Budgeting for REACH Authorisation
The REACH Authorisation Application: a major project
The Authorisation procedure is described in Title VII of Regulation (EC) No 1907/2006; its objective is to ensure control of the risks associated with the use of the substances identified as of very high concern (SVHC) and listed in Annex XIV. After the Sunset Date, the use of an Annex XIV substances is banned in Europe. An authorisation application allows to extend the duration of use of the substance beyond that date.
Preparing an application for REACH Authorisation is a long, demanding project that involves all parties of the requesting company, and which requires a whole range of technical skills (scientific, toxicological, regulatory, socio-economic skills, knowledge on technical specificities related to the business of the authorisation applicant) due to the variety of arguments required.
It is necessary to collect, analyse and gather a large amount of data in the different parts of the dossier. The final document is supported by detailed arguments of several hundred pages (about 200 pages per use).
From EcoMundo's experience, the completion of the REACH Authorisation application (before submission) requires between 6 and 18 months. The authorisation application is then submitted to the European Chemicals Agency (ECHA) for evaluation. ECHA’s expert committees have 10 months to give their opinion, then forward it to the European Commission who will ultimately vote its decision, which will then be published in the Official Journal of the European Union.
Authorisation application: direct… and indirect costs
There are direct costs and indirect costs in completing the dossier.
- Direct costs:
- Cost of a consultant
- ECHA fees
- Indirect costs: Time spent internally on the project
The different cost items for the REACH Authorisation in detail
1/ Consultant costs (direct costs)
Due to the level of requirements of ECHA and the European Commission, and the variety of required areas of expertise, the completion of an application for authorisation requires the intervention of a panel of experts with various profiles.
For example, the EcoMundo REACH Authorisation team is composed of toxicologists, substance safety consultants, engineers and specialised chemists.
Consultant costs follow the authorisation application structure
Remember that the main purpose of the application for authorisation is to demonstrate that the risks associated with the use of the substance are controlled by the applicant.
An authorisation application must contain several parts: a chemical safety report, a socio-economic analysis and an analysis of alternatives.
NB: Several elements testify to the quality of a dossier and you can see an overview of the methodological elements which make the success of the EcoMundo’s dossiers here.
Consultant costs are evenly distributed according to the different parts of the dossier (CSR, AoA, SEA). A more detailed estimate is given in the table below.
Overview of consultant costs concerning the different stages of the dossier
This estimate remains intentionally broad, because depending on the scope of the Authorisation request, the number of substances and uses, the field of activity of the company, the budget (and the time required for the realization of the project) can vary a lot.
Key: The number of ‘€’ in the row of the table describes the amount of the budget to allocate to the corresponding item.
Project management €€€ Chemical Safety Report €€ Analysis of Alternatives €€ Socio-Economic Analysis €€ Submission of Application € DOSSIER TOTAL Between 80k€ and 150k€
2/ ECHA fees (direct costs)
When submitting an Authorisation application to ECHA, there is a fee payable to the European institution (which mainly covers the dossier evaluation carried out by ECHA’s experts).
These costs depend on the size of the company requesting the authorisation. The addition of a use, a substance, or a company (in the case of a joint application) within the same dossier is subject to additional fees.
consortium.jpg
All fees are detailed in the Official Journal of the European Union No 340/2008 of 16 April 2008, amended on 4 June 2015 by No 2015/864 from which are derived the costs given below.
ECHA fee calculator
Note: ECHA has developed a fee calculation tool based on the size of the company, the number of substances and uses, and the number of license applicants for the same dossier.
This calculator, is an Excel file, downloadable ici here for free.
3/ The time spent internally on the dossier (indirect costs)
Given the complexity of a REACH Authorisation Application, appointing an internal project manager for coordination is highly recommended. Other internal contributors will be solicited for data collection. The dossier requires several types of in-house functions (HSE, production, finance, R&D, marketing, etc.) as well as time anticipation for its realisation.
The resources to be allocated to the project depend on the scope, the number of contributors and the issues specific to the company's activity. As an indication, here is an idea of the distribution of these times internally according to the roles.
Cost items Internal project manager Internal contributors
- Project management
- Chemical Safety Report
- Analysis of Alternatives
- Socio-Economic Analysis
- Submission of application
Important note: the internal time needed to build the case can be optimised through the use of specific data collection tools such as those developed by EcoMundo experts.
Why deploy such resources for REACH Authorisation?
The evaluation of the dossiers by ECHA’s experts implies high-quality standards
ECHA experts are demanding in their assessment of the dossiers submitted, and involve two expert committees in this task: the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC), which give their respective opinions for the agency to make a decision.
- The RAC assesses risks to human health and the environment as well as the effectiveness of risk management measures.
- The SEAC assesses socio-economic factors and the impact on business, consumers and society as well as the viability of the substance substitution plan and information on alternatives provided by third parties.
The two committees have ten months to render their opinions, taking into account the application, the comments made during the public consultation and the information gathered on the alternatives. Note that it is not ECHA but the European Commission who decides whether Authorisation is granted or not.
Conclusion: only a high quality dossier makes it possible to obtain the requested duration
Experience has shown that if the authorisation to temporarily use the substance is generally granted after the evaluation of the dossier, there is no guarantee that the European Commission will issue the requested authorisation period…
The quality and specificity of the arguments developed in the dossier are key to obtaining a period of authorisation in line with the expectations of the applicant.
Budgeting for REACH Authorisation
The REACH Authorisation Application: a major project
The Authorisation procedure is described in Title VII of Regulation (EC) No 1907/2006; its objective is to ensure control of the risks associated with the use of the substances identified as of very high concern (SVHC) and listed in Annex XIV. After the Sunset Date, the use of an Annex XIV substances is banned in Europe. An authorisation application allows to extend the duration of use of the substance beyond that date.
Preparing an application for REACH Authorisation is a long, demanding project that involves all parties of the requesting company, and which requires a whole range of technical skills (scientific, toxicological, regulatory, socio-economic skills, knowledge on technical specificities related to the business of the authorisation applicant) due to the variety of arguments required.
It is necessary to collect, analyse and gather a large amount of data in the different parts of the dossier. The final document is supported by detailed arguments of several hundred pages (about 200 pages per use).
From EcoMundo's experience, the completion of the REACH Authorisation application (before submission) requires between 6 and 18 months. The authorisation application is then submitted to the European Chemicals Agency (ECHA) for evaluation. ECHA’s expert committees have 10 months to give their opinion, then forward it to the European Commission who will ultimately vote its decision, which will then be published in the Official Journal of the European Union.
Authorisation application: direct… and indirect costs
There are direct costs and indirect costs in completing the dossier.
- Direct costs:
- Cost of a consultant
- ECHA fees
- Indirect costs: Time spent internally on the project
The different cost items for the REACH Authorisation in detail
1/ Consultant costs (direct costs)
Due to the level of requirements of ECHA and the European Commission, and the variety of required areas of expertise, the completion of an application for authorisation requires the intervention of a panel of experts with various profiles.
For example, the EcoMundo REACH Authorisation team is composed of toxicologists, substance safety consultants, engineers and specialised chemists.
Consultant costs follow the authorisation application structure
Remember that the main purpose of the application for authorisation is to demonstrate that the risks associated with the use of the substance are controlled by the applicant.
An authorisation application must contain several parts: a chemical safety report, a socio-economic analysis and an analysis of alternatives.
NB: Several elements testify to the quality of a dossier and you can see an overview of the methodological elements which make the success of the EcoMundo’s dossiers here.
Consultant costs are evenly distributed according to the different parts of the dossier (CSR, AoA, SEA). A more detailed estimate is given in the table below.
Overview of consultant costs concerning the different stages of the dossier
This estimate remains intentionally broad, because depending on the scope of the Authorisation request, the number of substances and uses, the field of activity of the company, the budget (and the time required for the realization of the project) can vary a lot.
Key: The number of ‘€’ in the row of the table describes the amount of the budget to allocate to the corresponding item.
Project management €€€ Chemical Safety Report €€ Analysis of Alternatives €€ Socio-Economic Analysis €€ Submission of Application € DOSSIER TOTAL Between 80k€ and 150k€
2/ ECHA fees (direct costs)
When submitting an Authorisation application to ECHA, there is a fee payable to the European institution (which mainly covers the dossier evaluation carried out by ECHA’s experts).
These costs depend on the size of the company requesting the authorisation. The addition of a use, a substance, or a company (in the case of a joint application) within the same dossier is subject to additional fees.
consortium.jpg
All fees are detailed in the Official Journal of the European Union No 340/2008 of 16 April 2008, amended on 4 June 2015 by No 2015/864 from which are derived the costs given below.
ECHA fee calculator
Note: ECHA has developed a fee calculation tool based on the size of the company, the number of substances and uses, and the number of license applicants for the same dossier.
This calculator, is an Excel file, downloadable ici here for free.
3/ The time spent internally on the dossier (indirect costs)
Given the complexity of a REACH Authorisation Application, appointing an internal project manager for coordination is highly recommended. Other internal contributors will be solicited for data collection. The dossier requires several types of in-house functions (HSE, production, finance, R&D, marketing, etc.) as well as time anticipation for its realisation.
The resources to be allocated to the project depend on the scope, the number of contributors and the issues specific to the company's activity. As an indication, here is an idea of the distribution of these times internally according to the roles.
Cost items Internal project manager Internal contributors
- Project management
- Chemical Safety Report
- Analysis of Alternatives
- Socio-Economic Analysis
- Submission of application
Important note: the internal time needed to build the case can be optimised through the use of specific data collection tools such as those developed by EcoMundo experts.
Why deploy such resources for REACH Authorisation?
The evaluation of the dossiers by ECHA’s experts implies high-quality standards
ECHA experts are demanding in their assessment of the dossiers submitted, and involve two expert committees in this task: the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC), which give their respective opinions for the agency to make a decision.
- The RAC assesses risks to human health and the environment as well as the effectiveness of risk management measures.
- The SEAC assesses socio-economic factors and the impact on business, consumers and society as well as the viability of the substance substitution plan and information on alternatives provided by third parties.
The two committees have ten months to render their opinions, taking into account the application, the comments made during the public consultation and the information gathered on the alternatives. Note that it is not ECHA but the European Commission who decides whether Authorisation is granted or not.
Conclusion: only a high quality dossier makes it possible to obtain the requested duration
Experience has shown that if the authorisation to temporarily use the substance is generally granted after the evaluation of the dossier, there is no guarantee that the European Commission will issue the requested authorisation period…
The quality and specificity of the arguments developed in the dossier are key to obtaining a period of authorisation in line with the expectations of the applicant.
