The examples illustrate different practices of how applications for authorisation under REACH have been prepared. The analysis, submitted by DOMO Caproleuna GmbH for Trichloroethylene, represents an example of a downstream user analysis of alternatives.
ECHA summarizes the Analysis as follows: … applicant provides a concise summary of substance function based on a series of technical criteria. The assessment of the technical feasibility of alternative substances is then assessed against these criteria. The methodology and data used for the assessment of economic feasibility are set out. Conclusions are linked to the analysis and the applicant makes good use of summary tables.
The list of examples of socio-economic analyses and analyses of alternatives is available from ECHA’s website.
Under REACH Authorisation of chemical substances, Analysis of Alternatives aims to demonstrate that no alternative is appropriate, technically and economically feasible, less risky and available. All applications for Authorisation must include an analysis of alternatives.
Since ReachCentrum’s acquisition in June 2015, ReachCentrum and ERM have combined their technical and management expertise to support industry under REACH Authorisation. Services include Regulatory advice, Strategic planning, Communication facilitation (supply chain, data access), Application for Authorisation and Review of documents, Analysis of Alternatives and Socio Economic Analysis, and also setting up interest groups, taskforces and consortia to serve a common goal for Registration and Evaluation, and Authorisation. For further information, contact Cornelia Tietz at [email protected] and visit ReachCentrum’s website at http://www.reachcentrum.eu/services.html.
Authorisation is the REACH process related to controlling the risk of substances of very high concern (SVHC) by authorising just specific uses.
The authorisation process aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where technically and economically feasible alternatives are available.
Substances on the Authorisation List (annex XIV) cannot be placed on the market or used after the so called “sunset date” - unless an authorisation has been granted for a specific use, or the use has been exempted from authorisation.
Your substance has been selected as substance of potential concern. How can you prepare and follow all necessary steps ? How to organise your comments? What would be the best approach to have your uses authorised?
Those are some of the questions the ReachCentrum Authorisation Support Service can help you address. The main objective of the Authorisation Support Service is to assist your company in performing all the procedures and tasks necessary prior and within the framework of a REACH authorisation process.
Six manufacturers of sodium chlorate (Akzo Nobel, Arkema, Ecros, Electroquímica de Hernani, Kemira and Solvay ) have set up the sodium dichromate authorisation consortium to authorize their downstream use of sodium dichromate as a processing aid in the sodium chlorate process.
Ingrid Brassart, chairperson of the authorisation consortium from Akzo Nobel:
“ReachCentrum was selected first as the consortium secretariat based on its experience with consortia management, more particular relating to in financial and communication aspects but also due to their knowledge of REACH authorisation process as such. During the preparation for application ReachCentrum has proven to be very supportive in translating between the language of pure technical service providers and the understanding of our group. Also in reviewing documents for the application, ReachCentrum’s input is very helpful.”
The Lead registrant and a company specialized in the production and marketing of foaming agent formulations have taken action in setting up an ad-hoc taskforce due to the speedy and unexpected entry of ADCA into the authorisation scheme. The Asian manufacturers were not aligned to answer to this kind of regulatory process and their European downstream industries were largely not prepared for it. Representatives of both groups recognizing the urgency and wanting to have a more direct involvement was the main reason why the Taskforce joining all parties was set up.
ReachCentrum was approached in March 2013, the taskforce held its kick-off meeting in May and has meanwhile over 50 members. A first milestone was the submission of a consolidated and technical input to the public consultation on prioritization in September 2013 and the following awareness raising amongst member states.
ReachCentrum was selected by the founders due to its long experience in managing consortium and its close relation with Cefic and authorities. The Taskforce management as well as advocacy abilities were appreciated during the selection process.
Role of ReachCentrum
Next to managing the Taskforce by taking care of all administrative, financial and communication issues as well as organizing the meetings not only formally but also content-wise , ReachCentrum is also leading the technical issues by contacting and contracting the technical experts necessary. Last but not least organizing ReachCentrum is playing a major role when it comes to coordinating the awareness raising in member States, the EU Commission and aligning with other involved sectorial associations.
Eight founding members of the HBCDD in EPS consortium submitted successfully a joint Application for Authorisation. The eight submitting members of the consortium, set-up at the beginning of 2013 are: Ineos Styrenics, Monotez S.A., StyroChem Finland Oy, Sunpor Kunststoff GmbH Austria, Synbra Technology B.V., Synthos S.A., Unipol Holland B.V. and Versalis S.p.A. These companies submitted jointly 13 applications for two uses.
The consortium’s aim is to obtain a bridging authorisation for the continued safe use of HBCDD in EPS, until an identified alternative is commercially available in adequate quantities, together with the necessary technical and certification approvals. This is to allow sufficient time for a smooth transition away from HBCDD without market disturbance.
ReachCentrum offered a “one stop shop” approach together with the Technical Service Providers Peter Fisk Associates Ltd. and eftec. ReachCentrum was selected based on its well recognized experience with consortium management, financial administration and communication. The technical service providers brought historical knowledge on REACH and HBCDD to the members as well as an understanding of structure and content for Authorisation dossiers.
Role of ReachCentrum
In addition to managing the consortium and taking care for all financial administration, ReachCentrum was the focal point in the contact between ECHA and the members of the consortium. ReachCentrum was also the “Trustee” for the members. The role as “Trustee” was of added value in making the decision half-way of the dossier preparation to go for a “Joint Application”.
Once the documents for the AfA were finalized and ready for submission, ReachCentrum did the actual submission on behalf of the Lead Applicant and the 12 other co-applicants. The actual submission of the Application was done in close cooperation with ECHA to ensure a successful process. The Application of the HBCDD dossier was the first Joint Application received by ECHA.
REACH requires strategic thinking to get your company ready to pass the various phases of the legislation. ReachCentrum offers REACH expert consultancy to support REACH implementation within companies and other stakeholder groups, in order to help you adopt the most effective strategy.
ReachCentrum has gained a highly respected reputation in delivering consultancy on chemicals regulation. Our focus is on providing practical advice and guidance for those companies needing to fulfil their REACH obligations, whilst fully respecting your business strategy.
ReachCentrum‘s approach is to listen to and carefully analyse each customers’ needs, and then to find the best solution adapted to their requirements and fine tune the support needed throughout the registration, evaluation and authorisation phases of REACH.
Our service covers:
The European Chemicals Agency (ECHA) has released a preconfigured version of IUCLID 5, to help companies prepare applications for authorisation (AfA). Running on Microsoft Windows computers, without the need to install any other software, it is dedicated to those companies that do not yet have IUCLID 5 installed, particularly small and medium-sized companies (SMEs). The Preconfigured IUCLID 5 for AfA supplies partially pre-filled datasets for the substances in the Authorisation List. The new release doesn’t replace the most recent version of IUCLID 5 or existing installations, which can still be used to prepare dossiers for applications for authorisation, warns ECHA. More information is available in ECHA website.