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[Inspection and Quarantine Manual]

The item is relevant to compulsory inspection or quarantine. Hereinafter, inspection and quarantine in Taiwan will be outlined.

<Ⅰ. Commodity Inspection>

■ Outline

Taiwan has conducted inspection on import commodities for the benefits, safety, health, etc. of consumers, and such inspection is more stringent than that of other countries.

Designated commodities subject to inspection shall go through inspection from the Bureau of Standards, Metrology and Inspection of the Ministry of Economic Affairs, and commodities which fail to pass such inspection shall not undergo clearance.

In Taiwan, like other countries, more emphasis has been put on import inspection than export inspection. By considering it, hereafter, commodities inspection operations for import will be mainly explained.

■ Legal Base, Competent Authority, etc.

ㅇLegal base is the Commodity Inspection Act, the Enforcement Rules of the Commodity Inspection Act, the Regulations Governing Commission of Commodity Inspection Operations, etc.

ㅇThe competent authority shall be the Ministry of Economic Affairs.

The Ministry of Economic Affairs shall set up the Bureau of Standards, Metrology and Inspection (hereinafter referred to as the BSMI) to take charge of the commodity inspection operations.

■ Outline of Commodity Inspection Methods

Commodities inspection shall be conducted in four schemes, namely ①batch-by-batch inspection, ② monitoring inspection, ③ registration of product certification, and ④ declaration of conformity. Such four schemes have different procedure, requirements, cost, time, etc. from one another, and by item, more than 2 inspection schemes shall be satisfied at the same time.

The difficulty of each inspection scheme is different, but they have common ground that commodities which don't conform to requirements shall not go through import clearance.

※ This TCS program is providing detailed information on whether handling commodities of user are subject to inspection, and which exact inspection scheme from among four schemes relevant commodity shall go through, etc.

■ Inspection Target

Import commodities which are subject to compulsory inspection from the BSMI amount to around 2000 items by CCC code(11-digit HS code of Taiwan), covering machinery(including general machinery and electrical machinery), electronic appliances, feed, chemical goods, food, etc.

※ Among this, for foods, an inspection application shall be filed to the Food and Drug Administration of the Department of Health under the Executive Yuan, not to the BSMI.

■ Obligatory Inspection Applicant

The following persons are obliged to apply for an inspection of commodities:

ㅇThe person who needs to undergo batch-by-batch inspection and monitoring inspection are manufacturer or exporter of commodities, or his/her agent.

ㅇThe person subject to registration of product certification, and declaration of conformity is a domestic or foreign manufacturer of commodities, agent or importer who has residence or business office in Taiwan.

ㅇSeller of commodities may be an inspection applicant if manufacturer and exporter of commodities, or his/her agent may not be identified or difficult to be found.

The manufacturer as mentioned in the preceding Paragraph may be referred to either of the following parties:

ㅇThe assembler: for commodities assembled for sale from individual parts and components; or

ㅇThe modifier: for commodities conforming to the inspection requirements and modified for the purpose of sale before being placed on the market.

■ Exemption from Inspection

☉ Exemption Target from Inspection

Under any of the following circumstances, the commodity subject to inspection may be exempted from inspection:

ㅇWhere the imported commodity is attached with an inspection certificate issued by the government of the country of origin of the commodity which provides a reciprocal inspection exemption treatment to the commodities of the Republic of China;

ㅇWhere the commodity is exported from or imported to the Republic of China for personal use by any member of a foreign embassy or consulate located in the Republic of China or by any person who is entitled to diplomatic immunity;

ㅇWhere the products not for sale, such as products for own-use, commercial samples, products for exhibition, or articles for use in research and development or in testing activities are imported or exported, confirmed by the BSMI ;

ㅇImport commodities which fail to exceed money amount or quantity necessary for inspection exemption specified by the competent authority;

ㅇWhere the imported commodities are intended to be exported in its original form, and commodities whose inspection exemption is confirmed by the BSMI ;

ㅇWhere the imported or domestically manufactured parts or components of commodities subject to inspection are required for processing or assembly for the finished product(s) and will be inspected in its entirety as a finished product(s) in accordance with the same inspection standards applicable to such finished product(s), confirmed by the BSMI;

☉ Non-Exemption Target

Even for commodities which conform to above requirements or grounds, the following commodities shall not go through inspection exemption:

ㅇExplosion-proof motors;

ㅇLarge computer power rating greater than 30KVA;

ㅇElectromagnetic compatibility testing product rating greater than 30KVA;

ㅇCable;

ㅇElectric punching machines;

ㅇHook and carabiner for climbing.

☉ Application for and disposal of Inspection Exemption

ㅇApplicant for inspection exemption is the same as obligatory inspection applicant of cargo.

ㅇAt the time of application for inspection exemption, such exemption applicant shall lodge inspection exemption application and supporting documents for exemption grounds with the BSMI.

ㅇThe BSMI permits the exemption for applicant who conforms to regulations. But, applicant whose exemption is granted shall not transfer the use of commodities.

■ Batch-by Batch Inspection (逐批檢驗)

The term, "batch-by-batch inspection" refers to conducting inspection against manufactured or imported commodities on a batch-by-batch basis.

☉ The procedure of Batch-by Batch Inspection

Type approval(if necessary) → inspection declaration of import commodities(the time when import is declared) → declaration receipt of the BSMI → sampling for inspection → inspection → determination of conformity → marks attachment for commodities that passed inspection → clearance

Hereafter, the explanation in above-mentioned order will be made.

☉ Type approval

Among commodities subject to batch-by-batch inspection upon the importation to Taiwan, some commodities shall obtain a type approval prior to import inspection declaration. The commodities subject to type approval shall not declare a batch-by-batch inspection without a type approval certificate issued by testing laboratories authorized by the BSMI or Taiwanese government.

For the importation of commodities whose type approval was granted, such importer may be exempt from type approval procedures, but just need to declare commodities inspection.

1) Commodities subject to type approval

Among commodities subject to batch-by-batch inspection, commodities required for type approval include gas, paint, furniture, machinery, electronic products, etc.

2) Application for type approval

Applicants for type approval is only limited to manufacturer and importer of commodities and his/her juristic person, and such person shall file an application specified for the kind, specification, etc. of relevant commodity to the BSMI(importer or juristic person shall file to the BSMI located at the residence or business office.).

In the case where commodities whose type approval was granted need to be changed, or the validity term of type approval certificate needs to be extended, relevant person shall submit the original type approval certificate along with application form. Required documents to be submitted for application for type approval are as follows:

-Type approval application specified by kind and speculation.

-Business registration

-Business Registration Certificate

-Factory Registration

-Technical documents of commodity required by the BSMI

-The original type approval certificate(if change or extension is applied)

3) Type approval test

The BSMI which received type approval application requests applicant to provide samples of commodities depending on the kind and speculation, etc. of relevant commodity. The quantity of samples to be provided is specified depending on the kind and speculation.

The competent BSMI which received samples conducts tests for relevant commodity at designated testing laboratories, and fills out type approval report.

The BSMI issues a type approval certificate and type approval report to applicant which passed the inspection(the BSMI designates testing place separately for commodities such as large equipment, etc. which are difficult to be tested at designated testing laboratory.).

4) The validity term of type approval certificate

The validity term of type approval certificate is 1 year, 3 years, or 5 years depending on commodity.

5) Processing time, cost, etc.

ㅇThe processing time is different depending on commodity, but not exceeding 30 days. But, the period may be extended when related data isn't enough, or re-testing is necessary.

ㅇTesting cost is NTS 2000 yuan ~ 3500 yuan per type(model, specification), and the cost for issuing certificate and commissioned testing may be charged additionally.

6) Exemption from type approval

Under any of the following circumstances, the commodity may be exempted from type approval and an inspection application may be filed directly for such commodity. But, the BSMI shall confirm it.

ㅇWhere the commodity is required for use in testing;

ㅇWhere the commodity is re-imported after having been repaired abroad; or

ㅇWhere the commodity is needed for making emergency repair or maintenance.

☉ Inspection declaration of import commodities

Import commodities shall undergo batch-by-batch inspection in accordance with the Commodity Inspection Act, and such inspection shall be declared at the same point as import declaration is made to the BSMI. Required documents for inspection declaration are as below:

ㅇInspection declaration

ㅇType approval certificate(only limited to commodity which requires to obtain type approval)

☉ Receipt of declaration and Sampling

ㅇThe BSMI accepts the declaration of applicant if no irregularity is found in submitted declaration and type approval certificate. Then, the BSMI determines the place and time of inspection in accordance with the kind of commodity declared.

ㅇThe BSMI which accepted a declaration requests applicant to provide samples for inspection. Applicant shall submit samples in accordance with relevant regulations, and commodities imported after samples were submitted shall be sealed up, and shall not be released until the result of inspection comes out.

☉ Inspection and Determination of Result

ㅇDesignated testing laboratory(on-site inspection for large machines) conducts an inspection and issues an inspection certificate to applicant who passed the inspection.

ㅇThe commodities which fail to pass inspection may undergo re-inspection at no cost upon the request of applicant within 15 days from the date after receiving an unsatisfactory inspection notice. But, the same shall not apply to the case of exceeding 15 days.

ㅇA satisfactory inspection mark as shown below may be affixed on commodities that passed inspection, and such commodities may be released.

☉ Processing time, cost, etc.

ㅇFor commodities that passed type approval, it doesn't take long because batch-by-batch inspection may be proceeded in a simplified procedure. It may be completed within the period not exceeding 5 days if no irregularity is found.

ㅇInspection cost is around 1/1000 ~ 3/1000 of import dutiable value(CIF). But, the less amount of money may be charged for commodities that passed type approval, but at least NTS 100~300 yuan may be charged generally depending on the kind of commodities.

■ Monitoring Inspection (監視查驗)

The procedure of monitoring inspection is similar with that of batch-by-batch inspection, but monitoring inspection is conducted against commodities necessary for rapid inspection and clearance. That is, commodities subject to monitoring inspection have comparatively high risk, but this inspection is appropriate for commodities that are unsuitable for long-term inspection, or that may be damaged by inspection owing to the natures of commodities.

Monitoring inspection is only different from batch-by-batch inspection in terms of obligatory inspection applicant and processing time, but is similar with batch-by-batch inspection in terms of severity and precision of inspection

☉ Monitoring inspection target

Commodities subject to monitoring inspection amount to around 100 by CCC code(11-digit HS code of Taiwan), covering a variety of kinds of commodities such as cement, oil, paper products, textile products, toys, etc.

☉ Declaration of monitoring inspection

The person who manufactures or import commodities subject to monitoring inspection shall provide monitoring inspection declaration and cost concerned to the competent BSMI(BSMI located at the place of arrival for the case of importer) at the time of releasing or importing such commodities. A company which declares monitoring inspection for the first time shall provide the original factory registration, commercial registration certificate, or other similar certificates.

☉ Inspection

The monitoring inspection may conducted in the manner of batch-by-batch inspection, batch-by-batch verification, random-selected batch inspection, document examination, or a specific monitoring program depending on the level of hazard of commodity concerned.

ㅇBatch-by-batch inspection

Under the system, an examination on the matters such as packing, appearance, marks, etc. of import commodities may be made on a batch-by-batch basis, and sampling and inspection for such samples may be conducted.

ㅇBatch-by-batch verification

Under the system, a verification on the matters such as packing, appearance, marks, etc. of import commodities may be made on a batch-by-batch basis, and an inspection certificate may be issued to applicant which passed such inspection. But, for commodities that are involved with sanitary or safety issue, samples of such commodities may be taken like the way of batch-by-batch inspection, and inspection may be conducted.

ㅇRandom-selected batch inspection

Works on packing, appearance, and marks, and sampling test, etc. against a certain percentage of commodities may be conducted. Under this circumstance, the remaining commodities which have not been selected yet may undergo document examination.

ㅇDocument examination

Document examination only determines whether a commodity passes the inspection. But, if necessary, on-site inspection may be conducted for actual cargo.

ㅇSpecific monitoring program

This program refers to a special inspection scheme under which the BSMI sets monitoring plan for specific commodities, and such commodities are required to go through all inspection schemes above-mentioned.

☉ Monitoring inspection management system

In Taiwan, monitoring inspection through a management system has been conducted with respect to manufacturers that conform to a certain of requirements in order to simplify the procedure of monitoring inspection, and to promote the convenience of manufacturers of commodities subject to monitoring inspection. Management system means that a manufacturer conducts self-inspection, and monitoring inspection may be replaced by only verifying such self-inspection when the BSMI conducts an inspection.

A manufacturer whose management system is approved shall go through screening at least one time per year from the BSMI, and if failing the screening, the BSMI may cancel the qualification for such management system.

ㅇConditions for approving management system

-Applicant: manufacturer who manufactures commodities subject to monitoring inspection

-Facility condition : to furnish facilities for self-inspection approved by the BSMI

-System : to furnish quality inspection system registered and approved by the BSMI

-Documents : to furnish a registration of quality inspection system

ㅇRequired documents for application for management system approval

-Management system approval application form

-Registration of quality inspection system

-Supporting documents of facilities for self-inspection

-A letter of Attorney for the factory located at foreign countries(a juristic person shall have the residence or business office in Taiwan.)

ㅇMonitoring inspection through management system

There are two major categories for conducting monitoring inspection through management system.

-A scheme that manufacturer conducts self-inspection, and issues a monitoring inspection certificate(manufacturer shall submit inspection data and other documents to the BSMI on a regular basis, and the BSMI confirms it.).

-A scheme that a manufacturer conducts self-inspection, and submits the inspection data and documents concerned to the BSMI. And then, the BSMI issues an inspection certificate by verifying submitted documents.

■ Registration of Product Certification(驗證登錄)

Registration of Product Certification refers to a system under which registration of certification is made with the BSMI for specific products, and the BSMI controls such products registered. That is, commodities that underwent certification registration don't need to go through any specific inspection at the release or import to Taiwan. But, in practice, a majority of commodities subject to certification registration shall go through batch-by-batch inspection and monitoring inspection at the same time.

☉ Application

Any person who is obligated to register certification shall submit the following documents to the BSMI.

ㅇGeneral documents

-Application for registration for product certification

-Registration certificate of applicant's company(commercial registration certificate, factory registration certificate)

-Medium saving data for application of certification registration

ㅇDocuments for the Conformity Assessment

The conformity assessment documents to be submitted are all different depending on the kind of commodities, but generally, the following documents shall be submitted.

-Declaration of self-management;

-Technical documents specified;

-Type approval report(if necessary);

-Conformity declaration(if necessary);

-Factory inspection report(if necessary).

ㅇOther documents (submitted at the request of the BSMI)

-A letter of Attorney for import clearance for certification-registered products;

-The original registration certificate(limited to the existing registrant);

-Inspection certificate issued by inspection institutions of exporting country(limited to products exported from members with which Taiwan signed reciprocal recognition agreement, and products whose certificate was issued after passing inspection

☉ Registration and cost, and processing period

ㅇThe BSMI registers commodities which conform to the requirements concerned, and whose documents are complete, and it issues a registration to applicant.

ㅇThe cost for registration of product certification is divided into screening cost and annual fees of certificate. The screening cost is around NTS 3000 ~ 5000 yuan depending on the kind of commodities, and annual fees are around 200 ~ 5000 yuan depending on the kind of commodities.

ㅇSuch screening is processed around 7~ 28 days. But, such period may be extended if the BSMI request applicant to provide samples for precise inspection.

■ Declaration of Conformity(符合性聲明)

Declaration of Conformity means that manufacturer or importer of the commodity declares such commodity conforms to the inspection standards. That is, under this system, commodities subject to the declaration of conformity don't need to go through special inspection except for commodities imported or manufactured for the first time. In addition, a declaration of conformity(including e-documents) may replace the inspection in a simplified manner.

☉ Commodities subject to declaration of conformity

Currently, the commodities that replace the inspection by a declaration of conformity only mainly pertain to the high-tech products having comparatively low hazard to human body such as computers, power supply equipment, hard drives, CD - ROM drive, sound card, windows cards, graphics cards, network cards, control cards, digital cameras, etc.

☉ Application for a declaration of conformity

ㅇManufacturer or importer of products, and juristic person(hereafter referred to as the applicant) which are required to initially declare conformity shall register factory for declaration of conformity to the BSMI located at the place of factory where such commodities are manufactured, or the BSMI located at the place where such commodities are imported(hereafter, referred to as the competent BSMI).

ㅇThe person who is obligated to apply for registration of conformity declaration factory shall submit an application and following technical documents to the competent BSMI prior to the manufacture or import of commodities concerned.

-Name of product and relevant code of the commodity which is subject to inspection;

-Schematic;

-List of main parts or materials used;

-Color photos of internal or external main components of product;

-Manual in Chinese;

-Testing report(a testing report issued by the BSMI or testing laboratories designated by the BSMI, limited to a report issued within 1 year before a registration of conformity declaration factory was applied for);

-Other documents required by the BSM.

※ For declaration of conformity, a registration for all products(by each product) isn't made, but such registration shall be made to the BSMI by a unit of manufacturer or importer. That is, when manufacturer or importer who already registered factory intends to manufacture or import the commodities subject to declaration of conformity, such person don't need to register factory again if relevant commodities are subject to declaration of conformity even though he/she manufactures or imports different commodities from before.

☉ Issuance and cost

ㅇThe BSMI registers commodities whose documents are complete, and in compliant with the standards, and issues factory registration code and a declaration of conformity. For commodity manufactured or imported by factory or importer whose registration has been made, if such commodities are subject to declaration of conformity, the inspection may be declared in only a single code of factory registration, regardless of the kind of such commodities.

ㅇThe commodities subject to declaration of conformity, in principle, may not be charged with additional cost at the time of inspection declaration, but the business which registers factory for the first time shall pay registration cost which is NTS 1000 yuan.

☉ Mark of declaration of conformity

The commodity that already declared the conformity shall affix a mark which verifies the inspection is complete for relevant commodity. The mark is the same as marks of other inspections.

■ Market Surveillance(市場監督)

ㅇMarket Surveillance refers to a post-management system under which the BSMI conducts a check of the commodities whose inspection was already completed to ensure the compliance with the standards initially inspected before such commodities are entering into market.

ㅇMarket surveillance may be made randomly at business office, factory of manufacturer or importer, storage place, and the place installed or used.

ㅇFor commodities that completed inspection, and have been sold on the market, if such commodities fail to pass market surveillance, their sales may be suspended.

<Ⅱ. Commodity Quarantine>

■ Outline

Taiwan has enforced a compulsory quarantine system against designated animals and plants, and thereof which are imported to or exported from Taiwan(hereafter, referred to as designated quarantine items), in order to prevent the spread of infectious diseases caused by import and export animal and animal products, and to prevent the pests caused by plants and plants products.

The person who imports and exports designated quarantine items shall pass the inspection from the Council of Agriculture, Executive Yuan in order to go through export and import clearance.

Hereafter, quarantine procedure for designated quarantine items will be outlined.

■ Legal Base, Competent Authority, etc.

ㅇThis is legally based on Regulations of Animal and Plant Quarantine, Statute for Prevention and Control of Infectious Animal Disease, The Plant Protection and Quarantine Act and Enforcement Rules of Plant Protection and Quarantine Act, Regulations of Conduct For Executing Plant Protection And Quarantine. etc.

ㅇThe term "competent authority" shall denote the Council of Agriculture, Executive Yuan at the central government level (hereinafter referred to as the "central competent authority"), and its detailed matters are processed by the Animal and Plant Protection and Quarantine Bureau under the Council(hereafter referred to as "the Bureau").

■ Main Targets

The items that are required to undergo quarantine amount to 1200 items by CCC code(11-digit HS code of Taiwan), and major items covers animals and products thereof, and plants and products thereof, etc.

■ Quarantine Application

☉ Applicant

The person who is obligated to apply for quarantine contain the importer of designated quarantine items, exporter of designated quarantine items, or exporter or importer of designated quarantine items which transit in Taiwan, or the juristic person.

☉ The time limit and receipt of application

The exporter or importer of designated quarantine items shall apply for quarantine to the Bureau located at the place of import or export, or of transitting at the time of import declaration at Customs.

The said Bureau which received quarantine application conducts a quarantine on the day when such quarantine is applied for if there is no requirement(the following day if it's inappropriate). Provided, that if applicant specifies a certain day for quarantine, quarantine may be conducted at such specified date(within 7 days).

☉ Required documents for application for quarantine

ㅇApplication form;

ㅇSupporting document to verify relevant commodities have not been imported from infectious disease affected countries;

ㅇQuarantine certificate issued by a State of exporting country or quarantine agency designated by a State;

ㅇA letter of Attorney(submitted for consignment application).

☉ Issuance and cost

ㅇThe Bureau issues an inspection certificate only limited to the person who conforms to requirements and standards concerned, and applicant may proceed with clearance by attaching such inspection certificate.

ㅇThe costs related to quarantine may be divided into quarantine cost and document cost, and such cost may be different depending on the kinds of quarantine objects such as animals(products) and plants(products), and vehicles(ocean, air). Generally, quarantine cost is around nts 300 ~ 5000 yuan, and document cost is nts 50 ~ 80 yuan per a certificate.

■ Import-Prohibited Animals and Plants and Products Thereof

☉ Animals and their products

ㅇLive animals and their products to be imported from the regions where foot and mouth disease, rinderpest, contagious bovine pleura pneumonia, and African swine fever have occurred(imports are prohibited regardless of articles perishable, frozen, processed);

ㅇSingle-hoofed animals and their products to be imported from the regions where glanders have occurred;

ㅇBirds and their products to be imported from the regions where avian flu has occurred;

ㅇAnimals and their products to be imported from the regions where BES has occurred;

ㅇArticles transshipped through above regions, which don't conform to sealing provisions.

☉ Plants and their products

ㅇPests;

ㅇSoils;

ㅇPlants with soil; and

ㅇPackages or containers used by or harboring the articles under the preceding three subparagraphs.

■ Special Procedures for Animal Quarantine

☉ Isolation Quarantine

The importation of animals shall conform to all the regulations above-mentioned, and isolation quarantine shall be conducted. For animals subject to isolation quarantine, a consent from isolation quarantine place and other documents shall be submitted to the quarantine authority.

☉ Time limit for isolation quarantine

ㅇCattle, sheep, goats, pigs and other artiodactyla : 15 days

ㅇHorses, mules, donkeys and other single-hoofed animals: 10 days

ㅇPredators: 21 days

ㅇPoultry such as chickens, ducks, geese : 10 days

ㅇOther animals: 7 days

■ Special Procedures for Plants and Their Products

☉ Risk Assessment

Initially imported plants and plants products from a certain region or country shall undergo risk assessment form the Bureau. Said articles which fail to pass the risk assessment shall not be imported.

☉ Application for risk assessment

The person who is qualified for application for risk assessment shall be importer who initially imports plants or plants products from a country or region, or be his/her agent, and the following documents shall be attached upon the application for risk assessment.

ㅇProduction management documents of plants or plant products to be imported(documents related to country of origin, production quantity, and processing methods after harvest);

ㅇPests list, and methods and medicines used for prevention and treatment for plants and plants products, etc.;

ㅇRelevant inspection and testing documents, etc. for plants or plants products when they are exported from the regions of the outbreak of pests designated by Taiwanese government;

ㅇA quarantine certificate issued by the quarantine authority designated by the State and the State of the exporting country;

ㅇOther documents required by the Bureau.

☉ Procedure of risk assessment

The Bureau which received the application shall review submitted documents and send quarantine official to the exporting country. The applicant shall bear financial burden incurred for on-site inspection including travel expenses, accommodation costs, etc.