MalaysiaMalaysia

Update on “draft” proposal for the Environmentally Hazardous Substance

(“EHS”)Notification and Registration Scheme

PURPOSE“Identify substances of concern and make decisions about how to

manage these substances in a safe and sound manner”

Regulations not yet finalized or published Voluntary in 2009; mandatory requirement in 2010

Data in Register of Notified Substances to be used to prioritize substances for further risk assessment

Probable that Register of Notified Substances and all non-confidential substance information in database will be publicly available

Environmentally Hazardous Substances Notification and Registration Scheme

Environmentally Hazardous Substances Notification and Registration Scheme

Environmentally Hazardous Substances (“EHS”) requirements implemented and managed by Dept of Environment (DOE)

“An EHS is a substance that is included in the EHS Reference List (EU Annex I + CMR), or if not on the list, must be assigned a hazard category under the GHS classification scheme, as implemented by the Department of Occupational Safety and Health Malaysia.”

Reference lists searchable by function, CAS on website http://www.e-ehs.doe.gov.my/

Manufacturers and importers of “EHS” must notify substances and report volumes and other information to DOE

Reporting at “chemical substance level” if chemical is ‘EHS’ ‘EHS’ components of mixture reportable if >1% even if mixture

itself not hazardous

EXEMPTIONS

Pesticides, poisons and CWC Unless used for purpose other than currently regulated

Medical and dental products

Consumer products out of scope for now Future regulations will bring into scope

Articles - definition not decided

Environmentally Hazardous Substances Notification and Registration Scheme

BASIC NOTIFICATION for SUBSTANCES on REFERENCE LIST

Substance Identification - CAS, EC No. or Index No. Annual volume in kg or metric tons Use information Concentration range in products Country of export (for imports)

DETAILED REGISTRATION for SUBSTANCES not on REFERENCE LIST

Chemical identity, structural formula, MW Physical properties Toxicity data Ecotoxicity data GHS Classification

Environmentally Hazardous Substances Notification and Registration Scheme

CRITERIA FOR REPORTING Within volume bands

Regardless of volume CMR as defined by list on website in 2010, 2011 Chronic aquatic toxicity category 1 in 2010, 2011

YEAR kg/yr

2010, 2011 >100,000 kg/yr

2012, 2013 >10,000 to 100,000

2014, 2015 >1,000 to 10,000

2016 >100 to 1000 kg/yr

Environmentally Hazardous Substances Notification and Registration Scheme

Requirements not finalized or published; program is to be mandatory in 2010

Intended to use GHS classifications; GHS not yet implemented by DOSH; can use CPL, EU or GHS classification (??)

CBI concerns Obtaining supplier information; reporting supplier

information DOE Considering 3rd party provisions

Volume information is reportable What information will be publicly disclosed?

CBI allowed for company name, use and volume CBI allowed for chemical identity if <3 notifications

Environmentally Hazardous Substances Notification and Registration Scheme

Implementation and management Department of Occupational Safety and Health Malaysia (DOSH)

http://www.dosh.gov.my/ (no actual reference to GHS) Is intended to replace requirements issued in 1997 for

Packaging, Classification, Labeling and Safety Data Sheets for chemicals

Industry is still waiting for final requirements and regulations (should be in 2009)

Full enforcement is planned for 2010

MALAYSIAGHS

http://www.e-ehs.doe.gov.my/

To view the database, use general user ID and password for company registration: User ID: test password: test1

To actually enter data and notify/register substances, each company must obtain their own registration number

MALAYSIAfor more information.…

Environmentally Hazardous Substances (‘EHS’) Reporting-Industry Concerns and Discussion Points

Requirements not yet finalized and published (yet program is to be mandatory in 2010)

Environmentally Hazardous Substances (‘EHS’) Reporting -Intended to align with GHS (‘EHS’ based on GHS classification) but GHS (by DOSH) is not yet implemented

Reporting for components of formulations could be problematic• Purchased components• Confidential Business Information issues

Environmentally Hazardous Substances (‘EHS’) Reporting-Industry Concerns and Discussion Points

CBI is a significant issue for the DOE as well as industry.

Industry needs to protect critical information on composition and distribution of some products.

The Government burden for CBI protection could be extensive and expensive.• Information shared with other agencies or groups?• Use of contractors in handling or to access of

information?