Taiwan REACH: Current Status and Future Direction

At the CRAC-HCF 2020 Virtual Forum held by REACH24H on November 24, 2020, Ms. Yahui Ni from the Environmental Resource & Information Co., Ltd. (ERI), introduced the regulatory framework of Taiwan’s new and existing chemical registration system (Taiwan REACH) and the ongoing efforts made by regulatory authorities. Ms. Ni’s speech was mainly centered on the registration of 106 PECs, which represented industry’s first exposure to joint registration mechanism during which data ownership and reliability issues were encountered. Taiwan’s EPA (Environmental Protection Administration) encourages registrants to firstly cite international public databases (16 recommended in the Guidance for PECs Registration) for data and secondly, to use systematic literature reviews, QSAR, read-across, and testing proposal to fulfil requirements for all testing endpoints. It is however, not allowed to directly refer to the ECHA database. Additionally, the registrants shall not cite the literatures owned by private enterprises, such as BASF, DUPONT, etc. For data in reports such as OECD…

Dec. 28th, 2020

Dynamics of Vietnamese Regulations on Chemicals and the National Chemical Inventory

In recent years, Vietnam is prospering and attracts more and more International attention. The manufacturing sector is growing steadily in Vietnam, however the development of the chemical industry is still not enough to satisfy domestic demand. While importing large quantities and various kinds of chemical substances, more and more chemical companies are setting up facilities in Vietnam, which brings great challenges to Vietnam’s chemical management systems. Since the Law on Chemicals was issued in 2007, Vietnam has been developing a modern chemical regulatory system, but there is not a completed national chemical inventory yet. Speaking at CRAC 2020, Mr. Dinh Thanh Nghia from E&H Consulting Co., Ltd. brought the latest updates on chemical regulations and the National Chemical Inventory in Vietnam to the attendees. National Chemical Inventory The Vietnam National Chemical Inventory (NCI) is the overall list of existing chemical substances in Vietnam. It is still in its draft status, but…

Dec. 28th, 2020

Maintaining Your Business as UK REACH Arrives

Background On January 1st, 2020, the United Kingdom started the exit process from the European Union and entered into a Transition Period. As the often titled “Brexit” transition period ends on December 31st, 2020, the United Kingdom will no longer be a part of the European Union Customs Union and the European Single Market. Relevant free trade agreements will not be applicable to the UK from January 1st, 2021. For the chemical industry, an independent chemical regulatory framework, namely the UK REACH, will be officially implemented in the UK next year, as the EU REACH regulations and supervision mechanism will not be applicable then. It means that enterprises manufacturing, selling, importing and distributing chemicals in the UK and the EU will have to face two REACH systems separately. Interpretation of the UK REACH Transitional Measures Speaking at the CRAC 2020, Mr. Simon Johnson from the UK’s Department of Environment, Food…

Dec. 28th, 2020

Thailand Officially Releases the First Existing Chemicals Inventory

Author: Horace Wang Thailand’s Department of Industrial Works (DIW) has recently issued a notice [1] to release the First Thailand Existing Chemicals Inventory. At the same time, an online platform [2] for searching the inventory was open. The issuance of the existing chemical inventory is a milestone of Thailand’s management for chemicals and heralds the different management requirements for existing chemicals substances and new chemical substances. According to the online search platform, the inventory currently includes 11,474 entries. Users could search the target chemical substances by Chemical name, molecular formulas, hazardous substance type, chemical type, CAS number, and chemical code. The search results, as well as the entire inventory, could be exported and downloaded as a PDF or Excel document. The substance information in the inventory also includes the import quantity, production volume, and the physical/health/environmental hazards of the substance. Besides the hazardous substance type, the inventory also introduces chemical groups and chemical codes of…

Jul. 13th, 2020

Taiwan Releases Guidance for Priority Existing Chemical Substances Registration

On June 9, 2020, Taiwan finalized the Guidance on Existing Chemical Substances Standard Registration. It was initially drafted in March and updated in September 2019. The Guidance includes: Chapter 1 for introduction of regulations and terms Chapter 2 for registration process Chapter 3 for data waiving Chapter 4 and 5 for information requirements and data sources for reference Chapter 6 for dossier review, management and information disclosure The first batch of 106 priority existing chemical substances (PECs) were designated in 2019 as Annex 6 of the revised Regulation of New and Existing Chemical Substances Registration [2]. A priority existing substance if manufactured or imported in quantities greater than one tonne per year in Taiwan, is subject to mandatory standard registration from January 1, 2020. Joint registration is voluntary. The manufacturer or importer can appoint a third party representative (TPR) to comply with the obligations on their behalf. The registration deadlines for PECs are…

Jun. 10th, 2020

MEE Opens Public Consultation on New Chemical Registration Transitional Measures

On April 29, 2020, China’s MEE released the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No.12), which will enter into effect and replace the MEP Order No.7 on January 1, 2021 (ChemLinked News). On June 3, MEE issued a notice [1] to solicit public comments on the transitional measures that will be applied. The consultation will conclude on June 20. The transitional measures include: 1. From the date when MEE Order No.12 enters into effect, for a new chemical substance that has obtained the registration certificate for regular notification under MEP Order No.7, before it is added into the IECSC, 1) The registration certificate holder and downstream users shall take measures to control environmental risks indicated in the registration certificate. 2) The registration certificate holder shall, according to Article 38, 39, 41, and 42 of MEE Order No.12 engage in information communication, record and keep relevant documentation materials, submit…

Jun. 05th, 2020

China MEE Publishes Revised Measures for the Environmental Management of New Chemical Substances

On April 29, 2020, China’s MEE published the amendments of the Measures for the Environmental Management of New Chemical Substances (MEP Order 7 of 2010). It is renamed as the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order 12 of 2020), which will come into force on January 1, 2021. The current new chemical management system has been in effect since October 15, 2010. During the implementation, the notifying companies and ORs have gone through a lot of tough problems, which may not be clearly defined or even not covered in the current management legislation. The research and discussion on the revision of the MEP Order 7 has been underway for several years. The draft revision has been issued for public comments in July 2019 and notified the WTO in Sepetember 2019. It was finally approved on February 17, 2020. Below are the major amendments compared with the current…

May. 09th, 2020

TSCA’s 20 High-Priority Substances Requirement for Manufacturers/Importers to Self-Identify

Latest update:  On March 25, 2020, the EPA released a plan to consider a proposed rule that would look at potential exemptions to EPA’s fee’s rule. These three categories of exemptions are:  (1) importers of articles containing one of the 20 high-priority substances; (2) domestic producers of one of the 20 high-priority substances as a byproduct; and (3) domestic producers or importers of one of the 20 high-priority substances as an impurity. These manufacturers will not need to self-identify and will not be subject to the risk evaluation fees. In addition, since the rule isn’t final, and won’t be likely until 2021, the EPA also issued a “no action assurance” memo promising that the EPA will exercise its enforcement discretion for those three categories. This essentially means that even though the law hasn’t been formally changed, the EPA will not pursue any companies that didn’t self-identify because they fall into one of those three…

Mar. 24th, 2020

Taiwan area’s Existing Substance Standard Registration

Taiwan area’s current Regulation of New and Existing Chemical Substances Registration hereinafter referred to as ‘ the Regulation’, under the Toxic and Concerned Chemical Substances Control Act (TCCSCA) and the Regulation on New Chemical Substances Registration under the Occupational Safety and Health Act (OSHA) has been implemented for nearly 5 years. This regulation was initially developed on the basis of EU REACH（setting a pre-registration and standard registration for existing substances. This regulation has specific features compared to chemical management regulations in other regions. The first batch of standard registration for existing substances subjected to standard registration was officially launched on January 1, 2020. In 2019, the year before official registration was launched, the competent authority successively introduced revised versions of the regulation. Regulation, draft registration guidance, supporting documents and tools such as information sharing platforms. Taiwan area’s Existing Substance Standard Registration 21 REACH24H is currently integrating various resources to assist…

Mar. 24th, 2020

Sharing of Inorganic Compound Registration Strategies

With the wide application of chemical substances, the targets of new chemical substance registrations in China have also been expanding. In recent years, REACH24H has undertaken a number of inorganic substance registration projects. Inorganic substance is the abbreviation for inorganic compounds, which refers to all elementary substances and compounds with the exception of organic carbon (containing carbon-based substances). The vast majority of inorganic substances can be grouped into the four categories of oxides, acids, bases and salts. Due to the particular qualities of inorganic substances, physic-chemical and eco-toxicological data exemptions apply. The physical and chemical properties of the flashpoint, the partition coefficient(n-octanol/water), the stability in organic solvents and the characteristics of degradation products, as well as biodegradability in eco-toxicological data all point to clear descriptions of the inorganic compound which can be exempted. In terms of the qualitative analysis of substances, inorganic substances also have their particularity compared to organic…

Mar. 24th, 2020
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