EU Chemicals Legislation Topical Summary

Polymers* benefit from specific exemptions under the current European Union (EU) chemicals legislation, as well as under the US Toxic Substances Control Act requirements. It is not, however, clear or certain that similar exemptions will be applicable under the future new EU chemicals legislation. Should polymers become subject to registration and testing requirements, this would represent a dramatic change in their regulatory status with significant consequences for the polymers' production and marketing, including importation, in the EU.

Current Requirements

Every person who markets polymers in the EU for the first time has to submit a notification to a Member State Competent Authority (according to Directive 67/548/EEC on the classification, packaging and labeling of dangerous substances, as last amended by Directive 92/32/EC), unless:

• They contain in combined form less than 2% substances which are not EINECS listed (EINECS -- the European Inventory of Existing Chemical Substances - contains all the substances which were marketed in the EU prior to 1981 and which were grandfathered into the EU chemicals legislation);

• They are "no-longer polymers" (i.e. polymers which (a) met the definition of a polymer provided for in previously applicable Directive 79/831/EEC but do not meet the currently applicable definition of a polymer provided for in Directive 92/32/EEC, and (b) were marketed in the EU between 1981 and 1993);

  • They are marketed in yearly quantities of below 10 kg;
  • They are marketed for purposes of Research & Development or Process Oriented Research & Development; or
  • They are marketed for use exclusively as food or feed additives or flavorings, or as active ingredients used exclusively in medicinal products or in plant protection products or biocidal products.

  The White Paper

  The White Paper lays out the intention of the European Commission to propose new chemicals legislation. The main element of this Paper is the proposal to set out the REACH (Registration, Evaluation, and Authorization of Chemicals) system, whereby all substances produced or marketed in quantities above 1 ton per year per manufacturer/importer would be subject to registration. As polymers are not mentioned among the substances that would be exempted from registration, it is not clear whether the REACH system will include them or not.

  Industry has expressed concern, however, because of this uncertainty. In order to prevent the inclusion of polymers in the future testing and registration requirements, industry groups have argued that polymers should not be included in the proposed REACH system (see e.g. CEFIC's -- European Chemical Industry Council -- composite statement on European Commission's White Paper Working Group).

  Recent comments from the UK government support this position. The UK government Position Statement on the "New EU Chemicals Strategy" of December 2002 proposes a specific strategy relating to polymers, based on the assumption that a polymer is likely to be determined by the intrinsic properties of the monomer from which it is made. More specifically, the UK government proposes that:

  • Polymers should not be registered under the REACH system, unless they are considered to be of concern based on established criteria.
  • When the initial monomers are registered, an outline of the polymers that would be constructed from the monomers should be provided in the registration.
  • Polymers may be subject to testing if the risk assessment of the monomer identifies this need.

  Summary Conclusions

  The European Commission is expected to publish its official proposals setting into place the new EU chemicals legislation in the coming months. It will then become clear whether the future legislation will follow the current approach and rationale for exempting polymers from testing and registration requirements.

  These concerns illustrate the need for industry to follow the adoption of the future provisions regarding polymers closely, and intervene during the legislative process leading to the adoption of final legislation, as appropriate, and as warranted by its specific interests.

  Footnote

  * Defined 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 monomer units. In the context of this definition a "monomer unit" means the reacted form of a monomer in a polymer" (Article 2§1(c) of Directive 67/548/EEC on the classification, packaging and labeling, as last amended by Directive 92/32/EC).

Last Updated: January 2003