CFDA Release Long-awaited “Guidance for Cosmetic Safety Risk Assessment” for Public Consultation

A landmark “Guidance for Cosmetic Safety Risk Assessment” was released for public consultation by the Drug and Cosmetic Division of CFDA on 10 November. The guidance provides for the first time a full and complete technical standard on risk assessment of cosmetics in China. The consultation period (during which public feedback is accepted) will end on the 10^th of December 2015.

The draft version contains nine sections offering a clarification on a number of issues revolving around cosmetic risk assessment, such as risk assessment procedures, toxicological research (including animal testing), ingredient risk assessment, cosmetic product safety evaluation and risk assessment report compilation.

The processes involved in drafting the new risk assessment guidance can be better understood by consulting “Guidance Drafting Instruction. China’s new draft guidance is based on the 11^th edition of EU’s “GUIDANCE FOR THE TESTING OF COSMETIC SUBSTANCES AND THEIR SAFETY EVALUATION” but also takes into consideration the unique requirements of China’s cosmetic industry.

Guidance for Safety Risk Assessment of Cosmetics (Draft)

A major change that will have an influence on compliance requirements and market entry will see risk assessment exemptions granted to to several ingredients, including preservative, sunscreen agents, colorant and hair dyes if already compliant with China’s existing technical standard. Other notable changes include the acceptance of risk assessment results generated by international cosmetic safety assessment institutes or relevant recognized institutes if they meet the Chinese requirements.

A key concept in safety risk assessment—the “exposure level”, is missing in the guidance however CFDA has pledged to address this issue in future. The lack of corresponding Chinese exposure level data means that current risk assessment work will have to resort to data released by recognized international institutes in this field.

The guidance arrives at a time when China is in desperate need of such an inclusive technical reference to aid authorities in counteracting growing cosmetic safety issues and enhance efficiency of market inspection. There have been sporadic initiatives in recent years by CFDA to bolster risk assessment of cosmetics. “Risk Assessment Guidance for Potential Safety Risk Substance in Cosmetics” released in August 2010 and the “Notice regarding Relevant Affairs of Adjusting Cosmetic Application and Record-keeping Management” released in November 2013 were both steps forward in addressing risk assessment requirements but fell sorely short of offering systemic and comprehensive guidance for practical implementation.

Safety risk assessment is regarded as an effective means to evaluate cosmetic safety and more importantly addressing cosmetic safety issues and tailoring regulatory supervision and compliance requirements based on actual market conditions and consumption data.  Risk assessment is a given in Europe and the states and is expected to be emphasized in China’s future regulatory framework through improvements in hazard identification and risk characterization methodologies. 

Reference: CFDA Official News