(d) provide the means to improve communication, cooperation and resolve any SPS difficulties arising from the implementation of this Chapter.
Article 7.3. Scope of Application
This Chapter applies to all sanitary and phytosanitary measures adopted or applied by a Party that may, directly or indirectly, affect international trade in goods between the Parties.
Article 7.4. Establishment of Import Requirements
1. The importing Party undertakes, where appropriate, to establish, without undue delay, sanitary and phytosanitary requirements for products identified by the exporting Party.
2. In the event that the quantity of products identified by the exporting Party precludes prompt and expeditious boarding by the importing Party, the exporting Party shall establish a list of priority products. Progress in the establishment of import requirements for the prioritized list shall be jointly monitored in the framework of the Committee on Sanitary and Phytosanitary Measures (hereinafter referred to as the "SPS Committee") established in Article 7.12 of this Chapter.
3. Pursuant to the provisions contained in paragraph 2, the Parties agree to establish the sanitary and phytosanitary requirements without undue delay, for the products included in the priority list, without conditioning their progress on the completion of the first product on the list. For the above, the workload of the Parties shall be considered.
Article 7.5. Equivalence
1. The general objective of the recognition of equivalence shall be to promote mutual confidence between the respective national authorities, to simplify procedures to verify that goods subject to sanitary and phytosanitary measures of the exporting Party meet the requirements of the importing Party.
2. Equivalence arrangements between the Parties shall be established in accordance with the Decisions adopted by the WTO SPS Committee and the rules, guidelines and recommendations of the international organizations referenced in the SPS Agreement.
3. The Parties may mutually agree in the SPS Committee on procedures and timelines for the recognition of equivalence.
4. The exporting Party shall provide appropriate scientifically based and technical information, with a view to objectively demonstrating that its sanitary and phytosanitary measure achieves the appropriate level of protection defined by the importing Party.
5. If the assessment does not result in the recognition of equivalence, the importing Party shall provide in writing the scientific and technical reasons for its rejection.
6. In the event that a sanitary or phytosanitary measure applied by the importing Party may affect trade, the importing Party shall consider whether, exceptionally, an alternative sanitary or phytosanitary measure offered by the exporting Party ensures its appropriate level of protection.
Article 7.6. Risk Analysis
1. Where a risk assessment is necessary, and where relevant international standards, guidelines or recommendations do not exist or are not sufficient to achieve the appropriate level of protection, it should be conducted taking into account the risk assessment techniques adopted within the framework of the international reference organizations for the SPS Agreement.
2. Any re-evaluation of risk analysis, in situations where there is regular and fluid trade in the good in question between the Parties, should not be a reason to interrupt trade in the goods concerned, except in the case of a sanitary or phytosanitary emergency.
3. The Parties may establish, by mutual agreement in the SPS Committee, the procedures and deadlines for carrying out the risk analysis based on the standards, guidelines and recommendations approved by the international reference organizations of the SPS Agreement.
4. The importing Party undertakes to request the information strictly necessary to carry out the risk assessment.
5. The exporting Party shall submit all necessary information, scientific evidence to support the risk analysis process of the importing Party.
6. Once the importing Party has concluded the risk analysis and decided that trade may commence or continue, it shall take the regulatory measures necessary to commence or continue trade, within a reasonable period of time.
Article 7.7. Recognition of Sanitary and Phytosanitary Status
1. The exporting Party shall be responsible for objectively demonstrating to the importing Party the pest or disease free or low pest or disease prevalence status of the country, area or zone.
2. In such cases, the pest or disease free or low pest or disease prevalence area or zone should be subject to effective surveillance, pest or disease control or eradication measures and other requirements in accordance with relevant international standards.
3. The Parties may establish by mutual agreement in the SPS Committee the procedures and timelines for the recognition of a pest- or disease-free or low prevalence area or zone, based on the standards, guidelines and recommendations adopted by the international reference organizations of the SPS Agreement.
4. The Parties undertake to recognise their respective disease-free areas or zones recognised by the World Organisation for Animal Health (hereinafter referred to as the "OIE") without undue delay.
Article 7.8. Control, Inspection and Approval Procedures
1. The implementation of control, inspection and approval procedures shall not be transformed into disguised restrictions on international trade in goods between the Parties and shall be carried out in accordance with the SPS Agreement and the international standards, guidelines and recommendations set by the SPS Agreement reference bodies.
2. Any modification of the agreed sanitary or phytosanitary conditions regarding access to the market of the importing Party, without due justification, shall be considered an unjustified barrier to trade.
3. The Parties shall agree, where possible, on the simplification of controls and verifications and the frequency of inspections on the basis of the risks involved and the international standards, guidelines and recommendations adopted by the SPS Agreement reference bodies.
4. If an on-site visit by the importing Party to the exporting Party is necessary for the verification of compliance with sanitary and phytosanitary requirements, as well as for the recognition of pest- or disease-free areas or zones or areas of low pest or disease prevalence, it should conform to the rules provided for in the SPS Agreement and, in particular, Annex C of the SPS Agreement. In particular, the visit should be limited exclusively to verifying in situ what is necessary from a technical point of view, and should not take longer than necessary or generate unnecessary costs.
Article 7.9. Audit Systems
1. Where deemed appropriate, the importing Party may conduct on-site audits of the exporting Party's inspection systems with appropriate justification.
2. If an audit is conducted to verify compliance with SPS requirements, it should comply with the requirements set out in the SPS Agreement and, in particular, Annex C thereof. Specifically, the audit shall be limited exclusively to the verification of what is technically necessary, without causing undue delay and unnecessary costs.
3. Each Party, under this Chapter, has the right to receive information on the control system of the other Party and the results of the controls carried out under that system.
4. Deadlines for submission of reports on the audit by the importing Party, submission of comments by the exporting Party, and publication of the final report by the importing Party shall be agreed by the SPS Committee as set out in Article 7.12.3(c).
Article 7.10. Transparency and Exchange of Information
1. The Parties recognize the importance of observing the notification rules provided for in the SPS Agreement and, in this regard, compliance with these obligations shall be considered sufficient to strengthen transparency in bilateral trade.
2. The Parties shall strengthen reciprocal transparency of their SPS measures by publishing adopted measures on free and publicly accessible official websites, to the extent such websites exist.
3. The Parties shall exchange information on issues related to the development and application of sanitary and phytosanitary measures that may affect trade between them, as well as developments or new scientific information available relevant to this Chapter.
4. The Parties shall report on changes in animal health, such as the emergence of exotic diseases, and diseases listed in the OIE Terrestrial Animal Health Code.
5. The Parties shall report changes in sanitary and phytosanitary matters, such as the emergence of quarantine pests or the spread of pests under official control.
6. The importing Party shall inform the exporting Party of the results of the import verification procedures in case of rejected or non-compliant products, the reasons, the factual basis and the scientific justification for the rejection. For these purposes, the Parties shall establish deadlines for the exchange of information in the framework of the SPS Committee.
Article 7.11. Technical Cooperation
1. The Parties agree to give special importance to technical cooperation to facilitate the implementation of this Chapter, supporting the processes of cooperation and technical assistance for capacity building in sanitary and phytosanitary matters.
2. The competent authorities of the Parties, referred to in Annex 7.1, may conclude agreements on cooperation and coordination of activities.
3. The Parties shall, where possible, seek to coordinate positions in regional or multilateral fora where international SPS standards, guidelines or recommendations are developed or related aspects are negotiated.
Article 7.12. Committee on Sanitary and Phytosanitary Measures
1. The Parties agree to establish the SPS Committee for the purpose of monitoring the implementation of this Chapter. The SPS Committee shall be composed of the competent authorities and contact points that each Party designates, as indicated in Annex 7.1.
2. The SPS Committee shall meet once a year and may hold additional meetings as deemed necessary by the Parties. The venues of the meetings will alternate, with the Chair of the SPS Committee shall be the Chair of the SPS Committee. Parties may agree to hold meetings in person, by video or teleconference, or other appropriate means.
3. The functions of the SPS Committee shall be:
(a) exchange information on the competent authorities and Contact Points of each Party, detailing their areas of competence. The relevant information in Annex 7.1 may be updated in the event of changes;
(b) promote and develop cooperation and technical assistance projects, including cooperation in the development, application and enforcement of sanitary or phytosanitary measures;
(c) exchange information and establish procedures and timelines for the bilateral implementation of the disciplines provided for in the Chapter;
(d) to respond to a written request from a Party on any inquiry arising under this Chapter;
(e) establish technical working groups for the implementation of this Chapter;
(f) keep the Commission informed of the work of the SPS Committee, and
(g) develop all those actions that the Parties consider relevant for the fulfillment of this Chapter.
4. To order its functioning, and for the proper implementation, monitoring and evaluation of this Chapter, the SPS Committee shall establish its own rules of procedure at its first meeting. The SPS Committee may revise these rules by consensus when it deems it appropriate.
Article 7.13. Consultation Mechanism
1. The Parties shall give prompt and positive consideration to any request by the other Party for consultations on specific trade concerns regarding the application of sanitary or phytosanitary measures or a draft measure of the other Party, with a view to finding mutually acceptable solutions.
2. Upon receipt of the request, the Parties shall consult within thirty (30) days, unless they agree on a different time limit. Such consultations may be held by teleconference, videoconference, or any other means agreed between the Parties.
3. Where the Parties have resorted to consultations under subparagraph (d) of Article 7.12.3 without satisfactory results, such consultations shall replace consultations under Article 22.4 of Chapter 22 (Dispute Settlement).
Chapter 8. TECHNICAL BARRIERS TO TRADE
Article 8.1. General Provisions
The Parties reaffirm their rights and obligations under the TBT Agreement which is incorporated into and made part of this Chapter, mutatis mutandis.
Article 8.2. Objective
The objective of this Chapter is to facilitate trade in goods between the Parties by identifying, preventing and eliminating unnecessary technical barriers to trade, improving transparency and promoting cooperation between the Parties on matters dealt with under this Chapter.
Article 8.3. Scope of Application
1. This Chapter shall apply to all standards, technical regulations and conformity assessment procedures of the Parties, as defined in Annex 1 of the TBT Agreement, which may directly or indirectly affect trade in goods between the Parties.
2. The provisions of this Chapter shall not apply to the sanitary and phytosanitary measures of the Parties, which shall be governed by Chapter 7 (Sanitary and Phytosanitary Measures).
3. Government procurement specifications prepared by governmental agencies for the production or consumption needs of such agencies are not subject to the provisions of this Chapter, which shall be governed by Chapter 12 (Government Procurement).
Article 8.4. Regulatory Cooperation Mechanisms
1. The Parties shall strengthen their collaboration in order to increase mutual understanding of their respective systems and identify mechanisms for regulatory cooperation, which will contribute to the elimination of unnecessary technical barriers to trade.
2. The Parties shall, wherever possible, negotiate regulatory cooperation mechanisms in the areas of technical standards, technical regulations, conformity assessment procedures, including accreditation and metrology, in accordance with the provisions of the TBT Agreement.
3. A Party may propose to the other Party a joint analysis of potential sectors, products or group of products or regulatory issues, on which they may negotiate regulatory cooperation mechanisms in order to increase the flow of bilateral trade. In the event that a Party considers that this is not possible, the provisions of paragraph 6 shall apply.
4. The Parties shall exchange information relating to the analysis in the preceding paragraph and shall encourage the participation of representatives of the sectors, products or group of products, in a manner to be agreed by the Parties, and of their competent regulatory and governmental authorities.
5. The Parties, through their competent regulatory and governmental authorities, shall select, on a case-by-case basis, the appropriate tools to address the issue that has given rise to the request. For each sector, product or group of products identified, the Parties shall determine, by mutual agreement, mechanisms for regulatory cooperation, which may include, inter alia:
(a) exchange of information on regulatory practices and approaches;
(b) initiatives to seek harmonization of technical regulations and conformity assessment procedures with relevant international standards;
(c) regulatory convergence actions;
(d) the use of accreditation to qualify conformity assessment bodies, and
(e) mutual recognition of conformity assessment procedures and results thereof carried out in the other Party.
6. Where a Party does not accept a request to analyse a sector or set of sectors, products, groups of products or the suggestion of proposed regulatory cooperation mechanisms, it shall promptly provide the reasons for such a decision and offer, if possible, alternatives.
7. The mechanisms for regulatory cooperation shall be defined on a case-by-case basis by the Parties. To this end, the Parties shall establish sectoral working groups.
8. The Parties shall implement the results of the agreements reached under this Chapter, once approved by the Commission.
Article 8.5. Technical Regulations
1. The Parties agree to make use of good regulatory practices with respect to the preparation, adoption and application of technical regulations, as provided for in the TBT Agreement.
2. The Parties reaffirm the commitment to use relevant international standards as a basis for their technical regulations, except where such international standards would be an ineffective or inappropriate means for the achievement of the legitimate objectives pursued.
3. Where international standards have not been used as the basis for a technical regulation that may have a significant effect on trade, a Party shall, on request of the other Party, explain the reasons why such standards have been found to be inappropriate or ineffective for the objective pursued.
4. The Parties shall encourage their competent regulatory authorities to conduct regulatory impact analyses in accordance with their respective rules and procedures.
5. Each Party shall favorably consider accepting as equivalent the technical regulations of the other Party, even if they differ from its own, provided that they produce results that are equivalent to those produced by its own technical regulations in achieving its legitimate objectives and attaining the same level of protection.
Article 8.6. Standards
1. The Parties reaffirm the commitment set out in Article 4.1 of the TBT Agreement. In addition, they shall take into account, to the extent possible, the principles set out in the Decision of the Committee on Principles for the Development of International Standards, Guides and Recommendations concerning Articles 2, 5 and Annex 3 of the TBT Agreement, adopted by the WTO Committee on Technical Barriers to Trade on 13 November 2000, and its subsequent revisions.
2. In determining whether international standards, guidance or recommendations within the meaning of Articles 2 and 5 of the TBT Agreement and Annex 3 thereto exist, each Party shall consider the Decisions and Recommendations Adopted by the WTO Committee on Technical Barriers to Trade since 1 January 1995, Annexes to Part 1.2 (G/TBT/1/Rev.13) and their subsequent revisions.
Article 8.7. Conformity Assessment
1. The Parties recognize that the choice of appropriate conformity assessment procedures depends on the institutional structure and legal provisions in force in each Party, within the framework of the obligations set out in the TBT Agreement.
2. The Parties recognize that a wide range of mechanisms exist to facilitate the acceptance in the territory of a Party of the results of conformity assessment procedures conducted in the territory of another Party. In this regard, the Parties may include:
(a) voluntary agreements between conformity assessment bodies in the territory of the Parties;
(b) agreements on mutual acceptance of the results of conformity assessment procedures with respect to specific technical regulations, carried out by bodies located in the territory of the other Party;
(c) accreditation procedures for qualifying conformity assessment bodies;
(d) governmental approval or designation of conformity assessment bodies;
(e) the importing Party's acceptance of the supplier's declaration of conformity.
3. The Parties undertake to:
(a) exchange information on different mechanisms with a view to facilitating the acceptance of conformity assessment results;
(b) encourage testing, inspection and certification bodies to exchange experiences on the procedures used to assess conformity, and
(c) promote the exchange of information on accreditation systems and encourage accreditation bodies to participate actively in international cooperative arrangements in the field of accreditation, such as the International Laboratory Accreditation Cooperation and the International Accreditation Forum.
4. For purposes of transparency and mutual confidence, if a Party does not accept the results of conformity assessment procedures carried out in the territory of the other Party, it shall, on request of that other Party, explain the reasons for its decision.
5. Each Party shall accord to conformity assessment bodies of the other Party located in its territory treatment no less favourable than that accorded to its own conformity assessment bodies.
6. In order to enhance confidence in the continued mutual reliability of conformity assessment results, the Parties may consult, as appropriate, with a view to reaching a mutually satisfactory understanding on such matters as the technical competence of the conformity assessment bodies involved.
7. The Parties shall seek to ensure that the conformity assessment procedures applied between them facilitate trade by ensuring that they are not more restrictive as necessary to provide the importing Party with confidence that the products comply with the applicable technical regulations, taking into consideration the risks that non-compliance would create.
Article 8.8. Transparency
1. Parties shall ensure transparency with regard to information on technical regulations, standards and conformity assessment procedures.
2. The Parties shall notify each other electronically, through the contact point established by each Party, and in accordance with Article 10 of the TBT Agreement, of draft and amended technical regulations and conformity assessment procedures, as well as those adopted to address urgent problems under the terms of the TBT Agreement, at the same time as they send the notification to the WTO Central Registry of Notifications. Such notification shall include an electronic link to the notified document or a copy thereof.
3. Parties should notify even those draft technical regulations and conformity assessment procedures that are consistent with the technical content of relevant international standards.
4. Each Party shall publish adopted technical regulations and conformity assessment procedures on official and publicly available websites.
5. Each Party shall allow at least sixty (60) days from the date of electronic transmission of the draft technical regulations and conformity assessment procedures for written comments from the other Party and other interested persons. A Party shall give positive consideration to reasonable requests for extension of the comment period.
7. The period between publication and entry into force of technical regulations and conformity assessment procedures shall be not less than six (6) months, unless the legitimate objectives are impracticable to achieve within that period. A Party shall give positive consideration to reasonable requests for an extension of the time period.
Article 8.9. Technical Cooperation
1. The Parties agree to cooperate to:
(a) strengthen their respective metrology, standardization, technical regulation and conformity assessment bodies, as well as their information and notification systems within the structure of the TBT Agreement;
(b) strengthening the capacities of national institutions and training of human resources;
(c) increase and improve participation and, where possible, seek coordination of common positions in international organisations on matters related to standardisation and conformity assessment procedures;
(d) wherever possible, support the development and implementation of relevant international standards;
(e) promote technical assistance through competent regional or international organizations; and
(f) develop joint activities between the technical bodies involved in the activities covered by this Chapter.
Article 8.10. Committee on Technical Barriers to Trade
1. The Parties hereby establish a Committee on Technical Barriers to Trade (hereinafter referred to as the "TBT Committee"), which shall be composed of:
(a) in the case of Chile, the Directorate-General for Bilateral Economic Affairs of the Under-Secretariat for International Economic Relations of the Ministry of Foreign Affairs, or its successor.
(b) in the case of Ecuador, the Directorate of Negotiations on Sanitary and Phytosanitary Measures and Technical Barriers to Trade of the Ministry of Production, Foreign Trade, Investment and Fisheries, or its successor.
2. The functions of the TBT Committee are:
(a) monitor the implementation and administration of this Chapter, addressing any problems that either Party raises relating to its provisions;
(b) promote and enhance cooperation for the development and improvement of standards, technical regulations or conformity assessment procedures in accordance with Article 8.7;
(c) facilitate cooperation in accordance with Article 8.9, as well as support regulatory cooperation mechanisms and technical discussions as appropriate, in accordance with Article 8.4. To this end, the Parties shall establish a work plan;
(d) exchange information about work being carried out in non-governmental, regional, multilateral fora and cooperative programmes involved in activities related to standards, technical regulations and conformity assessment procedures;
(e) review this Chapter in the light of developments in the WTO Committee on Technical Barriers to Trade and develop recommendations to amend this Chapter, if necessary;
(f) report to the Commission on the implementation of this Chapter;
(g) establish, as necessary, working groups to deal with specific matters related to this Chapter and the TBT Agreement;
(h) to consult, at the request of a Party, on specific trade concerns arising under this Chapter, and
(i) take any other action that the Parties consider will assist them in the implementation of this Chapter and the TBT Agreement, with a view to facilitating trade in goods.
3. The TBT Committee shall meet once a year, at the request of a Party. The meetings shall be held in person, by teleconference, videoconference or by any other means, as agreed by the Parties.
4. In order to facilitate communication of activities under this Chapter, each Party shall designate and notify a contact point.
5. The responsibilities of the contact points referred to in paragraph 2 are:
(a) provide information or explanation at the request of the other Party, which shall be provided in printed or electronic form within sixty (60) days of the submission of the request;
(b) coordinate the involvement of relevant governmental authorities, including regulatory authorities, and, as appropriate, other stakeholders, on matters related to this Chapter; and
(c) carry out the additional responsibilities specified by the TBT Committee.
6. Each Party shall promptly notify the other Party of any change in its point of contact or details of relevant officials.
Article 8.11. Consultations on Specific Trade Concerns
1. The Parties shall give prompt and positive consideration to any request by the other Party for consultations on specific trade concerns relating to technical regulations and conformity assessment procedures of the other Party, in order to find mutually acceptable solutions through the modality to be agreed (face-to-face meetings, videoconferences or others).
2. Upon receipt of the request, the Parties shall consult within sixty (60) days, unless they agree on a different time limit. Such consultations may be held by teleconference, videoconference, or any other means agreed between the Parties.