Exchanging Information - The first deadline for Reach registration is approaching fast. This process requires that future registrants work together in Substance Information Exchange Forums (SIEF) in order to submit one joint registration dossier for one substance. In its efforts to make this registration process a success, Mercedes Viñas, manager of chemical regulation at Cefic, along with the Cefic SIEF working group have developed recommendations and tips in order to allow SIEFs to deliver.

Following the pre-registration phase, companies who have the intention to register the same substance are put in contact via Reach-IT system. Once the sameness of the substance is confirmed, companies can form a SIEF for that substance.
SIEF members need to nominate a lead registrant (LR) to submit the joint registration dossier on behalf of the SIEF members. The joint submission contains the main part of the technical dossier including the classification and labeling of the substance, study summaries and the proposal for further testing, if applicable. The rest of the SIEF members must still do a separate registration after signing up to the joint submission created by the LR in Reach-IT.

Recommendations For LR

Most of the recommendations for LR to kick off the activities in the SIEF should have taken place by now. Those include sending out a survey on the registration intentions of the SIEF members, establishing a system to support communication and keeping all the members of the SIEF informed. LR should have also coordinated the agreement on substance identity: indeed, the name and identity of the substance to be used for registration purposes should be agreed by all SIEF members.

Cefic recommends members of a SIEF to agree on operating rules, for example using the available Cefic model agreements.
It is extremely important to keep the SIEF regularly informed on the progress towards the joint submission, keeping communication channels open. For that, it is also advised to establish a single contact point for the SIEF and make this contact point known to all members. LRs are also advised to keep the SIEF distribution list up-to-date, taking late comers into account. Also, the use of old versions of software for SIEF communication is preferred in order to avoid problems when opening communications.

Communicate decision on the scope of Joint submission: Article 11 of the Reach Regulation defines the information that must be submitted jointly and the information that must be submitted individually by each registrant. There is also some information for which the registrants can decide whether it is submitted jointly or separately.
The scope of the joint submission, and particularly whether the Chemical Safety Report (CSR) is done and submitted jointly, must be communicated to all SIEF members as soon as possible.
If it is not decided to do a joint CSR, this very demanding task has to be carried out by the individual registrants (for all volume bands greater than 10 tons/year).

It should be noted that the CSR may need to be updated once the outcome of the newly generated tests is available, if any. Some SIEFs may decide to prepare the CSR jointly but submit it separately. This option may facilitate subsequent updates, which can then be handled by individual registrants.
Please consult Cefic guidance on ES development and Supply chain communication for more information and start early!

The other points that the LR should pay attention to are to set up an efficient system for invoicing and payment, find out availability of data, and create a joint submission in Reach-IT.
Besides the discussions regarding data sharing and the preparation of the registration dossier, it is highly recommended that all SIEF members (even with no intention to register) are informed of the agreed classification. This will facilitate having a harmonised classification in case SIEF members have to notify the substance classification to the European Chemicals Agency (ECHA).

Once the information is available and ready, attention has to be brought to the actual submission procedure. The submission process entails a number of checks, and many submissions may not be successful in the first attempt. Therefore, it is important to make sure your dossier passes the corresponding checks (in order of appearance):

• Business rules
• Technical Completeness
• Financial check (to check that registration fee has been paid).

We insist that SIEF members don't forget to activate the confidentiality claims if they wish to prevent some data from being published! ECHA has published a manual that explains which fields of the registration dossier will be published unless claimed confidential.
Please check Cefic tips on how to overcome the business rules and available information at the ECHA website.
All SIEF members need to take into consideration future updates of the registration dossier (joint submission) that may occur beyond the registration deadline, for example:

• The follow-up of test proposals for which ECHA gives a green light. The tests related to such proposals will need to be carried out, their results evaluated and submitted jointly.
• ECHA may also request additional information following the evaluation of the registration dossier. SIEF members need to decide beforehand the way such requests will be handled.
• Moreover, newcomers may come into the picture, for example companies who start to manufacture/import the substance for the first time may want to join the SIEF and the Joint submission in the future
• Updates of the CSR may be needed following the outcome of tests

Therefore, companies should bear in mind that SIEFs will be maintained at least until 2022 and beyond!

Cefic Recommendations for All Co-Registrants

The LR is not the only one who has work to do. All other members of the SIEF have to do their part and prepare and submit their individual registration dossiers. Although they are smaller dossiers, this task should not be underestimated.
First of all, be aware of deadlines! Cefic has prepared a chart that shows the main tasks that need to be carried out in the SIEF and the recommended timing for these tasks. This chart may give companies a useful overview in order to monitor the progress of the various SIEFs they are involved in and react if necessary. The chart follows the Gantt chart structure and can be found at the Cefic website, section "Reach/Reach for industries."
Find out the scope of joint submission and in particular whether the CSR will be jointly submitted:
If the CSR is not submitted as part of the joint submission, each individual registrant needs to prepare and submit their own individual CSR. This task may be quite burdensome; therefore it is central to find out whether you have to do it as soon as possible.
Before you submit your dossier as a member of a Joint submission, the following steps must be followed:

• Sign up to the joint submission: Once the joint submission object (JSO) is created by the lead registrant in Reach-IT, it is always associated with a name and a specific unique token generated by Reach-IT. The lead has to communicate this combination (joint submission name and token) to those SIEF members that have fulfilled the corresponding conditions agreed in the SIEF operating rules. Cefic encourages SIEF members to sign-up to this JSO in Reach-IT as soon as they receive the token.
• SIEF members need to wait for the LR to submit his registration before submitting the individual registrations as JS member.
• Each member of the SIEF should make sure that the dossier passes business rules and completeness check before submission. As explained above, there are a number of checks that the dossiers undergo in the ECHA systems. It is very important that individual registrants become familiar with these checks, in particular the business rules. Please see below links for more information.
• Set-up an efficient system for payment of registration fee: The companies' accounting departments should be informed about the upcoming Reach costs and invoices. Cefic recommends to considering the set up a different legal entity and separate bank account for SIEFs transactions. Outsourcing is also a possibility.
• Don't forget Classification and Labeling (CLP) notification! If the individual registration is not submitted by December 2010, a separate notification of the substance classification may be needed.
• It is highly recommended that all SIEF members (even with no intention to register) are informed of the agreed classification and on the possibility to join the joint notification if there is one.

Companies should bear in mind that SIEFs will be maintained at least until 2022 and beyond! As explained above, SIEFs may need to continue working together in case of newcomers, or requests for more information from ECHA.
Cefic recommends establishing clear and transparent SIEF communication, usingavailable guidance and tools as much as possible and becoming familiar with the submission process in order to have a smooth registration well in advance of the Dec. 1 registration deadline.

More Links:
ECHA Guidance on SIEF: http://echa.europa.eu/sief_en.asp
ECHA Guidance on data sharing: http://reach.jrc.it/docs/guidance_document/data_sharing_en.pdf
ECHA manual on business rules: ttp://echa.europa.eu/doc/reachit/how_pass_business_verification.pdf