General Services
- Management and supervisory personnel involved in business operations for an enterprise located in the territory of another Party.
- Tour bus operators entering the territory of a Party:
a) with a group of passengers on a tour bus trip that began in the territory of another Party and is to return to it;
(b) that is to pick up a group of passengers on a tourist bus tour that will take place and terminate for the most part in the territory of another Party; or
c) with a group of passengers in a tourist bus whose destination is in the territory of the Party from which temporary entry is requested, and which returns without passengers or with the group for transportation to the territory of another Party.
Definitions
For the purposes of this appendix, the following definitions shall apply:
tourist bus operator: the natural person required to operate the vehicle during the tourist trip, including any relief personnel accompanying or joining him/her at a later date.
transport operator: the natural person, other than a tour bus operator, required to operate the vehicle during the trip, including any relief personnel accompanying or joining him/her at a later date.
Chapter XIV. Technical Standards
Article 14-01. Definitions.
1. For the purposes of this chapter, the terms presented in the sixth edition of ISO/IEC Guide 2: 1991, "General Terms and their Definitions in Relation to Standardization and Related Activities", shall have the same meaning when used in this chapter, unless defined differently here.
2. For the purposes of this chapter, the following definitions shall apply:
to make compatible: to bring to the same level different standardization measures, but with the same scope, approved by different standardization bodies, so that they are identical, equivalent or have the effect of allowing goods and services to be used interchangeably or for the same purpose, in order to enable such goods and services to be traded between the Parties.
standardization measures: standards, technical regulations or conformity assessment processes.
standard: the document approved by a recognized institution with standardization activities, which provides for common and repeated use, rules, guidelines or characteristics for goods or related processes and production methods or for services or their related methods of operation, and whose observance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labeling requirements applicable to a related good, service, process or production method.
international standard: a standardization measure, or other guide or recommendation, adopted by an international standardization body and made available to the public.
legitimate objectives: among others, ensuring the safety and protection of human, animal and plant life and health, their environment and the prevention of practices that may mislead consumers, including matters relating to the identification of goods or services, considering among other aspects, where appropriate, fundamental climatic, geographical, technological or infrastructural factors or scientific justification.
international standardizing body: a standardizing body, open to participation by the relevant bodies of at least all parties to the GATT Agreement on Technical Barriers to Trade, including the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the Codex Alimentarius Commission, the World Health Organization (WHO), the International Telecommunication Union (ITU), or any other body designated by the Parties.
standardizing body: a body whose standardization activities are recognized.
conformity assessment procedure: any procedure used, directly or indirectly, to determine that the relevant requirements established by technical regulations or standards have been met, including sampling, testing, inspection, evaluation, verification, conformity assurance, accreditation, certification, registration or approval, used for such purposes, but does not mean an approval process.
approval process: the registration, communication or any other mandatory administrative process for obtaining a permit for a good or service to be marketed or used for defined purposes or in accordance with established conditions.
technical regulation: a document that establishes the characteristics of goods or their related processes and production methods, or of services or their related methods of operation, including the applicable administrative provisions, and whose observance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging or labeling requirements applicable to a good, service, process or related production method.
service: any of the services included in the framework of this Treaty, except financial services.
Article 14-02. Scope of Application.
The provisions of this Chapter apply to standardization measures, metrology and related measures of each Party that may affect, directly or indirectly, trade in goods and services between the Parties. The provisions of this Chapter do not apply to the phytosanitary and zoosanitary measures referred to in Chapter V, Section B.
Article 14-03. Scope of Obligations.
Each Party shall ensure, in accordance with its constitutional provisions, compliance with the obligations of this Chapter, in its territory at the central or federal, state or departmental and municipal levels, and shall adopt such measures in this regard as may be available to it with respect to non-governmental standardizing bodies in its territory.
Article 14-04. Reaffirmation of International Rights and Obligations.
The Parties mutually reaffirm their existing rights and obligations relating to standardization measures under the GATT and all other international treaties, including environmental and conservation treaties, to which the Parties are parties.
Article 14-05. Basic Obligations and Rights.
1. The Parties shall not develop, adopt, maintain or apply any standardizing measure that has the purpose or effect of creating unnecessary obstacles to trade between them. To this end, each Party shall ensure that its standardizing measures are no more trade-restrictive than necessary for the achievement of a legitimate objective, taking into account the risks that failure to achieve that objective would create.
2. Notwithstanding any other provision of this Chapter, and in accordance with Article 14-14, paragraph 3, each Party may establish the level of protection it considers appropriate in the pursuit of its legitimate objectives regarding the safety and protection of human, animal and plant life and health; and the protection of its environment and the prevention of practices that may mislead consumers, without constituting an obstacle to trade. To this end, each Party may develop, implement and maintain standardization measures to ensure this level of protection, as well as measures to ensure the application and enforcement of such standardization measures, including the relevant approval procedures, provided that such measures do not have the purpose or effect of creating unnecessary obstacles to trade.
3. With respect to its standards-related measures, each Party shall accord to goods and service suppliers of another Party national treatment no less favorable than that accorded to like goods and service suppliers of any other country.
Article 14-06. Use of International Standards.
1. Each Party shall use as a basis for its own standardization measures, international standards in force or of imminent adoption, except when such standards do not constitute an effective or adequate means to achieve its legitimate objectives; for example, due to fundamental factors of a climatic, geographical, technological or infrastructural nature, in accordance with the provisions of this Chapter.
2. Standardization measures of a Party that conform to an international standard shall be presumed to be consistent with the provisions of article 14-05, paragraphs 1 and 3.
3. In pursuing its legitimate objectives, each Party may adopt, maintain or apply any standardization measure that achieves a higher level of protection than would have been achieved if the measure were based on an international standard due to fundamental factors of a climatic, geographical, technological or infrastructural nature, among others.
Article 14-07. Compatibility and Equivalence.
1. Recognizing the central role that standardization measures play in the promotion and protection of legitimate objectives, the Parties shall work together, in accordance with this Chapter, to strengthen the level of safety and protection of human, animal and plant life and health; of their environment; and for the prevention of practices that may mislead consumers.
2. The Parties shall make compatible, to the greatest extent possible, their respective technical regulations and conformity assessment procedures, without reducing the level of safety or protection of human, animal and plant life and health, their environment or consumers, without prejudice to the rights conferred by this Chapter on any Party and taking into account international standardization activities.
3. At the request of a Party, the other Parties shall take reasonable measures within their power to promote the compatibility of the specific standardization measures existing in their territory with the standardization measures existing in the territory of the other Parties, taking into account international standardization activities.
4. Each Party shall accept a technical regulation adopted by another Party as equivalent to its own when, in cooperation with the importing Party, the exporting Party demonstrates to the satisfaction of the importing Party that its technical regulation adequately meets the legitimate objectives of the importing Party and, if appropriate, shall revise it.
5. At the request of the exporting Party, the importing Party shall communicate to it the reasons for non- acceptance of a technical regulation in accordance with paragraph 4.
6. Each Party shall, whenever possible, accept the results of conformity assessment procedures carried out in the territory of another Party, even if those procedures differ from its own, provided that such procedures offer a satisfactory assurance, equivalent to that offered by procedures carried out or to be carried out in its territory, the result of which it accepts, that the relevant good or service complies with the applicable technical regulations or standards that are developed or maintained in the territory of that Party, and if appropriate, shall review the relevant standardization measure.
7. Prior to acceptance of the results of a conformity assessment procedure, in accordance with paragraph 6, and in order to strengthen confidence in the continued integrity of each Party's conformity assessment results, the Parties may consult on matters such as the technical capability of conformity assessment bodies, taking into consideration verified compliance with relevant international standards and recommendations.
Article 14-08. Conformity Assessment.
1. The Parties recognize the desirability of achieving reciprocal recognition of their conformity assessment systems, including accreditation bodies, in order to facilitate trade in goods and services between them and undertake to work towards the achievement of this objective.
2. In addition to the provisions of paragraph 1, and recognizing the existence of differences in their conformity assessment procedures in their respective territories, the Parties shall make compatible, to the greatest extent possible, their respective conformity assessment systems and procedures so that they are mutually recognizable in accordance with the provisions of this Chapter.
3. For mutual benefit and on a reciprocal basis, each Party shall accredit, approve, license or recognize conformity assessment bodies in the territory of another Party on terms no less favorable than those granted to such bodies in its territory.
4. Each Party shall give favorable consideration to requests submitted by another Party to negotiate agreements on mutual recognition of the results of that Party's conformity assessment procedures.
5. When required to carry out any procedure for the assessment of conformity with technical regulations or standards, each Party shall have the obligation to:
a) not adopt, maintain or apply more stringent conformity assessment procedures than necessary to ensure that the good or service conforms to the applicable technical regulation or standard, taking into consideration the risks that nonconformity may create;
b) to initiate and complete such proceedings as expeditiously as possible;
c) establish a non-discriminatory order for the processing of applications;
d) publish the normal duration of each of these procedures or inform, upon request, the approximate duration of the procedure;
e) ensure that the competent body:
i) upon receipt of the application, promptly examine the documentation for completeness and inform the applicant of any deficiencies accurately and completely;
ii) as soon as possible, transmit to the applicant the results of the conformity assessment procedure in an accurate and complete manner, so that the applicant can carry out any corrective action;
iii) when the application is deficient, to advance the procedure as far as possible, if the applicant so requests; and
iv) report at the request of the applicant on the status of his application and the reasons for any delay;
f) limit to what is necessary, the information that the applicant must submit to assess conformity and to determine the relevant rights;
g) to grant confidential information arising out of or in connection with the proceeding:
(i) the same treatment as confidential information relating to a good or service of the Party making the assessment; and
ii) in any case, treatment that protects the legitimate commercial interests of the applicant;
h) ensure that any fee charged for assessing the conformity of a good or service imported from another Party is equitable in relation to any fee charged for assessing the conformity of an identical or similar good or service of the assessing Party, taking into account communication, transportation and other related costs;
i) ensure that the location of the facilities where the conformity assessment procedures are carried out does not cause unnecessary inconvenience to the applicant or its representative;
j) where possible, endeavor to ensure that the procedure is carried out at that facility and, where appropriate, a mark of conformity is awarded;
k) in the case of a good or service that has been modified as a result of a determination of conformity assessment with applicable technical regulations or standards, limit the procedure to what is necessary to determine that the good or service continues to comply with those regulations or standards; and
l) limit to reasonableness any requirement for samples of a good and ensure that the selection of samples does not cause unnecessary inconvenience to the applicant or its representative.
6. The Parties shall apply the provisions of paragraph 5 to their approval procedures with appropriate adjustments.
Article 14-09. Publication and Provision of Information.
1. Each Party shall inform the other Parties of the standardization measures it intends to adopt in accordance with the provisions of this Chapter prior to the entry into force of such measures and no later than to its nationals.
2. When proposing the adoption or modification of any standardization measure, each Party:
a) publish a notice and inform the other Parties of its intention to adopt or modify such measure, to enable interested parties to familiarize themselves with the proposal, at least 60 days prior to its adoption or modification;
b) identify in the notice and information the good or service to which the measure will be applied, and include a brief description of its objective and motivation;
c) provide a copy of the proposed measure to any Party or interested party upon request and, where possible, identify the provisions that deviate substantially from the relevant international standards;
d) without discrimination, allow other Parties and interested parties to comment and, upon request, discuss and take into account such comments, as well as the results of the discussions; and
e) ensure that, upon adoption of the measure, it is published in an expeditious manner, or otherwise made available to interested parties in the Party so that they may become familiar with it.
3. With respect to any technical regulation of a state or departmental or municipal government, each Party:
a) ensure that the intention of that government to adopt or amend such regulations at an appropriate initial stage is published in a notice and that the other Parties are informed of that government's intention;
b) ensure that the notice and information shall identify the good or service to which the technical regulation applies, and shall include a brief description of its objective and motivation;
c) ensure that a copy of the proposed regulations is provided to the Parties or to any interested person upon request;
d) take such reasonable measures as may be available to it to ensure that when the technical regulation is adopted, it is published expeditiously or otherwise made available to interested persons in the Party so that they may become familiar with it.
4. Each Party shall inform the other Parties of its standardization plans and programs.
5. Where a Party considers it necessary to address an urgent problem related to the safety or protection of human, animal and plant life and health, its environment or practices that mislead consumers, it may omit any of the steps set out in paragraph 2(a) and (b), provided that in adopting the standardization measure:
a) immediately inform the other Parties, in accordance with the requirements set forth in paragraph 2, subparagraph b), including a brief description of the urgent problem;
b) deliver a copy of the measure to any Party or interested party that so requests;
c) without discrimination, allow other Parties and interested parties to make comments in writing and, upon request, discuss and take into account such comments and the results of the discussions; and
d) ensure that the measure is published in an expeditious manner, or allow interested parties to become familiar with it.
6. The Parties shall allow a reasonable period to elapse between the publication of their standardization measures and the date on which they enter into force, in order to give interested parties the opportunity to adapt to the measures, except where it is necessary to address one of the urgent problems identified in paragraph 5.
7. Each Party shall designate a governmental authority responsible for the implementation of the information provisions of this Chapter at the federal or central level, and shall inform the other Parties thereof. Where a Party designates two or more governmental authorities for this purpose, it shall inform the other Parties, without ambiguity or exception, of the scope of responsibilities of those authorities.
Article 14-10. Information Centers.
1. Each Party shall ensure that there is at least one information center within its territory capable of answering all reasonable inquiries and requests from another Party and interested parties, as well as providing relevant documentation regarding:
a) any standardization measure adopted or proposed in its territory at the level of its federal or central, state or departmental, or municipal government;
b) the participation and membership of the Party, and of its relevant authorities at the federal or central, state or departmental or municipal level in international or regional standardizing bodies and conformity assessment systems, in bilateral or multilateral agreements, within the scope of this Chapter, as well as the provisions of such systems and agreements;
c) the location of notices published pursuant to this chapter, or the place where such information may be obtained;
d) the location of the information centers; and
e) the Party's risk assessment processes, the factors it takes into consideration in carrying out the assessment and in establishing the levels of protection it considers appropriate, in accordance with Article 14-05, paragraph 2.
2. When a Party designates more than one information center:
a) inform the other Parties of the scope of responsibilities of each of these centers; and
b) ensure that any request sent to the wrong clearinghouse is expeditiously forwarded to the correct clearinghouse.
3. Each Party shall take such measures as are reasonable and within its power to ensure that there is at least one information center, within its territory, capable of responding to all inquiries and requests from another Party and interested parties, as well as of providing relevant documentation, or information from which such documentation may be obtained, relating to:
a) any standard or conformity assessment process adopted or proposed by non-governmental standardizing bodies in its territory; and
b) participation and membership in international and regional standardization bodies and conformity assessment systems of relevant non-governmental bodies in its territory.
4. Each Party shall ensure that when another Party or interested parties, in accordance with the provisions of this Chapter, request copies of the documents referred to in paragraph 1, they shall be provided at the same price that applies to its nationals, except for the actual cost of delivery. Copies of mandatory technical regulations and conformity assessment procedures requested by the Parties shall be supplied free of charge.
Article 14-11. Limitations on the Provision of Information.
Nothing in this Chapter shall be construed to require a Party to provide any information the disclosure of which it considers contrary to its essential security interests, or prejudicial to the legitimate commercial interests of certain enterprises.
Article 14-12. Metrological Standards.
The Parties shall make compatible, to the greatest extent possible, their national metrological standards on the basis of the international standards in force, when such standards constitute or create unnecessary obstacles to trade.
Article 14-13. Health Protection.
1. Medicines, medical equipment, medical instruments, pharmochemical products and other inputs for human, animal and plant health that are subject to sanitary registration within the territory of any of the Parties, shall, where appropriate, be registered, recognized or evaluated by the competent authority of that Party based on a single national system of federal or central mandatory compliance.
2. Certificates of compliance with the standards and technical regulations of the companies producing or packaging the products referred to in paragraph 1 shall be accepted only if they have been issued by the competent regulatory authorities of the federal or central government of the Parties.
3. The Parties shall establish a system of mutual technical cooperation based on the following program:
a) identification of specific needs:
i) application of good manufacturing practices in the elaboration and approval of drugs, particularly those for human use;
ii) application of good laboratory practices in the analysis and evaluation systems established in the ISO 9000 and 25 guides in force;
iii) development of common identification and nomenclature systems for auxiliary health products and medical instruments;
b) standardization of labeling requirements and strengthening of standardization and surveillance systems in relation to warning labeling;
c) training and education programs, and the organization of a common system of training, continuing education, training and evaluation of sanitary officers and inspectors;
d) development of a mutual accreditation system for verification units and testing laboratories; e) updating of legal and regulatory frameworks; and
f) strengthening formal communication systems to monitor and regulate the exchange of products related to human, animal and plant health.
4. In order to carry out the activities proposed in paragraph 3, the Parties shall establish, in accordance with article 14-17, paragraph 5, a technical subcommittee in charge of monitoring and organizing such activities, to provide guidance and recommendations to the Parties upon their request.
Article 14-14. Risk Assessment.
1. Pursuant to Article 14-05, paragraph 2, Parties may carry out risk assessments. In doing so, they shall ensure that they take into consideration risk assessment methods developed by international organizations and that their standardization measures are based on an evaluation of the risk to human, animal and plant health and safety and their environment.
2. In conducting a risk assessment, the Party conducting the risk assessment shall take into consideration all relevant scientific evidence, available technical information, intended end use, processes or methods of production, operation, inspection, quality, sampling or testing, or environmental conditions.
3. Where a Party, in accordance with Article 14-05, paragraph 2, having established its level of safety protection it considers appropriate, conducts a risk assessment, it shall avoid arbitrary or unjustifiable distinctions between similar goods and services at the level of protection it considers appropriate, if such distinctions are made:
a) have the effect of arbitrarily or unjustifiably discriminating against goods or service suppliers of the other Parties;
b) constitute a disguised restriction on trade between the Parties; or
c) discriminate between similar goods or services for the same use, in accordance with the same conditions posing the same level of risk and conferring similar benefits.
4. Where the Party conducting a risk assessment concludes that the scientific evidence or other available information is insufficient to complete that assessment, it may adopt a technical regulation on an interim basis based on the relevant available information. Once it has been presented with sufficient information to complete the risk assessment, the Party shall complete its assessment as soon as possible and shall review, and where appropriate, reconsider the provisional technical regulation in the light of that assessment.
Article 14-15. Handling of Hazardous Substances.
For the control, management and acceptance of toxic or hazardous substances or wastes, each Party shall apply the provisions, guidelines or recommendations of the relevant international agreements to which it is a party.
Article 14-16. Labeling.
1. The labeling requirements for goods and services falling within the scope of this chapter shall be subject to the provisions set forth in this chapter.
2. Each Party shall apply its relevant labeling requirements within its territory and in accordance with the provisions of this Chapter.
3. The Parties shall seek to develop common labeling requirements. Proposals made by each Party shall be evaluated by the Committee referred to in Article 14-17.
4. The Committee referred to in article 14-17, may work and formulate recommendations, among others, on the following areas of labeling, packaging and packing:
a) acommon system of symbols and pictograms;
b) definitions and terminology; or
c) presentation of the information.
Article 14-17. Committee for Standardization Measures.
1. The Parties create a Committee for Standardization Measures.
2. The Committee's functions include, among others:
a) monitoring the implementation, enforcement and administration of this chapter, including the progress of the subcommittees and working groups established pursuant to paragraph 4 and the operation of the information centers established pursuant to article 14-10 paragraph 1;
b) to facilitate the process through which the Parties will make their standardization and metrology measures compatible;
c) provide a forum for the Parties to consult on matters related to standardization and metrology measures;
d) report annually to the Commission on the implementation of this chapter; and
e) to develop the necessary procedural mechanisms to achieve recognition of conformity assessment bodies.