China Implements New Labeling Requirements for Sunscreens

On June 1 2016 China Food and Drug Administration promulgated and implemented a regulation named “Requirements for Sunscreens Labeling”, revising the labeling requirements relating to SPF and PFA. The most significant change to the new regulation is the permission of marking SPF > 50 and PA ++++ on labels. In the past cosmetics can only be indicated by SPF > 30 and PA +++ even if the actual measured value is higher, which doesn’t align with the international standards. ... Reach24h’s Interpretation: For imported sunscreens, new claims can be marked on over-labels without the need of updating original packaging. The regulation mentioned that “measured SPF = 2~50, indication of the measured value”. It can be expected that SPF 13, 24, 48, etc will appear on labels and SPF value will be different between over-labels and original packaging due to deviation, which may confuse consumers. Manufacturers need to take the corresponding me

Take Home:

The most significant change to the new regulation is the permission of marking SPF > 50 and PA ++++ on labels. In the past cosmetics can only be indicated by SPF > 30 and PA +++ even if the actual measured value is higher, which doesn’t align with the international standards.

Requirements Changes

Related rules were included in the regulation “Guide for Technical Review of Cosmetics”. Now there is an independent document specifying the requirements.

Contents	Past	Now
SPF	Measured SPF < 2, no indication of sun protection effect Measured SPF = 2~30, labelled value can’t be higher than the measured value Measured SPF > 30 & SPF after subtracting standard deviation > 30, indication of SPF 30+	Measured SPF < 2, no indication of sun protection effect Measured SPF = 2~50, indication of the measured value Measured SPF > 50, indication of SPF50+
Sunscreen Water Resistant Performance	Sunscreens claiming “water resistant” shall be marked with measured SPF after bath; if measured SPF before bath is intended to be marked together, the wording “before bath” shall be labeled specially. “Water resistant” can’t be claimed if SPF after bath decreases 50 percent or higher compared to SPF before bath. Products with a name containing wordings “water resistant” or “sweat resistant” can’t bear SPF before bath.	Sunscreens claiming “water resistant” can be marked with both measured SPF after bath and SPF before bath, or only SPF after bath. Only indication of SPF before bath is not permitted. “Water resistant” can’t be claimed if SPF after bath decreases 50 percent or higher compared to SPF before bath or products haven’t been determined by water resistant performance test. Deleted
PFA	Integer of measured PFA < 2, no indication of UVA protection effect Integer of measured PFA = 2~3, indication of PA+ or the integer Integer of measured PFA = 4~7, indication of PA++ or the integer Integer of measured PFA≧8, indication of PA+++ or the integer	Measured PFA < 2, no indication of UVA protection effect Measured PFA = 2~3, indication of PA+ Measured PFA = 4~7, indication of PA++ Measured PFA = 8~15, indication of PA+++ Measured PFA≧16, indication of PA++++

For the determination methods of SPF, sunscreen water resistance performance and PFA, please refer to Safety and Technical Standards for Cosmetics 2015.

Transitional Measures

CFDA proposed the transitional measures to implement the new rules in the meantime.

Starting June 1 2016 manufactures that want to adjust the claims of their existing sunscreens with a license are permitted to apply for modification of license.
The sunscreens approved by CFDA already can use the old packaging before June 30 2017 and can be sold before the expiration date.
Starting December 1 2016, labels of sunscreens applying for license shall comply with this new regulation.

Reach24h’s Interpretation:

For imported sunscreens, new claims can be marked on over-labels without the need of updating original packaging.
The regulation mentioned that “measured SPF = 2~50, indication of the measured value”. It can be expected that SPF 13, 24, 48, etc will appear on labels and SPF value will be different between over-labels and original packaging due to deviation, which may confuse consumers. Manufacturers need to take the corresponding measures in advance.
The new labeling requirements are favorable for manufacturers whose products have higher SPF value. In the past products with higher measured SPF, e.g 46 was no different with 31.
China is far behind as SPF 50+, 70+ or higher has been already accepted in other countries while we can only mark SPF 30+.
The deletion of marking integer of measured PFA may be because few companies adopt this kind of labeling method.