1. For the purposes of this Chapter, the Parties shall apply as a reference the definitions and terms here established:
(a) the Agreement on the Application of Sanitary and Phytosanitary Measures, which is part of the WTO Agreement (Agreement on Sanitary and Phytosanitary Measures);
b) by the Office International des Epizooties (OIE);
(c) the International Plant Protection Convention; and
d) by the Codex Alimentarius Commission.
2. Additionally, for the purposes of this chapter, the Parties shall understand by:
food additive: any substance which by itself is not normally consumed as food, nor used as a basic ingredient in food, whether or not it has nutritional value, and the addition of which to food at the stage of production, manufacture, processing, preparation, treatment, packing, packaging, transport or storage results (or may reasonably be expected to result) directly or indirectly, by itself or by-products thereof, in a component of the food, or affects its characteristics. This definition does not include "contaminants" or substances added to the food to maintain or improve nutritional qualities;
food: any processed, semi-processed or raw substance intended for human consumption, including beverages, chewing gum and any other substances used in the manufacture, preparation or treatment of food, but does not include cosmetics, tobacco or substances used solely as drugs;
contaminant: any living substance or organism not intentionally added to food, which is present in such food as a result of the production (including operations carried out in agriculture, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packaging, packing, transport or storage of such food or as a result of environmental contamination. This term includes physical contaminants;
food safety: quality that ensures that food does not present any risk to human health;
approval procedure: any registration, certification, notification or other mandatory administrative procedure to approve the use of an additive or establish a tolerance for a contaminant for defined purposes or under agreed conditions in a food, beverage or feed prior to permitting its use or marketing when any of these contain the additive or contaminant;
control or inspection procedure: any procedure used, directly or indirectly, to determine compliance with a sanitary or phytosanitary measure, including sampling, testing, inspection, verification, monitoring, auditing, accreditation, or other procedures involving physical examination of a good, the packaging of the good, or equipment or facilities directly related to the production, marketing, or use of a good, but does not mean an approval procedure;
pesticide: any substance intended to prevent, destroy, attract, attract, repel or control any pest, including unwanted species of plants or animals, during the production, storage, transport, distribution and processing of food, agricultural products or animal feed, or which may be administered to animals to control ectoparasites. The term includes substances intended for use as plant growth regulators, defoliants, desiccants, fruit density reduction agents or germination inhibitors, and substances applied to crops before or after harvest to protect the product against deterioration during storage and transport. The term does not normally include fertilizers, nutrients of plant or animal origin, food additives or animal drugs; and
pesticide residue: any specified substance present in food, agricultural commodities or animal feedstuffs as a result of the use of a pesticide. The term includes any derivatives of a pesticide, such as conversion products, metabolites and reaction products and impurities considered to be of toxicological significance.
Article 5-02. Scope of Application
1. This Chapter applies to all sanitary and phytosanitary measures that may directly or indirectly affect trade in goods between the Parties. 2. The framework of rules and disciplines governing the adoption and enforcement of such measures shall be consistent with the Agreement on Sanitary and Phytosanitary Measures. 3. The Parties shall consider as competent authorities those authorities legally responsible for ensuring compliance with the sanitary and phytosanitary requirements of this Chapter.
Article 5-03. Rights and Obligations
1. Each Party may establish, adopt, maintain or apply any sanitary or phytosanitary measure that regulates the protection of life, human or animal health and plant health, including food safety and the importation of any good from the territory of the Parties, when they do not comply with the applicable requirements, or do not satisfy the approval procedures defined in these measures.
2. Each Party may establish, adopt, maintain or apply sanitary and phytosanitary measures that represent a higher level of protection than that which would be achieved by those based on an international standard, guideline or recommendation, provided that there is scientific justification for doing so.
3. Each Party shall ensure that its sanitary or phytosanitary measures:
a) be based on scientific principles, taking into account, where appropriate, both the relevant factors and the different geographical and technological conditions;
b) are maintained only when there is a scientific basis to support them; and
c) are based on a risk assessment appropriate to the circumstances.
4. Each Party shall ensure that its sanitary or phytosanitary measures do not arbitrarily or unjustifiably discriminate between its goods and like goods of another Party, or between the goods of the latter and like goods of any other non-Party, where similar or identical sanitary or phytosanitary conditions exist.
5. The sanitary or phytosanitary measures of each Party shall not constitute a disguised restriction on trade, nor have the purpose or effect of creating unnecessary barriers to trade between the Parties. In this regard, they shall ensure that their measures are applied only to the extent necessary to achieve their appropriate level of protection, taking into account technical, economic and scientific feasibility.
6. Each Party shall have the right to set its appropriate levels to protect life, human or animal health and plant health, in accordance with the provisions of Article 5 -06.
7. Each Party shall ensure that any non-governmental body on which it relies for the development or application of a sanitary or phytosanitary measure acts in a manner consistent with this Chapter.
8. In order to expeditiously apply sanitary and phytosanitary measures in the territory of the Parties and thus facilitate trade flows, the general procedures for the adoption and application of such measures shall be governed by the provisions of Annex 5 -03.
Article 5-04. International Standards and Harmonization.
1. Each Party shall use, as a frame of reference, international standards, guidelines or recommendations, for the establishment of its sanitary and phytosanitary measures, except when these do not constitute an effective or adequate means to protect life, human or animal health and plant health, due to factors of a climatic, geographical, technological or infrastructural nature, or for scientifically justified reasons, or because the level of protection it considers adequate Is not obtained.
2. A Party's sanitary or phytosanitary measure that conforms to an international standard, guideline or recommendation shall be presumed to be consistent with paragraphs 1 to 5 of Article 5 -03.
3. Where a Party has reason to believe that a sanitary or phytosanitary measure of another Party adversely affects or may adversely affect its exports, and the measure is not based on relevant international standards, guidelines or recommendations, it may request that Party to inform it in writing, within 30 days, of the reasons for the measure.
4. In order to promote the development and periodic review of international standards, guidelines and recommendations, as well as to achieve a greater degree of harmonization, each Party shall participate, according to its possibilities, in the competent international standardizing organizations, in particular the Codex Alimentarius Commission, the Office International des Epizooties and the International Plant Protection Convention.
5. The Parties shall develop criteria and procedures for the harmonization of methods of sampling, diagnosis, inspection and certification of animals, plants, their products and by-products, as well as food safety.
Article 5-05. Equivalence
1. Without reducing the level of protection of life, human or animal health and plant health established in their legislation and in order to facilitate trade, the Parties shall recognize equivalence of their respective sanitary or phytosanitary measures, without prejudice to the rights conferred on them by this chapter and taking into account the guidelines and recommendations of the competent international standardization organizations.
2. The importing Party shall accept a sanitary or phytosanitary measure established, applied or maintained by the exporting Party as equivalent, even if it differs from one of its own, provided that the exporting Party objectively demonstrates with scientific information and risk assessment methods based on international standards agreed by them, that the measure achieves the appropriate level of protection required by the importing Party.
3. For the purpose of establishing equivalence between measures, access for inspections, tests and other applicable procedures shall be provided to the importing Party upon request.
4. Each Party shall accept the results of sanitary and phytosanitary control procedures carried out in the territory of another Party, provided that they satisfactorily ensure that the good complies with the sanitary or phytosanitary measures established or maintained in the territory of that Party.
5. Upon request, a Party shall enter into consultations with another Party with a view to recognizing the equivalence of specific sanitary or phytosanitary measures.
6. In developing a sanitary or phytosanitary measure, each Party shall consider the sanitary or phytosanitary measures in force in or proposed by the other Parties.
Article 5-06. Risk Assessment and Adequate Level of Sanitary and Phytosanitary Protection.
1. Each Party shall ensure that its sanitary and phytosanitary measures are based on an assessment, appropriate to the circumstances, of the risks to life, human or animal health and plant health, taking into account risk assessment techniques developed by the relevant standardizing organizations agreed upon by the Parties.
2. In conducting a risk assessment on a good, including food additives and physical, chemical and biological contaminants, each Party shall take into account the following factors:
a) scientific and technical information available;
b) the existence of pests and diseases to be taken into account, including the existence of pest and disease free or low prevalence areas recognized by the Parties;
c) epidemiology of diseases and pests at risk;
d) critical control points in the production, handling, packing, packaging, packing and transportation processes;
e) ecological and other environmental conditions to be considered;
f) relevant inspection, sampling and testing methods; and
g) the applicable quarantine measures and treatments that satisfy the importing country in terms of risk mitigation.
3. In addition to the provisions of paragraph 2, in establishing the appropriate level of protection, each Party shall take into account the risk associated with the introduction, establishment and spread of a pest or disease; and in assessing the risk shall also take into account, where appropriate, the following economic factors:
a) the loss of production or sales in the event of the entry, establishment or spread of a pest or disease;
b) the costs of controlling or eradicating the pest or disease in its territory; and
c) the cost-effectiveness of other possible methods of limiting risk.
4. In establishing its appropriate level of protection, each Party shall take into account the objective of minimizing negative effects on trade, and with a view to achieving consistency in such levels of protection, shall avoid making arbitrary or unjustifiable distinctions that may lead to discrimination or constitute a disguised restriction on trade between the Parties.
5. Without prejudice to paragraphs 2 and 3 and paragraph 3(c) of Article 5 -03, where a Party conducts a risk assessment and concludes that scientific knowledge or other available information is insufficient to complete the assessment, it may adopt a sanitary or phytosanitary measure on a provisional basis, based on the information available.
6. Once the exporting Party has submitted sufficient information to the importing Party to complete the risk assessment, both Parties shall agree on a deadline for the completion of the risk assessment and, where appropriate, immediately modify the provisional sanitary or phytosanitary measure.
7. Where a Party is able to achieve its appropriate level of protection through the gradual application of a sanitary or phytosanitary measure, it may, at the request of another Party and in accordance with this Chapter, allow such gradual application or grant specific exceptions for the measure, during established periods, taking into account the export interests of the requesting Party.
Article 5-07. Recognition of Pest or Disease Free Areas and Areas of Low Pest or Disease Prevalence
1. Each Party shall ensure that its sanitary or phytosanitary measures are adapted to the sanitary or phytosanitary characteristics of the areas of origin and destination of the good, whether the whole territory of a Party, part of the territory of a Party or all or parts of the territories of several Parties.
2. In evaluating the sanitary or phytosanitary characteristics of an area, the Parties shall take into account, inter alia, the level of prevalence of specific diseases or pests, the existence of eradication or control programs, and criteria or guidelines developed by competent international organizations agreed upon by the Parties.
3. The Parties shall recognize the concepts of pest or disease free areas and areas of low pest or disease prevalence. The determination of such areas shall be based on factors such as geographical location, ecosystems, epidemiological surveillance and the effectiveness of sanitary or phytosanitary controls.
4. The Party that declares an area of its territory free of a specific pest or disease shall demonstrate with scientific information to another Party such condition and provide assurance that it will be maintained as such, based on the protection measures adopted by the authorities responsible for sanitary and phytosanitary services.
5. The Party interested in obtaining the recognition of a pest or disease free area shall make the request and provide the corresponding scientific and technical information to another Party.
6. The Party receiving the request for recognition referred to in paragraph 5 shall decide within a period agreed with the requesting Party, and may carry out verifications in the territory of the latter for inspection, tests and other procedures. In case of non-acceptance, it shall indicate in writing the technical basis for its decision.
7. The Parties shall establish agreements on specific requirements, compliance with which will allow a good produced in an area of low pest or disease prevalence to be imported if it achieves the required level of protection.
Article 5-08. Control, Inspection and Approval Procedures.
1. The Parties, in accordance with this Chapter, shall apply the provisions contained in Annex C of the Agreement on Sanitary and Phytosanitary Measures, as regards control, inspection and approval procedures, including systems for approving the use of additives or establishing tolerances for contaminants in foodstuffs, beverages or feedstuffs.
2. When the importing Party requires to carry out a control or inspection procedure at the production stage, the exporting Party shall, at the request of the importing Party, adopt measures to facilitate access to its territory and provide it with the necessary assistance for the execution of the control or inspection procedure.
3. To ensure the safety of food, beverages and feedstuffs, each Party may establish, in its approval procedures and in accordance with its current legislation, authorization requirements for the use of a food additive, or the establishment of a tolerance level for a contaminant therein, prior to granting access to its market. Where that Party so requires, it may adopt a relevant international standard, guideline or recommendation as a basis for granting access to these goods, pending a final determination.
Article 5-09. Transparency.
Each Party, when proposing the adoption or modification of a sanitary or phytosanitary measure to be applied in its territory, shall notify through its competent authorities:
a) adoptions and modifications of such measures and shall provide information on such measures, in accordance with the provisions of Annex B of the Agreement on Sanitary and Phytosanitary Measures, and shall make the pertinent adaptations;
b) additionally, it will notify:
i) changes or modifications to sanitary or phytosanitary measures that have a significant effect on trade between the Parties, at least 60 days prior to the entry into force of the new provision, to allow for comments from any Party or interested persons. Emergency situations shall be exempted from the above-mentioned time limit, in accordance with the provisions of Annex B of the Agreement on Sanitary and Phytosanitary Measures;
ii) changes occurring in the animal health field, such as the appearance of exotic and List A diseases of the Office International des Epizooties, within 24 hours of the diagnostic detection of the problem;
iil) changes in the phytosanitary field, such as the appearance of quarantine pests or the spread of pests under official control, within 72 hours of their verification;
iv) findings of epidemiological importance and significant changes in relation to diseases and pests not included in subparagraphs ii) and iii) that may affect trade between the Parties, within a maximum period of 10 days;
v) outbreaks of diseases in which the consumption of natural or processed imported foods is scientifically proven to be the cause; and
vi) the causes or reasons for which a good of the exporting Party is rejected, within seven days;
c) the Parties shall use as a channel of communication the notification and information centers established before the WTO Committee on Sanitary and Phytosanitary Measures; and
d) each Party shall ensure that there is an information center capable of responding to reasonable requests from any Party, and shall provide relevant documentation, in accordance with the principles set forth in Annex B, paragraph 3 of the Agreement on Sanitary and Phytosanitary Measures.
Article 5-10. Committee on Sanitary and Phytosanitary Measures.
1. The Parties establish the Committee on Sanitary and Phytosanitary Measures, composed of representatives of each Party with responsibilities in sanitary and phytosanitary matters. The deadline for its installation will be within 90 days from the entry into force of this treaty.
2. The Committee shall have the following functions:
a) except as provided for in article 18-01, to oversee compliance with and correct application of the provisions of this chapter;
b) facilitate agricultural trade between the Parties;
c) To promote the improvement of sanitary and phytosanitary conditions in the territory of the Parties;
d) facilitate consultations and issue expeditious recommendations on specific SPS matters;
e) serve as a forum for the Parties to consult and resolve issues related to this chapter and, when required, in coordination with the other committees, subcommittees, technical working groups or any other body established in the treaty;
f) establish technical working groups or subgroups in the areas of animal health, plant health and food safety, among others, and determine their mandates, objectives and functions in accordance with the provisions of Article 5 -11;
g) coordinate the exchange of information on sanitary and phytosanitary measures between the Parties;
h) conduct an annual evaluation of the inventory of sanitary and phytosanitary measures between the Parties, and keep it updated;
i) to annually self-evaluate its performance for the purpose of adapting it to the needs of trade between the Parties;
j) to carry out technical consultations with the support of the relevant regional or subregional organizations;
k) establish and monitor the process of harmonization of sanitary and phytosanitary measures in coordination with the competent regional and subregional organizations;
I) to carry out the necessary actions for the training and specialization of technical personnel;
m) to promote technical cooperation and exchange, including cooperation in the development, application and enforcement of sanitary and phytosanitary measures;
n) submit recommendations on matters within its competence to the Commission;
o) report annually to the Commission on the implementation of this chapter; and
p) any other function in connection with this chapter.
3. The organizational structure, functions and general procedures of the Committee shall be as set forth in Annex 5-10.
Article 5-11. Technical Working Groups.
The functions of the technical working groups will be:
a) prepare the terms of reference and its work program within the scope of its competence and report its results to the Committee;
b) develop procedures to achieve a greater degree of harmonization and recognition of equivalencies;
c) agree on processes and methodologies for the use of equivalent risk assessment techniques, both in the areas of food safety and plant and animal health;
d) exchange information on laboratories for the necessary analysis of animals, plants, products and by-products entering the territory of one of the Parties;
e) identify and give priority to technical cooperation actions in matters of common interest, in order to achieve better control of existing pests and diseases and thus facilitate trade between the Parties;
f) coordinate actions to prevent the introduction of quarantine pests or diseases;
g) exchange information on sanitary and phytosanitary legislation and status, as well as pest and disease control methods, diagnostic techniques, handling and processing of agricultural products;
h) propose sanitary and phytosanitary programs and treatments to expedite procedures for trade between the Parties;
i) to promote reciprocal technical collaboration in the aspects of recognition, diagnosis and prevention measures of sanitary and phytosanitary risk;
j) propose to the Committee specific sanitary or phytosanitary protocols involving greater technical-operational detail; and
k) such other functions as may be proposed by the technical working groups and approved by the Committee.
Article 5-12. Technical Cooperation.
1. The Parties:
a) facilitate the provision of technical assistance, on mutually agreed terms and conditions, to strengthen their sanitary and phytosanitary measures and related activities, including research, process technology, infrastructure and the establishment of standardization bodies; and
b) provide information on their technical assistance programs related to sanitary or phytosanitary measures in areas of particular interest.
2. Expenses derived from technical assistance activities shall be subject to the availability of funds and priorities in the matter for each Party and the expenses derived from control or inspection and approval procedures shall be borne by the interested parties.
Article 5-13. Technical Consultations.
1. Nothing in this Chapter shall prevent a Party, when in doubt as to the application or interpretation of its contents, from initiating consultations with another Party.
2. Where a Party considers that a sanitary or phytosanitary measure of the other Party is interpreted or applied in a manner inconsistent with the provisions of this Chapter, it shall have the burden of proving the inconsistency.
3. When a Party requests consultations and so notifies the Committee, the Committee shall facilitate the consultations and may refer them to an ad-hoc working group or other forum for non-binding technical advice or recommendation.
4. When the Parties have resorted to consultations pursuant to this Article without satisfactory results, such consultations shall constitute the consultations provided for in Article 19-05.
Article 5-14. Settlement of Disputes.
1. Nothing in this Chapter shall prevent a Party, when in doubt as to the application or interpretation of any of its provisions, from initiating consultations with another Party in accordance with the provisions of Chapter XIX.
2. When the Parties have resorted to consultations pursuant to paragraphs 1 and 2 of Article 5-13, such consultations shall constitute those provided for in Article 19-05, if so agreed by the Parties.
Chapter Vi. RULES OF ORIGIN
Article 6-01. Definitions.
For the purposes of this chapter, the following definitions shall apply:
good: any merchandise, product, article or matter;
fungible goods: goods that are interchangeable for commercial purposes, whose properties are essentially identical and which cannot be differentiated by simple visual examination;
identical goods: goods that are alike in all respects, including their physical characteristics, quality and commercial prestige; where minor differences in appearance do not prevent goods that otherwise conform to their definition from being considered identical;
similar goods: goods which, although not the same in all respects, have similar characteristics and composition, enabling them to perform the same functions and to be commercially interchangeable. In determining whether goods are similar, factors to be considered include, among others, their quality, commercial prestige and the existence of a trademark; goods wholly obtained or produced entirely in the territory of one or more of the Parties:
a) minerals extracted in the territory of one or more of the Parties;
b) harvested in the territory of one or more of the Parties;
c) live animals, born and raised in the territory of one or more of the Parties;
d) goods obtained from hunting or fishing in the territory of one or more of the Parties;
e) fish, crustaceans and other marine species obtained from the sea by vessels registered or recorded by a Party and flying the flag of that Party;
f) goods produced on board factory ships from the goods identified in subparagraph e), provided that such factory ships are registered or registered by a Party and fly the flag of that Party;
g) property obtained by a Party or a person of a Party from the seabed or subsoil outside the territorial waters, provided that the Party has rights to exploit that seabed or subsoil;
h) waste (1) and residues derived from:
i) production in the territory of one or more of the Parties; or
(ii) goods used or harvested in the territory of one or more of the Parties, provided that such goods are used only for the recovery of raw materials; or
i) goods produced in the territory of one or more of the Parties exclusively from the goods referred to in subparagraphs a) through h) or their derivatives, at any stage of production;
shipping containers and packaging materials: goods that are used to protect a good during transportation, other than retail containers and materials;
fungible materials: those which are interchangeable for commercial purposes, whose properties are essentially identical and which cannot be differentiated by simple visual examination;