1. Regulatory rationale for pre-registration
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 and hope to enjoy the grace period, shall submit pre-registration before the pre-registration deadline (30 June 2019). After pre-registration, if in any case, the following information changes, change in notification must be carried out.
- Chemical name
- Estimated annual quantity of manufacture or import
- Classification and Labelling
- Use information
- Additional information determined (required) by MoE such as company name of manufacturer or importer
2. 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.
3. 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.
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: 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