(a) monitor and enhance each Party’s implementation of this Chapter;
(b) identify, prioritize, manage, and resolve any issue that may arise concerning a sanitary or phytosanitary measure that may have a significant effect on trade between the Parties with a view to facilitating a mutually acceptable solution and resolving any trade concerns;
(c) consider sanitary and phytosanitary matters of mutual interest; and
(d) enhance communication and cooperation on sanitary and phytosanitary matters.
4. The SPS Committee may:
(a) enhance mutual understanding of each Party’s sanitary and phytosanitary measures and the regulatory processes that relate to those measures;
(b) establish and, as appropriate, determine the scope and mandate of technical working groups in areas such as animal health, plant health, and food safety, taking into account existing mechanisms, to undertake work related to the implementation of this Chapter; and
(c) identify and discuss proposed sanitary or phytosanitary measures or revisions to existing sanitary or phytosanitary measures that may have a significant effect on trade between the Parties, with a view to avoid any potential trade concerns.
5. The SPS Committee shall meet within one year of the date of entry into force of this Agreement and every 18 to 24 months thereafter or as decided by the Parties.
6. The SPS Committee shall establish its terms of reference at its first meeting and may revise those terms as needed.
7. The SPS Committee shall report on its work to the Joint Committee.
Article 6.15. Technical Consultations
1. A Party (requesting Party) may initiate technical consultations with the other Party (responding Party) to discuss any matter arising under this Chapter that may adversely affect its trade by delivering a written request to the contact point of the responding Party. The request shall identify the reason for the request, including a description of the requesting Party’s concerns about the matter.
2. The Parties shall meet within 30 days of the date of delivery of the request, with the aim of resolving the matter cooperatively within 180 days of the delivery of the request if possible. This meeting, and any subsequent meeting, may be held virtually or in person as decided by the Parties.
3. The Parties shall ensure the appropriate involvement of relevant government officials in meetings held pursuant to this Article.
4. Recognizing that Parties may decide to engage in consultations pursuant to this Article for any length of time, the requesting Party may cease technical consultations under this Article and have recourse to dispute settlement under Chapter 27 (Dispute Settlement) following the meeting referred to in paragraph 2 or if the meeting is not held.
5. A Party shall not have recourse to dispute settlement under Chapter 27 (Dispute Settlement) for a matter arising under this Chapter without first seeking to resolve the matter through technical consultations in accordance with this Article.
Article 6.16. Competent Authorities and Contact Points
1. For the purposes of this Chapter, the competent authority is:
(a) for Canada:
(i) the Canadian Food Inspection Agency, or its successor and
(ii) the Department of Health, or its successor;
(b) for Ecuador:
(i) Ministry of Production, Foreign Trade and Investments, or its successor;
(ii) Phytosanitary and Zoosanitary Control and Regulation Agency, or its successor; and
(iii) National Agency of Regulation, Control and Sanitary Surveillance, Doctor Leopoldo Izquieta Perez, or its successor.
2. For the purposes of this Chapter, the contact point is:
(a) for Canada, the Canadian Food Inspection Agency, or its successor;
(b) for Ecuador, the Ministry of Production, Foreign Trade, and Investments, or its successor.
3. Each Party shall promptly inform the other Party of any change in its competent authorities or contact point.
4. Each Party shall provide to the other Party the contact information of the designated contact point for matters arising under this Chapter and a written description of the sanitary and phytosanitary responsibilities of its competent authorities within 60 days of the entry into force of this Agreement.
Chapter 7. TECHNICAL BARRIERS TO TRADE
Article 7.1. Definitions
1. Annex 1 of the TBT Agreement, including the chapeau, is incorporated into and made part of this Chapter.
2. For the purposes of this Chapter:
(a) international standard means a standard that is consistent with the TBT Committee Decision on International Standards;
(b) TBT Agreement means the Agreement on Technical Barriers to Trade, set out in Annex 1A to the WTO Agreement; and
(c) TBT Committee Decision on International Standards means Annex 2 to Part 1 (Decision of the Committee on Principles for the Development of International Standards, Guides and Recommendations with relation to Articles 2, 5 and Annex 3 of the Agreement) in the Decisions and Recommendations adopted by the WTO Committee on Technical Barriers to Trade Since 1 January 1995 (G/TBT/1/Rev.15), as may be revised, adopted by the WTO Committee on Technical Barriers to Trade.
Article 7.2. Scope
1. This Chapter applies to the preparation, adoption and application of standards, technical regulations, and conformity assessment procedures, including any amendments, of central level of government bodies, which may affect trade in goods between the Parties.
2. Notwithstanding paragraph 1, this Chapter does not apply to:
(a) technical specifications prepared by a governmental body for production or consumption requirements of governmental bodies; or
(b) sanitary or phytosanitary measures.
Article 7.3. Incorporation of the TBT Agreement
Articles 2 through 9, and Annex 3 of the TBT Agreement are incorporated into and made part of this Agreement.
Article 7.4. International Standards, Guides and Recommendations
1. The Parties recognize the important role that international standards, guides and recommendations can play in supporting greater regulatory alignment, good regulatory practices and reducing unnecessary barriers to trade.
2. To determine whether there is an international standard, guide, or recommendation within the meaning of Articles 2 and 5 and Annex 3 of the TBT Agreement, each Party shall apply the TBT Committee Decision on International Standards.
3. The Parties shall cooperate with each other, if appropriate, to ensure that international standards, guides, and recommendations that are likely to become a basis for technical regulations and conformity assessment procedures do not create unnecessary obstacles to international trade.
Article 7.5. Technical Regulations
1. Each Party shall conduct an appropriate assessment concerning any technical regulation it proposes to adopt. An assessment may include:
(a) a regulatory impact analysis of the potential impacts of the technical regulation; or
(b) an analysis of alternative measures, if any, including voluntary actions, that are brought to the Party’s attention in a timely manner.
2. If a Party has not used an international standard as a basis for its technical regulation, it shall, on request from the other Party, explain why it has not used a relevant international standard or has substantially deviated from an international standard. To facilitate an appropriate explanation, the requesting Party shall ensure its request:
(a) identifies a relevant international standard that the other Party has not used as a basis for its technical regulation; and
(b) describes how the technical regulation is constraining or has the potential to constrain its exports.
3. If no international standard exists that fulfils the legitimate objectives of its technical regulation or conformity assessment procedure, a Party may consider whether a standard developed by a standardizing body domiciled in the other Party can fulfill its legitimate objectives. To that end, a Party may:
(a) consider and decide whether to accept that standard; and
(b) if the Party has decided not to accept a standard that was brought to its attention by the other Party, issue a written explanation for that decision, if practicable.
4. In order for a Party to consider accepting or using a standard as provided for in paragraph 3, the Parties recognize that a standard must be brought to the attention of the other Party during that Party’s planning stage or when the proposed technical regulation or conformity assessment procedure is published for comment as provided for under Article 7.8.
5. Each Party shall:
(a) periodically review its technical regulations and conformity assessment procedures in order to:
(i) examine increasing alignment with relevant international standards, including by reviewing any new developments in the relevant international standards and whether the circumstances that have given rise to divergences from any relevant international standard continue to exist; or
(ii) consider the existence of any less trade-restrictive approaches.
(b) maintain a process whereby persons of the other Party may directly petition the Party’s regulatory authorities to review a technical regulation or conformity assessment procedure on the grounds that:
(i) circumstances that were relevant to the content of the technical regulation have changed; or
(ii) a less trade-restrictive method to fulfil the technical regulation’s objective exists, such as a technical regulation based on an international standard.
6. A Party shall, on written request of the other Party, consider accepting as equivalent a technical regulation of the other Party, even if that regulation differs from its own, provided that it is satisfied that the regulation adequately fulfills the objectives of its own regulation.
7. Where a Party does not accept a technical regulation of the other Party as equivalent to its own, it shall, on request of the other Party, explain the reasons for its decision within a reasonable period of time.
8. If a Party detains a good originating from the territory of the other Party at a port of entry due to perceived non-compliance of that good with a technical regulation, the Party detaining the good shall notify the importer without undue delay of the reasons for the detention.
Article 7.6. Gender Responsive Technical Regulations and Standards
1. The Parties recognize the importance of improving the gender responsiveness of technical regulations and standards.
2. The Parties also recognize the importance of the United Nations Economic Commission for Europe’s Declaration for Gender Responsive Standards and Standards Development, adopted in Geneva on 14 May 2019, in advancing gender responsive standards and standards development.
3. Accordingly, each Party shall endeavour to develop gender responsive technical regulations, standards, and standards development processes including by:
(a) encouraging its national standards body to make standards and standards development processes gender responsive;
(b) encouraging its national standards body to cooperate with the other Party’s national standards body, including by developing knowledge and sharing best practices, to improve gender responsiveness in the development cycle of standards; and
(c) considering, where appropriate, gender responsiveness in the development of its technical regulations.
Article 7.7. Conformity Assessment
1. The Parties shall encourage their respective accreditation and conformity assessment bodies to participate in cooperation arrangements that promote the mutual acceptance of conformity assessment results.
2. Each Party shall recognize conformity assessment bodies located in the territory of the other Party under conditions no less favourable than those it applies for the recognition of conformity assessment bodies located in its own territory.
3. Each Party shall accept conformity assessment results conducted by conformity assessment bodies located in the other Party’s territory and that the importing Party recognizes, under conditions no less favourable than those it applies to the acceptance of conformity assessment results conducted by recognized conformity assessment bodies located in its own territory.
4. Further to paragraphs 2 and 3, a Party shall not require, as a pre-condition for the recognition of the other Party’s conformity assessment bodies or the acceptance of conformity assessment results, that conformity assessment bodies located in the territory of the other Party establish a legal or physical presence in its own territory or that a separate agreement or arrangement be concluded between the Parties. (1)
5. Notwithstanding paragraphs 2, 3, and 4, the following exceptions apply:
(a) with respect to radio and terminal telecommunications equipment, a Party may require a mutual recognition agreement for conformity assessment bodies; and
(b) with respect to the maritime and aviation sectors, a Party may require the establishment of a legal or physical presence in its own territory for a conformity assessment body.
6. Each Party is encouraged to recognize as competent to accredit conformity assessment bodies an accreditation body established in the territory of the other Party that is a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement or a signatory to the International Accreditation Forum Multilateral Recognition Arrangement, or their successors.
7. Each Party shall adopt or maintain reasonable measures to ensure that central level of government accreditation bodies accredit conformity assessment bodies established in the territory of the other Party as expeditiously as possible and under conditions no less favourable than the conditions applied to conformity assessment bodies located in its territory.
8. Each Party shall give positive consideration to a request of the other Party to enter into negotiations for a mutual recognition agreement or equivalency arrangement to accept the results of conformity assessment procedures of the other Party.
9. On the request of the other Party, a Party shall explain the reasons for its decision, whenever it declines to:
(a) accredit, approve, license, or otherwise recognize a conformity assessment body;
(b) recognize the results from a conformity assessment body that is accredited or otherwise recognized by a signatory to a mutual recognition agreement, or a mutual or multilateral recognition arrangement;
(c) accept conformity assessment results conducted in the territory of the other Party; or
(d) enter into or continue negotiations for a mutual recognition agreement or equivalency arrangement.
10. This Chapter does not prevent a Party from undertaking conformity assessment procedures solely by government bodies that are located in its territory, subject to the Parties’ obligations under the TBT Agreement.
11. The Parties recognize that the choice of conformity assessment procedure should include an evaluation of the risks involved, the need to adopt procedures to address those risks, relevant scientific and technical information, incidence of non-compliant products, and possible alternative approaches for establishing that a technical regulation or standard has been met.
Article 7.8. Transparency
1. Each Party shall allow persons of the other Party to participate in the development of technical regulations, standards and conformity assessment procedures by its central level of government bodies on terms no less favourable than those it accords to its own persons. (2)
2. In addition to Articles 2.9 and 5.6 of the TBT Agreement, if a Party prepares or proposes to adopt a technical regulation or conformity assessment procedure that is not in response to an urgent situation as referred to in Article 2.10 of the TBT Agreement, the Party shall:
(a) publish the proposed technical regulation or conformity assessment procedure, identifying the precise international standards, guides or recommendations used as a basis for the technical regulation or conformity assessment procedure;
(b) allow a person of the other Party to submit written comments during a public consultation period on no less favourable terms than it provides to its own persons, and when the authority proposing the measure has sufficient time to review those comments and, as appropriate, to revise the measure to take them into account;
(c) consider the written comments from a person of the other Party on no less favourable terms than it considers those submitted by its own persons; and
(d) if practicable, (3) accept a written request from the other Party to discuss written comments that the other Party has submitted.
3. Notwithstanding paragraph 2, if urgent problems of safety, health, environmental protection or national security arise or threaten to arise for a Party, that Party shall notify a technical regulation or conformity assessment procedure that is in accordance with the technical content of relevant international standards, guides or recommendations according to the procedures established under Article 2.10 or 5.7 of the TBT Agreement. The Party’s notification shall identify the international standards, guides or recommendations used as a basis for the technical regulation or conformity assessment procedure.
4. Each Party shall publish online and make freely accessible, preferably on a single website, all proposed and adopted technical regulations or conformity assessment procedures, and shall endeavour to publish the written comments received during a public consultation period, or a summary of how it has addressed substantive issues raised within the public consultation period, except with respect to any standards that have been incorporated by reference into a technical regulation or conformity assessment procedure.
5. Each Party shall, if appropriate, encourage non-governmental bodies including standardization bodies in its territory to act consistently with the obligations in paragraphs 1 and 7, in developing standards and voluntary conformity assessment procedures.
6. Each Party shall ensure that the work program of its central level of government standardizing body, containing the standards it has adopted or is proposing to adopt, is available online.
7. Each Party shall endeavour to consider methods to provide additional transparency in the development of technical regulations, standards and conformity assessment procedures, including through the use of electronic tools and public outreach or consultations.
8. With respect to notifications made under Articles 2.9 and 5.6 of the TBT Agreement and paragraph 4 of this Article, each Party shall notify proposed technical regulations and conformity assessment procedures, at an early and appropriate stage, using the notification format and guidelines outlined in the Decisions and Recommendations Adopted by the WTO Committee on Technical Barriers to Trade Since 1 January 1995 (G/TBT/1/Rev.15), as may be revised, and by identifying how the proposed technical regulation or conformity assessment procedure fulfills its objective.
9. With respect to notifications made under Articles 2.9 and 5.6 of the TBT Agreement and paragraph 4 of this Article, each Party shall normally allow 60 days following the notification of its proposed technical regulations and conformity assessment procedures for the other Party or an interested person of a Party to provide comments in writing on the proposal. A Party shall consider any reasonable request from the other Party, or if practicable an interested person of a Party, to extend the comment period.
10. Each Party, when making a notification under Articles 2.10 or 5.7 of the TBT Agreement, shall at the same time transmit electronically the notification and text of the technical regulation or conformity assessment procedure, or a web page where the text of the measure can be viewed, to the other Party’s contact point referred to in Article 7.13.
11. If a Party is notifying a proposed technical regulation or conformity assessment procedure to the WTO TBT Committee and the other Pary for the first time, (4) the Party shall notify it to the WTO TBT Committee and the other Party as a regular notification. (5) Each Party shall endeavour to identify the scope of its proposed technical regulation or conformity assessment procedure in its notification by reference to the specific harmonized tariff schedule codes or chapter or heading and number for the products that would be affected by the proposal.
12. If a Party is notifying a proposed technical regulation or conformity assessment procedure that is related to a measure that was previously notified, including because it is a revision, amendment, or replacement to the previously notified measure, the Party shall provide the WTO notification symbol for the previously notified measure.
13. Each Party shall endeavour to submit a revision to a notification if the notified measure has been substantially redrafted prior to its entry into force. If the Party files a revision, it shall endeavour to allow either a new or extended period of time for interested persons to submit comments to the Party.
14. Each Party shall submit an addendum to a notification it has previously made to the WTO TBT Committee and the other Party in any of the following circumstances:
(a) if the period of time to submit comments on the proposed measure has changed;
(b) the notified measure has been adopted, its final text has been published or otherwise entered into force, or the compliance dates for the final measure have changed; or,
(c) the notified measure has been withdrawn, revoked, or replaced. (6)
15. For the purposes of determining whether a proposed technical regulation or conformity assessment procedure may have a significant effect on trade and should be notified in accordance with Articles 2.9, 2.10, 3.2, 5.6, 5.7, or 7.2 of the TBT Agreement and this Chapter, a Party shall consider, among other things, the relevant guidance in the Decisions and Recommendations Adopted by the WTO Committee on Technical Barriers to Trade Since 1 January 1995 (G/TBT/1/Rev.15), as may be revised.
16. If a Party adopts a technical regulation or conformity assessment procedure that may have a significant effect on trade, that Party shall promptly publish online:
(a) an explanation of how the technical regulation or conformity assessment procedure achieves the Party’s objectives;
(b) a description of alternative approaches, if any, that the Party considered in developing the technical regulation or conformity assessment procedure and the explanation of why it chose one approach over the others it considered;
(c) its views on any substantive issues raised in timely comments on the technical regulation or conformity assessment procedure when it was being developed;
(d) any impact assessment it has undertaken;
(e) if not addressed by an impact assessment, an explanation of the relationship between the technical regulation and the key evidence, data, and other information the regulatory authority considered in finalizing its work on the technical regulation; and
(f) the date of entry into force of the technical regulation or conformity assessment procedure.
Article 7.9. Compliance Period for Technical Regulations and Conformity Assessment Procedures
1. For the purposes of applying Articles 2.12 and 5.9 of the TBT Agreement, the term “reasonable interval” means normally a period of not less than six months, except when this would be ineffective in fulfilling the legitimate objectives pursued by the technical regulation or the conformity assessment procedure. (7)
2. A Party shall endeavour to give positive consideration to a reasonable request of the other Party, received prior to the end of the comment period following the notification of a proposed technical regulation or conformity assessment procedure, for extending the period of time between the publication of the technical regulation or conformity assessment procedure and its entry into force, except where this extension would be ineffective in fulfilling the legitimate objectives pursued.
Article 7.10. Information Exchange and Technical Discussions
1. The Parties recognize that technical discussions and information exchange can serve an important function in reaching mutually satisfactory solutions to trade concerns by promoting cooperation and consultation informed by relevant technical and scientific information. Accordingly, with respect to a matter that arises under this Chapter, a Party may request that the other Party:
(a) engage in technical discussions concerning the matter; or
(b) provide information regarding any proposed or final technical regulation or conformity assessment procedure that relates to the matter.
2. The Party shall make the request in writing and identify:
(a) the matter, including those provisions of this Chapter to which the matter relates;
(b) the reasons for the request, including any concerns with a proposed or final measure;
(c) whether the matter is urgent; and
(d) if applicable, the precise information that is being requested.
The Party shall transmit the request to the contact point of the other Party designated under Article 7.13.
3. With respect to a request made under paragraph 1(a), the Parties shall discuss the matter identified in the request within 60 days from the date on which the request was transmitted to the contact point of a Party, unless the request identifies the matter as urgent, in which case the Parties shall endeavour to hold the technical discussions sooner. With respect to a request made under paragraph 1(b), the Party receiving the request shall provide appropriate information within a reasonable period of time.
4. Unless the Parties decide otherwise, any discussions or information exchanged under this Article, other than the information provided in a request made under paragraph 1, shall be kept confidential and is without prejudice to the Parties’ rights and obligations under this Agreement, the WTO Agreement or any other agreement to which the Parties are party.
Article 7.11. Cooperation
The Parties recognize that a broad range of mechanisms exist to support greater regulatory alignment and to eliminate unnecessary technical barriers to trade between them, including:
(a) regulatory dialogue and cooperation to: