

Off-line services: distribution of CD roms or software on diskettes. 

Services which are not provided via electronic processing/inventory systems: 

(a) 

voice telephony services;  

(b) 

telefax/telex services;  

(c) 

services provided via voice telephony or fax;  

(d) 

telephone/telefax consultation of a doctor;  

(e) 

telephone/telefax consultation of a lawyer;  

(f) 

telephone/telefax direct marketing. 

3. 

Services not supplied "at the individual request of a recipient of services" 

Services provided by transmitting data without individual demand for simultaneous 
reception  by  an  unlimited  number  of  individual  receivers  (point  to  multipoint 
transmission): 

EN 

18 

   EN 

 
(a) 

television  broadcasting  services  (including  near-video  on-demand  services), 
covered by point (a) of Article 1 of Directive 89/552/EEC;  

(b) 

radio broadcasting services;  

(c) 

(televised) teletext.  

EN 

19 

   EN 

 
Indicative list of the financial services covered by the third subparagraph of point 5 of  
Article 1 

ANNEX II 

– 

– 

– 

– 

– 

Investment services 

Insurance and reinsurance operations 

Banking services 

Operations relating to pension funds 

Services relating to dealings in futures or options 

Such services include in particular: 

(a) 

(b) 

investment services referred to in the Annex to Directive 2004/39/EC16; services of 
collective investment undertakings, 

services  covered  by  the  activities  subject  to  mutual  recognition  referred  to  in  the 
Annex to Directive 2000/12/EC17, 

(c) 

operations covered by the insurance and reinsurance activities referred to in: 

– 

– 

– 

– 

Article 1 of Directive 73/239/EEC18, 

Annex I of Directive 2002/83/EC19, 

Directive 64/225/EEC20, 

Directives 92/49/EEC21 and 2002/83/EC22. 

16 
17 
18 
19 
20 
21 
22 

OJ L 145,30.4.2004, p.1 
OJ L 126, 26.5.2000, p.1 
OJ L 228, 16. 8. 1973, p. 3. and subsequent amendments. 
OJ L 345, 19.12.2002,p.1 
OJ 56, 4. 4. 1964, p. 878/64. Directive as amended by the 1973 Act of Accession. 
OJ L 228, 11. 8. 1992, p. 1. 
OJ L 345, 19. 12. 2002, p. 1. 

EN 

20 

   EN 

 
                                                 
Pursuant  to  Article  11  (2)  of  the  Agreement,  the  following  communications  by  electronic 
means are considered necessary:  

ANNEX III 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

notification  slips.  They  may  be  communicated  before  or  together  with  the 
transmission of the full text; 

the full text of the draft notified; 

acknowledgement  of  receipt  of  the  draft  text,  containing  inter  alia,  the  relevant 
expiry date of the standstill period; 

messages requesting supplementary information; 

answers to request for supplementary information; 

comments; 

requests for ad hoc meetings; 

answers to requests for ad hoc meetings; 

requests for final texts; 

10. 

information that a six-month standstill has been called. 

The  following  communications  may,  for  the  time  being,  be  transmitted  by  fax,  however 
electronic means are preferable: 

11. 

12. 

basic legal texts or regulatory provisions; 

the final text; 

Administrative  arrangements  concerning  the  communications  shall  be  jointly  agreed  by  the 
Contracting Parties. 

EN 

21 

   EN 

 
AGREEMENT 

laying down a procedure for the provision of information in the field of technical 
regulations and of rules on information society services between the European 
Community and Romania 

THE EUROPEAN COMMUNITY, 

on the one hand, and 

ROMANIA, 

on the other hand, 

The above being hereinafter referred to as the Contracting Parties, 

HAVING  REGARD  to  the  Europe  Agreement  establishing  an  Association  between  the 
European Communities and their Member States, of the one part, and Romania, of the other 
part23, and in particular to the aims set out in Article 1, 

HAVING  REGARD  to  the  information  procedure  on  technical  regulations  and  rules  on 
information society services applied within the European Community24, 

CONSIDERING  the  commitment  of  Romania  and  the  European  Community  to  promote 
harmonious economic relations between the Contracting Parties, 

CONSIDERING the ongoing cooperation between the European Community and Romania in 
the  field  of  technical  barriers  to  trade  and  the  common  understanding  reached  within  the 
framework of that cooperation to extend this information procedure on technical regulations 
and rules on information society services applied in the European Community to Romania, 

HAVE AGREED AS FOLLOWS: 

For the purpose of this Agreement, the following definitions apply: 

Article 1 

1. 

2. 

23 
24 

“product”:  any  industrially  manufactured  product  and  any  agricultural  product, 
including fish products; 

“service”:  any  Information  Society  service,  that  is  to  say,  any  service  normally 
provided  for  remuneration,  at  a  distance,  by  electronic  means  and  at  the  individual 
request of a recipient of services. 

For the purposes of this definition: 

OJ L 357, 31.12.1994, p.2 
Directive  98/34/EC  (OJ  L  204,  21.7.1998,  p.  37),  as  amended  by  Directive  98/48/EC  (OJ  L  217, 
5.8.1998, p. 18) 

EN 

22 

   EN 

 
                                                 
– 

– 

– 

“at  a  distance”:  means  that  the  service  is  provided  without  the  parties  being 
simultaneously present, 

“by electronic means”: means that the service is sent initially and received at 
its destination by means of electronic equipment for the processing (including 
digital  compression)  and  storage  of  data,  and  entirely  transmitted,  conveyed 
and received by wire, by radio, by optical means or by other electromagnetic 
means, 

“at the individual request of a recipient of services”: means that the service is 
provided through the transmission of data on individual request. 

An indicative list of services not covered by this definition is set out in Annex I. 

This Agreement shall not apply to: 

– 

– 

radio broadcasting services, 

television broadcasting services covered by point (a) of Article 1 of Directive 
89/552/EEC25. 

“technical  specification”:  a specification contained in a document  which lays down 
the characteristics required of a product such as levels of quality, performance, safety 
or  dimensions,  including  the  requirements  applicable  to  the  product  as  regards  the 
name  under  which  the  product  is  sold,  terminology,  symbols,  testing  and  test 
methods, packaging, marking or labelling and conformity assessment procedures. 

The  term  “technical  specification”  also  covers  production  methods  and  processes 
used  in  respect  of  agricultural  products  as  referred  to  Article  38(1)  of  the  Treaty 
establishing  the  European  Community,  products  intended  for  human  and  animal 
consumption,  and  medicinal  products  as  defined  in  Article  1  of  Directive 
2001/83/EC26,  as  well  as  production  methods  and  processes  relating  to  other 
products, where these have an effect on their characteristics. 

“other requirements”: a requirement, other than a technical specification, imposed on 
a product for the purpose of protecting, in particular, consumers or the environment, 
and  which  affects  its  life  cycle  after  it  has  been  placed  on  the  market,  such  as 
conditions  of  use,  recycling,  reuse  or  disposal,  where  such  conditions  can 
significantly influence the composition or nature of the product or its marketing; 

“rule  on  services”:  requirement  of  a  general  nature  relating  to  the  taking-up  and 
pursuit  of  service  activities  within  the  meaning  of  point  2,  in  particular  provisions 
concerning the service provider, the services and the recipient of services, excluding 
any rules which are not specifically aimed at the services defined in that point. 

This  Agreement  shall  not  apply  to  rules  relating  to  matters  which  are  covered  by 
European Community legislation in the field of telecommunications services, defined 

OJ L 298, 17.10.1989, p. 23. Directive as last amended by Directive 97/36/EC (OJ L 202, 30.7.1997, p. 
1). 
OJ L 311, 28.11.2001, p. 67. 

3. 

4. 

5. 

25 

26 

EN 

23 

   EN 

 
                                                 
as  “services  whose  provision  consists  wholly  or  partly  in  the  transmission  and 
routing of signals on a telecommunications network by means of telecommunications 
processes, with the exception of radio broadcasting and television.” 27 

This  Agreement  shall  not  apply  to  rules  relating  to  matters  which  are  covered  by 
European  Community  legislation  in  the  field  of  financial  services,  as  listed  non-
exhaustively in Annex II to this Agreement. 

With the exception of Article 11, this Agreement shall not apply to rules enacted by 
or for regulated markets within the meaning of Directive 2004/39/EC28 or by or for 
other  markets  or  bodies  carrying  out  clearing  or  settlement  functions  for  those 
markets. 

For the purposes of this definition: 

– 

– 

a  rule  shall  be  considered  to  be  specifically  aimed  at  Information  Society 
services where, having regard to its statement of reasons and its operative part, 
the  specific  aim  and  object  of  all  or  some  of  its  individual  provisions  is  to 
regulate such services in an explicit and targeted manner, 

a rule shall not be considered to be specifically aimed at Information Society 
services if it affects such services only in an implicit or incidental manner. 

6. 

“technical  regulation”:  technical  specifications  and  other  requirements  or  rules  on 
services, including the relevant administrative provisions, the observance of which is 
compulsory,  de  jure  or  de  facto,  in  the  case  of  marketing,  provision  of  a  service, 
establishment  of  a  service  operator  or  use  in  one  of  the  Member  States  of  the 
European Community or a major part thereof, or in Romania or a major part thereof, 
as well as laws, regulations or administrative provisions of the Member States of the 
European  Community  or  of  Romania,  except  those  provided  for  in  Article  12, 
prohibiting  the  manufacture,  importation,  marketing  or  use  of  a  product  or 
prohibiting the provision or use of a service, or establishment as a service provider. 

De facto technical regulations include: 

– 

laws,  regulations  or  administrative  provisions  of  a  Member  State  of  the 
European Community or Romania which refer either to technical specifications 
or  to  other  requirements  or  to  rules  on  services,  or  to  professional  codes  or 
codes  of  practice  which  in  turn  refer  to  technical  specifications  or  to  other 
requirements  or  to  rules  on  services,  compliance  with  which  confers  a 
presumption of conformity with the obligations imposed by the aforementioned 
laws, regulations or administrative provisions, 

27 

28 

This definition arises by virtue of Directive 98/48/EC which makes reference to Directive 90/387/EEC 
(OJ  L  192,  24.7.1990,  p.  1).  The  latter  directive  has  been  repealed  by  Directive  2002/21/EC  on  a 
common  regulatory  framework  for  electronic  communications  networks  and  services  (OJ  L  108, 
24.04.2002,  p.3).  However,  the  definition  of  ‘telecommunications  services’  found  in  Directive 
90/387/EEC has been retained for the purposes of Directive 98/48/EC. 
OJ L 145, 30.4.2004, p.1. 

EN 

24 

   EN 

 
                                                 
– 

– 

voluntary  agreements  to  which  a  public  authority  is  a  contracting  party  and 
which  provide,  in  the  general  interest,  for  compliance  with  technical 
specifications  or  other  requirements  or  rules  on  services,  excluding  public 
procurement tender specifications, 

technical  specifications  or  other  requirements  or  rules  on  services  which  are 
linked to fiscal or financial measures affecting the consumption of products or 
services by encouraging compliance with such technical specifications or other 
technical  specifications  or  other 
requirements  or 
requirements or rules on services linked to national social security systems are 
not included. 

rules  on  services; 

This  comprises  technical  regulations  imposed  by  the  authorities  designated  by  the 
Member States and appearing on a list drawn up by the Commission of the European 
Community29  (thereinafter  called  ‘the  Commission’)  in  the  framework  of  the 
Committee  referred  to  in  Article  5  of  Directive  98/34/EC.  Romania  shall  draw  up 
such a list and forward it to the Commission the first day of the first month following 
entry into force of this Agreement. 

The same procedure shall be used for amending this list. 

7. 

“draft technical regulation”: the text of a technical specification or other requirement 
or of a rule on services, including administrative provisions, formulated with the aim 
of  enacting  it  or  of  ultimately  having  it  enacted  as  a  technical  regulation,  the  text 
being at a stage of preparation at which substantial amendments can still be made. 

Article 2 

This  Agreement  shall  not  apply  to  those  measures  Member  States  consider  necessary  under 
the Treaty establishing the European Community or Romania considers necessary: 

– 

for the protection of persons, in particular workers, when products are used, provided 
that such measures do not affect the products. 

Article 3 

Subject  to  Article  12,  the  European  Community  shall  notify  Romania  of  the  draft 
1. 
technical  regulations  notified  to  it  by  its  Member  States.  Where  these  technical  regulations 
merely transpose the full text of an international or European standard, information regarding 
the relevant standard shall suffice. It shall also let Romania have a statement of the grounds 
which  make  the  enactment  of  such  a  technical  regulation  necessary,  where  these  have  not 
already been made clear in the draft. 

2. 
Subject to Article 12, Romania shall likewise notify the European Community of its 
draft technical regulations. Where these technical regulations merely transpose the full text of 
an  international  or  European  standard,  information  regarding  the  relevant  standard  shall 
suffice. It shall also let the European Community have a statement of the grounds which make 

29 

OJ C 23, 27.1.2000, p. 3. 

EN 

25 

   EN 

 
                                                 
the  enactment  of  such  a  technical  regulation  necessary,  where  these  have  not  already  been 
made clear in the draft. 

Article 4 

A  full  text  of  the  draft  technical  regulation  notified  shall  be  made  available  in  the  original 
language  as  well  as  in  a  full  translation  into  one  of  the  official  languages  of  the  European 
Community. 

Article 5 

1. 
Where appropriate, and unless it has already been sent with a prior communication, a 
full text in the original language of the basic legislative or regulatory provisions principally 
and directly concerned shall also be simultaneously communicated, should knowledge of such 
text be necessary in order to assess the implications of the draft technical regulation notified.  

2. 
Where,  in  particular,  the  draft  seeks  to  limit  the  marketing  or  use  of  a  chemical 
substance,  preparation  or  product  on  grounds  of  public  health  or  of  the  protection  of 
consumers  or  the  environment,  Member  States  and  Romania  shall  also  forward  either  a 
summary or the references of all relevant data relating to the substance, preparation or product 
concerned and to known and available substitutes, where such information may be available, 
and communicate the anticipated effects of the measure on public health and the protection of 
the  consumer  and  the  environment,  together  with  an  analysis  of  the  risk  carried  out  as 
appropriate  in  accordance  with  the  general  principles  for  the  risk  evaluation  of  chemical 
substances as referred to in Article 10(4) of Regulation (EEC) No. 793/9330 in the case of an 
existing  substance  or  in  Article  3(2)  of  Directive  67/548/EEC31,  in  the  case  of  a  new 
substance. 

Article 6 

The  Member  States  and  Romania  shall  communicate  the  draft  again  under  the  above 
conditions  if  they  make  changes  to  the  draft  that  have  the  effect  of  significantly  altering  its 
scope, shortening the timetable originally envisaged for implementation, adding specifications 
or requirements, or making the latter more restrictive. Transmission of these communications 
shall take place in accordance with the provisions set out in Article 3. 

Each  Contracting  Party  may  ask  for  further  information  on  a  draft  technical  regulation 
notified in accordance with this Agreement. 

Article 7 

30 

31 

Council  Regulation  (EEC)  No.  793/93  of  23  March  1993  on  the  evaluation  and  control  of  the  
risks of existing substances (OJ L 84, 5.4.1993, p.1). 
Council  Directive  67/548/EEC  of  27  June  1967  on  the  approximation  of  the  laws,  regulations  and 
administrative provisions relating to the classification, packaging and labelling of dangerous substances 
(OJ L 196, 16.8.1967, p. 1). Directive, as amended by Directive 92/32/EEC (OJ L 154, 5.6.1992, p. 1) 
and subsequent directives 

EN 

26 

   EN 

 
                                                 
Article 8 

1. 
The  European  Community  and  Romania  may  make  comments  upon  the  drafts 
communicated.  The  comments  of  Romania  shall  be  forwarded  to  the  Commission  and  the 
comments of the European Community shall be forwarded by the Commission to Romania. 

The  Member  States  and  Romania  shall  take  such  comments  into  account  as  far  as 

2. 
possible in the subsequent preparation of the technical regulation. 

3. 
With respect to the technical specifications or other requirements or rules on services 
referred  to  in  the  third  indent  of  the  second  subparagraph  of  point  6  of  Article  1,  the 
comments of the Contracting Parties may concern only aspects which may hinder trade or, in 
respect of rules on services, the free movement of services or the freedom of establishment of 
service operators and not the fiscal or financial aspects of the measure.  

The Commission shall, when a six-month standstill is invoked according to the rules 

4. 
set out in Directive 98/34/EC, inform Romania thereof. 

Article 9 

The competent authorities of the Member States and Romania shall postpone the adoption of 
draft  technical  regulations  notified  for  three  months  from  the  date  of  receipt  by  the 
Commission of the text of the draft regulation. 

Article 10 

The standstill period referred to in Article 9 shall not apply in those cases where: 

– 

– 

for urgent reasons, occasioned by serious and unforeseeable circumstances relating to 
the protection of public health or safety, the protection of animals or the preservation 
of plants and, for rules on services, also for public policy, notably the protection of 
minors,  the  competent  authorities  are  obliged  to  prepare  technical  regulations  in  a 
very  short  space  of  time  in  order  to  enact  and  introduce  them  immediately  without 
any consultations being possible or 

for urgent reasons occasioned by serious circumstances relating to the protection of 
the  security  and  the  integrity  of  the  financial  system,  notably  the  protection  of 
depositors,  investors  and  insured  persons,  the  competent  authorities  are  obliged  to 
enact and implement rules on financial services immediately. 

The reasons which warrant the urgency of the measures taken shall be given. The justification 
for  urgent  measures  shall  be  detailed  and  clearly  explained  with  particular  emphasis  on  the 
unpredictability  and  the  seriousness  of  the  danger  confronting  the  concerned  authorities  as 
well as the absolute necessity for immediate action to remedy it. 

The  final  text  in  the  original  language  of  the  technical  regulation  shall  also  be 

1. 
communicated. 

Article 11 

EN 

27 

   EN 

 
The administrative arrangements for the above mentioned notifications are detailed in 

2. 
Annex III, which forms an integral part of this Agreement. 

Article 12 

1. 
Articles  3  to  10  shall  not  apply  to  those  laws,  regulations  and  administrative 
provisions  of  the  Member  States  and  Romania  or  voluntary  agreements  by  means  of  which 
Member States or Romania: 

– 

– 

– 

– 

– 

– 

– 

comply  as  far  as  the  Member  States  are  concerned  with  binding  European 
Community acts which result in the adoption of technical specifications or rules on 
services,  and  as  far  as  Romania  is  concerned  transpose  into  national  law  European 
Community acts which result in the adoption of technical specifications or rules on 
services, 

fulfil  as  far  as  the  Member  States  are  concerned  the  obligations  arising  out  of 
international  agreements  which  result  in  the  adoption  of  common  technical 
specifications or rules on services in the European Community, 

fulfil  as  far  as  Romania  is  concerned  the  obligations  arising  out  of  international 
agreements which result in the adoption of common technical specifications or rules 
on services in Romania and the European Community, 

make use of safeguard clauses provided for in binding European Community acts, 

apply Article 12(1) of Directive 2001/95/EC32, 

restrict  themselves  to  implementing  a  judgement  of  the  Court  of  Justice  of  the 
European Communities, 

restrict themselves to amending a technical regulation within the meaning of point 6 
of Article 1, in accordance with a Commission request, with a view to removing an 
obstacle to trade or, in the case of rules on services, to the free movement of services 
or the freedom of establishment of service operators. 

2. 
Articles 9 and 10 shall not apply to the laws, regulations and administrative provisions 
of the Member States and of Romania prohibiting manufacture insofar as they do not impede 
the free movement of products. 

3. 
Article 9 and 10 shall not apply to the technical specifications or other requirements or 
the rules on services referred to in the third indent of the second subparagraph of point 6 of 
Article 1.  

Information supplied under this Agreement shall be considered as confidential upon request. 
However,  both  the  European  Community  and  Romania  may,  provided  that  the  necessary 

Article 13 

32 

Directive 2001/95/EC of 3 December 2001 on general product safety (OJ L 011, 15.01.2002,p.4). 

EN 

28 

   EN 

 
                                                 
precautions are taken, consult for an expert opinion natural or legal persons, including persons 
in the private sector. 

Article 14 

1. 
The  Contracting  Parties  shall,  within  the  framework  of  the  established  cooperation 
between experts of the European Community and Romania in the field of technical barriers to 
trade, hold regular consultations both to ensure the satisfactory functioning of the procedure 
laid  down  in  this  Agreement  and  to  exchange  views  on  the  comments  which  have  been 
submitted  by  any  Contracting  Party  concerning  a  draft  technical  regulation  notified  in 
accordance  with  this  Agreement.  Furthermore,  by  common  consent,  the  Contracting  Parties 
may hold additional ad hoc meetings to deal with specific cases of particular interest to any 
Contracting Party. 

2. 
Romania  shall  appoint  an  expert  to  represent  it  in  meetings  of  the  Committee 
established  under  article  5  of  Directive  98/34/EC,  part  ‘information  society  services’  and 
‘technical regulations’. The expert must be a member of the government services of Romania. 
The expert shall not be entitled to vote.  

3. 
The Commission shall, in good time, inform the expert of the dates of the meetings, 
and  of  the  items  on  the  agenda  of  the  Committee.  The  Commission  shall  forward  relevant 
information to the expert. 

On  the  initiative  of  its  chairman,  the  Committee  may  meet  without  the  expert 

4. 
representing Romania being present. In that case Romania shall be informed. 

Article 15 

This  Agreement  shall  apply,  on  the  one  hand,  to  the  territories  in  which  the  Treaty 
establishing the European Community is applied and under the conditions laid down in that 
Treaty and, on the other hand, to the territory of Romania.  

Article 16 

This Agreement shall enter into force on the first day of the second month following the date 
on  which  the  Contracting  Parties  have  exchanged  Notes  confirming  the  completion  of  their 
respective procedures for the entry into force of this Agreement. 

This Agreement shall expire on the date of accession of Romania to the European Union. 

Article 17 

Article 18 

This Agreement is drawn up in two originals in the Czech, Danish, Dutch, English, Estonian, 
Finnish,  French,  German,  Greek,  Hungarian,  Italian,  Latvian,  Lithuanian,  Maltese,  Polish, 
Portuguese,  Slovene,  Slovak,  Spanish,  Swedish  and  Romanian  languages,  each  text  being 
equally authentic. 

EN 

29 

   EN 

 
ANNEX I 

Indicative list of services not covered by the second subparagraph of point 2 of Article 1 

1. 

Services not provided "at a distance" 

Services provided in the physical presence of the provider and the recipient, even if 
they involve the use of electronic devices: 

(a)  medical  examinations  or  treatment  at  a  doctor's  surgery  using  electronic 

equipment where the patient is physically present; 

(b) 

consultation of an electronic catalogue in a shop with the customer on site;  

(c) 

(d) 

plane  ticket  reservation  at  a  travel  agency  in  the  physical  presence  of  the 
customer by means of a network of computers;  

electronic  games  made  available  in  a  video-arcade  where  the  customer  is 
physically present. 

2. 

Services not provided "by electronic means" 

– 

Services having material content even though provided via electronic devices: 

(a) 

automatic cash or ticket dispensing machines (banknotes, rail tickets);  

(b) 

access  to  road  networks,  car  parks,  etc.,  charging  for  use,  even  if  there 
are  electronic  devices  at  the  entrance/exit  controlling  access  and/or 
ensuring correct payment is made. 

– 

– 

Off-line services: distribution of CD roms or software on diskettes. 

Services which are not provided via electronic processing/inventory systems: 

(a) 

voice telephony services;  

(b) 

telefax/telex services;  

(c) 

services provided via voice telephony or fax;  

(d) 

telephone/telefax consultation of a doctor;  

(e) 

telephone/telefax consultation of a lawyer;  

(f) 

telephone/telefax direct marketing. 

3. 

Services not supplied "at the individual request of a recipient of services" 

Services provided by transmitting data without individual demand for simultaneous 
reception  by  an  unlimited  number  of  individual  receivers  (point  to  multipoint 
transmission): 

EN 

30 

   EN 

 
(a) 

television  broadcasting  services  (including  near-video  on-demand  services), 
covered by point (a) of Article 1 of Directive 89/552/EEC;  

(b) 

radio broadcasting services;  

(c) 

(televised) teletext.  

EN 

31 

   EN 

 
Indicative list of the financial services covered by the third subparagraph of point 5 of  
Article 1 

ANNEX II 

– 

– 

– 

– 

– 

Investment services 

Insurance and reinsurance operations 

Banking services 

Operations relating to pension funds 

Services relating to dealings in futures or options 

Such services include in particular: 

(a) 

(b) 

investment services referred to in the Annex to Directive 2004/39/EC33; services of 
collective investment undertakings, 

services  covered  by  the  activities  subject  to  mutual  recognition  referred  to  in  the 
Annex to Directive 2000/12/EC34, 

(c) 

operations covered by the insurance and reinsurance activities referred to in: 

– 

– 

– 

– 

Article 1 of Directive 73/239/EEC35, 

Annex I of Directive 2002/83/EC36, 

Directive 64/225/EEC37, 

Directives 92/49/EEC38 and 2002/83/EC39. 

33 
34 
35 
36 
37 
38 
39 

OJ L 145,30.4.2004, p.1 
OJ L 126, 26.5.2000, p.1 
OJ L 228, 16. 8. 1973, p. 3. and subsequent amendments. 
OJ L 345, 19.12.2002,p.1 
OJ 56, 4. 4. 1964, p. 878/64. Directive as amended by the 1973 Act of Accession. 
OJ L 228, 11. 8. 1992, p. 1. 
OJ L 345, 19. 12. 2002, p. 1. 

EN 

32 

   EN 

 
                                                 
Pursuant  to  Article  11  (2)  of  the  Agreement,  the  following  communications  by  electronic 
means are considered necessary:  

ANNEX III 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

notification  slips.  They  may  be  communicated  before  or  together  with  the 
transmission of the full text; 

the full text of the draft notified; 

acknowledgement  of  receipt  of  the  draft  text,  containing  inter  alia,  the  relevant 
expiry date of the standstill period; 

messages requesting supplementary information; 

answers to request for supplementary information; 

comments; 

requests for ad hoc meetings; 

answers to requests for ad hoc meetings; 

requests for final texts; 

10. 

information that a six-month standstill has been called. 

The  following  communications  may,  for  the  time  being,  be  transmitted  by  fax,  however 
electronic means are preferable: 

11. 

12. 

basic legal texts or regulatory provisions; 

the final text; 

Administrative  arrangements  concerning  the  communications  shall  be  jointly  agreed  by  the 
Contracting Parties. 

EN 

33 

   EN 

 
LEGISLATIVE FINANCIAL STATEMENT 

Policy area(s): Enterprise 

Activit(y/ies): Internal Market for Goods and Sectoral Policies 

TITLE  OF  ACTION:  COUNCIL  DECISION  ON  THE  CONCLUSION  OF  BILATERAL  AGREEMENTS 
LAYING  DOWN  A  PROCEDURE  FOR  THE  PROVISION  OF  INFORMATION  IN 
THE  FIELD  OF  TECHNICAL  REGULATIONS  AND  RULES  ON  INFORMATION 
SOCIETY SERVICES WITH TWO CANDIDATE COUNTRIES 

1. 

BUDGET LINE(S) + HEADING(S) 02.0101 
AND 
STAFF HOLDING A POST PROVIDED FOR IN THE ESTABLISHMENT PLAN" 

"OFFICIALS 

TEMPORARY 

02.010401  Technical and logistical support and assistance to users 

02.0301  Operation  and  development  of  the  internal  market,  particularly  in  the  field 

of notification, certification and sectoral approximation 

2. 

OVERALL FIGURES 

2.1. 

Total allocation for action (Part B): € million in commitments: 0.014 

2.2. 

Period of application: 

The agreements will be of limited duration. Each agreement will end upon the accession 
to  the  European  Union  of  the  two  candidate  countries  with  which  it  was  concluded. 
Accordingly, there is no provision for renewing the agreements. 

2.3. 

Overall multiannual estimate of expenditure: 

(a) 

Schedule of commitment appropriations/payment appropriations (financial intervention) 
(see point 6.1.1) 

(€ million to three decimal places) 

2006 

2007 

2008 

2009 

2010 

Commitments 

0.014 

pm 

pm 

Payments 

0.007 

0.007 

pm 

pm 

pm 

pm 

pm 

n + 5 
and 
subs. 
years 
pm 

pm 

Total 

0.014 

0.014 

EN 

34 

   EN 

 
 
 
 
 
 
 
 
 
 
(b) 

Technical and administrative assistance and support expenditure (see point 6.1.2) 

Commitments 

None  None  None  None  None  None  None 

Payments 

None  None  None  None  None  None  None 

Subtotal a+b 

Commitments 

0.014 

pm 

pm 

Payments 

0.007 

0.007 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

0.014 

0.014 

(c) 

Overall  financial  impact  of  human  resources  and  other  administrative  expenditure 
(see points 7.2 and 7.3) 

0.0173 

pm 

pm 

pm 

pm 

pm 

0.0173 

Commitments/ 
payments 

TOTAL a+b+c 

Commitments 

0.0313 

pm 

Payments 

0.0156 

0,0156 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

0.0313 

0.0313 

2.4. 

Compatibility with financial programming and financial perspective 

Proposal is compatible with existing financial programming. 

2.5. 

Financial impact on revenue: 

Proposal  has  no  financial 
implementation of a measure). 

implications  (involves 

technical  aspects  regarding 

3. 

BUDGET CHARACTERISTICS 

Type of expenditure 

New 

(03 02 01) 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

Non-comp 

Diff 

YES 

NO 

NO 

N° 1.1 

4. 

LEGAL BASIS 

Article 133 EC 

EN 

35 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5. 

DESCRIPTION AND GROUNDS 

5.1. 

Need for Community intervention 

5.1.1.  Objectives pursued 

The objective is for the two candidate countries with which the agreements have been 
negotiated  to  participate,  before  their  accession  to  the  European  Union,  in  the 
notification  system  for  technical  regulations  established  by  Directive  98/34/EC,  as 
amended by Directive 98/48/EC. 

This  Directive  provides  for  the  prior  notification  of  draft  regulations  related  to  the 
products of all types and information society services of each of the 25 Member States 
of  the  European  Community  in  order  to  avoid  technical  barriers  to  trade  before  they 
appear.  According  to  the  Directive,  a  standstill  period  (of  at  least  three  months)  is 
provided  during  which  the  notified  draft  cannot  be  adopted  at  national  level.  A 
simplified  notification  system  (with  a  maximum  standstill  period  of  three  months  and 
the  possibility  to  make  comments  only)  applies  to  the  countries  of  the  European 
Economic Area and, as of 1 January 2001, to Turkey also. 

The mechanism envisaged by these agreements reproduces this simplified system so it 
can be applied to the candidate countries in order to: 

– 

– 

avoid  new  barriers  to  trade  between  the  European  Union  and  the  candidate 
countries; 

prepare these countries as early as possible for accession to the European Union as 
regards the notification procedure; 

– 

and thus strengthen the spirit of dialogue and mutual understanding. 

5.1.2.  Measures taken in connection with ex ante evaluation 

The ex ante evaluation revealed the following: 

– 

– 

It  is  in  the  interests  of  the  European  Community  and  of  its  Member  States  to 
conclude such agreements in that the system envisaged will allow them to be kept 
regularly informed of the regulatory initiatives under preparation in the candidate 
countries and, then, where appropriate, to make comments on drafts which would 
have serious legal and economic implications, particularly from the point of view 
of the free movement of products and information society services (among other 
matters,  for  example,  for  Community  subjects  or  enterprises  operating  in  the 
candidate countries). 

Furthermore, the application, in simplified form, of a procedure which will apply 
fully  from  accession  will  enable  all  the parties  to  prepare  for  that  accession  and 
thus to implement Community obligations correctly  

5.1.3.  Measures taken following ex post evaluation 

None. 

EN 

36 

   EN 

 
5.2. 

Actions envisaged and budget intervention arrangements 

The  objective  of  the  agreements  with  the  candidate  countries  is  that  they  should 
participate prior to their accession to the European Union in the notification system that 
was  put  in  place  at  Community  level  in  1983.  This  system  should  prevent  the 
emergence of new barriers to trade between the Community and the candidate countries. 

The  geographical  coverage  is  limited  to  the  2  candidate  countries  with  whom 
agreements have been negotiated. The draft regulations will be exchanged between the 
Commission,  the  candidate  countries  and  the  Member  States  within  the  framework  of 
the  administrative  mechanism  provided  for  by  Directive  98/34/EC,  and  which  has 
already been operational at EC level since 1984. 

A  maximum  of  around  20  drafts  per  year  can  reasonably  be  expected  from  the  two 
candidate countries. This figure is based on the fact that: 

– 

the  candidate  countries  are  concentrating  their  legislative  activities  more  on 
incorporating  the  acquis  communautaire  (measures  that  are  not  covered  by  this 
planned notification procedure) than on strictly unilateral initiatives. 

Participation  in  the  notification  procedure  of  2  candidate  countries  at  the  same  time 
should  result  in  5  notifications  per  candidate  country  for  the  remaining  period  up  to 
accession  (i.e.  6  months,  assuming  enlargement  takes  place  on  January  1  2007).  This 
figure is confirmed by experience with the EFTA countries. 

5.3.  Methods of implementation 

Action 1 

The  computer  application  necessary  for  the  automatic  transmission  of  texts  from  the 
Community Member States to the candidate countries and vice versa is already in place 
due to the previous exercise with former candidate countries prior to May 1 2004 (See 
COM(2003) 203 final. No additional funding is, therefore, needed. 

Action 2 

In  line  with  the  notification  procedure  established  with  the  European  Economic  Area 
countries,  the  candidate  countries  will  have  to  make  their  notifications  in  one  of  the 
official  Community  languages.  It  can  be  reasonably  expected  that  most  notifications 
will be in English.  

Similarly,  as  with  the  European  Economic  Area  countries,  notifications  will  be 
translated only into English, French and German. 

Based on 10 notifications for 6 months until accession (cf. point 5.2.) with an average of 
20 pages per notification, 200 pages of translation, can be expected. This figure has to 
be  doubled  with  regard  to  both  Bulgarian  and  Romanian  notifications,  because  a  text 
notified in English, for example, will be translated into French and German (5 x 20 x 2 
=  200  pages).  The  cost  is  therefore  estimated  at  € 14 000  (400  pages  at  € 35  /  page). 
This  amount  will  be  funded  from  DG  Enterprise  and  Industry’s  existing  budget 
(02.0301), which already provides for a slight increase in translation costs for 2006 in 
view of the preparation for enlargement. 

EN 

37 

   EN 

 
Action 3 

DG Enterprise and Industry will be responsible for: 

– 

– 

coordinating the analysis of the drafts by the other departments concerned within 
the Commission; 

coordinating with the Member States comments on the candidate countries' texts 
and  the  replies  to  the  comments  from  the  candidate  countries  on  the  Member 
States' texts; 

– 

managing the database and translations, and forwarding of messages. 

The staff required for this will be paid for out of DG Enterprise and Industry's financial 
resources. 

6. 

FINANCIAL IMPACT 

6.1. 

Total financial impact on Part B - (over the entire programming period) 

6.1.1.  Financial intervention 

Commitments (in € million to three decimal places) 

Breakdown 

2006 

2007 

2008 

2009 

2010 

Action 2 

0.014 

TOTAL 

0.014 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

pm 

n + 5 
and subs. 
years 
pm 

Total 

0.014 

pm 

0.014 

6.1.2.  Technical  and  administrative  assistance,  support  expenditure  and  IT  expenditure 

(commitment appropriations) 

None 

6.2. 

Calculation of costs by measure envisaged in Part B (over the entire programming 
period) 

Commitments (in € million to three decimal places) 

Breakdown 

Type  
of outputs 
(projects, files ) 

Number of outputs
(total for years 
1…n) 

Average unit cost 

Total cost 
(total for years 
1…n)  

Action 2 

- translation 

TOTAL COST 

1 

Files 

2 

10 

3 

4=(2X3) 

0.0014 

0.014 

0.014 

(Action 2: 10 notifications of 20 pages each = 200 pages to be translated into two languages = 
400 pages of translation at a cost of € 35 / page). 

EN 

38 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
7. 

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE  

7.1. 

Impact on human resources 

Types of post 

Staff to be assigned to management of the 
action using existing and/or additional 
resources 

Number of 
permanent posts 

Number of 
temporary posts 

Officials or 
temporary staff 

A 

B 

C 

0.1 

0.1 

0.1 

Other human resources 

Total 

Description of tasks deriving from 
the action 

Legal analysis and administrative 
support 

Total 

0.05 

0.05 

0.05 

0.15 

7.2. 

Overall financial impact of human resources 

Type of human resources 

Amount (€) 

Method of calculation *  

Officials 

Temporary staff 

Other human resources 

17 250 

115.000 x 0.15 

(specify budget line) 

Total 

17 250 

The amounts are total expenditure for 6 months (i.e. period up to accession). 

7.3. 

Other administrative expenditure deriving from the action 

Amount € 

Method of calculation 

Budget line 

(number and heading) 

Overall allocation (Title A7) 

A0701 – Missions 

A07030 – Meetings 
A07031 – Compulsory committees1 
A07032 – Non-compulsory committees1 

A07040 – Conferences 

A0705 – Studies and consultations 

Other expenditure (specify) 

Information systems 

Other expenditure – (A-2422) 

The amounts are total expenditure for 6 months. 

Total 

I. 

II. 

Annual total (7.2 + 7.3) 

Duration of action 

€ 17 250 

Until  the  accession  of  the  2  candidate  countries 
concerned to the Community 

EN 

39 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
III. 

Cost of the operation (I x II) 

The needs for human and administrative resources shall be covered within the allocation granted 
to the managing DG in the annual allocation procedure. 

8. 

FOLLOW-UP AND EVALUATION 

8.1. 

Follow-up arrangements 

The candidate countries' notifications will be integrated in the existing database system 
(TRIS) for the notification procedure. This system will allow a "day by day" follow-up 
these 
of 
notifications,  and  also  the  reactions  of  the  candidate  countries  to  the  Member  States' 
notifications. 

the  candidate  countries'  notifications, 

the  Community's  reactions 

to 

8.2. 

Arrangements and schedule for evaluation 

The  data  supplied  by  TRIS  will  be  used  to  evaluate  annually  the  impact  of  the 
Community intervention. 

9. 

ANTI-FRAUD MEASURES 

None (in the absence of actions and follow-up studies). 

EN 

40 

   EN