Approval Status of New Chemical Substances Registrations in China under MEE Order 12
The Measures on the Environmental Management Registration of New Chemical Substances (MEE Order 12) were implemented two years ago on January 1, 2021. It has not only optimized and adjusted the registration types and relevant data requirements to lessen the burden on enterprises, but also focused on environmental risk prevention and control for new chemical substances with high environmental risks. In addition, MEE Order 12 has specified the registration standards and improved the approval requirements for new chemical substances in the review and evaluation, stating the specific circumstances for approval, disapproval, reapplication, change, withdrawal, and revocation of registrations.
Attention: Brazil REACH Regulation is Coming
On November 23, 2022, Bill PL 6120/2019 was approved by the Commission of Economic Development, Industry, Trade, and Commercial Services (CDEICS) of the Brazilian Chamber of Deputies and has been submitted to the Commission on Constitution, Justice and Citizenship (CCJS) for further review. If the Bill successfully passes the review, it will act as the Brazilian REACH Regulation. Domestic enterprises involved in exporting chemicals to Brazil should pay close attention to the Bill. If the Bill becomes law, Brazil will become the third country in South America, to set up chemical management rules, after Chile and Colombia.
Six Substances Added into China's Existing Substances Inventory
On December 5, 2022, China's Ministry of Ecological Environment (MEE) announced the addition of a batch of six substances that fulfill the requirements of existing substances for inclusion in the IECSC. These six substances were all manufactured, sold, processed in, or imported into China before October 15, 2003. Following its review of the application materials and evidence documents submitted by the applicant, the MEE believed that these substances fulfill the requirements for IECSC supplementation.
36 Substances Added into China's List of Existing Chemical Substances
On December 5, 2022, 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 Produced or Imported in China (IECSC). These 36 substances were all registered under the original MEP Order 7 and five years have passed since they reported their first activity.
UK REACH Registration Deadlines Might be Extended by three Years
With the first UK REACH submission deadline (October 2023) approaching, the UK government has released a consultation on extending the current submission deadlines. According to the consultation results published on November 29, 2022, 82% of respondents selected to extend the deadline by three years.
South Korea Amended the Registration Procedures for Multi-component Reactants
On October 20, 2022, South Korea made amendments to the guidelines on registration procedures for existing chemical substances. The guidelines provide specific pre-registration and registration procedures for substances that are identified as existing chemical substances under Article 3 of the Notice on Existing Chemical Substances (Notice No.2021-160) yet cannot be searched as existing chemical substances on the National Chemicals Information System (NCIS). The amendments mainly focused on the pre-registration and registration procedures of multi-component reactants.
CIRS Group Offers New Solutions to Polymers Stability Tests
The Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No.12) has entered into force since January 1, 2021. In accordance with its supporting document, the Guidelines for Environmental Management Registration of New Chemical Substances (hereinafter referred to as the “Guidelines”), polymers containing no more than 2% monomers or reactants of new chemical substances or belong to polymers of low concern can apply for records without quantity limitation if they are excluded in exemption circumstances.
22 Substances Supplemented into China Existing Chemical Substance Inventory
19 July 2022, China MEE announced that the 22 substances have fulfilled the requirements for IECSC supplementation and will be managed as existing chemical substances. CIRS warmly reminds that related enterprises must make sure whether their substances are existing substances. The Provisions on Environmental Administration of New Chemical Substances (MEE Order No. 12) require enterprises to complete new substance registration/record before manufacturing or importing, or they may face various punishments. To find whether the substance is existing substance, please search CIRS APCISS system.
Summary of the Latest Management Regulations and Regulatory Requirements on Chemicals in RCEP Countries (2022)
In January 2022, the RCEP Agreement entered into force, covering 10 ASEAN countries, China, Japan, South Korea, Australia and New Zealand. After RCEP comes into effect, more than 90% of the trade of goods in the region will eventually achieve zero tariffs, which involves the chemical industry with more than 1,000 tariff numbers of RCEP origin rules, benefiting the import and export trade of chemicals. Within the RCEP coverage, most countries, including China, have adopted GHS classification and labelling systems, which requires the Safety Data Sheet (SDS) and labels of chemicals to comply with the GHS-related regulations and standards of each country and region.
Application of In Vitro Methods in the Registration of New Chemical Substances in China
In health toxicology study, in vitro methods usually utilizes isolated organs, in vitro cultured bacteria, cells or organelles, and biological simulations in the laboratories to refine, reduce and replace traditional animal tests. In vitro methods are developed to protect animal welfare, which is a major focus in testing currently. At present, in vitro methods for skin corrosion/irritation, eye irritation, and skin sensitization have been greatly developed, and have been applied in EU REACH registration. China is also advancing the application of in vitro methods step by step. For example, under the previous Measures for Environmental Management of New Chemical Substances (MEE Order No.7), positive results generated by in vitro skin corrosion/ irritation and eye irritation methods are accepted.