Lead Registrant VS Member Registrant: what is at stake for each role?

REACH in 4 key-points

If we start at the very beginning, REACH was established in 2007 with the aim to ensure, on a European level, human health and environmental protection from chemical substance hazards.

To get to this objective, different steps would have to be established:

• First, a complete list of chemical substances currently on the market has to be gathered, with data about their intrinsic dangerous properties. This corresponds to the Registration procedure.
• Then, the really hazardous ones have to be identified from the safe ones, using the data provided by the registration procedure. This Evaluation process aims to classify the hazards of the substances, in order to get at the end a harmonized hazard classification (CLP regulation EC 1272/2008) on a European level.
• The most hazardous substances are then being strictly banned from Europe. Unfortunately, the ban of some of these substances has socio-economic consequences that outweigh the hazard of the substance. In some cases, a period of use of the banned substance for a specific use can be negotiated with the European authorities, which is the Authorisation part of REACH.
• Some hazardous substances may not be banned but only restricted according to their conditions of use, creating the Restriction procedure.

These 4 bullet points respectively correspond to the REACH acronym: Registration, Evaluation, Authorisation and Restriction of chemical substances.

The REACH registration procedure in short

Let’s quickly go through the registration procedure.

The core principle: “one substance, one registration”

“One substance, one registration” means that there needs to be only one registration dossier for each substance, no matter the number of companies working on the same substance. The aim here is to dramatically reduce the tests on animals, such as toxicological and ecotoxicological that are used to determine the potential effects of a dangerous substance on humans and the environment. This means that all companies using the same substance have to gather data in order to submit the registration dossier jointly.

As in any work conducted as a group, there is always someone who needs to coordinate the project to get to the given objectives. It is the same for registration dossiers. A joint dossier will be composed of a Lead Registrant – LR – (the project manager if you may) and its Members Registrants.

The Lead Registrant submits a complete registration dossier (Lead Registrant dossier) with all the toxicological, ecotoxicological and physico-chemical data. The other companies will submit a more lightweight dossier (Member dossier), with only analytical and administrative data that are specific to each company, and will buy to the Lead Registrant a right to refer to the Lead Registrant dossier through a Letter of Acces (LoA).

The Lead Registrant is also in charge of managing all the companies that wish to join the joint submission, from the first contact to the calculation of the cost for the shared data and the final selling of data through a Letter of Access (LoA).

The registration procedure in a few key-steps

• There are 2 types of registration dossiers:
• Substance: A substance is a chemical element and its compounds in the natural state or the result of a manufacturing process. There are three main types of substances: mono-constituent, multi-constituents and UVCB substances.
• Intermediate: Intermediates are substances transformed by a chemical reaction into another substance. There are three types of intermediates under REACH: non-isolated intermediates, on-site isolated intermediates and transported isolated intermediates. Only on-site and transported intermediates have to be registered. Intermediate registration requires less data than full registration.
• Depending on the dossier type there are different documents to provide (which might be time-consuming and also long to obtain):
• analytical data (chemical characterization of the substance, product composition, etc.)
• toxicological / ecotoxicological data (effects of the substance on the human health / environment)
• administrative data (company address, contact person, etc.)
• data on the uses of the substances
• Data is inputted into IUCLID, a software developed by ECHA that enables to produce the registration dossier files
• Submission of the IUCLID dossier onto the REACH-IT account of the company (REACH-IT is the webplatform developed by the ECHA where to submit the IUCLID dossier)
• ECHA checks that everything has been completed and complies on REACH-IT. They then send you ECHA’s fee invoice to finalise the registration.
• Once the fee is paid, you get your registration number and your registration is official!

A few definitions to better understand what follows

Here is some technical lingo, to help you with the next few paragraphs:

REACH registration

If you manufacture or import your substances between 1 and 100 tonnes a year, you are directly concerned by REACH and have to elaborate and submit your registration dossier before 2018.

The SIEF

Once a substance has been pre-registered, co-declarants join a Data Sharing and Substance Information Exchange Forum (SIEF). One of the objectives of the SIEF is to limit animal testing while encouraging manufacturers and importers of substances to share costs.

The Letter of Access

A Letter of Access (LoA) is a document that grants you the right to refer to the Lead Registrant’s (LR’s) registration dossier.

IUCLID

IUCLID (International Uniform Chemical Information Database) is a free software developed by ECHA and the OECD in 2007. The software plays a central role in the IT environments of all organizations that have to cope with the data submission requirements of REACH.

Member registrant

Member Registrants (MRs) have to submit dossiers with the specific information of their company and substance (for instance the substance profile, the substance use and the production volume). Member Registrants are not obliged to submit information that has already been presented in the Lead Registrant’s dossier.

Lead registrant

Members of a SIEF have to appoint a Lead Registrant (LR) who will act on behalf of them. The Lead Registrant has to prepare the principal dossier of the joint submission gathering data on the substance and its uses: physiochemical, toxicological and eco-toxicological properties.

CHESAR

CHESAR (Chemical Safety Assessment and Reporting Tool) is an application developed by ECHA to help companies carry out their chemical safety assessments and prepare their chemical safety reports and exposure scenarios for communication in the supply chain.

REACH-IT

REACH-IT is the central IT system that supports companies and ECHA to securely submit, process and manage data and dossiers. The platform provides a secure communication channel between both parties to help them coordinate the processing and evaluation of data and dossiers.

What differences between Lead Registrant and Member Registrant?

What do the respective roles of Lead Registrant and Member Registrant entail?

As the definition implies, an LR has more responsibility as he submits on behalf of the group the complete registration dossier. He must assess the situation beforehand by checking who would possibly be interested by the registration of the substance, and who would possibly be interested in taking the role of LR for this substance.

In the case where a pre-SIEF already exists, he needs to find out if these pre-registrants are actually going to register, under which status they wish to register (MR or LR) and if there is already data available on the substance (this step of gathering all available toxicological / ecotoxicological data before the registration process is called data gap). The data gap basically aims at assessing the cost of the registration process.

To get all of this information, the Lead Registrant must establish a SIEF survey. To do so, he must go onto the REACH IT account, where there can be 100 to 200 pre-registrations! The email addresses from these pre-registrations will be used to send the survey. As the email addresses are not always valid, the survey must specify that if there is no answer before the given date, it means everyone agrees with the LR being the official LR.

The Lead Registrant role

He can then declare himself as the Lead Registrant to ECHA by creating the joint submission on REACH-IT: he gives the official SIEF name and then gets a token (later given to the members who want to join the submission).

As official Lead Registrant of the SIEF, he must:

• manage it
• answer member requests
• establish the way he wants to share data (SIEF agreement, calculation of LoA costs…)
• share the substance classification as well as toxicological / ecotoxicological data
• work on identifying and carrying out additional studies
• decide whether he wants to share the CSR (Chemical Safety Report) for substances registered at more than 10 tons/year

This is the longest process as data could be missing and only a toxicologist could fill data gaps, which can be a long and costly process.

The LR also makes sure that the data sharing conditions are fair for Members in accordance with the regulation 2016/9. For example the LR needs to ensure that new Members only share costs of data needed for their tonnage band. Once the SIEF agreement is signed and that the LoA is paid for, the Lead Registrant distributes the tokens to the Members who have asked to join the submission.

The Member role:

On the other hand, the Member:

• checks that the substance is pre-registered or pre-registers the substance himself
• checks in the pre-SIEF who the LR is
• contacts him to find out about the SIEF agreement, the Letter of Access cost and the Substance Identification Profile, so that he can establish whether his substance is within the scope of the LR dossier or not
• checks that the SIEF agreement is formatted according to the CEFIC’s template and discuss data sharing conditions in the SIEF if necessary
• once the LR and Member agree, the SIEF agreement is signed and the Member pays the LoA (he only pays for the data he needs).
  The LR is obligated to be transparent with the Member. So, if the Member thinks the cost is unjustified, he can ask the Lead Registrant how the LoA was calculated and the LR has to give the details of the costs to the member.

NB: For the first member registrants, LoAs may be very expensive if there are very few SIEF Members. But as soon as everyone has joined a SIEF, the price is divided into the number of Members in it. The Member then receives the token that gives access to the joint submission.

Last steps for the Member Registrant:

• prove that his substance falls within the scope of the Lead Registrant’s SIP
• enter the SIEF, refer to data, and create his registration member dossier.

The pros and cons

Now that we know what both roles entail, let’s look at the actual pros and cons of each of them:

For Members

PROS

For Members, there is less technical work to be done as the main part of the dossier is prepared by the LR. All there is to do is pay for the LoA to gain access to all the information you need + prepare your individual dossier with your own specific data.

Herebelow is a summary of the data required for both LR dossiers and MR dossiers:

Source: ECHA

For Lead Registrants

CONS

The Lead Registrant has to pay large upfront costs if he wants to fill data gaps and conduct missing toxicological and ecotoxicological tests. Some laboratories are already at capacity, which may also mean that time won’t be on his side.

The need for ongoing management can be time-consuming as well: the LR takes care of the SIEF agreement, the LoA, potential conflicts between members. He is also responsible for keeping registration information up-to-date as soon as there is new relevant available information concerning the uses, classification, and tonnage band for example. If it results from a decision made by ECHA or the Commission, the data must be updated within a deadline. This is generally the case if the information isn’t detailed enough, e.g. a poorly described UVCB or missing confidentiality claims.

Useful note for LRs

Gathering the data and creating the dossier is very much the same as for Members. The only change is the amount of data submitted that can vary depending on the case.

When you have all the data, the money, and a complex substance that is difficult to describe and won’t easily fit into the characteristics of a SIP already established; being an LR can be a good strategic choice. Of course, it is a lot of work if you do it by yourself, but a third party (EcoMundo) can help you in your LR role.

ECHA highly recommends that LR dossiers are submitted before the end of March 2018 to leave time for SIEF Members to submit theirs.

Conclusion

Ask yourself: is your substance complex? Do you have the time to coordinate a SIEF? Would you prefer someone to do the work (third party for LRs, LRs for Members)? Would you prefer to buy an expensive LoA than to do the studies and tests?

If you assume the LR role, you need to know that the more you wait the less time you will have to prepare your dossiers, and conduct the required tests, especially since laboratories are already being booked up.

Check out our REACH registration services for 2018

EcoMundo is an expert service provider for REACH registration 2018 our services include:

• REACH compliance Service
• REACH consulting Service
• REACH for non-EU manufacturer
• REACH registration
• Only Representative (OR) Services
• REACH Late pre-registration and inquiry process
• Representation of your interests within the SIEF and/or consortium
• Negotation on your behalf and purchase of the Letter of Access (LoA) from the Lead Registrant
• Data exchange and drafting of your REACH IUCLID dossier
• Submission of your REACH dossier to ECHA and follow-up until acceptance
• Delivery of your REACH certificate
• Regulatory watch when needed