22006A1205(01)

Protocol

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, on Conformity Assessment and Acceptance of Industrial Products (PECA)

THE EUROPEAN COMMUNITY AND ROMANIA,

hereinafter referred to as "the Parties",

WHEREAS Romania has applied for membership of the European Union and such membership implies the effective implementation of the acquis of the European Community,

RECOGNISING that the progressive adoption and implementation of Community law by Romania provides the opportunity to extend certain benefits of the internal market and to ensure its effective operation in certain sectors before accession,

CONSIDERING that, in the sectors covered by this Protocol, Romanian national law substantially takes over Community law,

CONSIDERING their shared commitment to the principles of free movement of goods and to promoting product quality, so as to ensure the health and safety of their citizens and the protection of the environment, including through technical assistance and other forms of cooperation between them,

DESIRING to conclude a Protocol 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, (hereafter referred to as "the Europe Agreement") on Conformity Assessment and Acceptance of Industrial Products (hereafter referred to as "this Protocol") providing for the application of the mutual acceptance of industrial products which fulfil the requirements for being lawfully placed on the market in one of the Parties and of the mutual recognition of the results of conformity assessment of industrial products which are subject to Community or national law, noting that Article 75 of the Europe Agreement provides, where appropriate, for the conclusion of an agreement on mutual recognition,

NOTING the close relationship between the European Community and Iceland, Liechtenstein and Norway through the Agreement on the European Economic Area, which makes it appropriate to consider the conclusion of a parallel European Conformity Assessment Agreement between Romania and these countries equivalent to this Protocol,

BEARING IN MIND the Parties' status as Contracting Parties to the Agreement establishing the World Trade Organisation, and conscious in particular of their obligations under the World Trade Organisation Agreement on Technical Barriers to Trade,

HAVE AGREED AS FOLLOWS:

Article 1

Purpose

The purpose of this Protocol is to facilitate the elimination by the Parties of technical barriers to trade in respect of industrial products. The means to this end is the progressive adoption and implementation by Romania of national law, which is equivalent to Community law.

This Protocol provides for:

(a) the mutual acceptance of industrial products, listed in the Annexes on mutual acceptance of industrial products, which fulfil the requirements for being lawfully placed on the market in one of the Parties;

(b) the mutual recognition of the results of conformity assessment of industrial products subject to Community law and to the equivalent Romanian national law, both listed in the Annexes on mutual recognition of results of conformity assessment.

Article 2

Definitions

For the purpose of this Protocol,

(a) "industrial products" means products as specified in Article 9 of the Europe Agreement and in Protocol 2 thereto;

(b) "Community law" means any legal act and implementing practice of the European Community applicable to a particular situation, risk or category of industrial products, as interpreted by the Court of Justice of the European Communities;

(c) "national law" means any legal act and implementing practice by which Romania takes over Community law applicable to a particular situation, risk or category of industrial products.

The terms used in this Protocol shall have the meaning given in Community law and Romanian national law.

Article 3

Alignment of legislation

For the purpose of this Protocol, Romania agrees to take appropriate measures, in consultation with the Commission of the European Communities, to maintain or complete the take-over of Community law, in particular in the fields of standardisation, metrology, accreditation, conformity assessment, market surveillance, general safety of products, and producer liability.

Article 4

Mutual acceptance of industrial products

The Parties agree that, for the purpose of mutual acceptance, industrial products listed in the Annexes on mutual acceptance of industrial products, which fulfil the requirements for being lawfully placed on the market of a Party, may be placed on the market of the other Party, without further restriction. This shall be without prejudice to Article 36 of the Europe Agreement.

Article 5

Mutual recognition of the results of conformity assessment procedures

The Parties agree to recognise the results of conformity assessment procedures carried out in accordance with the Community or national law listed in the Annexes on mutual recognition of the results of conformity assessment. The Parties shall not require procedures to be repeated, nor shall they impose additional requirements, for the purposes of accepting that conformity.

Article 6

Safeguard clause

Where a Party finds that an industrial product placed on the market on its territory by virtue of this Protocol, and used in accordance with its intended use, may compromise the safety or health of users or other persons, or any other legitimate concern protected by legislation identified in the Annexes, it may take appropriate measures to withdraw such a product from the market, to prohibit its placing on the market, putting into service or use, or to restrict its free movement. The Annexes shall provide for the procedure to be applied in such cases.

Article 7

Extension of coverage

As Romania adopts and implements further national law taking over Community law, the Parties may amend the Annexes or conclude new ones, in accordance with the procedure laid down in Article 14.

Article 8

Origin

The provisions of this Protocol shall apply to industrial products irrespective of their origin.

Article 9

Obligations of Parties as regards their authorities and bodies

The Parties shall ensure that authorities under their jurisdiction which are responsible for the effective implementation of Community and national law shall continuously apply it. Further, they shall ensure that these authorities are able, where appropriate, to notify, suspend, remove suspension and withdraw notification of bodies, to ensure the conformity of industrial products with Community or national law or to require their withdrawal from the market.

The Parties shall ensure that bodies, notified under their respective jurisdiction to assess conformity in relation to requirements of Community or national law specified in the Annexes, continuously comply with the requirements of Community or national law. Further, they shall take all necessary steps to ensure that these bodies maintain the necessary competence to carry out the tasks for which they are notified.

Article 10

Notified bodies

Initially, the bodies notified for the purpose of this Protocol shall be those included in the lists which Romania and the Community have exchanged before the completion of the procedures for entry into force.

Afterwards, the following procedure shall apply for the notification of bodies to assess conformity in relation to the requirements of Community or national law specified in the Annexes:

(a) a Party shall forward its notification to the other Party in writing;

(b) on the acknowledgement of the other Party, given in writing, the body shall be considered as notified and as competent to assess conformity in relation to the said requirements specified in the Annexes from that date.

If a Party decides to withdraw the notification of a body under its jurisdiction, it shall inform the other Party in writing. The body will cease to assess conformity in relation to the said requirements specified in the Annexes from the date of its withdrawal at the latest. Nevertheless, conformity assessment carried out before that date shall remain valid, unless otherwise decided by the Association Council.

Article 11

Verification of notified bodies

Each Party may request the other Party to verify the technical competence and compliance of a notified body under its jurisdiction. Such request shall be justified in order to allow the Party responsible for the notification to carry out the requested verification and report speedily to the other Party. The Parties may also jointly examine the body, with the participation of the relevant authorities. To this end, the Parties shall ensure the full cooperation of bodies under their jurisdiction. The Parties shall take all appropriate steps, and use whatever available means may be necessary, with a view to resolving any problems which are detected.

If the problems cannot be resolved to the satisfaction of both Parties, they may notify the Chairman of the Association Council of their disagreement, giving their reasons. The Association Council may decide on appropriate action.

Unless and until decided otherwise by the Association Council, the notification of the body and the recognition of its competence to assess conformity in relation to the requirements of Community or national law specified in the Annexes shall be suspended in part or totally from the date on which the disagreement of the Parties has been notified to the Chairman of the Association Council.

Article 12

Exchange of information and cooperation

In order to ensure a correct and uniform application and interpretation of this Protocol, the Parties, their authorities and their notified bodies shall:

(a) exchange all relevant information concerning implementation of law and practice including, in particular, on the procedure to ensure compliance of notified bodies;

(b) take part, as appropriate, in the relevant mechanisms of information, coordination and other related activities of the Parties;

(c) encourage their bodies to cooperate with a view to establishing mutual recognition arrangements in the voluntary sphere.

Article 13

Confidentiality

Representatives, experts and other agents of the Parties shall be required, even after their duties have ceased, not to disclose information acquired under this Protocol which is of the kind covered by the obligation of professional secrecy. This information may not be used for purposes other than those envisaged by this Protocol.

Article 14

Management of the Protocol

Responsibility for the effective functioning of this Protocol shall be borne by the Association Council in accordance with Article 106 of the Europe Agreement. In particular, it shall have the power to take decisions regarding:

(a) amending the Annexes;

(b) adding new Annexes;

(c) appointing a joint team or teams of experts to verify the technical competence of a notified body and its compliance with the requirements;

(d) exchanging information on proposed and actual amendments to the Community and national law referred to in the Annexes;

(e) considering new or additional conformity assessment procedures affecting a sector covered by an Annex;

(f) resolving any questions relating to the application of this Protocol.

The Association Council may delegate the above responsibilities set out under this Protocol, in accordance with Article 110(2) of the Europe Agreement.

Article 15

Technical cooperation and assistance

The European Community may provide technical cooperation and assistance to Romania where necessary in order to support the effective implementation and application of this Protocol.

Article 16

Agreements with other countries

Agreements on conformity assessment concluded by either Party with a country which is not a Party to this Protocol shall not entail an obligation upon the other Party to accept the results of conformity assessment procedures carried out in that third country, unless there is an explicit agreement between the Parties in the Association Council.

Article 17

Entry into force

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

Article 18

Status of the Protocol

This Protocol shall constitute an integral part of the Europe Agreement.

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

Hecho en Bucarest, el veintisiete de octubre de dos mil seis.

V Bukure拧ti dne dvac谩tého sedmého 艡铆jna dva tis铆ce 拧est.

Udf忙rdiget i Bukarest, den syvogtyvende oktober totusind og seks.

Geschehen zu Bukarest am siebenundzwanzigsten Oktober zweitausendsechs.

Koostatud kahe tuhande kuuenda aasta oktoobrikuu kahek眉mne seitsmendal p盲eval Bukarestis.

螆纬喂谓蔚 蟽蟿慰 螔慰蠀魏慰蠀蟻苇蟽蟿喂, 蟽蟿喂蟼 蔚委魏慰蟽喂 蔚蟺蟿维 螣魏蟿蠅尾蟻委慰蠀 蟿慰蠀 未蠉慰 蠂喂位喂维未蔚蟼 苇尉喂.

Done at Bucharest on the twenty-seventh day of October in the year two thousand and six.

Fait 脿 Bucarest, le vingt-sept octobre de l‘檃n deux mille six.

Fatto a Bucarest, add矛 ventisette ottobre duemilasei.

Bukarest膿, divi t奴ksto拧i sest膩 gada divdesmit sept墨taj膩 oktobr墨

Priimta du t奴kstan膷iai 拧e拧t懦 met懦 spalio dvide拧imt septint膮 dien膮 Bukare拧te

Kelt Bukarestben, a kétezerhatodik év okt贸ber hav谩nak huszonhetedik napj谩n.

Mag魔mul f'Bukarest fis-sebg魔a u g魔oxrin jum ta' Ottubru fis-sena elfejn u sitta.

Gedaan te Boekarest, de zevenentwintigste oktober tweeduizend zes.

Sporz膮dzono w Bukareszcie, dnia dwudziestego si贸dmego pa藕dziernika dwa tysi膮ce sz贸stego roku.

Feito em Bucareste, aos vinte e sete dias do m锚s de Outubro do ano de dois mil e seis.

V Bukure拧ti d艌a dvadsiateho siedmeho okt贸bra dvetis铆c拧es钮.

V Bukare拧ti, sedemindvajsetega oktobra leta dva tiso膷 拧est

Tehty Bukarestissa kahdentenakymmenenten盲seitsem盲nten盲 p盲iv盲n盲 lokakuuta vuonna kaksituhattakuusi.

Utf盲rdat i Bukarest den tjugosjunde oktober 氓r tjugohundrasex.

脦ntocmit la Bucure葯ti 卯n a dou膬zeci 葯i 葯aptea zi a lunii octombrie anul dou膬 mii 葯ase.

Por la Comunidad Europea

Za Evropské spole膷enstv铆

For Det Europ忙iske F忙llesskab

F眉r die Europ盲ische Gemeinschaft

Euroopa 脺henduse nimel

螕喂伪 蟿畏谓 螘蠀蟻蠅蟺伪蠆魏萎 螝慰喂谓蠈蟿畏蟿伪

For the European Community

Pour la Communauté européenne

Per la Comunit脿 europea

Eiropas Kopienas v膩rd膩

Europos bendrijos vardu

az Eur贸pai K枚z枚sség részér艖l

G魔all-Komunit谩 Ewropea

Voor de Europese Gemeenschap

W imieniu Wsp贸lnoty Europejskiej

Pela Comunidade Europeia

Za Eur贸pske spolo膷enstvo

Za Evropsko skupnost

Euroopan yhteis枚n puolesta

P氓 Europeiska gemenskapens v盲gnar

Pentru Comunitatea European膬

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Por Ruman铆a

Za Rumunsko

For Rum忙nien

F眉r Rum盲nien

Rumeenia nimel

螕喂伪 蟿畏 巍慰蠀渭伪谓委伪

For Romania

Pour la Roumanie

Per la Romania

Rum膩nijas v膩rd膩

Rumunijos vardu

Rom谩nia részér艖l

G魔ar-Rumanija

Voor Roemeni毛

W imieniu Rumunii

Pela Roménia

Za Rumunsko

Za Romunijo

Romanian puolesta

F枚r Rum盲nien

Pentru Rom芒nia

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ANNEX

ANNEX

on mutual acceptance of industrial products

(for the record)

ANNEX

on mutual recognition of results of conformity assessment

Table of contents

1. Pressure equipment

PRESSURE EQUIPMENT

SECTION I

COMMUNITY AND NATIONAL LAW

Community law : Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment.

National law : Government Decision No 584/2004 establishing the conditions for placing on the market of pressure equipment, as subsequently amended.

SECTION II

NOTIFYING AUTHORITIES

European Community

Belgium : Ministère des Affaires Economiques/Ministerie van Economische Zaken.

Czech Republic : 脷艡ad pro technickou normalizaci, metrologii a st谩tn铆 zku拧ebnictv铆.

Germany : Bundesministerium f眉r Arbeit und Sozialordnung.

Estonia : Majandus- ja Kommunikatsiooniministeerium.

Greece : 违蟺慰蠀蟻纬蔚委慰 螒谓维蟺蟿蠀尉畏蟼. 螕蔚谓喂魏萎 螕蟻伪渭渭伪蟿蔚委伪 螔喂慰渭畏蠂伪谓委伪蟼 (Ministry of Development. General Secretariat of Industry).

Spain : Ministerio de Industria, Turismo y Comercio.

France : Ministère de l‘檈mploi et de la solidarité, Direction des relations du travail, Bureau CT 5.

Ireland : Department of Enterprise and Employment.

Italy : Ministero dell‘橧ndustria, del commercio e dell'artigianato.

Latvia : Ekonomikas ministrija.

Hungary : Gazdas谩gi és K枚zlekedési Minisztérium.

Malta : Under the authority of the Government of Malta: Consumer and Industrial Goods Directorate of the Malta Standards Authority.

Austria : Bundesministerium f眉r Wirtschaft und Arbeit.

Poland : Ministerstwo Gospodarki, Pracy i Polityki Spo艂ecznej.

Slovenia : Ministrstvo za gospodarstvo.

Slovakia : 脷rad pre normaliz谩ciu, metrol贸giu a sk煤拧obn铆ctvo Slovenskej republiky.

Finland : Kauppa- ja teollisuusministeri枚/Handels- och industriministeriet.

Sweden : Under the authority of the Government of Sweden: Styrelsen f枚r ackreditering och teknisk kontrol (SWEDAC).

United Kingdom : Department of Trade and Industry.

Romania : Ministerul Economiei si Comertului ‘�Ministry of Economy and Commerce.

SECTION III

NOTIFIED BODIES

European Community

Bodies which have been notified by the Member States of the European Community in accordance with the Community law of Section I and notified to Romania in accordance with Article 10 of this Protocol.

Romania

Bodies which have been designated by Romania in accordance with the Romanian national law of Section I and notified to the European Community in accordance with Article 10 of this Protocol.

SECTION IV

SPECIFIC ARRANGEMENTS

Safeguard clauses

A. Safeguard clause relating to industrial products:

1. Where a Party has taken a measure to deny free access to its market: for industrial products subject to this Annex bearing the CE marking;

or,

for industrial products subject to this Annex which are referred to in Article 3(3) or Article 14 of Directive 97/23/EC corresponding to Articles 10 and Article 17 respectively of Government Decision No 584/2004, but for which CE marking is not required;

it shall immediately inform the other Party, indicating the reasons for its decision and how non compliance has been assessed.

2. The Parties shall consider the matter and the evidence brought to their knowledge, and shall report to each other the results of their investigations.

3. In the case of agreement, the Parties shall take appropriate measures to ensure that such products are not placed on the market.

4. In the case of disagreement on the outcome of such investigations the matter shall be forwarded to the Association Council which may decide to have an expertise carried out.

5. Where the Association Council finds that the measure is:

(a) unjustified, the national authority of the Party which has taken the measure shall withdraw it;

(b) justified, the Parties shall take appropriate measures to ensure that such products are not placed on the market.

B. Safeguard clause relating to harmonised standards:

1. Where Romania considers that a harmonised standard referred to in the legislation defined in this Annex, does not meet the essential requirements of such legislation, it shall inform the Association Council giving the reasons therefore.

2. The Association Council shall consider the matter and may request the Community to proceed in accordance with the procedure provided for in the Community legislation identified in this Annex.

3. The Community shall keep the Association Council and the other Party informed of the proceedings.

4. The outcome of the procedure shall be notified to the other Party.

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