Understand REACH in 4 key-points
REACH regulation 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, the regulation establishes four processes:
- The registration of substances placed on the European market in quantities of one metric tonne or more per year,
- The evaluation of substances and registration dossiers to verify their hazard potential, compliance and completeness,
- The removal from the market of substances deemed to be the most hazardous, unless socio-economic considerations take precedence under the terms of an authorisation,
- The restriction of the use of other substances in relation to the risks they pose
These 4 bullet points respectively correspond to the REACH acronym: Registration, Evaluation, Authorisation and Restriction of chemical substances.
The REACH registration procedure in short
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 manufacture or import 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 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, whether occurring naturally or obtained by a manufacturing process, including any additive necessary to preserve its stability and any impurity resulting from the process used, but excluding any solvent that can be separated without affecting the stability of the substance or altering its composition. There are three main types of substances: mono-constituent, multi-constituents and UVCB substances.
- Intermediate: An intermediate is a substance manufactured for the purpose of chemical transformation and consumed or used as part of that transformation with a view to being converted into another substance (synthesis). Under REACH, there are three types of intermediates: non-isolated intermediates, isolated intermediates remaining on-site, and isolated intermediates transported off-site. Only on-site isolated intermediates and transported isolated intermediates must be registered. The registration of intermediates requires less information than a full registration.
Depending on the dossier type there are different documents to provide:
- analytical data (chemical characterization of the substance, product composition, etc.)
- administrative data (company address, contact person, etc.)
- data on the uses of the substances
- toxicological / ecotoxicological data (effects of the substance on the human health / environment)
Data is inputted into IUCLID, a software developed by ECHA.
- the dossier created in this way is then uploaded to the REACH-IT platform for submission to the authorities.
- upon receipt of a complete dossier, ECHA issues an invoice.
Once this invoice has been paid, the declarant receives a registration number: the registration is then official!
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 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.
The Lead Registrant role
The Lead Registrant selected from among the companies wishing to register the substance, must register with ECHA: 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 and transparent 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 thereby ensuring they have access to the registration of their substance, and thus to the market.
The Member Registrant role:
On the other hand, the Member Registrant:
- checks in the SIEF who the LR is
- contact him to enquire about the SIEF agreement, the cost of the Data Access Letter and the Substance Identification Profile (SIP), in order to assess whether his substance is the same (including impurity ranges) as the substance in the joint submission
- once the LR and the Member have agreed on the SIEF contract, the agreement is signed and the Member proceeds to purchase the LoA, in accordance with their tonnage band.
Last steps for the Member Registrant:
- to compile a comprehensive analytical dossier to prove the identity of the substance
- enter the SIEF, refer to data, and create his registration member dossier.
Summary of the information to be provided for LR and Members files:
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Source: ECHA
Advantages and Disadvantages of Lead Registrant or Member Registrant
Advantages of Members Registrant
For Member notifiers, the technical workload is reduced, as the majority of the dossier is prepared by the Lead Notifier.
Disadvantages of Members Registrant
The cost of data sharing (LoA) can prove to be expensive if few companies have joined the joint submission.
The Member Registrant is dependent on the activity and responsiveness of the lead registrant.
Advantages of Lead Registrants
The lead declarant drafts the SIP and determines the acceptable impurities.
They carry out the tests and manually assess their quality.
Disadvantages of Lead Registrants
The Lead Registrant has to pay large upfront costs if he wants to fill data gaps and conduct missing toxicological and ecotoxicological tests. Managing the SIEF and any studies requested by ECHA, for example, in the event of a dossier evaluation, can be time-consuming.
Our teams can assist you with the REACH registration of your substances
Our experts are here to help you with:
- Assessing the REACH compliance of your portfolio
- REACH registration of your substances
- Acting as your Only Representative (OR) if you are a non-European company
- Submitting your enquiries
- Representing your interests within the SIEF and/or consortium
- Negotiating on your behalf the purchase of the Letter of Access (LoA) from the Lead Registrant
Want to know more about REACH registration?
For more information, feel free to contact our experts.
Understand REACH in 4 key-points
REACH regulation 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, the regulation establishes four processes:
- The registration of substances placed on the European market in quantities of one metric tonne or more per year,
- The evaluation of substances and registration dossiers to verify their hazard potential, compliance and completeness,
- The removal from the market of substances deemed to be the most hazardous, unless socio-economic considerations take precedence under the terms of an authorisation,
- The restriction of the use of other substances in relation to the risks they pose
These 4 bullet points respectively correspond to the REACH acronym: Registration, Evaluation, Authorisation and Restriction of chemical substances.
The REACH registration procedure in short
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 manufacture or import 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 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, whether occurring naturally or obtained by a manufacturing process, including any additive necessary to preserve its stability and any impurity resulting from the process used, but excluding any solvent that can be separated without affecting the stability of the substance or altering its composition. There are three main types of substances: mono-constituent, multi-constituents and UVCB substances.
- Intermediate: An intermediate is a substance manufactured for the purpose of chemical transformation and consumed or used as part of that transformation with a view to being converted into another substance (synthesis). Under REACH, there are three types of intermediates: non-isolated intermediates, isolated intermediates remaining on-site, and isolated intermediates transported off-site. Only on-site isolated intermediates and transported isolated intermediates must be registered. The registration of intermediates requires less information than a full registration.
Depending on the dossier type there are different documents to provide:
- analytical data (chemical characterization of the substance, product composition, etc.)
- administrative data (company address, contact person, etc.)
- data on the uses of the substances
- toxicological / ecotoxicological data (effects of the substance on the human health / environment)
Data is inputted into IUCLID, a software developed by ECHA.
- the dossier created in this way is then uploaded to the REACH-IT platform for submission to the authorities.
- upon receipt of a complete dossier, ECHA issues an invoice.
Once this invoice has been paid, the declarant receives a registration number: the registration is then official!
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 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.
The Lead Registrant role
The Lead Registrant selected from among the companies wishing to register the substance, must register with ECHA: 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 and transparent 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 thereby ensuring they have access to the registration of their substance, and thus to the market.
The Member Registrant role:
On the other hand, the Member Registrant:
- checks in the SIEF who the LR is
- contact him to enquire about the SIEF agreement, the cost of the Data Access Letter and the Substance Identification Profile (SIP), in order to assess whether his substance is the same (including impurity ranges) as the substance in the joint submission
- once the LR and the Member have agreed on the SIEF contract, the agreement is signed and the Member proceeds to purchase the LoA, in accordance with their tonnage band.
Last steps for the Member Registrant:
- to compile a comprehensive analytical dossier to prove the identity of the substance
- enter the SIEF, refer to data, and create his registration member dossier.
Summary of the information to be provided for LR and Members files:
Source: ECHA
Advantages and Disadvantages of Lead Registrant or Member Registrant
Advantages of Members Registrant
For Member notifiers, the technical workload is reduced, as the majority of the dossier is prepared by the Lead Notifier.
Disadvantages of Members Registrant
The cost of data sharing (LoA) can prove to be expensive if few companies have joined the joint submission.
The Member Registrant is dependent on the activity and responsiveness of the lead registrant.
Advantages of Lead Registrants
The lead declarant drafts the SIP and determines the acceptable impurities.
They carry out the tests and manually assess their quality.
Disadvantages of Lead Registrants
The Lead Registrant has to pay large upfront costs if he wants to fill data gaps and conduct missing toxicological and ecotoxicological tests. Managing the SIEF and any studies requested by ECHA, for example, in the event of a dossier evaluation, can be time-consuming.
Our teams can assist you with the REACH registration of your substances
Our experts are here to help you with:
- Assessing the REACH compliance of your portfolio
- REACH registration of your substances
- Acting as your Only Representative (OR) if you are a non-European company
- Submitting your enquiries
- Representing your interests within the SIEF and/or consortium
- Negotiating on your behalf the purchase of the Letter of Access (LoA) from the Lead Registrant
Want to know more about REACH registration?
For more information, feel free to contact our experts.
