A new UK REACH functionality will create a ‘lead registrant’ role when registering with the HSE from now on.
If there are more than one registrant for a substance from now on, co-registrants in the substance group will need to establish amongst themselves who the ‘lead registrant’ is. This new position will act as the primary contact for substance registration with the HSE. These lead registrants will face new responsibilities and challenges but also reap benefits. At the moment the only step that needs to be taken is claiming the status, dossiers are not yet required.
Responsibilities
While claiming lead registrant status might be simple, it is important to recognize the pros and cons of doing so. There are several main responsibilities for the lead registrants. They will eventually need to submit a joint registration dossier on behalf of all members of the substance group. This dossier will need to contain all relevant information under Article 10 of the UK REACH legislation.
The lead registrant will have the responsibility to approve which other organizations can become members in the joint registration group. These co-registrants should submit their own company-specific information where they are part of the joint submission. On request, the lead registrant should also share data from the joint dossier with potential new registrants according to a data sharing agreement.
Co-registrants will be able to agree on further responsibilities for the lead registrant. These responsibilities range from submitting guidance on safe use of a product, submitting chemical safety reports for substances manufactured/imported in quantities of 10 tonnes or more per year and an indication that the relevant information has been reviewed by an assessor chosen by the registrant and with relevant experience.
Advantages:
The main advantage to adopting the lead registrant status is the ability to organize data-sharing amongst co-registrants. This grants the lead registrant the opportunity to recoup costs from studies/data generation via data sharing arrangement with other registrants and avoids any repetition of unnecessary testing.. The ‘sharing of cost for data’ needs to be accomplished in a fair and non-discriminatory way.
Withdrawals:
If the lead registrant wants to withdraw from their position at any stage, they need to work with the co-registrants to organize a successor. This status can be transferred online through the HSE.
How we can help
Deenamic Ltd has a team of experienced consultants who can help your organization in the creation of the necessary dossiers as well as advise on regulatory strategy going into the future. If you want to hear more, questions are welcome. We can be reached through our email info@deenamicltd.com