An Overview of Sunscreen Regulatory Requirements in China

Reference Regulation

New label standard

The first major update to the regulation is that the SPF value on all sunscreens should be based on empirical measurement using Chinese national standards as the primary reference. To help industry avoid labelling compliance issues caused by experimental error CFDA issued a detailed calculation rule on SPF measurement:

Measured SPF < 2	No indication of sun protection effect.
Measured SPF = 2~5	Indication of the integer measured value.
Measured SPF = 6~50	Indication upper limit is the integer measured value and indication lower limit is a smaller one between Lower 95% Confidence interval Limit of measured value and maximum integral multiple of 5 while less than measured value.
Measured SPF > 50 and the Lower 95% Confidence interval Limit of measured SPF value > 50	Indication of SPF 50+
Measured SPF > 50 and the Lower 95% Confidence interval Limit of measured SPF value ≤ 50	Indication upper limit is SPF 50+, indication lower limit is the Lower 95% Confidence interval Limit of measured value.

Examples:

SPF testing average result (Measured SPF)	95% Confidence interval (hypothesis)	Maximum integral multiple of 5 while less than measured SPF value	Lower 95% Confidence interval Limit of measured value(integer)	Indication SPF upper limit (integer)	Acceptable SPF indication range(integer)	SPF indication in product (choose one of them)
1.87	-	-	-	-	-	No SPF indication
3.11	-	-	-	-	-	3
37.26	34.06-40.46	35	34	36	34-36	34、35、36
29.68	27.01-32.35	25	27	29	25-29	25、26、27、28、29
47.87	45.64-50.10	45	45	47	45-47	45、46、47
56.33	54.18-58.48	55	54	50+	50+	50+
51.06	49.25-52.87	50	49	50+	49-50+	49、50、50+

In terms of PFA, CFDA also revised requirements on labelling, the new regulation states that there is no need to mark the specific PFA measured value but instead the following system can be used:

PFA < 2	No indication of UVA protection effect
PFA = 2~3	Indication of PA+
PFA = 4~7	Indication of PA++
PFA = 8~15	Indication of PA+++
PFA≧16	Indication of PA++++

The new labelling regulation stipulates, that beginning June 1st ,2016 manufactures/importers that want to adjust the claims of their existing sunscreens are permitted to apply for modification by submitting corresponding testing reports. The sunscreens already approved by CFDA can manufacture using old packaging until June 30 2017 and products can be sold until expiration date. Starting December 1 2016, labels of sunscreens applying for a license shall comply with this new regulation.

Stricter market surveillance

During July 2016 to September 2017, CFDA published data on approximately 460 unqualified sunscreen products found during random inspection. Almost 96% of these compliance failures were attributable to nonconformity of actual ingredients and labelling which fall into 3 categories. One is using sunscreen agents in concentrations in excess of labelled values, the second issue is labelled ingredients which cannot be found in the product and the third is use of prohibited ingredients.

Sunscreen products are seasonal cosmetic, purchases increase dramatically from June to September each year, thus CFDA takes measures to increase the frequency and quantity of random inspections.

Another important reason why CFDA put more focus on sunscreen random inspection is the regulation of cosmetic supervision and random inspection was announced in July 31, 2017 "Cosmetic supervision and random inspection technical specifications". Some typical and main inspection points from the draft regulation are highlighted below.

On-site inspection before random sampling:

1. Check whether cosmetic manufacturer production license, business license and product certification are effective and conform to marketed product, mainly verifying enterprise name and address;

2. Check for illegal labels and claims in the outer packaging, including medical or exaggerated claims;

Random sampling:

1. Search for prohibited ingredients, unapproved new cosmetic material or excessive use of restricted ingredients

2. Search for unqualified ingredient, container or packaging material

3. Search for deterioration or contaminated cosmetics.

CFDA is clamping down on manufacture of all non-compliant cosmetics which deviate from Chinese regulations. CFDA will request local FDA to verify unqualified products and supervise relevant manufacturing or agent enterprises to take action such as recalling marketed products. Violators will be subject to both legal and financial sanctions as well as having enterprise information publicized.