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:
These 4 bullet points respectively correspond to the REACH acronym: Registration, Evaluation, Authorisation and Restriction of chemical substances.
“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).
There are 2 types of registration dossiers:
Depending on the dossier type there are different documents to provide:
Find the definitions to understand REACH on our page: the 7 steps to create your REACH registration dossier (SIEF, Access Letter, IUCLID, Member Registrant, Lead Registrant, CHESAR, REACH-IT).
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.
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:
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.
On the other hand, 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:
Now that we know what both roles entail, let’s look at the actual Advantages and Disadvantages of each of them:
Advantages
For Members, there is less technical work to be done since most of the dossier is prepared by the Lead Registrant. You need to pay the LoA to access all the necessary data, and then create your individual dossier with your own information.
Herebelow is a summary of the data required for both LR dossiers and MR dossiers:
Source: ECHA
Disadvantages
However, in order to be able to join the SIEF, your substance must comply with the Lead Registrant's SIP (Substance Identification Profile). Paying for the LoA can sometimes be quite costly.
Advantages
As the Lead Registrant, you have more flexibility in creating the Substance Identification Profile (SIP), especially for multi-constituents and UVCBs. For single-constituents, the Lead Registrant may decide not to include certain substances containing impurities that affect the classification in your SIP.
You have more flexibility in choosing the toxicological and ecotoxicological testing methods.
Disadvantages
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.
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. A third party, as EcoMundo, can help you in your LR role.
Ask yourself: is your substance complex? Do you have the time to coordinate a SIEF? Would you like to be assisted (third party for LRs, LRs for Members)? Would you prefer to buy an expensive LoA than to do the studies and tests?
EcoMundo is an expert service provider for REACH registration, our services include:
For more information, feel free to contact our experts.
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:
These 4 bullet points respectively correspond to the REACH acronym: Registration, Evaluation, Authorisation and Restriction of chemical substances.
“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).
There are 2 types of registration dossiers:
Depending on the dossier type there are different documents to provide:
Find the definitions to understand REACH on our page: the 7 steps to create your REACH registration dossier (SIEF, Access Letter, IUCLID, Member Registrant, Lead Registrant, CHESAR, REACH-IT).
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.
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:
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.
On the other hand, 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:
Now that we know what both roles entail, let’s look at the actual Advantages and Disadvantages of each of them:
Advantages
For Members, there is less technical work to be done since most of the dossier is prepared by the Lead Registrant. You need to pay the LoA to access all the necessary data, and then create your individual dossier with your own information.
Herebelow is a summary of the data required for both LR dossiers and MR dossiers:
Source: ECHA
Disadvantages
However, in order to be able to join the SIEF, your substance must comply with the Lead Registrant's SIP (Substance Identification Profile). Paying for the LoA can sometimes be quite costly.
Advantages
As the Lead Registrant, you have more flexibility in creating the Substance Identification Profile (SIP), especially for multi-constituents and UVCBs. For single-constituents, the Lead Registrant may decide not to include certain substances containing impurities that affect the classification in your SIP.
You have more flexibility in choosing the toxicological and ecotoxicological testing methods.
Disadvantages
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.
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. A third party, as EcoMundo, can help you in your LR role.
Ask yourself: is your substance complex? Do you have the time to coordinate a SIEF? Would you like to be assisted (third party for LRs, LRs for Members)? Would you prefer to buy an expensive LoA than to do the studies and tests?
EcoMundo is an expert service provider for REACH registration, our services include:
For more information, feel free to contact our experts.