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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
Cosmetic Registration in India Goes Online
Jun 02, 2016
From 6 June 2016 cosmetic registration in India must be submitted online. On 30 May India Central Drug Standard Control Organization (CDACO) announced that from 06 June the registration for cosmetics have to be mandatorily filed online through its e-portal.
India
Pre-market Approval
NEWS
Updates on Ban of Repackaging of Cosmetics
May 27, 2016
The news that repackaging will be no longer be permitted in China has garnered huge attention in the media and many cosmetic companies have taken extra steps to confirm this with local FDAs. Tianjin FDA affirmed the news while Shanghai FDA still permits repackaging under the condition of obtaining related certificates. It is also revealed that the ban was decided during an internal CFDA training course.
Chinese Mainland
Pre-market Approval
NEWS
China Likely to Ban Repackaging of Cosmetics
May 19, 2016
Our sources have reliably informed us that in the near future the sale of repackaged cosmetics will be prohibited by CFDA. In fact it has been revealed by some companies that filing of repacked cosmetics has already been rejected by Beijing FDA. Guangdong FDA has notified companies within its prefecture of the upcoming dramatic change but no specific enforcement rule or transitional measures have been issued. However, in some provinces e.g. Jiangsu, filing is still acceptable. Changes to Regulatory Requirements Industry first became aware of the changes in cosmetic regulatory requirements when companies applied for filing modification of repacked cosmetics. The notification released by the CFDA on Dec 15th 2015 stipulated that since January 1st 2016, Cosmetics manufacturers shall exchange National Industrial Manufacture License and Hygiene License for Cosmetics Manufacturers for one Cosmetics Manufacture License and complete the exchange before January 1st 2017. The new lic
Chinese Mainland
Pre-market Approval
NEWS
Unnotified Chinese-brand Cosmetics Sold Online Sealed by the Philippine FDA
May 18, 2016
Recently, a line of Chinese brand cosmetics sold online are seal by the Philippine FDA for the lack of proper authorization. With unsound regulations and scrutinize, the cosmetic online market may seem a blank area for law implementation. However, online sold cosmetics shall still be aligned to the local regulation. Through its post-marketing surveillance activities, the Philippine FDA found that several online shopping websites are selling or offering for sale a line of unnotified cosmetics of a brand based on the Chinese province of Guangdong. Cosmetics of this brand found in the Philippine market are currently sealed by the FDA Field Regulatory Office (FROO), which is responsible for monitoring the market for the manufacture, importation, exportation, distribution, sale, offer for sale, transportation, promotion and/or advertisement of the abovementioned cosmetic products. Citizens are advised against purchasing and using those cosmetics for safety’s concern. The FDA then a
Philippines
Pre-market Approval
NEWS
Taiwan to Ban Antihistamine in Cosmetics
May 13, 2016
On May 10th "Taiwan Ministry of Health and Welfare" declared that Antihistamine will be prohibited to be used in cosmetics. The detailed measures are as follows: As of the day when the official announcement releases, cosmetics containing the ingredient shall not be manufactured or imported and existing license holders are required to apply for ingredient modification or cancellation of lic...
Taiwan, China
Pre-market Approval
Ingredients
NEWS
Shanghai Pudong to Implement Filing System for First Import Non-special Use Cosmetics
May 10, 2016
The State Council of China released a notice that from May 5 2016 to December 21 2018 it is to adjust 11 administrative approvals in Shanghai Pudong New Area including the adjustment of requirements for non-special use cosmetics imported for the first time. According to Regulations concerning the Hygiene Supervision over Cosmetics, cosmetics imported for the first time are subject to registration with CFDA by submitting a series of documents such as quality control specification, testing reports, free sale certificate, etc.. Under the new administrative requirements Pudong New Area will stop enforcing registration requirements and change to filing management according to the notice. The simplification of the approval process has drawn the attention...
Chinese Mainland
Pre-market Approval
Pudong Filing
NEWS
Philippines to Adopt A New Application System for LTO
May 06, 2016
On May 2 2016, Philippines Food and Drug Administration announced that it is to adopt a new application process and form for License to Operate (LTO) which is navigable and accessible on FDA Electronic Portal (e-portal). The new application system will be on a pilot run from June 1 to 31 August. Mandatory use of the web-based application form shall be strictly implemented starting September 1 2016 with no exemptions. The current Integrated Application Form will be replaced as of the same implementation date. To access the e-portal applicants are required to apply an authorized user account by submitting an Authorization Letter and sending a request to pair@fda.gov.ph. Applicants who want to try the new application form during the pilot run shall refer to the following schedules:
Philippines
Pre-market Approval
NEWS
Zhongshan FDA Use Red and Black List Administrative Method for Cosmetics Companies
Apr 13, 2016
The FDA of Zhongshan City, Guangdong province has implemented “red and black list” administrative methods to ensure the safety of food, drug, medical instruments and cosmetics. How to become a company in the red list? According to the new administrative methods, companies should proactively apply to add their names in the red list which will mean they are designated as a credible manufacturer. Their applications will be reviewed by Zhongshan FDA, and then their names will be added to the red list if they pass the review. Companies with no safety or compliance violations in the last two years that meet the following three requirements will be qualified to be added to the red list. Companies designated as “Class A Companies” or “Standard Companies” with high credit rating by FDA; Companies have been publicly praised by governments or relevant departments at prefectural level; Companies that have been officially issued with a
Chinese Mainland
Pre-market Approval
Post-market Surveillance
NEWS
China to Set New Cosmetic Classification Standard
Apr 08, 2016
The recent development of China’s economy and innovation within the cosmetics industry has meant that China’s Cosmetic Hygiene and Management Regulation, the fundamental regulation on the definition and classification of cosmetics in China is no longer suitable to serve as a foundation for China’s regulatory framework. CFDA believes that the current cosmetic classification standard needs to be optimized and subdivided for risk management and product quality and safety substantiation. Therefore, CFDA organized a study on the classification of cosmetics with the aim of establishing a scientific and reasonable method for cosmetic classification.
Chinese Mainland
Children Cosmetics
Pre-market Approval
Post-market Surveillance
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