Legal Challenge to the Monomer Registration Requirement

Before and after the adoption of REACH, many have questioned if it makes sense to require the registration of monomers when they 

In Canada, polymers are defined under the CEPA in the same manner as they are in the EU and under the polymer exemption in the US, but the regulatory implications are different. In Canada, all types of new polymers (those not present on the DSL) must be notified (unless manufactured or imported in certain small quantities), unlike the general exemption in the EU or the specific polymer exemption in the US. As mentioned previously, meeting the polymer definition in Canada allows the substance to be notified as a polymer and not a chemical, which reduces the amount of test data and other information that must be submitted. Therefore, it is critical that a substance be carefully analysed, particularly for molecular weight distribution, so that its notification in Canada as a polymer is validated. 

There is an apparent gray area for certain low molecular weight polymers that are often collectively referred to as oligomers. The term oligomer has no significance in the determination as to how a substance should be notified in Canada, a substance is a polymer or it is a chemical. Certain polymers are characterised as requiring reduced regulatory requirement (RRR) polymers, and these new 

Other factors used to determine if a polymer meets the RRR criteria are similar to those used in the determination as to whether a substance qualifies for the polymer exemption in the US, but subtle differences exist. Eor example, in the US, if one of the reactants used at greater than two weight percent to manufacture a polymer is not on the TSCA Inventory or covered by an applicable Section 5 exemption, this fact alone will disqualify the polymer from meeting the polymer exemption criteria. In Canada, such a situation would not disqualify a polymer from being considered to be RRR, although the reactant s presence on the DSL does affect which Schedule of data must be submitted. 

Code of Federal Regulations (CFR) - http //www.gpoaccess.gov/cfr/ index.html 

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