New Labelling Requirements of Cosmetics Released in China

On 15 Aug 2016, CFDA released the Reply of the Request on Clearing the Labeling Requirements of Cosmetics Submitted by China Association of Fragrance Flavor and Cosmetic Industries. As we know, on 1 Jun 2016, CFDA released the Notice on the Labeling Requirements for the Efficacy of Sunblock, which requires that the highest SPF value will be adjusted from SPF 30+ to SPF 50+ since the release of this Notice. Additionally, the PA labeling shall be no higher than PA++++. When the actual SPF value ranges from 2 to 50, the actual SPF value shall be labeled. Traditionally, the SPF value labelled shall be the maximum integer multiples of 5 which is lower than actual SPF value for most of sunblock products with high SPF value. Due to the sampling error during measurement and the traditional labelling habits of cosmetic industry, the SPF value of sunscreen products shall be labelled based on the following principles:    

SPF value

Labeling

Example

2≤SPF≤5

Actual testing value

-

6≤SPF≤50

The labelling upper limit is actual testing value, and the lower limit is the lower value between lower limit on 95% confidence interval of actual testing value and the maximum integer multiples of 5 which is lower than actual value.

In case the actual SPF value is 46, and the 95% confidence interval is between 43.6 and 48.5, the SPF value can be labelled as 43, 44, 45 or 46.

SPF> 50 , and the lower limit on 95% confidence interval of actual testing value is higher than 50

The SPF value shall be labelled as “50+”

In case the actual SPF value is 55, and the 95% confidence interval is between 52.1 and 58.9, the SPF value shall be labelled as “SPF 50+”

SPF> 50, and the lower limit on 95% confidence interval of actual testing value is lower than or equivalent to 50

The labelling upper limit is “50+” , and the lower limit on the 95% confidence interval of actual testing value as the labeling lower limit.

In case the actual SPF value is 52, and the 95% confidence interval is between 50.0 and 55.0, the SPF value can be labelled as “SPF 50+” or “50”.

In addition, on the basis of Technical Safety Standard for Cosmetics (2015), a restricted ingredient is not used as preservative in cosmetics, the function of the ingredient shall be indicated on the label.

CIRS Interpretation:

  1. In case 2≤SPF≤5, only actual testing value should be labelled.
  2. In case 6≤SPF≤50, there are multiple options to label the SPF value, and the traditional labelling habit, the maximum integer multiples of 5 which is lower than actual testing value, is maintained.
  3. In case SPF>50, SPF value can be labelled by two methods.
  4. The Technical Safety Standard for Cosmetics (2015) will be implemented on 1 Dec 2016. When the restricted ingredient is not used as preservatives in cosmetics, the function of the restricted ingredient should be indicated on the product label since the Standard takes effect. 

Source

The Reply of the Request on Clearing the Labeling Requirements of Cosmetics Submitted by China Association of Fragrance Flavor and Cosmetic Industries