REACH: Only Representative Rules Change Again

Overview

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.

Key changes

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...