The Chemical Manufacturers Committee greatly appreciates the efforts of government agencies to engage in two-way communication with industrial stakeholders, conduct effective inter-agency cooperation through the National Chemical Substance Management Board, and pursue efforts to improve Taiwan’s chemical management as part of meeting the 2030 target for achieving the United Nations Sustainable Development Goals.
The Committee hopes that the Environmental Protection Administration (EPA) will specify the extension due date for the Existing Chemical Substance Standard Registration (ECSSR) requirement as a response to the COVID-19 pandemic, as well as introduce various dossier preparation schemes and data acceptance principles.
With respect to the content and template for Safety Data Sheets (SDS) and product labels, along with the withholding of confidential business information (CBI) on SDS, the Committee urges the Ministry of Labor (MOL) to establish reasonable review criteria, adopt a global approach, and set up a mentoring program.
Suggestion 1: Improve the efficiency of the Existing Chemical Substance registration system.
1.1 Confirm the deadline for ECSSR registration. The chemical industry has been waiting to learn the progress of proposed amendments to the Regulations of New and Existing Chemical Substances Registration. It is still unclear to industrial stakeholders whether the deadline will be extended for more than a year, as the information was announced in several public seminars but without any written confirmation. Considering that registrants in the high-tonnage band (more than 100 metric tons per year) are encountering difficulties acquiring letters of credit from consortia under the EU’s REACH (Registration, Evaluation, Authorization and Restriction) regulation or other data owners abroad while the original registration deadline is rapidly approaching, the Committee urges the MOL to promulgate the amendment by the end of the year, extending the ECSSR deadline by more than a year, or at the very least officially confirm its intention to enact such an amendment in a written document.
1.2 Announce the training schedule and specify the priority of the substances. The Committee appreciates the EPA’s holding of several workshops and training sessions to build up industrial stakeholders’ competence in preparing registration dossiers and engaging in data searching in the public domain. The chemical industry is looking forward to similar training opportunities for additional substances. To facilitate the registration progress, the Committee suggests that the EPA establish an annual training schedule and announce the priority of the substances to be assessed, so that industry members can re-allocate their internal resources and focus more on substances for which public data is lacking. Adopting these measures would ease the anxiety of small and medium enterprises in Taiwan.
1.3 Build industry competence in hazard and exposure assessment. Hazard and exposure assessment reports are required for ECSSR levels 2 and above. Currently the EPA accepts dossiers without the assessment report and requests registrants to provide the report afterwards, but the pertinent technical guidance and reference have been available in draft form only, with no further progress or update since 2016. As most industrial stakeholders were not even aware of the draft, they had no choice but to turn for support to consulting companies, despite the considerable burden and expense. The Committee urges the EPA to publish the technical guidance as soon as possible – and to take into consideration the lack of expertise among many industrial stakeholders in conducting reliable hazard and exposure assessments. To help build up this competence, we urge the EPA to offer workshops and training or counseling programs so that the goal of implementing world-class chemical source management in Taiwan can be achieved.
1.4 Align the CMR classification for 106 priority existing chemicals. The Committee is aware of cases where registrants selectively ignored the International Agency for Research on Cancer (IARC) classification for carcinogenic, mutagenic, or toxic for reproduction (CMR) substances, instead referring to other existing data in the public domain. Seeking to avoid upgrading the registration level, they deliberately adopted a less severe GHS (Globally Harmonized System) classification. Such activity will negatively impact Taiwan’s chemical management and health risk assessment program. The Committee therefore urges the EPA to enforce a consistent standard on CMR classification.
1.5 Exempt on-site isolated intermediates. The Committee urges the EPA to consider providing exemptions for on-site isolated intermediates. Other jurisdictions have regulatory frameworks specifying that on-site isolated intermediates be treated similarly to non-isolated intermediates and that they be subject to fewer data requirements and/or lower registration fees. For example, the EU’s REACH stipulates that on-site isolated intermediates are exempt from the standard registration process and from certain data requirements as long as manufacturers provide confirmation that the on-site isolated intermediate is used under controlled conditions.
Suggestion 2: Address shortcomings in the SDS, labeling, and CBI withholding processes.
2.1 Establish reasonable review criteria for SDS and labels. Due to misinterpretations of the “Regulations for the Labeling and Hazard Communication of Hazardous Chemicals,” many downstream users recently requested chemical companies to prepare their SDS exactly in accordance with the “Content and Template for Safety Data Sheet” in the Regulation’s appendix. The Committee believes that instead of obsession with the terms and headings for SDS preparation and labeling, it is more important to adhere to the spirit of the GHS Purple Book by providing downstream users with hazardous chemical information and safety and protection measures. The Committee urges MOL to provide a clarification to prevent unreasonable requests from labor inspectors or downstream users.
2.2 Follow global procedures for CBI withholding and refine the review criteria. The EU, Taiwan, and Korea are the only jurisdictions requiring an additional application to qualify for confidential business information (CBI) withholding in SDS and labeling. In accordance with the rules for GHS classification, “cannot be classified” is acceptable in the EU when there is no thorough data, while in Taiwan it is mandatory to prove the lack of a health hazard in each case. In Korea, GHS classification results and SDS documents are sufficient. Further, the Korean system allows for minimized dossier preparation and quicker review period for R&D samples. The Committee urges the MOL to adopt the EU and Korean practices to ensure that the CBI withholding process in Taiwan is not excessively burdensome.
2.3 Establish standardized review criteria, a specified review period, and a mentoring program for CBI withholding applications. Since the implementation of CBI withholding came into effect, CBI applicants have encountered inconsistent review standards, including contradictory comments on the same application dossier or failure to provide all review comments at one time. The absence of a limitation on the length of the review period has caused them to last for an average of 3-6 months, which presents an obstacle for the development of time-sensitive R&D products. The Committee urges MOL to reinforce the training of CBI reviewers with an emphasis on standardized review criteria and to establish a clear review period by regulation. We urge MOL to follow EPA’s practice regarding ECSSR requirements by holding workshops for the applicants, setting up a helpdesk to give a timely response to applicants’ questions, and preparing Q&A reference documents to facilitate the application process.