Newsletter
[Newsletter No. 41] Pre-registration of existing chemicals ends, 30th June
NEWS LETTER 2019.(VOL.41)
Chemtopia thinks ahead of clients
Chemtopia gives honest consultation to clients
ISSUE & FOCUS
- I. Regulatory rationale for pre-registration
- II. Factors to consider for pre-registration (pre-notification)
- III. Consequence for disregarding pre-registration.
I. Regulatory rationale for pre-registration
Remarks Amended K-REACH, Article 10 (Registration of chemical etc)
| Anyone who annually manufactures or imports 1ton or more than 1 ton of existing chemical or 100kg or over 100kg of new chemical should register with MoE prior to manufacturing or importing. (Excludes anyone subject to the Art 4 subparagraph 2) |
Anyone who plans to manufacture or import chemicals, yet have not registered during the given grace period, will have to notify the below information prior to manufacturing or importing. If in any case, information required as Presidential Decree changes, change in notification must be carried out. | |
Required Information for pre-registration | 1. Chemical name 2. Estimated annual quantity of manufacture or import 3. Classification and Labelling 4. Use information 5. Additional information determined(required) by MoE such as company name of manufacturer or importer |
II. Factors to consider for pre-registration (pre-notification)
Below factors must be considered prior to pre-registration (pre-notification).● Is the annual quantity of manufacture or import 1ton or more than 1 ton?
● Is the chemical subject to the exemption of Registration or Notification like an impurity and low concerned polymer etc?
● Is polymer an existing chemical substance which satisfies the 2% rule? (which excluded monomers with a molecular weight of less than 2% from the polymer).
● How GHS classification of the relevant chemical will be secured?
● Is the chemical for consumer use? If so, how can this be confirmed within the supply chain?
● Had the chemical substance been examined as a new chemical substance under the TCCA (Toxic Chemical Control Act)?
● Has the registration been completed as a PEC chemical substance under the previous K-REACH?
● Who is the applicant for the pre-registration if a foreign manufacturer appoints an Only Representative (OR)?
Information required for pre-registration is fairly simple, but if above certain factors are met pre-registration and/or formal registration is avoidable, therefore, they should be considered carefully.
III. Consequence for disregarding pre-registration.
If pre-registration is incomplete within 30th June 2019, the grace period cannot be received. Therefore, when 6 months long pre-registration period comes to an end, manufacture, import, sales and use of any existing chemical of annual quantity more than 1 ton may be hindered. Additionally, penalties are as stated below. *Imprisonment for up to 5 years or fines of up to 100 million KR-won for those who did not register or falsely registered the existing chemical yet manufactured or imported*
FAQ
Q. | During the enforcement of the amended K-REACH, do I need to pre-register the existing substance that has already been imported? |
A | With enforcement of the amended K-REACH, any existing chemical whose annual import quantity 1ton or exceeds 1 ton, pre-registration must be completed until 30th June, 2019 to receive the grace period. However, newly manufacturing or importing volume exceeds 1 ton or over 1 ton, chemical substance must be notified prior to manufacture and import. |
Q. | Is it possible that the importer does pre-registration and foreign manufacturer appoints an OR in the later stage to complete the registration for that chemical substance? |
A | Yes, it would be possible. (Note: It was a verbal response from the responsible person from MoE at the meeting, therefore it is not lawful) |
Q. | Are 510 PEC (Priority Control Substances) substances announced under the previous K-REACH subject to pre-registration as well? |
A | If you registered the PEC substance already, it is not subject to pre-registration under the amended K-REACH. |
Q. | In accordance with TCCA, I received the new chemical substance hazard examination, do I need to register my chemical substance again? |
A | Ans: During the below time period, you must notify NIER (National Institute of Environmental Research) with hazard examination notice and/or documents which confirm the quantity of relevant chemical manufactured or imported during the recent 3 years. Over 1000ton or CMR substances over 1 ton: Until 2019 100-1000 ton : Until 2022 10-100 ton : Until 2025 1-10 ton : Until 2028 |
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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
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