Tags: | SAMR | Food | Health Food | 市场监管总局 | 食品 | 保健食品 |

I. Purpose:
Avoid failure of CFDA registration due to incompliance with CFDA requirements in the formula ingredients..
 
II.  Background:
Incompliance of formula ingredients with the requirements accounts for above 60% of the overall registration failures according to the statistics of the reasons for imported Food supplement CFDA registration failure, followed by unqualified product testing (incompliance of Quality Indicator), incompliance of submission application documents with the requirements and unmet requirements for packaging and labeling.
The following several conditions will lead to registration failure in the formula reason:
1.  Containing new Food supplement ingredient, which has not been approved by China;
2.  Containing prohibited ingredients and additives by CFDA;
3.  Containing CFDA limited risk ingredients and additives, the concentration of those ingredient exceeds CFDA maximum allowable limits;
4.  Unreasonable formula design, lack of scientific evidence to support its function claim;
5.  Unreasonable formula design, may produce hazard or risk substance, cause health safety issues;
6.  Product dosage form is unreasonable;
7.  Production process is unreasonable;
 
III.  Benefit:
1.  To reduce risk of CFDA registration failure due to formula reason;
Find risk factors in the formula through pre-analysis of formula. Applicant can select not to submit this variety or submit after modification of formula, thereby avoiding registration failure.
2.  To save testing fee, avoid loss of money, time and human resource;
As CFDA will perform product safety test first, and then review formula and registration dossiers, hasty testing and registration submission will cause loss of testing fee, time and human resource for applicant due to registration failure for formula reason in case no pre-analysis of formula.
 
IV. Feasibility Analysis Item:
1.   Formula Ingredients Basic Analysis Items:   
1)   Analysis for Prohibited raw materials and ingredients in the formulaa
2)   Analysis for Limiting use of raw materials and ingredients in the formula
3)   Analysis for new food raw materials in the formula
4)   Analysis for food additives in the formula
5)   Analysis for Nutrition fortifier in the formula
6)   Analysis for the animal and plant raw materials amount limit in the formula
7)   Analysis for functional or nominal ingredients in the formula
8)   Analysis for Daily intake limit of functional ingredients
2.   Formula Scientific basis and rationality Analysis Items: (Option) 
1)   Analysis for Formula’s scientific basiss
2)   Analysis for Formula’s rationality
3)   Analysis for Formula’s safety
4)   Analysis for Formula’s defect and risk
3.   Product Quality Indicator Analysis Items: (Option)
1)   Analysis for Physical and chemical indicators
2)   Analysis for Pollutant limits
3)   Analysis for Microbiological pathogens limits
4)   Analysis for Other quality indicators
4.   Product Instruction and Chinese Labeling Analysis Items: (Option)
1)   Analysis for Product Instructions
2)   Analysis for Chinese labeling
 
V.   Analysis Timeframe
1.   Formula Basic Analysis Items: 2-4 week
2.   Formula Scientific basis and rationality Analysis Items: 2-4 week
3.   Product Quality Indicator Analysis Items: 1 week
4.   Product Instruction and Chinese Labeling Analysis Items: 1 week
 
VI. Feasibility Analysis Fee:
1.   Formula Basic Analysis Items: USD$**** Inquire us
2.   Formula Scientific basis and rationality Analysis Items: USD$**** Inquire us
3.   Product Quality Indicator Analysis Items: USD$***Inquire us
4.   Product Instruction and Chinese Labeling Analysis Items: USD$*** Inquire us
 
Note:
1)  If more than 20 ingredients, the Excess ingredients add USD $100 / per ingredient.
2)  If the formula is qualified and the applicant decides to start CFDA registration, this pre-analysis fee will be subtracted from the registration agent fee.