Industry Calls for Increased Alignment among Countries and Regions for Polymers Registration

Polymers are used in a wide range of industries such as food, agriculture, industry and consumer products sectors, which make it more important for the globe to regulate them while not hindering innovation. Speaking at the Second Week of CRAC-HCF 2021 Virtual Forum held on December 6, 2021, Mr. Raymond Zhu, the regulatory affairs consultant of REACH24H, introduced the regulations for polymers and shared his opinions on multinational registration strategies.

Mr. Zhu firstly introduced the regulations for polymer registration in nine different countries and regions including Chinese mainland, China's Taiwan, the U.S., South Korea, Australia, the Philippines, Japan, New Zealand and the European Union. Although all these countries and regions have adopted the OECD definition of polymers, their polymer management schemes are quite different. 

For EU, only monomers require registration while the others (except for New Zealand) require registration of the whole polymer. Due to the great difference of the nature of monomer and polymer, the registrants will face significant data gaps since the monomer’s data generated for EU REACH may not be accepted universally. In New Zealand, non-hazardous polymers are not regulated. A hazardous polymer shall be assigned to an appropriate Group Standard. In addition, Japan’s CSCL and ISHL uses different criteria to identify new and existing polymers, which makes it more complicated in developing compliance strategies. The differences among global regulations on polymers will inevitably add to the burden on registrants. 

In addition to New Zealand and the EU, most countries and regions offer exemptions or reduced requirements for polymers, e.g., polymers of low concern (PLCs), polymers that fit the 2% rule, PFS polymers, etc. Businesses exporting polymers to concerned market therefore need to identify whether full registration mandates or can apply for an exemption or simplified registration. However, for example, the criteria for identification of PLCs are not identical. Mr. Zhu told ChemLinked that the industry calls to increase alignment among countries and regions, so that unnecessary testing can be avoided, and a polymer won’t be exempted in one country and be required for registration in another.

To learn more about this coference, please click here for live playback.