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NEWS
Korea to Expand Functional Cosmetic Regulatory Scope
Sep 14, 2016
Korea MFDS recently proposed the addition of 8 kinds of products into the functional cosmetic category, including: Hair dye products Decolorizing products Depilatories Hair growth products Hair loss protection products Products reducing dryness of sensitive skin Product preventing acne skin from skin keratinizing and dryness Products improving the stretch marks and skin chapping and protecting damaged skin In future functional cosmetics will include 11 kinds of products in addition to whitening products, sunscreens and anti-wrinkle cosmetics. Among the newly added products, hair growth products were previously regulated as drugs while the rest were previously regulated as quasi drugs. Different categories are subject to different degrees of regulatory strictness in respect of registration requirements and inspection stringency whereby:
South Korea
Pre-market Approval
ANALYSIS
China Children Cosmetics Regulations
Sep 08, 2016
In China Children cosmetics refer to cosmetics produced specifically for children from age 0-12 years old (including infants). The majority of children cosmetics are classified as non-special use cosmetics except for sunscreens which are special use cosmetics. Some functional products such as whitening products, hair dyes are usually not approved as children cosmetics...
Chinese Mainland
Children Cosmetics
Pre-market Approval
Labeling/Claim/Advertising
Testing
NEWS
Updates on Revision of Taiwan Overarching Cosmetic Regulation: Abolishment of Pre-market Approval
Aug 24, 2016
Last year ChemLinked was told that Taiwan is revising the overarching cosmetic regulation Statute for Control of Cosmetic Hygiene. Only limited information related to the revision has thus far been released. Recently ChemLinked attended a meeting hosted by TFDA and obtained some first-hand information. According to the presentation given by TFDA’s official, the Statute will be renamed as Cosmetic Hygiene Law. The guiding principle of the revision is to transfer government responsibility for product safety to manufacturers with the goal of fostering a self-regulating industry and a shift towards post market supervision. All the amendments of the revision are in accordance with this principle. Compared to the previous version the most significant change is the abolishment of pre-market approval. In its place Taiwan will implement a system of
Taiwan, China
Pre-market Approval
NEWS
CFDA Clarifies Cosmetic Registration Dossier Requirements for Dual Listed Ingredients
Aug 18, 2016
Since the release of STSC 2015 many companies have consulted with CFDA on the cosmetic registration application dossier requirements in instances where an ingredient is listed in both the “List of Restricted Ingredients” and the “List of Permitted Preservatives” in the new standard.
Chinese Mainland
Pre-market Approval
Ingredients
NEWS
China Clarifies Sunscreen Labeling Requirements
Aug 17, 2016
CFDA’s announcement on June 1 relating to new sunscreen labeling requirements indicated that when measured SPF is between 2 and 30, products shall be marked with the measured value. The clause on labelling requirements is particularly confusing for both consumers and manufacturers which neglect the possible SPF error measured by the testing institutions. To respond to industry’s concern, on Aug 15th CFDA released a notification to further specify the labeling requirements. According to the notification, products with SPF≥2 are subject to the following rules: Measured SPF =2-5 (including 2 and 5): indication of the actual measured value Measured SPF=6-50 (including 6 and 50): the maximum labeling SPF shall be actual measured value; the minimum labeling SPF shall be the smaller number comparing the lower limit of 95% confidence intervals of the actual measured value with the largest integer (less than the actual measured value) of multiple of 5 Me
Chinese Mainland
Pre-market Approval
Labeling/Claim/Advertising
NEWS
Japan Revises Standards for Quasi Drugs Additives
Aug 10, 2016
Japan PMDA released “Standards for Quasi Drugs Additives 2016”, a revision of the Standards 2015. There are no big changes to the Standards. The contents of IB-0028 non-woven fabric have been deleted. The changes are applicable to future application for marketing approval.
Japan
Pre-market Approval
Ingredients
NEWS
Vietnam Implements Detailed Requirements for Manufacturers
Aug 08, 2016
On July 1 2016 Vietnam implemented detailed requirements relating to personnel management, facility management and quality management for manufacturers, which were stipulated in the Decree No. 93/2016/ND-CP.
Vietnam
Pre-market Approval
ANALYSIS
China Cosmetics Market Entry Walkthrough: CIQ Inspections and Custom Clearance
Aug 05, 2016
After getting approval from CFDA, companies can begin to export cosmetics to China. Before goods reach their destination port and undergo inspection by Chinese Customs, they shall appoint an agent in China to file a record with the provincial Inspection and Quarantine Bureau (CIQ) at the destination port, submitting the certificate/license granted by CFDA simultaneously. When goods arrive, activities such as on-site examination of labels and packaging, sampling inspection and testing will be conducted by CIQ. Qualified products will obtain a CIQ certificate. Customs clearance is also a mandatory requirement...
Chinese Mainland
Pre-market Approval
Entry-exit
ANALYSIS
Whitening products regulatory status in Chinese Mainland, China Taiwan, Korea and Japan
Aug 02, 2016
Whitening products with active whitening ingredients were classified as special use cosmetics since December 2013, which require registration with CFDA. Certain categories of whitening products are defined under Chinese regulations as "products which make people look white by physical covering". Although they are regulated as special-use cosmetics these whitening products (in contrast to whitening products which alter the actual appearance of the skin) are subject to more relaxed registration requirements and shorter duration...
Chinese Mainland
Taiwan, China
South Korea
Japan
Pre-market Approval
Testing
ANALYSIS
A Recurring Question Posed to China Cosmetic Regulatory Affairs Consultants
Jul 25, 2016
Since I have been working with Reach24H Consulting Group I actually have been asked a certain question by foreign cosmetics producers more often than others. "We are thinking about the possibility of releasing our products on the Chinese market, could you please advise which kind of product we should start with?" There is not always an easy answer to this question because we need to know what kind of products the client is intending to release in order to assist the client perfectly...
Chinese Mainland
Pre-market Approval
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