Last week, we introduced the basic information for novel food ingredients. Now, let's take a look of the requirements for novel food ingredients application materials.

Requirements for Novel Food Ingredients Application Materials

If the ingredients used by the enterprise meet the definition of novel food ingredients, the ingredients need to be applied as novel food ingredients before using. According to the requirements of the Rules of Application and Acceptance for Novel Food Ingredient, the materials required for the application of novel food ingredients are as follows (specific details should be determined according to different types of ingredients).

(1) Application form

(2) Novel food ingredients research report

(3) Safety assessment report

a) Composition analysis report

b) Hygiene inspection report (qualify required)

c) Toxicology evaluation report (There are qualification requirements, the test items are determined by the using conditions of domestic and foreign countries, and the amount of test items fluctuates from 2 to 7)

d) Microbial resistance test report and toxicity production capacity test report (qualify required, only for microorganisms)

e) Safety evaluation opinions (The basic information of the declared substance, composition analysis, toxicology data, population data, consumption and using status and intake assessment and other information need to be written by the organization that meets the qualification requirements)

(4) Production process

(5) Implementation of relevant standards

(6) Product label and instruction

(7) Domestic and foreign research and utilization and related safety assessment data

(8) Power of attorney (if attorney existed)

(9) Other materials helpful to review and evaluation

(10) One sealed samples of minimum package or 30g ingredient

In addition, if the declared substance is imported, the following documents are also required.

(11) Materials to be submitted for imported novel food ingredient

a) A certificate or document that allows the product to be produced or sold in the country (region) of origin issued by relevant departments or organizations of the exporting country (region)

b) A certificate or document that proves the manufacturer is reviewed or authenticated, issued by relevant departments or organizations of the country (region) where the manufacturer is located

Next week, we will introduce the more information for novel food ingredients application. Please pay attention to us!

Contact Information

Lillian Fan

+86-10-51301566

Lillian.fan@ieasytrip.com

Relevant Reading

Basic information for novel food ingredients

Approval Process of Novel Food Ingredients

Introduction of Food Related Application & Registration Services