(c) recognition of the health status of each Party and applying the principle of regionalisation zoning and compartmentalisation;
(d) further implementing the principles of the WTO SPS Agreement; using existing standards established under the World Organisation for Animal Health (hereinafter referred to as "WOAH"), the Codex Alimentarius and the International Plant Protection Convention (hereinafter referred to as "IPPC");
(e) establishing mechanisms and procedures for trade facilitation; and improving communication, consultation and cooperation between the Parties on SPS measures.
Article 4.2. Affirmation of WTO SPS Agreement
Each Party affirms its rights and obligations with respect to the other Parties under the WTO SPS Agreement. Nothing in this Agreement shall affect the rights and obligations that each Party has under the WTO SPS Agreement.
Article 4.3. Scope
This Chapter shall apply to all SPS measures of a Party that may, directly or indirectly, affect trade between the Parties.
Article 4.4. Internal Harmonisation
Each Party shall ensure that animals, animal products, plants and plant products lawfully put on the market can move freely within its territory provided that they comply with the relevant SPS requirements of the market at the point of entry.
Article 4.5. Competent Authorities
1. The Parties shall exchange names, addresses and competences of their competent authorities responsible for the implementation of this Chapter.
2. In accordance with Article 4.16, the Parties shall inform each other about any significant changes in such information.
Article 4.6. Recognition of Pest and Disease Area Status
The Parties recognise the concepts of zoning, compartmentalisation and regional conditions, including pest- or disease-free areas and areas of low pest or disease prevalence. The Parties shall take into account the relevant decisions of the WTO SPS Committee and international standards, guidelines and recommendations.
Article 4.7. Determination of Equivalence
1. Equivalence may be determined for an individual measure, groups of measures, or systems related to a certain commodity or categories of commodities.
2. The consideration of equivalence by the importing Party upon request of the exporting Party for recognition of its measures shall not be a reason to disrupt trade or suspend ongoing imports from the exporting Party.
3. Within a reasonable period of time after conclusion of its assessment, the importing Party shall notify the exporting Party in writing about the equivalence determination. The importing Party shall implement the measure within a reasonable period of time. If an equivalence determination does not result in recognition by the importing Party, the importing Party shall provide the exporting Party with the rationale for its decision.
4. The decision of recognition, non-recognition, withdrawal or suspension of equivalence rests solely with the importing Party acting in accordance with its administrative and legislative framework taking into account the guidelines, standards, and recommendations of the WOAH, IPPC and the Codex Alimentarius.
5. If the importing Party formally recognises equivalence, it shall promptly adopt measures to give effect to the equivalence and enable trade between the Parties.
Article 4.8. Verifications
1. In order to obtain or maintain confidence in the effective implementation of this Chapter, each Party, within the scope of this Chapter, shall have the right to carry out audits and verifications of the competent authorities' control programs or procedures of any other Party.
2. The process shall be carried out in accordance with the relevant international standards, guidelines and recommendations of the Codex Alimentarius, WOAH and IPPC. In particular, verification activities shall concentrate primarily on evaluating the effectiveness of the official inspection and certification systems rather than on specific commodities or establishments in order to determine the ability of the exporting Party's competent authority to control and deliver the required assurances to the importing Party.
3. The frequency of verifications shall depend on the results of previous verifications.
4. If the importing Party decides to carry out a verification visit in the exporting Party, the importing Party shall notify the exporting Party of the verification visit at least two months prior to such visit, except in emergency cases or if the Parties agree otherwise. Any modification concerning the verification visit shall be agreed by the Parties concerned.
Article 4.9. Import Checks and Certification Procedures
1. Each Party shall ensure that its control, inspection and approval procedures, including, inter alia, procedures for sampling, testing and certification are in accordance with Annex C of the WTO SPS Agreement and this Article.
2. Each Party shall ensure that animals and animal products, plants and plant products, or other related goods - exported to another Party comply with the SPS requirements set out in the certificates of the importing Party.
3. The importing Party shall ensure that its import conditions for products imported from another Party are applied in a non-discriminatory manner and proportional to the risk associated with such products.
4. Import checks applied to imported products shall be carried out without undue delay and in the least trade-restrictive manner.
5. Information about the frequencies of import checks on such importations shall be made available upon request.
6. If goods are rejected at a port of entry due to a verified sanitary or phytosanitary issue, the importing Party shall inform the exporting Party's competent authority as soon as possible.
7. If the importing Party finds that certain goods are not in compliance with its requirements, it may put such goods under official detention and, in consultation with the exporter or its representative, decide to subject such goods to appropriate measures as defined in its domestic law. In taking these decisions, the importing Party shall take into account any information available to it or information submitted to it in a timely manner depending upon the risk, including submissions from the exporter or its representative. The persons responsible for the consignment shall be liable for the costs incurred by the importing Party for these activities.
8. Each Party shall ensure that the exporter or its representative shall have the right of appeal against decisions, and that he or she is provided with information about his or her rights of appeal, the applicable procedure and time limits.
9. This Article shall be without prejudice to the right of the competent authorities to promptly take an appropriate decision concerning emergency measures for the protection of human, animal or plant life or health taken to address serious risks for human, animal or plant life or health. The circumstances leading to the decision shall be explained to the exporter or its representative.
10. Inspection fees shall be equitable in relation to fees charged for the inspection of like domestic products.
11. Without prejudice to each Partyâs right to import controls, the importing Party shall accept certificates issued by the relevant competent authority in the exporting Party in compliance with the regulatory requirements of the importing Party.
Article 4.10. Risk Assessment
1. The Parties shall strengthen cooperation on risk assessment in accordance with the WTO SPS Agreement while taking into account the relevant decisions of the WTO SPS Committee and international standards, guidelines and recommendations.
2. When conducting a risk assessment, the importing Party shall ensure that the tisk assessment is documented and that it provides the concerned exporting Party or Parties with an opportunity to comment, in a manner to be determined by the importing Party.
3. Upon request by the exporting Party, the importing Party shall inform the exporting Party about the progress of the specific risk assessment request and any delay that may occur during the process.
4. Without prejudice to emergency measures, no Party shall stop the importation of a good of another Party solely for the reason that the importing Party is undertaking a review of an existing SPS measure.
Article 4.11. Emergency Measures
1. If a Party adopts an emergency measure which is necessary for the protection of human, animal, plant life or health and that may have an effect on trade, it shall immediately notify the exporting Parties concerned in writing through the contact points established under Article 4.16 or already established communication channels of the Parties.
2. The exporting Parties concerned may request discussions with the Party adopting an emergency measure according to paragraph 1. Such discussions shall be held as soon as practicable. Each Party shall endeavour, as part of these discussions, to provide relevant information. Each Party involved in the discussions shall take due account of any information provided through the discussions.
3. If a Party adopts an emergency measure, it shall review that measure within a reasonable period of time or upon request of the exporting Party. The importing Party may, if necessary, request relevant information and the exporting Party shall endeavour to provide the relevant information to assist the importing Party in the review of the adopted emergency measure. The importing Party shall provide the result of the review to the exporting Party upon request. If the emergency measure is maintained after the review, the importing Party shall review the measure periodically based on the most recent available information and, upon request of the exporting Party, shall explain the reason for the continuation of the emergency measure.
Article 4.12. Transparency
1. The Parties recognise the importance of transparency as set out in Annex B of the WTO SPS Agreement.
2. The Parties recognise the importance of exchanging information on the development, adoption and application of SPS measures that may have significant effects on trade between or among the Parties.
3. In implementing this Article, each Party shall take into account relevant decisions of the WTO SPS Committee and international standards, guidelines and recommendations.
4. Each Party shall notify proposed measures or changes to existing SPS measures that may have a significant effect on its trade with the other Parties through the WTO SPS online submission system or contact points established under Article 4.16, or through already established communication channels of the Parties.
5. Unless urgent problems of health arise or threaten to arise, or the measure is of a trade facilitating nature, a Party shall normally allow a period of at least 60 days for other Parties to provide written comments after it makes a notification pursuant to paragraph 4. A Party shall consider reasonable requests from another Party to extend the comment period.
6. Upon reasonable request from another Party, a Party shall provide relevant information and clarification regarding any SPS measure to the requesting Party, within a reasonable period of time, including:
(a) the SPS requirements that apply for the import of specific products;
(b) the status of the Party's application; and
(c) procedures for authorising the import of specific products.
7. An importing Party shall provide timely and appropriate information to Parties concerned through contact points established under Article 4.16, or through already established communication channels of the Parties, where there is:
(a) significant or recurring sanitary or phytosanitary non-compliance associated with exported consignments identified by the importing Party;
(b) a sanitary or phytosanitary measure adopted provisionally against or affecting the export of another Party considered necessary to protect human, animal or plant life or health within the importing Party.
Article 4.13. Information Exchange
1. The Parties shall exchange information which is relevant for the implementation of this Chapter systematically, with a view to provide assurance, to strengthen mutual confidence and to demonstrate the efficacy of the programmes controlled. Where appropriate, this exchange of information may include exchange visits of officials. Upon request, notifications not covered by the WTO SPS Agreement shall be made to the contact points established under Article 4.16 in English. However, in case a Party wishes to notify in any other WTO language, an English translation shall be made available to the Parties.
2. Without prejudice to the WTO SPS Agreement, as regards notification of measures, the Parties may also exchange information on other relevant topics, including:
(a) any serious or significant human, animal or plant life or health risk, including any food emergencies; and
(b) sanitary and phytosanitary import requirements and their amendments, including the models for the official certificates or attestations, as prescribed by the importing Party.
3. An information exchange shall be considered to have taken place, in accordance with this Article if the information referred to in this Article has been made available:
(a) by a notification to the WTO in accordance with its relevant rules; or
(b) on the Parties' official and publicly accessible websites free of charge.
Article 4.14. Review Clause
Upon request of a Party, the Parties shall without undue delay negotiate an arrangement extending to each other equivalent treatment related to SPS measures which all Parties have agreed with a non-Party.
Article 4.15. Sub-Committee on Sanitary and Phytosanitary Measures
1. A Sub-Committee on sanitary and phytosanitary measures (hereinafter referred to as the “Sub-Committee on SPS”) is hereby established under the Joint Committee, consisting of government representatives of the Parties.
2. The Sub-Committee on SPS shall consider any matter arising under this Chapter, including:
(a) monitoring and reviewing the implementation of this Chapter;
(b) encouraging discussions, cooperation and the exchange of information between the competent authorities on matters related to this Chapter;
(c) the preparation of recommendations and reports to the Joint Committee as necessary; and
(d) any other matter as referred to it by the Joint Committee.
3. The Sub-Committee on SPS shall act by consensus.
4. The Sub-Committee on SPS shall normally meet every two years unless otherwise agreed by the Parties. Such meetings may be conducted in any agreed manner on a case-by-case basis. The meetings of the Sub-Committee on SPS shall be chaired jointly by an EFTA State and India.
Article 4.16. Contact Points
1. Each Party shall designate a contact point responsible for coordinating the implementation of this Chapter
2. Each Party shall provide the other Parties with the contact details of its contact point and shall promptly notify the other Parties of any change in contact point.
Article 4.17. Consultations
Ifa Party has taken a measure which is likely to create, or has created an obstacle to trade between the Parties, another Party may request consultations. Such consultations shall be initiated as early as possible and conducted by the competent authorities of the Parties concerned in a mutually agreed manner. The outcome of the consultations shall be reported to the Sub-Committee on SPS.
Article 4.18. Cooperation
1. The Parties shall strengthen their cooperation with a view to facilitate the implementation of this Chapter. In their cooperation, the Parties shall work to identify, develop and promote trade facilitating measures which may include:
(a) training and exchange of experience programmes for government officials and technical staff in relation to inspection, certification, testing procedures, verifications, meeting regulatory and market requirements;
(b) development and improvement of risk assessment procedure;
(c) forums such as seminars and workshops for the exchange of views and best practices on "the Parties" SPS regimes; and
(d) international standardisation activities and activities of the relevant international organisations.
2. The Parties may cooperate on any matter of mutual interest under this Chapter, including sector-specific proposals.
Chapter 5. TECHNICAL BARRIERS TO TRADE
Article 5.1. Objectives
The objective of this Chapter is to facilitate and increase trade in goods and obtain effective access to each Party's market. For this purpose, the Parties shall take steps to:
(a) improve the implementation of the Agreement on Technical Barriers to Trade, as set out in Annex 1A to the WTO Agreement (hereinafter referred to as the "WTO TBT Agreement");
(b) ensure that technical regulations, standards and conformity assessment procedures do not create unnecessary obstacles to trade;
(c) enhance cooperation between them in areas relevant to the application of this Chapter;
(d) increase their capacity to ensure, whenever appropriate, compliance with international standards and with their technical regulations, conformity assessment procedures and standards;
(e) promote convergence and alignment of technical regulations and standards towards relevant international technical regulations and standards, whenever applicable; and
(f) promote recognition of equivalence of technical regulations and facilitate acceptance of conformity assessment procedures.
Article 5.2. Affirmation of the WTO TBT Agreement
1. The Parties affirm their rights and obligations with respect to each other under the WTO TBT Agreement which is hereby incorporated into and made part of this Agreement, mutatis mutandis.
2. No Party shall have recourse to dispute settlement under Chapter 12 (Dispute Settlement) for a matter that exclusively alleges a violation of the provisions of the WTO TBT Agreement.
Article 5.3. Scope
1. 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.
2. Each Party shall take such reasonable measures as may be available to it to ensure compliance with this Chapter by regional level government bodies on the level directly below that of the central level of government within its territory, which are responsible for the preparation, adoption and application of technical regulations, standards and conformity assessment procedures.
3. Notwithstanding paragraph 1, this Chapter shall not apply to:
(a) purchasing specifications prepared by governmental bodies for production or consumption requirements of such bodies; and
(b) sanitary and phytosanitary measures as defined in Annex 1A of the Agreement on the Application of Sanitary and Phytosanitary Measures, as set out in Annex 1A to the WTO Agreement (hereinafter referred to as the "WTO SPS Agreement").
Article 5.4. Cooperation
1. The Parties shall strengthen their cooperation with a view to increase the mutual understanding of their respective systems and facilitate access to their respective markets. To this end, they may establish regulatory dialogues at both the horizontal and sectoral levels.
2. In their cooperation, the Parties shall work to identify, develop and promote trade facilitating measures which may include:
(a) reinforcing regulatory cooperation through, for example, training, exchange of information, experience and data whenever available, and scientific and technical cooperation with a view to create technical regulations that are not more trade restrictive than necessary and make efficient use of regulatory resources;
(b) where appropriate, considering the simplification of technical regulations, standards and conformity assessment procedures;
(c) working towards the possibility of converging or aligning technical regulations, standards and conformity assessment procedures, in particular where no international standards exist;
(d) promoting and encouraging cooperation between their respective organisations, public or private, responsible for technical regulations, standardisation, conformity assessment procedures and metrology, both bilaterally and in international fora;
(e) programmes to increase the capacity of enterprises, in particular micro, small and medium-sized enterprises, to meet regulatory and market requirements;
(f) cooperating on good regulatory practices;
(g) promoting and encouraging participation in international standard setting bodies, such as the Intemational Organization for Standardization, the International Electrotechnical Commission and the International Telecommunication Union, and promoting the use of international standards as a basis for technical regulations;
(h) exchanging views, in the context of international fora, such as the WTO Committee on Technical Barriers to Trade, in particular on the use of international standards in support of regulation; and
(i) promoting the development of the necessary technical infrastructure in the field of standardisation, conformity assessment and metrology.
Article 5.5. Technical Regulations
1. The Parties recognise the importance of the use of international standards and agree:
(a) to use relevant international standards or relevant parts of them as a basis for technical regulations, except when such international standards would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives pursued in accordance with Article 2.4 of the WTO TBT Agreement;
(b) where international standards have not been used as a basis for technical regulations, upon request of a Party, to explain to that Party in writing the reasons why such standards have been judged inappropriate or ineffective for the aim pursued and, whenever possible, to identify the parts which in substance deviate from relevant international standards;
(c) to each publish, free of charge, technical regulations on an official website;
(d) to ensure that interested persons of another Party are allowed to participate in any consultation open to the general public concerning the preparation of technical regulations;
(e) when making notifications in accordance with Article 2.9 of the WTO TBT Agreement, to allow for the Party receiving the notification, normally 60 days from the notification, to provide comments in writing on the proposal unless in exceptional cases where urgent problems explicitly stated, of safety, health, environmental protection or national security arise or threaten to arise; and where practicable to give appropriate consideration to reasonable requests for extending the comment period;
(f) except in urgent circumstances referred to in Article 2.10 of the WTO TBT Agreement, to 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 exporting Party to adapt their products or methods of production to the requirements of the importing Party; and
(g) to consider the possibility of recognising the equivalence of technical regulations of another Party. For that purpose, a Party which has prepared a technical regulation that it considers to be equivalent to a technical regulation of another Party, having essentially the same objective, scope and level of protection to be achieved may request in writing that another Party recognises it as equivalent. Such written request shall set out the reasons why the technical regulations are considered to be equivalent.
2. To facilitate an appropriate explanation under subparagraph 1 (a), the requesting Party shall ensure that its request for an explanation:
(a) identifies the relevant international standard, guide or recommendation that the requested Party has not used as the basis for its technical regulation; and
(b) describes how the technical regulation which is not based on the international standard, guide or recommendation is a restriction, or has the potential to restrict trade between the Parties.
3. The Parties shall ensure that products lawfully put on the market can move freely within their respective territories provided that they comply with the relevant requirements on technical barriers to trade of the market at the point of entry.
Article 5.6. Standards
The Parties shall, upon request, exchange information on:
(a) their use of standards related to technical regulations;
(b) their standardisation processes and the use of international standards as a basis for their national standards; and
(c) cooperation agreements or arrangements on standardisation with third parties or international organisations, subject to the confidentiality obligations of those agreements or arrangements.
2.Where standards are made mandatory in a technical regulation, the transparency obligations set out in Article 5.12 shall be fulfilled.
3. Each Party shall encourage its recognised standardisation bodies to cooperate with the relevant recognised standardisation bodies of the other Parties in international standardisation activities. Such cooperation may take place through the Partiesâ activities in regional and international standardisation bodies of which the recognised standardisation bodies of all the Parties are members.
Article 5.7. Conformity Assessment
1. The Parties recognise that a broad range of mechanisms exist to facilitate the acceptance of the results of conformity assessment procedures conducted in another Party, which may contribute to increased efficiency, avoidance of duplication and cost effectiveness. These mechanisms include:
(a) the importing Party's acceptance of a supplier's declaration of conformity;
(b) agreements on mutual acceptance of the results of conformity assessment procedures with respect to specific technical regulations conducted by bodies located in another Party;
(c) use of accreditation procedures for qualifying conformity assessment bodies located in the territory of another Party;
(d) governmental designation of conformity assessment bodies located in another Party;
(e) tecognition by a P of the results of conformity assessment pr ocedures conducted in another F arty;
(f) voluntary arrangements between conformity assessment bodies in each Party; and
(g) utilising existing regional and international mutual recognition agreements of which both Parties are parties.
2. Having regard to these considerations, the Parties agree to: