Chapter 2 Registration
Article 9
Agro-pesticides shall not be manufactured, processed, or imported without having passed the examination of, approval for registration with, and obtained a permit from the central competent authority, unless otherwise prescribed in this Act or in case that the agro-pesticides are promulgated by the central competent authority as exempted from registration agro-pesticides.
Article 10
When the agro-pesticide manufacturers and dealers apply for approval of registration for formulated agro-pesticides under specified in the preceding Article, the applicants shall fill in the application form, attach the certification documents that the agro-pesticides passed the tests of standard specifications prescribed, and submit the data of physicochemical and toxicological tests, field trials, and other relevant documents.
In the following period, the data in the preceding Paragraph 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 ten 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 seven 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 four years starting from the date of approval for registration.
When the agro-pesticide manufacturers and dealers apply for approval of registration for formulated agro-pesticides, if one of the following conditions applies, all or a portion of the test data mentioned in Paragraph 1 may be exempted from submission.
1. After the expiration of the period stipulated in the preceding Paragraph, when applying for approval of registration with the same active ingredient, formulation, content, or the scope of application of the registered agro-pesticide, all or a portion of the data of the field trials and toxicological test may be exempted from submission.
2. Under the permission of data holder for the use of test data during the period in the preceding Paragraph, when applying for approval of registration with the same active ingredient, formulation, content, or the scope of application of the registered agro-pesticide, all data of the field trials and toxicological test may be exempted from submission.
3. When applying for registration approval for technical grade agro-pesticides, the data of the field trials may be exempted from submission.
4. The field trials may be exempted if a registered formulated agro-pesticide had previously applied for the permit of a comparatively safer new formulation and was approved by the central competent authority.
5. All or a portion of the data of the toxicological test may be exempted when applying for approval of registration for formulated agro-pesticide considered to be safe or has a low risk of application and was approved by the central competent authority.
The directions for the standard specifications, physicochemical property test, toxicological test, and field trials under Paragraph 1 shall be prescribed by the central competent authority.
Article 11
For the purpose of solving the lack of preventive agro-pesticides for the pests of minor crops, the competent authority may carry out the field trials for the new use and application of agro-pesticides,
and extend the use according to the actual circumstances; the conducting procedures shall be promulgated by the central competent authority.
Article 12
The inspection of agro-pesticide on standard specifications shall be promulgated by the central competent authority; if the analytical method of inspection is not promulgated, a feasible method in current use shall be applied.
Article 13
The central competent authority shall promulgate the common name, active ingredients and the contents, the use and the scope of application of a registered agro-pesticide.
Article 14
The use and change of agro-pesticide labelling shall be approved by the central competent authority at first, and after such a change occurs, the original labelling shall be replaced within six months.
The regulations governing the text, due contents, the pattern of warning and attention marks, and other relevant prescription regarding the agro-pesticide labelling under the preceding paragraph shall be prescribed by the central competent authority.
Article 15
An agro-pesticide permit shall specify the following information:
1. Permit number, date of registration, and period of validity;
2. Personal/business name and address of the manufacturer or dealer, name of the responsible person, and name and address of the original manufacturer overseas;
3. Common name, manufacturer brand, type of formulation, and physical properties of the agro-pesticide as well as description and percentage of active ingredients and other ingredients thereof;
4. Application method of the agro-pesticide and its scope; and
5. Other matters promulgated by thecentral competent authority.
Unless otherwise approved by the competent authority, change in any of the registered material facts under the preceding Paragraph shall not be permissible.
Upon any change in the standard specifications of an agro-pesticide, the registrant of the related agro-pesticide permit shall, within six months after the change, be filed for the alteration of the registration.
Article 16
An agro-pesticide permit shall be valid for five years. An application for an extension of said validity may be filed with the central competent authority within six months before the expiration, provided each extension shall not exceed five years.
Inspection of the agro-pesticide on standard specifications may be waived with respect to the application for extension under the preceding Paragraph.
After the enforcement of the amendment of this Act, on December 9, 2014, five years thereafter, the agro-pesticides obtained approval for registration more than fifteen years shall provide toxicity test report prescribed in Article 10 when applying for extension of permit validation. However, some items of the report shall be exempted, if they had been provided when registered.
The regulations governing the application for, issuance, re-issuance, exchange, extension, and alteration of the registered affairs of agro-pesticide permit, and other relevant affairs specified in Paragraph 1 shall be prescribed by the central competent authority.
Article 17
If an agro-pesticide manufacturer or importer uses fake data or certificates to apply for approval and registration of agro-pesticides, extension of permit, or alteration of registration, the central competent authority shall not approve such application; if approved, shall revoke the agro-pesticide permit.
In case of severe violation referred to the preceding Paragraph, the central competent authority shall not receive re-applications filed by the violator within two years from the date when the application is not approved or the permit is revoked.
Article 18
The central competent authority may perform safety assessment over the registered agro-pesticides; if an agro-pesticide endangers the human health or pollutes the environment, the central competent authority shall announce restrictions on its usage or its scope of application according to the actual necessity or declare it to be prohibited agro-pesticide and annul the agro-pesticide permit.
The central competent authority may perform effect assessment over the use and scope of registered agro-pesticides; if the effect is not obvious and there are no safety problems mentioned in the preceding Paragraph, the central competent authority may make a public notice to restrict the use and scope of application in whole or in part.
For the agro-pesticides, the permit of which is annulled or the use and scope of which are restricted as specified in the preceding two Paragraphs, if it is proven by scientific method that the reason for annulment or restriction has been eliminated, the central competent authority may make a public notice to recover the registration or cancel the restriction.
Article 19
If the permit of an agro-pesticide is annulled or revoked in accordance to this Act, the central competent authority may order the manufacturers or dealers to recall or destroy the said agro-pesticide within a specified time limit.