Why use a service provider for REACH Registration?
The service provider allows you to build an optimal and tailor-made REACH Registration strategy
Each registrant is required to submit to ECHA by 31 May 2018 a Registration dossier for substances that they manufacture or import on the European market at more than one ton per year, in accordance with the REACH regulation (EC No. 1907/2006). However, the modalities And the Registration costs are very diverse depending on the substances, the size of the company and the role you decide to take on.
A service provider guides you through the choice of the type of file to be submitted at ECHA once your pre-registration has been completed. In particular, it tells you whether it is better to register your substance as Declaring Member or Principal Declarant depending on the characteristics and purity of your substance (mono-constituent, multi-constituent, UVCB), available data, costs, etc.
The expertise of the provider will allow you to better budget the costs of your registration, by asking you, among other things, about information and tests missing to complete your file. This allows you to set up a adapted strategy to your substance portfolio,optimize costs And of Meet the deadlines thanks to progressive and pre-planned deadlines.
In fact, the obtaining of data on chemical substances (analytical and/or toxicological data) is subject to availability of laboratories, and wait times can sometimes be significant. The service provider knows like the back of his hand which tests to save for your Registration file.
Each REACH Registration dossier includes a certain number of tests on the substance:
- Analytical tests which allow the substance to be characterized from a physicochemical point of view (NMR, UV, XRD, etc.)
- Dossier as Principal Declarant: Toxicological and eco-toxicological tests which make it possible to assess the impact of the substance on human health and the environment (detailed in Annex VII, VIII, IX and X of the REACH Regulation)
Depending on the nature of the substance, Not all tests are relevant, and sometimes it may be necessary to choose the most suitable protocol to the substance. This trade-off between the various tests and protocols requires solid knowledge in both chemistry and toxicology.
Outsourcing the choice of tests allows you to rely on the informed choice from a professional. The provider can also
save valuable time by ordering the relevant tests for you, which additionally relieves you of the research phase of laboratories in a position to conduct your tests.
The service provider works with a network of laboratories
To be able to meet regulatory deadlines, the fact of working in contact with a network of laboratories is a necessity. In fact:
- The availability of laboratories is a crucial issue because it involves the respect Or the Non-compliance Of Regulatory registration deadlines. Working with several partner laboratories makes it possible to better distribution of tests to be carried out in case of overload.
- Working regularly with partner laboratories allows you to benefit from preferential deadlines And of competitive costs
The service provider relieves you of the management of the SIEF and defends the interests of your company.
The service provider acts, while respecting the confidentiality of your data, as intermediary between your company and other SIEF member companies (Substance Information Exchange Forum). It can:
- Buy the Letters of Access (LoA) and validate the data sharing conditions and the associated test costs on your behalf. It is possible to justify this cost and challenge it in the event of unfair or non-transparent sharing. All this in order to allow you to join SIEF and to be able to refer to the Principal Declarant's file containing all the studies.
- Managing SIEF newcomers, negotiate the terms of the SIEF contract And the LoA billing for SIEF members if you choose to register as a Lead Declarant.
It can also help you in case of conflict management. Indeed, experience has shown that some Lead Declarants can be difficult to contact by Member Declarants who want to join an SIEF. The service provider can therefore “absorb” management problems for you that may occur during the process of collecting information and drafting administrative documents.
Ce role of “external” intermediary What the provider plays is not only beneficial to conflict management and you discharge from unavoidable administrative management and potentially very time-consuming.
The service provider is used to handling IUCLID and REACH-IT
The management of the SIEF and the submission of the file are carried out via the computer platform REACH-IT which was developed by ECHA. Likewise, the final compilation of the data in the Registration file is carried out thanks to the IUCLID 6 software.
The use of these two computer tools requires a specific training. Of course there are tutorials,
training courses, webinars to train you on the subject, but experience shows that nothing can replace the effectiveness acquired by a long habit of using these two tools.
A service provider therefore allows you to save data compilation time, of online submission, theREACH-IT account administration but also the training time to these computer tools.
4 criteria for choosing a provider for REACH Registration
#1 - A service provider who is not only an expert in the REACH regulation
One of the main criteria for choosing a good provider for REACH Registration is the extent of its expertise.
Indeed, REACH registration requires expertise in three different areas:
Regulatory expertise and mastery of computer tools
It is of course necessary for the service provider to know the REACH regulation and more particularly the articles dedicated to the registration of chemical substances inside out, both in terms of administrative procedures and Computers What of nature of the data to be provided for the file.
Also check that your service provider is used to handling REACH-IT, IUCLID (and possibly Chesar if you plan to carry out a CSR) in their latest versions (REACH-IT 3 and IUCLID 6).
Of legal knowledge for the negotiation of SIEF contracts (SIEF agreement) and the possible remedies in the event of a dispute are a definite advantage. Indeed, difficulties have been raised by SMEs who would like ECHA to work for a more equal distribution of costs.
But while it is obvious to expect a service provider to have such expertise, it is not enough!
Expertise in chemistry
Expertise in chemistry and more particularly in analytical chemistry is essential for everything related to analytical data of the substance, data that is mandatory to provide both for Member Declarants and for the Primary Declarant. This expertise is all the more important for more complex substances than single-component substances such as multi-component substances or UVCBs.
A good command of the chemical characterization of substances is therefore essential for order relevant tests. Indeed, analytical tests for the identification of a substance are very dependent on its nature.
This expertise also allows the service provider to be in a position to: check the quality of available analytical data (if the NMR spectra correspond to the right molecule for example), verification that must be completed before submitting the Registration file.
Toxicology expertise
Expertise in toxicology And in eco-toxicology is essential for the service provider if you mandate him to carry out a data gap (bibliographic search of the toxicological and eco-toxicological data available on the substance), and/or if you ask him to order tests specific to your substance for the Registration file.
The service provider must then be in a position to:
- Know the different bibliographical sources toxicological and eco-toxicological data
- Power read and interpret reports by knowing the endpoints relevant to the substance (and these reports are often about ten pages long!)
- Know the specific tests to be carried out to guide the production of data for your Registration file.
NB: the toxicological and eco-toxicological data to be provided for a Registration file (Principal declarant only) are listed in the Annexes VII, VIII, IX and X of the REACH regulation.
Objective: to minimize test costs
With his knowledge of analytical tests, a competent chemist allows you to choose to carry out only the analytical tests that are essential for your substance.
Likewise, a good toxicologist allows you to minimize test costs:
- via expert bibliographical research
- Bibliographical research of available data on the substance
- then by identifying the substances for which we can carry out a reading across (approach by analogy or by category on other similar substances).
Insofar as the purchase of bibliographic data is less expensive than carrying out tests, he then deduces a strategy for optimizing the number of tests and thus minimizing the associated costs.
#2 - An experienced service provider to manage the influx of files
Remember to check theexperiment from your service provider.
Indeed, the approach of the REACH 2018 deadline means a massive increase in the number of cases which will be submitted to ECHA, which implies a very condensed activity for both laboratories and regulatory consultants. It is better to make sure that your provider is able to absorb the shock!
For Ensure the methods of your service provider, you can for example find out about the registrations they supervised around the two previous REACH deadlines in 2010 and 2013.
The number of customers And ofRecordings made by the service provider is in fact a criterion to be taken into account: the more experienced a service provider is, the more he will have potentially had to manage complex situations (substances with a poorly defined composition, difficult SIEF management, etc.) and will be able to make you benefit from this know-how.
#3 - A service provider who knows how to be adaptable according to your size and sector of activity
Les sectors of activity companies that will need to register their substances in order to continue marketing their products on the European market after the deadline set by REACH 2018 are very diverse ! Chemistry, Construction, Engineering, Transport, Transport, Coatings, Aerospace, Automotive... and the list is still long. Even companies in the Cosmetic sector are affected by the REACH Registration.
Les Number of future tax filers Are also very varied, but with a majority of small structures. Indeed, according to INSEE figures from 2014 on the distribution of companies in the industrial sector according to their workforce (table below), we can clearly see that the majority of French companies working in the industrial sector are small or very small structures:
< 10 employees< 50 employees< 200 employees< 500 employees < 500 employees< 2 000 employés> 2,000 employees Total distribution by headcount 86.08% 10.73% 2.33% 0.58% 0.58% 0.23% 0.23% 0.23% 0.23% 0.08% 100.00%
Your REACH registration provider must therefore know how to adapt to very different sizes and types of substance portfolios and must also know how to work with major groups in the chemical industry Only with SMES.
When you review your provider's references, be sure to check that they have already worked with companies of your size and in a sector of activity similar to yours.
#4 - A service provider who knows how to demonstrate diplomacy as well as rigor
The REACH registration certainly requires very technical skills... but not only that! Indeed, during the Registration process, it is also crucial to be able to master administrative procedures such as:
- La negotiation of the conditions of SIEF contract, or at least its verification before acceptance
- Buying or selling Of a Access Letter (LoA) depending on your role as Principal Declarant or Member, and the negotiation of its price if applicable
- La management of a SIEF and its newcomers if you are the Principal Declarant (management of the contact, the contract, effective billing of the LoA, transmission of the token for access to the joint submission once the LoA has been paid, etc.)
- The payment of the fee to ECHA which conditions the allocation of your Registration Number, the final phase of your compliance
These various tasks require rigor in operational follow-up, and very often qualities of diplomacy when it comes to exchanges with other members of SIEF.
How can you be sure that the service provider you want to work with has these human qualities?
- First, find out about the values carried by the company. Does it value the human aspect as much as technical expertise?
- Do not hesitate to evaluate his degree of experience in managing SIEF, for example, by asking him the question directly when making contact.
It is better to make your choice quickly!
EcoMundo hopes that these four criteria will be useful for you in determining the provider that is most able to help you register your substances on time.
Given the proximity of the May 31, 2018 deadline, we strongly recommend Start the registration process quickly, especially if you want to report certain substances as a Principal Notifier — more data is required and the tests take longer.
Do you want to know more about REACH registration?
If you still have questions after reading this article, EcoMundo can help answer them and support you through all the stages of REACH Registration.
Our teams are listening to you!
Why use a service provider for REACH Registration?
The service provider allows you to build an optimal and tailor-made REACH Registration strategy
Each registrant is required to submit to ECHA by 31 May 2018 a Registration dossier for substances that they manufacture or import on the European market at more than one ton per year, in accordance with the REACH regulation (EC No. 1907/2006). However, the modalities And the Registration costs are very diverse depending on the substances, the size of the company and the role you decide to take on.
A service provider guides you through the choice of the type of file to be submitted at ECHA once your pre-registration has been completed. In particular, it tells you whether it is better to register your substance as Declaring Member or Principal Declarant depending on the characteristics and purity of your substance (mono-constituent, multi-constituent, UVCB), available data, costs, etc.
The expertise of the provider will allow you to better budget the costs of your registration, by asking you, among other things, about information and tests missing to complete your file. This allows you to set up a adapted strategy to your substance portfolio,optimize costs And of Meet the deadlines thanks to progressive and pre-planned deadlines.
In fact, the obtaining of data on chemical substances (analytical and/or toxicological data) is subject to availability of laboratories, and wait times can sometimes be significant. The service provider knows like the back of his hand which tests to save for your Registration file.
Each REACH Registration dossier includes a certain number of tests on the substance:
- Analytical tests which allow the substance to be characterized from a physicochemical point of view (NMR, UV, XRD, etc.)
- Dossier as Principal Declarant: Toxicological and eco-toxicological tests which make it possible to assess the impact of the substance on human health and the environment (detailed in Annex VII, VIII, IX and X of the REACH Regulation)
Depending on the nature of the substance, Not all tests are relevant, and sometimes it may be necessary to choose the most suitable protocol to the substance. This trade-off between the various tests and protocols requires solid knowledge in both chemistry and toxicology.
Outsourcing the choice of tests allows you to rely on the informed choice from a professional. The provider can also
save valuable time by ordering the relevant tests for you, which additionally relieves you of the research phase of laboratories in a position to conduct your tests.
The service provider works with a network of laboratories
To be able to meet regulatory deadlines, the fact of working in contact with a network of laboratories is a necessity. In fact:
- The availability of laboratories is a crucial issue because it involves the respect Or the Non-compliance Of Regulatory registration deadlines. Working with several partner laboratories makes it possible to better distribution of tests to be carried out in case of overload.
- Working regularly with partner laboratories allows you to benefit from preferential deadlines And of competitive costs
The service provider relieves you of the management of the SIEF and defends the interests of your company.
The service provider acts, while respecting the confidentiality of your data, as intermediary between your company and other SIEF member companies (Substance Information Exchange Forum). It can:
- Buy the Letters of Access (LoA) and validate the data sharing conditions and the associated test costs on your behalf. It is possible to justify this cost and challenge it in the event of unfair or non-transparent sharing. All this in order to allow you to join SIEF and to be able to refer to the Principal Declarant's file containing all the studies.
- Managing SIEF newcomers, negotiate the terms of the SIEF contract And the LoA billing for SIEF members if you choose to register as a Lead Declarant.
It can also help you in case of conflict management. Indeed, experience has shown that some Lead Declarants can be difficult to contact by Member Declarants who want to join an SIEF. The service provider can therefore “absorb” management problems for you that may occur during the process of collecting information and drafting administrative documents.
Ce role of “external” intermediary What the provider plays is not only beneficial to conflict management and you discharge from unavoidable administrative management and potentially very time-consuming.
The service provider is used to handling IUCLID and REACH-IT
The management of the SIEF and the submission of the file are carried out via the computer platform REACH-IT which was developed by ECHA. Likewise, the final compilation of the data in the Registration file is carried out thanks to the IUCLID 6 software.
The use of these two computer tools requires a specific training. Of course there are tutorials,
training courses, webinars to train you on the subject, but experience shows that nothing can replace the effectiveness acquired by a long habit of using these two tools.
A service provider therefore allows you to save data compilation time, of online submission, theREACH-IT account administration but also the training time to these computer tools.
4 criteria for choosing a provider for REACH Registration
#1 - A service provider who is not only an expert in the REACH regulation
One of the main criteria for choosing a good provider for REACH Registration is the extent of its expertise.
Indeed, REACH registration requires expertise in three different areas:
Regulatory expertise and mastery of computer tools
It is of course necessary for the service provider to know the REACH regulation and more particularly the articles dedicated to the registration of chemical substances inside out, both in terms of administrative procedures and Computers What of nature of the data to be provided for the file.
Also check that your service provider is used to handling REACH-IT, IUCLID (and possibly Chesar if you plan to carry out a CSR) in their latest versions (REACH-IT 3 and IUCLID 6).
Of legal knowledge for the negotiation of SIEF contracts (SIEF agreement) and the possible remedies in the event of a dispute are a definite advantage. Indeed, difficulties have been raised by SMEs who would like ECHA to work for a more equal distribution of costs.
But while it is obvious to expect a service provider to have such expertise, it is not enough!
Expertise in chemistry
Expertise in chemistry and more particularly in analytical chemistry is essential for everything related to analytical data of the substance, data that is mandatory to provide both for Member Declarants and for the Primary Declarant. This expertise is all the more important for more complex substances than single-component substances such as multi-component substances or UVCBs.
A good command of the chemical characterization of substances is therefore essential for order relevant tests. Indeed, analytical tests for the identification of a substance are very dependent on its nature.
This expertise also allows the service provider to be in a position to: check the quality of available analytical data (if the NMR spectra correspond to the right molecule for example), verification that must be completed before submitting the Registration file.
Toxicology expertise
Expertise in toxicology And in eco-toxicology is essential for the service provider if you mandate him to carry out a data gap (bibliographic search of the toxicological and eco-toxicological data available on the substance), and/or if you ask him to order tests specific to your substance for the Registration file.
The service provider must then be in a position to:
- Know the different bibliographical sources toxicological and eco-toxicological data
- Power read and interpret reports by knowing the endpoints relevant to the substance (and these reports are often about ten pages long!)
- Know the specific tests to be carried out to guide the production of data for your Registration file.
NB: the toxicological and eco-toxicological data to be provided for a Registration file (Principal declarant only) are listed in the Annexes VII, VIII, IX and X of the REACH regulation.
Objective: to minimize test costs
With his knowledge of analytical tests, a competent chemist allows you to choose to carry out only the analytical tests that are essential for your substance.
Likewise, a good toxicologist allows you to minimize test costs:
- via expert bibliographical research
- Bibliographical research of available data on the substance
- then by identifying the substances for which we can carry out a reading across (approach by analogy or by category on other similar substances).
Insofar as the purchase of bibliographic data is less expensive than carrying out tests, he then deduces a strategy for optimizing the number of tests and thus minimizing the associated costs.
#2 - An experienced service provider to manage the influx of files
Remember to check theexperiment from your service provider.
Indeed, the approach of the REACH 2018 deadline means a massive increase in the number of cases which will be submitted to ECHA, which implies a very condensed activity for both laboratories and regulatory consultants. It is better to make sure that your provider is able to absorb the shock!
For Ensure the methods of your service provider, you can for example find out about the registrations they supervised around the two previous REACH deadlines in 2010 and 2013.
The number of customers And ofRecordings made by the service provider is in fact a criterion to be taken into account: the more experienced a service provider is, the more he will have potentially had to manage complex situations (substances with a poorly defined composition, difficult SIEF management, etc.) and will be able to make you benefit from this know-how.
#3 - A service provider who knows how to be adaptable according to your size and sector of activity
Les sectors of activity companies that will need to register their substances in order to continue marketing their products on the European market after the deadline set by REACH 2018 are very diverse ! Chemistry, Construction, Engineering, Transport, Transport, Coatings, Aerospace, Automotive... and the list is still long. Even companies in the Cosmetic sector are affected by the REACH Registration.
Les Number of future tax filers Are also very varied, but with a majority of small structures. Indeed, according to INSEE figures from 2014 on the distribution of companies in the industrial sector according to their workforce (table below), we can clearly see that the majority of French companies working in the industrial sector are small or very small structures:
< 10 employees< 50 employees< 200 employees< 500 employees < 500 employees< 2 000 employés> 2,000 employees Total distribution by headcount 86.08% 10.73% 2.33% 0.58% 0.58% 0.23% 0.23% 0.23% 0.23% 0.08% 100.00%
Your REACH registration provider must therefore know how to adapt to very different sizes and types of substance portfolios and must also know how to work with major groups in the chemical industry Only with SMES.
When you review your provider's references, be sure to check that they have already worked with companies of your size and in a sector of activity similar to yours.
#4 - A service provider who knows how to demonstrate diplomacy as well as rigor
The REACH registration certainly requires very technical skills... but not only that! Indeed, during the Registration process, it is also crucial to be able to master administrative procedures such as:
- La negotiation of the conditions of SIEF contract, or at least its verification before acceptance
- Buying or selling Of a Access Letter (LoA) depending on your role as Principal Declarant or Member, and the negotiation of its price if applicable
- La management of a SIEF and its newcomers if you are the Principal Declarant (management of the contact, the contract, effective billing of the LoA, transmission of the token for access to the joint submission once the LoA has been paid, etc.)
- The payment of the fee to ECHA which conditions the allocation of your Registration Number, the final phase of your compliance
These various tasks require rigor in operational follow-up, and very often qualities of diplomacy when it comes to exchanges with other members of SIEF.
How can you be sure that the service provider you want to work with has these human qualities?
- First, find out about the values carried by the company. Does it value the human aspect as much as technical expertise?
- Do not hesitate to evaluate his degree of experience in managing SIEF, for example, by asking him the question directly when making contact.
It is better to make your choice quickly!
EcoMundo hopes that these four criteria will be useful for you in determining the provider that is most able to help you register your substances on time.
Given the proximity of the May 31, 2018 deadline, we strongly recommend Start the registration process quickly, especially if you want to report certain substances as a Principal Notifier — more data is required and the tests take longer.
Do you want to know more about REACH registration?
If you still have questions after reading this article, EcoMundo can help answer them and support you through all the stages of REACH Registration.
Our teams are listening to you!
