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
THE EUROPEAN COMMUNITY (hereinafter referred to as the Community)
on the one hand, andROMANIA,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 the Contracting Parties to promote harmonious economic relations between
themselves,
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 ontechnical 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;
(2) ‘service ’: any Information Society service, by which is meant
any service normally provided for remuneration, at adistance, by electronic means and at the individual requestof 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 ofelectronic equipment for the processing (includingdigital compression) and storage of data, and entirelytransmitted, 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 thetransmission 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/EEC (
3);
(3) ‘technical specification’: a specification contained in a
document which lays down the characteristics required ofa product such as levels of quality, performance, safety ordimensions, including the requirements applicable to theproduct as regards the name under which the product issold, terminology, symbols, testing and test methods,packaging, marking or labelling and conformity assessmentprocedures.12.2.2007 EN Official Journal of the European Union L 40/119
(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 andrules 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 EuropeanParliament and of the Council (OJ L 202, 30.7.1997, p. 60).
This definition also covers production methods and
processes used in respect of agricultural products asreferred to Article 38(1) of the Treaty establishing theEuropean Community, products intended for human andanimal consumption, and medicinal products as defined inArticle 1 of Directive 2001/83/EC (
1), as well as production
methods and processes relating to other products, wherethese have an effect on their characteristics;
(4) ‘other requirements’ : a requirement, other than a technical
specification, imposed on a product for the purpose ofprotecting, in particular, consumers or the environment,and which affects its life cycle after it has been placed on themarket, such as conditions of use, recycling, reuse ordisposal, where such conditions can significantly influencethe composition or nature of the product or its marketing;
(5) ‘rule on services’: requirement of a general nature relating to
the taking-up and pursuit of service activities within themeaning of point 2, in particular provisions concerning theservice provider, the services and the recipient of services,excluding any rules which are not specifically aimed at theservices defined therein.
This Agreement shall not apply to rules relating to matters
which are covered by Community legislation in the field oftelecommunications services, defined as ‘services whose
provision consists wholly or partly in the transmission androuting of signals on a telecommunications network bymeans of telecommunications processes, with the exceptionof radio broadcasting and television’ (
2).
This Agreement shall not apply to rules relating to matters
which are covered by Community legislation in the field offinancial services, as listed non-exhaustively in Annex II tothis Agreement.
With the exception of Article 11, this Agreement shall not
apply to rules enacted by or for regulated markets withinthe meaning of Directive 2004/39/EC (
3) or by or for other
markets or bodies carrying out clearing or settlementfunctions 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 toits statement of reasons and its operative part, thespecific aim and object of all or some of its individualprovisions is to regulate such services in an explicitand targeted manner,
— a rule shall not be considered to be specifically aimed
at Information Society services if it affects suchservices only in an implicit or incidental manner;
(6) ‘technical regulation’: technical specifications and other
requirements or rules on services, including the relevantadministrative provisions, the observance of which iscompulsory, de jure or de facto, in the case of marketing,provision of a service, establishment of a service operatoror use in one of the Member States of the EuropeanCommunity, 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 ofthe Member States or of Romania, except those providedfor 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 totechnical specifications or to other requirements or torules on services, or to professional codes or codes ofpractice which in turn refer to technical specificationsor to other requirements or to rules on services,compliance with which confers a presumption ofconformity with the obligations imposed by theaforementioned laws, regulations or administrativeprovisions,
— voluntary agreements to which a public authority is a
contracting party and which provide, in the generalinterest, for compliance with technical specificationsor other requirements or rules on services, excludingpublic procurement tender specifications,
— technical specifications or other requirements or rules
on services which are linked to fiscal or financialmeasures affecting the consumption of products orservices by encouraging compliance with suchtechnical specifications or other requirements or ruleson services; technical specifications or other require-ments or rules on services linked to national socialsecurity systems are not included.L 40/120 EN Official Journal of the European Union 12.2.2007
(1) Directive 2001/83/EC of the European Parliament and of the
Council of 6 November 2001 on the Community Code relating tomedicinal 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).
(
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 theestablishment of the internal market for telecommunicationsservices 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.
(
3) Directive 2004/39/EC of the European Parliament and of the
Council of 21 April 2004 on markets in financial instruments (OJL 145, 30.4.2004, p. 1). Directive as amended by Directive 2006/31/EC (OJ L 114, 27.4.2006, p. 60).
This comprises technical regulations imposed by the
authorities designated by the Member States and appearingon 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 ofDirective 98/34/EC. Romania shall draw up such a list andforward it to the Commission the first day of the firstmonth 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, includingadministrative provisions, formulated with the aim ofenacting it or of ultimately having it enacted as a technicalregulation, the text being at a stage of preparation at whichsubstantial amendments can still be made.
Article 2
This Agreement shall not apply to those measures Member States
consider necessary under the Treaty establishing the European
Community or Romania considers necessary for the protectionof 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 MemberStates. Where these technical regulations merely transpose thefull text of an international or European standard, informationregarding the relevant standard shall suffice. It shall also letRomania have a statement of the grounds which make theenactment of such a technical regulation necessary, where thesehave not already been made clear in the draft.
2. Subject to Article 12, Romania shall likewise notify the
European Community of its draft technical regulations. Wherethese technical regulations merely transpose the full text of aninternational or European standard, information regarding therelevant standard shall suffice. It shall also let the Communityhave a statement of the grounds which make the enactment ofsuch a technical regulation necessary, where these have notalready 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 translationinto one of the official languages of the institutions of theEuropean 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 thebasic legislative or regulatory provisions principally and directlyconcerned shall also be simultaneously communicated, should
knowledge of such text be necessary in order to assess theimplications 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 groundsof public health or of the protection of consumers or theenvironment, Member States and Romania shall also forwardeither a summary or the references of all relevant data relating tothe substance, preparation or product concerned and to knownand available substitutes, where such information may beavailable, 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 riskcarried out as appropriate in accordance with the generalprinciples for the risk evaluation of chemical substances asreferred to in Article 10(4) of Regulation (EEC) No 793/93 (
2) in
the case of an existing substance or in Article 3(2) ofDirective 67/548/EEC (
3), in the case of a new substance.
Article 6
The Member States and Romania shall communicate the draft
technical regulation again under the above conditions if theymake changes to the draft that have the effect of significantlyaltering its scope, shortening the timetable originally envisagedfor implementation, adding specifications or requirements, ormaking the latter more restrictive. Transmission of thesecommunications shall take place in accordance with theprovisions set out in Article 3.
Article 7
Either Contracting Party may ask for further information on a
draft technical regulation notified in accordance with thisAgreement.
Article 8
1. The Community and Romania may make comments upon
the draft technical regulations communicated. The comments ofRomania shall be forwarded to the Commission and the
comments of the Community shall be forwarded by the
Commission to Romania.
2. The Member States and Romania shall take such comments
into account as far as possible in the subsequent preparation ofthe technical regulation.
3. With respect to the technical specifications or other
requirements or rules on services referred to in the third indentof the second subparagraph of point 6 of Article 1, thecomments of the Contracting Parties may concern only aspectswhich may hinder trade or, in respect of rules on services, thefree movement of services or the freedom of establishment ofservice operators and not the fiscal or financial aspects of themeasure.12.2.2007 EN Official Journal of the European Union L 40/121
(1) OJ C 23, 27.1.2000, p. 3.(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 (OJL 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 byCommission Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1).
4. The Commission shall, when a six-month standstill is
invoked according to the rules set out in Directive 98/34/EC,inform Romania thereof.
Article 9
The competent authorities of the Member States and Romania
shall postpone the adoption of draft technical regulationsnotified for three months from the date of receipt by theCommission 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 orsafety, the protection of animals or the preservation ofplants and, for rules on services, also for public policy,notably the protection of minors, the competent authoritiesare obliged to prepare technical regulations in a very shortspace of time in order to enact and introduce themimmediately without any consultations being possible, or
— for urgent reasons occasioned by serious circumstances
relating to the protection of the security and the integrity ofthe financial system, notably the protection of depositors,investors and insured persons, the competent authoritiesare obliged to enact and implement rules on financialservices 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 confrontingthe concerned authorities as well as the absolute necessity forimmediate action to remedy it.
Article 11
1. The final text in the original language of the technical
regulation shall also be communicated.
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 Romaniaor voluntary agreements by means of which Member States orRomania:
— comply as far as the Member States are concerned with
binding Community acts which result in the adoption oftechnical specifications or rules on services, and as far asRomania is concerned transpose into national law Com-munity acts which result in the adoption of technicalspecifications or rules on services,
— fulfil as far as the Member States are concerned the
obligations arising out of international agreements whichresult in the adoption of common technical specifications
or rules on services in the Community,
— fulfil as far as Romania is concerned the obligations arising
out of international agreements which result in theadoption of common technical specifications or rules on
services in Romania and the Community,
— make use of safeguard clauses provided for in binding
Community acts,
— apply Article 12(1) of Directive 2001/95/EC (
1),
— 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 accordancewith a Commission request, with a view to removing anobstacle to trade or, in the case of rules on services, to thefree movement of services or the freedom of establishmentof service operators.
2. Articles 9 and 10 shall not apply to the laws, regulations and
administrative provisions of the Member States and of Romaniaprohibiting manufacture insofar as they do not impede the freemovement of products.
3. Article 9 and 10 shall not apply to the technical
specifications or other requirements or the rules on servicesreferred to in the third indent of the second subparagraph ofpoint 6 of Article 1.
Article 13
Information supplied under this Agreement shall be considered
as confidential upon request. However, both the Community andRomania may, provided that the necessary precautions are taken,consult for an expert opinion natural or legal persons, includingpersons in the private sector.
Article 14
1. The Contracting Parties shall, within the framework of the
established cooperation between experts of the Community andRomania in the field of technical barriers to trade, hold regularconsultations both to ensure the satisfactory functioning of theprocedure laid down in this Agreement and to exchange viewson the comments which have been submitted by any ContractingParty concerning a draft technical regulation notified inaccordance with this Agreement. Furthermore, by commonconsent, the Contracting Parties may hold additional ad hocmeetings to deal with specific cases of particular interest to eitherContracting Party.
2. Romania shall appoint an expert to represent it in meetings
of the Committee established under article 5 of Directive 98/34/EC, part ‘information society services’ and‘technical regulations’.
The expert must be a member of the government services ofRomania. The expert shall not be entitled to vote.L 40/122 EN Official Journal of the European Union 12.2.2007
(1) Directive 2001/95/EC of the European Parliament and of the
Council of 3 December 2001 on general product safety (OJ L 11,15.1.2002, p. 4).
3. The Commission shall, in good time, inform the expert of
the dates of the meetings, and of the items on the agenda of theCommittee. The Commission shall forward relevant informationto the expert.
4. On the initiative of its chairman, the Committee may meet
without the expert representing Romania being present. In thatcase 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 isapplied and under the conditions laid down in that Treaty and,on the other hand, to the territory of Romania.
Article 16
This Agreement shall enter into force on the first day of the
second month following the date on which the ContractingParties 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 Romanianlanguages, each text being equally authentic.
For the European Community For Romania12.2.2007 EN Official Journal of the European Union L 40/123
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) 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.L 40/124 EN Official Journal of the European Union 12.2.2007
ANNEX II
Indicative list of the financial services covered by the third subparagraph of point 5 of Article 1
— 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).12.2.2007 EN Official Journal of the European Union L 40/125
(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
business of credit institutions (recast) (OJ L 177, 30.6.2006, p. 1).
(2) 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.
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.L 40/126 EN Official Journal of the European Union 12.2.2007