chapter sanitary and phytosanitary measures the objectives ... · resultado del proceso de...

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Chapter Sanitary and Phytosanitary Measures

Article 1: Objectives 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 upon the implementation of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (WTO SPS Agreement)

(c) strengthen communication, consultation, and cooperation between the Parties, and particularly between the Parties’ competent authorities;

(d) ensure that sanitary and phytosanitary measures implemented by the Parties do not create unnecessary barriers to trade;

(e) improve consistency, certainty and transparency of each Party's SPS measures and their implementation; and

(f) encourage the development and adoption of international standards, guidelines and recommendations issued by the relevant international organisations and enhance their implementation by the Parties.

Article 2: Rights and obligations

1. The Parties reaffirm their rights and obligations with respect to each other under the WTO SPS Agreement.

2. The Parties shall avail themselves of the necessary resources to effectively implement this Chapter.

Article 3: Definitions

1. The “SPS Agreement” means the World Trade Organisation Agreement

on the Application of Sanitary and Phytosanitary Measures.


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2. The definitions in Annex A of the SPS Agreement apply, as well as those

of the Codex Alimentarius Commission (Codex), the World Organisation for Animal Health (OIE) and the International Plant Protection Convention (IPPC).

3. Emergency measure: Means a sanitary or phytosanitary measure that is applied by the importing Party to the other Party to address an urgent problem of human, animal or plant life or health protection that arises or threatens to arise in the Party applying the measure.

Article 4: Scope

1. This Chapter shall apply to all sanitary and phytosanitary measures of

a Party that may, directly or indirectly, affect trade between the Parties.

Article 5: Equivalence

1. The Parties acknowledge that recognition of the equivalence of sanitary

and phytosanitary measures is an important means to facilitate trade.

2. The importing Party shall accept sanitary and phytosanitary measures of the exporting Party as equivalent to its own if the exporting Party objectively demonstrates to the importing Party that its measure achieves the importing Party’s appropriate level of sanitary and phytosanitary protection.

3. The final determination whether a sanitary or phytosanitary measure maintained by an exporting Party achieves the importing Party’s appropriate level of sanitary and phytosanitary protection rests with the importing Party.

4. Each Party’s equivalence assessment and determination shall take into account inter alia the following, where relevant:

a. decisions of the WTO SPS Committee; b. the work of the relevant international organisations;


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c. any knowledge and past experience it has in trading with the exporting Party; and

d. information provided by the other Party. 5. Each Party shall base its determinations and maintenance of

equivalence on standards, guidelines, and recommendations of the relevant international standard-setting bodies or on an assessment of the risks, as appropriate to the circumstances.

6. When the importing Party receives a request for an equivalence assessment from the other Party that is supported by the required information, it shall promptly initiate the assessment to determine the equivalence.

7. Where an importing Party concludes an equivalence assessment, it shall promptly notify its determination to the other Party.

8. When the importing Party has concluded a positive equivalence determination that recognises the exporting Party’s measure as equivalent, the importing Party shall promptly initiate the necessary legislative and/or administrative measures to implement it.

9. Without prejudice to Article 17 (Emergency measures), if a Party plans to adopt, modify or repeal a measure subject to an SPS equivalence determination affecting trade between the Parties:

a. the Party shall notify the other Party of its plans. The notification should take place at an early appropriate stage where any comments submitted from the other Party can be taken into account. Upon request of either Party, the Parties shall discuss the plans;

b. the Party shall, upon request of the other Party, provide information and rationale concerning its planned changes. The other Party shall review any information submitted without undue delay;

c. pending any change to the measure, the importing Party shall maintain its equivalence determination provided the measure for which the change is being planned remains in effect.

10. When a Party adopts, modifies or repeals a measure subject to an SPS equivalence determination, the importing Party shall maintain its


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determination provided that the exporting Party’s measures concerning the product continue to achieve the appropriate level of protection of the importing Party. Upon request of a Party, the Parties shall promptly discuss the determination made by the importing Party.

Article 6: Risk Assessment 1. The Parties recognize the importance of ensuring that their respective

sanitary and phytosanitary measures are based on scientific principles, and conform to the relevant international standards, guidelines and recommendations. Where a Party has reasons to believe that a specific measure introduced or maintained by the other Party is constraining, or has the potential to constrain, its exports and the measure is not based on the relevant international standards, guidelines or recommendations, or such standards, guidelines or recommendations do not exist, an explanation of the reasons and pertinent relevant information for such SPS measures may be requested and shall be provided by the Party maintaining the measure.

2. In cases where relevant scientific evidence is insufficient, a Party may

provisionally adopt a sanitary or phytosanitary measure on the basis of available pertinent information, including that from the relevant international organizations. In such circumstances, the Party adopting the measure shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time.

3. Recognising the Parties’ rights and obligations under the relevant

provisions of the SPS Agreement, nothing in this Chapter shall be construed to prevent a Party from:

a) establishing the level of protection it determines to be appropriate, in accordance with Article 5 of the SPS Agreement;

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; or


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c) adopting or maintaining sanitary or phytosanitary precautionary measures in accordance with Article 5.7 of the SPS Agreement.

4. Each Party shall ensure that its sanitary and phytosanitary measures do

not arbitrarily or unjustifiably discriminate between Parties where identical or similar conditions prevail, including between its own territory and that of the other Party. Sanitary and phytosanitary measures shall not be applied in a manner that would constitute a disguised restriction to trade between the Parties.

5. When conducting its risk analysis, each Party shall: (a) take into account relevant guidance of the WTO SPS Committee

and international standards, guidelines and reccomendations;

(b) consider risk management options that are no more trade restrictive than required, to achieve the level of protection the Party has determined to be appropriate, as provided in Article 5.3 of the SPS Agreement, taking into account technical and economic feasibility, and

(c) take into account the objective of minimising negative trade

effects when determining the appropriate level of sanitary or phytosanitary protection, as provided for in Article 5.4 of the SPS Agreement and select a risk management option that is no more trade restrictive than required to achieve the sanitary or phytosanitary objective, taking into account technical and economic feasibility.

6. On request of the exporting Party, the importing Party shall inform the

exporting Party of the progress of a specific risk analysis request, and of any delay that may occur during the process.

7. Without prejudice to Article 17 (Emergency measures), no Party shall stop the importation of a product of the Party solely 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 product of the other Party when the review was initiated.


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Article 7: Adaptation to Regional Conditions, Including Pest- or Disease-Free Areas and Areas of Low Pest or Disease Prevalence

General

1. The Parties recognise that the adaptation of SPS measures to regional pest or disease conditions is an important means to protect animal and plant life or health, and to facilitate trade.

2. The Parties shall, in particular, recognize the concepts of pest- or disease- free areas and areas of low pest or disease prevalence. Determination of such areas shall be based on factors such as geography, ecosystems, epidemiological surveillance, and the effectiveness of sanitary or phytosanitary controls.

3. The exporting Party claiming that areas within its territory are pest- or disease-free areas or areas of low pest or disease prevalence shall provide the necessary evidence thereof in order to objectively demonstrate to the importing Party that such areas are, and are likely to remain, pest- or disease-free areas or areas of low pest or disease prevalence, respectively. For this purpose, reasonable access shall be given, upon request, to the importing Party for inspection, testing and other relevant procedures.

4. When taking regionalisation decisions, the Parties shall take into account the relevant guidance of the WTO SPS Committee and base their measures on international standards, guidelines and recommendations; or in case those do not achieve the importing Party´s appropriate level of protection, on a risk assessment as appropriate to the circumstances.

5. The importing Party shall take into account any relevant information of and prior experience with the authorities of the exporting Party.

6. The importing Party may determine that an expedited process can be used to evaluate a request from the exporting Party for recognition of pest- or disease-free areas or areas of low pest or disease prevalence.


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7. If the exporting Party does not agree with the determination made by the importing Party, the importing Party shall provide justification to the exporting Party.

Animals, animal products and animal by-products

8. The Parties recognise the principle of zoning which they agree to apply in their trade. The Parties also recognise the official animal health status as determined by the OIE.

9. The importing Party shall normally base its own determination of the animal health status of the exporting Party on the evidence provided by the exporting Party in accordance with the SPS Agreement and the OIE Terrestrial and Aquatic Code.

10. The exporting Party shall, if requested by the importing Party, provide full explanation and supporting data for the determinations and decisions covered by this Article, as requested by the importing Party. During the process, the Parties shall endeavour to avoid unnecessary disruption to trade.

11. The importing Party shall assess any additional information received from the exporting Party without undue delay and normally within 90 days after receipt. Any verification the importing Party may request shall be carried out in accordance with Article 10 (Audits) and within 90 days following receipt of the request for verification unless otherwise agreed between the Parties.

12. The Parties also recognise the concept of compartmentalisation and agree to cooperate on this matter.

Plants and plant products

13. The Parties recognise the concepts of Pest Free Areas, Pest Free Places of Production and Pest Free Production Sites, as well as areas of low pest prevalence as means to protect plant life or health, and to facilitate trade


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and as specified in relevant IPPC International Standards for Phytosanitary Measures (ISPM), which they agree to apply in their trade.

14. On request, when establishing or maintaining phytosanitary measures, the importing Party shall take into account pest free areas, pest free places of production, pest free production sites, as well as areas of low pest prevalence established by the exporting Party, and in accordance with the relevant international standards.

15. The exporting Party shall identify Pest Free Areas, Pest Free Places of Production, Pest Free Production Sites, or areas of low pest prevalence to the other Party and, upon request, provide a full explanation and supporting data as provided for in the relevant ISPM or otherwise deemed appropriate.

16. Without prejudice to Article 17 (Emergency measures), the importing Party shall in principle base its own determination of the plant health status of the exporting Party or parts thereof on the information provided by the exporting Party in accordance with the SPS Agreement and the ISPM.

17. The importing Party shall assess any additional information received from the exporting Party without undue delay and normally within 90 days after receipt. Any verification the importing Party may request shall be carried out in accordance with Article 10 (Audits) and within 6 months following receipt of the request for verification unless otherwise agreed between the Parties. This period shall be agreed taking into account the biology of the pest and the crop concerned.

Article 8: Transparency

1. The Parties recognise the value of sharing information about their sanitary

and phytosanitary measures on an ongoing basis, and of providing the other Party with the opportunity to comment on their proposed sanitary and phytosanitary measures.

2. In implementing this Article, each Party shall take into account relevant guidance of the WTO SPS Committee and international standards, guidelines and recommendations.


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3. Unless urgent problems of human, animal or plant life or health protection

arise or threaten to arise, or the measure is of a trade-facilitating nature, a Party shall normally allow at least 60 days for the other Party to provide written comments on the proposed measure which may affect trade between the Parties, after it makes the notification. If feasible and appropriate, the Party should allow more than 60 days. The Party shall consider any reasonable request from the other Party to extend the comment period. On request, the Party shall respond to the written comments of the other Party in an appropriate manner.

4.The Parties shall:

(a) pursue transparency as regards SPS measures applicable to trade; (b) enhance mutual understanding of each Party’s SPS measures and

their application; (c) exchange information on matters related to the development and

application of SPS measures, that affect, or may affect, trade between the Parties with a view to minimising their negative trade effects;

(d) upon request of a Party, communicate the import requirements that apply for the import of specific products normally within fifteen days from the receipt of the request; and

(e) upon request of a Party, communicate progress on the application for the approval of specific products normally within fifteen days from the receipt of the request.

5. When the information pursuant to paragraph 4 has been made available by notification to the WTO in accordance with its relevant rules and procedures or when the above information has been made available on the official, publicly accessible and fee free web-sites of the Parties, paragraph 4 is deemed to be fulfilled.

6. Upon request, a Party shall provide to the other Party, the relevant information as appropriate to the circumstances, that the Party considered to develop the proposed measure and to the extent permitted by the confidentiality and privacy requirements of the Party providing the information.


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7. A Party that proposes to adopt a sanitary or phytosanitary measure may discuss with the other Party, on request and if appropriate and feasible, any trade concern that the other Party may raise regarding the proposed measure and the availability of alternative, significantly less trade-restrictive approaches for achieving the objective of the measure. 8. Each Party shall publish, preferably by electronic means, notices of final sanitary or phytosanitary measures in an official journal or website.

9. 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.

10. An exporting Party shall notify the importing Party in a timely and appropriate manner:

(a) if it has knowledge of a significant sanitary or phytosanitary risk related to the current trade;

(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 pest or disease status, such as the

presence and evolution of pests or diseases (including where regionalisation is applied); and

(d) 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 should provide an interval of more than six months between the date it publishes a final sanitary or phytosanitary measure that may affect trade between the Parties 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 is of a trade-facilitating nature.


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12. A Party shall provide to the other Party, on request, all sanitary or phytosanitary measures related to the importation of a product into that Party’s territory.

Article 9: Trade Facilitation/ Conditions

Approval procedures

1. The Parties recognize that each Party has the right to develop and apply approval procedures to ensure the fulfillment of the importing Party appropriate level of protection while minimizing negative trade effects.

2. The Parties shall ensure that all sanitary and phytosanitary approval procedures affecting trade between the Parties:

a) are undertaken and completed without undue delay and

b) are not applied in a manner which would constitute an arbitrary or unjustifiable discrimination against the other Party.

3. Each Party shall endeavour to ensure that products exported to the other Party meet the appropriate level of protection of the importing Party. To this end, the exporting Party shall establish and carry out appropriate control measures, including risk-based on-site inspections where appropriate. The importing Party may require that the relevant competent authority of the exporting Party objectively demonstrate, to the satisfaction of the importing Party, that its import requirements are fulfilled.

4. Where a Party requires a product to be approved prior to its importation, each Party shall promptly make available, upon request, to the other Party information about sanitary and phytosanitary import procedures, in particular that:

a) the standard processing period of each procedure is published or that the anticipated processing period is communicated to the exporting Party upon request;

b) when receiving an application, the competent authority of the importing Party promptly examines the completeness of the documentation and informs the exporting Party in a precise and complete manner of all deficiencies;


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c) the competent authority of the importing Party transmits as soon as possible the results of the procedure in a precise and complete manner to the exporting Party so that corrective action may be taken if necessary; and

d) even when the application has deficiencies, the competent authority of the importing Party proceeds as far as practicable with the procedure if the exporting Party so requests; and that upon request, the exporting Party is informed of the stage of the procedure, with any delay being explained.

5. When a risk assessment is required, each Party under normal circumstances shall promptly, and normally within one year from the date of receipt of the required information for exporting the product, make available the risk assessment it conducts as part of an approval process

6. Each Party shall endeavour to apply reasonable timelines for all steps in its approval processes and shall promptly start these processes upon receipt of an application from the other Party.

7. Each Party shall avoid unnecessary duplication and administrative burdens with respect to:

(a) any documentation, information, or actions that it requires of the applicant as part of its approval processes; and

(b) any information the Party evaluates as part of the approval processes, unless duly justified.

8. Each Party shall promptly make available any changes to its required approval processes or related requirements. Except in duly justified circumstances related to its level of protection, each Party shall endeavour to provide a transition period between the publication of any changes to its approval processes or related requirements and their entry into force to allow the other Party to become familiar with and adapt to such changes. Each Party shall endeavour to accommodate and avoid lengthening the approval process for applications that were submitted prior to publication of the changes. However, where the change reduces burdens, entry into force shall not be unnecessarily delayed.


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9. Upon request, each Party shall provide, in a timely manner, to the other Party information on the stage of the approval procedure.

Specific plant health related conditions

10. In accordance with applicable standards agreed under the IPPC, the Parties undertake to maintain adequate information on their pest status, which may include surveillance, eradication and containment programmes and their results, in order to support the categorisation of pests and to justify import phytosanitary measures.

11. The Parties shall endeavour to establish and update lists of regulated pests for products for which where a phytosanitary concern exists. The list shall contain:

(a) the quarantine pests not present within any part of its territory,

(b) the quarantine pests present but not widely distributed and under official control, and

(c) the regulated non-quarantine pests.

12. Each Party shall limit its import requirements for plants or plant products for which a phytosanitary concern exists to measures ensuring the absence of regulated pests. Such import requirements shall be applicable to the entire territory of the exporting Party taking into account the regional conditions.

13. Consignments of regulated products shall be accepted on the basis of adequate guarantees provided by the exporting Party, without pre-clearance programmes. The system approach for the trade of products conferring the related activities to the phytosanitary authority of the exporting Party, may be applied.

14. The Parties shall only establish phytosanitary measures that are technically justified, consistent with the pest risk involved and represent the least restrictive measures available.

15. For the purpose of the implementation of this section (plant health), the Parties shall take into account the relevant ISPM.


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Specific sanitary and phytosanitary import requirements

16. Where a range of alternative sanitary or phytosanitary measures may be available to achieve the appropriate level of protection of the importing Party, the Parties shall, upon request of the exporting Party, establish a technical dialogue to avoid unnecessary trade disruption and with a view to selecting the most practicable solution.

Article 10: Audits

1. To determine the 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.

2. The importing Party may determine that it is necessary to carry out an audit as one of the tools to assess the exporting Party's official inspection and certification systems. These audits shall follow a systems-based approach which relies on the examination of a sample of system procedures, documents or records and, where required, on-site inspections of facilities within the scope of the audit.

3. Audits shall concentrate primarily on evaluating the effectiveness of the official inspection and certification systems as well as the capacity of the exporting Party to comply with the sanitary and phytosanitary import requirements and related control measures rather than on specific establishments in order to determine the ability of the exporting Party's competent authorities to have and maintain control and deliver the required assurances to the importing country.

4. In undertaking an audit, the importing Party shall take into account relevant guidance of the WTO SPS Committee and that any audit it conducts of the exporting Party's competent authorities conform to relevant international standards, guidelines, and recommendations.

5. The nature and frequency of audits and verifications shall be determined by the importing Party taking into account the inherent risks of the product, the track record of past import checks and other available information,


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such as audits and inspections undertaken by the competent authority of the exporting Party.

6. The Parties shall also endeavour to reduce the frequency and number of audit visits. Where it is deemed necessary by the importing Party to carry out an audit as one of the tools to assess the exporting country's official inspection and certification systems, as well as the capacity of the exporting Party to comply with the sanitary and phytosanitary import requirements and related control measures, the following shall apply:

(a) In case of first-time export request for specific products, the importing Party shall carry out an audit in a representative sample of the other Party.

(b) In case of a subsequent export request related to the same product, with the aim to shorten the time of the approval procedure, the importing Party shall carry out an audit to the exporting Party only in duly justified circumstances. Should the importing Party carry out an audit, it shall provide an explanation to the exporting Party.

7. Prior to the commencement of an audit, the importing Party and exporting Party shall discuss the rationale and decide the objectives and scope of the audit; the criteria or requirements against which the exporting Party will be assessed; and the itinerary and procedures for conducting the audit which shall be laid down in an audit plan. Unless otherwise agreed by the Parties, the importing Party shall provide the exporting Party an audit plan at least 30 days prior to the commencement of the audit.

8. The importing Party shall provide information about the results of audits in writing to the exporting Party. The importing Party shall set forth its findings, conclusions and recommendations (if any) from the audit in writing in a draft audit report.

9. The importing Party shall provide the draft audit report to the imported Party, normally within 30 days of the conclusion of the audit.

10. The exporting Party shall inform the importing Party of any corrective actions based on the importing Party’s findings and conclusions.


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11. The importing Party shall provide the exporting Party the opportunity to comment on the findings of the audit and may take any such comments into account before the importing Party makes its conclusions and takes any action. The importing Party shall provide a final report in writing to the exporting Party normally within two months from the date of receipt of those comments.

12. Each Party shall ensure that procedures are in place to prevent the disclosure of confidential information that is acquired during an audit of the exporting Party’s competent authorities, including procedures to remove any confidential information from a final audit report that is made publicly available.

13. Any measures taken as a consequence of audits and verifications shall be proportionate to the risks identified and shall not be more trade restrictive than required to achieve its appropriate level of protection. If so requested, technical consultations regarding the situation shall be held in accordance with Article 20 (Technical Consultation). The Parties shall consider any information provided through such consultations.

14. Each Party shall bear its own costs associated with the audit or verification.

Article 11: Import Checks 1. Each Party shall ensure that its import checks are risk-based, carried out without undue delay and are applied in a proportionate and non-discriminatory manner.

2. Each Party shall ensure that products exported to another Party meet the sanitary and phytosanitary requirements of the importing Party.

3. Each Party shall make available to the other Party, on request, information on its import procedures including on the frequency of import checks regarding sanitary and phytosanitary measures and the factors it considers to determining the risks associated with importations.


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4. Where an import check reveals a non-compliance with the relevant import requirements, the following provisions shall apply: a) the action taken by the importing Party shall be based on an assessment

of the risk involved, and shall not be more trade-restrictive than necessary to achieve the Party’s appropriate level of sanitary or phytosanitary protection.

b) The importing Party shall inform the importer, or its representative of the reason for the non-compliance, the legal basis for the action, and as appropriate, on the disposition of that consignment. The importer, or its representative, shall be given the opportunity to provide relevant information to assist the importing Party in taking a final decision.

5. When a Party prohibits or restricts the importation of a good of another Party on the basis of an adverse result of an import check, the importing Party, shall, consistent with its domestic law and regulations, if requested by the competent authority of the exporting Party or the operator responsible of the consigment, provide in writing through normal channels the reason for the prohibition or restriction, the legal basis or authorization for the action and, as appropriate, information on the disposition of that consignment1.

6. Where the consignment is accompanied by a certificate, the importing

Party shall inform the competent authority of the exporting Party in case of a rejection and provide all appropriate information, including the legal basis for the action, detailed laboratory results and methods. The importing Party shall maintain physical and electronic documentation regarding the identification, collection, sampling, transportation and storage of the test sample and the analytical methods used on the test sample. The importing Party shall also inform the importer or its representative on the disposal of

1 For greater certainty, nothing in this Article prevents an importing Party from disposing of a consignment which is found to have an infectious pathogen or pest that can, if urgent action is not taken, spread and cause damage to human, animal or plant life or health in the Party’s territory.


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that consignment. In the case of pest interceptions, the notification shall indicate the pest at the species level whenever feasible.

7. If an importing Party determines that there is a significant, sustained or recurring pattern of non-conformity with a sanitary or phytosanitary measure, the importing Party shall notify the exporting Party of the non-conformity.

8. Notwithstanding paragraph 6, on request, the importing Party shall provide to the exporting Party available information on goods from the exporting Party that were found not to conform to a sanitary or phytosanitary measure of the importing Party.

9. Any fees imposed for the procedures on imported products from the

exporting Party shall not be higher than the actual cost of the service.

Article 12: Certification

1. When a Party requires an export certificate for the importation of a

product, this shall be based on the international standards of the Codex, the IPPC and the OIE.

2. Each Party shall ensure that its certification forms, including any attestations are prepared in a manner that avoids imposing unnecessary burden.

3. An importing Party shall promptly provide to another Party, on request, information on the certificates required for a specific product.

4. The Parties shall strengthen their cooperation in developing model certificates with a view to reducing administrative burdens and facilitating access to their respective markets.

5. The Parties shall promote the implementation of electronic certification and other technologies to facilitate trade.


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6. Each Party shall accept the exchange of original certificate information either by a paper-based system or a secure method of electronic data transmission that offers an equivalent certification guarantee. The exporting Party may select to provide electronic official certification if the importing Party has determined that equivalent security guarantees are being provided, including the use of a digital signature and on the guarantee of the authenticity of the document.

Article 13: Committtee 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 (Committee), composed of official representatives of each Party who have responsibility for sanitary and phytosanitary matters.

2. The objectives of the Committee are to: (a) enhance each Party’s implementation of this Chapter;

(b) consider sanitary and phytosanitary matters of mutual interest; and

(c) enhance communication and cooperation on sanitary and phytosanitary matters.

3. The Committee:

(a) shall provide a forum to improve the Parties’ understanding of

sanitary and phytosanitary issues that relate to the implementation of this Chapter; including the regulatory processes related to SPS measures;

(b) shall provide a forum to monitor the implementation of this Chapter and to consider any matter relating to this Chapter, and to examine all matters which may arise in relation to its implementation;

(c) shall provide a forum for discussion of concerns from the


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application of sanitary or phytosanitary measures with a view to reaching mutually acceptable solutions and promptly addressing any matters that may create unnecessary obstacles to trade among the Parties;

(d) shall exchange information, expertise and experiences on sanitary

and phytosanitary matters; (e) may identify and prioritise areas for cooperation between the

Parties on sanitary and phytosanitary measures which may include technical assistance;

(f) may promote cooperation between the Parties on sanitary and

phytosanitary issues under discussion in multilateral fora, including the WTO SPS Committee and international standard setting bodies, as appropriate;

(g) may establish working groups consisting of expert-level

representatives of the Parties, to address specific SPS issues. When additional expertise is needed, participants from non-governmental organisations may be included, with the modalities decided by the Parties;

(h) may identify and discuss on any other function that is mutually

agreed between the Parties; (i) In the event that the Committee is unable to reach a solution for a

specific issue , the Committee shall, upon request of a Party, report promptly to the "Joint Committee".

4. Any action shall be agreed by both Parties.

5. The Committee shall establish its terms of reference at its first meeting and

may revise those terms as needed.

6. The Committee shall meet within one year of the day of entry into force of this Agreement and once a year thereafter unless Parties agree otherwise.


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Article 14: Competent Authorities and Contact Points

1. For the purposes of this chapter, the competent authorities and the contact points of the Parties are listed in the Annex (competent authorities and contact points).

2. The Parties shall inform each other of any change of the competent authorities and contact points.

Article 15: Application of SPS measures

1. Except as provided for in Article 7 (Adaptation to Regional Conditions, Including Pest- or Disease-Free Areas and Areas of Low Pest or Disease Prevalence) each Party shall apply its sanitary or phytosanitary import conditions to the territory of the other Party.

2. In order to avoid an arbitrary or unjustifiable discrimination, the same import requirements shall apply to the territory of the exporting Party where identical or similar sanitary or phytosanitary conditions exist.

3. In case of a first time export request for a specific product, the importing

Party shall promptly start the approval procedure for an application from the other Party, or, as the case may be, for a group of States2 of the other Party. The approval procedure shall follow the procedure laid down in Article 9 (Trade facilitation/conditions) and, in case of an application of a group of States where identical or similar sanitary or phytosanitary conditions exist, shall not take longer than for an application from one State of the other Party.

4. In case of a subsequent export request related to the same product, the importing Party shall approve the application no later than 6 months, unless in duly justified circumstances. Information requirements shall be limited to what is necessary and shall take into account information already

2 For greater certainty the term States only applies to the EU and refers to EU Member States.


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available in the importing Party, such as on the legislative framework and audit reports.

Article 16: Elimination of redundant control measures3

1. The Parties recognise that the exporting Party is responsible to ensure that establishments, facilities and products eligible for exports meet the applicable sanitary requirements of the importing Party.

2. If the importing Party maintains a list of authorised establishments or facilities for the import of a commodity, it shall approve an establishment or facility situated in the territory of the exporting Party without prior inspection of that establishment or facility if the exporting Party has requested such an approval for the establishment or facility, accompanied by the appropriate guarantees; and the following conditions and procedures are fulfilled:

a. The importing Party has authorised the import of the product on the basis of an evaluation of the control system on animal health and food safety conditions applied by the competent authorities of the exporting Party;

b. the establishment or facility concerned has been approved by the

competent authority of the exporting Party;

c. the competent authority of the exporting Party has the authority to suspend or withdraw the approval of the establishment or facility; and

d. the exporting Party has provided relevant information requested

by the importing Party.

3. The importing Party shall include the establishments on the list of approved establishments normally within 45 days from the date of receipt of the request. The list shall be made publicly available.

4. The importing Party shall have the right to audit the system after the export

approval. These audits may include on the spot inspection of a 3Plants and plant products are excluded from this article.


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representative number of establishments or facilities appearing on the approved establishment list or lists of establishments or facilities to be approved provided by the exporting Party. If as a result of the audit serious recurrent non-compliances are identified, the importing Party shall have the right to suspend the recognition of the system of the exporting Party competent authority.

5. In duly justified circumstances, the importing Party may refuse the approval of establishments or facilities that are considered to be non-compliant with its import requirements. In such cases the importing Party shall notify the exporting Party about the rejections to approve establishments and provide justifications for the refusal.

6. The importing Party may carry out verifications in accordance with the provisions of Article 10 (Audits) of this Chapter as part of the approval procedure. Such verification shall concern the structure, organisation and responsibilities of the competent authority responsible for the approval of the establishment or facility and the sanitary guarantees regarding the compliance with the importing Party’s requirements. These checks may include on the spot inspection of a representative number of establishments or facilities appearing on the approved establishment list or lists of establishments or facilities to be approved provided by the exporting Party.

7. Based on the results of such verification, the importing Party may amend the list of establishments or facilities.

Article 17: Emergency Measures

1. The importing Party may, on serious grounds, provisionally take emergency measures necessary for the protection of human, animal or plant life or health.

2. If a Party adopts an emergency measure that is necessary for the protection

of human, animal or plant life or health, the importing Party shall promptly notify in writing the other Party of that measure through the normal


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channels. The Party that adopts the emergency measure shall take into consideration any information provided by the other Party.

3. If a Party adopts an emergency measure, it shall review the rationale of that

measure normally within six months, provided that the relevant information is available, and inform the results of the review to the other Party on request. Emergency Measures shall not be maintained unless the urgent problem or the threat persists and in that case it should be reviewed periodically.

4. The importing Party that adopts an emergency measure shall consider the most suitable and proportionate solution for consignments in transport between the Parties, according to the identified risk in order to avoid unnecessary disruptions to trade.

Article 18: Cooperation

1. The Parties shall explore opportunities for further cooperation, collaboration and information exchange between the Parties on sanitary and phytosanitary matters of mutual interest, consistent with this Chapter. Those opportunities may include trade facilitation initiatives.

2. The Parties shall cooperate to facilitate the implementation of this Chapter and may jointly identify work on sanitary and phytosanitary matters with the goal of eliminating unnecessary barriers to trade between the Parties.

3. The Parties may promote the cooperation in all multilateral fora, in

particular with the relevant international standard setting bodies.

Article 19: Information Exchange

Without prejudice to any other information exchange´ provision under this Chapter, a Party may request information from the other Party on a matter arising under this Chapter. A Party that receives a request for information shall endevour to provide available information, permitted by the


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confidentiality and privacy requirements of the Party providing the information, to the requesting Party within a reasonable period of time, and if possible, by electronic means.

Article 20: Technical Consultations

1. Each Party can request to hold technical discussions on specific trade concerns for SPS measures.

2. The Parties shall hold technical consultations upon 30 days following the application of the Party requesting the consultations, unless the Parties agree on additional time.

3. The Parties shall endeavour to provide all relevant information necessary to avoid unnecessary disruption to trade and to reach a mutually acceptable solution.

Annex

Competent Authorities and Contact Points For the purposes of Article 14, the Competent Authorities are the following, or its successors:

a) In the case of Mexico:

- General Directorate of Agrifood Safety, Aquaculture and Fisheries of the National Service of Food and Agriculture Health, Safety, and Quality (SENASICA);

- General Directorate of Animal Health of the National Service of Food and Agriculture Health, Safety, and Quality (SENASICA);


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- General Directorate of Plant Health of the National Service of Food and Agriculture Health, Safety, and Quality (SENASICA);

Commission of Sanitary Enforcement – Federal Commission for Protection against Sanitary Risk (COFEPRIS);

- Commission of Evidence and Risk Management – Federal Commission for Protection against Sanitary Risk (COFEPRIS);

- General Coordination of the Federal Sanitary System – Federal Commission for Protection against Sanitary Risks (COFEPRIS), and

- General Direction of Forest and Soil Management of the Ministry of Environment and Natural Resources (SEMARNAT).

b) In the case of the EU control is shared between the national Services of the Member States and the European Commission. In this respect the following applies:

- As regards exports to Mexico, the Member States are responsible for control of the production circumstances and requirements, including statutory inspections or audits and issuing health and animal welfare certifications attesting to the agreed standards and requirements;

- As regards imports from Mexico, the Member States are responsible for control of the compliance of the imports with the European Union Party’s import conditions; and

- The European Commission is responsible for the overall co-ordination, inspection or audits of control systems and the necessary measures, including legislative action to ensure uniform application of standards and requirements within the European Union Party

For the purposes of Article 14, the Contact Points are the following, or its successors:

a) In the case of Mexico:

- General Direction of International Trade Rules of the Vice Ministry of Foreign Trade of the Ministry of Economy.


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b) In the case of the EU:

-The European Commission

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