The Guideline Principles for Efficacy Claim Verification of Cosmetic Products regulation will respond to the needs of a rapidly changing market

Authorities in China are developing new regulations for efficacy claims – alongside other regulations covering labelling and ethics – which, when passed, will have a broad-ranging impact for domestic and foreign cosmetics manufacturers. The proposed regulations are aimed at standardising the industry and providing a basis on which prosecutions can be brought in order to reduce safety concerns. They also provide a framework for further alignment with international standards, notably those of the European Union (EU).

These Guideline Principles for Efficacy Claim Verification of Cosmetic Products were announced by the National Institutes for Food and Drug Control in November 2015, launching a public consultation period that closed on 31 March 2016. No date for the introduction of regulations has been announced, though an analyst in China told SPC that she expects it to be this year.

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What to expect

The Guideline Principles for Efficacy Claim Verification of Cosmetic Products sets out verification methods including human trials (right through to rules on how to advertise trials to potential candidates) and in vitro tests. They state what types of tests must carried out in what types of laboratory for claims to be made, and even what courses laboratory staff must take (no fewer than ten covering dermatosis and cosmetics science) and the amount of experience staff need.

Certain verification tests can be performed in third-party laboratories, for instance, the company’s own, whereas others have to be done in listed designated laboratories.

Under the system, efficacy claims will be graded from ‘1’ to ‘5’, with ‘1’ attaining clinical research based on large-scale double-blind, randomised control data, through to ‘5’, with claims based only on related literature. Manufacturers and distributors will be responsible for substantiating efficacy claims.

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