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Taiwan's EPA has opened a 60-day public consultation on the draft revisions to the Regulation of New and Existing Chemical Substances Registration. The comment period will end on 29 May. Major revisions compared to the current registration practice have been introduced by ChemLinked in this Expert Article.
Three industry focused seminars were held by Taiwanese authority in early May to outline the revisions. Based on the comments put forwarded in the seminars, some controversial issues that may be of your interest are introduced as below.
(1) Exemption conditions
According to the current regulation, a polymer can be exempted from Taiwan’s chemical registration measures if the “2% Rule” is applicable (refer to Article 3 Point VI of the regulation) and is listed on the inventory of existing chemical substances, or it is a new chemical substance which meets “2% Rule” eligibility criteria. However, in the draft, the exemption condition is not applicable to polymers classified as new chemical substances which fit the “2% Rule”.
The authority agrees that for existing polymers there is existing data available for reference, and minor changes in the composition that maintain “2% Rule” applicability can be regarded as not changing the properties of the original polymer. Thus when the original polymer A is registered, then polymer B can be exempt from registration (provided it also qualifies for 2% rule). However, for a polymer that is a new chemical substance, the changes may result in unforeseen risks since the original polymer is new as well. Thus the authority prefer to strengthen the management and give no exemption for such kind of polymers even if the original new polymer is registered. This point is strongly opposed by some enterprises representatives and we may see some adjustment in the future.
(2) Volume standards for standard registration
Standard registration deadline for priority existing chemicals (PECs) is based on the volume when applying for phase 1 registration (see details). However, most of the volume data submitted is based on the statistics generated from year of 2012 to 2014, which may have changed in recent years. Many enterprises manufacturing or importing the proposed 106 PECs advised authorities to update the volume data, prior to the implementation of the new registration regulation and thus the grace period for standard registration could be adjusted accordingly.
(3) Data sources
Previously the authority planned to collect qualified data available in international databases. Provided the authority can collect sufficient data and omit certain testing endpoints, potential registrants will have reduced compliance burdens. However according to the seminar, the plan may be abolished.
The proposed 106 PECs are commonly circulated in Taiwanese market. There is a large amount of existing data available on ECHA’s website (data for EU REACH). However, such data cannot be directly used by registrants due to copyright issues with data holders. In addition to purchasing existing data, the authority expressed they are open to accept some data from public database and literatures, etc. However, to what extent such data can be accepted has not be clarified or standardized.
The authority will offer considerable assistance to enterprises trying to complete standard registration of the PECs, including establishing SIEF-like platform for registrants to communicate and share data and providing supporting documents on joint registration, etc.
