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Chapter IV Execution method
Article 14
Inspection of commodities subject to monitoring inspection shall be conducted in accordance with the following procedures:
1. Batch-by-batch examination: a monitoring inspection certificate shall be issued only if each batch of commodities has passed an on-site examination of the packaging, appearance and labels, and also found conformity to the inspection requirements after a sampling inspection;
2. Batch-by-batch verification: a monitoring inspection certificate shall be issued only if each batch of commodities has passed an on-site examination of the packaging, appearance and labels. However, if any sanitary or safety concerns arise, a sampling inspection may be conducted;
3. Random-selected batch inspection: the commodities shall be randomly selected for inspection. For batches that are selected, a monitoring inspection certificate shall be issued only if they have passed an on-site examination of the packaging, appearance and labels, and have found conformity after sampling inspection. For batches that are not selected, the procedure of release after document examination shall apply;
4. Release after document examination: a monitoring inspection certificate shall be issued when the commodities have been approved by document examination. However, if any sanitary or safety concerns arise, an on-site examination of the packaging, appearance and labels or a sampling inspection may be conducted; and
5. Specific monitoring programs: a monitoring plan shall be drafted by the BSMI to conduct inspection of specific commodities and items. For commodities that are covered in the monitoring plan, a monitoring inspection certificate shall be issued only if the selected batches have passed an on-site examination of the packaging, appearance and labels, and have found conformity after sampling inspection.
The inspection items as mentioned in subparagraphs 1 to 4 of the preceding paragraph shall be conducted in accordance with the announcements. The BSMI may conduct part of or major inspection items in the light of the characteristics of commodities or inspection results.
Article 15
Under any of the following circumstances, the procedure of batch-by-batch examination may apply to commodities subject to monitoring inspection:
1. Where international/domestic safety information or scientific evidence shows that the commodity may substantially endanger human health;
2. Where the inspection results during the past do not comply with applicable requirements;
3. Where the monitoring results do not comply with applicable requirements;
4. Where the inspection results of commodities placed on the market do not comply with applicable requirements; and
5. Where there is any other non-compliance.
For commodities that are mentioned in subparagraphs 1 to 2 of the preceding paragraph and apply batch-by-batch examination, the procedure of random-selected batch inspection shall apply if the applicant has made applications for commodities of the same origin, same manufacturing site or brand, or same type or specification and these commodities comply with the requirements for a certain number of consecutive batches. If non-conformities are found during the procedure of random-selected batch inspection, batch-by-batch examination will be applied thereafter to commodities of that applicant.
For commodities that are mentioned in subparagraph 3 of the preceding paragraph and apply batch-by-batch examination, the procedure of specific monitoring program shall apply if the applicant has made applications for commodities of the same origin, same manufacturing site or brand, or same type or specification and these commodities comply with the requirements for a certain number of consecutive batches.
For commodities that are mentioned in subparagraph 4 to 5 of the preceding paragraph and apply batch-by-batch examination, the originally announced procedure shall apply if the applicant has made applications for commodities of the same origin, same manufacturing site or brand, or same type or specification and these commodities comply with the requirements for a certain number of consecutive batches.
Article 16
Under any of the following circumstances, the procedure of batch-by-batch verification may apply to commodities subject to monitoring inspection:
1. Where the purpose of usage of the commodity has been changed and such change is likely to cause healthy, safety or sanitary concerns;
2. Where the verification results during the past do not comply with applicable requirements; and
3. Where there is any other non-compliance.
For commodities that are mentioned in the preceding paragraph and apply batch-by-batch verification, the procedure of batch-by-batch examination shall apply if the applicant has made applications for commodities of the same origin, same manufacturing site or brand, or same type or specification and these commodities do not comply with the requirements for a certain number of consecutive batches. The procedure of batch-by-batch verification shall apply if a certain number of consecutive batches of the commodities under the procedure of batch-by-batch examination comply with the requirements.
Article 17
The procedure of random-selected batch inspection shall apply to commodities that are not covered by the procedures of batch-by-batch examination or batch-by-batch verification. If the batches that are selected do not comply with the applicable requirements, the procedure of batch-by-batch examination shall apply to the next batches of same commodities filed for inspection from the same applicant. The procedure of random-selected batch inspection shall apply if a certain number of consecutive batches of the same commodities comply with the requirements.
Article 18
The procedure of release after document examination shall apply to batches of commodities that are not selected under random-selected batch inspection.
Article 19
The BSMI may set up annual monitoring plans in accordance with categories of commodities to ensure and understand the sanitary and safety conditions of commodities.
Article 20
The procedure of release after document examination shall apply if the applicant has a testing report, inspection certificate or other relevant inspection certificates mentioned in Article 15 of the Act.
Article 21
If commodities that are selected under the procedure of batch-by-batch examination or random-selected batch inspection have the inspection certificates or testing reports, issued by designated testing laboratories recognized by the BSMI, a monitoring inspection certificate shall be issued when they have passed an on-site examination of the packaging, appearance and labels. If any sanitary or safety concern arises, a sampling inspection may be conducted.
Article 21-1
For a commodity apply to random inspection of a premises sampling, the obligatory inspection applicant thereof shall fill in and submit an application form and attach the following documents to apply to the inspection authority for random inspection of a premises sampling:
1. Monitoring inspection commodity registration certificate.
2. The delivery quantity of all items of the specific production factory in the last calendar year within the due inspection scope; if the production of the last calendar year is not available, the estimated delivery quantity of the current year shall be attached.
3. Other documents designated by the BSMI.
Where the preceding application conforms to the examination of the inspection authority, random inspection agreement will be issued.
The obligatory inspection applicant that has acquired the preceding agreement shall submit the Registration Form for Domestic Goods Entry into the Domestic Market to the inspection authority before the end of January of every calendar year and fill in the delivery quantity and delivery amount of the last calendar year.
The inspection authority will carry out premises sampling and receive inspection fees according to the preceding information.
For a commodity apply to random inspection of a sample purchased on the market, the inspection authority shall set up an annual inspection plan for performing inspections on samples purchased on the market.
Article 21-2
Where an obligatory inspection applicant’s commodity is applied to a random inspection on a premises sampling and has any one of the following circumstances, the inspection authority may inform such an applicant to change to batch by batch monitoring inspection for the inspection application; the random inspection on a premises sampling can only be recovered after such circumstances have disappeared.
1. Fails to submit the Registration Form for Domestic Goods Entry into the Domestic Market as required, and still fails to submit it upon the expiration of the submission deadline, or the record in the Registration Form for Domestic Goods Entry into the Domestic Market is false.
2. Fails to pay the inspection fees and still fails to pay upon the expiration of the payment deadline.
3. Fails to coordinate with the inspection authority for the performance of sampling inspection.
4. Fails to provide samples for inspection in due time after being informed to do so by the inspection authority.
5. Voluntarily applies to cease the random inspection on a premises sampling.
6. Cessation of business, with unknown whereabouts, or fails to report its delivery quantity for two consecutive years.
Provided any one of the circumstances prescribed from Paragraph 1 to Paragraph 4 above exists, after changing the inspection method, if such circumstances persist, the random inspection on premises sampling can only be recovered four months after such circumstances have disappeared.