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NEWS
CFDA's Explanations to Formula Modification Requirements during the Transitional Period of STSC
Jul 08, 2016
CFDA’s notification relating to transitional measures for implementing Safety and Technical Standards for Cosmetics on June 1 stipulated that if there is a change of formula for domestic special use cosmetics and all imported cosmetics approved already, modification application form, revised formula, description and diagram of the production process, packaging design and safety assessment report (for risk-concern substance) shall be submitted before Dec 1st 2016. After a technical review, CFDA will renew the license (keeping the previous license number) for qualified products. Unqualified products will require submission of safety-related documents. During a CFDA internal training course, Qi Liubin Director of Cosmetic Registration Department explained that the safety-related documents include testing reports. Therefore, it is unnecessary for companies to submit testing reports in the first phase of applying modification. Testing reports are only required to supplement provided
Chinese Mainland
Pre-market Approval
Ingredients
Testing
NEWS
Impacts of China’s New Sunscreen Labeling Requirements
Jul 01, 2016
The new sunscreens labeling requirements released by CFDA on June 1 permits the marking of SPF > 50 and PA ++++ on labels. 1 International Companies The new requirements are expected to be favorable for international companies by allowing greater labeling flexibility. As stipulated, starting June 1 2016 manufactures/importers that want to adjust the claims of their existing sunscreens are permitted to apply for modification by submitting corresponding testing reports. Different from other cosmetics, sunscreens enjoy a preferential policy which CFDA can accept UV test reports of SPF value, water resistance and PFA value from overseas labs. As overseas countries/regions such as EU, America and Japan have accepted SPF 50+ and PA++++ for a long time importers have existing qualified testing reports which are acceptable by CFDA. In such case, they can submit their applications immediately and change th...
Chinese Mainland
Pre-market Approval
Labeling/Claim/Advertising
Testing
NEWS
Taiwan officially Bans Antihistamine in Cosmetics
Jul 01, 2016
On June 30 Taiwan announced to ban the production and import of cosmetics containing antihistamine. Sales, supply and display of the cosmetics will be prohibited starting Jan 1 2017. Related license holders are required to apply for ingredient modification or cancellation of license before Jan 1 2017. Otherwise, their licenses will be annulled.
Taiwan, China
Pre-market Approval
Ingredients
NEWS
Malaysia NPCB Regulates Manufacturing of Insect Repelling Products
Jun 24, 2016
Considering the huge demand NPCB made an exception that if the active ingredients of a product manufactured are listed in the Drug Registration Guidance Document (DRGD) those products are considered as cosmetics which are subject to cosmetic manufacturing regulations and the applications are acceptable to NPCB.
Malaysia
Pre-market Approval
NEWS
Japan Amends Standards of Quasi-drug Ingredients 2016
Jun 20, 2016
Last week Japan Ministry of Health, Labour and Welfare solicited public consultation on the amendments to Japanese Standards of Quasi-drug Ingredients 2016. The amendments are mainly related to quasi drugs’ testing methods.
Japan
Testing
NEWS
Japan Permits Tris-Biphenyl Triazine for Use in Cosmetics
Jun 14, 2016
From June 1 2016 Japan Ministry of Health, Labour and Welfare permits cosmetic companies to use Tris-Biphenyl Triazine in cosmetics within specific limitations.
Japan
Ingredients
NEWS
Philippines Adopts New License to Operate Format
Jun 12, 2016
On June 7 Philippines FDA released and adopted a new format of License to Operate (LTO) for establishments. The new mandatory format requirement is a supplement to the Order No. 2016-003 “Guidelines on the Unified Licensing Requirements and Procedures” (See CL news on May 6 2016).
Philippines
Pre-market Approval
NEWS
Interpretation of Transitional Measures regarding Safety and Technical Standards for Cosmetics
Jun 08, 2016
On 1 June 2016 CFDA formally released an announcement specifying the transitional measures for implementing Safety and Technical Standards for Cosmetics. The announcement clarified relevant measures and deadlines for the implementation of the new standard, which are almost the same as reported by a Chemlinked at the end of May (CL news). Formula “For already approved or filed cosmetics, the manufacturers and importers should submit modification applications to CFDA before 1st Dec 2016. Domestic non-special cosmetics only require submission of new formula and packaging while other categories require submission of description and diagram of the production process, safety assessment report (for risk-concern substance) and testing reports together.” However testing reports could be a big problem for manufacturers/importers applying for modification. At present almost all the accredited testing institutions do not conduct related testing according to the new Standard, so the
Chinese Mainland
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Testing
NEWS
ASEAN Ban 3-Benzylidene Camphor and Add 9 Restricted Hair Dyes
Jun 07, 2016
During the 23rd ACC Meeting and its related events, several amendments to ACD technical documents were proposed and passed. Corresponding grace periods for different countries were simultaneously determined based on industry status quos. UV filter 3-Benzylidene camphor will be banned for use in Cosmetics, which are added to the Annex II “List of Substances Which Must Not Form Part of the Composition of Cosmetic Products”. Different implementation grace periods for the ban are: Cambodia, Lao PDR, Malaysia, Myanmar, Singapore until 30th June 2016 Indonesia and Philippines 6-12 months (until Nov 30 2016-May 31 2017) Thailand and Vietnam 12 months (unt...
Indonesia
Malaysia
ASEAN
Philippines
Singapore
Thailand
Vietnam
Ingredients
NEWS
Australia to Ban Sale of Imported Animal Tested Cosmetics
Jun 06, 2016
The Federal Government pledged to phase out the cosmetics cruelty. From July next year the testing of cosmetic ingredients on animals in Australia and the sale of cosmetic products and ingredients that have been tested on animals outside of Australia will be banned.
Australia
Entry-exit
Animal Testing
Testing
Pre
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Stay Current: China’s Cosmetic Safety Assessment Regulatory Landscape
Under the current regulatory framework, cosmetics registrants and notifiers can continue to submit a simplified version of the safety assessment report during the registration or notification process until May 1, 2025. Following this deadline, a full version of the safety assessment will be mandated. To facilitate a smooth transition, China is planning to release a set of technical guidelines.
China’s Safety and Technical Standards for Cosmetics (STSC) and Its Updates
The current cosmetic technical standard STSC 2015 specifies the cosmetics' general safety standards, prohibited/restricted/permitted ingredients and testing methods. It is revised aperiodically in response to changing trade practices in the industry. China is planning to issue a new version of STSC.
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