Declaration for new varieties of genetically modified microbial food additives

1、Product information

1.1 Product composition, target product content and other testing data

1.2 Detection data of foreign gene residues in products

1.3 Detection data of genetically modified microorganism residues in products

1.4 Product control measures and effects

1.5 Product classification description, determine whether the product is Class I or Class II

2、Information related to genetically modified microorganisms

2.1 Basic information

2.2 Taxonomy and identification data

2.3 Biological characteristics information

2.4 Growth environmental conditions information

2.5 Other countries’ regulatory information

2.6 Evaluation of genetically modified microorganisms for food processing

3、Safety evaluation of recipient microorganisms

3.1 Background information

3.2 Biological properties

3.3 Adaptable ecological environment

3.4 Genetic variation

3.5 Other information

3.6 Security level

4、Safety evaluation of genetic manipulation

4.1 Description of traits and characteristics introduced or modified in genetically modified microorganisms for food processing

4.2 Data on actual insertion or deletion of sequences

4.3 Carrier information

4.4 Information about each fragment of the insertion region in the vector

4.5 Gene manipulation methods

4.6 Genetic stability

4.7 Detection and identification technology of target genes

4.8 Determining the type of safety for genetic manipulation

Serial number

List of application materials

1

Application form

2

Common name, functional classification, dosage and scope of use

3

Information or documents proving the technical necessity and effectiveness of use

4

Quality specification requirements, production and use processes and inspection methods, inspection methods or instructions for the additives in food

5

Safety assessment information (if the scope of use or dosage is expanded, it is exempted from providing)

6

Sample labels or instructions

7

Other countries (regions) and international organizations allow production and use that are helpful for safety assessment.

8

Power of attorney for declaration

9

One piece of unopened minimum package sample or 30 grams of raw materials

10

Certification materials issued by the relevant departments or institutions of the exporting country (region) of the new imported food additive species that allow the product to be produced or sold in the country (region)

11

Certification materials for the review or certification of the production company issued by relevant institutions or organizations in the country (region) where the production company of the new imported food additive variety is located