Pesticide Registration in Taiwan, China

In Taiwan, agro-pesticides are regulated by Agro-pesticides Management Act. Agro-pesticides shall not be manufactured, processed, or imported without pesticide registration with the Ministry of Agriculture in Taiwan.  Non-agricultural pesticides such as chemical agents or microbial preparations used for environmental sanitation and pollution control are regulated by the Environmental Agents Control Act in Taiwan.

Definition of Agro-pesticides

In Taiwan, agro-pesticides can be divided into formulated agro-pesticides and technical grade agro-pesticide. They include both chemical pesticides and bio-pesticides which are used for：

(1) preventing and eliminating pests of crops and forest or the products thereof;
(2) regulating the growth of crops and forest or for influencing the physiological functions thereof;
(3) regulating the growth of beneficial insects;
(4) Any other chemicals designated by the central competent authority for protecting plants.

Main Pesticide Regulations in Taiwan

• Agro-pesticides Management Act

• Enforcement Rules of the Agro-pesticides Management Act

Who Shall Register

• Pesticide manufacturer: a domestic enterprise with agro-pesticide factory in Taiwan

• Pesticide importers or dealers: importers or dealers with agro-pesticide dealers' license in Taiwan

Both agro-pesticide manufacturers and dealers in Taiwan can apply for the approval of registration for formulated agro-pesticides. Only the agro-pesticide manufacturers may apply for import of technical grade agro-pesticides.

Authorities

• Agricultural Chemicals Research Institute (ACRI), Ministry of Agriculture

• Animal and Plant Health Inspection Agency, Ministry of Agriculture

Registration Data Protection

Taiwan provides data protection to pesticide registrants. The test data submitted by early registrants shall not be cited by other applicants without receiving the approval of the data holder for use of the test data.

1. For a product that has a new active ingredient which has previously obtained approval for registration, a period of 10 years starting from the date of approval for registration.

2. For a product that has a new or changed content or formulation that has previously obtained approval for registration, a period of 7 years starting from the date of approval for registration.

3. For a product that has new scope of application that has previously obtained approval for registration, a period of 4 years starting from the date of approval for registration.

Registration Data Requirements

Pesticide registration applicant shall submit required registration data to agriculture authority according to relevant product registration type, which typically includes test reports on product chemistry, toxicology, environment, field efficacy, sample labels, application form, and qualifications of applicants.

For me-too registrations (i.e., a formulated product that has previously obtained approval for registration eight years ago), a lot of test data can be exempt, for example, field test and toxicology test.

Pesticide Registration Permit and Validity

An agro-pesticide permit shall specify the following:
1. Permit number, date of registration, and period of validity;
2. Personal/business name and address of the manufacturer or dealer, name of responsible person, and the name and address of original manufacturer overseas;
3. Common name, manufacturer brand, type of formulation, and physical properties of the agro-pesticides as well as description and percentage of active ingredients and other ingredients thereof;
4. Application method of agro-pesticides and its scope;
5. Other matters promulgated by the central competent authority.

An agro-pesticide permit shall be valid for 5 years. An application for extension of said validity may be filed with the central competent authority within six months of the expiration；provided each extension shall not exceed five years.

Our Services

We provide one-stop solutions to help you comply with pesticide regulation in Taiwan and China.

Our services include:

• Pesticide registration;

• Pesticide registration legislation and policy survey;

• Registration budget, cost control and registration strategy;

• Data evaluation and gap analysis;

• Testing coordination;

• Product safety assessment report(environment/health/dietary);

• Dossier preparation and submission;

• Renewal of pesticide registration certificate;

• Advice and training on pesticide production permit.

If you need any assistance or have any questions, please get in touch with us via service@hfoushi.com .