Measures within the scope of application of the Agreement on Technical Barriers to Trade

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1 MODULE 4 Measures within the scope of application of the Agreement on Technical Barriers to Trade ESTIMATED TIME: 2 ½ hours OBJECTIVES OF MODULE 4 Conceptualize and give practical examples of the measures under the TBT Agreement: Technical Regulations, Standards and Conformity Assessment Procedures.

2 I. INTRODUCTION In the previous Module, we learned that while the main objective of the TBT Agreement is to ensure that technical regulations, standards and conformity assessment procedures do not create unnecessary obstacles to international trade, no Member shall be prevented from taking measures necessary to ensure, inter alia, the following: The quality of its exports. The protection of human, animal or plant life or health. The protection of the environment. The prevention of deceptive practices, at levels it considers appropriate. The protection of its essential security interest. We also learned that the TBT Agreement does not apply to sanitary and phytosanitary measures, purchasing specifications prepared by governments (government procurement) and to regulations related to services. After having completed Module 3, you are aware that the TBT Agreement applies to measures in legal force, regardless of the date they were enacted by the Member. Finally, the three types of measures which fall within the scope of application of this Agreement are: technical regulations, standards, and conformity assessment procedures. It is time for us to explain these in more detail. We hope that with some practical examples you may fully understand the definition and characteristics of each type of measure. Let's get started! 2

3 II. TECHNICAL REGULATIONS IN DETAIL A technical regulation is defined in TBT Annex 1, paragraph 1 as a: Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method. Figure 1: TBT Annex 1.1 Pursuant to Annex 1 paragraph 1, the following requirements may be included in a technical regulation: Terminology requirements. Symbol requirements. Packaging requirements. Marking requirements. Labelling requirements. According to Article 2.8 of the TBT Agreement, technical regulations should preferably specify performance requirements, rather than design or descriptive characteristics, whenever possible. Obligations regarding technical regulations in the TBT Agreement are found in two provisions on "Preparation, Adoption and Application of Technical Regulations": one related to central governmental bodies (Article 2); and another on local government bodies and non-governmental bodies (Article 3). In order to verify if a measure or document is a technical regulation, the Appellate Body laid down three criteria while deciding on two TBT related cases, the EC - Asbestos (WT/DS135) and the EC - Sardines (WT/DS231) cases: 1. The document must apply to an identifiable product or group of products. 2. The document must lay down one or more characteristics of the product. 3. Compliance with the product characteristics must be mandatory. 3

4 Let's learn more about the Asbestos cases. CASE STUDY 1 EUROPEAN COMMUNITIES ASBESTOS (WT/DS135) Overview European Communities Measures Affecting Asbestos and Products Containing Asbestos Complaint by Canada Third Parties: Brazil, Zimbabwe and the United States To control the health risks associated with asbestos, the French Government, which had previously been an importer of large quantities of chrysotile asbestos, imposed a ban on the substance as well as on products that contained asbestos and asbestos fibres. The European Union justified its prohibition on the grounds of human health protection, arguing that asbestos was hazardous not only to the health of construction workers subject to prolonged exposure, but also to population subject to occasional exposure. Being the second largest producer of asbestos world-wide, Canada contested the prohibition in the WTO. While it did not challenge the hazards associated with asbestos, it argued that a distinction should be made between chrysotile fibres and chrysotile encapsulated in a cement matrix. The latter, it argued, prevented release of fibres and did not endanger human health. It also argued that the substances which France was using as substitutes for asbestos had not been sufficiently studied and could themselves be harmful to human health. What were their arguments? Arguments from the Parties: Canada claimed that the Decree violated GATT Articles III:4 and XI, and Articles 2.1, 2.2, 2.4 and 2.8 of the TBT Agreement, and also nullified or impaired benefits under GATT Article XXIII:1(b). The EU argued that the Decree was not covered by the TBT Agreement. With regard to GATT 1994, it requested the panel to confirm that the Decree was either compatible with Article III:4 or necessary to protect human health within the meaning of Article XX(b). What did the Panel and the Appellate Body say? The WTO Appellate Body upheld the panel's ruling in favour of the EU, while modifying its reasoning on a number of issues. For instance, it reversed the Panel's finding that it was not appropriate to take into consideration the health risks associated with chrysotile asbestos fibres while examining the "likeness" of products under GATT Article III:4. The Appellate Body also argued that the EU measures was a technical regulation and that the case should have been looked at under the TBT Agreement rather than under GATT rules, but did not itself pursue the analysis under TBT since the Appellate Body only has a mandate to examine issues of "law" while reviewing a case and cannot itself embark on new analyses. The right of France to ban the import of asbestos and asbestos products was confirmed. 4

5 One of the most important issues analysed by the Appellate Body were the criteria for determining if the EU measure was a technical regulation. The Panel had determined that the part of the EU Decree that banned the import of asbestos and asbestos-containing products was not a technical regulation, and did not analyse the case under the TBT Agreement. The Appellate Body, on the other hand, claimed that the EU Decree should have been examined as a whole, and with this in view, proposed the following criteria to identify if the measure in question was a technical regulation: The document must apply to an identifiable product or group of products: It is important to note that a product does not necessarily have to be mentioned explicitly in a document for that product to be an identifiable product; identifiable does not mean expressly identified. The document must lay down one or more characteristics of the product: Annex 1, paragraph 1 gives certain examples of "product characteristics" which may be prescribed or imposed in either a positive or a negative form, and which include not only features and qualities intrinsic to the product itself but also related "characteristics", such as the means of identification, the presentation and the appearance of a product. Compliance with the product characteristics must be mandatory: A technical regulation must regulate the "characteristics" of products in a binding or compulsory fashion. It follows that, with respect to products, a "technical regulation" has the effect of prescribing or imposing one or more "characteristics". Since the EU Decree applied to an identifiable product asbestos, laid down asbestos characteristics and was mandatory, the Appellate Body determined it to be a technical regulation. 5

6 ILLUSTRATION "Technical regulations"... The concept may seem quite abstract or even vague when we first hear about it, right? With some of the examples we have collected below, we hope that it will all become clearer. FIRST EXAMPLE: ENERGY SAVING ELECTRONIC APPLIANCES We all know that some of the natural resources we have on Earth, such as Petrol, will end someday. That is, they are exhaustible. Therefore, much has been invested in renewable sources of energy, such as solar energy, and hydroelectric power. Governments, industries and consumers have been worried about finding electric appliances which are more efficient, in terms of energy consumption. The same has been done regarding automotive vehicles. Such demands have presented themselves at different levels. For instance, governments may impose a standard for electrical appliances' maximum electricity consumption, e.g. a washing machine. A WTO Member may issue a regulation with which compliance is mandatory for the industry (either domestic producers and or imports destined to that Member), which states that no washing machine commercialised within the territory shall have a consumption over XXX Kilowatts a year. This is a typical technical regulation on a product's characterristics, based on performance. In order to make sure that a certain product complies with the regulation, the government may require a label to be placed on the product. Below is the label used by the European Union Member States. Although many countries may have similar requirements, i.e., that electric appliances be energetically efficient, they may have imposed different limits on energy consumption, if compared to their trading partners. They may even have different methodologies for measuring how efficient an appliance is, hence the importance of applying the principle of equivalence to technical regulations. Members recognize a technical regulation equivalent to their own, provided they are satisfied that the regulation adequately fulfils the objective of their own regulation, even if they differ from each other. The acceptance of conformity assessment results is also an invaluable tool to facilitate trade and to assure conformance with technical regulations and standards. Both topics Equivalence and Acceptance of Conformity Assessment Results - are regulated under the TBT Agreement and shall be explained in our course in Module 5. Figure 2: EU Energy Efficiency Label 6

7 SECOND EXAMPLE: NUTRITION FACTS OF FOOD Nutrition is an important matter in modern society. Nowadays, the food produced in one place is consumed in another. Hence, there are many requirements to be fulfilled concerning food safety, consumer information, human health, etc. Often, these requirements take form of packaging and labelling obligations, such as the case for Nutrition Facts. Although some WTO Members do not oblige domestic producers (or importers) to have nutrition facts on their products, many of them do. However, just as in the example on Energy Labels, information on Nutrition Facts may vary around the world, while several countries may adopt similar formats. The harmonisation of the information to be provided to the consumer is firstly useful for the producer, who would then not require different packages for different markets. It is useful for the customs authority, who can assess foreign merchandise more easily. It is also useful for the consumer, as to easily identify the nutrition content of a product everywhere he or she goes, or no matter where it comes from. Furthermore, we could say that, although in most cases the requirement to explicitly state the nutrition facts (or energy consumption) is a technical regulation, the labelling format is nonrarely a standard. That is, even if a Member requires the producer to place a label that fulfils certain criteria, it may be the case that the format of the label is not specified. Hence the producer is allowed to use any the format he chooses, or one of the privately or internationally designed formats. Figure 3: Nutrition Facts on the package EXERCISES: 1. What is the definition of a technical regulation? 2. What are the three criteria for identifying a technical regulation? 7

8 III. STANDARDS IN DETAIL A standard is defined in Annex 1, paragraph 2 as a: Document approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method. Figure 4: TBT Annex 1.2 The term "recognized body" is defined neither by the TBT Agreement nor by ISO/IEC Guide 2. However, Annex 1 (paragraphs 4 to 8) refers to the different types of bodies whose documents are either covered by, or referred to, in the TBT Agreement: International body or system; regional body or system; central government body; local government body; and non-governmental body. Remember that Annex 1 definition on standards refers to the definition contained in ISO/IEC Guide 2:1991, in its Explanatory note. As we discussed in Module 3, the definition and coverage of standards as provided in the TBT Agreement prevail over those presented in the ISO/IEC Guide 2:1991, to the extent of their differences. Note The ISO/IEC Guide 2:1991 applies to services and incorporates mandatory and voluntary standards. Furthermore, it defines standards as documents adopted by consensus. As we learned earlier, the TBT Agreement excludes services from its application and defines standards exclusively as voluntary requirements. The TBT Agreement covers also documents which are not based on consensus. 8

9 Pursuant to Annex 1, paragraph 2, the following requirements may be included in a standard: Terminology requirements Symbol requirements Packaging requirements Marking requirements Labelling requirements Obligations on standards in the TBT Agreement are found in two provisions: Preparation, adoption and application of Standards (Article 4) Code of Good Practice for the Preparation, Adoption and Application of Standards (Annex 3) Article 4 of the TBT Agreement establishes the "Code of Good Practice for the Preparation, Adoption and Application of Standards". Its text is contained in Annex 3 (Code of Good Practice). Annex 3.B establishes that the Code is open to acceptance by any standardizing body within the territory of a Member of the WTO, whether a central government body, a local government body, a non-governmental body, any governmental or non-governmental regional standardizing body to which a Member (or body within its territory) is a party to. RECALL As explained in Module 3 - Institutional Coverage - the obligations of Members with regard to standards vary according to the level of body concerned: Central government standardizing bodies: Members shall ensure that they accept and comply with the Code of Good Practice. Local government, non-governmental, and regional standardizing bodies: Members shall take such reasonable measures as may be available to them to ensure that they accept and comply with the Code. Regarding all standardizing bodies: Members shall not take measures which have the effect of, directly or indirectly, requiring or encouraging them to act in a manner inconsistent with the Code. Standards, as we said, are not mandatory. However, they are the vast majority of requirements to which a producers and exporters are subject to. That is why the acceptance of the Code of Good Practice by standardizing bodies is so important to international trade. By adopting common practices, such bodies may ensure that standards are non-discriminatory and not more trade restrictive than necessary vis-à-vis to fulfil a legitimate interest. Moreover, industries are not obliged to accept the Code of Good Practice, and in general are not seen as non-governmental standardizing bodies, since their main activity is not to set standards, but actually to produce a product that follows certain standards, even if created by them. Despite the fact that the relationship between private standards and the TBT Agreement is not as yet clear, the influence that industry standards have in international trade among nations cannot be neglected. That is why we would like to give you an illustration of an industry standard, so that you may understand what it is. This will be our fourth example, below. 9

10 Several examples will demonstrate how standards are part of our every day life. ILLUSTRATION FIRST EXAMPLE: PLUG SOCKETS FOR ELECTRICAL APPLIANCES Have you noticed that different countries have different standards for plug sockets? This means that if you move with your Fridge around the five continents, you will probably end up having to buy an adaptor in every different place, unless you find an universal adaptor! Here are some examples on plug sockets that we can find around the globe: Figures 5: Plugs of the world In fact, there is a "universal" plug and socket system designed by the International Electrotechnical Commission, which is used in few countries, because developed countries, including European countries, Australia and the USA, have a well-entrenched system of their own. This universal plug system may grown on popularity with time, as a way of promoting harmonisation and facilitating trade flows. SECOND EXAMPLE: MOBILE PHONE COMMUNICATION STANDARDS GSM, CDMA, TDMA... Have you heard these abbreviations before? These are all abbreviations for mobile phone communications systems. These mobile communication standards have been developed in different parts of the globe, with the same aim, that of providing mobile voice and data communication services. They use different systems for interface communication and different frequency ranges. While GSM systems were firstly used in Europe, the United States started off with the CDMA technology, while most countries in Latin America had their first systems under TDMA. Nowadays, most countries have GSM systems in addition to the systems they had previously adopted, so as to facilitate international roaming for services users. GSM technology is currently used by 200 million people. 10

11 These technologies have been developed in most part by private parties, but have been actually harmonized under the auspices of international and regional standardizing bodies, such as the International Telecommunications Union and the European Telecommunications Standards Institute. Without the efforts of these standardizing bodies it is quite likely that domestic technologies would have remained incompatible with each other, to the detriment of global communications and the international movement of people. Figure 6: Map with Mobile Phone Communications use in the World (population ownership percentage) Source: THIRD EXAMPLE: INTERNATIONAL PAPER SIZES Standard paper sizes like A4 are widely used everywhere, nowadays. They allow people all over the world to use the same printer, the same fax machines, the same photocopiers, because they make use of the same size of paper sheet. The A4 standard for paper sheets is a case of a highly successful use of international standards. It was proposed by the International Organization for Standardization (ISO) in 1975, on its standard ISO 216:1975 "Writing paper and certain classes of printed matter Trimmed sizes A and B series". Canada and the United States, however, have kept to the use of another format of paper sheet for documents, the "Letter" format. For legal documents, the "Legal" format (taller in height and narrower in width) is predominately used in these two countries. The "Letter" format prevails over A4 format as the common laser-printer paper format in North America. With the continuing introduction of the metric system in the United States, it is likely that the A4 paper formats will eventually replace non-standard paper formats. 11

12 Elsewhere in the world, you can expect to find a paper that fits the A4 size. In addition to the A series ("large paper"), ISO also has envisaged a B ("medium sized papers") and C ("small papers") series of standards. FOURTH EXAMPLE: INDUSTRY STANDARDS FOR DVD PLAYERS Just as it happened 20 years ago, when both VHS and BETAMAX standards for video players were in the market, there are currently two different streams for the new generation of DVD players arising: Blue-Ray Disc and HD DVD. While Blue-Ray Disc has been widely supported, especially by Sony; HD DVD is mainly promoted by Toshiba. These companies have not reached an agreement on the compatibility of both discs, which means that one format of disc does not work if played on the competitor's equipment. Standards are being developed by accredited associations of electronic equipments producers and are seen by most as industry standards, based on the argument that setting standards is not the primary activity of such entities. Others would disagree and would regarded such standards as non-governmental standards. So far, these are voluntary requirements setting product characteristics, adopted by the industry. It is left to consumers to choose the most convenient format for them. Thus, they are standards, but it is not yet clear if they are standards regulated by the TBT Agreement, as neither WTO Members, nor case law at the WTO, has clarified the issue. EXERCISES: 3. What is the definition of a standard, according to the TBT Agreement? 4. What are the three criteria for identifying if a measure is a standard? 12

13 IV. CONFORMITY ASSESSMENT PROCEDURES (CA PROCEDURES) A conformity assessment procedure is defined in TBT Annex 1, paragraph 3 as: Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled. Explanatory Note: Conformity assessment procedures include, inter alia, procedures for sampling, testing and inspection; evaluation, verification and assurance of conformity; registration, accreditation and approval, as well as their combination. Figure 7: TBT Annex 1.3 Five out of 15 articles of the TBT Agreement deal exclusively with conformity assessment procedures (CA). Article 5 and Article 6 contain the basic disciplines with regard to central government bodies. These basic disciplines are then applied, in Articles 7 to 9, to (i) local government bodies, (ii) non-governmental bodies and (iii) international and regional systems. The Explanatory note to Annex 1.3 presents a non-exhaustive list of conformity assessment procedures which includes: Procedures for sampling, testing and inspection; evaluation, verification and assurance of conformity; and registration, accreditation and approval, as well as their combination. Important note The TBT Agreement does not define the various procedures for conformity assessment listed in the Explanatory Note of Annex 1. Under the TBT Agreement, Members are required to grant no less favourable access to CA procedures for suppliers of like products domestic and foreign, and to make CA procedures no more strict than what is necessary to ensure conformity of products with technical regulations and standards. As it will be explained in Module 5, this applies for time delays, information requirements, fees, sampling procedures, location of facilities, etc. 13

14 TYPES OF PROCEDURES As we mentioned, conformity assessment procedures are used to verify whether a product meets the set of technical requirements set forth in technical regulations and standards, and include a wide range of activities which may be linked. For instance, testing may form part of inspection and inspection and testing results may be used to support certification. The TBT Agreement contains no relevant definitions of the types of procedures used for conformity assessment. However, for pedagogical purposes, we would like to introduce you to some of the definitions currently used in the field. Testing, inspection and certification procedures, for example, are defined in the document ISO/IEC Guide 2:1991, while the definition of metrology presented below is the one adopted by the International Bureau of Weights and Measures (BIPM). Firstly, it should be noted that conformity assessment takes a variety of forms: procedures performed in relation to the conformity assessment of products (Testing; Inspection; and Certification); procedures performed in relation to the activity of conformity assessment (Metrology and Calibration; and Accreditation). The following figure represents the overall technical infrastructure of conformity assessment: Figure 8: Overall technical infrastructure of conformity assessment The diagram above explains the procedures that an imported product is likely to be faced with while entering the export market. The product may be tested by a laboratory, or may be inspected or certified by an inspection or a certification body, respectively. These phases are neither consecutive nor mutually exclusive. They may happen simultaneously, or individually. A WTO Member may also choose one or two procedures, according to its needs and depending on the product and the information provided by the producer, exporter, importer, etc. Most importantly, WTO Members are granted the right of "control", that is, the right to have results provided by bodies that perform the abovementioned activities checked. Therefore, the activity of assessing the conformity of the conformity assessment bodies is an important one, which is performed by metrological 14

15 and/or accreditation bodies. These are the institutions that examine the examiners and that provide credibility to the system. IV.A. PROCEDURES IN RELATION TO CA OF PRODUCTS Conformity assessment in relation to products includes a wide range of activities and may be performed by a first, second or third party: First Party Assessment: the supplier carries out the conformity assessment procedure; Second Party Assessment: the purchaser or a conformity assessment body on his/her behalf carries out the conformity assessment procedure; and Third Party Assessment: a body independent from both the supplier and the purchaser carries out the conformity assessment procedure. Let us now present the definition testing, inspection and certification below. IV.A.1. TESTING Pursuant to the ISO/IEC Guide 2:1991, a test is a: Technical operation that consists of the determination of one or more characteristics of a given product, process or service according to a specified procedure. Testing is probably the most commonly performed procedure of conformity assessment: it is the process of determining that a product complies with specified requirements. Testing provides the basis for other major procedures, such as inspection and certification, and is operated by a wide range of organizations, including government agencies, academic and research institutions, commercial organizations, and industry. Typical tests involve measurement of dimensions, chemical composition, microbiological purity, strength or other physical characteristics of materials or structures. Different procedures may be used in order to test products. For example, sampling is the process of selecting one or more specimens of a product in a statistically valid manner for the purpose of evaluating the conformity of the product to specified requirements. Another possibility is a hundred per cent testing, whereby every product specimen of a batch is tested individually. IV.A.2. INSPECTION An inspection is defined in the ISO/IEC Guide 2:1991 as: Evaluation for conformity by measuring, observing, testing or gauging the relevant characteristics. 15

16 Important Note There may be an overlap between testing and inspection and such activities are often performed by the same organizations. However: Inspection relies mostly on visual examinations but may also involve testing, usually with simple instruments such as scales. Inspection usually relies on the subjective judgement and experience of the inspector. Testing is generally carried out according to objective and standardized procedures by highly trained staff. IV.A.3. CERTIFICATION The ISO/IEC Guide 2:1991 defines certification as follows: Procedure by which a third party gives written assurance that a product process or service conforms to specified requirements. Certification goes beyond testing and inspection. The certification body provides a formal attestation ("certificate") that the product meets the specified requirements and/or licences a manufacturer to place a certification mark on the product. Usually, certification bodies operate in narrow product areas, with a particular emphasis on products where there is a potential concern about health and safety. Certification is normally based on type approval and not a hundred per cent testing of every individual item. Apart from certifying product characteristics, certain certification bodies also attest to the conformity of systems, for example, the conformity of an organization's quality management system to a particular international standard (e.g. ISO 9000). IV.B. PROCEDURES IN RELATION TO CA ACTIVITY Metrology and calibration are addressed in the same section as accreditation because of their common horizontal nature. These procedures underpin all other forms of conformity assessment, as the adequate functioning of measurement instruments, their proper use, and the recognition of competence of conformity assessment bodies are key elements in building confidence in the evaluation of compliance. IV.B.1. METROLOGY AND CALIBRATION The International Bureau of Weights and Measures (BIPM) defines metrology as follows: Metrology is the science of measurement embracing both experimental and theoretical determinations at any level of uncertainty in any field of science and technology. 16

17 Metrology consists of the set of operations required to ensure that measuring equipment complies with the requirements for its intended use. The performance of measuring and test equipments may change for various reasons such as: age, improper use, mishandling or the influence of the environment. The accuracy of measurements therefore needs to be checked at the time of purchase and thereafter on a regular basis. To do this, the value of a quantity measured by the equipment is compared with the value of the same quantity provided by a measurement standard. This procedure is called calibration. IF YOU WANT TO KNOW MORE METROLOGY Two international organizations deal with metrology: the International Bureau of Weights and Measures (BIPM) and the International Organization of Legal Metrology (OIML). The BIPM, established in 1875 by the Metre Convention (a diplomatic treaty between 51 nations), ensures worldwide uniformity of measurements and their traceability to the International System of Units (SI). See The OIML, established in 1955, is an intergovernmental organization whose principal aim is to harmonize the regulations and metrological controls applied by the national metrology services of its national members. To know more, check IV.B.2. ACCREDITATION The ISO/IEC Guide 2:1991 defines accreditation as follows: Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. Accreditation bodies are authoritative and independent entities that do not themselves deal with verification of product specifications but whose task is to evaluate organizations carrying out such functions. This formal evaluation and recognition of competence may be applied to testing laboratories, inspection bodies and certification bodies. 17

18 ILLUSTRATION Do you remember the example we used for Technical Regulations above, about Energy Labels? We come back to that example to discuss conformity assessment procedures. As we presented before, the EU uses a label to state the energy consumption of a product. Many other countries use that same label. However, others, as Australia, have their own label (on the right side). Therefore, the importing country may wish to proceed to a conformity assessment procedure, either to test, inspect or certify the imported product with the aim to attest that it complies with domestic requirements embodied in technical regulations and/or standards. Alternatively, instead of testing the products, it may decide to verify if the foreign certifying body is accredited by an accreditation body, or may seek its accreditation. Finally, the importing Member may recognize the foreign label as equivalent to its own or seek another form of cooperation, as shall be further explained in Module 5, on "Procedures to facilitate the Acceptance of Conformity Assessment Results". Figure 9: EU Energy Efficiency label (left) and Australia Energy Efficiency label (right) EXERCISES: 5. What is the definition of a conformity assessment procedure, according to the TBT Agreement? 6. What are the main types of conformity assessment procedures? 18

19 V. PRINCIPLES INCORPORATED IN THE TBT AGREEMENT The understanding of the TBT Agreement can be enhanced if we analyse its provisions according to the principles they incorporate. As we have seen, the Agreement covers three types of measures: technical regulations, standards and conformity assessment procedures. The principles embodied in the TBT Agreement pervade the provisions regarding the three types of measures and should therefore be analysed as a whole. The five principles which can be singled out in the TBT Agreement are: Non-Discrimination Avoidance of unnecessary obstacles to international trade Harmonisation (and Equivalence) Transparency Special and Differential Treatment, and Technical Assistance to Developing Country Members These are the object of our next four modules of study, in which we will examine how these principles apply to technical regulations, standards and conformity assessment procedures. WE HOPE YOU WILL ENJOY THE RIDE!!! 19

20 VI. SUMMARY A TECHNICAL REGULATION IS: A Document which lays down product characteristics; or their related processes and production methods; with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements, as they apply to a product, process or production method. A STANDARD IS: A Document approved by a Recognised Body; that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods; with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements, as they apply to a product, process or production method. CONFORMITY ASSESSMENT PROCEDURES ARE: Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled. They include, but are not limited to: Procedures for sampling, testing and inspection; evaluation, verification and assurance of conformity; and registration, accreditation and approval, as well as their combination. THE FIVE PRINCIPLES WHICH CAN BE SINGLED OUT IN THE TBT AGREEMENT ARE: Non-Discrimination Avoidance of unnecessary obstacles to international trade Harmonisation (and Equivalence) Transparency Special and Differential Treatment, and Technical Assistance to Developing Members 20

21 PROPOSED ANSWERS: 1. A document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method. 2. The three criteria are: 1) The document lays down product characteristics. 2) The document lays down related processes and production methods. 3) Compliance with the document is mandatory. 3. Document approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method. 4. The three criteria are: 1) The document is approved by a recognised body. 2) The document provides for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods. 3) Compliance is voluntary. 5. Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled. 6. The Explanatory note of the TBT Agreement's Annex 1, paragraph 3 provides a non-exhaustive list of conformity assessment procedures which include: Procedures for sampling, testing and inspection; evaluation, verification and assurance of conformity; and registration, accreditation and approval; as well as their combination. 21

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