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켐토피아 뉴스레터

NEWS LETTER 2019.(VOL.29)

Chemtopia thinks ahead of clients

Chemtopia gives honest consultation to clients

[Newsletter No. 29] Approval of K-REACH Amendment and K-BPR Legislation in Cabinet Meeting

Dear precious clients:

 

Draft amendment of K-REACH and draft legislation of K-BPR are approved in Cabinet meeting on August 8th, 2017. Two main contents are:

 

- Registration of existing chemical is to be expanded to all existing chemicals exceeding 1ton/year

- Its data requirement will be different depending on GHS classification.

 

This is the details: There will be no change in expanding of registration of all existing chemicals exceeding 1ton per year according to decision on K-REACH amendment which was made in Cabinet meeting on August 8th, 2017.

 

Recently, Korea MOE made it clear that grace period on current joint registration for 510 priority existing chemicals (pecs) will not be extended but remains same as June 30th of 2018.

 

In addition, relating to expanding of existing chemicals subject to registration, the MOE gave an outline for data requirements. And, simplified registration for below 100 kg per year (small quantity registration) is to be changed to notification.

 

The following tables will show you a summary of main contents of amended K-REACH and draft K-BPR legislation:

ISSUE & FOCUS

1. K-REACH main amendments

- Enforcement data: July 1st, 2018 (Planned)

- Main contents:
 

Current K-REACH

Amendment (Draft)

Notification of existing chemicals subjects to registration every 3 years. (1st batch 510 substances: Register until June 30th of 2018)

Different registration timeline is applied depending on volume band of existing chemicals exceeding 1 ton.

Registration of all new chemicals regardless of their volume.

Registration of new chemical exceeding 100 kg/year still exists, but a simple notification system is applied for new chemical below 100 kg/year. 

No pre-registration.   

Pre-registration system is adapted in order to identify co-registrants. (i.e. notification of chemical name, expected manufactured or imported tonnage band, and other simple information)

 

-

Notification of CMR component and its content are required when a CMR substance is present in a product exceeding 0.1% and 1 ton.

Information communication in supply chain (Both manufacturer and importer are required to provide downstream users about chemical information for registered chemical substance and product containing of this substance).

Expanding of information communication (It is applied not only for registered substance, but only hazardous substance*)  

*Definition of hazardous substance : Toxic, authorized and restricted & banded chemicals)

Penalty for manufacture/import without registration is less than 5 years of imprisonment or less than USD $88,000 fine.

Penalty for manufacture/import without registration is proportionally applied on sales profit. (less than 5 % of sales profit is imposed as fine, but 2.5 % is imposed for a small sized enterprise having a single business unit)

 

- Data requirement for existing chemical exceeding 1 ton will differ in two groups, A and B:

Group A - Classified as hazardous according to GHS

: Sequential registration depending on tonnage band by 2030 with preparing data

Requirement.

 

Group B – Classified as non-hazardous according to GHS

: Requiring a simple data (approx. 15 data) regardless of substance’s volume.

 

- Registration timeline for existing chemicals exceeding 1 ton per year.

: Registration of approx. 7,000 over 1ton of existing chemicals is required by 2030.

1) ~2021: Carcinogenic substance and substance exceeding 1,000 ton/yr (approx. 1,100 substances)

2) ~2024: Substance having its volume band 100-1,000 ton/yr (approx. 1,100 substances)

3) ~2027: Substance having its volume band 10-100 ton/yr (approx. 2,000 substances)

4) ~2030: Substance having its volume band 1-10 ton/yr (approx. 2,300 substances)

 

- Change in new chemicals having a small quantity from registration to notification. 

: Registration remain same with new chemicals exceeding 100 kg per year, but a simple notification is required for less than 100kg per year of new chemical.

2. The legislation of K-BPR (draft)

- Enforcement data: January 1st, 2019 (planned)

- Main contents:
 

K-BPR

Application for grace period is required for approval of active ingredients being circulated before enforcement data, January 1st, 2019.

 

Step-wise approval for active ingredient that is already applied for grace period.

 

For a product containing active ingredient, authorization is required based on its safety, effect & efficacy information.  

 

After changing name of “Risk concerned product” under K-REACH to “Household chemical product subject to suitability check” in K-BPR, corresponding product includes not only products used in household, but also products used in office and in multi-use facilities.

à Requires suitability check on safety standard every 3 years.  

  

It is banded for advertisement using a phrase such as “Safe”, “Eco-friendly”, etc. that may lead misunderstanding to consumer.

 

 

- In summary, K-BPR adapts a pre-approval system for all biocides and biocidal products in order to circulate only safety approved substance and product in market through hazard and risk assessment in advance.  

 

[Impact on industry and its countermeasure]

 

- Since there is no change in registration deadline for 510 pecs, completion of joint registration on time (~June 30th of 2018) is inevitable.

 

- Pre-registration period is expected for 6 months from the enforcement date of amended K-REACH, which is July 1st, 2018, therefore, chemical inventory work for each company to identify relevant substance is recommended to avoid missing pre-registration.

 

- Especially for overseas manufacturers/exporters, it is important to appoint Only Representative for relevant substances, before the enforcement date of amended K-REACH.

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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