When navigating the complexities of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) registration, one crucial question arises: Is REACH registration a one-time cost? The simple answer is no. REACH registration is an ongoing commitment, necessitating periodic updates to ensure compliance with evolving regulations and current scientific knowledge.
The Living Document
The essence of REACH registration lies in its dynamic nature. Once a registration dossier is submitted and a registration number is received, the registrant’s responsibilities are far from over. The dossier must continuously reflect up-to-date knowledge on the safe use of the substance at production sites and throughout the supply chain. This ongoing requirement means that registrants must update their dossiers whenever new information or changes arise.
When to Update Your REACH Registration
Several scenarios necessitate an update to your REACH registration:
Change in Substance or Use: Updates are required if there is new knowledge about the substance or its uses, such as an increase in the tonnage band, new applications, or alterations
in the substance’s composition.
Evaluation Decisions: If the European Chemicals Agency (ECHA) issues an evaluation decision requesting additional information, the registration dossier must be updated accordingly.
Regulatory Changes: Changes in REACH information requirements or updates to the harmonised classification and labelling of hazardous substances (issued annually by the European Commission) may impact your dossier.
IT Screening Campaigns: ECHA’s IT screening campaigns can highlight areas needing improvement, prompting registrants to update their dossiers to address these concerns.
Practical Points for Updating Your REACH Dossier
Manufacturing/Importing Status
Ensure that your REACH-IT account accurately reflects whether you still manufacture or import the substance. If you cease these activities, update your account to stop the registration.
2. Tonnage Band Accuracy
Verify that your registered tonnage band is current, based on the quantity manufactured or imported in the previous calendar year. If your tonnage band changes—either increasing or decreasing—update your dossier to reflect this.
3. Contact Information
Keep contact details in REACH-IT up to date. Accurate contact information is vital for communication with ECHA and potential co-registrants.
4. Substance Composition
Confirm that your substance’s composition fits within the boundary composition of the jointly submitted data. If not, collaborate with the lead registrant to adjust the boundary composition or opt out and submit necessary data independently.
5. Use Coverage
Ensure all uses of the substance are covered in your registration dossier(s). If the Chemical Safety Report (CSR) is provided jointly, check that all uses are reported by the lead registrant. If not, include all relevant uses within your own dossier.
6. Supply Chain Communication
Communicate any significant changes to your registration within your supply chain, particularly updates affecting (extended) Safety Data Sheets (eSDS), hazard classifications, or Guidance on Safe Use.
Ongoing Duties Post-Registration
Successful registration marks the beginning of an ongoing obligation. Co-registrants must contribute to updating the registration dossier, adhering to data and cost-sharing responsibilities. This collaborative effort ensures compliance and the continuous safe use of substances within the EU market.
Updates may be managed by a consortium or individually, incurring additional costs such as ECHA fees for changes, cost-sharing for analyses, and dossier preparation expenses. These costs emphasize that REACH registration is not a one-time expenditure but an investment in the sustainable management and regulation of chemicals.
Conclusion
REACH registration is a continuous process requiring regular updates to maintain compliance and ensure the safe use of substances. By treating the registration dossier as a living document and staying vigilant about changes in substance use, regulatory requirements, and scientific knowledge, companies can navigate the complexities of REACH effectively. This proactive approach not only helps in meeting legal obligations but also contributes to a safer and more transparent chemical industry.
SOURCE: ECHA
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