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___________________________________________________________________________ 2010/SOM1/CD/WKSP/011 Agenda Item: Afternoon Session I Environmentally Hazardous Substances Notification and Registration Scheme Submitted by: Malaysia Case Study Workshop on the Chemicals Sector - From Principles to Practice Hiroshima, Japan 1-2 March 2010

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Page 1: Environmentally Hazardous Substances Notification and ...mddb.apec.org/Documents/2010/CDSG/WKSP1/10_cd_wksp1_011.pdf · will minimise and reduce the risks from Environmentally Hazardous

___________________________________________________________________________

2010/SOM1/CD/WKSP/011 Agenda Item: Afternoon Session I

Environmentally Hazardous Substances Notification and Registration Scheme

Submitted by: Malaysia

Case Study Workshop on the Chemicals Sector - From Principles to Practice

Hiroshima, Japan1-2 March 2010

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www.doe.gov.my

Department of Environment, Malaysia

ENVIRONMENTALLY HAZARDOUS SUBSTANCES (EHS)

NOTIFICATION AND REGISTRATIONSCHEME

Dr.Ab. Rahman Awang ([email protected]) and Hanili Ghazali ([email protected])

EHS Notification and Registration Scheme

ROAD MAP FOR PRESENTATION

Background to proposed scheme Need for the Chemical Management The notification scheme - objectives and purpose, definition of

EHS, scope, substances to be notified, exemptions from notification and who to notify

The notification process – types of notification, data to be submitted, when and how to notify

Proposed implementation of the scheme Expected output and benefits of the scheme Conclusion

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EHS Notification and Registration Scheme

Background to the Proposed Scheme

Many chemical substances and products are currently put into market in Malaysia

The influx of chemicals far surpassed the information that are collected

As a result, there is an uncertainty on types of chemicals used in a wide range of consumer products

Large percentage of existing chemicals have not been assessed

Government is concerned about human and environmental exposure from toxic substances and unregulated chemicals used in a wide range of chemical products

Long term persistence and accumulation of many chemicals in eco-system and humans

Continued use of chemicals with inherently dangerous properties such as carcinogens, mutagens and reproductive toxicants and substances dangerous for the environment

EHS Notification and Registration Scheme

Need for the Chemicals Management

Need for an overall strategy and coordination of activities in the area of chemicals management as well as an increased capacity and awareness of chemicals management issues among stakeholders

Need for information on the use of hazardous chemicals in Malaysia and for implementation of methodologies for assessment risks to human and the environment

Need for capacity in terms of staff and training for the management of chemicals in general and particularly with respect to the use of risk assessment as a chemicals management tool

To address these needs, an EHS Notification and Registration Scheme is proposed for implementation under the EHS Component of the Malaysian-Danish Environmental Cooperation Programme

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EHS Notification and Registration Scheme

EHS Component Objectives

Development objective:

An effective and sustainable management system is established that will minimise and reduce the risks from Environmentally Hazardous Substances

Immediate objective:

A draft strategy and action plan for management of Environmentally Hazardous Substances is agreed among ministerial agencies involved in management of chemicals and their capacity forenvironmentally sound management of hazardous chemical substances has increased as a result of training and implementation of management systems and assessment schemes

EHS Notification and Registration Scheme

What is EHS? EHS are defined in Section 2 of the Environmental Quality Act, 1974

(Act 127) 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 substances or any living organism intended for any environmental protection, conservation and control activity, which can cause pollution

For the purposes of Notification and Registration under the EQA 1974, the following definition is used:

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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EHS Notification and Registration Scheme

The Malaysian EHS Reference List

The EHS Reference List adopted by the Department of Environment Malaysia is based on the proposal for a harmonised European list of classification and labelling of substances according to GHS. This list has been translated from the harmonised classification and labelling in the European Annex VI to the REGULATION (EC) No 1272/2008).

Annex VI contains at approximately 3427 individual substances. The reference list also includes a number of substances considered of global concern because of endpoints not covered by the GHS

classification system.

EHS Notification and Registration Scheme

About EHS Notification and Registration Scheme

Objective

The EHS Notification and Registration Scheme of the Department of Environment Malaysia (DOE) is a scheme to collect information from the chemical industry about environmentally hazardous substances in Malaysia.

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Screenshot from N&R Website

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EHS Notification and Registration Scheme

The Purpose of EHS Notification and Registration Scheme

To provide the necessary information to the Malaysian Governmentso as to enable the DOE and other agencies involved in chemicalsmanagement to identify substances of concern in the country and make decisions on how to manage these substances in a safe and sound manner

To establish a Malaysian EHS Register. The Malaysian EHS Register will contain information about the identity of substances that have been notified to DOE, their uses in Malaysia, their hazard classifications and the accumulated amounts present in Malaysia

EHS Notification and Registration Scheme

What is covered under the Scheme?

Covers all substances not covered by other notification/registration schemes in Malaysia and present on the EHS fulfilling the criteria for classification as hazardous according to GHS, or until GHS is fully implemented, the classification according to the current classification requirements for chemicals in Malaysia.

Other substances that are considered substances of concern due to

properties not covered by the GHS classification scheme

What is not covered under the Scheme? Substances for which 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

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EHS Notification and Registration Scheme

Substances Included in the EHS Notification

1 Petrochemicals including plastic and resins

2 Chemicals in fertilizers

3 Soaps and detergents

4 Organic chemicals

5 Oleo-chemicals

6 Industrial gases

7 Paints and paint products

8 Basic industrial chemicals

9 Rubber industry chemicals

EHS Notification and Registration Scheme

Substances Exempted from NotificationNo Substance Type

1 Naturally-occurring materials e.g. minerals, ores and ore concentrates as well as cement clinker

2 Incidental/end-use reaction products3 Substances formed during the manufacture of an article4 Mixtures (but not components of mixture )5 Impurities6 By-products7 Non-isolated intermediates ie chemical substances used to manufacture other

chemical substances that are never separated from the mixture of other chemicals inside a closed system

8 Contained site-limited intermediates9 Transported intermediates10 Substances manufactured solely for export11 Substances used in research and development12 Substances produced for test marketing

13 Substances produced in low volume (<0.1 tonnes per annum)

14 Imported finished consumer products, e.g. household products. However, it is likely that these may be covered at a later stage of the EHS Notification and Registration Scheme

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EHS Notification and Registration Scheme

Who Shall Notify

Manufacturers and importers of EHS and importers of chemical mixtures or finished products that contain EHS as their constituents

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

Who Shall Not Notify

Chemical industries involved in the manufacture of chemical mixtures or products using locally manufactured EHS or imported EHS sourced from local suppliers as raw materials are NOT subject to notification and registration of EHS.

Chemical companies involved in formulation, distribution, retailing and use of EHS or EHS containing mixtures/products from locally sourced EHS are NOT subject to notification and registration of EHS

EHS Notification and Registration Scheme

The Notification Process

The Notification of EHS to DOE by chemical industries shall be done in two stages:

– Basic Notification: A basic notification of EHS must first be made by all manufacturers and importers

– Detailed Notification: A follow-up detailed notification is also required, if the EHS is not the EHS Reference List

The basic notification of EHS is to be carried out annually, at the beginning of the year (data of past one/two year). Detailednotification if required will only be carried out once, unless new information that change the hazard classification are available for notification

The notification and registration shall be done on-line through the DOE’s official website at www.doe.gov.my

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Difference Between Basic and Detail Notification of HS

Basic Notification Detail Notification

Chemical manufacturer or importer are only required to furnish the following data:

Chemical manufacturer or importer are required to furnish the following data:

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 concentration) Country 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 concentration 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 bio-accumulation, etc)Overall GHS Classification

EHS Notification and Registration Scheme

Implementation

The Notification and Registration of EHS by chemical industries in Malaysia will be implemented in phases. Initially the scheme will be introduced on a voluntary basis (2009).

When legislation is in place (expected date after 2010) to start phasing in the scheme, manufacturers and importers covered by the first phase will be required to notify their substances. The notification will be phased in based on tonnage and toxicity.

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EHS Notification and Registration Scheme

Implementation

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’ (+) must also be notified during years 2011 and 2012

Annual Tonnages

(MT)

Year of Implementation of EHS Notification

2009 2010 2011 2012 2013 2014 2015 2016 2017

> 100Voluntary

Notification

* + * +

10 –100

* + * +

1 – 10 * + * +

0.1 - 1 * + * +

Prepare an Inventoryof all Substances

and Amounts

Are Substances EHS?

Retain Data for DOE Audit

Inventory of EHS and Amounts

Are Amounts > 0.1 Tpa?

Retain Data for DOE Audit

Inventory of Notifiable

EHS and Amounts

Check RequirementsFor Phase In

Is my Sector and Tonnage

Notifiable now?Retain Data And Notify at

Appropriate Time

No

No

No

Yes

Yes

Yes

How do I Notify?

Complete –forms to

Notify Each EHS

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EHS Notification and Registration Scheme

Benefits of Scheme

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

There is sufficient information available on the EHS imported into or manufactured in Malaysia (Malaysian EHS Register) so as to be able to identify priority substances and enable protection of people and the environment from the possible harmful effects of these substances

The scheme provides a means of anticipating potential problems and facilitate the implementation of timely and appropriate control measures for specific EHS

The scheme provides input for the risk assessment of EHS and thereby a means of anticipating potential problems and facilitate the implementation of timely and appropriate control measures for specific EHS. It provides amechanism for identifying, evaluating and controlling of EHS

EHS Notification and Registration Scheme

Awareness Raising and Training

The DOE and CICM conducted awareness seminar for importers and manufacturers of EHS

Hands-on training were conducted for importers and manufacturers of EHS to familiarise with the on-line EHSNR system

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EHS Notification and Registration Scheme

Status Report on Voluntary EHS Notification and Registration Scheme (21January 2010)

EHS Indicators Data

No. of Companies Identified as Potential EHS Notifiers 1084

No. of Chemical Companies Registered To-Date 154

No. of EHS Entered By Industry Into System 346

No. of EHS Officially Notified To DOE 215

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

60

No. of EHS Officially Notified in Detail by Industry to DOE 29

EHS Notification and Registration Scheme

CONCLUSION

The EHS Notification and Registration Scheme is the initial effort of getting information and enabling the prioritisation, risk assessment, risk reduction strategy and the risk reduction actions to be taken in the future.

Much work is needed to achieve sound management of EHS. Therefore, the need for all those involve in EHS to commit and work together is imperative because how everyone handle and manage EHS will determine its impact and the future of the people and the environment.

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THANK YOU