(e) any other customs issue as the Parties may decide.
Chapter 6. SANITARY AND PHYTOSANITARY MEASURES
Article 6.1. Definitions
1. The definitions in Annex A of the SPS Agreement are incorporated into and made part of this Chapter.
2. For the purposes of this Chapter:
competent authority means a government body of a Party responsible for measures and matters referred to in this Chapter;
emergency measure means a sanitary or phytosanitary measure that is applied by the importing Party to the exporting Party to address an urgent problem of human, animal or plant life or health protection that arises or threatens to arise for the Party applying the measure;
SPS Agreement means the Agreement on the Application of Sanitary and Phytosanitary Measures, set out in Annex 1A to the WTO Agreement; and
WTO SPS Committee means the WTO Committee on Sanitary and Phytosanitary Measures.
3. The definitions adopted by the:
(a) Codex Alimentarius Commission (“the Codex”),
(b) World Organisation for Animal Health (“the WOAH”), and
(c) International Plant Protection Convention, done at Rome on 6 December 1951 (“the IPPC”);
are incorporated into and made part of this Chapter.
4. To the extent there is an inconsistency between the definitions referred to in paragraphs 1 and 2, and those referred to in paragraph 3, the definitions in paragraphs 1 and 2 prevail to the extent of the inconsistency.
Article 6.2. Objectives
1. The objectives of this Chapter are to:
(a) protect human, animal or plant life or health in the territories of the Parties while facilitating trade between them;
(b) reinforce and build on the SPS Agreement;
(c) strengthen communication, consultation, and cooperation between the Parties, and particularly between the Parties’ competent authorities;
(d) ensure that sanitary or phytosanitary measures implemented by a Party are science-based and do not create unjustified barriers to trade;
(e) enhance transparency in and understanding of the application of each Party’s sanitary and phytosanitary measures; and
(f) encourage the adoption of science-based international standards, guidelines, and recommendations, and promote their implementation by the Parties.
Article 6.3. Scope
This Chapter applies to all sanitary and phytosanitary measures of a Party that may, directly or indirectly, affect trade between the Parties.
Article 6.4. General Provisions
1. The following provisions of the SPS Agreement are incorporated into and made part of this Chapter: Articles 1 through 9, Article 13, Annex B and Annex C.
2. In implementing the following articles, each Party shall take into account relevant decisions and guidance of the WTO SPS Committee and international standards, guidelines and recommendations:
(a) Article 6.5;
(b) Article 6.6;
(c) Article 6.7;
(d) Article 6.8;
(e) Article 6.9;
(f) Article 6.10;
(g) Article 6.11;
(h) Article 6.12; and
(i) Article 6.13.
Article 6.5. Science and Risk Analysis
1. Recognizing the Parties’ rights and obligations under the relevant provisions of the SPS Agreement, this Chapter does not prevent a Party from:
(a) establishing its appropriate level of sanitary or phytosanitary protection; or
(b) establishing or maintaining an approval procedure that requires a risk assessment to be conducted before the Party grants a product access to its market.
2. In conducting its risk assessment and risk management, each Party shall ensure that each risk assessment it conducts is appropriate to the circumstances of the risk to human, animal, or plant life or health, and take into account the available relevant scientific evidence.
3. Each Party shall consider, as a risk management option, taking no measure if that would achieve the Party’s appropriate level of sanitary or phytosanitary protection.
4. Each Party shall conduct its risk analysis with respect to a sanitary or phytosanitary measure that constitutes a sanitary or phytosanitary regulation as defined in footnote 5 of Annex B of the SPS Agreement in a manner that is documented and provides the other Party an opportunity to comment, in a manner to be determined by the Party conducting the risk analysis.
5. If the importing Party requires a risk assessment to evaluate a request from the exporting Party to authorize importation of a good of the exporting Party, the importing Party shall provide, on request of the exporting Party, an explanation of the information required for the risk assessment. On receipt of the requisite information from the exporting Party, the importing Party shall endeavour to facilitate the evaluation of the request for authorization by scheduling work on this request in accordance with the procedures, policies, resources, laws, and regulations of the importing Party.
6. On request of the exporting Party, the importing Party shall inform the exporting Party of the status of a request to authorize trade, including the status of any risk assessment or other evaluation the importing Party requires to authorize trade and of any delay that occurs during the process.
7. If the importing Party, as a result of a risk assessment, adopts a sanitary or phytosanitary measure that may facilitate trade between the Parties, the importing Party shall implement the measure without undue delay.
8. If a Party adopts or maintains a provisional sanitary or phytosanitary measure when relevant scientific evidence is insufficient, that Party shall within a reasonable period of time:
(a) complete the risk assessment after obtaining the requisite information; and
(b) review and, if appropriate, revise the provisional measure in light of the risk assessment.
9. Without prejudice to Article 6.9, a Party shall not stop the importation of a good of the other Party for the reason that the importing Party is undertaking a review of its sanitary or phytosanitary measure, if the importing Party permitted the importation of that good of the other Party when the review was initiated.
10. The importing Party shall not be considered as having stopped imports for the reason that it is undertaking a review if that Party stops the importation of a good on the basis that the review identified that additional information is necessary to permit the importation of a good. The importing Party shall ensure that this review is undertaken in a manner that is consistent with this Chapter.
Article 6.6. Equivalence
1. Further to Article 4 of the SPS Agreement, the Parties shall apply recognition of equivalence to a specific sanitary or phytosanitary measure, or to the extent feasible and appropriate, to a group of measures or on a systems-wide basis.
2. The importing Party shall recognize the equivalence of a sanitary or phytosanitary measure, group of measures, or system, even if the measure, group of measures, or system differs from its own, if the exporting Party objectively demonstrates to the importing Party that the exporting Party’s measure, group of measures or system achieves the importing Party’s appropriate level of sanitary or phytosanitary protection taking into account outcomes that the exporting Party’s measures, group of measures, or system achieves.
3. In determining the equivalence of a sanitary or phytosanitary measure, the importing Party shall take into account available knowledge, information, and relevant experience, including knowledge acquired through experience with the exporting Party’s relevant competent authority.
4. On request of the exporting Party, the importing Party shall explain the objective and rationale of its sanitary or phytosanitary measure and identify the risk the sanitary or phytosanitary measure is intended to address.
5. When the importing Party receives a request for an equivalence determination and determines that the information provided by the exporting Party is sufficient, it shall initiate the equivalence assessment without undue delay.
6. On request of the exporting Party, the importing Party shall inform the exporting Party of the status of the equivalence assessment.
7. When the importing Party initiates an equivalence assessment, it shall explain, on request of the exporting Party, and without undue delay, its equivalence process, and, if the determination results in recognition of equivalence, its plan for enabling trade.
8. If the importing Party accepts the exporting Party’s sanitary or phytosanitary measures, group of measures, or system as equivalent, the importing Party shall communicate this acceptance to the exporting Party in writing and shall apply this recognition to trade from the exporting Party without undue delay.
9. If an equivalence assessment does not result in acceptance of equivalence, the importing Party shall communicate that determination and its rationale to the exporting Party without undue delay.
10. If a Party intends to modify or repeal a measure that is the subject of a sanitary or phytosanitary recognition of equivalence or to adopt a measure relating to a sanitary or phytosanitary recognition of equivalence, the following applies:
(a) that Party shall notify the other Party of its intention, which may include a draft measure or the modification or repeal of an existing measure. The notification should take place at an appropriately early stage, when any comments submitted by the other Party can be taken into account, including by revising its intended approach. Upon request of the other Party, the Parties shall discuss whether the modification, repeal, or adoption of the measure may affect the recognition of equivalence;
(b) that Party shall, upon request of the other Party, provide information and rationale concerning its intended modification, repeal, or adoption. The other Party shall review any information provided to it and submit any comments to the Party that intends to modify, repeal, or adopt the measure, without undue delay; and
(c) the importing Party shall not revoke its recognition of equivalence on the basis that modification, repeal, or adoption of the measure is pending.
11. If a Party adopts, modifies, or repeals a measure that is the subject of a sanitary or phytosanitary recognition of equivalence, the importing Party shall maintain its recognition of equivalence if the exporting Party objectively demonstrates that the exporting Party’s measures concerning the good continue to achieve the appropriate level of sanitary or phytosanitary protection of the importing Party. Upon request of a Party, the Parties shall promptly discuss the determination made by the importing Party.
Article 6.7. Adaptation to Regional Conditions, Including Pest - or Disease - Free Areas and Areas of Low Pest or Disease Prevalence
1. The Parties recognize that adaptation to regional conditions, including regionalization, zoning, and compartmentalization, is an important means to facilitate trade.
2. The Parties may cooperate on the recognition of pest - or disease - free areas, and areas of low pest or disease prevalence with the objective of acquiring confidence in the procedures followed by each Party for the recognition of pest - or disease - free areas, and areas of low pest or disease prevalence.
3. When the importing Party receives a request for a determination of regional conditions from the exporting Party and determines that the information provided by the exporting Party is sufficient, the importing Party shall initiate an assessment without undue delay.
4. When the importing Party initiates an assessment of a request for a determination of regional conditions under paragraph 3, that Party shall promptly, on request of the exporting Party, explain its process for making the determination of regional conditions.
5. On request of the exporting Party, the importing Party shall inform the exporting Party of the status of the assessment of the exporting Party’s request for a determination of regional conditions.
6. The importing Party shall finalize the assessment and all necessary stages involved for the determination of regional conditions of the exporting Party without undue delay once the importing Party’s competent authority determines that it has received sufficient information from the exporting Party.
7. When the importing Party adopts a sanitary or phytosanitary measure that recognizes specific regional conditions of the exporting Party, the importing Party shall communicate that measure to the exporting Party in writing and implement the measure without undue delay.
8. The Parties may also decide in advance the risk management measures that shall apply to trade between them in the event of a change in the status of the determination of regional conditions.
9. If the assessment of the evidence provided by the exporting Party does not result in a determination to recognize pest- or disease- free areas, or areas of low pest and disease prevalence, the importing Party shall provide to the exporting Party, in writing, with the rationale for its determination without undue delay.
10. If there is an incident that results in the importing Party modifying or revoking the determination recognizing regional conditions, on request of the exporting Party, the Parties shall cooperate to assess whether the determination can be reinstated.
Article 6.8. Transparency
1. The Parties recognize the value of sharing information about their sanitary and phytosanitary measures on an ongoing basis, and of providing the other Party and persons of the other Party with the opportunity to comment on their proposed sanitary and phytosanitary measures.
2. A Party shall notify a proposed sanitary or phytosanitary measure that may have an effect on the trade of the other Party, including any that conforms to international standards, guidelines or recommendations, by using the WTO SPS notification submission system as a means of notifying the other Party.
3. Unless urgent problems of human, animal, or plant life or health protection arise or threaten to arise requiring the adoption of an emergency measure, or the measure is of a trade-facilitating nature, a Party shall normally allow at least 60 days for the other Party or persons of the other Party to provide written comments on the proposed measure, other than proposed legislation, after it makes the notification under paragraph 2. The Party shall consider any reasonable request from the other Party or persons of the other Party to extend the comment period. On request of the other Party, the Party shall respond to the written comments of the other Party in an appropriate manner.
4. The Party shall make available on a free, publicly available website or official journal, the proposed sanitary or phytosanitary measure notified under paragraph 2, the legal basis for the measure, and shall endeavour to, if consistent with its practice, publish the written comments or a summary of the significant written comments that the Party has received from the public on the measure.
5. If a Party proposes a sanitary or phytosanitary measure which does not conform to a relevant international standard, guideline or recommendation, that Party shall provide to the other Party, on request, the relevant documentation that the Party considered in developing the proposed measure, including documented and objective scientific evidence that is rationally related to the measure, such as risk assessments, relevant studies and expert opinions.
6. A Party that proposes to adopt a sanitary or phytosanitary measure shall discuss with the other Party, on request and when appropriate during its regulatory process, any scientific or trade concerns that the other Party may raise regarding the proposed measure and the availability of alternative, less trade-restrictive approaches for achieving the Party’s appropriate level of sanitary or phytosanitary protection.
7. Each Party shall publish, by electronic means, notices of final sanitary or phytosanitary measures in an official journal or website.
8. Each Party shall notify the other Party of final sanitary or phytosanitary measures through the WTO SPS notification submission system. Each Party shall ensure that the text or the notice of a final sanitary or phytosanitary measure specifies the date on which the measure takes effect and the legal basis for the measure.
9. If a final sanitary or phytosanitary measure is substantively altered from the proposed measure, the Party shall also include in the notice of the final sanitary or phytosanitary measure that it publishes, an explanation of:
(a) the objective and rationale of the measure and how the measure advances that objective and rationale; and
(b) any substantive revisions that it made to the proposed measure.
10. The exporting Party shall notify the importing Party through the competent authorities referred to in Article 6.16 in a timely and appropriate manner:
(a) if it has knowledge of a significant sanitary or phytosanitary risk related to the export of a good from its territory;
(b) of urgent situations where a change in animal or plant health status in the territory of the exporting Party may affect current trade;
(c) of significant changes in the status of a regionalized pest or disease;
(d) of new scientific findings of importance which affect the regulatory response with respect to food safety, pests, or diseases; and
(e) of significant changes in food safety, pest, or disease management, control or eradication policies or practices that may affect current trade.
11. If feasible and appropriate, a Party shall normally provide an interval of no less than six months between the date it publishes a final sanitary or phytosanitary measure and the date on which the measure takes effect, unless the measure is intended to address an urgent problem of human, animal, or plant life or health protection or the measure facilitates trade.
12. Paragraphs 1 to 11 apply to sanitary or phytosanitary measures that constitute sanitary or phytosanitary regulations as defined in footnote 5 of Annex B of the SPS Agreement.
13. A Party shall provide to the other Party, on request, all sanitary or phytosanitary measures related to the importation of a good into that Party’s territory.
Article 6.9. Emergency Measures
1. If the importing Party adopts an emergency measure to address an urgent problem of human, animal or plant life or health protection that arises or threatens to arise and applies it to the exports of the exporting Party, the importing Party shall promptly notify the exporting Party of that measure through the relevant contact point referred to in Article 6.16. The importing Party shall take into consideration any information provided by the exporting Party in response to the notification.
2. If the importing Party adopts an emergency measure under paragraph 1, it shall review the scientific basis of that measure within six months and make available the results of the review to the exporting Party on request. If the emergency measure is maintained after the review, because the reason for its adoption remains, the importing Party should review the measure periodically.
Article 6.10. Import Checks
1. Each Party shall ensure that its import checks are based on the risks associated with importations, and that its import checks are carried out without undue delay.
2. A Party shall make available, on request of the other Party, information on its import procedures and its basis for determining the risk associated with the importation of goods.
3. The importing Party may amend the frequency of its import checks as a result of experience gained through import checks or as a result of actions by, or exchange of information, between competent authorities.
4. The importing Party shall provide, on request of the other Party, information regarding the analytical methods, quality controls, sampling procedures and facilities that the importing Party uses to test a good. The importing Party shall ensure that any testing is conducted using appropriate and validated methods in a facility that operates under a quality assurance program that is consistent with international laboratory standards. The importing Party shall maintain physical or electronic documentation regarding the identification, collection, sampling, transportation and storage of the test sample, and the analytical methods used on the test sample.
5. Each Party shall conduct import checks in a manner that preserves the integrity of the goods, except for the individual specimens or samples obtained pursuant to the requirements referred to in subparagraph 1(e) of Annex C of the SPS Agreement.
6. The importing Party shall ensure that its final decision in response to a finding of non-compliance with the importing Party’s sanitary or phytosanitary measure is limited to what is reasonable and necessary in response to the non-compliance and is rationally related to the available science.
7. If the importing Party prohibits or restricts the importation of a good of the other Party on the basis of an adverse result of an import check, the importing Party shall provide a physical or electronic notification about the adverse result to at least one of the following: the importer or its agent, the exporter, the manufacturer, or the exporting Party.
8. When the importing Party provides a notification pursuant to paragraph 7, that Party shall:
(a) include in its notification:
(i) the reason for the prohibition or restriction;
(ii) the legal basis or authorization for the action; and
(iii) information on the status of the affected goods and, if appropriate, on their disposition; and
(b) transmit the notification as soon as possible and no later than seven days after the date of the decision to prohibit or restrict, unless the good is seized by a customs administration.
9. The importing Party that prohibits or restricts the importation of a good of the other Party on the basis of an adverse result of an import check shall provide an opportunity for a review of the decision and consider any relevant information submitted to assist in the review. The review request and information should be submitted to the importing Party within a reasonable period of time.
10. This Chapter does not prevent the importing Party from disposing of goods which are found to have any infectious pathogen or pests that, if urgent action is not taken, can spread and cause damage to human, animal, or plant life or health in the Party’s territory, provided that the measure is in conformity with this Chapter.
11. If the importing Party determines that there is a significant, sustained, or recurring pattern of non-compliance with a sanitary or phytosanitary measure, the importing Party shall notify the exporting Party of the non-compliance.
Article 6.11. Audits
1. The Parties shall establish the conditions for carrying out an audit, which may include on-site, remote, or virtual options for any part of the audit.
2. To determine an exporting Party’s ability to provide required assurances and meet the sanitary and phytosanitary measures of the importing Party, the importing Party shall have the right, subject to this Article, to audit the exporting Party’s competent authorities and associated or designated inspection systems. That audit may include an assessment of the competent authorities’ control programs, including, if appropriate, reviews of the inspection and audit programs, and on-site inspections of facilities.
3. Each Party shall ensure that the audit is systems-based and designed to check the effectiveness of the regulatory controls of the competent authorities of the exporting Party.
4. Prior to the commencement of an audit, the Parties shall discuss and decide upon the rationale, objectives, scope of the audit and the criteria or requirements on the basis of which the audited Party will be assessed. At that time, the Parties shall also decide the itinerary and procedure for conducting the audit.
5. Unless the Parties decide otherwise, the auditing Party shall hold a closing meeting at a mutually decided time, that includes an opportunity for the competent authority of the audited Party to raise questions or seek clarification on the preliminary findings and observations provided at the meeting.
6. The auditing Party shall provide the audited Party the draft written audit report, including its initial findings. The auditing Party shall provide the audited Party the opportunity to comment on the accuracy of the draft audit report and shall take any comments into account before the auditing Party finalizes its report. The auditing Party shall provide a report setting out its conclusions in writing to the audited Party within a reasonable period of time.
7. In undertaking an audit in cases in which the importing Party has recognized equivalence on a systems-wide basis, the importing Party shall:
(a) conduct the audit to verify that the audited Party’s system achieves an equivalent outcome to the appropriate level of sanitary or phytosanitary protection of the importing Party; and
(b) audit against the exporting Party’s implementation of the equivalent oversight and control system.
8. A decision or action taken by the auditing Party as a result of the audit shall be supported by objective evidence and available data that can be verified, taking into account the auditing Party’s knowledge of, relevant experience with, and confidence in, the audited Party’s regulatory controls. The auditing Party shall, on request of the audited Party, provide that evidence and data to the audited Party for verification.
9. If the auditing Party makes a final audit report publicly available, the final audit report must incorporate, or be accompanied by, the comments or written response to the draft report provided by the competent authority of the audited Party.
10. The costs incurred by the auditing Party shall be borne by the auditing Party, unless the Parties decide otherwise.
11. Each Party shall ensure that procedures are in place to prevent the disclosure of confidential information that is acquired during the audit process.
Article 6.12. Certification
1. Each Party shall ensure that at least one of the following conditions is satisfied before imposing a sanitary or phytosanitary certification requirement:
(a) the certification requirement is based on the relevant international standards; or
(b) the certification requirement is appropriate to the circumstances of risks to human, animal, or plant life or health.
2. The importing Party shall limit attestations and information it requires on the certificates to essential information that is necessary to provide assurances to the importing Party that its appropriate level of sanitary or phytosanitary protection has been met.
3. The importing Party shall provide to the exporting Party, on request, the rationale for any attestation or information that the importing Party requires to be included in a proposed or existing certificate.
4. The Parties may decide to work cooperatively to develop model certificates to accompany specific goods traded between the Parties, taking into account relevant decisions and guidance of the WTO SPS Committee and international standards, guidelines, and recommendations.
5. The Parties shall promote the implementation of electronic certification and other technologies to facilitate trade.
Article 6.13. Approval Procedures for Import Maximum Residue Limits for Plant Protection Products
1. In the absence of an import Maximum Residue Limit (“MRL”) in the importing Party for a plant protection product (“PPP”) for an imported good, upon request by the exporting Party, the importing Party shall use the Codex MRL as the basis for market access until a final MRL determination is made by the importing Party. If a Codex MRL does not exist for that PPP, the importing Party shall consider using the exporting Party’s domestic MRL for that PPP.
2. Each Party shall ensure that any import MRL it adopts or maintains for a PPP is based on an assessment of dietary risk to human health associated with the imported good, taking into account risk assessment techniques developed by Codex.
3. Each Party shall publish, on a publicly available website, the import MRLs it adopts or maintains for PPPs. If possible, each Party shall endeavour to make that information available in English.
4. If a Party notifies the WTO SPS Committee of its proposed sanitary measure to revoke or lower an MRL for a PPP that applies to an imported good, unless the Party determines a shorter transition period is required to address human life or health risks, that Party shall provide a transition period of no less than twelve months between the date it publishes its final sanitary measure and the date on which the sanitary measure enters into force.
Article 6.14. Committee on Sanitary and Phytosanitary Measures
1. For the purposes of the effective implementation and operation of this Chapter, the Parties hereby establish a Committee on Sanitary and Phytosanitary Measures (“SPS Committee”).
2. Each Party shall ensure that appropriate government representatives, which may include those with responsibility for sanitary and phytosanitary measures from its relevant trade and regulatory agencies or ministries, participate in the SPS Committee meetings.
3. The objectives of the SPS Committee are to: