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NEWS
Cosmetics Traded through CBEC Require Approval from CFDA
Apr 15, 2016
On April 14 2016, China Ministry of Finance released an announcement to explain the note “cosmetics imported for the first time excluded” in the China CBEC Commodities Positive List. The announcement states that in the future cosmetics sold through CBEC shall obtain administrative license or filing certificate based on the rule stipulated by the Regulations concerning the Hygiene Supervision over Cosmetics “cosmetics imported for the first time shall obtain the administrative license granted by the CFDA (filing for non-special use cosmetics)”. The actual meaning of CBEC “positive list” is finally clear. Categories excluded from the list are not permitted to be imported and cosmetics in the list are required to be registered or file a record with the CFDA prior to being imported to China via CBEC. In fact license requirement is not surprising. Last year, CIQs of certain CBEC pilot cities such as Ningbo and Shenzhen have required companies to submit
Chinese Mainland
Entry-exit
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 CBEC Commodities Positive List: More Doubts than Solutions
Apr 11, 2016
Although to some extent the list clears up the confusion on the commodities that are regulated under the new tax it also leaves several doubts in regards to actual implementation and may result in more negative impacts on CBEC companies and third-party platforms.
Chinese Mainland
Entry-exit
NEWS
China Releases Positive List of CBEC Commodities
Apr 08, 2016
On April 8, two days before the implementation of the new tax system for CBEC goods (see CL news on Mar 25), China Ministry of Finance together with 11 other departments including the CFDA published the “List of CBEC Retail Imported Goods” to define the applicable scope of the new tax. Goods on the list shall comply with the new tax requirements while those excluded on it are imported based on general trade tax or personal postal article tax scheme. The list totally includes 1142 commodities, of which there are 20 kinds of cosmetics:
Chinese Mainland
Entry-exit
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
NEWS
Indonesia Releases Guidelines for Control of Cosmetics Advertising
Apr 06, 2016
To protect the public from misleading and disingenuous advertisements, Indonesia BPOM released “Technical Guidelines for the Control of Cosmetics Advertising” to standardize the advertising and to align with the current industry conditions. The guidelines stipulate that the advertisement notification number holder bears full responsibility to monitor and ensure the legality of advertisements. The holder can only advertise cosmetics after obtaining marketing authorization in the form of notification. The holder must ensure that the advertisement fulfils the following 3 requirements: Objective, to provide information in accordance
Indonesia
Labeling/Claim/Advertising
NEWS
China to Introduce Requirements for Cosmetic Efficacy Verification Institutions
Apr 06, 2016
China Food and Drug Administration introduced the concepts of validation of efficacy claims for the first time in the draft “Administrative Measures on Cosmetics Labeling” on Nov 15 2014. The draft stipulated that all products except moisturizing products and hair dyes with efficacy validated by accredited testing institutions can be labeled with relevant validation data. Products without validated efficacy data should be labeled with “efficacy has not been validated”. Although not a mandatory regulatory requirement, efficacy claims are necessary in terms of consumer acceptance of cosmetics. Indicating a specific efficacy claim requires adequate testing and evaluation data to support the claim, making efficacy testing in these instances a mandatory requirement. The draft does however not stipulate which testing facilities are accredited to perform efficacy testing and what conditions efficacy evaluation and validation institutions should conform to. Qi Liubin,
Chinese Mainland
Labeling/Claim/Advertising
Efficacy
Testing
NEWS
Indian National Green Tribunal Seeks Ban on the Use of Microbeads
Apr 06, 2016
The National Green Tribunal is a specialized body to handle environment disputes involving multidisciplinary issues in India. It was established under the National Green Tribunal Act 2010 on Oct. 18th 2010. Recently, the National Green Tribunal issued notices to the ministries of environment, water resources and health, asking for their comments on microbeads found in personal care products.
India
Ingredients
NEWS
Taiwan to Regulate Infant Wet Wipes as Cosmetics from June 1st 2017
Apr 06, 2016
On early April, Taiwan FDA released a notice that they will regulate wet wipes for infants as cosmetics from June 1st 2017. All wet wipes made for infants must obey the specific rules in Statute for Control of Cosmetic Hygiene.
Taiwan, China
Pre-market Approval
Labeling/Claim/Advertising
NEWS
Korea Revises Quasi Drug Evaluation Requirements
Apr 05, 2016
Korea adjusted the existing evaluation requirements for quasi drugs to align with the new quasi drug reevaluation scheme implemented on December 4th 2015. Enlarge the scope of high risk ingredients MFDS newly adds polyhexamethylene guanidine hydrochloride (PHMG), oligo (2-2-ethyoxy) ethoxyethylguanidim chloride (PGH), cetylpyridinum chloride (CPC) -- when concentration above 0.05%, and dipropylisocinchomeronate into the scope of high risk ingredients which can potentially cause cellular damage. Both PHMG and PGH have been discovered as risk factors in the development of lung disease if inhaled. The preparations of inhalation, spray,
South Korea
Pre-market Approval
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