# EUR-Lex - 52006PC0573 - EN

Important legal notice

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# 52006PC0573

**Proposal for a Council Decision on the conclusion of bilateral Agreements laying down a procedure for the provision of information in the field of technical regulations and of rules on information society services between the European Community and the Republic of Bulgaria, the European Community and Romania /* COM/2006/0573 final - ACC 2006/0179 */ **

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[pic] | COMMISSION OF THE EUROPEAN COMMUNITIES |

Brussels, 5.10.2006

COM(2006) 573 final

2006/0179 (ACC)

Proposal for a

COUNCIL DECISION

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

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. CONTEXT OF THE PROPOSAL

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

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

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

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

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

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

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

2. LEGAL ELEMENTS OF THE PROPOSAL

2 .1. Summary of the proposed agreements

The Agreements provide for the participation of the above mentioned two candidate countries in the notification procedure, which was introduced at Community level by Directive 83/189/CEE (amended several times, then codified by Directive 98/34/EC, and subsequently amended by Directive 98/48/EC) [3].

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

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

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

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

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

2.2 Explanation article-by-article

The Agreement

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

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

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

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

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

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

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

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

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

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

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

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

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

Article 12: Exceptions to notification obligation. This Article stipulates the cases in which notification is not required. These exceptions are identical to those listed inDirective 98/34/EC, as amended by Directive 98/48/EC. With regard to international agreements concluded by the candidate country concerned, it is foreseen that it does not have to notify those laws, regulations and administrative provisions arising out of the obligations of an international agreement that applies in the candidate country and in the entire European Community. The reason for this is that the same provisions will apply in the candidate country and in the European Community, as the candidate country and all the Member States have transposed the international agreement.

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

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

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

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

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

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

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

The Annexes to the Agreement

There follows an assessment of the content of the annexes.

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

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

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.

2006/0179 (ACC)

Proposal for a

COUNCIL DECISION

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

T HE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission[4],

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

HAS DECIDED AS FOLLOWS:

Article 1

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

Article 2

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

Done at Brussels,

For the Council

The President

AGREEMENT

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

THE EUROPEAN COMMUNITY,

on the one hand, and

THE REPUBLIC OF BULGARIA,

on the other hand,

The above being hereinafter referred to as the Contracting Parties,

HAVING REGARD to the Europe Agreement establishing an Association between the European Communities and their Member States, of the one part, and the Republic of Bulgaria, of the other part[6], 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 Community[7],

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

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

HAVE AGREED AS FOLLOWS:

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, 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/EEC[8].

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

The term “technical specification” also covers production methods and processes used in respect of agricultural products as referred to Article 38(1) of the Treaty establishing the European Community, products intended for human and animal consumption, and medicinal products as defined in Article 1 of Directive 2001/83/EC[9], as well as production methods and processes relating to other products, where these have an effect on their characteristics.

4. “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;

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

This Agreement shall not apply to rules relating to matters which are covered by European Community legislation in the field of telecommunications services, defined as “services whose provision consists wholly or partly in the transmission and routing of signals on a telecommunications network by means of telecommunications processes, with the exception of radio broadcasting and television”[10].

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

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

For the purposes of this definition:

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

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

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

De facto technical regulations include:

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

- 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 requirements or rules on services linked to national social security systems are not included.

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 Community[12] (thereinafter called ‘the Commission’) in the framework of the Committee referred to in Article 5 of Directive 98/34/EC. The Republic of Bulgaria shall draw up such a list and forward it to the Commission the first day of the first month following entry into force of this Agreement.

The same procedure shall be used for amending this list.

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

Article 2

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

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

Article 3

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

2. Subject to Article 12, the Republic of Bulgaria 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.

Article 4

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

Article 5

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

2. Where, in particular, the draft seeks to limit the marketing or use of a chemical substance, preparation or product on grounds of public health or of the protection of consumers or the environment, Member States and the Republic of Bulgaria shall also forward either a summary or the references of all relevant data relating to the substance, preparation or product concerned and to known and available substitutes, where such information may be available, and communicate the anticipated effects of the measure on public health and the protection of the consumer and the environment, together with an analysis of the risk carried out as appropriate in accordance with the general principles for the risk evaluation of chemical substances as referred to in Article 10(4) of Regulation (EEC) No. 793/93[13] in the case of an existing substance or in Article 3(2) of Directive 67/548/EEC[14], in the case of a new substance.

Article 6

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

Article 7

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

Article 8

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

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

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

Article 9

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

Article 10

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

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

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

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

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

Article 12

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

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

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

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

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

- apply Article 12(1) of Directive 2001/95/EC[15],

- 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 Bulgaria 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 Bulgaria may, provided that the necessary precautions are taken, consult for an expert opinion natural or legal persons, including persons in the private sector.

Article 14

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

2. the Republic of Bulgaria 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 Bulgaria. The expert shall not be entitled to vote.

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

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

Article 15

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

Article 16

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

Article 17

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

Article 18

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

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.

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[16]; services of collective investment undertakings,

(b) services covered by the activities subject to mutual recognition referred to in the Annex to Directive 2000/12/EC[17],

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

- Article 1 of Directive 73/239/EEC[18],

- Annex I of Directive 2002/83/EC[19],

- Directive 64/225/EEC[20],

- Directives 92/49/EEC[21] and 2002/83/EC[22].

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 by the Contracting Parties.

AGREEMENT

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

THE EUROPEAN COMMUNITY,

on the one hand, and

ROMANIA,

on the other hand,

The above being hereinafter referred to as the Contracting Parties,

HAVING REGARD to the Europe Agreement establishing an Association between the European Communities and their Member States, of the one part, and Romania, of the other part[23], 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 Community[24],

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

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

HAVE AGREED AS FOLLOWS:

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, 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/EEC[25].

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

The term “technical specification” also covers production methods and processes used in respect of agricultural products as referred to Article 38(1) of the Treaty establishing the European Community, products intended for human and animal consumption, and medicinal products as defined in Article 1 of Directive 2001/83/EC[26], as well as production methods and processes relating to other products, where these have an effect on their characteristics.

4. “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;

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

This Agreement shall not apply to rules relating to matters which are covered by European Community legislation in the field of telecommunications services, defined as “services whose provision consists wholly or partly in the transmission and routing of signals on a telecommunications network by means of telecommunications processes, with the exception of radio broadcasting and television.” [27]

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

With the exception of Article 11, this Agreement shall not apply to rules enacted by or for regulated markets within the meaning of Directive 2004/39/EC[28] or by or for other markets or bodies carrying out clearing or settlement functions for those markets.

For the purposes of this definition:

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

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

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

De facto technical regulations include:

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

- 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 requirements or rules on services linked to national social security systems are not included.

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 Community[29] (thereinafter called ‘the Commission’) in the framework of the Committee referred to in Article 5 of Directive 98/34/EC. Romania shall draw up such a list and forward it to the Commission the first day of the first month following entry into force of this Agreement.

The same procedure shall be used for amending this list.

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

Article 2

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

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

Article 3

1. Subject to Article 12, the European 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.

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

Article 4

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

Article 5

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

2. Where, in particular, the draft seeks to limit the marketing or use of a chemical substance, preparation or product on grounds of public health or of the protection of consumers or the environment, Member States and Romania shall also forward either a summary or the references of all relevant data relating to the substance, preparation or product concerned and to known and available substitutes, where such information may be available, and communicate the anticipated effects of the measure on public health and the protection of the consumer and the environment, together with an analysis of the risk carried out as appropriate in accordance with the general principles for the risk evaluation of chemical substances as referred to in Article 10(4) of Regulation (EEC) No. 793/93[30] in the case of an existing substance or in Article 3(2) of Directive 67/548/EEC[31], in the case of a new substance.

Article 6

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

Article 7

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

Article 8

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

2. The Member States and Romania shall take such comments into 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.

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 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

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

Article 12

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

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

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

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

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

- apply Article 12(1) of Directive 2001/95/EC[32],

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

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

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

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

Article 13

Information supplied under this Agreement shall be considered as confidential upon request. However, both the European 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.

Article 14

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

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

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

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

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.

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, Slovene, Slovak, Spanish, Swedish and Romanian languages, each text being equally authentic.

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.

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[33]; services of collective investment undertakings,

(b) services covered by the activities subject to mutual recognition referred to in the Annex to Directive 2000/12/EC[34],

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

- Article 1 of Directive 73/239/EEC[35],

- Annex I of Directive 2002/83/EC[36],

- Directive 64/225/EEC[37],

- Directives 92/49/EEC[38] and 2002/83/EC[39].

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 by the Contracting Parties.

LEGISLATIVE FINANCIAL STATEMENT

Policy area(s): Enterprise Activit(y/ies): Internal Market for Goods and Sectoral Policies |

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

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

02.010401 Technical and logistical support and assistance to users

02.0301 Operation and development of the internal market, particularly in the field of notification, certification and sectoral approximation

2. OVERALL FIGURES

2.1. Total allocation for action (Part B): € million in commitments: 0.0 14

2.2. Period of application:

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

2.3. Overall multiannual estimate of expenditure:

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

(€ million to three decimal places)

2006 | 2007 | 2008 | 2009 | 2010 | n + 5 and subs. years | Total |

Commitments | 0.014 | pm | pm | pm | pm | pm | 0.014 |

Payments | 0.007 | 0.007 | pm | pm | pm | pm | 0.014 |

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

Commitments | None | None | None | None | None | None | None |

Payments | None | None | None | None | None | None | None |

Subtotal a+b |

Commitments | 0.014 | pm | pm | pm | pm | pm | 0.014 |

Payments | 0.007 | 0.007 | pm | pm | pm | pm | 0.014 |

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

Commitments/ payments | 0.0173 | pm | pm | pm | pm | pm | 0.0173 |

TOTAL a+b+c |

Commitments | 0.0313 | pm | pm | pm | pm | pm | 0.0313 |

Payments | 0.0156 | 0,0156 | pm | pm | pm | pm | 0.0313 |

2.4. Compatibility with financial programming and financial perspective

Proposal is compatible with existing financial programming.

2.5. Financial impact on revenue:

Proposal has no financial implications (involves technical aspects regarding implementation of a measure).

3. BUDGET CHARACTERISTICS

Type of expenditure (03 02 01) | New | EFTA contribution | Contributions from applicant countries | Heading in financial perspective |

Non-comp | Diff | YES | NO | NO | N° 1.1 |

4. LEGAL BASIS

Article 133 EC

5. DESCRIPTION AND GROUNDS

5.1. Need for Community intervention

5.1.1. Objectives pursued

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

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

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

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

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

- and thus strengthen the spirit of dialogue and mutual understanding.

5.1.2. Measures taken in connection with ex ante evaluation

The ex ante evaluation revealed the following:

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

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

5.1.3. Measures taken following ex post evaluation

None .

5.2. Actions envisaged and budget intervention arrangements

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

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

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

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

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

5.3. Methods of implementation

Action 1

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

Action 2

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

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

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

Action 3

DG Enterprise and Industry will be responsible for:

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

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

- managing the database and translations, and forwarding of messages.

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

6. FINANCIAL IMPACT

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

6.1.1. Financial intervention

Commitments (in € million to three decimal places)

Breakdown | 2006 | 2007 | 2008 | 2009 | 2010 | n + 5 and subs. years | Total |

Action 2 | 0.014 | pm | pm | pm | pm | pm | 0.014 |

TOTAL | 0.014 | pm | pm | pm | pm | pm | 0.014 |

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

None

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

Commitments (in € million to three decimal places)

Breakdown | Type of outputs (projects, files ) | Number of outputs (total for years 1...n) | Average unit cost | Total cost (total for years 1...n) |

1 | 2 | 3 | 4=(2X3) |

Action 2 - translation | Files | 10 | 0.0014 | 0.014 |

TOTAL COST | 0.014 |

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

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 | Total | Description of tasks deriving from the action |

Number of permanent posts | Number of temporary posts |

Officials or temporary staff | A B C | 0.1 0.1 0.1 | 0.05 0.05 0.05 | Legal analysis and administrative support |

Other human resources |

Total | 0.15 |

7.2. Overall financial impact of human resources

Type of human resources | Amount (€) | Method of calculation * |

Officials Temporary staff | 17 250 | 115.000 x 0.15 |

Other human resources (specify budget line) |

Total | 17 250 |

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

7.3. Other administrative expenditure deriving from the action

Budget line (number and heading) | Amount € | Method of calculation |

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) |

Total |

The amounts are total expenditure for 6 months.

I. Annual total (7.2 + 7.3) II. Duration of action III. Cost of the operation (I x II) | € 17 250 Until the accession of the 2 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 the candidate countries' notifications, the Community's reactions to these notifications, and also the reactions of the candidate countries to the Member States' notifications.

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).

[1] OJ L098, 02/04/2004, P.0030

[2] OJ L 117, 22/04/2004, P.0001

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

[4] OJ C [...], [...], p. [...]

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

[6] OJ L 358, 31.12.1994, p.3

[7] 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)

[8] 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).

[9] OJ L 311, 28.11.2001, p. 67.

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

[11] OJ L 145, 30.4.2004, p.1

[12] OJ C 23, 27.1.2000, p. 3.

[13] Council Regulation (EE8ALOUV[_efg...†‡ˆ¿ Ý ø =œ?kC) No. 793/93 of 23 March 1993 on the evaluation and control of therisks of existing substances (OJ L 84, 5.4.1993, p.1).

[14] Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ L 196, 16.8.1967, p. 1). Directive, as amended by Directive 92/32/EEC (OJ L 154, 5.6.1992, p. 1) and subsequent directives

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

[16] OJ L 145,30.4.2004, p.1

[17] OJ L 126, 26.5.2000, p.1

[18] OJ L 228, 16. 8. 1973, p. 3. and subsequent amendments.

[19] OJ L 345, 19.12.2002,p.1

[20] OJ 56, 4. 4. 1964, p. 878/64. Directive as amended by the 1973 Act of Accession.

[21] OJ L 228, 11. 8. 1992, p. 1.

[22] OJ L 345, 19. 12. 2002, p. 1.

[23] OJ L 357, 31.12.1994, p.2

[24] 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)

[25] 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).

[26] OJ L 311, 28.11.2001, p. 67.

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

[28] OJ L 145, 30.4.2004, p.1.

[29] OJ C 23, 27.1.2000, p. 3.

[30] Council Regulation (EEC) No. 793/93 of 23 March 1993 on the evaluation and control of therisks of existing substances (OJ L 84, 5.4.1993, p.1).

[31] Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ L 196, 16.8.1967, p. 1). Directive, as amended by Directive 92/32/EEC (OJ L 154, 5.6.1992, p. 1) and subsequent directives

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

[33] OJ L 145,30.4.2004, p.1

[34] OJ L 126, 26.5.2000, p.1

[35] OJ L 228, 16. 8. 1973, p. 3. and subsequent amendments.

[36] OJ L 345, 19.12.2002,p.1

[37] OJ 56, 4. 4. 1964, p. 878/64. Directive as amended by the 1973 Act of Accession.

[38] OJ L 228, 11. 8. 1992, p. 1.

[39] OJ L 345, 19. 12. 2002, p. 1.