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.
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