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.
Technical 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.
Labelling 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 acceptable).
- 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.