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- 01/19/2017

REACH 2018 – Submit your Registration Dossier ‘IUCLID 6 & REACH-IT’

Chimica Oggi-Chemistry Today

IUCLID 6 is built on new technology, which allows the development of customized interfaces, as well as to connect IUCLID to other data management systems. All information that users have stored in IUCLID 5.6 can be migrated to IUCLID 6. This can be achieved by the migration of the entire database, during the upgrade process. The same migration is also performed when a data element of IUCLID 5.6 format is imported into IUCLID 6.  IUCLID 6 contains an extensive help system within the tool itself, allowing the user to get targeted help while filling in the data. Registrants can check the completeness of their information with a verification tool called the ‘Validation Assistant’, which is available within IUCLID. This tool will also report potential inconsistencies, which can be fixed before submitting the registration to ECHA. 

REACH-IT plays a central role in dossier submission between ECHA and industry. Made available in June 2016, the new version of REACH-IT is far more intuitive, user-friendly and introduces new features in line with the changes made to the REACH registration process in 2016.  Based on a new navigation structure and design, the REACH-IT homepage allows you to quickly access key functionalities and information directly from the homepage or through the revised menu. Submitting a IUCLID dossier is now simpler due to a revamped submission wizard, which also includes checklists that give further help. In addition, the system allows quick and easy access to post-submission information (e.g. the status of your submission) through the submission report and the reference number overview pages. The reference number overview page gives an administrative overview for each regulatory process, and is your starting point when you update your dossier. In addition, the search functionality has been redefined. After selecting the type of item to search, you can filter the search results by specific criteria. 

As part of the new generation of ECHA’s IT tools, REACH-IT has been upgraded to meet the requirements of the new version of IUCLID. Started in late June 2016, REACH-IT only accepts dossiers prepared in IUCLID 6 format. The completeness check that ECHA performs on each incoming registration has also been adapted to the new IUCLID format and to the changes in the information requirements (e.g. the extended one-generation reproductive toxicity study). The IUCLID Validation Assistant has been updated so that you can check your dossiers before submitting them to ECHA through REACH-IT. The automated completeness check in REACH-IT is complemented by a manual verification performed by ECHA on elements that cannot be checked automatically.   

One substance, one registration – REACH-IT now makes sure that dossiers cannot be submitted individually if a registration for the same substance and registration type already exists (the ‘one substance, one registration’ principle of REACH). It features an automated system, which verifies that there are no existing joint submissions for the same substance and registration type. Preparing the registration dossier is the fifth phase of ECHA’s REACH 2018 Roadmap. Companies registering the same substance are advised to continue to cooperate in this phase of the preparatory work. Two types of dossiers can be prepared for submission in IT format: the lead registrant dossier includes information specific for the lead’s company and information that has been agreed by all the registrants, such as the classification and labelling of the substance and the (robust) study summaries. The other members of the joint submission need to create a member registration dossier with their company-specific information, such as the exact identity of their substance and its uses. The lead registration dossier can only be created in the new IUCLID 6 software, which is available for free on the IUCLID website. The member registration dossier can be created in IUCLID 6 as well, but also directly in the new REACH-IT, without having to install IUCLID.

The new generation of these tools has been tested by industry users, who confirmed that they are easier to use than the previous generation. The visibility of lead registrants is more prominent in the new REACH-IT, and when you create a joint submission, REACH-IT will automatically display your contact details as a lead registrant, or of the assigned third party representative, to those who have registered, pre-registered or inquired for the same substance. Additionally, if you as a lead registrant agree to have your company name published on ECHA’s website, you have to indicate that in the joint submission page of REACH-IT.   All lead registrants are encouraged to allow their name to be published on ECHA’s website to increase their visibility among potential registrants and reassure downstream users that the substance they are using is being registered further up in the supply chain. 

The search for a joint submission gives members of a joint submission easy access to relevant information. They can, for example, see all the other members of the same joint submission.  In addition, potential registrants (i.e. companies who have pre-registered or inquired for a specific substance but have not yet joined the joint submission) are now able to see the existing joint submissions for their substance by ticking the dedicated box Show other joint submissions in the search.   

REACH-IT’s new feature aims to ease the work of small and medium-sized enterprises (SMEs) who need to assess their company size and provide related supporting documentation to ECHA. It includes useful information and guidance on how to determine your company size under REACH. An introduction to the IUCLID software and practical advice on how to create a dossier in IUCLID or directly in REACH-IT is now available on ECHA’s website. The IUCLID 6 and REACH-IT 3 user manuals are also available – soon in 23 EU languages. 

REGISTER NOW! The sixth and final step to successfully register chemicals by the 31. May 2018 deadline is to submit one’s dossier electronically through REACH-IT to ECHA. One will receive his/her firm’s registration number once ECHA verifies that the dossier is complete and that the registration fee is naturally paid. After completing the REACH registration, one can continue to legally supply their chemicals on the EU market. 

Before logging into REACH-IT to send, go through this simple checklist:

  • Check the completeness of your registration dossier with IUCLID’s Validation Assistant and save the correct IUCLID file on your computer.
  • Make sure you are part of the correct joint submission for your chemical. By law, all registrations for the same substance must be part of the same registration.
  • Check that your company contact details are up-to-date in REACH-IT as ECHA might contact you about your registration.
  • Check your company size category. Your registration fee depends on the size of your company, and there are guidelines to help you determine your correct size. We follow the European Commission’s definition of SMEs. If you indicate that you are a micro, small or medium-sized company, you will need to give documentary evidence to back this up. ECHA will ask you for this information if it is missing from your submission.
  • Have a look at the document Discover REACH-IT to get familiar with the new interface of the tool.

Steps to take – If you are a lead registrant, make sure you submit your registration well before the deadline, preferably before April 2018, so that member registrants have enough time to submit theirs. Member dossiers can only be sent after the lead dossier has been successfully submitted.
Lead registrant, you need to:

  • Create the joint submission in REACH-IT
  • Give member registrants access to the joint submission with the security token
  • Submit the lead dossier, containing the joint part of the registration.

Member registrant, you need to:

  • Get access to the joint submission from the lead registrant
  • Use the security token to confirm your membership in the joint submission in REACH-IT
  • Submit your member dossier through REACH-IT

The REACH-IT submission wizard will guide you through the submission process – it identifies the tasks and actions you need to take according to your submission type and role (lead/member). If any questions, pls. contact us, CONUSBAT Regulatory Services.

Register to REACH-IT: https://reach-it.echa.europa.eu/reach/




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