CIRS Regulatory Newsletter #11 July 2024
This newsletter brings you the latest chemical cosmetic and food industry news.
For chemicals, this includes updates from the US TSCA inventory and recommended GHS classifications for Japan.
From the cosmetics industry, Chinese authorities have announced the full implementation of the electronic registration and filing for cosmetics and new ingredients, and we provide Q&As on common technical issues for new cosmetic ingredients in China.
In food news, there is an informative article on what claims are permitted on US food labels, details on the implementation of FSMP policies in the Hainan Boao Lecheng Pilot Zone as well as in-depth analysis of application approvals for food products in China in the first half of this year.
And so much more, so grab a drink and dive right in.
Are there any topics that you'd like to see us cover in a webinar or article? Then send an email to our managing editor via [email protected] to let her know and we'll see what we can do.
Chemical News
Over 130 Confidential Chemicals Added to US TSCA Non-Confidential Inventory
On May 29, 2024, the US Environmental Protection Agency (EPA) released the latest version of the Toxic Substances Control Act (TSCA) Inventory, which includes 886,770 chemical substances, of which 42,377 are active chemicals.
This update to the TSCA Inventory includes the addition of more than 130 substances formerly on the confidential list and 29 existing substances.
Find out more in the article below.
Japan Updates GHS Classifications for 160 Chemicals
Recently, Japan's Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MOE) jointly released the latest version of Japan's recommended Globally Harmonized System of Classification and Labelling of Chemicals (GHS) classification list on the National Institute of Technology and Evaluation (NITE) website.
This update is based on the Chemical Substances Control Law (CSCL), the Industrial Safety and Health Act (ISHA), and relevant guidelines, monitoring, and evaluation results from the 2023 fiscal year. It includes 160 substances, with 48 being newly classified and 112 having updated classifications. Japan's recommended GHS classification list is updated annually, with the current fiscal year starting on April 1, 2023, and ending on March 31, 2024. Prior to this, Japanese authorities issued partial updates on February 21, 2024.
Find out more in the article below.
If you want to find GHS classifications or search the substances on US TSCA inventory then you can use our free tool ChemRadar
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Cosmetic news
NMPA Announced Full Implementation of Electronic Registration and Filing for Cosmetics
China's National Medical Products Administration (NMPA) announced the full implementation of the electronic registration and filing for cosmetics and new ingredients.
This comes as part of the NMPA's efforts to further improve government services and promote the digitization of archives for the registration and filing of cosmetics and new cosmetic ingredients (including toothpaste), thereby enhancing the efficiency of the process.?
Starting from September 1, 2024, domestic registrants, filers, domestic responsible persons, and cosmetic manufacturing enterprises are required to submit user information as well as registration and filing documents for cosmetics and new cosmetic ingredients exclusively via the Cosmetic Registration and Filing Information Service Platform (hereinafter referred to as the Information Service Platform) electronically.
Find out more in the article below.
Q&As on Common Technical Issues for New Cosmetic Ingredients in China
Our cosmetics team has collated the latest FAQs on the technical issues for new cosmetic ingredients registration and filing in China and translated them into English for your reference. The article below answers the following questions:
1. How do you Compile the "Research and Development Background" section for a development report?
2. How do you Fill in the "Ingredient Composition" section?
3. How do you Fill in the "Specifications for Use" section?
4. How do you Fill in the "Physical and Chemical Properties/Constants" section?
5. How do you ensure the accuracy of the source of new cosmetic ingredients derived from plants/animals?
Q&As on Ordinary Cosmetics Filing in Guangzhou (Vol. 62)
This FAQ answers the following questions:
SCCS Issued the Final Opinion on the Safety of Silver
On July 3, 2024, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued final opinion on Silver (CAS/EC No. 7440-22-4/231-131-3, SCCS/1665/24). The preliminary opinion was released on March 27, 2023.
Find out more details via the link below.
领英推荐
Food and food contact material (FCM) news
What Claims are Permitted on US Food Labels?
In the US, three categories of claims can be used on food and dietary supplement labels, these include:
In the article below, the CIRS food team introduces the requirements for these three claims in detail.
The Implementation of FSMP Policies in the Hainan Boao Lecheng Pilot Zone
This article provides more detail on the Hainan Boao Lecheng International Medical Tourism Pilot Zone (Lecheng Pilot Zone) in China. The zone was officially established on February 28, 2013, and endowed with nine preferential policies aimed at international medical tourism industries such as licensed medical services, health management, care and rehabilitation, medical aesthetics, and anti-aging.
It aims to gather high-end international and domestic medical tourism services and cutting-edge international medical technology, creating a hub for international medical technology services.
This article provides more detail on the implementation and the privileges bestowed on foods for special medical purposes (FSMP).
Q&As on the Key Points and Considerations in Health Food Development
On July 2, 2024, our food team hosted a free webinar on the key points and considerations in health food development. Because there were so many questions raised during the webinar we collated them and have made a Q&A summary that answers the following questions:
Q1: It is necessary to supplement additional identification research materials for re-registration, what steps should be taken?
Q2: Is stimulant testing still required for the function of losing weight and alleviating physical fatigue according to the latest requirements?
Q3: How do you distinguish the primary and secondary raw materials of health food?
Q4: If multiple new ingredients are used in health food products, is it necessary to apply for new food raw materials first?
Q5: Do two traditional Chinese medicine compound formulations require identification?
Q6: For health food products using Ginseng radix et rhizoma and Ganoderma as single ingredients, how long is the entire filing process?
Q7: Can stability samples be tested internally, or must they be entrusted to someone else?
Q8: Are there specific standards or requirements for packaging materials that come into direct contact with the product?
Q9: Are the physicochemical parameters in the product technical requirements research reports the same as what the entrusted agency refers to as hygiene testing items?
Q10: Can common food and health food be manufactured on the same production line?
Q11: For filing products: 1) Is microbial testing required for warehouse-in inspection of raw and auxiliary materials? 2) Can the manufacturer’s report be used directly for the inspection, or is internal control testing necessary?
China’s CFSA Collects Public Comment on One New Food Raw Material
On July 16, 2024, the China National Center for Food Safety Risk Assessment (CFSA) issued a call for public comment on one new food raw material – Camellia petelotii Culture. Comments are welcome until August 15, 2024. Details can be found below.
Weekly Summary – Updates on the Approval and Review of “Three New Foods”
From June 27-July 2
Weekly Summary - Updates on the Acceptance of “Three New Foods”
From June 20-July 5; and
Longer reads
Analysis of the Application and Approval Status of New Food Raw Materials in the First Half of 2024
As of June 30, 2024,?the National Health Commission (NHC) issued Announcement No. 2 of 2024, approving a total of 23 products, including new food raw materials (novel food), new food additives, and new food-related products (new food contact substances).
Notably, six new food raw materials were approved: Dendrobium protocorm, Meso-zeaxanthin, Pichia kluyveri, Bacillus subtilis DE111, L-alpha-Glycerylphosphorylcholine, and Leuconostoc pseudomesenteroides.
In addition, according to information released by the NHC and the China National Center for Food Safety Risk Assessment (CFSA), in the first half of 2024, applications for 16 new food raw materials were accepted, seven draft announcements were issued for public comment, and one substance was added to the list for termination of review.
In this article, the food team at CIRS Group provides an overview of the acceptance and approval status of new food raw materials in China for the first half of 2024.
Analysis of the Approval and Review Status of New Food Additives in the First Half of 2024
As of the end of June 2024, China's National Health Commission (NHC) has issued one announcement (No. 2 of 2024), approving a total of 23 products as “three new foods” (new food raw material, new food additive, and new food-related product). Among these, there are 12 new food additives, including those with expanded scope of use.
In this article, CIRS Group provides you with a detailed overview of the acceptance and approval status of new food additives in China for the first half of 2024.
Analysis of the Application and Approval of New Food-Related Products in the First Half of 2024
As of the end of June 2024, the National Health Commission (NHC) has issued one announcement (No. 2 of 2024), approving a total of 23 products as “three new foods” (new food raw material, new food additive, and new food-related product). Among these, there are 5 new food-related products, including those with expanded scope of use.
In this article, CIRS Group provides you with a detailed analysis of the acceptance and approval of new food-related products in China for the first half of 2024.