What is the registration process for new ingredients for cosmetics?

Release time:

2024-05-13 15:26

According to the "Regulations", new cosmetic raw materials with anti-corrosion, sun protection, coloring, hair dyeing, freckle removal and whitening functions can only be used after registration by the drug regulatory authority under the State Council.The registration process of new cosmetic ingredients mainly includes the following steps:

1. Preparation of application materials:

1) The name, address and contact information of the registration applicant, the record holder and the domestic responsible person.

2) New raw material development report, including research and development background, basic information, use information, efficacy basis data, etc.

3) Research data of new raw materials, including preparation process, structure, composition identification and physical and chemical properties, quality control standards, etc.

4) Safety assessment data of new raw materials, including toxicological safety evaluation review, skin allergy test, teratogenic test, etc. In addition, other relevant materials such as production license and sales license of raw materials may be required.

2. Submission of application:

1) After preparing all the application materials, the applicant shall submit the application materials to the drug regulatory department of the State Council (or the NMPA of the State Drug Administration).

2) When submitting the application, you need to pay the registration fee in accordance with the relevant regulations and fill in the relevant information on the application form.

3. Acceptance and review:

1) The drug regulatory department of the State Council accepts the application of the applicant and transfers the application materials to the technical review agency within 3 working days from the date of accepting the application for registration of new raw materials for cosmetics.

2) The technical review institution shall complete the technical review within 90 working days from the date of receipt of the application materials, and submit the review opinions to the drug regulatory department of the State Council.

3. Approval and certification:

1) The drug regulatory department under the State Council shall make a decision within 20 working days from the date of receipt of the review opinions.

2) For those who meet the requirements, they shall be allowed to register and issue a new cosmetic raw material registration certificate; for those who do not meet the requirements, they shall not be registered and explain the reasons in writing.

4. Regulation:

After the registration is successful, the national drug supervision and administration department will supervise the new cosmetic raw materials to ensure that they comply with the relevant cosmetic regulations and standards in China.

It should be noted that different types of new cosmetic ingredients need to follow different regulations and standards during registration and safety assessment. Therefore, before the registration of new cosmetic raw materials, it is recommended to understand the relevant regulations and standards, and consult the opinions and suggestions of professional institutions.

Interpretation! Historical evidence for the safe use of new cosmetic raw materials in China

Why do you need to submit cosmetic raw materials? How to submit cosmetic raw materials?

Interpretation! Historical evidence for the safe use of new cosmetic raw materials in China

Why do you need to submit cosmetic raw materials? How to submit cosmetic raw materials?

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