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Dr Reach: REACH and CLP deadlines – getting it right

The 30 September deadline for registration has everyone on edge. Although the official deadline is 30 November 2010, registrations submitted within the last two months may not receive registration confirmations until early 2011.

But even then, a registration dossier could be incomplete or rejected, the latter case resulting in the substance not being registered, the former requiring a resubmission with the possibility of a second failure.

The legal status of a substance on the European market may therefore be undefined for an extended period of time. In comparison, registrations submitted before 30 September benefit from a maximum response time from ECHA of three weeks.

By the end of this year, ECHA currently expects:

• 25,000 registration dossiers
• 1,500 inquiry dossiers
• 2 million classification and labelling notifications
• 500 data-sharing decisions
• 100 appeals
• 15,000 helpdesk queries

These are ECHA’s ‘baseline’ figures. It recognises the high level of uncertainty involved in the estimates and that these numbers may be ‘conservative’.

This anticipated workload, and the associated REACH-IT user traffic, reinforces the message from industry and ECHA to get dossiers in as soon as possible. This would work to everyone’s advantage because the REACH-IT system can be expected to become slower as usage increases towards the end of the year. Companies are already starting to log their time and usage of the system to document their efforts in meeting the deadline.

There can be hundreds of registration dossiers for a single substance. Take, for instance, monomers such as ethylene oxide, butadiene and vinyl chloride, which are used to create common polymers. There will be a multitude of registrants, as the one tonne per year threshold rule for a 2010 registration applies.

Once a lead registrant successfully submits a joint registration, members must follow up with their own dossiers. The process works by means of the lead registrant acquiring a ‘token’ from ECHA. The new REACH-IT process enables these other registrants to then register in parallel (CW 28 May 2010).

After submitting its own dossier, a company must pay ECHA any relevant registration fee and track its own dossier progress to ensure that it meets business rules and is deemed complete. Internally companies need to ensure that they have procedures set up to execute payments for access to joint registrations and ECHA in time.

Companies must still continue to monitor communications from lead registrants to establish when the joint registration dossier is successfully registered. This can have implications for all registrants, their dossier and obligations.

It is clear that even being a member of a joint registration demands dedication of personnel time to execute the administrative parts of the registration process. As tokens expire after 30 days, one can expect that lead registrants may have to re-apply and re-issue tokens to some late runners.

A universal unique identifier (UUID) is needed for each Legal Entity as part of the REACH registration process. The UUID entered in a registration dossier must match that of the Legal Entity in the REACH-IT account.

Thankfully, there is not a mandatory need for ECHA-issued UUIDs for each member of a ‘group notification’ under the EU classification, labelling and packaging (CLP) Regulation. Other identifiers such as company name and VAT number will suffice. Otherwise, all CLP notifiers would have had to create user accounts in REACH-IT, which would have markedly increased user traffic on the IT system.

CLP notifications can trickle over into the new year, as the formal deadline is not until 1 January 2011. Although REACH registration deadlines are fixed in stone, ECHA appears to have some flexibility in moving the date for notification from the 1st to the 3rd of January in order to account for public holidays.

‘Only representatives’ (ORs) were struggling with how to assist their non-EU clients and the EU customer-base with the CLP notification process. The omission of ORs from CLP appears to have been an oversight. ECHA has confirmed that the following present real solutions:

• Identify an importer (customer) that can fulfil the requirement on behalf of the other affected parties, or groups thereof; and/or,
• The OR can become an ‘importer’ under the CLP Regulation by importing a small quantity of the relevant substance(s).

Ideally, industry sector associations can provide classification templates and elect nominees to cover their membership. This can significantly reduce the number of CLP files being submitted and also facilitate agreements on classifications.

ECHA has a ‘plan B’ in case its primary IT system cannot handle the volume. But this is a back-up IT system to manage data processing; essentially serving as a reservoir that feeds back into the main REACH-IT system.

Plan B does not involve changes to the registration process! So companies should not expect a backdoor to registration.

By the end of this year, we can expect announcements of REACH success. Substances will be registered.

A review of the average workload per substance and dossier, with a breakdown according to activity, would be fascinating. Compared with original estimates, I expect that administrative elements will represent a significant hidden cost of REACH.