February 10, 2020 by Sylwia Kosmala-Grzechnik
ECHA’s concerns that companies are not keeping their REACH registrations up to date has led to the drafting of an Implementing Regulation, setting out a deadline of 3 months for submitting administrative updates, and deadlines of 6 or 12 months for updates which are considered more complex and require generating new data or changes in the safety assessment.
REACH registration dossiers should be considered as “living documents” and reflect the most up-to date knowledge on a substance. However, there are concerns that many registrants consider that once their REACH registration has been submitted and their REACH registration number is assigned, no further action is required. Indeed, a 2017 study commissioned by ECHA revealed that over 60% of the registration dossiers submitted from 2008 had not been updated since their original submission.
Article 22 of the REACH Regulation specifies in which cases a dossier has to be updated and that it is the responsibility of the registrant to update their registration dossier when needed. Companies are required to spontaneously update their dossier ‘without undue delay’ whenever new data are available or a need to improve the quality of data is identified, but no further details are provided with regards to the timelines for submitting the information to ECHA.
Therefore, to ensure that dossiers are updated with new data without delay, the European Commission is preparing a new Implementing Regulation clarifying the conditions set out in Article 22. According to the proposal, registrants will be required to provide updates as quickly as possible and no later than the relevant deadline specified in the Implementing Regulation.
Deadlines for submitting the ‘new information’ depend on the type of change. The new deadlines in the draft Implementing Regulation are as follows:
- 3 months: changes in registrant status or identity, changes in tonnage band, changes in identified uses and uses advised against, changes in the access granted to information in the registration, and updates to the joint submission.
- 6 months: changes in composition, new data on the risks to human health and/or the environment, changes in the classification and labelling, testing proposals prior to conducting a test listed in Annex IX or Annex X.
- 12 months: updates of the chemical safety report, testing proposals prior to conducting a test listed in Annex IX or Annex X in the case of a testing strategy developed for a group of substances.
The draft Implementing Regulation also sets out that where a co-registrant of a joint submission's update is dependent on the lead registrant making an update prior to them, the co-registrant will have three months from the date when ECHA confirm that the update made by the lead registrant is complete.
The deadlines specified in the draft Implementing Regulation are considered as upper limits for submitting the new data and apply only to the obligation in Article 22 of REACH. The deadlines will not supersede other updating obligations for which deadlines are specified in other documents, for example in ECHA’s decision letters.
Feedback on the draft Implementing Regulation has been provided by the stakeholders and, in their comments, industry have raised concerns that the deadlines are too short, especially in cases of complex registrations and where a large number of companies are involved. The feedback is currently under review by the European Commission and it is expected that the draft Implementing Regulation will be adopted later this year.
At wca, we keep a close eye on the latest developments in various regulations and regions and we are able to alert you about potential issues that may affect your company and offer advice on how to adapt your registration strategy to stay complaint on the market. Please contact us if you would like further information on our services or if you have a specific enquiry concerning the potential impact of the draft Implementing Regulation on your registration.