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NEWS
MoCRA Updates: US Consults on Electronic Portal and Paper Forms for Cosmetic Facility Registration and Product Listing
Sep 21, 2023
On September 18, 2023, the U.S. Food and Drug Administration (FDA) unveiled its newly developed draft electronic submission portal (Cosmetics Direct), Paper Form FDA 5066-Registration of Cosmetic Product Facility and Paper Form FDA 5067-Cosmetic Product Listing for public consultation. The period for public consultation will last until October 18, 2023.
Pre-market Approval
US
MoCRA
NEWS
[Updated] China Implements Technical Guidelines for Filling in and Submitting Cosmetic Formula
Sep 05, 2023
On May 4, 2023, China National Institutes for Food and Drug Control (NIFDC) released the draft Technical Guidelines for Filling in and Submitting Cosmetic Formula (Guidelines) for public consultation. After a period of four months, the finalized Guidelines was released and implemented by NIFDC.
Chinese Mainland
Pre-market Approval
Ingredients
CSAR
Enterprise Obligations
NEWS
[Updated] China Finalizes Technical Guidance on Ingredient Safety Information Filling and Submission
Sep 04, 2023
On May 4, 2023, China National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on the Technical Guidelines for Filling in and Submitting Safety Information of Cosmetic Ingredients. Consisting of 11 parts, the Guidelines specifies cosmetic registrants’ and notifiers’ responsibility for ingredient quality and safety, refines the requirements for filling in and submitting ingredient safety information, as well as gives instructions on handling changes to ingredient safety information.
Chinese Mainland
Pre-market Approval
NEWS
[Updated] China Implements Guidelines for Submitting Information through the Cosmetic Ingredient Safety Information Submission Platform
Sep 04, 2023
On September 4, 2023, China National Institutes for Food and Drug Control (NIFDC) approved the Guidelines for Submitting Information through the Cosmetic Ingredient Safety Information Submission...
Chinese Mainland
Pre-market Approval
Ingredients
CSAR
Enterprise Obligations
NEWS
MoCRA Updates: How to Conduct Cosmetic Product Listing in the U.S.?
Aug 11, 2023
On August 7, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on cosmetic facility registrations and product listings (draft guidance)...
Pre-market Approval
US
MoCRA
NEWS
MoCRA Updates: How to Conduct Cosmetic Product Facility Registration in the U.S.?
Aug 11, 2023
In a significant move on August 7, 2023, the U.S. Food and Drug Administration (FDA) unveiled a draft guidance on cosmetic facility registrations and product listings (draft guidance)...
Pre-market Approval
US
MoCRA
NEWS
MoCRA Updates: US FDA Unveils the Draft Guidance for Cosmetic Facility Registration and Product Listing
Aug 11, 2023
On August 7, 2023, the U.S. Food and Drug Administration released a draft guidance on cosmetic facility registration and product listing (draft guidance), which explained in detail the two mandatory enterprises obligations from the...
Pre-market Approval
US
MoCRA
NEWS
Philippines Launches a New Round of Consultation on Amended Requirements for LTO Application
Jun 12, 2023
On June 5, 2023, Philippines Food and Drug Administration (FDA) released a new draft of Updated Guidelines on the Application for License to Operate of Health Product Establishments with the Food and Drug Administration (the Updated Guidelines). Compared with two previous drafts, the newly released amendment introduces stricter guidelines for initial, renewal and variation applications for the LTO, detailing the circumstances under which the LTO may be cancelled, and strengthens the requirements for the Qualified Person.
Philippines
Pre-market Approval
Enterprise Obligations
NEWS
China NIFDC Clarifies Detailed Registration Requirements for Special Cosmetics and New Cosmetic Ingredients
Jun 06, 2023
On June 5, 2023, China National Institutes for Food and Drug Control (NIFDC) released nine guidelines pertaining to the registration of Chinese domestic and imported special cosmetics, as well as high-risk new cosmetic ingredients (NCIs). These guidelines provide clear details and time limits for the first registration, registration change, registration renewal and registration cancellation applications, which are highly informative for enterprises seeking guidance.
Chinese Mainland
Pre-market Approval
CSAR
New Ingredient Management
Enterprise Obligations
NEWS
India Proposes Amendments to Cosmetics Rules 2020
Jun 05, 2023
On May 17, 2023, the Ministry of Health and Family Welfare of India initiated a public consultation on proposed amendments to the Cosmetics Rules 2020, with the goal of...
India
Pre-market Approval
Labeling/Claim/Advertising
Entry-exit
Testing
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[Updated] EU Amends the Use Requirements for 13 Nanomaterials in Cosmetics
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[Updated] EU Adopts 11 Changes to the Use Requirements for Cosmetic Ingredients
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China May Provide Six-month Transition Period for Submission of Cosmetic Safety Assessment Report (Full Version)
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Monthly Recap: Global Cosmetic Regulatory Updates | February 2024
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China Consults on Guidelines for Submission of Cosmetic Safety Assessment Dossiers: Exemptions for Two Types of Cosmetics from Safety Assessment Report Submission
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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.
Cannabis Cosmetics Regulatory Updates in the Asia Pacific Region
Cannabis cosmetics are undoubtedly one of the hottest products across the globe in recent years, but with few regulations. To assist cosmetics companies to avoid compliance risks and seize market opportunity, ChemLinked has compiled the regulations.
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