Pre-registration of substances under REACH started on 1 June 2008 and ends on 1 December 2008. Substances on their own, in preparations or in articles (i.e. finished products) which are not pre-registered during that period cannot be manufactured in the EU or imported into the EU until a fully completed registration dossier is completed – a lengthy process. This means that companies must ensure that all of the substances they use are pre-registered, or else face a period during which they cannot market products. National sanctions (including possible fines and criminal sanctions) could also apply if these obligations are not respected.
An additional complication facing non-EU established companies exporting to the EU is that they cannot pre-register (or register) themselves. Either their EU importer or nominated EU-established "Only Representative" ("OR") must pre-register (and register). Steptoe offers an OR service to clients.
A steady stream of guidance on REACH continues to be issued. Previously issued guidance is also being revised. Guidance on appointment of an OR has changed in a number of important ways, addressing various points which it had previously been argued discriminated against non-EU manufacturers compared to their EU based competitors.
The following change has been made in the latest (May 2008) European Chemicals Agency ("ECHA") guidance on registration:
1. ORs who act on behalf of more than one non-EU manufacturer for a certain substance must submit a separate registration for each of these substance manufacturers.
This removes concerns with the Commission's previously stated position that ORs would, in this situation, need to submit a single registration aggregating those exporting tonnages of the substance in question resulting in non-EU manufacturers potentially having to comply with heavier data submission requirements and earlier registration deadlines (required for higher tonnage bands) than their EU based competitors producing equivalent volumes.
In addition, we understand that the Commission publicly announced the following changes earlier this month and that these will be reflected in further amendments to the ECHA technical guidance documents in the coming weeks.
2. A non-EU manufacturer of a substance which is exported into Community territory 'indirectly' by a non-EU formulator (which uses that substance in its preparation) can appoint an OR to register the tonnage exported by that formulator.
The latest (May 2008) ECHA guidance on registration suggests that a non-EU manufacturer may appoint an OR to register tonnages of a substance exported by its non-EU distributor. However, that guidance does not make clear whether the non-Community manufacturer could appoint an OR where such export was made by a formulator. The Commission has now clarified that it can. It appears that this applies both where the non-EU manufacturer also exports the same substance directly to Community and where it does not.
3. Instead of having to appoint its own OR to carry out registration of a substance used in its preparation which is exported to the EU market, a non-EU formulator can refer to a registration made by an OR appointed by its non-EU supplier.
This follows logically from point 2, above, but again has not been clear from ECHA guidance to date.
4. Non-EU manufacturers that decide to change the OR they have appointed for a particular substance can submit an update to the ECHA and do not need to submit an entirely new registration dossier.
The latest (May 2008) ECHA guidance on registration states that the newly appointed OR would have to submit a new registration dossier. However, it appears that the Commission has now returned to its previous position stated in an earlier guidance (June 2007) that the new OR can, in agreement with the former OR, simply update the registration dossier.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.