CIRS regulatory newsletter – #16 September 2023
This issue brings you the latest chemical, cosmetic, and food regulation news including:
We also highlight our upcoming free webinar series:
Plus our Global Chemical Regulation Conference in London is just a few weeks away, and we’d like to say a big thank you to our sponsors.
You can find out more about the conference below.
Meet the team in person
September
October
November
Chemical news
China's MEE Approves the 11th Batch of Simplified Registrations of New Chemical Substances
China’s Ministry of Ecology and Environment (MEE) approved a total of seven simplified registration applications of new chemical substances after review. To find out more, click the link below.
Japan Released the Schedule for Declaration of New Chemical Substances in 2024
On September 8, 2023, Japan's Ministry of Health, Labor and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), and the Ministry of the Environment (MOE) jointly published a notice on the declaration schedule for the manufacturing and import of new chemical substances in 2024, bringing important information to industries in the chemical sector.
In accordance with laws on chemical substance review and manufacturing, enterprises must make a declaration according to the regulations before manufacturing or importing new chemical substances.
Details regarding the declaration schedule in 2024, the deadline for submission of preliminary review materials, and the declaration date can be found in the article below.
The review of substance properties is divided into two stages: preliminary review and review committee. The preliminary review will open upon the submission of materials. If you plan to make a declaration, please refer to the information on submitting the preliminary review materials to NITE.
Additionally, the schedule for the declaration of new chemical substances in 2025 will be released around September 2024, so enterprises can plan and prepare in advance.
35 Chemicals Added to EU PIC Regulation
On August 25, 2023, the European Commission released the Commission Delegated Regulation (EU) 2023/1656 amending Regulation (EU) No 649/2012. 35 chemicals (27 pesticides and 8 industrial chemicals) were added. Currently, there are 295 entries in the Annex I. You can find out more in the link below.
The Prior Informed Consent (PIC) Regulation governs the trade of certain hazardous chemicals that are banned or severely restricted in the EU. It places obligations on companies that wish to export these chemicals to non-EU countries or import them into the EU.
PIC implements the Rotterdam Convention within the EU. It promotes shared responsibility and cooperation in the international trade of hazardous chemicals. It also protects human health and the environment by providing importing countries with information on how to store, transport, use, and dispose of hazardous chemicals safely. The PIC Regulation has been in force since March 1, 2014.
A big thank you to our sponsors!
With our Global Chemical Regulation Conference in London just a few weeks away, we’d like to say a big thank you to our sponsors Chemsafe Srl , CHEMTREC? , Lisam , and QACS - The Challenge Test Laboratory .
You’ll have the opportunity to meet members of their teams on October 5, and find out more about them and how they could help your business. But in the meantime visit our special sponsors page or click one of the links below and find out how they can help your business.
If you still need a little convincing that this is the event for you then check out the full pdf agenda ??
FREE WEBINAR SERIES: Custom Clearance for Chemicals and the Latest Updates to EU and Asian GHS Regulations
Whether you are new to the world of the Globally Harmonized System (GHS) of Classification and Labeling of Chemicals, and crossover with the customs regulations when importing or exporting chemicals across international borders, or you just want a refresher, then this free webinar series is for you.
Our team will cover the latest updates to GHS regulations in Europe (EU CLP) and Asian Pacific countries, providing you with background and practical tips from our extensive knowledge.
Guest speaker Conor Monaghan , the Global Head of Operations at Customs Complete, will also delve into the world of customs regulations and the crossover with chemical regulations when importing or exporting across international borders.
September 20, 2:00 pm (BST) – The latest updates to EU CLP.
Presented by Dean Winder .
September 25, 2:00 pm (BST) – The crossover between customs and chemical regulation.
Presented by Conor Monaghan .
October 2, 2:00 pm (BST) – Updates to GHS Regulations in Asian Pacific Countries.
Presented by Dean Winder.
领英推荐
If you miss any of the webinars you can listen to them free and on demand after the event here. You can find our full back catalog here.
Food and food contact material (FCM) news
China Officially Released the Function Evaluation Methods for Health Food: Summary of Key Changes
The Technical Specifications for Testing and Evaluation of Health Food (2003 Version) was abolished in July 2018. After five years, on August 31, China’s State Administration for Market Regulation (SAMR) finally published several long-awaited health food documents, including:
The registration of new health food products officially began on August 31. The article below will guide you through the key changes in the above-mentioned documents and summarize the testing requirements for registered health food products.
EU 2023/1442 Comes into Effect
On July 11, the EU published EU 2023/1442 amending Annex I to Regulation (EU) No.10/2011 on plastic materials and articles intended to come into contact with food.
The amendment reduces the specific migration limit (SML) for five substances from a group commonly known as ‘phthalates’. These five substances are:
Find out more about the reduced SMLs in the link below.
The amendment entered into force on August 1. Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, which are first placed on the market before February 1, 2025, can remain on the market until the exhaustion of stocks.
China's Directory of Health Food Functions is Expected to be Expanded
On August 28, the State Administration for Market Regulation (SAMR) issued the Detailed Rules for Technical Evaluation of New Functions and Products of Health Food (Trial) (hereinafter referred to as the Detailed Rules), which take effect on the day of release.
The Detailed Rules serve as the supplementary document of the Administrative Measures on Health Food Raw Materials Directory and Function Directory, providing more comprehensive requirements for the application of health food new functions and products. Enterprises can now refer to the Detailed Rules for a clear understanding of the application processes, dossier, and testing requirements.
This marks a significant shift where health functions will no longer be confined to the current 24 functions outlined in the Directory of Health Functions Available to Be Claimed for Health Food - Non-nutrition Supplements?(2023 Version), and a broader range of new health functions are expected to be included in the Directory of Health Food Functions.
In the article below we summarize the key points of the detailed rules.
DEHCH Added to EU's Authorized Substances List for Food Contact Plastic Materials
On August 11, the European Commission published the Commission Regulation (EU) 2023/1627, amending Annex I to Regulation (EU) No 10/2011 by adding bis(2-ethylhexyl)cyclohexane-1,4-dicarboxylate (FCM No 1079) into the authorized substance list for food contact plastic materials.
Find out more in the link below.
Personal and home care news
Q&As on Ordinary Cosmetics Filing in Guangzhou (Vol. 44)
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.
The article below provides the answers to the following questions:
1. What are the requirements for submitting the "Explanation Document for Cancellation and Re-registration of Ordinary Cosmetics" when re-filing after cancellation？
2. Can cosmetics be sold in blind boxes?
3. What is the difference between product dosage form "aerosol" and "spray"?
4. What is binary packaging aerosol? Do binary packaging aerosols need to be checked for "use of propellants in direct contact with the contents"?
Indonesia Released the Product Information File Guidelines for Cosmetics
On August 2, the Indonesian Food and Drug Administration (Badan Pengawas Obat dan Makanan, BPOM) issued Regulation No. 17 of 2023 on the Product Information File (PIF) guidelines for cosmetics, which came into effect from the date of publication. Parties that obtained product notification codes before August 2, must update PIF within six months.
A PIF must be prepared by cosmetic manufacturers and importers, and submitted to the BPOM before products obtain market authorization.
FREE WEBINAR SERIES: Autumn Global Cosmetic Webinar Series
Our Free Autumn Global Cosmetic Webinar Series, is a comprehensive exploration of the intricate regulatory landscape impacting the cosmetics industry across the EU, the UK, China, and South Korea.
In this illuminating series, we will dissect the key regulatory issues impacting the cosmetics industry and provide invaluable insights for professionals and enthusiasts alike.
The series aims to provide you with a deeper understanding of key aspects, including: Cosmetic Ingredient Management; Animal Testing;?Labeling Claims and Requirements; and?Microplastics.
Join us to gain valuable insights into the cosmetics landscape and make informed decisions in this globalized industry.
All webinars will be presented twice – at 2pm (BST) and 2pm (EST). You can find all the information and register via the link below.
If you miss any of the webinars you can listen to them free and on demand after the event here. You can find our full back catalog here.
Chemical Watch training – Introduction to Cosmetic Management Regulations in China and South?Korea
On November 15, Bryan Zhou , Julie Harrington , and Xiang Li will be providing Chemical Watch news & events by Enhesa members with an overview of the regulations on the management of cosmetics in China and South Korea, including cosmetic ingredients and finished products.
By attending this one-day training course, you will learn:
Find out more via the link below.