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Chapter Law Content

Title: Agro-pesticides Management Act CH
Category: Ministry of Agriculture(農業部)
Chapter II. 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 non-controlled agro-pesticides.
Article 10
When the agro-pesticide manufacturers and dealers apply for approval of registration for formulated agro-pesticides under the preceding Article, they shall fill in the application form, attach the certification documents that the agro-pesticides passed the tests of standard specifications prescribed, submit the data of physicochemical and toxicological test and field test 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, then all or a portion of the test data in paragraph one may be exempted from submission.
1. After the expiration of 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 or a portion of the data of the field test 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 test and toxicological test may be exempted from submission.
3. When applying for approval of registration for technical grade agro-pesticides, the data of the field test may be exempted from submission.
4. The field test may be exempted if a registered formulated product 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 product 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 test under paragraph one shall be prescribed by the central competent authority.
Article 11
For the purpose of solving the lack of preventive chemicals for the pests of minority crops, the competent authority may carry out the field tests for the new use and application of agro-pesticide, and extend the use according to the actual circumstances; the conducting procedures shall be promulgated by the central competent authority.
Article 12
The inspection methods of agro-pesticide standard specifications shall be promulgated by the central competent authority; if there without proclamation, a feasible method in current use shall be referred to.
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 pesticide labeling shall be approved by the central competent authority at first, and after the original labeling shall be replaced within six months from such a change occurs.
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:
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.
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 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 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.
Inspection of agro-pesticide 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, December nine, 2014, for five years, agro-pesticide obtained approval for registration more than 15 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 referred to in Paragraph One as well as the relevant affairs shall be established 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-pesticide, 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 in the preceding paragraph ,the central competent authority shall not receive re-applications filed by the violator within two years from the day 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 health of human body or pollutes the environment,restrict the use or its scope of application according to the actual necessity; or declare it to be prohibited agro-pesticides and abolish 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 is no safety problems mentioned in the preceding paragraph, 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 abolished or the use and scope of which are restricted as prescribed in the preceding two paragraphs, if it is proven by scientific method that the reason for abolishment 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 abolished or revoked under this Act, the central competent authority may order the manufacturers or dealers to call back or destroy the said agro-pesticide within a specified time limit.