These are example questions and answers (accurate at the time) from the Antea Griup Global RegSupport HelpDesk. See http://us.anteagroup.com/en-us/services/operational-performance-and-assurance/global-regsupport-help-desk for more information.
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Antea Group Global RegSupport HelpDesk
1.
2. Ministry of Employment and Labor Public – Standard
for Classification Labeling of Chemical Substance and
Material Safety Data Sheet
Regulation in Question
(Korea)
3. Response:
In the case of imported substance, a domestic contact is needed
to be included in Section 1 of the MSDS (SDS) which includes
company name, address and emergency phone number.
Is the requirement to include a domestic
contact mandatory?
4. Response:
"Supplier" is defined in the requirement as the Korean-based
manufacturer, importer, distributor and/or any company who is
in charge of 'supplying' the substance to the markets of Korea.
As long as the legal entity or third party is in charge of supplying
the substance in the country, it can be qualified as 'supplier'.
What is implied by the term supplier? Does this
include any legal entity or third party in Korea?
5. Response:
In-country emergency phone number of a 'supplier', as defined
above, is required to be added to the MSDS (SDS) to any
chemical placed on the market in Korea.
Do you need an in-country emergency phone number
from the actual supplier or does the emergency phone
number from a third party provider such as CHEMTREC
sufficient?
6. Potential minimal air emissions and sink in new
laboratory
Regulation in Question
(United States)
7. Response:
There are two options concerning the new R&D laboratory at the facility:
1. If the facility is a true minor source for air permitting, then the facility should update
the facility inventory to document emissions from the laboratory and to ensure that
the facility can remain a true minor. No agency notification is required.
2. If the facility is currently operating as a Synthetic Minor or Title V air permit source,
then the facility will need to update the current air permit to add the laboratory to
the permit.
It is recommended that the client document projected actual emissions vs. potential
emissions from the proposed laboratory process, and if needed, update any current air
permit; or retain emissions as part of the emissions inventory as a true minor facility.
Is there any concern to obtain air permit at these low
levels? Is a potential to emit calculation needed to
document that we do not “trigger” a permit?
8. Response:
Assuming that the sink discharges to the facility’s sanitary sewer system, the sink in the
laboratory will not require a wastewater discharge permit or notifications. Wastewater
discharge permits are only required for operations that require pre-treatment prior to
discharge to the Publically Owned Treatment Works (POTW), or for significant (>~25,000
gallons per day) process wastewater discharge. These requirements apply to ‘categorical’
dischargers where potential untreated pollutants may ‘upset’ the POTW wastewater
treatment, or for large industrial operations that use and discharge significant amounts of
water. Local sewer ordinances also prohibit certain direct discharges to sewers including
flammable materials, toxic materials, materials < pH5 or > pH11, etc. It is recommended
that the site be able demonstrate knowledge and compliance with local sewer
regulations.
Is a permit or notification required for
sinks located in labs?
10. Response:
Every company in Belgium has to establish an Internal Department for Health & Safety at work
(IDHSW). This IDHSW has several obligations for promoting and monitoring Health and Safety at
work. Depending on the size and the type of the company, this IDHSW can be managed by the
employer himself if the number of employees is below 20. For companies with > 20 employees a
safety officer has to be appointed. This safety officer has to have specific basic knowledge (Level 1 /
2 / 3) of Health & Safety at work, also depending on the size and type of activities (NACE‐code) of
the company.
In Belgium the following required level of knowledge for the Safety Officer exists:
‐ Level 1 Safety Officer ≥ 499 (or 1000) employees
‐ Level 2 Safety Officer ≥ 199 (or 499) employees
‐ Level 3 or basic knowledge ≤ 99 (or 199) employees
Polish law requires that any offices with more than 100
associates needs to have a training and designated
safety professional on staff, does any similar
requirement exist in Belgium?
11. Response:
The employer is required to ensure the health and safety of the employees in all areas
linked to work. Depending on the size of the workplace, he or she can make use of
internal or external experts to provide a health and safety service but ultimate
responsibility remains with the employer. Part of the responsibility is to inform and
consult with employees and their representatives.
In Luxembourg, beside the employer, the following people have obligations related to
Health & safety at work:
• •an designated worker;
• •the employee delegate for safety
Polish law requires that any offices with more than 100
associates needs to have a training and designated
safety professional on staff, does any similar
requirement exist in Luxembourg?
13. Response:
As per advice from the Ministry of Environment and
Urbanization (Ministry):
The new “REACH Regulation” has not yet officially come into
force; the Ministry is still working on the Regulation at the time
this response was prepared.
Is the regulation in force today?
14. Response:
As per advice from the Ministry of Environment and
Urbanization (Ministry):
The new REACH Regulation will apply to both producer of
substances and importer of substances.
Does it apply to just substances or to
substance/manufacturer or the importer?
15. Response:
As per advice from the Ministry of Environment and
Urbanization (Ministry):
The Ministry did not want to make net comments relating to
whether a substance (specifically carbon black) if registered by
one supplier is another (different) supplier covered, because the
related areas of the Regulation are still under development and
subject to revisions at the time this response was prepared.
If a substance (specifically carbon black) is already
registered by one supplier, is another different
supplier covered?
16. Response:
As per advice from the Ministry of Environment and
Urbanization (Ministry):
At the time this response was prepared, the REACH regulation
has not been published. However, Antea®Group provided the
current and valid regulation, “Regulation on the Inventory and
Control of Chemicals” in English translation.
Is there a public English translation
available?