Little Pro on 2016-10-19
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 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:
Regulation | Requirements | PLC Definition and Exclusion | ||||||||||||
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EU REACH |
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USA TSCA |
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China MEP Order 7 |
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Japan CSCL |
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Korea K-REACH |
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Taiwan TCSCA |
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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.
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Tags: Topics - Registration, REACH-like Regulation and Registration