Prior to applying for CFDA certification or registration, foreign companies must first ensure that their formulas meet the relevant product standards. The ingredients must be compliant with CFDA approved ingredient lists. In addition, the content levels must adhere to CFDA recommendations.

Knudsen&Co’s team of pharmacists and nutritionists can assist in screening the ingredients list for restricted or forbidden ingredients, and provide recommendations for potential ingredient substitutions. This process is a prerequisite for ensuring that a formula is compliant with CFDA regulations, and if it is not, to develop a new one.


Cosmetics screening sample

Service introduction

  1. We will provide the standard Chinese name for each ingredient
  2. If the ingredient is on CFDA approved list, it will be marked by “Approved”
  3. If the ingredient is on CFDA approved list but the name needs to be changed, it will be marked by “Approved with a standard name”
  4. If the ingredient is not on CFDA approved list and no substitution has been found, it will be marked by “NOT FOUND and need to apply for new raw material”
  5. If the ingredient is not on CFDA approved list but there are substitutions, it will be marked by “NOT FOUND with the substitutions”
  6. We will also provide the recommended Level of Usage for the ingredients if it is necessary.

The screening information includes:

  1. Whether it is approved by CFDA or not
  2. Standard Chinese name
  3. Approved usage level for each ingredient
  4. Substitution for unapproved ingredient

Filing sample

Service introduction

According to this Product’s ingredient screening, it only contains vitamins and minerals, so we will preliminarily classify this product into nutrition supplement.

Then we will check the ingredients, sources, and daily intake levels according to the raw material approved list as well as the food additive approved list for nutrition supplement issued by CFDA.

The screening information includes:

  1. Whether it is approved by CFDA or not
  2. Standard Chinese name
  3. Daily intake level for vitamins and minerals
  4. The approved sources
  5. Substitution for unapproved ingredient

The report we will provide you is as follow:

No. Ingredients Chinese name Daily intake limitation (per day) Comments
1 Vitamin C (as ascorbic acid) 维生素C 30-500 mg Approved
2 Vitamin D 维生素D 2-15ug Approved
3 Magnesium (as magnesium lactate) 65-350mg Approved
4 Cooper 0.2-1.5 mg Approved
5 Manganese 1-4 mg Approved
6 Potassium (as potassium citrate) 400-2000mg Approved
7 Boron —— NOT ON THE CFDA LIST, delete it
8 Vitamin K2 维生素K2 15-100 ug, calculated by phytonadione Approved
9 Cacium 200-1000 mg Approved
10 Zinc 3-15 mg Approved
Function claim recommendation for nutrition supplement: Muti-vitamins and minerals

If you apply for functional health food, the function claim can be Bone Density Improvement

Note: The reason why we recommend applying for filing is that it costs less money and time compared with registration. But you can only claim as Muti-vitamins and minerals. If you make functional health food registration, it will take at least 2 years to get approval while you can have the function claim such as Bone Density Improvement.


Health food ingredient screening

Service introduction

According to this Product’s ingredient screening, it contains Q-10 and it belongs to Blue hat ingredient, so we will preliminarily classify this product into functional health food.

Then we will check the ingredients, the sources, and daily intake levels according to the raw material approved list as well as the food additive approved list for functional health food issued by CFDA.

  1. We will provide you the standard Chinese name for each ingredient
  2. If the ingredient is on CFDA approved general food list, it will be marked by “General food”
  3. If the ingredient is on CFDA approved health food list, it will be marked by “Health food with the daily intake recommendation”
  4. If the ingredient belongs to drugs, it will be marked by “Used in drugs and Replace or delete”
  5. If the ingredient is not on CFDA approved list, it will be marked by “Not found and Need to apply for new raw material”

The screening information includes:

  1. Whether it is approved by CFDA or not
  2. Standard Chinese name
  3. Daily intake level
  4. The approved sources
  5. Substitution for unapproved ingredient

The report we will provide you is as follow:

No. Ingredients Chinese name Daily intake limitation (per day) Comments
1 Coenzyme 辅酶Q10 25 mg Blue hat
2 Gelatin 明胶 Food additive
3 Soybean Oil 大豆油 Food additive
4 Glycerin 甘油 Food additive
5 Chlorophyll 叶绿素 1200-2000 mg Blue hat
6 Titanium Dioxide (Natural Mineral Whitener 二氧化钛 Food additive
Function claim recommendation: Anti-oxidant