Each Party acknowledges that the threat of antimicrobial resistance requires developing and implementing a National Action Plan in line with the Global Action Plan on Antimicrobial Resistance.
The Parties shall endeavour to cooperate on areas of mutual interest in antimicrobial resistance and exchange their experiences, relevant information, expertise and data with each other.
The Parties affirm the right of each Party to set its policies, needs, and priorities on antimicrobial resistance specific to their own sensitivities and to adopt or modify its laws, regulations, and policies in this area, informed by the global effect of antimicrobial resistance.
If a Party has specific concerns regarding sanitary or phytosanitary measures proposed or implemented by the other Party, or any other measure within the scope of this Chapter, it may request technical consultations through the appropriate contact point or focal point, as identified in accordance with Article
6.18 (Competent Authorities and Contact Points).
Unless the Parties determine otherwise, the technical consultations shall be held as soon as possible, and in any case, within 30 days of the request. Consultations may be conducted by electronic or other means, as determined by the Parties.
The purpose of technical consultations is to share information and increase understanding, with a view to resolving any concerns about the specific measure that is the subject of the consultations, within a reasonable period of time.
If the Parties have already resorted to other mechanisms than those referred to in this Article to address the concerns, they shall continue to make use of them to avoid unnecessary duplication. A Party may request technical consultations to address these concerns, in accordance with paragraph 1, if such other mechanisms do not result in a mutually satisfactory resolution, including if it is not practicable to make use of those mechanisms within a reasonable period of time.
Notification and Information Exchange
Each Party shall promptly notify the other Party of a:
significant change to disease status, such as the presence and evolution of a disease listed in the WOAH list of terrestrial and aquatic animal diseases;
finding of epidemiological importance for an animal disease which is not listed in the WOAH list of terrestrial and aquatic animal diseases, or which is a new disease;
occurrence, outbreak, or spread of plant pests in their territory in accordance with the relevant IPPC standards; or
significant food safety issue related to a product traded between the Parties.
The Parties shall endeavour to exchange information on other relevant issues including:
changes to a Party’s sanitary and phytosanitary measures and approval
procedures that may affect trade between the Parties;
on reasonable request, information on matters related to the development and application of sanitary and phytosanitary measures, that affect or may affect trade between the Parties, with a view to minimising their negative effects; and
information that may enhance mutual understanding of the Parties’
sanitary and phytosanitary measures and their application.
Unless the SPS Subcommittee decides otherwise, when the information referred to in paragraphs 1 or 2 has been made available via notification to the WTO, or to the relevant international organisations in accordance with its relevant rules, or on publicly available websites of the Parties, the requirement in those paragraphs is deemed to be fulfilled.
The Parties hereby establish a Subcommittee on Sanitary and Phytosanitary Measures, composed of government representatives of each Party responsible for sanitary and phytosanitary matters.
The functions of the SPS Subcommittee shall include:
monitoring implementation and considering any matter related to this Chapter;
providing an opportunity for the identification, prioritisation, discussion, and resolution of sanitary and phytosanitary issues;
facilitating the elimination of unnecessary sanitary and phytosanitary barriers to trade between the Parties;
recommending any agreed proposals to this Chapter to the Joint Committee;
agreeing a written record of the discussions between the Parties on their work and decisions made by the SPS Subcommittee, within a reasonable period of time;
providing a forum to exchange information on each Party’s sanitary and phytosanitary regulatory system;
exchanging views, information and experiences related to the cooperation activities on protecting animal welfare and the threat of antimicrobial resistance under Article 6.12 (Animal Welfare) and Article 6.13 (Antimicrobial Resistance); and
any other function as agreed by the Parties.
The SPS Subcommittee may:
identify opportunities for greater cooperation activities relevant to this Chapter;
provide opportunities to identify initiatives to strengthen bilateral technical cooperation relevant to this Chapter;
discuss, on reasonable request, a new sanitary or phytosanitary measure being considered;
facilitate improved understanding between the Parties on the implementation of the SPS Agreement and promote cooperation between the Parties on sanitary and phytosanitary issues in multilateral fora, including the WTO SPS Committee, and relevant international organisations, as appropriate; and
perform any other actions as agreed by the Parties.
The SPS Subcommittee may establish technical working groups comprising of expert-level representatives of the competent authorities of the Parties to address specific sanitary or phytosanitary issues, or any other issue arising from this Chapter.
A Party may refer any sanitary or phytosanitary issue, or any other issue arising under this Chapter, to the SPS Subcommittee and the SPS Subcommittee shall consider the issue as expeditiously as possible. The SPS Subcommittee shall report to the Joint Committee if it resolves the said issue. If the SPS Subcommittee is unable to resolve an issue it shall, on request of a Party, report promptly to the Joint Committee.
The SPS Subcommittee shall meet within one year of the date of entry into force of this Agreement, and thereafter on an annual basis, unless the Parties agree otherwise. The SPS Subcommittee may decide to meet by electronic means, and it may also address issues out of session by correspondence. Additional meetings may be held upon request of a Party or the Joint Committee.
On entry into force of this Agreement, each Party shall designate and inform the other Party, in writing, of a contact point or focal point, as applicable, to coordinate the SPS Subcommittee meetings in accordance with Article 6.18 (Competent Authorities and Contact Points).
The SPS Subcommittee shall establish its rules of procedure within one year of the date of entry into force of this Agreement, unless the Parties decide otherwise. The SPS Subcommittee shall modify its own rules of procedure if the SPS Subcommittee deems it appropriate.
The SPS Subcommittee shall take decisions and make recommendations by mutual agreement.
The SPS Subcommittee shall report as needed on its activities to the Joint Committee.
A technical working group, established by the SPS Subcommittee, shall meet as agreed by the Parties and shall function on an ad hoc basis.
Technical working groups shall be co-chaired by expert-level representatives of the competent authorities of the Parties, and shall identify, address and attempt to resolve issues arising from this Chapter. If these issues are not able to be resolved at the level of the established technical working group, they shall be reported to the SPS Subcommittee in order to reach a mutually acceptable resolution with the least disruption to trade.
A technical working group, when addressing an issue agreed by the SPS Subcommittee in accordance with paragraph 2, may:
engage, at an early stage, in technical exchange and cooperation regarding sanitary and phytosanitary matters and other matters arising from this Chapter;
consider any sanitary or phytosanitary measure or set of measures identified that is likely to affect bilateral trade, directly or indirectly, and provide technical advice with a view to facilitating the resolution of specific trade concerns relating to that measure or set of measures;
serve as a forum to facilitate discussion and consideration of specific risk assessments; and
report to the SPS Subcommittee on progress of work.
The technical working group shall report its recommendation on a sanitary or phytosanitary issue to the SPS Subcommittee. The technical working group shall also inform the SPS Subcommittee of its recommendation that it be continued, suspended or dissolved.
Competent Authorities and Contact Points
Each Party shall notify to the other Party a list of its competent authorities on entry into force of this Agreement. The notification shall include the respective role, responsibilities, and contact information of these authorities.
Upon entry into force of this Agreement, each Party shall also designate and notify a single contact point that serves as the focal point to respond to enquiries by the other Party about the appropriate contact point for any matter arising from this Chapter, to facilitate any communication between the Parties relating to this Chapter, and any other appropriate contact points for matters arising from this Chapter.
Each Party shall promptly notify the other Party of any change of its competent authorities, the contact information of its competent authorities, or its contact point.
Non-Application of Dispute Settlement
Neither Party shall have recourse to dispute settlement under Chapter 29 (Dispute Settlement) for any matter arising under this Chapter.
Article Article 7.1 Definitions
For the purposes of this Chapter, the terms and definitions set out in Annex 1 to the TBT Agreement, including the chapeau and explanatory notes of Annex 1, shall apply.
The objective of this Chapter is to facilitate trade, including by eliminating unnecessary technical barriers to trade, enhancing transparency, facilitating information exchange, and promoting cooperation.
Unless this Chapter provides otherwise, this Chapter shall apply to the preparation, adoption, and application of all technical regulations, standards, and conformity assessment procedures of central level of government bodies which may affect trade in goods between the Parties.
Each Party shall take such reasonable measures as may be available to it to ensure compliance with this Chapter by regional level of government bodies within its territory, which are responsible for the preparation, adoption, and application of technical regulations, standards, and conformity assessment procedures.
All references in this Chapter to technical regulations, standards, and conformity assessment procedures shall be construed to include any amendments to them and any addition to the rules or the product coverage of those technical regulations, standards, and procedures except amendments and additions of an insignificant nature.
This Chapter shall not apply to:
purchasing specifications prepared by a governmental body for production or consumption requirements of a governmental body; or
sanitary or phytosanitary measures.
Nothing in this Chapter shall prevent a Party from adopting or maintaining technical regulations, standards, or conformity assessment procedures in
accordance with its rights and obligations under this Agreement and the TBT Agreement.
The Parties affirm their rights and obligations under the TBT Agreement.
Standards, Guides, and Recommendations
The Parties recognise the important role that international standards, guides, and recommendations can play in supporting greater harmonisation of technical regulations, conformity assessment procedures, and national standards and in reducing unnecessary barriers to trade.
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 relevant definitions as they are set out and referred to in Annex 1 to the TBT Agreement and shall take into account the Decision of the TBT Committee on Principles for the Development of International Standards, Guides and Recommendations with relation to Articles 2, 5 and Annex 3 of the Agreement.
When developing technical regulations or conformity assessment procedures each Party shall:
use relevant international standards, guides, or recommendations, or relevant parts of them, to the extent provided for in paragraph 4 of Article 2 and in paragraph 4 of Article 5 of the TBT Agreement, as the basis for its technical regulations and conformity assessment procedures; and
avoid deviation from the relevant international standards, guides or recommendations, or the introduction of additional requirements when compared to those standards, guides, or recommendations,
except where it considers that such international standards, guides, or recommendations would be ineffective or inappropriate for the fulfilment of the legitimate objectives pursued, as referred to in Article 2.2 and in Article 5.4 of the TBT Agreement.
Where a Party does not use relevant international standards, guides or recommendations, or the relevant parts of them, as referred to in paragraph 3, that Party shall, on request from the other Party:
explain the reasons; and
provide the available information on which this assessment is based.
To facilitate an appropriate explanation under paragraph 4, the requesting Party shall ensure that its request for an explanation:
identifies a relevant international standard, guide, or recommendation that the Party has not used as a basis for its technical regulation or conformity assessment procedures; and
describes how the technical regulation or conformity assessment procedures that is not based on the international standard, guide, or recommendation is a restriction, or has the potential to restrict, trade between the Parties.
With a view to encouraging the development of international standards, guides, and recommendations that do not create unnecessary obstacles to trade, each Party shall encourage national standards bodies within its territory to cooperate with the national standards bodies in the territory of the other Party.
The Parties shall exchange available information on:
each Party’s use of standards in technical regulations;
the standard setting processes; and
cooperation agreements or arrangements on standardisation with third parties or international organisations subject to any confidentiality obligations under those agreements or arrangements.
Each Party shall encourage national standards bodies within its territory to make standards and the standards development process gender responsive in line with the United Nations Economic Commission for Europe (UNECE) Declaration for Gender Responsive Standards and Standards Development approved at the 28th Annual Session of the UNECE Working Party on Regulatory Cooperation and Standardization Policies on 15 November 2018.
Each Party shall give positive consideration to accepting, as equivalent, technical regulations of the other Party, even if these regulations differ from its own, provided it is satisfied that these regulations adequately fulfil the objectives of its own regulations.
In addition to Article 2.7 of the TBT Agreement, a Party shall, on request of the other Party,1 provide the reasons why it has not or cannot accept a technical regulation of that Party as equivalent to its own. The Party to which the request
1 The Party’s request should identify with precision the respective technical regulation it considers to be equivalent and any data or evidence that supports its position.
is made should provide its response to the other Party within a reasonable period of time.
Upon request of a Party that has an interest in developing a technical regulation similar to a technical regulation of the other Party, the requested Party shall endeavour to provide, to the extent practicable, relevant information, including any studies or documents, except for confidential information, on which it has relied in its development of that regulation.
Where a Party requires that conformity assessment procedures in relation to specific products are performed by specified government authorities of the Party, the Party conducting the conformity assessment procedures shall:
ensure the conformity assessment fee takes into account the cost of the services rendered; and
make information on the conformity assessment fees publicly available.
Where a Party requires a conformity assessment as a positive assurance that a product conforms with a technical regulation, it shall:
select conformity assessment procedures that take into account the risks of nonconformity;
consider, as appropriate, as proof of compliance with technical regulations, the use of a supplier’s declaration of conformity; and
where requested by the other Party, consider, if feasible, providing information on the criteria used to select the conformity assessment procedures for specific products.
The Parties recognise the advantages of enabling conformity assessment procedures to be carried out online where applicable and reasonably practicable. Where a Party does not allow a conformity assessment procedure to be carried out online, it shall, on request of the other Party, share its reasons.
In cases where a positive assurance is required that a product conforms with technical regulations or standards, and relevant international standards, guides or recommendations issued by international standardising bodies exist or their completion is imminent, each Party shall ensure that central level of government bodies use them, or the relevant parts of them, as a basis for their conformity assessment procedures, except where, as duly explained upon request by the other Party, such international standards, guides or recommendations, or relevant parts are inappropriate for the Party concerned, for, amongst other
2 Nothing in this Article requires a party to accept the results of a conformity assessment body which has not been accredited by an accreditation body of that Party.
things, reasons such as: national security requirements; the prevention of deceptive practices; protection of human health or safety, animal or plant life or health, or the environment; fundamental climatic or other geographical factors; or fundamental technological or infrastructural problems.
Procedures for assessment of conformity by central level of government bodies of each Party shall be in accordance with Article 5 of the TBT Agreement.
Further to Articles 6.1 and 6.3 of the TBT Agreement, a Party shall ensure, whenever possible, that results of the conformity assessment procedures in the other Party are accepted, even when those procedures differ from its own, provided it is satisfied that those procedures offer an assurance of conformity with applicable technical regulations or standards equivalent to its own procedures.3 A Party shall, upon request of the other Party, explain its reasons for not accepting the results of a conformity assessment procedure conducted in the other Party.
The Parties recognise that a broad range of mechanisms exist to facilitate the acceptance in a Party’s territory of the results of conformity assessment procedures conducted in the other Party’s territory. For example:
a Party may agree with the other Party to accept the results of conformity assessment procedures that conformity assessment bodies located in the other Party’s territory conduct for specific technical regulations;
a Party may adopt accreditation procedures for qualifying conformity assessment bodies located in the other Party’s territory;
a Party may recognise the results of conformity assessment procedures conducted in the other Party’s territory;
conformity assessment bodies located in the territory of either Party may enter into voluntary arrangements to accept the results of each other’s assessment procedures; and
the importing Party may rely on a supplier’s declaration of conformity.
The Parties shall exchange information on the range of mechanisms relevant to conformity assessment procedures in their respective territories with a view to facilitating the acceptance of conformity assessment results.
A Party shall, if it considers appropriate and in accordance with its laws and regulations, permit participation of conformity assessment bodies which are located in the territory of the other Party, in its conformity assessment procedures for the sectors set out in Annex 7A (Product Sectors), under conditions no less favourable than those accorded to conformity assessment bodies located in the territory of the permitting Party.
3 For greater certainty, it is recognised that prior consultations may be necessary in order to arrive at a mutually satisfactory understanding.
Where a Party permits participation of its conformity assessment bodies and does not permit participation of conformity assessment bodies of the other Party in its conformity assessment procedures as referred to in paragraph 9, it shall, upon reasonable written request of the other Party, explain the reason for its refusal in writing.
The Parties recognise the important role that relevant regional or international organisations can play in cooperation in the area of conformity assessment. In this regard, each Party shall take into consideration the participation status or membership in such organisations of relevant bodies in the Parties in facilitating this cooperation.
The Parties shall encourage cooperation between their relevant conformity assessment bodies in working closer on matters such as the acceptance of conformity assessment results between Parties.
The Parties shall exchange information on accreditation policy and promote the use of accreditation to facilitate acceptance of conformity assessment results and consider how to make best use of international standards for accreditation and international agreements involving the Parties’ accreditation bodies, for example, through the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement or the International Accreditation Forum Multilateral Arrangement. Each Party shall use accreditation with authority derived from its government or performed by its government, as appropriate, as a means to demonstrate the technical competence of a conformity assessment body.
Each Party shall ensure that its technical regulations concerning product marking and labelling:
accord treatment no less favourable than that accorded to like goods of national origin; and
do not create unnecessary obstacles to trade between the Parties.
In particular, if a Party requires marking or labelling of a product in the form of a technical regulation:
the Party shall accept that labelling and corrections to labelling may take place in custom warehouses or other designated areas in the country of import, subject to its relevant laws, regulations, and customs procedures, as an alternative to labelling and corrections to labelling in the country of origin, unless such labelling and corrections to labelling are required to be carried out by approved persons for reasons of public health or safety;
the Party shall, unless it considers that legitimate objectives under the TBT Agreement are compromised thereby, endeavour to accept supplementary, non-permanent, or detachable labels, or marking or labelling in the accompanying documentation rather than physically attached to the product; and
provided that it is not misleading, contradictory, inconsistent or confusing, or that the Party’s legitimate objectives are not compromised, the importing Party shall permit the following in relation to the information it requires:
information in other languages in addition to the language required in the Party;
internationally accepted nomenclatures, pictograms, symbols, or graphics in addition to those required in the Party; and
additional information to that required in the Party.
A Party shall, where feasible, not require any prior approval, registration or certification of markings or the labels of products as a precondition for placing on its market products that otherwise comply with its mandatory technical requirements, unless necessary to fulfil its legitimate objectives.
The Parties recognise the importance of the provisions relating to transparency in the TBT Agreement. In this respect, the Parties shall take into account the relevant Decisions and Recommendations adopted by the WTO Committee on Technical Barriers to Trade Since 1 January 1995 (G/TBT/1/Rev.13), as may be revised, issued by the WTO Committee on Technical Barriers to Trade.
Upon request, a Party shall provide, if already available, the full text or summary of its notified technical regulations and conformity assessment procedures in English. If unavailable, the Party shall provide a summary stating the requirements of the notified technical regulations and conformity assessment procedures to the requesting Party in English within a reasonable period of time agreed between the Parties and, if possible, no later than 30 days after receiving the written request. In implementing the preceding sentence, the contents of the summary shall be determined by the responding Party.
Unless otherwise provided for in this Chapter, any information or explanation requested by a Party pursuant to this Chapter shall be provided by the other Party in English, in print or electronically, within a reasonable period of time mutually agreed by the Parties and, if possible, within 60 days of the request.
Each Party shall allow persons of the other Party to participate in the consultation procedures which are available to the general public for the development of technical regulations, national standards and conformity
assessment procedures, subject to its laws and regulations or administrative arrangements on terms no less favourable than those accorded to its own persons.
A Party making a notification in accordance with Article 2.9.2 or Article 5.6.2 of the TBT Agreement shall include in the notification a statement describing the objective of the proposal and the rationale for the approach the Party is proposing.
Each Party shall normally allow 60 days from the date of notification to the WTO in accordance with Articles 2.9 and 5.6 of the TBT Agreement for the other Party to make comments in writing, except where urgent problems of safety, health, environmental protection, or national security arise or threaten to arise. A Party shall give positive consideration to a reasonable request from the other Party to extend the comment period.
Each Party shall take the comments of the other Party into account and shall endeavour to provide a response to these comments upon request of the other Party.
Upon request of the other Party, a Party shall provide the other Party with information regarding the objective of, and rationale for, a technical regulation or conformity assessment procedure that the Party has adopted or is proposing to adopt.
Each Party shall 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.
Each Party shall publish, preferably by electronic means, in at least one official journal or website, all proposals for new technical regulations and conformity assessment procedures and proposals for amendments to existing technical regulations and conformity assessment procedures, and all new final technical regulations and conformity assessment procedures and final amendments to existing technical regulations and conformity assessment procedures, of central level of government bodies, that a Party is required to notify or publish under the TBT Agreement or this Chapter, and that may have a significant effect on trade.4 These publications shall be made available in English.
Each Party shall take such reasonable measures as may be available to it to ensure that, all proposals for new technical regulations and conformity assessment procedures, and proposals for amendments to existing technical regulations and conformity assessment procedures, and all new final technical regulations and conformity assessment procedures, and final amendments to existing technical regulations and conformity assessment procedures, of its
4 For greater certainty, a Party may comply with this obligation by ensuring that the proposed and final measures in this paragraph are published on, or otherwise accessible through, the WTO’s official website.
regional level of governments are published, and are accessible through an official website or journal.
For the purposes of applying Article 2.12 and Article 5.9 of the TBT Agreement, the term “reasonable interval” shall mean 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 by the requirements concerning the conformity assessment procedure.