Taiwan EPA publishes the PEC Registration Guidance
On 9th June, Taiwan Environmental Protection Administration published the long awaited Guidance on Standard Registration of Priority Existing Chemical substances (the PEC Guidance). The PEC Guidance regulates the registration of the first batch of 106 priority existing chemical substances (PECs). If the annual tonnage is over 1 tonne/year, the Manufacturer/Importer/Third-party representative of the listed substances needs to complete the registration before the given deadlines (depending on the tonnage and the time of Phase 1 registration).
Important updates in the PEC Guidance
Change of regulatory structure
The final version of the PEC Guidance has 6 Chapters and the structure is different from the draft version.
The new data acceptability rule
The EPA prefers the applicant to use non-testing methods if possible. The following data types are accepted for physchem, tox and eco-tox endpoints:
○ Public databases: Information from certain public databases will be regarded by the EPA as “Reliable without Restriction”. If data from other databases are referenced, the data will be regarded as “Reliable with Restriction”.○ Non-Testing methods: When the data is not available in the above-mentioned databases, the following non-testing methods are recommended: (Q)SAR; Read-across; Systematic literature review; Testing proposals
○ Testing reports: When the data is not available in the above-mentioned databases and non-testing methods, the following testing methods can be used: Full Study Reports and Robust Study Summary.
There are parallels between the PEC Guidance and ECHA Guidance, for example:
○ Data reliability: Reliability of data can be scored using the same scoring system as ECHA. This method can also be used in Systematic Review and Read-across work.
○ The data exemption principles in the PEC Guidance reference the ECHA Guidance on Information Requirements and Chemical Safety Assessment.
Dossier preparation: The following information is required for PEC registration:
○ Basic identification information of registrants and substances
○ Information on substance manufacturing, use and exposure
○ Hazard classification and labelling
○ Safe use information
○ Information on physical and chemical properties
○ Toxicology information
○ Eco-toxicology information
○ Information on hazard and exposure assessment information
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