What is REACH Authorisation?
According to REACH regulation, a dangerous substance can be banned by the authorities if the risks it presents cannot be contained. Authorities can also decide to limit its use or submit it to prior approval.
Thus, Annex XIV or “list of substances submitted to Authorisation” gathers the substances whose dangers for human health and/or the environment are severe and verified and whose use then becomes banned from a certain date onwards, unless you have a temporary use Authorisation granted by ECHA, after the submission of an Authorisation application dossier.
Therefore, the Authorisation procedure aims at making sure that SVHCs are progressively replaced by other substances or technologies less dangerous when economically and technically appropriate substitutions exist.
The Analysis of Alternatives
The Analysis of Alternatives (or AoA) exhaustively presents substitution solutions for a given substance. It is divided into five parts:
- First part - Summary
- Second part - Description of the service provided by the substance
- Third part - Identification of possible alternatives
- Forth part - Description of the adaptability and availability of the alternatives
- Fifth part - Conclusion of the report
What components for a convincing Analysis of Alternatives?
The methodology recommended by EcoMundo in terms of AoA in an Authorisation dossier aims at capitalising on the expertise and experience of the company submitting the dossier. Thus, the description of the substitution processes considered by the applicant, mostly relies on the company’s internal resource expertise (in R&D and innovation) in order to demonstrate the unavailability of an alternative solution
It appears that the Analysis of Alternatives aims at demonstrating the non-feasibility of known alternatives and then defining a non-use scenario. In that way, the AoA plays a key role in the dossier by justifying the length of Review period asked and sets the scene for the reasoning that will be developed in the socio-economic analysis.
4 key aspects
The determination of the substance's function
The definition of the substance function constitutes a fundamental element of the Analysis of Alternatives and contains, among other things, a presentation of the functional properties and levels of performance expected to be achieved by the substance.
The identification and description of the potential alternatives
This step requires an inventory of the potential alternatives, the study of their availability and feasibility (both technically and economically) as well as their risk level for human health and the environment. All this has to be dealt with alongside the client.
Select the most probable alternatives and focus on them in the AoA
This step participates in the demonstration of the efforts specifically made for a product and its use in terms of substitution; whether they are in progress or even envisioned. This entails a description of the R&D trials or even a calendar of full substitution of said substance.
More specifically, this third point will have to be debated through the following elements:
- Logistic and technical (or even economic) elements standing for the difficulty - or impossibility - to substitute.
- In the context of already organised work of substitution by the company, the reasons why the trials failed or could possibly fail, the path potentially selected or the other one, now intended.
- The chronology of substitution in order to determine the intended period for the full substitution of the substance, which includes the time allocated to R&D steps, technical, toxicological and economic validation of the substitution and the industrialisation of the process.
Anticipate the phase of comments on the alternatives
After you submit your Authorisation dossier, the latter will be evaluated by the Risk Assessment Committee (RAC) and the Socio-economic Analysis Committee (SEAC) and be submitted to a public consultation during eight weeks. The public version of your dossier will be available on ECHA’s website during that period and all the stakeholders (general public, NGOs, National Healthcare Agencies, competing companies or companies from the same line of business etc.) will therefore be able to leave comments. These comments, as well as your potential replies, will also be published on ECHA’s website.
On the whole, to be fully prepared for this part of the dossier, you should define the essential performance criteria fulfilled by the substance’s function so as to anticipate the potential proposals of alternatives by other parties that could emerge during this period of public consultation. By exhaustively defining the functions and performances expected by the substance, it will be easier for you to demonstrate that – despite the extensive research you have conducted – you did not manage to find a suitable substitution that would perfectly adapt to all the criteria fulfilled by the current substance and that the proposal of alternative that is being submitted to you is not appropriate either.
Want to know more about the Analysis of Alternatives?
For more information on REACH Authorisation, do not hesitate to contact our expert Mrs. Maryon Pailleux by phone at: +33 1 83 64 20 54 for Europe or +1 (778) 234 1607 for North America or by email at [email protected]
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