Substance identity profile

A. General Q&As

Where can I find more information on the substance identity profile (SIP)?

For more information on the SIP, please read appendix III - Substance identification and joint submission of data - of the Guidance for identification and naming of substances under REACH and CLP available on ECHA’s website at https://echa.europa.eu/guidance-documents/guidance-on-reach. You can also find technical instructions on reporting substance identity information in IUCLID 6 format in the manual “how to prepare PPORD and registration dossiers” available on the ECHA website.

What is the difference between the substance identity profile (SIP) and the boundary composition?

The SIP is the collective agreement between companies. The boundary composition is the technical reporting to reflect the compositions of all members in the joint submission. In some cases, the boundary composition includes, besides the composition information, also any other relevant parameter(s), such as the manufacturing process.

I have included a boundary composition record in my IUCLID registration dossier. Does ECHA publish this information on its website?

Yes. ECHA will disseminate the information reported in the boundary composition record by extracting it from registration dossiers submitted in IUCLID 6 format and will publish it through our Information on Chemicals part of the ECHA website. Information on chemicals can be searched through the Search box on the homepage of the ECHA website.

Our registration has not yet been updated in IUCLID 6 format to include a boundary composition record. In that case, will the legal entity composition record be published by default as the boundary composition?

The boundary composition record will not be published until the lead registrant updates the registration in IUCLID 6.

There is a Dissemination Preview tool included in IUCLID with which users can see what data will be published and how. We strongly encourage registrants to use this to check their dossier before submitting it to ECHA.

My composition falls outside the boundary composition reported in the lead registration dossier. What should I do?

Where your composition is outside the boundary composition of an existing joint submission, the first step would be for you to contact the existing registrant(s) and discuss with him whether the Annex VII-XI data reported in the joint registration would be sufficient as to apply to your substance. Where it is agreed that the data is sufficient, it would then be necessary for the lead registrant to update the boundary composition record reported in the lead dossier to expand its scope. This would mean updating the boundary composition to cover the compositions of both your composition and that of the existing registrants.

All parties would need to ensure that the criteria applied are transparent and that the relevant Annex VII-XI data collected/generated demonstrably covers all agreed compositions.

I am the lead registrant of an existing registration in IUCLID 5 format. Do I need to update it immediately in IUCLID 6 format to include the boundary composition?

No. You only have to include a boundary composition record the next time you update your submission.

However, we strongly encourage lead registrants to discuss the boundary composition with their members and potential registrants and update their dossiers as soon as possible.

For a new registration, it is now mandatory for lead registrants to include the boundary composition record when they submit their IUCLID dossier.

Is the lead registrant obliged to update the boundary composition when a new registrant enters the joint submission?

It is important that the compositions and parameters defining the boundaries of the substance covered by the joint submission are agreed by all the co-registrants and are clearly documented in the boundary composition. Accordingly, the boundary composition may need to be modified or extended following the request of any new potential registrant, if all co-registrants agree that part or all of the jointly-submitted data is also relevant for the substance manufactured or imported by this registrant. However, the lead registrant is not obliged to amend the existing boundary composition if he and the other co-registrants consider that by doing so they could no longer rely on the data to address the hazard properties of the extended composition. The rationale would need to be transparently documented.

Can more than one boundary composition record be included in the lead registrant dossier?

More than one boundary composition record may be reported depending on how the co-registrants want to structure the reporting of their joint Annex VII-XI data. For example if there are compositions that have impurities/constituents that triggered PBT assessment and/or have different classification and labelling, these can be reported in their own boundary composition record in IUCLID.

Do all the co-registrants have to report and keep the boundary composition record information up-to-date?

Only the lead registrant, with the agreement of the other co-registrants, is required to report the boundary composition(s) in his dossier and keep it up-to-date. Any change made by the lead registrant at the level of the boundary composition will be visible to every member of the joint submission in REACH-IT.

Does the boundary composition have to include only impurities that have an impact on the hazard profile of the substance?

The level of detail reported for the boundary composition is not dependent on whether the substance is hazardous or not. However, the level of detail for the boundary composition should be customised around the considerations used to construct the hazard dataset, including also the relevant considerations made at the impurity level to derive the classification and/or PBT assessment of the substance.