In today's globalized market environment, the safe use and management of chemicals are of vital importance. The REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) Regulation is a chemical management regulation established by the European Union to protect human health and the environment. As the Only Representative (OR) for many domestic chemical manufacturers, CIRS Group is well aware of the importance of complying with the REACH Regulation for Chinese chemical companies' trade with Europe. According to the REACH Regulation (EC 1907/2006), manufacturers, importers, and Only Representatives (ORs) designated by non-EU manufacturers of substances must submit registration dossiers for the substances they produce and import to the European Chemicals Agency (ECHA) and update any relevant new information in the dossier in a timely manner in accordance with Article 22 of the Regulation.
After the end of the registration transition period in 2018, member states and ECHA began to focus on the issue of updating registered dossiers. Therefore, on October 12, 2020, the European Commission issued Implementing Regulation (EU) 2020/1435, which clarified the specific meaning of "without undue delay" under the REACH Regulation and set a clear time frame for registration updates. The regulation stipulates that for more administrative updates, registrants must complete them within three months; for complex updates, such as data generation or changes in safety assessments, they must be completed within six or twelve months.
Given this, CIRS Group would like to remind chemical companies that strictly complying with the update requirements of the REACH Regulation is a necessary condition to ensure market access and compliant operations. Below are the key points for updating dossiers after completing REACH registration:
Timely Update of Dossier Information
Companies must regularly review and update their substance registration dossiers in accordance with the requirements of the REACH Regulation to ensure that they reflect the latest safe use information. Some key areas for updates are as follows:
- Substance Composition and Uses: Check whether the composition of the substance has changed and ensure that it complies with the boundary composition (SIP) requirements for joint submission. At the same time, members of the joint submission should reflect their own substance uses in the registration dossier and confirm that all uses are covered in the Lead Registrant's (LR) registration dossier. For specific uses not covered, communication with the LR is necessary to request inclusion or to develop a Chemical Safety Report (CSR) for exposure assessment.
- Tonnage Range and Usage: Verify whether the current production or import tonnage is still within the registered tonnage range and ensure that the registered tonnage range accurately reflects the quantity of the substance produced or imported in the previous year. If there are changes, the dossier should be updated in a timely manner. Additionally, companies should regularly check whether they are still using the registered substance. If not, the "cessation of production" registration should be promptly reflected through the REACH-IT account.
- Safety Data Sheet (SDS) and Extended Safety Data Sheet (eSDS): If the substance has a hazard classification and its registered quantity exceeds 10 tons/year, an extended safety data sheet (eSDS), i.e., an SDS with exposure scenarios, is required. Companies need to ensure that the information in the SDS and eSDS is accurate, promptly communicated downstream, and kept up-to-date.
- Hazard Classification and Labeling: Check whether the hazard classification of the substance is correctly reflected in the SDS, product labeling, and related documents (e.g., for transportation and product handling purposes) and disseminated throughout the supply chain.
Focus on Joint Submission Updates
For co-registrants participating in joint submissions, their dossier updates may depend on the updates to the Lead Registrant's (LR) dossier. In such cases, co-registrants should update and submit their own dossiers within the prescribed time limits after ECHA has confirmed that the LR's registration dossier has been submitted and accepted. The following are the timelines for submitting updated dossiers based on different types of information changes:
- Within 3 months: If the reason for the co-registrant's update is changes in the registrant's status or identity, changes in the substance composition, changes in the tonnage range, changes in the substance uses, new study data on risks to human health and/or the environment, changes in the classification and labeling of the registered substance, or changes in access to information in the registration.
- Within 9 months: If the co-registrant needs to update or modify the Chemical Safety Report (CSR) or Guidance on Safe Use (GSU).
- Within 9 months: If the co-registrant needs to update any of the updates mentioned in point 1, which would trigger updates or modifications to the existing CSR or GSU.
The above deadlines apply from the date ECHA notifies the Lead Registrant and the joint submission members that the LR dossier update is complete.
The consortium/Lead Registrant should notify co-registrants of the reasons for the update after ECHA accepts the LR dossier update and share relevant documents with co-registrants, such as IUCLID files and CSR.
Comply with Data Sharing and Cost-Sharing Obligations
As co-registrants in a joint submission, companies are responsible for participating in the dossier update process, including data sharing and cost-sharing. Failure to pay for dossier update costs may result in the loss of the right to reference the joint submission dossier, and even the loss of the registration number and market access opportunities.
Regular Review and Self-Inspection
Companies should regularly review their registration dossiers to ensure compliance with current regulatory requirements. CIRS Group, as the Only Representative for many non-EU manufacturers under EU-REACH, prioritizes compliance.
In summary, REACH registration is not a one-time effort; companies must continuously monitor regulatory changes and update their registration dossiers in a timely manner. By following the above suggestions, companies can effectively reduce compliance risks and ensure the legality and safety of their products in the European market. CIRS Group will continue to provide you with professional support and services to help you successfully meet the challenges of the REACH Regulation.
