REGULATION & COMPLIANCE
1 . Preparation of lead registrations - Testing skin irritation - Testing acute tox . ( oral ) - Testing 28d repeat tox . ( oral ) - Write CSR - Submission & competition of lead-registrations
2 . Preparation of co-registrations - Write CSR - Submission & completion of co-registrations
Table 3 : Combination of the timeline of full registration under K-REACH .
Impending deadline
As stated above full registration deadline for substances in the 100- 1,000 tonnes / year band is the end of 2024 . Based on the most recent statistics , the MoE is expecting approximately 1,100 individual substances to be fully registered for this coming deadline .
For both lead registrants ( LRs ) and co-registrants , it is important to be proactive because , whilst the deadline is the end of 2024 , this is the date by which registration must be completed . Currently it is expected that LRs will require approximately three months with the National Institute of Economic Standards ( NIER ). Co-registrants can only submit their registration once the LR has completed its registration and should expect the NIER process to take one to two months .
Before the LR can consider submitting the registration , they must fulfil the testing requirements for their substance . Such testing data can be obtained in several ways including :
• From data already owned by the LR
• From data made available by the active members of the Substance
Information Communicative Organisaion ( CICO , the Korean version of the Substance Information Exchange Forum )
• By performing the testing directly with a qualified laboratory If the data is not available from the LR , or another member of the CICO and the testing must be completed , registrants must be aware of how long this is likely to take ( Table 2 ).
The 28-day repeat toxicity ( oral ) endpoint is the most time critical , with full testing taking about six months , while the pre-requisite for this and for acute toxicity ( oral ) plus the latter test itself all require about three . Currently lab capacity is low for extended studies : for example , the eco-toxicity endpoint acute fish / daphnia has at least a 12-month waiting period . A further mandatory section of the registration dossier is the Chemical Safety Report ( CSR ). Assuming that the exposure scenarios have been collect from DUs the expected timeline for CSR authoring for the LR and the DU is approximately one month .
Due to the time requirements to prepare for the full registration deadline at the end of 2024 , it is recommended that companies interested in substance at this tonnage band engage with the CICO to ensure progress is being made . ●
Dean Winder
SENIOR REGULATORY CONSULTANT ,
CIRS EUROPE J + 353 1 477 3706 j dean . winder @ cirs-reach . com
40 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981