International treaty

Chapter 7: Technical Barriers to Trade (web version)

Published 28 February 2022

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Section A: General Provisions

Article 7.1: Definitions

For the purposes of this Chapter, the terms and definitions set out in Annex 1 to the TBT Agreement apply. In addition, for the purposes of this Chapter:

“cosmetic product” means:

(a) for New Zealand, a product or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, or correcting body odours, or protecting them, or keeping them in good condition;

(b) for the United Kingdom, a substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition, or correcting body odour;

“market surveillance” means activities conducted and measures taken by market surveillance and enforcement authorities, including activities conducted and measures taken in cooperation with economic operators, on the basis of procedures of a Party to enable that Party to monitor or address the safety of products and their compliance with the requirements set out in its laws and regulations;

“medicinal product” means:

(a) for New Zealand:

(i) a product for human use defined as a “medicine” in section 3(1) of the Medicines Act 1981; and

(ii) a product for veterinary use defined as a “veterinary medicine” in section 2(1) of the Agricultural Compounds and Veterinary Medicines Act 1997;

(b) for the United Kingdom:

(i) a product for human use defined as a “medicinal product” in regulation 2 of the Human Medicines Regulations 2012, unless it is a “herbal medicinal product” or a “homeopathic medicinal product”; and

(ii) a product for veterinary use defined as a “veterinary medicinal product” in regulation 2(1) of the Veterinary Medicines Regulations 2013; and

“TBT Agreement” means the Agreement on Technical Barriers to Trade in Annex 1A to the WTO Agreement.

Article 7.2: Objectives

The objectives of this Chapter are to increase and facilitate trade in goods between the Parties by preventing, identifying, and eliminating unnecessary technical barriers to trade, enhancing transparency, and promoting regulatory cooperation and good regulatory practice.

Article 7.3: Scope

1. Unless otherwise indicated, 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 the trade in goods between the Parties.

2. 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 conformity assessment procedures, except amendments and additions of an insignificant nature.

3. This Chapter shall not apply to:

(a) technical specifications prepared by a governmental body for production or consumption requirements of a governmental body; or

(b) sanitary or phytosanitary measures which are covered by Chapter 5 (Sanitary and Phytosanitary Measures).

4. For greater certainty, 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, the TBT Agreement, and any other relevant international agreement.

5. Each Party shall take those reasonable measures as may be available to it to encourage observance of the provisions of Article 7.7 (Equivalency of Technical Regulation) and Article 7.8 (Conformity Assessment) by regional level of government bodies, which are responsible for the preparation, adoption, and application of technical regulations, standards, and conformity assessment procedures.

Article 7.4: Incorporation of Certain Provisions of the TBT Agreement

1. The Parties affirm their rights and obligations under the TBT Agreement.

2. The following provisions of the TBT Agreement are incorporated into and made part of this Agreement, mutatis mutandis:

(a) Article 2 (Preparation, Adoption and Application of Technical Regulations by Central Government Bodies);

(b) Article 5 (Procedures for Assessment of Conformity by Central Government Bodies);

(c) Annex 1 (Terms and their Definitions for the Purpose of this Agreement) including its chapeau and explanatory notes; and

(d) paragraphs D to F of Annex 3 (Code of Good Practice for the Preparation, Adoption and Application of Standards).

Article 7.5: Cooperation

1. The Parties shall strengthen their cooperation and intensify their joint work in the fields of technical regulations, standards, and conformity assessment procedures with a view to facilitating access to each other’s market.

2. In particular, the Parties shall seek to identify, develop, and promote trade facilitating initiatives of mutual interest. Those initiatives may include:

(a) promoting good regulatory practices through regulatory cooperation between the Parties, including the exchange of information, experience, and data;

(b) increasing the convergence of their respective technical regulations, standards, and conformity assessment procedures with relevant international standards, guides, or recommendations;

(c) cooperation through joint standards development in areas of shared interest; and

(d) promoting or enhancing cooperation between organisations in the Parties in charge of standardisation, conformity assessment procedures, metrology, market surveillance, or monitoring and enforcement activities.

3. At the request of the other Party, a Party shall give positive consideration to any sector-specific proposal that the requesting Party makes for further cooperation under this Chapter.

4. The Parties shall explore opportunities to promote cooperation and the exchange of information between themselves and between their respective standards development and conformance organisations,^{[footnote 1]} public or private, on how those organisations may support the participation of developing countries in relevant international fora and in overcoming barriers to trade.

Article 7.6: International Standards, Guides, and Recommendations

1. The Parties recognise the important role that international standards, guides, and recommendations can play in supporting greater regulatory alignment, good regulatory practice, and reducing unnecessary barriers to trade.

2. To determine whether there is an international standard, guide, or recommendation within the meaning of Article 2, Article 5, and Annex 3 of the TBT Agreement, the Parties shall apply the relevant definitions as they are set out, and referred to, in Annex 1 to the TBT Agreement and follow the principles and procedures set out in the TBT Committee Decision on International Standards.^{[footnote 2]}

3. Where a Party does not use relevant international standards, guides, or recommendations, or the relevant parts thereof, as the basis for its technical regulations and conformity assessment procedures, that Party shall, on request from the other Party:

(a) identify any substantial deviation from the relevant international standards, guides, or recommendations;

(b) explain the reasons why those international standards, guides, or recommendations have been considered inappropriate or ineffective for the aim pursued; and

(c) provide the evidence on which this assessment is based, where available.

4. With a view to encouraging that the development of international standards, guides, and recommendations, which are likely to become a basis for technical regulations and conformity assessment procedures, do not create unnecessary obstacles to international trade, the Parties shall encourage national standardising bodies within their territories to cooperate with each other in appropriate circumstances.

Article 7.7: Equivalency of Technical Regulation

1. A Party shall, at the written request of the other Party, give positive consideration to accepting technical regulations of the other Party as equivalent, even if they differ, provided that it is satisfied that the technical regulation of the other Party adequately fulfils the objectives of its own technical regulation. If the requested Party does not accept a technical regulation of the other Party as equivalent, it shall, at the request of the other Party, explain the reasons for its decision.

2. A Party shall also give positive consideration to a request by the other Party to develop general or further arrangements, or to negotiate and conclude agreements, for achieving the equivalence of technical regulations. Where a Party declines a request, it shall, at the request of the other Party, explain the reasons for its decision.

Article 7.8: Conformity Assessment

1. The Parties recognise that a broad range of mechanisms exists to facilitate the acceptance of conformity assessment results, which may include:

(a) accepting suppliers’ declarations of conformity;

(b) unilateral recognition by a Party of the results of conformity assessment procedures performed in the territory of the other Party;

(c) cooperative arrangements between conformity assessment bodies of the Parties;

(d) mutual recognition of conformity assessment procedures conducted by bodies located in the territory of the other Party;

(e) use of accreditation procedures for qualifying conformity assessment bodies;

(f) government designation of conformity assessment bodies; and

(g) cooperative arrangements between accreditation bodies of the Parties.

2. 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.

3. The Parties acknowledge the trade facilitation role played by the Agreement on Mutual Recognition in Relation to Conformity Assessment between the Government of the United Kingdom of Great Britain and Northern Ireland and the Government of New Zealand done at London on 21 January 2019 (“NZ-UK MRA”), and the importance of cooperating in the field of mutual recognition in relation to conformity assessment in accordance with that agreement. The Parties may agree, in accordance with the NZ-UK MRA, to extend the coverage of that agreement.

4. The Parties shall commence a review of this Article within 12 months of the date of entry into force of this Agreement, or such longer period as the Parties shall agree. The review shall be with a view to:

(a) amending this Agreement to include a requirement that each Party shall accord to conformity assessment bodies located in the territory of the other Party treatment no less favourable than that it accords to conformity assessment bodies located in its own territory if, by the date of the review, the Comprehensive and Progressive Agreement for Trans-Pacific Partnership done at Santiago on 8 March 2018 (“CPTPP”) has entered into force in respect of the United Kingdom; or

(b) exploring amending this Agreement to include a requirement in line with subparagraph (a) if, by the date of the review, the CPTPP has not entered into force in respect of the United Kingdom.

5. Where a Party requires conformity assessment as a positive assurance that a product conforms with a technical regulation, it shall:

(a) select conformity assessment procedures that are proportionate to the risks involved, as determined on the basis of a risk assessment;

(b) consider as proof of compliance with technical regulations the use of a supplier’s declaration of conformity, i.e. a declaration of conformity issued by the manufacturer on the sole responsibility of the manufacturer without a mandatory non-party assessment, as assurance of conformity among the options for showing compliance with technical regulations; and

(c) where requested by the other Party, provide information on the criteria used to select the conformity assessment procedures for specific products.

6. Where a Party requires a non-party conformity assessment as a positive assurance that a product conforms with a technical regulation and it has not reserved this task to a government authority in accordance with paragraph 7, it shall:

(a) use accreditation, as appropriate, as a means to demonstrate technical competence to qualify conformity assessment bodies. Without prejudice to its right to establish requirements for conformity assessment bodies, each Party recognises the valuable role that accreditation operated with authority derived from government and on a non-commercial basis can play in the qualification of conformity assessment bodies;

(b) use relevant international standards for accreditation and conformity assessment;

(c) encourage accreditation bodies and conformity assessment bodies located within its territory to join any relevant functioning international agreements or arrangements for harmonisation or facilitation of acceptance of conformity assessment results, and where appropriate, consider using those agreements or arrangements in approving conformity assessment bodies;

(d) if two or more conformity assessment bodies are authorised by a Party to carry out conformity assessment procedures required for placing a product on the market, ensure that economic operators have a choice amongst the conformity assessment bodies designated by the authorities of a Party for a particular product or set of products;

(e) ensure that conformity assessment bodies carry out their activities in a manner that prevents conflicts of interests affecting the outcome of the assessment;

(f) allow conformity assessment bodies to use subcontractors to perform testing or inspections in relation to the conformity assessment, including subcontractors located in the territory of the other Party, and may require subcontractors to meet the same requirements the conformity assessment body must meet to perform that testing or those inspections itself; and

(g) ensure the details, including the scope of the designation, of the bodies that have been designated to perform that conformity assessment are published by digital means.

7. Nothing in this Article shall preclude a Party from requiring that conformity assessment in relation to specific products is performed by its specified government authorities. If a Party requires that conformity assessment is performed by its specified government authorities, that Party shall:

(a) limit the conformity assessment fees to the approximate cost of the services rendered and, at the request of an applicant for conformity assessment, explain how any fees it imposes for that conformity assessment are limited to the approximate cost of services rendered; and

(b) make publicly available the conformity assessment fees.

Article 7.9: Transparency

1. In order to enhance the opportunity for persons to provide meaningful comments, a Party making a notification in accordance with Article 2.9.2 or Article 5.6.2 of the TBT Agreement shall:

(a) include in the notification a statement describing the objective of the proposal and the rationale for the approach the Party is proposing; and

(b) transmit the notification electronically to the other Party through the enquiry point established in accordance with Article 10 of the TBT Agreement at the same time as it notifies WTO members in accordance with the TBT Agreement.

2. Each Party shall endeavour to allow at least 60 days from the transmission under subparagraph 1(b) for the other Party or persons of the other Party to make comments in writing on the proposal. A Party shall give positive consideration to a reasonable request from the other Party to extend the comment period.

3. When a Party makes a notification in accordance with Article 2.10 or Article 5.7 of the TBT Agreement, it shall at the same time transmit the notification to the other Party, electronically, through the enquiry point referred to in subparagraph 1(b).

4. Each Party shall provide information on the adoption and the entry into force of the technical regulation or conformity assessment procedure and the adopted final text through an addendum to the original notification.

5. Further to Article 2.12 and Article 5.9 of the TBT Agreement, the phrase “reasonable interval” shall be understood to mean normally a period of no less than six months, except when this would be ineffective in fulfilling the legitimate objectives pursued.

6. Each Party shall take those reasonable measures as may be available to it to ensure that all proposals for, and final, technical regulations and conformity assessment procedures of the regional level of government are published.

7. Each Party shall ensure that all final technical regulations and conformity assessment procedures, and, to the extent practicable, all proposals for technical regulations and conformity assessment procedures, of the regional level of government are accessible through official websites or journals.^{[footnote 3]}

Article 7.10: Contact Points

1. Each Party shall designate and notify a contact point for matters arising under this Chapter. The contact points shall work jointly to facilitate the implementation of this Chapter and cooperation between the Parties on matters relating to this Chapter.

2. A Party shall promptly notify the other Party of any change of its contact point or the details of the relevant officials.

3. The responsibilities of each contact point shall include:

(a) communicating with the other Party’s contact point, including facilitating discussions, requests, and the timely exchange of information on matters arising under this Chapter;

(b) communicating with and coordinating the involvement of relevant government agencies, including regulatory authorities, in its territory on relevant matters pertaining to this Chapter; and

(c) consulting and, if appropriate, coordinating with interested persons in its territory on relevant matters pertaining to this Chapter.

Article 7.11: Technical Discussions

1. A Party may request technical discussions with the other Party with the aim of resolving any matter that arises under this Chapter to the mutual satisfaction of both Parties.

2. Unless the Parties agree otherwise, the Parties shall hold technical discussions within 60 days of the request for technical discussions, and by any agreed method. The Parties shall endeavour to resolve the matter as expeditiously as possible and if the requesting Party considers that the matter is urgent, it may request that any discussions commence within a shorter timeframe. In that case, the responding Party shall give positive consideration to this request.

3. For greater certainty, for technical regulations or conformity assessment procedures of the regional level of government that may have a significant effect on trade, a Party may request technical discussions under this Article with the other Party regarding those matters.

4. For greater certainty, information exchanged in the course of technical discussions is subject to Article 32.8 (Confidentiality – General Exceptions and General Provisions). Unless the Parties agree otherwise, those discussions shall be without prejudice to the rights and obligations of the Parties under this Agreement, the WTO Agreement, or any other agreement to which both Parties are party.

Article 7.12: Annexes and Implementing Arrangements

1. The Parties may conclude, in accordance with Article 33.3 (Amendments – Final Provisions), Annexes to this Chapter setting out agreed principles and procedures relating to technical regulations and conformity assessment applicable to trade between them.

2. The Parties may develop arrangements setting out details for the implementation of this Chapter, including the Annexes. Those arrangements may include provisions for the implementation of cooperation in respect of particular sectors or areas of mutual interest.

3. The rights and obligations set out in each Annex to this Chapter shall apply only to the sector specified in that Annex and shall not affect a Party’s rights or obligations under any other Annex.

4. An Annex to this Chapter may set out the scope which is to apply to that Annex.

Article 7.13: Market Surveillance

1. Each Party shall endeavour to:

(a) exchange information with the other Party on market surveillance and enforcement activities, which may include information on the authorities responsible for market surveillance and enforcement, and on measures taken against dangerous products;

(b) ensure the impartial functioning of market surveillance functions from conformity assessment functions with a view to avoiding conflicts of interest;^{[footnote 4]} and

(c) ensure that there are no conflicts of interest between market surveillance authorities and the persons concerned, subject to control or supervision, including the manufacturer, the importer, and the distributor.

2. Further to Article 32.8 (Confidentiality – General Exceptions and General Provisions), any discussions or information exchanged under this Article shall be designated confidential, unless the Parties agree otherwise.

Article 7.14: Marking and Labelling

1. In accordance with Article 7.4 (Incorporation of Certain Provisions of the TBT Agreement), each Party shall ensure that its technical regulations concerning product marking and labels comply with Article 2.1 and Article 2.2 of the TBT Agreement.

2. In particular, if a Party (“the Importing Party”) requires marking or labelling of a product in the form of a technical regulation:

(a) the Importing Party shall accept that labelling and corrections to labelling take place within its territory but prior to offering the product for sale in the Importing Party’s territory, subject to its relevant applicable laws, regulations, and customs procedures, as an alternative to labelling in the exporting Party, unless that labelling is required for reasons of public health or safety;

(b) the Importing 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

(c) provided that it is not misleading, contradictory, inconsistent, or confusing, or that the Importing Party’s legitimate objectives are not compromised, the Importing Party shall permit the following in relation to the information required in the Importing Party:

(i) information in other languages in addition to the language required in the Importing Party;

(ii) internationally accepted nomenclatures, pictograms, symbols, or graphics in addition to those required in the Importing Party; and

(iii) additional information to that required in the Importing Party.

Section B: Sector-Specific Provisions

Article 7.15: Cosmetic Products

1. Each Party shall maintain its prohibitions on animal testing in its cosmetic products laws and regulations. Neither Party shall require that a cosmetic product or ingredient be tested on animals for the purposes of determining safety, efficacy, or to comply with the respective laws and regulations governing the placing on the market of cosmetic products. Each Party shall support the research, development, validation, and regulatory acceptance of alternative methods to animal testing for cosmetic ingredients and products.

2. The Parties shall seek to collaborate, where appropriate, through relevant international initiatives, such as those aimed at harmonisation, to improve the alignment of their respective regulations and regulatory activities for cosmetic products.

3. The Parties shall seek to collaborate, where appropriate, on guidance addressing appropriate handling of the differing labelling requirements in each of their regulatory systems.

Article 7.16: Medicinal Products

1. The Parties shall seek to collaborate, where appropriate, on matters such as improving their respective regulations and regulatory activities for medicinal products and resolving issues relating to the medicines supply chain and its security, through relevant international initiatives such as:

(a) for medicinal products for human use, the International Coalition of Medicines Regulatory Authorities (ICMRA) and the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (PIC/S); and

(b) for medicinal products for veterinary use, the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

2. The Parties shall endeavour to promote dialogue on scientific and regulatory matters and the exchange of information on regulatory activities between their agencies, in order to support greater regulatory alignment and to eliminate unnecessary technical barriers to trade between the Parties. The exchange of information may include, for example, efforts to share expertise, work in broader initiatives with other regulatory authorities, collaboration on inspections of medicinal products, and cooperation on the interoperability of data standards for the traceability of medicinal products.

3. The Parties shall seek to collaborate, where appropriate, on the development of guidelines, recommendations, and initiatives on evolving areas, in particular to seek to improve the international response to global health threats, including epidemics, diseases of epidemic potential, and antimicrobial resistance.

Article 7.17: Medical Devices

The Parties shall seek to collaborate, where appropriate, through relevant international organisations and initiatives, such as the International Medical Devices Regulators Forum (IMDRF), to improve the alignment of their respective regulations and regulatory activities for medical devices.

1. “conformance organisations” here refers to those bodies that develop conformity assessment procedures or perform conformity assessment. ↩

2. This refers to the Decision of the Committee on Principles for the Development of International Standards, Guides and Recommendations with Relation to Articles 2, 5 and Annex 3 of the TBT Agreement, adopted by the WTO Committee on Technical Barriers to Trade on 13 November 2000 (Annex 4 to G/TBT/9). ↩

3. For greater certainty, the Parties confirm their understanding that paragraph 2 of Article 7.3 (Scope) shall apply to this paragraph and to paragraph 6. ↩

4. For greater certainty, this subparagraph does not apply to authorisation functions performed by a Party itself when it retains the final decision-making authority regarding the conformity of a product. ↩