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Comparison of Global Polymer Registration Requirements

By Little Pro on 2016-10-19 Views:  Update:2017-01-18

Polymers are used in a vast range of applications such as formulation, packaging, building materials and electrical and electronic equipment. They are generally regarded as representing a low safety concern due to their high molecular weight (thus less likely to cross bio-membranes). Many countries with chemical registration scheme in place have specifically defined polymers of low concern (PLC) and such polymers benefit from exemption or reduced registration requirements. In this article, we will summarize the definition of polymer, how to determine if a polymer is PLC or not, and compare current polymer registration requirements. EU, USA, China, Japan, Korea and Taiwan are covered. 

OECD Definition of Polymer

OECD definition of polymer is widely adopted. It defines a polymer as a substance consisting of molecules characterized 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.

EU, USA, China and Korea have gone further by specifying that:

  •  Over 50 percent of the weight must consist of polymer molecules (with at least three monomer units);
  • The amount of polymer molecules presenting the same molecular weight must be less than 50 weight percent.

Overview of Polymer Registrations and PLC Definition

Regulation Requirements PLC Definition and Exclusion
EU REACH
  • Polymer is exempt from registration.
  • Registration of monomer or reactant>2%w/w is required if the volume of monomer or reactant exceeds 1t/y;
USA TSCA
  • Only new polymers (not listed on TSCA inventory) are subject to pre-manufacture notice (PMN).
  • PLCs are exempt from PMN or reporting.
  • The average molecular weight (MW) of the polymer is between 1,000~10,000 Da. At the same time, the weight percentage of oligomer with MW<500 is less than 10%, and the weight percentage of oligomer with MW<1000 is less than 25%.  Additional restriction on reactive functional groups; or
  • The average molecular weight (MW) of the polymer is greater than10,000 daltons. At the same time, the weight percentage of oligomer with MW<500 is less than 2%, and the weight percentage of oligomer with MW<1000 is less than 5%.
  • Exclusions: Some cationic polymers, Polymers which degrade, decompose, or depolymerize, polymers that are prepared from monomers or other reactants that are not on the TSCA inventory, water-absorbing polymers with number-average MW equal to or greater than 10,000, and polymers containing as an integral part of their composition, except as impurities, certain perfluoroalkyl moieties consisting of a CF3- or longer chain length.
  • Source: EPA polymer exemption guide
China MEP Order 7
  • Only new polymers require registration (those not listed on IECSC).
  • PLC: Simplified notification
  • Non-PLC: simplified notification (if <1t/y) or regular notification with reduced requirements (>=1t/y). 
  • For polymer with an average molecular weight (MW) of 1,000~10,000 daltons, the content of oligomer (MW < 500) must be less than 10%, and the content of oligomer (MW < 1,000) must be less than 25%. In addition, these polymers cannot have ‘an obvious content’ of active functional groups, such as heavy metals, cyano groups, acrylic ester, ethyleneimine, isocyanate, isothiocyanate, and vinyl etc.
  • For polymers with an average MW of more than 10,000 daltons, the content of oligomer (MW < 500 daltons) must be less than 2%, and the content of oligomer (MW < 1,000 daltons) must be less than 5%.
  • Polyesters belong to PLCs.
  • Source: China new substance notification  guidance (2016 draft) - English translation. Available for a small fee.Contact us.
Japan CSCL
  • Only new polymers require registration (those not listed on ENCS/ISHL).
  • PLC: Application of exemption.
  • Non-PLC: Standard registration
  • Number average molecular weight(MW) >=1,000 Da;
  • Physically and chemically stable;
  • Meet following a or b:  (a) insoluble in water, organic solvents and in acid or base, or insoluble in water, organic solvents and having specific molecular structure; (b) soluble in water and organic solvents, but the weight percentage of Oligomer (MW<1,000) is <=1% w/w and no information to indicate high accumulation;
  • No heavy metals or cationic properties;
  • Not polymers that the government concludes that they might have adverse effect on human health or environment;
  • Must pass PLC flow scheme test.
Korea K-REACH
  • Only new polymers and desginated polymers require registration .
  • PLC: Application of exemption.
  • Non-PLC: Standard registration with reduced data requirements.
  • For polymer with an average molecular weight (MW) of 1,000~10,000 daltons, the content of oligomer (MW < 500) must be less than 10%, and the content of oligomer (MW < 1,000) must be less than 25%. In addition, these polymers must not contain more than 2% monomers which are hazard chemical substances, epoxy compound, aziridine compound or new chemical substance.
  • For polymers with an average MW of more than 10,000 daltons, the content of oligomer (MW < 500 daltons) must be less than 2%, and the content of oligomer (MW < 1,000 daltons) must be less than 5%. In addition, the polymers must not be cationic polymer (except in solid form not soluble or dipersible in water)
Taiwan TCSCA
  • Only new polymers and desginated polymers require registration.
  • <1t/y PLC: Exempt, prior verification needed;
  • >=1t/y PLC: Small quantity registration, very limited info.
  • Non-PLC: standard registration
  • For polymer with an average molecular weight (MW) of 1,000~10,000 daltons, the content of oligomer (MW < 500) must be less than 10%, and the content of oligomer (MW < 1,000) must be less than 25%. In addition, these polymers cannot contain the following high concern functional groups:

    Acrylates or methacrylates

    Amines

    Aziridine

    Carbodiimides

    Epoxides

    Hydrazines

    Isocyanates or isothiocyanates

    (Alpha- or beta-) lactones

    Phenolic hydroxyl

    (Halo-, Hydro- or Alkoxy-) silanes

    Sulfo

    Vinyl sulfones

  • For polymers with an average MW of more than 10,000 daltons, the content of oligomer (MW < 500 daltons) must be less than 2%, and the content of oligomer (MW < 1,000 daltons) must be less than 5%.
  • Polyesters belong to PLCs.
  • When a polymer is insoluble in both water and designated solvent at the same time, it shall be considered a polymer of low concern. The designated solvent includes four types: n-caprylic alcohol, normal heptanes, tetrahydrofuran and dimethylformamide. 
  • Source: Taiwan EPA guidance on new and existing substance registration (2015) - English translation. Available for a small fee. Contact us.

It should be noted that all above countries have adopted 2% polymer rules: A polymer is not considered as new if it is manufactured by modifying the formulation of an existing one by adding existing reactants, none of which constitutes more than 2% w/w of the polymer. In China, Japan and Korea, a polymer may still be regarded as a new substance if the polymer itself is not listed on existing chemical substance inventory. 

More detailed info about how polymers are registered in various countries can be found out in Technical assistance related to the review of REACH with regard to the registration requirements on polymers.

Related Readings: Chemical Registrations

 

 Tags: Topics - RegistrationREACH-like Regulation and Registration

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