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NEWS
Indonesia Amends Required Documents for Product Information File (PIF)
Aug 15, 2023
The updated Guidelines for Product Information File (PIF) clarifies the standards for documents included in PIF, and amends the documents required in PIF.
Indonesia
Post-market Surveillance
NEWS
New EU Regulation on General Product Safety to Take Effect in 2024
Jun 07, 2023
On May 23, 2023, EU published the new law Regulation (EU) 2023/988 on General Product Safety (GPSR) in its Official Journal, repealing Directive 87/357/EEC and Directive 2001/95/EC. This regulation aims to strengthen the protection of consumers while enhancing the functioning of the internal market. It will be fully enforced in all Member States from December 13, 2024.
Labeling/Claim/Advertising
Post-market Surveillance
Enterprise Obligations
EU
NEWS
Canada Proposes to Require Cosmetics to Be Labeled with Fragrance Allergens
Mar 20, 2023
On Feb. 11, 2023, Health Canada (HC) published the Canada Gazette, Part I, Volume 157, Number 6. According to the Gazette, the Government of Canada plans to amend Cosmetic Regulations, requiring cosmetics to be labeled with fragrance allergens, allowing the disclosure of the full ingredient list of cosmetics sold in small packages on the website, and modifying cosmetic supervision requirements. Stakeholders can mail any suggestions to cosmetics@hc-sc.gc.ca before Apr. 22, 2023.
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Canada
NEWS
New Zealand Consults on the Revised Cosmetic Products Group Standard 2020, a Blanket Ban on PFAS Included
Mar 13, 2023
On March 2, 2023, New Zealand's Environmental Protection Authority (EPA) released a new draft of Cosmetic Products Group Standard 2020 (the Standard) for public consultation. The new draft expands its applicable scope to non-hazardous products containing hazardous ingredients, updates the ingredient lists to align with the latest amendments adopted by EU, modifies labelling requirements, and requires the record keeping of nanomaterial.
Pre-market Approval
Ingredients
Labeling/Claim/Advertising
Post-market Surveillance
Cosmetic Sustainability
New Zealand
NEWS
[Updated] CSAR Subsidiary Regulations: China Implements the Strictest Cosmetic Sampling Testing Regulation
Mar 08, 2023
In September 2020 and June 2022, China National Medical Products Administration (NMPA) issued two drafts of Measures for the Management of Cosmetic Sampling Testing. Finally, on January 12, 2023, NMPA released the finalized Measures, which was implemented on March 1, 2023. The Measures is divided into 8 chapters and 61 articles, providing detailed requirements on the formulation of sampling testing work plan, sampling, testing and result submission, objection and re-testing, verification and disposal of unqualified products, as well as information disclosure. The key points are summarized and analyzed as follows.
Chinese Mainland
Post-market Surveillance
Testing
CSAR
NEWS
[Updated] Philippines to Impose New Requirements on the PIF Audit for Cosmetic Products
Feb 01, 2023
Compared to the Circular No. 2018-001 currently in force, the Updated Guidelines adopts proper classification to present the previously included guidelines in a more clear and logical manner, and provides important supplements to PIF Audit.
Philippines
Post-market Surveillance
NEWS
Breaking! US Passes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) to Overhaul Cosmetics Regulatory Framework
Jan 09, 2023
On December 29, 2022, US President Joe Biden signed the Consolidated Appropriations Act, 2023 into law, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)...
Pre-market Approval
Labeling/Claim/Advertising
Post-market Surveillance
Animal Testing
GMP
US
MoCRA
NEWS
China NMPA Issues a New Cosmetics Supplementary Testing Method: Five Imidazoline Drugs Involved
Dec 25, 2022
On December 23, 2022, China NMPA released a new cosmetics supplementary testing method, BJH 202204 Determination of Five Components Including Tetrahydrozoline in Cosmetics, which specifies the qualitative and quantitative determination method...
Chinese Mainland
Post-market Surveillance
Testing
NEWS
China Clarifies Specific Practices of Cosmetic Adverse Reaction Monitoring and Reporting
Dec 06, 2022
On Nov. 25, 2022, the Center for Drug Reevaluation and the National Center for ADR Monitoring of China released the draft of Cosmetic Adverse Reaction Collection and Reporting Guidelines for Cosmetic Registrants and Notifiers (Trial) for public comments. Any suggestions can be mailed lilan@cdr-adr.org.cn before Dec. 9.
Chinese Mainland
Post-market Surveillance
CSAR
Enterprise Obligations
NEWS
Thailand Issues Amendments to the Cosmetic Act B.E. 2558 (2015)
Nov 09, 2022
On October 12, 2022, Thailand published the Cosmetics Act (No. 2) B.E. 2565 (2022) in the Government Gazette (Vol. 139, Chapter 63) to amend the existing Cosmetic Act B.E. 2558 (2015) ...
Thailand
Pre-market Approval
Post-market Surveillance
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[Updated] EU Amends the Use Requirements for 13 Nanomaterials in Cosmetics
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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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