pira 2009 sept. arlington taiwan new chemical regulation2
TRANSCRIPT
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 [email protected]: +886-2-2500-2247Cell: +886-932381765
Address
7FL, No. 37,Min Chuan E. Rd. 3rd Sec.Taipei, Taiwan