Polymers: Global Notification Procedures
US
- Canada
- Japan
- Australia
- China (Peoples Republic)
- Korea
- Philippines
- Taiwan
- Switzerland
-
Not going to cover: EU (in any detail)
Malaysia
New Zealand
Turkey
John Moore Regulatory Consultant
Manufacturing & Marketing of New Polymers
Many of the regulatory principles for new polymers have been taken
from the rules developed for new non-polymeric substances:
 Exemption/applications for Exemptions
 Research & Development
 Reduced datasets for low volume chemicals
 Simplified Notification
Notifying new polymers is not that difficult .
CHALLENGE:
• Minimise testing hence reduce costs and resources
• Compile a dataset to satisfy all regions and meet MSDS/CLP
responsibilities
• Gain early market access
John Moore Regulatory Services
Manufacturing & Marketing of New Polymers
Planning is key: Do not rush into testing, consider your options
and then plan carefully and accordingly.
Questions to consider:
 In which regulatory controlled regions do you wish to market your new polymer?
 Is your polymer a true regulatory polymer in those regions?
 Understand polymer chemistry, chemical & structural features, & key properties
- Is your polymer really new – globally, could it be an existing polymer?
- Apply inventory rules (especially exemption rules)
- Benefits of assessing monomers
- Is your new polymer one of Low Concern?
- PLC
- RRR
- RTP
- Do exemptions from notification apply? (application?)
- Simplified/reduced/limited/abbreviated notifications?
 Special provisions for REACH EU & Switzerland
Goal: Establish minimum data / information requirements – Global
perspective
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Early Planning Consideration
EU
Use Monomers and Other Reactants present in your
polymer in combined form that are REACH compliant
within your supply chain no regulatory action required.
SWITZERLAND, CHINA, US, CANADA & PHILIPPINES
Offer exemptions/reduced testing facilities for
Regulatory Polymers produced from Inventory listed
monomers/reactants
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What is a Regulatory Polymer …?
“Polymer” means a substance consisting of molecules characterised by the
sequence of one or more types of monomer units and comprising a simple
weight majority of molecules containing at least three monomer units which
are covalently bound to at least one other monomer unit or other reactant and
consists of less than a simple weight majority of molecules of the same
molecular weight. Such molecules must be distributed over a range of
molecular weights wherein differences in the molecular weight are primarily
attributable to differences in the number of monomer units.
MW spread sufficient to ensure no more than half the species present have the
same MW, and consist of at least 50% (w/w) of molecules which consist of a chain
of 3 (or more) monomer units linked to at least one other unit i.e. 50% of a
polymer must be of 4 units or more, but it does not matter how many monomer
types are present
Adopted by
US, Canada, Australia & Switzerland
EU (REACH) - slightly truncated version
China, Korea, Taiwan & Philippines - very
similar
Japan additionally require Mn >1000
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Polymer, Structure Chemistry & Key Properties
Chemical identification, purity, structure, molecular formula
- world wide regulatory status
Chemical characteristics (polyester, dissociation, functionality)
GPC understand MW properties
- low Mw species, residual monomer(s) content
Stability especially under conditions of use
Biodegradable ?
Physico-chemical properties (water solubility / extractivity,
particle size)
Information for MSDS, CPL
worker & customer safety
Basic Core Information set useful across most regulatory
controlled regions.
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New or Existing Polymer …?
In-depth knowledge
of polymer chemistry
EU, Switzerland,
China & Philippines:
Monomers are key
US (TSCA)
Canada (DSL/N-DSL) Philippines (PICCS)
Australia (AICS)
Japan (ENCS & ISHL)
China (IECSC)
Taiwan
Korea (ECL)
CAS Number listed which
fully describes your new polymer:
No further actions required.
Unrestricted manufacture &
import
In-depth knowledge
of inventory rules
Japanese ENCS. Many
generic listings. Not
fully CAS# indexed.
Expertise needed to
search. Do not assume
a new polymer is not
represented
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Inventory Conforming: Inventory “Exemption” Rules
<2% monomer rule – Utilise inventory listings that do not include monomers present <2%
US, Canada, Australia, Philippines, Taiwan, EU (REACH), Switzerland Korea China
>99% & >98% listed rule
Japan
Top 2 monomer rule
Philippines
Monomers listed
Philippines, Switzerland China
Reduced testing US, Canada
China special simplified
notification
Graft & Block co-polymer rule
Japan Taiwan Korea
Special Salt rule
Japan
Not as simple as obtaining a CAS# and checking inventory listing. Use of these rules
can lead to significant savings (money & resource)
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Polymers of Low Concern
If you have a new polymer, endeavour to meet Polymer
of Low Concern (PLC) criteria in as many regulatory
controlled regions as possible and take advantage of
the reduced testing facilities these offer
Save:
• Time to market
• Capital
• Resource
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Criteria for PLC - General
US, Canada, China, Australia, Taiwan
Other terms for PLC:
Canada: RRR
Switzerland: RTP
Polymers : Mn >10,000
Species of MW <1000 limit : <5%
“
“ < 500 limit : <2%
Polymers Mn >1000 - <10,000
Species of MW <1000 limit : <25%
“
“ < 500 limit : <10%
Taiwan: Polymers classified (GHS)
CMR or Env haz do not qualify
MW and oligomer content are not the only considerations….
Korea
PLC covers:
Non-ionic polymer Mn >10000
Other polymers with Mn >1000 if: of which all starting monomers /reactants are
listed in KECI and not listed on the toxic chemicals (except inorganic compound)
listing specified/published by NIER.
 Philippines
 Switzerland
 Japan
 China
Other common features which apply to some but not all the regions: inventory listed reactants;
stability; solubility / extractivity / absorbivity; functionality; non-hazardous (to human health)
classification; special considerations for polyesters
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PLC: Japan
Since April 1 2010, to be a polymer of low concern, the polymeric material must
either meet all the conditions 1-4
1) Stability tests at various pHs:
- including the various criteria stipulated
2) No weight change (<2 wt.%) in solubility tests in acidic and alkaline conditions
or the basic structure of the substance has no positive charge.
3) <2 wt. % soluble in water and organic solvents.
may not need
to meet this
4) No metals other than Na, Mg, K or Ca are contained in the structure.
OR……………..
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PLC: Japan (cont)
Polymers meeting conditions 1, 2, 4, (but not condition 3), can attain PLC
status, by fulfilling conditions 5 and 6 and either 7i or 7ii.
5) Oligomer (MW 1000) content is <1%, and no concerns for bioaccumulation.
6) As or Se are not contained in the structure.
7) i. Mn is >10,000
ii. Polymers with Mn <10,000 consisting of existing chemical substances,
with no C-C, C-N double or triple bonds and containing no designated
functional groups in the structure.
Designated functional groups are: Aziridyl-, Amino-, Epoxy-, Sulfonic acid-,
Hydrazino-, Phenolic hydroxyl, or Fluoro-groups.
ISHL requirements: MW & chemical characteristics
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PLC: China Simplified Notification
MW criteria same as US, Canada, Australia etc.
Simplified Notification
i. average molecular weight of polymers is 1,000-10,000 Daltons, oligomers with
molecular weight less than 500 Daltons have less than 10% content, and oligomers
with molecular weight less than 1000 Daltons have less than 25% content. Low
concern polymers shall not contain high concern or high activity groups, such as
heavy metal, cyan group, acrylic ester, aziridine, isocyanate, thio-isocyanate and
vinyl sulphone.
ii. average molecular weight of polymers is not less than 10,000 Daltons, oligomers
with molecular weight less than 500 Daltons have less than 2% content, and
oligomers with molecular weight less than 1000 Daltons have less than 5% content.
iii. Polyesters which contain at least two carboxylic ester bonds in polymeric molecules and
at least one carboxylic ester bond combined with internal monomers.
…………Still have another chance to attain PLC
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PLC: China Simplified Notification
Structural /phys-chem assessment:
Heavy metals or cationic
No
Water solubility
Not soluble
General/Typical Notification
Solvent solubility
Not soluble
pH stability
October 2010, a simplified
notification system replaced the
former annual application procedure.
Stable
Conclude as PLC
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PLC: Taiwan
Simplified Notification of Polymers
(a) Mn 1000 - 10000 with no active functional groups
MW <500, <10% and MW <1000, < 25%
(b) Mn >10,000 with no active functional groups
MW <500, <2% and MW <1000, <5%
(c) If the blocks and branch chains of your new polymer are all listed in
the soon to be published existing chemical substances inventory
- Regarded as a PLC
- Notified via the simplified notification scheme
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US: Using the PLC exemption route
Annual submission to EPA
Structural Representation
Identity of reactants/monomers and verification of TSCA listings
Analytical Data
Note
No PMN – no inventory listing, therefore
re-importation may be restricted.
Assessment criteria difficult
Benefit:
no 90 day
review
period
Alternative: File PMN & NOC
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Canada: Using the PLC route
PLC= Reduced Regulatory Requirement (RRR)
Schedule 9
Highest Schedule for RRR polymers (Unlimited quantities)
and other polymers at <10MT/annum
Mainly bibliographic & polymer specific MW information.
30-day review period. Supports DSL listing
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Japan: Using the PLC route
In Japan if you meet and decide to take the PLC route, it is said that
formal notification is no longer required .......
However you do need to:
• Obtain approval from the Ministries by submitting the appropriate
application form
• Submit test results and information that confirms PLC
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Australia: Using the PLC route
PLC Conforming:
• Dossier submission to NICNAS is required
• 90-day review period (permit available after 28-days)
• Listed on AICS after 5 years, or earlier at notifier’s request
Self assessment available for PLCs which are non-hazardous
(human health)
Benefits: No study reports.
28 day review period.
Reduced fee
Data is required to confirm PLC status
Data is required to confirm non-hazardous
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Korea: Using the PLC route
Information requirements for application for exemption from Non-ionic
notification of PLC
polymer
Mn >10000
Other PLC
Mn >1000
Chemical name and CAS No of the Polymer


Structure (if defined)


GPC - molecular weight information
Non-GLP lab testing data are acceptable but it must include
molecular distribution curve, slice table, test method/condition, etc
in a formal report form signed by responsible person with the
name/address of test lab – OECD TG 118.



Chemical name/CAS No of each monomers/reactants
demonstrating they are neither new chemical substances i.e. all
listed on KECI nor toxic chemicals (except inorganic compound)
defined by NIER under the TCCA
Information requirements for application for exemption from Non-ionic
notification of PLC
polymer
Mn >10000
Chemical name and CAS No of the Polymer

Other PLC
Mn >1000

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China: Using the PLC Simplified Notification Route
Routine Simplified Notification
• Complete simplified notification form
• Information to demonstrate that the polymer meets the
PLC criteria
• Chemicals notified via the simplified scheme are not
listed on IECSC
Non PLC: notify as a non-polymeric substance…………..
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Taiwan: Using the PLC Simplified Notification Route
Submission requires:
Notifier’s details
Chemical name (English & Chinese)
CAS Registry Number (if available)
Appearance, colour, odour
Safe use information (handling, storage, transportation etc)
GHS classification & labelling
Characterisation / identification data
Physico-chemical properties
Non-PLC: Full notification
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Turkeyto Full Notification
Non-PLC: Other Alternatives
If you do not meet PLC, there are other
polymer specific facilities available which
may lead to reduced testing
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Canada Non-RRR : Reduced Notification based on MW and Volume
Considerations
If: N-DSL Polymer or polymer produced from DSL/N-DSL monomers
reactants & Manufactured or imported at >10-<50MT/annum
Schedule 10 : final for polymers that do not meet the high
release/exposure category guidelines/. Mainly MW, phys-chem &
basic tox & env information.
60 day review period
Manufactured or imported >50MT/annum, requires a
Schedule 10 update. Additional information needed
Schedule 11 for other non-RRR polymers
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Non-PLC: Australia Limited/Abbreviated Notification Schemes
Australia: Non-PLC:
Mn>1000 – reduced data set
Mn <1000 – treat as a non-polymeric substance
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Non-PLC: Korea Reduced Data Sets
Reduced testing compared to full notification of non-polymers.
General information (all substances):
Plus:
Polymer specific test data - Option 1
or
Certain polymer specific information + mutagenicity & toxicity
(acute oral) – Option 2
or
Certain polymer specific information + mutagenicity & ecotoxicity
(acute fish) – Option 3
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Non-PLC: Philippines Abbreviated Notification Schemes
Philippines: Abbreviated notification scheme for polymers
listed on one other inventory
• No specific polymer tests
• Supply the information in your possession in a 16 section
MSDS format
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Switzerland Partially Revised ChemO
Polymers produced from EINECS listed monomers/reactants do not
require notification
New polymer:
• not been previously notified
• contains in combined polymerised form >2% of non-EINECS listed monomer(s).
Notification required if the new monomer is “placed on the market” i.e. in
combined form > 1MT/annum
 Notification according to REACH Registration for the new monomer(s)
Information is based on vols of the monomer in Switzerland + EEA
OECD regulatory polymers produced from EINECS listed monomers do
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Full Notification: Data/Information/Testing
Testing/Information Requirements for Global
Notifications:
Real Challenge for unlimited volumes in the absence of:
• PLC
• Reduced/simplified schemes being available
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Planning Tests/Information
Building Block Approach.
2. “Typical”
1. “Basic Core Information”
Basic Core information Set +
Hydrolysis as a function of pH
Solubility: water/solvents/acid alkaline
Log P/Abs/desorption/diss const/
Charge density
Particle Size
Mpt/Bpt/ vapour
Density
Flammability/Explosivity/flash point
Auto ignition/Oxidising/reactivity
Ames
Oral toxicity
Fish toxicity
pH Stability
Chemical identity/purity
Mw GPC etc
Solubility
Dissociation properties
Functionality
Biodegradability
MSDS/ label
pH stability
3. “Higher” Level
Cationic/ionic props
Classification
Further extraction studies
Further stability tests
4. “Non-polymer substance
Type ”
Full battery of Tox / Env acute studies and
mutagenicity tests
Plus longer term studies
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Testing Information: Regions Covered
1. Basic tests typically cover:
US (PLC and other typical polymers)
Canada (RRR & Schedule 9)
China (PLC)
Korea (PLC/Option 1)
Taiwan (PLC)
Australia (PLC but may fall short)
2. Typical tests additionally
cover:
Australia (Mn >1000)
Canada (Schedule 10)
3. Higher Level
Japan (PLC)
Philippines
Switzerland (RTP)
Korea Options (2&3)
4 “Non-polymer substance Type ”
Canada (Schedule 11)
Japan (non-PLC)
Australia (Mn <1000)
China (non PLC)
Switzerland (non-RTP)
Monomers (REACH/Switzerland)
John Moore Regulatory Services
Final Message, Conclusion
Plan well
• Understand your polymer chemistry
• If possible, design chemistry to provide alternatives to full
notification
• Understand inventory rules
• Develop some basic information
• Make full use of all available exemptions & reduced testing facilities
• Develop a robust, cost effective, global testing plan
Thanks for your kind attention
John Moore Regulatory Services