Environmentally Hazardous Substances Notification and...

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2012/CTI2/CD/FOR/004 Morning Session II

Environmentally Hazardous Substances Notification and Registration Scheme

Purpose: Information

Submitted by: Malaysia

APEC Chemical Regulators’ ForumSingapore

30 March 2012

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OVERVIEW OF EHS NOTIFICATION AND REGISTRATION SCHEME

Malaysia, as a developed nation by the year 2020, shouldensures that chemicals are produced and used in ways thatminimize the risk and significant adverse impacts on theenvironment and human health with cross‐sectorcommitment by all stakeholders to coordinated approachesand common principles in the adoption and strengthening of

d ti f f d l i ll t i blgood practices for safe and ecologically sustainablechemicals management

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1. Strengthening of legislative framework to manage environmentallyhazardous chemicals

2. Adoption and strengthening measures to reduce risk and manageexposure

3. Building and Strengthening National Capacities to Manage Chemicals

4. Building Information and Knowledge

5. Creating Awareness and Education

6. Monitoring and Evaluation

7 Strengthening and Improving International Cooperation in Chemicals7. Strengthening and Improving International Cooperation in Chemicals

• Under the Danish Environmental Cooperation Program 2003‐2006

Background

• Development Objective : An effective and sustainable managementsystem is established that will minimize andreduce the risks from EHS

• Immediate objective : A draft strategy and action plan formanagement of EHS is agreed

• The online system for EHSNR scheme was launched on 15th July 2008

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• The online system for EHSNR scheme was launched on 15th July 2008

• The scheme is to collect information about EHS and provide information toMalaysian Government

• The EHSNR started in 2009 on voluntary basis until a specific regulation onthe EHS is gazetted and enforced.

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STRATEGY – RISK REDUCTION

STRATEGY AND ACTION PLANS FOR EHS MANAGEMENT IN MALAYSIA

to collect information from industry about thehazardous substances (EHS) that are on the Malaysianmarket

Introducing a notification requirement for suchsubstances manufactured in or imported to Malaysiasubstances manufactured in or imported to Malaysia

Malaysia establish an EHS Notification and RegistrationScheme

The EHS component will target the goal of the National Policy on theEnvironment regarding the development of an environmentally soundmanagement system for EHS.

The EHS Component has its focus on the upstream regulation of EHSThe EHS Component has its focus on the upstream regulation of EHS,i.e. regulation before application takes place, rather than regulation atthe downstream end of the chemical life cycle (waste streams andhazardous wastes).

Tools to be applied at the entry of chemicals into the society, i.e.upstream regulation before application takes place

Life‐cycle of the chemical to be considered

Th EHS t ill t t h i l b t t t l t dThe EHS component will target chemical substances not yet regulatedunder existing legislation covering pesticides, cosmetics,pharmaceuticals or foods.

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National Policy on the

environment (MOSTE, 2002)

Sound management systems for

Ninth Malaysia Plan

Adoption of a global harmonized systemSound management systems for hazardous chemicals and toxic wastes.

Integrating environmental dimensions in the planning and implementation of the policies, objectives and mandates of all sectors to protect the environment

Strengthening the role of the private sector in environmental protection and management

Adoption of a global harmonized system for the registration of imports, transportation and a safe handling of chemical and hazardous substances.

Approaches and technologies to treat and convert toxic wastes into a resource for reuse.

Appropriate incentives for the proper management of hazardous chemicals.

Proper risk assessment techniques and procedures

Steps to address the indiscriminate use of chemicals, particularly in agricultural practices, will be intensified

Many chemical substances and products are currentlyput into market in Malaysia

Background to the Scheme

put into market in Malaysia

The influx of chemicals far surpassed the informationthat are collected

As a result, there is an uncertainty on types of chemicalsused in a wide range of consumer productsg p

Large percentage of existing chemicals have not beenassessed

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Government is concerned about human and environmental

Background to the Scheme

Government is concerned about human and environmentalexposure from toxic substances and unregulated chemicalsused in a wide range of chemical products

Long term persistence and accumulation of manychemicals in eco‐system and humans

Continued use of chemicals with inherently dangerousproperties such as carcinogens, mutagens and reproductivetoxicants and substances dangerous for the environment

Need for an overall strategy and coordination of activitiesin the area of chemicals management as well as anincreased capacity and awareness of chemicalsmanagement issues among stakeholders

Need for information on the use of hazardous chemicals inMalaysia and for implementation of methodologies forassessment risks to human and the environment

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Need for capacity in terms of staff and training for theNeed for capacity in terms of staff and training for themanagement of chemicals in general and particularly withrespect to the use of risk assessment as a chemicalsmanagement tool

To address these needs, an EHS Notification andRegistration Scheme is proposed for implementationg p p punder the EHS Component of the Malaysian‐DanishEnvironmental Cooperation Programme.

For the purpose of Notification and Registration, an EHS is

defined as:

Environmentally Hazardous Substances (EHS)

• “ An EHS is a substance that is assigned a hazard category under the GHS classification scheme or is present on a proscribed list of internationally recognised substances of special concern”

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Purpose


• to provide the necessary information to the Malaysian Government so asto enable the DOE and other agencies involved in chemicals managementto identify substances of concern in the country and make decisions onhow to manage these substances in a safe and sound manner

• Based on the information submitted by industry, the Department ofEnvironment (DOE) will establish a Malaysian EHS Register which willcontain information about;

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‐ the identity of substances that have been notified to DOE,‐ their uses in Malaysia, ‐their hazard classifications and,‐ the accumulated amounts present in Malaysia.

Scope of Scheme


The EHS Notification and Registration scheme covers;

• All substances not covered by other notification/registration schemes inMalaysia and;

• present on the EHS fulfilling the criteria for classification as hazardousaccording to GHS;

• or until GHS is fully implemented the classification according to the

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• or until GHS is fully implemented, the classification according to thecurrent classification requirements for chemicals in Malaysia.

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Scope of Scheme (cont.)


• Other substances that are considered substances of concern due to properties not covered by the GHS classification scheme

• The notification requirement does not apply to substances for which information is already submitted to government agencies in Malaysia by

p ( )

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information is already submitted to government agencies in Malaysia by means of other legislations, unless the substance is also used for other purposes not covered by Pesticides, Poisons and Chemicals Weapons Convention Acts

Who Shall Notify


• The EHS Notification and Registration Scheme is aimed at manufacturers and importers of EHS and importers of chemical mixtures or finished products that contain EHS as their constituents

Who Shall Notify

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• The company is an importer of individual EHS and/or chemical mixtures or finished products containing EHS as constituents above certain cut‐off limits.

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Who Shall NOT Notify (cont )


• Chemical companies involved in formulation, distribution, retailingand use of EHS or EHS containing mixtures/products from locallysourced EHS are NOT subject to notification and registration of EHS

• Chemical industries involved in the manufacture of chemical

Who Shall NOT Notify (cont.)

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Chemical industries involved in the manufacture of chemicalmixtures or products using locally manufactured EHS or importedEHS sourced from local suppliers as raw materials are NOT subjectto notification and registration of EHS.

EHS

Importer

EHS

Manufacturer

WHO SHALL AND SHALL NOT NOTIFY UNDER EHSNR?

Register and Notify

Importer Manufacturer

Importers of EHS substances , mixtures and finished products that contain EHS

Manufactures of EHS substances , mixtures and finished products that contain EHScontain EHS contain EHS

Cut off limit for mixtures/finished products;For EHS ‐ > 1% of the total concentrationFor CME ‐ >0.1% of the total concentration

Locally sourced

EHS

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The Notification Process

BasicAnnually

Notification

BasicJan ‐ June

DetailedOnce Only

Jan ‐ Dec

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• The notification for detailed is to be done once only unless new informationthat change the hazard classification are available for notification

• The notification to be done online at www.doe.gov.my

Basic Detail

Chemical manufacturer or importer areonly required to furnish the followingdata:

Chemical manufacturer or importer are required to furnish the followingdata:

Differences Between Basic and Detailed Notification of EHS

Substance identification (CAS No, EC Noor Index No)Annual tonnage in metric tonsUse of the substanceConcentration interval of substance inraw materials or finished products(maximum and minimum concentration)Economy of export (if imported)

Substance identification (CAS No, EC No or Index No)Annual tonnage in metric tonsUse of the substanceConcentration interval of substance in raw materials or finished products(maximum and minimum concentrationEconomy of export (if imported)

Data on Substance Identification (e.g. structural formula, molecular weight,

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a a o Subs a ce de ca o (e g s uc u a o u a, o ecu a e g ,etc)Data on Physical Chemical Properties (e.g. melting point, auto‐ignitiontemperature, etc)Data on Physical Hazards (e.g. flammability, corrosivity to metals, etc)Data on Hazards to Human Health (e.g. acute toxicity, skincorrosion/irritation, etc)Data on Hazards to Aquatic Environment (e.g. acute aquatic toxicity andproperties like bio‐accumulation, etc)Overall GHS Classification

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ANNUAL TONNAGE(MT)

YEAR OF IMPLEMENTATION FOR EHSNR

2009 2011 2012 2013 2014 2015 2016 2017

IMPLEMENTATION

(MT) 2009 - 2011 2012 - 2013 2014 - 2015 2016 - 2017

> 100 Voluntarynotification

* *

10 -100 * *

1 - 10 * *

*All substances that, under GHS classification, are assigned anaquatic toxicity classification of ‘chronic 1’ or are ‘suspected orknown human carcinogens, reproductive toxicants or mutagens’must also be notified during years 2012 and 2013

EXTERNAL NOTIFICATION

• DOE allows detailed notification to be submitted directly by the overseas suppliers in the case of Confidential Business Information (CBI)Information (CBI)

Register

• Importers to register details of overseassuppliers together with the temporaryusername and password

Notify

• An email will be sent to the overseassupplier to notify about the requestednotificationNotify notification

Submit

• Overseas suppliers will change the usernameand password

• Submission will be directly to DOE

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DECISION

‐Advocacy

‐Enforcement

2017

Authorization

Proposed Road Map for EHS Notification and Registration Scheme

‐Baseline data collected

‐Evaluate and analyze risk assessment

‐Identify the needs

‐Proposed regulation oncontrolling EHS

2013

2015

Evaluation

Authorization

Period of establishing EHS Register (voluntary)

Activities ‐ Awareness/ Outreach

‐ Develop skill in Risk Assessment‐ Assessment

2009

Registration

• There is sufficient information available on the EHS imported into ormanufactured in Malaysia (Malaysian EHS Register)

Benefits of The Scheme

• The scheme provides a means of anticipating potential problems andfacilitate the implementation of timely and appropriate control measuresfor specific EHS

• It helps the industry in identifying likely data gaps which are required forGHS classification of substances and compliance with DOSH regulations.

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• The scheme provides input for the risk assessment of EHS

• It provides a mechanism for identifying, evaluating and controlling of EHS

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Status Report on Voluntary EHS Notification and Registration Scheme (28 December 2011)

EHS Indicators Data

No. of Companies Identified as Potential EHS Notifiers 1134

No. of Chemical Companies Registered To‐Date 321

No. of EHS Entered By Industry Into System 1372

No. of EHS Officially Notified To DOE 726

No. of EHS Not In EHS Reference List (Detailed Notification Required) 176

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( q )

No. of EHS Officially Notified in Detail by Industry to DOE 145

No. of EHS Reviewed and Profiled in Detail by DOE 156

THANK YOU

Thahirah Kamarulzaman/ Nor Azam Bin Abdul Aziz

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Thahirah Kamarulzaman/ Nor Azam Bin Abdul AzizEmail : [email protected] /[email protected] : +60 3 88712000Website : www.doe.gov.my

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