Guidance for the industry
on
The Notification and Registration Scheme of
Environmentally Hazardous Substances (EHS) in
Malaysia
Department of Environment
Hazardous Substances Division
ISBN 978-983-3895-17-5
2nd Edition 2012
FOREWORD
The Environmentally Hazardous Substances Notification
Registration Scheme (EHSNR) has been developed
implemented by the Department of Environment since 2008.
objective of which is to collect information on hazardous
stances that are available or used in the country.
and
and
The
sub
The notification and registration is done electronically through
EHS link that is available on the Department of Environment
website, www.doe.gov.my.
This Guidance document is to facilitate the importers and
manufacturers to notify to the Department of Environment on the
EHS that are important or manufactured.
Halimah Hassan
Director General
Department of Environment, Malaysia
Page
Contents
1.0
Background to the proposed scheme
1
2.0
The Purpose of a Notification and Registration Scheme
1
3.0
Scope of the Scheme 2
4.0
What is an Environmentally Hazardous Substance (EHS)? 2
5.0
Who Shall Notify?
6.0
7.0
Who Shall Not Notify?
3
Substances which are exempted from the EHSNR
8.0
9.0
Substances which are included for the EHSNR
4
Notification
9.1
Pre-Registration
4
9.2
Registration
5
9.3
Type of notification required 5 - 6
9.4
Notification Process 6 - 9
10.0
Period for Notification
10
11.0
External Notification 10
3
3
4
12.0 Proposed Road Map for EHS Notification and 11 - 12
Registration Scheme 13. 0 Proposed Notification Plan
14.0
12
Role of DOE
13
1.0
2.0
Background to the proposed scheme
1.1
At the present there is very limited information available on
the nature and amounts of Environmentally Hazardous
Substances (EHS) present in Malaysia. The Environmental
Quality Act established that there was a need to manage
and control EHS in order to minimise effects to people and
the nvironment. In order to be able to manage the potential
adverse impacts of EHS imported into, produced and used
in Malaysia, the government needs information on the
amounts of such substances that are used.
1.2
While some types and some aspects of chemicals and their
effects are already managed, many chemicals that are poten
tially EHS are not currently managed. The proposed
Chemicals Notification and Registration scheme is
designed
toclose that gap in knowledge and provide
government with theinformation they need.
The Purpose of a Notification and Registration Scheme
2.1
The purpose of the notification and registration scheme in
Malaysia is to provide the necessary information to the
Malaysia Government that will enable the Department of
Environment to identify substances of concern in the country
and make decisions about how manage these substances
in a safe and sound manner.
2.2
Based on the information submitted by industry, Department
of Environment (DOE) will establish the Malaysian
Chemicals Register. The Malaysian Chemicals Register will
contain information about the identify of substances that
have been notified to Doe, their uses in Malaysia, their hazard
market in classification and the accumulated amounts
placed on the Malaysia.
1
3.0
4.0
Scope of the Scheme
3.1
This Scheme will cover all substances not covered by other
notification/registration schemes in Malaysia, and substances
fulfilling
the
criteria
for
classification
as
hazardous in accor dance with Globally Harmonised System
(GHS) or until the full implementation of GHS, in accordance
with the current classification requirements for chemicals in
Malaysia. The scheme also covers substances not covered by
the GHS classification but considered to be substances of
concern.
3.2
This Scheme does not apply to substances from which
information has already been submitted to other government
agencies in Malaysia by means of other legislations, unless
the substance is also used for other purposes not covered by
the Pesticides, Poisons and Chemicals Weapons Convention
Acts.
What is an Environmentally Hazardous Substances (EHS)?
4.1
Environmentally Hazardous Substances (EHS), under the
environmental Quality Act (EQA) 1974, is defined as “any natural
or artificial substances including any raw material, whether in
a solid, semi-solid or liquid form, or in the form of gas or
vapour, or in a mixture of at least two of these s ubstances,
or any living organism intended for any environmental
protection, conservation and control activity, which can
cause pollution”.
4.2
For the purposes of Notification and Registration under
the EQA, an EHS will be defined as follows:
‘“An EHS is a substance that is assigned a hazard
caegory under the GHS classification scheme or is
present on an existing internationally agreed list of
proscribed substances”
2
5.0
6.0
7.0
Who Shall Notify?
5.1
The Scheme The Scheme is aimed at manufacturers and
importers of EHS and importers of chemical mixtures or
finished products that contain EHS as their constituents.
5.2
The Scheme is also aimed at companies importing individual
EHS and/or chemical mixtures or finished products
containing EHS as constituents above certain cut-off limits.
Who Shall Not Notify?
6.1
Chemical industries involved in the manufacturing of
chemical mixtures or products using locally manufactured
EHS or imported EHS sourced from local suppliers as raw
materials are not subject to this scheme.
6.2
Chemical companies involved in formulation, distribution,
retailing and use of EHS or EHS containing mixtures/products
from locally sourced EHS are not subject to this scheme.
Substances which are exempted from the EHSNR
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
l.
m.
n.
naturally-occurring materials
incidental/end-use reaction products
substances formed during the manufacture of an article
mixtures (but not mixture components)
impurities
by-products
non-isolated intermediates
contained site-limited intermediates
transported intermediates
substances manufactured solely for export
substances used in research and development
substances produced for test marketing
low volume substances (<1 tonne per annum)
polymers
3
8.0
Substances which are included for the EHSNR
The N & R scheme will cover substances such as:
a. Petrochemicals including plastics and resins
b. Chemicals in fertilizers and pesticides *
c. Soap and detergents
d. Cosmetics, toiletries and household products
e. Organic chemicals
f. Oleo-chemical products
g. Chemicals in pharmaceutical* products
h. Industrial gases
i. Paints and paints products
j. Basic industrial chemicals
k. Rubber industry
* Not active ingredients which are already regulated
9.0
Notification
1.1
9.1
Pre-Registration
9.1.1
List out chemicals imported or manufactured into a
table which contains;
Name of substances
CAS no/ EC no / Index no
Tonnage imported/manufactured
9.1.2
Prepare any available Material Safety Data Sheet
(MSDS) for each of the substances
9.1.3
Get ready with the document related to the company
registration, i.e. SSM registration number
9.1.4
Go through the guideline or guidance document
provided in
the EHSNR website
at
http://www.doe.gov.my
4
9.2
9.3
Registration
9.2.1
Register your company with the Department of
environment Malaysia to participate in the EHS
NOTIFICATION AND REGISTRATION SCHEME
This can be done by logging into the DOE website
(http://www.doe.gov.my) and activating the menu on
EHS Notification and Registration. Select the option
on Company
Registration
in
the resultant
output to register your company. A letter of approval,
sent by e-mail, will be communicated to you once the
registration is verified and approved by the
Department.
9.2.2
Fill in all the empty boxes provided. Boxes with * are
mandatory. Submission for registration cannot be
done without completing all the relevant fields re
required. Once completed, click the “submit” button.
9.2.3
The submission will be reviewed by DOE and once
approved a confirmation letter will be send directly
to the registered email. Users now can start enter
the system by using the registered username and
password.
Type of notification required
9.3.1
Check whether your substance required Basic or
Detailed Notification. This can be done by providing
the substance CAS/EC/Index No. in the box
provided at the homepage.
9.3.2
Substances which are already listed in the EHS
reference List or CMR Reference List are required
t o do Basic Notification only
9.3.3
Substances which are Not Listed in the EHS Refer
ence List or CMR Reference List are required to go
for further clarification. There are two possibilities;
5
i)
The substance may be classified as not
hazardous based on the GHS hazard
classification. The Manufacturer/Importer
(M/I) are required to go through the
substance Material Safety Data Sheet and
search for any clues or statements which can
relate the substance as hazardous or not
hazardous.
ii)
The substance is not yet classified and there
fore is not yet listed in the list. In this case, M/I
are required to submit additional information
(Detailed Notification) together with the basic
information. The information required are;
a.
b.
c.
d.
e.
f.
9.4
Data on Data on Substance
Identification (e.g. structural formula,
molecular weight, etc)
Data on Physical Chemical
Properties (e.g. melting point,
auto-ignition temperature, etc)
Data on Physical Hazards (e.g. flam
flammability, corrosivity to metals, etc)
Data on Hazards to Human Health
(e.g. acute toxicity, skin corrosion/
irritation, etc)
Data on Hazards to Aquatic
Environment (e.g. acute aquatic toxicity
and properties like bioaccumulation, etc)
Overall GHS Classification
Notification Process
9.4.1
1.1.1
A two stage approach is recommended to chemical
industries for the Notification and Registration of EHS.
Once access to your company private domain or win
window is obtained, i.e. after entering the User ID
and Password, follow the procedures listed below:
6
9.4.2
9.4.1.1
Active the menu on Basic Notification of EHS to
undertake a basic notification for each hazardous
substance which you have finalized. On
completion of data entry, check for correctness of
your data before submitting the information to
DOE, since information once submitted will not be
subject to any changes. Repeat the basic
notification for all substances in your list. A display
listing all substances entered into the system and
notified by your company is available for your
viewing and printing, if required. Explanatory texts
to assist you in entering the data as well as how to
proceed with the notification process are given in
the system.
9.4.1.2
Once the basic notification has been completed,
a detailed notification can then be undertaken. In
this case, the substances which require detailed
notification will be listed when the menu Detailed
Notification of EHS is activated. Select a particular
substance to begin the detailed notifications
process. (Note: All six sets of data, i.e. EHS
Identification, Physical Chemical Properties,
Physical Hazards, Hazards to Human Health,
Hazards to Aquatic Environment and Overall GHS
Classification must be completed before submitting
the data to the Department of Environment Malaysia).
If a substance had been previously notified in detail
(e.g. in the previous year), a detailed notification of the
said substance is not required anymore. However a
new detailed notification of the substance should be
made if new data are available to the company. In this
case, detailed data previously notified can be accessed
and edited to reflect the changes
7
9.4.3
Notification has to be done online at EHS Notification
and Registration website. The website can be
accessed at www.doe.gov.my or www.e-ehs.gov.my
9.4.4
To start with the notification, please login to the system
by using the registered username and password.
9.4.5
Click “Notify Substance” and fill in the information
required. Click save in order to save the data without
submitting first and click submit to completely submit
the data to the department. M/I are advised to check
the data completely before submitting to DOE. Please
take note that no changes are allowed after the data
submitted to the department.
9.4.6
For substances that are unable to be classified due
to lack of data or data cannot be submitted due to no
information available, the M/I can submit the
notification with reasons on why those information
cannot be submitted.
9.4.7
Importers can request the overseas suppliers to submit
detailed notification on behalf of them in case where the
substances are classified as confidential. Please refer
to the external notification for further explanation.
9.4.8
The differences between Basic Notification and
Detailed Notification are shown in the table 1 below;
Table 1: Differences Between Basic and Detailed Notification of EHS
Basic
Detailed
Chemical manufacturer or
importer are only required to
furnish the following data;
Chemical manufacturer or
importer are required to furnish
the following data;
8
Substance identification (CAS
No, EC No or Index No)
Substance identification (CAS
No, EC No or Index No)
Annual tonnage in metric tons
Annual tonnage in metric tons
Use of the substance
Use of the substance
Concentration interval of
substance in raw materials or
finished products (maximum and
minimum concentration)
Concentration interval of
substance in raw materials or
finished products (maximum and
minimum concentration
Country of export (if imported)
Country of export (if imported)
Data on Substance Identification
(e.g. structural formula, molecular
weight, etc)
Data on Physical Chemical
Properties (e.g. melting point,
auto-ignition temperature, etc)
Data on Physical Hazards (e.g.
flammability, corrosivity to metals,
etc)
Data on Hazards to Human
Health (e.g. acute toxicity, skin
corrosion/irritation, etc)
Data on Hazards to Aquatic
Environment (e.g. acute aquatic
toxicity and properties like
bioaccumulation, etc)
Overall GHS Classification
9
10.0
Period for Notification
10.1 For the purpose of this notification, the recommended period
for industries to submit Basic Notification is from January to
June. Notification to be done annually based on the previous
year data.
10.2 The recommended notification period for Detailed Notification
is from January to December. Notification for detailed
notification is only required once unless there are some major
changes in the hazard classification for the substance. Once
submitted the substance will be registered in the list and
therefore the substance will fall under Basic Notification in
the following year.
11.0
External Notification
11.1
In the case where Manufacturer/Importer (M/I) cannot
provide the data due to the reason that the overseas supplier
classifies the substance as Confidential Business Information
(CBI), the M/I can request the overseas suppliers to notify it
directly to DOE. This is known as “external notification” and
can only be done online through registration by local
Malaysian companies.
11.2
Malaysia companies who want to request overseas suppliers
to notify on behalf of them due to the confidential issues can
register their overseas suppliers in the system.
11.3
The overseas suppliers will receive a notification email
together with the auto generated username and password.
The overseas suppliers can immediately change to their own
preference username and password. Local companies who
make the request can only monitor the notification made by
the overseas suppliers by logging to the system.
11.4
Request made to the overseas suppliers on the same
substance will be based on the first notification request only.
Other notifiers will be sharing the same submission made for
the first notifier.
10
12.0 Proposed Road Map for EHS Notification and Registration Scheme
2017
Authorization
2015
Evaluation
2013
Registration
2009
The EHS Notification and Registration (EHSNR) Road Map
•
•
•
2009 to 2013 – set up initial inventory by encouraging importers and
manufacturers of substances classified as hazardous to register
and submit the notification. This scheme will remain as voluntary
and industries can continue to do the registration and notification on
the following years.
2013 to 2015 – during this period, the department will start on
evaluating substances and establish prioritise list base on certain
criteria for risk assessment.
11
•
•
•
•
•
2015 to 2017 – during this period, the risk assessment measures
proposed on selected substances will be identified and substances
which are potential to cause bad impact to the environment will
be managed by introducing some control measures to control the
usage of that particular substance in the country.
2017 onward – Control measures on selected substances, such as
regulation to control single substance, will be introduced.
13. 0
Proposed Notification Plan
ANNUAL
TONNAGE
(MT)
> 100
10 -100
1 - 10
PROPOSED YEAR FOR NOTIFICATION
2009 2013 2015 2017 2012
2014
2016
2018
Initial
Baseline
Data
Collected
*
*
*
*
*
*
The main objective of introducing this table is just for helping the industries
on steps that they might want to follow for the notification process. Since
the scheme is a voluntary scheme, industries have their own choices of
submitting the notification to the department.
2013 – 2014: All substances that, under GHS classification, are assigned
an aquatic toxicity classification of ‘chronic 1’ or are ‘suspected or known
human carcinogens, reproductive toxicants or mutagens’ and those which
the accumulated tonnage imported or manufactured more than 100 MT are
encouraged to notify during years 2012 and 2013
2015 – 2016: During this period industries can focus on accumulated
tonnage between 10 – 100 MT
2017 – 2018: During this period focus should be given to those accumulated
tonnage of 1
12
14.0
Role of DOE
14.1 DOE will check the substance classification data supplied by
the M/I for;
a.
b.
c.
Accuracy and self consistency.
Consistency of classification assigned
with those by other M/I and/or Department
of Occupational Safety and
Health DOSH) to that substance.
Correct assignment of GHS classification
based on the substance data supplied
and GHS classification rules.
14.2 In the case of DOE disputing the GHS classification assigned
by the M/I, there will be discussion between DOE and the M/I
to resolve any disagreement or misunderstanding. If
agreement still cannot be reached, the Technical
Committeeon Classification will decide on the agreed GHS
classification.
14.3 Once the GHS classification has been accepted, DOE will
enter the substance and the associated data into the Register
of Notified Substances (EHS Register).
Hazardous Substances Division
Department of Environment
Putrajaya
13