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 Czech Republic, the European Community and the Republic of Estonia, the European Community and the Republic of Latvia, the European Community and the Republic of Lithuania, the European Community and the Republic of Malta, the European Community and the Republic of Poland, the European Community and the Slovak Republic, the European Community and the Republic of Slovenia
Date: 2003-04-24
Institutions: European Commission
Subjects: Czechia, Estonia, Lithuania, Malta, Poland, Slovakia, Slovenia, agreement (EU), exchange of information, technical regulations, telecommunications, telematics

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 24.04.2003
COM(2003) 203 final

2003/0080 (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 Czech Republic, the European
Community and the Republic of Estonia, the European Community and the Republic of
Latvia, the European Community and the Republic of Lithuania, the European
Community and the Republic of Malta, the European Community and the Republic of
Poland, the European Community and the Slovak Republic, the European Community
and the Republic of Slovenia

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. EXPLANATORY MEMORANDUM

On  the  basis  of  the  negotiating  directives  adopted  by  the  Council  on  21.10.2002,  the
Commission has 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  eight  candidate  countries:  the  Czech  Republic,  the
Republic of Estonia, the Republic of Latvia, the Republic of Lithuania, the Republic of Malta,
the Republic of Poland, the Slovak Republic and the Republic of Slovenia.

The  text  of  the  Agreements  and  their  Annexes  are  attached  to  this  Communication.  The
following provides an assessment of the Agreements in the light of the negotiating directives
approved  by  the  Council,  and  proposes  that  the  Council  authorise  the  signature  of  these
Agreements and decide to approve their conclusion on behalf of the Community.

1.1. Assessment of the Agreements

The Agreements provide for the participation of the above mentioned candidate countries in
the  notification  procedure,  which  was 
level  by
Directive  83/189/CEE  (amended  several  times,  then  codified  by  Directive  98/34/EC,  and
subsequently amended by Directive 98/48/EC)1.

at  Community 

introduced 

Each bilateral Agreement  contains exactly the same  articles. Only the  recitals  differ.  Where
candidate  countries  have  already  concluded  PECA  Agreements,  reference  is  made  to  them.
With  regard  to  the  Republic  of  Malta,  reference  is  made  in  the  recitals  to  the  Agreement
establishing an Association between the European Community and the Republic of Malta, and
not to the  Europe  Agreements,  given that  the  Republic  of  Malta  did  not  conclude  a  Europe
Agreement with the European Communities.

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.

1

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.

2

                                                
Each  of  the  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 candidate country with whom a bilateral Agreement
has been drawn up; and each candidate country has the right to make comments on the drafts
thus notified by the Member States.

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

1.2. Explanation article-by-article

1.2.1. The Agreement

An  article-by-article  assessment  follows  (given  that  the  articles  are  the  same  in  all
agreements, the description given below applies to all 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.

in  Directive  98/34/EC,  as  amended  by
Article  2:  Exception  from  scope.  Like 
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.

3

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.

is  not 

required.  These  exceptions  are 

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

identical 

listed 

those 

to 

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.

4

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.

1.2.2. 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 
identical  with  Annex  V  of  Directive  98/34/EC,  as  amended  by
Directive 98/48/EC.

is 

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
identical  with  Annex  VI  of
subparagraph  of 
Directive 98/34/EC, as amended by Directive 98/48/EC.

the  Agreement).  The  Annex 

is 

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.

2. DRAFT COUNCIL DECISION

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

Signature is required by each candidate country 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.

5

2003/0080 (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 Czech Republic, the European
Community and the Republic of Estonia, the European Community and the Republic of
Latvia, the European Community and the Republic of Lithuania, the European
Community and the Republic of Malta, the European Community and the Republic of
Poland, the European Community and the Slovak Republic, the European Community
and the Republic of Slovenia

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 Commission2,

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 Czech Republic, the European Community and the Republic of
Estonia, the European Community and the Republic of Latvia, the European Community and
the Republic of Lithuania, the European Community and the Republic of Malta, the European
Community and the Republic of Poland, the European Community and the Slovak Republic,
the European Community and the Republic of Slovenia 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 Czech Republic, the European Community and the Republic of
Estonia, the European Community and the Republic of Latvia, the European Community and
the Republic of Lithuania, the European Community and the Republic of Malta, the European
Community and the Republic of Poland, the European Community and the Slovak Republic,
the European Community and the Republic of Slovenia, are hereby approved on behalf of the
European  Community.  The  text  of  the  Agreements  and  the  Annexes  are  attached  to  this
Decision.

2

OJ C […], […], p. […]

6

                                                
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 15 of the Agreements (3).

Done at Brussels,

For the Council
The President

3

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.

7

                                                
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 Czech Republic

THE EUROPEAN COMMUNITY,

on the one hand, and

THE CZECH REPUBLIC,

on the other hand,

All 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 Czech Republic, of
the other part4, 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 Community5,

HAVING  REGARD  to  the  Protocol  to  the  Europe  Agreement  establishing  an  Association
between  the  European  Communities  and  their  Member  States,  of  the  one  part,  and  the
Czech Republic, of the other part6, on Conformity Assessment and Acceptance of  Industrial
Products and in particular to the aims set out in Article 12,

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

CONSIDERING  the  ongoing  cooperation  between  the  European  Community  and  the
Czech  Republic  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
the
technical 
European Community to the Czech Republic,

information  society  services  applied 

regulations  and 

rules  on 

in 

HAVE AGREED AS FOLLOWS:

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

Article 1

1.

4

5

6

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

OJ L 360, 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)
OJ L 135, 17.5.2001, p. 1.

8

                                                
2.

“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:

– 

– 

“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/EEC7.

“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, 
of
Directive 2001/83/EC8, as well as production methods and processes relating to other
products, where these have an effect on their characteristics.

and  medicinal 

in  Article 

products 

defined 

as 

1 

“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

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.

9

3.

4.

5.

7

8

                                                
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,  as
defined by Directive 90/387/EEC9.

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  93/22/EEC  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.

“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 Czech  Republic  or  a major
part thereof, as well as laws, regulations or administrative provisions of the Member
States of the European Community or of the Czech Republic, 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  Czech  Republic  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,

– 

voluntary  agreements  to  which  a  public  authority  is  a  contracting  party  and
which  provide,  in  the  general  interest,  for  compliance  with  technical

6.

9

OJ L 192, 24.7.1990, p. 1. Directive as amended by Directive 97/51/EC (OJ L 295, 29.10.1997, p. 23).

10

                                                
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
requirements  or 
technical  specifications  or  other
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
Community10  (thereinafter  called  ‘the  Commission’)  in  the  framework  of  the
Committee referred to in Article 5 of Directive 98/34/EC. The Czech Republic 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 Czech Republic 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 Czech Republic 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 Czech Republic
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  Czech  Republic 

2.
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  the  enactment  of  such  a  technical  regulation  necessary,  where
these have not already been made clear in the draft.

likewise  notify 

shall 

10

OJ C 23, 27.1.2000, p. 3.

11

                                                
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

Where appropriate, and unless it has already been sent with a prior communication, a
1.
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  Czech  Republic  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. 793/9311 in the
case  of  an  existing  substance  or  in  Article  3(2)  of  Directive  67/548/EEC12,  in  the  case  of  a
new substance.

Article 6

The  Member  States  and  the  Czech  Republic  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

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

Article 8

11

12

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).

12

                                                
Commission  and  the  comments  of  the  European  Community  shall  be  forwarded  by  the
Commission to the Czech Republic.

The Member States and the Czech Republic shall take such comments into account as

2.
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 Czech Republic thereof.

Article 9

The competent authorities of the Member States  and the  Czech  Republic  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.

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.

13

Article 12

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

– 

– 

– 

– 

– 

– 

– 

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

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

apply Article 8(1) of Directive 92/59/EEC13,

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 the Czech Republic 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.

Article 13

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

13

Council Directive 92/59/EEC of 29 June 1992 on general product safety (OJ L 228, 11.8.1992, p. 24).

14

                                                
Article 14

1.
The  Contracting  Parties  shall,  within  the  framework  of  the  established  cooperation
between experts of the European Community and the Czech Republic 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.
The  Czech  Republic  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 the Czech Republic. The expert shall not be entitled to vote.

The Commission shall, in good time, inform the expert of the dates of the  meetings,
3.
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  Czech  Republic  being  present.  In  that  case  the  Czech  Republic  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 Czech Republic.

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  Czech  Republic  to  the
European Union.

Article 17

Article 18

This Agreement is drawn up in two originals in the Danish, Dutch, English, Finnish, French,
German, Greek, Italian, Portuguese, Spanish, Swedish and Czech languages, each text being
equally authentic.

15

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.

16

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):

(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.

17

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  93/22/EEC14;  services  of
collective investment undertakings,

services  covered  by  the  activities  subject  to  mutual  recognition  referred  to  in  the
Annex to Directive 89/646/EEC15,

(c)

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

– 

– 

– 

– 

Article 1 of Directive 73/239/EEC16,

the Annex to Directive 79/267/EEC17,

Directive 64/225/EEC18,

Directives 92/49/EEC19 and 92/96/EEC20.

14

15

16

17

18

19

20

OJ L 141, 11. 6. 1993, p. 27.
OJ L 386, 30. 12. 1989, p. 1. Directive as amended by Directive 92/30/EEC (OJ L 110, 28. 4. 1992, p.
52).
OJ L 228, 16. 8. 1973, p. 3. Directive as last amended by Directive 92/49/EEC (OJ L 228, 11. 8. 1992,
p. 1).
OJ L 63, 13. 3. 1979, p. 1. Directive as last amended by Directive 90/619/EEC (OJ L 330, 29. 11. 1990,
p. 50).
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 360, 9. 12. 1992, p. 1.

18

                                                
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.

19

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 Estonia

THE EUROPEAN COMMUNITY,

on the one hand, and

THE REPUBLIC OF ESTONIA,

on the other hand,

All 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 Estonia,
of the other part21, 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 Community22,

CONSIDERING the commitment of the Republic of Estonia 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 Estonia 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 
the
European Community to the Republic of Estonia,

information  society  services  applied 

regulations  and 

rules  on 

in 

HAVE AGREED AS FOLLOWS:

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

Article 1

1.

2.

21

22

“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 68, 9.3.1998, 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)

20

                                                
– 

– 

“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/EEC23.

“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, 
of
Directive  2001/83/EC24,  as  well  as  production  methods  and  processes  relating  to
other products, where these have an effect on their characteristics.

and  medicinal 

in  Article 

products 

defined 

as 

1 

“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.

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.

21

3.

4.

5.

23

24

                                                
6.

This  Agreement  shall  not  apply  to  rules  relating  to  matters  which  are  covered  by
European  Community  legislation  in  the  field  of  telecommunications  services,  as
defined by Directive 90/387/EEC25.

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  93/22/EEC  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.

“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  Estonia  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  Estonia,  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 Estonia 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,

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,

25

OJ L 192, 24.7.1990, p. 1. Directive as amended by Directive 97/51/EC (OJ L 295, 29.10.1997, p. 23).

22

                                                
– 

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
requirements  or 
technical  specifications  or  other
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
Community26  (thereinafter  called  ‘the  Commission’)  in  the  framework  of  the
Committee referred to  in Article 5 of  Directive 98/34/EC.  The Republic of Estonia
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  Estonia  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 Estonia 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
Estonia  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  Estonia  shall 

2.
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  the  enactment  of  such  a  technical  regulation  necessary,  where
these have not already been made clear in the draft.

likewise  notify 

26

OJ C 23, 27.1.2000, p. 3.

23

                                                
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

Where appropriate, and unless it has already been sent with a prior communication, a
1.
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 Estonia 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. 793/9327 in the
case  of  an  existing  substance  or  in  Article  3(2)  of  Directive  67/548/EEC28,  in  the  case  of  a
new substance.

Article 6

The Member States and the Republic of Estonia 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

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

Article 8

27

28

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).

24

                                                
Commission  and  the  comments  of  the  European  Community  shall  be  forwarded  by  the
Commission to the Republic of Estonia.

The  Member  States  and  the  Republic  of  Estonia  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 Estonia thereof.

Article 9

The competent authorities of the Member States and the Republic of Estonia 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.

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.

25

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  Estonia  or  voluntary  agreements  by
means of which Member States or the Republic of Estonia:

– 

– 

– 

– 

– 

– 

– 

as 

far 

comply  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 Estonia  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  Estonia  is  concerned  the  obligations  arising  out  of
international  agreements  which  result  in  the  adoption  of  common  technical
specifications  or  rules  on  services 
the
in 
European Community,

the  Republic  of  Estonia  and 

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

apply Article 8(1) of Directive 92/59/EEC29,

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 the Republic of Estonia 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.

Article 13

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

29

Council Directive 92/59/EEC of 29 June 1992 on general product safety (OJ L 228, 11.8.1992, p. 24).

26

                                                
Article 14

1.
The  Contracting  Parties  shall,  within  the  framework  of  the  established  cooperation
between  experts  of  the  European  Community  and  the  Republic  of  Estonia  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.
The  Republic  of  Estonia  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 the Republic of Estonia. The expert shall not be entitled to vote.

The Commission shall, in good time, inform the expert of the dates of the  meetings,
3.
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 Estonia being present. In that case the Republic of Estonia 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 Estonia.

Article 16

This Agreement shall enter into force on the first day of the first 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  Estonia  to  the
European Union.

Article 17

Article 18

This Agreement is drawn up in two originals in the Danish, Dutch, English, Finnish, French,
German,  Greek,  Italian,  Portuguese,  Spanish,  Swedish  and  Estonian  languages,  each  text
being equally authentic.

27

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.

28

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):

(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.

29

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  93/22/EEC30  services  of
collective investment undertakings,

services  covered  by  the  activities  subject  to  mutual  recognition  referred  to  in  the
Annex to Directive 89/646/EEC31,

(c)

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

– 

– 

– 

– 

Article 1 of Directive 73/239/EEC32,

the Annex to Directive 79/267/EEC33,

Directive 64/225/EEC34,

Directives 92/49/EEC35 and 92/96/EEC36.

30 
31

32

33

34

35

36

OJ L 141, 11. 6. 1993, p. 27.
OJ L 386, 30. 12. 1989, p. 1. Directive as amended by Directive 92/30/EEC (OJ L 110, 28. 4. 1992, p.
52).
OJ L 228, 16. 8. 1973, p. 3. Directive as last amended by Directive 92/49/EEC (OJ L 228, 11. 8. 1992,
p. 1).
OJ L 63, 13. 3. 1979, p. 1. Directive as last amended by Directive 90/619/EEC (OJ L 330, 29. 11. 1990,
p. 50).
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 360, 9. 12. 1992, p. 1.

30

                                                
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.

31

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 Latvia

THE EUROPEAN COMMUNITY,

on the one hand, and

THE REPUBLIC OF LATVIA,

on the other hand,

All 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 Latvia,
of the other part37, 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 Community38,

HAVING  REGARD  to  the  Protocol  to  the  Europe  Agreement  establishing  an  Association
between  the  European  Communities  and  their  Member  States,  of  the  one  part,  and  the
Republic  of  Latvia,  of  the  other  part39,  on  Conformity  Assessment  and  Acceptance  of
Industrial Products and in particular to the aims set out in Article 12,

CONSIDERING the commitment of the Republic of Latvia 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 Latvia 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
the
technical 
European Community to the Republic of Latvia,

information  society  services  applied 

regulations  and 

rules  on 

in 

HAVE AGREED AS FOLLOWS:

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

Article 1

1.

37

38

39

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

OJ L 26, 2.2.1998, 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)
OJ L 202, 31.7.2002, p. 3.

32

                                                
2.

“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:

– 

– 

“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/EEC40.

“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, 
of
Directive  2001/83/EC41,  as  well  as  production  methods  and  processes  relating  to
other products, where these have an effect on their characteristics.

and  medicinal 

in  Article 

products 

defined 

as 

1 

“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

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.

33

3.

4.

5.

40

41

                                                
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,  as
defined by Directive 90/387/EEC42.

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  93/22/EEC  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.

“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 Latvia 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  Latvia,  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 Latvia 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,

– 

voluntary  agreements  to  which  a  public  authority  is  a  contracting  party  and
which  provide,  in  the  general  interest,  for  compliance  with  technical

6.

42

OJ L 192, 24.7.1990, p. 1. Directive as amended by Directive 97/51/EC (OJ L 295, 29.10.1997, p. 23).

34

                                                
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
requirements  or 
technical  specifications  or  other
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
Community43  (thereinafter  called  ‘the  Commission’)  in  the  framework  of  the
Committee  referred  to  in  Article  5  of  Directive  98/34/EC.  The  Republic  of  Latvia
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  Latvia  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 Latvia 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
Latvia  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  Latvia  shall 

2.
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  the  enactment  of  such  a  technical  regulation  necessary,  where
these have not already been made clear in the draft.

likewise  notify 

43

OJ C 23, 27.1.2000, p. 3.

35

                                                
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

Where appropriate, and unless it has already been sent with a prior communication, a
1.
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 Latvia 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. 793/9344 in the
case  of  an  existing  substance  or  in  Article  3(2)  of  Directive  67/548/EEC45,  in  the  case  of  a
new substance.

Article 6

The Member States  and the Republic of  Latvia 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

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

Article 8

44

45

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).

36

                                                
Commission  and  the  comments  of  the  European  Community  shall  be  forwarded  by  the
Commission to the Republic of Latvia.

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

2.
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 Latvia thereof.

Article 9

The competent authorities of the Member States and the Republic of Latvia 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.

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.

37

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  Latvia  or  voluntary  agreements  by
means of which Member States or the Republic of Latvia:

– 

– 

– 

– 

– 

– 

– 

as 

far 

comply  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  Latvia  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  Latvia  is  concerned  the  obligations  arising  out  of
international  agreements  which  result  in  the  adoption  of  common  technical
specifications  or  rules  on  services 
the
in 
European Community,

the  Republic  of  Latvia  and 

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

apply Article 8(1) of Directive 92/59/EEC46,

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 the Republic of  Latvia 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.

Article 13

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

46

Council Directive 92/59/EEC of 29 June 1992 on general product safety (OJ L 228, 11.8.1992, p. 24).

38

                                                
Article 14

1.
The  Contracting  Parties  shall,  within  the  framework  of  the  established  cooperation
between  experts  of  the  European  Community  and  the  Republic  of  Latvia  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.
The  Republic  of  Latvia  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 the Republic of Latvia. The expert shall not be entitled to vote.

The Commission shall, in good time, inform the expert of the dates of the  meetings,
3.
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 Latvia being present. In that case the Republic of Latvia 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 Latvia.

Article 16

This Agreement shall enter into force on the first day of the first 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  Latvia  to  the
European Union.

Article 17

Article 18

This Agreement is drawn up in two originals in the Danish, Dutch, English, Finnish, French,
German, Greek, Italian, Portuguese, Spanish, Swedish and Latvian languages, each text being
equally authentic.

39

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.

40

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):

(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.

41

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  93/22/EEC47;  services  of
collective investment undertakings,

services  covered  by  the  activities  subject  to  mutual  recognition  referred  to  in  the
Annex to Directive 89/646/EEC48,

(c)

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

– 

– 

– 

– 

Article 1 of Directive 73/239/EEC49,

the Annex to Directive 79/267/EEC50,

Directive 64/225/EEC51,

Directives 92/49/EEC52 and 92/96/EEC53.

47

48

49

50

51

52

53

OJ L 141, 11. 6. 1993, p. 27.
OJ L 386, 30. 12. 1989, p. 1. Directive as amended by Directive 92/30/EEC (OJ L 110, 28. 4. 1992, p.
52).
OJ L 228, 16. 8. 1973, p. 3. Directive as last amended by Directive 92/49/EEC (OJ L 228, 11. 8. 1992,
p. 1).
OJ L 63, 13. 3. 1979, p. 1. Directive as last amended by Directive 90/619/EEC (OJ L 330, 29. 11. 1990,
p. 50).
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 360, 9. 12. 1992, p. 1.

42

                                                
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.

43

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 Lithuania

THE EUROPEAN COMMUNITY,

on the one hand, and

THE REPUBLIC OF LITHUANIA,

on the other hand,

All 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
Lithuania, of the other part54, 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 Community55,

HAVING  REGARD  to  the  Protocol  to  the  Europe  Agreement  establishing  an  Association
between  the  European  Communities  and  their  Member  States,  of  the  one  part,  and  the
Republic  of  Lithuania,  of  the  other  part56,  on  Conformity  Assessment  and  Acceptance  of
Industrial Products and in particular to the aims set out in Article 12,

CONSIDERING the commitment of the Republic of Lithuania 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 Lithuania 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
the
technical 
European Community to the Republic of Lithuania,

information  society  services  applied 

regulations  and 

rules  on 

in 

HAVE AGREED AS FOLLOWS:

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

Article 1

1.

54

55

56

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

OJ L 51, 20.2.1998, 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)
OJ L 202, 31.7.2002, p. 21.

44

                                                
2.

“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:

– 

– 

“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/EEC57.

“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, 
of
Directive  2001/83/EC58,  as  well  as  production  methods  and  processes  relating  to
other products, where these have an effect on their characteristics.

and  medicinal 

in  Article 

products 

defined 

as 

1 

“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

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.

45

3.

4.

5.

57

58

                                                
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,  as
defined by Directive 90/387/EEC59.

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  93/22/EEC  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.

“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  Lithuania  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 Lithuania, 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  Lithuania  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,

– 

voluntary  agreements  to  which  a  public  authority  is  a  contracting  party  and
which  provide,  in  the  general  interest,  for  compliance  with  technical

6.

59

OJ L 192, 24.7.1990, p. 1. Directive as amended by Directive 97/51/EC (OJ L 295, 29.10.1997, p. 23).

46

                                                
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
requirements  or 
technical  specifications  or  other
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
Community60  (thereinafter  called  ‘the  Commission’)  in  the  framework  of  the
Committee referred to in Article 5 of Directive 98/34/EC. The Republic of Lithuania
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  Lithuania  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 Lithuania
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
Lithuania  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,  the  Republic  of  Lithuania  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  the  enactment  of  such  a  technical  regulation  necessary,  where
these have not already been made clear in the draft.

60

OJ C 23, 27.1.2000, p. 3.

47

                                                
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

Where appropriate, and unless it has already been sent with a prior communication, a
1.
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  Lithuania  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.
793/9361 in the case of an existing substance or in Article 3(2) of Directive 67/548/EEC62, in
the case of a new substance.

Article 6

The  Member  States  and  the  Republic  of  Lithuania  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

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

Article 8

61

62

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).

48

                                                
the  Commission  and  the  comments  of  the  European  Community  shall  be  forwarded  by  the
Commission to the Republic of Lithuania.

The  Member  States  and  the  Republic  of  Lithuania  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 Lithuania thereof.

Article 9

The competent authorities of the Member States and the Republic of Lithuania 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.

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.

49

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  Lithuania  or  voluntary  agreements  by
means of which Member States or the Republic of Lithuania:

– 

– 

– 

– 

– 

– 

– 

as 

far 

comply  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 Lithuania 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 Lithuania 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  Lithuania  and 
the
European Community,

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

apply Article 8(1) of Directive 92/59/EEC63,

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  the  Republic  of  Lithuania  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.

Article 13

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

63

Council Directive 92/59/EEC of 29 June 1992 on general product safety (OJ L 228, 11.8.1992, p. 24).

50

                                                
Article 14

1.
The  Contracting  Parties  shall,  within  the  framework  of  the  established  cooperation
between  experts  of  the  European  Community  and  the  Republic  of  Lithuania  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.
The  Republic  of  Lithuania  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 the Republic of Lithuania. The expert shall not be entitled to vote.

The Commission shall, in good time, inform the expert of the dates of the  meetings,
3.
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  Lithuania being present.  In that case the Republic  of  Lithuania
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 Lithuania.

Article 16

This Agreement shall enter into force on the first day of the first 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  Lithuania  to  the
European Union.

Article 17

Article 18

This Agreement is drawn up in two originals in the Danish, Dutch, English, Finnish, French,
German,  Greek,  Italian,  Portuguese,  Spanish,  Swedish  and  Lithuanian  languages,  each  text
being equally authentic.

51

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.

52

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):

(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.

53

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  93/22/EEC64;  services  of
collective investment undertakings,

services  covered  by  the  activities  subject  to  mutual  recognition  referred  to  in  the
Annex to Directive 89/646/EEC65,

(c)

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

– 

– 

– 

– 

Article 1 of Directive 73/239/EEC66,

the Annex to Directive 79/267/EEC67,

Directive 64/225/EEC68,

Directives 92/49/EEC69 and 92/96/EEC70.

64

65

66

67

68

69

70

OJ L 141, 11. 6. 1993, p. 27.
OJ L 386, 30. 12. 1989, p. 1. Directive as amended by Directive 92/30/EEC (OJ L 110, 28. 4. 1992, p.
52).
OJ L 228, 16. 8. 1973, p. 3. Directive as last amended by Directive 92/49/EEC (OJ L 228, 11. 8. 1992,
p. 1).
OJ L 63, 13. 3. 1979, p. 1. Directive as last amended by Directive 90/619/EEC (OJ L 330, 29. 11. 1990,
p. 50).
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 360, 9. 12. 1992, p. 1.

54

                                                
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.

55

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 Malta

THE EUROPEAN COMMUNITY,

on the one hand, and

THE REPUBLIC OF MALTA,

on the other hand,

All the above being hereinafter referred to as the Contracting Parties,

the
HAVING  REGARD 
European  Economic  Community,  of  the  one  part,  and  the  Republic  of  Malta,  of  the  other
part71, and in particular to the aims set out in Article 2(1),

the  Agreement  establishing  an  Association  between 

to 

HAVING  REGARD  to  the  information  procedure  on  technical  regulations  and  rules  on
information society services applied within the European Community72,

CONSIDERING the commitment of the Republic of Malta 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  Malta  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 Malta,

HAVE AGREED AS FOLLOWS:

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

Article 1

1.

2.

71

72

“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 61, 14.3.1971, 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)

56

                                                
– 

– 

“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/EEC73.

“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, 
of
Directive  2001/83/EC74,  as  well  as  production  methods  and  processes  relating  to
other products, where these have an effect on their characteristics.

and  medicinal 

in  Article 

products 

defined 

as 

1 

“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.

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.

57

3.

4.

5.

73

74

                                                
6.

This  Agreement  shall  not  apply  to  rules  relating  to  matters  which  are  covered  by
European  Community  legislation  in  the  field  of  telecommunications  services,  as
defined by Directive 90/387/EEC75.

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  93/22/EEC  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.

“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 Malta 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  Malta,  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 Malta 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,

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,

75

OJ L 192, 24.7.1990, p. 1. Directive as amended by Directive 97/51/EC (OJ L 295, 29.10.1997, p. 23).

58

                                                
– 

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
requirements  or 
technical  specifications  or  other
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 Community76 (thereinafter  called ‘the  Commission’)  in the framework of
the Committee referred to in Article 5 of Directive 98/34/EC. The Republic of Malta
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  Malta  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 Malta 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
Malta  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  Malta  shall 

2.
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  the  enactment  of  such  a  technical  regulation  necessary,  where
these have not already been made clear in the draft.

likewise  notify 

76

OJ C 23, 27.1.2000, p. 3.

59

                                                
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

Where appropriate, and unless it has already been sent with a prior communication, a
1.
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 Malta 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. 793/9377 in the
case  of  an  existing  substance  or  in  Article  3(2)  of  Directive  67/548/EEC78,  in  the  case  of  a
new substance.

Article 6

The Member  States  and the Republic of  Malta  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

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

Article 8

77

78

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).

60

                                                
Commission  and  the  comments  of  the  European  Community  shall  be  forwarded  by  the
Commission to the Republic of Malta.

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

2.
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 Malta thereof.

Article 9

The competent authorities of the Member States and the Republic of Malta 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.

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.

61

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 Malta or voluntary agreements by means
of which Member States or the Republic of Malta:

– 

– 

– 

– 

– 

– 

– 

as 

far 

comply  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  Malta  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  Malta  is  concerned  the  obligations  arising  out  of
international  agreements  which  result  in  the  adoption  of  common  technical
specifications  or 
the
European Community,

the  Republic  of  Malta  and 

rules  on  services 

in 

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

apply Article 8(1) of Directive 92/59/EEC79,

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 the Republic of Malta 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.

Article 13

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

79

Council Directive 92/59/EEC of 29 June 1992 on general product safety (OJ L 228, 11.8.1992, p. 24).

62

                                                
Article 14

1.
The  Contracting  Parties  shall,  within  the  framework  of  the  established  cooperation
between  experts  of  the  European  Community  and  the  Republic  of  Malta  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.
The  Republic  of  Malta  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 the Republic of Malta. The expert shall not be entitled to vote.

The Commission shall, in good time, inform the expert of the dates of the  meetings,
3.
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 Malta being present. In that case the Republic of Malta 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 Malta.

Article 16

This Agreement shall enter into force on the first day of the first 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  Malta  to  the
European Union.

Article 17

Article 18

This Agreement is drawn up in two originals in the Danish, Dutch, English, Finnish, French,
German, Greek, Italian, Portuguese, Spanish, Swedish and Maltese languages, each text being
equally authentic.

63

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.

64

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):

(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.

65

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  93/22/EEC80;  services  of
collective investment undertakings,

services  covered  by  the  activities  subject  to  mutual  recognition  referred  to  in  the
Annex to Directive 89/646/EEC81,

(c)

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

– 

– 

– 

– 

Article 1 of Directive 73/239/EEC82,

the Annex to Directive 79/267/EEC83,

Directive 64/225/EEC84,

Directives 92/49/EEC85 and 92/96/EEC86.

80

81

82

83

84

85

86

OJ L 141, 11. 6. 1993, p. 27.
OJ L 386, 30. 12. 1989, p. 1. Directive as amended by Directive 92/30/EEC (OJ L 110, 28. 4. 1992, p.
52).
OJ L 228, 16. 8. 1973, p. 3. Directive as last amended by Directive 92/49/EEC (OJ L 228, 11. 8. 1992,
p. 1).
OJ L 63, 13. 3. 1979, p. 1. Directive as last amended by Directive 90/619/EEC (OJ L 330, 29. 11. 1990,
p. 50).
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 360, 9. 12. 1992, p. 1.

66

                                                
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.

67

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 Poland

THE EUROPEAN COMMUNITY,

on the one hand, and

THE REPUBLIC OF POLAND,

on the other hand,

All 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 Poland,
of the other part87, 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 Community88,

CONSIDERING the commitment of the Republic of Poland 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 Poland 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 
the
European Community to the Republic of Poland,

information  society  services  applied 

regulations  and 

rules  on 

in 

HAVE AGREED AS FOLLOWS:

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

Article 1

1.

2.

87

88

“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 348, 31.12.1993, 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)

68

                                                
– 

– 

“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/EEC89.

“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, 
of
Directive  2001/83/EC90,  as  well  as  production  methods  and  processes  relating  to
other products, where these have an effect on their characteristics.

and  medicinal 

in  Article 

products 

defined 

as 

1 

“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.

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.

69

3.

4.

5.

89

90

                                                
6.

This  Agreement  shall  not  apply  to  rules  relating  to  matters  which  are  covered  by
European  Community  legislation  in  the  field  of  telecommunications  services,  as
defined by Directive 90/387/EEC91.

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  93/22/EEC  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.

“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  Poland  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  Poland,  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 Poland 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,

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,

91

OJ L 192, 24.7.1990, p. 1. Directive as amended by Directive 97/51/EC (OJ L 295, 29.10.1997, p. 23).

70

                                                
– 

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
requirements  or 
technical  specifications  or  other
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 Community92 (thereinafter  called ‘the  Commission’)  in the framework of
the  Committee  referred  to  in  Article  5  of  Directive  98/34/EC.  The  Republic  of
Poland 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  Poland  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 Poland 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
Poland  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  Poland  shall 

2.
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  the  enactment  of  such  a  technical  regulation  necessary,  where
these have not already been made clear in the draft.

likewise  notify 

92

OJ C 23, 27.1.2000, p. 3.

71

                                                
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

Where appropriate, and unless it has already been sent with a prior communication, a
1.
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 Poland 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. 793/9393 in the
case  of  an  existing  substance  or  in  Article  3(2)  of  Directive  67/548/EEC94,  in  the  case  of  a
new substance.

Article 6

The Member States and the Republic of Poland 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

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

Article 8

93

94

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).

72

                                                
Commission  and  the  comments  of  the  European  Community  shall  be  forwarded  by  the
Commission to the Republic of Poland.

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

2.
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 Poland thereof.

Article 9

The  competent  authorities of  the  Member  States  and  the  Republic  of  Poland  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.

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.

73

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  Poland  or  voluntary  agreements  by
means of which Member States or the Republic of Poland:

– 

– 

– 

– 

– 

– 

– 

as 

far 

comply  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  Poland  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  Poland  is  concerned  the  obligations  arising  out  of
international  agreements  which  result  in  the  adoption  of  common  technical
specifications  or  rules  on  services 
the
in 
European Community,

the  Republic  of  Poland  and 

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

apply Article 8(1) of Directive 92/59/EEC95,

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 the Republic of Poland 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.

Article 13

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

95

Council Directive 92/59/EEC of 29 June 1992 on general product safety (OJ L 228, 11.8.1992, p. 24).

74

                                                
Article 14

1.
The  Contracting  Parties  shall,  within  the  framework  of  the  established  cooperation
between  experts  of  the  European  Community  and  the  Republic  of  Poland  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.
The  Republic  of  Poland  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 the Republic of Poland. The expert shall not be entitled to vote.

The Commission shall, in good time, inform the expert of the dates of the  meetings,
3.
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 Poland being present. In that case the Republic of Poland 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 Poland.

Article 16

This Agreement shall enter into force on the first day of the first 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  Poland  to  the
European Union.

Article 17

Article 18

This Agreement is drawn up in two originals in the Danish, Dutch, English, Finnish, French,
German, Greek, Italian, Portuguese, Spanish, Swedish and Polish languages, each text being
equally authentic.

75

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.

76

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):

(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.

77

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  93/22/EEC96;  services  of
collective investment undertakings,

services  covered  by  the  activities  subject  to  mutual  recognition  referred  to  in  the
Annex to Directive 89/646/EEC97,

(c)

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

– 

– 

– 

– 

Article 1 of Directive 73/239/EEC98,

the Annex to Directive 79/267/EEC99,

Directive 64/225/EEC100,

Directives 92/49/EEC101 and 92/96/EEC102.

96

97

98

99

100

101

102

OJ L 141, 11. 6. 1993, p. 27.
OJ L 386, 30. 12. 1989, p. 1. Directive as amended by Directive 92/30/EEC (OJ L 110, 28. 4. 1992, p.
52).
OJ L 228, 16. 8. 1973, p. 3. Directive as last amended by Directive 92/49/EEC (OJ L 228, 11. 8. 1992,
p. 1).
OJ L 63, 13. 3. 1979, p. 1. Directive as last amended by Directive 90/619/EEC (OJ L 330, 29. 11. 1990,
p. 50).
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 360, 9. 12. 1992, p. 1.

78

                                                
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.

79

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 Slovak Republic

THE EUROPEAN COMMUNITY,

on the one hand, and

THE SLOVAK REPUBLIC,

on the other hand,

All 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 Slovak Republic, of
the other part103, 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 Community104,

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

CONSIDERING  the  ongoing  cooperation  between  the  European  Community  and  the
Slovak  Republic  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 
the
European Community to the Slovak Republic,

information  society  services  applied 

regulations  and 

rules  on 

in 

HAVE AGREED AS FOLLOWS:

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

Article 1

1.

2.

103

104

“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 359, 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)

80

                                                
– 

– 

“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/EEC105.

“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, 
of
Directive  2001/83/EC106,  as  well  as  production  methods  and  processes  relating  to
other products, where these have an effect on their characteristics.

and  medicinal 

in  Article 

products 

defined 

as 

1 

“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.

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.

81

3.

4.

5.

105

106

                                                
This  Agreement  shall  not  apply  to  rules  relating  to  matters  which  are  covered  by
European  Community  legislation  in  the  field  of  telecommunications  services,  as
defined by Directive 90/387/EEC107.

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  93/22/EEC  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 Slovak Republic or a major
part thereof, as well as laws, regulations or administrative provisions of the Member
States of the European Community or of the Slovak Republic, 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  Slovak  Republic  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,

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,

107

OJ L 192, 24.7.1990, p. 1. Directive as amended by Directive 97/51/EC (OJ L 295, 29.10.1997, p. 23).

82

                                                
– 

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
requirements  or 
technical  specifications  or  other
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
Community108  (thereinafter  called  ‘the  Commission’)  in  the  framework  of  the
Committee referred to in Article 5 of Directive 98/34/EC. The Slovak Republic 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 Slovak Republic 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  Slovak  Republic  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 Slovak Republic
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  Slovak  Republic 

2.
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  the  enactment  of  such  a  technical  regulation  necessary,  where
these have not already been made clear in the draft.

likewise  notify 

shall 

108

OJ C 23, 27.1.2000, p. 3.

83

                                                
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

Where appropriate, and unless it has already been sent with a prior communication, a
1.
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  Slovak  Republic  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. 793/93109 in the
case of an existing substance or in Article 3(2) of Directive 67/548/EEC110, in the case of a
new substance.

Article 6

The  Member  States  and  the  Slovak  Republic  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

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

Article 8

109

110

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).

84

                                                
Commission  and  the  comments  of  the  European  Community  shall  be  forwarded  by  the
Commission to the Slovak Republic.

The Member States and the Slovak Republic shall take such comments into account as

2.
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 Slovak Republic thereof.

Article 9

The competent authorities of the Member States and the Slovak Republic 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.

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.

85

Article 12

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

– 

– 

– 

– 

– 

– 

– 

as 

far 

comply  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  Slovak  Republic  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  Slovak  Republic  is  concerned  the  obligations  arising  out  of
international  agreements  which  result  in  the  adoption  of  common  technical
specifications  or 
the
European Community,

the  Slovak  Republic  and 

rules  on 

services 

in 

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

apply Article 8(1) of Directive 92/59/EEC111,

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 the Slovak Republic 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.

Article 13

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

111

Council Directive 92/59/EEC of 29 June 1992 on general product safety (OJ L 228, 11.8.1992, p. 24).

86

                                                
Article 14

1.
The  Contracting  Parties  shall,  within  the  framework  of  the  established  cooperation
between experts of the European Community and the Slovak Republic 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.
The  Slovak  Republic  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 the Slovak Republic. The expert shall not be entitled to vote.

The Commission shall, in good time, inform the expert of the dates of the  meetings,
3.
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  Slovak  Republic  being  present.  In  that  case  the  Slovak  Republic  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 Slovak Republic.

Article 16

This Agreement shall enter into force on the first day of the first 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  Slovak  Republic  to  the
European Union.

Article 17

Article 18

This Agreement, is drawn up in two originals in the Danish, Dutch, English, Finnish, French,
German, Greek, Italian, Portuguese, Spanish, Swedish and Slovak languages, each text being
equally authentic.

87

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.

88

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):

(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.

89

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 93/22/EEC112; services of
collective investment undertakings,

services  covered  by  the  activities  subject  to  mutual  recognition  referred  to  in  the
Annex to Directive 89/646/EEC113,

(c)

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

– 

– 

– 

– 

Article 1 of Directive 73/239/EEC114,

the Annex to Directive 79/267/EEC115,

Directive 64/225/EEC116,

Directives 92/49/EEC117 and 92/96/EEC118.

112

113

114

115

116

117

118

OJ L 141, 11. 6. 1993, p. 27.
OJ L 386, 30. 12. 1989, p. 1. Directive as amended by Directive 92/30/EEC (OJ L 110, 28. 4. 1992, p.
52).
OJ L 228, 16. 8. 1973, p. 3. Directive as last amended by Directive 92/49/EEC (OJ L 228, 11. 8. 1992,
p. 1).
OJ L 63, 13. 3. 1979, p. 1. Directive as last amended by Directive 90/619/EEC (OJ L 330, 29. 11. 1990,
p. 50).
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 360, 9. 12. 1992, p. 1.

90

                                                
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.

91

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 Slovenia

THE EUROPEAN COMMUNITY,

on the one hand, and

THE REPUBLIC OF SLOVENIA,

on the other hand,

All the above being hereinafter referred to as the Contracting Parties,

HAVING  REGARD  to  the  Europe  Agreement  establishing  an  Association  between  the
European  Communities  and 
the
the  one  part,  and 
Republic of Slovenia, of the other part119, and in particular to the aims set out in Article 1,

their  Member  States,  of 

HAVING  REGARD  to  the  information  procedure  on  technical  regulations  and  rules  on
information society services applied within the European Community120,

CONSIDERING the commitment of the Republic of Slovenia 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 Slovenia 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 
the
European Community to the Republic of Slovenia,

information  society  services  applied 

regulations  and 

rules  on 

in 

HAVE AGREED AS FOLLOWS:

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

Article 1

1.

2.

119

120

“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 51, 26.2.1999, 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)

92

                                                
– 

– 

“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/EEC121.

“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, 
of
Directive  2001/83/EC122,  as  well  as  production  methods  and  processes  relating  to
other products, where these have an effect on their characteristics.

and  medicinal 

in  Article 

products 

defined 

as 

1 

“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.

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.

93

3.

4.

5.

121

122

                                                
6.

This  Agreement  shall  not  apply  to  rules  relating  to  matters  which  are  covered  by
European  Community  legislation  in  the  field  of  telecommunications  services,  as
defined by Directive 90/387/EEC123.

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  93/22/EEC  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.

“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  Slovenia  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 Slovenia, 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  Slovenia  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,

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,

123

OJ L 192, 24.7.1990, p. 1. Directive as amended by Directive 97/51/EC (OJ L 295, 29.10.1997, p. 23).

94

                                                
– 

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
requirements  or 
technical  specifications  or  other
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 Community124 (thereinafter called ‘the Commission’) in the framework of
the  Committee  referred  to  in  Article  5  of  Directive  98/34/EC.  The  Republic  of
Slovenia 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  Slovenia  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 Slovenia
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
Slovenia  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  Slovenia  shall 

2.
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  the  enactment  of  such  a  technical  regulation  necessary,  where
these have not already been made clear in the draft.

likewise  notify 

124

OJ C 23, 27.1.2000, p. 3.

95

                                                
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

Where appropriate, and unless it has already been sent with a prior communication, a
1.
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  Slovenia  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.
793/93125 in the case of an existing substance or in Article 3(2) of Directive 67/548/EEC126, in
the case of a new substance.

Article 6

The Member States and the Republic of Slovenia 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

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

Article 8

125

126

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).

96

                                                
Commission  and  the  comments  of  the  European  Community  shall  be  forwarded  by  the
Commission to the Republic of Slovenia.

The  Member  States  and  the  Republic  of  Slovenia  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 Slovenia thereof.

Article 9

The competent authorities of the Member States and the Republic of Slovenia 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.

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.

97

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  Slovenia  or  voluntary  agreements  by
means of which Member States or the Republic of Slovenia:

– 

– 

– 

– 

– 

– 

– 

as 

far 

comply  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 Slovenia 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  Slovenia  is  concerned  the  obligations  arising  out  of
international  agreements  which  result  in  the  adoption  of  common  technical
specifications  or  rules  on  services 
the
in 
European Community,

the  Republic  of  Slovenia  and 

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

apply Article 8(1) of Directive 92/59/EEC127,

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 the Republic of Slovenia 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.

Article 13

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

127

Council Directive 92/59/EEC of 29 June 1992 on general product safety (OJ L 228, 11.8.1992, p. 24).

98

                                                
Article 14

1.
The  Contracting  Parties  shall,  within  the  framework  of  the  established  cooperation
between  experts  of  the  European  Community  and  the  Republic  of  Slovenia  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.
The  Republic  of  Slovenia  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 the Republic of Slovenia. The expert shall not be entitled to vote.

The Commission shall, in good time, inform the expert of the dates of the  meetings,
3.
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  Slovenia  being  present.  In  that  case  the  Republic  of  Slovenia
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 Slovenia.

Article 16

This Agreement shall enter into force on the first day of the first 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  Slovenia  to  the
European Union.

Article 17

Article 18

This Agreement is drawn up in two originals in the Danish, Dutch, English, Finnish, French,
German,  Greek,  Italian,  Portuguese,  Spanish,  Swedish  and  Slovenian  languages,  each  text
being equally authentic.

99

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.

100

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):

(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.

101

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 93/22/EEC128; services of
collective investment undertakings,

services  covered  by  the  activities  subject  to  mutual  recognition  referred  to  in  the
Annex to Directive 89/646/EEC129,

(c)

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

– 

– 

– 

– 

Article 1 of Directive 73/239/EEC130,

the Annex to Directive 79/267/EEC131,

Directive 64/225/EEC132,

Directives 92/49/EEC133 and 92/96/EEC134.

128

129

130

131

132

133

134

OJ L 141, 11. 6. 1993, p. 27.
OJ L 386, 30. 12. 1989, p. 1. Directive as amended by Directive 92/30/EEC (OJ L 110, 28. 4. 1992, p.
52).
OJ L 228, 16. 8. 1973, p. 3. Directive as last amended by Directive 92/49/EEC (OJ L 228, 11. 8. 1992,
p. 1).
OJ L 63, 13. 3. 1979, p. 1. Directive as last amended by Directive 90/619/EEC (OJ L 330, 29. 11. 1990,
p. 50).
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 360, 9. 12. 1992, p. 1.

102

                                                
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.

103

LEGISLATIVE FINANCIAL STATEMENT

Policy area(s): Enterprise

Activit(y/ies): Getting still more from the Internal Market

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 EIGHT CANDIDATE COUNTRIES

1.

BUDGET LINE(S) + HEADING(S)

A-110

"Officials  and  temporary  staff  holding  a  post  provided  for  in  the
establishment plan"

A-2422

Technical and logistical support and assistance to users

B5-3002 Operation  and  development  of  the  internal market, particularly  in  the  field

of notification, certification and sectoral approximation

2.

2.1.

2.2.

OVERALL FIGURES

Total allocation for action (Part B): € million in commitments: 0.128

Period of application:

The agreements will be of limited duration. Each agreement will end upon the accession
to  the  European  Union  of  the  candidate  country  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)

2003

2004

2005

2006

2007

Commitments

0.128

pm

Payments

0.064

0.064

pm

pm

pm

pm

pm

pm

n + 5
and
subs.
years
pm

pm

Total

0.128

0.128

104

(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

0.128

pm

Payments

0.064

0.064

pm

pm

pm

pm

pm

pm

pm

pm

0.128

0.128

(c)

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

0.167

pm

pm

pm

pm

pm

0.167

Commitments/
payments

TOTAL a+b+c

Commitments

0.295

pm

Payments

0.231

0,064

pm

pm

pm

pm

pm

pm

pm

pm

0.295

0.295

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

(B5-3002)

EFTA
contribution

Contributions
from applicant
countries

Heading in
financial
perspective

Non-comp

Diff

YES

NO

NO

No [3]

4.

LEGAL BASIS

Article 133 EC

105

5.

DESCRIPTION AND GROUNDS

5.1.

Need for Community intervention

5.1.1. Objectives pursued

The  objective  is  for  the  8  candidate  countries  with  which  the  agreements  have  been
negotiated  (in  the  following  the  candidate  countries)  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 15 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.

106

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 8candidate 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 80 drafts per year can reasonably be expected from the 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  8  candidate  countries  at  the  same  time
should result in 10 notifications per candidate country per year. This figure is confirmed
by experience with the EFTA countries.

5.3.

Methods of implementation

Action 1

It will be necessary to set up a computer application for the automatic transmission of
texts from the Community Member States to the candidate countries and vice versa.

Setting  up  such  an  application  by  adapting  the  existing  application  administering  the
current Community system, and running it, will require about 10 days' work per year, or
an annual amount of € 5 000 (10 days at € 500/day)(cf. point 7.3.). This amount will be
funded from the existing computer budget of DG Enterprise (Unit F/1).

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 or German.

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

Based  on  80  notifications  per  year  (cf.  point  6.2.)  with  an  average  of  20  pages  per
notification, 1 600 pages of translation per year, can be expected. This figure has to be
doubled because a text notified in English, for example, will be translated into French
and German. The annual cost is therefore estimated at € 128 000 (3 200 pages at € 40 /
page).  This  amount  will  be  funded  from  DG  Enterprise's  existing  budget  (B5-3002),

107

which already provides for a slight increase in translation costs for 2003 in view of the
preparation for enlargement.

Action 3

DG Enterprise 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'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

2003

2004

2005

2006

2007

Action 2

0.128

0.128

pm

pm

pm

pm

pm

pm

pm

pm

TOTAL

n + 5
and subs.
years
pm

pm

Total

0.128

0.128

6.1.2.

Technical  and  administrative  assistance,  support  expenditure  and  IT  expenditure
(commitment appropriations)

None.

108

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

80

3

4=(2X3)

0.0016

0.128

0.128

(Action 2: 80 notifications of 20 pages each = 1 600 pages to be translated into two languages =
3 200 pages of translation at a cost of € 40 / page).

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

0.5

0.5

0.5

Other human resources

Total

Description of tasks deriving from
the action

Legal analysis and administrative
support

Total

0.5

0.5

0.5

1.5

7.2.

Overall financial impact of human resources

Type of human resources

Amount (€)

Method of calculation *

Officials

Temporary staff

Other human resources

162 000

108 000 x 1.5

(specify budget line)

Total

162 000

The amounts are total expenditure for 12 months.

109

7.3.

Other administrative expenditure deriving from the action

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)

Amount €

Method of calculation

5 000

5 000

Total

10 days at € 500 / day

The amounts are total expenditure for 12 months.

I.

II.

III.

Annual total (7.2 + 7.3)

Duration of action

Cost of the operation (I xII)

€ 167 000

Until  the  accession  of  the  8  candidate  countries
concerned to the Community

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
of 
these
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).

110