Chemicals Update
17 June 2008
REACH pre-registration and registration started:
outstanding and practical issues
1 June 2008 marked an important date in the REACH
'nomenclature': it was the start of the registration and
pre-registration period, in other words the date from which
chemical substances cannot be manufactured or imported in the EU,
unless companies submit specific information in support of their
activities.
It is understood that, during the first week of registration,
1,000 companies signed up to use the REACH-IT system and
pre-registered nearly 5,000 substances. They have also sent
notifications, inquiries and registrations using the temporary
submission procedures.
Notwithstanding the major business implications of the
registration obligations, companies continue to be confronted with
important outstanding issues, making advance preparation very
difficult and having a direct impact on business continuity.
This update provides an overview of the outstanding issues
(including those relating to Only Representatives) analyses the
latest REACH guidance provided by the European Chemicals Agency
(ECHA), and reviews recent practical experiences with
consortia.
1. Outstanding issues having a direct impact on business
continuity
Only Representatives
The REACH Regulation allows non-EU companies to appoint an Only
Representative (OR) to pre-register and register on behalf of the
importers. Questions frequently raised include: who can
appoint an OR and what should/can the OR cover through its (pre-)
registration submission.
The European Commission (EC) and ECHA have already stated that a
non-EU distributor cannot appoint an OR, only non-EU manufacturers,
formulators or article producers have this possibility.
However, in the absence of a definition of "non-EU manufacturer" or
"formulator", companies may have difficulties deciding whether they
can or cannot appoint the OR.
The EC and ECHA have also confirmed that an OR who is appointed
by two or more non-EU legal entities must submit as many
registrations as there are non-EU legal entities appointing
them. This, in practice, means that a multinational company
with production sites across the world may need to submit separate
registrations for each of these production sites (and corresponding
legal entities), even if the same OR is appointed.
Difficulties related to the participation of an OR to consortia
remain, and questions are just starting to occur as consortia
agreements are being signed. For example, such agreements may
impose conditions on the access to and/or ownership of information
obtained through membership or letters of access. If such
conditions restrict the possibility for members to provide further
access to other companies, ORs - who in most cases will be the
signatories to these agreements - must consider how they can make
the appointing non-EU company benefit from these data in the event,
for example, of a change of OR.
Business continuity during completeness check
period
When a company registers between 1 June 2008 and 1 December 2008
without pre-registering first, again, much as in the previous case,
the logic and the text of the REACH Regulation (in particular
Article 21(1)) dictate that such a company should be allowed to
continue manufacturing or importation during the three weeks
completeness check following the submission of the registration
dossier. However, the text of the RIP 3.4 guidance document
on data sharing indicates otherwise: activities involving the
substances concerned can only be resumed three weeks after the
submission date of the a complete registration dossier. We expect
that companies will raise this issue with the authorities in the
coming weeks/months.
2. Recent ECHA Guidance
ECHA, with the participation of many stakeholders (Industry,
Member States and NGOs), developed several guidance documents with
the objective to facilitate the implementation of the REACH
Regulation by describing good practice compliance actions.
Just before the start of the REACH registration and
pre-registration period, two new documents were published: Guidance
on information requirements and CSA and Guidance for articles. In
addition, the guides on registration and on monomers and polymers
were updated. The completion of seven more guides is outstanding,
three of which are expected in summer 2008. In the meantime, ECHA
started to collect feedback from users of the REACH guidance
documents, with the aim to solve problems and incorporate comments
in future updates.
Stakeholders are therefore encouraged to continue engaging ECHA
and Competent Authorities with specific issues in order to add
to/amend the current guidance documents, which are considered
"living documents".
3. Practical experiences with consortia
Several sectors have set up, or are setting up, REACH consortia
to register their substances jointly. As there are no set rules, it
is up to industry to decide how to cooperate. Some consortia
publish openly their existence (e.g. through a web page or
announcements in the media) and approach proactively other
manufacturers and importers in the same sector. Others are set up
(e.g. within consultancy firms) and are more difficult to identify.
There are also consortia that are set up within large trade
organizations.
Consortia have no legal obligation to publicly announce their
creation or to officially notify the authorities. If a consortium
or one of its members is contacted directly, it will generally
respond and give information about membership conditions and nature
of the consortium activities (in order to avoid suspicion of
anti-competitive behavior).
For further information, please contact Ruxandra Cana.