CIRS Alert on Technical Safety Standards for Cosmetics and New Labelling Requirements of Sunblock
5 August 2016
original article from CIRS
On 1 June 2016,
China Food and Drug Administration (CFDA) published a notice concerning the labelling
requirements for the efficacy of sunblock (No. 107 of 2016) and notice on the implementation
of Technical Safety Standard for Cosmetics (TSSC) (No. 108 of 2016). According
to the two announcements, TSSC and the labelling requirements of sunblock will
both be officially implemented on 1 Dec. 2016. Enterprises may face huge
challenges and uncertainties during the transitional period. Therefore, China
Food and Drug Administration Institute of Executive Development carried out
relevant trainings in which Qi Liubing, Division Chief of Department of Drug
and Cosmetic Registration, CFDA, Liu Baojun, Division Chief of Center for the Food
Supplement Evaluation, CFDA as well as experts from National Institutes for
Food and Drug Control, Shanghai Dermatology Hospital and other institutes gave
their explanations to these two new regulations.
Based on years
of its experience in cosmetics registration and expert analysis given in this
training, CIRS gives the following interpretation to the two regulations.
Safety Standard for Cosmetics (abbreviated as TSSC hereinafter)
Please click here for comparison between the
old and the new regulation.
TSSC amended the list of banned
ingredients, restricted ingredients, allowed substances, limit of hazard
substances, requirements for labelling and others. Enterprises shall adjust
their products according to the new technical requirements and finish relevant
notification or alteration of license.
Products information that shall be
adjusted: Products quality and safety control requirements, package of
products, manufacturing technique, testing report, products safety risk
assessment report and technical requirements of products, etc.
Products manufactured in
accordance with the original Hygienic Standards for Cosmetics do not mean that
these kinds of products are not harmful to human health. As a result, the TSSC
requires cosmetics products to be more scientific and safe.
CFDA has opened formula adjustment
channels for imported cosmetics through which enterprises may directly alter
their products formula. This channel will be closed on 1 December. If
enterprises only need to alter the content of restricted substances and no
other new substances added to the products based on the TSSC before 1 December,
re-testing is not required; or if enterprises need to change the product
formula after 1 December, they shall fulfill the registration as new products.
The formula amending method for domestic non-special cosmetic
is alteration rather than cancellation. Enterprise shall give reasons for
formula amendment through the online notification system, and re-submit amended
product formula, sale package as well as other materials in accordance with
current notification management regulation request
Whether cadmium (Cd) will be added into technical requirements
indicators is based on whether Measures
on Cosmetic Administrative Inspection Management is to be amended.
requirements of sunblock
The maximum SPF value on the label adjusts to 50+; when
SPF<2, product cannot claim sun block; when SPF>50, the SPF shall be
indicated as SPF 50+ on the label; in case SPF ranges from 2 to 50, the actual
value shall be labeled.
In case FPA value is lower than 2, UVA protection mark cannot
be labeled; in case PFA ranges from 2 to 3, PA+ shall be indicated on the
label; if PFA ranges from 4 to 7, PA++ shall be indicated on the label; if PFA
value is between 8 and 15, PA+++ can be labeled; when PFA value is higher than
16, PA++++ is available.
In case the sun protection cosmetic would like to claim
waterproof, it shall meet following requirements: SPF value is reduced by less
than 50% after shower in the waterproof capacity test, and both the SPF values
before and after shower shall be signed on the label or only the SPF value
after shower shall be indicated (only revealing SPF value before shower is not
Enterprises can conduct initial applications or alteration applications
on the basis of notice request since the notice was released. Alternation shall
be completed for approved sun protection cosmetics before 30 June 2017.
In case the mark of sun protection effect is changed,
enterprise shall submit original sun protection effect testing report. If the
sun protection effect test has been re-conducted, the new testing report, the original
testing report and the alteration reason shall be submitted.
Formula adjustment channel for imported products will be closed on
1 December. If product formula adjustment application exceeds the time limit,
enterprise shall apply for administrative approval as new products. Since
Notice No.107/2016 published, CFDA has accepted relevant alteration application
on the labelling of sun protection effect. In order to satisfy the regulation
requirement and promote product market competitiveness, enterprise shall
perform relevant alteration as soon as possible.
If you have any question, please contact us at Service@cirs-reach.com.
1. Notice on the implementation of Technical Safety Standard for Cosmetics (TSSC)
2. Notice concerning the labelling requirements for the efficacy of sunblock