Laws of the People's Republic of China

The Ministry of Agriculture

Decree of the Ministry of Agriculture of the People's Republic of China

No. 9

The Measures for the Administration of the Safe Import of Agricultural Transgenic Living Things have been passed at the fifth executive meeting of the Ministry of Agriculture on July 11, 2001, and are hereby promulgated for implementation as of March 20, 2002.

The Ministry of Agriculture

January 5, 2002

Measures for the Administration of the Safe Import of Agricultural Transgenic Living Things

Chapter I General Provisions

Article 1

The present Measures have been formulated on the basis of the relevant provisions of the Regulation on the Safety of Agricultural Transgenic Living Things (referred to as the Regulation) for the purpose of controlling the safe import of agricultural transgenic living things.

Article 2

The present Measures shall be applicable to the safety control of the import of agricultural transgenic living things carried out within the territory of the People's Republic of China.

Article 3

The State Committee for the Safety of Agricultural Transgenic Living Things shall be responsible for assessing of the safety of the import of agricultural transgenic living things. The Office for the Safety Control of Agricultural Transgenic Living Things shall be responsible for the safety control in the import of agricultural transgenic living things.

Article 4

Administration of the imported agricultural transgenic living things shall be carried out according to any of the three purposes thereof: for research and experiment, for production and for raw materials

Chapter II Agricultural Transgenic Living Things Used for Research and Experiment

Article 5

To import any of the agricultural transgenic living things that falls within the safety grades I and II from without the People's Republic of China, the importer shall file an application to the Office for the Safety Control of Agricultural Transgenic Living Things, and shall submit the following materials:

1.

The qualification documents for application as required by the Ministry of Agriculture;

2.

Registration Forms for the control of safe import (see Supplement);

3.

Certification documents proving that considerable research has been done on the agricultural transgenic living things to be imported;

4.

The safety measures to be adopted by the importer in the process of importation.

If the application is found to be eligible after examination, the Ministry of Agriculture shall issue approval for importing the agricultural transgenic living things. The importer shall handle relevant procedures at relevant departments by showing the approving documents.

Article 6

To import any of the agricultural transgenic living things that falls within the safety grades I, II and IV from without the territory of the People's Republic of China for experiments and research and to import any of the agricultural living things of all safety grade for intermediate experiments, the importer shall file an application to the Office for the Safety Control of Agricultural Transgenic Living Things and shall submit the following materials:

1.

The application qualification documents as required by the Ministry of Agriculture;

2.

The registration forms for the safety control of import (see Appendix);

3.

Certification documents proving that considerable research or experiments have been done abroad on the agricultural transgenic living things;

4.

The safety control measures to be adopted by the importer in the process of importation;

5.

The materials as required by the Measures for the Administration of the Safety Assessment of Agricultural Transgenic Living Things during the corresponding phases.

If the application is found to be eligible after examination, the Ministry of Agriculture shall issue an approval for the import of the agricultural transgenic living things. The importer shall go through relevant procedures at relevant departments by showing the approving documents.

Article 7

To import any of the agricultural transgenic living things from without the territory of the People's Republic of China for environmental release or productive experiments, the importer shall file an application to the Office for the Safety Control of Agricultural Transgenic Living Things and shall submit the following materials:

1.

The application qualifications documents as required by the Ministry of Agriculture;

2.

The Registration forms for the safety control of import (see Appendix);

3.

Certification documents proving that considerable research or experiments have been done abroad on the agricultural transgenic living things;

4.

The safety control measures to be adopted by the importer in the process of importation;

5.

The materials as required by the Measures for the Administration of the Safety Assessment of Agricultural Transgenic Living Things during the corresponding phases.

If the application is found to be eligible after examination, the Ministry of Agriculture shall issue a certificate of the safety of the agricultural transgenic living things. The importer shall go through relevant procedures at relevant departments by showing the certificate of safety.

Article 8

To import any of the agricultural transgenic living things for experiments, the importer shall start to apply to the Ministry of Agriculture from the phase of intermediate experiments.

Chapter III Agricultural Transgenic Living Things to Be Used for Production

Article 9

Where any extraterritorial company exports any of the transgenic plant seeds, seed livestock or bird, aquatic seedlings or any of the plant seeds, seed livestock or birds, aquatic seedlings, pesticides, animal medicine, fertilizers or additives that are made from agricultural transgenic living things or containing elements of agricultural transgenic living things for the purpose of production, it shall file an application to the Office for the Safety Control of Agricultural Transgenic Living Things, and shall submit the following materials:

1.

Registration forms of safety control for import (see Appendix);

2.

Certification documents proving that it is allowed by the country or region of export to be used for corresponding uses;

3.

Materials proving that scientific experiments of the country or region of export have showed that no harm will result to the human being, animals and plants, microorganisms and the biological environment;

4.

The safety measures to be adopted by the extraterritorial company in the process of exporting to the People's Republic of China;

5.

The materials as required by the Measures for the Administration of the Safety Assessment of Agricultural Transgenic Living Things during the corresponding phases.

Article 10

When filing any of the above-mentioned applications, the extraterritorial companies shall, make the application prior to the beginning of the intermediate experiments, obtain approval therefor and can then let the experimental materials enter into the territory, and shall pass three experimental phases --- intermediate experiment, environmental release and productive experiments as well as the phase of applying for a safety certificate of agricultural transgenic living things.

If an application filed during the phase of intermediate experiment is found to be eligible after examination, the Ministry of Agriculture shall issue an approval for importing the agricultural transgenic living things, and the extraterritorial companies shall go through relevant procedures at relevant departments by showing the approving documents. If an application filed during the phase of environmental release and productive experiment has passed the safety assessment, the Ministry of Agriculture shall issue a letter of safety approval of agricultural transgenic living things, and the extraterritorial companies shall go through relevant procedures at relevant departments by showing the letter of safety approval. If an application for safety certificates has passed the safety assessment, the Ministry of Agriculture shall issue a safety certificate of agricultural transgenic living things, and the extraterritorial companies shall go through relevant procedures at relevant departments by showing the safety certificates.

Article 11

Before the imported agricultural transgenic living things are put into production, a safety certificate for agricultural transgenic living things shall be obtained and then can the relevant procedures of examination, registration or assessment or approval be handled according to the provisions of laws or regulations concerning the seeds, livestock and bird seedlings, aquatic seedlings, pesticides, animal medicines, fertilizers, additives, etc.

Chapter IV Agricultural Transgenic Living Things to Be Used as Raw Materials

Article 12

To export agricultural transgenic living things to the People's Republic of China so as to be used as raw materials, the extraterritorial companies shall file an application to the Office for the Safety Control of Agricultural Transgenic Living Things for safety certificates of agricultural transgenic living things.

Article 13

When filing the above-mentioned applications, the extraterritorial companies shall submit the following materials:

1.

Registration forms of safety control for import (see Appendix);

2.

A declaration for safety assessment (see Appendix V to the Measures for the Administration of the Safety Assessment of Agricultural Transgenic Living Things);

3.

Certification documents proving that it is permitted in the country or region of export to use them for corresponding purposes and to be put into market;

4.

Materials proving that scientific experiments in the country or region of export have showed that no harm will result to the human being, animals, plants, microorganisms and the biological environment;

5.

Test reports issued by the technological institutions upon the entrustment of the Ministry of Agriculture concerning the safety to the human beings, animals, plants, microorganisms and biological environment;

6.

The safety measures to be adopted by the extraterritorial companies in to the process of exporting to the People's Republic of China.

If the application has passed the safety assessment, the Ministry of Agriculture shall issue a safety certificate of agricultural transgenic living things.

Article 14

Where any one who has obtained approval for its application and before it files further application to the People's Republic of China, if the application meets the requirements concerning the same company and the same conditions regarding the agricultural transgenic living things, the application procedures for safety assessment may be simplified while the following materials shall be submitted:

1.

Registration forms of safety control for import (see Appendix);

2.

Photocopy of the safety certificates of agricultural transgenic living things initially issued by the Ministry of Agriculture;

3.

The safety measures to be adopted by the extraterritorial companies in the process of exporting to the People's Republic of China.

If the application is found to be eligible after examination, the Ministry of Agriculture shall issue a safety certificate of agricultural transgenic living things.

Article 15

The extraterritorial companies shall go through relevant procedures at relevant departments by showing the safety certificates of agricultural transgenic living things issued by the Ministry of Agriculture.

Article 16

If any of the agricultural transgenic living things imported to be used as raw materials is alive, import archivist files shall be established to specify the source, storage, transportation thereof, etc, and safety control measures that suit the agricultural transgenic living things shall be adopted so as to ensure that the agricultural transgenic living thing will not come into the environment.

Chapter V General Provisions

Article 17

The Ministry of Agriculture shall make a decision of approval or disapproval within 270 days after receiving the application of the applicant, and shall inform the applicant of the result.

Article 18

In the import of agricultural transgenic living things for production or raw materials, the contracts thereof may not be concluded until safety certificates of agricultural transgenic living things issued by the Ministry of Agriculture has been obtained.

Article 19

In the import of agricultural transgenic living things, if no safety certificate of agricultural transgenic living things or relevant approving documents or if they are not in conformity with the certificates or approving documents, such agricultural transgenic living things shall be returned back or be destroyed.

Article 20

The power to interpret the present Measures shall remain with the Ministry of Agriculture.

Article 21

The present Measures shall enter into force as of March 20, 2002.

Appendix: Registration Forms of Safety Control for Import of the Agricultural Transgenic Living Things (omitted)