The final REACH registration deadline on 31 May 2018 is fast approaching as there is less than 9 months left for companies across Europe to meet this major regulatory challenge. This final tranche of phase-in registrations is involving both first time registrants from small and medium sized enterprises (SMEs) and large companies with previous registration experience, including those with wide-ranging portfolios of substances to register. ECHA is currently forecasting that up to 70,000 dossiers could potentially be expected; nearly three times as many dossiers as under the first deadline in 2010, which will cover up to 25,000 substances. Registration is a significant undertaking for many SMEs and large companies alike. Whilst working on registration, companies are also likely to be affected by other REACH processes such as evaluation, authorisation and restrictions. This has generated a significant impact in terms of resources, especially on those companies that have registered in 2010 and 2013 and are still busy preparing their submissions ahead of 2018 deadline.
For those companies that are planning to submit a dossier for the 2018 deadline we would like to remind you that REACH requirements for skin corrosion/irritation, serious eye damage/eye irritation, acute dermal toxicity and skin sensitisation changed last year. This change made the non-animal testing the default requirement for those endpoints. In many cases, the information needed under REACH for the classification or risk assessment of a substance is now obtained through non-animal methods. Companies need to take the changed requirements into account when submitting registrations to ECHA. To pass the completeness check of registration dossiers, registrants need to give information according to the new legal requirements.
ECHA’s IT tools are at the centre of the creating and submitting a dossier process and are periodically updated to ensure that this process runs smoothly. Every registrant must prepare a registration dossier that has to include information specific to their company and their substance. IUCLID software application is the IT tool in which dossiers must be created in order to fulfil the requirements of REACH. In the latest version, IUCLID 6, 1.3.0, released at the end of April, several new functionalities were introduced to create a more user-friendly experience. These include a predicted no effect concentration (PNEC) calculator that uses data submitted in IULCID, the capability of re-using dossier headers, the ability for user to access a file after directly importing it via the background jobs window and the possibility to compare two dossiers.
The validation assistant plug in for IUCLID 6 is another crucial feature as it highlights if any information is missing from the dossier. ECHA recommends that before submitting your dossier it is checked by the validation assistant as if information is missing the dossier will fail ECHA’s completeness check. Any failure it draws attention to should be corrected before submission. However, if no failures are indicated it does not guarantee that the dossier is complete. This is because further manual checks will be carried out by ECHA that can’t be displayed by the validation assistant.
Infrequent users and SMEs can now access the IUCLID software via ECHA’s cloud services that were launched in April. IUCLID Cloud for SME’s has been designed for SME’s who need to prepare their dossiers for the 2018 REACH deadline. It’s anticipated that this service will be used by less frequent users of IUCLID who stand to benefit from the user friendly cloud environment and not having to download the IUCLID software locally. Users are able to access their data anytime from anywhere as long as they have an internet connection. They also have a reduced risk of losing data as it is regularly and automatically backed up by ECHA.
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The REACHReady team can support you to successfully achieve this important milestone. REACHReady offers a confidential, comprehensive and cost-effective “one-stop shop” service, right through from keeping you informed of all the latest developments, to fulfilling your specific registration and authorisation needs. We aim to save you time, trouble and money. If there is any aspect of REACH registration you would like to discuss with us – just let us know!
Join us in Manchester on 23 November for our CPD accredited ‘REACH Registration: Are you ready for 2018?’ workshop.
Email firstname.lastname@example.org or visit www.reachready.co.uk for booking and further information.