New Labelling Requirements for the Efficacy of Sunblock Available in China

On 1June 2016, China Food and Drug Administration (CFDA) published Notice on the Labelling Requirements for the Efficacy of Sunblock (No. 107/2016). Since the notice was released, CFDA requests enterprises to comply with following requirements:

  • In case the labels of sun protection effect should be adjusted for approved sunblock, cosmetic manufacturers shall submit alteration applications on the basis of Notice No.107/2016.
  • From 1 Dec 2016, the labelling of efficacy of sunblock should comply with the Notice No. 107/2016 when applying for the administrative license of sunblock
  • The old packages of approval sunblock can be used until 30 Jun 2017, and their relevant products are permitted to sell before the end of shelf life.

Comparison between the new and old labelling requirements of sun protection effect

 

Notice on Main Points and Guides of Cosmetic Technical Review

(28, Sep, 2010)

Notice on the Labelling Requirements for the Efficacy of Sunblock

(1, Jun, 2016)

SPF

Labelling SPF value in following ways:

(1) Labelling SPF value of sunblock is not mandatory. 

(2) In case the SPF value is lower than 2, the product cannot claim sun protection.

(3) In case the SPF value is between 2 and 30, it cannot be labelled higher than actual value.。

(4) If the SPF value is higher than 30 when subtracting standard deviation, labelling SPF 30+ as maximum to replace the actual SPF value. If the SPF value is 30 or less than 30 when subtracting standard deviation, labelling SPF 30 as maximum. 

SPF value after shower should be labelled for sunblock claiming waterproof. A remark required in case labelling SPF value before shower as well. If the SPF value after shower is reduced by higher than 50% compared with the SPF value before shower, the product cannot claim waterproof. If the Chinese product name contains the word like “waterproof”, “sweatproof”, the labelling of SPF value before shower is not allowed.

Labelling Sun Protection Factor (SPF) in terms of actual SPF value in the test.

(1) When the SPF value is lower than 2, the product cannot claim sun protection.

(2) When the SPF value ranges from 2 to 50, the actual SPF value shall be labelled;

(3) When the SPF value is higher than 50, labelling SPF 50+ as maximum.

If the performance measurement of waterproof is not conducted or SPF value after shower is reduced by higher than 50% compared with the SPF value before shower, the product cannot claim waterproof.

Except the SPF value before shower, the SPF value after shower or both the SPF value before and after shower can be labelled for sunblock claiming waterproof.

 

UVA

For products claiming UVA protection or broad spectrum sunblock, the critical wavelength as the parameter of anti UVA ability by instrument or PFA value by human body should be performed. If the critical wavelength is not less than 370 nm, broad spectrum can be labelled. Or vice versa.

PFA value test should be performed for sunblock labelling PFA (Ultraviolet A Protection Factor) value or PA+~PA+++.

Labelling PFA value in following ways:

(1) In case the integer part of actual PFA value is lower than 2, UVA protection effect cannot be claimed;

(2) In case the integer part of actual PFA value ranges from 2 to 3 (including 2 and 3), PA+ or integer part of actual PFA value shall be indicated on the package;

(3) In case the integer part of actual PFA value ranges from 4 to 7 (including 4 and 7), PA++ or integer part of actual PFA value shall be indicated;

(4) If the integer part of actual PFA value is higher than 8, PA+++ or integer part of actual PFA value shall be indicated.

In case the Critical Wavelength (CW) of sunblock is not less than 370nm, broad spectrum sunblock can be claimed.

The labelling of long wave ultraviolet A (UVA) shall be based on the actual PFA value. The UVA protection grade “PA” shall be indicated on the label.

(1) When PFA value is lower than 2, the claiming of UVA protection is not allowed;

(2) When PFA value ranges from 2 to 3, labelling as PA+.

(3) When PFA value ranges from 4 to 7, labelling as PA++; when PFA value is between 8 and 15, labelling as PA+++.

(4) When PFA value is 16 or more than 16, labelling as PA++++.

Dossier requirements for alteration of labelling of sun protection effect

When changing the label of sun protection effect, the following materials should be submitted to CFDA:

  1. Alteration application form
  2. Product package design
  3. Testing report of sun protection effect
  4. The copy of testing report is acceptable if using the previous testing report as the alteration proof.
  5. The original testing report shall be submitted when regarding the new testing report of sun protection effect as the alteration proof.

Testing requirements

Tests of SPF, waterproof performance, critical wavelength, PFA of sunblock shall be conducted in terms of testing methods on Technical Safety Standard for Cosmetic (2015). If necessary, these tests can refer to relevant testing methods published by International Standard Organization (ISO).

According to China national standard for the labelling of SPF value released in November 2002, SPF 30+ is regarded as the maximum level while SPF 50+ can be labelled as maximum in EU and US. The new labelling requirements for sun protection effect are geared to international standards. There is no doubt that the new labelling requirements are beneficial to domestic and overseas cosmetic enterprises. It means more sun protection cosmetic with high SPF value will come onto the market.

If you have any question, please contact us at Service@cirs-reach.com


Source:

Notice on Main Points and Guides of Cosmetic Technical Review (No.393/2010)

http://www.sda.gov.cn/WS01/CL0846/54432_4.html

Notice on the Labelling Requirements for the Efficacy of Sunblock (No. 107/2016)

http://www.sfda.gov.cn/WS01/CL0087/154562.html