CIRS Regulatory Newsletter # 5 April 2024
This issue brings you the latest chemical, cosmetic and food regulation news, including:
We are also thrilled to announce that CIRS Group Korea has been elected as the executing agency for:
Plus, we will be hosting two free webinars in April, they are:
Chemical news
Japan Updates GHS Classification List
On February 21, 2024, the National Institute of Technology and Evaluation (NITE) in Japan updated the classification list under the hazard general knowledge of chemicals based on the GHS - Labelling and Safety Data Sheet (SDS). Seven substances are involved in the update. Currently, there are 3,327 substances on the list.
Find out more details via the link below.
China Solicits Feedback on GB 30000.1 Classification and Labelling of Chemicals—Part 1: General Specifications (Draft)
On March 12, 2024, China's Ministry of Industry and Information Technology released the draft of the GB 30000.1 Rules for the Classification and Labelling of Chemicals—Part 1: General Specifications for approval. Comments are welcomed before April 12, 2024.
The draft?aligns with?UN GHS Rev. 8?and is set to replace the General Rules for Classification and Hazard Communication of Chemicals (GB 13690-2009).
The standard covers the following parts, including:
In terms of labeling requirements on transport packaging, the UN TDG shall prevail.
Find out more details via the links below.
Chlorpyrifos to Enter Risk Management Evaluation Phase under POPs Regulation
On March 13, 2024, the Persistent Organic Pollutants Review Committee (POPRC) under the European Chemicals Agency (ECHA) initiated a risk management evaluation and public consultation for chlorpyrifos, scientifically known as O, O-diethyl O-(3,5,6-trichloro-2-pyridyl) phosphorothioate. The committee proposed to list chlorpyrifos in Annex A/B of the Persistent Organic Pollutants (POPs) Regulation, with the public consultation period set to conclude on August 5, 2024.
Chlorpyrifos is recognized for its effectiveness as a broad-spectrum organophosphate insecticide, finding widespread use across agriculture, veterinary medicine, and industry. However, its environmental persistence, coupled with its tendency to accumulate in water, soil, and biota, and its capacity for biomagnification through the food chain, poses a significant risk to human health.
Find out more details via the link below.
PCN Inspection to Begin in Early 2025
ECHA's Enforcement Forum will initiate a project to check if suppliers have notified hazardous chemical mixtures to the poison centres from January 2025. The inspections will last for six months, with the final report expected to be published at the end of 2025. Inspectors will check that poison center notifications have been submitted and the accuracy of labels and Safety Data Sheets (SDS) for mixtures.
Find out more details via the link below.
US EPA Bans All Ongoing Uses of Chrysotile Asbestos
On March 18, 2024, the U.S. Environmental Protection Agency (EPA) announced that it has finished the risk management rule under the updated existing chemical review process in Toxic Substances Control Act (TSCA), banning the manufacture, import, processing, distribution and use of chrysotile asbestos in: diaphragms in the chlor-alkali industry; sheet gaskets in chemical production; brake blocks in the oil industry; aftermarket automotive brakes and linings; other vehicle friction products; and other gaskets, etc.
Find out more details via the link below.
CIRS Group Korea Selected as the Executing Agency for KCMA's 2024 Chemical Act and Product Act Small and Medium Business Support Project
On February 29, 2024, CIRS Group Korea was re-selected as the executing agency for the 『2024 Chemical Act and Product Act Small Business Support Project』 of the Korea Chemical Management Association (KCMA).
About?CIRS?Korea
Established in November 2018,?CIRS Group Korea is considered an important milestone of CIRS?Group's global strategy. It devotes itself to providing global chemical regulation consultancy services, especially K-REACH compliance and product safety regulation consultancy services in South Korea. After four years of development,?CIRS?South Korea has become one of the top regulatory compliance consulting companies in South Korea, which, in return, further expands the businesses of?CIRS?Group in South Korea, and helps enhance the?CIRS?Group's global market appeal.
Find out more details via the link below.
Personal and home care news
European Union Revised List of Prohibited and Restricted Substances in Cosmetics
On March 14, 2024, the European Union revised the list of prohibited substances (Appendix II) and restricted substances (Appendix III) for cosmetics in the EU Cosmetics Regulation (EC) No 1223/2009. This revision is mainly aimed at the use of some nanomaterials in cosmetics and setting the limit of hydroxyapatite (nano).
Find out more details via the link below.
Q&As on Ordinary Cosmetics Filing in Guangzhou (Vol. 55)
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.
Find out more details via the link below.
SCCS Issued Final Opinion on the Safety of Hydroxypropyl p-phenylenediamine and its dihydrochloride salt (A165)
On March 5, 2023, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued a final opinion on Hydroxypropyl p-phenylenediamine and its dihydrochloride salt (A165)(SCCS/1659/23). The preliminary opinion was released on December 7, 2023.
The SCCS concludes the following:
Find out more details via the link below.
领英推荐
SCCS Issued the Final Opinion on the Safety of Hexyl Salicylate
On March 11, 2024, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued a final opinion on Hexyl Salicylate (SCCS/1658/23). The preliminary opinion was released on November 9, 2023.
The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Hexyl Salicylate for the environment.
Find out more details via the link below.
CIRS Group Korea Selected as the Executing Agency for KCII's 2024 Cosmetic Ingredient Safety Evaluation Research Project
On February 20, 2024, according to the announcement No. 2024-001 by the Korea Cosmetic Industry Institute (KCII),?CIRS?Group Korea, a subsidiary of?CIRS?Group, together with the Risk Management Research Institute Co., Ltd. and Duksung Women's University, was designated as the executing agency for the KCII’s 『2024 Cosmetic Ingredient Safety Evaluation Research Project』 in the name of the Duksung Women's University Industry-Academic Cooperation Foundation.
This research project aims to secure safety and efficacy evaluation data for frequently used raw materials, and to update the "Safety Evaluation Results Database" to ultimately facilitate the creation of Product Information Files (P.I.F) necessary for the overseas export of domestic companies, aligning with international regulatory standards for the safety of cosmetics exports and imports.
Find out more details via the link below.
Food and food contact materials news
Free Webinar: Interpretation of the Latest Regulations regarding Health Food and Requirements for Replacement of Old Certificate
Since 2023, the State Administration for Market Regulation (SAMR) has been rolling out a series of regulations on health food. The long-awaited health food functions catalog, evaluation methods for health food functions, and implementation details for new health food function applications have finally been established, offering hope for revitalizing the long-dormant market. Against the backdrop of current regulations, the change of health food registration certificate process is about to commence.
This webinar aims at introducing the latest regulations regarding health food, to assist businesses in gaining a better understanding of health food regulatory requirements. Major contents cover:
The webinar will be hosted on Tuesday, April 16, 2025, at 14:00 (GMT).
We also prepared a list of our free webinars on food for 2024, click here to check.
Free Webinar: U.S. GRAS Pathway for Food Ingredients
The U.S. is an expansive market for new food ingredients but accessing it takes knowledge about its regulatory requirements. Generally Recognized as Safe (GRAS) substantiation is one common regulatory pathway businesses can choose to ensure their ingredient complies with U.S. standards. We will cover important points that are unique to the U.S. GRAS process and that need to be considered for long-term business success.
Join CIRS for an insightful and comprehensive webinar on Thursday, April 18, 2024 at 9:00 (GMT+8) on how GRAS status can help your company’s ingredients make it to the U.S. marketplace faster.
Contact Ms. Cathy Yu at [email protected] to register.
We also prepared a list of our free webinars on food for 2024, click here to check.
【FSMP】Nutritionally Complete Food for Ages 1-10: Formula Research and Design Recommendations (Part 2)
In our previous article (nutritionally complete food for ages 1-10 formula research and design recommendations Part 1), CIRS Group delves into the energy density, energy supply ratio of three macronutrients, and the impact of the raw materials sources on formula research. In this article, we further analyzed the vitamins, minerals, optional components and other nutritional components in 9 approved nutritionally complete foods for children aged 1-10.
Find out more details via the link below.
CIRS FAQ: Can Different Companies Use the Same Formula to Apply for Heath Food Filing? Vol. 3, 2024
From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on health food to help you gain a clearer understanding of the current requirements in China.
Q1: Do samples for toxicological tests of health food need to be from the same batch as those for hygiene tests?
Q2: Are health food raw materials Ginseng radix et rhizoma, Panacis quinquefolii radix and Ganoderma only applicable for domestic health food filing?
Q3: Can different companies apply for health food filing using the same formula?
Q4: If an unapproved raw material is used in health food, is it mandatory to first apply for a new food raw material before applying for health food?
Q5: Is it mandatory to list the food additives that comply with the carryover principle on product labels as stipulated in GB 2760?
Find out more details via the link below.
CIRS FAQ: Which FSMP are Eligible for Inclusion in the Priority Review and Approval Process? Vol. 4, 2024
From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on foods for special medical purposes (FSMP) to help you gain a clearer understanding of the current requirements in China.
Q1: Is batch testing required for FSMP modules?
Q2: Is on-site inspection required when an overseas production company applies for FSMP?
Q3: Does the applicant for FSMP need to have their own research and development center and production line? Is entrusted production allowed?
Q4: What are the requirements for FSMP production factories?
Q5: Are there any other policy documents besides the Measures concerning the priority review and approval of FSMP?
Find out more details via the link below.
China SAMR Encouraged Food Enterprises to Improve the Labeling of Production Dates and Shelf Lives of Pre-packaged Foods
In response to consumer complaints about difficulties finding, reading, and calculating the production dates and shelf lives of pre-packaged foods, the State Administration for Market Regulation (SAMR), in accordance with the Food Safety Law of the People's Republic of China and relevant standards and regulations, recently issued Announcement on Encouraging Food Enterprises to Improve the Labeling of Production Dates and Shelf Lives of Pre-packaged Foods (hereinafter referred to as the Announcement) to address these concerns.
The Announcement aims to encourage food enterprises to adopt targeted measures to empower consumers with enhanced clarity and transparency in their food choices. Specific provisions include requirements for the location, size, and clarity of production dates and shelf life labeling, sequence of dates, as well as methods for indicating shelf life. Furthermore, food enterprises are encouraged to standardize packaging dates for subdivided foods.
Find out more details via the link below.
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