1. Reminder: REACH Authorisation and consortium
1.1. REACH Authorisation process
The Authorisation procedure is one of the chemical risk management options established by the REACH regulation at European scale.
It applies to substances identified as SVHCs (“Substances of Very High Concern”) and deemed to pose a serious threat to human health or the environment:
- CMR 1A and 1B: carcinogenic, mutagenic or toxic to reproduction
- PBT: persistent, bioaccumulative and toxic
- vBvP: very persistent and very bioaccumulative
- Substance of equivalent concern,, e.g. endocrine disruptors or respiratory sensitisers
The substances included in Annex XIV of REACH are subject to Authorisation and are due to see their use forbidden in the European Union within a short-term period (36 to 48 months after inclusion). REACH Authorisation is a temporary exemption for a specific substance and a specific use. Three exemption durations (“revision periods”) are generally considered: 4, 7 or 12 years.
Producing an application for Authorisation under REACH requires to characterize the risk generated by the use of the substance (Chemical Safety Report), to present in detail the potential alternatives to the substance as well as the substitution strategy (Analysis of Alternatives) and finally to carry out a comparative impact assessment of the continued use of the substance and its withdrawal (Socio-Economic Analysis).
1.2 Creating a consortium
When several companies have similar uses of chemical substances, as it can be the case within an industrial sector, a possibility exists to produce an application for Authorisation as a consortium. This organization is very interesting as it can enable to generate synergies between companies and thus optimize the resources and costs associated to an application for Authorisation.
1.3 The different steps to constitute a REACH Authorisation dossier under a consortium
The production of an application for Authorisation dossier via a consortium is a nine- to eighteen-month project.
However, such a process presents a set of challenges linked to the fact the members of the consortium may be competitors:
- Within which legal framework does the procedure takes place?
- How can confidentiality and data management be guaranteed?
- Which consortium organization to choose (instance and decision process, meeting time, tools and support, etc.)?
2. EcoMundo’s feedback: 5 tips to succeed in your application for Authorisation dossier under a consortium
Because of the challenges described above, the application for Authorisation implementation process under a consortium requires to set up some dispositions. This ensures an efficient participation of every member of the consortium, but also provides the overall process with an optimal legislative and organizational framework.
A legal and contractual framework is essential
The primary goal of an application for Authorisation process organized under a consortium is to bring distinct (and potentially competing) legal entities to exchange data and collaborate in order to build a common dossier. In that sense, the establishment of a consortium contract is a prerequisite to the application’s undertaking.
Such a contract enables to establish the consortium’s common goals, as well as the data confidentiality and management rules for the overall project.
On the other hand, it enables to formulate the group project organization: instances and decision mode, rules for entering or leaving the consortium, rules for cost-sharing, etc.
The consortium contract establishes the process legal framework, and enables to ensure good governance inside the workgroup, but also towards the external stakeholders and regulations in place (especially the respect of the competition law).
The consortium contract forms the working framework that is essential to distinct companies’ collaboration for the production of an application for Authorisation dossier.
Data confidentiality as a structuring element of the process: the importance of a consortium manager
A consortium brings together companies with similar uses of a substance which means that they are generally competitors. In order to enable an efficient participation of every consortium member, it is essential to establish rules about data confidentiality as soon as the project starts.
Two sections of the application for Authorisation dossier can mainly include sensitive elements in terms of data confidentiality: the Analysis of Alternatives and the Socio-Economic Analysis.
The objective of the Analysis of Alternatives is to present the alternatives considered for the replacement of the substance subject to Authorisation. A company’s research work on alternatives can thus constitute a major competitive edge in a competitive context, which would be lost in case of its disclosure inside the consortium.
The Socio-Economic Analysis especially aims to evaluate the impacts of the denial of an Authorisation (and thus, the substance’s use cessation) for the concerned companies. The resulting impact assessment thus relies on data consolidation finely characterizing the economic activity of the concerned companies. Because these data generally aren’t public, and since they can constitute strategic elements for the consortium members, their circulation inside the consortium can then be problematic.
In both cases it is necessary to define a consortium animator who plays a crucial role: to not only present the confidentiality challenges and suggest a common work strategy to the consortium members, but also to act as an intermediary or trusted third party in the data collection process. The consortium animator being the data collection focal point, he/she can guarantee the data confidentiality inside the consortium by ensuring that the data identified as confidential is never disclosed to the other members of the working group. This option is crucial because it enables to remove the bottlenecks on data confidentiality, thereby guaranteeing the project launch and collaboration of all participants.
Should the need arise, data confidentiality can then be guaranteed all along the project, until its submission to the European Chemicals Agency (ECHA).
It is highly recommended to define a manager for the consortium who acts as the project leader, process animator, but also guarantor of the exchanged data confidentiality.
The question of the defined use as a major project issue
The definition of the use of the substance is central in the production of an application for Authorisation. In the process, the use is mainly characterized by the functional properties and the requirements in terms of performance for the substance, but also by the progress in research for alternatives and the situation of the substitution process. From all these parameters results the revision period duration that will be sought-after.
In the context of a sectoral process, it is essential to exchange in the early stages of the project on these parameters, so as to identify the synergies or divergences between the uses of each company. The comprehension of the situation of every company on these criteria will enable to precisely define the parameter of the project, as well as the feasibility of a joint submission versus several individual submissions.
The definition of the uses applied for constitutes a key step of the application for Authorisation process, defining the scope of the project in terms of resources on the one hand, as well as the dossier global strategy on the other hand.
The articulation of the different decisional instances: operational and strategic levels
The production of an application for Authorisation dossier requires a wide range of data (description of the procedures and characterization of the chemical risk, presentation of the alternatives and the replacement process, characterization of the impacts of a substance’s use cessation, etc.), as well as strategic decision-making (consortium contract signature, identification of the dossier’s general strategy, choice of the submission mode, etc.)
In order to ensure the project’s progress, the project governance will mainly rely on two instances: the working group and the steering committee. The working group gathers the project leaders and experts and meets on a weekly basis; the steering committee is composed of the directors of the company and meets on a tri-monthly basis, for the main decision steps of the project.
The definition of the decisional instances of the project (working group and steering committee) and their good articulation are crucial to the construction of an application for Authorisation.
The choice of a submission mode, an important step to define the strategy
Two modes of submission are possible for an application for Authorisation produced by a consortium:
- The joint submission (one unique dossier submitted for all consortium members) enables to optimize the resources at best, by producing a unique dossier for all of consortium members
- The individual submission (one dossier submitted by each legal entity) enables to capitalize on a part of the contents produced by the consortium but enables better control over the dossier’s confidentiality, and requires more resources and implies increased ECHA fees
The choice of the decision mode doesn’t necessarily have to be made at the beginning of the project: it is possible to start the process, the data collection and the redaction of the common content, and then define if the submission will be carried out individually or jointly. The choice of the submission mode is a fundamental structural step for the form and the strategy of the dossier and is subject to a meeting of the steering committee.
The production of a REACH Authorisation application as a sectoral consortium is very beneficial because it enables an optimization of the resources and the process costs for the concerned entities.
Indeed, the sectoral scale appears to be optimal for the realization of such a dossier as the challenges in terms of procedures, alternatives and economic impacts are relevant for all participants. In that context, a sectoral consortium enables to meet a relatively restricted number of companies and thus to produce a dossier finely presenting the specificity of each entity.
The anticipation of the inherent challenges of this type of organization enables to lift the potential difficulties related to the process and ensure an efficient participation of all participants.
EcoMundo & R2A
EcoMundo is a partner of the REACH Authorisation Alliance, R2A, an initiative that aims to create a forum for exchange and reflection on authorisation strategies. The working groups focus on specific substances and uses and the Alliance aims to optimise authorisation application strategies by submitting joint dossiers.
1. Reminder: REACH Authorisation and consortium
1.1. REACH Authorisation process
The Authorisation procedure is one of the chemical risk management options established by the REACH regulation at European scale.
It applies to substances identified as SVHCs (“Substances of Very High Concern”) and deemed to pose a serious threat to human health or the environment:
- CMR 1A and 1B: carcinogenic, mutagenic or toxic to reproduction
- PBT: persistent, bioaccumulative and toxic
- vBvP: very persistent and very bioaccumulative
- Substance of equivalent concern,, e.g. endocrine disruptors or respiratory sensitisers
The substances included in Annex XIV of REACH are subject to Authorisation and are due to see their use forbidden in the European Union within a short-term period (36 to 48 months after inclusion). REACH Authorisation is a temporary exemption for a specific substance and a specific use. Three exemption durations (“revision periods”) are generally considered: 4, 7 or 12 years.
Producing an application for Authorisation under REACH requires to characterize the risk generated by the use of the substance (Chemical Safety Report), to present in detail the potential alternatives to the substance as well as the substitution strategy (Analysis of Alternatives) and finally to carry out a comparative impact assessment of the continued use of the substance and its withdrawal (Socio-Economic Analysis).
1.2 Creating a consortium
When several companies have similar uses of chemical substances, as it can be the case within an industrial sector, a possibility exists to produce an application for Authorisation as a consortium. This organization is very interesting as it can enable to generate synergies between companies and thus optimize the resources and costs associated to an application for Authorisation.
1.3 The different steps to constitute a REACH Authorisation dossier under a consortium
The production of an application for Authorisation dossier via a consortium is a nine- to eighteen-month project.
However, such a process presents a set of challenges linked to the fact the members of the consortium may be competitors:
- Within which legal framework does the procedure takes place?
- How can confidentiality and data management be guaranteed?
- Which consortium organization to choose (instance and decision process, meeting time, tools and support, etc.)?
2. EcoMundo’s feedback: 5 tips to succeed in your application for Authorisation dossier under a consortium
Because of the challenges described above, the application for Authorisation implementation process under a consortium requires to set up some dispositions. This ensures an efficient participation of every member of the consortium, but also provides the overall process with an optimal legislative and organizational framework.
A legal and contractual framework is essential
The primary goal of an application for Authorisation process organized under a consortium is to bring distinct (and potentially competing) legal entities to exchange data and collaborate in order to build a common dossier. In that sense, the establishment of a consortium contract is a prerequisite to the application’s undertaking.
Such a contract enables to establish the consortium’s common goals, as well as the data confidentiality and management rules for the overall project.
On the other hand, it enables to formulate the group project organization: instances and decision mode, rules for entering or leaving the consortium, rules for cost-sharing, etc.
The consortium contract establishes the process legal framework, and enables to ensure good governance inside the workgroup, but also towards the external stakeholders and regulations in place (especially the respect of the competition law).
The consortium contract forms the working framework that is essential to distinct companies’ collaboration for the production of an application for Authorisation dossier.
Data confidentiality as a structuring element of the process: the importance of a consortium manager
A consortium brings together companies with similar uses of a substance which means that they are generally competitors. In order to enable an efficient participation of every consortium member, it is essential to establish rules about data confidentiality as soon as the project starts.
Two sections of the application for Authorisation dossier can mainly include sensitive elements in terms of data confidentiality: the Analysis of Alternatives and the Socio-Economic Analysis.
The objective of the Analysis of Alternatives is to present the alternatives considered for the replacement of the substance subject to Authorisation. A company’s research work on alternatives can thus constitute a major competitive edge in a competitive context, which would be lost in case of its disclosure inside the consortium.
The Socio-Economic Analysis especially aims to evaluate the impacts of the denial of an Authorisation (and thus, the substance’s use cessation) for the concerned companies. The resulting impact assessment thus relies on data consolidation finely characterizing the economic activity of the concerned companies. Because these data generally aren’t public, and since they can constitute strategic elements for the consortium members, their circulation inside the consortium can then be problematic.
In both cases it is necessary to define a consortium animator who plays a crucial role: to not only present the confidentiality challenges and suggest a common work strategy to the consortium members, but also to act as an intermediary or trusted third party in the data collection process. The consortium animator being the data collection focal point, he/she can guarantee the data confidentiality inside the consortium by ensuring that the data identified as confidential is never disclosed to the other members of the working group. This option is crucial because it enables to remove the bottlenecks on data confidentiality, thereby guaranteeing the project launch and collaboration of all participants.
Should the need arise, data confidentiality can then be guaranteed all along the project, until its submission to the European Chemicals Agency (ECHA).
It is highly recommended to define a manager for the consortium who acts as the project leader, process animator, but also guarantor of the exchanged data confidentiality.
The question of the defined use as a major project issue
The definition of the use of the substance is central in the production of an application for Authorisation. In the process, the use is mainly characterized by the functional properties and the requirements in terms of performance for the substance, but also by the progress in research for alternatives and the situation of the substitution process. From all these parameters results the revision period duration that will be sought-after.
In the context of a sectoral process, it is essential to exchange in the early stages of the project on these parameters, so as to identify the synergies or divergences between the uses of each company. The comprehension of the situation of every company on these criteria will enable to precisely define the parameter of the project, as well as the feasibility of a joint submission versus several individual submissions.
The definition of the uses applied for constitutes a key step of the application for Authorisation process, defining the scope of the project in terms of resources on the one hand, as well as the dossier global strategy on the other hand.
The articulation of the different decisional instances: operational and strategic levels
The production of an application for Authorisation dossier requires a wide range of data (description of the procedures and characterization of the chemical risk, presentation of the alternatives and the replacement process, characterization of the impacts of a substance’s use cessation, etc.), as well as strategic decision-making (consortium contract signature, identification of the dossier’s general strategy, choice of the submission mode, etc.)
In order to ensure the project’s progress, the project governance will mainly rely on two instances: the working group and the steering committee. The working group gathers the project leaders and experts and meets on a weekly basis; the steering committee is composed of the directors of the company and meets on a tri-monthly basis, for the main decision steps of the project.
The definition of the decisional instances of the project (working group and steering committee) and their good articulation are crucial to the construction of an application for Authorisation.
The choice of a submission mode, an important step to define the strategy
Two modes of submission are possible for an application for Authorisation produced by a consortium:
- The joint submission (one unique dossier submitted for all consortium members) enables to optimize the resources at best, by producing a unique dossier for all of consortium members
- The individual submission (one dossier submitted by each legal entity) enables to capitalize on a part of the contents produced by the consortium but enables better control over the dossier’s confidentiality, and requires more resources and implies increased ECHA fees
The choice of the decision mode doesn’t necessarily have to be made at the beginning of the project: it is possible to start the process, the data collection and the redaction of the common content, and then define if the submission will be carried out individually or jointly. The choice of the submission mode is a fundamental structural step for the form and the strategy of the dossier and is subject to a meeting of the steering committee.
The production of a REACH Authorisation application as a sectoral consortium is very beneficial because it enables an optimization of the resources and the process costs for the concerned entities.
Indeed, the sectoral scale appears to be optimal for the realization of such a dossier as the challenges in terms of procedures, alternatives and economic impacts are relevant for all participants. In that context, a sectoral consortium enables to meet a relatively restricted number of companies and thus to produce a dossier finely presenting the specificity of each entity.
The anticipation of the inherent challenges of this type of organization enables to lift the potential difficulties related to the process and ensure an efficient participation of all participants.
EcoMundo & R2A
EcoMundo is a partner of the REACH Authorisation Alliance, R2A, an initiative that aims to create a forum for exchange and reflection on authorisation strategies. The working groups focus on specific substances and uses and the Alliance aims to optimise authorisation application strategies by submitting joint dossiers.
