EcoMundo’s unique methodology for REACH Authorisation success has ensured that all the
dossiers submitted since 2015 have obtained the review periods requested of the European
authorities, without any restrictions or exceptions. See the keys to our success.
The Chemical Safety Report requires a detailed description of the potential exposures of the substance concerned when used as described in the application. The report must contain two key items:
To produce this document, our experts rely solely and systematically on visits to the sites concerned. This approach enables producing the necessary descriptions of every stage in the processes concerned, thereby producing a realistic and representative model of the potential exposures. It is this intimate knowledge of the processes and the facilities that enables generating recommendations designed to reduce the level of risk. To optimise the entire process, our experts have developed a specific set of tools dedicated to data collection.
Finally, as the characterisation of the risk is a key component of the Chemical Safety Report, our toxicology and eco-toxicology experts have developed vast experience in the use of the various exposure modelling tools, for operating personnel and the general public alike.
The Analysis of Alternatives (AoA) has two main objectives:
DESCRIPTION OF THE SUBSTITUTION PROCESS AND POTENTIAL ALTERNATIVE SOLUTIONS
The description of the substitution processes relies on the expertise of our experienced internal staff (Research & Development, innovation) to demonstrate the lack of availability of any alternative solution. Therefore, EcoMundo carefully creates and structures the technical arguments that are necessary to meet ECHA’s requirements in the detailed terms requested. The information provided by the company is systematically assessed against the state of the art in terms of knowledge and understanding (expert opinions, scientific publications, etc.) in order to be sure of the strength of the arguments.
DEFINITION OF THE ‘NON-USE’ SCENARIO
This scenario is the reference assessment of the socio-economic impacts that an Authorisation refusal may potentially produce. Such impacts are compared with those generated by a ‘Use’ scenario in order to generate the Socio-economic Analysis.
The definition of the ‘non-use’ scenario is thus crucial for an Authorisation application. The work on this subject is carried out in close collaboration with the company’s strategy departments so as to have the most realistic scenario, which will be based on both strategic and financial arguments.
The Socio-economic Analysis aims at providing a cost-benefit study of what is at stake with the Authorisation application. To achieve this, specific techniques are used to put a monetary value on the costs and benefits resulting from an Authorisation.
To produce a solid analysis, EcoMundo has developed specific methodologies to evaluate the impact on the environment and on human health based on the recommendations from ECHA and the OECD.
There are two components for assessing the impacts resulting from cessation of using the substance:
A QUANTITATIVE ASSESSMENT
This can be carried out for most of the direct impacts on the company, such as loss of revenue or cancelled investments , for instance. Such costs will be used to calculate the cost-benefit ratio and provide the strategic elements on which the ECHA’s Expert Committees. will focus their attention. The assessment methods used by EcoMundo are based on recognised institutional and academic sources..
Qualitative arguments can be used to clarify the analysis using other impacts resulting from a possible Authorisation refusal. It is often quite difficult to put a monetary value on some of these elements - regulatory problems, running costs, indirect impact on employment, etc. Thus, to be taken into proper consideration, and to influence the Committees’ decisions, such elements need to be very clearly justified, if possible using previous similar experiences and/or the results of a concrete example.
To provide the most accurate and relevant content possible to meet the requirements of the Assessment Committees , and at the same time optimising the company resources used, EcoMundo has developed a set of dedicated data collection tools. These are designed to provide an exhaustive picture of the data to be collected as well as a means of monitoring progress in the collection process.
The tools are major items in managing the project and enable an effective reduction in the workload and resources required to produce a solid dossier for the Authorisation application.