Regulations for Certificate Inspections of Genetically Modified Feed 
and Feed Additives (Draft)  
Article 1  
Article 1  This Regulation was established with reference to Paragraph 4 of Article 
11-1 of the Feed Control Act (this Act henceforth).  
 
Article 2   
When applying for a permit with reference to Paragraph 1 of Article 11- 1 of this Act 
or for a certificate of feed use approval with reference to Paragraph 2 of Article 11 -1 
of this Act, developers shall complete an application form and submit the following 
information prepared in a DVD to the competent authority of the central government. 
Based on the notification of the competent authority of the central government, 
developers shall submit the  payment receipt, samples, inspection methods, and other 
supplementation by the deadline:  
1. Certificate of identity of developer. Corporate applicants shall submit the permit 
of establishment or certificate of registration and the certificate of identity of the person- in-charge.  
2. The basic datasheet of the genetically modified feed or feed additives.  
3. The biosafety datasheet of the genetically modified feed or feed additives.  
4. Relevant research reports and literature and an index of them.  
5. When ap plying for a certificate of feed use approval specified in Paragraph 2 of 
Article 11 -1 of this Act, applicants shall also submit the field test review of the 
genetically modified feed or feed additives completed by the law and the certificate of 
plantation  or culture approval. 
6. For applications made on and for the behalf of a foreign developer, applicants 
shall also submit the power of attorney of this foreign developer.  
 
Article 3  
The competent authority of the central government may reject applications mentioned 
above or directly review existing information without further notice when applicants 
fail to make the payment, submit relevant information and samples, or make 
corrections thereof by the deadline advised by the competent authority of the central 
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 government.  
 
Article 4  
Applications made under Article 2 shall be disapproved under any of the following 
circumstances:  
1. Feed or feed additives that are not announced as feed and feed additives by the 
competent authority of the central government with reference to Paragraph 1 of 
Article 3 or Paragraph 1 or Article 3- 1 of this Act; or feed or feed additives banned by 
the competent authority of the central government with reference to Paragraph 1 of Article 20 of this Act.  
2. Genetically modified feed or feed additives failed in the biosafety check.  
3. Feed or feed additives with uncorrectable defects or errors or not corrected with 
reference to the regulations in the foregoing article.  
Article 5  
The longest review period of applications made under Article 2 may be 18 months. In 
addition, the competent authority of the central government may notify applicants of 
extension for another six months for applications requiring more complicated testing methods or biosafety checks, provided that only a one -time extension shall be 
allowed.  
The competent authority of the central government may invite experts or scholars of 
relevant agencies, corporations, schools or groups to assist in the review of the 
abovementioned topics.  
 
Article 6  
Applicants applying for extension with reference to Paragraph 3 of Article 11- 1 of this 
Act shall complete an application form and submit the following information to the 
competent authority of the central government. After approving the extension, the 
competent authority of the central government shall remark this in the certificate of 
feed use approval. When there is no suitable column for recording this, applicants 
shall make the payment to renew a certificate of feed use approval:  
1. Original certificate of feed use approval.  
2. Research reports or literature regarding the biosafety of the genetically modified 
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 feed or feed additives within the past five years.  
3. Other supplementation specified by the competent authority of the central 
government.  
Applicants applying for the re -issue or renewal of a lost or damaged certificate of feed 
use approval specified in Paragraphs 1 and 2 of Article 11- 1 of this Act shall specify 
the reasons for re -issue or renewal, make the payment, and apply to the original 
issuing agency.  
After a chang e of the entries recorded in the certificate of feed use approval specified 
in Paragraphs 1 and 2 of Article 11- 1 of this Act, certificate holders shall complete an 
application form and submit the original certificate of feed use approval and the 
certifica te of changed entries to apply for a certificate change to the competent 
authority of the central government within two months after the change. After approving the change, the competent authority of the central government may record 
such change in the cer tificate of feed use approval. When there is no suitable column 
for recording such change, applicants shall make the payment and submit the original certificate of feed use approval to renew the certificate of feed use approval.  
  
Article 7  
With the approval of the competent authority of the central government, applicants 
may be exempted from the biosafety checks under any of the following circumstances 
when applying for genetically modified feed or feed additives. 
1. Holders of the certificate of use  approval of genetically modified foods issued by 
the health competent authority of the central government with reference to Paragraph 2 of Article 21 of the Act Governing Food Safety and Sanitation and relevant 
regulations prior to the implementation of t he Regulations.  
2. Applicants registering genetically modified foods registered for review to the 
health competent authority of the central government with reference to Paragraph 2 of 
Article 21 of the Act Governing Food Safety and Sanitation and obtaining  the 
certificate of use approval for genetically modified foods after the implementation of the Regulations.  
 
Article 8  
A Chinese or English translation shall be provided for submittals or information not 
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 prepared in Chinese or English.  
Submittals or infor mation specified in the Regulations issued by a foreign government 
and/or assignment documents made overseas shall be certified by a ROC embassy or 
consulate, representative office, office, or other organizations authorized by the 
Ministry of Foreign Affai rs. Documents issued by the competent authority of Hong 
Kong, Macau, or mainland China or and/or assignment documents made in these countries or areas shall be certified by the organization established or appointed by 
the Executive Yuan or civilian groups it assigns.  
 
Article 9  
The Regulations shall be implemented as of the date of proclamation. 
 
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