Get organised with your co-registrants
Organisation of work among co-registrants
If no registration for your substance exists yet, you have to agree with your co-registrants how to work and communicate within your SIEF. This can include hiring a consultant or sharing the workload among SIEF members.
Each SIEF must also select a lead registrant who will submit the lead registration dossier, to enable the co-registrants to submit their member registration dossiers.
Model SIEF agreements have been set up by industry associations. Links to their web pages are available from the Accredited Stakeholders page on ECHA's website.
If the lead registrant registered for the 2010 or 2013 deadlines, it is likely that the preparatory work has already been done. You need to contact the lead registrant and ask to become a member of the joint submission after agreeing on data and cost sharing.
SIEF members must share available scientific data and decide how to fill data gaps. This takes time and has to be done before preparing and submitting the registration dossier. You need to discuss the relevance, reliability and adequacy of the data available. Additionally, you may need to select from overlapping data.
If a registration already exists, you need to negotiate with the existing registrants to get access to the submitted data. However, you might not need access to all the data, but only to the data required for your tonnage band. You might also consider using your own data. This needs to be discussed with your co-registrants.
Under REACH, the costs of registration need to be shared in a fair, transparent and non-discriminatory way. Data sharing is not designed to generate profit for any party, but to share the actual costs.
SIEF members must reach an agreement on how to share the cost of data and the cost of SIEF administration. Importantly, you only pay for the information and the management of the SIEF that directly relates to your own registration.
You also have the right to know the basis for the costs you pay. Remember that data submitted more than 12 years ago can be used free of charge.
Support from ECHA
As a last resort, if you cannot agree on data and cost sharing with your co-registrants, ECHA can assess your case. This applies to disagreements on performing missing tests as well as disputes on sharing the data and its cost. The data-sharing dispute procedure is free of charge and can be managed without legal support.
- Guidance on data sharing [PDF]
- DCG documents of cost sharing and sound SIEF management
- Checklist to hire a consultant [PDF]
- ECHA's decisions on data sharing disputes
- Support by ECHA's stakeholders
- Competition issues in the context of REACH and SIEFs (EC) [PDF]
- Commission Implementing Regulation (EU) 2016/9 of 5 January 2016 on joint submission of data and data sharing (EurLex)
- Guidance on data sharing, 30 November 2016
- Working together with your co-registrants, presentation 25 May 2016
- REACH 2018: Work together to share data and its costs, 1 March 2016
- Special e-News, 1 March 2016
- Be aware of false invitations - check that the lead registrant is credible, 22 February 2016
- ECHA clarifies criteria for 'one substance, one registration', 27 January 2016
- Registrants of the same substance must be part of the same registration, 25 January 2016
- REACH data-sharing principles clarified, 7 January 2016
- DCG documents of cost sharing and sound SIEF management, 10 October 2014
Practical examples & case studies
- Sharing the costs of an individual study
- Cost sharing between co-registrants with different data requirements
- REACH 2018 - things for SMEs to think about, ECHA Newsletter 2/2016
- How to get organised with your co-registrants, ECHA Newsletter 1/2016
- Know your rights when negotiating for data, ECHA Newsletter 4/2015