Corrigendum:#Agreement between the European Community and Romania laying down a procedure for the provision of information in the field of technical regulations and of rules on information society services
Date: 2007-02-12
Institutions: European Community, Romania
Subjects: European standard, Romania, agreement (EU), bilateral agreement, exchange of information, information society, service, technical regulations

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

AGREEMENT

THE EUROPEAN COMMUNITY (hereinafter referred to as the Community)

on the one hand, and

ROMANIA,

on the other hand,

hereinafter referred to as ‘the Contracting Parties’,

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

HAVING REGARD to the information procedure on technical regulations and rules on information society services applied
within the European Community (2),

CONSIDERING the commitment of
themselves,

the Contracting Parties to promote harmonious economic relations between

CONSIDERING the ongoing cooperation between the Contracting Parties 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 Community to Romania,

HAVE AGREED AS FOLLOWS:

Article 1

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

(1)

‘product’: any industrially manufactured product and any
agricultural product, including fish products;

— ‘at the individual request of a recipient of services’:
the service is provided through the

means that
transmission of data on individual request.

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

(2)

‘service’: any Information Society service, by which is meant
any service normally provided for remuneration, at a
distance, by electronic means and at the individual request
of a recipient of services.

This Agreement shall not apply to:

— radio broadcasting 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,

— television broadcasting services covered by point (a) of

Article 1 of Directive 89/552/EEC (3);

(3)

‘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,
testing and test methods,
packaging, marking or labelling and conformity assessment
procedures.

terminology, symbols,

(1) OJ L 357, 31.12.1994, p. 2.
(2) 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 and
rules on Information Society services (OJ L 204, 21.7.1998, p. 37).
Directive as last amended by the 2003 Accession Act.

(3) Council Directive 89/552/EEC of 3 October 1989 on the
coordination of certain provisions laid down by Law, Regulation
or Administrative Action in Member States concerning the pursuit of
television broadcasting activities (OJ L 298, 17.10.1989, p. 23).
Directive as last amended by Directive 97/36/EC of the European
Parliament and of the Council (OJ L 202, 30.7.1997, p. 60).

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

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

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

(4)

(5)

This Agreement shall not apply to rules relating to matters
which are covered by Community legislation in the field of
telecommunications services, defined as ‘services whose
provision consists wholly or partly in the transmission and
routing of signals on a telecommunications network by
means of telecommunications processes, with the exception
of radio broadcasting and television’ (2).

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

With the exception of Article 11, this Agreement shall not
apply to rules enacted by or for regulated markets within
the meaning of Directive 2004/39/EC (3) or by or for other
markets or bodies carrying out clearing or settlement
functions for those markets.

(1) Directive 2001/83/EC of

the European Parliament and of

the
Council of 6 November 2001 on the Community Code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
Directive as last amended by Directive 2004/27/EC (OJ L 136,
30.4.2004, p. 34).

the internal market

(2) This definition arises by virtue of Directive 98/48/EC which makes
reference to Council Directive 90/387/EEC of 28 June 1990 on the
establishment of
telecommunications
services through the implementation of open network provision
(OJ L 192, 24.7.1990, p. 1). The latter directive has been repealed by
Directive 2002/21/EC on a common regulatory framework for
electronic communications networks and services (OJ L 108,
24.04.2002, p. 3). However, the definition of ‘telecommunications
services’ found in Directive 90/387/EEC has been retained for the
purposes of Directive 98/48/EC.

for

(3) Directive 2004/39/EC of

the
Council of 21 April 2004 on markets in financial instruments (OJ
L 145, 30.4.2004, p. 1). Directive as amended by Directive 2006/31/
EC (OJ L 114, 27.4.2006, p. 60).

the European Parliament and of

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
it affects such

at
services only in an implicit or incidental manner;

Information Society services if

(6)

technical specifications and other
‘technical regulation’:
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, hereinafter referred to as ‘Member States’, or a
major part thereof, or in Romania or a major part thereof,
as well as laws, regulations or administrative provisions of
the Member States or of Romania, except those provided
for in Article 12, prohibiting the manufacture, importation,
marketing or use of a product or prohibiting the provision
or use of a service, or establishment as a service provider.

De facto technical regulations include:

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

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

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

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technical

regulations

imposed by the
This comprises
authorities designated by the Member States and appearing
on a list (1) drawn up by the Commission of the European
Community, hereinafter referred to as ‘the Commission’ in
the framework of the Committee referred to in Article 5 of
Directive 98/34/EC. Romania shall draw up such a list and
forward it to the Commission the first day of the first
month following entry into force of this Agreement.

The same procedure shall be used for amending this list;

(7)

‘draft technical regulation’: the text of a technical specifica-
tion or other requirement or of a rule on services, including
formulated with the aim of
administrative provisions,
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.

concerned shall also be simultaneously communicated, should
knowledge of such text be necessary in order to assess the
implications of the draft technical regulation notified.

2. Where, in particular, the draft seeks to limit the marketing or
use of a chemical substance, preparation or product on grounds
of public health or of
the protection of consumers or the
environment, Member States and Romania shall also forward
either a summary or the references of all relevant data relating to
the substance, preparation or product concerned and to known
and available substitutes, where such information may be
available, and communicate the anticipated effects of
the
measure on public health and the protection of the consumer
and the environment, together with an analysis of the risk
carried out as appropriate in accordance with the general
principles for the risk evaluation of chemical substances as
referred to in Article 10(4) of Regulation (EEC) No 793/93 (2) in
the case of an existing substance or
in Article 3(2) of
Directive 67/548/EEC (3), in the case of a new substance.

Article 2

Article 6

This Agreement shall not apply to those measures Member States
consider necessary under the Treaty establishing the European
Community or Romania considers necessary for the protection
of persons,
in particular workers, when products are used,
provided that such measures do not affect the products.

Article 3

1.
Subject to Article 12, the Community shall notify Romania
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
Romania have a statement of the grounds which make the
enactment of such a technical regulation necessary, where these
have not already been made clear in the draft.

Subject to Article 12, Romania shall

likewise notify the
2.
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 Community
have a statement of the grounds which make the enactment of
such a technical regulation necessary, where these have not
already been made clear in the draft.

Article 4

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

Article 5

1. Where appropriate, and unless it has already been sent with
a prior communication, a full text in the original language of the
basic legislative or regulatory provisions principally and directly

(1) OJ C 23, 27.1.2000, p. 3.

The Member States and Romania shall communicate the draft
technical regulation 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
take place in accordance with the
communications
provisions set out in Article 3.

shall

Article 7

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

technical

Article 8

1. The Community and Romania may make comments upon
the draft technical regulations communicated. The comments of
Romania shall be forwarded to the Commission and the
the Community shall be forwarded by the
comments of
Commission to Romania.

2. The Member States and Romania shall take such comments
into account as far as possible in the subsequent preparation of
the technical regulation.

to the technical

3. With respect
specifications or other
requirements or rules on services referred to in the third indent
the
the second subparagraph of point 6 of Article 1,
of
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.

(2) 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). Regulation as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council (OJ
L 284, 31.10.2003, p. 1).

(3) Council Directive 67/548/EEC of 27 June 1967 on the approxima-
tion 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 last amended by
Commission Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1).

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is
4. The Commission shall, when a six-month standstill
invoked according to the rules set out in Directive 98/34/EC,
inform Romania thereof.

result in the adoption of common technical specifications
or rules on services in the Community,

Article 9

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

technical

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

— make use of safeguard clauses provided for in binding

Community acts,

Article 10

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

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

— restrict themselves to implementing a judgement of the

Court of Justice of the European Communities,

— 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
time in order to enact and introduce them
space of
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

— restrict

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

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

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

Article 13

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

1. The final text in the original
regulation shall also be communicated.

language of the technical

Article 14

2. The administrative arrangements for the above mentioned
notifications are set out in Annex III.

Article 12

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

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

in the adoption of

— fulfil as far as the Member States are concerned the
obligations arising out of international agreements which

1. The Contracting Parties shall, within the framework of the
established cooperation between experts of the Community and
Romania in the field of technical barriers to trade, hold regular
consultations both to ensure the satisfactory functioning of the
procedure laid down in this Agreement and to exchange views
on the comments which have been submitted by any Contracting
Party concerning a draft
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 either
Contracting Party.

technical

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

(1) Directive 2001/95/EC of

the
Council of 3 December 2001 on general product safety (OJ L 11,
15.1.2002, p. 4).

the European Parliament and of

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

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

Article 15

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

Article 16

Parties have exchanged Notes confirming the completion of their
respective procedures for the entry into force of this Agreement.

Article 17

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

Article 18

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

This Agreement shall enter into force on the first day of the
second month following the date on which the Contracting

For the European Community

For Romania

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

ANNEX I

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)

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

(d)

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

2.

Services not provided ‘by electronic means’

Services having material content even though provided via electronic devices:

(a)

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

(b)

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

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

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

(a)

voice telephony services;

(b)

telefax/telex services;

(c)

services provided via voice telephony or fax;

(d)

telephone/telefax consultation of a doctor;

(e)

telephone/telefax consultation of a lawyer;

(f)

telephone/telefax direct marketing.

3.

Services not supplied ‘at the individual request of a recipient of services’

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

(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.

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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)

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

(b)

services covered by the activities subject to mutual recognition referred to in the Annex to Directive 2006/48/EC (1);

(c)

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

— Article 1 of Directive 73/239/EEC (2),

— Directive 64/225/EEC (3),

— Directive 92/49/EEC (4) and Directive 2002/83/EC (5).

(1) Directive 2006/48/EC of the European Parliament and of the Council of 14 June 2006 relating to the taking up and pursuit of the

(2)

business of credit institutions (recast) (OJ L 177, 30.6.2006, p. 1).
First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the
taking-up and pursuit of the business of direct insurance other than life insurance (OJ L 228, 16.8.1973, p. 3). Directive as last amended
by Directive 2005/68/EC of the European Parliament and of the Council (OJ L 323, 9.12.2005, p. 1).

(3) Council Directive 64/225/EEC of 25 February 1964 on the abolition of restrictions on freedom of establishment and freedom to provide
services in respect of reinsurance and retrocession (OJ 56, 4. 4. 1964, p. 878/64). Directive as amended by the 1973 Act of Accession.
(4) Council Directive 92/49/EEC of 18 June 1992 on the coordinating of laws, regulations and administrative provisions relating to direct

insurance other than life assurance (OJ L 228, 11.8.1992, p. 1). Directive as last amended by Directive 2005/68/EC.

(5) Directive 2002/83/EC of the European Parliament and of the Council of 5 November 2002 concerning life assurance (OJ L 345,

19.12.2002, p. 1). Directive as last amended by Directive 2005/68/EC.

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ANNEX III

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

(1)

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

(2)

the full text of the draft notified;

(3)

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

(4) messages requesting supplementary information;

(5)

answers to request for supplementary information;

(6)

comments;

(7)

requests for ad hoc meetings;

(8)

answers to requests for ad hoc meetings;

(9)

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) basic legal texts or regulatory provisions;

(12)

the final text.

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