Chemical Notification/Food Contact

World Summit 2009

Arlington VA

September 2009

Taiwan New Chemicals Control Regulation

Dereke Tsao

Taiwan / Taipei

Ashland

Ashland Aqualon Functional Ingredients

Ashland Hercules Water Technologies

Ashland

Performance Materials

Ashland Consumer Markets

Ashland Distributions

Content 11:20 – 11:55

How Taiwan government plans to construct their Taiwan Existing Chemicals List.

A preview of the Taiwan New Chemicals Nomination & Notification procedure.

What concerns Taiwanese chemical industry?

Actions for your company to undertake now.

How to participate this exercise if you are not in Taiwan.

Taiwan New Chemicals Control Regulation

Authorities in charge of chemicals Current chemicals regulations in Taiwan New regulation Actions Contact

Taiwan Gov. Dept. in charge chemicals

Taiwan Council of Labor Affairs www.cla.gov.tw/

− Labor Safety & Hygiene− Dangerous & Hazardous Chemicals− GHS http://ghs.cla.gov.tw/ (Registration required)

− New Chemicals Regulation

Taiwan EPA www.epa.gov.tw/

− Toxic Chemicals− VOCs− Environmental hygiene chemicals− Pollution control chemicals− Environmental hygiene antimicrobial chemicals

Council of Agriculture www.coa.gov.tw

− Pesticides

Industrial Bureau www.moeaidb.gov.tw/− In charge CWC

Taiwan Current Chemicals Control Regulations

Taiwan does not have new chemicals control mechanism installed

We do not know what is out there on Taiwanese market

Chemicals that are controlled:− Dangerous & Hazardous chemicals− Toxic chemicals− CWC chemicals− Environmental hygiene chemicals− Pollution control chemicals− Environmental hygiene antimicrobial

chemicals− Pesticides

Regulation of Labelling and Hazard Communication of Dangerous and Harmful Materials [TW HAZCOM / GHS] 2007.10.19

− CNS 6864 Z5071 2006.10 Transportation Label for Dangerous Goods

− CNS 15030 Z1501 2006.10 Chemicals classification & labelling [GHS]

Taiwan GHS implemented 2008.12.31

− PHASE I: 1062 chemicals, transit period.• TW HAZCOM : 413 chemical substances• 以勞安 3 字第 0970146313 號令 : 649

chemical substances

− PHASE II: 2010, mandatory GHS label for 1062 chemical substances.

Taiwan Current Chemicals Control Regulations

Toxic chemicals− Regulation of toxic chemical substances

administration.− 259 toxic substances are listed

Taiwan Current Chemicals Control Regulations

WHY:− Protect Taiwanese people health− International society wave – SAICM− Cooperate in GHS

HOW:− Build Taiwan Existing Chemicals List – NOMINATION− Control new chemicals not on TECL – NOTIFICATION

Taiwan New Chemicals Control Regulations

WHO:− Manufacturers / Importers− Government agencies

• Council of Labor Affairs• SAHTECH (Safety & Health Technology Center)

WHEN:− From now till July 2010: NOMINTION− 2010 July – 2011 July: Build TECL− 2011 July: NOTIFICATION

Taiwan New Chemicals Control Regulations

TECL NOMINATIONNOMINATION of Taiwan Exisitng Chemicals

Guidance for Existing Chemical Substance Nomination (ECN)[ 2009 3rd Revised Draft][2009.8]

WHO:− Local manufacturers− Local importers− Off-shore exporters ( chemicals -> Taiwan)

HOW:− Use official tool – EXCEL program provided

by Taiwanese government (CLA)• General version• Database version

TECL NOMINATIONNOMINATION of Taiwan Existing Chemical Substances

WHAT can be nominated:− 15 years prior to new chemicals regulation

promulgated.− Imported chemicals− Local manufactured chemicals− Locally treated, use, sold chemicals− Need provide evident documentation

• Not required when submit nomination list.• Need to present the document if inquired by

regulatory agency (SAHTECH).• If evident doc. Not available, company

statement may be accepted but not guaranteed.• If lacking of evident documentation, the whole

nomination list submitted may be rejected and a new resubmission will be required.

TECL NOMINATIONNOMINATION CONTENT

Nominator (company) basic information Chemical Abstract Service Registry Number,

CAS No. Chemical substance Chinese / English name

− Nomenculture• Chinese name refer to

Taiwanese guide of chemical substance nomenculture

• English name follows IUPACs rule.

QTY 6 levels > 1000 ton / yr 100 – 1000 ton / yr 10 – 100 ton / yr 1 -10 ton / yr 10 -1000 Kg / yr < 10 Kg / yr

TECL NOMINATIONNOMINATION INFO. CONFIDENTIALITY

Information automatically protected:− Company (nominator) basic information.− Average quantity

Apply for confidentiality− Criteria:

• Company proprietary commercial information.• Company has taken proper action to protect the

information confidentiality and will maintain it.• Can not be obtained via other companies.

Public information:− Chemical name− CAS No.

NOTIFICATION Guidelines for New Chemical Substance

Notification (NCN) [2009 2nd Revised Draft][2009.04]

Exclusion• Natural substance or natural polymer untreated

physically or chemically.• Chemical substance that is used for machine or

equipment trial.• Intermediate that can not be isolated from the

chemical reaction in reactor or within manufacturing process.

• Chemicals for the purpose of national security and national defense.

• Impurity or by-product without commercial value.• Customs supervised materials• Mixture that does not contain any new chemical

substances.• Waste• 2% Polymer Rule• Chemical substances that is subject to other

regulatory control, ex. food additives, drugs etc.

Taiwan New chemicals Notification

NOTIFICATION

Notification Type

Simplified Notification− Manufacturing or import < 1000 kg / Yr− R & D chemical substances < 100 Kg / Yr− Low concern polymer

Completed Notification (2 scenarios)− Listed on 2 countries from U.S.A., EU,

Japan, China, Canada, Australia• Working days: 30 days

− Exclude from simplified notification and not listed on any of the 6 countries.

• Working days: 90 days

NOTIFICATION

Notification Dossier

Simplified Notification1. General Information2. GHS classification and labelling3. Safe Use Information4. Polymer identification data

Completed Notification1. General Information2. GHS classification and labelling3. Manufacture, Use & Exposure4. Physical & chemcial properties5. Environmental fate and path ways6. Ecotoxicological Information7. Toxicological information8. Analytical Methods9. Guidance on safe use10. Literature search11. Assessment reports

Actions – prepare yourself

Start Now! Nominate your ECL! Collect full chemical substances list in your

company that has been exported or manufactured in Taiwan in the past 15 years.

Use official EXCEL tool files Nominate chemical substances Find local contact in Taiwan (optional) Submit the file to SAHTECH by your local

contact or by yourself. Ensure you have evident document ready for

inspection.

TOOL TOOL

Contact

http://ghs.cla.gov.tw/en/contact.php?item=contact

Contact

Dereke Tsao

EH&S Program Manager (Regulatory) Ashland Inc.dtsao@ashland.comTel: +886-2-2500-2247Cell: +886-932381765

Address

7FL, No. 37,Min Chuan E. Rd. 3rd Sec.Taipei, Taiwan