01999A0204(01) — EN — 27.03.2017 — 003.001

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Amended by:





Corrected by:









▼B

AGREEMENT

on mutual recognition between the European Community and the United States of America

TABLE OF CONTENTS 1. Framework 2. Telecommunication Equipment 3. Electromagnetic Compatibility (EMC) 4. Electical Safety 5. Recreational Craft 6. Pharmaceutical Good Manufacturing Practices (GMPs) 7. Medical Devices







The EUROPEAN COMMUNITY, and THE UNITED STATES OF AMERICA, hereinafter referred to as ‘the Parties’, CONSIDERING the traditional links of friendship that exist between the United States of America (US) and the European Community (EC); DESIRING to facilitate bilateral trade between them; RECOGNISING that mutual recognition of conformity assessment activities is an important means of enhancing market access between the Parties; RECOGNISING that an agreement providing for mutual recognition of conformity assessment activities is of particular interest to small and medium-sized businesses in the US and the EC; RECOGNISING that any such mutual recognition also requires confidence in the continued reliability of the other Party's conformity assessments; RECOGNISING the importance of maintaining each Party's high levels of health, safety, environmental and consumer protection; RECOGNISING that mutual recognition agreements can positively contribute in encouraging greater international harmonisation of standards; NOTING that this Agreement is not intended to displace private sector bilateral and multilateral arrangements among conformity assessment bodies or to affect regulatory regimes allowing for manufacturers' self-assessments and declarations of conformity; BEARING IN MIND that the Agreement on Technical Barriers to Trade, an agreement annexed to the Agreement establishing the World Trade Organization (WTO), imposes obligations on the Parties as Contracting Parties to the WTO, and encourages such Contracting Parties to enter into negotiations for the conclusion of agreements for the mutual recognition of results of each other's conformity assessment; RECOGNISING that any such mutual recognition needs to offer an assurance of conformity with applicable technical regulations or standards equivalent to the assurance offered by the Party's own procedures; RECOGNISING the need to conclude an Agreement on Mutual Recognition (MRA) in the field of conformity assessment with sectoral annexes; and BEARING in mind the respective commitments of the Parties under bilateral, regional and multilateral environment, health, safety and consumer protection agreements. HAVE AGREED AS FOLLOWS:







Article 1

Definitions

1. The following terms and definitions shall apply to this Agreement only:

— ‘Designating Authority’ means a body with power to designate, monitor, suspend, remove suspension of, or withdraw conformity assessment bodies as specified under this Agreement.

— ‘Designation’ means the identification by a Designating Authority of a conformity assessment body to perform conformity assessment procedures under this Agreement.

— ‘Regulatory Authority’ means a government agency or entity that exercises a legal right to control the use or sale of products within a Party's jurisdiction and may take enforcement action to ensure that products marketed within its jurisdiction comply with legal requirements.

2. Other terms concerning conformity assessment used in this Agreement shall have the meaning given elsewhere in this Agreement or in the definitions contained in Guide 2 (1996 edition) of the International Organization for Standardisation (ISO) and the International Electrotechnical Commission (IEC). In the event of an inconsistency between ISO/IEC Guide 2 and definitions in this Agreement, the definitions in this Agreement shall prevail.

Article 2

Purpose of the Agreement

This Agreement specifies the conditions by which each Party will accept or recognise results of conformity assessment procedures, produced by the other Party's conformity assessment bodies or authorities, in assessing conformity to the importing Party's requirements, as specified on a sector-specific basis in the Sectoral Annexes, and to provide for other related cooperative activities. The objective of such mutual recognition is to provide effective market access throughout the territories of the Parties with regard to conformity assessment for all products covered under this Agreement. If any obstacles to such access arise, consultations will promptly be held. In the absence of a satisfactory outcome of such consultations, the Party alleging its market access has been denied, may, within 90 days of such consultation, invoke its right to terminate the Agreement in accordance with Article 21.

Article 3

General obligations

1. The United States shall, as specified in the Sectoral Annexes, accept or recognise results of specified procedures, used in assessing conformity to specified legislative, regulatory, and administrative provisions of the United States, produced by the other Party's conformity assessment bodies and/or authorities.

2. The European Community and its Member States shall, as specified in the Sectoral Annexes, accept or recognise results of specified procedures, used in assessing conformity to specified legislative, regulatory and administrative provisions of the European Community and its Member States, produced by the other Party's conformity assessment bodies and/or authorities.

3. Where sectoral transition arrangements have been specified in Sectoral Annexes, the above obligations will apply following the successful completion of those sectoral transition arrangements, with the understanding that the conformity assessment procedures utilised assure conformity to the satisfaction of the receiving Party, with applicable legislative, regulatory and administrative provisions of that Party, equivalent to the assurance offered by the receiving Party's own procedures.

Article 4

General coverage of the Agreement

1. This Agreement applies to conformity assessment procedures for products and/or processes and to other related cooperative activities as described in this Agreement.

2. Sectoral Annexes may include:

(a) a description of the relevant legislative, regulatory and administrative provisions pertaining to the conformity assessment procedures and technical regulations;

(b) a statement on the product scope and coverage;

(c) a list of Designating Authorities;

(d) a list of agreed conformity assessment bodies or authorities or a source from which to obtain a list of such bodies or authorities and a statement of the scope of the conformity assessment procedures for which each has been agreed;

(e) the procedures and criteria for designating the conformity assessment bodies;

(f) a description of the mutual recognition obligations;

(g) a sectoral transition arrangement;

(h) the identity of a sectoral contact point in each Party's territory; and

(i) a statement regarding the establishment of a Joint Sectoral Committee.

3. This Agreement shall not be construed to entail mutual acceptance of standards or technical regulation of the Parties and, unless otherwise specified in a Sectoral Annex, shall not entail the mutual recognition of the equivalence of standards or technical regulations.

Article 5

Transitional arrangements

The Parties agree to implement the transitional commitments on confidence building as specified in the Sectoral Annexes.

1. The Parties agree that each sectoral transition arrangement shall specify a time period for completion.

2. The Parties may amend any transition arrangement by mutual agreement.

3. Passage from the transitional phase to the operational phase shall proceed as specified in each Sectoral Annex, unless either Party documents that the conditions provided in such Sectoral Annex for a successful transition are not met.

Article 6

Designating Authorities

The Parties shall ensure that the Designating Authorities specified in the Sectoral Annexes have the power and competence in their respective territories to carry out decisions under this Agreement to designate, monitor, suspend, remove suspension of, or withdraw conformity assessment bodies.

Article 7

Designation and listing procedures

The following procedures shall apply with regard to the designation of conformity assessment bodies and the inclusion of such bodies in the list of conformity assessment bodies in a Sectoral Annex:

(a) The Designating Authority identified in a Sectoral Annex shall designate conformity assessment bodies in accordance with the procedures and criteria set forth in that Sectoral Annex;

(b) A Party proposing to add a conformity assessment body to the list of such bodies in a Sectoral Annex shall forward its proposal of one or more designated conformity assessment bodies in writing to the other Party with a view to a decision by the Joint Committee;

(c) Within 60 days following receipt of the proposal, the other Party shall indicate its position regarding either its confirmation or its opposition. Upon confirmation, the inclusion in the Sectoral Annex of the proposed conformity assessment body or bodies shall take effect; and

(d) In the event that the other Party contests on the basis of documented evidence the technical competence or compliance of a proposed conformity assessment body, or indicates in writing that it requires an additional 30 days to more fully verify such evidence, such conformity assessment body shall not be included on the list of conformity assessment bodies in the applicable Sectoral Annex. In this instance, the Joint Committee may decide that the body concerned be verified. After the completion of such verification, the proposal to list the conformity assessment body in the Sectoral Annex may be resubmitted to the other Party.

Article 8

Suspension of listed conformity assessment bodies

The following procedures shall apply with regard to the suspension of a conformity assessment body listed in a Sectoral Annex:

(a) A Party shall notify the other Party of its contestation of the technical competence or compliance of a conformity assessment body listed in a Sectoral Annex and the contesting Party's intent to suspend such conformity assessment body. Such contestation shall be exercised when justified in an objective and reasoned manner in writing to the other Party;

(b) The conformity assessment body shall be given prompt notice by the other Party and an opportunity to present information in order to refute the contestation or to correct the deficiencies which form the basis of the contestation;

(c) Any such contestation shall be discussed between the Parties in the relevant Joint Sectoral Committee. If there is no Joint Sectoral Committee, the contesting Party shall refer the matter directly to the Joint Committee. If agreement to suspend is reached by the Joint Sectoral Committee or, if there is no Joint Sectoral Committee, by the Joint Committee, the conformity assessment body shall be suspended;

(d) Where the Joint Sectoral Committee or Joint Committee decides that verification of technical competence or compliance is required, it shall normally be carried out in a timely manner by the Party in whose territory the body in question is located, but may be carried out jointly by the Parties in justified cases;

(e) If the matter has not been resolved by the Joint Sectoral Committee within 10 days of the notice of contestation, the matter shall be referred to the Joint Committee for a decision. If there is no Joint Sectoral Committee, the matter shall be referred directly to the Joint Committee. If no decision is reached by the Joint Committee within 10 days of the referral to it, the conformity assessment body shall be suspended upon the request of the contesting Party;

(f) Upon the suspension of a conformity assessment body listed in a Sectoral Annex, a Party is no longer obligated to accept or recognise the results of conformity assessment procedures performed by that conformity assessment body subsequent to suspension. A Party shall continue to accept the results of conformity assessment procedures performed by that conformity assessment body prior to suspension, unless a Regulatory Authority of the Party decides otherwise based on health, safety or environmental considerations or failure to satisfy other requirements within the scope of the applicable Sectoral Annex; and

(g) The suspension shall remain in effect until agreement has been reached by the Parties upon the future status of that body.

Article 9

Withdrawal of listed conformity assessment bodies

The following procedures shall apply with regard to the withdrawal from a Sectoral Annex of a conformity assessment body:

(a) A Party proposing to withdraw a conformity assessment body listed in a Sectoral Annex shall forward its proposal in writing to the other Party;

(b) Such conformity assessment body shall be promptly notified by the other Party and shall be provided a period of at least 30 days from receipt to provide information in order to refute or to correct the deficiencies which form the basis of the proposed withdrawal;

(c) Within 60 days following receipt of the proposal, the other Party shall indicate its position regarding either its confirmation or its opposition. Upon confirmation, the withdrawal from the list in the Sectoral Annex of the conformity assessment body shall take effect;

(d) In the event the other Party opposes the proposal to withdraw by supporting the technical competence and compliance of the conformity assessment body, the conformity assessment body shall not at that time be withdrawn from the list of conformity assessment bodies in the applicable Sectoral Annex. In this instance, the Joint Sectoral Committee or the Joint Committee may decide to carry out a joint verification of the body concerned. After the completion of such verification, the proposal for withdrawal of the conformity assessment body may be resubmitted to the other Party; and

(e) Subsequent to the withdrawal of a conformity assessment body listed in a Sectoral Annex, a Party shall continue to accept the results of conformity assessment procedures performed by that conformity assessment body prior to withdrawal, unless a Regulatory Authority of the Party decides otherwise based on health, safety and environmental considerations or failure to satisfy other requirements within the scope of the applicable Sectoral Annex.

Article 10

Monitoring of conformity assessment bodies

The following shall apply with regard to the monitoring of conformity assessment bodies listed in a Sectoral Annex:

(a) Designating Authorities shall assure that their conformity assessment bodies listed in a Sectoral Annex are capable and remain capable of properly assessing conformity of products or processes, as applicable, and as covered in the applicable Sectoral Annex. In this regard, Designating Authorities shall maintain, or cause to maintain, ongoing surveillance over their conformity assessment bodies by means of regular audit or assessment;

(b) The Parties undertake to compare methods used to verify that the conformity assessment bodies listed in the Sectoral Annexes comply with the relevant requirements of the Sectoral Annexes. Existing systems for the evaluation of conformity assessment bodies may be used as part of such comparison procedures;

(c) Designating Authorities shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment procedures. With the consent of both Parties, this consultation may include joint participation in audits/inspections related to conformity assessment activities or other assessments of conformity assessment bodies listed in a Sectoral Annex; and;

(d) Designating Authorities shall consult, as necessary, with the relevant Regulatory Authorities of the other Party to ensure that all technical requirements are identified and are satisfactorily addressed.

Article 11

Conformity assessment bodies

Each Party recognises that the conformity assessment bodies listed in the Sectoral Annexes fulfil the conditions of eligibility to assess conformity in relation to its requirements as specified in the Sectoral Annexes. The Parties shall specify the scope of the conformity assessment procedures for which such bodies are listed.

Article 12

Exchange of information

1. The Parties shall exchange information concerning the implementation of the legislative, regulatory, and administrative provisions identified in the Sectoral Annexes.

2. Each Party shall notify the other Party of legislative, regulatory and administrative changes related to the subject matter of this Agreement at least 60 days before their entry into force. Where considerations of safety, health or environmental protection require more urgent action a Party shall notify the other Party as soon as practicable.

3. Each Party shall promptly notify the other Party of any changes to its Designating Authorities and/or conformity assessment bodies.

4. The Parties shall exchange information concerning the procedures used to ensure that the listed conformity assessment bodies under their responsibility comply with the legislative, regulatory, and administrative provisions outlined in the Sectoral Annexes.

5. Regulatory Authorities identified in the Sectoral Annexes shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment procedures and to ensure that all technical requirements are identified and are satisfactorily addressed.

Article 13

Sectoral contact points

Each Party shall appoint and confirm in writing contact points to be responsible for activities under each Sectoral Annex.

Article 14

Joint Committee of the Parties

1. The Parties hereby establish a Joint Committee consisting of representatives of each Party. The Joint Committee comprised shall be responsible for the effective functioning of the Agreement.

2. The Joint Committee may establish Joint Sectoral Committees comprised of appropriate Regulatory Authorities and others deemed necessary.

3. Each Party shall have one vote in the Joint Committee. The Joint Committee shall make its decisions by unanimous consent. The Joint Committee shall determine its own rules and procedures.

4. The Joint Committee may consider any matter relating to the effective functioning of this Agreement. In particular it shall be responsible for:

(a) listing, suspension, withdrawal and verification of conformity assessment bodies in accordance with this Agreement;

(b) amending transitional arrangements in Sectoral Annexes;

(c) resolving any questions relating to the application of this Agreement and its Sectoral Annexes not otherwise resolved in the respective Joint Sectoral Committees;

(d) providing a forum for discussion of issues that may arise concerning the implementation of this Agreement;

(e) considering ways to enhance the operation of this Agreement;

(f) coordinating the negotiation of additional Sectoral Annexes; and

(g) considering whether to amend this Agreement or its Sectoral Annexes in accordance with Article 21.

5. When a Party introduces new or additional conformity assessment procedures affecting a Sectoral Annex, the Parties shall discuss the matter in the Joint Committee with a view to bringing such new or additional procedures within the scope of this Agreement and the relevant Sectoral Annex.

Article 15

Preservation of regulatory authority

1. Nothing in this Agreement shall be construed to limit the authority of a Party to determine, through its legislative, regulatory and administrative measures, the level of protection it considers appropriate for safety; for protection of human, animal, or plant life or health; for the environment; for consumers; and otherwise with regard to risks within the scope of the applicable Sectoral Annex.

2. Nothing in this Agreement shall be construed to limit the authority of a Regulatory Authority to take all appropriate and immediate measures whenever it ascertains that a product may: (a) compromise the health or safety of persons in its territory; (b) not meet the legislative, regulatory, or administrative provisions within the scope of the applicable Sectoral Annex; or (c) otherwise fail to satisfy a requirement within the scope of the applicable Sectoral Annex. Such measures may include withdrawing the products from the market, prohibiting their placement on the market, restricting their free movement, initiating a product recall, and preventing the recurrence of such problems, including through a prohibition on imports. If the Regulatory Authority takes such action, it shall inform its counterpart authority and the other Party within 15 days of taking such action, providing its reasons.

Article 16

Suspension of recognition obligations

Either Party may suspend its obligations under a Sectoral Annex, in whole or in part, if:

(a) a Party suffers a loss of market access for the Party's products within the scope of the Sectoral Annex as a result of the failure of the other Party to fulfil its obligations under the Agreement;

(b) the adoption of new or additional conformity assessment requirements as referenced in Article 14(5) results in a loss of market access for the Party's products within the scope of the Sectoral Annex because conformity assessment bodies designated by the Party in order to meet such requirements have not been recognized by the Party implementing the requirements; or;

(c) the other Party fails to maintain legal and regulatory authorities capable of implementing the provisions of this Agreement.

Article 17

Confidentiality

1. Each Party agrees to maintain, to the extent required under its laws, the confidentiality of information exchanged under this Agreement.

2. In particular, neither Party shall disclose to the public, nor permit a conformity assessment body to disclose to the public, information exchanged under this Agreement that constitutes trade secrets, confidential commercial or financial information, or information that relates to an ongoing investigation.

3. A Party or a conformity assessment body may, upon exchanging information with the other Party or with a conformity assessment body of the other Party, designate the portions of the information that it considers to be exempt from disclosure.

4. Each Party shall take all precautions reasonably necessary to protect information exchanged under this Agreement from unauthorised disclosure.

Article 18

Fees

Each Party shall endeavour to ensure that fees imposed for services under this Agreement shall be commensurate with the services provided. Each Party shall ensure that, for the sectors and conformity assessment procedures covered under this Agreement, it shall charge no fees with respect to conformity assessment services provided by the other Party.

Article 19

Agreements with other countries

Except where there is written agreement between the Parties, obligations contained in mutual recognition agreements concluded by either Party with a party not a signatory to this Agreement (a third party) shall have no force and effect with regard to the other Party in terms of acceptance of the results of conformity assessment procedures in the third party.

Article 20

Territorial application

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 United States.

Article 21

Entry into force, amendment and termination

1. This Agreement including its Sectoral Annexes on Telecommunication Equipment, Electromagnetic Compatibility, Electrical Safety, Recreational Craft, Pharmaceutical Good Manufacturing Practices (GMPs), and Medical Devices shall enter into force on the first day of the second month following the date on which the Parties have exchanged letters confirming the completion of their respective procedures for the entry into force of this Agreement.

2. This Agreement including any Sectoral Annex may, through the Joint Committee, be amended in writing by the Parties. The Parties may add a Sectoral Annex upon the exchange of letters. Such Annex shall enter into force 30 days following the date on which the Parties have exchanged letters confirming the completion of their respective procedures for the entry into force of the Sectoral Annex.

3. Either Party may terminate this Agreement in its entirety or any individual Sectoral Annex thereof by giving the other Party six months notice in writing. In the case of termination of one or more Sectoral Annexes, the Parties will seek to achieve by consensus to amend this Agreement, with a view to preserving the remaining Sectoral Annexes, in accordance with the procedures in this Article. Failing such consensus, the Agreement shall terminate at the end of six months from the date of notice.

4. Following termination of the Agreement in its entirety or any individual Sectoral Annex thereof, a Party shall continue to accept the results of conformity assessment procedures performed by conformity assessment bodies under this Agreement prior to termination, unless a Regulatory Authority in the Party decides otherwise based on health, safety and environmental considerations or failure to satisfy other requirements within the scope of the applicable Sectoral Annex.

Article 22

Final provisions

1. The Sectoral Annexes referred to in Article 21(1), as well as any New Sectoral Annexes added pursuant to Article 21(2), shall form an integral part of this Agreement.

2. For a given product or sector, the provisions contained in the relevant Sectoral Annexes shall apply in the first place, and the provisions of this text in addition to those provisions. In the case of any inconsistency between the provisions of a Sectoral Annex and this text, the Sectoral Annex shall prevail, to the extent of that inconsistency.

3. This Agreement shall not affect the rights and obligations of the Parties under any other international agreement.

4. In the case of the Sectoral Annex on Medical Devices, the Parties shall review the status of such Annex at the end of three years from entry into force.

This Agreement and the Sectoral Annexes are drawn up in two original in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each text being equally authentic. In the event of inconsistencies of interpretation, the English text shall be determinative.

Hecho en Londres, el dieciocho de mayo de mil novecientos noventa y ocho.Udfærdiget i London den attende maj nitten hundrede og otteoghalvfems.Geschehen zu London am achtzehnten Mai neunzehnhundertachtundneunzig.Έγινε στο Λονδίνο, στις δέκα οκτώ Μαϊου χίλια εννιακόσια ενενήντα οκτώ.Done at London on the eighteenth day of May in the year one thousand nine hundred and ninety-eight.Fait à Londres, le dix-huit mai mil neuf cent quatre-vingt-dix-huit.Fatto a Londra, addì diciotto maggio millenovecentonovantotto.Gedaan te Londen, de achttiende mei negentienhonderd achtennegentig.Feito em Londres, em dezoito de Maio de mil novecentos e noventa e oito.Tehty Lontoossa kahdeksantenatoista päivänä toukokuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäkahdeksan.Som skedde i London den artonde maj nittonhundranittioåtta.

Por la Comunidad EuropeaFor Det Europæiske FællesskabFür die Europäische GemeinschaftΓια την Ευρωπαϊκή ΚοινότηταFor the European CommunityPour la Communauté européennePer la Comunità europeaVoor de Europese GemeenschapPela Comunidade EuropeiaEuroopan yhteisön puolestaPå Europeiska gemenskapens vägnar

Por los Estados Unidos de AméricaFor Amerikas Forenede StaterFür die Vereinigten Staaten von AmerikaΓια τις Ηνωμένες Πολιτείες της ΑμερικήςFor the United States of AmericaPour les États-Unis d'AmériquePer gli Stati Uniti d'AmericaVoor de Verenigde Staten van AmerikaPelos Estados Unidos da AméricaAmerikan yhdysvaltojen puolestaPå Amerikas förenta staternas vägnar

SECTORAL ANNEX FOR TELECOMMUNICATION EQUIPMENT

PREAMBLE

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of Conformity Assessment between the United States and the European Community.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS







EC USA Directive 98/13/EC of the European Parliament and of the Council of 12 February 1998 relating to telecommunications terminal equipment and satellite earth station equipment, including the mutual recognition of their conformity, and interpretation thereof; Communications Act of 1934, as amended by the Telecommunication Act of 1996, (Title 47 of the United States Code). The US regulatory and administrative provisions in respect of telecommunication equipment, including 47 CFR Part 68, and FCC interpretation thereof; (The Parties recognize that the Handbook on the implementation of Directive 98/13/EC (ADLNB and ACTE approved), provides useful guidelines for the implementation of conformity assessment procedures falling under this Directive.); (The Parties recognize that the FCC Form 730 Application Guide provides useful guidelines for the implementation of conformity assessment procedures for telecommunication terminal equipment falling within these regulations.); Commission Decisions (CTRs) established under Directive 98/13/EC; The EC Member States' legislation and regulations in respect of: (a) non-harmonised analogue connection to the public telecommunications network (1); (b) non-harmonised radio transmitters for which there is a civilian equipment authorization requirement; The US regulatory and administrative provisions in respect of all radio transmitters subject to an equipment authorisation requirement. A non-exclusive list of FCC regulations are contained in Section II; For electrical safety, see Electrical Safety Sectoral Annex to the Agreement; For electrical safety, see Electrical Safety Sectoral Annex to the Agreement; For electromagnetic compatibility aspects, see Electromagnetic Compatibility (EMC) Sectoral Annex to the Agreement. For electromagnetic compatibility aspects, see Electromagnetic Compatibility (EMC) Sectoral Annex to the Agreement. (1) The EC agrees to seek authority to include non-harmonised digital connections;

SECTION II

SCOPE AND COVERAGE

1. This Sectoral Annex shall apply to equipment, interfaces, and services subject to Section I. In general terms the provisions of this Sectoral Annex shall apply to the following types of telecommunication terminal equipment, satellite terminal equipment, radio transmitters, and information technology equipment:

(a) equipment intended for connection to the public telecommunications network in order to send, process or receive information, whether the equipment is to be connected directly to the ‘termination’ of the network or to inter-work with such a network, being connected directly or indirectly to the termination point. The system of connection may be wire, radio, optical or other electro-magnetic means;

(b) equipment capable of being connected to a public telecommunications network even if it is not its intended purpose, including information technology equipment having a communication port; and

(c) all radio transmitters subject to an equipment authorisation procedure by either Party.

2. The following is a non-exclusive list of the equipment, interfaces, and services included within the scope of this Sectoral Annex:







EC USA The following equipment categories are included: ISDN Basic Rate Access ISDN Primary Rate Access ISDN Telephony X21/V.24/V.35 Access X25 Access PSTN Non-Voice PSTN Voice Band (Analog) ONP Leased Line Terminal types: — 64 kbits/sec — 2 048 kbit/s unstructured — 2 048 kbit/s structured — 34 Mbits/s access — 140 Mbits/s access — 2 wire analogue — 4 wire analogue Equipment categories covered under 47 CFR, Part 68, including: ISDN Basic Access ISDN Primary Rate Access Digital Service Access: — 2.4 kbps — 3.2 kbps (2.4 kbps with Secondary Channel) — 4.8 kbps — 6.4 kbps (4.8 kbps with SC) — 9.6 kbps — 12.8 kbps (9.6 kbps with SC) — 19.2 kbps — 25.0 kbps (19.2 kbps with SC) — 56.0 kbps — 64.0 kbps (uses 72 kbps channel) — 72.0 kbps (56.0 kbps with SC) — 1.544 Mbps 2-wire analog tie trunks/ops 4-wire analog tie trunks/ops PSTN Voice Band (Analog) Access Private Line (Analog) Access Radio transmitters subject to an equipment authorisation requirement, including: — Short range devices, including low power devices such as cordless telephones/microphones; — Land mobile, including: — — Private Mobile Radio (PMR/PAMR) — Mobile telecom — Paging systems — Terrestrial fixed — Satellite mobile — Satellite fixed — Broadcast — Radio determination



Commercial Mobile Radio (Part 20) Domestic Public Fixed (Part 21) Domestic Mobile (Part 22) Personal Communication Service (Part 24) Satellite Communications (Part 25) Broadcast (Part 73) Auxiliary Broadcast (Part 74) Cable Television Radio (Part 78) Maritime (Part 80) GMDSS (Part 80W) Private Land Mobile (Part 90) Private-Fixed Microwave (Part 94) Personal Radio Services (Part 95) IVDS (Part 95 F) Amateur Radio (Part 97) Radio Frequency Devices (Part 15) Fixed Microwave Services (Part 101) Note: A list of acronyms and a glossary is contained in Appendix I to this Sectoral Annex.

SECTION III

CONFORMITY ASSESSMENT PROCEDURES FOR TELECOMMUNICATION EQUIPMENT

1. Description of Mutual Recognition Obligations

In accordance with the provisions of the Agreement, the result of the conformity assessment procedures produced by a Party's conformity assessment bodies listed in Section V shall be recognised by the Regulatory Authorities of the other Party without any further conformity assessment of the products, pursuant to Section I.

2. Conformity Assessment Procedures

Taking into account the legislative, regulatory, and administrative provisions as identified in Section I, each Party recognises that the conformity assessment bodies of the other Party, listed in Section V, are authorised to perform the following procedures with regard to the importing Party's technical requirements for telecommunication terminal, satellite terminal equipment, radio transmitters or information technology equipment:

(a) testing and issuing of test reports;

(b) issuing certificates of conformity to the requirements of the laws and regulations applicable in the territories of the Parties for products covered under this Sectoral Annex; and

(c) performing quality assurance certification pursuant to Directive 98/13/EC.

SECTION IV

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V







EC USA — Belgium — Institut belge des services postaux et des télécommunications — Belgisch instituut voor postdiensten en telecommunicatie — Denmark — Telestyrelsen — Germany — Bundesministerium für Wirtschaft — Greece — Yπουργείο Μεταφορών και Επικοινωνιών — Ministry of Transport and Communications — Spain — Ministerio de Fomento — France — Ministère de l'économie, des finances et de l'industrie — Ireland — Department of Transport, Energy and Communications — Italy — Ministero delle Communicazioni — DGROS e ISETI (Radiotransmettitori) — Luxembourg — Administration des Postes et Télécommunications — Netherlands — De Minister van Verkeer en Waterstaat — Austria — Bundesministerium für Wissenschaft und Verkehr — Portugal — Instituto das Communicações de Portugal — Finland — LiikenneministeriöTrafikministeriet — TelehallintokeskusTeleförvaltningscentralen — Sweden — Under the authority of the Government of Sweden: — Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kingdom — Department of Trade and Industry National Institute of Standards and Technology (NIST) Federal Communications Commission (FCC)

SECTION V

CONFORMITY ASSESSMENT BODIES







EC access to the US market US access to the EC market Conformity assessment bodies located in the EC shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. Conformity assessment bodies located in the US shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. ►M2

TÜV Österreich

Deutschstraße, 10

A-1230 Wien

Tel. (43-1) 61 09 10

Fax (43-1) 610 91 89

Telefication BV — KTL

PO Box 60004

6800 JA Arnhem

The Netherlands

Tel. (31-26) 378 07 80

Fax (31-26) 378 07 89

Swedish National Testing and Research Institute (SP)

Box 857

S-501 15 Borås

Tel. (46-33) 16 50 00

Fax (46-33) 13 55 02 ►M21

Cambridge Test and Measurement Services Ltd

PO Box 465

St Andrews Road

Cambridge CB4 1ZJ

United Kingdom

Tel.: (44-1223) 87 68 76

Fax: (44-1223) 87 68 51 ◄

Radio Frequency Investigations Ltd

Ewhurst ParkRamsdell Basingstoke

Hampshire RG26 5RQ

United Kingdom

Tel. (44-1256) 85 11 93

Fax (44-1256) 85 11 92

TRL Compliance Services

Long Green

Forthampton

Tewkesbury

Gloucestershire GL19 4QH

United Kingdom

Tel. (44-1684) 83 38 18

Fax (44-1684) 83 38 58

BABT Product Services Ltd

Segensworth Roads

Fareham

Hampshire PO15 5RH

United Kingdom

Tel. (44-1932) 25 12 00

Fax (44-1932) 25 12 01 ◄ ►M9

Phoenix Test-Lab GmbH

Königswinkel 10

D-32825 Blomberg

Tel. (49-5235) 95 00 24

Fax (49-5235) 95 00 28

CETECOM

CETECOM ICT Services GmbH

Untertürkheimer Str. 6-10

D-66117 Saarbrücken

Tel. (49-681) 598 87 23

Fax (49-681) 598 90 75

CETECOM GmbH

Im Teelbruch 122

D-45219 Essen

Tel. (49-2054) 951 99 24

Fax (49-2054) 951 99 02

EMCC Dr. Rašek

Moggast

D-91320 Ebermannstadt

Tel. (49-9194) 90 16

Fax (49-9194) 81 25 ◄ ►M20

BZT-ETS Certification GmbH

Storkower Str. 38 c

D-15526 Reichenwalde

Tel: (49-33631) 88 82 22

Fax: (49-33631) 88 86 80 ◄ ►M2

Communication Certification Laboratory

1940 West Alexander Street

Salt Lake City, UT 84119-2039

USA

Tel. (1-801) 972 61 46

Fax (1-801) 972 84 32

Compliance Certification Services, Inc.

561F Monterey Rd.

Morgan Hill, CA, 95037

USA

Tel. (1-408) 752 81 66

Fax (1-408) 752 81 68

CKC Laboratories, Inc.

5473 A. Clouds Rest

Mariposa CA 95338

USA

Tel. (1-209) 966 52 40

Fax (1-209) 742 61 33

110 Olinda Place

Brea, CA 92823

USA

Tel. (1-209) 966 52 40

Fax (1-209) 742 61 33

1100 Fulton Place

Fremont, CA 94539

USA

Tel. (1-209) 966 52 40

Fax (1-209) 742 61 33

5289 NE Elam Young Pkwy.

Suite G900

Hillsboro, OR 97124

USA

Tel. (1-209) 966 52 40

Fax (1-209) 742 61 33

1853 Los Vibras Rd

Hollister, CA 95023

USA

Tel. (1-209) 966 52 40

Fax (1-209) 742 61 33

3800 148th Ave., NE

Redmond, WA 98052

USA

Tel. (1-209) 966 52 40

Fax (1-209) 742 61 33

22105 Wilson River Hwy.

Tillamook, OR 97141

USA

Tel. (1-209) 966 52 40

Fax (1-209) 742 61 33

D.L.S. Electronic Systems, Inc.

1250 Peterson Drive

Wheeling, IL 600090-6454

USA

Tel. (1-847) 537 64 00

Fax (1-847) 537 64 88

Elite Electronic Engineering, Inc.

1516 Cente Circle

Downers Grove, IL 60515-1082

USA

Tel. (1-630) 495 97 70

Fax (1-630) 495 97 85

Intertek Testing Services, Inc.

1950 Evergreen Blvd., Suite 100

Duluth, GA 30096

USA

Tel. (1-607) 753 67 11

Fax (1-607) 753 66 99

70 Codman Hill Road

Boxborough, MA 01719

USA

Tel. (1-607) 753 67 11

Fax (1-607) 753 66 99

7435 4th Street North,Oakdale, MN 55128

USA

Tel. (1-607) 753 67 11

Fax (1-607) 753 66 99

1365 Adams Ct,Menlo Park, CA 94025

USA

Tel. (1-607) 753 67 11

Fax (1-607) 753 66 99

MET Laboratories, Inc.

914 W. Patapsco Avenue

Baltimore, MD 21230-3432

USA

Tel. (1-410) 354 33 00

Fax (1-410) 354 33 13

Northwest EMC, Inc.

22975 Evergreen Blvd., Suite 400

Hillsboro, OR 97124

USA

Tel. (1-503) 844 40 66

Fax (1-503) 844 38 26

PCTEST Engineering Lab, Inc.

6660 Dobbin Rd.

Columbia, MD 21045

USA

Tel. (1-410) 290 66 52

Fax (1-410) 290 66 54

Underwriters Laboratories, Inc.

1285 Walt Whitman Rd.

Melville, NY 11747

USA

Tel. (1-847) 272 88 00

Fax (1-847) 272 81 29

33 Pfingston Rd.

Northbrook, IL 60062

USA

Tel. (1-847) 272 88 00

Fax (1-847) 272 81 29

2600 N.W. Lake Rd.

Camas, WA 98607

USA

Tel. (1-847) 272 88 00

Fax (1-847) 272 81 29

12 Laboratory Dr.

RTP, NC 27709

USA

Tel. (1-847) 272 88 00

Fax (1-847) 272 81 29

1655 Scott Blvd.

Santa Clara, CA 95050

USA

Tel. (1-847) 272 88 00

Fax (1-847) 272 81 29 ◄ ►M3

Retlif Testing Laboratories

795 Marconi Avenue

Ronkonkoma, New York 11779

USA

Tel. (1-631) 737 15 00

Fax (1-631) 737 14 97 ◄ ►M8

Integrity Test & Design, an Entela Company

37-7 Ayer Road

Littleton, Massachusetts, 01460

USA

Tel. (1-616) 247 05 15

Fax (1-616) 247 75 27 ◄ ►M15

TIMCO Engineering, Inc.

849 NW State Road 45

Newberry, Florida 32669

USA

Tel. (1-352) 472 55 00

Fax (1-352) 472 20 30 ◄ ►M19

L.S. Compliance, Inc.

W66 N220 Commerce Court

Cedarburg,Wisconsin, 53012-2636

USA

Tel: (1-262) 375 44 00

Fax: (1-262) 375 42 48 ◄ ►M23

Washington Laboratories, Ltd

7560 Lindbergh Drive

Gaithersburg, Maryland 20879

USA

Tel. (1-301) 417 02 20

Fax (1-301) 417 90 69 ◄

SECTION VI

DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V







EC access to the US market US access to the EC market EC Authorities identified in Section IV shall designate conformity assessment bodies located in the EC in accordance with the US legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based on compliance with the appropriate ISO/IEC Guides (e. g. Guide 22, 25, 28, 58, 61, 62, 65, etc.) or the comparable EN-45000 Series Standards. US Authorities identified in Section IV shall designate conformity assessment bodies located in the US in accordance with the EC legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based on compliance with the appropriate EN-45000 Series Standards or the comparable ISO/IEC Guides (e. g. 22, 25, 28, 58, 61, 62, 65, etc.) Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9 and 10 of the Agreement. Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9 and 10 of the Agreement.

SECTION VII

ADDITIONAL PROVISIONS

1. Sub-contracting

1.1. Any sub-contracting by conformity assessment bodies shall be in accordance with the sub-contracting requirements of the other Party. Notwithstanding the use of sub-contracting, the final results of conformity assessment remain the full responsibility of the listed conformity assessment body. In the EC, these requirements are described in Council Decision 93/465/EEC.

1.2. The conformity assessment bodies shall record and retain details of their investigation of the competence and compliance of their subcontractors and maintain a register of all sub-contracting. These details will be available to the other Party on request.

2. Post-market surveillance, border measures and internal movement

2.1. For the purpose of post-market surveillance, the Parties may maintain any existing labelling and numbering requirements. The assignment of the numbers may take place in the territory of the exporting Party. The numbers will be allocated by the importing Party. Numbering and labelling systems shall not introduce additional requirements within the meaning of this Sectoral Annex.

2.2. Nothing in this Sectoral Annex shall prevent the Parties from removing products from the market that do not in fact conform to the requirements for approval.

2.3. The Parties agree that border inspections and checks of products which have been certified, labelled or marked as conforming with the importing Party's requirements specified in Section I shall be completed as expeditiously as possible. With regard to any inspections related to internal movement within their respective territories, the Parties agree that these shall be completed in no less a favourable manner than for like domestic goods.

3. Joint Sectoral Committee

3.1. A combined Joint Sectoral Committee for this Sectoral Annex and the Electromagnetic Compatibility (EMC) Sectoral Annex is hereby established (the JSC). The JSC shall operate during the transitional period and after completion of the transitional arrangement. The JSC shall meet as appropriate to discuss technical, conformity assessment and technology issues relating to this Sectoral Annex and the EMC Sectoral Annexes. The JSC shall determine its own rules of procedure.

3.2. The JSC consists of representatives of the US and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the US shall have one vote in the JSC. The representatives of the EC shall have one vote in the JSC. Decisions of the JSC shall be made by unanimous consent. In the event of disagreement either the US or EC representative may raise the matter in the Joint Committee.

3.3. The JSC may address any matter related to the effective functioning of this Sectoral Annex, including:

(a) providing a forum for discussion of issues and resolving problems that may arise concerning the implementation of this Sectoral Annex;

(b) developing a mechanism for ensuring consistency of interpretations of legislation, regulations, standards, and conformity assessment procedures;

(c) advising the Parties on matters relating to this Sectoral Annex; and

(d) providing guidance and, if necessary, developing guidelines during the transitional period to facilitate the successful completion of the transitional period.

4. Contact point

Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other Party regarding procedures, regulations, and complaints under this Sectoral Annex.

5. Regulatory changes and updating the Sectoral Annex

In the event that there are changes to the legislative, regulatory, and administrative provisions referenced in Section I or the introduction of new legislative, regulatory, and administrative provisions affecting either Party's conformity assessment procedures under the Agreement, such changes shall take effect for the purpose of this Sectoral Annex at the same time they take effect domestically within the territory of each Party. The parties shall update this Sectoral Annex to reflect the changes.

SECTION VIII

TRANSITIONAL ARRANGEMENT

1. There shall be a transitional period of 24 months.

2. The purpose of this transitional arrangement is to provide a means whereby the Parties to the Agreement can build confidence in and an understanding of each other's system for designating and listing conformity assessment bodies and in the ability of these bodies to test and certify products. Successful completion of the transitional arrangement should result in the determination that conformity assessment bodies listed in Section V comply with the applicable criteria and are competent to conduct conformity assessment activities on behalf of the other Party. Upon successful completion of the transition period, the results of conformity assessment procedures performed by the exporting Party's conformity assessment bodies listed in Section V of the exporting country shall be accepted by the importing Party.

3. This transitional period shall be used by the Parties:

(a) to consider new legislative changes needed to support the objectives of the Agreement;

(b) to initiate regulatory changes needed to support the objectives of the Agreement;

(c) to exchange information on and develop better understanding of their respective regulatory requirements;

(d) to develop mutually agreed mechanisms for exchanging information on changes in technical requirements or methods of designating conformity assessment bodies; and

(e) to monitor and evaluate the performance of the listed conformity assessment bodies during the transitional period.

4. Parties may designate, list, suspend and withdraw conformity assessment bodies during the transitional period according to the procedures in Section VI of this Sectoral Annex.

5. During the transitional period each Party shall accept and evaluate test reports and related documents issued by designated conformity assessment bodies of the other Party. To this end, the Parties shall ensure that:

(a) on receipt of tests reports, related documents and a first evaluation of conformity, the dossiers are promptly examined for completeness;

(b) the applicant is informed in a precise and complete manner of any deficiency;

(c) any request for additional information is limited to omissions, inconsistencies or variances from the technical regulations or standards; and

(d) procedures for assessing the conformity for equipment, modified subsequent to a determination of compliance, are limited to procedures necessary to determine continued conformance.

6. Each Party ensures that issuance of approvals, certificates, or advice to the applicant shall be given no later than six weeks from receipt of the test report and evaluation from a designated conformity assessment body in the territory of the other Party.

7. Any proposal made during or at the end of the transitional period to limit the scope of recognition of any designated conformity assessment body or to exclude it from the list of bodies designated under this Sectoral Annex shall be based on objective criteria and documented. Any such body may apply for reconsideration once the necessary corrective action has been taken. To the extent possible, the Parties shall implement such action prior to the expiry of the transitional period.

8. The Parties may jointly sponsor two seminars, one in the US and one in the European Community, concerning the relevant technical and product approval requirements during the first year after this Sectoral Annex enters into force.

▼M1 —————

▼B

Appendix 1

Lists of acronyms and glossary

ACTE Approvals Committee for Terminal Equipment

ADLNB Association of Designated Laboratories and Notified Bodies

CAB Conformity Assessment Body

CFR U.S. Code of Federal Regulations, Title 47 CFR

CTR Common Technical Regulation

EC European Community

EEC European Economic Community

EN Norme Européenne (European Standard)

EU European Union

FCC Federal Communications Commission

IEC International Electrotechnical Commission

ISDN Integrated Services Digital Network

ISO International Standards Organization

ITU International Telecommunications Union

MRA Mutual Recognition Agreement

MS Member States (of the European Union)

NB Notified Bodies

NIST National Institute of Standards and Technology

OJ Official Journal (of the European Union)

ONP Open Network Provision

PSTN Public Switched Telephone Network

STG Sectoral Technical Group for Telecommunications

TBR Technical Basis for Regulation

X21 ITU-T Recommendation X21

X25 ITU-T Recommendation X25

SECTORAL ANNEX FOR ELECTROMAGNETIC COMPATIBILITY (EMC)

PREAMBLE

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of Conformity Assessment between the United States and the European Community.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS







EC USA Council Directive 89/336/EEC, as amended by Council Directive 92/31/EEC, and Directive 98/13/EC of the European Parliament and of the Council and interpretation thereof. Communications Act of 1934, as amended by the Telecommunication Act of 1996, (Title 47 of the United States Code), The US regulatory and administrative provisions in respect of equipment subject to electromagnetic requirements including: — 47 CFR Part 15 — 47 CFR Part 18, and FCC interpretation thereof. For electrical safety aspects see Electrical Safety Sectoral Annex to the Agreement. For electrical safety aspects see Electrical Safety Sectoral Annex to the Agreement. For telecommunication equipment and radio transmitters, see also Telecommunication Equipment Sectoral Annex to the Agreement. For telecommunication equipment and radio transmitters, see also Telecommunication Equipment Sectoral Annex to the Agreement.

SECTION II

SCOPE AND COVERAGE







US access to the EC market EC access to the US market Any product falling under the scope of Council Directive 89/336/EEC. Any products falling under the scope of 47 CFR Part 15 and 18.

SECTION III

CONFORMITY ASSESSMENT PROCEDURES FOR EQUIPMENT IDENTIFIED IN SECTION II

1. Description of Mutual Recognition Obligations

In accordance with the provisions of the Agreement, the results of the conformity assessment procedures produced by a Party's conformity assessment bodies listed in Section V, shall be recognised by the Regulatory Authorities of the other Party without any further conformity assessment of the products, pursuant to Section I.

2. Conformity Assessment Procedures

Taking into account the legislative, regulatory, and administrative provisions as identified in Section I, each Party recognises that the conformity assessment bodies of the other Party, listed in Section V, are authorised to perform the following procedures with regard to the importing Party's technical requirements for equipment identified in Section II:

(a) testing and issuing of the test reports,

(b) issuing certificates of conformity to the requirements of the laws and regulations applicable in the territories of the Parties for products covered under this Sectoral Annex.

SECTION IV

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V







EC USA — Belgium — Ministère des Affaires Economiques — Ministerie van Economische Zaken — Denmark — for telecommunication equipment: — Telestyrelsen — for other equipment: — Danmarks Elektriske Materielkontrol (DEMKO) — Germany — Bundesministerium für Wirtschaft — Greece — Yπουργείο Μεταφορών και Επικοινωνιών — Ministry of Transport and Communications — Spain — for telecommunication equipment: — Ministerio de Fomento — for other equipment: — Ministerio de Industria y Energía — France — Ministère de l'économie, des finances et de l'industrie — Ireland — Department of Transport, Energy and Communications — Italy — Ministero dell'Industria, del Commercio e dell'Artigianato — Luxembourg — Ministère des Transports — Netherlands — De Minister van Verkeer en Waterstaat — Austria — for telecommunication equipment: — Bundesministerium für Wissenschaft und Verkehr — for other equipment: — Bundesministerium für wirtschaftliche Angelegenheiten — Portugal — Instituto das Comunicações de Portugal — Finland — for telecommunication equipment: — LiikennemimsteriöTrafikministeriet — for other equipment: — Kauppa- ja teollisuusministeriöHandels- och industriministeriet — Sweden — Under the authority of the Government of Sweden: — Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kingdom — Department of Trade and Industry National Institute for Standards and Technology (NIST) Federal Communications Commission (FCC) Federal Aviation Administration (FAA)

SECTION V

CONFORMITY ASSESSMENT BODIES







EC access to the US market US access to the EC market Conformity assessment bodies located in the EC shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. Conformity assessment bodies located in the US shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex. ►M2

TÜV Österreich

Deutschstrasse, 10

A-1230 Wien

Tel. (43-1) 61 09 10

Fax (43-1) 610 91 89

Radio Frequency Technologies Ltd

40, Marrowbone Lane

Dublin 8, Ireland

Tel. (353-1) 454 53 23

Fax (353-1) 454 53 24

KEMA Registered Quality BV

Postbus 9035

6800 ET Arnhem

The Netherlands

Tel. (31-26) 356 34 17

Fax (31-26) 351 01 78

Philips Consumer Electronics BV

PO Box 80002

5600 JB Eindhoven

The Netherlands

Tel. (31-40) 273 26 39

Fax (31-40) 273 61 77

Telefication BV — KTL

PO Box 60004

6800 JA Arnhem

The Netherlands

Tel. (31-26) 378 07 80

Fax (31-26) 378 07 89

CEIS

Carretera de Villaviciosa de Odón a Móstoles, Km. 1,700

Apartado 233

E-28930 Mostóles — Madrid

Tel. (34) 916 16 00 18

Fax (34) 916 16 23 72

CETECOM

Parque Tecnológico de Andalucía. c/Severo Ochoa s/n

E-29590 Campanillas — Málaga

Tel. (34) 952 61 91 05

Fax (34) 952 61 91 13

INTA

Carretera de Ajalvir, Km. 4

E-28850 Torrejón de Ardoz — Madrid

Tel. (34) 915 20 21 25

Fax (34) 915 20 20 21

LABEIN

Cuesta de Olaveaga, 16

E-48013 Bilbao — Vizcaya

Tel. (34) 944 89 26 00

Fax (34) 944 89 24 95

LCOE

c/José Gutiérrez Abascal, 2

E-28006 Madrid

Tel. (34) 915 62 51 16

Fax (34) 915 61 88 18

LGAI

Ctra de acceso a la Facultad de Medicina UAB

E-08290 Cerdanyola del Vallès — Barcelona

Tel. (34) 936 91 92 11

Fax (34) 936 91 59 11

Telub AB

Box 360

S-831 25 Östersund

Tel. (46-63) 15 60 00

Fax (46-63) 15 61 99

Swedish National Testing and Research Institute (SP)

Box 857

S-501 15 Borås

Tel. (46-33) 16 50 00

Fax (46-33) 13 55 02

BSI Testing

Maylands Avenue

Hemel

Hempstead Herts HP2 4SQ

United Kingdom

Tel. (44-1442) 23 04 42

Fax (44-1231) 23 14 42 ►M21 ◄

EMC Projects

Holly Grove Farm/Verwood Road/Ashley Ringwood

Hampshire BH24 2DB

United Kingdom

Tel. (44-1425) 47 99 79

Fax (44-1425) 48 06 37

Hursley EMC Services Ltd

Unit 16/Brickfiel Lane

Chandlers Ford

Hampshire SO53 4DP

United Kingdom

Tel. (44-1703) 27 11 11

Fax (44-1703) 27 11 44

Radio Frequency Investigations Ltd

Ewhurst Park

Ramsdell Basingstoke

Hampshire RG26 5RQ

United Kingdom

Tel. (44-1256) 85 11 93

Fax (44-1256) 85 11 92

TRL EMC

Long Green

Forthampton

Tewkesbury

Gloucestershire GL19 4QH

United Kingdom

Tel. (44-1684) 83 38 18

Fax (44-1684) 83 38 58

TUV Product Service

Segensworth Road

Titchfield

Fareham

Hampshire PO15 5RH

United Kingdom

Tel. (44-1329) 44 33 00

Fax (44-1329) 44 34 22

A D Compliance Services Ltd

1, Hilton Square

Pendlebury

Manchester M27 4DB

United Kingdom

Tel. (44-161) 727 66 19

Fax (44-161) 727 85 67

Celestica

Westfields House

West Avenue Kidsgrove

Stoke-on-Trent Staffs.. ST7 1TL

United Kingdom

Tel. (44-1782) 79 48 48

Fax (44-1782) 78 42 10

BABT Product Services Ltd

Segensworth Road

Fareham

Hampshire PO15 5RH

United Kingdom

Tel. (44-1932) 25 12 00

Fax (44-1932) 25 12 01

KTL

Saxon Way — Priory Park West

Hull

Humberside HU13 9PB

United Kingdom

Tel. (44-1482) 80 18 01

Fax (44-1482) 80 18 06

Motor Industry Research Association

Watling Street

Nuneaton

Warwickshire CV 10 0TU

United Kingdom

Tel. (44-1203) 35 50 00

Fax (44-1203) 35 53 55 ◄ ►M3

Alcatel Espana SA

C/Ramírez de Prado 5

E-28045 Madrid

Tel. (34) 913 30 44 55

Fax (34) 913 30 56 52

EMCEC Oy

PO Box 19

FIN-02601 Espoo

Tel. (358) 42 45 45 41

Fax (358) 42 45 45 43 22

SGS Fimko Ltd

PO Box 30

FIN-00211 Helsinki

Tel. (358-9) 69 63 61

Fax (358-9) 696 32 61 ◄ ►M4

AEMC Mesure

665, rue de la Maison Blanche

F-78680 Orgeval

Tel. (33) 1 39 75 22 22

Fax (33) 1 39 75 97 46

Z.I. Mi-plaine

7, rue Georges Melies

F-69680 Chassieu

Tel: (33) 4 78 40 66 55

Fax: (33) 4 72 47 00 39

Emitech

3, rue des Coudriers

Z.A. de l'Observatoire

F-78180 Montigny-le-Bretonneux

Tel. (33) 1 30 57 45 12

Fax (33) 1 30 43 48 00

15, rue de la Claie

Z.I. Angers-Beaucouzé

F-4970 Beaucouzé

3, rue du Massacan

Z.I. Vallée du Salaison

F-34740 Vendargues

Utac

BP 312

Autodrome de Linas-Monthéry

F-91311 Monthéry cedex

Tel. (33) 1 69 80 17 90

Fax (33) 1 69 80 17 09 ►M8 ◄

NCE

19, rue François Blumet

Z.I. de l'Argentière

F-38360 Sassenage

Tel. (33) 4 76 27 83 83

Fax (33) 4 76 27 77 00 ◄ ►M6

Compliance Engineering Ireland Ltd

Rayston

Rathoath Road

Ashourne

County Meath

Ireland

Tel. (353-1) 825 67 22

Fax (353-1) 825 67 33

SGS United Kingdom

International Electrical Approvals

South Industrial Estate

Bowburn

County Durham DH6 5AD

United Kingdom

Tel. (44-191) 377 20 00

Fax (44-191) 377 20 20

York EMC Services Ltd

Department of Electronics

University of York

Heslington

York YO1 5DD

United Kingdom ◄ ►M7

EMI-EMC Laboratory, Alcatel Italia

Via Trento 30

I-20059 Vimercate (MI

Fax (39) 39 686 31 89 ◄ ►M9

ICEM — Laboratoria CEM de la UPV-ETSI

Camino de la Vera, s/n

E-46022 Valencia

Tel. (34) 963 87 73 06

Fax (34) 963 87 73 09

Phoenix Test-Lab GmbH

Königswinkel 10

D-32825 Blomberg

Tel. (49-5235) 95 00 24

Fax (49-5235) 95 00 28

CETECOM

CETECOM ICT Services GmbH

Untertürkheimer Str. 6-10

D-66117 Saarbrücken

Tel. (49-681) 598 87 23

Fax (49-681) 598 90 75

CETECOM GmbH

Im Teelbruch 122

D-45219 Essen

Tel. (49-2054) 951 99 24

Fax (49-2054) 951 99 02

EMCC Dr. Rašek

Moggast

D-91320 Ebermannstadt

Tel. (49-9194) 90 16

Fax (49-9194) 81 25 ◄ ►M10

TCC Tampere

P.O. Box 68(Sinitaival 5)FIN-33720

Tel. (358) 718 00 80 00

Fax (358) 718 04 68 80 ◄ ►M11

Fujitsu Siemens Computers GmbH

Center for Tests and Compliance

Buergermeister Ulrich-Str. 100

D-86199 Augsburg

Tel. (49-821) 804 21 60

Fax (49-821) 804 26 75

Obering. Berg & Lukowiak GmbH

Löher Str. 157

D-32609 Hüllhorst

Tel. (49-5744) 13 37

Fax (49-5744) 28 90

Siemens A&D ATS 6

EMC Center

Paul-Gossen-Str. 100

D-91052 Erlangen

Tel. (49-9131) 73 14 53

Fax (49-9131) 72 50 07

ALCATEL Laboratory

Francis Wellesplein 1

B-2018 Antwerpen

Tel. (32-3) 240 40 11

Fax (32-3) 240 99 99

Laboratoria DE NAYER

Jan De Nayerlaan 3

B-2860 Sint-Katelijne-Waver

Tel. (32-15) 31 33 22

Fax (32-15) 31 74 53 ◄ ►M13

Samsung Euro QA Lab (SEQAL)

Blackbushe Business Park

Saxony Way

Yateley

Hampshire

GU46 6GG

United Kingdom

Tel. (44-1252) 86 38 00

Fax (44-1252) 86 38 14 ◄ ►M17

TILAB, Telecom Italia Lab SpA

TILAB-LAP (EMC Center)

Via G. Reiss Romoli, 274

I-10148 Torino

Tel. (39) 112 28 52 99

Fax (39) 112 28 75 40 ◄ ►M18

TÜV Italia srl

Via Bettola, 32

I-20092 Cinisella Balsamo (MI)

Tel. (39) 125 52 54 00

Fax (39) 125 52 54 99

NEMKO SpA

Via Trento e Trieste, 116

I-20046 Biassono (MI)

Tel. (39) 392 20 12 01

Fax (39) 392 75 32 40 ◄ ►M19

E.S.M. (Dep Pioneer)

Joseph Cardijnstraat 31

B-9420 Erpe-Mere

Tel: (32-53) 82 13 12

Fax: (32-53) 82 13 00 ◄ ►M20

BZT-ETS Certification GmbH

Storkower Str. 38 c

D-15526 Reichenwalde

Tel: (49-33631) 88 82 22

Fax: (49-33631) 88 86 80 ◄ ►M22

EMCE GmbH

Laupheimer Str. 25d

D-88483 Burgrieden

Tel. (49 7392) 91 13 70

Fax (49 7392) 91 13 72

EMV TESTHAUS GmbH

Gustav-Hertz-Straße 35

D-94315 Straubing

Tel. (49 9421) 92 30 33

Fax (49 9421) 92 30 35 ◄ ►M24

GYL Technologies

Parc d’activités de Lanserre

21, rue de la Fuye

F-49610 Juigné-sur-Loire

Tel: (33 2) 41 57 57 40

Fax: (33 2) 41 45 25 77 ◄ ►M25

D.A.R.E. Consultancy BV

Vijzelmolenlaan 7

3447 GX Woerden

Netherlands

Tel. (31) 348 430 979

Fax (31) 348 430 645 ◄ ►M26

IMQ — Istituto Italiano del Marchio di Qualità

Via Quintiliano, 43

I-20138 MILANO

Tel.: +39 02 5073 392

Fax: +39 02 5099 1509 ◄ ►M27

TÜV Rheinland-EPS BV

Smidshornerweg 18

9822 ZG Niekerk

NETHERLANDS

Bicon Laboratories BV (BICON)

Waterdijk 3A, 5705 CW Helmond

PO box 118, 5700 AC Helmond

NETHERLANDS

SIQ – Slovenian Institute of Quality and Metrology

Tržaška cesta 2

SI-1000 Ljubljana

SLOVENIA ◄ ►M28

ALTER TECHNOLOGY TÜV NORD, S.A.U.

ATN EC

Emilia Santiago & Jorge Berkowitsch

C/la Majada, 3

28760 — Tres Cantos (Madrid)

SPAIN

M. DUDDE HOCHFREQUENZ-TECHNIK

Rottland 5a

51429 — Bergisch Gladbach

GERMANY ◄ ►M29

INTEL MOBILE COMMUNICATIONS France S.A.S.

425 Rue de Goa, Le Cargo Bat. B6

Zone des 3 Moulins

Antibes, 06600

FRANCE ◄ ►M31

PRIMA RICERCA & SVILUPPO S.r.l.

via Campagna, 92

I-22020 Faloppio (Como)

ITALY ◄ ►M32

AT4 wireless S.A.U.

Parque Tecnológico de Andalucía

C/Severo Ochoa 2 y 6

29590 Málaga

SPAIN ◄ ►M33

Intertek Deutschland GmbH.

Innovapark 20

87600 Kaufbeuren

GERMANY ◄ ►M34

TÜV RHEINLAND ITALIA S.R.L.

via E. Mattei, 3

20010 Pogliano Milanese

ITALY ◄ ►M35

DELTA Development Technology AB

Finnslätten, Elektronikgatan 47

721 35 Västerås

SWEDEN ◄ ►M36

7layers GmbH

Borsigstrasse 11

40880 Ratingen

GERMANY ◄ ►M2

3M Product Safety EMC Laboratory

410 E. Filmore Avenue

St Paul, Minnesota 55144-1000

USA

Tel. (1-612) 778 63 36

Fax (1-612) 778 62 52

Acme Testing, Inc.

PO Box 3, 2002 Valley Highway

Acme, Washington 98220-0003

USA

Tel. (1-360) 595 27 85

Fax (1-360) 595 27 22

CKC Laboratories, Inc.

5473 A. Clouds Rest

Mariposa, California 95338

USA

Tel. (1-209) 966 52 40

Fax (1-209) 742 61 33

110 Olinda Place

Brea, California 92621

USA

1100 Fulton Place

Fremont, California 92621

USA

1653 Los Viboras Road

Hollister, California 95023

USA

5289 NE Elam Young Parkway

Suite G-900

Hillsboro, Oregon 97124

USA

22105 Wilson River Highway

Tillamook, Oregon 97141

USA

14797 NE 95th Street

Redmond, Washington 98052

USA

Communication Certification Laboratory

1940 West Alexander Street

Salt Lake City, Utah 84119-2039

USA

Tel. (1-801) 972 61 46

Fax (1-801) 972 84 32

Compatible Electronics, Inc.

114 Olinda Drive

Brea, California 92823

USA

2337 Troutdale Drive

Agoura, California 91301

USA

Tel. (1-714) 579 18 50

Fax (1-714) 579 18 50

Curtis-Straus LLC

527 Great Road

Littleton, Massachusetts 01460

USA

Tel. (1-978) 486 88 80

Fax (1-978) 486 88 28

DLS Electronic Systems, Inc.

1250 Peterson Drive

Wheeling, Illinois 60090-6454

USA

Tel. (1-847) 537 64 00

Fax (1-847) 537 64 88

Dell Regulatory Test Laboratories

One Dell Way, MS 6201

Round Rock, TX 78682

USA

Tel. (1-512) 728 73 80

Fax (1-512) 728 56 47

Elite Electronic Engineering, Inc.

1516 Centre Circle

Downers Grove, Illinois 60515-1082

USA

Tel. (1-630) 495 97 70

Fax (1-630) 495 97 85

Elliott Laboratories Inc.

684 West Maude Avenue

Sunnyvale, California 94086-3518

USA

Tel. (1-408) 245 78 00

Fax (1-408) 245 34 99

Instrument Specialties Company, Inc.

PO Box 650

Shielding Way

Delaware Water Gap, Pennsylvania 18327-0136

USA

Tel. (1-570) 424 85 10

Fax (1-570) 421 42 27

Intertek Testing Services

24 Groton Avenue

Cortland, New York 13045

USA

Tel. (1-607) 758 63 36

Fax (1-607) 756 66 99

(Cortland serves as point of contact only)

70 Codman Hill Road

Boxborough, Massachusetts 01719

USA

7250 Hudson Boulevard, Suite 100

Oakdale, Minnesota 55128

USA

1950 Evergreen Boulevard, Suite 100

Deluth, Georgia 30096

USA

1365 Adams Court

Menlo Park, California 94025

USA

L.S. Compliance Inc.

W66 N220 Commerce Court

Cedarburg, Wisconsin 53012-2636

USA

Tel. (1-262) 375 44 00

Fax (1-262) 375 42 48

M. Flom Associates, Inc.

3356 North San Marcos Place, Suite 107

Chandler, Arizona 85225-7176

USA

Tel. (1-480) 926 31 00

Fax (1-480) 926 35 98

MET Laboratories, Inc.

914 West Patapsco Avenue

Baltimore, Maryland 21230-3432

USA

Tel. (1-410) 354 33 00

Fax (1-410) 354 33 13

Motorola SSG EMC/Tempest Laboratory

8201 E. McDowell Road

Scottsdale, Arizona 85252

USA

Tel. (1-602) 441 31 38

Fax (1-602) 441 36 25

National Technical Systems (NTS)

533 Main Street

Acton, Massachusetts 01720

USA

(Acton serves as point of contact only)

1146 Massachusetts Avenue

Boxborough, Massachusetts 01719

USA

1701 East Plano Parkway, Suite 150

Plano, Texas 75074

USA

1536 East Valencia Drive

Fullerton, California 92831

USA

Tel. (1-978) 263 29 33

Fax (1-978) 263 57 34

PCTEST Engineering Laboratory, Inc.

6066-B Dobbin Road

Columbia, Maryland 21045-4708

USA

Tel. (1-410) 290 66 52

Fax (1-410) 290 66 54

Quest Engineering Solutions, Inc.

7 Sterling Road

N. Billerica, Massachusetts 01862

USA

Tel. (1-978) 667 70 00

Fax (1-978) 667 33 88

Rhein Tech Laboratories, Inc.

360 Herndon Parkway, Suite 1400

Herndon, Virginia 20170-4824

USA

Tel. (1-703) 689 03 68

Fax (1-703) 689 20 56

Underwriters Laboratories

333 Pfingsten Road

Northbrook, lllinois 60062-2096

USA

Tel. (1-847) 272 88 80 ×43281

Fax (1-847) 509 63 21

2600 NW Lake Road

Camas, Washington 98607-8542

USA

1285 Walt Whitman Road

Melville, New York 11747-3081

USA

12 Laboratory Drive

Research Triangle Park, North Carolina 27709

USA

1655 Scott Boulevard

Santa Clara, California 95050

USA

Washington Laboratories, Ltd

7560 Lindbergh Drive

Gaithersburg, Maryland 20879

USA

Tel. (1-301) 417 02 20

Fax (1-301) 417 90 69

Wyle Laboratories

7800 Highway 20 West

Huntsville, Alabama 35806

USA

Tel. (1-256) 837 44 11

Fax (1-256) 830 21 09 ◄ ►M3

Retlif Testing Laboratories

795 Marconi Avenue

Ronkonkoma, New York 11779

USA

Tel. (1-631) 737 15 00

Fax (1-631) 737 14 97

Analab L.L.C.

PO Box 34

Spring Hill Road

Sterling, Pennsylvania 18463

USA

Tel. (1-570) 689 39 19

Fax (1-570) 689 93 60

Integrity, Testing & Design, an Entela Company

37-7 Ayer Road

Littleton, Massachusetts 01460

USA

Tel. (1-616) 248 96 08

Fax (1-616) 247 75 27

Compliance Certification Services, Inc.

561F Monterey Road

Morgan Hill, California 95037

USA

Tel. (1-408) 463 08 85

Fax (1-408) 463 08 88

Northwest EMC, Inc.

22975 NW Evergreen Parkway, Suite 400

Hillsboro, Oregon 97124

USA

Tel. (1-503) 844 40 66

Fax (1-503) 844 38 26 ◄ ►M6

TÜV Rheinland of North America, Inc.

12 Commerce Road

Newtown, Connecticut 06470-1607

USA

Tel: (1-203) 426 08 88

Fax (1-203) 270 88 83 ◄ ►M7

TÜV Product Service, a Division of TÜV America Inc.

1775 Old Highway 8, NW

Suite 104

New Brighton, Minnesota 55112-1891

USA

Tel. (1-651) 638 02 44

Fax (1-651) 638 02 85

5541 Central Avenue

Boulder, Colorado 80301-2846

USA

10040 Mesa Rim Road

San Diego, California 92121-1034

USA ◄ ►M12

TIMCO Engineering, Inc.

849 NW State Road 45

P.O. Box 370

Newberry, Florida 32669

USA

Tel. (1-352) 472 55 00

Fax (1-352) 472 20 30 ◄ ►M16

Compatible Electronics, Inc.

Site at:

19121 El Toro Road

Silverado/Lake Forest, California 92676

USA

Tel. (1-714) 579 05 00

Fax (1-714) 579 18 50

Test Site Services, Inc.

PO box 766

Marlboro, Massachusetts 01752

USA

Tel. (1-508) 481 16 84

Fax (1-508) 481 16 84 ◄

SECTION VI

DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V







EC access to the US market US access to the EC market EC Authorities identified in Section IV shall designate conformity assessment bodies located in the EC in accordance with the US legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based upon compliance with the appropriate ISO/IEC Guides (e.g. Guide 22, 25, 28, 58, 61, 62, 65, etc.) or the comparable EN-45000 Series Standards. US Authorities identified in Section IV shall designate conformity assessment bodies located in the US in accordance with the EC legislative, regulatory, and administrative provisions identified in Section I that govern designation of conformity assessment bodies, based on compliance with the appropriate EN-45000 Series Standards or the comparable ISO/IEC Guides (e.g. Guide 22, 25, 28, 58, 61, 62, 65, etc.). Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9, and 10 of the Agreement. Procedures for designating, listing, suspending, withdrawing, and monitoring a conformity assessment body listed in Section V shall be undertaken pursuant to Articles 7, 8, 9, and 10 of the Agreement.

SECTION VII

ADDITIONAL PROVISIONS

1. Sub-contracting

1.1. Any sub-contracting by conformity assessment bodies shall be in accordance with the sub-contracting requirements of the other Party. Notwithstanding the use of sub-contracting, the final results of conformity assessment remain the full responsibility of the listed conformity assessment body. In the EC, these requirements are described in Council Directive 93/465/EEC.

1.2. The conformity assessment bodies shall record and retain details of its investigation of the competence and compliance of its sub-contractors and maintain a register of all sub-contracting. These details will be available to the other Party on request.

2. Post-market surveillance, border measures and internal movement

2.1. For the purpose of post-market surveillance, the Parties may maintain any existing labeling and numbering requirements. The assignment of the numbers may take place in the territory of the exporting Party. The numbers will be allocated by the importing Party. Numbering and labeling systems shall not introduce additional requirements within the meaning of this Sectoral Annex.

2.2. Nothing in this Sectoral Annex shall prevent the Parties from removing products from the market that do not in fact conform to the requirements for approval.

2.3. The Parties agree that border inspections and checks of products which have been certified, labeled or marked as conformity with the importing Party's requirements specified in Section I shall be completed as expeditiously as possible. With regard to any inspections related to internal movement within their respective territories, the Parties agree that these shall be completed in no less a favorable manner than for like domestic goods.

3. Joint Sectoral Committee

3.1. A combined Joint Sectoral Committee for this Sectoral Annex and the Telecommunications Equipment Sectoral Annex is hereby established (the JSC). The JSC shall operate during the transitional period and after completion of the transitional arrangement. The JSC shall meet as appropriate to discuss technical, conformity assessment and technology issues relating to this Sectoral Annex and the Telecommunications Equipment Sectoral Annex. The JSC shall determine its own rules of procedure.

3.2. The JSC consists of representatives of the US and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the US shall one vote in the JSC. The representatives of the EC shall have one vote in the JSC. Decisions of the JSC shall be made by unanimous consent. In the event of disagreement either the US or EC representatives may raise the matter in the Joint Committee.

3.3. The JSC may address any matter related to the effective functioning of this Sectoral Annex, including:

(a) providing a forum for discussion of issues and resolving problems that may arise concerning the implementation of this Sectoral Annex;

(b) developing a mechanism for ensuring consistency of interpretations of legislation, regulations, standards, and conformity assessment procedures;

(c) advising the Parties on matters relating to this Sectoral Annex;

(d) providing guidance and, if necessary, developing guidelines during the transitional period to facilitate the successful completion of the transitional period.

4. Contact point

Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other Party regarding procedures, regulations and complaints under this Sectoral Annex.

5. Regulatory changes and updating the Sectoral Annex

In the event that there are changes to the legislative, regulatory and administrative provisions referenced in Section I or the introduction of new legislative, regulatory and administrative provisions affecting either Party's conformity assessment procedures under the Agreement, such changes shall take effect for the purpose of this Sectoral Annex at the same time they take effect domestically within the territory of each Party. The Parties shall update this Sectoral Annex to reflect the changes.

SECTION VIII

TRANSITIONAL ARRANGEMENT

1. There shall a transitional period of 24 months.

2. The purpose of this transitional arrangement is to provide a means whereby the Parties to the Agreement can build confidence in and understanding of each others system for designating and listing conformity assessment bodies and in the ability of these bodies to test and certify products. Successful completion of the transition arrangement should result in the determination that conformity assessment bodies listed in Section V comply with the applicable criteria and are competent to conduct conformity assessment activities on behalf of the other Party. Upon completion of the transition period, the results of conformity assessment procedures performed by the exporting Party's conformity assessment bodies listed in Section V shall be accepted by the importing Party.

3. This transitional period shall be used by the Parties:

(a) to consider new legislative changes needed to support the objectives of the Agreement;

(b) to initiate regulatory changes needed to support the objectives of the Agreement;

(c) to exchange information on and develop better understanding of their respective regulatory requirements;

(d) to develop mutually agreed mechanisms for exchanging information on changes in technical requirements or methods of designating conformity assessment bodies; and

(e) to monitor and evaluate the performance of the listed conformity assessment bodies during the transitional period.

4. Parties may designate, list, suspend and withdraw conformity assessment bodies during the transitional period according to the procedures in Section VI of this Sectoral Annex.

5. During the transitional period each Party shall accept and evaluate test reports and related documents issued by designated conformity assessment bodies of the other Party. To this end, the Parties shall ensure that:

(a) on receipt of test reports, related documents and a first evaluation of conformity, the dossiers are promptly examined for completeness;

(b) the applicant is informed in a precise and complete manner of any deficiency;

(c) any request for additional information is limited to omissions, inconsistencies or variances from the technical regulations or standards;

(d) procedures for assessing the conformity for equipment modified subsequent to a determination of compliance, are limited to procedures necessary to determine continued conformance.

6. Each Party ensures that issuance of approvals, certificates or advice to the applicant shall be given no later than six weeks from receipt of the test report and evaluation from a designated conformity assessment body in the territory of the other Party.

7. Any proposal made during or at the end of the transitional period to limit the scope of recognition of any designated conformity assessment body or to exclude it from the list of bodies designated under this Sectoral Annex shall be based on objective criteria and documented. Any such body may apply for reconsideration once the necessary corrective action has been taken. To the extent possible, the Parties shall implement such action prior to the expiry of the transitional period.

8. The Parties may jointly sponsor two seminars, one in the US and one in the European Community, concerning the relevant technical and product approval requirements during the first year after this Sectoral Annex enters into force.

▼M1 —————

▼B

SECTORAL ANNEX FOR ELECTRICAL SAFETY

PREAMBLE

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Community.

SECTION I

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS







US access to the EC market EC access to the US market Council Directive 73/23/EEC of 19 February 1973 as amended by Directive 98/13/EC of the European Parliament and of the Council. 29 USC 651 et seq. US 29 CFR 1910.7 Products that are certified or approved under the Federal Mine Safety and Health Act (30 USC 801 et seq.) or its regulations and used in areas under the authority of the Mine Safety and Health Administration, are not covered under this Annex. Occupational Safety and Health Administration (OSHA) will consider regulatory and legislative changes needed to support the objectives of the MRA. For medical devices, see the Medical Devices Sectoral Annex to this Agreement. For medical devices, see the Medical Devices Sectoral Annex to this Agreement. For electromagnetic compatibility aspects, see the Electromagnetic Compatibility (EMC) Sectoral Annex to this Agreement. For electromagnetic compatibility aspects, see the Electromagnetic Compatibility (EMC) Sectoral Annex to this Agreement. For telecommunication equipment, see the Telecommunication Equipment Sectoral Annex to this Agreement. For telecommunication equipment, see the Telecommunication Equipment Sectoral Annex to this Agreement.

SECTION II

SCOPE AND COVERAGE







US access to the EC market EC access to the US market The electrical safety requirements of products falling under the scope of Council Directive 73/23/EEC on the harmonisation of the laws of the Member States relating to electrical equipment designed or use within certain voltage limits. The electrical safety requirements of products falling under the scope of 29 CFR 1910 subpart S. This includes the electrical safety aspects for workplace safety of medical equipment and telecommunication terminal equipment within the scope of those Sectoral Annexes. Products that are certified or approved under the Federal Mine Safety and Health Act (30 USC 801 et seq.) or its regulations and used in areas under the authority of the Mine Safety and Health Administration, are not covered under this Annex.

SECTION III

DESCRIPTION OF MUTUAL RECOGNITION OBLIGATIONS

In accordance with the provisions of the Agreement, EC conformity assessment bodies listed in Section V of this Annex shall be recognised to test, certify and mark products within the scope of their Nationally Recognised Testing Laboratory (NRTL) recognition for assessing conformity to US requirements.

With regard to US conformity assessment bodies listed in Section V of this Annex, in the event of a challenge within the European Community under Article 8(2) of Council Directive 73/23/EEC of 19 February 1973, test reports issued by such conformity assessment bodies shall be accepted by the European Community Authorities in the same way that reports from European Community notified bodies are accepted. That is, (listed conformity assessment bodies) in the US shall be recognised under Article 11 of Council Directive 73/23/EEC as ‘bodies which may make a report in accordance with Article 8.’

SECTION IV

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V







EC access to the US market US access to the EC market — Belgium — Ministère des Affaires Economiques — Ministerie van Economische Zaken — Denmark — Bygge- og Boligstyrelsen — Danmarks Elektriske Materielkontrol (DEMKO) — Germany — Bundesministerium für Arbeit und Sozialordnung — Greece — Yπουργείο Ανάπτυξης — Ministry of Development — Spain — Ministerio de Industria y Energía — France — Ministère de l'économie, des finances et de l'industrie — Ireland — Department of Enterprise and Employment — Italy — Ministero dell'Industria, del Commercio e dell'Artigianato — Luxembourg — Ministère des Transports — Netherlands — De Minister van Volksgezondheid, Welzijn en Sport National Institute for Standards and Technology (NIST) — Austria — Bundesministerium für wirtschaftliche — Angelegenheiten — Portugal — Under the authority of the Government of Portugal: — Instituto Português da Qualidade — Finland — Kauppa- ja teollisuusministerio/Handels- och industriministeriet — Sweden — Under the authority of the Government of Sweden: — Styrelsen för ackreditering och teknisk kontroll (SWEDAC) — United Kingdom — Department of Trade and Industry

SECTION V

CONFORMITY ASSESSMENT BODIES







EC access to the US market US access to the EC market The names and scope of responsibilities of Conformity Assessment Bodies located in the EC and listed in accordance with this Sectoral Annex: The names and scope of responsibilities of Conformity Assessment Bodies located in the US and listed in accordance with this Sectoral Annex: (to the provided by the EC) (to be provided by the U.S.)

SECTION VI

DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES







EC access to the US market US access to the EC market Conformity assessment bodies from the EC shall be designated by the EC Authorities identified in Section IV and recognised by the Joint Committee, in accordance with the recognition procedures in the Agreement and this Annex. Conformity assessment bodies from the US shall be designated by the US Authority identified in Section IV and recognised by the Joint Committee, in accordance with the recognition procedures in the Agreement and Council Directive 73/23/EEC. Conformance with the appropriate ISO/IEC Guides or the corresponding EN-45000 series of standards shall be deemed consistent with US requirements identified in Section I. Conformance with the appropriate EN-45000 series of standards or the corresponding ISO/IEC Guides shall be deemed consistent with the requirements of Council Directive 73/23/EEC. For purposes of designation and listing, EC Designating Authorities identified in Section IV shall designate conformity assessment bodies located in the EC by filing a properly prepared proposal for listing, which includes a complete lab assessment under the US OSHA procedures. OSHA shall notify the EC Designating Authority normally within 30 days as to whether the proposal is complete or whether additional information is required. For purposes of designating and listing, the US Designating Authority identified in Section IV shall designate conformity assessment bodies located in the US by filing a properly prepared proposal for listing with the EC, which includes a complete lab assessment under the following EC or Member State procedures, as appropriate. OSHA shall rely on the EC Designating Authorities identified in Section IV for conducting on-site reviews at the respective Member States' conformity assessment bodies. The EC shall notify the US Designating Authority within 30 days as to whether the proposal is complete and shall indicate, where applicable, any additional information that is required. Upon receipt of a complete proposal, the US exercising its authority under its law shall: (a) prior to the passage from the transitional phase into the operational phase in the Telecommunication Equipment and Electromagnetic Compatibility (EMC) Sectoral Annexes, give notice of its consent or objection to a proposed conformity assessment body to the Joint Committee. The listing of an agreed conformity assessment body in Section V of this Sectoral Annex shall only occur upon such passage from the transitional phase into the operational phase of those Sectoral Annexes; (b) subsequent to passage from the transitional phase into the operational phase in the Telecommunication Equipment and Electromagnetic Compatibility (EMC) Sectoral Annexes, give notice of its consent or objection to a proposed conformity assessment body to the Joint Committee normally within 120 business days. The listing of an agreed conformity assessment body in Section V of this Sectoral Annex shall occur upon notice of consent to the Joint Committee and the Joint Committee's decision to list such body. These listing procedures shall supersede the procedures in Article 7(c) of the Agreement in its entirety and the time periods set out in Article 7(d) of the Agreement. Upon receipt of a complete proposal, the EC shall give notice of consent or objection to the Joint Committee within 60 days. The Joint Committee shall monitor the recognition of conformity assessment bodies and confirm such a recognition by listing them in Section V of this Sectoral Annex. EC conformity assessment bodies listed in Section V shall have NRTL status in the US. The US conformity assessment bodies listed in Section V shall have Notified Body status within the EC. With regard to the suspension of a conformity assessment body listed in this Sectoral Annex, the period specified in Article 8(e) of the Agreement shall begin to run after a Party has notified the Joint Sectoral Committee or the Joint Committee, pursuant to Article 8(c) of the Agreement, that it proposes to revoke the conformity assessment body's recognition in accordance with its procedures under its applicable domestic law. Except as provided for in this Section, procedures for designation, listing, suspension and withdrawal of conformity assessment bodies under this Sectoral Annex shall be carried out in accordance with Articles 7, 8 and 9 of the Agreement.

SECTION VII

JOINT SECTORAL COMMITTEE FOR ELECTRICAL SAFETY

1. The Joint Sectoral Committee for Electrical Safety (JSC/ES) consists of representatives of the US and the EC. OSHA shall represent the US on this Joint Sectoral Committee. The EC and OSHA may invite the participation of others as deemed necessary. Each Party shall have one vote and decisions shall be made by unanimous consent, unless otherwise specified herein. The Joint Sectoral Committee shall determine its own rules of procedure.

2. The Joint Committee may address any matter related to the effective functioning of this Sectoral Annex, including:

— developing improved procedures and criteria for designation in order to facilitate the assessment and preparation of proposals by Designating Authorities, with a view towards expediting the period between designation and listing;

— providing a forum for discussion of issues that may arise concerning the implementation of this Sectoral Annex;

— advising the Parties on matters relating to this Sectoral Annex; and

— enhancing the operation of this Sectoral Annex.

SECTORAL ANNEX FOR RECREATIONAL CRAFT

PREAMBLE

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Community.

The purpose of this Sectoral Annex is to establish a framework to accept certificates of conformity issued in the territory of one Party in accordance with the regulatory requirements of the other Party as referenced in this Sectoral Annex.

To facilitate that purpose, a transitional period of 18 months is arranged to build confidence as defined in this Sectoral Annex, Section VI.

SECTION I

LEGISLATIVE, REGULATORY, AND ADMINISTRATIVE REQUIREMENTS

1. For the European Community:

Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to recreational craft.

2. For the US:

46 USC Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58.

SECTION II

SCOPE AND COVERAGE

1. This Sectoral Annex applies to all recreational craft which in the European Community or the United States are subject to conformity assessment by a conformity assessment body or an approval procedure, as applicable, before being put on the market.

2. The product coverage for each Party shall be determined by the following relevant requirements:

(a) for the European Community:

Recreational craft as defined in Directive 94/25/EC;

(b) for the United States:

Any product falling under the scope of 46 USC Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58.

3. The Parties agree that for mutual recognition to operate under this Sectoral Annex, the following arrangements shall apply:

(a) for approvals to European Community requirements, conformity assessment bodies designated by the US shall establish compliance as required to be demonstrated by Directive 94/25/EC. This demonstration of compliance shall be recognised in the European Community and products so certified shall have unrestricted access to the EC market for sale as recreational craft, pursuant to Section I;

(b) for approvals to United States requirements, conformity assessment bodies designated by the European Community shall establish compliance as required to be demonstrated as set forth in paragraph 2(b) of this Section, and products so certified shall have unrestricted access to the US market for sale as recreational craft, pursuant to Section I.

SECTION III

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES







EC access to the US market US access to the EC market — Belgium — Ministère des Communications et de l'infrastructure — Ministerie van Verkeer en Infrastructuur — Germany — Bundesministerium für Wirtschaft — Spain — Ministerio de Fomento — France — Ministère de l'Equipment, des Transports et du Logement — Italy — Ministero dell'Industria, del Commercio e dell'Artigianato — Netherlands — De Minister van Verkeer en Waterstaat — Finland — Merenkulkuhallitus/sjöfartsstyrelsen — Sweden — Under the authority of the Government of Sweden: — Styrelsen for ackreditering och teknisk kontroll (SWEDAC) — United Kingdom — Department of Trade and Industry National Institute for Standards and Technology (NIST)

SECTION IV

DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES

1. For the purpose of this Sectoral Annex, each Party shall designate competent conformity assessment bodies to carry out conformity assessment and approval to the requirements of the other Party. Such designation shall be carried out according to the procedures set out in Article 7 of the Agreement. A list of conformity assessment bodies together with the products and procedures for which they have been listed, is set out in Section V below.

2. Each Party agrees that the listed conformity assessment bodies comply with the requirements for such bodies established by the other Party. These are:

(a) for the European Community, bodies which are Notified Bodies in accordance with Directive 94/25/EC, are deemed to be in compliance with US requirements;

(b) for the US, in accordance with the requirements set out in the regulations listed in Section I, the conformity assessment bodies listed in Section V are designated by NIST using the evaluation procedures contained in the appropriate EN-45000 series of standards or the corresponding ISO/IEC Guides.

3. With regard to the designation, listing, suspension and withdrawal of conformity assessment bodies under this Sectoral Annex, the specific procedures in Articles 7, 8 and 9 of the Agreement shall be followed.

SECTION V

CONFORMITY ASSESSMENT BODIES







EC access to the US market US access to the EC market The names and scope of responsibilities of Conformity Assessment Bodies located in the EC and listed in accordance with this Sectoral Annex: The names and scope of responsibilities of Conformity Assessment Bodies located in the US and listed in accordance with this Sectoral Annex: (to be provided by EC) ►M6

Underwriters Laboratories Inc. (UL)

12 Laboratory Drive Research Triangle Park, North Carolina 27709

USA

Tel: (1-847) 272 88 00 ext. 43894

Fax: (1-847) 509 63 21 ◄

SECTION VI

TRANSITIONAL ARRANGEMENT

1. There shall be a transitional period of 18 months prior to the operations of this Sectoral Annex.

2. The purpose of the transitional arrangement is to provide a mean whereby the Parties to this Agreement can cooperate to establish a system for designating conformity assessment bodies and can mutually build confidence in the abilities of these bodies. Successful completion of this transitional arrangement is intended to result in a determination that conformity assessment bodies comply with the applicable criteria and to have the equipment approved by the conformity assessment bodies of the exporting country accepted by the approval authority of the importing country.

3. During this transitional period, the parties shall:

(a) exchange information on technical data and conformity assessment criteria and procedures, thus developing greater familiarity with their respective regulatory requirements; and

(b) carry out or recommend any applicable policy, legislative and regulatory changes necessary for the provisions of this Annex.

4. Product Scope

All products covered by Section II of this Annex.

5. Cooperation

During this transitional period, both Parties shall endeavour to sponsor jointly seminars for the purpose of improving the understanding of technical specifications applicable in each Party's jurisdiction.

6. Inspections

Inspections or audits shall be permitted to verify compliance of conformity assessment bodies with their responsibilities under this Agreement. The scope of these inspections or audits shall be agreed upon in advance by both Parties.

SECTION VII

ADDITIONAL PROVISIONS

1. In accordance with the relevant provisions of the Agreement, the Parties shall ensure the continued availability of the names of their respective notified bodies or conformity assessment bodies, and shall regularly supply details of certifications issued in order to facilitate post market surveillance.

2. The Parties note that, to the extent that requirements for electrical safety or electromagnetic compatibility may apply to products covered by this Sectoral Annex, the provisions of the Sectoral Annexes on Electrical Safety and Electromagnetic Compatibility apply.

SECTION VIII

DEFINITIONS

‘Notified Body’ means a third party authorised to perform the conformity assessment tasks specified in Directive 94/25/EC, which has been appointed by a Member State from the bodies falling within its jurisdiction. The Notified Body has the necessary qualifications to meet requirements laid down in Directive 94/25/EC and has been notified to the Commission and to the other Member States.

▼M30

United States — European Union amended sectoral annex for pharmaceutical good manufacturing practices (GMPS)

PREAMBLE

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Union, amending the Sectoral Annex for Pharmaceutical Good Manufacturing Practices done in 1998.







CHAPTER 1

DEFINITIONS, PURPOSE, SCOPE AND PRODUCT COVERAGE

Article 1

Definitions

For purposes of this Annex:

1. ‘Assessment pursuant to this Annex’ means:

for the European Union (EU), an equivalence assessment; and

for the United States, a capability assessment.

An assessment pursuant to this Annex includes a reassessment.

2. ‘Recognized authority’ means:

for the EU, an equivalent authority; and

for the United States, a capable authority.

3. ‘Capable authority’ means an authority that the Food and Drug Administration (FDA) FDA has determined is capable according to the criteria and procedures specified in Appendix 4 and referred to in the U.S. laws, regulations and administrative provisions listed in Appendix 1. For greater certainty, a finding that a regulatory authority is ‘capable’ does not require that the authority maintain procedures for conducting inspections and overseeing manufacturing facilities that are identical to FDA's procedures.

4. ‘Equivalent authority’ means an authority in respect of which the EU has made a positive equivalence determination according the criteria and procedures specified in Appendix 4 and as referred to in the EU laws, regulations and administrative provisions listed in Appendix 1.

5. ‘Equivalence’ means that the regulatory system under which an authority operates is sufficiently comparable to assure that the process of inspection and the ensuing official GMP documents will provide adequate information to determine whether respective statutory and regulatory requirements of the authorities have been fulfilled. For greater certainty, ‘equivalence’ does not require that the respective