Are you confused by what is meant by dissemination of Safety Data Sheet information and confidentiality claims?
If so, I bet you are not alone. The recent upgrade to IUCLID 5.4 with the corresponding new version of REACH IT will allow ECHA to increase the amount of information currently available to the public from REACH registrations through the dissemination portal on their web-site.
This applies to already registered substances, former NONs and new registrations. H2 Compliance has already written a blog on the NONs dissemination timelines and it will not be covered it in this blog.
As of November 1, 2012, safety data sheet information included in your REACH registrations is going to be made available. You might be thinking, Does this mean my safety data sheet is going to be shared on the website? No, ECHA does not require a copy of the safety data sheet, with the registration dossiers so the SDS itself will not be disseminated. Instead, in accordance with Article 119(2) (d) of the REACH Regulation ,selected sections of the dossier that are also required in a safety data sheet, , will now be shared publically unless you take action to protect this information.
So what specifically is “Safety Data Sheet Information”?
The SDS information to be disseminated includes:
For manufacturers and importers, the registrant name will be disseminated unless it is claimed confidential. It’s a bit more complicated for registrations under an Only Representatives (ORs), where the OR name or the supplier name from section 1.7 will be disseminated unless they are claimed confidential. If neither the OR or supplier name has been claimed as confidential, then the supplier name, from section 1.7, will be shared instead of the OR name.
The full (18 digits) Registration number will be disseminated unless claimed confidential. If the registrant name has been claimed confidential but the registration number has not, the last four digits of the registration number will be hidden to protect the identification of the registrant.
life cycle description (formerly identified uses) and uses advised against information
This information is already disseminated unless claimed confidential and really just represents a renaming of section 3.5 to life cycle description from identified uses.
Exposure scenario elements
Section 3.7.1 is a new section in IUCLID 5.4 allowing for a better organization of exposure scenarios and portions of this new section are present on a SDS. However, there is currently no need to flag this section as ECHA is not planning to disseminate this section until after May 2013 and they still need to define the corresponding fields.
Section 3.7.3 is also new and includes portions of IUCLID section 3.5 on uses. It covers generic exposure potential, and will be disseminated in full, unless it is claimed confidential.
The result of the PBT (Persistent, Bioaccumulative and Toxic chemicals) and vPvB (very Persistent and very Bioaccumulative) assessment (new section 2.3 of IUCLID dossier)
The results of these assessments plus corresponding endpoint summary and endpoint study records will be shared.It is an Indication of whether a chemical safety assessment (CSA) was performed.The actual CSA will not be disseminated; merely an indication if one was completed.
Competent person responsible for the safety data sheet
This is a new field in IUCLID 5.4(section 1.1). This type of contact person will be disseminated unless claimed confidential, while the standard REACH registration contact details will not. The fields that will be disseminated are the organisation name, the full address fields and phone number
So what should I do?
Determine if any of the Safety Data Sheet information is a concern to your registrations. If so, then prepare to update the dossier including a robust justification for confidentiality of each required item.
1) Review the listing of new SDS information to be disseminated,
2) Prepare a listing of your current and planned registrations against the safety data sheet information and designate any confidentiality concerns.
3) Prioritize the registrations requiring action,
4) Define the reasoning for each confidentiality claim,
5) Develop your justifications using the “template” included in IUCLID 5.4 with the confidentiality flags,
6) Submit updated registration(s),
7) Pay required fee
Remember each item requiring confidentiality requires its own confidentiality flag and a justification in the corresponding IUCLID section
Charges will only be levied if a substance requires a SDS and you will be charged only once per registration, regardless of the number of confidentiality claims on some or all of the specific items of SDS information.
The resubmission deadline is October 31, 2012. After that time, ECHA will begin to re-disseminate REACH registrations in batches and any safety data sheet information that has not been claimed confidential will be made publicly available.
Need support with your REACH Dossier Updates?
Then contact the experts at H2 Compliance and ask how they can assist with registration updates and confidentiality claims and justification. In addition, stay tuned to this blog for a future article on the confidentiality justification process.