EU Commission sets deadlines for updating registrations
vendredi 30 octobre 2020
The European Commission has decided to set deadlines for updating REACH registration dossiers after a large number of dossiers have been found to be non-compliant with REACH requirements. REACH Article 22 states that updating registration dossiers is mandatory and should be done « without undue delay ». The article does however not clearly indicate the meaning of this, which has led to different interpretations and many registrants failing to fulfil their duties. The European Commission has therefore decided to clarify the deadlines.
Registrants are required to update the dossiers they have submitted as soon as changes occur and additional information becomes available. Registration dossiers must provide information on the uses, hazards and risks presented by a substance, which is why it is important that dossiers be kept up to date at all times. Commission Implementing Regulation (EU) 2020/1435 of 9 October 2020 gives the different scenarios that may trigger the need for registrants to update their registration dossiers. A few examples are given below: - Changes in a registrant’s status or identity - Changes in the composition of the substance - Changes in tonnage band - New knowledge of the risks to human health and/or the environment - Changes in the classification and labelling of the substance - Testing proposals prior to conducting a test listed in Annex IX or X - Updates of joint submissions
All registrants will now be legally obligated to modify and add any new piece of information to registration dossiers no later than the specified deadlines. Different deadlines are set according to the complexity of the information required. A deadline of three months will apply for updates of an administrative nature for example. A deadline of six, nine or twelve months will apply for more complex updates such as changes to the chemical safety report (CSR) or the guidance on safe use. These deadlines are presented as upper limits, meaning all changes must be made as soon as possible.
In the case of joint submissions, co-registrants may, when their update depends on the lead registrant, be able to update their dossier only once he has successfully completed his. They will have nine months to update the CSR or the guidance on safe use, and three months for all other scenarios, after the lead registrant has submitted his update.
The requirements of this regulation will enter into force by the end of the year, sixty days after its publication in the Official Journal of the European Union. Registrants are encouraged to monitor and keep track of changes at all times, so as to ensure that their registration dossiers are up to date.