REACH authorization: 4 key lessons for a successful Alternatives Analysis
The REACH regulation allows companies to apply for authorization in order to continue using substances included in the Authorization List. The Analysis of Alternatives is a crucial step in creating your Authorization file. EcoMundo shares 4 key lessons with you to successfully complete your analysis.
What is the REACH authorization?
According to the REACH regulation, a dangerous substance may be prohibited by the authorities if the risks it presents cannot be controlled. Authorities may also decide to restrict a use or to subject it to prior authorization.
So, theAnnex XIV or” List of substances subject to authorization ” includes substances whose dangers to human health and/or the environment are severe and proven and whose use is therefore prohibited from a certain date, unless they have obtained a Temporary use authorization granted by ECHA, following the submission for evaluation of an application file.
The purpose of the Authorization procedure is therefore to ensure that SVHCs are gradually replaced by other less dangerous substances or technologies when economically and technically viable alternatives exist.
The Analysis of Alternatives
The Analysis of Alternatives (or AoA) comprehensively presents the alternatives for the substance concerned. It consists of five parts:
- Part 1 - Summary
- Part 2 - Description of the service provided by the substance
- Part 3 - Identifying possible alternatives
- Part 4 - Description of the suitability and availability of alternatives
- Part 5 - Conclusion of the report
What are the elements for a convincing Alternative Analysis?
The methodology that EcoMundo recommends and applies in terms of AoA in an Authorization file aims to capitalize on the expertise and experience of the company who submits the file. The description of the substitution processes envisaged by the applicants is based largely on the expertise of internal resources (Research and Development, innovation) for demonstrate the unavailability of an alternative solution.
The Analysis of Alternatives therefore aims to demonstrate the non-feasibility of known alternatives and then to define the “non-use” scenario. In this sense, the AoA plays a pivotal role in the case by justifying the duration of the requested “Review period” and by laying the foundations of the reasoning that will be developed in the Socio-Economic Analysis.
4 key lessons
Determining the function of the substance
The definition of the function of the substance is a fundamental element of the Analysis of Alternatives and includes in particular a presentation of the functional properties and expected performance levels of the substance.
Identifying and describing potential alternatives
This stage involves carrying out an inventory of potential alternatives, studying their availability, feasibility (technical and economic) and their level of risk for human health and the environment. All this, in collaboration with the customer.
Select the most likely alternatives and focus on them in AoA
This step is used to demonstrate the substitution efforts made, in progress, or even envisaged that are specific to the product and to the use in question. This therefore requires a description of R&D tests or a schedule for total substitution of the substance.
More specifically, this third point should be argued using the following elements:
- Of logistical and technical elements (or even economic) justifying the difficulty - or the impossibility - of substituting.
- As part of replacement work already carried out by the company, the reasons why the trials may have failed or could fail, the path potentially chosen or the other now being considered.
- La substitution chronology, in order to define the duration envisaged for the total substitution of the substance, which includes in particular those relating to the R&D stages, to the technical, toxicological and economic validation of the solution, and to the industrialization of the process
Anticipate the phase of commenting on alternatives
After the submission of your Authorization file and in parallel with the evaluation work by the RAC (Risk Assessment Committee) and SEAC (Socio-Economic Analysis Committee) Committees, your file will be submitted to a public consultation for eight weeks. The public version of your file will therefore be available on the ECHA website during this period, and the various stakeholders (general public, NGOs, National Health Agencies, competing companies or companies in the same sector, etc.) will therefore be able to leave comments. These, as well as any answers you may have, will also be published on the ECHA website.
Therefore, to properly prepare for this phase of the case, it is necessary to Define the essential performance criteria fulfills the function of the substance in order to anticipate possible alternative proposals by external third parties that may emerge during this period of public consultation. By precisely and comprehensively defining the functions and performances expected of the substance, it will be easier for you to demonstrate that — despite the extensive research you have carried out — you have not been able to find a substitution that perfectly fits all the criteria met by the current substance and that the alternative proposal that is being made to you is also not appropriate.
Do you want to know more about AoA?
For more information on the REACH Authorization, do not hesitate to contact our experts.
The REACH regulation allows companies to apply for authorization in order to continue using substances included in the Authorization List. The Analysis of Alternatives is a crucial step in creating your Authorization file. EcoMundo shares 4 key lessons with you to successfully complete your analysis.
What is the REACH authorization?
According to the REACH regulation, a dangerous substance may be prohibited by the authorities if the risks it presents cannot be controlled. Authorities may also decide to restrict a use or to subject it to prior authorization.
So, theAnnex XIV or” List of substances subject to authorization ” includes substances whose dangers to human health and/or the environment are severe and proven and whose use is therefore prohibited from a certain date, unless they have obtained a Temporary use authorization granted by ECHA, following the submission for evaluation of an application file.
The purpose of the Authorization procedure is therefore to ensure that SVHCs are gradually replaced by other less dangerous substances or technologies when economically and technically viable alternatives exist.
The Analysis of Alternatives
The Analysis of Alternatives (or AoA) comprehensively presents the alternatives for the substance concerned. It consists of five parts:
- Part 1 - Summary
- Part 2 - Description of the service provided by the substance
- Part 3 - Identifying possible alternatives
- Part 4 - Description of the suitability and availability of alternatives
- Part 5 - Conclusion of the report
What are the elements for a convincing Alternative Analysis?
The methodology that EcoMundo recommends and applies in terms of AoA in an Authorization file aims to capitalize on the expertise and experience of the company who submits the file. The description of the substitution processes envisaged by the applicants is based largely on the expertise of internal resources (Research and Development, innovation) for demonstrate the unavailability of an alternative solution.
The Analysis of Alternatives therefore aims to demonstrate the non-feasibility of known alternatives and then to define the “non-use” scenario. In this sense, the AoA plays a pivotal role in the case by justifying the duration of the requested “Review period” and by laying the foundations of the reasoning that will be developed in the Socio-Economic Analysis.
4 key lessons
Determining the function of the substance
The definition of the function of the substance is a fundamental element of the Analysis of Alternatives and includes in particular a presentation of the functional properties and expected performance levels of the substance.
Identifying and describing potential alternatives
This stage involves carrying out an inventory of potential alternatives, studying their availability, feasibility (technical and economic) and their level of risk for human health and the environment. All this, in collaboration with the customer.
Select the most likely alternatives and focus on them in AoA
This step is used to demonstrate the substitution efforts made, in progress, or even envisaged that are specific to the product and to the use in question. This therefore requires a description of R&D tests or a schedule for total substitution of the substance.
More specifically, this third point should be argued using the following elements:
- Of logistical and technical elements (or even economic) justifying the difficulty - or the impossibility - of substituting.
- As part of replacement work already carried out by the company, the reasons why the trials may have failed or could fail, the path potentially chosen or the other now being considered.
- La substitution chronology, in order to define the duration envisaged for the total substitution of the substance, which includes in particular those relating to the R&D stages, to the technical, toxicological and economic validation of the solution, and to the industrialization of the process
Anticipate the phase of commenting on alternatives
After the submission of your Authorization file and in parallel with the evaluation work by the RAC (Risk Assessment Committee) and SEAC (Socio-Economic Analysis Committee) Committees, your file will be submitted to a public consultation for eight weeks. The public version of your file will therefore be available on the ECHA website during this period, and the various stakeholders (general public, NGOs, National Health Agencies, competing companies or companies in the same sector, etc.) will therefore be able to leave comments. These, as well as any answers you may have, will also be published on the ECHA website.
Therefore, to properly prepare for this phase of the case, it is necessary to Define the essential performance criteria fulfills the function of the substance in order to anticipate possible alternative proposals by external third parties that may emerge during this period of public consultation. By precisely and comprehensively defining the functions and performances expected of the substance, it will be easier for you to demonstrate that — despite the extensive research you have carried out — you have not been able to find a substitution that perfectly fits all the criteria met by the current substance and that the alternative proposal that is being made to you is also not appropriate.
Do you want to know more about AoA?
For more information on the REACH Authorization, do not hesitate to contact our experts.
