The final REACH Registration deadline is just four years away, on May 31st 2018. A Registration Dossier takes approximately six months to assemble, involving input and communication between numerous companies. It is also expected that lab availability will become more scare as the deadline approaches. Therefore, it is important that your company plans sufficiently in advance of this deadline.
When a company first places a substance onto the EU market in a quantity greater than one metric Tonne Per Annum (TPA), that substance is subject to Registration under REACH 1907/2006/EC.
There are two routes after this – file a pre-registration (if your substance meets certain criteria), or file an Inquiry Dossier. Going the latter route can add two to four months to the timeline.
Your consultant then must get in touch with the SIEF/Consortium for this Substance. Here you will find a platform for where your company can obtain access to the Lead Registrant’s data. The company that acts as Lead Registrant are normally the largest Manufacturer or Importer of the Substance. Your company must pay to access the Phys Chem and Tox test data generated by the Lead Registrant, which is split as a function of SIEF size. The more users of the Substance, the larger the SIEF. SIEF size for Ethanol is 3700 companies. Other Substances may be so rare that they only have less than 20 companies in the SIEF. The larger the SIEF, the less expensive the Letter Of Access (LOA). Budget for €15k.
The next step is to prove that your Substance fits the Consortium’s Substance Identity Profile (SIP). The Consortium will usually provide a list of recommended analytical techniques to characterise your Substance in the lab. Budget for €3k.
During this process, your consultant will be building your Joint Registration Dossier in IUCLID 5 software system. Once assembled, this Dossier is submitted to ECHA through their IT system (“REACH –IT”). For this process, you should budget for €5k.
The final element is to make a payment to ECHA for filing and processing the Dossier. This figure ranges from €64 right up to €24,901, depending on company size and tonnage band. Exact pricing is stated in 254/2013/EU. SME’s benefit from reduced fees, but proof of being an SME is required on the basis of Balance Sheet/Turnover and number of employees for the past two years).
After these steps are complete and approved by ECHA (usually one working week or less) the Joint Registration number is granted. This number will be similar in format to the Lead Registrant but the last 4 digits will be unique. This is the REACH Registration number. You are then permitted to sell your Substance in the tonnage band for which your company has Registered.
For a free consultation on this complex process, please feel free to contact the Dossier build specialist H2 Compliance.