China New Cosmetic Ingredient


Overview


In China, a new cosmetic ingredient is a natural or artificial ingredient that is applied in cosmetic products for the first time in China.

Since 30 June, 2014, the Inventory of Existing Cosmetic Ingredients in China (IECIC) has become the standard for judging new cosmetic ingredients in China, and now the present effective version is IECIC 2015, Ingredients not listed on IECIC (2015) have to be registered before their use in cosmetics. Cosmetic ingredients also need to comply with specific chemical regulations if the ingredients are to be sold in China. Formula compliance is one of the most vital steps before entering the China market.

Administrative department

National Medical Products Administration (NMPA)

Approval System

Registration

Relevant Regulations

• Regulations concerning the Supervision and Administration of Cosmetics

• Rules on administrative approval for cosmetics

• Safety and Technical Standards for Cosmetics 2015

• Inventory of Existing Cosmetic Ingredient in China

• Guidance on registration and safety evaluation for new cosmetic ingredient

Registration Process


Registration Dossier

1. New cosmetic ingredient administrative license application form;

2. Research & Development Report:

3. Basic description and diagram of the production process;

4. The quality and safety control requirements of the ingredients, including specifications, quantitative/qualitative analytical methods, impurities and their control measures;

5. Toxicological safety evaluation material, including:

  • A summary of the evaluation;
  • Toxicological testing data;
  • Safety evaluation data on potential risk substances (i.e., prohibited substances).

6. The Power of Attorney and the Business License of the responsible agent by the overseas applicant;

7. Testing sample verification reports (to demonstrate the consistency or to prove the new ingredient was employed in the actual toxicological tests);

8. Analytical method validation reports (if the analytical method for identification and quality control was developed by the applicant itself, not derived from CFDA-published testing guidelines, the validation should be carried out by three separate CFDA-approved testing institutions);

9. Other supportive documents.

The toxicological safety assessment mainly focuses on identifying prohibited substances or toxic impurities present in cosmetic ingredients.

Our Services


Regulatory consultation

• Registration process

• Registration required documents

• Data gap analysis and customized registration proposal based on specific products

Responsible Agent

• Responsible for oversea manufacture on cosmetic ingredient registration

• Multi-language supporting

Registration and Follow-up

• Review required documents

• Complete registration dossier

• Test monitoring

• Follow-up experts (for review and comments)