CIRS Regulatory Newsletter #14

This newsletter brings you the latest updates from the chemical, cosmetic, food, and food contact material industries.

For those of you that are short on time, we've prepared bullet points of the headlines. For those of you with a bit more time, make yourself a drink and scroll through the summaries ??

Chemical news

• ECHA Updates Fee Structure for Administrative Penalties Affecting SMEs
• Seven Substances Added to the Administration of Precursor Chemicals in China
• EU Extends Chemical Regulations to Embrace DMAC and NEP under REACH Annex XVII
• Ukraine to Enforce REACH Regulations by January 2025
• China Officially Updates GHS General Rules (GB GB 30000.1-2024) in line with GHS 8
• Conference updates
• Global Chemical Inventory Updates

Cosmetic news

• Q&As on Ordinary Cosmetics Filing in Guangzhou (Vol. 65)
• SCCS Issued a Preliminary Opinion on Biphenyl-2-ol and Sodium 2-biphenylolate
• SCCS Issued a Preliminary Opinion on Hair Dye HC Yellow No. 16
• Free Webinar Series: Navigating EU and UK Cosmetic Regulations – CPNP, SCPN, CPSR, and PIF Explained

Food and food contact material (FCM) news

• Compliance Analysis of Hydroxytyrosol in China, Europe, the US, Australia, and New Zealand
• CIRS Group Assists Client in Securing Approval for New Antioxidant Hydroxytyrosol
• China CFSA Collects Public Comment on Four New Food Additives
• Analysis of 19 Approved Preterm/Low Birth Weight Infant Formulas for Special Medical Purposes
• Analysis of 15 Approved Lactose-Free/Low-Lactose Infant Formulas for Special Medical Purposes in China
• Four Substances Added to the List of Substances Traditionally Used as Both Food and TCM in China
• CFSA FAQ: Can Food Extracts and Red Ginseng Be Used as Food Ingredients?
• CFSA FAQ: How Are “Three New Foods” Defined and Regulated?

Chemical news

China Officially Updates GHS General Rules (GB GB 30000.1-2024) in line with GHS 8

Chinese authorities have published an update to the regulations for the classification and hazard communication of chemicals. This document is technically consistent with the United Nations "Globally Harmonized System of Classification and Labelling of Chemicals" (GHS) Eighth revised edition (GHS 8).

The State Administration for Market Regulation and the Standardization Administration of China issued the first part of the GB 30000 series, titled "Specifications for Classification and Labeling of Chemicals Part 1: General Rules" (GB 30000.1-2024) on July 24, 2024.

This standard is set to replace the General Rules for Classification and Hazard Communication of Chemicals" (GB 13690-2009), which generally follows GHS 4 and will come into effect on August 1, 2025.

Find out more about the changes in the link below.

Ukraine to Enforce REACH Regulations by January 2025

On July 23, 2024, the Ukrainian government approved the Ukrainian Technical Regulation on Chemical Safety, modeled after EU REACH. This requires the registration of chemical substances produced or imported over one ton annually. The regulation becomes effective on January 23, 2025, six months after its approval.

The pre-registration deadline, crucial for businesses, is set for January 23, 2026. This process will simplify registration for chemicals already on the Ukrainian market, ensuring ongoing market operations during full registration.

Find out more about all the deadlines and what it will mean for companies in the article below.

ECHA Updates Fee Structure for Administrative Penalties Affecting SMEs

On July 23, 2024, the European Chemicals Agency (ECHA) announced adjustments to administrative fines under the EU REACH Regulation, effective from July 22, 2024. This update aims to increase transparency, ensure fairness in fee structures, and align fees with actual business costs.

ECHA charges fees for specific services under the REACH Regulation. It offers reduced fees for eligible small enterprises to ease their financial burden, while companies unable to verify their eligibility face additional fines.

Original Penalty Standards: SMEs that accurately declare their size during registration are granted fee reductions. However, if an applicant cannot validate their discount eligibility, ECHA will charge a fee equal to the avoided amount due to false information.

Updated Penalty Standards: Companies failing to verify eligibility for reductions face additional penalties. In joint applications, only the highest fee is charged, payable by the principal applicant. If a company corrects a misreported size and verifies this promptly, the penalty is halved.

Additionally, the concept of 'financial benefits' has been expanded to include pre-invoice verification, extending its reach. Administrative penalties remain the same from last year, you can find them and additional information in the link below.

Seven Substances Added to the Administration of Precursor Chemicals in China

On August 5, 2024, China's Ministry of Public Security and five other departments jointly issued a notice regarding the addition of seven substances to the Regulation on the Administration of Precursor Chemicals (henceforth managed as precursor chemicals).

The specific substances are:

• N-phenylpiperidin-4-amine;
• 1-N-Boc-4-(Phenylamino)piperidine;
• Norfentanyl, Cannabidiol;
• BMK glycidic acid and its esters;?
• 3-oxo-2-phenylbutanoic acid and its esters; and
• PMK glycidic acid esters.

In the article below you can find out more about the specific administration measures that will become effective from September 1, 2024.

EU Extends Chemical Regulations to Embrace DMAC and NEP under REACH Annex XVII

The European Commission announced updates to Annex XVII of the REACH Regulation with new restrictions on N,N-dimethylacetamide (DMAC) and N-ethylpyrrolidone (NEP). It submitted Notification G/TBT/N/EU/1079 to the WTO on July 30, 2024. These changes are set to take effect 20 days after publication in the EU Official Journal.

Annex XVII restricts the use of certain hazardous chemicals in the EU market. The inclusion of DMAC and NEP will subject these chemicals to strict regulatory oversight, ensuring that all products containing them, whether produced or sold in the EU, meet stringent safety standards to protect health and the environment.

Find out more about the specific restrictions in the article below.

Global Chemical Inventory Updates

The Global Chemical Inventory Search (GCIS) developed by CIRS Group supports users to search the latest inventory of chemicals globally by entering CAS number or substance name in both Chinese and English. It also provides obligation analysis for global chemical compliance.

CIRS continuously monitors updates to global chemical inventories in real-time, trying to help users to know more details of compliance obligations of their substances.

Updates to the Global Inventories:

→ Australian Inventory of Industrial Chemicals (AIIC)

Three substance added to the Australia Inventory of Industrial Chemicals (AIIC);

Try our free tool via the link below.

Free webinars

Free Webinar Series: What you need to know about product compliance in the EU and UK

???Unlock the secrets to ensuring your products meet the highest safety and quality standards in the EU and UK with our free Product Compliance Webinar Series!

??????This comprehensive series will cover food contact materials, textiles, and electricals, providing you with expert insights and practical knowledge to navigate the complex regulations and testing requirements in these sectors.

??Whether you're a manufacturer, retailer, or compliance professional, this series is tailored to equip you with the tools you need to ensure your products are safe, compliant, and market-ready.

• September 3, at 2pm, EU Food Contact Material (FCM) Regulations and Testing presented by Adam Hembrecht , Register here
• September 10, at 2pm, Electrical and Electronic Equipment Regulations presented by Adam Hembrecht, Register here
• September 17, at 2pm, EU Textiles Compliance & Testing presented by Xiang Li , Register here

Find out more in the pdf below and sign up today!

Free Webinar: The GHS in Asia: an overview in different Countries

On September 11, join Bryan Zhou from CIRS Group Europe and Sara Valenti from Telematic Srl, for a free webinar on the Globally Harmonized System (GHS) in Asia.

We'll cover essential topics such as compliance strategies, safety data sheet (SDS) requirements, and key regulatory updates. This session is ideal for chemical regulatory affairs, compliance, and product safety professionals who need to stay up-to-date on GHS regulations across various Asian markets.

Find out more and register here.

Free webinar: How does Ecovadis improve supply chain sustainability?

Nowadays, corporate sustainability has evolved to become a critical factor in building reputations, financial stability, and customer trust, especially in supply chain sustainability.

EcoVadis provides a unique opportunity to assess and enhance your company's corporate sustainability performance. With the support of Ecovadis, companies can share their sustainability performances with their clients by positively fostering transparency and driving innovation.

During this session, we will also explore the benefits of integrating EcoVadis into your CSR strategy, highlighting the platform's ability to streamline procurement processes, reduce costs, and increase operational efficiencies.

• September 19, 9am, Register here

Or find out more in the link below.

Free webinar: Global PFAS Regulations and Compliance Overview

Per- and Polyfluoroalkyl Substances (PFAS) have emerged as a global concern due to their widespread use and persistent nature in the environment. These chemicals, often referred to as "forever chemicals," are coming under increasing scrutiny by regulatory bodies and environmental organizations worldwide.

Our upcoming free webinar will delve into the complexities of PFAS, focusing on the latest regulatory updates, testing methodologies, and mitigation strategies. Join us to gain a comprehensive understanding of why PFAS have become a focal point in environmental safety and public health discussions globally.

• September 26, at 2.30pm, Register here

Or find out more in the link below.

Conference updates

As our October Conference approaches we'd like to begin highlighting our valued sponsors starting with Telematic Srl , an Italian software company with 40 years of experience in developing solutions related to the regulations that determine classification, labeling, and transport of chemical substances and mixtures.

Cosmetic news

SCCS Issued a Preliminary Opinion on Biphenyl-2-ol and Sodium 2-biphenylolate

On August 1, 2024, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued the preliminary opinion (SCCS/1669/24) on Biphenyl-2-ol and Sodium 2-biphenylolate (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6). The deadline for comments is set for September 27, 2024.

Find out more about the opinion in the link below.

Q&As on Ordinary Cosmetics Filing in Guangzhou (Vol. 65)

This article covers the latest FAQs on ordinary?cosmetics filing from the Guangzhou Administration for Market Regulation (translated them into English for your reference).

It answers the following questions:

1. When conducting compatibility studies for cosmetic products, is it still necessary to perform a "one product, one study" approach for products with similar formulation systems?

2. Can the registration or filing application be submitted only after the completion of long-term testing?

3. How should the duration and time points for influence factor tests, accelerated tests, and long-term tests be set?

4. What are the stability evaluation requirements for cosmetic products with similar formulations and identical packaging materials?

SCCS Issued a Preliminary Opinion on Hair Dye HC Yellow No. 16

On August 1, 2024, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued the preliminary opinion (SCCS/1670/24) on hair dye HC Yellow No. 16 (Colipa No. B123) (CAS No. 1184721-10-5). The deadline for comments is set for September 27, 2024.

Find out more about the opinion in the link below.

Free Webinar Series: Navigating EU and UK Cosmetic Regulations – CPNP, SCPN, CPSR, and PIF Explained

?Introduction

Are you navigating the complex world of cosmetic product regulations in the EU and UK? Join our upcoming free four-part webinar series designed to guide you through every step of the process, from product notification to compliance maintenance.

Each session will break down the critical aspects of regulatory requirements, including how to successfully submit product notifications through the CPNP and SCPN portals, create a compliant Cosmetic Product Safety Report (CPSR), and organize your Product Information File (PIF) to meet EU and UK standards.

Whether you're new to the regulatory landscape or looking to refine your approach, this series will provide actionable insights, expert advice, and practical solutions to ensure your products meet all necessary guidelines.

Don't miss out on this opportunity to enhance your regulatory knowledge and ensure your cosmetic products are compliant and ready for market success. Register now and stay ahead of evolving regulations!

• September 11 – Notification process for the Cosmetic Product Notification Portal (CPNP) Register here
• September 18 – Notification process for the Submission of Cosmetic Products Notification (SCPN) Register here
• September 25 – Content of a Cosmetic Product Safety Report (CPSR) Register here
• October 2 – Content of a Product Information File (PIF) Register here

Food and food contact material (FCM) news

Compliance Analysis of Hydroxytyrosol in China, Europe, the US, Australia, and New Zealand

Hydroxytyrosol is a naturally occurring polyphenol primarily found in olives and their products, such as olive oil and olive leaves. It is widely studied for its outstanding antioxidant properties and has numerous applications in the food and cosmetic industries. As a powerful antioxidant, hydroxytyrosol helps reduce oxidation in foods, extending shelf life and preserving flavor. Due to its health benefits, hydroxytyrosol is often added to health foods to support cardiovascular health, boost immunity, and reduce inflammation.

This article analyzes the regulatory status of hydroxytyrosol in China, Europe, the United States, Australia, and New Zealand from a food industry perspective.

CIRS Group Assists Client in Securing Approval for New Antioxidant Hydroxytyrosol

On August 5, 2024, China’s National Health Commission (NHC) issued Announcement No. 3 of 2024, officially approving eight “three new foods.” Among them is hydroxytyrosol, a new food additive for which CIRS Group assisted a client in the synthetic biology field in securing approval. [see the article above for more information on how it is regulated globally]

This article highlights how our food team can effectively assist you.

China CFSA Collects Public Comment on Four New Food Additives

On August 14, 2024, the China National Center for Food Safety Risk Assessment (CFSA) issued a call for public comment on four new food additives: one new food additive, one new food nutrition enhancer, and two food additives with expanded scope.

Comments are welcome until September 14, 2024. The details are as follows:

• New food additive – Butylated hydroxytoluene (BHT);
• New food nutrition enhancer – 2’-fucosyllactose, 2’-FL;
• Food additives with expanded scope (two types) – Curdlan; and Enzymatically produced steviol glycosides.

Find out more about them in the link below.

Analysis of 19 Approved Preterm/Low Birth Weight Infant Formulas for Special Medical Purposes

As of now, China has officially approved 19 preterm/low birth weight infant formulas for special medical purposes. The article below was prepared by our food team. It provides a detailed analysis of the energy density, macronutrient energy supply ratio, and ingredient sources of these products.

Analysis of 15 Approved Lactose-Free/Low-Lactose Infant Formulas for Special Medical Purposes in China

As of now, China has officially approved 15 lactose-free/low-lactose infant formulas for special medical purposes. These are designed for infants aged 0 to 12 months with lactose intolerance.

The 15 products consist of 12 domestic formulas and three imported ones from 14 companies. Among these, Wissun International has had two formulas approved, while the other 13 companies each have had one. All 15 products are in powdered form. Notably, only one low-lactose formula for special medical purposes has been approved, which is Neng Dun by Wissun International.

Find out more about the formula characteristics in the article below.

Four Substances Added to the List of Substances Traditionally Used as Both Food and TCM in China

China’s National Health Commission (NHC) and the State Administration for Market Regulation (SAMR) jointly issued an announcement adding four substances to the list of substances traditionally used as both food and traditional Chinese medicine (TCM). Announcement No. 4 of 2024, was issued on August 26, 2024, the four substances are:

• Rehmannia glutinosa Libosch;
• Ophiopogon japonicus (L.f) Ker-Gawl;
• Asparagus cochinchinensis (Lour.) Merr; and
• Citri grandis exocarpium.

Find out more about the substances and their safety limits in the link below.

CFSA FAQ: Can Food Extracts and Red Ginseng Be Used as Food Ingredients?

On August 26, 2024, China’s National Center for Food Safety Risk Assessment (CFSA) issued a set of FAQs on “three new foods” and substances traditionally used as both food and traditional Chinese medicine (TCM), covering a total of 25 questions.

In this article, CIRS Group summarizes the key issues regarding the use of various food ingredients, including food extracts, red ginseng, Ganoderma spore powder, and protein hydrolysates, that are of concern to businesses.

It provides the answers to the following questions:

Q1: Can food extracts be used as food ingredients?

Q2: Is it necessary to strictly follow the “properties” of the approved new food raw material described in the announcement?

Q3: Can protein hydrolysates be used as food ingredients?

Q4: Can red ginseng be used as a food ingredient?

Q5: Can lotus rhizome node and Chinese waxgourd peel be used as ordinary food ingredients?

Q6: Can ganoderma lucidum spore, ganoderma lucidum spore powder, and broken ganoderma lucidum spore powder be used as food ingredients?

Q7: How is Imperatae Rhizoma defined in the directory of substances traditionally used as both food and TCM? Can it be labeled as Cogongrass Rhizomeon product labels?

CFSA FAQ: How Are “Three New Foods” Defined and Regulated?

Recently, China’s National Center for Food Safety Risk Assessment (CFSA) issued a set of FAQs on “three new foods” and substances traditionally used as both food and traditional Chinese medicine (TCM), covering a total of 25 questions.

In this article, we answer the following questions:

Q1: What are “three new foods,” and how are they regulated in China?

Q2: What is the relationship between the “three new foods” announcements and food safety standards?

Q3: How are new food raw materials and substances traditionally used as both food and TCM defined and regulated?

Q4: What are the approved substances traditionally used as both food and TCM?

Find out more in the link below.