FORM – IV

APPLICATION FOR IMPORT OF PROCESSED FOOD/ PRODUCTS DERIVED FROM LIVING MODIFIED ORGANISM (LMO) / GENETICALLY MODIFIED ORGANISMS (GMO).

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Part A

(a) Not all the points included will apply to every case. It is to be expected, therefore, that individual applicant will address only the particular parameters that are appropriate to individual situations. In each case where it is not technically possible or it does not appear necessary to give the information, the reasons shall be stated.

(b) The details required in response to each parameter are also likely to vary according to the nature and scale of the proposed release.

(c) The description of the methods used or the reference to the standardized or internationally recognized methods shall also be mentioned in the form together with the name of the body or bodies responsible for carrying out the studies.

(d) A 1-2 page summary of the proposal shall be appended with application.

Part B

1. Name and contact details of the Applicant

2. Name and contact details of the organization/firm

3. Approval required.

4. Quantity per year of the product to be imported/marketed.

Part C

1. Name of the product:

2. Intended use:

3. Purpose of import.

4. Whether derived from living modified organism or one of the ingredients has been derived from LMO/GMO? Provide details.

5. List of gene/events approved in the same crop species for commercial production in the country of export/ country of origin.

6. Name and identity of the living modified organism(s) from which the product has been derived.

7. Description of the gene modification, the technique used, and the resulting characteristics of the living modified organism.

8. Any unique identification of the living modified organism.

9. Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety.

10. Whether the product has been approved for consumption (food/feed) in Countries other than producing countries. If so, details of the same.

11. Whether the gene/events from which the product has been derived is in commercial production and has been approved for marketing in the country of origin/export.

12. Approved uses of the living modified organism in the country of origin/export

13. Food safety studies conducted in the country of origin/export.

14. Analytical / compositional report from the country of origin/export.

15. Whether further processing is envisaged after import. If so details of the same.

16. Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.

17. Quality Control and Quality Assurance.

18. Stability and Shelf Life of product.

19. Regulatory status in India / abroad. In case the certificate is issued by the concerned authority of country of origin, the certificate should be endorsed/ authenticated by Indian Embassy/High Commission/Consulate in that country.

20. Every certificate shall be accompanied by other statutory information like manufacturing batch, no. date of manufacture, date of analysis, date of release of the certificate, signatory to the certificate etc.

21. A declaration that the above-mentioned information is factually correct.

Applicant’s signature with seal.