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[K-BPR newsletter # 2] Additional notification of existing active substance & pre-announcement for t 2019

Date :2019.12.16

NEWS LETTER 2019.(VOL.49)

Chemtopia thinks ahead of clients

Chemtopia gives honest consultation to clients

ISSUE & FOCUS

  • Additional notification of existing active substance
  • Pre-announcement for the list of existing active substance that will grant a grace period for an approval








Additional notification of existing active substance

MoE announced that additional notification of existing active substance is now available until Dec. 11th. Those of who missed the notification original deadline (June 30th, 2019) or have any other additional active substance to notify, shall proceed the additional notification in order to get a grace period for an approval under K-BPR. 

Without notification, as of next year, the active substance cannot be manufactured or imported into Korea unless Korea-based manufacturer or importer complies K-BPR regulation such as the approval of active substance or the authorization of biocidal product, prior to manufacture or import. 

Notification must be done by the Korea-based manufacturer or importer. Overseas supplier cannot directly proceed it without the help of local importer. There is no OR (Only representative) concept in the K-BPR yet but MoE is considering to adopt it in the stage of active substance approval. Continuous and close monitoring is required.

Korea-based manufacturer or importer is able to proceed the notification in the website below. 

https://chemp.me.go.kr/

Pre-announcement for the list of existing active substance that will grant a grace period for an approval

Pre-announcement for the list of existing active substance that will grant a grace period for approval was promulgated on Nov. 15th, 2019. The list contains the followings.

 

Name of active substance
CAS Number
Usable product type
Grace period
Name of Korea-based company who already notified their existing active substance

 

Total number of active substances on the list was 673 and the total number of company who notified by June 30th, 2019 was 712.

After the additional notifications of existing active substance is completed, they will also be on the final announcement list of existing active substance that will grant a grace period for an approval. The final announcement list will be promulgated on Dec. 31st. 2019.

Chemtopia Co., Ltd. provides corresponding services to comply with amended and legislated regulations :

· Chemical registration service including Pre-registration, OR service, Read-across or QSAR approach, CSR preparation, Data sharing and negotiation
· Chemical inventory for regulatory tracking
· Support of regulatory monitoring and volume tracking with chemical management system
· Provision of domestic and foreign chemical regulatory database
· MSDS and label authoring system
· Test arranging & its monitoring with domestic and foreign test institutes

This newsletter is available in Korean, English, and Japanese

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