EcoMundo is the French market leader for Authorisation. The company has developed a unique methodology aimed at optimising the ability of Authorisation applications to obtain the required review period from the European authorities.

 

REACH AUTHORISATION DOSSIER

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 15 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.

CREATING AND MANAGING AN AUTHORISATION CONSORTIUM

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.

DEFENCE EXEMPTION ASSESSMENT AND DRAFT OF THE REQUEST

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

REGULATORY PLANNING: IDENTIFY THE SUBSTANCES AT RISK

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 could 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.

REACH AUTHORISATION 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.

Our experts:

  • 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.

AFTER THE AUTHORISATION: BECOME AND REMAIN COMPLIANT

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.

Our experts:

  • 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 conduct thorough on-site audits. About ten companies with an Authorisation or covered by an upstream Authorisation have already requested this compliance update in order to be prepared for inspections.

FOCUS: REGULATORY NEWS ON CHROMIUM VI

What are your obligations following the upcoming decision of the European Commission on the authorisation periods of different compounds of Chromium VI?

  • Notify your uses of Chromium VI to ECHA
  • Ensure that your uses comply with the operating conditions and risk management measures of the Chemical Safety Report (CSR) filed by upstream applicants.
  • Prepare your demonstration of compliance in case of control by the authorities.

Thanks to its experience in Chromium VI Authorisation dossiers, EcoMundo can assist you in all the steps mentioned above.