Ask Dr Reach: Preparations, polymers and what must be registered
QUESTION: A company imports a product that contains a polymer and other additives. Is this a substance, preparation or polymer and what must be registered? The questioner is a Hungarian trade association.
It would appear that this is either a polymer or a preparation containing a polymer and other substances. In either case, when meeting the REACH definition of a polymer, the polymer can itself be considered as a substance. Many polymer-based materials will be some sort of preparation (unless an article), as a polymer substance will often be part of a ‘polymer system’.
Any additive that acts as a stabiliser for the polymer can be considered as part of the polymer substance (and therefore exempt from registration – if imported) up to the tonnage needed to perform that function. The same applies to solvents necessary to preserve the stability of a substance. Therefore, the product in the question could in fact be a polymer. Nevertheless, the presence of these stabilisers/solvents as well as impurities must be accounted for during classification and labelling.
Generally, it is only the quantity of an additive or solvent necessary to perform the stability function that may be considered as an integral part of the polymer substance. Any other additive or additional quantity of stabiliser/solvent would result in a preparation. For determining the scope of registration, any dual function stabiliser should be assessed accordingly.
For instance, an extra amount of a stabiliser may be added during formulation to achieve a particular desired ‘effect’ – such as foam when mixed with water. In the above question, such an additional quantity of a stabiliser would be subject to REACH as a substance in an imported preparation.
When examining the polymer, it is the relevant monomers and other reactants that are subject to registration (even when the polymer is manufactured outside the EU). REACH requirements in the legal text should be followed and the corresponding RIP 3.1 guidance can serve as a reference. Companies may want to closely follow the legal challenge on these polymer requirements CW Newslink 7 January 2008.
It may be possible to register some reactants used in polymer manufacture as intermediates. It may also be feasible to waive registration data requirements using arguments considering exposure to bound monomers. There are further special circumstances such as monomers only formed in situ and chemically modified, naturally sourced polymers.
Send questions to Dr Steffen Erler and read his previous answers http://chemicalwatch.com/dr_reach
BOX: Legal Disclaimer
The information contained in this communication follows a technical interpretation of REACH to serve as a thought-starter for discussions; it does not constitute legal or any other form of advice. Note that technical aspects are subject to review and references should be checked for updates. The legal text of the REACH Regulation must serve as the basis for REACH compliance and it may be advisable to seek legal and/or other expert advice on any given issue. The author and Chemical Watch accept no liability whatsoever with regard to the use of information contained in this communication.
