Regulations Governing Implementation of HACCP System Certification
for Exporting Food-Processing Establishments
[Chronicle of Promulgation and Amendments]
Adopted and promulgated by Ministerial Order on 19 June 2002.
Article 1
These Regulations are established in accordance with Paragraph Two of Article 14 of the Commodity Inspection Act.
Article 2
The organizations referred to under these Regulations shall mean exporting food-processing establishments.
Each of the organizations shall have at least one staff acquiring a training certificate for HACCP System.
The above mentioned HACCP System training means relevant training conducted by training organizations which have been approved by the competent sanitation authority.
Article3
Application for HACCP System certification shall be conducted an assessment by the Bureau of Standards, Metrology and Inspection (BSMI)of the Ministry of Economic Affairs or its branches (all referred to as the Inspection Authority). The assessment contents and certification standards shall be prescribed by the BSMI and the competent sanitation authority.
Article 4
Organizations applying for HACCP System certification shall apply to the Inspection Authority by submitting an application form and attaching the following documents:
1. A copy of factory registration certificate; and
2. The training certificate of staff mentioned in Paragraph Two of Article 2.
Article 5
Once an organization submits an application, the Inspection Authority shall review the documents and assign auditors to conduct an assessment.
The certification requirements, such as documents review and auditors assignment mentioned in the previous paragraph, shall be prescribed by the BSMI.
Article 6
The Inspection Authority shall reject an application:
- If the application documents do not comply with the requirements mentioned in Article 4.
- If the applicant organization is unable to arrange for an assessment to be conducted within six months after its application is accepted. But if a reasonable explanation is provided, the organization may apply to the Inspection Authority for a single extension of no longer than six months.
Article 7
The BSMI shall grant certification based on the scope of product specified in the application documents of organizations that are assessed to be in compliance with related certification requirements. These organizations are allowed to use the certification mark and will be issued certificates valid for three years.
Article 8
Registered organizations that intend to make changes to items specified in a certificate, and therefore require a revised certificate shall apply to the Inspection Authority by providing relevant documents for such changes.
The Inspection Authority shall conduct surveillance of the organization’s HACCP System if necessary. If the HACCP System continues to comply with the certification standards, the BSMI shall approve the changes and issue a revised certificate. If not, the case shall be processed according to paragraph 2 of Article 10.
Registered organizations may apply to the BSMI for a replacement of the original certificate if the original certificate is lost or damaged.
Article9
Applicant organizations that are assessed and found to be not in compliance with the certification standards may apply for a second assessment within two months upon receipt of the notice of the result. Applicant organization shall arrange for the second assessment to be conducted within six months of application. Applicant organizations that are unable to complete a second assessment within the specified period shall be considered to give up the opportunity for making second assessment application. If a reasonable explanation is provided, the organization may apply to the Inspection Authority for a single extension of no longer than six months.
Article 10
Registered organizations shall be subject to surveillance visits by the Inspection Authority at least once a year.
If the HACCP System of a registered organization does not comply with certification standards during the surveillance visits, the organization shall implement corrective actions within one month after receiving the results of the surveillance. The Inspection Authority shall then conduct another surveillance visit after the one-month period.
Article 11
Applicant organizations that are assessed or reassessed and found not to be in compliance with the certification standards may re-apply for HACCP System certification two months after the decision of non-compliance is made.
Article 12
Registered organizations that suspend production or business for more than one month shall report to the Inspection Authority within one month of the suspension.
A period of suspension shall not exceed six months, unless a reasonable explanation is provided as to why production or operation is unable to resume within the reported period. A registered organization may apply in advance for a single extension of the suspension period for a period of no longer than six months.
Article 13
Registered organizations, when moving to a new address, shall make new applications for HACCP System certification within three months after the relocation.
Article 14
The BSMI shall revoke registration that was acquired through fraudulent means and request that the certificate be returned within a specified time limit. The BSMI shall automatically cancel the registration if the certificate is not returned by the deadline.
Article 15
Registration shall be rescinded under any of the following circumstances:
1.If the HACCP system of a registered organization fails to comply with certification standards after a second surveillance is conducted in accordance with Paragraph 2 of Article 10;
2.If a registered organization fails to make payments in accordance with related requirements after receiving a notice to make payments;
3.If a registered organization fails to report to the Inspection Authority about its suspension of production or business according to Article 12, and fails to report or resume production within 15 days after receiving notice from the Inspection Authority;
4.If a registered organization fails to resume its production or operation after expiration of the suspension period;
5.If related licenses or certificates of the registered organization have been revoked, cancelled, or rescinded by the relevant authorities;
6.If a registered organization applies for cancellation of registration;
7.If a registered organization is found to be operating on a seriously false basis; or
8.If a registered organization moves to a new address and fails to make new applications for certification within the specified period.
Article 16
If the registration of an organization has been revoked or rescinded, the organization may re-apply for certification of its HACCP System four-months after the revocation or rescission.
Article 17
The date from which these Regulations shall take effect shall be determined by the Ministry of Economic Affairs.
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