Polymers: Global Notification Procedures - … · John Moore Regulatory Services Manufacturing &...

John Moore Regulatory Consultant

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 Services

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


Manufacturing & Marketing of New Polymers

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?

Goal: Establish minimum data / information requirements – Global

perspective

Special provisions for REACH EU & Switzerland

Planning is key: Do not rush into testing, consider your options

and then plan carefully and accordingly.

Questions to consider:


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


What is a Regulatory Polymer …?

Adopted by US, Canada, Australia & Switzerland

EU (REACH) - slightly truncated version

China, Korea, Taiwan & Philippines - very

similar

Japan additionally require Mn >1000

“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


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.

Polymer, Structure Chemistry & Key Properties


New or Existing Polymer …?

US (TSCA)

Canada (DSL/N-DSL) Philippines (PICCS)

Australia (AICS) Japan (ENCS & ISHL)

China (IECSC) Taiwan

Korea (ECL)

EU, Switzerland,

China & Philippines:

Monomers are key

CAS Number listed which

fully describes your new polymer:

No further actions required.

Unrestricted manufacture &

import

In-depth knowledge

of polymer chemistry

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


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

Not as simple as obtaining a CAS# and checking inventory listing. Use of these rules

can lead to significant savings (money & resource)

>99% & >98% listed rule

Japan

Top 2 monomer rule

Philippines

Special Salt rule

Japan

Monomers listed

Philippines, Switzerland China

Reduced testing US, Canada

Graft & Block co-polymer rule

Japan Taiwan Korea

China special simplified

notification

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


Criteria for PLC - General

US, Canada, China, Australia, Taiwan

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%

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

Other terms for PLC:

Canada: RRR

Switzerland: RTP

Taiwan: Polymers classified (GHS)

CMR or Env haz do not qualify


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.

4) No metals other than Na, Mg, K or Ca are contained in the structure.

may not need

to meet this

OR……………..


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 bio-

accumulation.

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


PLC: China Simplified Notification

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

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.


PLC: China Simplified Notification

Structural /phys-chem assessment:

Heavy metals or cationic

Water solubility

Solvent solubility

pH stability

Conclude as PLC

No

Not soluble

Not soluble

Stable

General/Typical Notification

October 2010, a simplified

notification system replaced the

former annual application procedure.


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


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

Alternative: File PMN & NOC

Benefit:

no 90 day

review

period


Canada: Using the PLC route

Schedule 9

Mainly bibliographic & polymer specific MW information.

30-day review period. Supports DSL listing

Highest Schedule for RRR polymers (Unlimited quantities)

and other polymers at <10MT/annum

PLC= Reduced Regulatory Requirement (RRR)


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


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

Australia: Using the PLC route


Information requirements for application for exemption from

notification of PLC

Non-ionic

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

notification of PLC

Non-ionic

polymer

Mn >10000

Other PLC

Mn >1000

Chemical name and CAS No of the Polymer

Korea: Using the PLC route


China: Using the PLC Simplified Notification Route

• 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…………..

Routine Simplified Notification


Taiwan: Using the PLC Simplified Notification Route

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

Submission requires:


Turkey Non-PLC: Other Alternatives to Full Notification

If you do not meet PLC, there are other

polymer specific facilities available which

may lead to reduced testing


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


Australia: Non-PLC:

Mn>1000 – reduced data set

Mn <1000 – treat as a non-polymeric substance

Non-PLC: Australia Limited/Abbreviated Notification Schemes


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

Non-PLC: Korea Reduced Data Sets


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

Non-PLC: Philippines Abbreviated Notification Schemes


Switzerland Partially Revised ChemO

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

Polymers produced from EINECS listed monomers/reactants do not

require notification


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


Planning Tests/Information

Building Block Approach.

1. “Basic Core Information”

pH Stability

Chemical identity/purity

Mw GPC etc

Solubility

Dissociation properties

Functionality

Biodegradability

MSDS/ label

pH stability

2. “Typical”

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

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


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)


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

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