(b) reply in writing to the comments no later than the date of publication of the technical regulation or conformity assessment procedure.
4. Each Party shall endeavour to publish on a website its responses to the comments it receives following the notification referred to in paragraph 1 no later than on the date of publication of the adopted technical regulation or conformity assessment procedure.
5. Each Party shall, where requested by another Party, provide information regarding the objectives of, legal basis for and rationale for, any technical regulation or conformity assessment procedure that the Party has adopted or is proposing to adopt.
6. Each Party shall ensure that the technical regulations and conformity assessment procedures it has adopted are published on a website that is accessible free of charge.
7. Each Party shall provide information on the adoption and the entry into force of technical regulations or conformity assessment procedures and the adopted final texts through an addendum to the original notification to the WTO.
8. Each Party shall allow a reasonable interval between the publication of technical regulations and their entry into force, in order to allow time for the economic operators of the other Parties to adapt.
9. A Party shall give positive consideration to a reasonable request from another Party received prior to the end of the comment period set out in paragraph 1 to extend the period of time between the adoption of the technical regulation and its entry into force, except where the delay would be ineffective in fulfilling the legitimate objectives pursued.
10. Each Party shall ensure that the enquiry point established in accordance with Article 10 of the TBT Agreement provides information and answers in one of the official WTO languages to reasonable enquiries from the other Parties or from interested persons of the other Parties regarding adopted technical regulations and conformity assessment procedures.
Article 2.28. Marking and Labelling
1. The technical regulations of a Party may include or exclusively address mandatory marking or labelling requirements. In such cases, the principles of Article 2.2 of the TBT Agreement apply to these technical regulations.
2. Where a Party requires mandatory marking or labelling of products, all of the following conditions shall apply:
(a) it shall only require information which is relevant for consumers or users of the product or information that indicates that the product conforms to the mandatory technical requirements;
(b) it shall not require any prior approval, registration or certification of the labels or markings of products, nor any fee disbursement, as a precondition for placing on its market products that otherwise comply with its mandatory technical requirements unless it is necessary in view of legitimate objectives;
(c) where the Party requires the use of a unique identification number by economic operators, it shall issue such a number to the economic operators of another Party without undue delay and on a nondiscriminatory basis;
(d) unless the information listed in points (i), (ii) or (iii) would be misleading, contradictory or confusing in relation to the information that the importing Party requires with respect to the goods, the importing Party shall permit:
(i) information in other languages in addition to the language required in the importing Party of the goods;
(ii) internationally-accepted nomenclatures, pictograms, symbols or graphics; and
(iii) additional information to that required in the importing Party of the goods;
(e) it shall accept that labelling, including supplementary labelling or corrections to labelling, take place in customs warehouses or other designated areas in the country of import as an alternative to labelling in the country of origin, unless such labelling is required for reasons of public health or safety or required for products – other than food, feed and seeds – consisting of or containing genetically modified organisms;
(f) unless it considers that legitimate objectives may be undermined, it shall endeavour to accept the use of non-permanent or detachable labels, or marking or labelling in the accompanying documentation, rather than requiring labels or marking to be physically attached to the product; and
(g) paragraph 2 does not apply for tobacco products, nicotine products and related products.
Article 2.29. Cooperation on Market Surveillance and Non-Food Product Safety and Compliance
1. The Parties recognise the importance of cooperation on market surveillance, compliance and the safety of non-food products for the facilitation of trade and for the protection of consumers and other users, and the importance of building mutual trust based on shared information.
2. To guarantee the independent and impartial functioning of market surveillance, the Parties shall ensure:
(a) the separation of market surveillance functions from conformity assessment functions; and
(b) the absence of any interests that would affect the impartiality of market surveillance authorities in the performance of their control or supervision of economic operators.
3. The Parties shall cooperate and exchange information in the area of nonfood product safety and compliance, which may include in particular the following:
(a) market surveillance and enforcement activities and measures;
(b) risk assessment methods and product testing;
(c) coordinated product recalls or other similar actions;
(d) scientific, technical and regulatory matters in order to improve nonfood product safety and compliance;
(e) emerging issues of significant health and safety relevance;
(f) standardisation-related activities;
(g) exchanges of officials.
4. The Parties may establish arrangements on the regular exchange of information, including the exchange of information by electronic means, regarding measures taken on non-compliant non-food products.
5. Each Party shall use the information obtained pursuant to paragraphs 3 and 4 for the sole purpose of protecting consumers, health, safety or the environment.
6. Each Party shall treat the information obtained pursuant to paragraphs 3 and 4 as confidential. This provision shall not prevent disclosure of such information which may be required under national law.
7. The arrangements referred to in paragraph 4 shall specify the type of information to be exchanged, the modalities for the exchange and the application of confidentiality and personal data protection rules.
8. For the purposes of this Article, “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 safety of products and their compliance with the requirements set out in its laws and regulations.
9. Each Party shall ensure that any measure taken by its market surveillance or enforcement authorities to withdraw or recall from its market or to prohibit or restrict the making available on its market of a product imported from another Party, for reasons related to non-compliance with the applicable legislation, is proportionate, states the exact grounds on which the measure is based and is communicated without delay to the relevant economic operator.
Article 2.30. Technical Discussions
1. If a Party considers that a draft or proposed technical regulation or conformity assessment procedure of another Party might have a significant effect on trade between the Parties, it may request technical discussions on the matter. The request shall be made in writing to the Party concerned and shall identify:
(a) the measure at issue;
(b) the provisions of this Section or of an Annex to this Section to which the concerns relate; and
(c) the reasons for the request, including a description of the requesting Party’s concerns regarding the measure.
2. A Party shall deliver its request to the contact point of the Party concerned designated pursuant to Article 2.32 (Contact Points).
3. At the request of a Party, the Parties shall meet to discuss the concerns raised in the request, in person or via videoconference or teleconference, within 60 days of the date of the request and shall endeavour to resolve the matter as expeditiously as possible. If a requesting Party believes that the matter is urgent, it may request that any meeting take place within a shorter time frame. In such cases, the responding Party shall give positive consideration to such a request.
Article 2.31. Cooperation
1. The Parties shall cooperate in the field of technical regulations, standards and conformity assessment procedures, where it is in their mutual interest, and without prejudice to the autonomy of their own respective decisionmaking and legal orders. The Sub-Committee on Technical Barriers to Trade may exchange views with respect to the cooperation activities carried out under this Article or the Annexes to this Section.
2. For the purposes of paragraph 1, the Parties shall seek to identify, develop and promote cooperation activities of mutual interest. These activities may in particular relate to:
(a) the exchange of information, experience and data related to technical regulations, standards and conformity assessment procedures;
(b) ensuring efficient interaction and cooperation of their respective regulatory authorities at international, regional or national level;
(c) exchanging information, to the extent possible, about international agreements and arrangements regarding technical barriers to trade to which one or all Parties are party; and
(d) establishment of or participation in trade facilitating initiatives.
Article 2.32. Contact Points
1. Upon the entry into force of this Agreement, each Party shall designate a contact point for the implementation of this Section and shall notify the other Parties of the contact details for the contact point, including information regarding the relevant officials. The Parties shall promptly notify each other of any change of those contact details.
2. The contact point shall provide any information or explanation requested by the contact point of the other Parties in relation to the implementation of this Section within a reasonable period of time and, if possible, within 60 days of the date of receipt of the request.
Article 2.33. Sub-Committee on Technical Barriers to Trade
1. The Parties hereby establish a Sub-Committee on Technical Barriers to Trade which shall supervise the implementation and operation of this Section and the Annexes to it and shall promptly clarify and address, where possible, any issue raised by a Party relating to the development, adoption or application of technical regulations, standards and conformity assessment procedures under this Section or the TBT Agreement.
2. The Sub-Committee on Technical Barriers to Trade shall without undue delay review this Section and related annexes in light of relevant developments under the UK-EU TCA. In such reviews, the Parties shall endeavour to agree on recommendations for alignment of this Section with the Technical Barriers to Trade Chapter and related annexes under the TCA. Such recommendations for amendments shall be submitted to the Joint Committee.
3. The Sub-Committee on Technical Barriers to Trade may establish, if necessary, to achieve the objectives of this Section, ad hoc technical working groups to deal with specific issues or sectors.
4. The Sub-Committee on Technical Barriers to Trade shall meet on request of a Party, and no later than five years after the entry into force of this Agreement, and thereafter on request by a Party.
Section 2.3. SANITARY AND PHYTOSANITARY MEASURES
Article 2.34. Objectives
The objectives of this Section are to:
(a) protect human, animal and plant life or health, and the environment while facilitating trade;
(b) further the implementation of the SPS Agreement;
(c) ensure that the Parties’ SPS measures do not create unjustified barriers to trade;
(d) promote greater transparency and understanding on the application of each Party’s SPS measures;
(e) enhance cooperation between the Parties on animal welfare, the promotion of sustainable food systems, and in the fight against antimicrobial resistance;
(f) enhance cooperation in international standard-setting bodies to develop international standards, guidelines and recommendations on animal health, food safety and plant health, including international plant commodity standards; and
(g) promote the implementation by each Party of international standards, guidelines and recommendations.
Article 2.35. Scope
1. This Section applies to SPS measures of a Party that may, directly or indirectly, affect trade between the Parties.
2. This Section also applies to cooperation between the Parties on animal welfare, antimicrobial resistance and sustainable food systems.
Article 2.36. Definitions
1. For the purposes of this Section and Annex XIII (Provisions and Arrangements Concerning Sanitary and Phytosanitary Matters), the following definitions apply:
(a) the definitions in Annex A to the SPS Agreement;
(b) the definitions adopted under the auspices of the Codex Alimentarius Commission (Codex);
(c) the definitions adopted under the auspices of the World Organisation for Animal Health (OIE); and
(d) the definitions adopted under the auspices of the International Plant Protection Convention (IPPC).
2. For the purposes of this Section and Annex XIII (Provisions and Arrangements Concerning Sanitary and Phytosanitary Matters):
(a) “import conditions” means any SPS measures that are required to be fulfilled for the import of products;
(b) “sanitary or phytosanitary measure” means any measure as defined in paragraph 1 of Annex A to the SPS Agreement falling within the scope of this Agreement;
(c) “SPS Sub-Committee” means the Sub-Committee on Sanitary and Phytosanitary Measures established pursuant to Article 2.50 (SubCommittee on Sanitary and Phytosanitary Measures); and
(d) “SPS Agreement” means the Agreement on the Application of Sanitary and Phytosanitary Measures, contained in Annex 1A to the WTO Agreement.
3. The SPS Sub-Committee may make a recommendation to the Joint Committee established under Article 15.1 (Joint Committee) of Chapter 15 (Institutional Provisions) to adopt other definitions for the purposes of this Section, taking into consideration the glossaries and definitions of the relevant international organisations, such as the Codex, OIE and IPPC.
4. The definitions under the SPS Agreement prevail to the extent that there is an inconsistency between the definitions adopted under this Agreement or adopted under the auspices of the Codex, OIE, or IPPC and the definitions under the SPS Agreement. To the extent that there is an inconsistency between definitions adopted under this Agreement and the definitions set out in the Codex, OIE or IPPC, the definitions set out in the Codex, OIE or IPPC shall prevail.
Article 2.37. Rights and Obligations
The Parties affirm their rights and obligations under the SPS Agreement. This includes the right to adopt measures in accordance with paragraph 7 of Article 5 of the SPS Agreement.
Article 2.38. General Principles
1. Each Party shall apply SPS measures for achieving their appropriate level of protection that are based on risk assessments in accordance with relevant provisions, including Article 5 of the SPS Agreement.
2. A Party shall not use SPS measures to create unjustified barriers to trade.
3. Regarding trade-related SPS procedures and approvals established under this Section, each Party shall ensure that these procedures and approvals, and related SPS measures:
(a) are initiated and completed without undue delay;
(b) do not include unnecessary, scientifically and technically unjustified or unduly burdensome information requests that might delay access to another Party’s market;
(c) are not applied in a manner which would constitute arbitrary or unjustifiable discrimination against another Party or parts of another Party where identical or similar SPS conditions exist; and
(d) are proportionate to the risks identified and not more trade restrictive than necessary to achieve the importing Party’s appropriate level of protection.
4. A Party shall not use the procedures and approvals referred to in paragraph 3, or any requests for additional information, to delay access to their markets without scientific and technical justification.
5. Each Party shall ensure that any administrative procedure it requires concerning the import conditions on food safety, animal health or plant health is not more burdensome or trade restrictive than necessary to give the importing Party adequate confidence that these conditions are met. Each Party shall ensure that the negative effects on trade of any administrative procedures are kept to a minimum and that the clearance processes remain simple and expeditious while meeting the importing Party’s conditions.
6. The importing Party shall not put in place any additional administrative system or procedure that unnecessarily hampers trade.
Article 2.39. Specific Provisions and Arrangements Concerning Sanitary and Phytosanitary Matters
Annex XIII (Provisions and Arrangements Concerning Sanitary and Phytosanitary Matters) contains specific provisions and arrangements concerning sanitary and phytosanitary matters.
Article 2.40. Minimum Standard of Treatment on Sanitary Measures
1. This Article applies to each Party’s sanitary measures if the United Kingdom and the EU enter into any agreement concerning sanitary measures which is in force between the United Kingdom and the European Union on or after 1 January 2021 (UK-EU Sanitary Agreement).
2. With respect to the sanitary matters provided for in Annex XIII (Provisions and Arrangements Concerning Sanitary and Phytosanitary Matters), each Party shall be afforded treatment no less favourable than that which is afforded to the United Kingdom and the European Union under the terms of any UK-EU Sanitary Agreement. At the request of a Party, the Parties shall hold consultations within the SPS Sub-Committee to consider the incorporation of relevant provisions of any UK-EU Sanitary Agreement into this Agreement in accordance with subparagraph 2(a) of Article 2.50 (SubCommittee on Sanitary and Phytosanitary Measures). The terms and basis of any such incorporation shall be agreed between the Parties and subject to their respective domestic legal requirements.
3. This Article shall not apply to Iceland in respect of sanitary measures in relation to trade in live animals, other than fish and aquaculture animals, and animal products such as ova, semen and embryos.
Article 2.41. Cooperation on Sanitary Matters
Without prejudice to Article 2.40 (Minimum Standard of Treatment on Sanitary Measures), the Parties agree to cooperate on the sanitary matters to be set out in Annex XIV (Cooperation on Sanitary Matters) in accordance with subparagraph 2(b) of Article 2.50 (Sub-Committee on Sanitary and Phytosanitary Measures). At the request of a Party, the Parties shall hold consultations within the SPS Sub-Committee on the sanitary matters which are to be the subject of cooperation, and the nature and extent of such cooperation.
Article 2.42. Transparency and Exchange of Information
1. Each Party shall pursue transparency as regards SPS measures applicable to trade and shall for those purposes undertake the following actions:
(a) promptly communicate to the other Parties any changes to its SPS measures and approval procedures, including changes that may affect its capacity to fulfil the SPS import requirements of a Party for certain products;
(b) enhance mutual understanding of its SPS measures and their application;
(c) exchange information with the other Parties on matters related to the development and application of SPS measures, including the progress on new available scientific evidence that affect, or may affect, trade between the Parties with a view to minimising negative trade effects;
(d) upon request of a Party, communicate the conditions that apply for the import of specific products without undue delay;
(e) upon request of a Party, communicate the state of play of the procedure for the authorisation of specific products without undue delay;
(f) communicate to the other Parties any significant change to the structure or organisation of a Party’s competent authority;
(g) on request, communicate the results of a Party’s official control and a report that concerns the results of the control carried out;
(h) on request, communicate the results of an import check provided for in case of a rejected or a non-compliant consignment; and
(i) on request, communicate, without undue delay, a risk assessment or scientific opinion produced by a Party that is relevant to this Section.
2. Where a Party has made available the information in paragraph 1 via notification to the WTO’s Central Registry of Notifications or to the relevant international standard-setting body, in accordance with its relevant rules, the requirements in paragraph 1, as they apply to that information, are fulfilled.
Article 2.43. Recognition of Plant Pest Status and Regional Conditions
1. The Parties shall 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 specified in the IPPC International Standards for Phytosanitary Measures (ISPMs), which the Parties agree to apply in the trade between them, in accordance with the SPS Agreement, including the Guidelines to further the practical implementation of Article 6 of the SPS Agreement (WTO/SPS Committee Decision G/SPS/48), and the relevant ISPMs.
2. When determining Pest Free Areas, Pest Free Places of Production, Pest Free Production Sites and areas of low pest prevalence, whether for the first time or after an outbreak of a plant pest, the importing Party shall 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 ISPMs, and take into consideration the determination made by the exporting Party.
3. The exporting Party shall communicate Pest Free Areas, Pest Free Places of Production, Pest Free Production Sites and areas of low pest prevalence to the other Parties and, upon request, provide an explanation and supporting data as provided for in the relevant ISPMs or otherwise deemed appropriate.
4. Without undue delay following the receipt of the information referred to in paragraph 2, the importing Party may raise an explicit objection, request additional information or consultation, or require verification. The importing Party shall assess any additional information without undue delay following its receipt.
5. Unless the importing Party raises an objection, requests additional information or consultation, or requires verification without undue delay following the receipt of the information referred to in paragraph 2, the recognition of the determination of the Pest Free Areas, Pest Free Places of Production, Pest Free Production Sites and/or areas of low pest prevalence of the exporting Party shall be understood as accepted by the importing Party.
6. After finalisation of the procedure established in this Article, if the importing Party takes the decision to approve the requested Pest Free Areas, Pest Free Places of Production, Pest Free Production Sites and/or areas of low pest prevalence then it shall allow trade on that basis, without undue delay.
7. In the event that the importing Party does not approve the requested Pest Free Areas, Pest Free Places of Production, Pest Free Production Sites and/or areas of low pest prevalence, it shall notify its decision to the exporting Party and explain the reasons for the rejection and, upon request, hold consultations.
8. If consultations are requested by the importing Party or the exporting Party, they shall be conducted in accordance with paragraph 2 of Article 2.44 (Notification and Consultation).
9. Any verification the importing Party may require shall be carried out taking into account the biology of the pest and the crop concerned.
10. The phytosanitary requirements of the importing Party shall be established taking into consideration the phytosanitary status in the exporting Party and, if required by the importing Party, the result of a Pest Risk Analysis (PRA). The PRA shall be carried out in accordance with the relevant ISPM. The risk analysis shall take into account available scientific and technical information.
11. 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, and areas of low pest prevalence.
12. The SPS Sub-Committee may define further details for the procedures set out in this Article, taking into account the SPS Agreement and IPPC guidelines, standards and recommendations.
Article 2.44. Notification and Consultation
1. A Party shall notify the other Parties without undue delay of:
(a) a significant change to pest or disease status;
(b) the emergence of a new animal disease;
(c) a finding of epidemiological importance with respect to an animal disease;
(d) a significant food safety issue identified by a Party;
(e) any additional measures beyond the basic requirements of their respective SPS measures taken to control or eradicate animal disease or protect human health, and any changes in preventive policies, including vaccination policies;
(f) on request, the results of a Party’s official control and a report that concerns the results of the control carried out; and
(g) any significant changes to the functions of a system or database.
2. If a Party has a significant concern with respect to food safety, plant health, or animal health, or an SPS measure that another Party has proposed or implemented, that Party may request technical consultations with the other Party. The requested Party should respond to the request without undue delay. Each of the requesting Party and the requested Party shall endeavour to provide the information necessary to avoid a disruption to trade and, as the case may be, to reach a mutually acceptable solution.
3. Consultations referred to in paragraph 2 may be held via telephone conference, videoconference, or any other means of communication mutually agreed on by the Parties concerned.
Article 2.45. Multilateral International Fora
The Parties agree to cooperate in the Codex, OIE and IPPC on the development of international standards, guidelines and recommendations in the areas under the scope of this Section.
Article 2.46. Implementation and Competent Authorities
1. For the purposes of the implementation of this Section, each Party shall take all of the following into account:
(a) decisions of the WTO Committee on Sanitary and Phytosanitary Measures;