On November 27, 2021, Taiwan Environmental Protection Administration promulgated the revised “Regulations of New and Existing Chemical Substances Registration”. The main amendments are as follows.
Addition of exempted items
The following substances have been added to the list of substances exempted from application of the Regulation.
- “Controlled chemicals ” in “Occupational Safety and Health Act”.
- “Concerned Chemical Substances” as defined in “Toxic and Concerned Chemical Substances Control Act”.
Amendments to the Registration Validity Period and CBI Protection Period
Under the former law, registration validity period and CBI (Confidential Business Information) protection period of “simplified registration” and “small quantity registration” of new chemical substances are 2 years, but under the revised law, both of them are extended to 5 years.
|Before amendment||Revised law|
|Registration validity period||CBI protection period||Registration validity period||CBI protection period|
|Standard registration of new chemical substances||5 years||5 years||5 years||5 years|
|Polymer of low concern||5 years||5 years|
|Simplified registration of new chemical substances||2 years||2 years|
|Small quantity registration of new chemical substances||2 years||2 years|
|Existing chemical substances||long term validity||5 years||long term validity|
A clear provision on the upper limit of CBI Protection Period for new chemical substances has been established, which is a maximum of 15 years, including the period before and after the substance is added to existing chemical substances.
Deadline Extension of standard registration (phase 2 registration) of existing chemical substances
In view of the impact of the new coronavirus, the deadlines for standard registration of existing chemical substances have all been extended to 5 years. For example, the standard registration deadline has been extended to December 31, 2024, for those who have already obtained a phase1 registration code before December 31, 2019, and whose annual production or import quantity registered at the time of acquisition was at least 1 ton.
Note: Although the draft amendment stated that the registration deadline would be extended to 4 years, the revised law officially promulgated this time extends the deadline to 5 years.
Addition of Exemptions from Standard Registration for Existing Chemical Substances
A provision was added to exempt On-site Isolated Intermediates from standard registration.
On-site Isolated Intermediates: A substance manufactured for or used for chemical processing in order to be transformed into another substance, the synthesis of which takes places on the same site and which is operated by one or more legal entities.
Revision of the Standard Registration Procedure for Existing Chemical Substances
It has been changed to the provision that the standard registration completion code is issued after the materials for major items 1 to 7 specified in Appendix 3 are submitted and passed the review, and the registration for the remaining items (hazard and exposure assessment information) (Appendix 4) shall be completed by the specified deadline.
Amendments to annual return related regulations
A provision has been added that any deficiencies in annual return materials must be corrected within the time limit and that failure to comply with the correction will result in disciplinary action.
Deletion of retention provisions for registration-related documents
The provision on retention of registration-related documents in Article 32 of the former Regulation has been deleted (preservation by the registrant is not required).
The original text of the amended version can be viewed at the following URL (in traditional Chinese).