CIRS Regulatory Newsletter #7 April 30, 2024
This issue brings you the latest chemical, cosmetic and food regulation news, including:
Plus, we are also highlighting some of our free webinars throughout the second quarter of 2024:
Chemical News
2024 Free Webinar Series on Products Exported to EU Market
Are you new to the chemical industry or do you need a refresher on the existing regulatory requirements in the EU? Throughout the second Quarter of 2024, Lucy Wang from CIRS USA and Lynn He from C&K testing will present a series of webinars on REACH regulations about chemical registration, UK REACH, CLP regulation, article notification, SVHC testing and EU PFAS requirements.
The topic cover:
Find out more details via the link below.
Ukraine REACH Expected to Come into Force in June, Enterprises Facing Registration Challenges
The Ministry of Environment Protection and Natural Resources of Ukraine has issued the Ukraine REACH Resolution - "On the Approval of Technical Regulations on the Safety of Chemicals" and is open for comments as of March 22, 2024.
The Ukraine REACH draft, identical to the one submitted to the World Trade Organization in 2023, establishes the Ukrainian chemical legislative framework and aims to align Ukraine's chemical safety regulations with EU standards. Foreign companies that are importers, manufacturers, or represented by a local sole representative, companies that sell chemicals (substances/mixtures) on the Ukrainian market, as well as downstream users of these chemicals will be affected by Ukraine REACH.
The Ukraine REACH draft is accompanied by a draft decree detailing the implementation of the regulation, setting a deadline for the registration of substances:
Find out more details via the link below.
South Korea Released a List of New and Existing Substances Support Programs Under K-REACH
To promote K-REACH registration and alleviate the pressure on registering companies, the South Korean government has introduced a series of government support programs. On April 11, 2024, the Korea Chemicals Management Association (KCMA) published three lists of substances that can be supported by the government during the registration.
Find out more details via the link below.
Japan Plans to Designate NPE as Class II Specified Chemical Substances
Recently, Japan's Ministry of the Environment hosted a public symposium focused on the topic of designating polyoxyethylene nonylphenyl ether (NPE) as Class II Specified Chemical Substances under the Chemical Substances Control Law (CSCL). This symposium marks a significant improvement in the management of substances that pose potential risks to the environment and health.
The CSCL designates substances as Class I, Class II Specified Chemical Substances, etc. based on their degradability, accumulability, toxicity, and environmental residues. This classification aims to strictly regulate the manufacturing, importation, and use of chemicals that could damage human health or habitats of flora and fauna, thus preventing environmental pollution.
Find out more details via the link below.
Canada Revises CBI Exemption Rules for SDS, Effective April
In April 2024, Health Canada declared modifications to the Hazardous Materials Information Review Act (HMIRA), aimed at streamlining the procedure for businesses to request exemptions for confidential business information (CBI) on Safety Data Sheets (SDS) and labels. These regulatory changes, which took effect on April 1st, are designed to enhance the efficiency of CBI submission timelines under the HMIRA.
Find out more details via the link below.
Personal and home care news
CIRS Group Assists Enterprise in Obtaining Two New Cosmetic Ingredient Registration Numbers
On April 16, 2024, CIRS Group once again assisted our client in obtaining two new cosmetic ingredient registration numbers, marking the fourth and fifth new cosmetic ingredient registration numbers that CIRS Group has helped companies acquire in 2024.
As of now, in 2024, 28 new cosmetic ingredients have been registered, with 18 of these new cosmetic ingredient registrations held by domestic enterprises and 10 held by enterprises located abroad.
Find out more details via the link below.
China Extended Deadline to Submit the Complete Cosmetic Safety Assessment Report to May 1, 2025
On April 22, 2024, China’s National Medical Products Administration issued a notice regarding the measures to optimize the management of cosmetic safety assessments.
Main contents of NMPA notice:
Find out more details via the link below.
SCCS Issued a Preliminary Opinion on Triphenyl Phosphate
On April 4, 2024, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued the preliminary opinion (SCCS/1664/24) on Triphenyl phosphate (CAS No.115-86-6, EC No.204-112-2). The deadline for comments is set for 2 June 2024.
Find out more details via the link below.
SCCS Issued Final Opinion on the Safety of Aluminium
On April 4, 2024, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued a final opinion on Aluminium(SCCS/1662/23). The preliminary opinion was released on December 14, 2023.
Find out more details via the link below.
Food and food contact materials news
领英推荐
Summary of US FDA GRAS Acceptance and Approval Status in the First Quarter of 2024
In the first quarter of 2024, the official website of the FDA updated the GRAS status of 27 products. Among these, approval was granted for 2 substances, 2 substances ceased to be evaluated at the notifier’s request, and 23 substances are still pending after submission.
This article provides a summary of the US FDA GRAS acceptance and approval status in the first quarter of 2024, for the information and reference of businesses.
Find out more details via the link below.
Summary of EU EFSA Novel Food Application and Approval Status in the First Quarter of 2024
In the first quarter of 2024, according to the European Food Safety Authority (EFSA) and the Official Journal of the European Union, EFSA published assessment results for 6 Novel Foods, including applications for 4 new Novel Foods, notification on 1 new traditional food from a third country and the modification of 1 novel food already authorized.
Additionally, EFSA requested scientific and technical assistance as regards the evaluation of 1 Novel Food, and there were no new authorizations (approvals) for Novel Food in the EU in the first quarter of 2024.
This article provides a summary of the EU EFSA Novel Food application and approval status for the first quarter of 2024 for the reference of businesses.
Find out more details via the link below.
【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China - Research and Development Capacity
It’s specified in Article 8 of the Administrative Measures for the Registration of Infant Formula Products that the applicant shall possess proper R&D capabilities aligned with its products. When applying for registration of infant formula milk powder products, the applicant shall submit 9 required documents to the State Administration for Market Regulation (SAMR), including 8) Materials on R&D, production, and inspection capabilities. Additionally, the review agency may organize on-site inspections as necessary for verification to ensure the consistency between the application materials and the actual circumstances.
CIRS Group provides a comprehensive analysis of the detailed requirements for preparing R&D capabilities-related materials for registration under the new national standard.
Find out more details via the link below.
【Infant Formula Milk Powder】Key Technical Points for Registration under the New National Standard in China - Production Capacity
It’s specified in Article 8 of the Administrative Measures for the Registration of Infant Formula Products that the applicant shall possess proper production capabilities compatible with the production of its products, comply with good manufacturing practices for powdered infant formula foods, and implement a Hazard Analysis and Critical Control Point (HACCP) system.
When applying for infant formula milk powder registration, the applicant shall submit 9 required documents to the State Administration for Market Regulation (SAMR), including “8) Materials on R&D, production, and inspection capabilities”. Additionally, the review agency may organize on-site inspections as necessary for verification to ensure the consistency between the application materials and the actual circumstances.
Based on regulatory requirements, CIRS Group provides a comprehensive analysis of the detailed requirements for preparing production capability certification materials for registration under the new national standard.
Find out more details via the link below.
CIRS FAQ: For Food Additives Listed in GB 2760 involving New Synthetic Biology Processes, Is the Safety Assessment from the Ministry of Agriculture Required Only? Vol. 05, 2024
From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on new food raw material and new food additive to help you gain a clearer understanding of the current requirements in China.
1. How is genetic modification defined? And what constitutes a genetically modified microorganism (GMO)?
2. When applying for a fermented product involving genetically modified (GM) process as a new food additive, does the Ministry of Agriculture assess the safety of the GM microorganism or the safety of the fermented product?
3. When applying for food additives or raw materials, can methodological validation be conducted by the company itself, or is it necessary to commission to a third-party service?
4. When applying for new food raw materials or new food additives, can toxicological testing be exempted if authoritative toxicological data for the same substance can be found?
....
Find out more details via the link below.
CIRS FAQ: Can the Registration Certificates of Filing Products Be Transferred? Vol. 06, 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.
1. Can I apply for health food registration renewal and change of registration at the same time?
2. Can the registration certificates of filing products be transferred?
3. Is it true that new health food products cannot be sold during the registration and evaluation period in China, even if this process takes 1-2 years?
4. Can imported products be imported as special dietary foods first, and then, after obtaining health food registration/filing approval, be imported as health foods?
5. How should the shelf life of health food be determined and what should be considered?
6. If health food undergoes a 3-month accelerated stability test and the shelf life is set at 2 years, is it still necessary to conduct long-term tests afterwards?
...
Find out more details via the link below.
EU Approves 5 Substances as Novel Foods and Amends the Specifications and Conditions of Use of 3 Authorised Novel Foods
On April 10, 2024, the European Commission issued Implementing Regulation (EU) 2024/1037, (EU) 2024/1047, (EU) 2024/1046, and (EU) 2024/1048, having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, authorizing the placing on the market of monosodium salt of L-5-methyltetrahydrofolic acid, 3'-Sialyllactose sodium salt produced using a derivative strain of Escherichia coli W (ATCC 9637), beta-glucan from Euglena gracilis microalgae, and protein concentrate from Lemna gibba and Lemna minor as a novel food. These Regulations enter into force from April 30, 2024.
On April 11, 2024, the European Commission issued Implementing Regulation (EU) 2024/1052, authorizing the placing on the market of calcidiol monohydrate as a novel food. This Regulation enters into force from May 1, 2024.
Moreover, the the European Commission amended the specifications and conditions of use of 3 already authorised novel foods, namely astaxanthin-rich oleoresin from Haematococcus pluvialis algae, lactitol, and galacto-oligosaccharide.
Find out more details via the link below.
CIRS Assists PTTMCC in Obtaining Approval for New Biodegradable Plastic PBSA
On March 13, 2024, the National Health Commission (NHC) of China issued Announcement No. 2 of 2024, officially approving 23 “three new foods”, including a new food-related product, Polybutylene succinate adipate (PBSA)”, submitted by CIRS Group on behalf of PTTMCC Biochem Co., Ltd. (PTTMCC).
Find out more details via the link below.
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