CIRS Regulatory Newsletter - # 8 May 2024
This issue brings you the latest chemical, cosmetic and food regulation news, including:
The sponsorship opportunities for the 2024 Global Chemical Regulation Conference - London are still available! If you'd like to showcase your talent and expertise to 100+ attendees then don't miss out.
Plus, we are also highlighting some of our free webinars throughout the second quarter of 2024:
2024 Global Chemical Regulation Conference in London
Do you want to meet industry experts to understand more about your obligations globally and share your experiences? Then you don't want to miss our 2024 Global Regulatory Conference in London on Thursday, October 17, 2024.
This event brings together brings together manufacturers, distributors and those looking to move into new markets or trying to understand their obligations in the ever-changing landscape to cover a variety topics including UK chemical regulations, EU chemical regulations, China chemical regulations, Korea REACH, biocidal regulatory compliance, global GHS, etc.
Find out more details via the link below.
Sponsorship Opportunities Available!
We still have a few spots left for sponsorship. So come and showcase your expertise and services to over 100 industry professionals at our 2024 Global Chemical Regulation Conference in London! Click here to find out more about your benefits. If you'd like to discuss sponsorship opportunities, please contact us at [email protected].
Chemical news
CIRS to Exhibit at ChemCon Asia 2024 in Bangkok, Thailand
CIRS are delighted to announce that we will be exhibiting at ChemCon Asia 2024 on 3-7 June, 2024. We will be available at our booth throughout the event to answer any regulatory queries you may have about global compliance. Feel free to drop by and say hello. Our team is here to provide the insights and solutions you need to excel in the world of regulatory and product compliance.
Conference Details
Event Link:?https://chemcon.net/
Location: Bangkok, Thailand
Date: 3-7 June, 2024
Find out more details via the link below.
2024 Free Webinar Series on Products Exported to EU Market
Are you new to the chemical industry or do you need a refresher on the existing regulatory requirements in the EU? Throughout the second Quarter of 2024, Lucy Wang from CIRS USA and Lynn He from C&K testing will present a series of webinars on REACH regulations about chemical registration, UK REACH, CLP regulation, article notification, SVHC testing and EU PFAS requirements.
The topic cover:
Find out more details via the link below.
Webinar: Europe & Great Britain: navigating regulatory differences
On May 22, 2024, Telematic and CIRS will jointly host a webinar to introduce the regulatory divergence between Europe and Great Britain.? The webinar is lasting about 90 minutes. There is also a Question & Answer session to allow you to raise any concerns you may have.?
Main contents:
Find out more details via the link below.
South Korea Updates Labeling Standards for Consumer Chemical Products
Recently, the Ministry of Environment (MOE) of South Korea issued Notice No. 2024-213, announcing a proposal to revise the Designation of Consumer Chemical Products Subject to Safety Verification, and Safety and Labeling Standards Thereof and is requesting public comments.
Main contents:
a. Establishes a Misidentification and Confusion Review Committee for Consumer Chemical Products
b. Adds new marking for product changes.
Find out more details via the link below.
Japan Releases Reporting Guidelines for General Chemicals, Priority Assessment Chemicals, and Monitoring Chemicals
Recently, the Ministry of Economy, Trade and Industry (METI) of Japan released reporting guidelines regarding the manufacturing/import quantity for general chemicals, priority assessment chemicals, and monitoring chemicals. It aims to enhance the management of chemicals that pose potential environmental risks. The guidelines require companies that manufacture or import general chemicals, priority assessment chemicals of 1 ton or more, or monitoring chemicals of 1 kilogram or more during the fiscal year 2023 (April 1, 2023 to March 31, 2024), to submit a detailed report to the METI.
According to the Chemical Substances Control Law (CSCL), general chemicals refer to those not categorized into other specific types, usually with relatively minor environmental impacts. Priority assessment chemicals are those that, due to their environmental persistence, bioaccumulativeness, or potential high risk to human health, require priority assessment. Monitoring chemicals require special monitoring due to their environmental persistence and bioaccumulativeness.
Find out more details via the link below.
Taiwan OSHA Revising GHS Classification Standards and Introducing 8th Revision of GHS
Taiwan's?Occupational Safety and Health Administration, Ministry of Labor (OSHA) has revised the GHS classification standards CNS 15030 based on the 8th version of GHS, involving 22 documents covering chemical classification and labeling-General Principles.
Find out more details via the link below.
ECHA to Broaden Scope of Chromium Substances in Restriction List, Including Authorized Compounds
On May 8, 2024, authorized by the European Commission, the European Chemicals Agency (ECHA) expanded its REACH XV restriction proposal to include at least 12 Chromium (VI) compounds, supplementing the initial measures for Chromium trioxide and Chromic acid introduced in September 2023.
The latest proposal has expanded the?Authorisation List?to include chromium substances in entries 16 to 22 and 28 to 31. Additionally, ECHA plans to add unlisted chromium compounds, such as chromic acid (EC No. 233-660-5), to the restriction proposal, due to their potential as substitutes for restricted substances and associated health risks to workers and the public.
Find out more details via the link below.
Personal and home care news
China Released Two Important Official Catalogues as Supporting Documents of Full Version of Safety Assessment Report
Recently, China's National Institutes for Food and Drug Control issued two catalogs, including,
These two catalogs were released to guide the cosmetics industry in enhancing the capability and level of cosmetic safety assessments, and to promote the orderly implementation of cosmetic safety assessment systems.
Find out more details via the link below.
China NIFDC Issued Latest Supporting Files for Full Version of Safety Assessment of Cosmetics
On April 30, 2024, the National Institutes for Food and Drug Control released seven documents and twelve Q&A sessions, all related to cosmetic safety assessment.
These documents are:
1. Guidelines for Submission of Cosmetic Safety Assessment Data
2. Technical Guidelines for Identification and Assessment of Risk Substances in Cosmetics
3. International Authoritative Cosmetic Safety Assessment Data Index and its Q&A
4. Usage Information for Ingredients in Marketed Products and its Q&A
领英推荐
5. Technical Guidelines for the Application of the Threshold of Toxicological Concern (TTC) Method and its Q&A
6. Technical Guidelines for the Application of the Read-Across Method and its Q&A
7. Guidelines for the Use of Cosmetic Ingredient Data and its Q&A.
These publications aim to enhance the safety standards of the cosmetic industry and provide clearer guidance and references for cosmetic companies.
Find out more details via the link below.
Chinese Cosmetic Ingredient Regulatory Database – China CosIng is Updated Again!
We are pleased to announce Chinese Cosmetic Ingredient Regulatory Database (China CosIng) is updated again! This time, we add the catalog of Usage Information for Ingredients in Marketed Products in China CosIng to better help global cosmetic companies and ingredient suppliers comply with cosmetic regulatory requirements in China. The catalog contains 2234 ingredients. The powerful new China CosIng is available in English, Japanese, and Korean.
Find out more details via the link below.
Q&As on Ordinary Cosmetics Filing in Guangzhou (Vol. 56 & 57)
We have collected the latest FAQs on ordinary?cosmetics filing?from the Guangzhou Administration for Market Regulation and translated them into English for your reference.
1.How should safety assessments be conducted for products that are used in combination with two or more doses?
2.What information should be provided when assessing the use of nanomaterials in a formulation?
3.Which ingredients are exempt from systemic toxicity assessment?
4.What are the differences between the safety assessment of children's cosmetics and that of ordinary cosmetics?
5.What are "cosmetic samples"?
6.What are the labeling requirements for "cosmetic samples"?
7.What are the production requirements for "cosmetic samples"?
8.What are the registration and filing requirements for "cosmetic samples"?
9.What are the requirements for the operation of "cosmetic samples"?
......
Find out more details via the links below.
Food and food contact materials news
China SAMR Issues Technical Requirements for Filing of Health Food Raw Materials Ginseng radix et rhizoma, Panacis quinquefolii radix, and Ganoderma
On April 30, 2024, the State Administration for Market Regulation (SAMR) issued Technical Requirements for Filing of Health Food Raw Materials Ginseng radix et rhizoma, Panacis quinquefolii radix, and Ganoderma (hereinafter referred to as the “Technical Requirements”), implementing a filing management system for health food products using these three ingredients as raw materials.
The Technical Requirements specify the available excipients, dosage forms, and processes during product filing, clarifying requirements for product quality and safety indicators such as characteristic components and pollutant indicators, which must comply with relevant national food safety standards in China.
Find out more details via the link below.
China SAMR Issues Revised General Rules for Food Business Licensing Review
To thoroughly implement the current Food Safety Law of the People’s Republic of China, the Administrative Measures on Food Business Licensing and Filing, and to address common concerns regarding food business safety, the State Administration for Market Regulation (SAMR) has recently revised and issued the General Rules for Food Business Licensing Review (hereinafter referred to as the “General Rules”), which will take into effect from the date of issuance.
The General Rules adhere to a problem-oriented approach, insist on source control, optimize the conditions for food business licensing to meet the needs of reform and development, scientifically set the threshold for licensing access, strengthen risk level prevention and control, and promote high-quality industry development with a high level of safety.
Find out more details via the link below.
China SAMR Collects Public Comments on the Procedures for Priority Review and Approval of Registration of Foods For Special Medical Purpose (Draft)
In order to standardize the procedure for the priority review and approval of registration of food for special medical purpose (FSMP), in accordance with the Administrative Measures for the Registration of Foods for Special Medical Purpose, the State Administration for Market Regulation (SAMR) has drafted the Procedures for Priority Review and Approval of Registration of Foods For Special Medical Purpose for public feedback. Comments are welcomed before May 30, 2024.
Find out more details via the link below.
China CFSA Collects Public Comments on 4 New Food Additives
On May 10, 2024, China National Center for Food Safety Risk Assessment (CFSA) issued 4 new food additives for public comments, including 1 new food enzyme, 2 new food nutrition enhancers, and 1 food nutrition enhancer with expanded scope.
Comments are welcomed before June 9, 2024.
Find out more details via the link below.
China CFSA Collects Public Comments on 7 New Food-related Products
On May 9, 2024, China National Center for Food Safety Risk Assessment (CFSA) issued 7 new food-related products for public comments, including 1 new food contact coating, 4 new food contact additives with expanded scope, 1 new food contact resin, and 1 food contact resin with expanded scope.
Comments are welcomed before May 27, 2024.
Find out more details via the link below.
Frequently Asked Questions on FDA Generally Recognized As Safe (GRAS) Certification, Vol. 2
With the development of the food industry, there has been a growing emergence of new technologies and substances in recent years. Meanwhile, there is an increasing demand from food companies to seek new food ingredient compliance, including the GRAS certification in the United States. This article aims to address common questions about the food substance classification under the FDA GRAS, covering topics such as whether the use of a certain substance in human or animal food shall be classified as GRAS, and GRAS application compliance, among others.
Q1: What does GRAS mean and how is it different from NDI?
Q2: If I submit a GRAS notice, how long will it take for me to receive a response from FDA?
Q3: What are the types of response I may receive from FDA when applying for FDA GRAS?
Q4: For food substances already in the marketplace, is GRAS application required if new manufacturing processes are adopted?
Q5: After submitting a GRAS notice, is it necessary to resubmit if the production factory is changed?
......
Find out more details via the link below.
Latest Updates on Clinical Trial Standards for Foods for Special Medical Purposes in China
To standardize the clinical trial process of foods for special medical purposes (FSMP), the State Administration for Market Regulation (SAMR) recently revised and issued the Quality Management Specifications for Clinical Trials of Foods for Special Medical Purposes (the Specification), which aims to ensure the scientific integrity, authenticity, and reliability of data and results, while safeguarding the safety and rights of trial subjects and consumers.
Find out more details via the link below.
China CFE Released Notice on Registration and Application for FSMP Proposed for Priority Review and Approval (Notice No. 2 of 2024)
On May 15, 2024, in accordance with the Administrative Measures for Foods for Special Medical Purposes Registration (Announcement No. 85) issued by the State Administration for Market Regulation (SAMR), the Center for Food Evaluation (CFE) has reviewed the registration applications for FSMP seeking priority review and approval, and is now making public FSMP proposed for this procedure. The public notice period is 5 working days.
Find out more details via the link below.
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