AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND
THE UNITED STATES OF AMERICA ON THE MUTUAL RECOGNITION OF
CERTIFICATES OF CONFORMITY FOR MARINE EQUIPMENT
Official Journal L 150 , 30/04/2004 P. 0046 – 0086
Of document: 27/02/2004
Of effect: 01/07/2004, Entry into force . See Art 21 And OJ L 234/2004 P. 9
Of signature: 27/02/2004; Washington
Of end of validity: 99/99/9999
Authentic language: The official languages ; German ; Danish ; Spanish ; Finnish ; French ; Greek ; Italian ; Dutch ; Portuguese ; Swedish ; English Author: European Community ; United States of America
Subject matter: External relations ; Commercial policy ; Technical barriers Directory code: 11404000 EUROVOC descriptor: EC agreement ; United States ; mutual recognition principle ; quality label ; IMO ; international standard ; technical standard ; maritime safety ; environmental protection
Legal basis 102E133................... Adoption 102E300-P2L1FR1........... Adoption 102E300-P3L1FR1........... Adoption 102E300-P4................ Adoption Instruments cited 396L0098.................. Amended by Corrected by.. 204A0430(03)R(01). (DA, DE, EL, EN, ES, FI, FR, IT, NL, PT, SV) Adopted by.... 304D0425.......... from 21/04/2004 Subsequent related instruments Relation...... 204X0703(01)......
/ 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 in marine equipment and to increase the effectiveness of each Party's regulatory actions;
RECOGNISING the opportunities offered to regulators by the elimination of unnecessary duplication of their activities;
NOTING .the shared commitment of the Parties to the work of the International Maritime Organisation (IMO);
CONSIDERING that the aim of the Parties is enhancing safety at sea and the prevention of marine pollution;
RECOGNISING, on the one hand, that mutual recognition agreements can positively contribute to greater international harmonisation of standards;
BEARING IN MIND, on the other hand, that the determination of equivalence must ensure that the fulfilment of the regulatory objectives of the Parties is fully respected and shall not lead to a lowering of their respective levels of safety and protection;
RECOGNISING that mutual recognition of certificates of conformity based on the equivalence of EC and US marine equipment regulations is an important means of enhancing market access between the Parties;
RECOGNISING that agreements providing for mutual recognition are of particular interest to small and medium-sized businesses in the US and the EC;
RECOGNISING that any mutual recognition also requires confidence in the continued reliability of the other Party's conformity assessments;
BEARING IN MIND that the Agreement on Technical Barriers to Trade, an agreement annexed to the Agreement Establishing the World Trade Organisation (WTO), encourages WTO Members to enter into negotiations for the conclusion of agreements for the mutual recognition of results of each other's conformity assessment procedures, as well as to give positive consideration to accepting as equivalent the technical regulations of other Members, provided they are satisfied that these regulations adequately fulfil the objectives of their own regulations,
HAVE AGREED AS FOLLOWS:
DEFINITIONS AND PURPOSE
Definitions 1. The following terms and definitions shall apply to this Agreement:
(a) "Regulatory Authority" means a government agency or entity that has the authority to issue regulations regarding issues related to^ safety at sea and prevention of marine pollution, that exercises a legal right to control the use or sale of marine equipment within a Party's jurisdiction, and that may take enforcement action to ensure that products marketed within its jurisdiction comply with applicable legal requirements. The Parties' respective Regulatory Authorities are identified in Annex III.
(b) "Conformity Assessment Body" means a legal entity, whether a Regulatory Authority or another body, public or private, that has the authority to issue Certificates of Conformity under a Party's domestic laws and regulations. For purposes of this Agreement, the Parties' respective Conformity Assessment Bodies are those referred to in Article 6.
(c) "Technical regulations" comprise the mandatory product requirements, testing and performance standards and conformity assessment procedures laid down in the legislative, regulatory and administrative provisions of the Parties related to marine equipment, as well as any applicable guidelines for their application.
(d) "Certificate of Conformity" means the document or documents issued by a Conformity Assessment Body of a Party certifying that a product fulfils the relevant legislative, regulatory and administrative requirements of that Party. In the US, this is the Certificate of Type Approval issued by the United States Coast Guard. In the EC, they are the certificates, approvals and declarations provided for by Directive 96/98/EC.
(e) "Equivalence of technical regulations" means that the technical regulations of the Parties related to a specific product are sufficiently comparable to ensure that the objectives of each
. Party's respective regulations are fulfilled. Equivalence of technical regulations does not require that the respective technical regulations are identical.
(f) "International Instrument" means the relevant international conventions, resolutions, codes and circulars of the International Maritime Organisation (IMO), and the relevant testing standards.
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 Standardization (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
1. This Agreement establishes the conditions under which the importing Party's Regulatory Authority shall accept the Certificates of Conformity issued by the exporting Party's Conformity Assessment Bodies in accordance with the technical regulations of the exporting Party, hereinafter referred to as "mutual recognition".
2. This Agreement also lays down a framework for regulatory cooperation with the objective of maintaining and furthering mutual recognition between the EC and the US of their respective regulatory requirements for marine equipment; of encouraging the improvement and evolution of regulatory requirements for the purpose of enhancing the safety at sea and the prevention of marine pollution; and ensuring a consistent application of this Agreement. This cooperation will take place fully respecting the Parties regulatory autonomy and their evolving policies and regulations as well as their shared commitment to the evolution of the relevant International Instruments.
3. This Agreement is intended to evolve as programs and policies of the Parties evolve. The Parties will review this Agreement periodically, in order to assess progress and identify potential enhancements to this Agreement as US and EC policies evolve over time. Particular attention will also be given to the evolution of the International Instruments.
ARTICLES Basic Obligations
1. With respect to each product listed in Annex II, the United States shall accept as complying with its own legislative, regulatory and administrative provisions as referred to in Annex I, without any further conformity assessment, Certificates of Conformity issued by the EC Conformity Assessment Bodies in accordance with the legislative, regulatory and administrative provisions of the EC.
2. With respect to each product listed in Annex II, the European Community and its Member States shall accept as complying with their own legislative, regulatory and administrative provisions as referred to in Annex I, without any further conformity assessment, Certificates of Conformity issued by the US Conformity Assessment Body in accordance with the legislative, regulatory and administrative provisions of the United States.
3. The technical regulations applicable in the US and the EC to each such product within the scope of this Agreement are specified in Annex II.
Equivalence of Technical Regulations
1. The mutual recognition obligations referred to in Article 3 are based on the determination by the Parties that the technical regulations applicable to each product listed in Annex II are equivalent.
2. Determination of equivalence of technical regulations of the Parties shall be based on their implementation of the relevant International Instruments in their respective legislation, regulations and administrative provisions, except where a Party regards the Instrument would be an ineffective or inappropriate means of fulfilment of its regulatory objectives. In the latter case, equivalency shall be determined on a mutually acceptable basis.
The Parties may maintain their respective requirements with regard to the marking, numbering and identification of products. With respect to the products listed in Annex II, the EC Conformity Assessment Bodies shall have the right to issue the marking and numbering required by the US legislation and regulations, as allocated to them by the US Coast Guard. The US Conformity Assessment Body shall be given the identification number provided for in Directive 96/98/EC, as allocated to it by the Commission of the European Communities, which shall be affixed next to the marking required by that Directive.
ARTICLE 6 ' Conformity Assessment Bodies
1. For the purpose of issuing Certificates of Conformity in accordance with the provisions of this Agreement, the following shall apply:
(a) The US recognises the Notified Bodies that have been designated by the EC Member States under Directive 96/98/EC as Conformity Assessment Bodies;
(b) The EC and its Member States recognise the United States Coast Guard together with the laboratories it has accepted under 46 CFR 159.010, as a Conformity Assessment Body.
2. Each Party recognises that the Conformity Assessment Bodies of the other Party are authorised to perform the following procedures in relation to the legislative, regulatory and administrative provisions referred to in Annex I:
(a) testing and issuing of test reports,
(b) performing quality assurance functions or system certification.
3. The Regulatory Authorities of the Parties are responsible for the following procedures, but may delegate some or all of these functions to Conformity Assessment Bodies:
(a) reviewing equipment design and test results against identified standards,
(b) issuing Certificates of Conformity.
4. Prior to the entry into force of this Agreement the Parties shall exchange their respective lists of Conformity Assessment Bodies. The Parties shall inform each other promptly of any changes to their list of Conformity Assessment Bodies. The Parties shall maintain on the World Wide Web updated lists of their Conformity Assessment Bodies.
5. Each Party shall require that its Conformity Assessment Bodies record and retain details of their investigations of the competence and compliance of their sub-contractors and maintain a register of all sub-contracting. These details will be available to the other Party on request.
6. Each Party shall require that its Conformity Assessment Bodies, upon request of a Regulatory Authority of the other Party listed in Annex III, make available to the Regulatory Authorities, copies of the Certificates of Conformity and related technical documentation they have issued.
1. The Parties hereby establish a Joint Committee consisting of representatives of each Party. The Joint Committee shall be responsible for the effective functioning of this Agreement.
2. Each Party shall have one vote in the Joint Committee. The Joint Committee shall make its decisions by unanimity. The Joint Committee shall determine its own rules of procedure.
3. The Joint Committee may consider any matter relating to the effective functioning of this Agreement. The Joint Committee shall have the authority to take decisions in the cases provided for in this Agreement. The Parties shall take the necessary measures to implement such decisions of the Joint Committee. In particular, the Joint Committee shall be responsible for:
(a) developing and maintaining the list in Annex II of products and associated legislative, regulatory and administrative provisions that the Parties have determined to be equivalent;
(b) discussing issues and resolving problems that may arise concerning the implementation of this Agreement, including concerns that technical regulations of the Parties applicable to a specific product in Annex II may no longer be equivalent;
(c) addressing technical, conformity assessment and technology issues in order to ensure a consistent application of this Agreement, in particular in relation to the relevant International Instruments;
(d) amending the Annexes;
(e) providing guidance and, if necessary, developing guidelines to facilitate the successful implementation and application of this Agreement;
(f) establish and maintain a work plan for aligning and harmonising the technical requirements of the Parties;
4. The Joint Committee may establish Joint Working Groups comprised of appropriate Regulatory Authorities' representatives and appropriate experts deemed necessary, in order to address and advise the Joint Committee on specific issues related to the functioning of this Agreement.
CHAPTER 4 REGULATORY COOPERATION
ARTICLES Preservation of Regulatory Authority
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 enhancing safety at sea and improving the prevention of marine pollution, or otherwise act with regard to risks within the scope of this Agreement.
Exchange of Information and Contact Points
1. The Regulatory Authorities of the Parties listed in Annex III will establish appropriate means of exchanging information on any regulatory problems concerning products subject to this Agreement.
2. Each Party shall designate at least one contact point, which may be the Regulatory Authorities listed in Annex III, to provide answers to all reasonable inquiries from the other Party and other interested parties such as manufacturers, consumers, trade unions, regarding procedures, regulations, and other matters related to this Agreement. The Parties shall exchange, and make publicly available, lists of contact points.
3. With regard to the exchange of information and notifications under this Agreement a Party shall have the right to communicate in its official language or languages. If a Party deems that information it receives must be translated into its official language or languages, that Party shall undertake the necessary translation and bear the cost.
4. Each Party agrees to make available to the public its list of products for which it has issued Certificates of Conformity under its respective legislative, regulatory and administrative provisions on the World Wide Web and update it on a regular basis.
1. When a Party introduces new technical regulations related to this Agreement, it shall do so on the basis of existing International Instruments, except when a Party considers the Instrument would be an ineffective or inappropriate means for fulfilment of its regulatory objectives.
2. Each Party shall notify the other Party of changes to technical regulations related to the subject matter of this Agreement at least 90 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. The Parties and their Regulatory Authorities shall inform and consult with one another, as permitted by their respective laws and regulations, on:
(a) proposals to amend or introduce new technical regulations as laid down in their respective legislative, regulatory and administrative provisions referred in, or related to, provisions listed in Annexes I and II;
(b) timely incorporation of amended or new international instruments into their respective legislation, regulations and administrative provisions; and
(c) the renewal of existing and valid Certificates of Conformity when the renewal is required by amended or new legislative, regulatory and/or administrative provisions.
The Parties will provide each other the opportunity to comment on such proposals.
4. In the event of changes to the legislation, regulations, and administrative provisions referred to in Annex I and II, the Joint Committee shall consider whether or not the equivalence of the technical regulations with respect to products listed in Annex II has been maintained.
If it is agreed in the Joint Committee that equivalence is maintained, then the product shall be retained in Annex II.
If it is agreed in the Joint Committee that equivalence cannot be maintained, references to products and the relevant technical regulations for which equivalence cannot be maintained shall be removed from Annex II. The Joint Committee shall update Annex II by a decision to reflect the changes. Upon the discontinuance of mutual recognition, the Parties are no longer bound by the obligations referred to in Article 3 of this Agreement for the specific product. However, the importing Party shall continue to recognize previously issued Certificates of Conformity for products that have been placed on the market of that Party prior to the discontinuance of mutual recognition, unless a Regulatory Authority in the Party decides otherwise based on health, safety or environmental considerations or failure to satisfy other requirements within the scope of this Agreement.
If the Parties, within the Joint Committee, cannot agree on whether or not equivalence of their technical regulations with respect to a product listed in Annex II is maintained, then mutual recognition with respect to that product shall be suspended according to the terms of Article 15.
5. The Parties shall make available on the World Wide Web an up-to-date version of Annex II.
ARTICLE 11 Regulatory Cooperation
1. The Parties agree to cooperate in the IMO and other relevant international organisation such as the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC) and the International Telecommunications Union (ITU), with a view to establishing and improving international rules for enhancing the safety at sea and the prevention of marine pollution.
2. The Parties will consider what technical work, data and information exchange, scientific and technological cooperation or other cooperative activities can be pursued between them with a view to improving the quality and level of their technical regulations applicable to marine equipment and making efficient use of resources for regulatory development.
3. For products that are not included in Annex II upon entry into force of this Agreement or for which equivalence of technical regulations has been discontinued or suspended, the Parties undertake to examine their respective technical regulations with a view to establishing, to the extent possible, mutual recognition. The Parties will set out a work program and time-table for alignment of their technical regulations, including the initiation of appropriate international standards work. The Parties shall endeavour to align their technical regulations to the extent possible on the basis of existing International Instruments in pursuit of the objective of their domestic legislation to enhance safety at sea and improve the prevention of marine pollution.
4. When the Parties have determined that equivalence can be established for a product and associated legislative, regulatory and administrative provisions, the Joint Committee shall take a decision to amend Annex II accordingly.
ARTICLE 12 Cooperation on Conformity Assessment
1.. The Parties and their authorities responsible for conformity assessment issues shall consult as necessary to ensure the maintenance of confidence in conformity assessment procedures and Conformity Assessment Bodies. This can take the form of, for example, comparison of methods to verify and monitor the technical competence and ability of Conformity Assessment Bodies, and, with the consent of both Parties, joint participation in audits/inspections related to conformity assessment activities or other assessment of Conformity Assessment Bodies.
2. The Parties shall encourage their Conformity Assessment Bodies to take part in coordination and cooperation activities organised by the Parties either separately or jointly.
SURVEILLANCE AND SAFEGUARD MEASURES
ARTICLE 13 Surveillance of Conformity Assessment Bodies
1. The Parties shall ensure that their Conformity Assessment Bodies are capable and remain capable of properly assessing conformity of products or processes, according to the applicable legislation, regulations and administrative provisions. In this regard, the Parties shall maintain, or cause to maintain, ongoing surveillance, as applicable, over their conformity assessment bodies and/or recognised laboratories, by means of regular audit or assessment.
2. In case a Party has objective reasons for contesting the technical competence of a Conformity Assessment Body of the other Party, it shall inform the other Party thereof. Such contestation shall be exercised when justified in an objective and reasoned manner. The other Party shall in a timely manner present information in order to refute the contestation or to correct the deficiencies which form the basis of the contestation. If necessary the matter shall be discussed in the Joint Committee. If agreement cannot be reached on the competency of the Conformity Body, the contesting Party may refuse to grant its marking and/or numbering to the contested Conformity Assessment Body and refuse to recognise the Certificates of Conformity issued by the contested Conformity Assessment Body.
1. 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) although correctly installed, maintained and used for its intended purpose, compromise the health and/or safety of the crew, the passengers or, where applicable, other persons, or adversely affect the marine environment;
(b) not meet the legislative, regulatory, or administrative provisions within the scope of the Agreement; or
(c) otherwise fail to satisfy a requirement within the scope of the Agreement.
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 the other Party no later than fifteen days after taking such action, providing its reasons for such action.
2. Nothing in this Agreement shall prevent the Parties from removing products from the market that do not in fact conform to a Parry's technical regulations.
3. The Parties agree that any applicable border inspections and checks of products which have been certified, labelled or marked as conforming with the importing Party's requirements specified in Annex 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 products.
ARTICLE 15 Suspending Mutual Recognition
1. In case a Party considers that equivalence of technical regulations with respect to one or more products listed in Annex II is not being or cannot be maintained, it shall inform the other Party thereof and give the objective reasons for this. Any contestation of equivalence shall be discussed in the Joint Committee. If no decision is reached by the Joint Committee within 60 days of the referral to it the mutual recognition obligation with respect to such products shall be suspended by one or both Parties. The suspension shall remain in effect until agreement has been reached by the Joint Committee.
2. The Joint Committee shall update Annex II by a decision to reflect the suspension of mutual recognition for the products in question. The Parties agree to cooperate according to the terms of Article 11 in view of establishing equivalence again, to the extent possible.
3. Upon suspension of mutual recognition of technical regulations referred to in Annex II the Parties are no longer bound by the obligations referred to in Article 3 of this Agreement for the specific product. However, the importing Party shall continue to recognize previously issued certificates of conformity for products that have been placed on the market of that Party prior to the suspension of mutual recognition, unless a Regulatory Authority in the Party decides otherwise based on health, safety or environmental considerations or failure to satisfy other requirements within the scope of this Agreement.
The Parties will put into place a two-way alert system between their Regulatory Authorities in order to inform each other of products that have been found not to comply with applicable technical regulations or can pose an imminent danger to health, safety or the environment.
ARTICLE 17 Confidentiality
1. Each Party agrees to maintain, to the extent required under its laws, the confidentiality of information exchanged under this Agreement. In particular, neither Party shall disclose to the public, nor permit a Conformity Assessment Body to disclose, information exchanged under this Agreement that constitutes trade secrets, confidential commercial or financial information, or information that relates to an ongoing investigation.
2. 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 wishes to be exempt from disclosure.
3. Each Party shall take all precautions reasonably necessary to protect information exchanged under this Agreement from unauthorised disclosure.
Each Party shall endeavour to ensure that fees imposed for services related to the subject matter of this Agreement shall be commensurate with the services provided. Each Party shall ensure that, for 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 Territorial Application
1. 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.
2. Without prejudice to paragraph 1, this Agreement applies to ships entitled to fly the flag of either Party, or one of the Parties' Member States, operating in international voyages.
ARTICLE 20 Agreements with other Countries
1. 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.
2. In view of furthering trade facilitation in marine equipment with other countries, the EC and the US undertake to examine the possibility of establishing a multilateral agreement on the subject matter covered by this Agreement with other interested countries.
CHAPTER 7 FINAL PROVISIONS
ARTICLE 21 Entry into force, amendments and termination
1. This Agreement 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 may be amended as specified in Article 7 or by the Parties.
3. Either Party may terminate this Agreement by giving the other Party six months notice in writing. ,
4. Following termination of this Agreement, a Party shall continue to accept the Certificates of Conformity issued 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 this Agreement.
1. This Agreement shall not affect the rights and obligations of the Parties under any other international agreement.
2. The Parties will review the functioning of this Agreement on a regular basis, the first time no later than two years after its entry into force.
3. This Agreement is drawn up in two originals 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.
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