An Authorisation or defence Exemption diagnosis?
An individually drafted Authorisation dossier?
An Authorisation dossier drafted with other parties?
To anticipate inspections regarding your dossier?
EcoMundo is the French market leader for Authorisation and offers you complete support, throughout your whole project, including before the Community authorities or, in the case of defence exemption dossiers, before national authorities.
After nearly a dozen dossiers submitted to ECHA, EcoMundo has accumulated a huge know-how in Authorisation dossier production, whether the application is individual, joint, within a consortium or through an Only Representative.
Find out more about EcoMundo's Authorisation services:
The purpose of the REACH Authorisation dossier is to convince the appropriate authorities to grant your company an Authorisation for one or several uses of a given substance.
Our experts prepare your Authorisation application and plead your case with the European Chemicals Agency (ECHA).
For EcoMundo, the key points for an Authorisation are the following:
- Facilitate the interactions between the various partners and technical areas using dedicated tools and methodologies
- Ensure confidentiality for your data (sensitive information)
- Elaborate a tailor-made dossier reflecting your industrial requirements.
With already more than 10 Authorisation dossiers submitted, and almost as many in progress, EcoMundo is considered as an expert in the running of long and complex projects. 100% of the requests submitted since 2015 have been granted the review periods sought (including ‘long’ ones of 12 years), compared to 48% of all dossiers submitted at the European scale.
Submitting a REACH Authorisation request in a consortium optimises costs and resources between several entities when preparing the dossier for an Authorisation application.
Our experts enable you to:
- Create or join a consortium in order to prepare an Authorisation dossier common to several entities
- Optimise costs and resources by making the most of the synergy between consortium members
- Ensure confidentiality of information for each member of the consortium
- Rely on a consortium management expertise
EcoMundo recently helped the Connector’s Manufacturers Group (CMG) Consortium - which gathers companies from the Defence and Aeronautics sectors - with their Authorisation dossier for 3 different uses of Chromium (VI) in a number of their European production facilities. The dossier, submitted in February 2017, received a favourable vote from the European Commission in March 2018, bestowing it all three requested review periods.
For the defence exemption procedure, our experts help you:
- Analyse your situation to check for eligibility for defence exemption, or any other form of exemption, (e.g. Intermediate substances, ‘Scientific Research & Development’ exemption)
- Draft one or two sub-dossiers for a defence exemption request: ‘Risk management’ and ‘Defence interest’
- Plead the case for a defence exemption suited to both your situation and the national defence interest
Did you know that, by studying your portfolio of substances, you could predict which substances may undergo regulatory bans or restrictions?
Once these substances are identified, you can set up an action plan to try to prevent any such prohibition or restriction being a threat to your activity.
To find out how, go to our Substance Securing page.
Every year, EcoMundo carries out the regulatory analysis of hundreds of substances, over a 10 years’ horizon, for companies wanting to understand the legislation likely to affect the chemicals they either use or manufacture. Such a study may be complemented by a toxicological assessment.
A REACH Authorisation assessment enables you to evaluate the need and the feasibility of submitting an application before deciding to launch into the process.
This will provide all the elements required to make the right decision, in the form of a strategic document.
- Analyse your situation regarding REACH Authorisation
- Recommend a “Go/No go” concerning Authorisation
- Advise the preferred strategic route to take in the Authorisation request
- Assess the required resources
Currently, EcoMundo is helping some twenty organisations across Europe develop their strategy in these areas: Authorisation Request, review report, strategy for submitting the dossier, etc.
Once in possession of the REACH Authorisation granted by the European authorities, you need to be in a position to demonstrate, in the event of any inspection by national authorities (DREAL), that your activities are compliant with the conditions of Authorisation.
- Assess your compliance with the operational conditions and risk management procedures of an Authorisation dossier submitted in order to be compliant in case of inspection by national authorities
NB: this compliance is above all valid for companies that are covered by an Authorisation dossier dealing with the supply chain as a whole.
- Ensure compliance
EcoMundo travels throughout the European Union to carry out thorough on-site audits. Some ten companies with an Authorisation or covered by an upstream Authorisation have already requested this compliance update in order to be prepared for inspections.