Does your product need Cosmetic Efficacy Claim Evaluation for China entry?

China National Medical Products Administration, NMPA, issued Notice No. 50, namely Standard of Cosmetic Claim Evaluation, providing instructions on accepted scientific way of claim substantiation. Cosmetic products with efficacy claim shall be supported by efficacy evaluation. A summary of efficacy evaluation results shall be made available to the public at online platform specified by NMPA. Here are the highlights on this Standard.

  • Cosmetic notifiers or registrants shall submit a summary of efficacy evaluation at online platform specified by NMPA during notification and registration process.
  • Efficacy evaluation methods must be scientific, reasonable, and feasible to meet the purpose of claim substantiation.
  • Following products are not required to submit summary of efficacy evaluation.
    • Product with visual, olfactory or sensation description, like cleaning, make-up removal, hair dying, hair perming, deodorization etc
    • Products with efficacy delivered through physical action, like physical exfoliation, whitening by physical masking/coverage etc, and with clear indication of its efficacy delivering by physical action on the product label
  • Efficacy of products with claims of whitening, sunscreen, anti-hair loss shall be tested with mandatory test standard in Safety and Technical Standards for Cosmetics.
  • The summary of efficacy evaluation shall include a number of key points,
  • Product basic information
  • Parameters and the testing house of efficacy claim evaluation
  • Evaluation method and its result
  • Conclusion and relevance of test result and product claims.

Product claims

Human efficacy evaluation test

Consumer in-use test

Laboratory Test

Literature or Research Data

Whitening and spot removing1

   

Sunscreen

   

Anti-hair loss

   

Acne-removing

   

Nourishing2

   

Repairing2

   

Anti-wrinkle

Firming

Reliving

Oil control

Exfoliation

Anti-hair breakage

Anti-dandruff

Moisturizing

Hair conditioning

Specific claims (suitable for sensitive skin, tree-free formulation)

  

Specific claims (efficacy of raw material)

Gentle (Non-irritating)

Claims with quantification (period of time, statistic data)

New efficacy

Depending on the product claims statement.

✓denotes ‘mandatory to perform’.

●denotes ‘optional but must have at least one selected’

∆ denotes ‘as a combination with other parameters, but must be combined with either one of human efficacy evaluation test, consumer in-use test or laboratory test’

Remarks:

  1. If this is delivered through physical actions like covering or masking and product label is indicated as such, submission of efficacy evaluation summary is exempted
  2. If the claimed function is applicable to hair only, in-vitro test on real hair is possible.

This standard is implemented since 1st May 2021.

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