21999A0204(01)

21999A0204(01) 21999A0204(01) Agreement on mutual recognition between the European Community and the United States of America - Joint Declaration Official Journal L 031 , 04/02/1999 P. 0003 - 0080  Dates: of document:   18/05/1998 of effect:   01/12/1998; Entry into force See Art 21 And OJ L 31/99 P. 81 of signature:   18/05/1998; London end of validity:   99/99/9999 Authentic language: The official languages ; German ; English ; Danish ; Spanish ; Finnish ; French ; Greek ; Italian ; Dutch ; Portuguese ; Swedish Author: European Community ; United States of America Subject matter: Commercial policy ; External relations ; Technical barriers Directory code: 11404000 EUROVOC descriptor: mutual recognition principle ; EC agreement ; United States Legal basis: 192E113................... Adoption 192E228-P2F1.............. Adoption 192E228-P3L1.............. Adoption 192E228-P4................ Adoption Instruments cited: 294A1223(01).............. 294A1223(07).............. Amended by: Adopted by.... 399D0078.......... DP22/6/98 Amended by.... 201D0123(01)...... Amendment ANN from 12/12/2000 Amended by.... 201D0203(02)...... Amendment ANN from 04/12/2000 Amended by.... 201D0813.......... Completion ANN from 16/01/2001 Amended by.... 201D0814.......... Completion ANN from 21/05/2001 Amended by.... 201D0815.......... Completion ANN from 26/06/2001 Amended by.... 201D0816.......... Completion ANN from 17/07/2001 Amended by.... 201D0817.......... Completion ANN from 20/07/2001 Amended by.... 202D0288.......... Completion ANN from 05/10/2001 Amended by.... 202D0289.......... Amendment ANN from 21/11/2001 Amended by.... 202D0290.......... Completion ANN from 20/11/2001 Amended by.... 202D0291.......... Completion ANN from 30/11/2001 Amended by.... 202D0292.......... Completion ANN from 15/01/2002 Amended by.... 202D0293.......... Completion ANN from 12/02/2002 Amended by.... 202D0295.......... Completion ANN from 22/03/2002 Amended by.... 202D0872.......... Amendment ANN from 16/04/2002 Amended by.... 202D0873.......... Completion ANN from 06/05/2002 Amended by.... 202D0874.......... Completion ANN from 25/07/2002 Amended by.... 202D0875.......... Completion ANN from 28/08/2002 Amended by.... 202D0876.......... Completion ANN from 20/09/2002 Amended by.... 203D0108.......... Amendment ANN from 20/11/2002 Amended by.... 203D0109.......... Amendment ANN from 22/01/2003 Amended by.... 203D0110.......... Amendment ANN from 05/02/2003 Amended by.... 203D0648.......... Completion ANN from 03/09/2003 Amended by.... 203D0649.......... Amendment ANN from 03/09/2003 Amended by.... 204D0702.......... Completion ANN from 19/07/2004 Subsequent related instruments: Relation...... 202D0294.......... AGREEMENT on mutual recognition between the European Community and the United States of America 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. Udfördiget i London den attende maj nitten hundrede og otteoghalvfems. Geschehen zu London am achtzehnten Mai neunzehnhundertachtundneunzig. øółżõ ėĮ˙ Ė˙żōčż˙, ėĮłĖ ōąśń ˙śĮž ĢńĄ˙į ščūłń õżżłńśŽėłń õżõżČżĮń ˙śĮž. Done at London on the eighteenth day of May in the year one thousand nine hundred and ninety-eight. Fait š Londres, le dix-huit mai mil neuf cent quatre-vingt-dix-huit. Fatto a Londra, addü 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 pōivōnō toukokuuta vuonna tuhatyhdeksōnsataayhdeksōnkymmentōkahdeksan. Som skedde i London den artonde maj nittonhundranittioõtta. Por la Comunidad Europea For Det Europöiske Föllesskab FŽr die Europōische Gemeinschaft Ćłń Į÷ż ÅįęųĘńŪśČ Ź˙łżŽĮ÷Įń For the European Community Pour la Communautł europłenne Per la Comunitš europea Voor de Europese Gemeenschap Pela Comunidade Europeia Euroopan yhteisŠn puolesta Põ Europeiska gemenskapens vōgnar >REFERENCE TO A GRAPHIC> Por los Estados Unidos de Amłrica For Amerikas Forenede Stater FŽr die Vereinigten Staaten von Amerika Ćłń ĮłĖ ĒżųüążõĖ Š˙ūłĮõčõĖ Į÷Ė ĮüõęłśČĖ For the United States of America Pour les États-Unis d'Amłrique Per gli Stati Uniti d'America Voor de Verenigde Staten van Amerika Pelos Estados Unidos da Amłrica Amerikan yhdysvaltojen puolesta Põ Amerikas fŠrenta staternas vōgnar >REFERENCE TO A GRAPHIC> 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 >TABLE POSITION> 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: >TABLE POSITION> 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 >TABLE POSITION> SECTION V CONFORMITY ASSESSMENT BODIES >TABLE POSITION> SECTION VI DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V >TABLE POSITION> 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. 9. Passage from the transitional phase into the operational phase in this Sectoral Annex shall take place provided that a representative number of conformity assessment bodies have been accepted for recognition under the Electrical Safety Annex. Appendix 1 Lists of acronyms and glossary >TABLE POSITION> 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 >TABLE POSITION> SECTION II SCOPE AND COVERAGE >TABLE POSITION> 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 >TABLE POSITION> SECTION V CONFORMITY ASSESSMENT BODIES >TABLE POSITION> SECTION VI DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V >TABLE POSITION> 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. 9. Passage from the transitional phase into the operational phase in this Sectoral Annex shall take place provided that a representative number of conformity assessment bodies have been accepted for recognition under the Electrical Safety Annex. 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 >TABLE POSITION> SECTION II SCOPE AND COVERAGE >TABLE POSITION> 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 >TABLE POSITION> SECTION V CONFORMITY ASSESSMENT BODIES >TABLE POSITION> SECTION VI DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES >TABLE POSITION> 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 >TABLE POSITION> 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 >TABLE POSITION> 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 comp …