NEWS LETTER 2019.(VOL.42)
Chemtopia thinks ahead of clients
Chemtopia gives honest consultation to clients
ISSUE & FOCUS
- Ⅰ. (M)SDS preparation and obliged submission to the MoEL
- Ⅱ. Introduction of (M)SDS deliberation system for protection of trade secrets
- Ⅲ. Introduction of an Attorney in the system
- IV. Countermeasures from the industry
Ⅰ. (M)SDS preparation and obliged submission to the MoEL
○ (M)SDS preparation and obliged submission to the MoEL (ISHL, Article 110)
Any company intending to manufacture or import chemical substances and/or chemical products shall submit relevant (M)SDS to the MoEL.
○ A separate document submission to the MoEL is required for the chemicals whose composition information are not categorized under GHS classification in the (M)SDS
Submission of a separate document including the chemical name and its content to the MoEL is required for any chemical substance stated in the (M)SDS, which cannot be categorized under the GHS classification of hazardous factor (ISHL, Article 104). However, the two cases in the box below are exempt.
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- If the (M)SDS including the chemical name and content of chemical substance is not categorized under GHS classification had been submitted. - If the importer had submitted a relevant document given by a foreign manufacturer which confirms that no chemical other than stated in the (M)SDS is categorized under GHS classification. |
- Enforcement date: 16th Jan 2020 (Within 2 years from the date of promulgation (15th Jan 2019))
- Those who prepared or changed the (M)SDS before the enforcement of the amendment would be expected to receive a grace period based on the annual manufacture or import quantity of the chemical for allowing them to prepare and submit the (M)SDS.
Ⅱ. Introduction of (M)SDS deliberation system for protection of trade secrets
○ Required documents for (M)SDS deliberation system
- The necessity for substitution of the name and content of the chemical
: Document proving suitability of information as CBI
- The suitability of substitute document: Substituted name and content of the chemical.
- The appropriateness of (M)SDS
: The name and content of chemical in the (M)SDS which is not categorized under
GHS classification
- To determine the applicability for approval: Physical, health and environmental hazards of the chemical substance.
○ Validity of approval : Up to 5 years (possible to apply for extension every 5 years)
○ Dates for submission
Applying for approval : Prior to manufacture or import of the chemical substance
Extension of approval application: up until 30days before the end date of valid approval.
○ Method of submission
Submit the document via an IT system operated by the MoEL.
Ⅲ. Introduction of an Attorney in the system
The foreign manufacturer could appoint an attorney who satisfies the conditions announced under the MoEL Decree to complete the tasks stated below on behalf of the importer who imports the substances subject to the (M)SDS|
- Preparation of (M)SDS and submit to the MoEL - Submission of the name and content of the chemical not classified under GHS classification among the sections in the (M)SDS. And submission of the confirmation document given by a foreign manufacturer which confirms that no chemical other than stated in the (M)SDS is categorized under GHS classification. - Applying for the approval of the (M)SDS deliberation system for protection of trade secrets, the extension of approval and an appeal. |
IV. Countermeasures from the industry
○ Speculation of the expected Enforcement Decree and other related public notices
Attention is required for Enforcement Decree as well as other related public notices which are currently being prepared. Below are the main factors currently under review:
- Exemption from submission and preparation of (M)SDS for R&D chemical substances of small quantity. And simplified application procedure for (M)SDS deliberation system for protection of trade secrets.
- Reviewing of intermediate substances.
- Granting of grace period corresponding to the tonnage band to submit the (M)SDS up to 5 years from the effective date based on its annual manufacturing and importing volume.
- A standard form for submission of the confirmation document which will be given by foreign manufacturer for confirming that no chemical other than stated in the (M)SDS is categorized under GHS classification
- Conditions of an appropriate attorney.
○ Re-evaluation of internal (M)SDS
- Submit an (M)SDS to the MoEL when manufacturing or importing, however, in the case of (M)SDS not being categorized under GHS classification, a separate submission of the relevant information is required. Therefore, in order to cope with the strict monitoring, it is recommended that internal (M)SDS be accurately updated and re-evaluated during the first 2 years from the enforcement date.
○ Factors to consider when appointing an attorney for protection of CBI
- Sorting out the substance list requiring for the (M)SDS deliberation system for protection of trade secrets is essential because the application fee and other costs could be burdensome.
- Consider the measures for data protection. Receive a deliberation through applying for the (M)SDS deliberation system for protection of trade secrets. In the case of a foreign manufacturer, appoint an appropriate representative/3rd party consultancy who represents importers to prepare and submit (M)SDS as well as applying for the (M)SDS deliberation system for protection of trade secrets.
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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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