During the Global GHS Course, participates have asked several questions on:
CIRS have collected the questions and have provided the answers to these questions as follows.
1. Is CAS No. mandatory to state in label?
In relation to the EU CLP the CAS Number is not required to appear on the EU CLP label however, it is helpful to the user to include it when possible.
2. Are GB CLP notifications required now (or can we await guidance)?
For any substance that completed an EU C&L Notification and was included in the database of Notifications on or before the 31st of December 2020, they were directly imported into the GB database. Any new substance not included must submit a GB C&L notification if this product/substance is to be placed on the GB market.
3. Does this only count for EU C&L though? What about existing substance but want to source from US instead of EU. I am thinking this previous EU DUIN won't count?
The GB C&L notifications are separate to that of the DUIN notifications. The GB C&L must be processed as seen in the answer to question 2. However, for DUIN this must be carried out for all substances that wish to be placed on the GB market above 1 ton per year following the deadline (28th of October 2021). The DUIN is specific to substance registration while the under UK REACH, while the C&L Notification is governed by the GB CLP Regulations.
4. Are there non-mandatory sections in EU SDS?
All 16 sections of the standard SDS format are required under EU CLP and GB CLP. There are no non-mandatory sections of a SDS, however there is some information in those sections that it is not mandatory to provide. For example, it is not mandatory to include non-hazardous substances in section 3 of the SDS.
5. Will there be a grace period for needing a GB SDS ie current SDSs remain valid?
Currently, the full guidance for GB CLP has not been fully published. Therefore, the SDS and Labels that were incompliance with EU CLP before the end of the Brexit Transition period remain valid until the new Regulations under GB CLP are finalized. At that time, the authority will likely provide a deadline by which the SDS and labels should be updated to follow the GB CLP regulations. At this time no specific deadline has been issued and we await further information from the authorities.
6. Regarding to a mixture with different levels of aquatic toxicity (acute and chronic), will we have a specific webinar to cover the determination of the mixture's ecotoxicological classification?
At this time there are no plans for a webinar on this topic, if there is sufficient interest it may be something we will consider providing in the future.
7. Hi, what do you mean by developing inventories of substances and mixtures. What for? Is a database needed from the CLP standpoint?
It’s to help you clarify your own chemical regulatory obligations, e.g. if you shall comply with chemical regulations, e.g. EU REACH, CLP; who shall take the responsibility, etc.
8. If I am a downstream user, in which situations should I notify the Art. 40 CLP inventory and what information should I include (i.e. how do I find the notification information if my supplier give me nothing)?
You must notify a substance to the Classification and Labelling (C&L) Inventory within one month from being placed on the market and you: Manufacture the substance and it is subject to registration under the REACH Regulation; or Import the substance and it is subject to registration under the REACH Regulation; or Manufacture or import the substance and it is classified as hazardous, irrespective of the quantity; or Import a mixture which contains the substance that is classified as hazardous and is present above the relevant concentration limit, which results in the classification of the mixture as hazardous according to the CLP Regulation; or Import an article containing substances which are subject to registration under Article 7 of the REACH Regulation.
As a downstream user, if your substance is EU REACH registered by your supplier chain, normally the C&L notification is included in their registration dossier. You can check if EU REACH registration No. is available on the MSDS.
9. Have the concentration ranges changed recently? I remember seeing that they were much narrower than +/- 10%.
The latest concentration ranges accepted by MoEL for CBI protection are: 1) below 25% may be +/- 10% and 2) may be equal to or above 25%, +/- 20%
10. If we sell products into Korea that are non-hazardous, do we still need to submit information to MOEL?
It is not a mandatory requirement to submit an SDS to MoEL if the product is non-hazardous, but you still have the option of doing so.
11. Are there R&D exemptions for submitting the SDS?
Yes, R&D chemicals are exempt from requiring an SDS according to Korean GHS.
R&D chemicals are exempt from submitting an SDS to MoEL. However, an SDS still needs to be authored if the chemicals are hazardous.
12. Do I require an SDS for importing mixtures?
Yes, an SDS is required if you are importing a mixture containing hazardous substances (classified according to Korean GHS criterion). There are three options available for submitting the SDS in this case:
1) Submit the SDS with complete ingredients information in section 3 (all hazardous and non-hazardous ingredients listed);
2) Only hazardous ingredients are listed in section 3. Other non-hazardous ingredients are listed in a separate sheet; or
3) Only hazardous ingredients are listed in section 3. A separate sheet signed by overseas manufacturer indicating all other ingredients are non-hazardous (form No.62).
13. If the CAS number is revealed in the EU SDS Section 3, does the CAS number qualify for CBI application in Korea?
CBI protection can only be applied to the chemical name, where you can use an alternative chemical name e.g., generic name or the exact concentration where you can use a concentration range.
14. Were the GHS building blocks and classification hazard categories updated in 2020-130?
Yes, there have been some changes since the revision. Please refer to slides 9 and 10 of the presentation slides.
15. Which GHS revision is Korea GHS aligned with?
Korea is aligned with Revision 4 of UN GHS.
16. Is there any link between the Korean "48 use categories" and the EU REACH use descriptors?
There is not a comparison between K-OSHA usage and EU REACH usage.
17. For revised regulations regarding R&D exemptions, any limit on the volume e.g. if > 1000kgs, does the exemption still holds?
For R&D chemicals, SDS submission is not mandatory. The volume is not mentioned in the regulation. However, it is rare to come across very high volumes of R&D chemicals.
18. Is the Korean OR name and address information for SDS submission to the MoEL required to be listed in section 1 of the SDS?
It is not mandatory to add OR name/address to section 1.
19. When it is mentioned "contact of the importer" on the SDS must be the same entity that as makes the SDS notification to the MoEL? This entity is also the same as the Korean "supplier" in the label?
The supplier info should be the same in section 1 of the SDS and the GHS label.
20. Does the grace period for SDS submission apply to product volume or volume of hazardous substance across all products manufactured or imported which contain it?
The volume applies to each hazardous chemical imported or manufactured in Korea. In other words, it is the annual volume of the chemical in each submitted SDS. Different products with different KR MSDS should be calculated respectively.
21. What about if you import mixtures and SDS is put together for mixtures, how do you calculate the tonnage?
If you are importing mixtures, the tonnage is calculated based on the total tonnage of the mixtures imported to Korea in the previous year.
22. For the Letter of Confirmation meant for custom clearance, is it mandatory to write "CBI" at the "Phase-in Substance(s)"section?
The Letter of Confirmation used for customs clearance applies to the K-REACH regulation which is the regulation for chemical registration in Korea. This is a separate regulation to Korean GHS.
23. For the option of revealing 100% ingredient info on the SDS, can the concentrations be in a range if CBI is granted?
Yes, the concentration ranges can be used in the section 3 of the SDS.
24. If importing a product to Korea and the SDS was not authorized prior to Jan-16-2021, what should be done?
The SDS must be authored according to the latest revision MoEL 2020-130, submitted, and authorized by MoEL before importation to Korea can begin.
25. What is the definition of the Existing KR SDS? The former authorization procedure included which steps?
An existing Korean SDS is an SDS which was authored, submitted, and authorized by MoEL before January 16th, 2021. This SDS is eligible for one of the grace periods subject to the total tonnage manufactured/imported to Korea in the previous year.
26. We are a foreign formulator. What is the company size of CIRS Korea, so we understand the impact on CBI fees?
CIRS Korea is a small sized company. Therefore, the CBI administrative fee for a manufacturer/formulator appointing CIRS as their OR will be charged as a small sized company.
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