CIRS regulatory newsletter #19
This will be the final issue of our regulatory newsletter for 2024. We would like to take the opportunity to wish everyone a happy holiday season and wish you a prosperous new year. Thank you for your support this year and we look forward to keeping you up-to-date on all the regulatory developments in 2025!
As ever, for those of you short on time, you can skim the bullet point headlines. Otherwise, we suggest grabbing a cup of something warm and diving into the summaries below ?
Chemical news
Cosmetic news
Food and food contact material (FCM) news
Chemical news
China Implements Strict Export Controls on Dual-Use Items to US to Safeguard National Security
On December 3, 2024, the Ministry of Commerce of China announced that it will strengthen the control on dual-use items exported to the United States to safeguard national security and interests and to fulfill international non-proliferation obligations. The announcement takes effect immediately from the date of publication and could have a great impact on the?semiconductor industry.
Relevant enterprises please note, the following materials exported to the USA will be banned or strictly restricted:
The announcement emphasizes that any organization or individual from any country or region, if found violating the above regulations by transferring or supplying dual-use items originating from the People's Republic of China to organizations or individuals in the USA, will be held legally accountable.
To find out what impact this could have on supply chains, click the link below.
Are You Ready for the Latest Approved GHS Regulation (UA CLP) in Ukraine?
On December 1, 2022, Ukraine adopted the law “on ensuring chemical safety and management of chemical products” which was set to take effect on June 29, 2024. Article 35 and 36 stipulate that the classification and labelling of chemical substances shall conform to the GHS system. This legislation is part of Ukraine’s commitments to integrate with the European standards, aiming to safeguard both the public health and the environment.
Then on May 10, 2024, the Ukrainian government (М?н?стерство захисту довк?лля та природних ресурс?в Укра?ни) adopted the “Technical Regulation for the Classification of Hazards, Labelling and Packaging of Chemical Products” (also known as UA-CLP). This aligns Ukraine with the EU (EU Regulation 1272/2008) and UN GHS. The original name of this regulation is Про затвердження Техн?чного регламенту класиф?кац?? небезпечност?, маркування та пакування х?м?чно? продукц?? (Approval of the Technical Regulation for the classification of hazards, labelling and packaging of chemical products).
The UA CLP came into effect six months after its publication, on November 15, 2024. Products that have been placed on the market before November 15, 2024, even if they do not comply with current technical regulations, can continue to maintain their status until November 14, 2025, which is a one-year transition period.
The following two parts will come into effect on January 1, 2025:
To find out more click the link below.
CIRS will host a free webinar on the Ukrainian chemical regulations on December 18, 2024. Please click here to find out more and register.
European Commission to Withdraw Approval for Ethylene Oxide in Biocidal Products
The European Commission has announced its intention to withdraw approval for the use of ethylene oxide as a surface disinfectant in biocidal products, citing that the chemical's applications do not align with the scope of the Biocidal Products Regulation (BPR). This decision is set to impact the regulatory status of ethylene oxide under the EU's stringent health and environmental standards.
Ethylene oxide is primarily used for sterilizing medical devices before they enter the market. It was previously approved under the BPR in 2020, with the European Chemicals Agency’s (ECHA) Biocidal Products Committee (BPC) acknowledging the substance's effectiveness. However, the BPC also raised concerns about potential risks to workers in sterilization facilities and the general public, given the chemical's classification as carcinogenic, mutagenic, and toxic for reproduction (CMR).
The proposed date for the adoption of this decision is February 2025, with an anticipated entry into force 20 days following its publication in the Official Journal of the EU. Implementation for the affected products is expected to begin 12 months after adoption. Stakeholders and the public are invited to submit their comments on this decision until January 20, as part of a 60-day comment period following the notification to the World Trade Organization (WTO).
To find out more about the background of the decision click the article below.
Global Chemical Regulatory Updates – November 2024
This article compiles the chemical regulation updates for November in Europe, the Americas, and Asia. It covers the following news:
Chemradar Global Chemical Inventory Updates
The Global Chemical Inventory Search (GCIS) developed by CIRS Group supports users in searching the latest updates to global chemical inventories by entering a CAS number or substance name in Chinese or English. It also provides obligation analysis for global chemical compliance.
CIRS continuously monitors changes to global chemical inventories and regularly updates ChemRadar, to try and help users understand more about the compliance obligations of their substances.
Click the article below to find out more about recent updates globally.
The Inventory of Existing Chemical Substances in China – IECSC (2013 and updates)
On November 25, 2024, China's MEE announced the addition of 36 substances to the Inventory of Existing Chemical Substances. Please click here and here to view the detailed information.
The Inventory of Existing Chemical Substances Produced or Imported in China (IECSC) was first published in 2013. Up until November 25, 2024, the Ministry of Ecology and Environment (MEE) has released 26 supplementation notices, with a total of 1,435 substances.
The IECSC is divided into two parts:
The public part is freely accessible, companies only need to make inquiries?to Authorities for the classified/confidential part.
Find the full list of all the updates in the article below.
Thirty-six Substances Added into China’s Inventory of Existing Chemical Substances
On November 25, 2024, China's Ministry of Ecological Environment (MEE) announced the addition of a batch of 36 substances that fulfill the requirements of existing substances into the Inventory of Existing Chemical Substances in China (IECSC).
CIRS warmly reminds you that related enterprises must check whether your substances are existing substances. The Provisions on Environmental Administration of New Chemical Substances (MEE Order 12) require enterprises to complete new substance registration/record before manufacturing or importing, or they may face various punishments.
EU's Revised CLP Regulation Officially Came into Effect on December 10, 2024
On November 20, 2024, the European Union published Commission Regulation 2024/2865 (REGULATION (EU) 2024/2865 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) in its Official Journal, amending the EU CLP Regulation (Regulation (EC) No 1272/2008 on classification, labeling, and packaging of substances and mixtures). The amendment regulation takes effect on December 10, 2024, with most provisions becoming mandatory from July 1, 2026 (18 months), and the remaining provisions applicable from January 1, 2027 (24 months).
Find out more details via the link below.
ECHA's 2025 Blueprint: Spotlight on Regulation of E-Cigarettes and Air Fresheners
On November 26, 2024, the Enforcement Forum of the European Chemicals Agency (ECHA) outlined its 2024-2025 agenda, including
Find out more details via the link below.
Stunning Reversal: EU Axes RoHS Directive's TBBP-A and MCCPs Restriction Proposals
On December 10, 2024, the EU abandoned its plan to restrict Tetrabromobisphenol A (TBBP-A) and medium-chain chlorinated paraffins (MCCPs) under the RoHS Directive.
Timeline of the Proposal
Find out more details via the link below.
Cosmetic news
FAQs from Beijing Cosmetics Review and Inspection Center on Ordinary Cosmetics Filing (Vol. 38)
We have collected the latest FAQs on ordinary cosmetics filing from the Beijing Cosmetics Review and Inspection Center and translated them into English for your reference. This article answers the following questions:
1. Does the "Guidelines for the Use of Cosmetic Ingredients Data" specify a hierarchy of weight among the seven main types of ingredient data?
2. If a product formulation contains a plant extract and the plant is listed in the "China Food Composition", is it sufficient to provide evidence of this listing to exempt the plant extract from systemic toxicity evaluation?
3. When using a complete safety assessment with a 3-year usage history of an ingredient as evidence, how does it differ from Evidence Type 3 in a simplified safety assessment?
4. When conducting compatibility assessments between cosmetics and packaging materials, should cosmetics registrants adhere to the "Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials"?
5. What relevant pharmaceutical and food standards can cosmetic registrants refer to when conducting compatibility assessments between cosmetics and packaging materials?
Cosmetic Sampling Inspection Data and Information Sharing for November 2024
This article compiles data on cosmetic sampling inspections conducted within China and updates related information for November 2024.
It covers cosmetic sampling inspection data and information sharing. Find out more in the link below.
领英推荐
FAQs from Beijing Cosmetics Review and Inspection Center on Ordinary Cosmetics Filing (Vol. 39)
We have collected the latest FAQs on ordinary cosmetics filing from the Beijing Cosmetics Review and Inspection Center and translated them into English for your reference. This article answers the following questions:
1. What is the purpose of the cosmetic preservative challenge test?
2. When conducting a preservative challenge test, is it mandatory for cosmetic registrants to follow the "Technical Guidelines for Preservative Challenge Testing and Assessment of Cosmetics"?
3. Besides the "Technical Guidelines for Preservative Challenge Testing and Assessment of Cosmetics", what other standards and methods can be referenced for cosmetic preservative challenge tests?
4. What role does a neutralizer play in cosmetic preservative challenge tests?
5. How should neutralizers be selected and used in cosmetic preservative challenge tests?
Q&As on Ordinary Cosmetics Filing in Guangzhou
Vol. 67
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. Why does the "Technical Guidelines for Preservative Challenge Testing and Assessment of Cosmetics" recommend using CMCC strains?
2. Can cosmetic registrants and filers choose other methods for preservative challenge test evaluation?
3. If the product uses the four neutralizers from Appendix A.6 to A.9, but validation results show that these neutralizers are still ineffective against certain strains, what methods should be employed to resolve this issue?
4. Can the "Technical Guidelines" include a method for mixed microbial inoculation?
5. What are the evaluation requirements for the preservative challenge test for products with the same preservative system and similar formulations?
Vol. 68
1. What should be considered when setting pH control indicators in cosmetic product standards?
2. What issues should be considered regarding the control indicators for functionality ingredients in the standards implemented for cosmetic products?
3. How to handle the situation when the "Legal Entity Verification Unsuccessful" message appears during the registration of a corporate account on the National Medical Products Administration's government service portal?
4. How to handle the situation when the "Legal Representative Real-Name Verification Unsuccessful" message appears during the registration of a corporate account, or "Real-Name Verification Unsuccessful" during personal account registration on the National Medical Products Administration's government service portal?
5. How to handle the situation when receiving a prompt saying "You have not changed your password for over 90 days" when logging into the National Medical Products Administration's government service portal?
Food and food contact material (FCM) news
Acceptance and Approval Status of "Three New Foods" in China
In China, "Three new food" covers:
China's National Health Commission (NHC) regularly announces the acceptance and approval status of "Three new foods" on its government service platform.
Acceptance Status
In November, applications for three?new food raw materials, four new food-related products and five new food additives have been accepted.
December 4, applications for one new food additives have been accepted.
Approval Status
In November, two non-approval decisions were issued.
December 2 to 8, twenty-four decisions were issued, including:
FAQs| American Dietary Supplement (1) – How Do You Label A Dietary Supplement?
We have collected frequently asked questions on the dietary supplement in the United States for your reference. This article answers the following questions:
Q1. What is a Dietary Supplement?
Q2. What contents should the manufacturers label on their supplement facts?
Q3: Is it necessary to label all ingredients on the supplement facts?
Q4. Are the serving sizes for dietary supplements standardized? Or is there a limit on the amount of a specific dietary ingredient in a serving of a dietary supplement?
Q5. What types of claims can be made on the label of a dietary supplement?
Q6. Why do some dietary supplements have the statement that "This claim has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?
[FSMP] FAQs: Eighteen Questions Related to Formulas for Special Medical Purposes
On December 5, 2024, China's Center for Food Evaluation (CFE) published eighteen frequently asked questions relating to formulas for special medical purposes (FSMP), covering various items including formulas, labels and instructions for use, production process, quality and safety, and clinical trails.
This article provides the answers to the following questions:
Formulas
Question 1: What are the formulation characteristics and technical requirements for thickening components?
Question 2: What are the formulation characteristics and technical requirements for liquid formulations?
Question 3: What are the formulation characteristics and technical requirements for fat components?
Labels and Instructions for Use
Question 1: How should the values for energy, nutrients, and optional ingredients be determined?
Production Process
Question 1: What materials should be provided when producing different varieties of products on the same production line?
Question 2: What materials can the applicants provide to demonstrate that they have established a quality management system that meets the requirements of Good Manufacturing Practices (GMP)?
Quality and Safety
Question 1: How should stability studies be conducted for products that require stability research?
Question 2: Is it possible for a third-party testing agency to provide product testing reports for three batches of products?
Question 3: What are the requirements for the amino acid raw materials used in the product?
Question 4: How should product standards be set for products containing ingredients such as nucleotides?
Clinical Trial
Question 1: What should applicants focus on when submitting clinical trial materials?
Question 2: What are stamping requirements for the clinical trial summary report and sub-center clinical trial summaries?
Question 3: What are the design requirements for clinical trial protocols?
Question 4: How do you apply for clinical trial communication?
Question 5: Does a clinical trial institution for special medical purpose formula foods need to be registered?
Other Questions
Question 1: What additional application materials are required when the net content and specifications change during registration?
Question 2: What additional application materials are required when the product formulation changes during registration?
Question 3: What additional application materials are required when the production process changes during registration?
FAQs on the Replacement of Health Food Registration Certificate in China (Vol. 1)
We have collected frequently asked questions on the change of health food registration in China and translated them into English for your reference.
1. What is the scope of replacement of health food registration certificate ? What is the application category?
2. What is the procedure for handling the “Dual No” health food re-certification application?
3. For products produced by cross-provincial entrusted manufacturing, should the re-certification opinion be issued by the provincial market regulatory department where the applicant is located, or the department where the entrusted manufacturer is located?
4. Should the change of registration application for products be processed separately, or can it be handled together with the re-certification application?
5. How should the transfer of technology for health food be handled?