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英譯法規內容

Title Regulations Governing Implementation of Hygiene and Safety Management System Certification of Fishery Products for Export Ch
Date 2020.05.26
Legislative 1.Adopted and promulgated by Ministerial Order on June 19, 2002.
Adoption by Ministerial Order on November 11, 2002 and enter into force from January 1, 2003.
2.Amended and promulgated by Ministerial Order on April 14, 2011.
3.Article 17 amended, Articles 18 deleted, and promulgated by Ministerial Order on October 29, 2014.
4.Amended and promulgated by Ministerial Order on May 26, 2020.
Content Article 1
These Regulations are established in accordance with paragraph 2 of Article 14 of the Commodity 
Inspection Act.

Article 2
The fishery products mentioned in these Regulations refer to the products made from the aquatic 
animals (except for mammals, reptiles and frogs), and the processed or composite products resulting 
from the edible parts of such animals as the main ingredients.
The certification audit authority(ies) mentioned in these Regulations refers to the Bureau of 
Standards, Metrology and Inspection of Economic Affairs (hereinafter referred to as BSMI) and its 
branches, or other commissioned government agencies (bodies), juristic persons or organizations, to 
implement the matters including document review, on-site certification audits, surveillance audits, 
acceptance for the application of alteration of registration or suspension of production and business.

Article 3
The hygiene and safety management system certification of fishery products for export (hereinafter 
referred to as certification) refers that BSMI conducts impartial and independence conformity 
assessments to the management system established by the operator for his establishment, and 
certifies such system comply with certification audit criteria for applied certification categories 
including the EU system certification (herein refer as EU certification), Hazard Analysis and 
Critical Control Points system certification (herein refer as HACCP certification) and warehouse 
system certification.
The certification audit criteria referred to in the preceding paragraph shall be prescribed by BSMI 
referred with the related applicable principles of international organizations and adopted provisions 
of the import country or regions.
 
Article 4
The operator(s) mentioned in these Regulations refers to the business, juridical persons or 
organizations that own the processing plants or cold chain warehouse for export fishery products.
The operator shall manage factory registration according to the Factory Management Act before 
applying the certification, and establish food safety management and control team (hereinafter 
referred as the HACCP team), which composed of at least 3 staffs, and the responsible person or his 
authorized representative shall be the necessary member.

Article 5
The operator shall submit a certification application for owned processing plant with filled 
application form and the following documents to BSMI:
1. The copy of the company registration, business registration or other document of legal 
registration. Where the application form is correctly filled with unified business administration 
number which can be verified on the government public websites, the copy can be exempted.
2. The copy of factory registration.
3. The copies of the training certificates related to the courses over thirty hours of hygiene and 
safety management system for each HACCP team members; additionally copies of the training 
documents related to the courses of EU’s legislations on fishery products chain for at least one 
member for applying the EU certification.
4. The processing flow chart.
5. The hygiene and safety management system plan, including written standard operation 
procedures based on Good Hygiene Practices (GHP) and Hazard Analysis Critical Control Points 
(HACCP).
6. The factory layout, including personnel flow, material flow, water flow and air flow.
7. Other documents specified by BSMI.
To apply for EU certification could apply for HACCP certification at the same time.
The operator shall submit a certification application for owned warehouse with filled application 
form and the documents referred to in subparagraph 1, GHP in subparagraph 5, subparagraph 6 and 
7 of paragraph 1.

Article 6
BSMI shall notify the operator who submitted nonconforming or uncompleted documents to take 
corrections during one month; where the operator does not submit corrected ones before a given 
date, BSMI cannot accept the application; where otherwise BSMI shall notify the operator in written 
to accept the application formally once the submitted documents complying with the requirements.
After accepting the certification application, BSMI should forward all documents to a certification 
audit authority for review. Once found any noncompliance in documents after reviewing, the 
certification audit authority shall notify the operator to correct the findings during one month. 
Where the operator has not completed the corrections or failed to correct before indicated date, 
BSMI shall notify the operator in written to reject the application.
The certification audit authority shall notify the operator in written to take arrangements for an 
on-site certification audit after ensuring all documents complying to the requirements as required 
reviewing in the preceding paragraph.

Article 7
The operator shall cooperate with the on-site certification audit within three months from the next 
day receiving the notice in paragraph 3 of the preceding article, and the operator could apply single 
extension of no longer than three months with a reasonable explanation to the certification audit 
authority. BSMI shall reject the certification application after receiving a notice from the 
certification audit authority in which described the operator failed to cooperate with the audit before 
given period.

Article 8
Where the operator’s establishment assessed and deemed comply with the certification audit criteria, 
BSMI shall grant certification with an approval number based on certification category, product 
category and the information stated in the application and issue a certificate valid for three years.
The certification audit authority shall notify the operator, whose establishment assessed and deemed 
noncompliant to the certification audit criteria, to take corrective actions within a given period; 
when necessary, the certification audit authority should verify the effectiveness of corrections 
on-site after given period. For that establishment, incapable of making corrective actions or failing 
to complete the corrections according to the requirements, the certification audit authority shall 
notify BSMI, and BSMI shall send a notice of failure to grant the certification. That operator could 
re-submit a certification application after two months from the next day receiving the written notice.

Article 9 
The certification audit authority shall conduct surveillance audits for the registered establishments at 
least once a calendar year; the date of the first surveillance audit shall not exceed twelve months 
after the date of the initial certification decision. Where necessary, BSMI should conduct 
unannounced audits based on risk.
The certification audit authority shall notify the operator, whose establishment assessed and deemed 
noncompliant to the certification audit criteria upon surveillance audit, to take corrective actions 
within a given period; when necessary, the certification audit authority should verify the 
effectiveness of corrections on-site after given period.

Article 10
The registered establishment shall take all arrangements for audits conducted by the certification 
audit authority.

Article 11
The registered establishment shall not mislead the third parties to recognize as product certification 
upon product labeling, advertisement and publicity.

Article 12
Whenever BSMI amends or changes the certification audit criteria, the registered establishment 
shall complete the corrections within the transition period designated by BSMI. The certification 
audit authorities shall validate that all the registered establishments have completed the corrections 
within one month after the transition period.

Article 13
BSMI shall review the conformity assessments of surveillance audits for the last three years before 
the expiration of certificate, then notify the operator for a renewal certificate after all programs 
deemed to comply with the requirements.
The establishment registered with HACCP certification, hereafter to apply for EU certification and 
be granted EU certification, could apply for HACCP certificate with the same validity period as EU 
certificate, and combine the subsequent surveillance audits.

Article 14
The registered establishment, whose registered basic information or items described in certificate 
were altered, shall apply for alteration of registration with the original certificate and relevant 
documents to the certification audit authority within one month from the date of any changes. The 
operator, whose establishment relocating the site, shall re-apply in accordance with the requirements 
in Article 5.
The certification audit authority shall conduct document review for the application in the preceding 
paragraph, and shall notify the operator whose application do not comply with the requirements to 
take corrections within a given period; when necessary, the certification audit authority should 
conduct an on-site verification audit. After verified the alteration to comply with the requirements, 
the certification audit authority shall approve the alteration application for that do not affect the 
content of certificate, otherwise shall report to BSMI to re-issue a new certificate.
The operator should apply for re-issuance of certificate to BSMI when the original one was gone or 
damaged.

Article 15
The operator shall report his suspension of production or business over month to the certification 
audit authority within one month from the day of suspension. For mandatory one, it shall be 
reported within five day from the next day receiving the mandatory punishment order.
The autonomous suspension mentioned in preceding paragraph should be limited to no more than 
six months. The operator could apply single extension of no longer than six months with a 
reasonable explanation to the certification audit authority before the expiration of first suspension.
The operator, whose registered establishment is autonomous to suspend production or business for 
more than six months, or is mandatory to suspend production or business, shall apply to the 
certification audit authority for a surveillance audit before resuming production or business.

Article 16
BSMI shall revoke the operator's certificate(s) which was granted due in a fraudulent manner.

Article 17
To the registered establishment under any of the following circumstances, the granted certification 
shall be ceased by BSMI:
1. Where it was deemed noncompliant to the certification audit criteria in compliance with the 
audits described in the Article 9(1) and did be incapable of make corrections.
2. Where it did not complete the corrections as required in Article 9(2), or still was deemed 
noncompliant to the certification audit criteria upon on-site re-verification.
3. Where it did not take arrangements to facilitate the audits as required in Article 10.
4. Where it violated the requirements described in the Article 11 and did not make corrections 
within a given period.
5. Where it did not complete the corrections within the transition period as required in Article 12.
6. Where it did not apply the alteration as required in Article 14(1), and has not taken actions 
within 15 days after receiving notice.
7. Where it did not report or apply single extension as required in Article 15, and has not taken 
actions within 10 days after receiving notice or did not resume production or business.
8. Where it reported or applied single extension as required in Article 15, but has not resumed 
production or business in time.
9. Where it did not apply for a surveillance audit as required in Article 15(3), and resumed 
production or business before the certification audit authority deemed comply with the certification 
audit criteria.
10. Where it did not pay the fees in accordance with related regulations, and did not deal with the 
overdue fees in time after receiving notice.
11. Where its company registration, business registration, factory registration or other equivalent 
registration has been revoked, cancelled or repealed by the competent authority(ies).
12. Where it applied for rescinding the registration itself.
13. Where the certification audit criteria or product categories were rescinded.
14. Where it was dissolved or gone out for business.

Article 18
The operator, whose registered establishment was subjected to the revocation or cease disposition 
by BSMI, shall surrender the certificate(s) within 15 days after the next day from receiving the 
notice of disposition, and could apply for returning the certificate(s) with labeled the cancelled mark 
by BSMI.
The operator, whose registered establishment was subjected to the cease disposition by BSMI as 
required in subparagraph 1-9 of preceding article, can re-submit a new certification application after 
four months from the next date receiving the notice of cease disposition. For whose registered 
establishment was subjected to the revocation by BSMI as required in Article 16, the operator 
cannot re-submit a new certification application shorter than three years from the next date 
receiving the notice of revocation disposition.

Article 19
The operator, whose registered establishment granted certification in accordance with those 
Regulations regarding hygiene and safety management system certification of food and feed for 
export, could continue to use the certificate(s) before the expiration of the certificate(s); and the 
certification audit authority could conduct the surveillance audit as required in the procedures 
governing implementation of hygiene and safety management system certification of food and feed 
for export.

Article 20
These Regulations shall come into force from the date of promulgation.