Directions for the Application Form for Registration of
Environmental Management on the First Import of Chemicals (Form 2)

A. Classification of Application for Registration of Environmental Management on the First Import of Chemicals

Applications for Registration of Environmental Management on the First Import of Chemicals will be classified into following six classes according to scheduled import weights of chemicals. Information requisition will vary with the application classes.

B. Information Requisition of Application for Registration of Environmental Management on the First Import of Chemicals

The Application Form for Registration of Environmental Management on the First Import of Chemicals (Form 2) is an application form with full information requisition. The information requisition for applications of every import class is described as following. However, chemicals first imported for experimental purposes in quantities less than 50 kg annually shall be exempted from registration (except for those chemicals included in the List of Toxic Chemicals Banned or Severely Restricted in the People's Republic of China).

1. Item I, II, III, IV, V, VI, X, XI and XII in Application Form for Registration of Environmental Management on the First Import of Chemicals (Form 2) are fundamental data for an application for registration of environmental management on the first import of chemicals. Any Import Class shall provide data of those items.

2. Item VII, VIII and IX in the Application Form for Registration of Environmental Management on the First Import of Chemicals (Form 2) are data of environmental effects of chemicals for an application for registration of environmental management on the first import of chemicals. The data requisition is described for each Import Class as following.

(1) First imported in a quantity less than 0.1 tons/year (Import Class A): Following information in the form shall be provided.
in Item VII Physical and chemical properties

1. State at 20℃ and 101.3 kPa
10. Flash point (open and closed cup)
11. Flammability

in Item IX Toxicology
in 1. Acute toxicity
(1) Inhalation
(2) Orally

(2) First imported in a quantity equal to or more than 0.1 tons/year and less than 1 tons/year, or totally reaching 0.5 tons (Import Class B): Following information in the form shall be provided.

in Item VII Physical and chemical properties
1. State at 20℃ and 101.3 kPa
2. Melting point
3. Boiling point
7. Water solubility
9. Partition coefficient (n-octanol/water)
10. Flash point (open and closed cup)
11. Flammability
in Item VIII Ecotoxicology
in 1. Degradation

(1) Biotic
(2) Antibiotic (If the substance is not readily biodegradable)
in 3. Bioaccumulation
(1) Bioaccumulation in fish (If the substance is neither readily biodegradable nor antibiotic degradable)
in Item IX Toxicology
in 1. Acute toxicity
(1) Inhalation
(2) Orally
(4) Eye & skin irritation
(5) Skin sensitization
in 3. Other effects
in (1) Mutagenicity
in a. Bacteriological test

i) With metabolic activation
ii) Without metabolic activation
b.Non-bacteriological test

(3) First imported in a quantity equal to or more than 1 tons/year or totally reaching 5 tons (Import Class C, D, E, or F): All information in Item VII, VIII and IX in the form shall be provided.

(4) First imported in a quantity equal to or more than 10 tons/year and less than 100 tons/year, or totally reaching 50 tons (Import Class D): Without prejudice to Paragraph B. 2. (3), the competent authority of the registration of environmental management on the first import of chemicals may require some or all of the additional test/studies laid down in Annex I, level 1, to be carried out by the applicant within a time limit which the competent authority will determine.

(5) First imported in a quantity equal to or more than 100 tons/year and less than 1000 tons/year, or totally reaching 500 tons (Import Class E): Without prejudice to Paragraph B. 2. (3), the competent authority shall require the additional test/studies laid down in Annex I, level 1, to be carried out by the applicant within a time limit which the competent authority will determine, unless the applicant can give good reason why a given test/study is not appropriate or an alternative scientific test/study would be preferable.

(6) First imported in a quantity equal to or more than 1000 tons/year or totally reaching 5000 tons (Import Class F): Without prejudice to Paragraph B. 2. (3), the competent authority of the registration of environmental management on the first import of chemicals shall draw up a program of test/study according to Annex I, level 2, to be carried out by the application within a time limit which the competent authority will determine.

(7) When additional tests/studies in Annex I are carried out either in accordance with the requirements of Paragraph B. 2. (4), (5) and/or (6), the applicant shall provide the competent authority with the results of the tests/studies carried out.

C. Besides the information provided by the applicant according to the requirements of Paragraph B., when the competent authority, based on the evaluation result made by the State Committee for Evaluation of Toxic Chemicals, considers that effects of the expected imported chemical substance on the environment has not yet clearly described with the information for the application provided by the applicant, the applicant may be required to provide the competent authority with the relevant information.

D. Attestation of the information for the application for registration of environmental management on the first import of chemicals provided by the applicant

The applicant shall provide the competent authority with appropriate testimonial materials for the data filled in the Item VII, VIII and IX of the Application Form for Registration of Environmental Management on the First Import of Chemicals (Form 2). The testimonial materials shall be the following materials or their transcripts or copies: 1) Test/study reports made by testing facilities attested by the competent authority; or 2) Relevant testimony offered by attested testing facilities; or 3) Other acceptable materials.

The applicant shall provides the competent authority with acceptable testimonial materials for the data filled in the Item XI and XII of the Application Form for Registration of Environmental Management on the First Import of Chemicals (Form 2).

The applicant shall provides the competent authority with acceptable testimonial materials for the information of the additional tests/studies, laid down in Annex I, required by the competent authority.

The competent authority has the right to attest the information provided by the applicant for the application for registration of environmental management on the first import of chemicals.

E. After being issued a Registration Certificate of Environmental Management on the First Import/Export of Chemicals for a chemical substance, if the applicant expects to import the chemical substance in a quantity more than that registered in the Registration Certificate, he shall, in advance, obtain a permission from the competent authority. If the applicant's expected import quantity is not at the same Import Class (annual import or total import quantity) of that registered in the Registration Certificate, the competent authority may require the applicant to re-apply for the Registration Certificate.

F. When required, the applicant shall provide the competent authority with a sample of the expected import chemical substance (usually not less than 250g).

G. Confidentiality of data

If the applicant considers that there is a confidentiality problem, he may indicate the information, provided for the Application Form for Registration of Environmental Management on the First Import of Chemicals (Form 2), which he considers to be commercially sensitive and disclosure of which might harm him industrially or commercially, and which he therefore wishes to be kept secret from all persons other than the competent authority and the Evaluation Committee. Full justification must be given in such cases. However, the secrecy shall not apply to the following items in the Application Form for Registration of Environmental Management on the First Import of Chemicals (Form 2).
1. 'I. Institution of application'
2. '3. Trade name' in 'II. Identity of product'
3. 'VII. Physical and chemical properties'
4. 'X. Measures for accident prevention, first aid & handling'
5. The summary results of the toxicological and ecotoxicological tests

H.Additional information and Tests

If it is not technically possible or if it does not appear scientifically necessary to give information, the reasons shall be clearly sated and be subject to acceptance by the competent authority.

Level 1

1. Toxicological studies

- Fertility study (one species, one generation, male and female, most appropriate route of administration). If there are equivocal findings in the first generation, study of a second generation is required.

Depending upon the dosing schedule it may be possible in this study to obtain an indication of teratogenicity. A positive indication should be examined in a formal teratology study.

-Teratology study (one species, most appropriate route of administration). This study is required if teratogenicity has not been examined in the above fertility study.

- Sub-chronic and /or chronic toxicity study, including special studies (one species, male and female, most appropriate route of administration). It shall be required if the results of '2. Sub-acute toxicity (28 days)' in 'IX Toxicology' of the Application Form for Registration of Environmental Management on the First Import of Chemicals (Form 2), or other relevant results, show a further test is necessary. The effects which would indicate the need for such a study could include for example:
a. Serious or irreversible lesions
b. A very low or absence of a "no effect" level
c. A clear relationship in chemical structure between the substance being studies and other substances which have been proved dangerous.

- Additional mutagenesis studies and/or carcinogenesis screening study(ies)
A. If the result of the mutagenesis study is negative, verification mutagenesis and verification carcinogenesis screening tests shall be conducted according to the specific properties and the purposed use of the substance.

If the result of the verification mutagenesis tests is also negative, formal mutagenesis tests may not be conducted. otherwise, further mutagenesis tests shall be conducted (referred to B.).
If the result of the verification screening carcinogenesis test is also negative, formal carcinogenesis screening tests may not be conduced. Otherwise, further carcinogenesis screening tests shall be conducted (referred to B.).

B. When the result of the mutagenesis test is positive, at least two verification tests shall be conducted. In such case, mutagenesis and carcinogenesis screening tests are recommended. If the result of the carcinogenesis screening test is positive, a formal carcinogenesis test shall be conducted.

- Basic toxicokinetic information

2. Ecotoxicity studies

- Alga growth inhibition

- Prolonged toxicity study with Daphnia magna (21 days)

- Test on higher plants

- Test on earthworms

- Further toxicity studies with fish (14 days)

- Tests for species accumulation; one species, preferably fish

- Supplementary degradation study(ies), if sufficient degradation has not been proved by the study result laid down in '1. Degradation' in 'VIII Ecotoxicology' of the Application Form for Registration of Environmental Management on the First Import of Chemicals (Form 2).

Level 2

1. Toxicological study

The test program shall cover the following aspects unless there are strong reasons to the contrary, supported by evidence, that it should not be followed.

- Chronic toxicity study

- Carcinogenicity study

- Fertility study (e.g. three-generation study); only if an effect on fertility has been established at Level 1

- Teratology study (species not employed in the respective Level 1)

- Acute and sub-acute toxicological tests to second species. Only when the results of tests at Level 1 show the necessity, or when the test results are necessary to cover biotransformation and pharmacokinetics.

- Additional tests for toxicity metabolicokinetics

2. Ecotoxicological studies

- Additional tests for accumulation, degradation, mobility

- Further toxicity studies with fish

- Toxicity studies with birds (if BCF is more than 100)

- Additional toxicity studies with other organisms (if necessary)

- Adsorption/desorption test (especially the substance is not readily degradable)

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