Preparation - The next milestone in Reach is coming up: the 2010 deadline. So what are the hurdles in completing registration, and what happens if it doesn't go to plan?

2010 Deadline

All phase-in substances manufactured or imported into the EU taking advantage of delayed registration via pre-registration at more than 1,000 tons per year must be registered by Dec. 1. Substances deemed to be of great hazard (e.g. carcinogens, mutagens or reproductive toxicants, also known as CMRs) that are manufactured or imported into the EU at more than 1 ton per year; or substances deemed to be very toxic to aquatic organisms (R50/53) that are manufactured or imported into the EU at more than 100 tons per year are also to be registered by this date.

Dossier Preparation

So, you've read the guidance, completed pre-registration, Substance Information Exchange Forum (SIEF) registration strategies, data sharing and entered all the data into the much improved IUCLID 5 dossier system (the electronic platform within which data on the manufacture and use, mammalian toxicity, eco-toxicity and environmental fate of chemicals can be added and assessed), and completed the chemical safety report (CSR). The deadline is finally here, so what's next for a successful registration?

Registration dossiers submitted to European Chemicals Agency (ECHA) go through a virus and XML format check and a business rules validation; if they pass, they are forwarded for technical and financial completeness checks. If the dossier fails at these points, it is returned to the submitter for completion before the deadline. Dossiers are then randomly selected for a dossier check. Those dossiers submitted closer to the deadline that fail may not be verified until well into 2011, so it is a good idea to submit your dossier as early as you can!

To see if your documentation is acceptable from a technical viewpoint a plug-in tool is available that will run a technical completeness check (TCC) on your IUCLID dossier. This tool highlights any gaps in the dossier that will need completing before submission, to avoid it being rejected by ECHA. The process is very much one of iteration, as the tool may reveal more gaps on subsequent runs. Although not a concrete failsafe for ensuring that the dossier will be accepted, the TCC tool will ensure that the dossier is robust. The most recent version of the TCC was released in July and now includes a check for compliance with business rules, inquiry and Classification, Labelling and Packaging of Substances and Mixture (CLP) notifications. It is hoped that this new version, with its increased accuracy, will decrease the number of registration failures. However, it should be noted that some Business rules can only be corrected in Reach IT.

Once you are happy with your dossier, all you need to do is submit via Reach-IT!
It is not only lead registrants (LR) who need to plan carefully for these next steps. Joint registrants (who are encouraged in Reach) with a 2010 deadline may only submit their necessary information when the lead dossier has been successfully submitted. Also, how a particular substance may be used is included in the registration and is it is important that downstream users of chemicals have made their uses known to their supplier so that these can be included.

Early Bird Incentive

ECHA have realised that they may be in-undated with all the dossiers at the last minute, and have issued an early-bird incentive to registrants. Registrants who submit their dossiers before Nov. 31 will have priority from ECHA in dealing with any requests and will be able to access assistance over the phone, which may be vitally important when ensuring that everything is submitted correctly. To have access to this service, LRs have to notify their appointment in this role via the web form on ECHA's website and create the "joint submission object" in Reach-IT.

ECHA has assured stakeholders that they are ready and are able to cope with the massive influx of registration expected.

CLP Coming Up Quickly

Also, don't forget that CLP notification is required by the quickly following deadline of the Jan. 3, 2011, when notification of the classification of substances on the CLP inventory is required by ECHA. Registrants submitting by December 2010 can notify as part of their registration.

Consequences

Only substances that have been registered can be used legally (taking into account the registration dates) within the European Union. Therefore, any of the substances to be registered by 2010, that have not been registered - or have been rejected for failing the completeness check - will be deemed to be in breach of the regulation.

Reach is enforced at the state level, with an overall Forum for the Exchange of Information on Enforcement operating at EU level. Each member state has put into place varying levels of enforcement, from encouraging better tactics, all the way to fines, which can range from €50,000-€100,000 for the first infringement.

Summary

The first deadline for Reach registration is only a couple of months away, and approaching fast so there is little time to waste. Unless data are submitted to ECHA before the deadline, companies will not be permitted to market their products within the EU.

Are you ready?

WRc and NCET
The National Centre for Environmental Toxicology (NCET) within WRc can assist with Reach obligations at all stages of the process. The NCET team consists of experienced mammalian and eco-toxicologists, risk assessment analysts, chemists and experts on Reach legislation. NCET is able to provide advice, conduct chemical safety assessments, and prepare registration documentation to aid in the meeting of submission requirements.